Earnings Labs

GeoVax Labs, Inc. (GOVX)

Q3 2020 Earnings Call· Sun, Nov 8, 2020

$1.10

-0.90%

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Transcript

Operator

Operator

Good morning and welcome to the GeoVax Third Quarter 2020 Corporate Update Call. I am Cole with Chorus Call and will facilitate today's call. With me are David Dodd, Chairman and CEO; Mark Reynolds, Chief Financial Officer; and Mark Neumann, Chief Scientific Officer. [Operator Instructions] Please note this event is being recorded. I will now I would like to turn the conference over to Scott Gordon of CORE IR, who will provide forward-looking statement regarding this call and information herein. Please go ahead.

Scott Gordon

Analyst

Thank you, Cole, and thank you everyone for joining the call. 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 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 and other factors, over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements and not intended to do so. More information about these factors is contained GeoVax's filings with the Securities and Exchange Commission, including those set forth risk factors GeoVax's form 10-K. It's now my pleasure to introduce Chairman and CEO of GeoVax, David Dodd. David, please go ahead.

David Dodd

Analyst

Thank you, Scott. Good morning and thank you for participating in this inaugural GeoVax's quarterly update call. During the third quarter 2020, GeoVax capitalized the company and achieved a NASDAQ listed, securing the resources in support of accelerating our development programs towards clinical development, hopefully, leading to eventual prevented vaccines and meaningful cancer immunotherapies. We are focused on delivering meaningful results and value milestones over the next six to 12 months. This would not have been possible without the support and commitment of our existing investors and more recent new shareholders as well as our dedicated highly capable staff and our excellent external support resource teams. Thank you to all of those individuals and we hope that our efforts will provide improved health for people worldwide, while delivering attractive financial returns to our investors and career development opportunity to GeoVax staff. We look forward to your continued commitment and support as we advanced our programs as well as value developments for shareholder, stakeholders and public health worldwide. Throughout 2020 GeoVax has been highly focused on what many are calling the scourge of the century, now known as COVID-19. Our response of this pandemic has resulted in the development of four vaccine candidates that are either already begun or will soon begin animal testing for which we are seeking federal funding support to more rapidly accelerate our program through animal testing, selection of the lead candidate, manufacturing scale up and two critical human testing. The recent NIH license illustrates our confidence and that it confirms GeoVax access to use of critical NIH patents and materials and support of, product development, clinical development and continued progress through FDA registration, manufacturing and commercialization. Despite there being vaccines that have entered clinical testing, constructed using different approaches and different vector platforms and ours, there…

Mark Reynolds

Analyst

Thanks David. Obviously the most important financial event during the third quarter was the closing of our public offering on September 29, and or uplisting to NASDAQ. So I'm going to start the financial review with our balance sheet since it really sets the stage for our progress moving forward. Cash balances at September 30 were $11.6 million as compared to just $283,000 at December 31, 2019. Working capital at September 30 was $10.8 million as compared to a negative $1.6 million at the end of 2019. That increase is obviously primarily due to the September public offering where we received net proceeds of approximately $11.2 million. But there are few other events that are also worth mentioning that happened during the year. Over the past several years, this is a very important point I want to make, all of the GeoVax's officers and directors took significant salary and fee deferrals in order to help the Company to conserve its cash resources and allow it to advance where we are today. Concurrent with public offering, $1.5 million of those deferrals were converted into equity, under essentially the same terms as units sold to the public. This removed a significant liability from our balance sheet, further strengthened our financial condition moving forward, and also demonstrates the commitment from our Board and management team to the success of GeoVax. In June, we received net proceeds of approximately $900,000 from the issuance of convertible debentures or bridge loan that gave us the cash runway we needed to complete the public offering. Again concurrent with the offering, those debentures were also converted into equity, thereby removing another significant liability from the balance sheet. And back in April, we received $170,000 under bank loan from the Paycheck Protection Program or PPP provision of the CARES…

Operator

Operator

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

Operator

Operator

[Operator Instructions] And our first question today will come from Jason McCarthy with Maxim Group. Please go ahead.

Jason McCarthy

Analyst

I want to ask a couple of questions on the ID side and one on the oncology side after. On the ID side, obviously so much focus on COVID. David, can you give us a sense of the timeline to select one or more of your candidates to get through animal studies and get into the clinic. Just the announcement, we think, just the announcement of the candidate is significant. And also as it relates to COVID vaccines, Can you speak a little bit broadly about the safety aspects of an MVA vaccine in terms of it being at that type of backlog being used in immuno compromised or high-risk patients and deemed as safe just from smallpox work that's been done. It's applicable we think to what you're doing.

David Dodd

Analyst

Yes. Thank you, Jason. In terms of timing, based upon the current testing which we've initiated and moving forward, what we are looking at is we don't know if we'll end-up, obviously, because we haven't completed the results, but we don't know if we'll end-up with one the lead candidate, or if it might be two that we have a difficult decision to make, which would be a good situation to be in. We are targeting that in the second half of 2021 to be ready to move into the clinic. Now, that includes our continued negotiations and discussions with BARDA specifically related to accelerated funding. We have had good encouraging discussions with them. We continue to have those and I think to a large extent, it's dependent on what we end-up reporting with the animal results and I think we'll begin to start seeing animal results in part - probably the latter part of first quarter, but first quarter and then clearly into early part of second quarter. And until - we are in the queue right now to go faster with that. We have things on order. There is a challenge across the industry of access to - and scheduling for non-human primates as you might imagine. The one thing we've been able to do in this recent period following the financing, is began to step forward, take a little more risk in terms of getting in the queues and scheduling stuff. So, our current plans are that in the second half of 2021 we would be initiating our clinical development. And so, then I'll go to the question you had asked about MVA in general as the backbone. As some people or many people are aware of, MVA was developed specifically as a smallpox vaccine for individuals…

Mark Newman

Analyst

No, I think that covers at all. As you mentioned the MVA is the vaccine on its own and that is - that you are building on that. So that's - it's an approved vaccines, in the European, U.S. stock piles. So, it's an ideal place to start.

Jason McCarthy

Analyst

Right. And just building a little bit further, because for the investment community, I think sometimes they can look at vaccines for COVID, as maybe a noisy crowded space right now, especially if you're in the early stages. But to our knowledge or you are the only other group that's working on MVA based vaccines and help us understand the history behind MVA in terms of being a potential booster or an add-on to another COVID vaccine, because that's what we saw with the MVA backbone for J&J's Ebola vaccine. And that was a big deal in 2014 and 2015. Mark, can you talk a little bit about that.

Mark Newman

Analyst

Yes, sure. So, as David mentioned and I think you're alluding too, the DNA and RNA products are totally experimental. There's nothing licensed. The adeno products that's a viral vector based on adenovirus. So that's AstraZeneca and J&J, and those products are based on viruses that don't circulate at high levels in the population. But, when you start immunizing several million people, you're now going to be inducing immune responses to both the vector and to the COVID antigens. So, you inducing anti-vector immunity. And we believe that as boosters are going to be needed, just like a flu shot, for a number of reasons, boosters will be kind of become part of this and it would be difficult in all likelihood to boost with an adenovirus vector vaccine because you're introducing an immune response to the vector, the backbone, as well as to the COVID. So, you're going to start seeing a mix and a match. If you've got a J&J product to start with, there'll be a booster opportunity next year with a different products, so that you're not seeing vector induced immunity, inhibiting the vaccine efficacy. So, it's not only a primary response, but then the booster. But additionally, as David mentioned, and we showed in that cartoon, the virus-like particles, that's a much more complex antigen structure in the vaccine, compared to what you're seeing with the Warp Speed products, patrol but role based just on the S proteins. Other designed to induce antibody responses as well as the VLP, will induce the same antibody responses plus helper and cytotoxic T lymphocyte responses. These are critical to amplifying the response to inducing immunological memory, so that if you are re-exposed later, you can respond more rapidly. So it's very much builds on the next step of the vaccine design based on what we know in immunology.

Jason McCarthy

Analyst

And then just last question on the oncology side, on that vaccine side. Can you guys talk just a little bit about combination therapies. It seems like investment calls we get all the time and other combination therapy for X, Y or Z but for cancer vaccines, a lot has changed in the last, call it five or six years where checkpoint have opened door for cancer vaccine to finally have the success that they were looking for work. Can you talk just a little bit about how that dynamic has changed and why the opportunity is now for cancer vaccines for like GeoVax?

Mark Newman

Analyst

David, you want to take or you want me?

David Dodd

Analyst

Yes, I take - Mark. I'll let you take that - you might be able to expand more scientifically.

Mark Newman

Analyst

So as I think, you recognize and the people you're talking to recognize the cancer vaccines have been something that - that's been a target within the research in the medical community for quite some time. But they've never - they've never generated the types of immune responses that were needed to be really an added component to cancer therapy. And the reason for that is the auto regulatory components for the numerous months and that's with the checkpoint inhibitors control. The checkpoint inhibitors, they inhibit the checkpoints and so that stops immune response from being down regulated and allows us to increase over time with continued therapy. The more potent the response to more likelihood, you're going to see anti-cancer effects. And so the checkpoint inhibitors literally have reopened the cancer vaccine field in my opinion. And this gives you a new environment in which to induce type of response that you want. Now the nice thing about the cancer vaccines, as far as the treatment is, it's somewhat in many independent part. So if you look at normal cancer therapy, you'll be looking at surgery and radiation and chemotherapy and these type of things as all individual components that can be mixed and matched, while the checkpoint inhibitors, the form of chemotherapy essentially and immunotherapy. And then the cancer vaccines add to that. So it's a new component, possibility within the therapy regimens. So it's not a total reinvention of the world, but it's taking it a step further. So I personally, I believe that the cancer vaccine field has a lot of opportunity right now, primarily because of the checkpoint inhibitors working so well and then these new technologies, things like the MVA-VLP and potentially new adjuvants for things like that. Does that answer your question?

Jason McCarthy

Analyst

It does. Very helpful, thank you guys.

David Dodd

Analyst

Let me just add, if you think about it, the approach we are following in the cancer therapy of this combination approach, is analogous to the trials that we are currently entering in HIV under the functional cure goals. So we're at University of California, San Francisco, they're using our vaccine to create the stimulus relation of the immune system then they're following that with a mix, a cocktail of antibodies and peptide to try and knock down the viral level and hold it at a certain level for which there'll be no need for the antiviral drugs. American Gene Technology, certainly and one of their arms will use our vaccine for the same purpose of stimulating and priming and then coming with their gene therapy. So this is following the same general type of concept but apply too in cancer. So thank you.

Operator

Operator

And our next question will come from Jeffrey Kraws with Crystal Research Associates. Please go ahead.

Jeffrey Kraws

Analyst

Thank you very much, David, you have taken a number of different approaches to the vaccines, which I commend you for. The couple of questions, one which of the collaborations that you're seeing that you've partnered in HPV, you went after the head and neck cancer with Emory University. You've also worked on technology and partnering other technology, as you mentioned just with UCFF. And you've got other partnership technologies with Virometix and other companies. Which of the vaccine programs, because you've got so many, the cancer, the COVID, the HIV and the malaria, which two are the ones that you would expect to move ahead first, because you have so many programs. It would be very difficult to focus on all of them. Which first two are the ones you expect to move ahead in your testing?

David Dodd

Analyst

Well, the first two programs, one will be the COVID-19. But if we look at the cancer immunotherapy area, the first one we think we'd be moving ahead would be in conjunction more than likely with Olivera Finn at University of Pittsburgh, into the clinic with the MVA-VLP MUC1 approach. And that's what we're targeting from that that standpoint. The other collaborations have all been established to really validate that and convince us that this technology and this approach is working and makes sense to move forward with. So in the none of the others, are there ones that would move collaborations necessarily forward. We're interested in and continue discussions in-depth with ViaMune because that has going very well. That also targets in the MUC1 area. We probably combine that association with what we're doing with Olivera Finn. And then the other projects that we have in the infectious diseases for those that are all being led through to government entities with the exception of malaria, where we've been working with Leidos but with funding for that vaccine. So we could see, depending on the results, we could see that when moving forward because for malaria, there's only one vaccine around today. It requires four doses and it has an efficacy of less than 40%. And yet it's a major need worldwide. So those results, which are now in animal testing, look promising. We could see that program accelerate, but that would largely be led through non-dilutive, probably financing and going forward with that, and we would be helping to manage and handle the R&D in those parts and manage of it. But it would not be distracting, I think, within the cancer area and the CogAT are two focus - areas of focus. I will say that Zika virus vaccine is one that has sort of been on hold for over a year now. We've had promising an interesting discussions for a full joint development going into the clinic based on what we've achieved thus far. That was all placed on hold due to the challenges of our capital structure. But with the more recent capitalization, we can move much more quickly. And that's an interesting one that I personally would be very, very nice to see get started and move forward with some speed because we could move into the clinic very quickly. We know that there is a major medical need and significant commercial opportunity available for that. And we believe our vaccine differentiates most of the others that are in development for commercial development use because the others do not utilize the NS1 protein which avoids this antibody dependent enhancement issue that is a big concern. So I hope that answer that gives you some flavor, but it's clearly, our primary focus right now is getting to the point, making a decision on the COVID-19 and moving into the clinic with our MUC1.

Jeffrey Kraws

Analyst

Next question is, you've obviously had a lot of success and a lot of interest in the HIV-AIDS area. Clearly, with over a million people walking around the United States with HIV, while people have been able to extend the survival. It still is very dramatic and being able to stop that and being able to stop the spread would be key. A number of people have partnered with you obviously expressing and validating the interest in your technology. You're able to partner with American Gene Technologies, you also partnered with UCSF and you're able to also go out, I believe in another area to start a clinical trial. Your AGT trial has been cleared by the FDA and you had expected the vaccine to be added to the trial on 2021. Is that still very much on track? And do you have any thoughts, and since that vaccine program has already been able to show and all the way through 2A, that might be expedited as far as getting to the marketplace because of its strong and durable humoral and cellular immune responses.

David Dodd

Analyst

Yes. The AGT trial, you're correct. We expect everything we know from AGT is they're IND, their program, we believe in its - latest we've been told is the arm that will include our vaccine will be in 2021. Now, I don't - I believe they plan to start patient enrollment in those activities starting in first quarter of 2021. I don't think that started that yet. Do know that at UCSF, they started patient enrollment in early August. So that program is sort of underway operationally at all. The other one, the HVTN 132 is a Phase 1 program using our vaccine against 70 patients, looking at our vaccine with a novel booster. Again that will - is scheduled to start in 2021. It was originally scheduled to start last year of all things, it was placed on hold, because one or the other participants in it had to redo some work. Than it were scheduled to start this year but COVID-19 has pushed back off the planning, because they're using all of the clinical sites for COVID-19 clinical program. So that will go forward. But the challenge with HIV is, as you point out, it remains a major health need in the United States and worldwide. And we'll never be ended until we have a preventive vaccine, and 40 years essentially, or it certainly 35 years after we were all introduced to HIV-AIDS, we remain without a vaccine. It was just a year ago that there was a publication out of the NBC News, where it had interviewed Dr. Fauci and Dr. Buchbinder out of San Francisco and they were discussing the possibility and there was no better expectation than at that point that there would be a vaccine, successful vaccine for available preventing HIV by 2021. They…

Jeffrey Kraws

Analyst

One last question on a comment, speaking with investors, investors have been very impressed that your entire team, not only has taken the company and really put it on its back taking - not taking the cash salaries early on and actually taking equity and obviously showing your confidence in the company by taking equity, at times when the company was in dire stress, certainly speaks the volumes to the investors as you voted with both your feet and your wallet. The last question is did or does the patent estate, which is the question we get most frequently because you're doing so many good things in so many areas, being able to protected is key. We have your worldwide patent estate is about 56 granted or pending patent applications, over 16 patent families. Is that about right, because obviously having the IP to protect all this is critical.

David Dodd

Analyst

That is correct. I always get it wrong. It's either 56-16 or 58-15 but you're essentially right. if I had from [indiscernible] we have - but you're correct. We - the commonality is the backbone being the MVA, we reflected in the recent NIH license, which is a very important one because it covers us in terms of rights all the way through commercialization. So all aspects of it. So It's a very comprehensive license but yes, that is what we have and then we individually filed patents on every product that we - that we design and develop. So, yes, that is the plan.

Operator

Operator

And this will conclude our question and answer session. I'd like to turn the conference back over to David Dodd for any closing remarks.

David Dodd

Analyst

Thank you and thank you to everyone for your continued support and interest in the progress and transformation of GeoVax. We look forward to updating you on our advances, when we discuss fourth quarter and full year 2020 results. The successful capitalization and NASDAQ listing of GeoVax provided the foundation from which we hope to develop a highly valuable company, contributing to improved health options against various infectious threats and cancers. In the interim, we will provide timely updates regarding the various results and progress of our infectious disease vaccine in immuno-oncology programs. Thank you for your continued support and commitment to these goals. I also want to again acknowledge and thank our GeoVax staff and the many other parties that continue to support, assist, kind of advise towards achieving success. For all of us, it is a great pleasure serving our shareholders and being part of this team. Thank you. Have a safe and enjoyable day.

Operator

Operator

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect your lines at this time.