CEL SCI CORP
10-Ks and 10-Qs
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FORM
10-K
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
(Mark
One)
(X)
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For the fiscal year
ended September 30, 2016.
OR
( )
TRANSITION REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For the transition
period from _________ to __________.
Commission file
number 1-11889
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CEL-SCI
CORPORATION
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(Exact name of
registrant as specified in its charter)
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COLORADO
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84-0916344
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(State or other
jurisdiction of incorporation or organization)
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(I.R.S. Employer
Identification No.)
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8229 Boone Blvd.,
Suite 802
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Vienna,
Virginia
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22182
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(Address of
principal executive offices)
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(Zip
Code)
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Registrant's
telephone number, including area code: (703) 506-9460
Securities
registered pursuant to Section 12(b) of the Act: None
Securities
registered pursuant to Section 12(g) of the Act:
Common Stock, $.01 par
value
Series S Warrants
(Title of
Class)
Indicate by check
mark if the registrant is a well-known seasoned issuer, as defined
in Rule 405 of the Securities
Act. [ ]
Indicate by check
mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Act. [ ]
Indicate by check
mark whether the registrant (1) has filed all reports required to
be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period
that the registrant was required to file such reports), and (2) has
been subject to such filing requirements for the past 90
days. Yes
[X] No
[ ]
Indicate by check
mark whether the registrant has submitted electronically and posted
on its corporate Web site, if any, every Interactive Data File
required to be submitted and posted pursuant to Rule 405 of
Regulation S-T (§232.405 of this chapter) during the preceding
12 months (or for such shorter period that the registrant was
required to submit and post such
files). Yes [X]
No [ ]
Indicate by check
mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K is not contained herein, and will not be
contained, to the best of
Registrant's knowledge, in definitive proxy
or information statements incorporated by reference in
Part III of this Form 10-K or any amendment to this Form 10-K.
[X]
Indicate by check
mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See the definitions of “large accelerated
filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange
Act.
Large accelerated
filer [
] Accelerated
filer [ X]
Non-accelerated
filer [ ] (Do not check if a smaller
reporting
company)
Smaller reporting company [ ]
Indicate by check
mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act): [ ]
Yes [X] No
The aggregate
market value of the voting stock held by non-affiliates of the
Registrant, based upon the closing sale price of the
registrant’s common stock on March 31, 2016, as quoted on the
NYSE MKT, was $60,807,407.
As of December 9,
2015, the Registrant had 188,724,407 issued and outstanding shares
of common stock.
Documents
Incorporated by Reference: None
CEL-SCI
is focused on finding the best way to activate the immune system to
fight cancer and infectious diseases. Its lead investigational
therapy Multikine® (Leukocyte Interleukin, Injection) is
currently in a pivotal Phase 3 clinical trial involving head and
neck cancer, for which CEL-SCI has received Orphan Drug Status from
the U.S. FDA. If the primary endpoint of this global study is
achieved, the results will be used to support applications to
regulatory agencies around the world for worldwide commercial
marketing approvals as a first line cancer therapy. Additional
clinical indications for Multikine include cervical dysplasia in
HIV/HPV co-infected women, for which a Phase 1 study was
successfully concluded; and the treatment of peri-anal warts in
HIV/HPV co-infected men and women.
CEL-SCI’s
immune therapy, Multikine, is being used in a different way than
immune therapy is usually used. It is administered locally to treat
local tumors or infections and it is given before any other therapy
has been administered.
For
example,
i
n the Phase 3
clinical trial, Multikine is given locally at the site of the tumor
as a first line of treatment before surgery, radiation and/or
chemotherapy because that is when the immune system is thought to
be strongest. The goal is to help the intact immune system kill the
micro metastases that usually cause recurrence of the cancer. In
short, CEL-SCI believes that local administration and
administration before weakening of the immune system by
chemotherapy and radiation will result in higher efficacy with less
or no toxicity.
CEL-SCI’s
focus on HPV is not the development of an antiviral against HPV in
the general population. Instead it is the development of an
immunotherapy to be used in patients who are immune-suppressed by
diseases such as HIV and are therefore less able or unable to
control HPV and its resultant diseases. This group of patients has
no viable treatments available to them and there are, to
CEL-SCI’s knowledge, no competitors at the current time. HPV
is also relevant to the head and neck cancer Phase 3 study since it
is now known that HPV is a cause of head and neck cancer. Multikine
was shown to kill HPV in an earlier study of HIV infected women
with cervical dysplasia.
CEL-SCI
is also investigating a different peptide-based immunotherapy
(LEAPS-H1N1-DC) as a possible treatment for H1N1 hospitalized
patients and as a vaccine (CEL-2000 and CEL-4000) for Rheumatoid
Arthritis (currently in preclinical testing) using its LEAPS
technology platform. The investigational immunotherapy
LEAPS-H1N1-DC treatment involves non-changing regions of H1N1
Pandemic Flu (www.jci.org/articles/view/67550), Avian Flu (H5N1),
and the Spanish Flu, as CEL-SCI scientists are very concerned about
the possible emergence of a new more virulent hybrid virus through
the combination of H1N1 and Avian Flu, or possibly Spanish
Flu.
CEL-SCI
Corporation was formed as a Colorado corporation in 1983.
CEL-SCI’s principal office is located at 8229 Boone
Boulevard, Suite 802, Vienna, VA 22182. CEL-SCI’s telephone
number is 703-506-9460 and its website is www.cel-sci.com. CEL-SCI
does not incorporate the information on its website into this
report, and you should not consider it part of this
report.
2
CEL-SCI
makes its electronic filings with the Securities and Exchange
Commission (SEC), including its annual reports on Form 10-K,
quarterly reports on Form 10-Q, current reports on Form 8-K and
amendments to these reports available on its website free of charge
as soon as practicable after they are filed or furnished to the
SEC.
CEL-SCI’S PRODUCTS
CEL-SCI
is dedicated to research and development directed at improving the
treatment of cancer and other diseases by using the immune system,
the body’s natural defense system. CEL-SCI is currently
focused on the development of the following product candidates and
technologies:
1)
Multikine,
an
investigational
immunotherapy under development for
the potential treatment of certain head and neck cancers, and anal
warts or cervical dysplasia in human immunodeficiency virus, or
HIV, and human papillomavirus, or HPV, co-infected
patients;
2)
L.E.A.P.S. (Ligand
Epitope Antigen Presentation System) technology, or LEAPS, with two
investigational therapies, LEAPS-H1N1-DC, a product candidate under
development for the potential treatment of pandemic influenza in
hospitalized patients, and CEL-2000 and CEL-4000, vaccine product
candidates under development for the potential treatment of
rheumatoid arthritis.
The
following chart depicts our product candidates, their indications
and their current stage of development:
MULTIKINE
CEL-SCI’s
lead investigational therapy, Multikine, is currently being
developed as a potential therapeutic agent directed at using the
immune system to produce an anti-tumor immune response. Data from
Phase 1 and Phase 2 clinical trials suggest that Multikine
simulates the activities of a healthy person’s immune system,
enabling it to use the body’s own anti-tumor immune response.
Multikine is the trademark that CEL-SCI has registered for this
investigational therapy, and this proprietary name is subject to
review by the U.S. Food and Drug Administration, or FDA, in
connection with CEL-SCI’s future anticipated regulatory
submission for approval. Multikine has not been licensed or
approved for sale, barter or exchange by the FDA or any other
regulatory agency, such as the European Medicine Agency, or EMA.
Neither has its safety or efficacy been established for any
use.
3
Multikine is an
immunotherapy product candidate comprised of a patented defined
mixture of 14 human natural cytokines and is manufactured in a
proprietary manner in CEL-SCI’s manufacturing facility.
CEL-SCI spent over 10 years and more than $80 million developing
and validating the manufacturing process for Multikine. The
pro-inflammatory cytokine mixture includes interleukins,
interferons, chemokines and colony-stimulating factors, which
contain elements of the body’s natural mix of defenses
against cancer.
Multikine is
designed to be used in a different way than immune therapy is
normally used. It is designed to be administered locally to treat
local tumors before any other therapy has been administered. For
example, in the Phase 3 clinical trial, Multikine is injected
locally at the site of the tumor and near the adjacent draining
lymph nodes as a first line of treatment before surgery, radiation
and/or chemotherapy because that is when the immune system is
thought to be strongest. The goal is to help the intact immune
system recognize and kill the micro metastases that usually cause
recurrence of the cancer. In short, CEL-SCI believes that local
administration and administration before weakening of the immune
system by chemotherapy and radiation will result in better
anti-tumor response than if Multikine were administered as a
second- or later-line therapy. In clinical studies of Multikine,
administration of the investigational therapy to head and neck
cancer patients has demonstrated the potential for less or no
appreciable toxicity
Source: Adapted from Timar et al., Journal of Clinical Oncology
23(15) May 20, 2005
The
first indication CEL-SCI is pursuing for its investigational drug
product candidate Multikine is an indication for the neoadjuvant
therapy in patients with squamous cell carcinoma of the head and
neck, or SCCHN (hereafter also referred to as advanced primary head
and neck cancer). As detailed below, the Phase 3 Clinical trial of
the Multikine investigational drug as neoadjuvant therapy in SCCHN
is currently on Partial Clinical Hold by the US FDA. SCCHN is a
type of head and neck cancer, and CEL-SCI believes that, in the
aggregate, there is a large, unmet medical need among head and neck
cancer patients. CEL-SCI believes the last FDA approval of a
therapy indicated for the treatment of advanced primary head and
neck cancer was over 50 years ago. In the aggregate, head and neck
cancer represents about 6% of the world’s cancer cases, with
approximately over 650,000 patients diagnosed worldwide each year,
and nearly 60,000 patients diagnosed annually in the United States.
Multikine investigational immunotherapy was granted Orphan Drug
designation for neoadjuvant therapy in patients with SCCHN by the
FDA in the United States.
4
Status
of Phase 3 Clinical Trial
Following
submissions to regulatory authorities in 24 countries around the
world, including the FDA in the United States, a global Phase 3
clinical trial of the investigational Multikine therapy as a
potential neoadjuvant therapy in patients with SCCHN was initially
commenced in late 2010. This clinical trial is currently on Partial
Clinical Hold.
This
trial is currently primarily under the management of two clinical
research organizations, or CROs: ICON Inc. (who acquired Aptiv
Solutions, Inc., one of the two CROs), or ICON, and Ergomed
Clinical Research Limited, or Ergomed. Ergomed is responsible for
new patient enrollment and the clinical study management of the
various study sites, although enrollment of new patients has been
on hold since the Company received verbal notice of FDA’s
Partial Clinical Hold on September 26, 2016. The following chart
reflects the number of patients enrolled per month from the point
at which the study management was transferred to the new CROs and
the enrolment since then and until the FDA put the study on Partial
Clinical Hold.
The
Phase 3 study was designed with the objective that, if the study
endpoint, which is an improvement in overall survival of the
subjects treated with the Multikine treatment regimen plus the
current standard of care (SOC) as compared to subjects treated with
the current SOC only, is satisfied, the study results are expected
to be used to support applications that the Company plans to submit
to regulatory agencies in order to seek commercial marketing
approvals for Multikine in major markets around the world. This
assessment can only be made when a certain number of deaths have
occurred in these two main comparator groups of the
study.
5
The
primary endpoint for the original protocol for this Phase 3 head
and neck cancer study required that a 10% increase in overall
survival be obtained in the Multikine group which also is
administered CIZ (CIZ = low dose (non-chemotherapeutic) of
cyclophosphamide, indomethacin and Zinc-multivitamins) all of which
are thought to enhance Multikine activity), plus Standard of Care
(Surgery + Radiotherapy or Chemoradiotherapy) arm of the study over
the Control comparator (Standard of Care alone) arm. As the study
originally was designed, the final determination of whether this
endpoint had been successfully reached could only be determined
when 298 events (deaths) had occurred in the combined comparator
arms of the study. Under the original study design, the plan was to
enroll 880 patients in order to be able to have 784 evaluable
patients for the per-protocol analysis.
In
August 2016, CEL-SCI announced that the currently available data
from the Clinical Study reflected that the accumulation of deaths
in the study was lower than that which was anticipated based on
reported literature at the Phase 3 study’s inception. If the
number of deaths continued to be accumulated at the current rate,
it had been determined that it would take longer than originally
planned to complete the study. To minimize this eventuality,
CEL-SCI decided it would be necessary to enroll up to 1,273
patients to have 1,146 evaluable patients. There were also other
changes in the protocol, such as the required number of deaths
(394) and the required increase in overall survival (6.5%) in favor
of the Multikine comparator arm. With this increased patient
enrollment, CEL-SCI expected a corresponding increase in the number
of deaths, and, if this plan were implemented, the study could be
completed in a more timely manner. As required by law and in order
to be able to implement the plan, CEL-SCI submitted an amendment to
the existing Phase 3 protocol for its head and neck cancer study to
multiple regulatory agencies in the countries abroad where the
Phase 3 study is being conducted as well as to the FDA to allow for
this expansion in patient enrolment.
On September
26, 2016, CEL-SCI received verbal notice from the FDA that the
Phase 3 clinical trial in advanced primary head and neck cancer has
been placed on clinical hold. At such time, enrollment in the Phase
3 study was 928 patients. On October 21, 2016, CEL-SCI received a
Partial Clinical Hold letter from the FDA and on November 21, 2016,
CEL-SCI submitted a response to the FDA’s Partial Clinical
Hold letter.
In its
partial clinical hold letter, FDA identified the following specific
deficiencies: a) FDA stated that there is an unreasonable and
significant risk of illness or injury to human subjects and cited
among other things the absence of prompt reports by us to the FDA
of IDMC recommendations to close the study entirely (made in spring
of 2014) or at least to close it to accrual of new patients (made
in spring of 2016); b) FDA stated that the investigator brochure is
misleading, erroneous, and materially incomplete; and c) FDA stated
that the plan or protocol is deficient in design to meet its stated
objectives. In its partial clinical hold letter, FDA also
identified the information needed to resolve these deficiencies. In
addition, FDA’s partial clinical hold letter included two
requests relating to quality information regarding our
investigational final drug product, which were noted by FDA as
non-hold issues. CEL-SCI believes that its response submitted to
FDA on November 18, 2016, addressed each of the deficiencies
identified by FDA including detailing our belief that, under the
applicable FDA guidance, there was no obligation to report the
cited IDMC recommendations to the FDA at the time they were issued,
and it also requested a face-to-face meeting with FDA, and outlined
our commitment to diligently work with FDA in an effort to have the
partial clinical hold for the study lifted.
On December 8,
2016, the FDA advised CEL-SCI that the agency was denying CEL-SCI's
request for a meeting at this time because FDA's review of
CEL-SCI's November 17, 2016 response was ongoing. CEL-SCI was also
advised that it will be receiving a letter addressing CEL-SCI's
response by December 18, 2016.
Throughout the
course of the Phase 3 study, an Independent Data Monitoring
Committee, or IDMC, has met periodically to review safety data from
the Phase 3 study, and the IDMC is expected to continue doing so
throughout the remainder of the Phase 3 study. At various points in
the study at which the IDMC has completed review of the safety data
and has issued recommendations, it has recommended that the Phase 3
study may continue, although on two occasions the IDMC has issued
recommendations that would have closed the study entirely (spring
of 2014) or at least closed it to accrual of new patients (spring
of 2016). On one occasion, in the spring of 2014, the IDMC made a
recommendation that the study be closed for safety and efficacy
reasons. However, following review of additional information
submitted by us, the IDMC recommended that the study may continue.
In the spring of 2016, with close to 800 patients enrolled, the
IDMC made a recommendation that enrollment in the Phase 3 study
should stop, but that patients already enrolled in the study should
continue treatment and follow-up. CEL-
SCI responded to
this letter and indicated it would address the remaining three
requests (generally relating to study design considerations) that
were not part of the IDMC recommendation in a follow-up
correspondence.
6
However,
before CEL-SCI could provide our follow-up response to the
remaining three requests, the IDMC sent another letter (a)
indicating that our initial letter responding to the IDMC
recommendation was unresponsive and (b) also indicating that the
IDMC was deeply concerned about patient safety in the trial based
on its review of cumulative data. The IDMC's initial letter in the
spring of 2016 did not mention that the IDMC was concerned about
safety. Instead, the initial letter in the spring of 2016 noted
that the study should be closed to further accrual, and that
patients who had been randomized may continue treatment and should
be followed. The statement that patients who had been randomized
may continue treatment suggested to us that safety was not an
issue. Because no safety concern had been raised by the IDMC since
the spring of 2014, when, after further communications with
CEL-SCI, the IDMC issued its recommendation that the study should
proceed, CEL-SCI believed based on the entirety of the course of
correspondence with the IDMC that acute safety was not an issue
underlying the IDMC's recommendation to halt accrual in the spring
of 2016. As noted above, all other correspondence to CEL-SCI from
the IDMC from study initiation through September 2015, with the
exception of the recommendation in spring 2014, stated that the
IDMC recommends “the study may continue". CEL-SCI responded
to the IDMC’s recommendation in spring of 2016 with a
statistical analysis showing that more patients were needed in
order to complete the study in a reasonable amount of follow-up
time, since the observed death rate in the study was lower than
that which was predicted from the literature at the onset of the
study. Subsequently a protocol amendment was prepared based on the
analysis provided to the IDMC and submitted to FDA in July 2016,
and a copy was then sent to the IDMC in response to its request for
a copy of the submission. To date, CEL-SCI has not received a
response from the IDMC regarding this protocol amendment. However,
two months after the amendment was submitted to FDA, FDA placed the
protocol on partial clinical hold. CEL-SCI expects to work through
the concerns raised by the IDMC while CEL-SCI works through the
partial hold with FDA. Ultimately, the decision as to whether
CEL-SCI’s drug product candidate is safe and effective can
only be made by FDA and/or by other regulatory authorities based
upon an assessment of all of the data from an entire drug
development program submitted as part of an application for
marketing approval. As detailed elsewhere in this document, whether
the partial clinical hold is lifted or not, the current Phase 3
clinical study for CEL-SCI’s investigational drug may or may
not be able to be used as the pivotal study supporting a marketing
application in the United States, and, if not, at least one
entirely new Phase 3 pivotal study would need to be conducted to
provide the pivotal study supporting a marketing application in the
United States.
7
CEL-SCI estimates
that the total remaining cash cost of the Phase 3 clinical trial,
excluding any costs that will be paid by CEL-SCI's partners, would
be approximately $12.1 million after September 30, 2016. This
ís based on the executed contract costs with the CROs only and
does not include other related costs, e.g. the manufacturing of the
drug.
Should the FDA allow the amended protocol filed with
them to proceed, which requires an enrollment of up to 1,273
subjects, the remaining cost of the Phase 3 clinical trial will be
higher than currently estimated. This is in addition to the
approximately $34.5 million that CEL-SCI already had spent on the
trial as of September 30, 2016. This estimate is based on
information currently available under the contracts with the CROs
responsible for managing the Phase 3 clinical trial. This number
may be affected by the rate of any future patient enrollment, rate
of death accumulation in the study, foreign currency exchange
rates, and many other factors, some of which cannot be foreseen
today. It is therefore possible that the cost of the Phase 3
clinical trial will be higher than currently
estimated.
Follow-Up Analysis of Overall Survival in Phase 2
Patients
Prior
to starting the Phase 3 study, CEL-SCI had tested Multikine in over
200 patients. The following is a summary of results from
CEL-SCI’s last Phase 2 study conducted with Multikine. This
study employed the same treatment protocol as is being followed in
CEL-SCI’s Phase 3 study:
●
Reported potential for improved
survival:
In a follow-up analysis of the Phase 2 clinical
study population, which used the same dosage and treatment regimen
as is being used in the Phase 3 study, head and neck cancer
patients with locally advanced primary disease who received the
investigational therapy Multikine as first-line investigational
therapy, followed by surgery and radiotherapy, were reported by the
clinical investigators to have had a 63.2% overall survival, or OS,
rate at a median of 3.33 years from surgery. This percentage of OS
was arrived at as follows: of the 21 subjects enrolled in the Phase
2 study, the consent for the survival follow-up portion of the
study was received from 19 subjects. OS was calculated using the
entire treatment population that consented to the follow-up portion
of the study (19 subjects), including two subjects who, as later
determined by three pathologists blinded to the study, did not have
oral squamous cell carcinoma, or OSCC. These two subjects were thus
not evaluable per the protocol and were not included in the
pathology portion of the study for purposes of calculating the
complete response rate, as described below, but were included in
the OS calculation. The overall survival rate of subjects receiving
the investigational therapy in this study was compared to the
overall survival rate that was calculated based upon a review of 55
clinical trials conducted in the same cancer population (with a
total of 7,294 patients studied), and reported in the peer reviewed
scientific literature between 1987 and 2007. Review of this
literature showed an approximate survival rate of 47.5% at 3.5
years from treatment. Therefore, the results of CEL-SCI's final
Phase 2 study were considered to be potentially favorable in terms
of overall survival recognizing the limitations of this early-phase
study. It should be noted that an earlier investigational therapy
Multikine study appears to lend support to the overall survival
findings described above - Feinmesser et al Arch Otolaryngol. Surg.
2003. However, no definitive conclusions can be drawn from these
data about the potential efficacy or safety profile of this
investigational therapy. Moreover, further research is required,
and these results must be confirmed in the Phase 3 clinical trial
of this investigational therapy that is currently in progress.
Subject to completion of that Phase 3 clinical trial and the
FDA’s review and acceptance of CEL-SCI's entire data set on
this investigational therapy, CEL-SCI believes that these
early-stage clinical trial results indicate the potential for the
Multikine product candidate to become a treatment for advanced
primary head and neck cancer, if approved.
8
●
Reported average of 50% reduction in tumor
cells in Phase 2 trials (based on 19 patients evaluable by
pathology, having OSCC):
The clinical investigators who
administered the three week Multikine treatment regimen used in the
Phase 2 study reported that, as was determined in a controlled
pathology study, Multikine administration appeared to have caused,
on average, the disappearance of about half of the cancer cells
present at surgery (as determined by histopathology assessing the
area of Stroma/Tumor (Mean+/- Standard Error of the Mean of the
number of cells counted per filed)) even before the start of
standard therapy, which normally includes surgery, radiation and
chemotherapy (Timar et al JCO 2005).
●
Reported 10.5% complete response in the final
Phase 2 trial (based on 19 patients evaluable by pathology, having
OSCC):
The clinical investigators who administered the
three-week Multikine investigational treatment regimen used in the
Phase 2 study reported that, as was determined in a controlled
pathology study, the tumor apparently was no longer present (as
determined by histopathology) in approximately 10.5% of evaluable
patients with OSCC (Timar et al JCO 2005). In the original study,
21 subjects received Multikine, two of which were later excluded,
as subsequent analysis by three pathologists blinded to the study
revealed that these two patients did not have OSCC. Two subjects in
this study had a complete response, leaving a reported complete
response rate of two out of 19 assessable subjects with OSCC (or
10.5%) (Timar et al JCO 2005).
●
Adverse events reported in clinical
trials:
In clinical trials conducted to date with the
Multikine investigational therapy, adverse events which have been
reported by the clinical investigators as possibly or probably
related to Multikine administration included pain at the injection
site, local minor bleeding and edema at the injection site,
diarrhea, headache, nausea, and constipation
.
Subsequently, an
analysis on the 21 subjects originally treated with Multikine in
the study to evaluate overall survival was conducted, as described
above. In connection with the follow-up portion of the study for
overall survival,
CEL-SCI
also
conducted an unreported post-hoc analysis of complete response rate
in the study population, which included subjects who provided
consent for the follow-up and who also had OSCC. Two of the 21
subjects did not re-consent for follow-up, and two of the remaining
19 subjects were excluded from the post-hoc complete response rate
analysis as they had previously been determined by pathology
analysis to not have OSCC. The two complete responders with OSCC
both consented to the follow-up study. Therefore, the post-hoc
analysis of complete response was based on a calculation of the two
complete responders out of 17 evaluable subjects who consented to
the follow-up analysis and who also had OSCC (or
11.8%).
9
Furthermore,
CEL-SCI reported an overall response rate of 42.1% based on the
number of evaluable patients who experienced a favorable response
to the treatment, including those who experienced minor, major and
complete responses. Out of the 19 evaluable patients, two
experienced a complete response, two experienced a major response,
and four experienced a minor response to treatment. Thus,
CEL-SCI
calculated the number
of patients experiencing a favorable response as eight patients out
of 19 (or 42.1%) (Timar et al, JCO 2005).
The
clinical significance of these and other data, to date, from the
multiple Multikine clinical trials is not yet known. These
preliminary clinical data do suggest the potential to demonstrate a
possible improvement in the clinical outcome for patients treated
with Multikine.
Peri-Anal Warts and Cervical Dysplasia in HIV/HPV Co-Infected
Patients
HPV is
a very common sexually transmitted disease in the United States and
other parts of the world. It can lead to cancer of the cervix,
penis, anus, esophagus and head and neck. Our focus in HPV,
however, is not on developing an antiviral for the potential
treatment or prevention of HPV in the general population. Instead,
the focus is on developing an immunotherapy product candidate
designed to be administered to patients who are immune-suppressed
by other diseases, such as HIV, and who are therefore less able or
unable to control HPV and its resultant or co-morbid diseases. Such
patients have limited treatment options available to
them.
One
condition that is commonly associated with both HIV and HPV is the
occurrence of anal intraepithelial dysplasia, or AIN, and anal and
genital warts. The incidence of AIN in HIV-infected people is
estimated to be about 25%. The incidence of anal HPV infection in
HIV-infected men who have sex with men, or MSM, is estimated to be
as high as 95%. In the aggregate, the United States and Europe have
about 875,000 HIV-infected patients with AIN (assuming AIN
prevalence of approximately 25% of the aggregate HIV-infected
population). Persistent HPV infection in the anal region is thought
to be responsible for up to 80% of anal cancers, and men and women
who are HIV positive have a 30-fold increase in their risk of anal
cancer. Persistent HPV infection can also be a precursor to
cervical cancer, as well as certain head and neck
cancers.
In
October 2013,
CEL-SCI
signed a
cooperative research and development agreement, or CRADA, with the
U.S. Naval Medical Center, San Diego, or the USNMC. Pursuant to
this agreement, the USNMC was to conduct a Phase 1 study, approved
by the Human Subjects Institutional Review Board, of
CEL-SCI’s investigational immunotherapy, Multikine, in
HIV/HPV co-infected men and women with peri-anal warts. The purpose
of this study was to evaluate the safety and clinical impact of
Multikine as a potential treatment of peri-anal warts and assess
its effect on AIN in HIV/HPV co-infected men and
women.
In July
2015, CEL-SCI added a clinical site at the University of
California, San Francisco, or UCSF, and Key Opinion Leader, or KOL,
to the ongoing Phase 1 study. In August 2016, the U.S. Navy
discontinued this Phase 1 study because of difficulties in
enrolling patients. UCSF is continuing with the study.
In
October 2013,
CEL-SCI
entered
into a co-development and profit sharing agreement with Ergomed for
development of Multikine as a potential treatment of HIV/HPV
co-infected men and women with peri-anal warts. This agreement is
supporting the development of Multikine with UCSF.
10
The
treatment regimen for this Phase 1 study of up to 15 HIV/HPV
co-infected patient volunteers with peri-anal warts, being
conducted by doctors at UCSF, is identical to the regimen that was
used in an earlier Institutional Review Board-approved Multikine
Phase 1 study in HIV/HPV co-infected patients, which was conducted
at the University of Maryland. In that study, the Multikine
investigational therapy was administered to HIV/HPV co-infected
women with cervical dysplasia, resulting in visual and histological
evidence of clearance of lesions in three out of the eight
subjects.
Furthermore, in
this earlier Phase 1 study, the number of HPV viral sub-types in
three volunteer subjects tested were reduced post-treatment with
Multikine, as opposed to pre-treatment, as determined by in situ
polymerase chain reaction performed on tissue biopsy collected
before and after Multikine treatment. As reported by the
investigators in the earlier study, the study volunteers, except
one subject volunteer, all appeared to tolerate the treatment with
no reported serious adverse events.
Development Agreements for Multikine
In
August 2008, CEL-SCI signed an agreement with Teva Pharmaceutical
Industries Ltd., or Teva, that gives Teva the exclusive right and
license to market, distribute and sell Multikine in Israel and
Turkey for treatment of head and neck cancer, if approved. The
agreement terminates on a country-by-country basis 10 years after
the product launch in each country or upon a material breach or
upon bankruptcy of either party. The agreement will automatically
extend for additional two year terms unless either party gives
notice of its intent not to extend the agreement. If CEL-SCI
develops Multikine for other oncology indications and Teva
indicates a desire to participate, the parties have agreed to
negotiate in good faith with respect to Teva’s participation
and contribution in future clinical trials.
Teva
has agreed to use all reasonable efforts to obtain regulatory
approval to market and sell Multikine in its territory at its own
cost and expense. Pursuant to the agreement, it is CEL-SCI’s
responsibility to supply Multikine and Teva’s responsibility
to sell Multikine, if approved. Net sales will be divided 50/50
between the two parties. Teva also initially agreed to fund certain
activities relating to the conduct of a clinical trial in Israel as
part of the global Phase 3 trial for Multikine. In January 2012,
pursuant to an assignment and assumption agreement between CEL-SCI,
Teva and GCP Clinical Studies Ltd., or GCP, Teva transferred all of
its rights and obligations concerning the Phase III trial in Israel
to GCP. GCP is now operating the Phase 3 trial in Israel pursuant
to a service agreement with CEL-SCI.
In July
2011, Serbia and Croatia were added to Teva’s territory,
pursuant to a joinder agreement between CEL-SCI and PLIVA Hrvatska
d.o.o., or PLIVA, an affiliate of Teva’s, subject to similar
terms as described above.
In
consideration for the rights granted by CEL-SCI to PLIVA under the
joinder agreement, CEL-SCI will be paid by PLIVA (in U.S.
dollars):
●
$100,000 upon EMA
grant of Marketing Authorization for Multikine;
●
$50,000 upon
Croatia’s grant of reimbursement status for Multikine in
Croatia; and
●
$50,000 upon
Serbia’s grant of reimbursement status for Multikine in
Serbia.
11
In
November 2000, CEL-SCI signed an agreement with Orient Europharma
Co., Ltd., or Orient Europharma, of Taiwan, which agreement was
amended in October 2008 and again in June 2010. Pursuant to this
agreement, as amended, Orient Europharma has the exclusive
marketing and distribution rights to Multikine, if approved, for
head and neck cancer, naso-pharyngeal cancer and potentially
cervical cancer indications in Taiwan, Singapore, Malaysia, Hong
Kong, the Philippines, South Korea, Australia and New Zealand.
CEL-SCI has granted Orient Europharma the first right of
negotiation with respect to Thailand and China.
The
agreement requires Orient Europharma to fund 10% of the cost of the
clinical trials needed to obtain marketing approvals in these
countries for head and neck cancer, naso-pharyngeal cancer and
potentially cervical cancer. Orient Europharma has signed ten
centers in Taiwan, four centers in Malaysia, three centers in
Philippines and one center in Thailand to enroll patients as part
of the Phase 3 Multikine clinical trial and has made further
financial contributions towards the cost of the Phase 3 clinical
trial.
If
Multikine is approved for sale, Orient Europharma will purchase
Multikine from CEL-SCI for 35% of the gross selling price in each
country.
Orient
Europharma is obligated to use the same diligent efforts to
develop, register, market, sell and distribute Multikine in the
territory as with its own products or other licensed
products.
The
agreement will terminate on a country-by-country basis 15 years
after the product approval for Multikine in each country, at which
point the agreement will be automatically extended for successive
two year periods, unless either party gives notice of its intent
not to extend the agreement. The agreement may also be terminated
upon bankruptcy of either party or material misrepresentations that
are not cured within 60 days. If the agreement ends before the 15
year term through no fault of either party, CEL-SCI will reimburse
Orient Europharma for a prorated part of Orient Europhorma’s
costs towards the clinical trials of Multikine. If Orient
Europharma fails to make certain minimum purchases of Multikine
during the term of the agreement, Orient Europhorma’s rights
to the territory will become non-exclusive.
CEL-SCI
has a licensing agreement with Byron Biopharma LLC, or Byron, under
which CEL-SCI granted Byron an exclusive license to market and
distribute Multikine in the Republic of South Africa, if approved.
This license will terminate 20 years after marketing approval in
South Africa or after bankruptcy or uncured material breach. After
the 20-year period has expired, the agreement will be automatically
extended for successive two year periods, unless either party gives
notice of its intent not to extend the agreement.
Pursuant to the
agreement, Byron will be responsible for registering Multikine in
South Africa. If Multikine is approved for sale in South Africa,
CEL-SCI will be responsible for manufacturing the product, while
Byron will be responsible for sales in South Africa. Sales revenues
will be divided between CEL-SCI and Byron. CEL-SCI will be paid
fifty (50%) percent of the net sales of Multikine.
12
INTELLECTUAL PROPERTY
Patents
and other proprietary rights are essential to CEL-SCI’s
business. CEL-SCI files patent applications to protect its
technologies, inventions and improvements to its inventions that
CEL-SCI considers important to the development of its business.
CEL-SCI files for patent registration in the United States and in
key foreign markets. CEL-SCI’S intellectual property
portfolio covers its proprietary technologies, including Multikine
and LEAPS, by multiple issued patents and pending patent
applications.
Multikine is
protected by a US patent, which is a composition-of-matter patent
issued in May 2005 that, in its current format, expires in 2024.
Additional composition-of-matter patents for Multikine have been
issued in Germany (issued in June 2011 and currently set to expire
in 2025), China (issued in May 2011 and currently set to expire in
2024), Japan (issued in November 2012 and currently set to expire
in 2025), and two in Europe (issued in September 2015 and May 2016
both currently set to expire in 2025).
CEL-SCI
has one patent applications pending in Europe for Multikine, which,
if issued, would extend protection through 2026, subject to any
potential patent term extensions. In addition to the patents and
applications that offer certain protections for Multikine, the
method of manufacture for Multikine, a complex biological product,
is held by CEL-SCI as trade secret.
LEAPS
is protected by patents in the United States issued in February
2006, April 2007, and August 2007. The LEAPS patents, which expire
in 2021, 2022 and 2021, respectively, include overlapping claims,
with composition of both matter (new chemical entity), process and
methods-of-use, to maximize and extend the coverage in their
current format. Additional patent applications are pending in the
United States and Europe that could offer protection through
2034.
CEL-SCI
has six patent applications pending in the United States and one in
Europe for LEAPS, which, if issued, would extend protection through
2034, subject to any potential patent term extensions. One pending
U.S. application is a joint application with Northeast Ohio Medical
University (“Neoucom”). If granted, CEL-SCI will share
the ability to use the patent, unless CEL-SCI licenses the rights
to the patent application and any ensuing patent from
Neoucom.
As of
December 1, 2016, there were no contested proceedings and/or third
party claims with respect to CEL-SCI’s patents or patent
applications.
MANUFACTURING FACILITY
Before
starting the Phase 3 clinical trial, CEL-SCI needed to build a
dedicated manufacturing facility to produce Multikine. This
facility has been completed and validated, and has produced
multiple clinical lots for the Phase 3 clinical trial. The facility
has also passed review by a European Union Qualified Person on
several occasions.
CEL-SCI’s
lease on the manufacturing facility expires on October 31,
2028.
CEL-SCI
completed validation of its new manufacturing facility in January
2010. The state-of-the-art facility is being used to manufacture
Multikine for CEL-SCI’s Phase 3 clinical trial. In addition
to using this facility to manufacture Multikine, CEL-SCI, only if
the facility is not being used for Multikine, may offer the use of
the facility as a service to pharmaceutical companies and others,
particularly those that need to “fill and finish” their
drugs in a cold environment (4 degrees Celsius, or approximately 39
degrees Fahrenheit). Fill and finish is the process of filling
injectable drugs in a sterile manner and is a key part of the
manufacturing process for many medicines. However, priority will
always be given to Multikine as management considers the Multikine
supply to the clinical studies and preparation for a final
marketing approval to be more important than offering fill and
finish services. See Item 2 of this report for more information
concerning the terms of this lease.
13
LEAPS
CEL-SCI’s
patented T-cell Modulation Process, referred to as LEAPS (Ligand
Epitope Antigen Presentation System), uses
“heteroconjugates” to direct the body to choose a
specific immune response. LEAPS is designed to stimulate the human
immune system to more effectively fight bacterial, viral and
parasitic infections as well as autoimmune, allergies,
transplantation rejection and cancer, when it cannot do so on its
own. Administered like a vaccine, LEAPS combines T-cell binding
ligands with small, disease associated, peptide antigens and may
provide a new method to treat and prevent certain
diseases.
The
ability to generate a specific immune response is important because
many diseases are often not combated effectively due to the
body’s selection of the “inappropriate” immune
response. The capability to specifically reprogram an immune
response may offer a more effective approach than existing vaccines
and drugs in attacking an underlying disease.
On July
15, 2014 CEL-SCI announced that it has been awarded a Phase 1 Small
Business Innovation Research (SBIR) grant in the amount of $225,000
from the National Institute of Arthritis Muscoskeletal and Skin
Diseases, which is part of the National Institutes of Health. The
grant is funding the further development of CEL-SCI’s LEAPS
technology as a potential treatment for rheumatoid arthritis, an
autoimmune disease of the joints. The work is being conducted at
Rush University Medical Center in Chicago, Illinois in the
laboratories of Tibor Glant, MD, Ph.D., The Jorge O. Galante
Professor of Orthopedic Surgery; Katalin Mikecz, MD, Ph.D.
Professor of Orthopedic Surgery & Biochemistry; and Allison
Finnegan, Ph.D. Professor of Medicine.
With
the support of the SBIR grant, CEL-SCI is developing two new drug
candidates, CEL-2000 and CEL-4000, as potential rheumatoid
arthritis therapeutic vaccines. The data from animal studies using
the CEL-2000 treatment vaccine demonstrated that it could be used
as an effective treatment against rheumatoid arthritis with fewer
administrations than those required by other anti-rheumatoid
arthritis treatments currently on the market for arthritic
conditions associated with the Th17 signature cytokine
TNF-
. The data for
CEL-4000 indicates it could be effective against rheumatoid
arthritis cases where a Th1 signature cytokine (IFN-c) is dominant.
CEL-2000 and CEL-4000 have the potential to be a more
disease-specific therapy, significantly less expensive, act at an
earlier step in the disease process than current therapies and may
be useful in patients not responding to existing rheumatoid
arthritis therapies. CEL-SCI believes this represents a large unmet
medical need in the rheumatoid arthritis market.
On
November 14, 2016, CEL-SCI announced new preclinical data that
demonstrate its investigational new drug candidate CEL-4000 has the
potential for use as a therapeutic vaccine to treat rheumatoid
arthritis. This efficacy study was supported in part by the SBIR
Phase I Grant and was conducted in collaboration with Drs. Katalin
Mikecz and Tibor Glant, and their research team at Rush University
Medical Center in Chicago, IL.
14
In
March 2015, CEL-SCI and its collaborators published a review
article on vaccine therapies for rheumatoid arthritis based in part
on work supported by the SBIR grant. The article is entitled
“Rheumatoid arthritis vaccine therapies: perspectives and
lessons from therapeutic Ligand Epitope Antigen Presentation System
vaccines for models of rheumatoid arthritis” and was
published in Expert Rev. Vaccines 1 - 18 and can be found at
http://www.ncbi.nlm.nih.gov/ pubmed/25787143.
In
August 2012, Dr. Zimmerman, CEL-SCI’s Senior Vice President
of Research, Cellular Immunology, gave a Keynote presentation at
the OMICS 2nd International Conference on Vaccines and Vaccinations
in Chicago. This presentation showed how the LEAPS peptides
administered altered only select cytokines specific for each
disease model, thereby improving the status of the test animals and
even preventing death and morbidity. These results support the
growing body of evidence that provides for its mode of action by a
common format in these unrelated conditions by regulation of Th1
(e.g., IL12 and IFN-c) and their action on reducing
TNF-
and other
inflammatory cytokines as well as regulation of antibodies to these
disease associated antigens. This was also illustrated by a
schematic model showing how these pathways interact and result in
the overall effect of protection and regulation of cytokines in a
beneficial manner.
In
February 2010, CEL-SCI announced that its CEL-2000 vaccine
demonstrated that it was able to block the progression of
rheumatoid arthritis in a mouse model, where a Th17 signature
cytokine (TNF-
) is
dominant. The results were published in the scientific
peer-reviewed Journal of International Immunopharmacology (online
edition) in an article titled “CEL-2000: A Therapeutic
Vaccine for Rheumatoid Arthritis Arrests Disease Development and
Alters Serum Cytokine / Chemokine Patterns in the Bovine Collagen
Type II Induced Arthritis in the DBA Mouse Model” Int
Immunopharmacol. 2010 Apr; 10(4):412-21 http://www.
ncbi.nlm.nih.gov/pubmed/20074669.
Using
the LEAPS technology, CEL-SCI has created a potential peptide
treatment for H1N1 (swine flu) hospitalized patients. This
LEAPS flu treatment is designed to focus on the conserved,
non-changing epitopes of the different strains of Type A Influenza
viruses (H1N1, H5N1, H3N1, etc.), including “swine”,
“avian or bird”, and “Spanish Influenza”,
in order to minimize the chance of viral “escape by
mutations” from immune recognition. Therefore one should
think of this treatment not really as an H1N1 treatment, but as a
potential pandemic flu treatment. CEL-SCI’s LEAPS flu
treatment contains epitopes known to be associated with immune
protection against influenza in animal models.
In
September 2009, the U.S. FDA advised CEL-SCI that it could proceed
with its first clinical trial to evaluate the effect of LEAPS-H1N1
treatment on the white blood cells of hospitalized H1N1 patients.
This followed an expedited initial review of CEL-SCI's regulatory
submission for this study proposal.
In
November 2009, CEL-SCI announced that The Johns Hopkins University
School of Medicine had given clearance for CEL-SCI’s first
clinical study to proceed using LEAPS-H1N1. Soon after
the start of the study, the number of hospitalized H1N1 patients
dramatically declined and the study was unable to complete the
enrollment of patients.
15
Additional work on
this treatment for the pandemic flu is being pursued in
collaboration with the National Institute of Allergy and Infectious
Diseases (NIAID), part of the National Institutes of Health, USA.
In May 2011 NIAID scientists presented data at the Keystone
Conference on “Pathogenesis of Influenza: Virus-Host
Interactions” in Hong Kong, China, showing the positive
results of efficacy studies in mice of LEAPS H1N1 activated
dendritic cells (DCs) to treat the H1N1 virus. Scientists at the
NIAID found that H1N1-infected mice treated with LEAPS-H1N1 DCs
showed a survival advantage over mice treated with control DCs. The
work was performed in collaboration with scientists led by Kanta
Subbarao, M.D., Chief of the Emerging Respiratory Diseases Section
in NIAID’s Division of Intramural Research, part of the
National Institutes of Health, USA.
In July
2013, CEL-SCI announced the publication of the results of influenza
studies by researchers from the NIAID in the Journal of Clinical
Investigation (
www.jci.org/articles/view/67550
).
The studies described in the publication show that when
CEL-SCI’s investigational J-LEAPS Influenza Virus treatments
were used “in vitro” to activate DCs, these activated
DCs, when injected into influenza infected mice, arrested the
progression of lethal influenza virus infection in these mice. The
work was performed in the laboratory of Dr. Subbarao.
Even
though the various LEAPS drug candidates have not yet been given to
humans, they have been tested in vitro with human cells. They have
induced similar cytokine responses that were seen in these animal
models, which may indicate that the LEAPS technology might
translate to humans. The LEAPS candidates have demonstrated
protection against lethal herpes simplex virus (HSV1) and H1N1
influenza infection, as a prophylactic or therapeutic agent in
animals. They have also shown some level of efficacy in animals in
two autoimmune conditions, curtailing and sometimes preventing
disease progression in arthritis and myocarditis animal models.
CEL-SCI’s belief is that the LEAPS technology may be a
significant alternative to the vaccines currently available on the
market for these diseases.
None of
the LEAPS investigational products have been approved for sale,
barter or exchange by the FDA or any other regulatory agency for
any use to treat disease in animals or humans. The safety or
efficacy of these products has not been established for any use.
Lastly, no definitive conclusions can be drawn from the
early-phase, preclinical-trials data involving these
investigational products. Before obtaining marketing approval from
the FDA in the United States, and by comparable agencies in most
foreign countries, these product candidates must undergo rigorous
preclinical and clinical testing which is costly and time consuming
and subject to unanticipated delays. There can be no assurance that
these approvals will be granted.
The
risks described below could adversely affect the price of
CEL-SCI’s common stock.
16
Risks Related to CEL-SCI
CEL-SCI’s Phase 3 Study has been placed on partial clinical
hold by the FDA
CEL-SCI
received a partial clinical hold letter from FDA stating that its
Phase 3 study had been placed on clinical hold, precluding CEL-SCI
from continuing the study except that patients enrolled prior to
September 26, 2016 may continue to receive protocol-specified
treatment at the discretion of the treating physician with written
confirmation of their consent to remain on study after receiving an
updated informed consent document. The FDA’s partial clinical
hold letter identified the following specific deficiencies: there
is an unreasonable and significant risk of illness or injury to
human subjects; the investigator brochure is misleading, erroneous,
and materially incomplete; and that the plan or protocol is
deficient in design to meet its stated objectives. In its partial
clinical hold letter, the FDA also identified the information
needed to resolve these deficiencies. Although CEL-SCI believes it
addressed each of the deficiencies identified by the FDA in its
November 17, 2016 response to the FDA, CEL-SCI nevertheless
requested a face-to-face meeting with the FDA. On December 8, 2016,
the FDA advised CEL-SCI that the agency was denying CEL-SCI’s
request for a meeting at this time because FDA’s review of
CEL-SCI’s November 17, 2016 response was ongoing. CEL-SCI was
also advised that it will be receiving a letter addressing
CEL-SCI’s response by December 18, 2016. CEL-SCI will not be
able to enroll any additional patients in the Phase 3 study unless
FDA lifts the clinical hold. In addition, in the spring of 2016,
the IDMC recommended to CEL-SCI that new patient enrollment should
stop in the Phase 3 study, but patients already on study should
continue to be treated and followed. CEL-SCI expects to work
through the concerns raised by the IDMC while CEL-SCI works through
the partial hold with FDA. However, if the clinical hold is not
removed or if it is determined that the study has been compromised
or if the IDMC does not allow enrollment to continue, the study may
be terminated.
CEL-SCI has incurred significant losses since inception, and
CEL-SCI anticipates that it will continue to incur significant
losses for the foreseeable future and may never achieve or maintain
profitability.
CEL-SCI
has a history of net losses, expects to incur substantial losses
and have negative operating cash flow for the foreseeable future,
and may never achieve or maintain profitability. Since
the date of its formation and through September 30, 2016, CEL-SCI
incurred net losses of approximately $286 million. CEL-SCI has
relied principally upon the proceeds from the public and private
sales of its securities to finance its activities to date. To date,
CEL-SCI has not commercialized any products or generated any
revenue from the sale of products, and CEL-SCI does not expect to
generate any product revenue for the foreseeable future. CEL-SCI
does not know whether or when it will generate product revenue or
become profitable.
CEL-SCI
is heavily dependent on the success of Multikine which is under
clinical development. CEL-SCI cannot be certain that Multikine will
receive regulatory approval or be successfully commercialized even
if CEL-SCI receives regulatory approval. On September 26, 2016, FDA
placed CEL-SCI’s Phase 3 clinical trial for Multikine on
partial clinical hold. CEL-SCI will not be able to enroll any
additional patients in the Phase 3 clinical trial unless FDA
removes the clinical hold. In addition, prior to FDA’s
issuance of the partial clinical hold, CEL-SCI was discussing with
its Independent Data Monitoring Committee issues related to
enrollment of additional patients in trial. Multikine is the only
product candidate in late-stage clinical development, and
CEL-SCI’s business currently depends heavily on its
successful development, regulatory approval and commercialization.
CEL-SCI has no drug products for sale currently and may never be
able to develop approved and marketable drug products.
17
Even
if CEL-SCI succeeds in developing and commercializing one or more
of its product candidates, CEL-SCI expects to continue to incur
significant operating and capital expenditures as
CEL-SCI:
●
continues
to undertake preclinical development and clinical trials for
product candidates;
●
seeks
regulatory approvals for product candidates;
●
implements
additional internal systems and infrastructure.
To
become and remain profitable, CEL-SCI must succeed in developing
and commercializing product candidates which must generate
significant revenue. This will require CEL-SCI to be successful in
a range of challenging activities, including completing preclinical
testing and clinical trials of its product candidates, discovering
or acquiring additional product candidates, obtaining regulatory
approval for these product candidates and manufacturing, marketing
and selling any products for which CEL-SCI may obtain regulatory
approval. CEL-SCI is only in the preliminary stages of most of
these activities. CEL-SCI may never succeed in these activities
and, even if CEL-SCI does, may never generate revenue that is
significant enough to achieve profitability.
Even
if CEL-SCI does achieve profitability, it may not be able to
sustain or increase profitability on a quarterly or annual basis.
The failure to become and remain profitable could depress the value
of CEL-SCI and could impair its ability to raise capital, expand
its business, maintain research and development efforts, diversify
product offerings or even continue in operation. A decline in the
value of CEL-SCI could cause its stockholders to lose all or part
of their investment.
CEL-SCI will require substantial additional capital to remain in
operation. A failure to obtain this necessary capital when needed
could force CEL-SCI to delay, limit, reduce or terminate the
product candidates’ development or commercialization
efforts.
As
of September 30, 2016, CEL-SCI had cash and cash equivalents of
$2.9 million. CEL-SCI believes that it will continue to
expend substantial resources for the foreseeable future developing
Multikine, LEAPS and any other product candidates or technologies
that it may develop or acquire. These expenditures will include
costs associated with research and development, potentially
obtaining regulatory approvals and having the products
manufactured, as well as marketing and selling products approved
for sale, if any. In addition, other unanticipated costs may arise.
Because the outcome of the current and anticipated clinical trials
is highly uncertain, CEL-SCI cannot reasonably estimate the actual
amounts necessary to successfully complete the development and
commercialization of the product candidates.
CEL-SCI’s
future capital requirements depend on many factors,
including:
●
the
rate of progress of, results of and cost of completing Phase 3
clinical development of Multikine for the treatment of certain head
and neck cancers;
18
●
the
results of the applications to and meetings with the FDA, the EMA
and other regulatory authorities and the consequential effect on
operating costs;
●
assuming
favorable Phase 3 clinical results, the cost, timing and outcome of
the efforts to obtain marketing approval for Multikine in the
United States, Europe and in other jurisdictions, including the
preparation and filing of regulatory submissions for Multikine with
the FDA, the EMA and other regulatory authorities;
●
the
scope, progress, results and costs of additional preclinical,
clinical, or other studies for additional indications for
Multikine, LEAPS and other product candidates and technologies that
CEL-SCI may develop or acquire;
●
the
timing of, and the costs involved in, obtaining regulatory
approvals for LEAPS if clinical studies are
successful;
●
the
cost and timing of future commercialization activities for the
products, if any of the product candidates are approved for
marketing, including product manufacturing, marketing, sales and
distribution costs;
●
the
revenue, if any, received from commercial sales of the product
candidates for which CEL-SCI receives marketing
approval;
●
the
cost of having the product candidates manufactured for clinical
trials and in preparation for commercialization;
●
the
ability to establish and maintain strategic collaborations,
licensing or other arrangements and the financial terms of such
agreements;
●
the
costs involved in preparing, filing and prosecuting patent
applications and maintaining, defending and enforcing its
intellectual property rights, including litigation costs, and the
outcome of such litigation; and
●
the
extent to which CEL-SCI acquires or in-licenses other products or
technologies.
Based
on the current operating plan, and absent any future financings or
strategic partnerships, CEL-SCI believes that its existing cash and
cash equivalents and investments will be sufficient to fund the
projected operating expenses and capital expenditure requirements
into the second quarter of fiscal year 2017. However,
CEL-SCI’s operating plan may change as a result of many
factors currently unknown to CEL-SCI, and CEL-SCI may need
additional funds sooner than planned. Additional funds may not be
available when CEL-SCI needs them on terms that are acceptable to
CEL-SCI, or at all. If adequate funds are not available to CEL-SCI
on a timely basis, CEL-SCI may be required to delay, limit, reduce
or terminate preclinical studies, clinical trials or other
development activities for Multikine, LEAPS, or any other product
candidates or technologies that CEL-SCI develops or acquires, or
delay, limit, reduce or terminate its sales and marketing
capabilities or other activities that may be necessary to
commercialize its product candidates. Due to recurring losses from
operations and future liquidity needs, there is substantial doubt
about CEL-SCI’s ability to continue as a going concern
without additional capital becoming available. The doubt about
CEL-SCI’s ability to continue as a going concern could have
an adverse impact on CEL-SCI’s ability to execute its
business plan, result in the reluctance on the part of certain
suppliers to do business with CEL-SCI, or adversely affect
CEL-SCI’s ability to raise additional debt or equity
capital.
19
The costs of the product candidates development and clinical trials
are difficult to estimate and will be very high for many years,
preventing CEL-SCI from making a profit for the foreseeable future,
if ever.
Clinical
and other studies necessary to obtain approval of a new drug can be
time consuming and costly, especially in the United States, but
also in foreign countries. The estimates of the costs associated
with future clinical trials and research may be substantially lower
than what CEL-SCI actually experiences. It is impossible to predict
what CEL-SCI will face in the development of a product candidate,
such as Multikine. The purpose of clinical trials is to provide
both CEL-SCI and regulatory authorities with safety and efficacy
data in humans. It is relatively common to revise a trial or add
subjects to a trial in progress. The difficult and often complex
steps necessary to obtain regulatory approval, especially that of
the FDA and the EMA, involve significant costs and may require
several years to complete. CEL-SCI expects that it will need
substantial additional financing over an extended period of time in
order to fund the costs of future clinical trials, related
research, and general and administrative expenses.
The
extent of the clinical trials and research programs are primarily
based upon the amount of capital available to CEL-SCI and the
extent to which CEL-SCI receives regulatory approvals for clinical
trials. CEL-SCI has established estimates of the future costs of
the Phase 3 clinical trial for Multikine, but, as explained above,
the estimates may not prove correct.
An adverse determination in any current or future lawsuits or
arbitration proceedings to which CEL-SCI is a party could have a
material adverse effect on CEL-SCI.
CEL-SCI is currently involved in a pending
arbitration proceeding,
CEL-SCI Corporation v.
inVentiv Health Clinical, LLC (f/k/a PharmaNet LLC) and PharmaNet
GmbH (f/k/a PharmaNet AG)
.
CEL-SCI initiated the proceedings against inVentiv Health Clinical,
LLC, or inVentiv, the former third-party CRO, and is seeking
payment for damages related to inVentiv’s prior involvement
in the Phase 3 clinical trial of Multikine. The arbitration claim,
initiated under the Commercial Rules of the American Arbitration
Association, alleges (i) breach of contract, (ii) fraud in the
inducement, and (iii) common law fraud. Currently, CEL-SCI is
seeking at least $50 million in damages in its amended statement of
claim.
In
an amended statement of claim, CEL-SCI asserted the claims set
forth above as well as an additional claim for professional
malpractice. The arbitrator subsequently granted
inVentiv’s motion to dismiss the professional malpractice
claim based on the “economic loss doctrine” which,
under New Jersey law, is a legal doctrine that, under certain
circumstances, prohibits bringing a negligence-based claim
alongside a claim for breach of contract. The arbitrator
denied the remainder of inVentiv’s motion, which had sought
to dismiss certain other aspects of the amended statement of
claim. In particular, the arbitrator rejected
inVentiv’s argument that several aspects of the amended
statement of claim were beyond the arbitrator’s
jurisdiction.
In
connection with the pending arbitration proceedings, inVentiv has
asserted counterclaims against CEL-SCI for (i) breach of contract,
seeking at least $2 million in damages for services allegedly
performed by inVentiv; (ii) breach of contract, seeking at least $1
million in damages for the alleged use of inVentiv’s name in
connection with publications and promotions in violation of the
parties’ contract; (iii) opportunistic breach, restitution
and unjust enrichment, seeking at least $20 million in disgorgement
of alleged unjust profits allegedly made by CEL-SCI as a result of
the purported breaches referenced in subsection (ii); and (iv)
defamation, seeking at least $1 million in damages for allegedly
defamatory statements made about inVentiv. CEL-SCI believes
inVentiv’s counterclaims are meritless and intends to
vigorously defend against them. However, if such defense is
unsuccessful, and inVentiv successfully asserts any of its
counterclaims, such an adverse determination could have a material
adverse effect on CEL-SCI’s business, results, financial
condition and liquidity.
20
In
October 2015 CEL-SCI signed an arbitration funding agreement with a
company established by Lake Whillans Litigation Finance, LLC, a
firm specializing in funding litigation expenses. Pursuant to the
agreement, an affiliate of Lake Whillans provides CEL-SCI with up
to $5 million in funding for litigation expenses to support its
arbitration claims against inVentiv. The funding is available to
CEL-SCI to fund the expenses of the ongoing arbitration and will
only be repaid if CEL-SCI receives proceeds from the
arbitration.
The
arbitration hearing on the merits began on September 26,
2016.
Additionally,
CEL-SCI may also be the target of claims asserting violations of
securities fraud and derivative actions, or other litigation or
arbitration proceedings in the future. Any future litigation could
result in substantial costs and divert management’s attention
and resources. These lawsuits or arbitration proceedings may result
in large judgments or settlements against CEL-SCI, any of which
could have a material adverse effect on its business, operating
results, financial condition and liquidity.
CEL-SCI has received a subpoena from the Securities and Exchange
Commission.
CEL-SCI
has received subpoenas from the Securities and Exchange Commission,
which is conducting a non-public, private investigation relating to
certain of CEL-SCI’s private and public financings as well as
reports, articles and other publications prepared by third parties
concerning CEL-SCI, the pending arbitration between CEL-SCI and
CEL-SCI’s former CRO, inVentiv Health, and CEL-SCI’s
Phase 3 clinical trial. This is the first SEC investigation
involving CEL-SCI. While CEL-SCI is confident that it has the
appropriate policies and procedures in place to ensure compliance
with all SEC rules and regulations, CEL-SCI cannot predict when the
SEC will conclude its investigation or the outcome of the
investigation. CEL-SCI is cooperating fully with the SEC in this
matter.
Compliance with changing regulations concerning corporate
governance and public disclosure may result in additional
expenses.
Changing
laws, regulations and standards relating to corporate governance
and public disclosure may create uncertainty regarding compliance
matters. New or changed laws, regulations and standards are subject
to varying interpretations in many cases. As a result, their
application in practice may evolve over time. CEL-SCI is committed
to maintaining high standards of corporate governance and public
disclosure. Complying with evolving interpretations of new or
changing legal requirements may cause CEL-SCI to incur higher costs
as CEL-SCI revises current practices, policies and procedures, and
may divert management time and attention from potential
revenue-generating activities to compliance matters. If the efforts
to comply with new or changed laws, regulations and standards
differ from the activities intended by regulatory or governing
bodies due to ambiguities related to practice, CEL-SCI’s
reputation may also be harmed. Further, CEL-SCI’s board
members, chief executive officer, and other executive officers
could face an increased risk of personal liability in connection
with the performance of their duties. As a result, CEL-SCI may have
difficulty attracting and retaining qualified board members and
executive officers, which could harm its business.
21
CEL-SCI has not established a definite plan for the marketing of
Multikine, if approved.
CEL-SCI
has not established a definitive plan for marketing nor has CEL-SCI
established a price structure for any of its product candidates, if
approved. However, CEL-SCI intends, if it is in a position to do
so, to sell Multikine itself in certain markets where it is
approved, and or to enter into written marketing agreements with
various third parties with established sales forces in such
markets. The sales forces in turn would, CEL-SCI
believes, focus on selling Multikine to targeted cancer centers,
physicians and clinics involved in the treatment of head and neck
cancer. CEL-SCI has already licensed future sales of Multikine, if
approved, to three companies: Teva Pharmaceuticals in Israel,
Turkey, Serbia and Croatia; Orient Europharma in Taiwan, Singapore,
Hong Kong, Malaysia, South Korea, the Philippines, Australia and
New Zealand; and Byron BioPharma, LLC in South
Africa. CEL-SCI believes that these companies will have
the resources to market Multikine appropriately in their respective
territories, if approved, but there is no guarantee that they
will. There is no assurance that CEL-SCI will be able to
find qualified third-party partners to market its products in other
areas, on terms that are favorable to CEL-SCI, or at
all.
CEL-SCI
may encounter problems, delays and additional expenses in
developing marketing plans with third parties. In addition, even if
Multikine, if approved, is cost-effective and demonstrated to
increase overall patient survival, CEL-SCI may experience other
limitations involving the proposed sale of Multikine, such as
uncertainty of third-party coverage and reimbursement. There is no
assurance that CEL-SCI can successfully market Multikine, if
approved, or any other product candidates it may
develop.
CEL-SCI hopes to expand its clinical development capabilities in
the future, and any difficulties hiring or retaining key personnel
or managing this growth could disrupt its operations.
CEL-SCI
is highly dependent on the principal members of its management and
development staff. If the Phase 3 Multikine clinical trial is
successful, CEL-SCI expects to expand its clinical development and
manufacturing capabilities, which will involve hiring additional
employees. Future growth will require CEL-SCI to continue to
implement and improve its managerial, operational and financial
systems and continue to retain, recruit and train additional
qualified personnel, which may impose a strain on its
administrative and its operational infrastructure. The competition
for qualified personnel in the biopharmaceutical field is intense.
CEL-SCI is highly dependent on its ability to attract, retain and
motivate highly qualified management and specialized personnel
required for clinical development. Due to limited resources,
CEL-SCI may not be able to manage effectively the expansion of its
operations or recruit and train additional qualified
personnel. If CEL-SCI is unable to retain key personnel
or manage its future growth effectively, CEL-SCI may not be able to
implement its business plan.
22
If product liability or patient injury lawsuits are brought against
CEL-SCI, CEL-SCI may incur substantial liabilities and may be
required to limit clinical testing or future commercialization of
Multikine or its other product candidates.
CEL-SCI
faces an inherent risk of product liability as a result of the
clinical testing of Multikine and other product candidates, and
will face an even greater risk if CEL-SCI commercializes any of its
product candidates. For example, CEL-SCI may be sued if its
Multikine or LEAPS product candidates, or any other future product
candidates, allegedly cause injury or are found to be otherwise
unsuitable during clinical testing, manufacturing or, if approved,
marketing or sale. Any such product liability claims may include
allegations of defects in manufacturing, defects in design, a
failure to warn of dangers inherent in the product candidate,
negligence, strict liability and a breach of warranties. Claims
could also be asserted under state consumer protection
acts.
Furthermore,
Multikine is made, in part, from components of human blood. There
are inherent risks associated with products that involve human
blood such as possible contamination with viruses, including
hepatitis or HIV. Any possible contamination could cause injuries
to patients who receive contaminated Multikine, or could require
CEL-SCI to destroy batches of Multikine, thereby subjecting CEL-SCI
to possible financial losses, lawsuits and harm to its
business.
If
CEL-SCI cannot successfully defend itself against product liability
claims, CEL-SCI may incur substantial liabilities or be required to
limit or cease the clinical testing or commercialization of its
product candidates, if approved. Even a successful defense would
require significant financial and management resources. Regardless
of the merits or eventual outcome, liability claims may result
in:
●
decreased
demand for Multikine or other product candidates, if
approved;
●
injury
to CEL-SCI’s reputation;
●
withdrawal
of existing, or failure to enroll additional, clinical trial
participants;
●
costs
to defend any related litigation;
●
a
diversion of management’s time and resources;
●
substantial
monetary awards to trial participants or patients;
●
product
candidate recalls, withdrawals or labeling, marketing or
promotional restrictions;
●
loss
of revenue;
●
inability
to commercialize Multikine or other product candidates;
and
●
a
decline in the price of CEL-SCI’s common stock.
Although
CEL-SCI has product liability insurance for Multikine in the amount
of $5.0 million, the successful prosecution of a product liability
case against CEL-SCI could have a materially adverse effect upon
its business if the amount of any judgment exceeds the insurance
coverage. Any claim that may be brought against CEL-SCI could
result in a court judgment or settlement in an amount that is not
covered, in whole or in part, by CEL-SCI’s insurance or that
is in excess of the limits of the insurance coverage.
CEL-SCI’s insurance policies also have various exclusions,
and CEL-SCI may be subject to a claim for which CEL-SCI has no
coverage. CEL-SCI may have to pay any amounts awarded by a court or
negotiated in a settlement that exceed the coverage limitations or
that are not covered by its insurance, and CEL-SCI may not have, or
be able to obtain, sufficient capital to pay such
amounts. CEL-SCI commenced the Phase 3 clinical trial
for Multikine in December 2010. Although no claims have been
brought to date, participants in the clinical trials could bring
civil actions against CEL-SCI for any unanticipated harmful effects
allegedly arising from the use of Multikine or any other product
candidate that CEL-SCI may attempt to develop.
23
CEL-SCI’s commercial success depends, in part, upon attaining
significant market acceptance of its product candidates, if
approved, among physicians, patients, healthcare payors and major
operators of cancer clinics.
Even
if CEL-SCI obtains regulatory approval for its product candidates,
any resulting product may not gain market acceptance among
physicians, healthcare payors, patients and the medical community,
which are critical to commercial success. Market acceptance of any
product candidate for which CEL-SCI receives approval depends on a
number of factors, including:
●
the
efficacy and safety as demonstrated in clinical
trials;
●
the
timing of market introduction of such product candidate as well as
competitive products;
●
the
clinical indications for which the drug is approved;
●
the
approval, availability, market acceptance and reimbursement for the
companion diagnostic;
●
acceptance
by physicians, major operators of cancer clinics and patients of
the drug as a safe and effective treatment;
●
the
potential and perceived advantages of a product candidate over
alternative treatments, especially with respect to patient subsets
that are targeted with a product candidate;
●
the
safety of a product candidate seen in a broader patient group,
including its use outside the approved indications;
●
the
cost of treatment in relation to alternative
treatments;
●
the
availability of adequate reimbursement and pricing by third-party
payors and government authorities;
●
relative
convenience and ease of administration;
●
the
prevalence and severity of adverse side effects; and
●
the
effectiveness of sales and marketing efforts.
If
CEL-SCI’s product candidates are approved but fail to achieve
an adequate level of acceptance by physicians, healthcare payors
and patients, CEL-SCI will not be able to generate significant
revenues, and CEL-SCI may not become or remain
profitable.
24
Our Independent Registered Public Accountants have included in its
report on our financial statements a paragraph stating that we may
be unable to continue as a going concern.
As
a result of our recurring losses from operations, our independent
registered public accounting firm, BDO USA, LLP, has issued a
report in connection with their audit of our financial statements
for the year ended September 30, 2016, that included an explanatory
paragraph referring to our recurring losses from operations and
expressing substantial doubt in our ability to continue as a going
concern without additional capital becoming available. The doubt
about our ability to continue as a going concern could have an
adverse impact on our ability to execute our business plan, result
in the reluctance on the part of certain suppliers to do business
with us, or adversely affect our ability to raise additional debt
or equity capital.
Risks Related to Government Approvals
CEL-SCI’s product candidates must undergo rigorous
preclinical and clinical testing and regulatory approvals, which
could be costly and time-consuming and subject CEL-SCI to
unanticipated delays or prevent CEL-SCI from marketing any
products.
CEL-SCI’s
product candidates are subject to premarket approval from the FDA
in the United States, the EMA in the European Union, and by
comparable agencies in most foreign countries before they can be
sold. Before obtaining marketing approval, these product candidates
must undergo costly and time consuming preclinical and clinical
testing which could subject CEL-SCI to unanticipated delays and may
prevent CEL-SCI from marketing the product candidates. There can be
no assurance that such approvals will be granted on a timely basis,
if at all.
Clinical
testing is expensive and can take many years to complete, and its
outcome is inherently uncertain. Failure can occur at any time
during the clinical trial process. The results of preclinical
studies and early clinical trials of the product candidates may not
be predictive of the results of later-stage clinical trials. A
number of companies in the biopharmaceutical industry have suffered
significant setbacks in advanced clinical trials due to lack of
efficacy or adverse safety profiles, notwithstanding promising
results in earlier trials. CEL-SCI’s current and future
clinical trials may not be successful.
Although
CEL-SCI is involved in Phase 1 and Phase 3 clinical trials for
Multikine, CEL-SCI may experience delays in the clinical trials and
CEL-SCI does not know whether the clinical trials will need to be
redesigned, enroll patients on a timely basis or be completed on
schedule, if at all. Clinical trials can be delayed for a variety
of reasons, including delays related to:
●
the
availability of financial resources needed to commence and complete
the planned trials;
●
obtaining
regulatory approval to commence a trial;
●
suspending
enrollment in clinical trials, as in the case of the partial
clinical hold issued by FDA related to our Phase 3 clinical trial
for Multikine;
25
●
reaching
agreement on acceptable terms with prospective contract research
organizations, or CROs, and clinical trial sites, the terms of
which can be subject to extensive negotiation and may vary
significantly among different CROs and trial sites;
●
obtaining
Institutional Review Board, or IRB, approval at each clinical trial
site;
●
recruiting
suitable patients to participate in a trial;
●
having
patients complete a trial or return for post-treatment
follow-up;
●
clinical
trial sites deviating from trial protocol or dropping out of a
trial;
●
adding
new clinical trial sites; or
●
manufacturing
sufficient quantities of the product candidate for use in clinical
trials.
Patient
enrollment, a significant factor in the timing of clinical trials,
is affected by many factors including the competence of the CRO
running the study, size and nature of the patient population, the
proximity of patients to clinical sites, the eligibility criteria
for the trial, the design of the clinical trial, competing clinical
trials and clinicians' and patients' perceptions as to the
potential advantages of the drug being studied in relation to other
available therapies, including any new drugs that may be approved
for the indications CEL-SCI is investigating. Furthermore, CEL-SCI
relies on CROs and clinical trial sites to ensure the proper and
timely conduct of the clinical trials and while CEL-SCI has
agreements governing their committed activities, CEL-SCI has
limited influence over their actual performance.
On
October 31, 2013, CEL-SCI commenced arbitration proceedings against
inVentiv Health Clinical, LLC, or inVentiv, its former clinical
research organization (CRO). The arbitration claim, initiated under
the Commercial Rules of the American Arbitration Association,
alleges (i) breach of contract, (ii) fraud in the inducement, and
(iii) common law fraud. Currently, CEL-SCI is seeking at least $50
million in damages in its amended statement of claim.
In
connection with the pending arbitration proceedings, inVentiv has
asserted counterclaims against us for (i) breach of contract,
seeking at least $2 million in damages for services allegedly
performed by inVentiv; (ii) breach of contract, seeking at least $1
million in damages for CEL-SCI alleged use of inVentiv’s name
in connection with publications and promotions in violation of the
parties’ contract; (iii) opportunistic breach, restitution
and unjust enrichment, seeking at least $20 million in disgorgement
of alleged unjust profits allegedly made by CEL-SCI as a result of
the purported breaches referenced in subsection (ii); and (iv)
defamation, seeking at least $1 million in damages for allegedly
defamatory statements made about inVentiv.
26
Should
CEL-SCI’s allegations be found to be true, regulatory
authorities may rule the data collected by that the former CRO
unusable in support of our marketing applications. Even if
CEL-SCI’s allegations are not found to be true, regulatory
authorities may rule the data collected by that former CRO unusable
in support of our marketing applications. In either case, CEL-SCI
has proposed to enroll approximately 125 additional subjects in its
Phase 3 study beyond the study design that was in place prior to
FDA’s imposition of a partial clinical hold on the study, but
those additional subjects can only be enrolled if the partial
clinical hold is lifted. The need to enroll those additional
patients will cause additional delays in our clinical testing and
development program, and there is no guarantee that the partial
clinical hold will be lifted, that if the partial clinical hold is
lifted the study will be in a position that additional patients can
be recruited and enrolled, or that CEL-SCI can successfully enroll
the additional patients necessary to complete the study if the
clinical hold is lifted. Currently, the Phase 3 study has been
placed on partial clinical hold by FDA. In its partial clinical
hold letter, FDA identified the following specific deficiencies: a)
FDA stated that there is an unreasonable and significant risk of
illness or injury to human subjects; b) FDA stated that the
investigator brochure is misleading, erroneous, and materially
incomplete; and c) FDA stated that the plan or protocol is
deficient in design to meet its stated objectives. In its partial
clinical hold letter, FDA also identified the information needed to
resolve these deficiencies. In CEL-SCI’s response submitted
to FDA on November 18, 2016, CEL-SCI believes it addressed each of
the deficiencies identified by FDA, requested a face-to-face
meeting with FDA, and detailed its commitment to diligently work
with FDA in an effort to have the partial clinical hold for the
study lifted.
On December 8,
2016, the FDA advised CEL-SCI that the agency was denying CEL-SCI's
request for a meeting at this time because FDA's review of
CEL-SCI's November 17, 2016 response was ongoing. CEL-SCI was also
advised that it will be receiving a letter addressing CEL-SCI's
response by December 18, 2016.
If
the partial clinical hold is not ever lifted, the Phase 3 study
will not be able to be completed to its prespecified endpoints in a
timely manner, if at all, and, if the Phase 3 study cannot be
completed to its prespecified endpoints, the study would not be
able to be used as the pivotal study supporting a marketing
application in the United States, and at least one entirely new
Phase 3 pivotal study would need to be conducted to provide the
pivotal study supporting a marketing application in the United
States. Even if the partial clinical hold is lifted, if it is not
lifted in a timely fashion, the nature and duration of the partial
clinical hold could irreparably harm the data from the Phase 3
study such that it may no longer be able to be used as the pivotal
study supporting a marketing application in the United States. Even
if the partial clinical hold is lifted in a timely fashion, it
remains possible that the regulatory authorities could determine
that the Phase 3 study is not sufficient to be used as a single
pivotal study supporting a marketing application in the United
States. In either of these latter circumstances, at least one
entirely new Phase 3 pivotal study would need to be conducted to
provide the pivotal study supporting a marketing application in the
United States. If there is a need to conduct an additional Phase 3
pivotal study, any such requirement would have significant and
severe material consequences for CEL-SCI and could impact its
ability to continue as a going concern.
CEL-SCI could also encounter significant delays
and/or need to terminate a development program for a product
candidate if physicians encounter unresolved ethical issues
associated with enrolling patients in clinical trials of the
product candidates in addition to existing treatments that have
established safety and efficacy profiles. Further, a clinical trial
may be suspended or terminated by CEL-SCI, one or more of the IRBs
for the institutions in which such trials are being conducted, by
CEL-SCI upon a final recommendation by the Independent Data
Monitoring Committee, or IDMC, with which CEL-SCI agrees for such
trial, or by FDA or other regulatory authorities due to a number of
factors, including failure to conduct the clinical trial in
accordance with regulatory requirements or the clinical protocols,
as a result of inspection of the clinical trial operations or trial
site(s) by FDA or other regulatory authorities, the imposition of a
clinical hold
or
partial clinical hold such as the partial clinical hold currently
imposed by FDA on the Phase 3 study of our investigational drug
Multikine as detailed elsewhere in this prospectus supplement,
unforeseen safety issues or adverse side effects, failure to
demonstrate a benefit from using a product candidate, changes in
governmental regulations or administrative actions or lack of
adequate funding to continue the clinical trial. The occurrence of
any one or more of these events would have significant and severe
material consequences for us and could impact our ability to
continue as an ongoing concern.
27
If
CEL-SCI experiences termination of, or delays in the completion of,
any clinical trial of its product candidates, the commercial
prospects for the product candidates will be harmed, and the
ability to generate product revenues will be delayed. In addition,
any delays in completing the clinical trials will increase the
costs, slow the product development and approval process and
jeopardize the ability to commence product sales and generate
revenues. Any of these occurrences may harm CEL-SCI’s
business, prospects, financial condition and results of operations
significantly. Many of the factors that cause, or lead to, a delay
in the commencement or completion of clinical trials may also
ultimately lead to a delay or the denial of regulatory approval for
the product candidates.
CEL-SCI
cannot be certain when or under what conditions it will undertake
future clinical trials. A variety of issues may delay
the Phase 3 clinical trial for Multikine, such as patients in the
Phase 3 clinical trial dying at a slower rate than projected and
the existing partial clinical hold, or preclinical and early
clinical trials for the other product candidates. For
example, early trials, or the plans for later trials, may not
satisfy the requirements of regulatory authorities, such as the
FDA. CEL-SCI may fail to find subjects willing to enroll in the
trials. CEL-SCI manufactures Multikine in its manufacturing
facility, but relies on third-party vendors to manage the trial
process and other activities, and these vendors may fail to meet
appropriate standards. Accordingly, the clinical trials
relating to the product candidates may not be completed on
schedule, the FDA or foreign regulatory agencies may order CEL-SCI
to stop or modify research, or these agencies may not ultimately
approve any of the product candidates for commercial sale. Varying
interpretations of the data obtained from pre-clinical and clinical
testing could delay, limit or prevent regulatory approval of the
product candidates. The data collected from the clinical trials may
not be sufficient to support regulatory approval of the various
product candidates, including Multikine. The failure to adequately
demonstrate the safety and efficacy of any of the product
candidates would delay or prevent regulatory approval of the
product candidates in the United States, which could prevent
CEL-SCI from achieving profitability. Although CEL-SCI had positive
results in the Phase 2 trials for Multikine, those results were for
a very small sample set, and CEL-SCI will not know how Multikine
will perform in a larger set of subjects until CEL-SCI is well
into, or completes, the Phase 3 clinical trial.
The
development and testing of product candidates and the process of
obtaining regulatory approvals and the subsequent compliance with
appropriate federal, state, local and foreign statutes and
regulations require the expenditure of substantial time and
financial resources. Failure to comply with the
applicable U.S. requirements at any time during the product
development process, approval process or after approval, may
subject an applicant to administrative or judicial sanctions. FDA
sanctions could include, among other actions, refusal to approve
pending applications, withdrawal of an approval, a clinical hold,
termination of the Phase 3 study, warning letters, product recalls
or withdrawals from the market, product seizures, total or partial
suspension of production or distribution, injunctions, fines,
refusals of government contracts, restitution, disgorgement or
civil or criminal penalties. Any agency or judicial enforcement
action could have a material adverse effect on
CEL-SCI.
The
requirements governing the conduct of clinical trials,
manufacturing and marketing of the product candidates, including
Multikine, outside the United States vary from country to country.
Foreign approvals may take longer to obtain than FDA approvals and
can require, among other things, additional testing and different
trial designs. Foreign regulatory approval processes include all of
the risks associated with the FDA approval process. Some of those
agencies also must approve prices for products approved for
marketing. Approval of a product by the FDA or the EMA does not
ensure approval of the same product by the health authorities of
other countries. In addition, changes in regulatory requirements
for product approval in any country during the clinical trial
process and regulatory agency review of each submitted new
application may cause delays or rejections.
28
CEL-SCI
has only limited experience in filing and pursuing applications
necessary to gain regulatory approvals. The lack of
experience may impede the ability to obtain timely approvals from
regulatory agencies, if at all. CEL-SCI will not be able to
commercialize Multikine and other product candidates until CEL-SCI
has obtained regulatory approval. In addition,
regulatory authorities may also limit the types of patients to
which CEL-SCI or its third-party partners may market Multikine or
the other product candidates. Any failure to obtain or any delay in
obtaining required regulatory approvals may adversely affect
CEL-SCI’s or its third-party partners’ ability to
successfully market the product candidates.
Even if CEL-SCI obtains regulatory approval for its investigational
products, CEL-SCI will be subject to stringent, ongoing government
regulation.
If
CEL-SCI’s investigational products receive regulatory
approval, either in the United States or internationally, those
products will be subject to limitations on the approved indicated
uses for which the product may be marketed or to the conditions of
approval, and may contain requirements for potentially costly
post-marketing testing, including Phase 4 clinical trials, and
surveillance of the safety and efficacy of the investigational
products. CEL-SCI will continue to be subject to
extensive regulatory requirements. These regulations are
wide-ranging and govern, among other things:
●
product
design, development and manufacture;
●
product
application and use
●
adverse
drug experience;
●
product
advertising and promotion;
●
product
manufacturing, including good manufacturing practices
●
record
keeping requirements;
●
registration
and listing of the establishments and products with the FDA, EMA
and other state and national agencies;
●
product
storage and shipping;
●
drug
sampling and distribution requirements;
●
electronic
record and signature requirements; and
●
labeling
changes or modifications.
29
CEL-SCI
and any of its third-party manufacturers or suppliers must
continually adhere to federal regulations setting forth
requirements, known as current, Good Manufacturing Practices, or
cGMPs, and their foreign equivalents, which are enforced by the
FDA, the EMA and other national regulatory bodies through their
facilities inspection programs. If the facilities, or the
facilities of the contract manufacturers or suppliers, cannot pass
a pre-approval plant inspection or fail such inspections in the
future, the FDA, EMA or other national regulators will not approve
the marketing applications for the product candidates, or may
withdraw any prior approval. In complying with cGMP and foreign
regulatory requirements, CEL-SCI and any of its potential
third-party manufacturers or suppliers will be obligated to expend
time, money and effort in production, record-keeping and quality
control to ensure that the product candidates meet applicable
specifications and other requirements.
If
CEL-SCI does not comply with regulatory requirements at any stage,
whether before or after marketing approval is obtained, CEL-SCI may
be subject to, among other things, license suspension or
revocation, criminal prosecution, seizure, injunction, fines, be
forced to remove a product from the market or experience other
adverse consequences, including restrictions or delays in obtaining
regulatory marketing approval for such products or for other
product candidates for which CEL-SCI seeks
approval. This could materially harm CEL-SCI’s
financial results, reputation and stock price. Additionally,
CEL-SCI may not be able to obtain the labeling claims necessary or
desirable for product promotion. If CEL-SCI or other parties
identify adverse effects after any of the products are on the
market, or if manufacturing problems occur, regulatory approval may
be suspended or withdrawn. CEL-SCI may be required to reformulate
products, conduct additional clinical trials, make changes in
product labeling or indications of use, or submit additional
marketing applications to support any changes. If
CEL-SCI encounters any of the foregoing problems, its business and
results of operations will be harmed and the market price of its
common stock may decline.
The
FDA and other governmental authorities’ policies may change
and additional government regulations may be enacted that could
prevent, limit or delay regulatory approval of CEL-SCI’s
product candidates. If CEL-SCI is slow or unable to adapt to
changes in existing requirements or the adoption of new
requirements or policies, or if CEL-SCI is not able to maintain
regulatory compliance, CEL-SCI may lose any marketing approval that
it may have obtained, which would adversely affect its business,
prospects and ability to achieve or sustain
profitability. CEL-SCI cannot predict the extent of
adverse government regulations which might arise from future
legislative or administrative action. Without government approval,
CEL-SCI will be unable to sell any of its product
candidates.
CEL-SCI’s product candidates may cause undesirable side
effects or have other properties that could delay or prevent their
regulatory approval, limit the commercial profile of an approved
label, or result in significant negative consequences following
marketing approval, if any.
Undesirable
side effects caused by the product candidates could cause CEL-SCI
or regulatory authorities to interrupt, delay or halt clinical
trials and could result in a more restrictive label or the delay or
denial of regulatory approval by the FDA or other comparable
foreign authorities. Results of the clinical trials could reveal a
high and unacceptable severity and/or prevalence of these or other
side effects. In such an event, the trials could be suspended or
terminated and the FDA or comparable foreign regulatory authorities
could order CEL-SCI to cease further development of, or deny
approval of, the product candidates for any or all targeted
indications. The drug-related side effects could affect patient
recruitment or the ability of enrolled patients to complete the
trial or result in potential product liability claims. Any of these
occurrences may harm CEL-SCI’s business, financial condition
and prospects significantly.
30
Additionally,
if one or more of the product candidates receives marketing
approval, and CEL-SCI or others later identify undesirable side
effects caused by such products, a number of potentially
significant negative consequences could result,
including:
●
regulatory
authorities may withdraw approvals of such product;
●
regulatory
authorities may require additional warnings on the
label;
●
CEL-SCI
may be required to create a medication guide outlining the risks of
such side effects for distribution to patients;
●
CEL-SCI
could be sued and held liable for harm caused to patients;
and
●
CEL-SCI’s
reputation may suffer.
Any
of these events could prevent CEL-SCI from achieving or maintaining
market acceptance of a particular product candidate, if approved,
and could significantly harm its business, results of operations
and prospects.
CEL-SCI relies on third parties to conduct its preclinical and
clinical trials. If these third parties do not successfully carry
out their contractual duties and meet regulatory requirements, or
meet expected deadlines, CEL-SCI may not be able to obtain
regulatory approval for or commercialize the product candidates and
its business could be substantially harmed.
CEL-SCI
has relied upon and plans to continue to rely upon third-party CROs
to prepare for, conduct, monitor and manage data for its ongoing
preclinical and clinical programs. CEL-SCI relies on these parties
for all aspects of the execution of its preclinical studies and
clinical trials, and although CEL-SCI diligently oversees and
carefully manages the CROs, CEL-SCI directly controls only certain
aspects of their activities and relies upon them to provide timely,
complete, and accurate reports on the conduct of the studies.
Although such third parties provide support and represent CEL-SCI
for regulatory purposes in the context of the clinical trials,
ultimately CEL-SCI is responsible for ensuring that each of the
studies is conducted in accordance with the applicable protocol,
legal, regulatory, and scientific standards, and the reliance on
the CROs does not relieve CEL-SCI of its regulatory
responsibilities. CEL-SCI and the CROs acting on CEL-SCI’s
behalf as well as principal investigators and trial sites are
required to comply with Good Clinical Practice, or GCP, and other
applicable requirements, which are implemented through regulations
and guidelines enforced by the FDA, the Competent Authorities of
the Member States of the European Economic Area, or EEA, and
comparable foreign regulatory authorities for all of the products
in clinical development. Regulatory authorities enforce these GCPs
through periodic inspections of trial sponsors, principal
investigators, and trial sites. If CEL-SCI or any of the CROs fail
to comply with applicable GCPs or other applicable regulations, the
clinical data generated in the clinical trials may be determined to
be unreliable and CEL-SCI may therefore need to enroll additional
subjects in the clinical trials, or the FDA, EMA or comparable
foreign regulatory authorities may require CEL-SCI to perform an
additional clinical trial or trials before approving the marketing
applications. Moreover, if CEL-SCI or any of the CROs, principal
investigators, or trial sites, fail to comply with applicable
regulatory and GCP requirements, then CEL-SCI, the CROs, principal
investigators, or trial sites may be subject to enforcement
actions, such as fines, warning letters, untitled letters, clinical
holds, civil or criminal penalties, and/or injunctions. CEL-SCI
cannot assure you that upon inspection by a given regulatory
authority, such regulatory authority will determine that any of the
clinical trials comply with GCP regulations. In addition, the
clinical trials must be conducted with product produced under GMP
regulations. The failure to comply with these regulations may
require CEL-SCI to delay or repeat clinical trials, which would
delay the regulatory approval process.
31
For
example, CEL-SCI is currently involved in a dispute with the former
CRO relating to the conduct of the Phase 3 study where CEL-SCI
alleges (i) breach of contract, (ii) fraud in the inducement and
(iii) fraud. In connection with this dispute, CEL-SCI has alleged
that the CRO failed to properly select, monitor and supervise the
study sites and principal investigators, ensure proper enrollment
of subjects, and ensure strict compliance with the Phase 3 trial
protocol and GCP and other applicable regulatory requirements.
Should CEL-SCI’s allegations be found to be true regulatory
authorities may rule the data collected by that former CRO unusable
in support of the marketing applications. This would result in
CEL-SCI having to enroll approximately 125 additional subjects in
the Phase 3 study beyond its current plans, which could cause
additional delays in the clinical testing and development program.
Currently the Phase 3 study is on partial clinical
hold.
If
any of the relationships with the third-party CROs terminate,
CEL-SCI may not be able to enter into arrangements with alternative
CROs or to do so on commercially reasonable terms. In addition, the
CROs are not CEL-SCI’s employees, and except for remedies
available to CEL-SCI under the agreements with such CROs, CEL-SCI
cannot control whether or not they devote sufficient time and
resources to the on-going clinical, nonclinical and preclinical
programs. If CROs do not successfully fulfill their regulatory
obligations, carry out their contractual duties or obligations or
meet expected deadlines, if they need to be replaced or if the
quality or accuracy of the clinical data they obtain is compromised
due to the failure to adhere to the clinical protocols, regulatory
requirements or for other reasons, the clinical trials may be
extended, delayed or terminated, and CEL-SCI may not be able to
obtain regulatory approval for or successfully commercialize the
product candidates. As a result, CEL-SCI’s results of
operations and the commercial prospects for the product candidates
would be harmed, the costs could increase and the ability to
generate revenues could be delayed.
Switching
or adding additional CROs involves additional cost and requires
management time and focus. In addition, there is a natural
transition period when a new CRO commences work. As a result,
delays may occur, which can materially impact CEL-SCI’s
ability to meet the desired clinical development timelines. Though
CEL-SCI diligently oversees and carefully manages its relationships
with the CROs, there can be no assurance that CEL-SCI will not
encounter similar challenges or delays in clinical development in
the future or that these delays or challenges will not have a
material adverse impact on CEL-SCI’s business, financial
condition and prospects.
32
CEL-SCI has obtained orphan drug designation from the FDA for
Multikine for neoadjuvant, or primary, therapy in patients with
squamous cell carcinoma of the head and neck, but CEL-SCI may be
unable to maintain the benefits associated with orphan drug
designation, including the potential for market
exclusivity.
Under
the Orphan Drug Act, the FDA may grant orphan drug designation to a
drug or biologic intended to treat a rare disease or condition,
which is defined as one occurring in a patient population of fewer
than 200,000 in the United States, or a patient population greater
than 200,000 in the United States where there is no reasonable
expectation that the cost of developing the drug or biologic will
be recovered from sales in the United States. In the United States,
orphan drug designation entitles a party to financial incentives
such as opportunities for grant funding towards clinical trial
costs, tax advantages and user-fee waivers. In addition, if a
product that has orphan drug designation subsequently receives the
first FDA approval for the disease for which it has such
designation, the product is entitled to orphan drug exclusivity,
which means that the FDA may not approve any other applications,
including a full Biologics License Application, or BLA, to market
the same biologic for the same indication for seven years, except
in limited circumstances, such as a showing of clinical superiority
to the product with orphan drug exclusivity or where the
manufacturer is unable to assure sufficient product
quantity.
Even
though CEL-SCI has received orphan drug designation for Multikine
for the treatment of squamous cell carcinoma of the head and neck,
CEL-SCI may not be the first to obtain marketing approval of a
product for the orphan-designated indication due to the
uncertainties associated with developing pharmaceutical products.
In addition, exclusive marketing rights in the United States may be
limited if CEL-SCI seeks approval for an indication broader than
the orphan-designated indication, or may be lost if the FDA later
determines that the request for designation was materially
defective or if CEL-SCI is unable to assure sufficient quantities
of the product to meet the needs of patients with the rare disease
or condition. Further, even if CEL-SCI obtains orphan drug
exclusivity for a product candidate, that exclusivity may not
effectively protect the product candidate from competition because
different drugs with different active moieties can be approved for
the same condition. Even after an orphan product is approved, the
FDA can subsequently approve another drug with the same active
moiety for the same condition if the FDA concludes that the later
drug is safer, more effective, or makes a major contribution to
patient care. Orphan drug designation neither shortens the
development time or regulatory review time of a drug nor gives the
drug any advantage in the regulatory review or approval
process.
The current and future relationships with healthcare professionals,
principal investigators, consultants, customers (actual and
potential) and third-party payors in the United States and
elsewhere may be subject, directly or indirectly, to applicable
healthcare laws and regulations.
Healthcare
providers, physicians and third-party payors in the United States
and elsewhere will play a primary role in the recommendation and
prescription of any drug candidates for which CEL-SCI obtains
marketing approval. The current and future arrangements with
healthcare professionals, principal investigators, consultants,
customers (actual and potential) and third-party payors may expose
CEL-SCI to broadly applicable healthcare laws, including, without
limitation:
●
the
federal Anti-Kickback Statute, which prohibits, among other things,
persons from knowingly and willfully soliciting, offering,
receiving or providing remuneration, directly or indirectly, in
cash or in kind, to induce or reward, or in return for, either the
referral of an individual for, or the purchase, lease, order or
recommendation of, any good, facility, item or service, for which
payment may be made, in whole or in part, under federal and state
healthcare programs such as Medicare and Medicaid. A person or
entity does not need to have actual knowledge of the statute or
specific intent to violate it to have committed a violation. In
addition, the Affordable Care Act provides that the government may
assert that a claim including items or services resulting from a
violation of the federal Anti-Kickback Statute constitutes a false
or fraudulent claim for purposes of the False Claims
Act;
33
●
federal
civil and criminal false claims laws, including the federal False
Claims Act, which impose criminal and civil penalties, including
civil whistleblower actions, against individuals or entities for,
among other things, knowingly presenting, or causing to be
presented, to the federal government, including the Medicare and
Medicaid programs, claims for payment that are false or fraudulent
or making a false statement to avoid, decrease or conceal an
obligation to pay money to the federal government;
●
the
civil monetary penalties statute, which imposes penalties against
any person or entity who, among other things, is determined to have
presented or caused to be presented a claim to a federal health
program that the person knows or should know is for an item or
service that was not provided as claimed or is false or
fraudulent;
●
the
federal Health Insurance Portability and Accountability Act of
1996, or HIPAA, which created new federal criminal statutes that
prohibit knowingly and willfully executing, or attempting to
execute, a scheme to defraud any healthcare benefit program or
obtain, by means of false or fraudulent pretenses, representations
or promises, any of the money or property owned by, or under the
custody or control of, any healthcare benefit program, regardless
of the payor (e.g., public or private), knowingly and willfully
embezzling or stealing from a health care benefit program,
willfully obstructing a criminal investigation of a healthcare
offense and knowingly and willfully falsifying, concealing or
covering up by any trick or device a material fact or making any
materially false statements in connection with the delivery of, or
payment for, healthcare benefits, items or services relating to
healthcare matters. A person or entity does not need to have actual
knowledge of the statute or specific intent to violate it to have
committed a violation;
●
HIPAA,
as amended by the Health Information Technology for Economic and
Clinical Health Act of 2009, or HITECH, and their respective
implementing regulations, which impose obligations on covered
entities, including healthcare providers, health plans, and
healthcare clearinghouses, as well as their respective business
associates that create, receive, maintain or transmit individually
identifiable health information for or on behalf of a covered
entity, with respect to safeguarding the privacy, security and
transmission of individually identifiable health
information;
●
the
federal Physician Payments Sunshine Act and its implementing
regulations, which imposed annual reporting requirements for
certain manufacturers of drugs, devices, biologicals and medical
supplies for payments and “transfers of value” provided
to physicians and teaching hospitals, as well as ownership and
investment interests held by physicians and their immediate family
members; and
●
analogous
state and foreign laws, such as state anti-kickback and false
claims laws, which may apply to sales or marketing arrangements and
claims involving healthcare items or services reimbursed by
non-governmental third-party payors, including private insurers;
state laws that require pharmaceutical companies to comply with the
pharmaceutical industry’s voluntary compliance guidelines and
the relevant compliance guidance promulgated by the federal
government or otherwise restrict payments that may be made to
healthcare providers; state and foreign laws that require drug
manufacturers to report information related to payments and other
transfers of value to physicians and other healthcare providers or
marketing expenditures; and state and foreign laws governing the
privacy and security of health information in certain
circumstances, many of which differ from each other in significant
ways and often are not preempted by HIPAA, thus complicating
compliance efforts.
34
Efforts
to ensure that the future business arrangements with third parties
will comply with applicable healthcare laws and regulations may
involve substantial costs. It is possible that governmental
authorities will conclude that the business practices may not
comply with current or future statutes, regulations or case law
involving applicable fraud and abuse or other healthcare laws. If
CEL-SCI’s operations are found to be in violation of any of
these laws or any other governmental regulations, CEL-SCI may be
subject to significant civil, criminal and administrative
penalties, including, without limitation, damages, fines,
imprisonment, exclusion from participation in government healthcare
programs, such as Medicare and Medicaid, and the curtailment or
restructuring of the operations, all of which could significantly
harm CEL-SCI’s business. If any of the physicians or other
healthcare providers or entities with whom CEL-SCI expects to do
business, including current and future collaborators, are found not
to be in compliance with applicable laws, they may be subject to
criminal, civil or administrative sanctions, including exclusions
from participation in government healthcare programs, which could
also adversely affect CEL-SCI’s business.
Failure to obtain or maintain adequate coverage and reimbursement
for the product candidates, if approved, could limit the ability to
market those products and decrease CEL-SCI’s ability to
generate revenue.
Sales
of CEL-SCI’s product candidates will depend substantially,
both domestically and abroad, on the extent to which the costs of
the product candidates will be paid by health maintenance, managed
care, pharmacy benefit, and similar healthcare management
organizations, or reimbursed by government authorities, private
health insurers and other third-party payors. CEL-SCI anticipates
that government authorities and other third-party payors will
continue efforts to contain healthcare costs by limiting the
coverage and reimbursement levels for new drugs. If coverage and
reimbursement are not available, or are available only to limited
levels, CEL-SCI may not be able to successfully commercialize its
product candidates. Even if coverage is provided, the approved
reimbursement amount may not be high enough to allow CEL-SCI to
establish or maintain pricing sufficient to realize a return on its
investment. It is difficult to predict at this time what
third-party payors will decide with respect to the coverage and
reimbursement for the product candidates.
35
Healthcare legislative reform measures may have a material adverse
effect on CEL-SCI’s business and results of
operations.
In
the United States, there have been and continue to be a number of
legislative initiatives to contain healthcare costs that may result
in more limited coverage or downward pressure on the price CEL-SCI
may otherwise receive for its product candidates. For example, in
March 2010, the Patient Protection and Affordable Care Act, as
amended by the Health Care and Education Reconciliation Act, or
collectively, the Affordable Care Act, was passed, which
substantially changes the way health care is financed by both
governmental and private insurers, and significantly impacts the
U.S. pharmaceutical industry. The Affordable Care Act, among other
things, addressed a new methodology by which rebates owed by
manufacturers under the Medicaid Drug Rebate Program are calculated
for drugs that are inhaled, infused, instilled, implanted or
injected, increased the minimum Medicaid rebates owed by
manufacturers under the Medicaid Drug Rebate Program and extended
the rebate program to individuals enrolled in Medicaid managed care
organizations, established annual fees and taxes on manufacturers
of certain branded prescription drugs, and established the Center
for Medicare and Medicaid Innovation with broad authority to test
and implement new payment models under Medicare and Medicaid, which
are designed to reduce expenditures while preserving and enhancing
quality of care.
In
addition, other legislative changes have been proposed and adopted
in the United States since the Affordable Care Act was enacted. On
August 2, 2011, the Budget Control Act of 2011 among other things,
created measures for spending reductions by Congress. A Joint
Select Committee on Deficit Reduction, tasked with recommending a
targeted deficit reduction of at least $1.2 trillion for the years
2013 through 2021, was unable to reach required goals, thereby
triggering the legislation's automatic reduction to several
government programs. This includes aggregate reductions of Medicare
payments to providers of 2% per fiscal year, which went into effect
in April 2013 and, due to subsequent legislative amendments to the
statute, will remain in effect through 2024 unless additional
Congressional action is taken. On January 2, 2013, President Obama
signed into law the American Taxpayer Relief Act of 2012, which,
among other things, further reduced Medicare payments to several
providers, including hospitals, imaging centers and cancer
treatment centers. On April 16, 2015, President Obama signed into
law the Medicare Access and CHIP Reauthorization Act of 2015, or
MACRA. Among other things, MACRA creates incentives for physicians
to participate in alternative payment models under Medicare that
emphasize quality and value in place of the traditional,
volume-based fee-for-service program. CEL-SCI expects that
additional state and federal healthcare reform measures will be
adopted in the future, any of which could limit the amounts that
federal and state governments will pay for healthcare products and
services, which could result in reduced demand for its product
candidates or additional pricing pressures.
Foreign governments often impose strict price controls, which may
adversely affect CEL-SCI’s future profitability.
CEL-SCI
intends to seek approval to market Multikine in both the United
States and foreign jurisdictions. If CEL-SCI obtains approval in
one or more foreign jurisdictions, CEL-SCI will be subject to rules
and regulations in those jurisdictions relating to Multikine. In
some foreign countries, particularly in the European Union,
prescription drug pricing is subject to governmental control. In
these countries, pricing negotiations with governmental authorities
can take considerable time after the receipt of marketing approval
for a drug candidate. Coverage and reimbursement decisions in one
foreign jurisdiction may impact decisions in other countries. To
obtain reimbursement or pricing approval in some countries, CEL-SCI
may be required to conduct clinical trials that demonstrate the
product candidate is more effective than current treatments and
that compare the cost-effectiveness of Multikine to other available
therapies. If reimbursement of Multikine is unavailable or limited
in scope or amount, or if pricing is set at unsatisfactory levels,
CEL-SCI may be unable to achieve or sustain
profitability.
36
Risks Related to Intellectual Property
CEL-SCI may not be able to achieve or maintain a competitive
position, and other technological developments may result in its
proprietary technologies becoming uneconomical or
obsolete.
CEL-SCI
is involved in a biomedical field that is undergoing rapid and
significant technological change. The pace of change continues to
accelerate. The successful development of product
candidates from the compounds, compositions and processes, through
research financed by CEL-SCI, or as a result of possible
third-party licensing arrangements with pharmaceutical or other
companies, is not assured. CEL-SCI may fail to apply for
patents on important technologies or product candidates in a timely
fashion, or at all.
Many
companies are working on drugs designed to cure or treat cancer or
cure and treat viruses, such as HPV or H1N1. Many of
these companies have financial, research and development, and
marketing resources, which are much greater than CEL-SCI’s,
and are capable of providing significant long-term competition
either by establishing in-house research groups or by forming
collaborative ventures with other entities. In addition, smaller
companies and non-profit institutions are active in research
relating to cancer and infectious diseases. The future
market share of Multikine or the other product candidates, if
approved, will be reduced or eliminated if the competitors develop
and obtain approval for products that are safer or more effective
than CEL-SCI’S product candidates. Moreover, the
patent positions of pharmaceutical companies are highly uncertain
and involve complex legal and factual questions for which important
legal principles are often evolving and remain unresolved. As a
result, the validity and enforceability of patents cannot be
predicted with certainty. In addition, CEL-SCI does not know
whether:
●
CEL-SCI
was the first to make the inventions covered by each of its issued
patents and pending patent applications;
●
CEL-SCI
was the first to file patent applications for these
inventions;
●
others
will independently develop similar or alternative technologies or
duplicate any of the technologies;
●
any
of the pending patent applications will result in issued
patents;
●
any
of the patents will be valid or enforceable;
●
any
patents issued to CEL-SCI or the collaboration partners will
provide CEL-SCI with any competitive advantages, or will be
challenged by third parties;
37
●
CEL-SCI
will be able to develop additional proprietary technologies that
are patentable;
●
the
U.S. government will exercise any of its statutory rights to
CEL-SCI’s intellectual property that was developed with
government funding; or
●
its
business may infringe the patents or other proprietary rights of
others.
CEL-SCI’s patents might not protect its technology from
competitors, in which case CEL-SCI may not have any advantage over
competitors in selling any products that CEL-SCI may
develop.
CEL-SCI’s
commercial success will depend in part on its ability to obtain
additional patents and protect its existing patent position, as
well as its ability to maintain adequate intellectual property
protection for the technologies, product candidates, and any future
products in the United States and other countries. If CEL-SCI does
not adequately protect its technology, product candidates and
future products, competitors may be able to use or practice them
and erode or negate any competitive advantage CEL-SCI may have,
which could harm CEL-SCI’s business and ability to achieve
profitability. The laws of some foreign countries do not protect
the proprietary rights to the same extent or in the same manner as
U.S. laws, and CEL-SCI may encounter significant problems in
protecting and defending its proprietary rights in these countries.
CEL-SCI will be able to protect its proprietary rights from
unauthorized use by third parties only to the extent that its
proprietary technologies, product candidates and any future
products are covered by valid and enforceable patents or are
effectively maintained as trade secrets.
Certain
aspects of CEL-SCI’s technologies are covered by U.S. and
foreign patents. In addition, CEL-SCI has a number of new patent
applications pending. There is no assurance that the applications
still pending or which may be filed in the future will result in
the issuance of any patents. Furthermore, there is no assurance as
to the breadth and degree of protection any issued patents might
afford CEL-SCI. Disputes may arise between CEL-SCI and others as to
the scope and validity of these or other patents. Any defense of
the patents could prove costly and time consuming and there can be
no assurance that CEL-SCI will be in a position, or will deem it
advisable, to carry on such a defense. A suit for patent
infringement could result in increasing costs, delaying or halting
development, or even forcing CEL-SCI to abandon a product
candidate. Other private and public concerns, including
universities, may have filed applications for, may have been
issued, or may obtain additional patents and other proprietary
rights to technology potentially useful or necessary to CEL-SCI.
CEL-SCI is not currently aware of any such patents, but the scope
and validity of such patents, if any, and the cost and availability
of such rights are impossible to predict.
Much of CEL-SCI’s intellectual property is protected as trade
secrets or confidential know-how, not as a patent.
CEL-SCI
considers proprietary trade secrets and/or confidential know-how
and unpatented know-how to be important to its
business. Much of the intellectual property pertains to
CEL-SCI’S manufacturing system, certain aspects of which may
not be suitable for patent filings and must be protected as trade
secrets and/or confidential know-how. This type of
information must be protected diligently by CEL-SCI to protect its
disclosure to competitors, since legal protections after disclosure
may be minimal or non-existent. Accordingly, much of the
value of this intellectual property is dependent upon the ability
of CEL-SCI to keep the trade secrets and know-how
confidential.
38
To
protect this type of information against disclosure or
appropriation by competitors, CEL-SCI’s policy is to require
its employees, consultants, contractors and advisors to enter into
confidentiality agreements with CEL-SCI. However, current or former
employees, consultants, contractors and advisers may
unintentionally or willfully disclose the confidential information
to competitors, and confidentiality agreements may not provide an
adequate remedy in the event of unauthorized disclosure of
confidential information. Enforcing a claim that a third party
obtained illegally, and is using, trade secrets and/or confidential
know-how is expensive, time consuming and unpredictable. The
enforceability of confidentiality agreements may vary from
jurisdiction to jurisdiction.
In
addition, in some cases a regulator considering the application for
product candidate approval may require the disclosure of some or
all of the proprietary information. In such a case,
CEL-SCI must decide whether to disclose the information or forego
approval in a particular country. If CEL-SCI is unable
to market its product candidates in key countries, CEL-SCI’s
opportunities and value may suffer.
Failure
to obtain or maintain trade secrets and/or confidential know-how
trade protection could adversely affect CEL-SCI’S competitive
position. Moreover, competitors may independently develop
substantially equivalent proprietary information and may even apply
for patent protection in respect of the same. If successful in
obtaining such patent protection, competitors could limit the use
of such trade secrets and/or confidential know-how.
CEL-SCI may be subject to claims challenging the inventorship or
ownership of its patents and other intellectual
property.
CEL-SCI
may also be subject to claims that former employees, collaborators
or other third parties have an ownership interest in its patents or
other intellectual property. CEL-SCI may be subject to ownership
disputes in the future arising, for example, from conflicting
obligations of consultants or others who are involved in developing
the product candidates. Litigation may be necessary to defend
against these and other claims challenging inventorship or
ownership. If CEL-SCI fails in defending any such claims, in
addition to paying monetary damages, CEL-SCI may lose valuable
intellectual property rights, such as exclusive ownership of, or
right to use, valuable intellectual property. Such an outcome could
have a material adverse effect on its business. Even if CEL-SCI is
successful in defending against such claims, litigation could
result in substantial costs and be a distraction to CEL-SCI’s
management and employees.
Risks Related to CEL-SCI’s common stock
You may experience future dilution as a result of future equity
offerings or other equity issuances.
CEL-SCI
expects that significant additional capital will be needed in the
future to continue its planned operations. To raise additional
capital, CEL-SCI may in the future offer additional shares of its
common stock or other securities convertible into or exchangeable
for the common stock. To the extent CEL-SCI
raises additional capital by issuing equity securities, the
stockholders may experience substantial dilution. These sales may
result in material dilution to CEL-SCI’s existing
stockholders and new investors could gain rights superior to
existing stockholders.
39
CEL-SCI’s outstanding options and warrants may adversely
affect the trading price of its common stock.
As
of September 30, 2016, there were outstanding warrants and options
which allow the holders to purchase 86,059,564 shares that may be
issued upon the exercise of outstanding warrants, with a weighted
average exercise price of $0.97 per share, and 8,589,287 shares
that may be issued upon the exercise of outstanding options, with a
weighted average exercise price of $2.37 per share. The outstanding
options and warrants could adversely affect the ability of CEL-SCI
to obtain future financing or engage in certain mergers or other
transactions, since the holders of options and warrants can be
expected to exercise them at a time when CEL-SCI may be able to
obtain additional capital through a new offering of securities on
terms more favorable to CEL-SCI than the terms of the outstanding
options and warrants. For the life of the options and
warrants, the holders have the opportunity to profit from a rise in
the market price of its common stock without assuming the risk of
ownership. The issuance of shares upon the exercise of
outstanding options and warrants will also dilute the ownership
interests of CEL-SCI’s existing stockholders.
CEL-SCI’s ability to utilize its net operating loss
carryforwards and certain other tax attributes may be
limited.
Under Section 382 of the Internal Revenue Code of
1986, as amended, if a corporation undergoes an “ownership
change” (generally defined as a greater than 50% change (by
value) in its equity ownership over a three-year period), the
corporation’s ability to use its pre-change net operating
loss carryforwards and other pre-change tax attributes to offset
its post-change income may be limited. Taking into account the
public offerings and other transactions, CEL-SCI may have triggered
an “ownership change” limitation. In addition, CEL-SCI
may experience ownership changes in the future as a result of
subsequent shifts in its stock ownership, some of which are outside
its control. As a result, the ability to use the pre-change net
operating loss carryforwards and other pre-change tax attributes to
offset U.S. federal taxable income may be subject to limitations,
which could result in increased tax liability to
CEL-SCI
.
Since CEL-SCI does not intend to pay dividends on its common stock,
any potential return to investors will result only from any
increases in the price of its common stock.
At
the present time, CEL-SCI intends to use available funds to finance
its operations. Accordingly, while payment of dividends rests
within the discretion of its board of directors, no common stock
dividends have been declared or paid by CEL-SCI and it has no
intention of paying any common stock dividends in the foreseeable
future. Additionally, any future debt financing arrangement may
contain terms prohibiting or limiting the amount of dividends that
may be declared or paid on CEL-SCI’s common
stock. Any return to CEL-SCI’s shareholders will
therefore be limited to appreciation in the price of its common
stock, which may never occur. If CEL-SCI’s stock
price does not increase, CEL-SCI’S shareholders are unlikely
to receive any return on their investments in CEL-SCI’s
common stock.
40
The price of CEL-SCI’s common stock has been volatile and is
likely to continue to be volatile, which could result in
substantial losses for CEL-SCI’s shareholders.
CEL-SCI’s
stock price has been, and is likely to continue to be, volatile. As
a result of this volatility, CEL-SCI’s shareholders may not
be able to sell their shares at or above its current market price.
The market price for CEL-SCI’s common stock may be influenced
by many factors, including:
●
actual
or anticipated fluctuations in CEL-SCI’s financial condition
and operating results;
●
actual
or anticipated changes in CEL-SCI’s growth rate relative to
competitors;
●
competition
from existing products or new products or product candidates that
may emerge;
●
development
of new technologies that may address the markets and may make
CEL-SCI’s technology less attractive;
●
changes
in physician, hospital or healthcare provider practices that may
make CEL-SCI’s product candidates less useful;
●
announcements
by CEL-SCI, its partners or competitors of significant
acquisitions, strategic partnerships, joint ventures,
collaborations or capital commitments;
●
developments
or disputes concerning patent applications, issued patents or other
proprietary rights;
●
the
recruitment or departure of key personnel;
●
failure
to meet or exceed financial estimates and projections of the
investment community or that CEL-SCI provides to the
public;
●
actual
or anticipated changes in estimates as to financial results,
development timelines or recommendations by securities
analysts;
●
variations
in its financial results or those of companies that are perceived
to be similar to CEL-SCI;
●
changes
to coverage and reimbursement levels by commercial third-party
payors and government payors, including Medicare, and any
announcements relating to reimbursement levels;
●
general
economic, industry and market conditions; and
●
the
other factors described in this “Risk Factors”
section.
CEL-SCI has been advised that it is not in compliance with certain
continued listing standards of the NYSE MKT.
On
December 9, 2016, CEL-SCI received a letter from the NYSE MKT, its
current listing exchange, which advised CEL-SCI that, based upon
its June 30, 2016 10-Q report, CEL-SCI was noncompliant with
certain continued listing standards of the NYSE MKT. CEL-SCI can
maintain its listing by submitting a plan of compliance by January
9, 2017. This plan must advise of actions CEL-SCI has taken or will
take to regain compliance with the continued listing standards by
June 11, 2018. CEL-SCI intends to submit such a plan by January 9,
2017. If the plan is not acceptable, or CEL-SCI does not make
sufficient progress under the plan to reestablish compliance by
June 11, 2018, the staff of the exchange may initiate proceedings
to delist CEL-SCI’s securities from the NYSE MKT. CEL-SCI may
appeal a delisting determination in accordance with the rules of
the exchange.
In
addition, the NYSE MKT will not normally remove the securities of
an issuer which is otherwise below the stockholders’ equity
criteria noted above if the issuer has a market capitalization of
at least $50 million.
The
letter from the NYSE MKT has no current effect on the listing of
CEL-SCI’s securities on the exchange.
Under its amended bylaws, stockholders that initiate certain
proceedings may be obligated to reimburse CEL-SCI and its officers
and directors for all fees, costs and expenses incurred in
connection with such proceedings if the claim proves
unsuccessful.
On
February 18, 2015, CEL-SCI adopted new bylaws which include a
fee-shifting provision in Article X for stockholder claims. Article
X provides that in the event any stockholder initiates or asserts a
claim against CEL-SCI, or any of its officers or directors,
including any derivative claim or claim purportedly filed on
CEL-SCI’s behalf, and the stockholder does not obtain a
judgment on the merits that substantially achieves, in substance
and amount, the full remedy sought, then the stockholder will be
obligated to reimburse CEL-SCI and any of its officers or directors
named in the action, for all fees, costs and expenses of every kind
and description that CEL-SCI or its officers or directors may incur
in connection with the claim. In adopting Article X, it
is the intent that:
41
●
all
actions, including federal securities law claims, would be subject
to Article X;
●
the
phrase “a judgment on the merits” means the
determination by a court of competent jurisdiction on the matters
submitted to the court;
●
the
phrase “substantially achieves, in both substance and
amount” means the plaintiffs in the action would be awarded
at least 90% of the relief sought;
●
only
persons who were stockholders at the time an action was brought
would be subject to Article X; and
●
only
the directors or officers named in the action would be allowed to
recover.
The
fee-shifting provision contained in Article X of the bylaws is not
limited to specific types of actions, but is rather potentially
applicable to the fullest extent permitted by law. Fee-shifting
bylaws are relatively new and untested. The case law and potential
legislative action on fee-shifting bylaws are evolving and there
exists considerable uncertainty regarding the validity of, and
potential judicial and legislative responses to, such bylaws. For
example, it is unclear whether the ability to invoke the
fee-shifting bylaw in connection with claims under the federal
securities laws would be pre-empted by federal law. Similarly, it
is unclear how courts might apply the standard that a claiming
stockholder must obtain a judgment that substantially achieves, in
substance and amount, the full remedy sought. The application of
the fee-shifting bylaw in connection with such claims, if any, will
depend in part on future developments of the law. CEL-SCI cannot
assure its shareholders that CEL-SCI will or will not invoke the
fee-shifting bylaw in any particular dispute. In addition, given
the unsettled state of the law related to fee-shifting bylaws, such
as CEL-SCI’s, CEL-SCI may incur significant additional costs
associated with resolving disputes with respect to such bylaw,
which could adversely affect its business and financial
condition.
If
a stockholder that brings any such claim, suit, action or
proceeding is unable to obtain the required judgment, the
attorneys’ fees and other litigation expenses that might be
shifted to a claiming stockholder are potentially significant. This
fee-shifting bylaw, therefore, may dissuade or discourage
stockholders (and their attorneys) from initiating lawsuits or
claims against CEL-SCI or its directors and officers. In
addition, it may impact the fees, contingency or otherwise,
required by potential plaintiffs’ attorneys to represent the
stockholders or otherwise discourage plaintiffs’ attorneys
from representing the stockholders at all. As a result, this bylaw
may limit the ability of stockholders to affect the management and
direction of CEL-SCI, particularly through litigation or the threat
of litigation.
The provision of the amended bylaws requiring exclusive venue in
the U.S. District Court for Delaware for certain types of lawsuits
may have the effect of discouraging lawsuits against CEL-SCI and
its directors and officers.
Article
X of CEL-SCI’s amended bylaws provides that stockholder
claims brought against CEL-SCI, or its officers or directors,
including any derivative claim or claim purportedly filed on
CEL-SCI’s behalf, must be brought in the U.S. District Court
for the district of Delaware and that with respect to any such
claim, the laws of Delaware will apply.
42
The
exclusive forum provision may limit a stockholder’s ability
to bring a claim in a judicial forum the stockholder finds
favorable for disputes with CEL-SCI or its directors or officers,
and may have the effect of discouraging lawsuits with respect to
claims that may benefit CEL-SCI or the stockholders.
None
CEL-SCI
leases office space at 8229 Boone Blvd., Suite 802, Vienna,
Virginia at a monthly rental of approximately $8,000. The lease on
the office space expires on June 30, 2020. CEL-SCI believes this
arrangement is adequate for the conduct of its present
business.
CEL-SCI
has a 17,900 square foot laboratory located in Baltimore, Maryland.
The laboratory is leased by CEL-SCI at a cost of approximately
$11,000 per month. The laboratory lease expires on February 28,
2022.
In
August 2007, CEL-SCI leased a building near Baltimore, Maryland.
The building, which consists of approximately 73,000 square feet,
has been remodeled in accordance with CEL-SCI’s
specifications so that it can be used by CEL-SCI to manufacture
Multikine for CEL-SCI’s Phase 3 clinical trial and sales of
the drug if approved by the FDA. The lease expires on October 31,
2028 and required annual base rent payments of approximately $1.6
million during the twelve months ending September 30, 2016. The
annual base rent escalates each year at 3% beginning on November
1st. CEL-SCI is also required to pay all real and personal property
taxes, insurance premiums, maintenance expenses, repair costs and
utilities, which were approximately $42,000 per month as of
September 30, 2016. The lease allows CEL-SCI, at its election, to
extend the lease for two ten-year periods or to purchase the
building at the end of the 20-year lease. The lease required
CEL-SCI to pay $3,150,000 towards the remodeling costs, which is
being recouped by reductions in the annual base rent of $303,228
beginning in fiscal year 2014. In August 2011, CEL-SCI was required
to deposit $1,670,917, the equivalent of one year of base rent. The
$1,670,917 was required to be deposited when the amount of
CEL-SCI’s cash had dropped below the amount stipulated in the
lease and is included in non-current assets at September 30,
2016.
CEL-SCI is
currently involved in a pending arbitration proceeding, CEL-SCI
Corporation v. inVentiv Health Clinical, LLC (f/k/a PharmaNet LLC)
and PharmaNet GmbH (f/k/a PharmaNet AG). CEL-SCI initiated the
proceedings against inVentiv Health Clinical LLC, or inVentiv,
CEL-SCI’s former third-party CRO, and is seeking payment for
damages related to inVentiv’s prior involvement in the Phase
3 clinical trial of Multikine. The arbitration claim, initiated
under the Commercial Rules of the American Arbitration Association,
alleges (i) breach of contract, (ii) fraud in the inducement, and
(iii) common law fraud.
Currently,
CEL-SCI seeks at least $50 million in damages in its amended
statement of claim.
43
In an
amended statement of claim, CEL-SCI asserted the claims set forth
above as well as an additional claim for professional
malpractice. The arbitrator subsequently granted
inVentiv’s motion to dismiss the professional malpractice
claim based on the “economic loss doctrine” which,
under New Jersey law, is a legal doctrine that, under certain
circumstances, prohibits bringing a negligence-based claim
alongside a claim for breach of contract. The arbitrator
denied the remainder of inVentiv’s motion, which had sought
to dismiss certain other aspects of the amended statement of
claim. In particular, the arbitrator rejected
inVentiv’s argument that several aspects of the amended
statement of claim were beyond the arbitrator’s
jurisdiction.
In
connection with the pending arbitration proceedings, inVentiv has
asserted counterclaims against CEL-SCI for (i) breach of contract,
seeking at least $2 million in damages for services allegedly
performed by inVentiv; (ii) breach of contract, seeking at least $1
million in damages for CEL-SCI’s alleged use of
inVentiv’s name in connection with publications and
promotions in violation of the parties’ contract; (iii)
opportunistic breach, restitution and unjust enrichment, seeking at
least $20 million in disgorgement of alleged unjust profits
allegedly made by CEL-SCI as a result of the purported breaches
referenced in subsection (ii); and (iv) defamation, seeking at
least $1 million in damages for allegedly defamatory statements
made about inVentiv. CEL-SCI believes inVentiv’s
counterclaims are meritless. However, if inVentiv successfully
asserts any of its counterclaims, such an adverse determination
could have a material adverse effect on CEL-SCI’s business,
results, financial condition and liquidity.
In
October 2015, CEL-SCI signed an arbitration funding agreement with
a company established by Lake Whillans Litigation Finance, LLC, a
firm specializing in funding litigation expenses. Pursuant to the
agreement, an affiliate of Lake Whillans provides CEL-SCI with
funding for litigation expenses to support its arbitration claims
against inVentiv. The funding is available to CEL-SCI to fund the
expenses of the ongoing arbitration and will only be repaid when
CEL-SCI receives proceeds from the arbitration.
The
arbitration hearing on the merits (the “trial”) began
on September 26, 2016.
Not
applicable.
As of
September 30, 2016 there were approximately 1,000 record holders of
CEL-SCI’s common stock. CEL-SCI’s common stock is
traded on the NYSE MKT under the symbol
“CVM”.
44
Shown
below are the range of high and low quotations for CEL-SCI’s
common stock for the periods indicated as reported on the NYSE MKT.
The market quotations reflect inter-dealer prices, without retail
mark-up, mark-down or commissions and may not necessarily represent
actual transactions.
|
Quarter Ending
|
High
|
Low
|
|
|
|
|
|
12/31/14
|
$
0.91
|
$
0.54
|
|
3/31/15
|
$
1.23
|
$
0.59
|
|
6/30/15
|
$
1.09
|
$
0.59
|
|
9/30/15
|
$
0.80
|
$
0.48
|
|
|
|
|
|
12/31/15
|
$
0.75
|
$
0.36
|
|
3/31/16
|
$
0.66
|
$
0.36
|
|
6/30/16
|
$
0.60
|
$
0.44
|
|
9/30/16
|
$
0.54
|
$
0.24
|
Holders
of common stock are entitled to receive dividends as may be
declared by CEL-SCI’s Board of Directors out of legally
available funds and, in the event of liquidation, to share pro rata
in any distribution of CEL-SCI’s assets after payment of
liabilities. CEL-SCI’s Board of Directors is not obligated to
declare a dividend. CEL-SCI has not paid any dividends on its
common stock and CEL-SCI does not have any current plans to pay any
common stock dividends.
The
provisions in CEL-SCI’s Articles of Incorporation relating to
CEL-SCI’s preferred stock allow CEL-SCI’s directors to
issue preferred stock with rights to multiple votes per share and
dividend rights which would have priority over any dividends paid
with respect to CEL-SCI’s common stock. The issuance of
preferred stock with such rights may make more difficult the
removal of management even if such removal would be considered
beneficial to shareholders generally, and will have the effect of
limiting shareholder participation in certain transactions such as
mergers or tender offers if such transactions are not favored by
incumbent management.
The
market price of CEL-SCI’s common stock, as well as the
securities of other biopharmaceutical and biotechnology companies,
have historically been highly volatile, and the market has from
time to time experienced significant price and volume fluctuations
that are unrelated to the operating performance of particular
companies. Factors such as fluctuations in CEL-SCI’s
operating results, announcements of technological innovations or
new therapeutic products by CEL-SCI or its competitors,
governmental regulation, developments in patent or other
proprietary rights, public concern as to the safety of products
which may be developed by CEL-SCI or other biotechnology and
pharmaceutical companies, and general market conditions may have a
significant effect on the market price of CEL-SCI’s common
stock.
The
graph below matches the cumulative 5-year total return of holders
of CEL-SCI’s common stock with the cumulative total returns
of the NYSE MTK Composite index and the RDG MicroCap Biotechnology
index. The graph assumes that the value of an investment in
CEL-SCI's common stock and in each of the indexes (including
reinvestment of dividends) was $100 on September 30, 2011 and
tracks it through September 30, 2016.
The
stock price performance included in this graph is not necessarily
indicative of future stock price performance.
45
|
|
|
9/11
|
9/12
|
9/13
|
9/14
|
9/15
|
9/16
|
|
|
|
|
|
|
|
|
|
|
CEL-SCI Corporation
|
|
100.00
|
94.52
|
46.58
|
24.98
|
16.44
|
8.36
|
|
NYSE MKT Composite
|
|
100.00
|
123.99
|
127.59
|
148.86
|
129.94
|
145.53
|
|
RDG MicroCap Biotechnology
|
|
100.00
|
166.25
|
182.33
|
136.22
|
97.34
|
52.30
|
46
The
following selected historical consolidated financial data are
qualified by reference to, and should be read in conjunction with
the consolidated financial statements and the related notes
thereto, appearing elsewhere in this report, as well as Item 7 of
this report.
|
|
2016
|
2015
|
2014
|
2013
|
2012
|
|
Grant
revenue and other
|
$
285,055
|
$
657,377
|
$
264,033
|
$
159,583
|
$
254,610
|
|
Operating
expenses:
|
|
|
|
|
|
|
Research
and development
|
19,351,779
|
21,098,147
|
17,172,587
|
12,934,121
|
10,814,405
|
|
General
and administrative
|
6,486,501
|
13,855,775
|
10,665,558
|
7,093,738
|
6,683,045
|
|
Gain
on derivative instruments
|
14,013,726
|
282,616
|
248,767
|
10,750,666
|
1,911,683
|
|
Loss
on debt extinguishment
|
-
|
(620,457
)
|
-
|
-
|
-
|
|
Interest
income (expense), net
|
73,001
|
(40,260
)
|
(40,920
)
|
(53,337
)
|
(146,153
)
|
|
Net
loss
|
(11,466,498
)
|
(34,674,646
)
|
(27,366,265
)
|
(9,170,947
)
|
(15,477,310
)
|
|
Issuance of additional shares due to reset
provision
|
(1,117,447
)
|
-
|
(250,000
)
|
||
|
Modification
of warrants
|
|
|
|
(59,531
)
|
(325,620
)
|
|
Inducement
warrants
|
-
|
-
|
-
|
-
|
(1,593,000
)
|
|
Net
loss available to common shareholders
|
$
(11,466,498
)
|
$
(34,674,646
)
|
$
(28,483,712
)
|
$
(9,230,478
)
|
$
(17,645,930
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss per common share
|
|
|
|
|
|
|
Basic
|
$
(0.09
)
|
$
(0.42
)
|
$
(0.48
)
|
$
(0.30
)
|
$
(0.70
)
|
|
Diluted
|
$
(0.09
)
|
$
(0.42
)
|
$
(0.49
)
|
$
(0.66
)
|
$
(0.78
)
|
|
Weighted average common shares
outstanding
|
|
|
|
|
|
|
Basic
and diluted
|
121,655,108
|
82,519,027
|
58,804,622
|
30,279,442
|
25,183,654
|
47
|
|
2016
|
2015
|
2014
|
2013
|
2012
|
|
|
|
|
|
|
|
|
Working
capital (deficit)
|
$
1,875,874
|
$
2,127,718
|
$
8,496,076
|
$
(1,033,370
)
|
$
5,529,438
|
|
Total
assets
|
$
11,598,247
|
$
15,447,603
|
$
19,230,434
|
$
10,838,572
|
$
16,067,450
|
|
Derivative
instruments (a)
|
$
8,394,934
|
$
13,686,587
|
$
5,505,246
|
$
433,024
|
$
6,983,690
|
|
Total
liabilities
|
$
12,554,315
|
$
20,532,722
|
$
8,787,034
|
$
4,138,482
|
$
9,040,018
|
|
Stockholders'
(deficit) equity
|
$
(956,068
)
|
$
(5,085,119
)
|
$
10,443,400
|
$
6,700,090
|
$
7,027,432
|
(a)
Included in total
liabilities.
CEL-SCI's
net loss available to common shareholders for each fiscal quarter
during the two years ended September 30, 2016 were:
|
|
|
Net income (loss) per share
|
|
|
Quarter
|
Net income (loss)
|
Basic
|
Diluted
|
|
|
|
|
|
|
12/31/15
|
$
2,341,813
|
$
0.02
|
$
0.02
|
|
3/31/16
|
$
(8,844,855
)
|
$
(0.07
)
|
$
(0.07
)
|
|
6/30/16
|
$
(3,849,324
)
|
$
(0.03
)
|
$
(0.03
)
|
|
9/30/16
|
$
(1,114,132
)
|
$
(0.01
)
|
$
(0.01
)
|
|
|
|
|
|
|
12/31/14
|
$
(7,845,318
)
|
$
(0.11
)
|
$
(0.14
)
|
|
3/31/2015
|
$
(12,556,236
)
|
$
(0.17
)
|
$
(0.17
)
|
|
6/30/2015
|
$
(4,429,137
)
|
$
(0.05
)
|
$
(0.06
)
|
|
9/30/2015
|
$
(9,843,955
)
|
$
(0.10
)
|
$
(0.10
)
|
Variances
in quarterly gains and losses for the quarters presented are caused
by the changes in the fair value of outstanding warrants accounted
for as derivatives each quarter. These changes in the fair
value of the warrants are recorded on the statements of
operations.
48
The
following discussion should be read in conjunction with the
financial statements and the related notes thereto appearing
elsewhere in this report.
CEL-SCI’s
lead investigational therapy, Multikine, is cleared for a Phase 3
clinical trial in advanced primary head and neck cancer. It has
received a go-ahead by the U.S. FDA as well as twenty-three other
countries.
On
September 26, 2016, CEL-SCI received verbal notice from the FDA
that the Phase 3 clinical trial in advanced primary head and neck
cancer has been placed on clinical hold. Pursuant to this
communication from FDA, patients currently receiving study
treatments can continue to receive treatment, and patients already
enrolled in the study will continue to be followed.
On
October 21, 2016, CEL-SCI issued a press release stating the
following: “following up on our press release issued on
September 26, 2016, we have received the Partial Clinical Hold
letter from the U.S. Food and Drug Administration (FDA).
On
November 21, 2016, CEL-SCI announced that it had submitted a
response to FDA’s Partial Clinical Hold letter referenced
above.
CEL-SCI
also owns and is developing a pre-clinical technology called
LEAPS.
All of
CEL-SCI’s projects are under development. As a result,
CEL-SCI cannot predict when it will be able to generate any revenue
from the sale of any of its products.
Since
inception, CEL-SCI has financed its operations through the issuance
of equity securities, convertible notes, loans and certain research
grants. CEL-SCI’s expenses will likely exceed its revenues as
it continues the development of Multikine and brings other drug
candidates into clinical trials. Until such time as CEL-SCI becomes
profitable, any or all of these financing vehicles or others may be
utilized to assist CEL-SCI’s capital
requirements.
Results of Operations
Fiscal 2016
During
the year ended September 30, 2016, grant and other income decreased
by approximately $372,000 compared to the year ended September 30,
2015. The decrease is primarily due to the timing of drug shipments
to supply the Company’s partner in Taiwan and the grant
income earned by the Company’s Small Business Innovation
Research (SBIR) grant during fiscal year 2016 compared to fiscal
year 2015.
During
the year ended September 30, 2016, research and development
expenses decreased by approximately $1.7 million compared to the
year ended September 30, 2015. The Company is continuing the Phase
3 clinical trial subject to the partial clinical hold and research
and development fluctuates based on the activity level of the
clinical trial.
During
the year ended September 30, 2016, general and administrative
expenses decreased by approximately $7.4 million, compared to the
year ended September 30, 2015. Major components of the decrease are
1) Lake Whillans Litigation Finance took over payment of legal fees
which were about $4.4 million in fiscal year 2015 in the
arbitrations against the former CRO that used to run the Company's
Phase 3 trial, 2) a $2.8 million decrease in share-based employee
compensation costs, which relates to the timing vesting for the
incentive stock bonus plan and 3) other miscellaneous decreases
netting to approximately $200,000.
49
During
the years ended September 30, 2016 and 2015, CEL-SCI recorded a
derivative gain of approximately $14.0 million and $283,000,
respectively. This variation was the result of the change in fair
value of the derivative liabilities during the period which was
caused by fluctuations in the share price of CEL-SCI’s common
stock.
Net
interest income (expense) decreased approximately $113,000 during
the year ended September 30, 2016 compared to the year ended
September 30, 2015, primarily due to an approximate $124,000
reduction in interest expense on the related party loan, which was
paid off in January 2016, offset by an approximate $9,000 reduction
in interest income due to lower cash balances.
Fiscal 2015
During
the year ended September 30, 2015, grant and other income increased
by approximately $393,000 compared to the year ended September 30,
2014. The increase is primarily due to the timing of drug shipments
to supply the Company’s partner in Taiwan and the grant
income earned by the Company’s Small Business Innovation
Research (SBIR) grant during fiscal year 2015 compared to fiscal
year 2014.
During
the year ended September 30, 2015, research and development
expenses increased by approximately $3.9 million compared to the
year ended September 30, 2014. CEL-SCI is continuing the Phase 3
clinical trial and research and development fluctuates based on the
activity level of the clinical trial. In fiscal year 2015, CEL-SCI
received clearance from seven new countries for the Phase 3
clinical trial, and enrolled 305 patients in fiscal year 2015 vs
142 in fiscal year 2014.
During
the year ended September 30, 2015, general and administrative
expenses increased by approximately $3.1 million, compared to the
year ended September 30, 2014. This increase is primarily due to an
increase of approximately $2.0 million of equity based compensation
costs for restricted stock granted, increased legal fees of
approximately $1.8 million relating to arbitration with the
Company’s former CRO, as discussed in Item 3 above, and an
increase of approximately $220,000 in fees for professional
services. These increases were offset by a decrease of
approximately $788,000 in employee compensation, primarily due to a
decrease in the number of stock options issued and vested in 2015
compared to 2014.
During
the years ended September 30, 2015 and 2014, CEL-SCI recorded a
derivative gain of approximately $283,000 and $249,000,
respectively. This variation was the result of the change in fair
value of the derivative liabilities during the period which
resulted from relative consistencies in the share price of
CEL-SCI’s common stock.
50
Interest expense
decreased by approximately $13,000 during the year ended September
30, 2015 compared to the year ended September 30, 2014, and
consisted primarily of interest expense on the loan from
CEL-SCI’s former president and interest on a capital lease.
Effective July 7, 2015, the interest rate on the related party loan
was reduced from 15% to 9%, resulting in approximately less
interest expense during 2015 than in 2014. Additionally, the
modifications of the loan from de Clara Trust were determined to be
substantive, resulting in an extinguishment loss of approximately
$620,000 during 2015.
Research and Development Expenses
During
the five years ended September 30, 2016, CEL-SCI’s research
and development efforts involved Multikine and LEAPS. The table
below shows the research and development expenses associated with
each project during this five-year period.
|
|
2016
|
2015
|
2014
|
2013
|
2012
|
|
|
|
|
|
|
|
|
MULTIKINE
|
$
18,960,871
|
$
20,604,337
|
$
16,797,809
|
$
12,556,636
|
$
10,423,327
|
|
LEAPS
|
390,908
|
493,810
|
374,778
|
377,485
|
391,078
|
|
TOTAL
|
$
19,351,779
|
$
21,098,147
|
$
17,172,587
|
$
12,934,121
|
$
10,814,405
|
In
January 2007, CEL-SCI received a “no objection” letter
from the FDA indicating that it could proceed with Phase 3 trials
with Multikine in head and neck cancer patients. CEL-SCI
had previously received a “no objection” letter from
the Canadian Biologics and Genetic Therapies Directorate which
enabled CEL-SCI to begin its Phase 3 clinical trial in
Canada. Subsequently, CEL-SCI received similar
authorizations from twenty-three other regulators.
CEL-SCI’s
Phase 3 clinical trial began in December 2010 after the completion
and validation of CEL-SCI’s dedicated manufacturing
facility.
As
explained in Item 1 of this report, as of November 30, 2016,
CEL-SCI was involved in pre-clinical studies with respect to its
LEAPS technology. As with Multikine, CEL-SCI does not know what
obstacles it will encounter in future pre-clinical and clinical
studies involving its LEAPS technology. Consequently, CEL-SCI
cannot predict with any certainty the funds required for future
research and clinical trials and the timing of future research and
development projects.
Clinical and other
studies necessary to obtain regulatory approval of a new drug
involve significant costs and require several years to complete.
The extent of CEL-SCI’s clinical trials and research programs
are primarily based upon the amount of capital available to CEL-SCI
and the extent to which CEL-SCI has received regulatory approvals
for clinical trials. The inability of CEL-SCI to conduct clinical
trials or research, whether due to a lack of capital or regulatory
approval, will prevent CEL-SCI from completing the studies and
research required to obtain regulatory approval for any products
which CEL-SCI is developing. Without regulatory approval, CEL-SCI
will be unable to sell any of its products.
On
September 26, 2016, CEL-SCI received verbal notice from the FDA
that the Phase 3 clinical trial in advanced primary head and neck
cancer has been placed on clinical hold. Pursuant to this
communication from FDA, patients currently receiving study
treatments can continue to receive treatment, and patients already
enrolled in the study will continue to be followed.
51
On
October 21, 2016, CEL-SCI issued a press release stating the
following: “following up on our press release issued on
September 26, 2016, we have received the Partial Clinical Hold
letter from the U.S. Food and Drug Administration (FDA). On
November 21, 2016, CEL-SCI announced that it had submitted a
response to FDA’s Partial Clinical Hold letter referenced
above.
Liquidity and Capital Resources
CEL-SCI
has had only limited revenues from operations since its inception
in March 1983. CEL-SCI has relied upon capital generated
from the public and private offerings of its common stock and
convertible notes. In addition, CEL-SCI has utilized
short-term loans to meet its capital
requirements. Capital raised by CEL-SCI has been used to
acquire an exclusive worldwide license to use, and later purchase,
certain patented and unpatented proprietary technology and know-how
relating to the human immunological defense system and for clinical
trials. Capital has also been used for patent
applications, debt repayment, research and development,
administrative costs, and the construction of CEL-SCI’s
laboratory facilities. CEL-SCI does not anticipate
realizing significant revenues until it enters into licensing
arrangements regarding its technology and know-how or until it
receives regulatory approval to sell its products (which could take
a number of years). As a result, CEL-SCI has been dependent upon
the proceeds from the sale of its securities to meet all of its
liquidity and capital requirements and anticipates having to do so
in the future. During fiscal year 2016 and 2015, CEL-SCI raised net
proceeds of approximately $21.4 million and $21.1 million,
respectively, through the sale of stock.
CEL-SCI
estimates the total cash cost of the Phase 3 clinical trial, with
the exception of the parts that will be paid by its licensees, Teva
Pharmaceuticals and Orient Europharma, to be approximately 12.1
million going forward.
In
August 2007, CEL-SCI leased a building near Baltimore, Maryland.
The building, which consists of approximately 73,000 square feet,
has been remodeled in accordance with CEL-SCI’s
specifications so that it can be used by CEL-SCI to manufacture
Multikine for CEL-SCI’s Phase III clinical trials and sales
of the drug if approved by the FDA. The lease expires on October
31, 2028, and required annual base rent payments of approximately
$1.6 million during the twelve months ended September 30, 2016. See
Item 2 of this report for more information concerning the terms of
this lease.
In
January 2014, CEL-SCI offered to the investors to extend the
outstanding Series N warrants by one year and allow for cashless
exercise in exchange for cancelling the reset provision in the
warrant agreement. One of the investors accepted this offer. In
March 2014, 106,793 Series N Warrants were exercised. On October
28, 2014, the remaining Series N warrants were transferred to the
de Clara Trust, of which the Company’s CEO, Geert Kersten, is
the trustee and a beneficiary. On June 29, 2015, concurrently with
the modification of the note payable held by the de Clara Trust,
CEL-SCI extended the expiration date of the Series N warrants to
August 18, 2017. As of September 30, 2016, the remaining 2,844,627
Series N warrants entitle the holders to purchase one share of
CEL-SCI's common stock at a price of $0.52731 per share at any time
prior to August 18, 2017.
52
On
January 13, 2016, CEL-SCI repaid the note payable to the de Clara
Trust, the balance of which was $1,105,989, including principal and
interest. At the same time the Company sold 3,000,000 shares of its
common stock and 3,000,000 Series X warrants to the de Clara Trust
for $1,110,000. Each warrant allows the de Clara Trust to purchase
one share of the Company's common stock at a price of $0.37 per
share at any time on or before January 13, 2021.
In
October 2013, CEL-SCI sold 17,826,087 shares of its common stock,
plus 20,475,000 Series S warrants, in an underwritten offering. The
net proceeds to CEL-SCI from the sale of the shares and warrants
were approximately $16.4 million, after deducting the underwriting
discount. The Series S warrants may be exercised at any time on or
before October 11, 2018 at a price of $1.25 per share.
In
December 2013, CEL-SCI sold 5,238,095 shares of its common stock
and Series S warrants, in an underwritten offering. The net
proceeds to CEL-SCI from the sale of the shares and Series S
warrants were approximately $2.7 million, after deducting the
underwriting discount. The Series S warrants may be exercised at
any time on or before October 11, 2018 at a price of $1.25 per
share.
In
February 2014, the S warrants began trading on the NYSE MKT under
the ticker symbol “CVM WS”. As of September 30, 2016,
2,088,769 Series S Warrants had been exercised. The remaining
25,928,010 Series S warrants entitle the holders to purchase one
share of CEL-SCI's common stock at a price of $1.25 per
share.
In
April 2014, CEL-SCI sold 7,128,229 shares of common stock, plus
1,782,057 Series T warrants, in an underwritten offering. The net
proceeds to CEL-SCI from the sale of the stock and warrants were
approximately $9.23 million. The Series T warrants had an exercise
price of $1.58 and expired on October 17, 2014. CEL-SCI also issued
445,514 Series U warrants to the underwriters for this offering.
The Series U warrants may be exercised beginning October 17, 2014
at a price of $1.75 per share and expire on October 17, 2017. As of
September 30, 2016, none of the Series U warrants had been
exercised.
In
October 2014, CEL-SCI sold 7,894,737 shares of common stock, plus
1,973,684 Series S warrants in an underwritten public offering. The
net proceeds to CEL-SCI from the sale of the stock and warrants
were approximately $5.5 million. The warrants are immediately
exercisable, expire October 11, 2018 and have an exercise price of
$1.25.
Additionally, in
October 2014, CEL-SCI sold 1,320,000 shares of common stock, plus
330,000 Series S warrants in a registered direct offering. The net
proceeds to CEL-SCI from the sale of the stock and warrants were
approximately $941,000. The warrants are immediately exercisable,
expire October 11, 2018 and have an exercise price of
$1.25.
On May
28, 2015, CEL-SCI sold 20,253,164 shares of common stock, plus
20,253,164 Series V warrants, in an underwritten public offering.
The common stock and Series V warrants were sold at a combined per
unit price of $0.79 for net proceeds of approximately $14.7
million. The Series V warrants are immediately exercisable at a
price of $0.79 and expire on May 28, 2020. As of September 30,
2016, none of the Series V warrants had been
exercised.
On
October 28, 2015, the Company closed an underwritten public
offering of 17,223,248 shares of common stock and 17,223,248 Series
W warrants to purchase shares of common stock. The common stock and
warrants were sold at a combined per unit price of $0.67 for net
proceeds of approximately $10.5 million, net of underwriting
discounts and commissions and offering expenses. The Series W
warrants are immediately exercisable at a price of $0.67 and expire
on October 28, 2020. As of September 30, 2016, none of the Series W
warrants had been exercised.
53
In
January 2016, the Company sold 3,000,000 shares of its common stock
and 3,000,000 Series X warrants to the de Clara Trust for
approximately $1.1 million, as noted above. The de Clara Trust is
controlled by Geert Kersten, the Company's Chief Executive Officer
and a director. Each Series X warrant allows the de Clara Trust to
purchase one share of the Company's common stock at a price of
$0.37 per share at any time on or before January 13, 2021. As of
September 30, 2016, none of the Series X warrants had been
exercised.
In
February 2016, the Company sold 1,300,000 shares of its common
stock and 650,000 Series Y warrants to a private investor for
$624,000. Each Series Y warrant allows the holder to purchase one
share of the Company's common stock at a price of $0.48 per share
at any time on or before February 15, 2021. As of September 30,
2016, none of the Series Y warrants had been
exercised.
On May
23, 2016, the Company closed a registered direct offering of
10,000,000 shares of common stock and 6,600,000 Series Z warrants
to purchase shares of common stock. The common stock and warrants
were sold at a combined per unit price of $0.50 for net proceeds of
approximately $4.6 million, net of placement agent’s
commissions and offering expenses. The Series Z warrants may be
exercised at any time on or after November 23, 2016 and on or
before November 23, 2021 at a price of $0.55 per share. The Company
also issued 500,000 Series ZZ warrants to the placement agent as
part of its compensation. The Series ZZ warrants may be exercised
at any time on or after November 23, 2016 and on or before May 18,
2021 at a price of $0.55 per share. As of September 30, 2016, none
of the Series Z and ZZ warrants had been exercised.
On August 26, 2016, the Company closed a
registered direct offering of 10,000,000 shares of common
stock and Series AA warrants to purchase up to 5,000,000 shares of
common stock. Each share of common stock was sold together with a
Series AA warrant to purchase one-half of a share of common stock
for the combined purchase price of $0.50. Each warrant can be
exercised at any time after February 22, 2017 and on or before
February 22, 2022 at a price of $0.55 per share.
The Company
also issued 400,000 Series BB warrants to the placement agent as
part of its compensation. The Series BB warrants may be exercised
at any time on or after February 22, 2017 and on or before August
22, 2021 at a price of $0.55 per share. The Company received
proceeds from the sale of Series AA and Series BB shares and
warrants of approximately $4.5 million, net of placement
agent’s commissions and offering expenses. As of September
30, 2016, none of the Series AA and BB warrants had been
exercised.
On December 8,
2016, the Company sold 34,024,000 shares of common stock and
warrants to purchase common stock at a price of $0.125 in a public
offering. The warrants consist of 17,012,000 Series CC warrants to
purchase 17,012,000 shares of common stock, 34,024,000 Series DD
warrants to purchase 34,024,000 shares of common stock and
34,024,000 Series EE warrants to purchase 34,024,000 shares of
common stock. The Series CC warrants are immediately exercisable,
expire in five-years and have an exercise price of $0.20 per share.
The Series DD warrants are immediately exercisable, expire in
six-months and have an exercise price of $0.18 per share. The
Series EE warrants are immediately exercisable, expire in
nine-months and have an exercise price of $0.18 per share. In
addition, the Company issued 1,701,000 Series FF warrants to
purchase 1,701,000 shares of common stock to the placement agent.
The FF warrants are exercisable at any time on or after June 8,
2017 and expire on December 1, 2021 and have an exercise price
$0.15625. The net proceeds to CEL-SCI from this offering was
approximately $3.8 million, excluding any future proceeds that may
be received from the exercise of the
warrants.
Inventory decreased
by approximately $393,000 at September 30, 2016 as compared to
September 30, 2015, due to the timing of supplies purchased and
used in the manufacturing of Multikine for the Phase 3 clinical
trial. In addition, receivables increased by approximately
$307,000, primarily due to the timing of payments reimbursed under
the litigation funding arrangement noted above.
54
During
the year ended September 30, 2016, CEL-SCI’s cash decreased
by approximately $2.8 million. Significant components of this
decrease include: 1) net cash used in operating activities of
approximately $23.1 million, 2) expenditures for equipment and
patents of approximately $34,000, 3) the approximate $1.1 million
repayment of the related party loan, and 4) the payment of
approximately $8,000 in capital lease obligations offset by
approximately $21.4 in proceeds from the sale of stock and
warrants.
Future Capital Requirements
Other
than funding operating losses, funding its research and development
program, and making required lease payments, CEL-SCI does not have
any material capital commitments. As of September 30, 2016,
material contractual obligations, consisting of operating lease
payments are as follows:
|
2017
|
$
1,930,244
|
|
2018
|
1,997,309
|
|
2019
|
2,066,329
|
|
2020
|
2,109,887
|
|
2021
|
2,099,785
|
|
Thereafter
|
15,830,794
|
|
|
$
26,034,348
|
For
information on employment contracts, see Item 11 of this
report.
Further, CEL-SCI
has contingent obligations with vendors for work that will be
completed in relation to the Phase 3 trial. The timing of these
obligations cannot be determined at this time.
CEL-SCI estimates
that the total remaining cash cost of the Phase 3 clinical trial,
excluding any costs that will be paid by CEL-SCI's partners, would
be approximately $12.1 million after September 30, 2016. This
ís based on the executed contract costs with the CROs only and
does not include other related costs, e.g. the manufacturing of the
drug.
CEL-SCI
will need to raise additional funds, either through the exercise of
outstanding warrants/options, through a debt or equity financing or
a partnering arrangement, to complete the Phase 3 trial and bring
Multikine to market. The ability of CEL-SCI to complete the
necessary clinical trials and obtain FDA approval for the sale of
products to be developed on a commercial basis is uncertain.
In
general, CEL-SCI believes that it will be able to raise sufficient
capital in fiscal year 2017 to continue operations through December
2017. However, it is possible that CEL-SCI will not be able to
generate enough cash to continue operations at its current level.
CEL-SCI's registered independent public accounting firm has issued
an audit opinion that includes an explanatory paragraph that
expresses substantial doubt about CEL-SCI’s ability to
continue as a going concern mainly due to continued losses from
operations and future liquidity needs of CEL-SCI. CEL-SCI’s
management has engaged in fundraising for over 20 years and
believes that the manner in which it is proceeding will produce the
best possible outcome for the shareholders. There can be no
assurances that CEL-SCI will be successful in raising additional
funds.
Clinical and other
studies necessary to obtain regulatory approval of a new drug
involve significant costs and require several years to complete.
The extent of CEL-SCI’s clinical trials and research programs
are primarily based upon the amount of capital available to CEL-SCI
and the extent to which CEL-SCI has received regulatory approvals
for clinical trials. The inability of CEL-SCI to conduct clinical
trials or research, whether due to a lack of capital or regulatory
approval, will prevent CEL-SCI from completing the studies and
research required to obtain regulatory approval for any products
which CEL-SCI is developing. Without regulatory approval, CEL-SCI
will be unable to sell any of its products.
55
In the
absence of revenues, CEL-SCI will be required to raise additional
funds through the sale of securities, debt financing or other
arrangements in order to continue with its research efforts.
However, there can be no assurance that such financing will be
available or be available on favorable terms. Ultimately, CEL-SCI
must complete the development of its products, obtain appropriate
regulatory approvals and obtain sufficient revenues to support its
cost structure.
Since
all of CEL-SCI’s projects are under development, CEL-SCI
cannot predict with any certainty the funds required for future
research and clinical trials, the timing of future research and
development projects, or
when it will be able to generate any
revenue from the sale of any of its products.
CEL-SCI's cash flow
and earnings are subject to fluctuations due to changes in interest
rates on its bank accounts, and, to an immaterial extent, foreign
currency exchange rates.
Critical Accounting Policies
CEL-SCI's
significant accounting policies are more fully described in Note 1
to the financial statements included as part of this report.
However, certain accounting policies are particularly important to
the portrayal of CEL-SCI’s financial position and results of
operations and require the application of significant judgments by
management. As a result, the financial statements are subject to an
inherent degree of uncertainty. In applying those policies,
management uses its judgment to determine the appropriate
assumptions to be used in the determination of certain estimates.
These estimates are based on CEL-SCI's historical experience, terms
of existing contracts, observance of trends in the industry and
information available from outside sources, as appropriate.
CEL-SCI’s significant accounting policies
include:
Stock Options and Warrants
–
Compensation cost is measured at fair value as of the grant date in
accordance with the provisions of ASC 718. The fair value of the
stock options is calculated using the Black-Scholes option pricing
model. The Black-Scholes model requires various judgmental
assumptions including volatility, forfeiture rates and expected
option life. The stock-based compensation cost is recognized on the
accelerated method as expense over the requisite service or vesting
period.
Options
to non-employees are accounted for in accordance with ASC 505-50,
“
Equity-Based Payments to
Non-Employees
.” Accordingly, compensation cost is
recognized when goods or services are received and is measured
using the Black-Scholes valuation model. The Black-Scholes model
requires CEL-SCI’s management to make assumptions regarding
the fair value of the options at the date of grant and the expected
life of the options.
Asset Valuations and Review for Potential
Impairments
- CEL-SCI reviews its fixed assets, intangibles
and deferred rent every fiscal quarter. This review requires that
CEL-SCI make assumptions regarding the value of these assets and
the changes in circumstances that would affect the carrying value
of these assets. If such analysis indicates that a possible
impairment may exist, CEL-SCI is then required to estimate the fair
value of the asset and, as deemed appropriate, expense all or a
portion of the asset. The determination of fair value includes
numerous uncertainties, such as the impact of competition on future
value. CEL-SCI believes that it has made reasonable estimates and
judgments in determining whether its long-lived assets have been
impaired; however, if there is a material change in the assumptions
used in its determination of fair values or if there is a material
change in economic conditions or circumstances influencing fair
value, CEL-SCI could be required to recognize certain impairment
charges in the future. As a result of the reviews, no changes in
asset values were required.
56
Derivative Instruments—
CEL-SCI
enters into financing arrangements that consist of freestanding
derivative instruments or hybrid instruments that contain embedded
derivative features. CEL-SCI accounts for these arrangements in
accordance with ASC 815, “
Accounting for Derivative Instruments and
Hedging Activities
, as well as related interpretations of
these standards. In accordance with accounting principles generally
accepted in the United States (“GAAP”), derivative
instruments and hybrid instruments are recognized as either assets
or liabilities in the statement of financial position and are
measured at fair value with gains or losses recognized in earnings
or other comprehensive income depending on the nature of the
derivative or hybrid instruments. Embedded derivatives that are not
clearly and closely related to the host contract are bifurcated and
recognized at fair value with changes in fair value recognized as
either a gain or loss in earnings if they can be reliably measured.
When the fair value of embedded derivative features cannot be
reliably measured, CEL-SCI measures and reports the entire hybrid
instrument at fair value with changes in fair value recognized as
either a gain or loss in earnings. CEL-SCI determines the fair
value of derivative instruments and hybrid instruments based on
available market data using appropriate valuation models, giving
consideration to all of the rights and obligations of each
instrument and precluding the use of “blockage”
discounts or premiums in determining the fair value of a large
block of financial instruments. Fair value under these conditions
does not necessarily represent fair value determined using
valuation standards that give consideration to blockage discounts
and other factors that may be considered by market participants in
establishing fair value.
Market
risk is the potential change in an instrument's value caused by,
for example, fluctuations in interest and currency exchange rates.
CEL-SCI enters into financing arrangements that are, or include,
freestanding derivative instruments or that are, or include, hybrid
instruments that contain embedded derivative features. CEL-SCI does
not enter into derivative instruments for trading purposes.
Additional information is presented in the notes to the financial
statements. The fair value of these instruments is affected
primarily by volatility of the trading prices of CEL-SCI’s
common stock. For three years ended September 30, 2016, CEL-SCI
recognized gains of $14,013,726, $282,616, and $248,767,
respectively, resulting from changes in fair value of derivative
instruments. CEL-SCI has exposure to risks associated with foreign
exchange rate changes because some of the expenses related to the
Phase 3 trial are transacted in a foreign currency. The interest
risk on investments on September 30, 2016 was considered immaterial
due to the fact that the interest rates at that time were nominal
at best and CEL-SCI keeps its cash and cash equivalents in short
term maturities.
57
See the
financial statements included with this report.
Not
applicable
Under
the direction and with the participation of CEL-SCI’s
management, including CEL-SCI’s Chief Executive Officer and
Chief Financial Officer, CEL-SCI carried out an evaluation of the
effectiveness of the design and operation of its disclosure
controls and procedures as of September 30, 2016. CEL-SCI maintains
disclosure controls and procedures that are designed to ensure that
information required to be disclosed in its periodic reports with
the Securities and Exchange Commission is recorded, processed,
summarized and reported within the time periods specified in the
SEC’s rules and regulations, and that such information is
accumulated and communicated to CEL-SCI’s management,
including its principal executive officer and principal financial
officer, as appropriate, to allow timely decisions regarding
required disclosure. CEL-SCI’s disclosure controls and
procedures are designed to provide a reasonable level of assurance
of reaching its desired disclosure control objectives. Based on
this evaluation, CEL-SCI’s Chief Executive and Principal
Financial Officer has concluded that CEL-SCI’s disclosure
controls were effective as of September 30, 2016.
Management’s Report on Internal Control Over Financial
Reporting
CEL-SCI’s
management is responsible for establishing and maintaining adequate
internal control over financial reporting and for the assessment of
the effectiveness of internal control over financial reporting. As
defined by the Securities and Exchange Commission, internal control
over financial reporting is a process designed by, or under the
supervision of CEL-SCI’s principal executive officer and
principal financial officer and implemented by CEL-SCI’s
Board of Directors, management and other personnel, to provide
reasonable assurance regarding the reliability of financial
reporting and the preparation of CEL-SCI’s financial
statements in accordance with U.S. generally accepted accounting
principles.
Because
of its inherent limitations, internal control over financial
reporting may not prevent or detect misstatements. Also,
projections of any evaluation of effectiveness to future periods
are subject to the risk that controls may become inadequate because
of changes in conditions, or that the degree of compliance with the
policies or procedures may deteriorate.
Geert
Kersten, CEL-SCI’s Chief Executive and Principal Financial
Officer, evaluated the effectiveness of CEL-SCI’s internal
control over financial reporting as of September 30, 2016 based on
criteria established in Internal Control - Integrated Framework
(2013) issued by the Committee of Sponsoring Organizations of the
Treadway Commission, or the COSO Framework. Management’s
assessment included an evaluation of the design of CEL-SCI’s
internal control over financial reporting and testing of the
operational effectiveness of those controls.
58
Based
on this evaluation, Mr. Kersten concluded that CEL-SCI’s
internal control over financial reporting was effective as of
September 30, 2016.
There
was no change in CEL-SCI’s internal control over financial
reporting that occurred during the fiscal year ended September 30,
2016 that has materially affected, or is reasonably likely to
materially affect, CEL-SCI’s internal control over financial
reporting.
CEL-SCI’s
independent registered public accounting firm BDO USA, LLP has
issued an attestation report on CEL-SCI’s internal control
over financial reporting.
59
Report of Independent Registered Public Accounting
Firm
Board
of Directors and Stockholders
CEL-SCI Corporation
Vienna, VA
We have audited CEL-SCI Corporation’s (the
Company) internal control over financial reporting as of September
30, 2016, based on criteria established in
Internal Control –
Integrated Framework
(2013)
issued by the Committee of Sponsoring
Organizations of the Treadway Commission (the COSO criteria). The
Company’s management is responsible for maintaining effective
internal control over financial reporting and for its assessment of
the effectiveness of internal control over financial reporting,
included in the accompanying “Item 9A, Management’s
Report on Internal Control Over Financial Reporting”. Our
responsibility is to express an opinion on the Company’s
internal control over financial reporting based on our
audit.
We
conducted our audit in accordance with the standards of the Public
Company Accounting Oversight Board (United States). Those standards
require that we plan and perform the audit to obtain reasonable
assurance about whether effective internal control over financial
reporting was maintained in all material respects. Our audit
included obtaining an understanding of internal control over
financial reporting, assessing the risk that a material weakness
exists, and testing and evaluating the design and operating
effectiveness of internal control based on the assessed risk. Our
audit also included performing such other procedures as we
considered necessary in the circumstances. We believe that our
audit provides a reasonable basis for our opinion.
A
company’s internal control over financial reporting is a
process designed to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally
accepted accounting principles. A company’s internal control
over financial reporting includes those policies and procedures
that (1) pertain to the maintenance of records that, in reasonable
detail, accurately and fairly reflect the transactions and
dispositions of the assets of the company; (2) provide reasonable
assurance that transactions are recorded as necessary to permit
preparation of financial statements in accordance with generally
accepted accounting principles, and that receipts and expenditures
of the company are being made only in accordance with
authorizations of management and directors of the company; and (3)
provide reasonable assurance regarding prevention or timely
detection of unauthorized acquisition, use, or disposition of the
company’s assets that could have a material effect on the
financial statements.
Because
of its inherent limitations, internal control over financial
reporting may not prevent or detect misstatements. Also,
projections of any evaluation of effectiveness to future periods
are subject to the risk that controls may become inadequate because
of changes in conditions, or that the degree of compliance with the
policies or procedures may deteriorate.
In our opinion, CEL-SCI Corporation maintained, in
all material respects, effective internal control over financial
reporting as of September 30, 2016, based on the COSO
criteria
.
We
also have audited, in accordance with the standards of the Public
Company Accounting Oversight Board (United States), the balance
sheets of CEL-SCI Corporation as of September 30, 2016 and 2015,
and the related statements of operations, stockholders’
(deficit) equity, and cash flows for each of the three years in the
period ended September 30, 2016 and our report dated December 14,
2016 expressed an unqualified opinion thereon that included an
explanatory paragraph regarding CEL-SCI Corporation’s ability
to continue as a going concern.
/s/BDO
USA, LLP
McLean,
Virginia
December 14, 2016
60
None.
Officers and Directors
|
Name
|
Age
|
Position
|
|
|
|
|
|
Geert R. Kersten, Esq.
|
57
|
Director, Chief Executive Officer and Treasurer
|
|
Patricia B. Prichep
|
65
|
Senior Vice President of Operations and Corporate
Secretary
|
|
Dr. Eyal Talor
|
60
|
Chief Scientific Officer
|
|
Dr. Daniel H. Zimmerman
|
75
|
Senior Vice President of Research, Cellular Immunology
|
|
John Cipriano
|
74
|
Senior Vice President of Regulatory Affairs
|
|
Alexander G. Esterhazy
|
75
|
Director
|
|
Dr. Peter R. Young
|
71
|
Director
|
|
Bruno Baillavoine
|
64
|
Director
|
The
directors of CEL-SCI serve in such capacity until the next annual
meeting of CEL-SCI's shareholders and until their successors have
been duly elected and qualified. The officers of CEL-SCI serve at
the discretion of CEL-SCI's directors.
On
August 31, 2016, Mr. Maximilian de Clara resigned for personal
health reasons, effective immediately. The 87 year-old visionary
funded the original research of what has become CEL-SCI’s
investigational drug Multikine at the Max Planck Institute in
Germany. Mr. de Cara by virtue of his former position as an officer
and director of CEL-SCI, was deemed to be the "parent" and
"founder" of CEL-SCI as those terms are defined under applicable
rules and regulations of the SEC.
All of
CEL-SCI’s directors have served as directors for a
significant period of time. Consequently, their long-standing
experience with CEL-SCI benefits both CEL-SCI and its
shareholders.
The
principal occupations of CEL-SCI's officers and directors, during
the past several years, are as follows:
Geert
Kersten has served in his current leadership role at CEL-SCI since
1995. Mr. Kersten has been with CEL-SCI since 1987. He has been
involved in the pioneering field of cancer immunotherapy for over
two decades and has successfully steered CEL-SCI through many
challenging cycles in the biotechnology industry. Mr. Kersten also
provides CEL-SCI with significant expertise in the fields of
finance and law and has a unique vision of how CEL-SCI's Multikine
product could potentially change the way cancer is treated.
Prior to joining CEL-SCI, Mr. Kersten worked at the law firm of
Finley & Kumble and worked at Source Capital, an investment
banking firm located in McLean, VA. He is a native of Germany,
graduated from Millfield School in England, and completed his
studies in the US. Mr. Kersten received his Undergraduate Degree in
Accounting and an M.B.A. from George Washington University, and a
law degree (J.D.) from American University in Washington,
DC.
61
Patricia B. Prichep
joined CEL-SCI in 1992 and has been CEL-SCI's Senior Vice President
of Operations since March 1994. Between December 1992 and March
1994, Ms. Prichep was CEL-SCI's Director of Operations. Ms. Prichep
became CEL-SCI's Corporate Secretary in May 2000. She is
responsible for all day-to-day operations of CEL-SCI, including
human resources and is the liaison with CEL-SCI’s independent
registered public accounting firm for financial reporting. From
June 1990 to December 1992, Ms. Prichep was the Manager of Quality
and Productivity for the NASD’s Management, Systems and
Support Department and was responsible for the internal auditing
and work flow analysis of operations. Between 1982 and 1990, Ms.
Prichep was Vice President and Operations Manager for Source
Capital, Ltd. She handled all operations and compliance for Source
Capital and was licensed as a securities broker. Ms. Prichep
received her B.A. from the University of Bridgeport in
Connecticut.
Eyal Talor, Ph.D. joined CEL-SCI in October 1993.
In October 2009, Dr. Talor was promoted to Chief Scientific
Officer. Between this promotion and March of 1994 he was the Senior
Vice President of Research and Manufacturing. He is a
clinical immunologist with over 19 years of hands-on management of
clinical research and drug development for immunotherapy
application; pre-clinical to Phase III, in the biopharmaceutical
industry. His expertise includes; biopharmaceutical R&D
and Biologics product development, GMP (Good Manufacturing
Practices) manufacture, Quality Control testing, and the design and
building of GMP manufacturing and testing facilities. He
served as Director of Clinical Laboratories (certified by the State
of Maryland) and has experience in the design of clinical trials
(Phase I – III) and GCP (Good Clinical Practices)
requirements. He also has broad experience in the different
aspects of biological assay development, analytical methods
validation, raw material specifications, and QC (Quality Control)
tests development under FDA/GMP, USP, and ICH guidelines. He
has extensive experience in the preparation of documentation for
IND and other regulatory submissions. His scientific area of
expertise encompasses immune response assessment. He is the
author of over 25 publications and has published a number of
reviews on immune regulations in relation to clinical immunology.
Before coming to CEL-SCI, he was Director of R&D and Clinical
Development at CBL, Inc., Principal Scientist - Project Director,
and Clinical Laboratory Director at SRA Technologies, Inc. Prior to
that he was a full time faculty member at The Johns Hopkins
University, Medical Institutions; School of Public Health. He
has invented technologies which are covered by
two US patents; one on Multikine’s
composition of matter and method of use in cancer, and one on a
platform Peptide technology (‘Adapt’) for the treatment
of autoimmune diseases, asthma, allergy, and transplantation
rejection. He also
is responsible for
numerous product and process inventions as well as
a number of pending US and PCT patent applications. He
received his Ph.D. in Microbiology and Immunology from the
University of Ottawa, Ottawa, Ontario, Canada, and had
post-doctoral training in clinical and cellular immunology at The
John Hopkins University, Baltimore, Maryland, USA. He holds
an Adjunct Associate teaching position at the Johns Hopkins
University Medical Institutions.
Daniel H. Zimmerman, Ph.D., was CEL-SCI's Senior
Vice President of Cellular Immunology between 1996 and December
2008 and again since November 2009. He joined CEL-SCI in
January 1996 as the Vice President of Research, Cellular
Immunology. Dr. Zimmerman founded CELL-MED, Inc. and was its
president from 1987-1995. From 1973-1987, Dr. Zimmerman
served in various positions at Electronucleonics, Inc. His
positions included: Scientist, Senior Scientist, Technical Director
and Program Manager. Dr Zimmerman held various teaching positions
at Montgomery College between 1987 and 1995. Dr. Zimmerman has
invented technologies which are covered by over a dozen US patents
as well as many foreign equivalent patents. He is the author of
over 40 scientific publications in the area of immunology and
infectious diseases. He has been awarded numerous grants from NIH
and DOD. From 1969-1973, Dr. Zimmerman was a Senior Staff
Fellow at NIH. For the following 25 years, he continued on at NIH
as a guest worker. Dr. Zimmerman received a Ph.D. in
Biochemistry in 1969, and a Masters in Zoology in 1966 from the
University of Florida as well as a B.S. in Biology from Emory and
Henry College in
1963.
62
John
Cipriano, was CEL-SCI’s Senior Vice President of Regulatory
Affairs between March 2004 and December 2008 and again since
October 2009. Mr. Cipriano brings to CEL-SCI over 30 years of
experience with both biotech and pharmaceutical companies. In
addition, he held positions at the United States Food and Drug
Administration (FDA) as Deputy Director, Division of Biologics
Investigational New Drugs, Office of Biologics Research and Review
and was the Deputy Director, IND Branch, Division of Biologics
Evaluation, Office of Biologics. Mr. Cipriano completed his B.S. in
Pharmacy from the Massachusetts College of Pharmacy in Boston,
Massachusetts and his M.S. in Pharmaceutical Chemistry from Purdue
University in West Lafayette, Indiana.
Alexander G.
Esterhazy has been a Director of CEL-SCI since December 1999 and
has been an independent financial advisor since November 1997.
Between July 1991 and October 1997, Mr. Esterhazy was a senior
partner of Corpofina S.A. Geneva, a firm engaged in mergers,
acquisitions and portfolio management. Between January 1988 and
July 1991, Mr. Esterhazy was a managing director of DG Bank in
Switzerland. During this period Mr. Esterhazy was in charge of the
Geneva, Switzerland branch of the DG Bank, founded and served as
Vice President of DG Finance (Paris) and was the President and
Chief Executive Officer of DG-Bourse, a securities brokerage
firm.
Peter
R. Young, Ph.D. has been a Director of CEL-SCI since August 2002.
Dr. Young has been a senior executive within the pharmaceutical
industry in the United States and Canada for most of his career,
originally in organizations that are now part of Sanofi S.A. Over
the last 20 years he has primarily held positions of Chief
Executive Officer or Chief Financial Officer and has extensive
experience with acquisitions and equity financing. Since November
2001, Dr. Young has been the President of Agnus Dei, LLC, which has
acted as a partner in an organization managing immune system
clinics which treats patients with diseases such as cancer,
multiple sclerosis and hepatitis. Dr. Young was also the President
and Chief Executive Officer of SRL Technology, Inc., a company
involved in the development of pharmaceutical drug delivery
systems. Between 1998 and 2001, Dr. Young was the Chief Financial
Officer of Adams Laboratories, Inc., the developer of
Mucinex®. Dr. Young received his Ph.D. in Organic Chemistry
from the University of Bristol, England after obtaining his
Bachelor's degree in Honors Chemistry, Mathematics and Economics.
Subsequently,
he qualified as a Fellow of the Chartered Institute of Management
Accountants.
Bruno
Baillavoine joined CEL-SCI’s board of directors in June 2015.
Since 2010, Mr. Baillavoine has been a partner of Globomass
Holdings Limited, a London, England based developer of renewable
energy projects from concept through final operations. Since 2012
Mr. Baillavoine has been the Executive Chairman of Globomass
Holdings. Globomass Holdings has subsidiaries in Ireland, Bulgaria,
Croatia, Serbia, and has recently acquired a 20% stake in a US
based renewable energy company. Between 1978 and 1982 he was the
marketing manager of Ravenhead Ltd., a manufacturer of glass
tableware, and part of United Distillers Group (later acquired by
Grand Metropolitan). During this time Mr. Baillavoine became the UK
Business Manager where he restored market share and profit for
United Distillers. From 1982 to 1986 Mr. Baillavoine was Group
Corporate Planning and Group Marketing Director for Prontaprint
where he expanded the number of shops to 500 locations in four
years. Mr. Baillavoine joined Grand Metropolitan Plc between
1986-1988 (now Diageo Plc), an FTSE 100 beverage, food, hotel and
leisure company, as director in the Special Operations division. In
this capacity, he developed plans for Grand Met’s
trouble-shooting division for over 20,000 Grand Met retail outlets.
From 1988-1991 he was the Managing Director of Nutri Systems (UK)
Ltd., a subsidiary of the US based provider of professionally
supervised weight loss programs. Between 1991 and 1995, Mr.
Baillavoine was Director of BET Group plc, a multinational business
support services group, and in 1992, was promoted to the Managing
Director for the manufacturing businesses. The £2.3 billion
turnaround of BET during his tenure is one of the most successful
turnarounds of a top 100 FTSE company. Since 1995, Mr. Baillavoine
has held a number of CEO positions across a wide range of
industries and geographical locations. Mr. Baillavoine has European
and American educations (US high school and University of Wisconsin
Eau Claire 1972-1976).
63
All of
CEL-SCI's officers devote substantially all of their time to
CEL-SCI's business.
CEL-SCI’s
Board of Directors does not have a “leadership
structure”, as such, since each director is entitled to
introduce resolutions to be considered by the Board and each
director is entitled to one vote on any resolution considered by
the Board. CEL-SCI’s Chief Executive Officer is not the
Chairman of CEL-SCI’s Board of Directors.
CEL-SCI’s
Board of Directors has the ultimate responsibility to evaluate and
respond to risks facing CEL-SCI. CEL-SCI’s Board of Directors
fulfills its obligations in this regard by meeting on a regular
basis and communicating, when necessary, with CEL-SCI’s
officers.
Alexander G.
Esterhazy, Dr. Peter R. Young and Bruno Baillavoine are independent
directors as that term is defined in section 803 of the listing
standards of the NYSE MKT.
CEL-SCI
has adopted a Code of Ethics which is applicable to CEL-SCI’S
principal executive, financial, and accounting officers and persons
performing similar functions. The Code of Ethics is available on
CEL-SCI’s website, located at
www.cel-sci.com.
If a
violation of this code of ethics act is discovered or suspected,
any person (anonymously, if desired) may send a detailed note, with
relevant documents, to CEL-SCI’s Audit Committee, c/o Dr.
Peter Young, 208 Hewitt Drive, Suite 103-143, Waco, TX
76712
.
For
purposes of electing directors at its annual meeting, CEL-SCI has a
nominating committee that is made up of CEL-SCI’s three
independent directors. The nominating committee selects the
nominees to the Board of Directors and they are approved by
CEL-SCI’s shareholders.
64
CEL-SCI
does not have any policy regarding the consideration of director
candidates recommended by shareholders since a shareholder has
never recommended a nominee to the Board of Directors and under
Colorado law, any shareholder can nominate a person for election as
a director at the annual shareholders’ meeting. However,
CEL-SCI’s Board of Directors will consider candidates
recommended by shareholders. To submit a candidate for the Board of
Directors the shareholder should send the name, address and
telephone number of the candidate, together with any relevant
background or biographical information, to CEL-SCI’s Chief
Executive Officer, at the address shown on the cover page of this
report. The Board has not established any specific qualifications
or skills a nominee must meet to serve as a director. Although the
Board does not have any process for identifying and evaluating
director nominees, the Board does not believe there would be any
differences in the manner in which the Board evaluates nominees
submitted by shareholders as opposed to nominees submitted by any
other person.
CEL-SCI
does not have a policy with regard to Board member’s
attendance at annual meetings. All Board members, with the
exception of Mr. de Clara and Mr. Esterhazy, attended the last
annual shareholder’s meeting held on July 22,
2016.
Holders
of CEL-SCI’s common stock can send written communications to
CEL-SCI’s entire Board of Directors, or to one or more Board
members, by addressing the communication to “the Board of
Directors” or to one or more directors, specifying the
director or directors by name, and sending the communication to
CEL-SCI’s offices in Vienna, Virginia. Communications
addressed to the Board of Directors as whole will be delivered to
each Board member. Communications addressed to a specific director
(or directors) will be delivered to the director (or directors)
specified.
Security holder
communications not sent to the Board of Directors as a whole are
not relayed to Board members.
Compensation Discussion and Analysis
This
Compensation Discussion and Analysis (CD&A) outlines
CEL-SCI’s compensation philosophy, objectives and process for
its executive officers.
This CD&A
includes information on how compensation decisions are made, the
overall objectives of CEL-SCI’s compensation program, a
description of the various components of compensation that are
provided, and additional information pertinent to understanding
CEL-SCI’s executive officer compensation
program.
The
Compensation Committee determines the compensation of
CEL-SCI’s Chief Executive Officer and delegates to the Chief
Executive Officer the responsibility to determine the base salaries
of all other officers, other than himself, under the constraints of
an overall limitation on the total amount of compensation to be
paid to them.
65
Compensation Philosophy
CEL-SCI’s
compensation philosophy extends to all employees, including
executive officers, and is designed to align employee and
shareholder interests. The philosophy’s objective is to pay
fairly based upon the employee’s position, experience and
individual performance. Employees may be rewarded through
additional compensation when CEL-SCI meets or exceeds targeted
business objectives. Generally, under CEL-SCI’s compensation
philosophy, as an employee’s level of responsibility
increases, a greater portion of his or her total potential
compensation becomes contingent upon annual
performance.
A
substantial portion of an executive's compensation incorporates
performance criteria that support and reward achievement of
CEL-SCI’s long term business goals.
The
fundamental principles of CEL-SCI’s compensation philosophy
are described below:
●
Market-driven.
Compensation programs
are structured to be competitive both in their design and in the
total compensation that they offer.
●
Performance-based.
Certain officers
have some portion of their incentive compensation linked to
CEL-SCI’s performance. The application of performance
measures as well as the form of the reward may vary depending on
the employee’s position and responsibilities.
Based
on a review of its compensation programs, CEL-SCI does not believe
that such programs encourage any of its employees to take risks
that would be likely to have a material adverse effect on
CEL-SCI. CEL-SCI reached this conclusion based on the
following:
●
The salaries paid
to employees are consistent with the employees’ duties and
responsibilities.
●
Employees who have
high impact relative to the expectations of their job duties and
functions are rewarded.
●
CEL-SCI retains
employees who have skills critical to its long term
success.
Review of Executive Officer Compensation
CEL-SCI’s
current policy is that the various elements of the compensation
package are not interrelated in that gains or losses from past
equity incentives are not factored into the determination of other
compensation. For instance, if options that are granted
in a previous year have an exercise price which is below the market
price of CEL-SCI’s common stock, the Committee does not take
that circumstance into consideration in determining the amount of
the options or restricted stock to be granted the next
year. Similarly, if the options or restricted shares
granted in a previous year become extremely valuable, the Committee
does not take that into consideration in determining the options or
restricted stock to be awarded for the next
year.
CEL-SCI
does not have a policy with regard to the adjustment or recovery of
awards or payments if relevant performance measures upon which they
are based are restated or otherwise adjusted in a manner that would
reduce the size of an award or payment.
66
Components of Compensation—Executive Officers
CEL-SCI’s
executive officers are compensated through the following three
components:
●
Base
Salary
●
Long-Term
Incentives (“LTIs”) (stock options and/or grants of
stock)
●
Benefits
These
components provide a balanced mix of base compensation and
compensation that is contingent upon each executive officer’s
individual performance. A goal of the compensation program is to
provide executive officers with a reasonable level of security
through base salary and benefits. CEL-SCI wants to ensure that the
compensation programs are appropriately designed to encourage
executive officer retention and motivation to create shareholder
value.
The Compensation Committee
believes that CEL-SCI’s stockholders are best served when
CEL-SCI can attract and retain talented executives by providing
compensation packages that are competitive but
fair.
In past
years, base salaries, benefits and incentive compensation
opportunities were generally targeted near the median of general
survey market data derived from indices covering similar
biotech/pharmaceutical companies. The companies included
Advaxis, Inc., Amicus Therapeutics, Inc., Celsion Corp., CytRx
Corporation, GERON Corp, Idera Pharmaceuticals, Inc., Northwest
Biotherapeutics, Inc., Oragenics, Inc., StemCells, Inc., TG
Therapeutics, Inc., Venaxis, Inc., Arrowhead Research Corp,
CorMedix Inc., Fibrocell Science, Inc., Hemispherx Biopharma, Inc.,
Opexa Therapeutics, Inc., Mateon Therapeutics, Inc. (formerly
OXiGENE, Inc.), Catalyst Bioscience, Inc., Sorrento Therapeutics,
Inc., Tenax Therapeutics, Inc., Trovagene, Inc. and ZIOPHARM
Oncology, Inc.
During
fiscal year 2014, CEL-SCI used a third party consultant to provide
it with recommendations for strategic long term incentive
compensation for certain key executives. The recommendation
resulted in the formation of the 2014 Incentive Stock Bonus Plan
that was voted on and passed by the shareholders at the annual
meeting on July 22, 2014.
Base Salaries
Base
salaries generally have been targeted to be competitive when
compared to the salary levels of persons holding similar positions
in other pharmaceutical companies and other publicly traded
companies of comparable size. Each executive officer’s
respective responsibilities, experience, expertise and individual
performance are considered.
A
further consideration in establishing compensation for the senior
employees is their long term history with CEL-SCI. Taken into
consideration are factors that have helped CEL-SCI survive in times
when it was financially weak, such as: willingness to accept salary
cuts, willingness not to be paid at all for extended time periods,
and in general an attitude that helped CEL-SCI survive during
financially difficult times.
67
Long-Term Incentives
Stock
grants and option grants help to align the interests of
CEL-SCI’s employees with those of its
shareholders. Options and stock grants are made under
CEL-SCI’s Stock Option, Incentive Stock Bonus, Stock Bonus
and Stock Compensation Plans. Options are granted with
exercise prices equal to the closing price of CEL-SCI’s
common stock on the day immediately preceding the date of grant,
with pro rata vesting at the end of each of the following three
years.
CEL-SCI
believes that grants of equity-based compensation:
●
Enhance the link
between the creation of shareholder value and long-term executive
incentive compensation;
●
Provide focus,
motivation and retention incentive; and
●
Provide competitive
levels of total compensation.
CEL-SCI’s
management believes that the pricing for biotechnology stocks is
highly inefficient until the time of product sales. As such, any
long term compensation tied to progress as measured by share price
is not as efficient as it should be. The plan approved by the
shareholders in July 2014, which covers senior and mid-level
employees, seeks to address this issue by rewarding employees for
meeting major operational milestones and significantly improved
share prices.
Benefits
In
addition to cash and equity compensation programs, executive
officers participate in the health and welfare benefit programs
available to other employees. In a few limited circumstances,
CEL-SCI provides other benefits to certain executive officers, such
as car allowances.
All
executive officers are eligible to participate in CEL-SCI’s
401(k) plan on the same basis as its other employees. CEL-SCI
matches 100% of each employee’s contribution up to 6% of his
or her salary.
68
The
following table sets forth in summary form the compensation
received by (i) the Chief Executive and Financial Officer of
CEL-SCI and (ii) by each other executive officer of CEL-SCI who
received in excess of $100,000 during the three fiscal years ended
September 30, 2016.
|
Name
and
Principal
Position
|
|
Fiscal
Year
|
Salary (1)
|
Bonus (2)
|
Restricted Stock Awards (3)
|
Option Awards (4)
|
All Other Compen-sation(5)
|
Total
|
|
|
|
|
$
|
$
|
$
|
$
|
$
|
$
|
|
|
|
|
|
|
|
|
|
|
|
Maximilian de
Clara,
|
|
2016
|
345,618
|
--
|
--
|
46,352
|
40,000
|
431,970
|
|
Former President
(6)
|
|
2015
|
332,750
|
--
|
--
|
69,190
|
40,000
|
441,940
|
|
|
|
2014
|
393,250
|
--
|
--
|
298,648
|
73,183
|
765,081
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Geert R.
Kersten,
|
|
2016
|
558,432
|
--
|
15,900
|
--
|
54,981
|
629,314
|
|
Chief
Executive
|
|
2015
|
514,083
|
--
|
16,050
|
--
|
54,981
|
585,114
|
|
Officer and
Treasurer
|
|
2014
|
584,621
|
--
|
3,236,526
|
82,917
|
57,581
|
3,961,645
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patricia B.
Prichep,
|
|
2016
|
245,804
|
--
|
14,725
|
--
|
9,031
|
269,559
|
|
Senior Vice
President
|
|
2015
|
235,702
|
--
|
14,128
|
--
|
6,906
|
256,736
|
|
of Operations
and
|
|
2014
|
247,852
|
--
|
1,735,938
|
55,278
|
6,531
|
2,045,599
|
|
Secretary
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eyal Talor,
Ph.D.,
|
|
2016
|
303,597
|
--
|
9,600
|
--
|
6,031
|
319,227
|
|
Chief Scientific
Officer
|
|
2015
|
290,983
|
--
|
9,600
|
--
|
6,031
|
306,613
|
|
|
|
2014
|
283,283
|
--
|
1,731,290
|
55,278
|
6,031
|
2,075,882
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Daniel Zimmerman,
Ph.D.,
|
|
2016
|
228,413
|
--
|
13,708
|
37,081
|
6,031
|
285,233
|
|
Senior Vice
President of
|
|
2015
|
219,026
|
--
|
13,148
|
52,003
|
6,031
|
290,209
|
|
Research,
Cellular
|
|
2014
|
213,231
|
--
|
13,274
|
227,319
|
6,031
|
459,855
|
|
Immunology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
John
Cipriano,
|
|
2016
|
211,405
|
--
|
--
|
--
|
31
|
211,437
|
|
Senior Vice
President of
|
|
2015
|
202,718
|
--
|
--
|
--
|
31
|
202,749
|
|
Regulatory
Affairs
|
|
2014
|
197,354
|
--
|
888,614
|
41,549
|
31
|
1,127,458
|
69
(1)
The dollar value of
base salary (cash and non-cash) earned. The officers of the Company
received stock in lieu of salary increases in FY 2016 and
2015.
(2)
The dollar value of
bonus (cash and non-cash) earned.
(3)
The fair value of
the shares of restricted stock issued during the periods covered by
the table is shown as compensation for services to the persons
listed in the table. For all persons listed in the table, the
shares were issued as CEL-SCI's contribution on behalf of the named
officer who participates in CEL-SCI's 401(k) retirement plan and,
by far the largest part, restricted shares issued from the 2014
Incentive Stock Bonus Plan that was voted on and passed by the
shareholders at the annual meeting on July 22, 2014. These shares
are not vested and are held in escrow. The shares will only be
earned upon the achievement of certain milestones leading to the
commercialization of CEL-SCI’s Multikine technology, or
specified increases in the market price of CEL-SCI’S stock.
If the performance or market criteria are not met as specified in
the Incentive Stock Bonus Plan, all or a portion of the awarded
shares will be forfeited. The value of all stock awarded during the
periods covered by the table is calculated according to ASC
718-10-30-3 which represented the grant date fair
value.
(4)
The fair value of
all stock options granted during the periods covered by the table
are calculated on the grant date in accordance with ASC 718-10-30-3
which represented the grant date fair value.
(5)
All other
compensation received that CEL-SCI could not properly report in any
other column of the table including the dollar value of any
insurance premiums paid by, or on behalf of, CEL-SCI with respect
to term life insurance for the benefit of the named executive
officer and car allowances paid by CEL-SCI. Includes board of
directors fees for Mr. de Clara and Mr. Kersten.
(6)
On August 31, 2016,
Mr. de Clara resigned as President for personal health
reasons.
70
Employee Pension, Profit Sharing or Other Retirement
Plans
CEL-SCI
has a defined contribution retirement plan, qualifying under
Section 401(k) of the Internal Revenue Code and covering
substantially all CEL-SCI’s employees. CEL-SCI’s
contribution to the plan is made in shares of CEL-SCI's common
stock. Each participant's contribution is matched by CEL-SCI with
shares of common stock which have a value equal to 100% of the
participant's contribution, not to exceed the lesser of $1,000 or
6% of the participant's total compensation. CEL-SCI's contribution
of common stock is valued each quarter based upon the closing price
of its common stock. The fiscal 2016 expenses for this plan were
$168,262. Other than the 401(k) Plan, CEL-SCI does not have a
defined benefit, pension plan, profit sharing or other retirement
plan.
Compensation of Directors During Year Ended September 30,
2016
|
Name
|
Paid in Cash
|
Stock Awards (1)
|
Option Awards (2)
|
Total
|
|
Maximilian de Clara
(3)
|
$
40,000
|
-
|
46,352
|
$
86,352
|
|
Geert
Kersten
|
$
40,000
|
-
|
-
|
$
40,000
|
|
Alexander
Esterhazy
|
$
45,000
|
-
|
46,352
|
$
91,352
|
|
Peter R.
Young
|
$
50,000
|
-
|
46,352
|
$
96,352
|
|
Bruno
Baillavoine
|
$
45,000
|
-
|
46,352
|
$
91,352
|
(1)
The fair value of
stock issued for services.
(2)
The fair value of
options granted computed in accordance with ASC 718-10-30-3 on the
date of grant which represents their grant date fair
value.
(3)
On August 31, 2016,
Mr. de Clara resigned as President for personal health
reasons.
Directors’
fees paid to Maximilian de Clara and Geert Kersten are included in
the Executive Compensation table.
On
August 31, 2016 Maximilian de Clara resigned as an officer and
director of the Company. In consideration for Mr. de Clara’s
past services to the Company, the Company entered into a
Termination Agreement with Mr. de Clara which provided for the
following:
1.
The Company issued
650,000 restricted shares of its common stock to Mr. de Clara. The
first 325,000 shares were issued promptly after August 31, 2016. Of
the first 325,000 shares, none of the shares may be sold prior to
February 28, 2017. Starting on February 28, 2017, each month the
Company will remove the restrictive legend on 65,000 shares. The
second 325,000 shares will be issued on August 31, 2017, but may
not be sold prior to February 28, 2018. Starting on February 28,
2018, each month the Company will remove the restrictive legend on
65,000 shares. The foregoing procedure will continue until the
restricted legend has been removed on all 650,000
shares.
71
2.
All options held by
Mr. de Clara vested as of August 31, 2016.
3.
Mr. de
Clara’s existing coverage under the Company’s group
health plan ended on August 31, 2016. However, Mr. de Clara may be
eligible to elect temporary continuation coverage under the
Company’s group health plan in accordance with the
Consolidated Omnibus Budget Reconciliation Act of 1985, as amended
(“COBRA”). Mr. de Clara did elect to receive COBRA
continuation coverage. Therefore, the Company will pay for COBRA
coverage (such payments will not include COBRA coverage with
respect to the Company’s Section 125 health care
reimbursement plan) until February 28, 2018, or the maximum period
permitted under COBRA if such period is less than eighteen months.
If Mr. de Clara exhausts the applicable COBRA period prior to
February 28, 2018, the Company will reimburse Mr. de Clara for the
cost of an individual health insurance policy in an amount not to
exceed the amount of the monthly COBRA premium previously paid by
the Company.
The
Termination Agreement was approved by the Company’s
Compensation Committee.
Employment Contracts
Geert Kersten
On
August 31, 2016, CEL-SCI entered into a three-year employment
agreement with Geert Kersten, CEL-SCI’s Chief Executive
Officer. The employment agreement with Mr. Kersten, which is
essentially the same as Mr. Kersten’s prior employment
agreement, as amended on August 30, 2013, provided that, during the
term of the agreement, CEL-SCI would pay Mr. Kersten an annual
salary of $559,052, plus any increases in proportion to salary
increases granted to other senior executive officers of CEL-SCI, as
well any increases approved by the Board of Directors during the
period of the employment agreement.
During
the employment term, Mr. Kersten will be entitled to receive any
other benefits which are provided to CEL-SCI's executive officers
or other full time employees in accordance with CEL-SCI's policies
and practices and subject to Mr. Kersten’s satisfaction of
any applicable condition of eligibility.
If Mr.
Kersten resigns within ninety (90) days of the occurrence of any of
the following events: (i) a reduction in Mr. Kersten’s salary
(ii) a relocation (or demand for relocation) of Mr. Kersten’s
place of employment to a location more than ten (10) miles from his
current place of employment, (iii) a significant and material
reduction in Mr. Kersten’s authority, job duties or level of
responsibility or the imposition of significant and material
limitations on the Mr. Kersten’s autonomy in his position, or
(iv) a Change in Control, then the employment agreement will be
terminated and Mr. Kersten will be entitled to receive a lump-sum
payment from CEL-SCI equal to 24 months of salary ($1,118,104) and
the unvested portion of any stock options would vest immediately
($590,329). For purposes of the employment agreement a change in
the control of CEL-SCI means: (1) the merger of CEL-SCI with
another entity if after such merger the shareholders of CEL-SCI do
not own at least 50% of voting capital stock of the surviving
corporation; (2) the sale of substantially all of the assets of
CEL-SCI; (3) the acquisition by any person of more than 50% of
CEL-SCI's common stock; or (4) a change in a majority of CEL-SCI's
directors which has not been approved by the incumbent
directors.
72
The
employment agreement will also terminate upon the death of Mr.
Kersten, Mr. Kersten’s physical or mental disability, willful
misconduct, an act of fraud against CEL-SCI, or a breach of the
employment agreement by Mr. Kersten.
If the
employment agreement is terminated for any of the foregoing, Mr.
Kersten, or his legal representatives, as the case may be, will be
paid the salary provided by the employment agreement through the
date of termination, any options or bonus shares of CEL-SCI then
held by Mr. Kersten will become fully vested and the expiration
date of any options which would expire during the four year period
following his termination of employment will be extended to the
date which is four years after his termination of
employment.
Patricia B. Prichep / Eyal Talor, Ph.D.
On
August 31, 2016, CEL-SCI entered into a three-year employment
agreement with Patricia B. Prichep, CEL-SCI’s Senior Vice
President of Operations. The employment agreement with Ms. Prichep,
which is essentially the same as Ms. Prichep’s prior
employment agreement entered into on August 30, 2013 provided that,
during the term of the agreement, CEL-SCI would pay Ms. Prichep an
annual salary of $245,804 plus any increases approved by the Board
of Directors during the period of the employment
agreement.
On
August 31, 2016, CEL-SCI entered into a three-year employment
agreement with Eyal Talor, Ph.D., CEL-SCI’s Chief Scientific
Officer. The employment agreement with Dr. Talor, which is
essentially the same as Dr. Talor’s prior employment
agreement entered into on August 30, 2013, provided that, during
the term of the agreement, CEL-SCI would pay Dr. Talor an annual
salary of $303,453 plus any increases approved by the Board of
Directors during the period of the employment
agreement.
If Ms.
Prichep or Dr. Talor resigns within ninety (90) days of the
occurrence of any of the following events: (i) a relocation (or
demand for relocation) of employee’s place of employment to a
location more than ten (10) miles from the employee’s current
place of employment, (ii) a significant and material reduction in
the employee’s authority, job duties or level of
responsibility or (iii) the imposition of significant and material
limitations on the employee’s autonomy in her or his
position, the employment agreement will be terminated and the
employee will be paid the salary provided by the employment
agreement through the date of termination and the unvested portion
of any stock options held by the employee will vest
immediately.
In the
event there is a change in the control of CEL-SCI, the employment
agreements with Ms. Prichep and Dr. Talor allow Ms. Prichep and/or
Dr. Talor (as the case may be) to resign from her or his position
at CEL-SCI and receive a lump-sum payment from CEL-SCI equal to 18
months of salary ($368,706 and $455,180 respectively). In addition,
the unvested portion of any stock options held by the employee will
vest immediately ($108,010 and $108,010 respectively). For purposes
of the employment agreements, a change in the control of CEL-SCI
means: (1) the merger of CEL-SCI with another entity if after such
merger the shareholders of CEL-SCI do not own at least 50% of
voting capital stock of the surviving corporation; (2) the sale of
substantially all of the assets of CEL-SCI; (3) the acquisition by
any person of more than 50% of CEL-SCI's common stock; or (4) a
change in a majority of CEL-SCI's directors which has not been
approved by the incumbent directors.
73
The
employment agreements with Ms. Prichep and Dr. Talor will also
terminate upon the death of the employee, the employee’s
physical or mental disability, willful misconduct, an act of fraud
against CEL-SCI, or a breach of the employment agreement by the
employee. If the employment agreement is terminated for any of
these reasons the employee, or her or his legal representatives, as
the case may be, will be paid the salary provided by the employment
agreement through the date of termination.
Compensation Committee Interlocks and Insider
Participation
CEL-SCI
has a compensation committee comprised of Mr. Alexander Esterhazy,
Mr. Bruno Baillavoine and Dr. Peter Young, all of whom are
independent directors.
During
the year ended September 30, 2016, no director of CEL-SCI was also
an executive officer of another entity, which had an executive
officer of CEL-SCI serving as a director of such entity or as a
member of the compensation committee of such entity.
Loan
from Officer and Director
Between
December 2008 and June 2009, CEL-SCI’s President, and a
director, Maximilian de Clara, loaned CEL-SCI
$1,104,057. Between July 2009 and July 2015, the loan
from Mr. de Clara bore interest at 15% per year. At Mr. de
Clara’s option, the loan was convertible into shares of
CEL-SCI’s common stock, determined by dividing the amount to
be converted by $4.00. In accordance with the loan
agreement, CEL-SCI issued Mr. de Clara warrants to purchase 164,824
shares of CEL-SCI’s common stock at a price of $4.00 per
share. These warrants expired on December 24,
2014. In consideration for an extension of the due date,
Mr. de Clara received warrants to purchase 184,930 shares of
CEL-SCI’s common stock at a price of $5.00 per
share. These warrants expired on January 6,
2015. In consideration of Mr. de Clara’s agreement
to subordinate his note to the convertible preferred shares and
convertible debt as part of a prior year settlement agreement,
CEL-SCI extended the maturity date of the note to July 6, 2015.
In August 2014, the loan was transferred to the de
Clara Trust, of which CEL-SCI’s Chief Executive Officer,
Geert Kersten, is the trustee and a beneficiary. Mr. de
Clara continued to receive the interest payments.
On June
29, 2015, CEL-SCI extended the maturity date of the note to July 6,
2017, lowered the interest rate to 9% per year and changed the
conversion price to $0.59, the closing stock price on the previous
trading day. The new terms were effective July 7,
2015. Concurrently, CEL-SCI extended the expiration
date of the Series N warrants to August 18,
2017.
On
October 11, 2015, at the request of Lake Whillans Vehicle I, LLC,
the note was extended for one year to July 6, 2018.
On
January 12, 2016, CEL-SCI owed the de Clara Trust $1,105,989, which
amount included accrued and unpaid interest. On January 13, 2016,
the de Clara Trust demanded payment on the note payable. At the
same time CEL-SCI sold 3,000,000 shares of its common stock and
3,000,000 Series X warrants to the de Clara Trust for approximately
$1,100,000. Each warrant allows the de Clara Trust to purchase one
share of CEL-SCI’s common stock at a price of $0.37 per share
at any time on or before January 13, 2021.
74
Stock Option, Bonus and Compensation Plans
CEL-SCI
has Incentive Stock Option Plans, Non-Qualified Stock Option, Stock
Bonus, Stock Compensation Plans and an Incentive Stock Bonus Plan.
All Stock Option, Bonus and Compensation Plans have been approved
by the stockholders. A summary description of these Plans follows.
In some cases these Plans are collectively referred to as the
"Plans".
Incentive Stock Option Plan
.
The Incentive Stock Option Plans authorize the issuance of shares
of CEL-SCI's common stock to persons who exercise options granted
pursuant to the Plans. Only CEL-SCI’s employees may be
granted options pursuant to the Incentive Stock Option
Plans.
Options
may not be exercised until one year following the date of grant.
Options granted to an employee then owning more than 10% of the
common stock of CEL-SCI may not be exercisable by its terms after
five years from the date of grant. Any other option granted
pursuant to the Plans may not be exercisable by its terms after ten
years from the date of grant.
The
purchase price per share of common stock purchasable under an
option is determined by the Committee but cannot be less than the
fair market value of the common stock on the date of the grant of
the option (or 110% of the fair market value in the case of a
person owning more than 10% of CEL-SCI's outstanding
shares).
Non-Qualified Stock Option
Plans
. The Non-Qualified Stock Option Plans authorize the
issuance of shares of CEL-SCI's common stock to persons that
exercise options granted pursuant to the Plans. CEL-SCI's
employees, directors, officers, consultants and advisors are
eligible to be granted options pursuant to the Plans, provided
however that bona fide services must be rendered by such
consultants or advisors and such services must not be in connection
with sale a capital-raising transaction or promoting
CEL-SCI’s common stock. The option exercise price is
determined by CEL-SCI’s Board of Directors.
Stock Bonus Plan
. Under the
Stock Bonus Plans shares of CEL-SCI’s common stock may be
issued to CEL-SCI's employees, directors, officers, consultants and
advisors, provided however that bona fide services must be rendered
by consultants or advisors and such services must not be in
connection with a capital-raising transaction or promoting
CEL-SCI’s common stock.
Stock Compensation Plan
. Under
the Stock Compensation Plan, shares of CEL-SCI’s common stock
may be issued to CEL-SCI’s employees, directors, officers,
consultants and advisors in payment of salaries, fees and other
compensation owed to these persons. However, bona fide services
must be rendered by consultants or advisors and such services must
not be in connection with the offer or sale of securities in a
capital-raising transaction or promoting CEL-SCI’s common
stock.
Incentive Stock Bonus Plan
.
Under the 2014 Incentive Stock Bonus Plan, shares of
CEL-SCI’s common stock may be issued to executive officers
and other employees who contribute significantly to the success of
CEL-SCI, to participate in its future prosperity and growth and
aligns their interests with those of CEL-SCI’s shareholders.
The purpose of the Plan is to provide long term incentive for
outstanding service to CEL-SCI and its shareholders and to assist
in recruiting and retaining people of outstanding ability and
initiative in executive and management positions.
75
Other Information Regarding the
Plans
. The Plans are administered by CEL-SCI's Compensation
Committee (“the Committee”), each member of which is a
director of CEL-SCI. The members of the Committee were selected by
CEL-SCI's Board of Directors and serve for a one-year tenure and
until their successors are elected. A member of the Committee may
be removed at any time by action of the Board of Directors. Any
vacancies which may occur on the Committee will be filled by the
Board of Directors. The Committee is vested with the authority to
interpret the provisions of the Plans and supervise the
administration of the Plans. In addition, the Committee is
empowered to select those persons to whom shares or options are to
be granted, to determine the number of shares subject to each grant
of a stock bonus or an option and to determine when, and upon what
conditions, shares or options granted under the Plans will vest or
otherwise be subject to forfeiture and cancellation.
In the
discretion of the Committee, any option granted pursuant to the
Plans may include installment exercise terms such that the option
becomes fully exercisable in a series of cumulating portions. The
Committee may also accelerate the date upon which any option (or
any part of any options) is first exercisable. Any shares issued
pursuant to the Stock Bonus Plan or Stock Compensation Plan and any
options granted pursuant to the Incentive Stock Option Plan or the
Non-Qualified Stock Option Plans will be forfeited if the "vesting"
schedule established by the Committee administering the Plans at
the time of the grant is not met. For this purpose, vesting means
the period during which the employee must remain an employee of
CEL-SCI or the period of time a non-employee must provide services
to CEL-SCI. At the time an employee ceases working for CEL-SCI (or
at the time a non-employee ceases to perform services for CEL-SCI),
any shares or options not fully vested will be forfeited and
cancelled. At the discretion of the Committee payment for the
shares of common stock underlying options may be paid through the
delivery of shares of CEL-SCI's common stock having an aggregate
fair market value equal to the option price, provided such shares
have been owned by the option holder for at least one year prior to
such exercise. A combination of cash and shares of common stock may
also be permitted at the discretion of the Committee.
Options
are generally non-transferable except upon death of the option
holder. Shares issued pursuant to the Stock Bonus Plans will
generally not be transferable until the person receiving the shares
satisfies the vesting requirements imposed by the Committee when
the shares were issued.
The
Board of Directors of CEL-SCI may at any time, and from time to
time, amend, terminate, or suspend one or more of the Plans in any
manner it deems appropriate, provided that such amendment,
termination or suspension will not adversely affect rights or
obligations with respect to shares or options previously
granted.
Stock Options
The
following tables show information concerning the options granted
during the fiscal year ended September 30, 2016, to the persons
named below:
76
Options Granted
|
Name
|
|
Grant
Date
|
Options Granted
|
Price Per Share
|
Expiration
Date
|
|
Daniel
Zimmerman
|
|
7/22/2016
|
100,000
|
$
0.47
|
7/21/2026
|
|
Alexander
Esterhazy
|
|
7/22/2016
|
125,000
|
$
0.47
|
7/21/2026
|
|
Peter
Young
|
|
7/22/2016
|
125,000
|
$
0.47
|
7/21/2026
|
|
Bruno
Baillavoine
|
|
7/22/2016
|
125,000
|
$
0.47
|
7/21/2026
|
|
Maximilian de
Clara
|
|
7/22/2016
|
125,000
|
$
0.47
|
7/21/2026
|
|
|
|
|
|
|
|
The
following tables show information concerning the options cancelled
and exercised during the fiscal year ended September 30, 2016, to
the persons named below:
Options Cancelled
|
|
|
Weighted
Average
|
Weighted Avergage
Remaining
Contractual
|
|
Employee
|
Total
Options
|
Exercise
Price
|
Term
(Years)
|
|
|
|
|
|
None
Options Exercised
|
|
Date
of
|
Shares
Acquired
|
Value
|
|
Name
|
Exercise
|
On
Exercise
|
Realized
|
|
|
|
|
|
None
77
The
following lists the outstanding options held by the persons named
below:
|
|
Shares underlying unexercised
|
|
|
|
|
|
Option which are:
|
Exercise
|
Expiration
|
|
|
Name
|
Exercisable
|
Unexercisable
|
Price
|
Date
|
|
|
|
|
|
|
|
Maximilian
de Clara
|
20,000
|
|
6.30
|
09/13/17
|
|
|
20,000
|
|
6.20
|
03/04/18
|
|
|
143,625
|
|
2.50
|
04/23/19
|
|
|
50,000
(2)
|
|
3.80
|
07/06/19
|
|
|
25,000
|
|
3.80
|
07/20/19
|
|
|
25,000
|
|
4.80
|
07/20/20
|
|
|
25,000
|
|
6.90
|
04/14/21
|
|
|
47,200
|
|
3.20
|
12/01/16
|
|
|
37,500
|
|
3.90
|
05/17/22
|
|
|
100,000
|
|
2.80
|
12/17/17
|
|
|
37,500
|
|
2.10
|
06/30/23
|
|
|
75,000
|
|
1.09
|
02/25/24
|
|
|
100,000
|
|
1.10
|
08/05/24
|
|
|
150,000
|
|
1.08
|
08/25/24
|
|
|
125,000
|
|
0.66
|
06/21/25
|
|
|
125,000
|
|
0.47
|
07/21/26
|
|
|
1,105,825
|
|
|
|
78
|
|
Shares underlying unexercised
|
|
|
|
|
|
Option which are:
|
Exercise
|
Expiration
|
|
|
Name
|
Exercisable
|
Unexercisable
|
Price
|
Date
|
|
|
|
|
|
|
|
Geert
R. Kersten
|
20,000
|
|
6.30
|
09/13/17
|
|
|
20,000
|
|
6.20
|
03/04/18
|
|
|
183,861
(1)
|
|
2.50
|
04/23/19
|
|
|
133,334
(2)
|
|
3.80
|
07/06/19
|
|
|
30,000
|
|
3.80
|
07/20/19
|
|
|
30,000
|
|
4.80
|
07/20/20
|
|
|
30,000
|
|
6.90
|
04/14/21
|
|
|
125,440
|
|
3.20
|
12/01/16
|
|
|
45,000
|
|
3.90
|
05/17/22
|
|
|
189,000
|
|
2.80
|
12/17/17
|
|
|
195,549
|
|
2.80
|
12/17/22
|
|
|
45,000
|
|
2.10
|
06/30/23
|
|
|
60,000
|
|
1.09
|
02/25/24
|
|
|
----------
|
|
|
|
|
|
1,107,184
|
|
|
|
|
|
|
266,666
(2)
|
3.80
|
07/06/19
|
|
|
|
304,451
|
2.80
|
12/17/22
|
|
|
|
30,000
|
1.09
|
02/25/24
|
|
|
|
----------
|
|
|
|
|
|
601,117
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patricia
B. Prichep
|
10,000
|
|
6.30
|
09/13/17
|
|
|
10,000
|
|
6.20
|
03/04/18
|
|
|
71,710
(1)
|
|
2.50
|
04/23/19
|
|
|
100,000
(2)
|
|
3.80
|
07/06/19
|
|
|
15,000
|
|
3.80
|
07/20/19
|
|
|
15,000
|
|
4.80
|
07/20/20
|
|
|
15,000
|
|
6.90
|
04/14/21
|
|
|
38,520
|
|
3.20
|
12/01/16
|
|
|
30,000
|
|
3.90
|
05/17/22
|
|
|
58,000
|
|
2.80
|
12/17/17
|
|
|
81,187
|
|
2.80
|
12/17/22
|
|
|
30,000
|
|
2.10
|
06/30/23
|
|
|
40,000
|
|
1.09
|
02/25/24
|
|
|
----------
|
|
|
|
|
|
514,417
|
|
|
|
|
|
|
200,000
(2)
|
3.80
|
07/06/19
|
|
|
|
68,813
|
2.80
|
12/17/22
|
|
|
|
20,000
|
1.09
|
02/25/24
|
|
|
|
----------
|
|
|
|
|
|
288,813
|
|
|
|
|
|
|
|
|
79
|
|
Shares underlying unexercised
|
|
|
|
|
|
Option which are:
|
Exercise
|
Expiration
|
|
|
Name
|
Exercisable
|
Unexercisable
|
Price
|
Date
|
|
Eyal
Talor, Ph.D.
|
10,000
|
|
6.30
|
09/13/17
|
|
|
10,000
|
|
6.20
|
03/04/18
|
|
|
24,082
(1)
|
|
2.50
|
04/23/19
|
|
|
100,000
(2)
|
|
3.80
|
07/06/19
|
|
|
15,000
|
|
3.80
|
07/20/19
|
|
|
15,000
|
|
4.80
|
07/20/20
|
|
|
15,000
|
|
6.90
|
04/14/21
|
|
|
27,773
|
|
3.20
|
12/01/16
|
|
|
30,000
|
|
3.90
|
05/17/22
|
|
|
37,417
|
|
2.80
|
12/17/17
|
|
|
81,187
|
|
2.80
|
12/17/22
|
|
|
30,000
|
|
2.10
|
06/30/23
|
|
|
40,000
|
|
1.09
|
02/25/24
|
|
|
----------
|
|
|
|
|
|
435,459
|
|
|
|
|
|
|
200,000
(2)
|
3.80
|
07/06/19
|
|
|
|
68,813
|
2.80
|
12/17/22
|
|
|
|
20,000
|
1.09
|
02/25/24
|
|
|
|
----------
|
|
|
|
|
|
288,813
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Daniel
Zimmerman, Ph.D.
|
7,500
|
|
6.30
|
09/13/17
|
|
|
7,500
|
|
6.20
|
03/04/18
|
|
|
15,000
|
|
4.80
|
07/20/20
|
|
|
15,000
|
|
6.90
|
04/14/21
|
|
|
25,200
|
|
3.20
|
12/01/16
|
|
|
22,500
|
|
3.90
|
05/17/22
|
|
|
39,200
|
|
2.80
|
12/17/17
|
|
|
22,500
|
|
2.10
|
06/30/23
|
|
|
30,000
|
|
1.09
|
02/25/24
|
|
|
133,334
|
|
1.10
|
08/05/24
|
|
|
33,334
|
|
0.62
|
06/25/25
|
|
|
----------
|
|
|
|
|
|
351,068
|
|
|
|
|
|
|
15,000
|
1.09
|
02/25/24
|
|
|
|
66,666
|
1.10
|
08/05/24
|
|
|
|
66,666
|
0.62
|
06/25/25
|
|
|
|
100,000
|
0.47
|
07/21/26
|
|
|
|
----------
|
|
|
|
|
|
248,332
|
|
|
80
|
|
Shares underlying unexercised
|
|
|
|
|
|
Option which are:
|
Exercise
|
Expiration
|
|
|
Name
|
Exercisable
|
Unexercisable
|
Price
|
Date
|
|
John
Cipriano
|
7,500
|
|
6.30
|
09/13/17
|
|
|
7,500
|
|
6.20
|
03/04/18
|
|
|
15,000
|
|
4.80
|
07/20/20
|
|
|
15,000
|
|
6.90
|
04/14/21
|
|
|
1,600
|
|
3.20
|
12/01/16
|
|
|
10,000
|
|
2.50
|
09/30/19
|
|
|
22,500
|
|
3.90
|
05/17/22
|
|
|
22,500
|
|
2.10
|
06/30/23
|
|
|
30,000
|
|
1.09
|
02/25/24
|
|
|
----------
|
|
|
|
|
|
131,600
|
|
|
|
|
|
|
15,000
|
1.09
|
02/25/24
|
|
|
|
----------
|
|
|
|
|
|
15,000
|
|
|
(1)
Options awarded to
employees who did not collect a salary, or reduced or deferred
their salary between September 15, 2008 and June 30, 2009. For
example, Mr. Kersten and Ms. Prichep did not collect any salary
between September 30, 2008 and June 30, 2009.
(2)
Long-term
performance options: The Board of Directors has identified the
successful Phase III clinical trial for Multikine to be the most
important corporate event to create shareholder value. Therefore,
one third of the options can be exercised when the first 400
patients are enrolled in CEL-SCI's Phase III head and neck cancer
clinical trial. One third of the options can be exercised when all
of the patients have been enrolled in the Phase III clinical trial.
One third of the options can be exercised when the Phase III trial
is completed. The grant-date fair value of these options awarded to
the senior management of the Company amounts to $3.3 million in
total.
Summary
. The following shows
certain information as of September 30, 2016 concerning the stock
options and stock bonuses granted by CEL-SCI. Each option
represents the right to purchase one share of CEL-SCI's common
stock.
|
Name of
Plan
|
Total Shares Reserved Under Plans
|
Shares Reserved for Outstanding
Options
|
Shares Issued
|
Remaining Options/Shares Under
Plans
|
|
|
|
|
|
|
|
Incentive Stock
Option Plans
|
3,460,000
|
1,648,966
|
N/A
|
1,511,334
|
|
Non-Qualified Stock
Option
Plans
|
9,680,000
|
6,940,321
|
N/A
|
2,059,261
|
|
Bonus
Plans
|
5,594,000
|
N/A
|
3,161,211
|
2,431,962
|
|
Stock Compensation
Plan
|
3,350,000
|
N/A
|
1,985,037
|
1,331,912
|
|
Incentive Stock
Bonus Plan
|
16,000,000
|
N/A
|
15,600,000
|
400,000
|
Of the
shares issued pursuant to CEL-SCI's Stock Bonus Plans, 1,108,203
shares were issued as part of CEL-SCI's contribution to its 401(k)
plan.
81
The
following table shows the weighted average exercise price of the
outstanding options granted pursuant to CEL-SCI’s Incentive
and Non-Qualified Stock Option Plans as of September 30, 2016,
CEL-SCI’s most recent fiscal year end. CEL-SCI's Incentive
and Non-Qualified Stock Option Plans have been approved by
CEL-SCI's shareholders.
|
Plan
category
|
Number of Securities to be Issued Upon Exercise of
Outstanding Options (a)
|
Weighted-Average Exercise Price of Outstanding
Options
|
Number of Securities Remaining Available For Future
Issuance Under Equity Compensation Plans, Excluding
SecuritiesReflected in Column (a)
|
|
|
|
|
|
|
Incentive Stock
Option Plans
|
1,648,966
|
$
2.97
|
1,511,334
|
|
Non-Qualified Stock
Option Plans
|
6,940,321
|
$
2.23
|
2,059,261
|
Long Term Incentive Plans - Awards in Last Fiscal Year
See
footnote 7 to the financial statements included as part of this
report.
The
following table shows, as of December 1, 2016, information with
respect to the only persons owning beneficially 5% or more of
CEL-SCI’s outstanding common stock and the number and
percentage of outstanding shares owned by each director and officer
of CEL-SCI and by the officers and directors as a group. Unless
otherwise indicated, each owner has sole voting and investment
powers over his shares of common stock.
|
Name and Address
|
Number of Shares (1)
|
Percent of Class (2)
|
|
|
|
|
|
Geert R.
Kersten
8229 Boone Blvd.,
Suite 802
Vienna, VA
22182
|
19,352,961
(3)
|
11.8
%
|
|
|
|
|
|
Patricia B.
Prichep
8229 Boone Blvd.,
Suite 802
Vienna, VA
22182
|
3,871,696
|
2.5
%
|
|
|
|
|
|
Eyal Talor,
Ph.D.
8229 Boone Blvd.,
Suite 802
Vienna, VA
22182
|
3,732,377
|
2.4
%
|
|
|
|
|
|
Daniel H.
Zimmerman, Ph.D.
8229 Boone Blvd.,
Suite 802
Vienna, VA
22182
|
509,154
|
0.3
%
|
82
|
John
Cipriano
8229 Boone Blvd.,
Suite 802
Vienna, VA
22182
|
1,774,318
|
1.1
%
|
|
|
|
|
|
Alexander G.
Esterhazy
20 Chemin du
Pre-Poiset
CH- 1253
Vandoeuvres
Geneve,
Switzerland
|
384,716
|
0.2
%
|
|
|
|
|
|
Peter R. Young,
Ph.D.
208 Hewitt Drive,
Suite 103-143
Waco, TX
76712
|
400,110
|
0.3
%
|
|
|
|
|
|
Bruno
Baillavoine
8229 Boone Blvd.,
Suite 802
Vienna, VA
22182
|
41,667
|
0.0
%
|
|
|
|
|
|
All Officers and
Directors
as a Group (8
persons)
|
30,066,999
|
18.1
%
|
(1)
Includes shares
issuable prior to February 28, 2017 upon the exercise of options or
warrants granted to the following persons:
|
Name
|
Options or Warrants ExercisablePrior to February 28,
2017
|
|
|
|
|
Geert R. Kersten,
Esq.
|
7,432,220
(3)
|
|
Patricia B.
Prichep
|
568,824
|
|
Eyal Talor,
Ph.D.
|
489,866
|
|
Daniel Zimmerman,
Ph.D.
|
366,068
|
|
John
Cipriano
|
146,600
|
|
Alexander G.
Esterhazy
|
361,400
|
|
Peter R. Young,
Ph.D.
|
370,334
|
|
Bruno
Baillavoine
|
41,667
|
(2)
Amount includes
shares referred to in (1) above but excludes shares which may be
issued upon the exercise or conversion of other options, warrants
and other convertible securities previously issued by
CEL-SCI.
(3)
Amount includes
shares held in trust for the benefit of Mr. Kersten's children and
warrants held in the de Clara Trust, of which Mr. Kersten is the
trustee and a beneficiary. Mr. Kersten is the stepson of Maximilian
de Clara, CEL-SCI’s former president and
director.
83
See
Item 7 of this report for information concerning modifications to
the terms of a loan originally made by Maximilian de Clara,
CEL-SCI’s former President and director, and subsequently
transferred to the de Clara Trust. Geert Kersten, CEL-SCI’s
Chief Executive Officer and a director, is the trustee and a
beneficiary of the de Clara Trust.
BDO
USA, LLP served as CEL-SCI’s independent registered public
accountant for the two years ended September 30, 2016. The
following table shows the aggregate fees billed to CEL-SCI for
these years by BDO USA, LLP:
|
|
Year Ended September 30,
|
|
|
|
2016
|
2015
|
|
|
|
|
|
Audit
Fees
|
$
311,000
|
$
362,000
|
|
Audit Related
Fees
|
-
|
-
|
|
Tax
Fees
|
-
|
-
|
|
All Other
Fees
|
-
|
-
|
Audit
fees represent amounts billed for professional services rendered
for the audit of CEL-SCI’s annual financial statements and
the reviews of the financial statements included in CEL-SCI’s
10-Q reports for the fiscal year and all regulatory filings. See
Note 1 to the financial statements included with this report for
more information.
Before
BDO USA, LLP was engaged by CEL-SCI to render audit or non-audit
services, the engagement was approved by CEL-SCI’s audit
committee. CEL-SCI’s Board of Directors is of the opinion
that the Audit Fees charged by BDO USA, LLP are consistent with BDO
USA, LLP maintaining its independence from CEL-SCI.
84
See the
Financial Statements attached to this Report.
|
Exhibits
|
|
|
|
|
|
|
|
3(a)
|
Articles
of Incorporation
|
Incorporated
by reference to Exhibit 3(a) of CEL-SCI's combined Registration
Statement on Form S-1 and Post-Effective Amendment ("Registration
Statement"), Registration Nos. 2-85547-D and 33-7531.
|
|
|
|
|
|
3(b)
|
Amended
Articles
|
Incorporated
by reference to Exhibit 3(a) of CEL-SCI's Registration Statement on
Form S-1, Registration Nos. 2-85547-D and 33-7531.
|
|
|
|
|
|
3(c)
|
Amended
Articles (Name change only)
|
Filed
as Exhibit 3(c) to CEL-SCI's Registration Statement on Form S-1
Registration Statement (No. 33-34878).
|
|
|
|
|
|
3(d)
|
Bylaws
|
Incorporated
by reference to Exhibit 3(b) of CEL-SCI's Registration Statement on
Form S-1, Registration Nos. 2-85547-D and 33-7531.
|
|
|
|
|
|
3(e)
|
Amended
Bylaws
|
Incorporated
by reference to Exhibit 3(ii) of CEL-SCI’s report on Form 8-K
dated March 16, 2015.
|
|
|
|
|
|
4
|
Shareholders
Rights Agreement, as Amended
|
Incorporated
by reference to Exhibit 4 filed with CEL-SCI’s 10-K
report for the year ended September 30, 2015.
|
|
|
|
|
|
4(b)
|
Incentive
Stock Option Plan
|
Incorporated
by reference to Exhibit 4 (b) filed on September 25, 2012 with the
Company’s registration statement on Form S¬8 (File
number 333-184092.
|
|
|
|
|
|
4(c)
|
Non-Qualified
Stock Option Plan
|
Incorporated
by reference to Exhibit 4 (b) filed on August 19, 2014 with the
Company’s registration statement on Form S¬8 (File
number 333-198244).
|
|
|
|
|
|
4(d)
|
Stock
Bonus Plan
|
Incorporated
by reference to Exhibit 4 (d) filed on September 25, 2012 with the
Company’s registration statement on Form S¬8 (File
number 333-184092.
|
|
|
|
|
|
4(e)
|
Stock
Compensation Plan
|
Incorporated
by reference to Exhibit 4 (e) filed on September 25, 2012 with the
Company’s registration statement on Form S¬8 (File
number 333-184092.
|
|
|
|
|
|
4(f)
|
2014
Incentive Stock Bonus Plan
|
Filed
with this Amendment No. 2 to the Company’s annual report on
Form 10-K for the year ended September 30, 2014.
|
85
|
10(f)
|
Securities
Purchase Agreement (together with schedule required by
Instruction 2 to Item 601 of Regulation S-K) pertaining
to Series K notes and warrants, together with the exhibits to
the Securities Purchase Agreement
|
Incorporated
by reference to Exhibit 10 to CEL-SCI’s report on Form
8-K dated August 4, 2006.
|
|
|
|
|
|
10(g)
|
Subscription
Agreement (together with Schedule required by Instruction 2
toItem 601 of Regulation S-K) pertaining to April 2007 sale of
20,000,000 shares of CEL-SCI’s common stock,
10,000,000 Series L warrants and 10,000,000 Series
M Warrants
|
Incorporated
by reference to Exhibit 10 of CEL-SCI’s report on Form
8-K dated April 18, 2007
|
|
|
|
|
|
10(h)
|
Warrant
Adjustment Agreement with Laksya Ventures
|
Incorporated
by reference to Exhibit 10(i) of CEL-SCI’s report on
Form 8-K dated August 3, 2010
|
|
|
|
|
|
10(l)
|
First
Amendment to Development Supply and Distribution Agreement
with Orient Europharma.
|
Incorporated
by reference to Exhibit 10(m) filed with CEL-SCI’s 10-K
report for the year ended September 30, 2010.
|
|
|
|
|
|
10(m)
|
Exclusive
License and Distribution Agreement with
Teva Pharmaceutical Industries Ltd.
|
Incorporated
by reference to Exhibit 10(n) filed with CEL-SCI’s 10-K
report for the year ended September 30, 2010.
|
|
|
|
|
|
10(n)
|
Lease
Agreement
|
Incorporated
by reference to Exhibit 10(o) filed with CEL-SCI’s 10-K
report for the year ended September 30, 2010.
|
|
|
|
|
|
10(o)
|
Promissory
Note with Maximilian de Clara, together with Amendments 1 and
2
|
Incorporated
by reference to Exhibit 10(p) filed with CEL-SCI’s 10-K
report for the year ended September 30, 2010.
|
|
|
|
|
|
10(p)
|
Licensing
Agreement with Byron Biopharma
|
Incorporated
by reference to Exhibit 10(i) of CEL-SCI’s report on
Form 8-K dated March 27, 2009
|
|
|
|
|
|
10(z)
|
Development,
Supply and Distribution Agreement with Orient
Europharma
|
Incorporated
by reference to Exhibit 10(z) filed with CEL-SCI’s
report on Form 10-K for the year ended September 30,
2003.
|
|
|
|
|
|
10(aa)
|
Securities
Purchase Agreement and form of the Series F warrants, which
is and exhibit to the Securities
Purchase Agreement
|
Incorporated
by reference to Exhibit 10(aa) of CEL-SCI’s report on
Form 8-K dated October 3, 2011.
|
|
|
|
|
|
10(bb)
|
Placement
Agent Agreement
|
Incorporated
by reference to Exhibit 10(bb) of CEL-SCI’s report on
Form 8-K dated October 3, 2011.
|
|
|
|
|
|
10(cc)
|
Securities Purchase
Agreement, together with the form of the
Series H warrant, which is an exhibit to the securities Purchase
Agreement
|
Incorporated
by reference to Exhibit 10(cc) of CEL-SCI’s report on Form
8-K dated January 25, 2012.
|
|
|
|
|
|
10(dd)
|
Placement
Agent Agreement
|
Incorporated
by reference to Exhibit 10(dd) of CEL-SCI’s report on
Form 8-K dated January 25, 2012.
|
|
|
|
|
86
|
10(ee)
|
Warrant
Amendment Agreement, together with the form of the Series P
warrant, which is an exhibit to the Warrant Amendment
Agreement
|
Incorporated
by reference to Exhibit 10(ee) of CEL-SCI’s report on
Form 8-K dated February 10, 2012.
|
|
|
|
|
|
10(ff)
|
Placement
Agent Agreement
|
Incorporated
by reference to Exhibit 10(ff) of CEL-SCI’s report on
Form 8-K dated February 10, 2012.
|
|
|
|
|
|
10(gg)
|
Securities Purchase Agreement and
the form of the Series
Q warrant, which is
an exhibit to the Securities Purchase
Agreement
|
Incorporated
by reference to Exhibit 10(gg) of CEL-SCI’s report on
Form 8-K dated June 18, 2012.
|
|
|
|
|
|
10(hh)
|
Placement
Agent Agreement
|
Incorporated
by reference to Exhibit 10(hh) of CEL-SCI’s report on
Form 8-K dated June 18, 2012.
|
|
|
|
|
|
10
(ii)
|
Securities Purchase Agreement and
the form of the Series
R warrant, which is
an exhibit to the Securities Purchase
Agreement
|
Incorporated
by reference to Exhibit 10(ii) of CEL-SCI’s report on
Form 8-K dated December 5, 2012.
|
|
|
|
|
|
10
(jj)
|
Placement
Agent Agreement
|
Incorporated
by reference to Exhibit 10(jj) of CEL-SCI’s report
on Form 8-K dated December 5, 2012.
|
|
|
|
|
|
10
(nn)
|
Underwriting
Agreement, together with the form of Series S warrant which is an
exhibit to the underwriting agreement
|
Incorporated
by reference to Exhibit 1.1 of CEL-SCI’s report on Form 8-K
dated October 8, 2013.
|
|
|
|
|
|
10
(oo)
|
Underwriting
Agreement, together with the form of Series S warrant which is an
exhibit to the underwriting agreement
|
Incorporated
by reference to Exhibit 1.1 of CEL-SCI’s report on Form 8-K
dated December 19, 2013.
|
|
|
|
|
|
10
(pp)
|
Underwriting
Agreement, together with the form of Series T warrant which is an
exhibit to the warrant agent agreement
|
Incorporated
by reference to Exhibit 1.1 of CEL-SCI’s report on Form 8-K
dated April 15, 2014.
|
|
|
|
|
|
10
(qq)
|
Underwriting
Agreement, together with the form of Series S warrant which is an
exhibit to the warrant agent agreement
|
Incorporated
by reference to Exhibit 1.1 of CEL-SCI’s report on Form 8-K
dated October 23, 2014.
|
|
|
|
|
|
10
(rr)
|
Assignment
and Assumption Agreement with Teva Pharmaceutical Industries, Ltd.
and GCP Clinical Studies, Ltd.
|
Incorporated
by reference to Exhibit 10(rr) of CEL-SCI’s report on Form
10-K/A report for the year ended September 30, 2014 dated
April 17, 2015.
|
|
|
|
|
|
10
(ss)
|
Service
Agreement with GCP Clinical Studies, Ltd., together with Amendment
1 thereto*
|
Incorporated
by reference to Exhibit 10(ss) of CEL-SCI’s first amendment
to its Form 10-K report for the year ended September 30, 2014
dated April 17, 2015.
|
|
|
|
|
|
10
(tt)
|
Joinder
Agreement with PLIVA Hrvatska d.o.o.
|
Incorporated
by reference to Exhibit 10(tt) of CEL-SCI’s first amendment
to its Form 10-K report for the year ended September 30, 2014
dated April 17, 2015.
|
|
|
|
|
|
10
(uu)
|
Master
Service Agreement with Ergomed Clinical Research,
Ltd., and Clinical Trial Orders thereunder
|
Incorporated
by reference to Exhibit 10(uu) of CEL-SCI’s first amendment
to its Form 10-K report for the year ended September 30, 2014
dated April 17, 2015.
|
|
|
|
|
87
|
10
(vv)
|
Co-Development
and Revenue Sharing Agreement with Ergomed Clinical Research Ltd.,
dated April 19, 2013, as amended
|
Incorporated
by reference to Exhibit 10(vv) of CEL-SCI’s first amendment
to its Form 10-K report for the year ended September 30, 2014
dated April 17, 2015.
|
|
|
|
|
|
10
(ww)
|
Co-Development
and Revenue Sharing Agreement II: Cervical
Intraepithelial Neoplasia in HIV/HPV co-infected women, with
Ergomed Clinical Research Ltd., dated October 10, 2013, as
amended
|
Incorporated
by reference to Exhibit 10(ww) of CEL- first amendment to its Form
10-K report for the year ended September 30, 2014 dated April
17, 2015.
|
|
|
|
|
|
10
(xx)
|
Co-Development
and Revenue Sharing Agreement III: Anal warts and anal
intraepithelial neoplasia in HIV/HPV co-infected patients, with
Ergomed Clinical Research Ltd., dated October 24, 2013
|
Incorporated
by reference to Exhibit 10(xx) of CEL-SCI’s first amendment
to its Form 10-K report for the year ended September 30, 2014
dated April 17, 2015.
|
|
|
|
|
|
10
(yy)
|
Master
Services Agreement with Aptiv Solutions, Inc.
|
Incorporated
by reference to Exhibit 10(yy) of CEL-SCI’s first amendment
to its Form 10-K report for the year ended September 30, 2014
dated April 17, 2015.
|
|
|
|
|
|
10
(zz)
|
Project
Agreement Number 1 with Aptiv Solutions, Inc. together with
Amendments 1 and 2 thereto*
|
Incorporated
by reference to Exhibit 10(zz) of CEL-SCI’s first amendment
to its Form 10-K report for the year ended September 30, 2014
dated April 17, 2015.
|
|
|
|
|
|
10
(aaa)
|
Second
Amendment to Development Supply and Distribution Agreement with
Orient Europharma
|
Incorporated
by reference to Exhibit 10(aaa) of CEL-SCI’s first amendment
to its Form 10-K report for the year ended September 30, 2014
dated April 17, 2015.
|
|
|
|
|
|
10
(bbb)
|
Amended
and Restated Promissory Note with Maximilian de Clara
|
Incorporated
by reference to Exhibit 10(bbb) of CEL-SCI’s report on Form
10-K/A report for the year ended September 30, 2014 dated
April 17, 2015.
|
|
|
|
|
|
10
(ccc)
|
Placement
Agent Agreement dated May 22,
2015 by
and among CEL-SCI Corporation and Dawson James Securities,
Inc.
|
Incorporated
by reference to Exhibit 1.1 of CEL-SCI’s report on Form 8-K
filed on May 26, 2015.
|
|
|
|
|
|
10
(ddd)
|
Warrant
Agent Agreement (as amended),
Series
V warrants
|
Incorporated
by reference to Exhibit 10 (ccc) of CEL-SCI’s report on Form
8-K filed on May 29, 2015.
|
|
|
|
|
|
10
(eee)
|
Assignment
of Proceeds and Investment Agreement between CEL-SCI Corporation
and Lake Whillans Vehicle 1.
|
Incorporated
by reference to Exhibit 10 (ddd) of CEL-SCI’s report on Form
8-K filed on October 16, 2015.
|
|
|
|
|
|
10
(fff)
|
Placement
Agent Agreement dated October 22, 2015 by and among CEL-SCI
Corporation and Dawson James Securities, Inc.
|
Incorporated
by reference to Exhibit 1.1 of CEL-SCI’s report on Form 8-K
filed on October 23, 2015.
|
|
|
|
|
|
10
(ggg)
|
Warrant
Agent Agreement, Series W warrants
|
Incorporated
by reference to Exhibit 10 (eee) of CEL-SCI’s report on Form
8-K filed on October 23, 2015.
|
|
|
|
|
88
|
10
(iii)
|
Amendment
to Co-Development and Revenue
Sharing
Agreement with Ergomed Clinical
Research,
Ltd., dated September 15, 2015
|
Incorporated
by reference to Exhibit 10 (iii) filed with CEL-SCI’s
10-K report for the year ended September 30,
2015.
|
|
|
|
|
|
10
(jjj)
|
Securities
Purchase Agreement
|
Incorporated
by reference to Exhibit 10(jjj) of CEL-SCI’s report on Form
8-K dated May 19, 2016.
|
|
|
|
|
|
10
(kkk)
|
Securities
Purchase Agreement
|
Incorporated
by reference to Exhibit 10(kkk) of CEL-SCI’s report on Form
8-K dated August 24, 2016.
|
|
|
|
|
|
10
(lll)
|
Termination
Agreement with Maximilian de Clara
|
Incorporated
by reference to Exhibit 10(lll) of CEL-SCI’s report on Form
8-K dated September 2, 2016.
|
|
|
|
|
|
10
(mmm)
|
Employment
Agreement with Geert Kersten (2016-2019)
|
Incorporated
by reference to Exhibit 10(mmm) of CEL-SCI’s report on Form
8-K dated September 2, 2016.
|
|
|
|
|
|
10
(nnn)
|
Employment
Agreement with Patricia Prichep (2016-2019)
|
Incorporated
by reference to Exhibit 10(nnn) of CEL-SCI’s report on Form
8-K dated September 2, 2016.
|
|
|
|
|
|
10
(000)
|
Employment
Agreement with Eyal Taylor (2016-2019)
|
Incorporated
by reference to Exhibit 10(ooo) of CEL-SCI’s report on Form
8-K dated September 2, 2016.
|
|
|
|
|
|
23.1
|
Consent
of BDO USA, LLP
|
|
|
|
|
|
|
31
|
Rule 13a-14(a) Certifications |
|
|
|
|
|
|
32
|
Section 1350 Certifications |
|
*
Portions of this
exhibit have been omitted pursuant to a request for confidential
treatment filed with the Commission under Rule 24b-2 of the
Securities Exchange Act of 1934. The omitted confidential material
has been filed separately with the Commission. The location of the
omitted confidential information is indicated in the exhibit with
asterisks (*)
89
CEL-SCI CORPORATION
TABLE OF CONTENTS
|
|
Page
|
|
|
|
|
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
|
F- 2
|
|
|
|
|
FINANCIAL STATEMENTS FOR THE YEARS
ENDED
SEPTEMBER 30, 2016, 2015 and 2014:
|
|
|
|
|
|
Balance Sheets
|
F- 3
|
|
|
|
|
Statements of Operations
|
F- 4
|
|
|
|
|
Statements of Stockholders’ (Deficit)
Equity
|
F- 5
|
|
|
|
|
Statements of Cash Flows
|
F- 6
|
|
|
|
|
Notes to Financial Statements
|
F- 8
|
F-1
Report of Independent Registered Public Accounting
Firm
Board
of Directors and Stockholders
CEL-SCI Corporation
Vienna, Virginia
We have
audited the accompanying balance sheets of CEL-SCI Corporation (the
“Company”) as of September 30, 2016 and 2015 and the
related statements of operations, stockholders’ (deficit)
equity, and cash flows for each of the three years in the period
ended September 30, 2016. These financial statements are the
responsibility of the Company’s management. Our
responsibility is to express an opinion on these financial
statements based on our audits.
We
conducted our audits in accordance with the standards of the Public
Company Accounting Oversight Board (United States). Those standards
require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of
material misstatement. An audit includes examining, on a test
basis, evidence supporting the amounts and disclosures in the
financial statements, assessing the accounting principles used and
significant estimates made by management, as well as evaluating the
overall financial statement presentation. We believe that our
audits provide a reasonable basis for our opinion.
In our
opinion, the financial statements referred to above present fairly,
in all material respects, the financial position of CEL-SCI
Corporation at September 30, 2016 and 2015, and the results of its
operations and its cash flows for each of the three years in the
period ended September 30, 2016, in conformity with accounting
principles generally accepted in the United States of
America.
The
accompanying financial statements have been prepared assuming that
the Company will continue as a going concern. As discussed in Note
2
to the financial statements,
the Company has a
history of
net
losses and
expects to incur
substantial losses for the foreseeable future
that raise
substantial doubt about its ability to continue as a going concern.
Management's plans in regard to these matters are also described in
Note
2
. The financial
statements do not include any adjustments that might result from
the outcome of this uncertainty.
We also
have audited, in accordance with the standards of the Public
Company Accounting Oversight Board (United States), CEL-SCI
Corporation’s internal control over financial reporting as of
September 30, 2016 based on criteria established in
Internal Control – Integrated
Framework
(2013)
issued by the Committee of Sponsoring Organizations of the Treadway
Commission (COSO) and our report dated December
14,
2016 expressed an unqualified opinion
thereon.
/s/ BDO USA, LLP
McLean, Virginia
December 14, 2016
F-2
CEL-SCI CORPORATION
BALANCE SHEETS
SEPTEMBER 30, 2016 and 2015
|
ASSETS
|
2016
|
2015
|
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
Cash
and cash equivalents
|
$
2,917,996
|
$
5,726,682
|
|
Receivables
|
394,515
|
87,214
|
|
Prepaid
expenses
|
981,677
|
979,655
|
|
Deposits
- current portion
|
154,995
|
150,000
|
|
Inventory
used for R&D and manufacturing
|
1,008,642
|
1,401,839
|
|
Deferred
rent - current portion
|
429,821
|
487,793
|
|
|
|
|
|
Total
current assets
|
5,887,646
|
8,833,183
|
|
|
|
|
|
RESEARCH
AND OFFICE EQUIPMENT, net
|
226,216
|
307,466
|
|
|
|
|
|
PATENT
COSTS, net
|
256,547
|
291,564
|
|
DEFERRED
RENT - net of current portion
|
3,406,921
|
4,044,473
|
|
|
|
|
|
DEPOSITS
- net of current portion
|
1,820,917
|
1,970,917
|
|
|
|
|
|
TOTAL
ASSETS
|
$
11,598,247
|
$
15,447,603
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' DEFICIT
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
Accounts
payable
|
$
3,091,512
|
$
5,128,682
|
|
Accrued
expenses
|
378,672
|
88,575
|
|
Due
to employees
|
538,278
|
365,131
|
|
Related
party loan
|
-
|
1,104,057
|
|
Deferred
rent - current portion
|
3,310
|
9,997
|
|
Lease
obligation - current portion
|
-
|
9,028
|
|
|
|
|
|
Total
current liabilities
|
4,011,772
|
6,705,470
|
|
|
|
|
|
Derivative
instruments
|
8,394,934
|
13,686,587
|
|
Deferred
revenue
|
125,000
|
126,639
|
|
Deferred
rent - net of current portion
|
17,609
|
9,026
|
|
Deposits
held
|
5,000
|
5,000
|
|
|
|
|
|
Total
liabilities
|
12,554,315
|
20,532,722
|
|
|
|
|
|
COMMITMENTS
AND CONTINGENCIES
|
|
|
|
|
|
|
|
STOCKHOLDERS'
DEFICIT
|
|
|
|
Preferred
stock, $.01 par value-200,000 shares authorized;
|
|
|
|
-0-
shares issued and outstanding
|
-
|
-
|
|
Common
stock, $.01 par value - 600,000,000 shares authorized;
|
|
|
|
155,962,079
and 112,360,568 shares issued and outstanding
|
|
|
|
at
September 30, 2016 and 2015, respectively
|
1,559,621
|
1,123,606
|
|
Additional
paid-in capital
|
283,152,288
|
267,992,754
|
|
Accumulated
deficit
|
(285,667,977
)
|
(274,201,479
)
|
|
|
|
|
|
Total
stockholders' deficit
|
(956,068
)
|
(5,085,119
)
|
|
|
|
|
|
TOTAL
LIABILITIES AND STOCKHOLDERS' DEFICIT
|
$
11,598,247
|
$
15,447,603
|
See notes to financial statements.
F-3
CEL-SCI CORPORATION
STATEMENTS OF OPERATIONS
YEARS ENDED SEPTEMBER 30, 2016, 2015 and 2014
|
|
2016
|
2015
|
2014
|
|
|
|
|
|
|
GRANT
INCOME AND OTHER
|
$
285,055
|
$
657,377
|
$
264,033
|
|
|
|
|
|
|
OPERATING
EXPENSES:
|
|
|
|
|
Research
and development
|
19,351,779
|
21,098,147
|
17,172,587
|
|
General
& administrative
|
6,486,501
|
13,855,775
|
10,665,558
|
|
|
|
|
|
|
Total
operating expenses
|
25,838,280
|
34,953,922
|
27,838,145
|
|
|
|
|
|
|
OPERATING
LOSS
|
(25,553,225
)
|
(34,296,545
)
|
(27,574,112
)
|
|
|
|
|
|
|
GAIN
ON DERIVATIVE INSTRUMENTS
|
14,013,726
|
282,616
|
248,767
|
|
|
|
|
|
|
LOSS
ON DEBT EXTINGUISHMENT
|
-
|
(620,457
)
|
-
|
|
|
|
|
|
|
INTEREST
INCOME (EXPENSE), net
|
73,001
|
(40,260
)
|
(40,920
)
|
|
|
|
|
|
|
NET
LOSS
|
(11,466,498
)
|
(34,674,646
)
|
(27,366,265
)
|
|
|
|
|
|
|
ISSUANCE
OF ADDITIONAL SHARES DUE TO RESET PROVISIONS
|
-
|
-
|
(1,117,447
)
|
|
|
|
|
|
|
NET
LOSS AVAILABLE TO COMMON SHAREHOLDERS
|
$
(11,466,498
)
|
$
(34,674,646
)
|
$
(28,483,712
)
|
|
|
|
|
|
|
NET
LOSS PER COMMON SHARE
|
|
|
|
|
BASIC
|
$
(0.09
)
|
$
(0.42
)
|
$
(0.48
)
|
|
DILUTED
|
$
(0.09
)
|
$
(0.42
)
|
$
(0.49
)
|
|
|
|
|
|
|
WEIGHTED
AVERAGE COMMON SHARES
|
|
|
|
|
OUTSTANDING
|
|
|
|
|
BASIC
and DILUTED
|
121,655,108
|
82,519,027
|
58,804,622
|
See
notes to financial statements.
F-4
CEL-SCI CORPORATION
STATEMENTS OF STOCKHOLDERS' (DEFICIT) EQUITY
YEARS ENDED SEPTEMBER 30, 2016, 2015 and 2014
|
|
|
|
Additional
|
|
|
|
|
Common
|
Stock
|
Paid-In
|
Accumulated
|
|
|
|
Shares
|
Amount
|
Capital
|
Deficit
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE,
OCTOBER 1, 2013
|
31,025,019
|
310,250
|
218,550,408
|
(212,160,568
)
|
6,700,090
|
|
|
|
|
|
|
|
|
Sale
of common stock
|
31,755,494
|
317,555
|
28,129,691
|
-
|
28,447,246
|
|
Issuance
of warrants in connection with
|
|
|
|
|
|
|
sale
of common stock
|
-
|
-
|
(7,791,448
)
|
-
|
(7,791,448
)
|
|
401(k)
contributions paid
|
|
|
|
|
|
|
in
common stock
|
164,787
|
1,647
|
153,787
|
-
|
155,434
|
|
Exercise
of warrants
|
2,668,508
|
26,686
|
4,253,632
|
-
|
4,280,318
|
|
Conversion
of warrant liability to equity
|
-
|
-
|
1,308,528
|
-
|
1,308,528
|
|
Stock
issued to nonemployees for service
|
579,968
|
5,800
|
621,318
|
-
|
627,118
|
|
Stock
issued for patents
|
8,695
|
87
|
9,912
|
-
|
9,999
|
|
Modification
of options issued to consultants
|
-
|
-
|
76,991
|
-
|
76,991
|
|
Issuance
of restricted stock
|
15,700,000
|
157,000
|
(157,000
)
|
-
|
-
|
|
Equity
based compensation - employees
|
-
|
-
|
3,958,637
|
-
|
3,958,637
|
|
Equity
based compensation - non-employees
|
-
|
-
|
36,752
|
-
|
36,752
|
|
Net
loss
|
-
|
-
|
-
|
(27,366,265
)
|
(27,366,265
)
|
|
|
|
|
|
|
|
|
BALANCE,
SEPTEMBER 30, 2014
|
81,902,471
|
819,025
|
249,151,208
|
(239,526,833
)
|
10,443,400
|
|
|
|
|
|
|
|
|
Sale
of common stock
|
29,467,901
|
294,679
|
20,853,699
|
-
|
21,148,378
|
|
Issuance
of warrants in connection with
|
|
|
|
|
|
|
sale
of common stock
|
-
|
-
|
(8,463,957
)
|
-
|
(8,463,957
)
|
|
401(k)
contributions paid
|
|
|
|
|
|
|
in
common stock
|
243,178
|
2,432
|
163,214
|
-
|
165,646
|
|
Stock
issued to nonemployees for service
|
739,968
|
7,400
|
526,576
|
-
|
533,976
|
|
Modification
of warrants and extingishment loss
|
-
|
-
|
620,457
|
-
|
620,457
|
|
Forfeiture
of unvested restricted stock
|
(100,000
)
|
(1,000
)
|
1,000
|
-
|
-
|
|
Equity
based compensation - employees
|
107,050
|
1,070
|
5,104,757
|
-
|
5,105,827
|
|
Equity
based compensation - non-employees
|
-
|
-
|
35,800
|
-
|
35,800
|
|
Net
loss
|
-
|
-
|
-
|
(34,674,646
)
|
(34,674,646
)
|
|
|
|
|
|
|
|
|
BALANCE,
SEPTEMBER 30, 2015
|
112,360,568
|
1,123,606
|
267,992,754
|
(274,201,479
)
|
(5,085,119
)
|
|
|
|
|
|
|
|
|
Sale
of common stock
|
41,523,248
|
415,232
|
20,958,464
|
-
|
21,373,696
|
|
Issuance
of warrants in connection with
|
|
|
|
|
|
|
sale
of common stock
|
-
|
-
|
(8,722,073
)
|
-
|
(8,722,073
)
|
|
401(k)
contributions paid
|
|
|
|
|
|
|
in
common stock
|
408,497
|
4,085
|
157,486
|
-
|
161,571
|
|
Stock
issued to nonemployees for service
|
1,248,831
|
12,489
|
677,824
|
-
|
690,313
|
|
Equity
based compensation - employees
|
420,935
|
4,209
|
2,008,474
|
-
|
2,012,683
|
|
Equity
based compensation - non-employees
|
-
|
-
|
79,359
|
-
|
79,359
|
|
Net
loss
|
-
|
-
|
-
|
(11,466,498
)
|
(11,466,498
)
|
|
|
|
|
|
|
|
|
BALANCE,
SEPTEMBER 30, 2016
|
155,962,079
|
$
1,559,621
|
$
283,152,288
|
$
(285,667,977
)
|
$
(956,068
)
|
See
notes to financial statements.
F-5
CEL-SCI CORPORATION
STATEMENTS OF CASH FLOWS
YEARS ENDED SEPTEMBER 30, 2016, 2015 and 2014
|
|
2016
|
2015
|
2014
|
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
Net
loss
|
$
(11,466,498
)
|
$
(34,674,646
)
|
$
(27,366,265
)
|
|
Adjustments
to reconcile net loss to
|
|
|
|
|
net
cash used in operating activities:
|
|
|
|
|
Depreciation
and amortization
|
150,243
|
206,750
|
231,752
|
|
Issuance
of common stock and options for services -
non-employees
|
751,651
|
565,915
|
694,955
|
|
Modification
of warrants issued to consultants
|
-
|
-
|
76,991
|
|
Equity
based compensation
|
2,113,433
|
5,105,827
|
3,958,637
|
|
Common
stock contributed to 401(k) plan
|
161,571
|
165,646
|
155,434
|
|
Impairment
loss on abandonment of patents
|
-
|
-
|
1,182
|
|
Loss
on retired equipment
|
248
|
313
|
268
|
|
Gain
on derivative instruments
|
(14,013,726
)
|
(282,616
)
|
(248,767
)
|
|
Loss
on debt extinguishment
|
-
|
620,457
|
-
|
|
(Increase)/decrease
in assets:
|
|
|
|
|
Receivables
|
(1,960
)
|
(5,394
)
|
(7,557
)
|
|
Deferred
rent
|
695,524
|
745,673
|
769,159
|
|
Prepaid
expenses
|
15,999
|
(68,268
)
|
(158,088
)
|
|
Inventory
used for R&D and manufacturing
|
393,197
|
50,181
|
(435,392
)
|
|
Deposits
|
145,005
|
150,000
|
(200,000
)
|
|
Increase/(decrease)
in liabilities:
|
|
|
|
|
Accounts
payable
|
(2,389,931
)
|
3,981,886
|
(751,971
)
|
|
Accrued
expenses
|
290,097
|
(458,633
)
|
433,712
|
|
Deferred
revenue
|
(1,639
)
|
48
|
46
|
|
Due
to employees
|
72,397
|
57,170
|
(78,376
)
|
|
Deferred
rent liability
|
1,896
|
6,358
|
(3,739
)
|
|
|
|
|
|
|
Net
cash used in operating activities
|
(23,082,493
)
|
(23,833,333
)
|
(22,928,019
)
|
|
|
|
|
|
|
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
Purchases
of equipment
|
(31,405
)
|
(73,399
)
|
(103,977
)
|
|
Expenditures
for patent costs
|
(2,819
)
|
(20,132
)
|
(34,887
)
|
|
|
|
|
|
|
Net
cash used in investing activities
|
(34,224
)
|
(93,531
)
|
(138,864
)
|
|
|
|
|
|
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
Proceeds
from issuance of common stock and warrants
|
21,420,301
|
21,148,378
|
28,428,641
|
|
Payment
on related party loan
|
(1,104,057
)
|
|
|
|
Proceeds
from exercise of warrants
|
-
|
-
|
3,118,387
|
|
Payments
on obligations under capital lease
|
(8,213
)
|
(8,452
)
|
(8,137
)
|
|
|
|
|
|
|
Net
cash provided by financing activities
|
20,308,031
|
21,139,926
|
31,538,891
|
|
|
|
|
|
|
NET
(DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
|
(2,808,686
)
|
(2,786,938
)
|
8,472,008
|
|
|
|
|
|
|
CASH
AND CASH EQUIVALENTS, BEGINNING OF YEAR
|
5,726,682
|
8,513,620
|
41,612
|
|
|
|
|
|
|
CASH
AND CASH EQUIVALENTS, END OF YEAR
|
$
2,917,996
|
$
5,726,682
|
$
8,513,620
|
See
notes to financial statements.
F-6
CEL-SCI CORPORATION
STATEMENTS OF CASH FLOWS
YEARS ENDED SEPTEMBER 30, 2016, 2015 and 2014
|
SUPPLEMENTAL SCHEDULE OF NON-CASH INVESTING AND FINANCING
ACTIVITIES:
|
|
||
|
|
|
|
|
|
|
2016
|
2015
|
2014
|
|
Receivable
due under the litigation funding arrangement offset by the same
amount
|
|
|
|
|
payable
to the legal firm providing the services
|
$
305,341
|
$
-
|
$
-
|
|
Research
and office equipment included in accounts payable at year
end
|
$
-
|
$
(2,345
)
|
$
(1,074
)
|
|
Capitalizable
patent costs included in accounts payable at year end.
|
$
-
|
$
(11,685
)
|
$
4,474
|
|
Patent
costs purchased with common stock
|
$
-
|
$
-
|
$
9,999
|
|
Lease
payments included in accounts payable at year end
|
$
815
|
$
43
|
$
3,477
|
|
Fair
value of warrant liabilities on the date of issuance reclassed to
liabilities
|
$
(8,722,073
)
|
$
(8,463,957
)
|
$
(5,320,989
)
|
|
Financing
costs included in accounts payable at year end
|
$
46,605
|
$
-
|
$
-
|
|
Forfeiture
of unvested restricted stock
|
$
-
|
$
1,000
|
$
-
|
|
Stock
issued under an anti-dilution provision and cashless exercise of
warrants
|
$
-
|
$
-
|
$
(16,375
)
|
|
Prepaid
amount under consulting services paid with issuance of common
stock
|
$
18,021
|
$
3,861
|
$
31,085
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
paid for interest expense
|
$
43,673
|
$
147,166
|
$
180,654
|
See notes to financial statements.
F-7
CEL-SCI CORPORATION
NOTES TO FINANCIAL STATEMENTS
1.
ORGANIZATION
CEL-SCI
Corporation (the Company) was incorporated on March 22, 1983, in
the state of Colorado, to finance research and development in
biomedical science and ultimately to engage in marketing and
selling products.
CEL-SCI
is focused on finding the best way to activate the immune system to
fight cancer and infectious diseases. The Company’s lead
investigational therapy, Multikine (Leukocyte Interleukin,
Injection), is currently in a Phase 3 clinical trial as a potential
therapeutic agent directed at using the immune system to produce an
anti-tumor immune response for advanced primary head and neck
cancer. Data from Phase 1 and Phase 2 clinical trials suggest
Multikine has the potential to directly affect tumor cells. These
data also indicate that it appears to activate the patient’s
own anti-tumor immune response. Multikine (Leukocyte Interleukin,
Injection) is the full name of this investigational therapy, which,
for simplicity, is referred to in the remainder of this document as
Multikine. Multikine is the trademark that the Company has
registered for this investigational therapy, and this proprietary
name is subject to FDA review in connection with the
Company’s future anticipated regulatory submission for
approval. Multikine has not been licensed or approved by the FDA or
any other regulatory agency. Neither has its safety or efficacy
been established for any use. Further research is required, and
early-phase clinical trial results must be confirmed in the Phase 3
clinical trial of this investigational therapy that is in progress
and that is currently subject to a clinical hold on enrollment of
additional new patients.
Multikine has been
cleared by the regulators in twenty four countries around the
world, including the U.S. FDA, for a global Phase 3 clinical trial
in advanced primary (not yet treated) head and neck cancer
patients. On September 26, 2016, the Company received verbal notice
from the FDA that the Phase 3 clinical trial has been placed on
clinical hold.
The FDA’s partial
clinical hold letter identified the following specific
deficiencies: there is an unreasonable and significant risk of
illness or injury to human subjects; the investigator brochure is
misleading, erroneous, and materially incomplete; and that the plan
or protocol is deficient in design to meet its stated
objectives.
Pursuant to this communication from FDA,
patients currently receiving study treatments could continue to
receive treatment, and patients already enrolled in the study would
continue to be followed, but no additional patients could be
enrolled. On October 21, 2016, the Company announced it had
received the Partial Clinical Hold letter from the FDA. On November
21, 2016, the Company announced it has submitted what it believes
to be a complete response to the FDA
.
On December 8, 2016, the FDA advised CEL-SCI that the agency was
denying CEL-SCI’s request for a meeting at this time because
FDA’s review of CEL-SCI’s November 17, 2016 response
was ongoing. CEL-SCI was also advised that it will be receiving a
letter addressing CEL-SCI’s response by December 18,
2016.
Multikine is also
being used in a Phase 1 study at the University of California, San
Francisco (UCSF) in HIV/HPV co-infected men and women with
peri-anal warts.
F-8
2
.
OPERATIONS AND FINANCING
The
Company has incurred significant costs since its inception in
connection with the acquisition of certain patented and unpatented
proprietary technology and know-how relating to the human
immunological defense system, patent applications, research and
development, administrative costs, construction of laboratory
facilities, and clinical trials. The Company has funded such
costs with proceeds from loans and the public and private sale of
its common and preferred stock.
The
Company is currently running a large multi-national Phase 3
clinical trial for head and neck cancer. The Company believes that
it has enough capital to support its operations as it believes that
it has ready access to new equity capital should the need arise.
During fiscal year 2016, the Company raised approximately $21.4
million in net proceeds through the sale of common stock and
warrants from public and private offerings. During fiscal year
2015, the Company raised $21.1 million net proceeds from public
offerings. To finance the study beyond the next 12 months, the
Company plans to raise additional capital in the form of corporate
partnerships, debt and/or equity financings. In addition, the
Company expects to receive proceeds from the arbitration against
its former clinical research organization, inVentiv. The Company
believes that it will be able to obtain additional financing
because it has done so consistently in the past, and because
Multikine is a product in the Phase 3 clinical trial stage.
However, there can be no assurance that the Company will be
successful in raising additional funds or that funds will be
available to the Company on acceptable terms or at all. If
the Company does not raise the necessary capital, the Company will
either have to slow or delay the Phase 3 clinical trial or even
significantly curtail its operations until such time as it is able
to raise the required funding. The financial statements have been
prepared assuming that the Company will continue as a going
concern, but due to the Company’s future liquidity needs,
history of net losses, and the expectation that the Company will
incur losses for the foreseeable future, there is substantial doubt
about the Company’s ability to continue as a going concern.
The financial statements do not include any adjustments that might
result from the outcome of this uncertainty.
Since
the Company launched its Phase 3 clinical trial for Multikine, the
Company has spent approximately $34.5 million as of September 30,
2016 on direct costs for the Phase 3 clinical trial.
T
he
total remaining cash cost of the Phase 3 clinical trial, excluding
any costs that will be paid by CEL-SCI's partners, would be
approximately $12.1 million after September 30, 2016. This ís
based on the executed contract costs with the CROs only and does
not include other related costs, e.g. the manufacturing of the
drug.
It should be noted that this estimate is based
only on the information currently available in the Company’s
contracts with the Clinical Research Organizations responsible for
managing the Phase 3 clinical trial. This number can be
affected by the speed of enrollment, foreign currency exchange
rates and many other factors, some of which cannot be
foreseen. The Company has filed an amendment to the original
Phase 3 protocol for it head and neck cancer study with the FDA to
allow for this expansion in patient enrollment. Should the FDA
allow the amended protocol filed with them to proceed, the
remaining cost of the Phase 3 clinical trial will be higher. It is
therefore possible that the cost of the Phase 3 clinical trial will
be higher than currently estimated.
On
September 26, 2016, the Company received verbal notice from the FDA
that the Phase 3 clinical trial has been placed on clinical hold.
Pursuant to this communication from FDA, patients currently
receiving study treatments could continue to receive treatment, and
patients already enrolled in the study would continue to be
followed, but no additional patients could be enrolled. On October
21, 2016, the Company announced it had received the Partial
Clinical Hold letter from the FDA. On November 21, 2016, the
Company announced it has submitted a complete response to the FDA
and will work diligently with the FDA to seek to have the partial
clinical hold lifted.
F-9
3.
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
Cash and Cash Equivalents
– For
purposes of the statements of cash flows, cash and cash equivalents
consist principally of unrestricted cash on deposit and short-term
money market funds. The Company considers all highly liquid
investments with a maturity when purchased of less than three
months as cash and cash equivalents.
Prepaid Expenses
– Prepaid
expenses are payments for future services to be rendered and are
expensed over the time period for which the service is rendered.
Prepaid expenses may also include payment for goods to be received
within one year of the payment date.
Inventory
– Inventory consists of
manufacturing production advances and bulk purchases of laboratory
supplies to be consumed in the manufacturing of the Company’s
product for clinical studies. Inventories are stated at the lower
of cost or market, where cost is determined using the first-in,
first out method applied on a consistent basis.
Deposits
– The deposits are
required by the lease agreement for the manufacturing facility and
by the clinical research organization (CRO)
agreements.
Research and Office Equipment
–
Research and office equipment is recorded at cost and depreciated
using the straight-line method over estimated useful lives of five
to seven years. Leasehold improvements are depreciated over the
shorter of the estimated useful life of the asset or the term of
the lease. Repairs and maintenance which do not extend the life of
the asset are expensed when incurred. The fixed assets are reviewed
on a quarterly basis to assess impairment, if any.
Patents
– Patent expenditures are
capitalized and amortized using the straight-line method over the
shorter of the expected useful life or the legal life of the patent
(17 years). In the event changes in technology or other
circumstances impair the value or life of the patent, appropriate
adjustment to the asset value and period of amortization is made.
An impairment loss is recognized when estimated future undiscounted
cash flows expected to result from the use of the asset, and from
disposition, are less than the carrying value of the asset. The
amount of the impairment loss would be the difference between the
estimated fair value of the asset and its carrying
value.
Deferred Rent (Asset)
–
Consideration paid, including deposits, related to operating leases
is recorded as a deferred rent asset and amortized as rent expense
over the lease term. Interest on the deferred rent is calculated at
3% on the funds deposited on the manufacturing facility and is
included in deferred rent. This interest income will be used to
offset future rent.
Deferred Rent (Liability)
–
Certain of the Company’s operating leases provide for minimum
annual payments that adjust over the life of the lease. The
aggregate minimum annual payments are expensed on a straight-line
basis over the minimum lease term. The Company recognizes a
deferred rent liability for rent escalations when the amount of
straight-line rent exceeds the lease payments, and reduces the
deferred rent liability when the lease payments exceed the
straight-line rent expense. For tenant improvement allowances
and rent holidays, the Company records a deferred rent liability
and amortizes the deferred rent over the lease term as a reduction
to rent expense.
Derivative Instruments
- The Company
has entered into financing arrangements that consist of
freestanding derivative instruments that contain embedded
derivative features, specifically, the settlement provisions in the
warrant agreements preclude the warrants from being treated as
equity. The Company accounts for these arrangements in accordance
with Accounting Standards Codification (ASC) 815, “Accounting
for Derivative Instruments and Hedging Activities”. In
accordance with accounting principles generally accepted in the
United States (U.S. GAAP), derivative instruments and hybrid
instruments are recognized as either assets or liabilities on the
balance sheet and are measured at fair value with gains or losses
recognized in earnings or other comprehensive income depending on
the nature of the derivative or hybrid instruments. The Company
determines the fair value of derivative instruments and hybrid
instruments based on available market data using appropriate
valuation models, giving consideration to all of the rights and
obligations of each instrument. The derivative liabilities are
remeasured at fair value at the end of each reporting period as
long as they are outstanding.
F-10
Grant Income
– The Company's
grant arrangements are handled on a reimbursement basis. Grant
income under the arrangements is recognized when costs are
incurred.
Research and Development Costs
–
Research and development expenditures are expensed as
incurred.
Net Loss Per Common Share
– The
Company calculates net loss per common share in accordance with ASC
260 “Earnings Per Share” (ASC 260). Basic and diluted
net loss per common share was determined by dividing net loss
applicable to common shareholders by the weighted average number of
common shares outstanding during the period. The Company’s
potentially dilutive shares, which include outstanding common stock
options, restricted stock units, convertible preferred stock and
common stock warrants, have not been included in the computation of
diluted net loss per share for all periods as the result would be
anti-dilutive.
Concentration of Credit Risk
–
Financial instruments, which potentially subject the Company to
concentrations of credit risk, consist of cash and cash
equivalents. The Company maintains its cash and cash
equivalents with high quality financial institutions. At
times, these accounts may exceed federally insured limits.
The Company has not experienced any losses in such bank
accounts. The Company believes it is not exposed to
significant credit risk related to cash and cash equivalents. All
non-interest bearing cash balances were fully insured
up to
$250,000 at September 30, 2016.
Income Taxes
– The Company uses
the asset and liability method of accounting for income taxes.
Under the asset and liability method, deferred tax assets and
liabilities are recognized for future tax consequences attributable
to differences between the financial statement carrying amounts of
existing assets and liabilities and their respective tax bases and
operating and tax loss carryforwards. Deferred tax assets and
liabilities are measured using enacted tax rates expected to apply
to taxable income in the years in which those temporary differences
are expected to be recovered or settled. The effect on deferred tax
assets and liabilities of a change in tax rates is recognized in
income in the period that includes the enactment date. The Company
records a valuation allowance to reduce the deferred tax assets to
the amount that is more likely than not to be recognized. A full
valuation allowance was recorded against the deferred tax assets as
of September 30, 2016 and 2015.
F-11
Use of Estimates
– The
preparation of financial statements in conformity U.S. GAAP
requires management to make estimates and assumptions that affect
the amounts reported in the financial statements and the
accompanying disclosures.
These
estimates are based on management’s best knowledge of current
events and actions the Company may undertake in the future.
Estimates are used in accounting for, among other items, inventory
obsolescence, accruals, stock options, useful lives for
depreciation and amortization of long-lived assets, deferred tax
assets and the related valuation allowance, and the valuation of
derivative liabilities.
Actual results could differ from
estimates, although management does not generally believe such
differences would materially affect the financial statements in any
given year. However, in regard to the valuation of derivative
liabilities determined using various valuation techniques including
the Black-Scholes and binomial pricing methodologies, significant
fluctuations may materially affect the financial statements in a
given year. The Company considers such valuations to be significant
estimates.
Fair Value Measurements
– The
Company evaluates financial assets and liabilities subject to fair
value measurements in accordance with a fair value hierarchy to
prioritize the inputs used to measure fair value. A financial
instrument’s level within the fair value hierarchy is based
on the lowest level of input significant to the fair value
measurement, where Level 1 is the highest and Level 3 is the
lowest. See Note 12 for the definition of levels and the
classification of assets and liabilities in those
levels.
Stock-Based Compensation
–
Compensation cost for all stock-based awards is measured at fair
value as of the grant date in accordance with the provisions of ASC
718, “Compensation – Stock Compensation.” The
fair value of stock options is calculated using the Black-Scholes
option pricing model. The Black-Scholes model requires various
judgmental assumptions including volatility and expected option
life. The stock-based compensation cost is recognized on the
straight line allocation method as expense over the requisite
service or vesting period.
Equity
instruments issued to non-employees are accounted for in accordance
with ASC 505-50, “Equity-Based Payments to
Non-Employees.” Accordingly, compensation is recognized when
goods or services are received and may be measured using the
Black-Scholes valuation model, based on the type of award. The
Black-Scholes model requires various judgmental assumptions
regarding the fair value of the equity instruments at the
measurement date and the expected life of the options.
The
Company has Incentive Stock Option Plans, Non-Qualified Stock
Options Plans, a Stock Compensation Plan, Stock Bonus Plans and an
Incentive Stock Bonus Plan. In some cases, these Plans are
collectively referred to as the “Plans.” All Plans have
been approved by the Company’s stockholders.
The
Company’s stock options are not transferable, and the actual
value of the stock options that an employee may realize, if any,
will depend on the excess of the market price on the date of
exercise over the exercise price. The Company has based its
assumption for stock price volatility on the variance of daily
closing prices of the Company’s stock. The risk-free interest
rate assumption was based on the U.S. Treasury rate at date of the
grant with term equal to the expected life of the option.
Historical data was used to estimate option exercise and employee
termination within the valuation model. The expected term of
options represents the period of time that options granted are
expected to be outstanding and has been determined based on an
analysis of historical exercise behavior. If any of the assumptions
used in the Black-Scholes model change significantly, stock-based
compensation expense for new awards may differ materially in the
future from that recorded in the current period.
F-12
Vesting
of restricted stock granted under the Incentive Stock Bonus Plan is
subject to service, performance or market conditions and meets the
classification of equity awards. These awards were measured at fair
market value on the grant-dates for issuances where the attainment
of performance criteria is probable and at fair value on the
grant-dates, using a Monte Carlo simulation for issuances where the
attainment of performance criteria is uncertain. The total
compensation cost will be expensed over the estimated requisite
service period.
Reclassification
– Certain prior
year items have been reclassified to conform to the current year
presentation.
Recent Accounting
Pronouncements
–
In May 2014, the FASB issued
Accounting Standards Update (ASU) 2014-09,
Revenue from Contracts with
Customers (Topic 606)
that will
supersede virtually all recognition guidance in US GAAP. For public
entities, the guidance is effective for annual and interim periods
beginning after December 15, 2017. Early adoption is permitted for
all entities for annual and interim periods beginning after
December 15, 2016. The FASB issued the following ASUs to amend the
new guidance: ASU 2015-14,
Revenue from Contracts with
Customers (Topic 606): Deferral of the Effective Date,
ASU 2016-08,
Revenue from Contracts with
Customers (Topic 606): Principal versus Agent Considerations
(Reporting Revenue Gross versus Net),
ASU 2016-10
, Revenue from Contracts with
Customers (Topic 606): Identifying Performance Obligations and
Licensing, and
ASU
2016-12
,
Revenue from Contracts with Customers (Topic 606): Narrow-Scope
Improvements and Practical Expedients.
Management does not expect the new standard or any
of the related updates to have a material effect on its financial
statements and related disclosures.
In January 2016, the FASB issued Accounting
Standards Update (ASU) No. 2016-01,
Financial Instruments –
Overall (Subtopic 825-10): Recognition and Measurement of Financial
Assets and Financial Liabilities.
The new guidance is intended to improve the
recognition and measurement of financial instruments. The new
guidance is effective for fiscal years beginning after December 15,
2017, including interim periods within those fiscal years. Early
adoption is permitted for specific provisions within the guidance.
Management does not expect the new standard to have a material
effect on its financial statements and related
disclosures.
In February 2016, the FASB issued
ASU
2016-02,
Leases
, which will require most leases (with the
exception of leases with terms of less than one year) to be
recognized on the balance sheet as an asset and a lease liability.
Leases will be classified as an operating lease or a financing
lease. Operating leases are expensed using the straight-line method
whereas financing leases will be treated similarly to a capital
lease under the current standard. The new standard will be
effective for annual and interim periods, within those fiscal
years, beginning after December 15, 2018, but early adoption is
permitted. The new standard must be presented using the modified
retrospective method beginning with the earliest comparative period
presented. The Company is currently evaluating the effect of the
new standard on its financial statements and related
disclosures.
F-13
In March 2016, the FASB issued ASU No.
2016-09,
Compensation - Stock
Compensation (Topic 718): Improvements to Employee Share-Based
Payment Accounting.
ASU 2016-09
simplifies several aspects of the accounting for share-based
payment award transactions, including income tax consequences,
classification of awards as either equity or liabilities and
classification on the statement of cash flows. The new standard
will be effective for annual and interim periods, within those
fiscal years, beginning after December 15, 2016 but early adoption
is permitted. The Company is currently evaluating the effect of the
new amendment on its financial statements and related
disclosures.
In
August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows
(Topic 230): Classification of Certain Cash Receipts and Cash
Payments. ASU 2016-15 amends eight specific cash flow issues: 1.)
Debt Prepayment or Debt Extinguishment Costs, 2.) Settlement of
Zero-Coupon Debt Instruments or Other Debt Instruments with Coupon
Interest Rates That Are Insignificant in Relation to the Effective
Interest Rate of the Borrowing, 3.) Contingent Consideration
Payments Made after a Business Combination, 4.) Proceeds from the
Settlement of Insurance Claims, 5.) Proceeds from the Settlement of
Corporate-Owned Life Insurance Policies, including Bank-Owned Life
Insurance Policies, 6.) Distributions Received from Equity Method
Investees, 7.) Beneficial Interests in Securitization Transactions,
8.) Separately Identifiable Cash Flows and Application of the
Predominance Principle. Management does not expect the adoption of
the amendments in this Update to have a material effect on its
financial statements and related disclosures.
In
November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows
(Topic 230): Restricted Cash. ASU 2016-18 requires that a statement
of cash flows explain the change during the period in the total of
cash, cash equivalents, and amounts generally described as
restricted cash or restricted cash equivalents. Therefore, amounts
generally described as restricted cash and restricted cash
equivalents should be included with cash and cash equivalents when
reconciling the beginning-of-period and end-of-period total amounts
shown on the statement of cash flows. The amendments in this Update
are effective for public business entities for fiscal years
beginning after December 15, 2017, and interim periods within those
fiscal years. Management does not expect the adoption of the
amendments in this Update to have a material effect on its
financial statements and related disclosures.
The
Company has considered all other recently issued accounting
pronouncements and does not believe the adoption of such
pronouncements will have a material impact on its financial
statements.
4.
WARRANTS AND
NON-EMPLOYEE OPTIONS
The
following chart represents the warrants and non-employee options
outstanding at September 30, 2016:
F-14
|
Warrant
|
|
Issue
Date
|
Shares Issuable upon Exercise of
Warrant
|
Exercise Price
|
Expiration
Date
|
Refer-ence
|
|
|
|
|
|
|
|
|
|
Series
R
|
|
12/6/12
|
2,625,000
|
$
4.00
|
12/6/16
|
1
|
|
Series
S
|
|
10/11/13
-10/24/14
|
25,928,010
|
$
1.25
|
10/11/18
|
1
|
|
Series
U
|
|
4/17/14
|
445,514
|
$
1.75
|
10/17/17
|
1
|
|
Series
V
|
|
5/28/15
|
20,253,164
|
$
0.79
|
5/28/20
|
1
|
|
Series
W
|
|
10/28/15
|
17,223,248
|
$
0.67
|
10/28/20
|
1
|
|
Series
X
|
|
1/13/16
|
3,000,000
|
$
0.37
|
1/13/21
|
2
|
|
Series
Y
|
|
2/15/16
|
650,000
|
$
0.48
|
2/15/21
|
2
|
|
Series
Z
|
|
5/23/16
|
6,600,000
|
$
0.55
|
11/23/21
|
1
|
|
Series
ZZ
|
|
5/23/16
|
500,000
|
$
0.55
|
5/18/21
|
1
|
|
Series
AA
|
|
8/26/16
|
5,000,000
|
$
0.55
|
2/22/22
|
1
|
|
Series
BB
|
|
8/26/16
|
400,000
|
$
0.55
|
8/22/21
|
1
|
|
Series
N
|
|
8/18/08
|
2,844,627
|
$
0.53
|
8/18/17
|
2
|
|
Series
P
|
|
2/10/12
|
590,001
|
$
4.50
|
3/6/17
|
2
|
|
Consultants
|
|
12/2/11-
7/1/16
|
640,000
|
$
0.37- $3.50
|
10/27/16-
6/30/19
|
3
|
The
following chart represents the warrants and non-employee options
outstanding at September 30, 2015:
|
Warrants
|
|
Issue
Date
|
Shares Issuable upon Exercise of
Warrants
|
Exercise Price
|
Expiration
Date
|
Refer-ence
|
|
|
|
|
|
|
|
|
|
Series
N
|
|
8/18/08
|
2,844,627
|
0.53
|
8/18/17
|
1
|
|
Series
Q
|
|
6/21/12
|
1,200,000
|
5.00
|
12/22/15
|
1
|
|
Series
R
|
|
12/6/12
|
2,625,000
|
4.00
|
12/6/16
|
1
|
|
Series
S
|
|
10/11/13-
10/24/14
|
25,928,010
|
1.25
|
10/11/18
|
1
|
|
Series
U
|
|
4/17/14
|
445,514
|
1.75
|
10/17/17
|
1
|
|
Series
V
|
|
5/28/15
|
20,253,164
|
0.79
|
5/28/20
|
1
|
|
Series
P
|
|
2/10/12
|
590,001
|
4.50
|
3/6/17
|
2
|
|
Consultants
|
|
10/14/05 –
7/1/15
|
238,000
|
0.66 – 20.00
|
10/14/15 -
6/30/18
|
3
|
F-15
1.
Warrant Liabilities
The
table below presents the warrants accounted for as derivative
liabilities at September 30.
|
|
2016
|
2015
|
|
Series S
warrants
|
$
3,111,361
|
$
7,363,555
|
|
Series U
warrants
|
-
|
44,551
|
|
Series V
warrants
|
1,620,253
|
6,278,481
|
|
Series W
warrants
|
1,799,858
|
-
|
|
Series Z
warrants
|
970,604
|
-
|
|
Series ZZ
warrants
|
70,609
|
-
|
|
Series AA
warrants
|
763,661
|
-
|
|
Series BB
warrants
|
58,588
|
-
|
|
|
|
|
|
Total derivative
liabilities
|
$
8,394,934
|
$
13,686,587
|
The
table below presents the gains and (losses) on the warrant
liabilities for the years ended September 30:
|
Warrant
Series
|
2016
|
2015
|
2014
|
|
Series A -
E
|
$
-
|
$
6,105
|
$
1
|
|
Series F and
G
|
-
|
-
|
12,667
|
|
Series
H
|
-
|
12,000
|
24,000
|
|
Series
N
|
-
|
-
|
(1,404,027
)
|
|
Series
Q
|
-
|
12,000
|
36,000
|
|
Series
R
|
-
|
157,500
|
131,250
|
|
Series
S
|
4,252,193
|
(1,705,466
)
|
1,098,787
|
|
Series
T
|
-
|
-
|
276,122
|
|
Series
U
|
44,552
|
75,738
|
73,967
|
|
Series
V
|
4,658,228
|
1,724,739
|
-
|
|
Series
W
|
3,260,913
|
-
|
-
|
|
Series
Z
|
997,226
|
-
|
-
|
|
Series
ZZ
|
75,229
|
-
|
-
|
|
Series
AA
|
672,246
|
-
|
-
|
|
Series
BB
|
53,139
|
-
|
-
|
|
|
|
|
|
|
Net
gain
|
$
14,013,726
|
$
282,616
|
$
248,767
|
F-16
The
Company reviews all outstanding warrants in accordance with the
requirements of ASC 815. This topic provides that an entity should
use a two-step approach to evaluate whether an equity-linked
financial instrument (or embedded feature) is indexed to its own
stock, including evaluating the instrument’s contingent
exercise and settlement provisions. The warrant agreements provide
for adjustments to the exercise price for certain dilutive events.
Under the provisions of ASC 815, the warrants are not considered
indexed to the Company’s stock because future equity
offerings or sales of the Company’s stock are not an input to
the fair value of a “fixed-for-fixed” option on equity
shares, and equity classification is therefore
precluded.
In
accordance with ASC 815, derivative liabilities must be measured at
fair value upon issuance and re-valued at the end of each reporting
period through expiration. Any change in fair value between the
respective reporting periods is recognized as a gain or loss in the
statement of operations.
Expired warrants
As of
September 30, 2015, all Series A, B, C, E, F, G, H, and Q warrants
had expired.
Series R Warrants
On
December 4, 2012, the Company sold 3,500,000 shares of its common
stock for $10,500,000, or $3.00 per share, in a registered direct
offering. The investors in this offering also received Series R
warrants which entitle the investors to purchase up to 2,625,000
shares of the Company’s common stock. The Series R warrants
may be exercised at any time before December 6, 2016 at a price of
$4.00 per share. The fair value at issuance of the warrants of $4.2
million was recorded as a warrant liability.
Series S Warrants
On
October 11, 2013, the Company closed a public offering of
17,826,087 units of common stock and warrants at a price of $1.00
per unit for net proceeds of approximately $16.4 million, net of
underwriting discounts and commissions and offering expenses of the
Company. Each unit consisted of one share of common stock and one
Series S warrant to purchase one share of common stock. The Series
S warrants were immediately exercisable, expire on October 11,
2018, and have an exercise price of $1.25. In November 2013, the
underwriters purchased an additional 2,648,913 warrants pursuant to
the overallotment option, for which the Company received net
proceeds of $24,370. The fair value at issuance of the Series S
warrants of $6.1 million was recorded as a warrant
liability.
On
December 24, 2013, the Company closed a public offering of
4,761,905 units of common stock and warrants at a price of $0.63
per unit for net proceeds of approximately $2.8 million, net of
underwriting discounts and commissions and offering expenses of the
Company. Each unit consisted of one share of common stock and one
Series S warrant to purchase one share of common stock. The
underwriters purchased an additional 476,190 units of common stock
and warrants pursuant to the overallotment option, for which the
Company received net proceeds of approximately $279,000. The fair
value at issuance of the Series S warrants of approximately $1.2
million was recorded as a warrant liability. On February 7, 2014,
the Series S warrants began trading on the NYSE MKT under the
symbol CVM WT.
F-17
On
October 24, 2014, the Company closed an underwritten public
offering of 7,894,737 shares of common stock and 1,973,684 Series S
warrants to purchase shares of common stock. Additionally, on
October 21, 2014, the Company sold 1,320,000 shares of common stock
and 330,000 Series S warrants to purchase shares of common stock in
a private offering. The common stock and Series S warrants were
sold at a combined per unit price of $0.76 for net proceeds of
approximately $6.4 million, net of underwriting discounts and
commissions and offering expenses. The fair value at issuance of
the Series S warrants of approximately $461,000 was added to the
existing Series S warrant liability.
During
the years ended September 30, 2016 and 2015, no Series S warrants
were exercised. During the year ended September 30, 2014, 2,088,769
Series S Warrants were exercised, and the Company received proceeds
of approximately $2.6 million.
Series T and U Warrants
On
April 17, 2014, the Company closed a public offering of 7,128,229
shares of common stock at a price of $1.40 and 1,782,057 Series T
warrants to purchase one share of common stock for net proceeds of
approximately $9.2 million, net of underwriting commissions and
offering expenses. The Series T warrants were immediately
exercisable and had an exercise price of $1.58. On October 17,
2014, all of the Series T warrants expired. The underwriters
received 445,514 Series U warrants to purchase one share of common
stock. The Series U warrants were exercisable beginning October 17,
2014, expire on October 17, 2017, and have an exercise price of
$1.75. The fair value at issuance of the Series T and U warrants of
approximately $470,000 was recorded as a warrant
liability.
Series V Warrants
On May
28, 2015, the Company closed an underwritten public offering of
20,253,164 shares of common stock and 20,253,164 Series V warrants
to purchase shares of common stock. The common stock and Series V
warrants were sold at a combined per unit price of $0.79 for net
proceeds of approximately $14.7 million, net of underwriting
discounts and commissions and offering expenses. The Series V
warrants were immediately exercisable at a price of $0.79 and
expire on May 28, 2020. The fair value at issuance of the Series V
warrants of approximately $8.0 million was recorded as a warrant
liability.
Series W Warrants
On
October 28, 2015, the Company closed an underwritten public
offering of 17,223,248 shares of common stock and 17,223,248 Series
W warrants to purchase shares of common stock. The common stock and
warrants were sold at a combined per unit price of $0.67 for net
proceeds of approximately $10.5 million, net of underwriting
discounts and commissions and offering expenses. The Series W
warrants are immediately exercisable at a price of $0.67 and expire
on October 28, 2020. The fair value at issuance of the Series W
warrants of approximately $5.1 million was recorded as warrant
liability.
Series Z and ZZ Warrants
On May
23, 2016, the Company closed a registered direct offering of
10,000,000 shares of common stock and 6,600,000 Series Z warrants
to purchase shares of common stock. The common stock and warrants
were sold at a combined per unit price of $0.50 for net proceeds of
approximately $4.6 million, net of placement agent’s
commissions and offering expenses. The Series Z warrants may be
exercised at any time on or after November 23, 2016 and on or
before November 23, 2021 at a price of $0.55 per share. The Company
also issued 500,000 Series ZZ warrants to the placement agent as
part of its compensation. The Series ZZ warrants may be exercised
at any time on or after November 23, 2016 and on or before May 18,
2021 at a price of $0.55 per share. The fair value of the Series Z
and Series ZZ warrants of approximately $2.1 million on the date of
issuance was recorded as a warrant liability.
F-18
Series AA and BB Warrants
On August 26, 2016, the Company closed a
registered direct offering of 10,000,000 shares of common
stock and 5,000,000 Series AA warrants to purchase shares of common
stock. The common stock and warrants were sold at a combined per
unit price of $0.50 for proceeds of approximately $4.5 million, net
of placement agent’s commissions and offering expenses. The
series AA warrants may be exercised at any time after February 22,
2017 and on or before February 22, 2022 at a price of $0.55 per
share.
The Company also issued 400,000 Series BB warrants to
the placement agent as part of its compensation. The Series BB
warrants may be exercised at any time on or after February 22, 2017
and on or before August 22, 2021 at a price of $0.55 per share. The
fair value of the Series AA and Series BB warrants of approximately
$1.5 million on the date of issuance was recorded as a warrant
liability.
2.
Equity Warrants
Series X Warrants
In
January 2016, the Company sold 3,000,000 shares of its common stock
and 3,000,000 Series X warrants to the de Clara Trust for
approximately $1.1 million. The de Clara Trust is controlled by
Geert Kersten, the Company's Chief Executive Officer and a
director. Each Series X warrant allows the de Clara Trust to
purchase one share of the Company's common stock at a price of
$0.37 per share at any time on or before January 13, 2021. The
Series X warrants qualify for equity treatment in accordance with
ASC 815. The relative fair value of the warrants was calculated to
be approximately $417,000.
Series Y Warrants
On
February 15, 2016, the Company sold 1,300,000 shares of its common
stock and 650,000 Series Y warrants to a private investor for
$624,000. Each Series Y warrant allows the holder to purchase one
share of the Company's common stock at a price of $0.48 per share
at any time on or before February 15, 2021. The Series Y warrants
qualify for equity treatment in accordance with ASC 815. The
relative fair value on the date of issuance of the warrants was
calculated to be approximately $144,000.
Series N Warrants
Series
N warrants were previously issued in connection with a financing.
On October 11, 2013 and December 24, 2013, in connection with
public offerings of common stock on those dates, the Company reset
the exercise price of the 518,771 outstanding Series N warrants
from $3.00 to $0.53 and issued the Series N warrant holders
2,432,649 additional warrants exercisable at $0.53, as required by
the warrant agreements. In January 2014, the Company offered the
investors the option to extend the Series N warrants by one year
and allow for cashless exercise in exchange for cancelling the
reset provision in the warrant agreement. One investor, holding
2,844,627 Series N warrants accepted this offer. Accordingly, these
warrants are no longer considered a derivative liability due to the
cancelation of the reset provision. The fair value of the warrants
on that date totaled approximately $1.3 million and was
reclassified from derivative liabilities to additional paid-in
capital. On March 21, 2014, the other investor exercised 106,793
Series N warrants. The Company received cash proceeds of
approximately $7,000 for 14,078 of the warrants exercised. The
remaining 92,715 warrants were exercised in a cashless exercise.
The fair value of the warrants on the date of exercise was $137,000
and was reclassified from derivative liabilities to additional
paid-in capital.
F-19
On
October 28, 2014, the outstanding 2,844,627 Series N Warrants were
transferred to the de Clara Trust, of which the Company’s
CEO, Geert Kersten, is the trustee and a beneficiary. On June 29,
2015, the Company extended the expiration date of the Series N
warrants to August 18, 2017. The incremental cost of this
modification was approximately $475,000. The modification was
concurrent with the extinguishment and reissuance of a note payable
also held in the de Clara Trust, and was recorded as a loss on debt
extinguishment.
As of
September 30, 2016, the remaining 2,844,627 Series N warrants
entitle the holder to purchase one share of the Company's common
stock at a price of $0.53 per share at any time prior to August 18,
2017. On September 30, 2016 and 2015, no derivative liability was
recorded because the warrants no longer were considered a liability
for accounting purposes.
Series L and Series M Warrants
Series
L and Series M warrants were previously issued in connection with a
financing. In April 2014, 25,000 Series L warrants, with an
exercise price of $7.50, expired. In April 2015, the remaining
70,000 of the Series L warrants, which had been repriced to $2.50
in April 2013, expired.
In
October 2013, the Company reduced the exercise prices of the Series
M warrants from $3.40 to $1.00 in exchange for a reduction in the
number of warrants from 600,000 to 500,000. The additional cost of
$76,991 was recorded as non-employee stock expense. In March 2014,
500,000 Series M warrants were exercised at a price of $1.00, and
the Company received proceeds of $500,000.
Series P Warrants
On
February 10, 2012, the Company issued 590,001 Series P warrants to
purchase up to 590,001 shares of the Company’s common stock
at a price of $4.50 per share as an inducement for the exercise of
previously issued warrants. The Series P warrants are exercisable
at any time prior to March 6, 2017.
3.
Options and Shares Issued to Consultants
The
Company typically enters into consulting arrangements in exchange
for common stock or stock options. During the years ended September
30, 2016 and 2015, the Company issued 1,248,831 and 739,968 shares
of common stock, respectively, to consultants, of which 784,000 and
180,000, respectively, were restricted shares. Under these
arrangements, the common stock was issued with stock prices ranging
between $0.37 and $1.11 per share.
Additionally,
during the years ended September 30, 2016 and 2015, the Company
issued to consultants 410,000 and 90,000 options, respectively, to
purchase common stock with exercise prices ranging from $0.37 to
$1.02 per share and fair values ranging from $0.12 to $0.50 per
share. The aggregate values of the issuances of restricted common
stock and common stock options are recorded as prepaid expenses and
are charged to general and administrative expenses over the periods
of service.
During the years
ended September 30, 2016 and 2015, the Company recorded total
expense of approximately $752,000 and $566,000, respectively,
relating to these consulting agreements. At September 30, 2016 and
2015, approximately $48,000 and $30,000, respectively, are included
in prepaid expenses. As of September 30, 2016, 640,000 options
issued to consultants as payment for services remained outstanding,
440,000 of which are fully vested, and all of which were issued
from the Non-Qualified Stock Option plans
F-20
5.
RESEARCH
AND OFFICE EQUIPMENT
Research and office
equipment consisted of the following at September 30:
|
|
2016
|
2015
|
|
|
|
|
|
Research
equipment
|
$
3,158,633
|
$
3,268,757
|
|
Furniture
and equipment
|
133,499
|
141,347
|
|
Leasehold
improvements
|
131,910
|
131,910
|
|
|
|
|
|
|
3,424,042
|
3,542,014
|
|
|
|
|
|
Accumulated
depreciation and amortization
|
(3,197,826
)
|
(3,234,548
)
|
|
|
|
|
|
Net
research and office equipment
|
$
226,216
|
$
307,466
|
Depreciation
expense for the years ended September 30, 2016, 2015 and 2014
totaled approximately $112,000, $166,000 and $189,000,
respectively. One asset is recorded under capital lease with a net
book value of $0 and approximately $8,000 on September 30, 2016 and
2015, respectively. Amortization of the capital lease asset is
included in general and administrative expenses on the Statements
of Operations.
6.
PATENTS
Patents
consisted of the following at September 30:
|
|
2016
|
2015
|
|
|
|
|
|
Patents
|
$
1,528,610
|
$
1,525,791
|
|
Accumulated
amortization
|
(1,272,063.00
)
|
(1,234,227.00
)
|
|
|
|
|
|
Net
Patents
|
$
256,547
|
$
291,564
|
F-21
During
the years ended September 30, 2016, 2015 there was no impairment of
patent costs and a nominal impairment charge in 2014. Amortization
expense for the years ended September 30, 2016, 2015 and 2014
totaled approximately $38,000, $40,000 and $43,000, respectively.
The total estimated future amortization is as follows:
|
Years ending September
30,
|
|
|
2017
|
$
37,000
|
|
2018
|
36,000
|
|
2019
|
35,000
|
|
2020
|
31,000
|
|
2021
|
28,000
|
|
Thereafter
|
90,000
|
|
|
$
257,000
|
7.
INCOME
TAXES
At
September 30, 2016 and 2015, the Company had federal net operating
loss carryforwards of approximately $169.7 million and $157.0
million, respectively. The NOLs begin to expire during the fiscal
year ending September 30, 2019 and become fully expired by the end
of the fiscal year ended 2036. In addition, the Company has a
general business credit as a result of the credit for increasing
research activities (“R&D credit”) of approximately
$1.2 million at September 30, 2016 and 2015. The R&D credit
begins to expire during the fiscal year ending September 30, 2020
and is fully expired during the fiscal year ended 2029. Deferred
taxes consisted of the following at September 30:
|
|
2016
|
2015
|
|
|
|
|
|
Net
operating loss carryforwards
|
$
64,366,000
|
$
61,363,000
|
|
|
|
|
|
R&D
credit
|
1,221,000
|
1,221,000
|
|
Stock-based
compensation
|
6,379,000
|
5,855,000
|
|
Fixed
assets and intangibles
|
57,000
|
41,000
|
|
Capitalized
R&D
|
18,508,000
|
15,082,000
|
|
Vacation
and other
|
179,000
|
114,000
|
|
Loan
modification
|
-
|
57,000
|
|
|
|
|
|
Total
deferred tax assets
|
90,710,000
|
83,733,000
|
|
|
|
|
|
Valuation
allowance
|
(90,710,000
)
|
(83,733,000
)
|
|
Net
deferred tax asset
|
$
-
|
$
-
|
F-22
In
assessing the realization of deferred tax assets, management
considered whether it was more likely than not that some, or all,
of the deferred tax asset will be realized. The ultimate
realization of the deferred tax assets is dependent upon the
generation of future taxable income. Management has considered the
history of the Company’s operating losses and believes that
the realization of the benefit of the deferred tax assets cannot be
reasonably assured. In addition, under Internal Revenue Code
Section 382, the Company’s ability to utilize these net
operating loss carryforwards may be limited or eliminated in the
event of future changes in ownership.
The
Company has no federal or state current or deferred tax expense or
benefit. The Company’s effective tax rate differs from the
applicable federal statutory tax rate. The reconciliation of these
rates is as follows at September 30:
|
|
2016
|
2015
|
2014
|
|
|
|
|
|
|
Federal
Rate
|
34.00
%
|
34.00
%
|
34.00
%
|
|
State
tax rate, net of federal benefit
|
3.92
|
5.12
|
5.15
|
|
State
tax rate change
|
(22.13
)
|
(0.15
)
|
(0.93
)
|
|
Other
adjustments
|
(0.03
)
|
(0.21
)
|
0.00
|
|
Adjustment
to deferreds
|
0.00
|
0.00
|
19.13
|
|
Permanent
differences (1)
|
45.08
|
(0.71
)
|
(0.43
)
|
|
Change
in valuation allowance
|
(60.84
)
|
(38.05
)
|
(58.78
)
|
|
Effective
tax rate
|
0.00
%
|
0.00
%
|
0.00
%
|
(1)
The 2016 amount is mainly due to the gain on derivative instruments
approximating $14 million from the change in fair value of the
Company’s warrant liabilities during the
year.
The
Company applies the provisions of ASC 740,
“Accounting for Uncertainty in Income
Taxes,”
which requires financial statement benefits to
be recognized for positions taken for tax return purposes when it
is more likely than not that the position will be sustained. The
Company has elected to reflect any tax penalties or interest
resulting from tax assessments on uncertain tax positions as a
component of tax expense. The Company has generated federal net
operating losses in tax years ending September 30, 1998 through
2015. These years remain open to examination by the major domestic
taxing jurisdictions to which the Company is subject.
8.
STOCK
COMPENSATION
The
Company recognized the following expenses for options issued or
vested and restricted stock awarded during the year:
|
|
Year Ended September
30,
|
||
|
|
2016
|
2015
|
2014
|
|
Employees
|
$
2,113,433
|
$
5,105,827
|
$
3,958,637
|
|
Non-employees
|
$
751,651
|
$
565,915
|
$
771,946
|
F-23
These
expenses were recorded as general and administrative expense.
During the years ended September 30, 2016, 2015 and 2014,
non-employee stock compensation excluded approximately $48,000,
$30,000 and $26,000, respectively, for future services to be
performed (Note 12).
During
the years ended September 30, the fair value of each option grant
was estimated on the date of grant using the Black-Scholes
option-pricing model with the following assumptions.
|
|
2016
|
2015
|
2014
|
|
Expected stock
price volatility
|
75.58
– 80.9
%
|
73.38
– 86.19
%
|
72.81
– 86.87
%
|
|
Risk-free interest
rate
|
0.71
– 1.56
%
|
0.93
– 2.35
%
|
0.59
– 2.65
%
|
|
Expected life of
options
|
3.0 – 9.69 Years
|
3.0 – 9.76 Years
|
3.0 –
9.76 Years
|
|
Expected dividend
yield
|
-
|
-
|
-
|
Non-Qualified Stock Option
Plans
--At September 30, 2016, the Company has collectively
authorized the issuance of 9,680,000 shares of common stock under
its Non-Qualified Stock Option Plans. Options typically vest over a
three-year period and expire no later than ten years after the
grant date. Terms of the options are to be determined by the
Company’s Compensation Committee, which administers the
plans. The Company’s employees, directors, officers, and
consultants or advisors are eligible to be granted options under
the Non-Qualified Stock Option Plans.
Incentive Stock Option
Plans
--At September 30, 2016, the Company had collectively
authorized the issuance of 3,460,000 shares of common stock under
its Incentive Stock Option Plans. Options typically vest over a
three-year period and expire no later than ten years after the
grant date. Terms of the options were determined by the
Company’s Compensation Committee, which administers the
plans. Only the Company’s employees are eligible to be
granted options under the Incentive Stock Option
Plans.
Activity in the
Company’s Non-Qualified and Incentive Stock Option Plans for
the two years ended September 30, 2016 is summarized as
follows:
F-24
Non-Qualified and Incentive Stock Option Plans
|
|
Outstanding
|
Exercisable
|
||||||
|
|
|
|
Weighted
|
|
|
|
Weighted
|
|
|
|
|
|
Ave
|
|
|
|
Ave
|
|
|
|
Number of
|
Weighted
Average |
Remaining Contractual
|
Aggregate
Intrinsic |
Number of
|
Weighted
Average |
Remaining Contractual
|
Aggregate
Intrinsic |
|
|
Shares
|
Exercise Price
|
Term (Years)
|
Value
|
Shares
|
Exercise Price
|
Term (Years)
|
Value
|
|
Outstanding
at October 1, 2014
|
6,831,149
|
$
2.98
|
6.55
|
$
3,600
|
3,443,884
|
$
3.40
|
5.49
|
$
3,600
|
|
|
|
|
|
|
|
|
|
|
|
Vested
|
|
|
|
|
1,153,357
|
$
2.48
|
|
|
|
Granted
(a)
|
893,700
|
$
0.66
|
|
|
|
|
|
|
|
Forfeited
|
116,665
|
$
1.87
|
|
|
|
|
|
|
|
Expired
|
70,499
|
$
4.15
|
|
|
70,499
|
$
4.15
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at September 30, 2015
|
7,537,685
|
$
2.71
|
5.98
|
$
50
|
4,526,742
|
$
3.15
|
5.01
|
$
0
|
|
Vested
|
|
|
|
|
1,401,716
|
$
1.27
|
|
|
|
Granted
(b)
|
1,213,600
|
$
0.48
|
|
|
|
|
|
|
|
Forfeited
|
55,998
|
$
0.86
|
|
|
|
|
|
|
|
Expired
|
106,000
|
$
5.80
|
|
|
106,000
|
$
5.80
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at September 30, 2016
|
8,589,287
|
$
2.37
|
5.35
|
$
0
|
5,822,458
|
$
2.65
|
4.76
|
$
0
|
(a)
Includes 90,000
stock options granted to consultants
(b)
Includes 410,000
stock options granted to consultants
A
summary of the status of the Company’s non-vested options for
the two years ended September 30, 2016 is presented
below:
|
|
|
Weighted Average
|
|
|
Number of
|
Grant Date
|
|
|
Options
|
Fair Value
|
|
|
|
|
|
Unvested
at October 1, 2014
|
3,387,265
|
$
2.15
|
|
Vested
|
(1,153,357
)
|
|
|
Granted
|
893,700
|
|
|
Forfeited
|
(116,665
)
|
|
|
Unvested
at September 30, 2015
|
3,010,943
|
$
1.72
|
|
Vested
|
(1,401,716
)
|
|
|
Granted
|
1,213,600
|
|
|
Forfeited
|
(55,998
)
|
|
|
Unvested
at September 30, 2016
|
2,766,829
|
$
1.48
|
F-25
Incentive Stock Bonus Plan
-- On
July 22, 2014 the Company's shareholders approved the 2014
Incentive Stock Bonus Plan, authorizing the issuance of up to
16,000,000 shares in the Company’s Incentive Stock Bonus
Plan. The shares will only be earned upon the achievement of
certain milestones leading to the commercialization of the
Company’s Multikine technology, or specified increases in the
market price of the Company’s stock
.
If the performance or market criteria
are not met as specified in the Incentive Stock Bonus Plan, all or
a portion of the awarded shares will be forfeited. The fair value
of the shares on the grant date was calculated using the market
value on the grant-date for issuances where the attainment of
performance criteria is likely and using a Monte Carlo simulation
for issuances where the attainment of performance criteria is
uncertain. The grant date fair value of shares issued that remain
outstanding as of September 30, 2016 is approximately $8.6 million.
The total value of the shares, if earned, is being expensed over
the requisite service periods for each milestone, provided the
requisite service periods are rendered, regardless of whether the
market conditions are met. No compensation cost is recognized for
awards where the requisite service period is not rendered. During
the years ended September 30, 2016 and 2015, the Company recorded
expense relating to the issuance of restricted stock pursuant to
the plan of approximately $634,000 and $3.4 million, respectively.
At September 30, 2016, the Company has unrecognized compensation
expense of approximately $3.1 million which is expected to be
recognized over a weighted average period of 5.03
years.
A
summary of the status of the Company’s restricted stock units
issued from the Incentive Stock Bonus Plan for the two years in the
period ended September 30, 2016 is presented below:
|
|
Number of Shares
|
Weighted Average Grant Date Fair
Value
|
|
Unvested at
October 1, 2014
|
15,700,000
|
$
0.55
|
|
Vested
|
(500,000
)
|
|
|
Granted
|
-
|
|
|
Forfeited
|
(100,000
)
|
|
|
Unvested at
September 30, 2015
|
15,100,000
|
$
0.55
|
|
Vested
|
-
|
|
|
Unvested at
September 30, 2016
|
15,100,000
|
$
0.55
|
Stock Bonus Plans
-- At
September 30, 2016, the Company was authorized to issue up to
5,594,000 shares of common stock under its Stock Bonus Plans. All
employees, directors, officers, consultants, and advisors are
eligible to be granted shares. During the year ended September 30,
2016, 408,497 shares were issued to the Company’s 401(k) plan
for a cost of approximately $162,000. During the year ended
September 30, 2015, 243,178 shares were issued to the
Company’s 401(k) plan for a cost of approximately $166,000.
During the year ended September 30, 2014, 164,787 shares were
issued to the Company’s 401(k) plan for a cost of
approximately $155,000. As of September 30, 2016, the Company has
issued a total of 3,161,211 shares of common stock from the Stock
Bonus Plans.
Stock Compensation Plans
-- At
September 30, 2016, 3,350,000 shares were authorized for use in the
Company’s stock compensation plans. During the years ended
September 30, 2016, 2015 and 2014, 464,831, 218,328 and 409,968
shares, respectively, were issued from the Stock Compensation Plans
to consultants for payment of services at a cost of approximately
$234,000, $147,000 and $439,000, respectively. During the year
ended September 30, 2016 and 2015, 95,935 and 107,050 shares,
respectively, were issued to employees from the Stock Compensation
Plans as part of their compensation at a cost of approximately
$45,000 and $58,000, respectively. No shares were issued to
employees from the Stock Compensation Plans during the year ended
September 30, 2014. As of September 30, 2016, the Company has
issued 1,984,765 shares of common stock from the Stock Compensation
Plans.
F-26
9.
EMPLOYEE
BENEFIT PLAN
The
Company maintains a defined contribution retirement plan,
qualifying under Section 401(k) of the Internal Revenue Code,
subject to the Employee Retirement Income Security Act of 1974, as
amended, and covering substantially all Company employees. Each
participant’s contribution is matched by the Company with
shares of common stock that have a value equal to 100% of the
participant’s contribution, not to exceed the lesser of
$10,000 or 6% of the participant’s total compensation. The
Company’s contribution of common stock is valued each quarter
based upon the closing bid price of the Company’s common
stock. Total expense, including plan maintenance, for the years
ended September 30, 2016, 2015 and 2014, in connection with this
Plan was approximately $168,000, $170,000 and $160,000,
respectively.
10.
COMMITMENTS AND CONTINGENCIES
Clinical Research Agreements
In
March 2013, the Company entered into an agreement with Aptiv
Solutions to provide certain clinical research services in
accordance with a master service agreement. The Company will
reimburse Aptiv for costs incurred. The agreement required the
Company to make $600,000 in advance payments which are being
credited against future invoices in $150,000 annual increments
through December 2017. As of September 30, 2016, the total balance
advanced is $300,000, of which $150,000 is classified as a current
asset.
In April 2013, the Company entered into a
co-development and revenue sharing agreement with Ergomed. Under
the agreement, Ergomed will contribute up to $10 million towards
the study in the form of offering discounted clinical services in
exchange for a single digit percentage of milestone and royalty
payments, up to a specific maximum amount
. In October 2015,
the Company entered into a second
co-development and revenue sharing agreement with
Ergomed
for an additional $2 million, for a total of $12
million. The Company accounted for the co-development and revenue
sharing agreement in accordance with ASC 808 “Collaborative
Arrangements”. The Company determined the payments to Ergomed
are within the scope of ASC 730 “Research and
Development.” Therefore, the Company records the discount on
the clinical services as a credit to research and development
expense on its Statements of Operations. Since the Company entered
into the co-development and revenue sharing agreement with Ergomed,
it has incurred research and development expenses of approximately
$19.2 million related to Ergomed’s services. This amount is
net of Ergomed’s discount of approximately $6.3 million.
During the years ended September 30, 2016, 2015 and 2014, the
Company recorded, approximately $7.2 million, $6.7 million and $4.4
million, respectively, as research and development expense related
to Ergomed’s services. These amounts were net of
Ergomed’s discount of approximately $2.1 million, $2.4
million and $1.5 million, respectively, over the comparable
periods.
In
October 2013, the Company entered into two co-development and
profit sharing agreements with Ergomed. One agreement
supports the Phase 1 study being conducted at UCSF for the
development of Multikine as a potential treatment for peri-anal
warts in HIV/HPV co-infected men and women. The other
agreement focuses on the development of Multikine as a potential
treatment for cervical dysplasia in HIV/HPV co-infected women.
Ergomed will assume up to $3 million in clinical and regulatory
costs for each study.
The
Company is currently involved in a pending arbitration proceeding,
CEL-SCI Corporation v. inVentiv Health Clinical, LLC (f/k/a
PharmaNet LLC) and PharmaNet GmbH (f/k/a PharmaNet AG). On October
31, 2013,
the Company initiated the
proceedings against inVentiv Health Clinical, LLC, or inVentiv, the
former third-party CRO, and are seeking payment for damages related
to inVentiv’s prior involvement in the ongoing Phase 3
clinical trial of Multikine. The arbitration claim, initiated under
the Commercial Rules of the American Arbitration Association,
alleges (i) breach of contract, (ii) fraud in the inducement, and
(iii) common law fraud. The Company is seeking at least $50 million
in damages in its amended statement of claim. Based upon further
analysis, however, the Company believes that its damages (direct
and consequential) presently total over $150
million.
F-27
In an
amended statement of claim, the Company asserted the claims set
forth above as well as an additional claim for professional
malpractice. The arbitrator subsequently granted
inVentiv’s motion to dismiss the professional malpractice
claim based on the “economic loss doctrine” which,
under New Jersey law, is a legal doctrine that, under certain
circumstances, prohibits bringing a negligence-based claim
alongside a claim for breach of contract. The arbitrator
denied the remainder of inVentiv’s motion, which had sought
to dismiss certain other aspects of the amended statement of
claim. In particular, the arbitrator rejected
inVentiv’s argument that several aspects of the amended
statement of claim were beyond the arbitrator’s
jurisdiction.
In
connection with the pending arbitration proceedings, inVentiv has
asserted counterclaims against the Company for (i) breach of
contract, seeking at least $2 million in damages for services
allegedly performed by inVentiv; (ii) breach of contract, seeking
at least $1 million in damages for the Company’s alleged use
of inVentiv’s name in connection with publications and
promotions in violation of the parties’ contract; (iii)
opportunistic breach, restitution and unjust enrichment, seeking at
least $20 million in disgorgement of alleged unjust profits
allegedly made by the Company as a result of the purported breaches
referenced in subsection (ii); and (iv) defamation, seeking at
least $1 million in damages for allegedly defamatory statements
made about inVentiv. The Company believes inVentiv’s
counterclaims are meritless. However, if inVentiv successfully
asserts any of its counterclaims, such an adverse determination
could have a material adverse effect on the Company’s
business, results, financial condition and liquidity.
In
October 2015 the Company signed an arbitration funding agreement
with a company established by Lake Whillans Litigation Finance,
LLC, a firm specializing in funding litigation expenses. Pursuant
to the agreement, an affiliate of Lake Whillans provides the
Company with funding for litigation expenses to support its
arbitration claims against inVentiv. The funding is available to
the Company to fund the expenses of the ongoing arbitration and
will only be repaid when the Company receives proceeds from the
arbitration. During the year ended September 30, 2016, the Company
recognized a gain of approximately $1.1 million on the
derecognition of legal fees to record the transfer of the liability
that existed prior to the execution of the financing agreement from
the Company to Lake Whillans. The gain on derecognition of legal
fees is recorded as a reduction of general and administration
expenses on the Statement of Operations. All related legal fees are
directly billed to and paid by Lake Whillans. As part of the
agreement with Lake Whillans, the law firm agreed to cap its fees
and expenses for the arbitration at $5 million.
The
arbitration hearing on the merits (the “trial”) began
on September 26, 2016.
Lease Agreements
The
approximate future minimum annual rental payments due under
non-cancelable operating leases for office and laboratory space are
as follows:
|
Years
Ending September 30,
|
|
|
2017
|
$
1,930,000
|
|
2018
|
1,997,000
|
|
2019
|
2,066,000
|
|
2020
|
2,110,000
|
|
2021
|
2,100,000
|
|
Thereafter
|
15,831,000
|
|
Total
minimum lease payments:
|
$
26,034,000
|
F-28
Rent
expense, including amortization of deferred rent, for the years
ended September 30, 2016, 2015 and 2014, was approximately $2.7
million. The Company’s three leases expire between June 2020
and October 2028.
The
Company leases a building near Baltimore, Maryland. The building
was remodeled in accordance with the Company’s specifications
so that it can be used by the Company to manufacture Multikine for
the Company’s Phase 3 clinical trial and sales of the drug if
approved by the FDA. The lease is for a term of twenty years and
requires annual base rent to escalate each year at 3%. The Company
is required to pay all real estate and personal property taxes,
insurance premiums, maintenance expenses, repair costs and
utilities. The lease allows the Company, at its election, to extend
the lease for two ten-year periods or to purchase the building at
the end of the 20-year lease.
At
September 30, 2016, the Company recorded a total deferred rent
asset of approximately $3.8 million, of which approximately $3.4
million is long term and the balance of approximately $430,000 is
included in current assets. At September 30, 2015, the Company
recorded a total deferred rent asset of approximately $4.5 million,
of which approximately $4 million is long term and the balance of
approximately $488,000 is included in current assets. On September
30, 2016 and 2015, the Company has included in deferred rent the
following: 1) deposit on the manufacturing facility ($3.1 million);
2) the fair value of the warrants issued to lessor ($1.4 million);
3) additional investment ($3.0); 4) deposit on the cost of the
leasehold improvements for the manufacturing facility ($1.8
million). At September 30, 2016, the Company has accumulated
amortization of approximately $5.5 million. At September 30, 2015,
the Company has also included accrued interest on deposit of
approximately $128,000, and accumulated amortization of
approximately $4.9 million.
The
Company was required to deposit the equivalent of one year of base
rent in accordance with the lease. When the Company meets the
minimum cash balance required by the lease, the deposit will be
returned to the Company. The approximate $1.7 million deposit is
included in non-current assets on September 30, 2016 and
2015.
The
Company subleases a portion of its rental space on a month to month
term lease, which requires a 30 day notice for termination. The
sublease rent for the years ended September 30, 2016, 2015 and 2014
was approximately $67,000, $65,000 and $63,000, respectively, and
is recorded in grant income and other in the statements of
operations.
The
Company leases its research and development laboratory under a 60
month lease which expires February 28, 2017. In September 2016, the
lease was extended through February 28, 2022. The operating lease
includes escalating rental payments. The Company is recognizing the
related rent expense on a straight line basis over the full 60
month term of the lease at the rate of approximately $11,000 per
month. As of September 30, 2016 and 2015, the Company has recorded
a deferred rent liability of approximately $2,000 and $6,000,
respectively.
The
Company leases its office headquarters under a 60 month lease which
expires June 30, 2020. The operating lease includes escalating
rental payments. The Company is recognizing the related rent
expense on a straight line basis over the full 60 month term of the
lease at the rate approximately $8,000 per month. As of September
30, 2016 and 2015, the Company has recorded a deferred rent
liability of approximately $18,000 and $13,000,
respectively.
The
Company leases office equipment under a capital lease arrangement.
The term of the capital lease is 48 months and expired on September
30, 2016. The monthly lease payment is $1,025. The lease bears
interest at approximately 6% per annum.
Vendor Obligations
Further, the
Company has contingent obligations with other vendors for work that
will be completed in relation to the Phase 3 trial. The timing of
these obligations cannot be determined at this time.
The total remaining
cash cost of the Phase 3 clinical trial, excluding any costs that
will be paid by CEL-SCI's partners, would be approximately $12.1
million after September 30, 2016. This ís based on the
executed contract costs with the CROs only and does not include
other related costs, e.g. the manufacturing of the
drug.
The Company has filed an amendment to the
original Phase 3 protocol for it head and neck cancer study with
the FDA to allow for this expansion in patient enrollment. Should
the FDA allow the amended protocol filed with them to proceed, the
remaining cost of the Phase 3 clinical trial will be
higher.
F-29
11.
RELATED PARTY TRANSACTIONS
Effective August
31, 2016, Maximilian de Clara, the Company’s President and a
director, resigned for health reasons. In payment for past
services, the Company agreed to issue Mr. de Clara 650,000 shares
of restricted stock; 325,000 shares upon his resignation and
325,000 on August 31, 2017. The market value of the shares granted,
including the accrued value of the shares to be issued in August
2017, totaled $253,500.
On
January 13, 2016, the de Clara Trust demanded payment on the note
payable, of which the balance, including accrued and unpaid
interest, was $1,105,989. The de Clara Trust was established by
Maximilian de Clara, the Company’s former President and a
director. The Company’s Chief Executive Officer, Geert
Kersten, is the trustee and a beneficiary. When the de Clara Trust
demanded payment on the note, the Company sold 3,000,000 shares of
its common stock and 3,000,000 Series X warrants to the de Clara
Trust for approximately $1.1 million. Each warrant allows the de
Clara Trust to purchase one share of the Company's common stock at
a price of $0.37 per share at any time on or before January 13,
2021.
Prior
to the repayment, on June 29, 2015, the Company had extended the
maturity date of the note to July 6, 2017, lowered the interest
rate from 15% to 9% and changed the conversion price from $4.00 to
$0.59, the closing stock price on the previous trading day. The
Company determined these modifications to be substantive and
accounted for the modification as an extinguishment of the
pre-modification note and issuance of the post-modification note.
The Company recorded an extinguishment loss and a premium on the
note payable of approximately $166,000, which was credited to
additional paid in capital. Concurrently, the Company extended the
expiration date of the Series N warrants to August 18, 2017. The
incremental cost of this modification was approximately $475,000
and was included in debt extinguishment loss on the note, for a
total loss of approximately $620,000 during the year ended
September 30, 2015.
During
the years ended September 30, 2016, 2015 and 2014, the Company paid
approximately $43,000, $146,000 and $179,000, respectively, in
interest expense to Mr. de Clara.
12.
STOCKHOLDERS’ EQUITY
During
the years ended September 30, 2016 and 2015, no warrants were
exercised. During the year ended September 30, 2014, 2,695,562
Series M, N and S warrants were exercised. The Company issued
2,668,508 shares of common stock and received approximately $3.1
million from the exercise of these warrants since 92,715 Series N
warrants were exercised in a cashless exercise.
On
October 11, 2013, the Company closed a public offering of units of
common stock and Series S warrants at a price of $1.00 per unit for
net proceeds of $16.4 million, net of underwriting discounts and
commissions. Each unit consisted of one share of common stock and a
warrant to purchase one share of common stock. The warrants were
immediately exercisable and expire on October 11, 2018, and have an
exercise price of $1.25. In November 2013, the underwriters
purchased an additional 2,648,913 warrants pursuant to the
overallotment option, for which the Company received net proceeds
of approximately $24,000.
On
December 24, 2013, the Company closed a public offering of units of
common stock and Series S warrants at a price of $0.63 per unit for
net proceeds of approximately $2.8 million, net of underwriting
discounts and commissions. Each unit consisted of one share of
common stock and a warrant to purchase one share of common stock.
The warrants are immediately exercisable and expire on October 11,
2018, and have an exercise price of $1.25. The underwriters
exercised the option for the full 10% overallotment, for which the
Company received net proceeds of approximately
$279,000.
The
October and December 2013 financings triggered the reset provision
from the August 2008 financing which resulted in the issuance of an
additional 1,563,083 shares of common stock. The cost of additional
shares issued was approximately $1.1 million. This cost was
recorded as a deemed a dividend.
F-30
On
October 24, 2014, the Company closed an underwritten public
offering of 7,894,737 shares of common stock and 1,973,684 Series S
warrants to purchase shares of common stock. Additionally, in a
related private offering on October 21, 2014, the Company sold
1,320,000 shares of common stock and 330,000 Series S warrants to
purchase shares of common stock. The common stock and Series S
warrants were sold at a combined price of $0.76 for net proceeds of
approximately $6.4 million, net of offering expenses. The Series S
warrants trade of the NYSE MKT under the symbol CVM
WT.
On
April 17, 2014, the Company closed a public offering of units
consisting of 7,128,229 shares of common stock and Series T
warrants to purchase an aggregate of 1,782,057 shares of common
stock. The units were sold at a price of $1.40 per unit. The
Company received net proceeds of approximately $9.1 million after
deducting the underwriting commissions and offering expenses. The
common stock and warrants separated immediately. The Series T
warrants, with an exercise price of $1.58 per share, expired on
October 17, 2014. The underwriters in the offering received 445,514
Series U warrants to purchase one share of common stock. The Series
U warrants expire on October 17, 2017, and have an exercise price
of $1.75.
On May
28, 2015, the Company closed an underwritten public offering of
20,253,164 shares of common stock and 20,253,164 Series V warrants
to purchase shares of common stock. The common stock and Series V
warrants were sold at a combined per unit price of $0.79 for net
proceeds of approximately $14.7 million, net of underwriting
discounts and commissions and offering expenses. The Series V
warrants are immediately exercisable at a price of $0.79 and expire
on May 28, 2020.
On
October 28, 2015, the Company closed an underwritten public
offering of 17,223,248 shares of common stock and 17,223,248 Series
W warrants to purchase shares of common stock. The common stock and
warrants were sold at a combined price of $0.67 for net proceeds of
approximately $10.5 million, net of underwriting commissions and
offering expenses. The warrants were immediately exercisable,
expire October 28, 2020 and have an exercise price of
$0.67.
On May
23, 2016, the Company closed a registered direct offering of
10,000,000 shares of common stock and 6,600,000 Series Z warrants
to purchase shares of common stock. The common stock and warrants
were sold at a combined per unit price of $0.50 for net proceeds of
approximately $4.6 million, net of placement agent’s
commissions and offering expenses. The Series Z warrants may be
exercised at any time on or after November 23, 2016 and on or
before November 23, 2021 at a price of $0.55 per share. The Company
also issued 500,000 Series ZZ warrants to the placement agent as
part of its compensation. The Series ZZ warrants may be exercised
at any time on or after November 23, 2016 and on or before May 18,
2021 at a price of $0.55 per share.
On August 26, 2016, the Company closed a
registered direct offering of 10,000,000 shares of common
stock and Series AA warrants to purchase up to 5,000,000 shares of
common stock. Each share of common stock was sold together with a
Series AA warrant to purchase one-half of a share of common stock
for the combined purchase price of $0.50. Each warrant can be
exercised at any time after February 22, 2017 and on or before
February 22, 2022 at a price of $0.55 per share.
The Company
also issued 400,000 Series BB warrants to the placement agent as
part of its compensation. The Series BB warrants may be exercised
at any time on or after February 22, 2017 and on or before August
22, 2021 at a price of $0.55 per share. The Company received
proceeds from the sale of Series AA and Series BB shares and
warrants of approximately $4.5 million, net of placement
agent’s commissions and offering expenses
13.
FAIR VALUE MEASUREMENTS
In
accordance with the provisions of ASC 820, “
Fair Value Measurements
,” the
Company determines fair value as the price that would be received
to sell an asset or paid to transfer a liability in an orderly
transaction between market participants at the measurement date.
The Company generally applies the income approach to determine fair
value. This method uses valuation techniques to convert future
amounts to a single present amount. The measurement is based on the
value indicated by current market expectations about those future
amounts.
ASC 820
establishes a fair value hierarchy that prioritizes the inputs used
to measure fair value. The hierarchy gives the highest priority to
active markets for identical assets and liabilities (Level 1
measurement) and the lowest priority to unobservable inputs (Level
3 measurement). The Company classifies fair value balances based on
the observability of those inputs. The three levels of the fair
value hierarchy are as follows:
o
Level 1 –
Observable inputs such as quoted prices in active markets for
identical assets or liabilities
o
Level 2 –
Inputs other than quoted prices that are observable for the asset
or liability, either directly or indirectly. These include quoted
prices for similar assets or liabilities in active markets, quoted
prices for identical or similar assets or liabilities in markets
that are not active and amounts derived from valuation models where
all significant inputs are observable in active
markets
o
Level 3 –
Unobservable inputs that reflect management’s
assumptions
F-31
For
disclosure purposes, assets and liabilities are classified in their
entirety in the fair value hierarchy level based on the lowest
level of input that is significant to the overall fair value
measurement. The Company’s assessment of the significance of
a particular input to the fair value measurement requires judgment
and may affect the placement within the fair value hierarchy
levels.
The
table below sets forth the liabilities measured at fair value on a
recurring basis, by input level, on the balance sheet at September
30, 2016:
|
|
Quoted Prices in
|
Significant
|
|
|
|
|
Active Markets for
|
Other
|
Significant
|
|
|
|
Identical
|
Observable
|
Unobservable
|
|
|
|
Liabilities (Level 1)
|
Inputs (Level 2)
|
Inputs (Level 3)
|
Total
|
|
|
|
|
|
|
|
Derivative
Instruments
|
$
3,111,361
|
|
$
5,283,573
|
$
8,394,934
|
The
table below sets forth the liabilities measured at fair value on a
recurring basis, by input level, on the balance sheet at September
30, 2015:
|
|
Quoted
Prices in
|
Significant
|
|
|
|
|
Active
Markets for
|
Other
|
Significant
|
|
|
|
Identical
|
Observable
|
Unobservable
|
|
|
|
Liabilities
(Level 1)
|
Inputs
(Level 2)
|
Inputs
(Level 3)
|
Total
|
|
|
|
|
|
|
|
Derivative
Instuments
|
$
7,365,555
|
|
$
6,323,032
|
$
13,686,587
|
The
following sets forth the reconciliation of beginning and ending
balances related to fair value measurements using significant
unobservable inputs (Level 3), as of September 30:
|
|
2016
|
2015
|
|
|
|
|
|
Beginning
balance
|
$
6,323,032
|
$
307,894
|
|
Issuances
|
8,722,073
|
8,003,220
|
|
Net realized
and unrealized derivative gain
|
(9,761,532
)
|
(1,988,082
)
|
|
Ending
balance
|
$
5,283,573
|
$
6,323,032
|
The
fair values of the Company’s derivative instruments disclosed
above under Level 3 are primarily derived from valuation models
where significant inputs such as historical price and volatility of
the Company’s stock as well as U.S. Treasury Bill rates are
observable in active markets. At September 30, 2016, the
Company’s Level 3 derivative instruments have a weighted
average fair value of $0.10 per share and a weighted average
exercise price of $0.86 per share. Fair values were determined
using a weighted average risk free interest rate of 1.04% and 75%
volatility.
F-32
14. NET LOSS PER COMMON
SHARE
Basic
loss per share is computed by dividing net loss available to common
shareholders by the weighted average number of common shares
outstanding during the period. The Company’s potentially
dilutive shares, which include outstanding common stock options,
common stock warrants, restricted stock and shares issuable on
convertible debt, have not been included in the computation of
diluted net loss per share for all periods presented, as the result
would be anti-dilutive. For the years presented, the gain on
derivative instruments is not included in net loss available to
common shareholders for purposes of computing dilutive loss per
share because its effect is anti-dilutive.
The
following table provides a reconciliation of the numerators and
denominators of the basic and diluted per-share
computations:
|
|
2016
|
2015
|
2014
|
|
|
|
|
|
|
Net
loss available to
|
|
|
|
|
common
shareholders
|
$
(11,466,498
)
|
$
(34,674,646
)
|
$
(28,483,712
)
|
|
Less:
Gain on derivative
|
|
|
|
|
Instruments
|
-
|
-
|
(248,767
)
|
|
Net
loss - diluted
|
$
(11,466,498
)
|
$
(34,674,646
)
|
$
(28,732,479
)
|
|
|
|
|
|
|
Weighted
average number of
|
|
|
|
|
shares
- basic and diluted
|
121,655,108
|
82,519,027
|
58,804,622
|
|
|
|
|
|
|
Loss
per share - basic
|
$
(0.09
)
|
$
(0.42
)
|
$
(0. 48
)
|
|
Loss
per share - diluted
|
$
(0.09
)
|
$
(0.42
)
|
$
(0. 49
)
|
For the
years ended September 30, 2016 and 2015, the gain on derivatives is
not excluded from the numerator in calculating diluted loss per
share because the gain relates to derivative warrants that were
priced higher than the average market price during the
period.
In
accordance with the contingently issuable shares guidance of FASB
ASC Topic 260,
Earnings Per
Share
, the calculation of diluted net loss per share
excludes the following dilutive securities because their inclusion
would have been anti-dilutive as of September 30:
|
|
2016
|
2015
|
2014
|
|
|
|
|
|
|
Options and
Warrants
|
91,882,022
|
58,421,058
|
39,994,707
|
|
Convertible
Debt
|
-
|
1,871,283
|
276,014
|
|
Unvested Restricted
Stock
|
15,100,000
|
15,100,000
|
15,700,000
|
|
Total
|
106,982,022
|
75,392,341
|
55,970,721
|
F-33
15. SEGMENT
REPORTING
ASC
280, “
Disclosure about
Segments of an Enterprise and Related Information
”
establishes standards for reporting information regarding operating
segments in annual financial statements and requires selected
information for those segments to be presented in interim financial
reports issued to stockholders. This topic also establishes
standards for related disclosures about products and services and
geographic areas. Operating segments are identified as components
of an enterprise about which separate discrete financial
information is available for evaluation by the chief operating
decision maker, or decision-making group, in making decisions how
to allocate resources and assess performance. The Company’s
chief decision maker, as defined under this topic, is the Chief
Executive Officer. To date, the Company has viewed its operations
as principally one segment, the research and development of certain
drugs and vaccines. As a result, the financial information
disclosed herein materially represents all of the financial
information related to the Company’s principal operating
segment.
16. QUARTERLY INFORMATION
(UNAUDITED)
The
following quarterly data are derived from the Company’s
statements of operations.
Financial Data
|
Fiscal
2016
|
|
|
|
|
|
|
|
Three months
|
Three months
|
Three months
|
Three months
|
|
|
|
ended
|
ended
|
ended
|
Ended
|
Year ended
|
|
|
December 31
2015 |
March 31,
2016 |
June 30,
2016 |
September 30, 2016 |
September 30,
2016 |
|
Grant
income and other
|
$
20,976
|
$
32,775
|
$
129,975
|
$
101,329
|
$
285,055
|
|
Operating
expenses
|
5,804,108
|
6,306,378
|
6,512,722
|
7,215,072
|
25,838,280
|
|
Non-operating
(expense) income, net
|
1,985
|
22,478
|
24,679
|
23,859
|
73,001
|
|
Gain
(loss) on derivative instruments
|
8,122,960
|
(2,593,730
)
|
2,508,744
|
5,975,752
|
14,013,726
|
|
Net
income (loss) available to
|
|
|
|
|
|
|
common
shareholders
|
$
2,341,813
|
$
(8,844,855
)
|
$
(3,849,324
)
|
$
(1,114,132
)
|
$
(11,466,498
)
|
|
EPS
(LPS) -basic and diluted
|
$
0.02
|
$
(0.07
)
|
$
(0.03
)
|
$
(0.01
)
|
$
(0.09
)
|
|
Weighted
average shares:
|
|
|
|
|
|
|
Basic
|
109,768,502
|
118,420,327
|
124,132,500
|
134,290,870
|
121,655,108
|
|
Diluted
|
111,639,785
|
118,420,327
|
124,132,500
|
134,290,870
|
121,655,108
|
F-34
|
Fiscal
2015
|
|
|
|
|
|
|
|
Three months
|
Three months
|
Three months
|
Three months
|
|
|
|
ended
|
ended
|
ended
|
Ended
|
Year ended
|
|
|
December 31
2014 |
March 31,
2015 |
June 30,
2015 |
September 30,
2015 |
September 30,
2015 |
|
Grant
income and other
|
$
136,838
|
$
197,620
|
$
389,223
|
$
(66,304
)
|
$
657,377
|
|
Operating
expenses
|
10,132,579
|
7,956,963
|
8,590,698
|
8,273,682
|
34,953,922
|
|
Non-operating
(expense) income, net
|
(12,547
)
|
(14,097
)
|
(35,985
)
|
22,369
|
(40,260
)
|
|
Gain
(loss) on derivative instruments
|
2,162,970
|
(4,782,796
)
|
4,428,780
|
(1,526,338
)
|
282,616
|
|
Loss
on debt extinguishment
|
-
|
-
|
(620,457
)
|
-
|
(620,457
)
|
|
Net
loss available to
|
|
|
|
|
|
|
common
shareholders
|
$
(7,845,318
)
|
$
(12,556,236
)
|
$
(4,429,137
)
|
$
(9,843,955
)
|
$
(34,674,646
)
|
|
Net
loss per share-basic
|
$
(0.11
)
|
$
(0.17
)
|
$
(0.05
)
|
$
(0.10
)
|
$
(0.42
)
|
|
Net
loss per share-diluted
|
$
(0.14
)
|
$
(0.17
)
|
$
(0.06
)
|
$
(0.10
)
|
$
(0.42
)
|
|
Weighted
average shares:
|
|
|
|
|
|
|
Basic
|
73,260,783
|
75,847,869
|
83,796,311
|
97,040,004
|
82,519,027
|
|
Diluted
|
73,260,783
|
75,847,869
|
85,134,107
|
97,040,004
|
82,519,027
|
The
Company has experienced large swings in its quarterly gains and
losses caused by the changes in the fair value of warrants each
quarter.
17. SUBSEQUENT
EVENTS
In
accordance with ASC 855, “
Subsequent Events
”, the Company
has reviewed subsequent events through the date of the
filing.
On
December 8, 2016, the Company sold 34,024,000 shares of common
stock and warrants to purchase common stock at a price of $0.125 in
a public offering. The warrants consist of 17,012,000 Series CC
warrants to purchase 17,012,000 shares of common stock, 34,024,000
Series DD warrants to purchase 34,024,000 shares of common stock
and 34,024,000 Series EE warrants to purchase 34,024,000 shares of
common stock. The Series CC warrants are immediately exercisable,
expire in five-years and have an exercise price of $0.20 per share.
The Series DD warrants are immediately exercisable, expire in
six-months and have an exercise price of $0.18 per share. The
Series EE warrants are immediately exercisable, expire in
nine-months and have an exercise price of $0.18 per share. In
addition, the Company issued 1,701,000 Series FF warrants to
purchase 1,701,000 shares of common stock to the placement agent.
The FF warrants are exercisable at any time on or after June 8,
2017 and expire on December 1, 2021 and have an exercise price
$0.15625. The
net
proceeds to
CEL-SCI from this offering
was
approximately $
3.8
million,
excluding any future proceeds that may be received from the
exercise of the warrants.
On
December 9, 2016, the Company reported on a communication received
from the staff of the NYSE MKT, its current listing exchange, that
it considered the Company to be noncompliant with certain listing
requirements based on its quarterly report for the period ended
June 30, 2016. The Company has been given the opportunity to
maintain its listing by submitting a plan of compliance by January
9, 2017. This plan must advise of actions the company has taken or
will take to regain compliance with the continued listing standards
by June 11, 2018. The Company intends to submit such a plan by
January 9, 2017. The communication and compliance plan has no
current effect on the listing of the Company's shares on the
exchange. If the plan is not acceptable or the Company does not
make sufficient progress under the plan or reestablish compliance
by June 11, 2018, then staff of the exchange may initiate
proceedings for delisting from the NYSE MKT. The Company may then
appeal a staff determination to initiate such proceedings in
accordance with the exchange's Company Guide.
F-35
SIGNATURES
In
accordance with Section 13 or 15(a) of the Securities Exchange Act
of 1934, the Registrant has caused this Report to be signed on its
behalf by the undersigned, thereunto duly authorized on the
14
th
day
of December 2016.
|
|
CEL-SCI CORPORATION
|
|
|
|
|
|
|
|
|
|
By:
|
/s/
Geert
R. Kersten
|
|
|
|
|
Geert R.
Kersten
, Chief Executive Officer
|
|
|
|
|
|
|
|
|
|
|
|
Pursuant to the
requirements of the Securities Act of l934, this Report has been
signed below by the following persons on behalf of the Registrant
and in the capacities and on the dates indicated.
|
Signature
|
Title
|
Date
|
|
|
|
|
|
|
|
|
|
/s/ Geert R.
Kersten
|
Chief Executive,
Principal
|
|
|
Geert R.
Kersten
|
Accounting,
Principal Financial
|
|
|
|
Officer and a
Director
|
December 14,
2016
|
|
|
|
|
|
|
|
|
|
/s/ Alexander G.
Esterhazy
|
Director
|
December 14,
2016
|
|
Alexander G.
Esterhazy
|
|
|
|
|
|
|
|
|
|
|
|
/s/Peter R.
Young
|
Director
|
December 14,
2016
|
|
Dr. Peter R.
Young
|
|
|
|
|
|
|
|
|
|
|
|
/s/ Bruno
Baillavoine
|
Director
|
December 14,
2016
|
F-36
TABLE OF CONTENTS
Part IItem 1. BusinessItem 1B. Risk FactorsItem 1B. Unresolved Sec CommentsItem 2. PropertiesItem 3. Legal ProceedingsItem 4. Mine Safety DisclosuresItem 5. Market For Cel-sci's Common Equity and Related Stockholder MattersItem 6. Selected Financial DataItem 7. Management's Discussion and Analysis Of Financial Condition and Results Of OperationsItem 7A. Quantitative and Qualitative Disclosure About Market RisksItem 8. Financial Statements and Supplementary DataItem 9. Changes in and Disagreements with Accountants on Accounting and Financial DisclosureItem 9A. Controls and ProceduresItem 9B. Other InformationItem 10. Directors and Executive Officers Of The RegistrantItem 11. Executive CompensationItem 12. Security Ownership Of Certain Beneficial Owners and Management and Related Stockholder MattersItem 13. Certain Relationships and Related TransactionsItem 14. Principal Accounting Fees and ServicesItem 15. Exhibits and Financial Statement Schedules