GeoVax Labs Inc
For the period ended Jun 30, 2024. Filed Aug 6, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2024 · Filed Aug 6, 2024
Contents
Item 1. Condensed Consolidated Financial Statements
| Condensed Consolidated Balance Sheets as of June 30, 2024 (unaudited) and December 31, 2023 | 1 | |
| Condensed Consolidated Statements of Operations for the three-month and six-month periods ended June 30, 2024 and 2023 (unaudited) | 2 | |
| Condensed Consolidated Statements of Changes in Stockholders’ Equity for the three-month and six-month periods ended June 30, 2024 and 2023 (unaudited) | 3 | |
| Condensed Consolidated Statements of Cash Flows for the six-month periods ended June 30, 2024 and 2023 (unaudited) | 4 | |
| Notes to Condensed Consolidated Financial Statements (unaudited) | 5 | |
| Item 2 | Management's Discussion and Analysis of Financial Condition and Results of Operations | 9 |
|---|---|---|
| Item 3 | Quantitative and Qualitative Disclosures about Market Risk | 15 |
| Item 4 | Controls and Procedures | 15 |
| PART II – OTHER INFORMATION | ||
| Item 1 | Legal Proceedings | 16 |
| Item 1A | Risk Factors | 16 |
| Item 2 | Unregistered Sales of Equity Securities and Use of Proceeds | 16 |
| Item 3 | Defaults Upon Senior Securities | 16 |
| Item 4 | Mine Safety Disclosures | 16 |
| Item 5 | Other Information | 16 |
| Item 6 | Exhibits | 17 |
| SIGNATURES | 18 | |
Part I -- FINANCIAL INFORMATION
| Item 1 | Financial Statements |
|---|
GEOVAX LABS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| (unaudited) | ||
| ASSETS | ||
| Current assets: | ||
| Cash and cash equivalents | $1,561,712 | $6,452,589 |
| Accounts receivable | 300,677 | - |
| Prepaid expenses | 1,981,134 | 1,433,153 |
| Total current assets | 3,843,523 | 7,885,742 |
| Property and equipment, net | 170,537 | 209,689 |
| Other assets | 81,010 | 1,187,788 |
| Total assets | $4,095,070 | $9,283,219 |
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | ||
| Current liabilities: | ||
| Accounts payable | $3,983,696 | $2,802,950 |
| Notes payable and accrued interest – related parties | 142,292 | - |
| Accrued expenses | 2,278,308 | 716,931 |
| Total current liabilities | 6,404,296 | 3,519,881 |
| Commitments (Note 5) | ||
| Stockholders’ equity (deficit): | ||
| Common stock, $.001 par value: | ||
| Authorized shares – 150,000,000 and 600,000,000 at June 30, 2024 and December 31, 2023, respectively | ||
| Issued and outstanding shares – 4,178,700 and 1,977,152 at June 30, 2024 and December 31, 2023, respectively | 4,179 | 1,977 |
| Additional paid-in capital | 112,964,554 | 110,125,146 |
| Accumulated deficit | (115,277,959) | (104,363,785) |
| Total stockholders’ equity (deficit) | (2,309,226) | 5,763,338 |
| Total liabilities and stockholders’ equity (deficit) | $4,095,070 | $9,283,219 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| Three Months Ended June 30, · Six Months Ended June 30, | ||||||
|---|---|---|---|---|---|---|
| 2024 · 2023 · 2024 · 2023 | ||||||
| Revenue from government contract | $300,677 | $ | - | $300,677 | $ | - |
| Operating expenses: | ||||||
| Research and development | 4,276,868 | 4,719,728 | 8,702,596 | 7,538,917 | ||
| General and administrative | 1,086,030 | 1,459,093 | 2,543,383 | 2,910,518 | ||
| Total operating expenses | 5,362,898 | 6,178,821 | 11,245,979 | 10,449,435 | ||
| Loss from operations | (5,062,221) | (6,178,821) | (10,945,302) | (10,449,435) | ||
| Other income (expense): | ||||||
| Interest income | 5,471 | 251,201 | 38,420 | 483,899 | ||
| Interest expense | (7,292) | - | (7,292) | - | ||
| Total other income (expense) | (1,821) | 251,201 | 31,128 | 483,899 | ||
| Net loss | $(5,064,042) | $(5,927,620) | $(10,914,174) | $(9,965,536) | ||
| Basic and diluted: | ||||||
| Net loss per common share | $(1.99) | $(3.79) | $(4.68) | $(5.66) | ||
| Weighted average shares outstanding | 2,539,878 | 1,562,910 | 2,334,464 | 1,759,427 | ||
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’** EQUITY (DEFICIT)**
(Unaudited)
| Total | |||||
|---|---|---|---|---|---|
| Common Stock · Additional · Accumulated · Stockholders’ | |||||
| Shares | Amount | Paid-in Capital | Deficit | Equity | |
| Balance at December 31, 2023 | 1,977,152 | $1,977 | $110,125,146 | $(104,363,785) | $5,763,338 |
| Issuance of common stock for services | 6,703 | 7 | 37,493 | - | 37,500 |
| Issuance of common stock upon warrant exercises | 269,032 | 269 | (269) | - | - |
| Fractional share roundup following reverse split | 55,422 | 55 | (55) | - | - |
| Stock option expense | - | - | 103,569 | - | 103,569 |
| Net loss for the three months ended March 31, 2024 | - | - | - | (5,850,132) | (5,850,132) |
| Balance at March 31, 2024 | 2,308,309 | 2,308 | 110,265,884 | (110,213,917) | $54,275 |
| Sale of common stock and warrants for cash | 220,000 | 220 | 1,209,318 | - | 1,209,538 |
| Issuance of common stock upon warrant exercises | 1,650,391 | 1,651 | 1,387,712 | - | 1,389,363 |
| Stock option expense | - | - | 101,640 | - | 101,640 |
| Net loss for the three months ended June 30, 2024 | - | - | - | (5,064,042) | (5,064,042) |
| Balance at June 30, 2024 | 4,178,700 | $4,179 | $112,964,554 | $(115,277,959) | $(2,309,226) |
| Total | |||||
|---|---|---|---|---|---|
| Common Stock · Additional · Accumulated · Stockholders’ | |||||
| Shares | Amount | Paid-in Capital | Deficit | Equity | |
| Balance at December 31, 2022 | 1,755,664 | $1,756 | $104,995,301 | $(78,397,023) | $26,600,034 |
| Issuance of common stock for services | 7,246 | 7 | 74,993 | - | 75,000 |
| Stock option expense | - | - | 228,039 | - | 228,039 |
| Net loss for the three months ended March 31, 2023 | - | - | - | (4,037,916) | (4,037,916) |
| Balance at March 31, 2023 | 1,762,910 | 1,763 | 105,298,333 | (82,434,939) | $22,865,157 |
| Stock option expense | - | - | 226,013 | - | 226,013 |
| Net loss for the three months ended June 30, 2023 | - | - | - | (5,927,620) | (5,927,620) |
| Balance at June 30, 2023 | 1,762,910 | $1,763 | $105,524,346 | $(88,362,559) | $17,163,550 |
GEOVAX LABS, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
| Six Months Ended June 30, | ||
|---|---|---|
| 2024 | 2023 | |
| Cash flows from operating activities: | ||
| Net loss | $(10,914,174) | $(9,965,536) |
| Adjustments to reconcile net loss to net cash used in operating activities: | ||
| Depreciation and amortization expense | 43,319 | 34,637 |
| Stock-based compensation expense | 259,376 | 515,552 |
| Changes in assets and liabilities: | ||
| Accounts receivable | (300,677) | - |
| Prepaid expenses and other current assets | (564,648) | (698,785) |
| Other assets | 1,106,778 | 976,498 |
| Accounts payable and accrued expenses | 2,745,248 | (662,382) |
| Total adjustments | 3,289,396 | 165,520 |
| Net cash used in operating activities | (7,624,778) | (9,800,016) |
| Cash flows from investing activities: | ||
| Purchase of equipment | - | (23,805) |
| Net cash used in investing activities | - | (23,805) |
| Cash flows from financing activities: | ||
| Net proceeds from issuance of notes payable – related parties | 135,000 | - |
| Net proceeds from sale of common stock and warrants | 1,209,538 | - |
| Net proceeds from warrant exercise | 1,389,363 | - |
| Net cash provided by financing activities | 2,733,901 | - |
| Net decrease in cash and cash equivalents | (4,890,877) | (9,823,821) |
| Cash and cash equivalents at beginning of period | 6,452,589 | 27,612,732 |
| Cash and cash equivalents at end of period | $1,561,712 | $17,788,911 |
Supplemental disclosure of non-cash financing activities:
During the six months ended June 30, 2024, we issued 2,549 shares of common stock upon the cashless exercise of 4,000 warrants.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2024
(unaudited)
| 1. | Nature of Business |
GeoVax Labs, Inc., headquartered in the Atlanta, Georgia metropolitan area, is a clinical-stage biotechnology company incorporated under the laws of the State of Delaware. GeoVax Labs, Inc. and its wholly owned subsidiary, GeoVax, Inc., a Georgia corporation, are collectively referred to herein as “GeoVax” or “the Company”.
The Company is focused on developing human vaccines for many of the world’s most threatening infectious diseases and therapies for solid tumor cancers using novel proprietary platforms. GeoVax’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which it was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In addition, the lead oncological clinical program is Gedeptin®, a novel oncolytic solid tumor gene-directed therapy, which is currently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. Additional preclinical research and development programs include preventive vaccines against Mpox (formerly known as monkeypox), hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan, and Marburg), and Zika virus, as well as immunotherapies for solid tumors.
| 2. | Summary of Significant Accounting Policies |
We disclosed in Note 2 to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023 those accounting policies that we consider significant in determining our results of operations and financial position. During the six months ended June 30, 2024, there have been no material changes to, or in the application of, the accounting policies previously identified and described in the Form 10-K.
Basis of Presentation
The accompanying financial statements include the accounts of GeoVax Labs, Inc. and GeoVax, Inc. All intercompany transactions have been eliminated in consolidation. The financial statements are unaudited, but include all adjustments, consisting of normal recurring entries, which we believe to be necessary for a fair presentation of interim periods presented. Interim results are not necessarily indicative of results for a full year. The financial statements should be read in conjunction with our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023. We expect our operating results to fluctuate for the foreseeable future; therefore, period-to-period comparisons should not be relied upon as predictive of the results in future periods.
We are devoting substantially all of our present efforts to research and development of our vaccine and immunotherapy candidates and will require additional funding to continue our research and development activities. Our existing cash resources are insufficient to continue our planned operations beyond the third quarter of 2024 without additional funding, which we are actively pursuing. We plan to pursue additional cash resources through public or private equity or debt financings, government grants/contracts, arrangements with strategic partners, or from other sources. There can be no assurance that additional funding will be available on favorable terms or at all. These factors collectively raise substantial doubt about the Company’s ability to continue as a going concern. Management believes that we will be successful in securing the additional capital required to continue the Company’s planned operations, but that our plans do not fully alleviate the substantial doubt about the Company’s ability to operate as a going concern.
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.
The accompanying consolidated financial statements, and all share and per share information contained herein, have been retroactively restated to reflect the reverse stock split described in Note 6.
Recent Accounting Pronouncements
During the six months ended June 30, 2024, there have been no new accounting pronouncements or changes in accounting pronouncements which we expect to have a material impact on our financial statements.
| 3. | Balance Sheet Components |
Prepaid Expenses – Prepaid expenses consist of the following:
| June 30, 2024 | December 31, 2023 | |
|---|---|---|
| Prepaid clinical trial costs (current portion) | $1,921,190 | $1,282,746 |
| Prepaid insurance premiums | 36,899 | 110,695 |
| Prepaid rent | 13,045 | 13,045 |
| Other prepaid expenses | 10,000 | 26,667 |
| Total prepaid expenses | $1,981,134 | $1,433,153 |
Property and Equipment – Property and equipment consist of the following:
| June 30, 2024 | December 31, 2023 | |
|---|---|---|
| Equipment and furnishings | $774,758 | $774,758 |
| Leasehold improvements | 115,605 | 115,605 |
| Total property and equipment | 890,363 | 890,363 |
| Accumulated depreciation and amortization | (719,826) | (680,674) |
| Total property and equipment, net | $170,537 | $209,689 |
Other Assets – Other assets consist of the following:
| June 30, 2024 · December 31, 2023 | |||
|---|---|---|---|
| Prepaid clinical trial costs (noncurrent portion) | $ | - | $1,106,778 |
| Prepaid technology license fees | 70,000 | 70,000 | |
| Deposits | 11,010 | 11,010 | |
| Total other assets | $81,010 | $1,187,788 | |
Accrued Expenses – Accrued expenses consist of the following:
| June 30, 2024 | December 31, 2023 | |
|---|---|---|
| Payroll-related liabilities | $168,974 | $114,337 |
| Accrued clinical trial costs | 351,460 | 490,635 |
| Accrued contract manufacturing costs | 1,687,874 | - |
| Other accrued expenses | 70,000 | 111,959 |
| Total accrued expenses | $2,278,308 | $716,931 |
| 4. | Notes Payable – Related Parties |
On May 10, 2024, we issued 10% Original Issue Discount Promissory Notes (the “Notes”) with an aggregate principal amount of $150,000 to members of our Board of Directors and senior management, in exchange for gross cash proceeds to us of $135,000. The Notes are unsecured, bear interest at a rate of 15% per annum, and mature upon the earlier of (i) six months from the issue date or (ii) three days following the date the Company completes an offering of its common stock with gross proceeds of not less than $5 million. We recorded a total debt discount of $15,000 upon the issuance of the Notes. Interest expense associated with the Notes was $7,292 for the three-month period ended June 30, 2024, consisting of $4,167 of debt discount amortization and $3,125 of accrued interest payable.
| 5. | Commitments |
*Operating Lease.*We lease approximately 8,400 square feet of office and laboratory space pursuant to an operating lease which expires on December 31, 2025. Rent expense for the three-month and six-month periods ended June 30, 2024 was $46,764 and $93,528, respectively, as compared to $45,414 and $90,828, respectively, for the same periods of 2023. Future minimum lease payments total $93,528 in 2024, and $192,708 in 2025 although the lease may be terminated at any time by either party with one hundred eighty days written notice.
*License Agreements.*We have entered into license agreements for various technologies and patent rights associated with our product development activities. These agreements may contain provisions for upfront payments, milestone fees due upon the achievement of selected development and regulatory events, minimum annual royalties or other fees, and royalties based on future net sales. Due to the uncertainty of the achievement and timing of the contingent events requiring payment under these agreements, the amounts to be paid by us in the future are not determinable.
Other Commitments. In the normal course of business, we enter into various contracts and purchase commitments including those with contract research organizations (“CROs”) for clinical trial services, contract manufacturing organizations (“CMOs”) for production of materials for use in our clinical trials, and other independent contractors or academic institutions for preclinical research activities and other services and products. Most contracts are generally cancellable, with notice, at the Company’s option. Payments due upon cancellation may consist of payments for services provided or expenses incurred to date, or cancellation penalties depending on the time of cancellation.
| 6. | Stockholders’ Equity |
Reverse Stock Split and Reduction of Authorized Shares of Common Stock
At a special meeting of our stockholders held on January 16, 2024, our stockholders approved an amendment to our certificate of incorporation to (i) reduce our authorized shares of common stock from 600,000,000 to 150,000,000 and (ii) effect a one-for-fifteen reverse split of our common stock. The amendment to our certificate of incorporation was filed with the Delaware Secretary of State on January 30, 2024 and our common stock began trading on the split-adjusted basis on January 31, 2024. The accompanying consolidated financial statements, and all share and per share information contained herein, have been retroactively restated to reflect the reverse stock split.
May 2024 Offering
On May 21, 2024, we closed a registered direct offering of 220,000 shares of common stock and pre-funded warrants to purchase an aggregate of 582,844 shares of common stock (the “May 2024 Pre-Funded Warrants”). In a concurrent private placement, we issued common warrants to the purchaser to purchase up to 1,605,688 shares of common stock at an exercise price of $1.68 per share (the “May 2024 Common Warrants”). Net proceeds after deducting placement agent commissions and other offering expenses were approximately $1.2 million. As noted under “Warrant Exercises” below, the May 2024 Pre-Funded Warrants were exercised in full during June 2024.
Warrant Exercises
During the first quarter of 2024, we issued 269,032 shares of our common stock upon the exercise of prefunded warrants issued in December 2023 (the “December 2023 Pre-Funded Warrants”). During June 2024, we issued 238,000 and 582,844 shares of our common stock upon the exercise of the December 2023 Pre-Funded Warrants and the May 2024 Pre-Funded Warrants, respectively; and 2,549 shares of our common stock upon the cashless exercise of 4,000 warrants issued in June 2020. Also during June 2024, we issued 826,998 shares of our common stock upon the exercise of common warrants issued in December 2023, with net cash proceeds to us of approximately $1.4 million.
Other Common Stock Transactions
During January 2024, we issued 6,703 shares of our common stock pursuant to a professional relations and consulting agreement and we issued 55,422 shares of our common stock for the roundup of fractional shares associated with the reverse stock split.
Stock Options
We have stock-based incentive plans (the “Plans”) pursuant to which our Board of Directors may grant stock options and other stock-based awards to our employees, directors and consultants. During the six months ended June 30, 2024,961 stock options were cancelled and there were no new grants of stock options or other transactions related to the Plans. As of June 30, 2024, there are 133,648 stock options outstanding, with a weighted-average exercise price of $28.39 per share and a weighted-average remaining contractual term of 7.7 years. Including the outstanding stock options, a total of 333,648 shares of our common stock are reserved for future issuance pursuant to the Plans.
Stock Purchase Warrants
The table below summarizes information concerning warrants outstanding as of June 30, 2024.
| Issue Date | Number of Shares | Exercise Price | Expiration |
|---|---|---|---|
| June 2020 | 4,000 | $1.68 | June 2025 |
| September 2020 | 159,781 | 75.00 | September 2025 |
| February 2021 | 4,800 | 103.13 | August 2024 |
| September 2021 | 6,668 | 195.00 | September 2026 |
| December 2023 | 582,000 | 1.68 | June 2029 |
| May 2024 | 1,605,688 | 1.68 | May 2029 |
| Outstanding at June 30, 2024 | 2,362,937 | ||
| 7. | Stock-Based Compensation Expense |
Stock-based compensation expense related to stock options is recognized on a straight-line basis over the requisite service period for the award and is allocated to research and development expense or general and administrative expense based upon the classification of the individual to whom the award is granted. Stock-based compensation expense related to stock option grants was $101,640 and $205,209 during the three-month and six-month periods ended June 30, 2024, respectively, as compared to $226,013 and $454,052, respectively, during the same periods of 2023. As of June 30, 2024, there is $342,156 of unrecognized compensation expense that we expect to recognize over a weighted-average period of 1.1 years.
We have also issued shares of our restricted common stock to consultants and recognize the related expense over the terms of the related agreements. During the three-month and six-month periods ended June 30, 2024 we recorded stock-based compensation expense of $-0- and $54,167, respectively, associated with common stock issued for consulting services, as compared to $43,500 and $61,500, respectively, for the same periods of 2023.
| 8. | Revenue from Government Contract |
On June 12, 2024, GeoVax was awarded a contract (the “BARDA Contract”) through the Rapid Response Partnership Vehicle (RRPV) to advance the clinical development of GEO-CM04S1, the Company’s next-generation COVID-19 vaccine. The RRPV is a consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS).
Under the BARDA Contract, GeoVax will sponsor a 10,000-participant, randomized, Phase 2b double-blinded study to assess the clinical efficacy, safety, and immunogenicity of GEO-CM04S1 compared with a U.S. Food and Drug Administration (FDA)-approved mRNA COVID-19 vaccine. The direct award to GeoVax of approximately $24.3 million, which may increase to as much as $45 million, will fund the manufacturing of clinical materials and support for the Phase 2b clinical trial, including regulatory activities. BARDA has made a separate award of approximately $343 million through its Clinical Studies Network to support execution of the study by Allucent, a global clinical research organization.
GeoVax’s role in the project is being funded in whole or in part with federal funds from BARDA under Other Transaction 75A50123D00005. Allucent’s role in the project is being funded in whole or in part with federal funds from BARDA under contract 75A50120D00016/75A50123F33005.
During the three-month and six-month periods ending June 30, 2024, GeoVax recognized revenue of $300,677 associated with the BARDA contract. We record revenue associated with this contract as the reimbursable costs are incurred.
| 9. | Net Loss Per Share |
Basic and diluted loss per common share are computed based on the weighted average number of common shares outstanding. The Company’s potentially dilutive securities, which include stock options and stock purchase warrants, have been excluded from the computation of diluted net loss per share as the effect would be antidilutive. The securities that could potentially dilute basic earnings per share in the future and that have been excluded from the computation of diluted net loss per share totaled 2,496,585 and 1,027,084 shares at June 30, 2024 and 2023, respectively.
| 10. | Income Taxes |
No provision for income taxes was recorded in either of the six-month periods ended June 30, 2024 and 2023. The Company remains in a cumulative loss position with a full valuation allowance recorded against its net deferred income tax assets as of June 30, 2024.
| 11. | Subsequent Events |
*July 2024 Offering.*On July 12, 2024, we closed a registered direct offering of 458,632 shares of common stock and pre-funded warrants to purchase an aggregate of 626,368 shares of common stock (the “July 2024 Pre-Funded Warrants”). In a concurrent private placement, we issued common warrants to the purchaser to purchase up to 2,170,000 shares of common stock at an exercise price of $2.86 per share (the “July 2024 Common Warrants”). Net proceeds after deducting placement agent commissions and other offering expenses were approximately $2.8 million. On July 18 and 23, 2024, we issued an aggregate of 626,368 shares of common stock upon full exercise of the July 2024 Pre-Funded Warrants.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.