GeoVax Labs, Inc.

Good afternoon and welcome everyone to the GeoVax Second Quarter 2022 Corporate Update Call. I am Andrew with Chorus Call and will facilitate today's call. With me are David Dodd, Chairman and CEO, Mark Reynolds, Chief Financial Officer, Mark Newman, PhD, Chief Scientific Officer, Kelly McKee, MD, MPH, Chief Medical Officer, and John Sharkey, PhD, Vice President, Business Development. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. Please note the following. Certain statements in this presentation may constitute forward looking statements within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether Geovax can develop and manufacture its vaccines with the desired characteristics in a timely manner. Geovax's vaccines will be safe for human use. Geovax's vaccines will effectively prevent targeted infections in humans. Geovax's vaccines will receive regulatory approvals necessary to be licensed and marketed. Geovax raises required capital to complete vaccine developments. There is development of competitive products that may be more effective or easier to use than Geovax's products. Geovax will be able to enter into favorable manufacturing and distribution agreements and other factors over which Geovax has no control. Geovax assumes no obligation to update these forward-looking statements and does not intend to do so. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission, including those set forth at Risk Factors in GeoVax's Form 10-K. It is now my pleasure to introduce the Chairman and CEO of GeoVax, David Dodd.

Thank you. Good afternoon, everyone. Thank you for participating in the 2022 second quarter update call. Second quarter represented an exciting and critical period for GeoVax in that we advanced clinical stage development status within the two priority areas of COVID-19 vaccine development and cancer therapy. In addition, we continued to advance our preclinical development stage programs. We also successfully strengthened our balance sheet during a very difficult investment environment, especially for the biotech sector. Our mission is to improve lives worldwide, preventing or treating some of the world's most challenging infectious diseases and cancers. Our pursuit is to deliver safe, affordable products, delivering increased value to shareholders and stakeholders while providing motivating career development opportunities to members of our team. The in-licensing of GEO CMO4 S1 and Godeptin have provided potential significant value expansion for the company. CMO4S1 is a leading next generation COVID-19 vaccine and phase two clinical development targeting both antibody and cellular immunity with the goal of providing more robust and durable protection than the current authorized vaccines. This vaccine holds promise from several critical areas of differentiation and value over the current authorized vaccines. Goodeptin is a cancer therapy currently in an expanding multi-site evaluation among patients suffering from advanced head and neck cancers. The product has received orphan drug designation from the FDA, as well as the initial funding in support of the current clinical trial coming from the FDA Orphan Drugs Clinical Trials Program. We believe that Goodeptin holds significant clinical promise, including a potential accelerated development pathway. Both CMO4S1 and Godeptin are now under the sponsorship of GeoVax, and our focus is on accelerating the clinical development of each of these products, including the potential for expedited regulatory review. At the same time, we continue to advance other internal development programs on the path to IND filing. Earlier this year, we issued a 2021 milestone report addressing the goals we established and communicated early last year. That report outlined our successful performance in executing upon our 2021 goals. In addition, we provided our goals for 2022. Our focus and activities remain on this year's goals, primarily reflecting and focusing on the acceleration of clinical development for Godeptin and CMO4S1 and the transition to a more efficient higher yield MVA manufacturing process. In January, we strengthened our balance sheet with a $10 million direct investment. In May, we closed a $20 million direct investment. In fact, just this week, an additional $5 million was added as a result of the exercise of warrants. We continue to receive strong interest related to investment capital, which we'll evaluate. But we're focused on execution towards our 2022 goals and building shareholder value. Mark Reynolds, GeoVax CFO, will provide a more comprehensive overview of our financials. Regarding Gdeptin, we previously confirmed two additional clinical sites in the assignment of Ellucian as our CRO partner responsible for leading the expansion and acceleration of the Gdeptin clinical program. Our focus on accelerated and expanded patient enrollment is actively underway. with the goal to complete patient enrollment in early 2023, followed by completion of patient evaluations by the end of 2023 or 2024. Should the results be supportive, a BLA filing may follow shortly thereafter, but that will determine based upon further discussions with the FDA. In parallel with the ongoing clinical program, we're also engaged with the CDMO to ensure sufficient product for the expanded clinical program, as well as to prepare for commercial manufacturing. We're confident that the Gdeptin Phase II program will be successfully managed by Ellucian and our clinical operations team with possible expansion of further additional clinical sites. We're highly excited about the outlook and promise of Gdeptin within advanced head and neck cancer. In addition, there are promising opportunities relative to the expanded use of Gdeptin and other indications as well as the GDEP technology in conjunction with other therapies and potential synergy with our MVA-BLP tumor-associated antigen approach. We're looking forward to providing milestone updates throughout this year about the progress of our GDEPTED program. We're highly focused on the clinical development of CMO4S1 against COVID-19, including the continued emerging variants of concern. CMO4S1 utilizes synthetic modified vaccinia-ancra technology, similar to our other vaccine programs under development at Geovax. CMO4S1 induces immunity to SARS-CoV-2 by stimulating the immune system to produce antibodies against SARS-CoV-2 that can block the virus from entering healthy cells, while the immune system can also grow new disease-fighting T cells that can recognize and Destroy Infected Cells. The vaccine includes both SARS-CoV-2 spike and nucleocapsid proteins differing from the current authorized vaccines, which only include the spike protein. This is an important distinction. By inserting both of these proteins into our vaccine design, the MVA delivery vehicle is able to drive the expression of both proteins within the body of the vaccine recipient, inducing immune responses. The role of the S protein is to elicit a neutralizing antibody response against the initial infection, while the N protein elicits a T cell response to directly attack virus-infected cells, reduce viral replication, and reduce severity, and provide viral clearance. Thus, the vaccine is designed to induce both neutralizing antibodies and T cell responses specific for the S protein and the N protein. The vaccine design was implemented specifically to induce an expanded immune response to better combat and clear infections regardless of the circulating SARS-CoV-2 variants. This vaccine is the first step in the worldwide goal to provide a vaccine that gets ahead of the variants versus having to chase the variants. If successful, this vaccine will reduce reliance on the repeated administration of booster doses of existing vaccines. We believe that a multi-punch approach such as this has the potential for providing a more robust and durable immune response and protection than the current authorized vaccines. We also believe that various high-risk populations, such as immune-compromised individuals, will benefit from such a multi-prong approach. In fact, in July, analysis of data from the Phase I study of CMO4S1 published in the peer-reviewed journal iScience showed that CM04S1 demonstrated potent and equivalent T-cell cross-reactivity against Delta and Omicron variants. These findings suggest that T-cell immunity stimulated by CM04S1 may constitute a critical second line of defense to provide long-term protection against SARS-CoV-2 variants. And I'll repeat, these were based upon the analysis of data from the Human Clinical Trial Phase 1 study of CM04S1. O4S1, which was indeed published in iScience. CMO4S1 is currently being evaluated in two Phase II clinical trials. One trial is a comparative study of CMO4S1 as the primary vaccine versus the current FDA-approved Pfizer vaccine in people that have received or are undergoing specific blood cancer therapies associated with transplantation or Part T therapy that suppress or severely reduce preexisting immunity to COVID-19 vaccines. Multiple clinical evidence has demonstrated that such patients fail to respond optimally to the current generation vaccines, and we believe that the CMO4S1 will prove to be more potent because it is multi-antigenic, delivered using the MVA vector. We believe this will differentiate CMO4S1 from the other vaccines by providing both a strong antibody response and a sustained T cell response in these patients who are still at high risk of severe COVID-19 due to their immunocompromised status. The other phase two trial underway is evaluating CMO4S1 as a booster for healthy patients who have previously received either the Pfizer or Moderna mRNA vaccine. We believe that providing a heterologicus booster rather than a continued multiple shots of the same vaccine or similar vaccine may provide more robust and durable immune response and protection. Heterologicus prime boost immunizations are well studied in other fields such as HIV and are being evaluated in multiple countries using different COVID vaccines. Finally, the ongoing GeoVax effort to develop an advanced MVA manufacturing process based on a continuously growing cell line to increase production consistency and capacity will well mesh with the clinical development activities and full development schedule associated with the CM04S1 and the CM02 vaccine. We're not alone in recognizing the limitations of the current authorized COVID-19 vaccines. The continued need for more durable immunity, the waning of protective response, insufficient protection among various high-risk immunocompromised populations, and other evident issues are well documented and of increasing concern. We applaud the federal government for realizing that significant incremental funding is needed in support of next-generation COVID vaccines, providing the promise such as our CMO4 S1 and our CMO2, as well as other vaccines, therapeutics, and technologies. This was underscored by the actions of the Senate Appropriations Committee's recent FY23 Health and Human Services Appropriations Bill, specifically targeting next generation COVID-19 vaccine developments. We look forward to continued dialogue and discussions in support of CMO4 S1 and CMO2 as we continue to advance the developments of these important COVID-19 or coronavirus vaccines. Recently, the WHO declared monkeypox a public health emergency of international concern. Nations worldwide are enacting procedures and policies in support of minimizing the health risk from monkeypox to their populations. Currently, there are two vaccines authorized in the U.S. for prevention of monkeypox, the primary vaccine being modified vaccinia agra or MVA, which is also the vaccine vector utilized in numerous GeoVax vaccines, including our CM04S1 and CM02, which target COVID-19. In addition, MVA is the vaccine vector used in our hemorrhagic fever virus vaccines against Zaire Ebola virus, Sudan Ebola virus, and Marburg, as well as our development stage Zika virus vaccine and even our Mach 1 cancer immunotherapy. In fact, previous peer-reviewed publications addressed the successful prevention of monkeypox and non-human primate models following the administration of GeoVax's MVA-based HIV vaccines. Recognizing the global public health need and attention to monkeypox, Evaluation is underway related to CMO4S1 and the prevention of monkeypox. It is anticipated that the results will demonstrate successful protection, validating the CMO4S1 as protective against both COVID-19 and monkeypox. We also anticipate validating our hemorrhagic fever virus vaccines as protective against monkeypox, potentially providing unique vaccines preventing both hemorrhagic fever viruses and Monkeypox in a single vaccine. This would be very important in certain endemic areas of the world. We look forward to reporting more on this topic soon. Now I'd like to turn the presentation over to Mark Reynolds, GFX Chief Financial Officer for a review of our recent results and financial status. Thank you, Mark.

Thank you, David. Starting with our income statement, I'm going to go through some of this pretty quickly. I know most everybody wants to get to the Q&A. But starting with the income statement, I'll focus on the comparative figures. Actually, that's our balance sheet showing up first. Okay, here we go. Income statement. Grant revenues were 82,000 in the six-month period of 2022 versus 190 in 21. That's reflecting a wind down in both our grant from the NIH supporting the COVID-19 vaccine and the grant from the U.S. Army supporting our loss of fever vaccine program. As of June 30, 2022, all the currently available funds from those grants have been utilized. We do intend to seek additional non-dilutive funding for our development programs in the future, though. R&D expenses were $2.6 million in 2022 versus $1.4 million in 2021, with the increase, as expected, primarily associated with new clinical trial activity for COVID-19 and the cancer programs. and that includes manufacturing costs for clinical trial materials. The increase is also reflective of higher personnel and consulting costs as we staffed up for an overall higher level of activity. G&A expenses were $2.1 million in 22 versus $1.8 million in 21 with the increase also associated with higher personnel, consulting and higher patent costs in there also. So overall net loss for the first six months of 22, or $4.7 million, or $0.47 per share, versus $2.9 million in 21, or $0.49 per share. Again, with the increase primarily associated with ramp-up of organizational infrastructure and other costs associated with the CMO4S1 and Cadeptin clinical trials. Going back to the balance sheet, Our cash balances at June 30 were approximately $31 million, as compared to $11.4 million at the end of 21. And as David mentioned earlier, the change in the cash balances were reflective of 8.2 million used in operating activities, all set by proceeds from our stock offerings in January and May, with combined net proceeds of nearly $28 million. and these numbers I'll point out also do not reflect the additional $5 million that came in just this week from warrant exercises. So current cash stands at about $35 million. Funding our three ongoing Phase II clinical programs and preparing for the next stages of development are the most significant use of our cash and our top financial priority. And as I noted, we just received the $5 million through the exercise of the warrants Based on that, our outstanding shares now stand at $24.7 million. That's a current number. So in summary, we are well positioned to accelerate and advance our clinical programs with a cash runway sufficient to fund our operations and priority programs toward the end of next year. And I'll be happy to answer any other questions during the Q&A, but I'll turn now the call back over to David.