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Delaware
(State or other jurisdiction of
incorporation or organization)
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45‑0705648
(I.R.S. Employer
Identification No.)
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Title of each class
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Name of each exchange on which registered
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Common Stock, $0.001, par value
Class A Warrants, consisting of the right to purchase one share of common stock at an exercise price of $4.55 per share Class B Warrants, consisting of the right to purchase one-half share of common stock at an exercise price of $3.90 per share |
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NASDAQ Stock Market
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Large accelerated filer ☐
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Accelerated filer ☐
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Non‑accelerated filer ☐
(Do not check if a
smaller reporting company)
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Smaller reporting company ☒
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Page
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PART IV
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CERC-501: Adjunctive Treatment of Major Depressive Disorder.
CERC-501 is a potent and selective kappa opioid receptor, or KOR, antagonist, or inhibitor, taken by mouth. It is being developed as an adjunctive treatment of major depressive disorder, or MDD. KORs have been shown to play an important role in stress, mood and addiction. CERC-501 is active in animal models of depression and addiction, and it has been generally well tolerated in four human clinical trials. Currently, three externally funded clinical trials are being conducted to evaluate the use of CERC-501 in treating depressive symptoms, stress-related smoking relapse and cocaine addiction. One trial is being conducted under the auspices of the National Institute of Mental Health, the second trial is a collaboration between Cerecor and Yale University with funding from the National Institutes of Health and the third trial is being conducted at Rockefeller University Hospital with funding from a private foundation. We recently completed a Phase 2 clinical trial for CERC-501 for smoking cessation that was partially funded by a grant from the National Institute on Drug Abuse at NIH. This trial evaluated the effect of 15 mg of CERC-501 administered orally once per day on tobacco reinstatement behavior and assessed subjects’ craving, mood and anxiety during abstinence periods. In December 2016, we reported that CERC-501 did not meet its primary efficacy endpoint in this trial, but it was generally well tolerated. We plan to initiate a Phase 2/3 clinical trial with CERC-501 as an adjunctive treatment of MDD in the next year, subject to the availability of additional funding.
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CERC-301: Adjunctive Treatment of Major Depressive Disorder.
We are developing CERC-301 as an oral, adjunctive treatment for patients with MDD who are failing to achieve an adequate response to their current antidepressant treatment and are severely depressed. We received fast track designation by the U.S. Food and Drug Administration, or FDA, in 2013 for CERC‑301 for the treatment of MDD. CERC‑301 belongs to a class of compounds known as antagonists of the N‑methyl‑D‑aspartate, or NMDA, receptor, a receptor subtype of the glutamate neurotransmitter system that is responsible for controlling neurological adaptation. We believe CERC‑301 has the potential to produce a significant reduction in depression symptoms in a matter of days, as compared to weeks or months with conventional therapies, because it specifically blocks the NMDA receptor subunit 2B, or NR2B. We believe this mechanism of action may provide rapid and significant antidepressant activity without the adverse side effect profile of non‑selective NMDA receptor antagonists, such as ketamine. We recently completed a Phase 2 clinical trial for CERC-301 for the treatment of MDD, in which we evaluated the effect of intermittent oral doses of 12 mg and 20 mg versus placebo. In November 2016, we reported that CERC-301 did not meet its primary endpoint in this trial, but we observed a numerical separation from placebo
of the 20 mg dose on day 2, which we believe may correspond to a clinically meaningful treatment effect
. We are currently evaluating potential next steps for this program.
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CERC-611: Adjunctive Treatment of Partial-Onset Seizures in Epilepsy.
CERC-611 is a potent and selective
transmembrane AMPA receptor regulatory proteins, or
TARP, γ-8-dependent
α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid, or
AMPA, receptor antagonist, or inhibitor. TARPs are a recently discovered family of proteins that have been found to associate with, and modulate the activity of, AMPA receptors. TARP γ-8-dependent AMPA receptors are localized primarily in the hippocampus, a region of the brain with importance in complex partial seizures and particularly relevant to seizure origination and/or propagation. We believe CERC-611 is the first drug candidate to selectively target and functionally block region-specific AMPA receptors after oral dosing, which we believe may improve the efficacy and side effect profile of CERC-611 over current anti-epileptics. Research also suggests that selectively targeting individual TARPs may enable selective modulation of specific brain circuits without globally affecting synaptic transmission. We plan to file an IND, with the FDA in 2017. Subject to the availability of additional funding, and, if clearance is received from the FDA, we plan to commence Phase 1 development in 2017. We intend to develop CERC-611 as an adjunctive therapy for the treatment of partial-onset seizures, with or without secondarily generalized seizures, in patients with epilepsy.
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CERC-406: Cognitive Impairment.
CERC‑406 is our preclinical candidate that inhibits catechol‑O‑methyltransferase, or COMT, within the brain. We believe CERC‑406 has potential as a treatment of residual cognitive impairment symptoms in patients with MDD among other psychiatric and neurological conditions frequently impacted by impaired cognition.
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Pursue financing arrangements to fund pipeline development.
We are evaluating opportunities to fund the future development of our clinical product candidates through financing arrangements that provide us with the capital required to achieve our development objectives.
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Pursue non-dilutive funding of pipeline development.
We are exploring opportunities to fund our development programs through collaborations and grants from the government and private foundations, as well as out-licensing arrangements.
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Explore strategic alternatives focused on maximizing stockholder value
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We are reviewing a range of strategic alternatives focused on maximizing stockholder value. Potential strategic alternatives that may be explored or evaluated include an acquisition, merger, business combination or other strategic transaction.
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Develop CERC-501 as an adjunctive treatment of MDD.
Subject to the availability of additional funding, in the next year we will prepare CERC-501 for a Phase 2/3 clinical trial as an adjunctive treatment of MDD in patients with an inadequate response to standard antidepressant therapies. We believe that preclinical and recent clinical evidence supports the use of other KOR antagonists as novel medicines for the treatment of mood- and stress-related conditions, such as MDD. We believe CERC-501 has similar potential.
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Develop CERC-611 as an adjunctive therapy for seizures in patients with epilepsy.
We believe CERC-611 is the first molecule to selectively target and functionally block regionally-specific AMPA receptors after oral dosing and the efficacy and side effect profile may represent an improvement compared to current antiepileptics. We intend to submit an IND with the FDA and, upon acceptance, commence Phase 1 development of CERC-611 in 2017, subject to the availability of additional funding.
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Time to therapeutic response.
Current monoamine antidepressants are slow in onset, allowing depressive symptoms to persist for multiple weeks before patients experience the onset of the drugs’ therapeutic effect or a conclusion can be made that the drug is not working for the patient. Full effect is frequently not seen until 12 weeks.
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High rates of treatment failures and low rates of remission.
Even with the widespread availability of serotonin reuptake inhibitors, or SSRIs, or serotonin norepinephrine reuptake inhibitors, or SNRIs, MDD remains a leading cause of disability in the world. According to the STAR‑D Report despite four courses of different antidepressant medications, 33% of patients did not achieve remission.
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Side effects.
Common side effects seen with current depression therapies include gastrointestinal disturbance, dizziness, drowsiness, insomnia and sexual dysfunction. A common symptom of depression is a loss of libido. Compounding this issue, although most side effects associated with SSRIs and SNRIs subside within the first few weeks of treatment, sexual dysfunction often persists throughout the course of treatment. According to the STAR‑D Report, many patients who experience side effects discontinue treatment. In addition, currently used adjunctive treatments include antipsychotic agents which have both efficacy and treatment‑limiting side effects, including weight gain, increased risk of diabetes and cardiovascular risk.
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1.
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Effective treatments for refractory epilepsy subtypes
: Despite advances in treatment, the efficacy of current AEDs remains limited, with up to 40% of patients continuing to suffer from uncontrolled seizures (known as refractory epilepsy) despite trying several medications. When two AEDs have failed as monotherapy, the chance of seizure freedom with further monotherapy is very low. Uncontrolled seizures have approximately 40 times higher risk of inflicting mortality.
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AEDs with safer and more tolerable side-effect profiles
: Adverse effects from AEDs are common and a major cause of discontinuing drug treatment. The side effects of epilepsy drugs vary widely, and include fatigue, nausea, vomiting, and long-term problems such as osteoporosis. Additionally, some AEDs may produce weight gain (such as valproate), while others may induce weight loss (such as zonisamide and topiramate). Therefore, a significant unmet need in epilepsy treatment is the availability of AEDs that are effective in controlling seizure activity in doses that do not induce adverse side effects.
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3.
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Better treatment options for elderly patients
: According to Datamonitor Healthcare’s research, there are over 1.3 million prevalent epilepsy patients aged 60 or older in the US, Japan, and the five major EU markets, representing 29% of the total prevalent epilepsy population. The management of epilepsy in the elderly population is becoming a global challenge because elderly patients frequently present with concomitant disease and age-related alterations in renal and hepatic function that alter drug metabolism. The changes in metabolism and excretion of drugs associated with aging can result in increased susceptibility to neurotoxic side effects. Furthermore, as many elderly patients are on existing drug treatment for other disorders, the risk of drug interactions is exacerbated.
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Product Candidate / Platform
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Potential Indication(s)
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Stage of Development
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Anticipated Milestones
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CERC‑501
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Adjunctive treatment of MDD
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Phase 2
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Initiate Phase 2/3 studies in the next year, subject to the availability of additional funding
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CERC‑301
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Adjunctive treatment of MDD with rapid onset
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Phase 2
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Next steps being evaluated
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CERC‑611
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Adjunctive treatment of partial-onset seizures in epilepsy
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Preclinical
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IND submission and initiate Phase 1 studies in 2017, subject to the availability of additional funding
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CERC‑406
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Residual cognitive impairment symptoms in MDD
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Preclinical
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IND submission (timing dependent on the availability of additional funding)
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highly specific and selective to KOR and, therefore, minimal off‑target pharmacology;
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available in convenient, once‑a‑day oral dosing; and
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potential efficacy against addictive disorders.
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Impact of the KOPr Antagonist OpRA Kappa in Persons at Specific Stages of Cocaine Addiction Trajectory, Versus Normal Volunteers
. This single site trial, which began in September 2014, is being conducted under the leadership of Mary Jeanne Kreek, MD, Professor and Head of Laboratory, The Rockefeller University, and Senior Physician, The Rockefeller University Hospital.
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A Phase 2 Study to Evaluate the Kappa Opioid Receptor As a Target for the Treatment of Mood and Anxiety Spectrum Disorders by Evaluation of Whether LY2456302 Engages Key Neural Circuitry Related to the Hedonic Response.
Dr. Andrew Krystal of Duke University Medical Center serves as the principal investigator of this 6 site clinical study, which began in 2015 and is being conducted under the auspices of the National Institute of Mental Health.
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Does CERC-501 Attenuate Stress-Related Smoking Lapse?
This trial, which enrolled its first subject in August 2016, is a collaborative effort between Cerecor and Dr. Sherry McKee of Yale University and is supported by funding from the National Institutes of Health.
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minimal, if any, psychotomimetic effects, such as hallucinations and intoxication;
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available in a convenient, oral dosing form suitable for intermittent dosing; and
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ability to use for the prevention of a relapse of depression.
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more rapid onset of action;
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higher rate of response and remission;
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reduced/absent sexual side‑effect profile; and
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enhanced safety profile with respect to weight gain and increased risk of diabetes.
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Have efficacy in refractory partial-onset seizures as an adjunctive therapy. It may be uniquely qualified to treat temporal lobe seizures, unlike any other current or pipeline therapy, due to its selectivity for the TARP γ-8-dependent AMPA receptors
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Lack sedative, ataxic, or falling side effects of global AMPA receptor antagonists such as perampanel-Fycompa™
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Have a reduced or absent requirement for multi-week dose titration
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Potentially mitigate some of the side-effect liabilities associated with other conjointly administered antiepileptic medications.
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demonstrate efficacy as it is a brain penetrant COMT inhibitor with selectivity for MB‑COMT to target the PFC dopamine deficit in this patient population;
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be more effective in Val homozygotes population, who have higher levels of COMT activity and lower prefrontal dopamine receptor activation; and
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be safer than existing COMT inhibitors—existing COMT inhibitors are not ideal as such inhibitors have adverse events such as liver toxicity and diarrhea.
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CERC‑501.
We possess worldwide exclusive rights to manufacture, use and sell certain KOR antagonist compounds. The CERC‑501 patent portfolio consists of a single patent family with dozens of issued patents and pending patent applications, including patents issued in the U.S., Australia, Canada, China, Europe and Japan. The patents in this family include composition of matter claims, including picture claims to CERC‑501 or a pharmaceutically acceptable salt thereof, and/or use claims of varying scope. The expiration date of the two U.S. patents is January 13, 2029, not including any potential patent term extension or market exclusivity period.
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CERC‑301.
We possess worldwide exclusive rights to manufacture, use and sell certain NR2B antagonist compounds. The CERC‑301 patent portfolio consists of three patent families. The first family consists of patents that have issued in the United States, Australia, Canada, Germany, France, Great Britain, Switzerland and Japan. The patents in the first family include composition of matter and use claims of varying scope, including picture claims to CERC‑301 or a pharmaceutically acceptable salt thereof. The expiration date of the U.S. patent in the first family is August 31, 2026, not including any patent term extension or market exclusivity period which may apply. The second family consists of patents that have issued in the United States, Germany, France and Great Britain. The patents in the second family include composition of matter claims (in U.S. patent only) and use claims that generically cover CERC‑301. The expiration date of the U.S. patent is June 3, 2022, not including any potential patent term extension or market exclusivity period. The third family consists of a U.S. provisional patent application which includes claims to compositions of matter, methods of use, and methods of manufacture. U.S. nonprovisional and international patent applications that claim priority to the provisional application were filed in
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CERC-611.
We possess worldwide exclusive rights to manufacture, use and sell LY3130481, now known as CERC-611. The CERC-611 patent portfolio consists of two patent families. The first family includes a U.S. patent and close to 50 international applications with composition of matter and use claims for CERC-611. The projected expiration date of the U.S. patent, exclusive of any patent term extension, is November 20, 2033. The second family includes U.S. and international applications with composition of matter and use claims of varying scope for additional selective TARP γ-8-dependent AMPA receptor antagonists. If granted, patents in the second family are expected to expire on or after May 21, 2035, depending on possible patent term adjustment and/or extension.
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CERC‑406 and COMTi Platform.
We possess worldwide exclusive rights to manufacture, use and sell COMT inhibitor compounds. The COMT patent portfolio includes three patent families. Each patent family consists of patent applications filed in the United States, Australia, Brazil, Canada, China, Europe, India, Japan, South Korea, Mexico and Russia. Any patents issuing from these patent applications are predicted to expire at the earliest in 2031, not including any potential patent term extension or market exclusivity period.
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Esketamine is in Phase 3 development by Johnson & Johnson, or J&J, for administration as a nasal spray;
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AZD8108 has completed Phase 1 development by AstraZeneca Pharmaceuticals LP, for oral administration;
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Rapastinel is approaching Phase 3 development by Allergan plc, or Allergan, for intravenous administration;
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NRX 1074 is approaching Phase 2 development by Allergan for oral administration; and
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AV-101, an oral prodrug of 7-chlorokynurenic acid, is in Phase 2 development by VistaGen Therapeutics
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identifying and validating targets;
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screening compounds against targets;
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preclinical and clinical trials of potential pharmaceutical products; and
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obtaining FDA and other regulatory clearances.
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capital resources;
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research and development resources;
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manufacturing capabilities; and
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sales and marketing.
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completion of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice, or GLP, regulations;
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submission to the FDA of an IND which must become effective before human clinical trials may begin;
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approval by local or central independent institutional review boards, or IRB, before each clinical trial may be initiated;
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performance of human clinical trials, including adequate and well‑controlled clinical trials, in accordance with good clinical practices, or GCP, and regulations to establish the safety and efficacy of the proposed drug product for each indication;
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submission to the FDA of an NDA;
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satisfactory completion of an FDA advisory committee review, if applicable;
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satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with current good manufacturing practice, or GMP, regulations and to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity, as well as satisfactory completion of an FDA inspection of selected clinical sites to determine GCP compliance; and
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FDA review and approval of the NDA.
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restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;
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fines, Warning Letters or Untitled Letters, holds or termination of post‑approval clinical trials or FDA debarment;
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delay or refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product license approvals;
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regulatory authority, including the FDA, issued safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings about such products;
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mandated modifications to promotional material or issuance of corrective information;
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product seizure or detention, or refusal to permit the import or export of products; or
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injunctions or the imposition of civil or criminal penalties, including imprisonment, disgorgement and restitution, as well as consent decrees, corporate integrity agreements, deferred prosecution agreements and exclusion from federal healthcare programs.
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the required patent information has not been filed;
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the listed patent has expired;
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the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration; or
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the listed patent is invalid, unenforceable, or will not be infringed by the new product.
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Decentralized procedure.
Using the decentralized procedure, an applicant may apply for simultaneous authorization in more than one European Union country of medicinal products that have not yet been authorized in any European Union country and that do not fall within the mandatory scope of the centralized procedure.
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Mutual recognition procedure.
In the mutual recognition procedure, a medicine is first authorized in one European Union Member State, in accordance with the national procedures of that country. Following this, further marketing authorizations can be sought from other European Union countries in a procedure whereby the countries concerned agree to recognize the validity of the original, national marketing authorization.
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significantly delay, scale back or discontinue the development or commercialization of one or more of our product candidates or cease operations altogether;
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seek strategic alliances for research and development programs at an earlier stage than we would otherwise desire or on terms less favorable than might otherwise be available; or
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relinquish, or license on unfavorable terms, our rights to technologies or any future product candidates that we otherwise would seek to develop or commercialize ourselves.
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the initiation, progress, timing, costs and results of preclinical and clinical studies for our product candidates and future product candidates we may develop;
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the outcome, timing and cost of seeking and obtaining regulatory approvals from the FDA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform more studies than we currently expect to perform;
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the cost to establish, maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with licensing, preparing, filing, prosecuting, defending and enforcing any patents or other intellectual property rights;
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the effect of competing technological and market developments;
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market acceptance of any approved product candidates;
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the costs of acquiring, licensing or investing in additional businesses, products, product candidates and technologies;
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the cost and timing of selecting, auditing and potentially validating a manufacturing site for commercial‑scale manufacturing; and
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the cost of establishing sales, marketing and distribution capabilities for our product candidates for which we may receive marketing approval and that we determine to commercialize ourselves or in collaboration with our partners.
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successfully complete research and clinical development of current and future product candidates;
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seek and obtain marketing approvals for product candidates for which we complete clinical trials;
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establish and maintain supply and manufacturing relationships with third parties, and ensure adequate and legally compliant manufacturing of bulk drug substances and drug products to maintain that supply;
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launch and commercialize product candidates for which we obtain marketing approval, if any, and if launched independently or under a co‑promotion agreement, successfully establish a sales force, marketing and distribution infrastructure;
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identify and validate new product candidates;
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obtain coverage and adequate product reimbursement from third‑party payors, including government payors;
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achieve market acceptance for our or our partners’ products, if any;
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implement additional internal systems and infrastructure as needed;
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negotiate favorable terms in any collaboration, licensing or other arrangements into which we may enter;
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address any competing technological and market developments;
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establish, maintain and protect our intellectual property rights, including patents, trade secrets and know‑how; and
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attract, hire and retain qualified personnel.
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exposure to unknown liabilities;
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disruption of our business and diversion of our management’s time and attention in order to develop acquired products, product candidates or technologies;
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incurrence of substantial debt or dilutive issuances of equity securities to pay for acquisitions;
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higher than expected acquisition and integration costs;
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write‑downs of assets or goodwill or impairment charges;
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increased amortization expenses;
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difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel;
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impairment of relationships with key suppliers or other counterparties of any acquired businesses due to changes in management and ownership; and
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inability to retain key employees of any acquired businesses.
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delays in reaching an agreement with or failure in obtaining authorization from the FDA, other regulatory authorities or institutional review boards, or IRBs, to commence or amend a clinical trial;
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imposition of a clinical hold or trial termination following an inspection of our clinical trial operations or trial sites by the FDA or other regulatory authorities, or due to concerns about trial design, or a decision by the FDA, other regulatory authorities, IRBs or the company, or recommendation by a data safety monitoring board, to place the trial on hold or otherwise suspend or terminate clinical trials at any time for safety issues or for any other reason;
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delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites;
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deviations from the trial protocol by clinical trial sites and investigators, or failing to conduct the trial in accordance with regulatory requirements;
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failure of our third parties, such as CROs, to satisfy their contractual duties or meet expected deadlines;
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failure to enter into agreements with third parties to obtain the results of clinical trials;
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delays in the importation and manufacture of clinical supply;
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delays in the testing, validation and delivery of the clinical supply of the product candidates to the clinical sites;
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for clinical trials in selected subject populations, delays in identification and auditing of central or other laboratories and the transfer and validation of assays or tests to be used to identify selected subjects;
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delays in recruiting suitable subjects to participate in a trial;
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delays in having subjects complete participation in a trial or return for post‑treatment follow‑up;
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delays caused by subjects dropping out of a trial due to side effects or disease progression;
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•
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delays in adding new investigators and clinical trial sites;
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•
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withdrawal of clinical trial sites from our clinical trials as a result of changing standards of care or the ineligibility of a site to participate in our clinical trials; or
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•
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changes in government regulations or administrative actions or lack of adequate funding to continue the clinical trials.
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•
|
the size and nature of the subject population;
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•
|
the number and location of clinical sites we enroll;
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•
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the proximity of subjects to clinical sites;
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•
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perceived risks and benefits of the product candidate under trial;
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•
|
competition with other companies for clinical sites or subjects;
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•
|
competing clinical trials;
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•
|
the eligibility and exclusion criteria for the trial;
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•
|
the design of the clinical trial;
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•
|
effectiveness of publicity for the clinical trials;
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•
|
inability to obtain and maintain subject consents;
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•
|
ability to monitor subjects adequately during and after the administration of the product candidate and the ability of subjects to comply with the clinical trial requirements;
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•
|
risk that enrolled subjects will drop out or be withdrawn before completion; and
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•
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clinicians’ and subjects’ 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 we are investigating.
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•
|
our methodology, including our screening technology, may not successfully identify medically relevant potential product candidates;
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•
|
our competitors may develop alternatives that render our product candidates obsolete;
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•
|
we may encounter product manufacturing difficulties that limit yield or produce undesirable characteristics that increase the cost of goods, cause delays or make the product candidates unmarketable;
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•
|
our product candidates may cause adverse effects in subjects, even after successful initial toxicology studies, which may make the product candidates unmarketable;
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•
|
our product candidates may not be capable of being produced in commercial quantities at an acceptable cost, or at all;
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•
|
our product candidates may not demonstrate a meaningful benefit to subjects;
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•
|
our potential collaboration partners may change their development profiles or plans for potential product candidates or abandon a therapeutic area or the development of a partnered product; and
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•
|
our reliance on third party clinical trials may cause us to be denied access to clinical results that may be significant to further clinical development.
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•
|
the FDA or comparable foreign regulatory authorities may disagree on the design or implementation of our clinical trials, including the methodology used in our trial, our chosen endpoints, our statistical analysis, or our proposed product indication. For instance, the FDA may find that the designs that we are utilizing in our planned Phase 2/3 clinical trial of CERC‑501 do not support an adequate and well‑controlled study. The FDA also may not agree with the various depression and other disease scales and evaluation tools that we may use in our clinical trials to assess the efficacy of our product candidates. Further, the FDA may not agree with our endpoints and/or indications selected for our trials;
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•
|
the FDA or comparable foreign regulatory authorities may disagree with our development plans for our product candidates. For instance, at this time we have not yet discussed our development plans for CERC‑501, CERC-611 or CERC‑406 with the FDA. While we plan to discuss the development of these product candidates with the FDA, the FDA may not agree with our current development approach;
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•
|
our failure to demonstrate to the satisfaction of the FDA or comparable regulatory authorities that a product candidate is safe and effective for its proposed indication;
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•
|
our clinical trials may fail to meet the level of statistical significance required for approval. For example, in a proof of concept study of CERC‑301 conducted by the National Institute of Mental Health, CERC‑301 failed to provide a significant improvement in subjects receiving the compound as compared to those receiving a placebo, as measured by the Montgomery‑Asberg Depression Rating Scale, the primary assessment tool. Further, we
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•
|
we may fail to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;
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•
|
the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;
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•
|
data collected from clinical trials of our product candidates may be insufficient to support the submission and filing of an NDA, other submission or to obtain marketing approval. For example, the FDA may require additional studies to show that our product candidates are safe or effective;
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•
|
we may fail to obtain approval of the manufacturing processes or facilities of third‑party manufacturers with whom we contract for clinical and commercial supplies; or
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•
|
there may be changes in the approval policies or regulations that render our preclinical and clinical data insufficient for approval.
|
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•
|
we may suspend marketing of, or withdraw or recall, such product;
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•
|
regulatory authorities may withdraw approvals of such product;
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•
|
regulatory authorities may require additional warnings on the label or other label modifications;
|
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•
|
the FDA or other regulatory bodies may issue safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings about such product;
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|
•
|
the FDA may require the establishment or modification of a REMS or other restrictions on marketing and distribution, or a comparable foreign regulatory authority may require the establishment or modification of a similar strategy that may, for instance, require us to issue a medication guide outlining the risks of such side effects for distribution to patients or restrict distribution of our products and impose burdensome implementation requirements on us;
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•
|
regulatory authorities may require that we conduct post‑marketing studies;
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•
|
we could be sued and held liable for harm caused to subjects or patients; and
|
|
•
|
our reputation may suffer.
|
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•
|
issue Warning Letters or Untitled Letters;
|
|
•
|
mandate modifications to promotional materials or labeling, or require us to provide corrective information to healthcare practitioners;
|
|
•
|
require us to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions and penalties for noncompliance;
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•
|
seek an injunction or impose civil or criminal penalties or monetary fines, restitution or disgorgement, as well as imprisonment;
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•
|
suspend or withdraw marketing approval;
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•
|
suspend or terminate any ongoing clinical studies;
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•
|
refuse to approve pending applications or supplements to applications filed by us;
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•
|
debar us from submitting marketing applications, exclude us from participation in federal healthcare programs, require a corporate integrity agreement or deferred prosecution agreements, debar us from government contracts and refuse future orders under existing contracts;
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•
|
suspend or impose restrictions on operations, including restrictions on marketing, distribution or manufacturing of the product, or the imposition of costly new manufacturing requirements or use of alternative suppliers; or
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•
|
seize or detain products, refuse to permit the import or export of products, or request that we initiate a product recall.
|
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•
|
different regulatory requirements for approval of drugs in foreign countries;
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•
|
the potential for so‑called parallel importing, which is what happens when a local seller, faced with high or higher local prices, opts to import goods from a foreign market (with low or lower prices) rather than buying them locally;
|
|
•
|
challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States;
|
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•
|
unexpected changes in tariffs, trade barriers and regulatory requirements;
|
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•
|
economic weakness, including inflation, or political instability in particular foreign economies and markets;
|
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•
|
compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
|
|
•
|
foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations incident to doing business in another country;
|
|
•
|
difficulties staffing and managing foreign operations;
|
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•
|
workforce uncertainty in countries where labor unrest is more common than in the United States;
|
|
•
|
potential liability under the Foreign Corrupt Practices Act of 1977 or comparable foreign regulations;
|
|
•
|
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
|
|
•
|
business interruptions resulting from geopolitical actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires.
|
|
•
|
the efficacy and safety profile of our product candidates, including relative to marketed products and product candidates in development by third parties;
|
|
•
|
the claims we may make for our product candidates based on the approved label or any restrictions placed upon our marketing and distribution of our product candidates;
|
|
•
|
the time it takes for our product candidates to complete clinical development and receive marketing approval;
|
|
•
|
how quickly and effectively we alone, or with a partner, can market and launch any of our product candidates that receive marketing approval;
|
|
•
|
the ability to commercialize any of our product candidates that receive marketing approval;
|
|
•
|
the price of our products, including in comparison to branded or generic competitors;
|
|
•
|
the ability to collaborate with others in the development and commercialization of new products;
|
|
•
|
whether coverage and adequate levels of reimbursement are available under private and governmental health insurance plans, including Medicare;
|
|
•
|
the ability to establish, maintain and protect intellectual property rights related to our product candidates;
|
|
•
|
the entry of generic versions of our products onto the market;
|
|
•
|
the number of products in the same therapeutic class as our product candidates;
|
|
•
|
the ability to secure favorable managed care formulary positions, including federal healthcare program formularies;
|
|
•
|
the ability to manufacture commercial quantities of any of our product candidates that receive marketing approval; and
|
|
•
|
acceptance of any of our product candidates that receive marketing approval by physicians and other healthcare providers.
|
|
•
|
the efficacy and safety profile of our product candidates, including relative to marketed products and product candidates in development by third parties;
|
|
•
|
the claims we may make for our product candidates based on the approved label or any restrictions placed upon our marketing and distribution of our product candidates;
|
|
•
|
the time it takes for our product candidates to complete clinical development and receive marketing approval;
|
|
•
|
how quickly and effectively we alone, or with a partner, can market and launch any of our product candidates that receive marketing approval;
|
|
•
|
the ability to commercialize any of our product candidates that receive marketing approval;
|
|
•
|
the price of our products, including in comparison to branded or generic competitors;
|
|
•
|
the ability to collaborate with others in the development and commercialization of new products;
|
|
•
|
whether coverage and adequate levels of reimbursement are available under private and governmental health insurance plans, including Medicare;
|
|
•
|
the ability to establish, maintain and protect intellectual property rights related to our product candidates;
|
|
•
|
the entry of generic versions of our products onto the market;
|
|
•
|
the number of products in the same therapeutic class as our product candidates;
|
|
•
|
the ability to secure favorable managed care formulary positions, including federal healthcare program formularies;
|
|
•
|
the ability to manufacture commercial quantities of any of our product candidates that receive marketing approval; and
|
|
•
|
acceptance of any of our product candidates that receive marketing approval by physicians and other healthcare providers.
|
|
•
|
expanded manufacturers’ rebate liability under the Medicaid Drug Rebate Program by increasing the minimum rebate for both branded and generic drugs, effective the first quarter of 2010;
|
|
•
|
revised the definition of “average manufacturer price,” or AMP, for reporting purposes, which can increase the amount of Medicaid drug rebates manufacturers are required to pay to states, and created a separate AMP for certain categories of drugs provided in non‑retail outpatient settings;
|
|
•
|
extended Medicaid drug rebates, previously due only on fee‑for‑service utilization, to Medicaid managed care utilization;
|
|
•
|
created an alternative rebate formula for certain new formulations of certain existing products that is intended to increase the amount of rebates due on those drugs;
|
|
•
|
expanded the types of entities eligible to receive discounted 340B pricing, although, with the exception of children’s hospitals, these newly eligible entities will not be eligible to receive discounted 340B pricing on orphan drugs. In addition, because 340B pricing is determined based on AMP and Medicaid drug rebate data, the revisions to the Medicaid rebate formula and AMP definition described above can cause the required 340B discounts to increase;
|
|
•
|
imposed a significant annual fee on companies that manufacture or import branded prescription drug products;
|
|
•
|
required manufacturers to provide a 50% discount off the negotiated price of prescriptions filled by beneficiaries in the Medicare Part D coverage gap, referred to as the “donut hole”; and
|
|
•
|
enacted substantial new provisions affecting compliance which may affect our business practices with healthcare practitioners.
|
|
•
|
decreased demand for any product candidates or products that we may develop;
|
|
•
|
termination of clinical trial sites or entire trial programs;
|
|
•
|
injury to our reputation and significant negative media attention;
|
|
•
|
withdrawal of clinical trial participants;
|
|
•
|
significant costs to defend the related litigation;
|
|
•
|
substantial monetary awards to trial subjects or patients;
|
|
•
|
loss of revenue;
|
|
•
|
product recalls, withdrawals or labeling, marketing or promotional restrictions;
|
|
•
|
diversion of management and scientific resources from our business operations;
|
|
•
|
the inability to commercialize any products that we may develop; and
|
|
•
|
a decline in our stock price.
|
|
•
|
the federal Anti‑Kickback Statute prohibits persons from, among other things, knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward, or in return for, the referral of an individual for the furnishing or arranging for the furnishing, or the purchase, lease or order, or arranging for or recommending purchase, lease or order, of any good or service for which payment may be made under a federal healthcare program such as Medicare and Medicaid;
|
|
•
|
the civil federal False Claims Act imposes civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent; knowingly making, using or causing to be made or used, a false record or statement to get a false or fraudulent claim paid or approved by the government; conspiring to defraud the government by getting a false or fraudulent claim paid or approved by the government; or knowingly making, using or causing to be made or used a false record or statement to avoid, decrease or conceal an obligation to pay money to the federal government. Civil False Claims Act liability may be imposed for Medicare or Medicaid overpayments, for example, overpayments caused by understated rebate amounts, that are not refunded within 60 days of discovering the overpayment, even if the overpayment was not cause by a false or fraudulent act;
|
|
•
|
the criminal federal False Claims Act imposes criminal fines or imprisonment against individuals or entities who willfully make or present a claim to the government knowing such claim to be false, fictitious or fraudulent;
|
|
•
|
the Veterans Health Care Act requires manufacturers of covered drugs to offer them for sale on the Federal Supply Schedule, which requires compliance with applicable federal procurement laws and regulations and subjects us to contractual remedies as well as administrative, civil and criminal sanctions;
|
|
•
|
the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal liability for, among other actions, knowingly and willfully executing a scheme to defraud any healthcare benefit program, knowingly and willfully embezzling or stealing from a health care benefit program, willfully obstructing a criminal investigation of a health care offense, or knowingly and willfully making false statements relating to healthcare matters;
|
|
•
|
the civil monetary penalties statute 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;
|
|
•
|
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and its implementing regulations, also imposes obligations on certain covered entity health care providers, health plans, and health care clearinghouses as well as their business associates that perform certain services involving individually identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information, as well as directly applicable privacy and security standards and requirements;
|
|
•
|
the federal Physician Sunshine Act, created under Section 6002 of the Affordable Care Act and its implementing regulations, requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the Centers for Medicare and Medicaid Services, or CMS, information related to payments or other “transfers of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, and requires applicable manufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by physicians (as defined above) and their immediate family members;
|
|
•
|
the Foreign Corrupt Practices Act, or FCPA, prohibits any United States individual or business from paying, offering, or authorizing payment or offering of anything of value, directly or indirectly, to any foreign official, political party or candidate for the purpose of influencing any act or decision of the foreign entity in order to assist the individual or business in obtaining or retaining business. The FCPA also obligates companies whose securities are listed in the United States to comply with accounting provisions requiring the company to maintain books and records that accurately and fairly reflect all transactions of the corporation, including international subsidiaries, and to devise and maintain an adequate system of internal accounting controls for international operations; and
|
|
•
|
analogous or similar state, federal, and foreign laws, regulations, and requirements 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 and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the applicable 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; laws, regulations, and requirements applicable to the award and performance of federal contracts and grants and state, federal and foreign laws that govern the privacy and security of health and other 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.
|
|
•
|
our inability to recruit and retain adequate numbers of effective sales and marketing personnel;
|
|
•
|
the inability of sales personnel to obtain access to physicians or educate adequate numbers of physicians on the clinical benefits of our products to achieve market acceptance;
|
|
•
|
the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines;
|
|
•
|
the costs associated with training sales personnel on legal compliance matters and monitoring their actions;
|
|
•
|
liability for sales personnel failing to comply with the applicable legal requirements; and
|
|
•
|
unforeseen costs and expenses associated with creating an independent sales and marketing organization.
|
|
•
|
the development of certain of our current or future product candidates may be terminated or delayed;
|
|
•
|
our cash expenditures related to development of certain of our current or future product candidates would increase significantly and we may need to seek additional financing, which may not be available on favorable terms, or at all;
|
|
•
|
we may be required to hire additional employees or otherwise develop expertise, such as sales and marketing expertise, for which we have not budgeted;
|
|
•
|
we will bear all of the risk related to the development of any such product candidates;
|
|
•
|
we may have to expend unexpected efforts and funds if we are unable to obtain the results of third party clinical trials; and
|
|
•
|
the competitiveness of any product candidate that is commercialized could be reduced.
|
|
•
|
reliance on the third parties for regulatory compliance and quality assurance;
|
|
•
|
the possible breach of the manufacturing agreements by the third parties because of factors beyond our control;
|
|
•
|
the possibility of termination or nonrenewal of the agreements by the third parties because of our breach of the manufacturing agreement or based on their own business priorities; and
|
|
•
|
the disruption and costs associated with changing suppliers, including additional regulatory filings.
|
|
•
|
the development status of our product candidates, and when any of our product candidates receive marketing approval;
|
|
•
|
our decision to initiate a clinical trial, not to initiate a clinical trial or to terminate an existing clinical trial;
|
|
•
|
our failure to commercialize our product candidates, if approved;
|
|
•
|
the success of competitive products or technologies;
|
|
•
|
regulatory actions with respect to our products or our competitors’ products;
|
|
•
|
actual or anticipated changes in our growth rate relative to our competitors;
|
|
•
|
announcements by us or our competitors of significant acquisitions, strategic collaborations, joint ventures, collaborations or capital commitments;
|
|
•
|
results of preclinical studies and clinical trials of our product candidates or those of our competitors;
|
|
•
|
regulatory or legal developments in the United States and other countries;
|
|
•
|
developments or disputes concerning patent applications, issued patents or other proprietary rights;
|
|
•
|
the recruitment or departure of key personnel;
|
|
•
|
the level of expenses related to any of our product candidates or clinical development programs;
|
|
•
|
the results of our efforts to discover, develop, in‑license or acquire additional product candidates or products;
|
|
•
|
actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;
|
|
•
|
the performance of third parties on whom we rely to manufacture our products and product candidates, supply API and conduct our clinical trials, including their ability to comply with regulatory requirements;
|
|
•
|
variations in our financial results or those of companies that are perceived to be similar to us;
|
|
•
|
variations in the level of expenses related to our product candidates or preclinical and clinical development programs, including relating to the timing of invoices from, and other billing practices of, our contract research organizations and clinical trial sites;
|
|
•
|
fluctuations in the valuation of companies perceived by investors to be comparable to us;
|
|
•
|
warrant or share price and volume fluctuations attributable to inconsistent trading volume levels of our warrants or shares;
|
|
•
|
announcement or expectation of additional financing efforts;
|
|
•
|
sales of our warrants or shares of our common stock by us, our insiders or our other security holders;
|
|
•
|
changes in the structure of healthcare payment systems;
|
|
•
|
changes in operating performance and stock market valuations of other pharmaceutical companies;
|
|
•
|
market conditions in the pharmaceutical and biotechnology sectors;
|
|
•
|
our execution of collaborative, co‑promotion, licensing or other arrangements, and the timing of payments we may make or receive under these arrangements;
|
|
•
|
the public’s response to press releases or other public announcements by us or third parties, including our filings with the SEC and announcements relating to litigation or other disputes, strategic transactions or intellectual property impacting us or our business;
|
|
•
|
the financial projections we may provide to the public, any changes in these projections or our failure to meet these projections;
|
|
•
|
changes in financial estimates by any securities analysts who follow our warrants or shares of common stock, our failure to meet these estimates or failure of those analysts to initiate or maintain coverage of our warrants or shares of common stock;
|
|
•
|
ratings downgrades by any securities analysts who follow our warrants or shares of common stock;
|
|
•
|
the development and sustainability of an active trading market for our warrants or shares of common stock;
|
|
•
|
future sales of our warrants or shares of common stock by our officers, directors and significant stockholders;
|
|
•
|
other events or factors, including those resulting from war, incidents of terrorism, natural disasters or responses to these events;
|
|
•
|
changes in accounting principles; and
|
|
•
|
general economic, industry and market conditions.
|
|
•
|
the provisions of Section 404(b) of the Sarbanes‑Oxley Act of 2002, or Sarbanes‑Oxley Act, requiring that our independent registered public accounting firm provide an attestation report on the effectiveness of our internal control over financial reporting;
|
|
•
|
the “say on pay” provisions (requiring a non‑binding shareholder vote to approve compensation of certain executive officers) and the “say on golden parachute” provisions (requiring a non‑binding shareholder vote to approve golden parachute arrangements for certain executive officers in connection with mergers and certain
|
|
•
|
the requirement to provide detailed compensation discussion and analysis in proxy statements and reports filed under the Securities Exchange Act of 1934, as amended, or the Exchange Act, and instead provide a reduced level of disclosure concerning executive compensation; and
|
|
•
|
any rules that the Public Company Accounting Oversight Board may adopt requiring mandatory audit firm rotation or a supplement to the auditor’s report on the financial statements.
|
|
•
|
authorizing the issuance of “blank check” preferred stock, the terms of which we may establish and shares of which we may issue without stockholder approval;
|
|
•
|
providing for a classified board of directors, with each director serving a staggered three‑year term;
|
|
•
|
prohibiting cumulative voting in the election of directors, which would otherwise allow for less than a majority of stockholders to elect director candidates;
|
|
•
|
prohibiting stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders;
|
|
•
|
eliminating the ability of stockholders to call a special meeting of stockholders; and
|
|
•
|
establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings.
|
|
Year Ended December 31, 2016
|
|
|
|
|
||||
|
First Quarter
|
|
High
|
|
Low
|
||||
|
Common stock
|
|
$
|
4.92
|
|
|
$
|
2.90
|
|
|
Class A warrants
|
|
$
|
1.50
|
|
|
$
|
0.64
|
|
|
Class B warrants
|
|
$
|
1.08
|
|
|
$
|
0.65
|
|
|
Second Quarter
|
|
|
|
|
||||
|
Common stock
|
|
$
|
4.01
|
|
|
$
|
1.94
|
|
|
Class A warrants
|
|
$
|
1.20
|
|
|
$
|
0.63
|
|
|
Class B warrants
|
|
$
|
0.98
|
|
|
$
|
0.40
|
|
|
Third Quarter
|
|
|
|
|
||||
|
Common stock
|
|
$
|
4.91
|
|
|
$
|
2.21
|
|
|
Class A warrants
|
|
$
|
1.61
|
|
|
$
|
0.45
|
|
|
Class B warrants
|
|
$
|
0.85
|
|
|
$
|
0.35
|
|
|
Fourth Quarter
|
|
|
|
|
||||
|
Common stock
|
|
$
|
5.23
|
|
|
$
|
0.88
|
|
|
Class A warrants
|
|
$
|
1.99
|
|
|
$
|
0.11
|
|
|
Class B warrants
|
|
$
|
1.00
|
|
|
$
|
0.02
|
|
|
Year Ended December 31, 2015
|
|
|
|
|
||||
|
Fourth Quarter (Beginning November 13, 2015):
|
|
High
|
|
Low
|
||||
|
Common stock
|
|
$
|
4.50
|
|
|
$
|
3.10
|
|
|
Class A warrants
|
|
$
|
1.50
|
|
|
$
|
0.51
|
|
|
Class B warrants
|
|
$
|
0.79
|
|
|
$
|
0.27
|
|
|
|
|
Year Ended December 31,
|
||||||||||||||
|
Statement of Operations Data:
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
||||||||
|
Grant revenue
|
|
$
|
1,152,987
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
||||||||
|
Research and development
|
|
10,149,879
|
|
|
6,587,183
|
|
|
12,240,535
|
|
|
8,914,084
|
|
||||
|
General and administrative
|
|
7,083,155
|
|
|
4,422,764
|
|
|
4,875,030
|
|
|
4,020,364
|
|
||||
|
Loss from operations
|
|
(16,080,047
|
)
|
|
(11,009,947
|
)
|
|
(17,115,565
|
)
|
|
(12,934,448
|
)
|
||||
|
Other income (expense):
|
|
|
|
|
|
|
|
|
||||||||
|
Change in fair value of warrant liability, unit purchase option liability and investor rights obligation
|
|
72,625
|
|
|
1,313,049
|
|
|
2,266,161
|
|
|
(121,115
|
)
|
||||
|
Interest income (expense), net
|
|
(464,181
|
)
|
|
(793,205
|
)
|
|
(1,206,187
|
)
|
|
10,555
|
|
||||
|
Total other income (expense):
|
|
(391,556
|
)
|
|
519,844
|
|
|
1,059,974
|
|
|
(110,560
|
)
|
||||
|
Net loss
|
|
$
|
(16,471,603
|
)
|
|
$
|
(10,490,103
|
)
|
|
$
|
(16,055,591
|
)
|
|
$
|
(13,045,008
|
)
|
|
Net loss attributable to common stockholders
|
|
$
|
(16,471,603
|
)
|
|
$
|
(10,490,103
|
)
|
|
$
|
(3,521,153
|
)
|
|
$
|
(13,126,972
|
)
|
|
Net loss per share of common stock, basic and diluted
|
|
$
|
(1.87
|
)
|
|
$
|
(4.71
|
)
|
|
$
|
(5.48
|
)
|
|
$
|
(20.72
|
)
|
|
Weighted-average shares of common stock outstanding, basic and diluted
|
|
8,830,396
|
|
|
2,226,023
|
|
|
642,052
|
|
|
633,669
|
|
||||
|
|
|
As of December 31,
|
||||||||||||||
|
Balance Sheet Data:
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
||||||||
|
Cash and cash equivalents
|
|
$
|
5,127,958
|
|
|
$
|
21,161,967
|
|
|
$
|
11,742,349
|
|
|
$
|
3,421,480
|
|
|
Total assets
|
|
5,768,865
|
|
|
21,657,565
|
|
|
12,316,894
|
|
|
5,075,600
|
|
||||
|
Long term debt, net of current portion and discount
|
|
—
|
|
|
2,353,482
|
|
|
5,308,211
|
|
|
—
|
|
||||
|
Total current liabilities
|
|
4,311,863
|
|
|
5,849,818
|
|
|
4,993,816
|
|
|
3,065,642
|
|
||||
|
Total liabilities
|
|
5,561,863
|
|
|
8,573,838
|
|
|
10,302,027
|
|
|
3,065,642
|
|
||||
|
Convertible preferred stock
|
|
—
|
|
|
—
|
|
|
28,345,531
|
|
|
19,856,633
|
|
||||
|
Common stock
|
|
9,434
|
|
|
8,650
|
|
|
650
|
|
|
643
|
|
||||
|
Additional paid-in capital
|
|
70,232,651
|
|
|
66,638,557
|
|
|
16,742,063
|
|
|
9,170,468
|
|
||||
|
Total stockholders’ equity (deficit)
|
|
207,002
|
|
|
13,083,727
|
|
|
(26,330,664
|
)
|
|
(17,846,675
|
)
|
||||
|
•
|
expenses incurred under agreements with third-party contract research organizations, or CROs, and investigative sites that conduct our clinical trials, preclinical studies and regulatory activities;
|
|
•
|
payments made to contract manufacturers for drug substance and acquiring, developing and manufacturing clinical trial materials; and
|
|
•
|
payments related to acquisitions of our product candidates and preclinical platform and milestone payments.
|
|
•
|
personnel-related expenses, including salaries, benefits and stock-based compensation expense;
|
|
•
|
consulting costs related to our internal research and development programs;
|
|
•
|
allocated facilities, depreciation and other expenses, which include rent and utilities, as well as other supplies; and
|
|
•
|
product liability insurance.
|
|
|
|
Year Ended December 31,
|
||||||||||||||||||||||
|
|
|
2016
|
|
2015
|
|
2014
|
||||||||||||||||||
|
Risk-free interest rate
|
|
1.01
|
%
|
|
—
|
|
1.93
|
%
|
|
1.64
|
%
|
|
—
|
|
1.97
|
%
|
|
0.85
|
%
|
|
—
|
|
1.97
|
%
|
|
Expected term of options (in years)
|
|
5.0
|
|
|
—
|
|
6.25
|
|
|
5.0
|
|
|
—
|
|
6.25
|
|
|
5.00
|
|
|
—
|
|
6.25
|
|
|
Expected stock price volatility
|
|
80
|
%
|
|
—
|
|
100.0
|
%
|
|
|
|
|
|
70.0
|
%
|
|
|
|
|
|
70.0
|
%
|
||
|
Expected annual dividend yield
|
|
|
|
|
|
—
|
%
|
|
|
|
|
|
—
|
%
|
|
|
|
|
|
—
|
%
|
|||
|
•
|
prices at which we sold shares of our preferred stock and the superior rights and preferences of our preferred stock relative to our common stock;
|
|
•
|
the progress of our research and development programs, including the status of non‑clinical studies and clinical trials for our product candidates;
|
|
•
|
our stage of development and commercialization and our business strategy;
|
|
•
|
our financial condition, including cash on hand;
|
|
•
|
our historical and forecasted performance and operating results;
|
|
•
|
the composition of, and changes to, our management team and board of directors;
|
|
•
|
the lack of an active public market for our common stock and our preferred stock;
|
|
•
|
the likelihood of achieving a liquidity event, such as a sale of our company or an initial public offering, or IPO, given prevailing market conditions;
|
|
•
|
the analysis of IPOs and the market performance of similar companies in the biopharmaceutical industry;
|
|
•
|
external market conditions affecting the biopharmaceutical industry; and
|
|
•
|
trends within the biopharmaceutical industry.
|
|
|
|
Number of Shares
|
|
|
|
Fair Market
|
|
|
Fair Value of
|
|||||||||||
|
|
|
Underlying Options
|
|
Exercise Price
|
|
Value per
|
|
|
Options per
|
|||||||||||
|
Date of Issuance
|
|
Granted
|
|
per Share
|
|
Common Share
|
|
|
Share
|
|||||||||||
|
4/30/2015
|
|
3,571
|
|
|
$
|
6.44
|
|
|
$
|
5.04
|
|
|
$
|
|
|
|
|
|
2.80
|
|
|
6/2/2015
|
|
69,285
|
|
|
$
|
6.16
|
|
|
$
|
5.04
|
|
|
$
|
2.52
|
|
|
—
|
|
2.80
|
|
|
10/20/2015
|
|
350,250
|
|
|
$
|
6.49
|
|
|
$
|
4.98
|
|
|
$
|
|
|
|
|
2.93
|
|
|
|
11/9/2015
|
|
100,284
|
|
|
$
|
5.80
|
|
|
$
|
4.11
|
|
|
$
|
|
|
|
|
2.32
|
|
|
|
1/1/2016
|
|
360,459
|
|
|
$
|
3.35
|
|
|
$
|
3.35
|
|
|
$
|
|
|
|
|
2.32
|
|
|
|
1/11/2016
|
|
21,714
|
|
|
$
|
3.56
|
|
|
$
|
3.56
|
|
|
$
|
2.46
|
|
|
—
|
|
2.49
|
|
|
2/24/2016
|
|
108,591
|
|
|
$
|
3.01
|
|
|
$
|
3.01
|
|
|
$
|
|
|
|
|
2.10
|
|
|
|
3/14/2016
|
|
1,000
|
|
|
$
|
4.45
|
|
|
$
|
4.45
|
|
|
$
|
|
|
|
|
3.11
|
|
|
|
5/18/2016
|
|
50,142
|
|
|
$
|
3.52
|
|
|
$
|
3.52
|
|
|
$
|
|
|
|
|
2.53
|
|
|
|
6/30/2016
|
|
19,044
|
|
|
$
|
2.20
|
|
|
$
|
2.20
|
|
|
$
|
|
|
|
|
1.53
|
|
|
|
8/17/2016
|
|
263,000
|
|
|
$
|
3.77
|
|
|
$
|
3.77
|
|
|
$
|
|
|
|
|
2.70
|
|
|
|
8/24/2016
|
|
35,000
|
|
|
$
|
4.38
|
|
|
$
|
4.38
|
|
|
$
|
|
|
|
|
3.10
|
|
|
|
9/30/2016
|
|
10,303
|
|
|
$
|
4.23
|
|
|
$
|
4.23
|
|
|
$
|
|
|
|
|
2.83
|
|
|
|
12/31/2016
|
|
45,989
|
|
|
$
|
0.88
|
|
|
$
|
0.88
|
|
|
$
|
|
|
|
|
0.66
|
|
|
|
|
|
Year Ended
|
||||||
|
|
|
December 31,
|
||||||
|
|
|
2016
|
|
2015
|
||||
|
|
|
|
|
|
||||
|
|
|
(in thousands)
|
||||||
|
Grant revenue
|
|
$
|
1,153
|
|
|
$
|
—
|
|
|
|
|
Year Ended
|
||||||
|
|
|
December 31,
|
||||||
|
|
|
2016
|
|
2015
|
||||
|
|
|
|
|
|
||||
|
|
|
(in thousands)
|
||||||
|
CERC-301
|
|
$
|
2,890
|
|
|
$
|
3,110
|
|
|
CERC-501
|
|
3,122
|
|
|
1,481
|
|
||
|
CERC-611
|
|
2,103
|
|
|
—
|
|
||
|
COMTi
|
|
124
|
|
|
260
|
|
||
|
Internal expenses not allocated to programs:
|
|
|
|
|
|
|
||
|
Salaries, benefits and related costs
|
|
1,534
|
|
|
1,367
|
|
||
|
Stock-based compensation expense
|
|
141
|
|
|
67
|
|
||
|
Other
|
|
236
|
|
|
302
|
|
||
|
|
|
$
|
10,150
|
|
|
$
|
6,587
|
|
|
|
|
Year Ended
|
||||||
|
|
|
December 31,
|
||||||
|
|
|
2016
|
|
2015
|
||||
|
|
|
|
|
|
||||
|
|
|
(in thousands)
|
||||||
|
Salaries, benefits and related costs
|
|
$
|
1,922
|
|
|
$
|
2,326
|
|
|
Legal, consulting and other professional expenses
|
|
2,806
|
|
|
1,289
|
|
||
|
Stock-based compensation expense
|
|
1,554
|
|
|
328
|
|
||
|
Other
|
|
801
|
|
|
480
|
|
||
|
|
|
$
|
7,083
|
|
|
$
|
4,423
|
|
|
|
|
Year Ended
|
||||||
|
|
|
December 31,
|
||||||
|
|
|
2015
|
|
2014
|
||||
|
|
|
|
|
|
||||
|
|
|
(in thousands)
|
||||||
|
CERC-301
|
|
$
|
3,110
|
|
|
$
|
8,711
|
|
|
CERC-501
|
|
1,481
|
|
|
—
|
|
||
|
COMTi
|
|
260
|
|
|
761
|
|
||
|
FP01
|
|
—
|
|
|
28
|
|
||
|
Internal expenses not allocated to programs:
|
|
|
|
|
||||
|
Salaries, benefits and related costs
|
|
1,367
|
|
|
2,277
|
|
||
|
Stock-based compensation expense
|
|
67
|
|
|
202
|
|
||
|
Other
|
|
302
|
|
|
262
|
|
||
|
|
|
$
|
6,587
|
|
|
$
|
12,241
|
|
|
|
|
Year Ended
|
||||||
|
|
|
December 31,
|
||||||
|
|
|
2015
|
|
2014
|
||||
|
|
|
|
|
|
||||
|
|
|
(in thousands)
|
||||||
|
Salaries, benefits and related costs
|
|
$
|
2,326
|
|
|
$
|
1,619
|
|
|
Legal, consulting and other professional expenses
|
|
1,289
|
|
|
1,776
|
|
||
|
Stock-based compensation expense
|
|
328
|
|
|
885
|
|
||
|
Other
|
|
480
|
|
|
595
|
|
||
|
|
|
$
|
4,423
|
|
|
$
|
4,875
|
|
|
|
|
Year Ended
|
||||||||||
|
|
|
December 31,
|
||||||||||
|
|
|
2016
|
|
2015
|
|
2014
|
||||||
|
|
|
|
|
|
|
|
||||||
|
|
|
(in thousands)
|
||||||||||
|
Net cash provided by (used in):
|
|
|
|
|
|
|
||||||
|
Operating activities
|
|
$
|
(14,573
|
)
|
|
$
|
(10,163
|
)
|
|
$
|
(15,518
|
)
|
|
Investing activities
|
|
(35
|
)
|
|
(20
|
)
|
|
(20
|
)
|
|||
|
Financing activities
|
|
(1,426
|
)
|
|
19,603
|
|
|
23,859
|
|
|||
|
Net increase (decrease) in cash and cash equivalents
|
|
$
|
(16,034
|
)
|
|
$
|
9,420
|
|
|
$
|
8,321
|
|
|
•
|
the progress and results of the three externally funded clinical trials being conducted for CERC‑501 and changes to our development plan with respect to CERC‑501, if any;
|
|
•
|
the progress of and our ability to successfully file an IND with the FDA for CERC-611, the progress and results of any subsequent clinical trials for CERC-611 and any changes to our development plan with respect to CERC-611, if any;
|
|
•
|
our plan and ability to enter into collaborative agreements for the development and commercialization of our product candidates;
|
|
•
|
the number and development requirements of any other product candidates that we may pursue;
|
|
•
|
the scope, progress, results and costs of researching and developing our product candidates or any future product candidates, both in the United States and in territories outside the United States;
|
|
•
|
the costs, timing and outcome of regulatory review of our product candidates or any future product candidates, both in the United States and in territories outside the United States;
|
|
•
|
the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution for any of our product candidates for which we receive marketing approval;
|
|
•
|
the costs and timing of any product candidate acquisition or in‑licensing opportunities;
|
|
•
|
any product liability or other lawsuits related to our products;
|
|
•
|
the expenses needed to attract and retain skilled personnel;
|
|
•
|
the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; and
|
|
•
|
the costs involved in preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending our intellectual property‑related claims, both in the United States and in territories outside the United States
|
|
|
|
|
|
Less than
|
|
|
|
|
More than
|
||||||||
|
Contractual Obligation(1)
|
|
Total
|
|
one year
|
|
1 ‑ 3 years
|
|
|
3 years
|
||||||||
|
Debt obligations(2)
|
|
$
|
2,332
|
|
|
$
|
2,332
|
|
|
$
|
—
|
|
|
|
$
|
—
|
|
|
Operating lease obligations(3)
|
|
314
|
|
|
155
|
|
|
159
|
|
|
|
—
|
|
||||
|
Total contractual obligations
|
|
$
|
2,646
|
|
|
$
|
2,487
|
|
|
$
|
159
|
|
|
|
$
|
—
|
|
|
(1)
|
This table does not include any contingent milestone or royalty payments that may become payable to third parties under license agreements because the timing and likelihood of such payments are not known.
|
|
(2)
|
Amount represents principal and interest cash payments over the life of the debt obligations, including anticipated interest payments that are not recorded on our balance sheet.
|
|
(3)
|
Operating lease obligations reflect our obligations pursuant to the terms of a lease agreement entered into on August 8, 2013 for our office space located in Baltimore, Maryland.
|
|
(a)
|
Documents filed as part of this report.
|
|
1.
|
The following financial statements of Cerecor, Inc. and Report of Ernst & Young, LLP, Independent Registered Public Accounting Firm, are included in this report:
|
|
2.
|
List of financial statement schedules. All schedules are omitted because they are not applicable or the required information is shown in the financial statements described above.
|
|
3.
|
List of Exhibits required by Item 601 of Regulation S-K. See part (b) below.
|
|
(b)
|
Exhibits
. See the Exhibit Index and Exhibits filed as part of this report.
|
|
Cerecor Inc.
|
|
|
|
/s/ Uli Hacksell
|
|
Uli Hacksell
|
|
President and Chief Executive Officer
|
|
|
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
|
|
/s/ Uli Hacksell
|
|
President, Chief Executive Officer and Chairman of the Board
|
|
March 14, 2017
|
|
Uli Hacksell
|
|
(Principal Executive Officer)
|
|
|
|
|
|
|
|
|
|
/s/ Mariam E. Morris
|
|
Chief Financial Officer
|
|
March 14, 2017
|
|
Mariam E. Morris
|
|
(Principal Financial and Accounting Officer)
|
|
|
|
|
|
|
|
|
|
/s/ Thomas Aasen
|
|
Director
|
|
March 14, 2017
|
|
Thomas Aasen
|
|
|
|
|
|
|
|
|
|
|
|
/s/ Eugene A. Bauer
|
|
Director
|
|
March 14, 2017
|
|
Eugene A. Bauer
|
|
|
|
|
|
|
|
|
|
|
|
/s/ Isaac Blech
|
|
Director
|
|
March 14, 2017
|
|
Isaac Blech
|
|
|
|
|
|
|
|
|
|
|
|
/s/ Phil Gutry
|
|
Director
|
|
March 14, 2017
|
|
Phil Gutry
|
|
|
|
|
|
|
|
|
|
|
|
/s/ Magnus Persson
|
|
Director
|
|
March 14, 2017
|
|
Magnus Persson
|
|
|
|
|
|
|
|
December 31,
|
||||||
|
|
|
2016
|
|
2015
|
||||
|
Assets
|
|
|
|
|
||||
|
Current assets:
|
|
|
|
|
||||
|
Cash and cash equivalents
|
|
$
|
5,127,958
|
|
|
$
|
21,161,967
|
|
|
Grants receivable
|
|
132,472
|
|
|
—
|
|
||
|
Prepaid expenses and other current assets
|
|
391,253
|
|
|
401,550
|
|
||
|
Restricted cash—current portion
|
|
11,111
|
|
|
58,832
|
|
||
|
Total current assets
|
|
5,662,794
|
|
|
21,622,349
|
|
||
|
Restricted cash, net of current portion
|
|
62,828
|
|
|
—
|
|
||
|
Property and equipment, net
|
|
43,243
|
|
|
35,216
|
|
||
|
Total assets
|
|
$
|
5,768,865
|
|
|
$
|
21,657,565
|
|
|
Liabilities and stockholders’ equity
|
|
|
|
|
||||
|
Current liabilities:
|
|
|
|
|
||||
|
Current portion of long term debt, net of discount
|
|
$
|
2,353,667
|
|
|
$
|
3,208,074
|
|
|
Accounts payable
|
|
1,010,209
|
|
|
678,109
|
|
||
|
Accrued expenses and other current liabilities
|
|
942,435
|
|
|
1,885,458
|
|
||
|
Warrant liability
|
|
5,501
|
|
|
27,606
|
|
||
|
Unit purchase option liability
|
|
51
|
|
|
50,571
|
|
||
|
Total current liabilities
|
|
4,311,863
|
|
|
5,849,818
|
|
||
|
Long term debt, net of current portion and discount
|
|
—
|
|
|
2,353,482
|
|
||
|
Other long term liabilities
|
|
1,250,000
|
|
|
370,538
|
|
||
|
Total liabilities
|
|
5,561,863
|
|
|
8,573,838
|
|
||
|
Stockholders’ equity (deficit):
|
|
|
|
|
||||
|
Preferred stock—$0.001 par value; 5,000,000 and zero shares authorized at December 31, 2016 and 2015, respectively; zero shares issued and outstanding at December 31, 2016 and 2015
|
|
—
|
|
|
—
|
|
||
|
Common stock—$0.001 par value; 200,000,000 shares authorized at December 31, 2016 and 2015; 9,434,141 and 8,650,143 shares issued and outstanding at December 31, 2016 and 2015, respectively
|
|
9,434
|
|
|
8,650
|
|
||
|
Additional paid-in capital
|
|
70,232,651
|
|
|
66,638,557
|
|
||
|
Accumulated deficit
|
|
(70,035,083
|
)
|
|
(53,563,480
|
)
|
||
|
Total stockholders’ equity
|
|
207,002
|
|
|
13,083,727
|
|
||
|
Total liabilities and stockholders’ equity
|
|
$
|
5,768,865
|
|
|
$
|
21,657,565
|
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
|
2016
|
|
2015
|
|
2014
|
||||||
|
Grant revenue
|
|
$
|
1,152,987
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Operating expenses:
|
|
|
|
|
|
|
||||||
|
Research and development
|
|
10,149,879
|
|
|
6,587,183
|
|
|
12,240,535
|
|
|||
|
General and administrative
|
|
7,083,155
|
|
|
4,422,764
|
|
|
4,875,030
|
|
|||
|
Loss from operations
|
|
(16,080,047
|
)
|
|
(11,009,947
|
)
|
|
(17,115,565
|
)
|
|||
|
Other income (expense):
|
|
|
|
|
|
|
||||||
|
Change in fair value of warrant liability, unit purchase option liability and investor rights obligation
|
|
72,625
|
|
|
1,313,049
|
|
|
2,266,161
|
|
|||
|
Interest income (expense), net
|
|
(464,181
|
)
|
|
(793,205
|
)
|
|
(1,206,187
|
)
|
|||
|
Total other income (expense)
|
|
(391,556
|
)
|
|
519,844
|
|
|
1,059,974
|
|
|||
|
Net loss
|
|
$
|
(16,471,603
|
)
|
|
$
|
(10,490,103
|
)
|
|
$
|
(16,055,591
|
)
|
|
Net loss attributable to common stockholders
|
|
$
|
(16,471,603
|
)
|
|
$
|
(10,490,103
|
)
|
|
$
|
(3,521,153
|
)
|
|
Net loss per share of common stock, basic and diluted
|
|
$
|
(1.87
|
)
|
|
$
|
(4.71
|
)
|
|
$
|
(5.48
|
)
|
|
Weighted-average shares of common stock outstanding, basic and diluted
|
|
8,830,396
|
|
|
2,226,023
|
|
|
642,052
|
|
|||
|
|
Series A, A-1 and B
|
|
Stockholders’ Equity (Deficit)
|
||||||||||||||||||||||
|
|
convertible preferred
|
|
|
|
|
|
Additional
|
|
|
|
Total
|
||||||||||||||
|
|
stock
|
|
Common stock
|
|
paid‑in
|
|
Accumulated
|
|
stockholders’
|
||||||||||||||||
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
capital
|
|
deficit
|
|
equity (deficit)
|
||||||||||||
|
Balance, January 1, 2014
|
40,190,902
|
|
|
$
|
19,856,633
|
|
|
642,844
|
|
|
$
|
643
|
|
|
$
|
9,170,468
|
|
|
$
|
(27,017,786
|
)
|
|
$
|
(17,846,675
|
)
|
|
Extinguishment upon modification of Series A and A-1 convertible preferred stock and issuance of common stock dividends
|
—
|
|
|
(6,004,417
|
)
|
|
6,877
|
|
|
7
|
|
|
6,004,604
|
|
|
—
|
|
|
6,004,611
|
|
|||||
|
Reclassification of common stock warrants from liabilities to equity
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
426,303
|
|
|
—
|
|
|
426,303
|
|
|||||
|
Conversion of convertible promissory notes in exchange for Series B convertible preferred stock
|
5,597,618
|
|
|
1,405,003
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
|
Conversion of demand notes in exchange for Series B convertible preferred stock, net of investor rights obligation
|
3,333,331
|
|
|
837,313
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
|
Issuance of Series B convertible preferred stock net of issuance costs and investor rights obligation
|
50,017,786
|
|
|
12,250,999
|
|
|
|
|
|
|
|
|
54,107
|
|
|
|
|
|
54,107
|
|
|||||
|
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,086,581
|
|
|
—
|
|
|
1,086,581
|
|
|||||
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(16,055,591
|
)
|
|
(16,055,591
|
)
|
|||||
|
Balance, December 31, 2014
|
99,139,637
|
|
|
$
|
28,345,531
|
|
|
649,721
|
|
|
$
|
650
|
|
|
$
|
16,742,063
|
|
|
$
|
(43,073,377
|
)
|
|
$
|
(26,330,664
|
)
|
|
Issuance of securities in initial public offering, including over-allotment and underwriters' unit purchase option, net of offering costs and underwriting discounts, commissions and expenses
|
—
|
|
|
—
|
|
|
4,020,000
|
|
|
4,020
|
|
|
21,161,569
|
|
|
—
|
|
|
21,165,589
|
|
|||||
|
Issuance of common stock for conversion of preferred stock upon closing of initial public offering
|
(99,139,637
|
)
|
|
(28,345,531
|
)
|
|
3,980,422
|
|
|
3,980
|
|
|
28,340,177
|
|
|
—
|
|
|
28,344,157
|
|
|||||
|
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
394,748
|
|
|
—
|
|
|
394,748
|
|
|||||
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(10,490,103
|
)
|
|
(10,490,103
|
)
|
|||||
|
Balance, December 31, 2015
|
—
|
|
|
$
|
—
|
|
|
8,650,143
|
|
|
$
|
8,650
|
|
|
$
|
66,638,557
|
|
|
$
|
(53,563,480
|
)
|
|
$
|
13,083,727
|
|
|
Issuance of common stock from sale of shares under common stock purchase agreement, net of offering costs
|
—
|
|
|
—
|
|
|
763,998
|
|
|
764
|
|
|
1,899,223
|
|
|
|
|
|
1,899,987
|
|
|||||
|
Shares purchased through employee stock purchase plan
|
—
|
|
|
—
|
|
|
20,000
|
|
|
20
|
|
|
(20
|
)
|
|
—
|
|
|
—
|
|
|||||
|
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,694,891
|
|
|
—
|
|
|
1,694,891
|
|
|||||
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(16,471,603
|
)
|
|
(16,471,603
|
)
|
|||||
|
Balance, December 31, 2016
|
—
|
|
|
$
|
—
|
|
|
9,434,141
|
|
|
$
|
9,434
|
|
|
$
|
70,232,651
|
|
|
$
|
(70,035,083
|
)
|
|
$
|
207,002
|
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
|
2016
|
|
2015
|
|
2014
|
||||||
|
Operating activities
|
|
|
|
|
|
|
||||||
|
Net loss
|
|
$
|
(16,471,603
|
)
|
|
$
|
(10,490,103
|
)
|
|
$
|
(16,055,591
|
)
|
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
||||||
|
Depreciation
|
|
26,856
|
|
|
23,508
|
|
|
28,943
|
|
|||
|
Loss on disposition of assets
|
|
—
|
|
|
—
|
|
|
17,806
|
|
|||
|
Stock-based compensation expense
|
|
1,694,891
|
|
|
394,748
|
|
|
1,086,581
|
|
|||
|
Write off of deferred public offering costs
|
|
—
|
|
|
—
|
|
|
1,064,106
|
|
|||
|
Non-cash interest expense
|
|
162,270
|
|
|
293,748
|
|
|
989,258
|
|
|||
|
Change in fair value of warrant liability, unit purchase option liability and investor rights obligation
|
|
(72,625
|
)
|
|
(1,313,049
|
)
|
|
(2,266,161
|
)
|
|||
|
Changes in assets and liabilities:
|
|
|
|
|
|
|
||||||
|
Grant receivable
|
|
(132,472
|
)
|
|
—
|
|
|
—
|
|
|||
|
Prepaid expenses and other assets
|
|
22,047
|
|
|
(41,243
|
)
|
|
353,973
|
|
|||
|
Restricted cash
|
|
(15,107
|
)
|
|
116,666
|
|
|
(498
|
)
|
|||
|
Accounts payable
|
|
332,100
|
|
|
(268,709
|
)
|
|
(708,366
|
)
|
|||
|
Accrued expenses and other liabilities
|
|
(119,495
|
)
|
|
1,121,054
|
|
|
(28,400
|
)
|
|||
|
Net cash used in operating activities
|
|
(14,573,138
|
)
|
|
(10,163,380
|
)
|
|
(15,518,349
|
)
|
|||
|
Investing activities
|
|
|
|
|
|
|
||||||
|
Purchase of property and equipment
|
|
(34,883
|
)
|
|
(19,984
|
)
|
|
(19,502
|
)
|
|||
|
Net cash used in investing activities
|
|
(34,883
|
)
|
|
(19,984
|
)
|
|
(19,502
|
)
|
|||
|
Financing activities
|
|
|
|
|
|
|
||||||
|
Proceeds from issuance of convertible promissory notes and demand notes
|
|
—
|
|
|
—
|
|
|
2,249,666
|
|
|||
|
Proceeds from issuance of term loan, net of costs
|
|
—
|
|
|
—
|
|
|
7,390,000
|
|
|||
|
Proceeds from issuance of Series B convertible preferred stock and common stock warrants, net of offering costs
|
|
—
|
|
|
—
|
|
|
14,584,307
|
|
|||
|
Payment of fractional shares upon conversion of preferred stock to common stock
|
|
—
|
|
|
(1,373
|
)
|
|
—
|
|
|||
|
Proceeds from initial public offering, including over-allotment, net of underwriting discounts, commissions and expenses
|
|
—
|
|
|
23,685,270
|
|
|
—
|
|
|||
|
Proceeds from sale of shares under common stock purchase agreement
|
|
2,003,182
|
|
|
—
|
|
|
—
|
|
|||
|
Principal payments on term debt
|
|
(3,314,225
|
)
|
|
(1,811,744
|
)
|
|
—
|
|
|||
|
Payment of offering costs
|
|
(114,945
|
)
|
|
(2,269,171
|
)
|
|
(365,253
|
)
|
|||
|
Net cash provided by (used in) financing activities
|
|
(1,425,988
|
)
|
|
19,602,982
|
|
|
23,858,720
|
|
|||
|
Increase (decrease) in cash and cash equivalents
|
|
(16,034,009
|
)
|
|
9,419,618
|
|
|
8,320,869
|
|
|||
|
Cash and cash equivalents at beginning of period
|
|
21,161,967
|
|
|
11,742,349
|
|
|
3,421,480
|
|
|||
|
Cash and cash equivalents at end of period
|
|
$
|
5,127,958
|
|
|
$
|
21,161,967
|
|
|
$
|
11,742,349
|
|
|
Supplemental disclosures of cash flow information
|
|
|
|
|
|
|
||||||
|
Cash paid for interest
|
|
$
|
348,888
|
|
|
$
|
568,299
|
|
|
$
|
173,514
|
|
|
Supplemental disclosures of non-cash financing activities:
|
|
|
|
|
|
|
||||||
|
Accrued deferred financing costs
|
|
$
|
81,832
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Conversion of promissory and demand notes into Series B convertible preferred stock
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,249,666
|
|
|
Reclassification of common stock warrants from liabilities to equity
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
426,303
|
|
|
Allocation of debt and equity proceeds to investor rights obligation
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2,598,510
|
|
|
Extinguishment upon modification of Series A and A-1 convertible preferred stock
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
12,534,438
|
|
|
|
|
Year ended December 31,
|
||||||||||
|
Net loss per share, basic and diluted calculation:
|
|
2016
|
|
2015
|
|
2014
|
||||||
|
Net loss
|
|
$
|
(16,471,603
|
)
|
|
$
|
(10,490,103
|
)
|
|
$
|
(16,055,591
|
)
|
|
Extinguishment upon modification of Series A and A-1 convertible preferred stock
|
|
—
|
|
|
—
|
|
|
12,534,438
|
|
|||
|
Net loss attributable to common stockholders
|
|
$
|
(16,471,603
|
)
|
|
$
|
(10,490,103
|
)
|
|
$
|
(3,521,153
|
)
|
|
Weighted-average common shares outstanding
|
|
8,830,396
|
|
|
2,226,023
|
|
|
642,052
|
|
|||
|
Net loss per share, basic and diluted
|
|
$
|
(1.87
|
)
|
|
$
|
(4.71
|
)
|
|
$
|
(5.48
|
)
|
|
|
|
December 31,
|
|||||||
|
|
|
2016
|
|
2015
|
|
2014
|
|||
|
Series A convertible preferred stock
|
|
—
|
|
|
—
|
|
|
31,116,391
|
|
|
Series A-1 convertible preferred stock
|
|
—
|
|
|
—
|
|
|
9,074,511
|
|
|
Series B convertible preferred stock
|
|
—
|
|
|
—
|
|
|
58,948,735
|
|
|
Stock options
|
|
1,849,359
|
|
|
959,188
|
|
|
552,726
|
|
|
Warrants on common stock
|
|
7,400,934
|
|
|
7,400,934
|
|
|
681,858
|
|
|
Warrants on preferred stock
|
|
—
|
|
|
—
|
|
|
625,208
|
|
|
Investor rights obligation
|
|
—
|
|
|
—
|
|
|
53,351,117
|
|
|
Underwriters' unit purchase option
|
|
40,000
|
|
|
40,000
|
|
|
—
|
|
|
•
|
Level 1—inputs to the valuation methodology are quoted prices (unadjusted) for an identical asset or liability in an active market.
|
|
•
|
Level 2—inputs to the valuation methodology include quoted prices for a similar asset or liability in an active market or model‑derived valuations in which all significant inputs are observable for substantially the full term of the asset or liability.
|
|
•
|
Level 3—inputs to the valuation methodology are unobservable and significant to the fair value measurement of the asset or liability.
|
|
|
|
December 31, 2016
|
||||||||||
|
|
|
Fair Value Measurements Using
|
||||||||||
|
|
|
Quoted prices in
|
|
Significant other
|
|
Significant
|
||||||
|
|
|
active markets for
|
|
observable
|
|
unobservable
|
||||||
|
|
|
identical assets
|
|
inputs
|
|
inputs
|
||||||
|
|
|
(Level 1)
|
|
(Level 2)
|
|
(Level 3)
|
||||||
|
Assets
|
|
|
|
|
|
|
||||||
|
Investments in money market funds*
|
|
$
|
4,758,539
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Liabilities
|
|
|
|
|
|
|
||||||
|
Warrant liability
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
5,501
|
|
|
Unit purchase option liability
|
|
—
|
|
|
$
|
—
|
|
|
$
|
51
|
|
|
|
|
|
December 31, 2015
|
||||||||||
|
|
|
Fair Value Measurements Using
|
||||||||||
|
|
|
Quoted prices in
|
|
Significant other
|
|
Significant
|
||||||
|
|
|
active markets for
|
|
observable
|
|
unobservable
|
||||||
|
|
|
identical assets
|
|
inputs
|
|
inputs
|
||||||
|
|
|
(Level 1)
|
|
(Level 2)
|
|
(Level 3)
|
||||||
|
Assets
|
|
|
|
|
|
|
||||||
|
Investments in money market funds*
|
|
$
|
21,122,553
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Liabilities
|
|
|
|
|
|
|
||||||
|
Warrant liability
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
27,606
|
|
|
Unit purchase option liability
|
|
—
|
|
|
$
|
—
|
|
|
$
|
50,571
|
|
|
|
|
|
|
|
|
|
|
||||||
|
|
|
Warrant
|
|
Unit purchase
|
|
Investor rights
|
|
|
||||||||
|
|
|
liability
|
|
option liability
|
|
obligation
|
|
Total
|
||||||||
|
Balance at December 31, 2015
|
|
$
|
27,606
|
|
|
$
|
50,571
|
|
|
$
|
—
|
|
|
$
|
78,177
|
|
|
Change in fair value
|
|
(22,105
|
)
|
|
(50,520
|
)
|
|
—
|
|
|
(72,625
|
)
|
||||
|
Balance at December 31, 2016
|
|
$
|
5,501
|
|
|
$
|
51
|
|
|
$
|
—
|
|
|
$
|
5,552
|
|
|
|
|
Warrant
|
|
Unit purchase
|
|
Investor rights
|
|
|
||||||||
|
|
|
liability
|
|
option liability
|
|
obligation
|
|
Total
|
||||||||
|
Balance at December 31, 2014
|
|
$
|
69,684
|
|
|
$
|
—
|
|
|
$
|
1,112,000
|
|
|
$
|
1,181,684
|
|
|
Issuance of unit purchase option
|
|
—
|
|
|
209,542
|
|
|
—
|
|
|
209,542
|
|
||||
|
Expiration of investor rights obligation
|
|
—
|
|
|
—
|
|
|
(1,112,000
|
)
|
|
(1,112,000
|
)
|
||||
|
Change in fair value
|
|
(42,078
|
)
|
|
(158,971
|
)
|
|
—
|
|
|
(201,049
|
)
|
||||
|
Balance at December 31, 2015
|
|
$
|
27,606
|
|
|
$
|
50,571
|
|
|
$
|
—
|
|
|
$
|
78,177
|
|
|
|
|
December 31,
|
||||||
|
|
|
2016
|
|
2015
|
||||
|
Furniture and equipment
|
|
$
|
58,126
|
|
|
$
|
34,918
|
|
|
Computers and software
|
|
72,808
|
|
|
61,133
|
|
||
|
Total property and equipment
|
|
130,934
|
|
|
96,051
|
|
||
|
Less accumulated depreciation
|
|
(87,691
|
)
|
|
(60,835
|
)
|
||
|
Property and equipment, net
|
|
$
|
43,243
|
|
|
$
|
35,216
|
|
|
|
|
December 31,
|
||||||
|
|
|
2016
|
|
2015
|
||||
|
Compensation and benefits
|
|
$
|
272,601
|
|
|
$
|
1,128,073
|
|
|
Research and development expenses
|
|
315,937
|
|
|
464,719
|
|
||
|
General and administrative
|
|
160,116
|
|
|
253,132
|
|
||
|
Accrued interest
|
|
193,781
|
|
|
39,534
|
|
||
|
Total accrued expenses and other current liabilities
|
|
$
|
942,435
|
|
|
$
|
1,885,458
|
|
|
|
|
December 31,
|
|
December 31,
|
||||
|
|
|
2016
|
|
2015
|
||||
|
Term loan
|
|
$
|
2,374,031
|
|
|
$
|
5,688,256
|
|
|
Less: debt discount
|
|
(20,364
|
)
|
|
(126,700
|
)
|
||
|
Term Loan, net of debt discount
|
|
2,353,667
|
|
|
5,561,556
|
|
||
|
Less: current portion, net of debt discount
|
|
(2,353,667
|
)
|
|
(3,208,074
|
)
|
||
|
Long term debt, net of current portion and debt discount
|
|
$
|
—
|
|
|
$
|
2,353,482
|
|
|
Number of shares
|
|
Exercise price
|
|
Expiration
|
||
|
underlying warrants
|
|
per share
|
|
date
|
||
|
109,976
|
|
$
|
28.00
|
|
|
February 2017
|
|
29,260
|
|
$
|
14.00
|
|
|
February 2017
|
|
90,529
|
|
$
|
28.00
|
|
|
March 2017
|
|
29,557
|
|
$
|
14.00
|
|
|
March 2017
|
|
130,233
|
|
$
|
28.00
|
|
|
April 2017
|
|
2,275,950
|
|
$
|
3.90
|
|
|
April 2017
|
|
20,000
|
|
$
|
4.49
|
|
|
April 2017
|
|
14,284
|
|
$
|
28.00
|
|
|
July 2017
|
|
80,966
|
|
$
|
28.00
|
|
|
August 2018
|
|
4,551,900
|
|
$
|
4.55
|
|
|
October 2018
|
|
40,000*
|
|
$
|
5.23
|
|
|
October 2018
|
|
3,571
|
|
$
|
28.00
|
|
|
December 2018
|
|
22,328*
|
|
$
|
8.40
|
|
|
October 2020
|
|
2,380
|
|
$
|
8.68
|
|
|
May 2022
|
|
7,400,934
|
|
|
|
|
||
|
|
|
|
|
|
||
|
*Accounted for as a liability instrument (see Note 4)
|
|
|
|
|
||
|
|
|
Year Ended December 31,
|
||||||
|
|
|
2016
|
|
2015
|
||||
|
Research and development
|
|
$
|
141,247
|
|
|
$
|
67,021
|
|
|
General and administrative
|
|
1,553,644
|
|
|
327,727
|
|
||
|
Total stock-based compensation
|
|
$
|
1,694,891
|
|
|
$
|
394,748
|
|
|
|
|
Options Outstanding
|
|||||||||||
|
|
|
|
|
|
|
|
|
Weighted average
|
|||||
|
|
|
|
|
|
|
Grant date
|
|
remaining
|
|||||
|
|
|
Number of
|
|
Weighted‑average
|
|
fair value of
|
|
contractual term
|
|||||
|
|
|
shares
|
|
exercise price
|
|
options granted
|
|
(in years)
|
|||||
|
Balance, January 1, 2015
|
|
552,726
|
|
|
$
|
9.17
|
|
|
|
|
|
||
|
Granted
|
|
523,390
|
|
|
$
|
6.31
|
|
|
$
|
1,467,886
|
|
|
|
|
Forfeited
|
|
(116,928
|
)
|
|
$
|
8.60
|
|
|
|
|
|
||
|
Balance, December 31, 2015
|
|
959,188
|
|
|
$
|
7.68
|
|
|
|
|
|
||
|
Granted
|
|
915,242
|
|
|
$
|
3.35
|
|
|
$
|
2,155,234
|
|
|
|
|
Forfeited
|
|
(25,071
|
)
|
|
$
|
5.04
|
|
|
|
|
|
||
|
Balance, December 31, 2016
|
|
1,849,359
|
|
|
$
|
5.57
|
|
|
|
|
8.44
|
||
|
Vested and expected to vest at December 31, 2016
|
|
1,849,359
|
|
|
$
|
5.57
|
|
|
|
|
8.44
|
||
|
Exercisable at December 31, 2016
|
|
791,251
|
|
|
$
|
7.55
|
|
|
|
|
7.24
|
||
|
|
|
Year Ended December 31,
|
||||||||||||||||||||||
|
|
|
2016
|
|
2015
|
|
2014
|
||||||||||||||||||
|
Risk-free interest rate
|
|
1.01
|
%
|
|
—
|
|
1.93
|
%
|
|
1.64
|
%
|
|
—
|
|
1.97
|
%
|
|
0.85
|
%
|
|
—
|
|
1.97
|
%
|
|
Expected term of options (in years)
|
|
5.0
|
|
|
—
|
|
6.25
|
|
|
5.0
|
|
|
—
|
|
6.25
|
|
|
5.00
|
|
|
—
|
|
6.25
|
|
|
Expected stock price volatility
|
|
80
|
%
|
|
—
|
|
100.0
|
%
|
|
|
|
|
|
70.0
|
%
|
|
|
|
|
|
70.0
|
%
|
||
|
Expected annual dividend yield
|
|
|
|
|
|
—
|
%
|
|
|
|
|
|
—
|
%
|
|
|
|
|
|
—
|
%
|
|||
|
•
|
Risk‑free interest rate: The Company bases the risk‑free interest rate on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected option term.
|
|
•
|
Expected term of options: Due to lack of sufficient historical data, the Company estimates the expected life of its stock options granted to employees and members of the board of directors as the arithmetic average of the vesting term and the original contractual term of the option. The Company estimates the expected life of its stock options granted to consultants and nonemployees to be the contractual term of the options.
|
|
•
|
Expected stock price volatility: The Company estimated the expected volatility based on actual historical volatility of the stock price of other publicly‑traded biotechnology companies engaged in lines of business that are the same or similar to the Company’s. The Company calculated the historical volatility of the selected companies by using daily closing prices over a period of the expected term of the associated award. The companies were selected based on their enterprise value, risk profiles, position within the industry, and with historical share price information sufficient to meet the expected term of the associated award. A decrease in the selected volatility would decrease the fair value of the underlying instrument.
|
|
•
|
Expected annual dividend yield: The Company estimated the expected dividend yield based on consideration of its historical dividend experience and future dividend expectations. The Company has not historically declared or paid dividends to stockholders. Moreover, it does not intend to pay dividends in the future, but instead expects to retain
|
|
Year ending December 31,
|
|
|
||
|
2017
|
|
$
|
815,654
|
|
|
2018
|
|
766,151
|
|
|
|
2019
|
|
357,279
|
|
|
|
2020
|
|
108,716
|
|
|
|
|
|
$
|
2,047,800
|
|
|
|
|
December 31,
|
||||||
|
|
|
2016
|
|
2015
|
||||
|
Deferred tax assets:
|
|
|
|
|
||||
|
Net operating losses
|
|
$
|
20,587,955
|
|
|
$
|
20,350,451
|
|
|
Research and development credits
|
|
1,840,505
|
|
|
1,814,296
|
|
||
|
Deferred rent
|
|
11,902
|
|
|
15,599
|
|
||
|
Accrued compensation
|
|
90,936
|
|
|
438,351
|
|
||
|
Stock-based compensation
|
|
2,169,070
|
|
|
1,500,520
|
|
||
|
Basis difference in tangible and intangible assets
|
|
6,174,163
|
|
|
207,157
|
|
||
|
Total deferred tax assets
|
|
30,874,531
|
|
|
24,326,374
|
|
||
|
Less valuation allowance
|
|
(30,874,531
|
)
|
|
(24,326,374
|
)
|
||
|
Net deferred tax asset
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
December 31,
|
||||
|
|
|
2016
|
|
2015
|
||
|
Federal statutory rate
|
|
34.00
|
%
|
|
34.00
|
%
|
|
Permanent differences
|
|
(0.02
|
)%
|
|
(0.02
|
)%
|
|
Warrants
|
|
0.15
|
%
|
|
4.26
|
%
|
|
State taxes
|
|
3.44
|
%
|
|
5.12
|
%
|
|
Research and development credit
|
|
2.18
|
%
|
|
2.69
|
%
|
|
Other
|
|
—
|
%
|
|
0.03
|
%
|
|
Change in valuation allowance
|
|
(39.75
|
)%
|
|
(46.08
|
)%
|
|
Effective income tax rate
|
|
—
|
%
|
|
—
|
%
|
|
Year ending December 31,
|
|
||
|
2017
|
$
|
154,845
|
|
|
2018
|
158,716
|
|
|
|
|
$
|
313,561
|
|
|
|
|
Three Months Ended
|
||||||||||||||
|
|
|
March 31,
|
|
June 30,
|
|
September 30,
|
|
December 31,
|
||||||||
|
|
|
2016
|
|
2016
|
|
2016
|
|
2016
|
||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
|
|
|
(in thousands, except per share data)
|
||||||||||||||
|
Grant revenue
|
|
$
|
—
|
|
|
$
|
650
|
|
|
$
|
321
|
|
|
$
|
182
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
||||||||
|
Research and development
|
|
2,293
|
|
|
2,502
|
|
|
4,582
|
|
|
773
|
|
||||
|
General and administrative
|
|
2,649
|
|
|
1,636
|
|
|
1,703
|
|
|
1,095
|
|
||||
|
Change in fair value of warrant liability and unit purchase option liability
|
|
(47
|
)
|
|
91
|
|
|
(101
|
)
|
|
130
|
|
||||
|
Interest income (expense), net
|
|
(151
|
)
|
|
(127
|
)
|
|
(104
|
)
|
|
(83
|
)
|
||||
|
Net loss
|
|
$
|
(5,140
|
)
|
|
$
|
(3,524
|
)
|
|
$
|
(6,169
|
)
|
|
$
|
(1,639
|
)
|
|
Net loss per share of common stock, basic and diluted
|
|
$
|
(0.59
|
)
|
|
$
|
(0.41
|
)
|
|
$
|
(0.70
|
)
|
|
$
|
(0.18
|
)
|
|
|
|
Three Months Ended
|
||||||||||||||
|
|
|
March 31,
|
|
June 30,
|
|
September 30,
|
|
December 31,
|
||||||||
|
|
|
2015
|
|
2015
|
|
2015
|
|
2015
|
||||||||
|
|
|
|
|
|
|
|
|
|
||||||||
|
|
|
(in thousands, except per share data)
|
||||||||||||||
|
Operating expenses:
|
|
|
|
|
|
|
|
|
||||||||
|
Research and development
|
|
$
|
1,723
|
|
|
$
|
1,875
|
|
|
$
|
1,238
|
|
|
$
|
1,751
|
|
|
General and administrative
|
|
761
|
|
|
1,016
|
|
|
722
|
|
|
1,924
|
|
||||
|
Change in fair value of warrant liability, unit purchase option liability and investor rights obligation
|
|
(535
|
)
|
|
198
|
|
|
1,465
|
|
|
185
|
|
||||
|
Interest income (expense), net
|
|
(219
|
)
|
|
(219
|
)
|
|
(197
|
)
|
|
(158
|
)
|
||||
|
Net loss
|
|
$
|
(3,238
|
)
|
|
$
|
(2,912
|
)
|
|
$
|
(692
|
)
|
|
$
|
(3,648
|
)
|
|
Net loss per share of common stock, basic and diluted
|
|
$
|
(4.98
|
)
|
|
$
|
(4.48
|
)
|
|
$
|
(1.06
|
)
|
|
$
|
(0.53
|
)
|
|
Exhibit
Number
|
|
Description of Exhibit
|
|
|
|
|
|
|
|
3.1
|
|
|
Amended and Restated Certificate of Incorporation of Cerecor Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on October 20, 2015).
|
|
|
|
|
|
|
3.2
|
|
|
Amended and Restated Bylaws of Cerecor Inc. (incorporated by reference to Exhibit 3.2 to Amendment No. 1 to the Current Report on Form 8-K filed on October 20, 2015).
|
|
|
|
|
|
|
4.1
|
|
|
Second Amended and Restated Investors' Rights Agreement, dated as of July 11, 2014 (incorporated by reference to Exhibit 4.1 to the Registration Statement on Form S-1 filed on June 12, 2015).
|
|
|
|
|
|
|
4.2
|
|
|
Form of Warrant to Purchase Shares of Common Stock issued in connection with the sale of Series A Convertible Preferred Stock (incorporated by reference to Exhibit 4.2 to the Registration Statement on Form S-1 filed on June 12, 2015).
|
|
|
|
|
|
|
4.3
|
|
|
Form of Warrant to Purchase Shares of Common Stock issued in connection with the sale of Series A-1 Convertible Preferred Stock, as amended by the Amendment to Common Stock Warrants, dated as of July 11, 2014 (incorporated by reference to Exhibit 4.3 to the Registration Statement on Form S-1 filed on June 12, 2015).
|
|
|
|
|
|
|
4.4
|
|
|
Form of Warrant to Purchase Shares of Common Stock, issued to CIFCO International Group and its affiliate (incorporated by reference to Exhibit 4.5 to the Registration Statement on Form S-1 filed on June 12, 2015).
|
|
|
|
|
|
|
4.5
|
|
|
Form of Warrant to Purchase Shares of Common Stock issued in connection with the issuance of convertible promissory notes from April 2014 through June 2014 (incorporated by reference to Exhibit 4.6 to the Registration Statement on Form S-1 filed on June 12, 2015).
|
|
|
|
|
|
|
4.6
|
|
|
Warrant Agreement, dated as of August 19, 2014, issued to Hercules Technology Growth Capital, Inc. (incorporated by reference to Exhibit 4.7 to the Registration Statement on Form S-1 filed on June 12, 2015).
|
|
|
|
|
|
|
4.7
|
|
|
Form of Unit Purchase Option (incorporated by reference to Annex IV of Exhibit 1.1 to the Registration Statement on Form S-1 filed on June 12, 2015).
|
|
|
|
|
|
|
4.9
|
|
|
Form of Class A Warrant Agreement (incorporated by reference to Exhibit 4.9 to the Registration Statement on Form S-1 filed on October 13, 2015).
|
|
|
|
|
|
|
4.10
|
|
|
Specimen Class A Warrant Certificate (incorporated by reference to Exhibit 4.10 to the Registration Statement on Form S-1 filed on October 13, 2015).
|
|
|
|
|
|
|
4.11
|
|
|
Form of Class B Warrant Agreement (incorporated by reference to Exhibit 4.11 to the Registration Statement on Form S-1 filed on October 13, 2015).
|
|
|
|
|
|
|
4.12
|
|
|
Specimen Class B Warrant Certificate (incorporated by reference to Exhibit 4.12 to the Registration Statement on Form S-1 filed on October 13, 2015).
|
|
|
|
|
|
|
4.13
|
|
|
Specimen Unit Certificate (incorporated by reference to Exhibit 4.13 to the Registration Statement on Form S-1 filed on October 13, 2015).
|
|
|
|
|
|
|
4.14
|
|
|
Registration Rights Agreement, dated as of September 8, 2016, by and between Aspire Capital Fund, LLC and Cerecor Inc. (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed on September 12, 2016).
|
|
|
|
|
|
|
10.1 #
|
|
|
Exclusive Patent and Know-How License Agreement, effective as of March 19, 2013, by and between Essex Chemie AG and Cerecor Inc. (incorporated by reference to Exhibit 10.1 to the Registration Statement on Form S-1 filed on June 12, 2015).
|
|
|
|
|
|
|
10.2 #
|
|
|
Exclusive Patent and Know-How License Agreement, effective as of March 19, 2013, by and between Essex Chemie AG and Cerecor Inc. (incorporated by reference to Exhibit 10.2 to the Registration Statement on Form S-1 filed on June 12, 2015).
|
|
|
|
|
|
|
10.3 #
|
|
|
Exclusive Patent and Know-How License Agreement, effective as of February 18, 2015, by and between Eli Lilly and Company and Cerecor Inc. (incorporated by reference to Exhibit 10.3 to the Registration Statement on Form S-1 filed on June 12, 2015).
|
|
|
|
|
|
|
10.4 +
|
|
|
Cerecor Inc. 2011 Stock Incentive Plan, as amended, including forms of Incentive Stock Option Agreements and Nonqualified Stock Option Agreements thereunder (incorporated by reference to Exhibit 10.4 to the Registration Statement on Form S-1 filed on June 12, 2015).
|
|
|
|
|
|
|
10.5 +
|
|
|
Cerecor Inc. 2015 Omnibus Incentive Plan, including form of Nonqualified Stock Option Agreements thereunder (incorporated by reference to Exhibit 10.5 to the Registration Statement on Form S-1 filed on September 8, 2015).
|
|
|
|
|
|
|
10.6 +
|
|
|
Offer Letter Agreement by and between Cerecor Inc. and John Kaiser, dated as of September 12, 2012 (incorporated by reference to Exhibit 10.7 to the Registration Statement on Form S-1 filed on June 12, 2015).
|
|
|
|
|
|
|
10.7 +
|
|
|
Offer Letter Agreement by and between Cerecor Inc. and James Vornov, dated as of September 18, 2012 (incorporated by reference to Exhibit 10.8 to the Registration Statement on Form S-1 filed on June 12, 2015).
|
|
|
|
|
|
|
10.8 +
|
|
|
Offer Letter Agreement by and between Cerecor Inc. and Ronald Marcus, dated as of May 5, 2015 (incorporated by reference to Exhibit 10.9 to the Registration Statement on Form S-1 filed on June 12, 2015).
|
|
|
|
|
|
|
10.9 +
|
|
|
Offer Letter Agreement by and between Cerecor Inc. and Uli Hacksell, dated as of May 20, 2015 (incorporated by reference to Exhibit 10.10 to the Registration Statement on Form S-1 filed on June 12, 2015).
|
|
|
|
|
|
|
10.10 +
|
|
|
Offer Letter Agreement by and between Cerecor Inc. and Mariam Morris, effective as of August 24, 2015 (incorporated by reference to Exhibit 10.11 to the Registration Statement on Form S-1 filed on September 8, 2015).
|
|
|
|
|
|
|
10.11 +
|
|
|
Employment Agreement by and between Cerecor Inc. and Uli Hacksell, effective January 1, 2016 (incorporated by reference to Exhibit 10.11 to the Annual Report on Form 10-K filed on March 23, 2016).
|
|
|
|
|
|
|
10.12 +
|
|
|
Separation Agreement by and between Cerecor Inc. and Blake Paterson, effective January 9, 2016 (incorporated by reference to Exhibit 10.12 to the Annual Report on Form 10-K filed on March 23, 2016).
|
|
|
|
|
|
|
10.13 +
|
|
|
Form of Director Indemnification Agreement (incorporated by reference to Exhibit 10.12 to the Registration Statement on Form S-1 filed on September 8, 2015).
|
|
|
|
|
|
|
10.14
|
|
|
List of current directors with a Director Indemnification Agreement in the form provided as Exhibit 10.12 (incorporated by reference to Exhibit 10.13 to the Registration Statement on Form S-1 filed on September 8, 2015).
|
|
|
|
|
|
|
10.15
|
|
|
Lease Agreement by and between Cerecor Inc. and PDL Pratt Associates, LLC, dated as of August 8, 2013 (incorporated by reference to Exhibit 10.14 to the Registration Statement on Form S-1 filed on June 12, 2015).
|
|
|
|
|
|
|
10.16
|
|
|
Loan and Security Agreement, dated as of August 19, 2014, by and between Cerecor Inc. and Hercules Technology Growth Capital, Inc. (incorporated by reference to Exhibit 10.15 to the Registration Statement on Form S-1 filed on June 12, 2015).
|
|
|
|
|
|
|
10.17
|
|
|
Non-Employee Director Compensation Plan (incorporated by reference to Exhibit 10.17 to the Annual Report on Form 10-K filed on March 23, 2016).
|
|
|
|
|
|
|
10.18 +
|
|
|
Cerecor Inc. 2016 Equity Incentive Plan (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on May 20, 2016).
|
|
|
|
|
|
|
10.19 +
|
|
|
Cerecor Inc. 2016 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed on May 20, 2016).
|
|
|
|
|
|
|
10.20
|
|
|
Common Stock Purchase Agreement, dated as of September 8, 2016, by and between Aspire Capital Fund, LLC and Cerecor Inc. (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on September 12, 2016).
|
|
|
|
|
|
|
10.21 #
|
|
|
Exclusive License Agreement, dated as of September 22, 2016, by and between Cerecor Inc. and Eli Lilly and Company (incorporated by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q filed on November 8, 2016).
|
|
|
|
|
|
|
10.21.1
|
|
|
Addendum to Exclusive License Agreement, dated as of October 13, 2016, by and between Cerecor Inc. and Eli Lilly and Company (incorporated by reference to Exhibit 10.1.1 to the Quarterly Report on Form 10-Q filed on November 8, 2016).
|
|
|
|
|
|
|
10.22
|
|
|
Equity Distribution Agreement, dated as of January 27, 2017, by and between Cerecor Inc. and Maxim Group LLC (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on January 27, 2017).
|
|
|
|
|
|
|
21.1
|
|
|
List of Subsidiaries of the Registrant.
|
|
|
|
|
|
|
23.1
|
|
|
Consent of Ernst & Young LLP, independent registered public accounting firm.
|
|
|
|
|
|
|
31.1 *
|
|
|
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|
|
|
31.2 *
|
|
|
Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|
|
|
32.1 *
|
|
|
Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|
|
|
101.INS
|
|
|
XBRL Instance Document.
|
|
|
|
|
|
|
101.SCH
|
|
|
XBRL Taxonomy Extension Schema Document.
|
|
|
|
|
|
|
101.CAL
|
|
|
XBRL Taxonomy Extension Calculation Linkbase Document.
|
|
|
|
|
|
|
101.DEF
|
|
|
XBRL Taxonomy Extension Definition Linkbase Document.
|
|
|
|
|
|
|
101.LAB
|
|
|
XBRL Taxonomy Extension Label Linkbase Document.
|
|
|
|
|
|
|
101.PRE
|
|
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
|
|
|
|
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|