GeoVax Labs, Inc. (NASDAQ:GOVX) Q4 2023 Earnings Call Transcript

GeoVax Labs, Inc. (NASDAQ:GOVX) Q4 2023 Earnings Call Transcript March 1, 2024

GeoVax Labs, Inc. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).

Operator: Good afternoon, and welcome, everyone, to the GeoVax Fourth Quarter 2023 Corporate Update Call. My name is Desiree, and I will facilitate today's call. With me are David Dodd, Chairman and CEO; Mark Reynolds, Chief Financial Officer; Dr. Mark Newman, Chief Scientific Officer; Dr. Kelly McKee, Chief Medical Officer; and Dr. John Sharkey, Vice President, Business Development. [Operator Instructions] As a reminder, this conference is being recorded. At this time, I am turning the call over to Max Gadicke of SternIR.

Max Gadicke: Thank you. 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 weather. GeoVax can develop and manufacture its product candidates with the desired characteristics in a timely manner and such products will be safe for human use. GeoVax's vaccines will effectively prevent targeted infections in humans. GeoVax's product candidates will receive regulatory approvals and necessaries to be licensed and marketed.

A scientist in a lab conducting research on cell-based therapeutics and biotechnology.

GeoVax raises required capital to complete development of its products. 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.

David Dodd: Good afternoon, and thank you for participating in the GeoVax corporate update call. Last year, and more specifically, during the fourth quarter, we successfully advanced our developments, focused on the two Phase 2 clinical stage products while also advancing other critically important initiatives. Today, we'll discuss the progress status and plans related to Gedeptin currently in development as a therapy against advanced head and neck cancer and GEO-CM04S1, our next-generation COVID-19 vaccine. Our goal is to develop innovative cancer therapies and infectious disease vaccines, addressing critically important unmet medical needs, pursuing initial indications that support expedited registration pathways. We anticipate worldwide development, commercialization and distribution via business partnerships and collaborations.

Following my comments, Mark Reynolds, our CFO, will provide an update on our financials and then your questions will be addressed. At year-end, we announced the closure of enrollment for the Phase 1/2 trial of Gedeptin among advanced head and neck cancer patients. This initial targeted patient population represents those who are in end-stage care, the 15,000 U.S. and 400,000 worldwide. These patients represent a critical unmet medical need. Many are unable to swallow food and have difficulty speaking. Typically, they have exhausted existing therapies and standard of care and are receiving palliative care. Our goal has been to provide an improved end-stage quality of life in these patients by shrinking and/or eliminating various targeted tumors and to provide clinical evidence supporting advancement of this therapy in earlier-stage disease.

As you may recall, this trial was funded by the FDA under the Orphan Drugs clinical trials program. Last July, initial clinical data results were presented at the AACR AHNS Conference in Montreal. That presentation noted that administration of Gedeptin was shown to be safe and feasible reflecting stabilization and/or reduction in size of treated tumors. We expect to report the final results of this trial during first half 2024, followed by discussing our plans for further evaluation of Gedeptin in patients with advanced head and neck cancer. Our strategy also considers Gedeptin therapy for earlier-stage HNSCC with less tumor burden, including a role similar to neoadjuvant or cytoreductive radiotherapy in combination with checkpoint blockade inhibition.

We also anticipate discussions with the FDA during 2024 related to an expedited path to registration. The vast array of unmet medical needs within oncology represents significant opportunities for GeoVax to advance novel approaches, addressing various cancer patient needs worldwide. We refer to Gedeptin as tumor-agnostic, meaning that this mechanism of action will enable us to address a variety of solid tumors, both cancerous and benign. We hold worldwide rights for all indications of this technology, and we are participating in various oncology and partnering conferences and some of which we will present conducting clinical data and with others to conduct partnering discussions. GEO-CM04S1, our next-generation COVID-19 vaccine aims to provide a more practical public health friendly COVID-19 vaccine solution than that offered with currently approved vaccines by stimulating a robust and durable immune response across multiple virus variants as a result of targeting both the antibody and cellular arms of the immune system and through the use of a proven safe and efficient replication-deficient vaccine delivery pathway.

This is critically important in addressing the high-risk populations of immune compromised individuals for whom the current vaccines in monoclonal antibody therapies are inadequate. The immune profile generated following receipt of GEO-CM04S1 also positions it well for more general use as a heterologous booster to current mRNA vaccines, providing a more robust durable functional response against emerging variants, potentially without the need for the continuous vaccine reconfiguration that appears necessary with the mRNA vaccines. Three Phase 2 clinical trials are underway with CM04S1, two of which address the high-risk populations of immunocompromised patients. The other Phase 2 trial is a evaluating our vaccine as a booster following prior receipt of an mRNA vaccine.

We hope to demonstrate that our COVID-19 vaccine substantially addresses the current unmet needs among the millions of immunocompromised patients while also demonstrating the vaccine as a more robust, durable universal booster for the current authorized vaccines. Last September, we completed enrollment in our Phase 2 trial assessing CM04S1 as the booster for the mRNA vaccines. This trial involves 63 healthy adults who had previously received the Pfizer or Moderna mRNA vaccine. The immunological responses measured throughout the study include both neutralizing antibodies against /SARS-CoV-2 variants and specific T cell responses. Earlier this month, we reported positive interim data from this trial, indicating no serious adverse events and statistically significant increases in neutralizing antibodies against multiple SARS-CoV-2 variants ranging from the original Wuhan strain through Delta in the highly virulent Omicron SBB 1.5, as well as demonstrating robust cellular immune responses.

Additional testing against the current variant of concern, the JN 1 variant is currently underway. Final results from this trial are anticipated during the fourth quarter of this year, reflecting the 12-month monitoring of these patients. Previously, we've discussed in the U.S., there are approximately 15 million immunocompromised individuals. Worldwide, they are estimated over $240 million. Such populations include those with various blood cancers, renal disease, autoimmune diseases such as lupus, they include transplant patients and others with disease or therapy-induced immunosuppression. Many of these patients are limited in their ability to respond adequately to the approved mRNA vaccine, placing them as significantly increased risk of severe COVID-19 infection hospitalization and potential death.

Recently, it was reported in JAMA in February 15 that the number of immunocompromised adults in the U.S. has been updated, indicating a population of $23 million versus the previous estimate of $15 million. There is a major critical need for next-generation COVID-19 vaccines to support such individual, and we believe that CM04S1 is the leading next-generation vaccine in clinical development in support of the needs of immunocompromised patients. During 2023, initial data from stem cell transplant trial was presented at several international conferences, including the World Vaccine Congress in Washington, D.C. In addition, results were published this past September in the peer-reviewed journal vaccines. These findings demonstrated robust immunogenicity illustrating the vaccine ability to strongly induce both antibody and T-cell responses essential for confirming protection, particularly in immunocompromised individuals.

The vaccines article also highlighted the unique feature of CM04S1, providing protective immune levels from the ancestral Wuhan strain all the way through what I mentioned earlier, the highly virulence Omicron XBB1.5 variant. Initial patient enrollments into this trial occurred at the City of Hope Medical Center in California. More recently, however, additional sites have been added as we seek to accelerate the pace of trial enrollment. In addition to the patients initially enrolled from City of Hope, there are now four additional sites actively recruiting patients in this critically important Phase 2 trial. The four expansion sites include the Fred Hutchinson Cancer Center in Seattle, University of Massachusetts Medical Center in Worcester, Mass, Wake Forest Baptist Medical Center in Winston-Salem of North Carolina and Eastern Carolina Medical Center in Benson, North Carolina.

While we are currently focused on optimizing patient enrollment from these sites, we've seen considerable interest, both domestically and internationally and participating in this clinical study. Following the initiation of patient enrollment in the immunocompromised CLL trial last August, this investigator-initiated trials continue to recruit and enroll patients more recently expanding to additional City of Hope locations. The trial is designed to evaluate CM04S1 among approximately 80 CLL patients directly comparing with the Pfizer-BioNTech mRNA vaccine. Typically, these patients are unable to generate adequate levels of protective antibodies following mRNA vaccination due to their underlying hematologic malignancy placing them at extreme risk of developing clinically severe COVID-19.

As a consequence, many of these patients remain homebound more than three years since the pandemic began. We are optimistic that CM04S1 can offer these individuals the protection from these buyers that they so desperately need. Results from an interim analysis of the ongoing trial are anticipated during the first half 2024. Relative developing CM04S1 immunocompromised patients we believe that an opportunity exists for an expedited regulatory path due to our focus on such high-risk unserved populations. Now I'd like to comment regarding Project NextGen. Last April, the White House announced this $5 billion initiative to follow on from operation Warp Speed. Seeking COVID-19 vaccines with enhanced breadth of protection against variants and improved durability, particularly insisted in novel vaccine candidates already in clinical trials.

We believe that CM04S1 is a prime example of the desired next-generation COVID-19 vaccine. Regarding Project NextGen, we continue with active discussions related to the formal participation in this program. Of the $5 billion set aside for funding there remains over $3 billion still to be awarded. Beyond noting that we remain in active discussions and negotiations regarding participation, we can't comment further at this time. Finally, related to CM04S1, we anticipate partnering and collaborations and additional clinical and research efforts and in support of worldwide commercialization and distribution. Active initiatives are underway in this area. Overall, we're addressing opportunities that provide us a basis for achieving leadership within those targeted patient areas and commercial markets.

Our current clinical stage products, Gedeptin and CM04S1, are focused on patient populations currently unserved by existing vaccine vendor therapies. We believe that the potential of achieving product leadership in addressing the therapeutic and vaccine needs of these respective populations exist and we're focused in that area. Also, GEO [MVA], our vaccine against Mpox and smallpox is intended to disrupt an existing global monopoly in that important area, providing us a leadership position as the first U.S.-based supplier of such a vaccine. We're confident that we're on the course that will build significant shareholder and stakeholder value while delivering critically important differentiated products to improve lives worldwide. During this year, we will report further progress and results from our CM04S1 Phase 2 programs.

And for Gedeptin, we expect to report the final results from the current trial and our plans with the expanded Phase 2 trial. We also expect to report further plans regarding next steps related to evaluating Gedeptin as combination therapy used in conjunction with immune checkpoint inhibitors. Relative to our MVA vaccine against Mpox and smallpox, we anticipate reporting our regulatory path and plans related to advancing that product towards registration. Finally, we anticipate further updates related to our advanced MVA manufacturing process targeted to enable GeoVax to effectively produce and distribute MVA-based vaccine in response to real-time market needs worldwide. To summarize, our various clinical stage products, Gedeptin, CM04S1 and MVA represent clinically important areas of medical needs, largely unserved by current products and standard of care.

We are pleased with the consistent encouraging results we're seeing from our clinical trials. More we believe the expedited path to registration are feasible for these products. From a potential commercial perspective, these product opportunities represent an estimated annual U.S. revenue potential of almost $30 billion. Now that's not a sales forecast, but rather a reflection of the significance of the need to address these critically important areas. Expanding this to a worldwide basis in conjunction with partners and collaborators adds to the confidence that we have relative to the outlook for GeoVax our shareholders and stakeholders. Now I'd like to turn the presentation over to Mark Reynolds, GeoVax's Chief Financial Officer, for a review of our recent results and financial status.

Mark?

Mark Reynolds: Thank you, David. I'll start the financial review with our income statement. We had no active grants during 2023, so we reported no grant revenues this year as compared to a small amount in 2022. However, as David has noted, we are having ongoing discussions with BARDA relative to Project NextGen. If an award were to be made, this would become a very important component of our financing mix going forward as well as a catalyst for other financing efforts, but there is no award to date, so these are definitely forward-looking statements. Research and development expenses were $20.7 million in 2023 versus $9.1 million in 2022, an increase of $11.6 million. This increase is primarily associated with the accelerated clinical trial activity for our CM04S1 and Gedeptin programs, including manufacturing costs for clinical trial materials.

The increase also includes costs associated with the AGE1 cell line manufacturing technology licensed from ProBiogen, which will be important to the future commercialization and partnering activities for all of our MVA-based vaccines. General and administrative expenses were $6 million in '23 versus $5 million in 2022, with the increase mostly associated with higher legal and patent costs, investor relations expenses, consulting fees and personnel costs. Interest income was $776,000 in '23 versus just $7,000 in '22 reflecting increasing interest rates available through our money market accounts. So overall, net loss for '23 was [$265] million or $14.29 per share versus $14 million in 2022 or $12.36 per share, again, with the increase being driven by clinical trial programs.

Now to the balance sheet. Our cash balances at December 31 of '23 were approximately $6.5 million as compared to $27.6 million at the end of 2022. The change in the cash loss is reflective of $25 million used in operating activities, partially offset by $4.1 million in net proceeds from the exercise of warrants in this past December. Outstanding common shares currently stand at $2.2 million following the reverse split we executed in January this year, which falls us back into full NASDAQ compliance. Funding our ongoing Phase 2 clinical programs for CM04S1 and Gedeptin will continue to be the most significant use of our cash for 2024. We don't expect this prioritization of our spending change if we receive a project NextGen award from BARDA as any incremental spending for that program will be funded by the award.

We do expect to raise additional capital to fund programs in 2024, and we intend to do that in conjunction with positive news flow. I'll be happy to answer questions during the Q&A, and I'll turn the call back to David now.

David Dodd: Thank you, Mark. My colleagues and I will now answer your questions. Joining us for the Q&A session are Dr. Mark Newman, Kelly McKee and John Sharkey, our Chief Scientific Officer, Chief Medical Officer and Vice President of Business Development, respectively. I'll now turn the call over to the operator for instructions on the question-and-answer period.

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