GeoVax Labs (NASDAQ:GOVX) Q4 2020 Earnings Call

0:00 Good morning and welcome everyone to the GeoVax fourth quarter year-end 2020 corporate update call. I am Jason with CourseCall 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. 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. I'd 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.

0:51 Thank you, Jason. 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 G of X's vaccine will effectively prevent targeted infections in humans. G of X's vaccines will receive regulatory approvals necessary to be licensed and marketed.

1:40 G of X raises required capital to complete vaccine development. There is development of competitive products that may be more effective or easier to use than G of X's products. G of X 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 410 . It is now my pleasure to introduce the Chairman and CEO of GeoVax, David Dodd. David, please go ahead.

2:25 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 and materials in support of COVID-19 vaccine product development, clinical development, and continued progress through FDA registration, manufacturing and commercialization.

3:29 Executing that license, pardon me, 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 through 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.

4:22 In January, we announced receipt of NIH funding in support of our COVID-19 vaccine development program. There is increasing evidence that the COVID-19 virus will continue to evolve, requiring expanded virus variant coverage, otherwise requiring annual reconfigured vaccines similar to what is necessary relative to influenza vaccination.

4:46 We hope to change that.

4:47 encompassing potential variants before they emerge versus chasing the evolving virus, as will be likely required of various competitive technologies. In November, this past November, less than a week following our previous corporate update call, the NIH issued a request for proposals for what it referred to as a pan-coronavirus vaccine development project, specifically seeking to fund preventive We'll speak more about this a little bit later Following the announcement of the NIH grant in support of our COVID-19 program, we had the opportunity to further increase our cash position, successfully raising over $10 million gross, resulting in a total cash position of $20-plus million with no debt. As a result, we are well capitalized to advance priority programs into clinical development over the next 12 to 15 months and more.

6:09 Meanwhile, we continue to strengthen our IP portfolio, now having over 70 granted or pending patent applications spread over 20 patent families. We are confident that we have a strong IP position, providing an increasingly more competitive position. 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 voucher program, most of which are continuing to advance with non-diluted funding. Our priority focus remains on advancing our COVID-19 vaccine program and our immuno-oncology developments, while these other programs will advance requiring minimal resources from GeoVax.

7:02 Now I'd like to turn the call over to Mark Newman, Ph.D., our Chief Scientific Officer.

7:10 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, ANCRA, 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 for use within the general population. The primary advantage of MVA is the large genetic coding capacity, which allows us to include multiple genes for a given target. This is shown in the pictures, antigen 1, antigen 2, and antigen 3.

7:59 This allows us to develop vaccines that will actually support the generation of virus-like particles within the body. of the vaccinated individual. So these accurately mimic the structure of the infectious virus and induce the correct immune responses, but they're totally non-replicative, but so particularly safe. These will induce both antibodies and cellular immune responses, and because they mimic the virus, ideally they'll be immunogenic and induce protective responses within a single dose. Now, our experimental COVID vaccines are designed to take advantage of the MVA-VLP technology and encode the spike protein, which is the focus of most of the current generation vaccines.

8:53 And we're producing these in combination with the matrix and envelope proteins, M and E. So the M and E proteins provide the structural components required for the VLP Thank you for joining us today. We are working to get ahead of the evolution of COVID rather than chase the new variants, as David noted. So we won't be producing modified vaccines on a yearly basis, but rather a universal coronavirus vaccine. Now, the first three experimental vaccine constructs are in the final stages of small animal testing, and this testing includes infectious challenges. So we're looking at protection.

10:03 The product that proves to induce the most protective immune responses will be the basis for the initial clinical development. Additional vaccine designs, which will allow us to target additional coronaviruses and based on the additional proteins from coronaviruses, will be selected based on existing population data, which is evolving over the coronavirus pandemic. These will be considered for future use to design new products to expand if necessary. Now, immuno-oncology is the other program that we're focusing on. The MVA VLP platform is ideally suited for inducing immune responses to selected tumor-associated antigens, abbreviated typically TAA.

10:55 So the VLPs produced within the body of a vaccinated individual are composed of a virus structural protein, which allows us to form the VLP, but also in connection with the tumor-associated antigen. These present the immune system with a highly concentrated form of the tumor-associated antigen to increase potency and induction of both antibody and cellular responses. Now, our approach is to combine vaccines with a potent anti-tumor agent, such as Checkpoint Inhibitors, which will result in immune responses that can contribute to the existing tumors and theoretically prevent the development and expansion of metastatic lesions.

11:43 Our initial focus is on the MUC1 or Mucin-1 tumor-associated antigen. This is a well-studied target for both antibody and cellular immune responses, but there are also multiple other tumor-associated antigens which we intend to investigate using this approach. Preliminary data generated with the MVA VLP MUC1 tumor-associated antigen is shown in slide 13. We tested our product in combination with two different experimental peptide vaccines and a checkpoint inhibitor in transgenic mouse models. which allowed for the evaluation of the vaccine effect against actual humanized tumors in a humanized setting. So in the treatment model using MVA plus the MT1 peptide in combination, we observed a 57% difference in tumor growth in animals immunized with a combination of MVA plus the MT1 peptide. Compared to control animals, also note that the combination of the vaccine was superior for reducing protection against the tumor compared to either peptide alone or checkpoint inhibitor alone.

13:05 So this represents an additive step to the existing standard of treatment. And a preventive model, which is actually designed to mimic a post-treatment recurrence setting in cancer, the MVA-VLP MUC1 peptide Thank you for joining us today. a novel and efficacious vaccine immunotherapies which will be added to the current standard of treatment.

14:00 Now I'm going to turn the presentation over to Mark Reynolds, the Chief Financial Officer.

14:07 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 from NASDAQ. So I'm gonna start the financial review with our balance sheet, which that 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 at the end of 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 The increase in cash balances again was primarily due to the September public offering which generated net proceeds of $11.2 million but we also raised another $900,000 from a bridge loan which was converted into equity in conjunction with the public offering. Earlier in the year we also received a $170,000 bank loan under the Paycheck Protection Program and we have applied for forgiveness I'll also mention that the officers and directors collectively converted a million and a half of deferred salaries and fees.

15:30 That was converted on the same terms into the public offering. Subsequent to year end, as David mentioned earlier in February, we raised an additional $9.4 million through an overnight offering that was priced at a premium to last year's public offering. It was priced at $6.25 per share. with no warrants issued. We've also seen around 690,000 of the warrants that were issued in the public offering. Those are the publicly traded warrants, exercisable at $5 a share. So we've seen those exercised early this year, giving proceeds of another $3.2 million. And so added all that up, David quoted the figure earlier, we're sitting on current cash balances in excess of $20 million right now.

16:22 So now turning to the income statement briefly. Grant and collaboration revenues were at 1.8 million during 2020 versus 1.2 million in 2019. 2020 includes 1.4 million related to our grant from the U.S. Army supporting our loss of fever vaccine program. under that grant we had received 674,000 in 2019. The 2020 period also includes 385,000 related to our collaboration with Leidos Corporation for work on a malaria vaccine. So at the end of the year we still have 165,000 remaining under the loss of fever grant that will be recognized in 2021.

17:10 And we also received in January this year of Phase 1 SBIR grant from the NIH to support the COVID vaccine program, and that adds another $300,000 that will be recognized during 2021. R&D expenses were $2.4 million in 2020 versus $1.9 million a year earlier, representing an increase of 28%. G&A expenses were $2.2 million versus $1.6. That's an increase of 34%. These increases are reflective of increased spending under our grant-funded programs as well as costs associated with NIH licenses and increased spending on investor relations programs subsequent to September offering.

17:59 Interest expense was $144,000 in 2020 versus $4,000 in 2019, with the increase primarily representing interest and debt discount amortization from the bridge line I mentioned earlier. all of which has been retired. So net loss in 2020 was right at 3 million or $2.14 a share compared to 2.4 million in 2019 or $781 a share. And the variance in the share amounts is primarily reflective from the retroactive restatement of common shares from the reverse stock splits in January and in September. that led to the capital restructuring and the public offering, NASDAQ uplisting.

18:47 So net cash flow during 2020 was approximately 2.8 million or about 230,000 a month. That was our basic cash burn during 2020. We do expect that to increase as we've, subsequent to the public offering, we've eliminated all salary and board fee deferrals. We're planning additions to our scientific staff. We're investing in laboratory infrastructure. And we are going to be incurring incremental external costs for advancing the development programs, which is expected, which is what we raised the money for. But in general, we expect our cash resources to sustain our operating plans at least through the end of 2022 and probably beyond that date.

19:33 Our core run rate or cash run rate for spending is less than $5 million annually. It's in the four to four and a half range right now. But as I mentioned earlier, we are going to be spending incremental funds on the programs as we progress to our clinical trials. And my final comments are related to our capital structure, subsequent to the 2020 offering, the February 2021 offering, and the warrant exercises so far during 2021. We currently have about 6.3 million common shares outstanding. About 1.9 million of the GOVXW, the publicly traded warrants, are outstanding. Those are exercisable at $5 per share. And there are approximately another 1.5 million of other stock options and warrants with an average exercise price of about 4.25. And most importantly, none of those warrants contain any of the toxic conversion features that have been associated with some of the prior capital structure of the company. So we've got all that fully behind us.

20:43 Our capital structure is clean. We're well positioned for supporting further growth. And with that, I'm going to turn it back to David. Thank you, Mark.

20:54 My colleagues and I will now answer your questions. I'm therefore turning the call over to the operator for instructions on the question and answer period. Thank you. We'll now begin the question and answer session. To ask a question, you may press star, then 1 on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star, then 2. At this time, we'll pause momentarily to assemble our roster. Our first question is from Jason McCarthy from Axon Group. Please go ahead.

21:29 Hi, guys. Thanks for taking the questions. I think my question is directed at Mark Newman. You had mentioned or someone had mentioned that part of the interaction with NIH or regulators in general was that they understand the need for another or variation of a COVID vaccine. Can you talk a little bit about why MVA and VLPs get you T-cells? Thank you for joining us.

22:27 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, COVID-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 an evolving variant.

23:17 Thank you very much. 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.

24:09 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 the field. Obviously, the NIH and government institutions have a lag time in response, but as David mentioned, there is a recognize an announcement for government support to move into the universal coronavirus program, you know, 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.

25:05 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 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.

25:41 Yeah, that's helpful. To your knowledge in the literature or from some of the other vaccine developers, particularly the ones that are using viral-based, is there any data out there or population-based data from exposed people that there are antibodies and T cells circulating targeting E and M proteins, not just S proteins?

26:10 Well, there is data existing from population studies that show that individuals who have never had COVID actually do have T-cell responses to COVID gene products. So they have preexisting immunity to coronavirus. It's not actually COVID. It's caused by something else. So those are out there. The antibodies, yes, they're circulating strains that cause colds to generate antibodies. They're usually effective and protective for a year to two years, and then they decay, and so you can become susceptible to reinfection. So those types of things are recognized, but it's never been studied to the extent that we need to study it now, right?

27:01 Because, you know, it Thank you for joining us. and moving ahead with these new approaches.

27:37 And this last question, what is the timing to move into at least a phase one study?

27:46 For us, we'll have the animal data and we'll do the down selection for the first candidate that we were looking at and we think we know which one that's going to be. Within the next, I would say, two to three 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 one trial in Q2, Q3 of next year for the universal, the first step in the universal coronavirus vaccine.

28:17 Got it. Thank you, Mark. Again, if you have a question, please press star, then one. 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.

28:39 Thank you, and thank you to the participants for your continued and supportive 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 GFX staff and the many other parties that continue to support, assist, and advise us towards achieving success.

29:28 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. Again, thank you for your interest and support of GFS. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.