GeoVax Labs, Inc.
Q4 2020 Earnings Call Transcript

Published: 24 Mar 2021

[Operator:]

Good morning and welcome everyone to the GeoVax Fourth Quarter Year-end 2020 Corporate Update Call. I am Jayson with Chorus Call and will facilitate today's call. With me are David Dodd, Chairman and CEO; Mark Reynolds, Chief Financial Officer; and Mark Newman, Ph.D., Chief Scientific Officer. Please note this event is being recorded. I would now like to turn the conference over to Scott Gordon of CORE IR, who will provide a forward-looking statement regarding this call and information herein.

[Scott Gordon:]

Thank you, Jayson. 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.

[David Dodd:]

Good morning and thank you for participating in the 2020 fourth quarter year-end GeoVax quarterly update call. At the cusp of third to fourth quarter 2020, GeoVax capitalized the company and achieved the NASDAQ listing, securing significant resources and support of accelerating our development programs towards clinical development. We are focused on delivering meaningful results and value milestones over the next 12 to 15 months. Our focus is on advancing our priority programs related to COVID-19 and immuno oncology, developing increased value for shareholders, stakeholders and public health worldwide. In October, we announced a license agreement with NIH providing GeoVax full access to and use of critical NIH patents of materials in support of COVID-19 vaccine product development, clinical development and continued progress through FDA registration, manufacturing and commercialization. Executing that license underscores our commitment to and confidence in our unique vaccine development approach relative to COVID-19. In November, we announced another license with NIH providing GeoVax full access to and use of the NIH patents and materials in support of vaccine product development against numerous pathogens including within cancer immunotherapy. This additional broad based product target license underscores our focus and commitment to advancing a high value, meaningful product pipeline for registration and commercialization. Once we decide to advance a specific product into clinical development, we anticipate executing a license with NIH similar to our COVID-19 agreement.

[Mark Newman:]

Thank you, David. What I'm going to do is go over the MVA vector program that we're working on. So as we've noticed previously, the GeoVax vaccine is based on the use of the modified Vaccinia Virus Ankara, abbreviated MVA. So MVA was developed as a smallpox vaccine for use in the elderly and immune compromised individuals with an enhanced focus on safety. So it's really ideally suited as a vaccine vector within the -- for use within the general population.

[Mark Reynolds:]

Thank you, Mark. So obviously the biggest event from a financial perspective during this past year was our public offering in September, and the concurrent uplisting to NASDAQ. So I'm going to start the financial review with our balance sheet, which really sets the stage for our progress moving forward. Cash balances at the end of the year were just under $10 million, $9.9 million as compared to only $283,000 in the last year. Working capital was $9.4 million as compared to a negative $1.6 million at the end of 2019. So we've dramatically improved our financial position here.

[David Dodd:]

Thank you Mark. My colleagues and I will now answer your questions, and therefore turning the call over to the operator for instructions on the question-and-answer period. Thank you.

[Operator:]

Our first question is from Jason McCarthy from Maxim Group. Please go ahead.

[Jason McCarthy:]

Hi, guys. Thanks for taking the questions. I think my question is directed at Mark Newman. Can you -- you had mentioned or someone had mentioned that part of the interaction with NIH or regulators in general was that they understand the need or another or variation of a COVID vaccine. Can you talk a little bit about why MVA and VLPs get you T cells and B cells for antibodies? Why you need the T cells and really why the mRNA vaccines, in immunology circles nobody really believes you get anything more than antibodies and you get nothing more than 90 days. And it seems like regulators are aware of this, but they're not very public about it at all. Can you elaborate a little bit on that?

[Mark Newman:]

Yes, I think I can address your point. So, bear in mind, there's four circulating variants of coronavirus, right? They cause severe common colds. And then in the last 15 years we've had SARS-1 which is deadly MERS which is still circulating in the Middle East and now the SARS-2, CoV-2, which has become pandemic and we're all familiar with that. So coronaviruses are a significant issue. What we are looking at doing is targeting kind of the core elements of coronavirus. There's a certain component within the virus that makes it a coronavirus, right, certain properties and these cannot be varied significantly similar to like the S protein in which that's where you're seeing a lot of the variations that people are worried about. You get a mutation and a evolving variant. The immune response needs to adapt and the vaccine is -- has generated response against an earlier variant. So we're targeting the core -- more core coronavirus features for cellular immune responses. Significant amount of animal data and now accumulating human data within the pandemic is showing that the cellular immune responses are critical and individuals who have been exposed will generate these memory cells. So you're talking about 90 days with an antibody decay. It's probably significantly better than that. But still, we're looking for memory cells, which would be reactivated upon a new coronavirus type of infection. So these would be conserved against coronaviruses, all the coronaviruses that infect humans theoretically that would be the goal. The conservation and they're less subject to mutation and evolution, because they are what make a coronavirus, a coronavirus. They actually can't mutate. If you get a mutation of these types of proteins, then you don't have a viable virus. It is recognized within a field, obviously, the NIH and government institutions have a lag time in response. But as David mentioned, there is a recognize and an announcement for government support to move into the universal coronavirus program, that field and that's what we're going to be targeting. It's really ideally suited for the MVA where we can incorporate large numbers of coronavirus gene products into the vaccine. Our current generation vaccines, as I said, these involve three gene products. They're in the end stage of animal testing. And then the next generation products, we've already had design meetings. We're going through the literature to see what is -- what would represent the best design and targets. And we're actually starting to make some of these already and see what we can get expressed within the MVA. So we're not the only ones doing this. There's others, but the MVA technology is ideally suited because of the large coding capacity. Does that answer?

[Jason McCarthy:]

Yes, that's helpful. To your knowledge in the literature, or from some of the other vaccine developers has been, particularly the ones that are using viral . Are there any data out there, or population based data from exposed people that there are antibodies and T cells circulating targeting E & M proteins, not just S proteins?

[Mark Newman:]

Well, there is data existing from population studies that show that individuals who have never had COVID actually do have responses to T cell responses to COVID gene products. So they have preexisting immunity to coronavirus. It's not actually a COVID. It's caused by something else. So those are out there. The antibodies, yes, they're circulating strains to cause colds do generate antibodies. They're usually effective and protective for a year to two years, and then you get -- they decay, and so you can become re-susceptible to re-infection. So those types of things are recognized. But it's never been studied to the extent that we need to study it now, right, because if there was interest in a cold vaccine, you probably would have seen it before. But people aren't necessarily becoming severely ill. But when you get these pandemics, then that's what drives a response. It's a reactive response would be better to be proactive. But it's just not how necessarily work. So we know what's out there, lots of people are aware of it. And now there is significant interest in moving ahead with these new approaches.

[Jason McCarthy:]

And just last question. What is the timing to move into at least a Phase 1 study?

[Mark Newman:]

A lot -- for us, we'll have the animal data and we'll do the down selection for the first candidate that we're looking at and we think we know which one that's going to be. Within the next, I would say 2 to 3 months, and then we'll initiate manufacturing of the MVA. So that can take up to a year. So we'd be looking at starting a Phase 1 trial in Q2, Q3 of next year for the universal -- the first step and the universal coronavirus vaccine.

[Jason McCarthy:]

Got it. Thank you, Mark.

[Operator:]

There are no more questions in the queue. This concludes our question-and-answer session. I would like to turn the conference back over to David Dodd for any closing remarks.

[David Dodd:]

Thank you, and thank you to the participants for your continued support and interest in the progress and transformation of GeoVax. We have several near-term data milestones in which we look forward to updating you. Following the successful capitalization, NASDAQ listing and progress in our development portfolio, we remain focused on developing a highly valuable company, contributing to improved health options against various infectious threats and cancers. We anticipate issuing updates regarding the near-term data milestones and continued progress with our development programs. Thank you for your continued support of our commitment to these goals. Finally, I want to acknowledge and thank our GeoVax staff and the many other parties that continue to support, assist and advise us towards achieving success. For all of us, it is a great pleasure serving our shareholders and being a part of this team. Have a safe and enjoyable day. And again, thank you for your interest and support to GeoVax.

[Operator:]

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.