Provectus Biopharmaceuticals, Inc 10-Q for FY2024 Q3
Provectus Biopharmaceuticals, Inc. (PVCT)
About this 10-Q
Provectus Biopharmaceuticals, Inc filed this 10-Q on November 12, 2024, covering the quarter ended September 30, 2024 (FY2024 Q3).
Headline figures
Quarter ended September 30, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $109.75K
- up 57.4% from $69.73K a year earlier
- Net loss
- $1.01M
- compared with a net loss of $775.84K a year earlier
- Diluted EPS
- $0.00
- compared with $0.00 a year earlier
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
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
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(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) | |
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(Registrant’s telephone number, including area code)
(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 | ☐ |
| ☒ | Smaller reporting company | ||
| 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
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The number of shares outstanding of the registrant’s common stock, par value $ per share, as of November 11, 2024, 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, 2023), and:
| ● | The uncertainty of generating (i) sales from rose bengal sodium-based drug candidates (if and when approved), such as PV-10® and PH-10®, and/or any other halogenated xanthene-based drug candidates (if and when approved), (ii) licensing, milestone, royalty, and/or other payments related to these drug candidates, and/or (iii) payments from the Company’s liquidation, dissolution, or winding up, or any sale, lease, conveyance, or other disposition of any intellectual property relating to these drug candidates and/or rose bengal sodium- and other halogenated xanthene-based active pharmaceutical ingredients; | |
| ● | The uncertainty of raising additional capital through the proceeds of private placement transactions of debt and/or equity securities, the exercise of existing warrants and outstanding stock options, and/or public offerings of debt and/or equity securities; and | |
| ● | The disruptions from the widespread outbreak of an illness or communicable/infectious disease, such as severe acute respiratory syndrome coronavirus 2, or another public health crisis to our business that could adversely affect our operations and financial condition. |
| 1 |
PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS.
PROVECTUS BIOPHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash | $ | $ | ||||||
| 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’ Deficit | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Unearned grant revenue | ||||||||
| Other accrued expenses | ||||||||
| Accrued interest | ||||||||
| Accrued interest - related parties | ||||||||
| Accrued interest | ||||||||
| Notes payable | ||||||||
| Convertible notes payable | ||||||||
| Convertible notes payable - related parties | ||||||||
| Convertible notes payable | ||||||||
| Operating lease liability, current portion | ||||||||
| Total Current Liabilities | ||||||||
| Operating lease liability, non-current portion | ||||||||
| Total Liabilities | ||||||||
| Commitments, contingencies, and litigations (Note 12) | ||||||||
| Stockholders’ Deficit: | ||||||||
| Preferred stock; par value $ per share; shares authorized; | ||||||||
| Series D Convertible Preferred Stock; and shares designated
at September 30, 2024 and December 31, 2023, respectively; and shares issued and outstanding at September
30, 2024 and December 31, 2023, respectively; aggregate liquidation preference of $ | ||||||||
| Series D-1 Convertible
Preferred Stock; and shares designated at September 30, 2024 and December 31, 2023, respectively;
and shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively; aggregate liquidation
preference of $ | ||||||||
| Preferred stock, value | ||||||||
| Common stock; par value $ per share; shares authorized; and shares issued and outstanding at September 30, 2024 and December 31, 2023 | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated other comprehensive loss | ( | ) | ( | ) | ||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total Stockholders’ Deficit | ( | ) | ( | ) | ||||
| Total Liabilities and Stockholders’ Deficit | $ | $ | ||||||
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 Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Grant Revenue | $ | $ | $ | $ | ||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Total Operating Expenses | ||||||||||||||||
| Total Operating Loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other Income/(Expense): | ||||||||||||||||
| Research and development tax credit | ( | ) | ||||||||||||||
| Interest expense, net | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Total Other Expense, Net | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Net Loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Basic and Diluted Loss Per Common Share | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| Weighted Average Number of Common Shares Outstanding - Basic and Diluted | ||||||||||||||||
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 Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Net Loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Other Comprehensive Income/(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’ DEFICIT
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2024
(Unaudited)
| Accumulated | ||||||||||||||||||||||||||||||||||||||||
| Preferred Stock | Preferred Stock | Additional | 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, 2024 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||
| Conversion of 2021 Note to Series D-1 Preferred Stock | - | - | ||||||||||||||||||||||||||||||||||||||
| Comprehensive loss: | ||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||
| Other comprehensive loss | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||
| Balance at March 31, 2024 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||
| Forfeited shares of Series D Preferred Stock | ( | ) | ( | ) | - | |||||||||||||||||||||||||||||||||||
| Issuance of Series D-1 Preferred Stock for forfeited shares of Series D Preferred Stock | - | - | ( | ) | ||||||||||||||||||||||||||||||||||||
| Conversion of 2021 Note to Series D-1 Preferred Stock | - | - | ||||||||||||||||||||||||||||||||||||||
| Comprehensive Income (loss): | ||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||
| Other comprehensive income | - | - | - | |||||||||||||||||||||||||||||||||||||
| Balance at June 30, 2024 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||
| Conversion of 2022 Note to Series D-1 Preferred Stock | - | - | ||||||||||||||||||||||||||||||||||||||
| Conversion of accrued directors’ fees to Series D-1 Preferred Stock | - | - | ||||||||||||||||||||||||||||||||||||||
| Conversion of Series D-1 Preferred Stock to Common Stock | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||
| Comprehensive Income (loss): | ||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||
| Other comprehensive income | - | - | - | |||||||||||||||||||||||||||||||||||||
| Balance at September 30, 2024 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||
| 5 |
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2023
(Unaudited)
| Accumulated | ||||||||||||||||||||||||||||||||||||||||
| Preferred Stock | Preferred Stock | Additional | 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, 2023 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||
| Conversion of 2021 Note to Series D-1 Preferred Stock | - | - | ||||||||||||||||||||||||||||||||||||||
| Comprehensive loss: | ||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||
| Other comprehensive income | - | - | - | |||||||||||||||||||||||||||||||||||||
| Balance at March 31, 2023 | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||
| Conversion of 2021 Note to Series D-1 Preferred Stock | - | - | ||||||||||||||||||||||||||||||||||||||
| Comprehensive loss: | ||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||
| Other comprehensive loss | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||
| Balance at June 30, 2023 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| Balance | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| Common stock issued for services | - | - | ||||||||||||||||||||||||||||||||||||||
| Conversion of 2021 Note to Series D-1 Preferred Stock | - | - | ||||||||||||||||||||||||||||||||||||||
| Conversion of 2022 Note to Series D-1 Preferred Stock | - | - | ||||||||||||||||||||||||||||||||||||||
| Conversion of Note to Series D-1 Preferred Stock | - | |||||||||||||||||||||||||||||||||||||||
| Comprehensive loss: | ||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||
| Other comprehensive loss | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||
| Balance at September 30, 2023 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||
| Balance | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||
See accompanying notes to condensed consolidated financial statements.
| 6 |
PROVECTUS BIOPHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
| For the Nine Months Ended | ||||||||
| September 30, | ||||||||
| 2024 | 2023 | |||||||
| Cash Flows From Operating Activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation | ||||||||
| Non-cash operating lease expense | ||||||||
| Depreciation | ||||||||
| Changes in operating assets and liabilities | ||||||||
| Short term receivables | ( | ) | ||||||
| Prepaid expenses and other current assets | ||||||||
| Accounts payable | ( | ) | ( | ) | ||||
| Unearned grant revenue | ( | ) | ( | ) | ||||
| Other accrued expenses | ||||||||
| Operating lease liability | ( | ) | ( | ) | ||||
| Accrued interest | ||||||||
| Net Cash Used In Operating Activities | ( | ) | ( | ) | ||||
| Cash Flows From Financing Activities: | ||||||||
| Proceeds from issuance of convertible notes payable | ||||||||
| Proceeds from issuance of convertible notes payable - related parties | ||||||||
| Repayment of short-term note payable | ( | ) | ( | ) | ||||
| Repayment of 2021 convertible note payable - related party | ( | ) | ||||||
| Net Cash Provided By Financing Activities | ||||||||
| Effect of exchange rates on cash and restricted cash | ( | ) | ||||||
| Net Decrease In Cash and Restricted Cash | ( | ) | ( | ) | ||||
| Cash and Restricted Cash, Beginning of Period | ||||||||
| Cash and Restricted Cash, End of Period | $ | $ | ||||||
| Cash and restricted cash consisted of the following: | ||||||||
| Cash | $ | $ | ||||||
| Restricted cash | ||||||||
| $ | $ | |||||||
| Supplemental Disclosures of Cash Flow Information: | ||||||||
| Cash paid during the year for: | ||||||||
| Interest | $ | $ | ||||||
| Income taxes | $ | $ | ||||||
| Non-cash investing and financing activities: | ||||||||
| Conversion of 2021 Notes and related accrued interest to Series D-1 Preferred Stock | $ | $ | ||||||
| Conversion of 2022 Notes and related accrued interest to Series D-1 Preferred Stock | $ | $ | ||||||
| Conversion of accrued directors’ fees to Series D-1 Preferred Stock | $ | $ | ||||||
| Forfeited shares of Series D Preferred Stock | $ | ( | ) | $ | ||||
| Issuance of Series D-1 Preferred Stock for forfeited shares of Series D Preferred Stock | $ | | $ | |||||
| Purchase of insurance policies financed by short-term note payable | $ | ( | ) | $ | ( | ) | ||
See accompanying notes to condensed consolidated financial statements.
| 7 |
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 bioactive synthetic small molecule halogenated xanthenes (“HXs”). Our lead HX molecule is named rose bengal sodium (“RBS”).
The Company’s proprietary, patented, pharmaceutical-grade RBS is the active pharmaceutical ingredient (“API”) in the drug candidates of our current clinical development programs and the formulations of our current non-clinical in vivo proof-of-concept and in vitro early discovery programs. Importantly, our pharmaceutical-grade RBS displays different therapeutic effects at different concentrations and can be formulated for delivery by different routes of administration.
The Company believes that RBS targets disease in a bifunctional multi-modal manner. Direct contact by RBS with disease may lead to cell death or repair, depending on the disease being treated and the concentration of RBS being utilized in the therapeutic formulation, by one or more targeting mechanisms. Multivariate innate and adaptive immune activation, signaling, and response may follow that may manifest as stimulatory, inhibitory, or both.
The Company believes that it is the first entity to advance an RBS formulation into clinical trials for the treatment of a disease, such as those trials reported on the clinical trials registry at ClinicalTrials.gov. The Company believes that it is the first and only entity to date to make pharmaceutical-grade RBS successfully, reproducibly, and consistently at a purity of nearly 100%.
The Company’s small molecule platform comprises several different drug candidates and non-clinical targets using different concentrations delivered by different routes of administration specific to each disease area and/or disease indication, including:
| ● | Clinical development programs in oncology (intratumoral administration), dermatology (topical), and ophthalmology (topical), | |
| ● | In vivo: Proof-of-concept programs in oncology (oral), hematology (oral), wound healing (topical), and canine cancers (intratumoral), and | |
| ● | In vitro: Early discovery programs in infectious diseases and tissue regeneration and repair. |
Risks and Uncertainties
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.
| 8 |
Basis of Presentation
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, 2023 filed with the SEC on March 28, 2024. 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 nine months ended September 30, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024.
2. Liquidity and Going Concern
To date, the Company has not generated any revenues or profits from planned principal operations.
The
Company’s cash and restricted cash were $
The Company plans to access capital resources through possible public or private equity offerings, including additional convertible debt issuance pursuant to the 2024 Financing (see Note 5 and Note 13), 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 there can be no assurance 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.
The primary business objective of management is to build the Company into a commercial-stage biotechnology company; however, there can be no assurance that it will be successful in co-developing, licensing, and/or commercializing PV-10, PH-10, and/or any other HX-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 2024 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, there can be no assurance that it will be able to obtain funds on commercially acceptable terms, or complete additional financing in a timely manner. Any such financing may result in significant dilution to stockholders.
These factors raise substantial doubt about our ability to continue as a going concern. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of liabilities that may be necessary should we be unable to continue as a going concern.
Our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”), which contemplate our continuation as a going concern and the realization of assets and satisfaction of liabilities in the normal course of business. The carrying amounts of assets and liabilities presented in the consolidated financial statements do not necessarily purport to represent realizable or settlement values.
| 9 |
3. Significant Accounting Policies
Since the date the Company’s December 31, 2023 consolidated financial statements were issued in its 2023 Annual Report on March 28, 2024, there have been no material changes to the Company’s significant accounting policies.
Principles of Consolidation
Intercompany balances and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States (“GAAP”) requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The Company’s significant estimates and assumptions include the recoverability and useful lives of long-lived assets, accrued liabilities, and the valuation allowance related to the Company’s deferred tax assets.
Restricted Cash
Restricted
cash consists of a grant award received from the State of Tennessee. Restricted cash available as of September 30, 2024 is $
Cash Concentrations
Cash
and restricted cash are maintained at financial institutions and, at times, balances may exceed federally insured limits of $
| 10 |
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:
| September 30, | ||||||||
| 2024 | 2023 | |||||||
| Warrants | ||||||||
| Options | ||||||||
| Convertible preferred stock | ||||||||
| 2021 unsecured convertible notes and accrued interest | ||||||||
| 2022 unsecured convertible notes and accrued interest | ||||||||
| 2024 unsecured convertible notes and accrued interest | ||||||||
| Total potentially dilutive shares | ||||||||
Recently Issued Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-07 “Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures.” These amendments require a public entity to disclose significant segment expenses and other segment items on an annual and interim basis and to provide in interim periods all disclosures about a reportable segment’s profit or loss and assets that are currently required annually. Public entities with a single reporting segment are required to provide both the new disclosures and all of the existing disclosures required under ASC 280. The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating any new disclosures that may be required upon adoption of ASU 2023-07.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The amendments in this update address investor requests for more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information. This update also includes certain other amendments to improve the effectiveness of income tax disclosures. The amendments in ASU 2023-09 are effective for the Company for annual periods beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating any new disclosures that may be required upon adoption of ASU 2023-09.
4. Other Accrued Expenses
The following table summarizes the other accrued expenses at September 30, 2024 and December 31, 2023:
Schedule of Other Accrued Expenses
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Accrued payroll and taxes | $ | $ | ||||||
| Accrued vacation | ||||||||
| Accrued directors’ fees | ||||||||
| Accrued other expenses | ||||||||
| Total other accrued expenses | $ | $ | ||||||
| 11 |
5. Convertible Notes Payable
2024 Financing
On
July 11, 2024, the Board approved a Financing Term Sheet (the “2024 Term Sheet”), which set forth the terms under which the
Company will use its best efforts to arrange for financing of a maximum of $
Pursuant to the 2024 Term Sheet, the 2024 Notes (defined below) will automatically convert into shares of the Company’s Series D-1 Preferred Stock twelve months after the issue date of a 2024 Note, subject to certain exceptions.
The 2024 Financing will be in the form of an unsecured convertible loan (the “2024 Loan”) from the investors (the “2024 Loan Investors”) and evidenced by convertible promissory notes (individually, a “2024 Note” and collectively, the “2024 Notes”). In addition to customary provisions, the 2024 Notes will contain the following provisions:
| (i) | The
2024 Loan will bear interest at the rate of eight percent ( | |
| (ii) | In the event there is a change of control of the Board, the term of the 2024 Notes will be accelerated and all amounts due under the 2024 Notes may be immediately due and payable at the 2024 Loan Investors’ option; | |
| (iii) | The outstanding principal amount and interest payable under the 2024 Loan may be convertible at the 2024 Loan Investors’ option into shares of Series D-1 Convertible Preferred Stock at a price per share equal to $. The Series D-1 Convertible Preferred Stock is convertible into ten () shares of common stock; and | |
| (iv) | The
outstanding principal amount and interest payable under the 2024 Loan will be automatically convertible into shares of the Company’s
Series D-1 Preferred Stock twelve (12) months after the issue date of a 2024 Note at a price per share equal to $ |
The following summarizes convertible notes payable activity during the nine months ended September 30, 2024:
2021 Financing
Schedule of Convertible Notes Payable
| Non-Related Party | Related Party | |||||||||||
| Face Amount | Face Amount | Total | ||||||||||
| Balance as of January 1, 2024 | $ | $ | $ | |||||||||
| Repayment | ( |
) | ( |
) | ||||||||
| Balance as of September 30, 2024 | $ | $ | $ | |||||||||
2022 Financing
| Non-Related Party | Related Party | |||||||||||
| Face Amount | Face Amount | Total | ||||||||||
| Balance as of January 1, 2024 | $ | $ | $ | |||||||||
| Issued | ||||||||||||
| Conversion | ( |
( |
) | ( |
) | |||||||
| Balance as of September 30, 2024 | $ | $ | $ | |||||||||
On
July 11, 2024, the board of directors (the “Board”) approved the closure of the 2022 Financing. Through September 30, 2024,
the Company received 2022 Notes proceeds in the aggregate amount of $
2024 Financing
| Non-Related Party | Related Party | |||||||||||
| Face Amount | Face Amount | Total | ||||||||||
| Balance as of January 1, 2024 | $ | $ | $ | |||||||||
| Issued | ||||||||||||
| Balance as of September 30, 2024 | $ | $ | $ | |||||||||
Through
September 30, 2024, the Company received 2024 Notes proceeds in the aggregate amount of $
| 12 |
2024 Repayment of 2021 Notes
During
the nine months ended September 30, 2024, the Company repaid $
2024 Conversions of 2022 Notes into Preferred Stock
During
the three months ended September 30, 2024, principal and interest in the aggregate amount of $
During
the nine months ended September 30, 2024, principal and interest in the aggregate amount of $
Interest expense on Convertible Notes Payable
During
the three and nine months ended September 30, 2024, the Company incurred $
6. Notes Payable
The
Company obtained short-term financing from AFCO Insurance Premium Finance for our commercial insurance policies. As of September 30,
2024 and December 31, 2023, the balance of the note payable was $
7. Related Party Transactions
During
the three months ended September 30, 2024 and 2023, the Company incurred consulting fees of $
Directors’ fees for Mr. Horowitz for
the nine months ended September 30, 2024 and 2023 were $
See Note 5 for details of other related party transactions.
Directors’
fees incurred during the three months ended September 30, 2024 and 2023, were $
| 13 |
8. Stockholders’ Deficit
Common Stock
During the three and nine months ended September 30, 2024, holders of shares of Series D-1 Preferred Stock voluntarily converted their Preferred Stock into shares of Common Stock.
Preferred Stock
During
the three months ended September 30, 2024, the Company issued
shares of Series D-1 Convertible Preferred Stock upon the conversion of $
During
the nine months ended September 30, 2024, the Company issued
shares of Series D-1 Convertible Preferred Stock upon the conversion of $
During
the three months ended September 30, 2024, the Company issued shares of Series D-1 Convertible Preferred Stock for accrued directors’
fees of $
On June 21, 2024, the Board approved the conversion of Series D Preferred Shares held by Dominic Rodrigues, our President and Board vice chairman, into shares of Series D-1 Preferred shares.
See Note 12 for details on conversions of 2022 Notes into Series D-1 Preferred Stock subsequent to September 30, 2024.
Number of Preferred Shares
On June 24, 2024, the Company filed an amended Series D Certificate of Designation to decrease the authorized shares from to shares of Series D Convertible Preferred Stock. The Series D-1 Certificate of Designation was also amended to increase the authorized shares from to shares of Series D-1 Convertible Preferred Stock.
2024 Equity Compensation Plan
At the shareholder meeting held on June 20, 2024, the proposal for the new 2024 Equity Compensation Plan was approved. The approval gives the Company the authority to grant Options and award Restricted Stock under the 2024 Equity Compensation Plan for up to shares of our common stock, which are approximately fifteen percent (%) of the issued and outstanding shares of Common Stock on an as converted basis as of the effective date of the 2024 Equity Compensation Plan.
Options
During the three and nine months ended September 30, 2024 and 2023, the Company did not have any issuances, grants, or exercises of options.
Schedule of Option Activity
| Weighted Average | Weighted Average Remaining | Aggregate Intrinsic | ||||||||||||||
| Shares | Exercise Price | Life in Years | Value | |||||||||||||
| Outstanding and exercisable at January 1, 2024 | $ | $ | ||||||||||||||
| Expired | ( |
|||||||||||||||
| Outstanding and exercisable at September 30, 2024 | $ | $ | ||||||||||||||
| 14 |
Schedule of Stock Options Outstanding
| Options Outstanding | Options Exercisable | |||||||||||||
| Outstanding | Weighted Average | Exercisable | ||||||||||||
| Number of | Remaining Life | Number of | ||||||||||||
| Exercise Price | Options | In Years | Options | |||||||||||
| $ | ||||||||||||||
| $ | ||||||||||||||
| $ | ||||||||||||||
Warrants
During the three and nine months ended September 30, 2024 and 2023, the Company did not have any issuances, grants, or exercises of warrants.
The following table summarizes warrant activities during the nine months ended September 30, 2024:
Schedule of Warrant Activity
| Number of | Weighted Average | Weighted Average Remaining | Aggregate Intrinsic | |||||||||||||
| Warrants | Exercise Price | Life in Years | Value | |||||||||||||
| Outstanding and exercisable at January 1, 2024 | $ | |||||||||||||||
| Expired | ( |
) | ||||||||||||||
| Outstanding and exercisable at September 30, 2024 | $ | $ | ||||||||||||||
Annual Stockholder Meeting Proposals
The Company held its annual meeting of stockholders on June 20, 2024. 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”), to effect a reverse stock split of the Company’s common stock, Series D Convertible Preferred Stock, and Series D-1 Convertible Preferred Stock at a ratio of between 1-for-10 and 1-for-50, where the ratio would be determined by the Board at its discretion, and to make corresponding amendments to the Certificates of Designation to provide for the proportional adjustment of certain terms upon a reverse stock split, consistent with the Board’s recommendation. The Company’s stockholders also authorized the Board to amend the Company’s Certificate of Incorporation, as amended by the Certificates of Designation, to decrease the number of authorized shares of the Company’s common stock and preferred stock by the same reverse stock split ratio determined by the Board, consistent with the Board’s recommendation. The Board has not acted on these stockholder authorizations as of the filing date.
| 15 |
9. Leases
On
June 18, 2022, the Company leased
Total
operating lease expense for the three months ended September 30, 2024 was $
Total
operating lease expense for the nine months ended September 30, 2024 was $
A summary of the Company’s right-of-use assets and liabilities is as follows:
Schedule of Right-of-use Assets and Liabilities
| For the Nine Months Ended | ||||||||
| September 30, | ||||||||
| 2024 | 2023 | |||||||
| 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 September 30, 2024 were as follows:
Future Minimum Payments
Schedule of Future Minimum Payments Under Non-cancellable Lease
| Years | Amount | |||
| 2024 | $ | |||
| 2025 | ||||
| Total lease payments | ||||
| Less: amount representing imputed interest | ( |
) | ||
| Present value of lease liability | ||||
| Less: current portion | ( |
) | ||
| Lease liability, non-current portion | $ | |||
10. Grants
On
October 25, 2021, the Company received a grant award of $
As
of September 30, 2024 and December 31, 2023, $
| 16 |
11. License Transactions
In
the third quarter of 2019, the Company entered into a dialog with Bascom Palmer Eye Institute (“BPEI”) regarding collaboration
on BPEI’s ophthalmic photodynamic antimicrobial therapy (“PDAT”) using the Company’s pharmaceutical-grade RBS.
On February 16, 2022, and later amended on May 11, 2022, the Company entered into an option agreement with the University of Miami (“UM”)
for an exclusive worldwide license of intellectual property (“IP”) developed by the Ophthalmic Biophysics Center (“OBC”)
of BPEI that included the use of OBC’s PDAT medical device in combination with formulations of the Company’s pharmaceutical-grade
RBS for the treatment of bacterial, fungal, and viral infections of the eye.
On March 21, 2024, the Company entered into an Exclusive License Agreement with the UM for the license and development of the University’s IP related to photodynamic antimicrobial therapy in ophthalmology. The License Agreement grants the Company exclusive, worldwide rights to research, develop, make, use, or sell Licensed Products and/or Licensed Processes based upon patent-related rights.
As consideration for the rights granted in the License
Agreement, the Company paid an upfront fee of $
The License Agreement provides that, within one year,
the Company will create a corporation (“NewCo”) for the purpose of developing and commercializing Licensed Products and Licensed
Processes, assign the License Agreement to NewCo, and enter into an equity agreement with respect to NewCo’s securities. Pursuant
to the equity agreement, NewCo will be required to issue to the University of the total number of issued and outstanding shares of
NewCo. The University will have certain anti-dilution rights related to additional issuances of NewCo securities before NewCo receives
a total of $
The License Agreement sets forth certain diligence
milestones that include forming NewCo, creating a Licensed Product suitable for submission to the Food and Drug Administration (“FDA”),
generating Licensed Product data suitable for required submission to the FDA, submitting a drug-device combination application to the
FDA, and receiving clearance, approval or other authorization from the FDA for the Licensed Product portion of the drug device combination.
The term of the License Agreement is the later of (i) the expiration or abandonment of all issued patents and patent applications related to patent rights under the License Agreement and/or no royalties are due, (ii) any regulatory exclusivity has expired, and (iii) 20 years from the first commercial sale of Licensed Product and/or Licensed Process. The License Agreement provides that the Company may terminate the License Agreement upon 90 days’ written notice to the University, and each party has the right to terminate the License Agreement if the other party commits a material breach of the terms of the License Agreement and such breach remains uncured for thirty days after receipt of written notice
12. Commitments, Contingencies and Litigation
The Company may, from time to time, be involved in litigation arising from the ordinary course of business. 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 condensed consolidated financial position, results of operations or cash flows.
13. 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 September 30, 2024, the Company entered into 2024 Notes with a related party investor (Executive Officer) in the aggregate principal
amount of $
Subsequent to September 30, 2024, the Company entered into 2024 Notes with non-related party investors in the aggregate principal amount of $.
Series D-1 Preferred Stock
Subsequent
to September 30, 2024, principal and interest in the aggregate amount of $
NewCo
Subsequent to September 30, 2024 and in connection with the License Agreement with UM, the Company entered into an agreement with non-related party investors for a seed round investment in NewCo, subject to negotiation, preparation, and execution of definitive agreements, after NewCo is created.
| 17 |
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, 2023 filed with the SEC on March 28, 2024 (“2023 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.
Clinical Development and Drug Discovery
The Company’s small molecule platform, which comprises different drug candidates and non-clinical formulations made from pharmaceutical-grade RBS using different concentrations and delivered by different routes of administration specific to each disease and/or disease indication, includes:
Clinical Development Programs
| ● | Oncology: Intratumoral (“ITU”) formulation PV-10 (“ITU PV-10”) has undergone and is undergoing multiple, monotherapy and combination therapy, early- to late-stage clinical trials, expanded access programs (“EAPs”) for groups of and individual patients, and/or quality of life (“QOL”) study at multiple clinical sites in Australia, Europe, and the U.S. for the treatments of Stage III and IV melanoma and different types of liver cancers. ITU PV-10 has undergone clinical monotherapy and combination therapy mechanism of action and mechanism of immune response study for melanoma, metastatic uveal melanoma, and metastatic neuroendocrine tumors at Moffitt Cancer Center (“Moffitt”) in Tampa, Florida, The Queen Elizabeth Hospital in Adelaide, Australia, and MD Anderson Cancer Center in Houston, Texas. The Company’s current lead indication is FOLRINOX-refractory pancreatic ductal adenocarcinoma metastatic to the liver, where patients may receive the combination therapy of ITU PV-10 and systemically administered gemcitabine and nab-paclitaxel. | |
| ● | Dermatology: Topical (“TOP”) formulation PH-10 (“TOP PH-10”) has undergone multiple mid-stage, monotherapy clinical trials for the treatments of psoriasis and atopic dermatitis at different clinical sites in the U.S. TOP PH-10 has undergone clinical monotherapy mechanism of action and mechanism of immune response study for psoriasis at The Rockefeller University in New York, New York (“TRU”). Different formulations have undergone non-clinical combination therapy study for psoriasis and are undergoing non-clinical monotherapy study for skin inflammation and skin aging at TRU. | |
| ● | Ophthalmology: The Company believes that clinical proof-of-concept (“POC”) of TOP administration of non-pharmaceutical grade rose bengal in combination with a medical device for the treatment of infectious keratitis has been shown by clinicians and researchers at the University of Miami’s Bascom Palmer Eye Institute (“BPEI”) in Miami, Florida, who are now collaborating with the Company to evaluate the potential use of our pharmaceutical-grade RBS. TOP PV-305 has undergone non-clinical monotherapy study for diseases and disorders of the eye, such as infectious keratitis, at BPEI. |
| 18 |
Non-clinical Proof-of-Concept In Vivo Programs
| ● | Oncology: ITU PV-10 has undergone non-clinical monotherapy and combination therapy study for the treatment of pancreatic cancer and human papillomavirus-positive and negative head and neck squamous cell carcinoma at Moffitt. ITU PV-10 has undergone non-clinical monotherapy study for the treatment of penile squamous cell carcinoma at an academic medical center. ITU PV-10 has undergone non-clinical monotherapy and combination therapy study for the treatment of relapsed and refractory pediatric solid tumor cancers at the University of Calgary’s Cumming School of Medicine in Calgary, Canada (“UCal”). The Company believes that the UCal researchers have achieved in vivo monotherapy POC of ITU administration. | |
| Oral (“PO”) formulations are undergoing non-clinical monotherapy study for high-risk and refractory adult solid tumor cancers at UCal. The Company believes that the UCal researchers and the Company have both achieved in vivo monotherapy POC of PO administration, that the Company has achieved in vivo monotherapy POC of PO administration in both prophylactic and therapeutic settings, and that the Company has achieved in vivo monotherapy POC of intravenous (“IV”) administration. | ||
| ● | Hematology: PO formulations have undergone non-clinical monotherapy study for the treatment of refractory and relapsed pediatric and other blood cancers, including leukemias, at UCal. The Company believes that the UCal researchers have achieved in vivo monotherapy POC of PO administration. | |
| ● | Wound Healing: Different formulations are undergoing non-clinical monotherapy study for the healing of full-thickness cutaneous wounds. The Company believes that in vivo monotherapy POC of TOP administration of non-pharmaceutical grade rose bengal for the treatment of this indication has been shown by researchers at the University of Texas Medical Branch in Galveston, Texas, who are now collaborating with the Company to use our pharmaceutical-grade RBS. | |
| ● | Animal Health: Different formulations are undergoing non-clinical monotherapy study for the treatment of canine soft tissue sarcomas at the University of Tennessee’s College of Veterinary Medicine in Knoxville, Tennessee. The Company believes that it has achieved monotherapy POC of ITU administration in canines. |
Non-clinical Early Drug Discovery (In Vitro) Programs
| ● | Immune vaccine adjuvant: Different formulations have undergone and are undergoing non-clinical study as a vaccine adjuvant to enhance T cell responses for anti-viral and anti-cancer vaccines. | |
| ● | Infectious Diseases: PO and intranasal (“IN”) formulations have undergone and are undergoing non-clinical monotherapy study for the treatment of SARS-CoV-2 at UCal, another Canadian academic research center, the University of Tennessee Health Science Center (“UTHSC”) in Memphis, Tennessee, and a U.S. contract research organization. Different formulations have undergone non-clinical monotherapy and combination therapy study for the treatment of gram-positive and gram-negative bacterial infections (including multi-drug-resistant strains) and have undergone non-clinical monotherapy study for the treatment of oral bacterial infections at UTHSC. Different formulations have undergone non-clinical monotherapy study for the treatment of fungal infections at UTHSC. | |
| ● | Tissue Regeneration and Repair: Different formulations have undergone non-clinical monotherapy study for vertebrate development, wound healing, and tissue regrowth at the University of Nevada, Las Vegas in Las Vegas, Nevada. | |
| ● | Proprietary: Different formulations are undergoing non-clinical study for proprietary diseases at an academic medical center. |
| 19 |
Business Strategy
The Company is selectively continuing ongoing and planning to initiate new monotherapy and combination therapy ITU PV-10 clinical trials in melanoma and liver cancer indications to generate more and/or new clinical data and appropriately utilizing clinical data from historical ITU PV-10 trials, EAPs, and/or QOL study of these oncology indications. Our goals are to pursue drug approval pathways and/or co-development relationships with commercial pharmaceutical companies for ITU PV-10 based on these indications and data.
The Company is developing a systemically administered formulation of pharmaceutical-grade RBS for the treatment of cancer. Our goals, when this work is complete, are to file an investigational new drug application (“IND”) with the U.S. Food and Drug Administration (“FDA”), take an initial systemic drug candidate into an early-stage clinic trial for an initial oncology or hematology indication, and/or pursue a co-development collaboration or out-license arrangement for this route of administration and disease area.
The Company is developing different formulations of pharmaceutical-grade RBS using different concentrations and different routes of administration for other disease areas by endeavoring to show non-clinical activity and lack of toxicity. Our goals, when each task of this work is completed, are to file an IND with the FDA, take an initial drug candidate into an early-stage clinic trial for an initial indication, and/or pursue a co-development collaboration or out-license arrangement for the respective disease area and route of administration.
The Company is endeavoring to fully elucidate the traits and characteristics of the RBS molecule using different academic medical centers under sponsored research and testing agreements. Our goal is to gain and communicate additional knowledge of the RBS molecule’s targeting, mechanism, signaling, immune response, and other features that are common to and/or different from each disease area and indication under research.
The Company is doing rigorous chemical analytical comparisons of non-pharmaceutical grades of rose bengal from specialty chemical suppliers against the Company’s pharmaceutical-grade RBS. Our goal is to demonstrate the proprietary nature of the Company’s pharmaceutical-grade RBS and that our pharmaceutical-grade RBS meets the necessary uniformity and purity requirements for commercial pharmaceutical use.
| 20 |
RBS API and Drug Candidate Manufacturing
Our pharmaceutical-grade RBS resulted from the Company’s innovation of a proprietary, patented, commercial-scale process to synthesize and utilize the RBS molecule into a viable active pharmaceutical ingredient (“API”) for commercial pharmaceutical use; the development of unique chemistry, manufacturing, and control (“CMC”) specifications for API and drug candidate manufacturing processes; the production and multi-year stability testing of multiple API and drug candidate lots; the comprehensive documentation of lot composition and reproducibility; and the review and acceptance of CMC data from these lots by seven different national drug regulatory agencies for use in a prior, multi-country, multi-center Phase 3 randomized control trial of the Company.
The Company’s API and drug candidate manufacturing processes employ Quality-by-Design principles, current good manufacturing practice (“cGMP”) regulations, and the guidelines of The International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use. These processes utilize controls that eliminate the formation of historical impurities and avoid the introduction of potentially hazardous impurities that the Company believes may have been and could be present in uncontrolled and unreported amounts in non-pharmaceutical grades of rose bengal.
The Company’s processes of synthesizing the RBS molecule into pharmaceutical-grade RBS and manufacturing RBS API and ITU PV-10 drug candidate, the processes’ CMC specifications, and the CMC data from the production of stability lots of API and drug candidate have been reviewed by multiple national drug regulatory agencies prior to granting clinical trial authorizations for the Company to commence a historical Phase 3 study of ITU PV-10 for the treatment of the Company’s former lead indication of locally advanced cutaneous melanoma, including the U.S. FDA, Germany’s Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Australia’s Therapeutic Goods Administration (TGA) under a clinical trial notification, France’s Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), Italy’s Agenzia Italiana del Farmaco (AIFA), Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), and Argentina’s Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT).
RBS Non-proprietary Name
The RBS name for the Company’s pharmaceutical-grade API was selected by and passed the review of the World Health Organization (“WHO”) Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations after the Company applied for a non-proprietary name in the third quarter of 2020 and reached the status of recommended International Non-proprietary Names (“INN”). INN Recommended List 88, which includes the RBS name, was published with the No. 3 issue of the WHO Drug Information, Volume 36 in the fourth quarter of 2022.
| 21 |
Non-Pharmaceutical Grades of Rose Bengal
Commercial Grade
Commercial grade rose bengal can be purchased from specialty chemical suppliers in the U.S. and in other parts of the world that manufacture it under non-cGMP conditions. Commercial grade rose bengal appears to have reported purities that may vary between 80% and 95% and may contain substantial amounts of unreported impurities and/or gross contaminants. Commercial grade rose bengal is typically used by researchers unaffiliated with the Company for non-clinical study of the rose bengal molecule for potential biomedical therapeutic applications.
We believe that commercial grade rose bengal is still manufactured using the original historical process, or a variant thereof, developed by the molecule’s original Swiss creator Rudolph Gnehm in 1881. Some chemical manufacturers may, however, apply purification techniques that the Company believes still result in commercial grade rose bengal possessing questionable purity and contaminants and substantial lot-to-lot manufacturing variability.
Diagnostic Grade
Diagnostic grade rose bengal describes non-approved rose bengal that is used as an ingredient in historical or current ophthalmic solutions, strips, and devices, has been historically or is presently compounded by pharmacists for ophthalmic use, and has been or is in other non-ophthalmic diagnostic tests such as the rose bengal test for human brucellosis.
We presume, but have not yet confirmed, that diagnostic grade rose bengal is derived from commercial grade rose bengal that may have undergone a form of purification under cGMP regulations and/or may have been compounded by a pharmacist, academic medical researcher, or commercial entity under cGMP regulations. Here too, the Company believes that purification may not sufficiently improve the amounts and accuracy of diagnostic grade rose bengal purity and lot contents and may not adequately reduce or eliminate lot-to-lot manufacturing variability.
Chemical Analytical Comparison
In the first quarter of 2022, the Company began work with a U.S. contract development and manufacturing organization to assess rigorously and methodically three lots of commercial grade rose bengal, one each from three different specialty chemical suppliers, and compare these non-pharmaceutical grade materials with the Company’s pharmaceutical-grade RBS. This chemical analytical work was substantially completed by the end of the third quarter of 2022. The Company believes that the preliminary results of these analyses indicate that all three lots of commercial grade rose bengal had rose bengal purity that was drastically different from what was represented on their respective certificates of analysis (“CofAs”), and that one of the three lots contained gross contaminants that were not represented on its CofA.
Potential Barriers to Entry
The Company believes that the Company’s proprietary, patented, pharmaceutical-grade RBS possesses several competitive advantages over non-pharmaceutical-grade rose bengal (i.e., commercial and diagnostic grades) that researchers, clinicians, and academic, business, and/or governmental competitors have used, are using, and/or may attempt to use for potential biomedical applications. The Company believes that non-pharmaceutical-grade rose bengal may suffer from the uncontrolled presence of substance-related impurities and/or gross contaminants, substantial lot-to-lot manufacturing variability, inaccurately reported and/or misrepresented purity and contents, and the lack of reproducible, consistent, and fulsome CMC specifications and documentation. The Company believes that historical and potentially hazardous impurities and other manufacturing and handling issues facing non-pharmaceutical grade rose bengal may pose significant scientific, technological, and economic challenges to overcome and validate for compliance with modern drug regulatory standards.
| 22 |
Components of Operating Results
Grant Revenue
Grant revenue is recognized when qualifying costs are incurred and there is reasonable assurance that the 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 grant revenue 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 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 candidates.
General and Administrative Expenses
General and administrative expenses consist 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.
| 23 |
Results of Operations
Comparison of the Three Months Ended September 30, 2024 and September 30, 2023
Overview
Grant revenue was $109,745 for the three months ended September 30, 2024, an increase of $40,012 or 57.4% compared to the three months ended September 30, 2023. Total operating expenses were $1,065,473 for the three months ended September 30, 2024, an increase of $281,592 or 35.9% compared to the three months ended September 30, 2023. The increase was driven primarily by (i) increased payroll and taxes for the addition of two officers, (ii) higher clinical trial costs related to study closure, (iii) higher legal expenses related to patent costs, partially offset by (iv) lower directors’ fees and professional fees due to the resignation of Mr. Horowitz, our former COO, and (v) lower other general and administrative costs primarily attributable to a refund received in July 2024 from the State of Tennessee following the repeal of the franchise/excise property tax measure. Net loss for the three months ended September 30, 2024 was $1,014,351, an increase of $238,512 or 30.7% compared to the three months ended September 30, 2023.
| For the Three Months Ended | ||||||||||||||||
| September 30, | ||||||||||||||||
| 2024 | 2023 | Increase/(Decrease) | % Change | |||||||||||||
| Grant Revenue | $ | 109,745 | $ | 69,733 | $ | 40,012 | 57.4 | % | ||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | 413,987 | 350,792 | 63,195 | 18.0 | % | |||||||||||
| General and administrative | 651,486 | 433,089 | 218,397 | 50.4 | % | |||||||||||
| Total Operating Expenses | 1,065,473 | 783,881 | 281,592 | 35.9 | % | |||||||||||
| Total Operating Loss | (955,728 | ) | (714,148 | ) | (241,580 | ) | -33.8 | % | ||||||||
| Other Income/(Expense): | ||||||||||||||||
| Research and development tax credit | 56 | (167 | ) | 223 | 133.5 | % | ||||||||||
| Interest expense, net | (58,679 | ) | (61,524 | ) | 2,845 | 4.6 | % | |||||||||
| Total Other Expense, Net | (58,623 | ) | (61,691 | ) | 3,068 | 5.0 | % | |||||||||
| Net Loss | $ | (1,014,351 | ) | $ | (775,839 | ) | $ | (238,512 | ) | -30.7 | % | |||||
Grant Revenue
For the three months ended September 30, 2024 and September 30, 2023, there was $109,745 and $69,733, respectively, of grant revenue recognized related to qualifying expenses that were incurred and included within research and development expenses on the condensed consolidated statements of operations.
Research and Development Expenses
Research and development expenses were $413,987 for the three months ended September 30, 2024, an increase of $63,195 or 18.0% compared to $350,792 for the three months ended September 30, 2023. The increase was primarily due to higher clinical trial costs associated with study closure.
The following table summarizes research and development expenses for the three months ended September 30, 2024 and 2023.
| For the Three Months Ended | ||||||||||||||||
| September 30, | ||||||||||||||||
| 2024 | 2023 | Increase/(Decrease) | % Change | |||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development: | ||||||||||||||||
| Clinical trial and research expenses | $ | 278,885 | $ | 198,002 | $ | 80,883 | 40.8 | % | ||||||||
| Depreciation/amortization | 1,764 | 1,764 | - | 0.0 | % | |||||||||||
| Insurance | 57,416 | 57,409 | 7 | 0.0 | % | |||||||||||
| Payroll and taxes | 67,360 | 85,244 | (17,884 | ) | -21.0 | % | ||||||||||
| Rent and utilities | 8,562 | 8,373 | 189 | 2.3 | % | |||||||||||
| Total research and development | $ | 413,987 | $ | 350,792 | $ | 63,195 | 18.0 | % | ||||||||
| 24 |
General and Administrative Expenses
General and administrative expenses were $651,486 for the three months ended September 30, 2024, an increase of $218,397 or 50.4% compared to $433,089 for the three months ended September 30, 2023. The increase was primarily due to (i) increased payroll and taxes for the addition of two new officers, and (ii) increased legal fees related to patents, partially offset by (iii) lower directors’ fees and professional fees due to the resignation of Mr. Horowitz, our former COO.
The following table summarizes general and administrative expenses for the three months ended September 30, 2024 and 2023.
| For the Three Months Ended | ||||||||||||||||
| September 30, | ||||||||||||||||
| 2024 | 2023 | Increase/(Decrease) | % Change | |||||||||||||
| Operating Expenses: | ||||||||||||||||
| General and administrative: | ||||||||||||||||
| Depreciation | $ | 466 | $ | 466 | $ | - | 0.0 | % | ||||||||
| Directors’ fees | 77,500 | 96,250 | (18,750 | ) | -19.5 | % | ||||||||||
| Insurance | 41,580 | 45,302 | (3,722 | ) | -8.2 | % | ||||||||||
| Legal and litigation | 199,791 | 71,222 | 128,569 | 180.5 | % | |||||||||||
| Other general and administrative cost | 8,063 | 15,724 | (7,661 | ) | -48.7 | % | ||||||||||
| Payroll and taxes | 201,623 | 60,829 | 140,794 | 231.5 | % | |||||||||||
| Professional fees | 117,657 | 138,620 | (20,963 | ) | -15.1 | % | ||||||||||
| Rent and utilities | 4,806 | 4,676 | 130 | 2.8 | % | |||||||||||
| Total general and administrative | $ | 651,486 | $ | 433,089 | $ | 218,397 | 50.4 | % | ||||||||
Other Expense, Net
Interest expense decreased by $2,845 or 4.6% from $61,524 for the three months ended September 30, 2023 to $58,679 for the three months ended September 30, 2024. The decrease was mainly due to the interest expense costs incurred in connection with the lower average notes payable balances.
Research and development tax credit in Australia increased by $223 or 133.5% from ($167) for the three months ended September 30, 2023 to $56 for the three months ended September 30, 2024. The increase was mainly due to currency fluctuations in Australia.
| 25 |
Comparison of the Nine Months Ended September 30, 2024 and September 30, 2023
Overview
Grant revenue was $602,808 for the nine months ended September 30, 2024, an increase of $166,208 or 38.1% compared to the nine months ended September 30, 2023. Total operating expenses were $2,800,655 for the nine months ended September 30, 2024, an increase of $67,491 or 2.5% compared to the nine months ended September 30, 2023. The increase was driven primarily by (i) higher clinical trial costs related to study closure, (ii) increased payroll and taxes due to the addition of two new officers, (iii) higher legal costs related to patents and general corporate matters, partially offset by (iv) reduced directors’ fees and professional fees due to the resignation of Mr. Horowitz, our former COO. Net loss for the nine months ended September 30, 2024 was $2,365,241, a decrease of $73,114 or 3.0% compared to the nine months ended September 30, 2023.
| For the Nine Months Ended | ||||||||||||||||
| September 30, | ||||||||||||||||
| 2024 | 2023 | Increase/(Decrease) | % Change | |||||||||||||
| Grant Revenue | $ | 602,808 | $ | 436,600 | $ | 166,208 | 38.1 | % | ||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | 1,442,449 | 1,333,399 | 109,050 | 8.2 | % | |||||||||||
| General and administrative | 1,358,206 | 1,399,765 | (41,559 | ) | -3.0 | % | ||||||||||
| Total Operating Expenses | 2,800,655 | 2,733,164 | 67,491 | 2.5 | % | |||||||||||
| Total Operating Loss | (2,197,847 | ) | (2,296,564 | ) | 98,717 | 4.3 | % | |||||||||
| Other Income/(Expense): | ||||||||||||||||
| Research and development tax credit | 9,357 | 15,798 | (6,441 | ) | -40.8 | % | ||||||||||
| Interest expense, net | (176,751 | ) | (157,589 | ) | (19,162 | ) | -12.2 | % | ||||||||
| Total Other Expense, Net | (167,394 | ) | (141,791 | ) | (25,603 | ) | -18.1 | % | ||||||||
| Net Loss | $ | (2,365,241 | ) | $ | (2,438,355 | ) | $ | 73,114 | 3.0 | % | ||||||
Grant Revenue
For the nine months ended September 30, 2024 and September 30, 2023, there was $602,808 and $436,600, respectively, of grant revenue recognized related to qualifying expenses that were incurred and included within research and development expenses on the condensed consolidated statements of operations.
Research and Development Expenses
Research and development expenses were $1,442,449 for the nine months ended September 30, 2024, an increase of $109,050 or 8.2% compared to $1,333,399 for the nine months ended September 30, 2023. The increase was primarily due to higher clinical trial costs associated with study closure.
The following table summarizes research and development expenses for the nine months ended September 30, 2024 and 2023.
| For the Nine Months Ended | ||||||||||||||||
| September 30, | ||||||||||||||||
| 2024 | 2023 | Increase/(Decrease) | % Change | |||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development: | ||||||||||||||||
| Clinical trial and research expenses | 1,037,706 | 913,881 | $ | 123,825 | 13.5 | % | ||||||||||
| Depreciation/amortization | 5,294 | 5,294 | - | 0.0 | % | |||||||||||
| Insurance | 172,503 | 172,065 | 438 | 0.3 | % | |||||||||||
| Payroll and taxes | 201,155 | 216,333 | (15,178 | ) | -7.0 | % | ||||||||||
| Rent and utilities | 25,791 | 25,826 | (35 | ) | -0.1 | % | ||||||||||
| Total research and development | $ | 1,442,449 | $ | 1,333,399 | $ | 109,050 | 8.2 | % | ||||||||
| 26 |
General and Administrative Expenses
General and administrative expenses were $1,358,206 for the nine months ended September 30, 2024, a decrease of $41,559 or 3.0% compared to $1,399,765 for the nine months ended September 30, 2023. The decrease was primarily due to (i) lower directors’ fees and professional fees due to the resignation of Mr. Horowitz, our former COO, partially offset by (ii) higher legal fees related to patents and corporate matters pertaining to the 2024 proxy statement and officer’s resignation, (iii) higher payroll and taxes due to addition of two new officers, and (iv) higher other general and administrative costs due to a refund received in 2023 for employee retention.
The following table summarizes general and administrative expenses for the nine months ended September 30, 2024 and 2023.
| For the Nine Months Ended | ||||||||||||||||
| September 30, | ||||||||||||||||
| 2024 | 2023 | Increase/(Decrease) | % Change | |||||||||||||
| Operating Expenses: | ||||||||||||||||
| General and administrative: | ||||||||||||||||
| Depreciation | $ | 1,397 | $ | 1,397 | $ | - | 0.0 | % | ||||||||
| Directors’ fees | (198,750 | ) | 288,750 | (487,500 | ) | -168.8 | % | |||||||||
| Insurance | 128,843 | 134,390 | (5,547 | ) | -4.1 | % | ||||||||||
| Legal and litigation | 513,271 | 278,819 | 234,452 | 84.1 | % | |||||||||||
| Other general and administrative cost | 49,410 | 28,634 | 20,776 | 72.6 | % | |||||||||||
| Payroll and taxes | 437,244 | 189,262 | 247,982 | 131.0 | % | |||||||||||
| Professional fees | 411,779 | 464,122 | (52,343 | ) | -11.3 | % | ||||||||||
| Rent and utilities | 14,503 | 14,391 | 112 | 0.8 | % | |||||||||||
| Foreign currency translation | 509 | - | 509 | 100.0 | % | |||||||||||
| Total general and administrative | $ | 1,358,206 | $ | 1,399,765 | $ | (41,559 | ) | -3.0 | % | |||||||
Other Expense, Net
Interest expense increased by $19,162 or 12.2% from $157,589 for the nine months ended September 30, 2023 to $176,751 for the nine months ended September 30, 2024. The increase was mainly due to the interest expense costs incurred in connection with the higher average note payables balances.
Research and development tax credit in Australia decreased by $6,441 or 40.8% from $15,798 for the nine months ended September 30, 2023 to $9,357 for the nine months ended September 30, 2024. The decrease was mainly due to no active clinical trials currently in Australia.
Liquidity and Capital Resources
The Company’s cash and restricted cash were $614,189 at September 30, 2024 which includes $426,732 of restricted cash resulting from a grant received from the State of Tennessee, compared to $1,026,799 at December 31, 2023, which included $950,223 of restricted cash. The Company’s working capital deficit was $5,464,760 and $7,652,098 as of September 30, 2024 and December 31, 2023, respectively. We have continuing net losses and negative cash flows from operating activities. In addition, we have an accumulated deficit of $255,055,650 as of September 30, 2024. 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. 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. 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 September 30, 2024, cash required for our current liabilities included approximately $2,977,080 for accounts payable and other accrued expenses (including operating lease liabilities) and a $110,544 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 $2,653,000 plus accrued interest will mature one year from the date of the notes. 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 issuance of 2024 unsecured convertible notes (the “2024 Financing”), to fund our capital requirements and on-going operations; however, there can be no assurance that the Company will be successful in these efforts. Significant funds will be needed to continue and complete our ongoing and planned clinical trials.
| 27 |
Access to Capital
Management plans to access capital resources through possible public or private equity offerings, including the 2024 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, there can be no assurance that management will be successful in implementing the Company’s business plan of developing, licensing, and/or commercializing our prescription drug 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 2024 and beyond. We anticipate that these funds will otherwise come from the proceeds of private placement transactions, the exercise of 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, there can be no assurance that we will be able to obtain funds on commercially acceptable terms, or complete additional financing in a timely manner. In addition, any such financing may result in significant dilution to stockholders.
Critical Accounting Estimates
We prepare our condensed consolidated financial statements in accordance with U.S. GAAP, which require our management to make estimates that affect the reported amounts of assets, liabilities and disclosures of contingent assets and liabilities at the balance sheet dates, as well as the reported amounts of revenues and expenses during the reporting periods. To the extent that there are material differences between these estimates and actual results, our financial condition or results of operations would be affected. We base our estimates on our own historical experience and other assumptions that we believe are reasonable after taking account of our circumstances and expectations for the future based on available information. We evaluate these estimates on an ongoing basis.
We consider an accounting estimate to be critical if: (i) the accounting estimate requires us to make assumptions about matters that were highly uncertain at the time the accounting estimate was made, and (ii) changes in the estimate that are reasonably likely to occur from period to period or use of different estimates that we reasonably could have used in the current period, would have a material impact on our financial condition or results of operations. There are items within our financial statements that require estimation but are not deemed critical, as defined above.
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”).
Available Information
Our website is located at www.provectusbio.com. We make available free of charge through this website our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed with or furnished to the SEC pursuant to Section 13(a) or 15(d) of the Exchange Act, as soon as reasonably practicable after they are electronically filed with or furnished to the SEC. Reference to our website does not constitute incorporation by reference of the information contained on the site and should not be considered part of this document.
The SEC maintains an Internet site that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC as we do. The website is http://www.sec.gov.
The Company also intends to use press releases, the Company’s website and certain social media accounts as a means of disclosing information and observations about the Company and its business, and for complying with the Company’s disclosure obligations under Regulation FD: the Provectus Substack account (provectus.substack.com), the @ProvectusBio X account (twitter.com/provectusbio), and the Company’s LinkedIn account (linkedin.com/company/provectus-biopharmaceuticals). The information and observations that the Company posts through these social media channels may be deemed material. Accordingly, investors should monitor these social media channels in addition to following the Company’s press releases, SEC filings, and website. The social media channels that the Company intends to use as a means of disclosing the information described above may be updated from time to time.
The contents of the websites provided above are not intended to be incorporated by reference into this Quarterly Report on Form 10-Q or our Annual Report on Form 10-K or in any other report or document we file with the SEC. Further, our references to the URLs for these websites are intended to be inactive textual references only.
| 28 |
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.
| 29 |
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 12.
ITEM 1A. RISK FACTORS.
There have been no material changes to the risk factors that were disclosed in the 2023 Form 10-K.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
2022 Financing
During the three and nine months ended September 30, 2024, the Company received aggregate proceeds of $215,000 and $1,853,000, respectively pursuant to certain unsecured convertible notes (the “2022 Notes”). Through September 30, 2024, the Company had drawn down $5,080,500 under the 2022 Notes.
For further details on the terms of the 2022 Notes, refer to our Form 10-K as filed with the SEC on March 28, 2024.
2024 Financing
During the three and nine months ended September 30, 2024, the Company received aggregate proceeds of $450,000 pursuant to certain unsecured convertible notes (the “2024 Notes”). Through September 30, 2024, the Company had drawn down $450,000 under the 2024 Notes.
The 2024 Financing will be in the form of an unsecured convertible loan (the “2024 Loan”) from the investors (the “2024 Loan Investors”) and evidenced by convertible promissory notes (individually, a “2024 Note” and collectively, the “2024 Notes”). In addition to customary provisions, the 2024 Notes will contain the following provisions:
| (i) | The 2024 Loan will bear interest at the rate of eight percent (8%) per annum on the outstanding principal amount of the Loan that has been funded to the Company; | |
| (ii) | In the event there is a change of control of the Board, the term of the 2024 Notes will be accelerated and all amounts due under the 2024 Notes may be immediately due and payable at the 2024 Loan Investors’ option; | |
| (iii) | The outstanding principal amount and interest payable under the 2024 Loan may be convertible at the 2024 Loan Investors’ option into shares of Series D-1 Convertible Preferred Stock at a price per share equal to $2.8620. The Series D-1 Convertible Preferred Stock is convertible into ten (10) shares of common stock; and | |
| (iv) | The outstanding principal amount and interest payable under the 2024 Loan will be automatically convertible into shares of the Company’s Series D-1 Preferred Stock twelve (12) months after the issue date of a 2024 Note at a price per share equal to $2.8620. |
Preferred Convertible Stock
During the three and nine months ended September 30, 2024, the Company issued 339,833 and 839,998 shares, respectively, of restricted Series D-1 Convertible Preferred Stock upon the conversion of $900,000 and $2,225,000 of principal and $72,600 and $179,056 accrued interest, respectively, outstanding on the Company’s convertible notes.
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.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM 4. Mine Safety Disclosures.
Not applicable.
ITEM 5. OTHER INFORMATION.
None.
| 30 |
ITEM 6. EXHIBITS.
| Exhibit No. | Description | |
| 4.1 | Form of Unsecured Convertible Promissory Note (incorporated by reference to Exhibit 4.1 of the Company’s current report on Form 8-K filed with the SEC on July 17, 2024). | |
| 10.1 | 2024 Financing Term Sheet (incorporated by reference to Exhibit 10.1 of the Company’s current report on Form 8-K filed with the SEC on July 17, 2024). | |
| 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.
| 31 |
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. | ||
| November 12, 2024 | By: | /s/ Dominic Rodrigues |
| Dominic Rodrigues | ||
| President (Principal Executive Officer) | ||
| By: | /s/ Heather Raines | |
| Heather Raines, CPA | ||
| Chief Financial Officer (Principal Financial Officer) | ||
| 32 |
Exhibit 31.1
CERTIFICATION
I, Dominic Rodrigues, certify that:
| 1. | I have reviewed this Quarterly Report on Form 10-Q of Provectus Biopharmaceuticals, Inc.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |
| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |
| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and | |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| Date: November 12, 2024 | By: | /s/ Dominic Rodrigues |
| Dominic Rodrigues | ||
| President (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION
I, Heather Raines, CPA, certify that:
| 1. | I have reviewed this Quarterly Report on Form 10-Q of Provectus Biopharmaceuticals, Inc.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |
| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |
| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |
| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and | |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| Date: November 12, 2024 | By: | /s/ Heather Raines |
| Heather Raines, CPA | ||
| Chief Financial Officer (Principal Financial Officer) |
Exhibit 32
CERTIFICATION PURSUANT TO RULE 13a-14(b) UNDER
THE SECURITIES EXCHANGE ACT OF 1934 AND
SECTION 1350 OF CHAPTER 63 OF TITLE 18 OF THE UNITED STATES CODE
Each of the undersigned, Dominic Rodrigues, the President (principal executive officer) of Provectus Biopharmaceuticals, Inc. (the “Company”), and Heather Raines, CPA, the Chief Financial Officer (principal financial officer) of the Company, certifies, pursuant to Rule 13a-14(b) under the Securities Exchange Act of 1934 (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code, that (1) this Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, fully complies with the requirements of Section 13(a) or 15(d) of the Exchange Act, and (2) the information contained in this report fairly presents, in all material respects, the financial condition and results of operations of the Company.
This Certification is signed on November 12, 2024.
| By: | /s/ Dominic Rodrigues | |
| Dominic Rodrigues | ||
| President (Principal Executive Officer) | ||
| By: | /s/ Heather Raines | |
| Heather Raines, CPA | ||
| Chief Financial Officer (Principal Financial Officer) |