All of us are aware that, increasingly, variants of the COVID-19 continue to emerge, presenting further pandemic threats to health worldwide. As a result, the NIH and CEPI have issued requests for proposals for “pan-coronavirus vaccine development projects”, specifically seeking to fund “preventive vaccines able to provide broad and durable protection against coronaviruses, especially COVID-19 and others with pandemic potential.” Indeed, it is now apparent that the COVID-19 virus will continue to evolve, requiring expanded virus variant coverage, otherwise requiring annual re-configured vaccines, similar to what is necessary relative to influenza vaccination. In other words, the continued challenge will be to provide vaccines that will be adaptable against variants that might emerge. To that end, I urge you to read the article here from our CSO, Mark Newman, when he reports on his presentation at ESMED regarding our work on a Universal Coronavirus Vaccine.
Recent research related to long-term immunity to the disease appears to underscore the importance of a broad-based vaccine design, beyond simply targeting the spike-protein (e.g., targeting antibody immunity), also focusing on stimulating cellular (e.g., T-cell) immunity. This is exactly our approach. Our goal and efforts continue to focus on providing a single-dose, safe, durable “universal coronavirus” vaccine, providing immunity against potential variants before they emerge. And, our technology allows for minimal-to-no refrigeration, providing a potential major advantage over other technologies relative to distribution and administration.
In January, we announced receipt of NIH funding in support of our Universal Coronavirus vaccine development program. We’ve remained in contact with NIH, BARDA, and other entities with whom we’ll review our results. Already, based upon encouraging results that we’ve received thus far in our animal testing, we have submitted another, larger proposal to NIH in support of our universal coronavirus vaccine development. Similarly, we will be submitting significant funding requests to other entities based on the encouraging results we’ve seen so far.
Following the announcement of the initial NIH grant in support of our universal coronavirus program, we had the opportunity to further increase our cash position, successfully raising over $10 million; we also added over $3 million resulting from warrant exercises. Today, we have a cash position of approximately $20 million. We expect to further strengthen our balance sheet as similar opportunities present to increase our capital base on favorable terms. In summary, we are well capitalized to advance priority programs into clinical development over the next 12-18 months. Our priority remains focused on the universal coronavirus program and immuno-oncology, while also strengthening our resources in support of accelerating our product development and path to clinical development.
As noted in our previous Corporate Update, we continue to strengthen our IP portfolio, now having over 70 granted or pending patent applications spread over 20 patent families, with additional applications occurring during the First Quarter. In February, we filed international and U.S. patent applications in our key focus areas of SARS-CoV-2 (COVID-19) and cancer immunotherapy. More recently, in July, the Company announced the issuance of a U.S. patent covering our Hepatitis B vaccine. We are confident that we have a strong IP position providing an increasingly more competitive position.
In addition to our Universal Coronavirus vaccine program, we continue to progress other initiatives. This includes our advancing plans relative to immuno-oncology where our animal-testing results have been encouraging in support of progressing into clinical development. Also, our Lassa, Ebola Sudan and Marburg vaccine programs are currently completing animal testing through non-human primate evaluation, supported through federal government non-dilutive funding. In summary, we have a compelling pipeline focused on major medical needs, providing significant commercial market opportunities, with near-term value milestones. Included in our development portfolio are six indications that qualify for the FDA Priority Review Voucher Program. Our priority focus remains on advancing our universal coronavirus vaccine program and our immuno-oncology developments, while these other programs will advance requiring minimal resources from GeoVax. In advancing our developments we will also consider opportunities to accelerate our progress through various strategic considerations that we identify.
In summary, we are pleased to have this opportunity to review and discuss our continued progress in accelerating our priority development programs towards clinical development and continuing to secure significant resources in support of GeoVax growth and development. Over the past year, we strengthened our cash position while advancing towards important data milestones related to several of our programs. We remain focused on delivering meaningful results and value milestones over the next 12-18 months focused on our priority programs related to COVID-19 and immuno-oncology, developing increased value for shareholders, stakeholders, and public health worldwide.
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing human vaccines against infectious diseases and cancer using novel patented platforms. GeoVax’s Modified Vaccinia Ankara-Virus Like Particle (MVA-VLP) based vaccine platform utilizes MVA, a large virus capable of carrying several vaccine antigens, that expresses proteins that assemble into VLP immunogens in the person receiving the vaccine. The production of VLP in the person being vaccinated can mimic virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. The MVA-VLP derived vaccines can elicit durable immune responses in the host similar to a live-attenuated virus, while providing the safety characteristics of a replication-defective vector.
GeoVax’s MVA-VLP development programs are focused on preventive vaccines against COVID-19, HIV, Zika Virus, and hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa), as well as therapeutic vaccines against multiple cancers. The Company has designed a preventive HIV vaccine candidate to fight against the subtype of HIV prevalent in the commercial markets of the Americas, Western Europe, Japan, and Australia; human clinical trials for this program are managed by the HIV Vaccine Trials Network (HVTN) with the support of the National Institutes of Health (NIH). GeoVax’s HIV vaccine is also part of a collaborative effort toward a functional cure for HIV.
Forward-Looking Statements
This release and the related conference call contain forward-looking statements regarding GeoVax’s business plans and financial results. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax and its collaborators are able to complete their work within the expected timeframes, GeoVax is able to obtain the patent protection sought, GeoVax’s COVID-19 vaccines can provoke responses to multiple COVID-19 antigens, and those vaccines can be used effectively as a primary or booster to other COVID-19 vaccines, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, 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 development, 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, the impact of the COVID-19 pandemic continues, and other factors, over which GeoVax has no control. Further information on our risk factors is contained in our registration statement on Form S-3 and the periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Contact: GeoVax Labs, Inc. investor@geovax.com 678-384-7220
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