Q2 2024 GeoVax Labs Inc Earnings Call
Speaker Change: [music].
Alex: Good afternoon, and welcome everyone to the GeoVax Second Quarter 2024 Corporate Update Call. My name is Alex, and I will facilitate today's call. With me are David Dodd, Chairman and CEO, Mark Reynolds, Chief Financial Officer, Mark Newman, Ph. D., Chief Scientific Officer, Kelly McKee, MDMPH Chief Medical Officer, and John Sharkey, Ph. D., Vice President, Business Development.
Good afternoon, and welcome everyone to the Geo bags second quarter 'twenty 'twenty four corporate update call. My name is Alex and I will facilitate todays call with me are David Dodd, Chairman and CEO, Mark Reynolds Chief Financial Officer.
Speaker Change: Mark Newman ph D Chief Scientific Officer, Kelly Mckee M. D M B, a chief Medical Officer, and John Sharkey, Phd Vice President business development.
Alex: At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. At this time, I am turning the call over to Max Gadicke of Precision HQ.
Speaker Change: At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded.
Matt Gottago: At this time I am turning the call over to Matt Gotta go off precision HQ.
Matt Gottago: Thank you.
Max Gadicke: 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.
Speaker Change: Please note the following.
Speaker Change: Certain statements in this presentation may constitute forward looking statements.
Speaker Change: The private Securities Litigation Reform Act.
Speaker Change: These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances.
Speaker Change: Actual results may differ materially from those included in these statements due to a variety of factors including weather.
Unknown Executive: 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. Moreover, GeoVax's vaccines will effectively prevent targeted infections. GeoVax's product candidates will receive regulatory approvals necessary to be licensed and marketed, while GeoVax raises the required capital to complete the development of this product. There is the development of competitive products that may be more effective or easier to use than GeoVax products, and GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors over which GeoVax has no control.
Speaker Change: <unk>.
Speaker Change: Pellet manufacturer its product candidates with the desired characteristics in a timely manner such products will be safe for human use.
Speaker Change: Geo bachelors vaccines will effectively prevent target of infections in humans.
Speaker Change: <unk> product candidates will receive regulatory approvals necessary to be licensed and marketed.
Speaker Change: Geovax raises required capital to complete development of its products.
Speaker Change: There is development competitive products, but maybe more effective are easier to use them to yoga products.
Speaker Change: <unk> will be able to enter into a favorable manufacturing and distribution agreements.
Speaker Change: Other factors over which Geovax has no control.
Unknown Executive: 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 step-forth at-risk factors in GeoVax's Form 10-K.
Speaker Change: <unk> assumes no obligation to update these forward looking statements and does not intend to do so.
Speaker Change: More information about these factors is contained in <unk> filings with the Securities Exchange Commission, including those set forth at risk factors NGL Abaxis Form 10-K.
Speaker Change: It is now my pleasure to introduce the chairman and CEO of <unk> David Dodd.
David Dodd: Thank you Max and good afternoon, and thank you for participating in the second quarter 2024, <unk> corporate update call.
Speaker Change: During my comments Mark Reynolds, our CFO will provide an update of our financials and then your questions will be interest.
Unknown Executive: The second quarter included several major events in the development of GeoVax, led by the BARDA Project NextGen Award, valued at almost $400 million, supporting GEO-CM04S1, our next-generation COVID-19 vaccine, in a Phase IIb, 10,000-patient trial comparing our vaccine to an FDA-authorized mRNA vaccine. Today, we'll discuss the progress, status, and plans related to CMO4S1 and Cadeptin, as well as provide updates on our other programs, including our progress in the advanced MVA manufacturing process.
Speaker Change: The second quarter included several major advance in the development of <unk> led by the BARDA Project Nextgen award valued at almost $400 million.
Speaker Change: According <unk> CMO for US one our next generation COVID-19 vaccine.
Speaker Change: Phase two the 10000 patient trial, comparing our vaccine to an FDA authorized mrna vaccine.
Speaker Change: This program is already underway with our having already initiated billings to BARDA as Mark will further discuss during the financial review, we were delighted to be partnered with elution as our CRO for the project Nextgen trial as elusive as our existing <unk> supporting both our CMO or S. One and good depth in clinical trials.
Speaker Change: In addition during Q2, we conducted a comprehensive review of the conducting phase <unk> trial in conjunction with a good definitely clinical Advisory Committee.
Speaker Change: Turning to proceed with the implementation of the phase III trial evaluating the depth and in combination with an immune checkpoint inhibitor therapy for patients with squamous cell head and neck cancer.
Speaker Change: Thus far clinical evaluation of <unk> therapy has demonstrated sufficient tumor stabilization or reduction activity to support plans to advance clinical development of good depth, such as expanded phase II clinical trial.
Speaker Change: These two events and decisions represents a significant milestone for GFS.
Speaker Change: Today, we will discuss the progress status and plans related to the CMO for US one that's happening as well as provide updates on our other programs, including our progress on the advanced MBA manufacturing process.
Unknown Executive: Our goal is to successfully develop innovative cancer therapies and infectious disease vaccines addressing critically important unmet medical needs and pursuing initial indications to support expedited registration pathways. The clinical data thus far from our current Phase II studies are supportive of this goal.
Speaker Change: Our goal is to successfully develop innovative cancer therapies and infectious disease vaccine addressing critically important unmet medical needs pursuing initial indications the support expedited registration pathways.
Speaker Change: We anticipate establishing business partnerships and collaborations and support a worldwide development commercialization and distribution.
Speaker Change: Last December we announced the closure of enrollment for the phase <unk> trial.
Speaker Change: Among advanced head and neck cancer patients. This initial targeted patient population represents those who are in end stage care, who unfortunately die each year as a result of head and neck cancer.
Speaker Change: This represents 17000 in the U S and over 400000 individuals worldwide. Our goal is to obtain clinical evidence supporting the advancement of this therapy, including in patients with earlier stage disease.
Speaker Change: You'll recall of this trial was funded by the FDA under the orphan drug clinical trials program.
Speaker Change: The April comprehensive review of the results from the phase one and the most recent phase <unk> trial, the depth and concluded the depth and has demonstrated acceptable safety and efficacy to support continued development of a phase II trial, and first recurrent head and neck cancer.
Speaker Change: Primary goal of this trial will be to establish efficacy of neo adjuvant therapy, combined with an immune checkpoint inhibitor in squamous cell head and neck cancer.
Speaker Change: Company has initiated the necessary planning activities, including protocol development manufacturing and CRO selection with the trial activation anticipated during the first half of 2025.
Speaker Change: We believe that the depth of the mechanism of action will enable us to address a variety of solid tumors. Both cancer benign we hold worldwide rights for all indications of this technology and we are participating in various oncology important conferences.
Speaker Change: We anticipate funding the expanded phase II trial through a combination of internal funding potential partnering and potential non dilutive funding resources.
Speaker Change: During the Q&A session. We welcome the opportunity to further discuss our plans for the expanded phase III trial.
Speaker Change: Our business. During Q2, however was the announcement of the BARDA project next Gen Award of almost $400 million supporting.
Speaker Change: Supporting CMO for S. One on a 10000 patient comparative trial against an FDA authorized mrna vaccine.
Speaker Change: This announcement.
Speaker Change: Toward represents a highly significant event in the evolution.
Speaker Change: Evolution of our company, which we believe represents a strong validation of our MVA technology and expertise.
Speaker Change: Vetting process was lengthy and rigorous but we remain confident throughout and we're delighted to be part of the project Nextgen vaccine program.
Speaker Change: Our aim with CMO for US one is to provide a more practical public health friendly COVID-19 vaccine than that offered from the first generation vaccines. We believe that this is achieved by stimulating a robust and durable immune response across multiple virus variants as a result of the induction of both the antibody.
Speaker Change: And cellular arms of the immune system against multiple virus outages.
Speaker Change: This distinction is critically important in addressing the high risk populations of immune compromised individuals for whom the current vaccine and monoclonal antibody therapies are typically inadequate. This represents the key differentiation between our vaccine and the first generation approved vaccines.
Speaker Change: Our vaccine utilizes a proven safe and efficient delivery platform modified vaccinia anchor or NVA, which does not replicate in mammalian cells.
Speaker Change: The safety of MBA has been well established and accepted by regulatory authorities worldwide, especially among patients with weakened immune systems as well as among pregnant women.
Speaker Change: That our vaccine platform MVA is also in stand alone.
Speaker Change: <unk> authorized for protection against <unk> smallpox is a unique feature with critically important clinical benefits, providing a significant differentiator for CMO for us, especially as a preferred COVID-19 vaccine and regions and then the impasse. A current example is within the Democratic Republic.
Speaker Change: The Congo, or DRC, where there is a threatening outbreak under was also the CDC recently issued a warning of continued ops threats and risks within the U S.
Speaker Change: We believe that CMO for <unk> offers an immune profile optimal for more general use logins booster to current MRI manufacturing, providing a more robust durable and broadly functional immune response against the emerging variants potentially without the need for the continuous vaccine reconfiguration that appears necessary.
Speaker Change: With the mrna vaccines and.
Speaker Change: In fact, the HHS press release announcing our project Nextgen Award specifically highlighted Iron award is providing the potential for COVID-19 vaccine that provides broader protection meeting encompassing a wider array of variance and the potential for increased durability than that evidenced by the current authorized.
Speaker Change: <unk> vaccine.
Speaker Change: The clinical data thus far from our current phase II studies is supportive of this potential.
Speaker Change: Relative to CMO for US one, we anticipate partnering and collaborations and additional clinical and research efforts and support of worldwide commercialization and distribution active initiatives are underway in these areas.
Speaker Change: As mentioned earlier, we are delighted to be partnered with elusive for this phase II trial, and we recognize the BARDA funding provided to both GFX Anil loosen to ensure successful operational execution of this critically important study.
Speaker Change: As you recall three phase II clinical trials are underway with CMO core swap two of which address the high risk populations of immuno compromised patients. The other phase II trial evaluates our vaccine as a hydrological booster among healthy adults following prior to receipt of an mrna vaccine.
Speaker Change: Overall, we hope to demonstrate that our COVID-19 vaccine successfully addresses the current unmet needs among the tens of millions of immuno compromised patients. While also demonstrating the vaccine is a more robust durable booster vaccine used in conjunction with mrna vaccine I won't delve further into the specific trials at.
Speaker Change: This time, but we welcome any questions you may have during our Q&A session.
Speaker Change: With the announced one of our project Nextgen Award last month and the progress in our other phase III clinical studies are activity related to partnering and collaboration has increased we believe the CMO for US one represent significant promise as a critically needed and important part of the COVID-19 vaccine armamentarium for <unk>.
Speaker Change: <unk> health worldwide.
Speaker Change: During the remainder of 2024, we anticipate continued expected expanded discussions and advancing business development negotiations.
Speaker Change: In summary, we are focused on addressing opportunities that provide a basis for achieving leadership with a differentiated patient areas of commercial markets.
Speaker Change: Our current clinical stage products, the depth and the CMO for US one of our focus on patient populations currently underserved or unserved by existing therapies <unk> vaccines.
Speaker Change: <unk> MBA or a vaccine candidate against anthrax and smallpox is intended to disrupt the current monopoly in that important area, providing us a leadership as the FERC.
Speaker Change: We will now begin question and answer session.
Speaker Change: To ask a question you May press Star then one on your telephone keypad. If you are using a speakerphone. Please pick up your handset before pressing the keys to withdraw your question. Please press Star then two at this at this time, we will pause momentarily to assemble our oyster.
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Unknown Attendee: Yeah, I was having some technical difficulties a little earlier, but you're loud and clear right now.
Speaker Change: April.
Speaker Change: And we've determined that the next target for the for the Phase two study will be the.
Speaker Change: Studying approximately it will be decided as we go through and finalize a protocol, but approximately 36 patients it'll be good depth and in combination with immune checkpoint inhibitor and it targets are those with first recurrent head and neck cancer.
Speaker Change: We also have been receiving proposals or interests that we also look at triple negative breast cancer and we also looked at earlier stage cancers no right now our focus is not on any of those others. It really is towards advancing with the phase II trial as we recently and.
Speaker Change: So I think it was last week, we announced what the plans are for that but we do anticipate that the good depth in technology of the therapy will be applicable to a variety of solid tumors as long as again as long as they're needle accessible, which which is virtually all of them with today's technology. So shall we.
Speaker Change: Have quite a bit of interest both internally as well as among our oncology advisors, but right now we're focused on moving forward with all of the planning activities that we've already initiated manufacturing.
Speaker Change: It.
Speaker Change: Development of protocols, so that will be prepared.
Speaker Change: And how you're going to manage the cash burn going forward.
Speaker Change: And I understand BARDA really has nothing to do with the strike, Florida is just kind of a pass through on the income statement.
Speaker Change: Mark do you want to.
Unknown Executive: Yeah, Jason, I'll address that. In fact, I don't know if the live stream is still available or not, but I flipped back through the slides to kind of cover some of this. We did have some across-the-board technical difficulties here where the stream just went down for some reason.
Mark: Yeah, I'll just I'll address that in fact, I don't know if the web lab stream is still available or not but are flipped back into slides.
Speaker Change: To kind of cover some of this I mean, we did have some some across the board technical difficulties here, where the the stream just went down for some reason so.
Speaker Change: So anyway.
Speaker Change: As I just answered with Robert for them for the quarter. We reported 300000 in revenues from the BARDA contract and as I said you know the the money will start flowing in fact for the well.
Speaker Change: And so it really wasn't asking about the BARDA Award I was really asking about the cash balance on the balance sheet and kind of how you perceive the.
Speaker Change: This spending.
Unknown Attendee: I know, we all know you can raise equity, right? But I'm wondering if there might be a more or a less dilutive approach. Have you considered debt? I noticed one of my other companies who's dealing with a depressed stock price actually did something really smart, you know; they did a debt offering, and I'm not a big fan of that, except that you have such a securitized asset, you know, with BARDA, that I would think you would, you know, open up some new financial levers for that. Well, yeah.
Unknown Executive: Yeah, okay, I understand now. The issue I have with debt is, and I'm not opposed to debt in the right circumstances,
Speaker Change: If the ball with the kind of offers you're getting that.
Speaker Change: You'll be able to continue to develop get that then you know in terms of the timeline you've already represented three.
Unknown Executive: Absolutely. I think that there's still a communication challenge. We have to really communicate the value of the assets we've got that is not being reflected in the stock price. And, you know, the current environment we're under and, you know, the crapper that the market is in right now just compounds that. But, you know, I think we're going to weather through it. We will find the funds to continue the programs, and I think there will be a lot of ups and downs.
Speaker Change: Yeah, absolutely I mean, I think that there is still.
Speaker Change: Our communication challenge, we have to really communicate the value of.
Ronda: The assets, we've got that is not being reflected in the stock price and the current environment Ronda Ronda.
Speaker Change: The cracker that the market is in right now just compounds that but.
Speaker Change: I think we're going to weather through it we will.
Speaker Change: Find the funds to continue the programs and I think that Theres a lot of upside here.
David Dodd: Well I mean this is what David David Donna. This is for you. What you are really good at so im glad youre at the helm for that alright, Thanks, guys I really appreciate it.
Jason: Yes, Thank you Jason.
Speaker Change: The next question comes from the line of Jeff Cross with Crystal Research. Please go ahead.
Speaker Change: Thank you very much and sorry, you had your technical difficulties on the call.
Jeff Cross: The questions basically been asked that I was going to ask although I will say I concur with your.
CMO: Your thoughts on the financial aspects and not using debt because I think that does limit your ability to do many things I'm the CMO for us one in the development.
Unknown Executive: The ongoing trial that we have in patients with blood cancers that have received cell transplants, we have
Unknown Executive: I think that's for a year, whatever it is. But basically, this will go very nicely, and we're off to an incredibly fast, successful start with this program. I could not be more thrilled and delighted at the pace that things are going. So that's where it is. That may help you understand it all.
This past quarter Q2 represented a watershed in the <unk> development as a result of the project Nextgen Award and our decision to proceed with an expanded good depth in phase II clinical trial.
Speaker Change: Your interest is greatly appreciated and we look forward to ongoing interactions.
CMO: As always we want to acknowledge and thank our board of directors and advisers are <unk> staff and the many other parties entities that continue to support us towards achieving success.
Speaker Change: We're also committed to providing meaningful career development opportunities for highly competitive quality oriented individuals seeking to disrupt the current paradigm of cancer therapy and infectious disease vaccine developers, we're most proud and appreciative of our team.
CMO: Including those external partners, who continue to contribute to the progress success underway at G events for all of US, It's a great pleasure, serving our shareholders and being part of this team. Our overriding goal is to improve lives worldwide development and commercialization of novel critically needed cancer therapies and infectious disease.
Sales of our <unk>.
Speaker Change: Safe and enjoyable day. Thank you.
Alex: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
Speaker Change: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
CMO: [music].
CMO: Okay.
CMO: Yeah.