PROVECTUS BIOPHARMACEUTICALS INC

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-clinicalin vivo proof-of-concept andin 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:

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.

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 $614,189 at September 30, 2024 which includes $426,732 of restricted cash resulting from a grant received from the State of Tennessee. The Company’s working capital deficit was $5,464,760 and $7,652,098 as of September 30, 2024 and December 31, 2023, respectively, net loss for the nine months ended September 30, 2024 and 2023 was $2,365,241 and $2,438,355, respectively, and cash used in operations was $2,372,083 and $2,010,767 for the nine months ended September 30, 2024 and 2023, respectively. The Company continues to incur significant operating losses. Management expects that significant on-going operating expenditures will be necessary to successfully implement the Company’s business plan and develop and market its products. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these unaudited condensed consolidated financial statements are issued. Implementation of the Company’s plans and its ability to continue as a going concern will depend upon the Company’s ability to develop PV-10, PH-10, and/or any other HX-based drug products, and to raise additional capital.

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.

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 $426,732. See Note 10, Grants.

Cash Concentrations

Cash and restricted cash are maintained at financial institutions and, at times, balances may exceed federally insured limits of $250,000, although the Company seeks to minimize this through treasury management. The Company has never experienced any losses related to these balances although there can be no assurance that it will not experience any losses in the future. As of September 30, 2024 and December 31, 2023, the Company had cash and restricted cash balances in excess of FDIC insurance limits of $364,189 and $776,799, respectively.

Basic and Diluted Loss Per Common Share

Basic loss per common share is computed by dividing net loss by the weighted average number of vested common shares outstanding during the period. Diluted earnings per share reflects the potential dilution that could occur if securities or other instruments to issue common stock were exercised or converted into common stock. The following securities are excluded from the calculation of weighted average dilutive common shares because their inclusion would have been anti-dilutive:

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:

5. Convertible Notes Payable

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 $10,000,000 (the “2024 Financing”), which amounts will be obtained in several tranches.

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:

The following summarizes convertible notes payable activity during the nine months ended September 30, 2024:

2021 Financing

2022 Financing

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 $5,080,500, of which $3,852,500 is from a related party investor (a Company officer/director).

Through September 30, 2024, the Company received 2024 Notes proceeds in the aggregate amount of $450,000, all of which is from a related party investor (a Company officer/director). See Note 12 for details on 2024 Notes received subsequent to September 30, 2024.

2024 Repayment of 2021 Notes

During the nine months ended September 30, 2024, the Company repaid $100,000 of principal owed on the 2021 Note. As of September 30, 2024, principal and interest in the amount of $100,000 and $48,094, respectively, remains outstanding on the 2021 Note.

2024 Conversions of 2022 Notes into Preferred Stock

During the three months ended September 30, 2024, principal and interest in the aggregate amount of $972,600, owed in connection with the 2022 Notes were converted into 339,833 shares of Series D-1 Preferred Stock at the Conversion Price of $2.862. Any fractional shares issuable pursuant to the formula were rounded up to the next whole share of Series D-1 Preferred Stock. See Note 8, Stockholders’ Deficit for additional information on the Series D-1 Preferred Stock.

During the nine months ended September 30, 2024, principal and interest in the aggregate amount of $2,404,057, owed in connection with the 2022 Notes were converted into 839,998 shares of Series D-1 Preferred Stock at the Conversion Price of $2.862. Any fractional shares issuable pursuant to the formula were rounded up to the next whole share of Series D-1 Preferred Stock. See Note 8, Stockholders’ Deficit for additional information on the Series D-1 Preferred Stock.

Interest expense on Convertible Notes Payable

During the three and nine months ended September 30, 2024, the Company incurred $55,193 and $166,327, respectively of interest expense on outstanding 2021, 2022 and 2024 Notes. As of September 30, 2024 and December 31, 2023, accrued interest on the convertible notes was $133,699 and $146,428, respectively.

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 $110,544 and $277,815, respectively.

7. Related Party Transactions

During the three months ended September 30, 2024 and 2023, the Company incurred consulting fees of $0 and $63,600 and during the nine months ended September 30, 2024 and 2023, the Company incurred consulting fees of $63,600 and $190,800, respectively, for services rendered by Bruce Horowitz (Capital Strategists) a former member of the Board and former Chief Operating Officer (“COO”). As of March 25, 2024, Mr. Horowitz resigned as COO and member of the Board. On March 26, 2024, the Company paid Mr. Horowitz $250,000 and on June 27, 2024, the Company paid $258,000 for outstanding consulting fees.

Directors’ fees for Mr. Horowitz for the nine months ended September 30, 2024 and 2023 were $0 and $56,250, respectively. Accrued director fees for Mr. Horowitz as of September 30, 2024 and December 31, 2023 were $0 and $431,250, respectively. Mr. Horowitz waived the amount of $450,000 due to him in directors’ fees upon his resignation.

See Note 5 for details of other related party transactions.

Directors’ fees incurred during the three months ended September 30, 2024 and 2023, were $77,500 and $96,250, respectively. Directors’ fees incurred during the nine months ended September 30, 2024 and 2023, were $251,250 and $288,750, respectively. Accrued directors’ fees as of September 30, 2024 and December 31, 2023 were $0 and $2,330,589, respectively.

8. Stockholders’ Deficit

Common Stock

During the three and nine months ended September 30, 2024, holders of 75,776 shares of Series D-1 Preferred Stock voluntarily converted their Preferred Stock into 757,760 shares of Common Stock.

Preferred Stock

During the three months ended September 30, 2024, the Company issued 339,833 shares of Series D-1 Convertible Preferred Stock upon the conversion of $900,000 of principal and $72,600 of accrued interest outstanding on the 2022 Notes.

During the nine months ended September 30, 2024, the Company issued 839,998 shares of Series D-1 Convertible Preferred Stock upon the conversion of $2,225,000 of principal and $179,057 of accrued interest outstanding on the 2022 Notes.

During the three months ended September 30, 2024, the Company issued 744,878 shares of Series D-1 Convertible Preferred Stock for accrued directors’ fees of $2,131,839 at a stock price of $2.862.

On June 21, 2024, the Board approved the conversion of 11,416,242 Series D Preferred Shares held by Dominic Rodrigues, our President and Board vice chairman, into 1,141,626 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 12,374,000 to 957,100 shares of Series D Convertible Preferred Stock. The Series D-1 Certificate of Designation was also amended to increase the authorized shares from 11,241,000 to 23,042,900 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 100,000,000 shares of our common stock, which are approximately fifteen percent (15%) 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.

The following table summarizes option activities during the nine months ended September 30, 2024:

The following table summarizes information about outstanding and exercisable options at September 30, 2024:

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:

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.

9. Leases

On June 18, 2022, the Company leased 2,700 square feet of corporate office space in Knoxville, Tennessee through an operating lease agreement for a term ofthree years ending on June 30, 2025. The monthly base rent ranges from $4,053 to $4,278 over the term of the lease.

Total operating lease expense for the three months ended September 30, 2024 was $12,842, of which $8,561 was included within research and development and $4,281 was included within general and administrative expenses on the condensed consolidated statements of operations. Total operating lease expense for the three months ended September 30, 2023 was $12,560 of which $8,373 was included within research and development and $4,187 was included within general and administrative expenses on the condensed consolidated statements of operations.

Total operating lease expense for the nine months ended September 30, 2024 was $38,686, of which $25,791 was included within research and development and $12,895 was included within general and administrative expenses on the condensed consolidated statements of operations. Total operating lease expense for the nine months ended September 30, 2023 was $38,739 of which $25,826 was included within research and development and $12,913 was included within general and administrative expenses on the condensed consolidated statements of operations.

A summary of the Company’s right-of-use assets and liabilities is as follows:

Future minimum payments under the Company’s non-cancellable lease obligations as of September 30, 2024 were as follows:

Future Minimum Payments

10. Grants

On October 25, 2021, the Company received a grant award of $2,500,000 from the State of Tennessee for the study of animal cancers and dermatological disorders for the period October 15, 2021 to June 30, 2022 (“the Tennessee Grant” or “the Grant”). The Tennessee Grant was pre-funded; therefore, the funds do not need to be used in full by June 30, 2022. The Tennessee Grant was provided as reimbursement of research and development expenses related to the development of animal health drug products. The Company has elected gross presentation of the Tennessee Grant income whereby grant revenue is recognized as qualifying costs are incurred and there is reasonable assurance that the conditions of the grant have been met. Qualifying costs are presented as research and development expenses included in the Company’s statement of operations, in the period that such costs are incurred.

As of September 30, 2024 and December 31, 2023, $350,440 and $953,248, respectively, are included in unearned grant revenue liability on the accompanying condensed consolidated balance sheets, respectively. The Company recorded grant revenue of $109,745 and $602,808 during the three and nine months ended September 30, 2024, respectively, and $69,733 and $436,600 during the three and nine months ended September 30, 2023, respectively.

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. The Company completed the arrangements of this collaboration during the third quarter of 2022, whereby the Company paid $5,000 for the option that expires on May 31, 2023; agreed to pay up to $10,000 of new UM patent expenses for this IP during the period of the option and up to $25,000 of past UM patent expenses for this IP; and entered into a sponsored research agreement with UM on September 16, 2022 to study the combination of OBC’s PDAT and PV-305, a formulation of the Company’s pharmaceutical-grade RBS, for the treatment of infectious keratitis.

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 $10,000, royalties equal to 10% of net sales of Licensed Products and/or Licensed Processes, and annual payments of $1,000 on the first through fourth anniversaries of the License Agreement and $10,000 on every anniversary thereafter. In the event of a sublicense to a third party, the Company is obligated to pay royalties to the University equal to a percentage of sublicense income ranging from 10% to 30% depending on the phase of clinical trials.

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 5% 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 $2,000,000 in cash.

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 License Agreement also provides for development milestone payments of $5,000 upon the first commercial sale of an approved Licensed Product and $50,000 upon net sales of Licensed Product of at least $500,000.

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 $50,000.

Subsequent to September 30, 2024, the Company entered into 2024 Notes with non-related party investors in the aggregate principal amount of $400,000.

Series D-1 Preferred Stock

Subsequent to September 30, 2024, principal and interest in the aggregate amount of $54,033, owed in connection with 2022 Notes was converted into 18,880 shares of Series D-1 Preferred Stock at the Conversion Price of $2.862. Any fractional shares issuable pursuant to the formula were rounded up to the next whole share of Series D-1 Preferred Stock.

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.