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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
|
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended
or
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission
file number
(Exact name of registrant as specified in its charter)
|
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(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
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| (Address of principal executive offices) | (Zip Code) |
(Registrant’s telephone number, including area code)
10025 Investment Drive, Suite 250, Knoxville, TN 37932
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| None | N/A | N/A |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. ☒
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). ☒
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ |
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☒ | Smaller reporting company |
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| Emerging growth company |
|
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒
The number of shares outstanding of the registrant’s common stock, par value $0.001 per share, as of August 10, 2022, was .
TABLE OF CONTENTS
Cautionary Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains “forward-looking statements” as defined under U.S. federal securities laws. These statements reflect management’s current knowledge, assumptions, beliefs, estimates, and expectations. These statements also express management’s current views of future performance, results, and trends and may be identified by their use of terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,” “plan,” “predict,” “project,” “should,” “strategy,” “will,” and other similar terms. Forward-looking statements are subject to a number of risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements. Readers should not place undue reliance on forward-looking statements. Such statements are made as of the date of this Quarterly Report on Form 10-Q, and we undertake no obligation to update such statements after this date, unless otherwise required by law.
Risks and uncertainties that could cause our actual results to materially differ from those described in forward-looking statements include those discussed in our filings with the U.S. Securities and Exchange Commission (the “SEC”) (including those described in Item 1A of Part I of our Annual Report on Form 10-K for the year ended December 31, 2021), and Item 1A of Part II of this Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, and:
| ● | Our potential receipt of sales from investigational rose bengal sodium-based drug products PV-10 ® and PH-10 ® , and/or any other halogenated xanthene-based drug products (if and when approved); and licensing, milestone, royalty, and/or other payments related to these investigational drug products and/or the Company’s liquidation, dissolution, or winding up, or any sale, lease, conveyance, or other disposition of any intellectual property relating to rose bengal sodium-based and other halogenated xanthene-based investigational drug products and/or drug substances, | |
| ● | Our ability to raise additional capital through the proceeds of private placement transactions, the exercise of existing warrants and outstanding stock options, and/or public offerings of debt or equity securities, | |
| ● | The widespread outbreak of an illness or communicable/infectious disease, such as severe acute respiratory syndrome coronavirus 2, or a public health crisis, could disrupt our business and adversely affect our operations and financial condition, and | |
| ● | Many companies across a variety of sectors have reported and continue to report disruptions, shortages, and other supply chain-related issues. In the biopharmaceutical sector, delays and interruptions in the supply chain have been particularly pronounced. During this second quarter of 2022, we were able to effectively manage our supply of prescription drug candidates in a manner that avoided any significant interruptions to our clinical programs. |
| 1 |
PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS.
PROVECTUS BIOPHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ |
|
$ |
|
||||
| Restricted cash |
|
|
||||||
| Short-term receivables |
|
|
||||||
| Prepaid expenses and other current assets |
|
|
||||||
| Total Current Assets |
|
|
||||||
|
Equipment and furnishings, less accumulated depreciation of $
|
|
|
||||||
| Operating lease right-of-use asset |
|
|
||||||
| Total Assets | $ |
|
$ |
|
||||
| Liabilities and Stockholders’ Deficiency | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ |
|
$ |
|
||||
| Deposit for purchase of Series D-1 Preferred Stock |
|
|||||||
| Unearned grant revenue |
|
|
||||||
| Other accrued expenses |
|
|
||||||
| Accrued interest |
|
|
||||||
| Accrued interest - related parties |
|
|
||||||
| Notes payable |
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||||||
| Convertible notes payable |
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|
||||||
| Convertible notes payable - related parties |
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||||||
| Operating lease liability, current portion |
|
|
||||||
| Total Current Liabilities |
|
|
||||||
| Operating lease liability, non-current portion |
|
|||||||
| Total Liabilities |
|
|
||||||
| Commitments, contingencies, and litigations (Note 11) | ||||||||
|
Stockholders’ Deficiency:
|
||||||||
| Preferred stock; par value $ per share; shares authorized; | ||||||||
|
Series D Convertible Preferred Stock;
shares designated;
shares issued and
outstanding at June 30, 2022 and December 31, 2021; aggregate liquidation preference of $
|
|
|
||||||
|
Series D-1 Convertible Preferred Stock;
shares designated;
and
shares
issued and outstanding at June 30, 2022 and December 31, 2021, respectively; aggregate liquidation preference of $
|
|
|
||||||
| Common stock; par value $ per share; shares authorized; shares issued and outstanding at June 30, 2022 and December 31, 2021 |
|
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||||||
| Additional paid-in capital |
|
|
||||||
| Accumulated other comprehensive loss |
(
|
) |
(
|
) | ||||
| Accumulated deficit |
(
|
) |
(
|
) | ||||
| Total Stockholders’ Deficiency |
(
|
) |
(
|
) | ||||
| Total Liabilities and Stockholders’ Deficiency | $ |
|
$ |
|
||||
See accompanying notes to condensed consolidated financial statements.
| 2 |
PROVECTUS BIOPHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| For the Three Months Ended | For the Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Grant Revenue | $ |
|
$ | $ |
|
$ | ||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development |
|
|
|
|
||||||||||||
| General and administrative |
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|
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||||||||||||
| Total Operating Expenses |
|
|
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||||||||||||
| Total Operating Loss |
(
|
) |
(
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) |
(
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) |
(
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) | ||||||||
| Other Income/(Expense): | ||||||||||||||||
| Research and development tax credit |
|
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|
||||||||||||
| Gain from extinguishment |
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||||||||||||||
| Interest income and interest expense |
(
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) |
(
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) |
(
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) |
(
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) | ||||||||
| Total Other Income/(Expense), Net |
|
(
|
) |
(
|
) |
(
|
) | |||||||||
| Net Loss | $ |
(
|
) | $ |
(
|
) | $ |
(
|
) | $ |
(
|
) | ||||
| Basic and Diluted Loss Per Common Share | $ |
(
|
) | $ |
(
|
) |
(
|
) | $ |
(
|
) | |||||
| Weighted Average Number of Common Shares Outstanding - Basic and Diluted |
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|
||||||||||||
See accompanying notes to condensed consolidated financial statements.
| 3 |
PROVECTUS BIOPHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
| For the Three Months Ended | For the Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Net Loss | $ |
(
|
) | $ |
(
|
) | $ |
(
|
) | $ |
(
|
) | ||||
| Other Comprehensive Loss: | ||||||||||||||||
| Foreign currency translation adjustments |
(
|
) |
(
|
) |
(
|
) |
(
|
) | ||||||||
| Total Comprehensive Loss | $ |
(
|
) | $ |
(
|
) | $ |
(
|
) | $ |
(
|
) | ||||
See accompanying notes to condensed consolidated financial statements.
| 4 |
PROVECTUS BIOPHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIENCY
(Unaudited)
FOR THE SIX MONTHS ENDED JUNE 30, 2022
| Preferred Stock | Preferred Stock | Additional |
Accumulated Other |
|||||||||||||||||||||||||||||||||||||
| Series D | Series D-1 | Common Stock | Paid-In | Comprehensive | Accumulated | |||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Capital | Loss | Deficit | Total | |||||||||||||||||||||||||||||||
| Balance at January 1, 2022 |
|
$ |
|
|
$ |
|
|
$ |
|
$ |
|
$ |
(
|
) | $ |
(
|
) | $ |
(
|
) | ||||||||||||||||||||
| Series D-1 Preferred Stock issued for cash | - |
|
|
- |
|
|
||||||||||||||||||||||||||||||||||
| Comprehensive loss: | ||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - |
(
|
) |
(
|
) | |||||||||||||||||||||||||||||||||
| Other comprehensive loss | - | - | - |
(
|
) |
(
|
) | |||||||||||||||||||||||||||||||||
| Balance at March 31, 2022 |
|
$ |
|
|
$ |
|
|
$ |
|
$ |
|
$ |
(
|
) | $ |
(
|
) | $ |
(
|
) | ||||||||||||||||||||
| Comprehensive loss: | ||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - |
(
|
) |
(
|
) | |||||||||||||||||||||||||||||||||
| Other comprehensive income | - | - | - |
(
|
) |
(
|
) | |||||||||||||||||||||||||||||||||
| Balance at June 30, 2022 |
|
$ |
|
|
$ |
|
|
$ |
|
$ |
|
$ |
(
|
) | $ |
(
|
) | $ |
(
|
) | ||||||||||||||||||||
FOR THE SIX MONTHS ENDED JUNE 30, 2021
| Preferred Stock | Preferred Stock | Preferred Stock | Additional |
Accumulated Other |
||||||||||||||||||||||||||||||||||||||||||||
| Series B | Series D | Series D-1 | Common Stock | Paid-In | Comprehensive | Accumulated | ||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Capital | Loss | Deficit | Total | |||||||||||||||||||||||||||||||||||||
| Balance at January 1, 2021 |
|
|
$ |
|
$ |
|
$ |
(
|
) | $ |
(
|
) | $ |
(
|
) | |||||||||||||||||||||||||||||||||
| Common stock issued upon exercise of warrants | - | - | - |
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation: | ||||||||||||||||||||||||||||||||||||||||||||||||
| Common stock | - | - | - |
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||
| Comprehensive loss: | ||||||||||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - |
(
|
) |
(
|
) | ||||||||||||||||||||||||||||||||||||||||
| Other comprehensive loss | - | - | - | - |
|
|
||||||||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2021 |
|
|
$ |
|
$ |
|
$ |
(
|
) | $ |
(
|
) | $ |
(
|
) | |||||||||||||||||||||||||||||||||
| Common stock issued upon exercise of warrants | - | - | - |
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||
| Stock-based compensation: | ||||||||||||||||||||||||||||||||||||||||||||||||
| Common stock | - | - | - |
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||
| Warrants | - | - | - | - |
|
|
||||||||||||||||||||||||||||||||||||||||||
| Conversion of PRH Notes to Series D Preferred Stock | - |
|
|
- | - |
|
|
|||||||||||||||||||||||||||||||||||||||||
| Conversion of PRH Notes to Series D-1 Preferred Stock | - | - |
|
|
- |
|
|
|||||||||||||||||||||||||||||||||||||||||
| Comprehensive loss: | ||||||||||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - |
(
|
) |
(
|
) | ||||||||||||||||||||||||||||||||||||||||
| Other comprehensive income | - | - | - | - |
(
|
) |
(
|
) | ||||||||||||||||||||||||||||||||||||||||
| Balance at June 30, 2021 |
|
$ |
|
$ |
|
|
$ |
|
|
$ |
|
$ |
|
$ |
(
|
) | $ |
(
|
) | $ |
(
|
) | ||||||||||||||||||||||||||
See accompanying notes to condensed consolidated financial statements.
| 5 |
PROVECTUS BIOPHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
| For the Six Months Ended | ||||||||
| June 30, | ||||||||
| 2022 | 2021 | |||||||
| Cash Flows From Operating Activities: | ||||||||
| Net loss | $ |
(
|
) | $ |
(
|
) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation |
|
|||||||
| Non-cash lease expense |
|
|
||||||
| Depreciation |
|
|
||||||
| Gain on forgiveness of PPP Loan and interest |
(
|
) | ||||||
| Changes in operating assets and liabilities | ||||||||
| Short term receivables |
|
(
|
) | |||||
| Prepaid expenses and other current assets |
|
|
||||||
| Accounts payable - trade |
|
|
||||||
| Unearned grant revenue |
(
|
) | ||||||
| Other accrued expenses |
|
|
||||||
| Operating lease liability |
(
|
) |
(
|
) | ||||
| Accrued interest expense |
|
|
||||||
| Net Cash Used In Operating Activities |
(
|
) |
(
|
) | ||||
| Cash Flows From Financing Activities: | ||||||||
| Proceeds from issuance of convertible notes payable |
|
|
||||||
| Repayment of short-term note payable |
(
|
) |
(
|
) | ||||
| Note Payable |
(
|
|||||||
| Proceeds from exercise of warrants |
|
|||||||
| Net Cash Provided By Financing Activities |
|
|
||||||
| Effect of exchange rates on cash, cash equivalents, and restricted cash |
(
|
) |
|
|||||
| Net Decrease In Cash, Cash Equivalents, and Restricted Cash |
(
|
) |
(
|
) | ||||
| Cash, Cash Equivalents, and Restricted Cash, Beginning of Period |
|
|
||||||
| Cash, Cash Equivalents, and Restricted Cash, End of Period | $ |
|
$ |
|
||||
| Cash, cash equivalents and restricted cash consisted of the following: | ||||||||
| Cash and cash equivalents | $ |
|
$ |
|
||||
| Restricted cash |
|
|||||||
| $ | 2,032,609 | $ | 47,407 | |||||
| Supplemental Disclosures of Cash Flow Information: | ||||||||
| Cash paid during the period for: | ||||||||
| Interest | $ | $ | ||||||
| Income taxes | $ | $ | ||||||
| Non-cash investing and financing activities: | ||||||||
| Purchase of insurance policies financed by short-term note payable | $ |
(
|
) | $ |
(
|
) | ||
| Deposit applied for purchase of Series D-1 Preferred Stock | $ |
(
|
) | $ | ||||
| Conversion of non-amended 2017 Notes to Series D Preferred Stock | $ | $ |
|
|||||
| Conversion of amended 2017 Notes and 2020 Notes to Series D-1 Preferred Stock | $ | $ |
|
|||||
|
Right-of-use assets obtained in exchange for operating lease liabilities |
$ |
|
$ |
|
||||
See accompanying notes to condensed consolidated financial statements.
| 6 |
PROVECTUS BIOPHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Business Organization, Nature of Operations and Basis of Presentation
Provectus Biopharmaceuticals, Inc., a Delaware corporation (together with its subsidiaries, “Provectus” or “the Company”), is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases based on a class of small molecules called halogenated xanthenes (“HXs”), a class entirely owned by the Company.
Our lead HX molecule is named rose bengal sodium (“RBS”). The Company has established a multi-step approach using quality-by-design principles for synthesizing and manufacturing pharmaceutical-grade RBS by current good manufacturing practice (“cGMP”) and under the guidelines of The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. A second HX molecule has been synthesized, 4,5,6,7-tetrabromo-3′,6′-dihydroxy-2′,4′,5′,7′-tetraiodo-3H-spiro[isobenz- ofuran-1,9′-xanthen]-3-one.
| ● |
Oncology: PV-10 ® , an investigational cancer immunotherapy administered by intralesional (“IL”) injection and an injectable formulation of cGMP RBS, is undergoing clinical study for adult solid tumor cancers.
Oral formulations of cGMP RBS are also undergoing preclinical study as prophylactic and therapeutic treatments for high-risk and refractory adult solid tumor cancers. |
|
| ● | Pediatric Oncology: IL PV-10 is undergoing preclinical study for pediatric solid tumor cancers. | |
| ● | Hematology: Oral formulations of cGMP RBS are undergoing preclinical study for refractory and relapsed pediatric blood cancers (including leukemias). | |
| ● | Virology: Systemic administration of formulations of cGMP RBS are undergoing preclinical study for the novel strain of coronavirus (“CoV”): severe acute respiratory syndrome (“SARS”) CoV 2 (“SARS-CoV-2”). | |
| ● | Microbiology: Different formulations of cGMP RBS are undergoing preclinical study as potential treatments for multi-drug resistant (“MDR”) bacteria. | |
| ● | Ophthalmology: Topical formulations of cGMP RBS are undergoing preclinical study as potential treatments for diseases and disorders of the eye. | |
| ● | Dermatology: PH-10 ® , an investigational immune-dermatology agent administered as a topical formulation of cGMP RBS, is undergoing monotherapy clinical study as well as preclinical study as a monotherapy and in combination therapy with approved drugs for inflammatory dermatoses. | |
| ● | Animal Health: Different formulations of cGMP RBS are undergoing development as potential treatments for animal cancers and dermatological disorders. |
To date, the Company has not generated any revenues or profits from planned principal operations. The Company’s activities are subject to significant risks and uncertainties, including failing to successfully develop and license or commercialize the Company’s prescription drug candidates.
| 7 |
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information pursuant to Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements and should be reviewed in conjunction with the Company’s audited consolidated financial statements included in the Company’s Form 10-K for the year ended December 31, 2021 filed with the SEC on March 29, 2022. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three and six months ended June 30, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022.
SARS-CoV-2 was first identified in late-2019 and subsequently declared a global pandemic by the World Health Organization on March 11, 2020. As a result of the SARS-CoV-2 pandemic, many companies have experienced disruptions of their operations and the markets they serve. The Company has taken several temporary precautionary measures intended to help ensure the well-being of its employees and contractors and to minimize business disruption. The Company considered the impact of SARS-CoV-2 pandemic on its business and operational assumptions and estimates, and determined there were no material adverse impacts on the Company’s results of operations and financial position at June 30, 2022.
The full extent of the SARS-CoV-2 pandemic impacts on the Company’s operations and financial condition is uncertain. The Company has experienced slower than normal enrollment and treatment of patients, and a prolonged SARS-CoV-2 pandemic could have a material adverse impact on the Company’s business and financial results, including the timing and ability of the Company to raise capital, initiate and/or complete current and/or future preclinical studies and/or clinical trials, disrupt the Company’s regulatory activities, and/or have other adverse effects on the Company’s clinical development.
2. Liquidity and Going Concern
The
Company’s cash, cash equivalents, and restricted cash were $
The Company plans to access capital resources through possible public or private equity offerings, including the 2021 financing (see Note 5), exchange offers, debt financings, corporate collaborations, or other means. In addition, the Company continues to explore opportunities to strategically monetize its lead drug candidates, PV-10 and PH-10, through potential co-development and licensing transactions, although there can be no assurance that the Company will be successful with such plans. The Company has historically been able to raise capital through equity offerings, although no assurance can be provided that it will continue to be successful in the future. If the Company is unable to raise sufficient capital, it will not be able to pay its obligations as they become due.
| 8 |
The primary business objective of management is to build the Company into a commercial-stage biotechnology company; however, the Company cannot assure that it will be successful in co-developing, licensing, and/or commercializing PV-10, PH-10, and/or any other halogenated xanthene-based drug candidate developed by the Company or entering into any financial transaction. Moreover, even if the Company is successful in improving its current cash flow position, the Company nonetheless plans to seek additional funds to meet its long-term requirements in 2022 and beyond. The Company anticipates that these funds will otherwise come from the proceeds of private placement transactions, the exercise of existing warrants and outstanding stock options, or public offerings of debt or equity securities. While the Company believes that it has a reasonable basis for its expectation that it will be able to raise additional funds, the Company cannot provide assurance that it will be able to complete additional financing in a timely manner. In addition, any such financing may result in significant dilution to stockholders.
3. Significant Accounting Policies
Since the date the Company’s December 31, 2021 consolidated financial statements were issued in its 2021 Annual Report, there have been no material changes to the Company’s significant accounting policies, except as disclosed below.
Recently Adopted Accounting Standards
In October 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2020-10 “Codification Improvements” , which improves consistency by amending the Codification to include all disclosure guidance in the appropriate disclosure sections and clarifies application of various provisions in the Codification by amending and adding new headings, cross referencing to other guidance, and refining or correcting terminology. The guidance is effective for the Company beginning in the first quarter of fiscal year 2022 with early adoption permitted. The Company adopted this standard on January 1, 2022 and it did not have a material effect on its condensed consolidated financial statements.
On May 3, 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. This new standard provides clarification and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (such as warrants) that remain equity classified after modification or exchange. This standard is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Issuers should apply the new standard prospectively to modifications or exchanges occurring after the effective date of the new standard. Early adoption is permitted, including adoption in an interim period. If an issuer elects to early adopt the new standard in an interim period, the guidance should be applied as of the beginning of the fiscal year that includes that interim period. The Company adopted this standard on January 1, 2022 and it did not have a material effect on its condensed consolidated financial statements.
Cash and Cash Equivalents
The
Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. As of
June 30, 2022 and December 31, 2021, the Company’s cash equivalents consist of Treasury bills of $
Restricted Cash
Restricted
cash consists of a grant award of $
Cash Concentrations
Cash,
cash equivalents, and restricted cash are maintained at financial institutions and, at times, balances may exceed federally insured limits
of $
Reclassifications
Certain prior year balances have been reclassified in order to conform to current year presentation. These reclassifications had no effect on previously reported results of operations or loss per share.
Basic loss per common share is computed by dividing net loss by the weighted average number of vested common shares outstanding during the period. Diluted earnings per share reflects the potential dilution that could occur if securities or other instruments to issue common stock were exercised or converted into common stock. The following securities are excluded from the calculation of weighted average dilutive common shares because their inclusion would have been anti-dilutive:
| June 30, | June 30, | |||||||
| 2022 | 2021 | |||||||
| Warrants |
|
|
||||||
| Options |
|
|
||||||
| Convertible preferred stock |
|
|
||||||
| 2021 unsecured convertible notes |
|
|||||||
| Total potentially dilutive shares |
|
|
||||||
| 9 |
4. Other Accrued Expenses
The following table summarizes the other accrued expenses at June 30, 2022 and December 31, 2021:
|
June 30, 2022 |
December 31, 2021 |
|||||||
| Accrued payroll and taxes | $ |
|
$ |
|
||||
| Accrued vacation |
|
|
||||||
| Accrued directors’ fees |
|
|
||||||
| Accrued other expenses |
|
|
||||||
| Total Other Accrued Expenses | $ |
|
$ |
|
||||
5. Convertible Notes Payable
2021 Financing
| Non-Related Party | Related Party | |||||||||||
| Face Amount | Face Amount | Total | ||||||||||
| Balance as of January 1, 2022 | $ |
|
$ |
|
$ |
|
||||||
| Issued |
|
|
||||||||||
| Balance as of March 31, 2022 | $ |
|
$ |
|
$ |
|
||||||
| Issued |
|
|
||||||||||
| Balance as of June 30, 2022 | $ |
|
$ |
|
$ |
|
||||||
For further details on the terms of the 2021 Notes, refer to our Form 10-K as filed with the SEC on March 29, 2022.
As
of June 30, 2022, the Company had received 2021 Notes proceeds of $
Subsequent
to June 30, 2022, the Company received 2021 Notes proceeds of $
6. Notes Payable
The
Company obtained short-term financing from AFCO Insurance Premium Finance for our commercial insurance policies. As of June 30, 2022
and December 31, 2021, the balance of the note payable was $
7. Related Party Transactions
During
the three months ended June 30, 2022 and 2021, the Company paid Mr. Bruce Horowitz (Capital Strategists) consulting fees of $
During
the six months ended June 30, 2022 and 2021, the Company paid Mr. Bruce Horowitz (Capital Strategists) consulting fees of $
Accrued
director fees for Mr. Horowitz as of June 30, 2022 and December 31, 2021 were $
See Note 5 for details of other related party transactions.
Director
fees during the three months ended June 30, 2022 and 2021 were $
8. Stockholders’ Deficiency
Preferred Stock
During
the six months ended June 30, 2022, the Company issued
shares of restricted Series D-1 Convertible Preferred Stock in exchange
for an investment of $
Annual Stockholder Meeting Proposals
The
Company held its annual meeting of stockholders on June 22, 2022. As proposal number 4, stockholders authorized the Company’s
board of directors (the “Board”) to amend the Company’s Certificate of Incorporation, as amended by the
Certificate of Designation of Series D Convertible Preferred Stock and Certificate of Designation of Series D-1 Convertible
Preferred Stock (the “Certificates of Designation”),
| 10 |
9. Leases
The
Company leased
On
June 30, 2022, the lease expired and was not renewed. On June 18, 2022, the Company moved into
Total
operating lease expense for the three months ended June 30, 2022 was $
Total
operating lease expense for the six months ended June 30, 2022 was $
A summary of the Company’s right-of-use assets and liabilities is as follows:
| For The Six Months Ended | ||||||||
| June 30, | ||||||||
| 2022 | 2021 | |||||||
| Cash paid for amounts included in the measurement of lease liabilities: | ||||||||
| Operating cash flows used in operating leases | $ |
|
$ |
|
||||
| Right-of-use assets obtained in exchange for lease obligations: | ||||||||
| Operating leases | $ |
|
$ | |||||
| Weighted Average Remaining Lease Term | ||||||||
| Operating leases |
|
|
||||||
| Weighted Average Discount Rate | ||||||||
| Operating leases |
|
% |
|
% | ||||
Future minimum payments under the Company’s non-cancellable lease obligations as of June 30, 2022 were as follows:
| Years | Amount | |||
| 2022 | $ |
|
||
| 2023 |
|
|||
| 2024 |
|
|||
| 2025 |
|
|||
| Total future minimum lease payments |
|
|||
| Less: amount representing imputed interest |
|
|||
| Total | $ |
|
||
10. Grants
On
October 25, 2021, the Company received a grant award of $
11. Commitments, Contingencies and Litigation
The Company may, from time to time, be involved in litigation arising from the ordinary course of business and/or that may be expected to be covered by insurance. The Company is not aware of any pending or threatened litigation that, if resolved against the Company, would have a material adverse effect on the Company’s consolidated financial position, results of operations or cash flows.
12. Subsequent Events
The Company has evaluated events that have occurred after the balance sheet and through the date the financial statements were issued. Based upon the evaluation, the Company did not identify any recognized or non-recognized subsequent events that would have required adjustment or disclosure in the financial statements, except as disclosed below.
Convertible Notes Payable
Subsequent
to June 30, 2022, the Company received 2021 Notes proceeds of $
Common Stock
Subsequent
to June 30, 2022, the Company issued an aggregate of
shares of immediately vested restricted common stock to a consultant with
a grant date value of $
Subsequent
to June 30, 2022, the Company issued an aggregate of
shares of immediately vested restricted common stock to an employee with
a grant date value of $
| 11 |
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
The following discussion is intended to assist in the understanding and assessment of significant changes and trends related to our results of operations and our financial condition together with our consolidated subsidiaries. This discussion and analysis should be read in conjunction with the accompanying unaudited condensed financial statements and our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 29, 2022 (“2021 Form 10-K”), which includes additional information about our critical accounting policies and practices and risk factors. Historical results and percentage relationships set forth in the consolidated statement of operations, including trends which might appear, are not necessarily indicative of future operations.
Components of Operating Results
Grant Revenue
Grant income is recognized when qualifying costs are incurred and there is reasonable assurance that conditions of the grant have been met. Cash received from grants in advance of incurring qualifying costs is recorded as unearned grant revenue and recognized as other income when qualifying costs are incurred.
Research and Development Expenses
A large component of our total operating expenses is the Company’s investment in research and development activities, including the clinical development of our product candidates. Research and development expenses represent costs incurred to conduct research and undertake clinical trials to develop our drug product candidates. These expenses consist primarily of:
| ● | Costs of conducting clinical trials, including amounts paid to clinical centers, clinical research organizations and consultants, among others; | |
| ● | Salaries and related expenses for personnel, including stock-based compensation expense; | |
| ● | Other outside service costs including cost of contract manufacturing; | |
| ● | The costs of supplies and reagents; and, | |
| ● | Occupancy and depreciation charges. |
We expense research and development costs as incurred.
Research and development activities are central to our business model. We expect our research and development expenses to increase in the future as we advance our existing product candidates through clinical trials and pursue their regulatory approval. Undertaking clinical development and pursuing regulatory approval are both costly and time-consuming activities. As a result of known and unknown uncertainties, we are unable to determine the duration and completion costs of our research and development activities, or if, when, and to what extent we will generate revenue from any subsequent commercialization and sale of our drug product candidates.
General and Administrative Expenses
General and administrative expense consists primarily of salaries, stock-based compensation expense and other related costs for personnel in executive, finance, accounting, business development, legal, information technology and corporate communication functions. Other costs include facility costs not otherwise included in research and development expense, insurance, and professional fees for legal, patent and accounting services.
| 12 |
Results of Operations
Comparison of the Three Months Ended June 30, 2022 and June 30, 2021
Overview
Total operating expenses were $1,399,690 for the three months ended June 30, 2022, an increase of $177,673 or 14.5% compared to the three months ended June 30, 2021. The increase was driven primarily by (i) increased clinical trial cost, (ii) higher insurance costs and (iii) higher professional fees, partially offset by (iv) lower legal and litigation fees. Net loss for the three months ended June 30, 2022 was $1,077,841, a decrease of $501,750 or 31.8% which was primarily attributable to lower interest expense costs incurred in connection with the 2017 and 2020 Notes which converted to preferred stock on June 20, 2021 and the recognition of grant revenue in the amount of $321,710.
| For the Three Months Ended | ||||||||||||||||
| June 30, | ||||||||||||||||
| 2022 | 2021 | Increase/(Decrease) | % Change | |||||||||||||
| Grant Revenue | $ | 321,710 | $ | - | $ | 321,710 | 0.0 | % | ||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | 816,648 | 602,979 | 213,669 | 35.4 | % | |||||||||||
| General and administrative | 583,042 | 619,038 | (35,996 | ) | -5.8 | % | ||||||||||
| Total Operating Expenses | 1,399,690 | 1,222,017 | 177,673 | 14.5 | % | |||||||||||
| Total Operating Loss | (1,077,980 | ) | (1,222,017 | ) | 144,037 | -11.8 | % | |||||||||
| Other Income/(Expense): | ||||||||||||||||
| Research and development tax credit | 38,259 | 32,144 | 6,115 | 19.0 | % | |||||||||||
| Gain from extinguishment | - | 63,094 | (63,094 | ) | -100.0 | % | ||||||||||
| Interest income and interest expense | (38,120 | ) | (452,812 | ) | 414,692 | -91.6 | % | |||||||||
| Total Other Income/ (Expense), Net | 139 | (357,574 | ) | 357,713 | -100.0 | % | ||||||||||
| Net Loss | $ | (1,077,841 | ) | $ | (1,579,591 | ) | $ | 501,750 | -31.8 | % | ||||||
Grant Revenue
For the three months ended June 30, 2022 and 2021, there was $321,710 and $0, respectively, of grant revenue recognized related to qualifying expenses that were incurred and included within research and development on the condensed consolidated statements of operations.
Research and Development Expenses
Research and development expenses were $816,648 for the three months ended June 30, 2022, an increase of $213,669 or 35.4% compared to $602,979 for the three months ended June 30, 2021. The increase was primarily due to (i) increased cost on clinical trials due to increased recruitment and treatment in clinical trials, and (ii) higher insurance cost.
| For the Three Months Ended | ||||||||||||||||
| June 30, | ||||||||||||||||
| 2022 | 2021 | Increase/(Decrease) | % Change | |||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development: | ||||||||||||||||
| Clinical trial and research expenses | $ | 674,294 | $ | 465,627 | $ | 208,667 | 44.8 | % | ||||||||
| Depreciation/amortization | 1,765 | 2,162 | (397 | ) | -18.4 | % | ||||||||||
| Insurance | 57,367 | 51,393 | 5,974 | 11.6 | % | |||||||||||
| Payroll and taxes | 67,360 | 67,706 | (346 | ) | -0.5 | % | ||||||||||
| Rent and utilities | 15,862 | 16,091 | (229 | ) | -1.4 | % | ||||||||||
| Total research and development | $ | 816,648 | $ | 602,979 | $ | 213,669 | 35.4 | % | ||||||||
| 13 |
General and Administrative Expenses
General and administrative expenses were $583,042 for the three months ended June 30, 2022, a decrease of $35,996 or 5.8% compared to $619,038 for the three months ended June 30, 2021. The decrease was primarily due to (i) lower legal fees relating to patents, partially offset by (ii) higher professional fees, and (iii) increased other general and administration expenses.
| For the Three Months Ended | ||||||||||||||||
| June 30, | ||||||||||||||||
| 2022 | 2021 | Increase/(Decrease) | % Change | |||||||||||||
| Operating Expenses: | ||||||||||||||||
| General and administrative: | ||||||||||||||||
| Depreciation | $ | 1,055 | $ | 1,055 | $ | - | 0.0 | % | ||||||||
| Directors fees | 96,250 | 96,250 | - | 0.0 | % | |||||||||||
| Insurance | 44,672 | 42,262 | 2,410 | 5.7 | % | |||||||||||
| Legal and litigation | 126,087 | 216,723 | (90,636 | ) | -41.8 | % | ||||||||||
| Other general and administrative cost | 34,476 | 15,583 | 18,893 | 121.2 | % | |||||||||||
| Payroll and taxes | 63,575 | 62,540 | 1,035 | 1.7 | % | |||||||||||
| Professional fees | 208,678 | 172,759 | 35,919 | 20.8 | % | |||||||||||
| Rent and utilities | 8,267 | 8,219 | 48 | 0.6 | % | |||||||||||
| Foreign currency translation | (18 | ) | 3,647 | (3,665 | ) | -100.5 | % | |||||||||
| Total general and administrative | $ | 583,042 | $ | 619,038 | $ | (35,996 | ) | -5.8 | % | |||||||
Other Income/(Expense)
Other income/(expense) decreased by $357,713 from ($357,574) for the three months ended June 30, 2021 to $139 for the three months ended June 30, 2022. The decrease was due to the lower interest expense costs incurred in connection with the 2017 and 2020 Notes which converted to preferred stock on June 20, 2021, offset by the gain from extinguishment of debt in 2021 relating to the PPP loan forgiveness.
| For the Three Months Ended | ||||||||||||||||
| June 30, | ||||||||||||||||
| 2022 | 2021 | Increase/(Decrease) | % Change | |||||||||||||
| Other Income/(Expense): | ||||||||||||||||
| Research and development tax credit | $ | 38,259 | $ | 32,144 | $ | 6,115 | 19.0 | % | ||||||||
| Gain from extinguishment | - | 63,094 | (63,094 | ) | -100.0 | % | ||||||||||
| Interest income and interest expense | (38,120 | ) | (452,812 | ) | 414,692 | -91.6 | % | |||||||||
| Total Other Income/(Expenses), Net | $ | 139 | $ | (357,574 | ) | $ | 357,713 | -100.0 | % | |||||||
| 14 |
Comparison of the Six Months Ended June 30, 2022 and June 30, 2021
Overview
Total operating expenses were $2,587,353 for the six months ended June 30, 2022, an increase of $184,660 or 7.7% compared to the six months ended June 30, 2021. The increase was driven primarily by (i) increased clinical trial cost, (ii) higher insurance costs and (iii) higher professional fees, partially offset by (iv) lower legal and litigation fees, and (v) lower rent and utility expense. Net loss for the six months ended June 30, 2022 was $2,108,763, a decrease of $1,140,778 or 35.1% which was primarily attributable to lower interest expense costs incurred in connection with the 2017 and 2020 Notes which converted to preferred stock on June 20, 2021 and the recognition of grant revenue in the amount of $509,315.
| For the Six Months Ended | ||||||||||||||||
| June 30, | ||||||||||||||||
| 2022 | 2021 | Increase/(Decrease) | % Change | |||||||||||||
| Grant Revenue | $ | 509,315 | $ | - | $ | 509,315 | 0.0 | % | ||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | 1,487,764 | 1,258,123 | 229,641 | 18.3 | % | |||||||||||
| General and administrative | 1,099,589 | 1,144,570 | (44,981 | ) | -3.9 | % | ||||||||||
| Total Operating Expenses | 2,587,353 | 2,402,693 | 184,660 | 7.7 | % | |||||||||||
| Total Operating Loss | (2,078,038 | ) | (2,402,693 | ) | 324,655 | -13.5 | % | |||||||||
| Other Income/(Expense): | ||||||||||||||||
| Research and development tax credit | 38,259 | 32,144 | 6,115 | 19.0 | % | |||||||||||
| Gain from extinguishment | - | 63,094 | (63,094 | ) |
-100.0 |
% | ||||||||||
| Interest income and interest expense | (68,984 | ) | (942,086 | ) | 873,102 | -92.7 | % | |||||||||
| Total Other Expense, Net | (30,725 | ) | (846,848 | ) | 816,123 | -96.4 | % | |||||||||
| Net Loss | $ | (2,108,763 | ) | $ | (3,249,541 | ) | $ | 1,140,778 | -35.1 | % | ||||||
Grant Revenue
For the six months ended June 30, 2022 and 2021, there was $509,315 and $0, respectively, of grant revenue recognized related to qualifying expenses that were incurred and included within research and development on the condensed consolidated statements of operations.
Research and Development Expenses
Research and development expenses were $1,487,764 for the six months ended June 30, 2022, an increase of $229,641 or 18.3% compared to $1,258,123 for the six months ended June 30, 2021. The increase was primarily due to (i) increased cost on clinical trials due to increased recruitment and treatment in clinical trials, and (ii) higher insurance cost, partially offset by (iii) lower payroll and payroll taxes, and (iv) a decrease in rent and utility expenses.
| For the Six Months Ended | ||||||||||||||||
| June 30, | ||||||||||||||||
| 2022 | 2021 | Increase/(Decrease) | % Change | |||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development: | ||||||||||||||||
| Clinical trial and research expenses | $ | 1,205,985 | $ | 977,207 | $ | 228,778 | 23.4 | % | ||||||||
| Depreciation/amortization | 3,929 | 4,324 | (395 | ) | -9.1 | % | ||||||||||
| Insurance | 115,890 | 102,781 | 13,109 | 12.8 | % | |||||||||||
| Payroll and taxes | 134,475 | 140,040 | (5,565 | ) | -4.0 | % | ||||||||||
| Rent and utilities | 27,485 | 33,771 | (6,286 | ) | -18.6 | % | ||||||||||
| Total research and development | $ | 1,487,764 | $ | 1,258,123 | $ | 229,641 | 18.3 | % | ||||||||
| 15 |
General and Administrative Expenses
General and administrative expenses were $1,099,589 for the six months ended June 30, 2022, a decrease of $44,981 or 3.9% compared to $1,144,570 for the six months ended June 30, 2021. The decrease was primarily due to (i) lower legal fees relating to patents, partially offset by (ii) higher professional fees, (iii) increased payroll and taxes, and (iv) increased other general and administration expenses.
| For the Six Months Ended | ||||||||||||||||
| June 30, | ||||||||||||||||
| 2022 | 2021 | Increase/(Decrease) | % Change | |||||||||||||
| Operating Expenses: | ||||||||||||||||
| General and administrative: | ||||||||||||||||
| Depreciation | $ | 2,109 | $ | 2,109 | $ | - | 0.0 | % | ||||||||
| Directors fees | 192,500 | 192,500 | - | 0.0 | % | |||||||||||
| Insurance | 92,890 | 85,828 | 7,062 | 8.2 | % | |||||||||||
| Legal and litigation | 238,621 | 348,738 | (110,117 | ) | -31.6 | % | ||||||||||
| Other general and administrative cost | 57,335 | 46,588 | 10,747 | 23.1 | % | |||||||||||
| Payroll and taxes | 127,874 | 108,600 | 19,274 | 17.7 | % | |||||||||||
| Professional fees | 375,033 | 338,475 | 36,558 | 10.8 | % | |||||||||||
| Rent and utilities | 13,866 | 16,945 | (3,079 | ) | -18.2 | % | ||||||||||
| Foreign currency translation | (639 | ) | 4,787 | (5,426 | ) | -113.3 | % | |||||||||
| Total general and administrative | $ | 1,099,589 | $ | 1,144,570 | $ | (44,981 | ) | -3.9 | % | |||||||
Other Income/(Expense)
Other income/(expense) decreased by $816,123 from ($846,848) for the six months ended June 30, 2021 to ($30,725) for the six months ended June 30, 2022. The decrease was due to the lower interest expense costs incurred in connection with the 2017 and 2020 Notes which converted to preferred stock on June 20, 2021, offset by the gain from extinguishment of debt in 2021 relating to the PPP loan forgiveness.
| For the Six Months Ended | ||||||||||||||||
| June 30, | ||||||||||||||||
| 2022 | 2021 | Increase/(Decrease) | % Change | |||||||||||||
| Other Income/(Expense): | ||||||||||||||||
| Research and development tax credit | $ | 38,259 | $ | 32,144 | $ | 6,115 | 19.0 | % | ||||||||
| Gain from extinguishment | - | 63,094 | (63,094 | ) | -100.0 | % | ||||||||||
| Interest income and interest expense | (68,984 | ) | (942,087 | ) | 873,103 | -92.7 | % | |||||||||
| Total Other Expenses, Net | $ | (30,725 | ) | $ | (846,848 | ) | $ | 816,123 | -96.4 | % | ||||||
Liquidity and Capital Resources
The Company’s cash, cash equivalents, and restricted cash were $2,032,609 at June 30, 2022 which includes the $1,948,335 of restricted cash resulting from a grant received from the State of Tennessee, compared to $3,106,942 at December 31, 2021, which included $2,423,958 of restricted cash. The Company’s working capital deficiency was $6,215,548 and $4,258,679 as of June 30, 2022 and December 31, 2021, respectively. The condensed consolidated financial statements and notes thereto included in this Quarterly Report on Form 10-Q have been prepared on a basis that contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. We have continuing net losses and negative cash flows from operating activities. In addition, we have an accumulated deficit of $248,142,721 as of June 30, 2022. These conditions raise substantial doubt about our ability to continue as a going concern for a period within one year from the date that the financial statements included elsewhere in this Quarterly Report on Form 10-Q are issued. Our financial statements do not include any adjustments to the amounts and classification of assets and liabilities that may be necessary should we be unable to continue as a going concern. Our ability to continue as a going concern depends on our ability to obtain additional financing as may be required to fund current operations.
As of June 30, 2022, cash required for our current liabilities included approximately $4,350,917 for accounts payable and accrued expenses (including lease liability) and a $142,693 note payable related to our short-term financing of our commercial insurance policies. Also, if not converted prior to maturity, convertible debt in the amount of $2,010,000 plus accrued interest will mature one year from the date of the notes. Cash requirements for long-term liabilities were $96,201 at June 30, 2022. The Company intends to meet these cash requirements from its current cash balance and from future financing.
Management’s plans include selling our equity securities and obtaining other financing, including the 2021 financing, to fund our capital requirements and on-going operations; however, there can be no assurance we will be successful in these efforts. The condensed consolidated financial statements do not include any adjustment that might be necessary if we are unable to continue as a going concern. Significant funds will be needed to continue and complete our ongoing and planned clinical trials.
| 16 |
The SARS-CoV-2 pandemic has already caused significant disruptions in the financial markets, and may continue to cause such disruptions, which could impact our ability to raise additional funds and may also impact the volatility of our stock price and trading in our stock. Moreover, the pandemic has also significantly impacted economies worldwide, which could result in adverse effects on our business and operations. We cannot be certain what the overall impact of the SARS-CoV-2 pandemic will be on our business. It has the potential to adversely affect our business, financial condition, results of operations, and prospects. The Company has experienced slower than normal enrollment and treatment of patients, and a prolonged SARS-CoV-2 pandemic could have a material adverse impact on the Company’s business and financial results, including the timing and ability of the Company to raise capital, initiate and/or complete current and/or future preclinical studies and/or clinical trials; disrupt the Company’s regulatory activities; and/or have other adverse effects on the Company’s clinical development. We have taken several temporary precautionary measures intended to help ensure the well-being of our employees and contractors and to minimize disruption to our business. We considered the impact of the SARS-CoV-2 pandemic on our business and operational assumptions and estimates, and determined there were no material adverse impacts on our results of operations and financial position at June 30, 2022.
Access to Capital
Management plans to access capital resources through possible public or private equity offerings, including the 2021 financing, equity financings, debt financings, corporate collaborations, or other means. If we are unable to raise sufficient capital, we will not be able to pay our obligations as they become due.
The primary business objective of management is to build the Company into a commercial-stage biotechnology company; however, we cannot assure you that management will be successful in implementing the Company’s business plan of developing, licensing, and/or commercializing our prescription drug product candidates. Moreover, even if we are successful in improving our current cash flow position, we nonetheless plan to seek additional funds to meet our current and long-term requirements in 2022 and beyond. We anticipate that these funds will otherwise come from the proceeds of private placement transactions, the exercise of existing warrants and outstanding stock options, or public offerings of debt or equity securities. While we believe that we have a reasonable basis for our expectation that we will be able to raise additional funds, we cannot assure you that we will be able to complete additional financing in a timely manner. In addition, any such financing may result in significant dilution to stockholders.
Critical Accounting Estimates
The preparation of financial statements and related disclosures must be in conformity with U.S. GAAP. These accounting principles require us to make estimates and judgments that can affect the reported amounts of assets and liabilities as of the date of the financial statements as well as the reported amounts of revenue and expense during the periods presented. We believe that the estimates and judgments upon which it relies are reasonably based upon information available to us at the time that it makes these estimates and judgments. To the extent that there are material differences between these estimates and actual results, our financial results will be affected. The accounting policies that reflect our more significant estimates and judgments and which we believe are the most critical to aid in fully understanding and evaluating our reported financial results are described below.
The following is not intended to be a comprehensive list of all of our accounting policies or estimates. Our accounting policies are more fully described in Note 3 –Significant Accounting Policies in Part 1, Item 1 of this Quarterly Report on Form 10-Q.
Stock-Based Compensation
We measure the cost of services received in exchange for an award of equity instruments based on the fair value of the award on the date of grant. The fair value amount of the shares expected to ultimately vest is then recognized over the period for which services are required to be provided in exchange for the award, usually the vesting period. The estimation of stock-based awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from original estimates, such amounts are recorded as a cumulative adjustment in the period that the estimates are revised. We account for forfeitures as they occur.
Research and Development
Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits for research and development employees and consultants, facilities expenses, overhead expenses, cost of laboratory supplies, manufacturing expenses, fees paid to third parties and other outside expenses. We accrue for costs incurred as the services are being provided by monitoring the status of the clinical trial or project and the invoices received from our external service providers. We adjust our accrual as actual costs become known.
Recently Adopted Accounting Standards
Recently adopted accounting standards are included in Note 3 – Significant Accounting Policies in Part 1, Item 1 of this Quarterly Report on Form 10-Q.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements, financings, or other relationships with unconsolidated entities or other persons, also known as special purpose entities (“SPEs”).
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
Not applicable.
ITEM 4. CONTROLS AND PROCEDURES.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our principal executive officer and principal financial officer, carried out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Based on this evaluation, our principal executive officer and principal financial officer concluded that, as of the end of the period covered in this report, our disclosure controls and procedures were effective to provide reasonable assurance that the information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.
Inherent Limitations on Effectiveness of Controls
Even assuming the effectiveness of our controls and procedures, our management, including our principal executive officer and principal financial officer, does not expect that our disclosure controls or our internal control over financial reporting will prevent or detect all error or all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. In general, our controls and procedures are designed to provide reasonable assurance that our control system’s objective will be met, and our principal executive officer and principal financial officer has concluded that our disclosure controls and procedures are effective at the reasonable assurance level. The design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Further, because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Projections of any evaluation of the effectiveness of controls in future periods are subject to risks. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures.
Changes in Internal Control Over Financial Reporting
There has been no change in our internal control over financial reporting that occurred during the fiscal quarter covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II - OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS.
The information required by this item is incorporated by reference from Part I, Item 1. Financial Statements, Notes to Condensed Consolidated Financial Statements, Note 11.
ITEM 1A. RISK FACTORS.
There have been no material changes to the risk factors that were disclosed in the 2021 Form 10-K.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
2021 Financing
During the three months ended June 30, 2022, the Company had received aggregate proceeds of $500,000 pursuant to certain unsecured convertible notes (the “2021 Notes”). As of June 30, 2022, the Company had cumulatively drawn down $2,010,000 under the 2021 Notes.
For further details on the terms of the 2021 Notes, refer to our Form 10-K as filed with the SEC on March 29, 2022.
The Company believes that such transactions were exempt from the registration requirements of the Securities Act of 1933, as amended, (the “Securities Act”), in reliance on Section 4(a)(2) of the Securities Act (or Rule 506(b) of Regulation D promulgated thereunder) as transactions by an issuer not involving a public offering.
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ITEM 3. DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM 4. Mine Safety Disclosures.
Not applicable.
ITEM 5. OTHER INFORMATION.
None.
ITEM 6. EXHIBITS.
| Exhibit No. | Description | |
| 31.1** | Certification of Principal Executive Officer Pursuant to Rule 13a-14(a) (Section 302 Certification). | |
| 31.2** | Certification of Chief Financial Officer Pursuant to Rule 13a-14(a) (Section 302 Certification). | |
| 32*** | Certification of Principal Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. Section 1350 (Section 906 Certification). | |
| 101.INS | Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. | |
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document. | |
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document. | |
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document. | |
| 101 PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document. | |
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document. | |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
** Filed herewith.
*** Furnished herewith.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| PROVECTUS BIOPHARMACEUTICALS, INC. | ||
| August 11, 2022 | By: | /s/ Bruce Horowitz |
| Bruce Horowitz | ||
| Chief Operating Officer (Principal Executive Officer) | ||
| By: | /s/ Heather Raines | |
| Heather Raines, CPA | ||
| Chief Financial Officer (Principal Financial Officer) | ||
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