GeoVax Labs Q3 2023 Earnings Call Transcript

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Provided by Quartr
November 8, 2023

Key Takeaways

  • During Q3, GeoVax advanced gedepin into a multi-site Phase 2 trial for advanced head and neck cancer with FDA orphan drug funding and initial data confirming safety and tumor size reduction.
  • The next-generation COVID-19 vaccine GEO CMO4S1 entered Phase 2 trials targeting immunocompromised patients, leveraging a dual antigen approach, and is under active discussion for BARDA’s Project NextGen funding.
  • GeoVax’s MVA vaccine against mpox and smallpox is positioned to disrupt the current supplier monopoly and is advancing regulatory plans alongside the development of an advanced MVA manufacturing system for rapid response.
  • In the first nine months of 2023, R&D expenses more than doubled to $14.5 million driven by clinical trial activity, contributing to an $18 million net loss and reducing cash to $12.7 million, prompting plans for additional capital raises.
  • GeoVax’s strategic framework—innovate, differentiate, accelerate and collaborate—focuses on underserved patient populations and expedited paths to registration through partnerships and business development.
AI Generated. May Contain Errors.
Earnings Conference Call
GeoVax Labs Q3 2023
00:00 / 00:00

There are 6 speakers on the call.

Operator

Good afternoon, and welcome everyone to the GeoVax Third Quarter 2023 Corporate Update Call. My name is Mandeep, and I will facilitate today's call. With me are David Dodd, Chairman and CEO Mark Reynolds, Chief Financial Officer Kelly McGee, MD, Miles per hour, Chief Medical Officer and John Sharpie, Ph. D, Vice President, Business Development. At this time, all participants are in a listen only mode.

Operator

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 Giedecki of Stern IR.

Speaker 1

Thank you. 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 Geovacs can develop and manufacture its product candidates with the desired characteristics in a timely manner and such products will be safe for human use.

Speaker 1

Geovacs' vaccines will effectively prevent targeted infections in humans. Geovacs' product candidates will receive regulatory approvals necessary to be licensed and marketed. GeoVax raises required capital to complete development of its products. There is development of competitive products that may be more effective or easier to use than GeoVax's products. GeoVax will be able to into favorable manufacturing and distribution agreements and other factors over which GeoVax has no control.

Speaker 1

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 Form 10 ks. It. It is now my pleasure to introduce the Chairman and CEO of GeoVax, David Dodd.

Speaker 2

Good afternoon, and thank you for participating in the GFx corporate update call. This year and more specifically during the Q3, We have successfully advanced the progress of our developments focused on the 2 Phase 2 clinical stage products, while also advancing other critically important initiatives. Today we'll address the progress, status and plans related to Godestan currently in development as a therapy against advanced head and neck cancer and GEO CMOS4S1, our next generation COVID-nineteen vaccine. But first, I want to address the strategy behind our activities and why we are confident that we're on a course that will build significant shareholder and stakeholder value while delivering critically important differentiated products improved lives worldwide. Following my comments, Mark Reynolds, our CFO, will provide an update of our financials and then your questions will be addressed.

Speaker 2

Our strategy at GeoVax is to develop innovative cancer therapies in infectious disease vaccines and provide meaningful differentiation, addressing clearly important unmet medical needs, pursuing initial indications to support expedited registration pathways. We anticipate worldwide development, commercialization, distribution via business partnerships and collaborations. In other words, our strategy is reflected as innovate, differentiate, accelerate and collaborate. It is this strategy that dictates our activities now and continuing through 2024. We are focused on our priorities in order to successfully implement our strategy.

Speaker 2

It is critically important that we advance through catalysts and milestones that demonstrate the differentiated value of our developments, while strengthening the confidence and support from our investors and other key stakeholders. In addition, we're addressing opportunities that provide us a basis for achieving leadership within those targeted patient areas and commercial markets. That's why our current clinical stage products, gedepin and GEO CMO-4S1 provide us the potential of achieving leadership in those respective populations. These represent areas where much larger competitors either aren't addressing such patients, perhaps due to the relatively small size of those opportunities such as the case for advanced head and neck cancer or their technologies are inadequate to address the respective patient populations, such as immunocompromised patients relative to the current authorized COVID-nineteen vaccines. Also, GEO MVA, our vaccine against mpox and smallpox, is intended to disrupt the existing monopoly in that important area, providing us leadership as the 1st U.

Speaker 2

S.-based supplier of such a vaccine. I'll reiterate that since we hold worldwide rights for our products, we are highly focused and engaged in discussions to ensure worldwide access and commercialization. Finally, we realized that adaptability to changing market conditions, emerging competitors and other challenges is required to achieve and maintain sustainability and success. The principles of focus, leadership and adaptability the foundation for implementing our strategy and progressing to successful growth and development. This is not only relevant to our portfolio development activities, but also relative to our financing strategy, which includes equity proceeds, non dilutive funding opportunities and capital resulting from business development activities.

Speaker 2

We believe that having this multi pronged strategy relative to capital development provides us the ability to continue to support our development priorities in the current challenging economic market environment. The vast array of unmet medical needs within oncology represents significant opportunities to advance novel approaches addressing various cancer patient needs worldwide. Increasingly, we are participating in various oncology conferences, some of which we expect to present at Godepin clinical data and with others conduct partnering discussions. Codepitant is based on a novel patented technology for the treatment of solid tumors through a gene therapy strategy known as gene directed enzyme prodrug therapy or GDEPT. In GDEPT, a vector is used to selectively transduce tumor cells with a non human gene which expresses an enzyme that can convert a non toxic prodrug into a highly toxic anti tumor compound in situ.

Speaker 2

Codepin is tumor agnostic, meaning that it provides the opportunity to address a variety of solid tumors either cancerous or benign. We hold worldwide rights for all indications of this technology or as we call it, this pipeline technology. Annually in the U. S, there are 67,000 new cases of head and neck cancers with approximately 15,000 deaths. Worldwide there are approximately 900,000 new cases of head and neck cancers annually and approximately 400,000 deaths.

Speaker 2

Our initial targeted patient population for the application of gedepine represents those who are in stage care, the 15,000 in the U. S. And the 400,000 worldwide. These patients represent a critical unmet medical need. Many are unable to swallow food and have difficulty speaking.

Speaker 2

Most have exhausted existing therapies and standard of care. Typically they are receiving palliative care. Our goal is to provide an improved end stage quality of life by reducing and or eliminating various targeted tumors. The current protocol entails up to 5 treatment cycles, each consisting of 3 intratumoral injections of gedepptin over 2 days, followed by infusion of a prodrug fludarabine phosphate once daily for 3 days. The Phase 1 dose ranging study demonstrated that treating a tumor with a single cycle of gedepin followed by fludarabine infusions was well tolerated with evidence of a reduction in tumor size in patients with solid tumors.

Speaker 2

As a result of that study, the FDA is funding the current trial under the orphan drug clinical trials program. In July, initial data from the current multi site trial was presented at the AACR NS International Conference in Montreal. That presentation included results from the initial 8 of the targeted 10 patients enrolled. As noted in the press release issued at that time, administration of Godefna was shown to be safe and feasible. For an expanded Phase 2 trial with the FDA focused on an expedited path to registration.

Speaker 2

In the interim, we are discussing partnerships and collaborations in support of worldwide development and commercialization of Godaptan against very solid tumors, both as monotherapy and as combination therapy in conjunction with immune checkpoint inhibitors. Turning now to COVID-nineteen. CMOS4S1, our next generation COVID-nineteen vaccine differentiates from the current authorized COVID-nineteen vaccines in targeting both the antibody and cellular arms of the immune system, focusing on providing a more robust and more durable protection than the current vaccines. These inadequate. Such populations include those with various blood cancers, renal disease, sickle cell anemia, HIV positive autoimmune diseases such as lupus and those on immunosuppressive therapy.

Speaker 2

In general, patient groups with ablated immune systems unable to respond adequately to the approved mRNA vaccines are at such a high risk. In the U. S, there are approximately 15,000,000 compromised individuals. Worldwide, there are an estimated 240 +1000000. There is a major critical need for next generation COVID-nineteen teams to support such individuals and we believe that CMO-four S1 is the leading next generation vaccine currently in clinical development.

Speaker 2

During Q2 of this year, the White House announced Project NextGen, a $5,000,000,000 initiative the follow on from Operation Warp Speed, seeking COVID-nineteen vaccines with enhanced breadth of protection against variants and improved durability, being particularly interested in novel vaccine candidates already in clinical trials. We believe that CMO-four S1 is a prime example of desired next generation COVID-nineteen vaccine. We have considerable interest both domestically and internationally in participating in our clinical development program. We believe that an opportunity for an expedited regulatory path likely exists due to our focus on high risk populations unserved by the current COVID-nineteen vaccines and monoclonal antibody therapies. Also, we anticipate partnering and collaborations in support of worldwide commercialization distribution.

Speaker 2

Regarding Project NextGen, We are currently in active discussions related to formal participation in this initiative. Of the $5,000,000,000 funding, So far, dollars 1,900,000,000 has been awarded, resulting in $3,100,000,000 remaining to be awarded. Project NextGen leadership has indicated their to award the full $5,000,000,000 with additional awards to be announced by year end. We hope to provide further updates soon. For the remainder of 2023 2024, we are focused on accelerating efforts in support of the Godaptan and CMOS4S1 Phase 2 clinical programs as well as advancing our MVA vaccine specific to mpox and smallpox in the development and further progress of our program focus on the Advanced MBA Manufacturing System.

Speaker 2

In 2024, this will include the further reporting of results from our CMOS4S1 Phase 2 programs, including results from the healthy volunteer booster trial, completion of enrollment and our results from the immunocompromised CLL trial and additional site initiations are further results from our immunocompromised stem cell transplant trial. For gadeptan in 2024, we expect to report the final results from the current trial and our plans for the expanded Phase 2 trial. We also expect to report plans regarding the next step related to evaluating gadeptan as combination therapy use in conjunction with immune checkpoint inhibitors. Relative to GEO MBA against mpox and smallpox, we anticipate reporting in 2024 our regulatory path and plans related to advancing that product towards registration. Finally next year we'll continue to provide updates related to our advanced MVA manufacturing process targeted to enable GeoVax to the company's ability to produce and distribute MVA based vaccines in response to real time market needs.

Speaker 2

Now, I'd like to turn the presentation over to Mark Reynolds, GFX Chief Financial Officer for a review of our recent results and financial status. Mark?

Speaker 3

Thank you, David. I'll start the financial review with our income statements. We had no active grants during 2023, so we reported no grant revenues this as compared to a small amount in 2022. However, as David has noted, we are having ongoing discussions with regard to Project NextGen. If an award were to be made by BARDA to GeoVax, this could become a very important component our financing mix in the future.

Speaker 3

In this regard, though, I'll state that there is no award to date and there are no guarantees that will be won. So I'll refer everyone back to the forward looking statements disclaimer at the beginning of this call as all of our comments regarding Project NextGen are forward looking statements. Research and development expenses were $6,900,000 $14,500,000 for the 3 month 9 month periods in 2023 versus $2,700,000 $5,400,000 respectively in 2022. These increases are primarily associated with clinical trial activity for the CMO-four S1 and conducting programs, which includes manufacturing costs for clinical trial materials. The increase is also reflective of higher personnel costs as we brought on 2 additional executive level employees in early 2023, adding depth to our regulatory and quality control functions.

Speaker 3

General and administrative expenses were $1,700,000 $4,600,000 for the 3 month 9 month periods in 2023 versus $1,200,000 $3,400,000 in 2022, with the increases mostly associated with higher personnel and consulting costs, patent costs and Investor Relations expenses. Interest income was 600 and 75,000 in 2023 versus just 4,000 in 20 22, reflecting increasing interest rates available through our Money Market Act accounts. So overall net loss for the 9 month period of 2023 was approximately $18,000,000 or $0.69 per share versus $8,600,000 in 2022 or $0.63 per share, again with the increase being driven by the CMO-four S1 and Godaptan clinical productivity. Turning now to the balance sheet. Our cash balances at September 30 were approximately $12,700,000 as compared to $27,600,000 at the end of 2022.

Speaker 3

The change in our cash balances is reflective of $14,900,000 used in operating activities. There were no significant financing or investing activities so far during 2023. Our outstanding common shares currently stand at 26,700,000. So going forward, funding our ongoing Phase 2 clinical programs for CMOS-one and geductant will continue to be the most significant use for our cash going into 'twenty four. We don't expect this prioritization of our spending change if we receive a Project Next Gen award from BARDA as any incremental spending for that program will be funded by the award.

Speaker 3

We do expect to raise additional capital to fund our programs in 2024 and we intend to do that in conjunction with positive news flow. I'll be happy to answer any questions for the Q and A. And I'll now turn the call back to David.

Speaker 2

Thank you, Mark. My colleagues and I will now answer your questions. Joining us for the Q and A session are doctors Mark Newman, Kelly McKee and John Charky, our Chief Scientific Officer, Chief Medical Officer and Vice President of Business Development, respectively. I'll now turn the call over to the operator instructions on the question and answer period.

Operator

We will now begin the question and answer session. Our first question comes from Jason Kolbert with Dawson James. Please go ahead.

Speaker 4

Hi, guys. Congratulations on all the progress. I have kind of a tangential question, but I think it's important. There have been a tremendous number of COVID reinfections, people who had COVID recovered from it and now they're getting it again. And I noticed that the emergency use authorization is now approved for Pfizer's paxlovid and paxlovid is getting prescribed quite a lot.

Speaker 4

So I'm just wondering how this impacts the marketplace and does it impact immune compromised patients at all?

Speaker 2

Thank you, Jason. What I'll do is I'll make a couple of comments on my thoughts on this, and then Kelly, I'll ask if you'd like to add to it. First of all, I'll say that I don't think it impacts the immunocompromised at all because it's been shown that they're not responding well to the monoclonal antibodies either Evusheld or PAXLOVID. So I think that's unchanged. There's still a tremendous need for a vaccine such as ours that will address their needs because they've been unmet since the beginning of the introduction of the vaccines.

Speaker 2

So I think from that standpoint, there's just really no impact. If anything, it further underscores the importance of what we have in development. Kelly, do you want to add anything there? Yes.

Speaker 5

Just a couple of thoughts. I mean, first of all, as far as the impact on the vaccine market overall, I mean, I think everybody sort of recognizes that the mRNA vaccine sales have been considerably lower than they were in the first stages of the pandemic for sure. And I there are so many factors that impact that and the sort of issue of recurrent infections or breakthrough infections is only a component of that. So I'm not sure you can sort of parse those issues efficiently. As far as the impact on the immunocompromised population, I mean, we're sort of talking apples and oranges.

Speaker 5

Paxlovid is a therapeutic, of course, and we've got a vaccine to offer and I think by anybody's measure if we can prevent people from getting sick, particularly for those to keep them from getting severely ill, we're better off than having to rely on a therapeutic and antiviral therapeutic that, number 1, isn't 100% effective and number 2, some substantial sort of side effects that you prefer not to deal with, not the least of which is a sort of long COVID syndrome that seems to sort of appear in people after they stop taking PAVELVID. So It shouldn't impact us at all. And whether it hasn't as what the influence is on the wider vaccine landscape. I can't really I don't know.

Speaker 4

Well, I was just what I see in the real world is

Speaker 2

a

Speaker 4

very large segment of the population does not want to get a 4th, 5th and 6th mRNA booster. They are hearing that Paxlovid does have some side effects, metallic taste in the mouth principally, but it's pretty effective at knocking virus down. But you're right, there is a lag and I think a segment of the population would really like an mRNA alternative and I'm really wondering if that might that not be a market segment that in addition to immune patients kind of becomes very attractive to you.

Speaker 2

Well, I think you could be go ahead, Kelly. I'm sorry.

Speaker 5

Well, I was just going to say, I mean, when you say that they prefer an mRNA option, I think the mRNAs are kind of what they have currently available to them. One of the big advantages I think our vaccine offers is sort of an alternative approach to immunization where we can provide sort of broad durable immune protection that is that won't require that shouldn't, I should say, require frequent once, twice a year boosting in order to maintain immune protective status.

Speaker 2

Well, I was going to add Jason, I was going to add that as the data comes out from the recently fully enrolled trial, where it's the healthy volunteers receiving our vaccine as a booster. I think that data may be demonstrative of sort of what Kelly was just touching on. It may be that our breadth of protection and the durability that's delivered from this dual antigen approach is going to give something that will be a value That they're not receiving from the mRNAs.

Speaker 4

In a prior life, I was involved in pharmaceutical sales. So a year from now before you hire a pharmaceutical sales

Operator

this concludes our question and answer session. I would now turn the conference back over to David Dodd for any closing remarks.

Speaker 2

Well, thank you for everyone. There weren't that many questions. We have a new sales manager coming in a year from now, I guess. But anyway, I want to thank everyone for participating in the call. We appreciate your interest.

Speaker 2

And I'd just say that again to reiterate our strategy that we're focused on is to innovate, to differentiate, to accelerate to the market and to do this while collaborating. And that reflects our focus towards building significant shareholder value. I want to acknowledge and thank our Board of Directors, our staff and the many other parties that continue to support and advise us towards achieving success. We're committed to providing meaningful career development opportunities for our highly competitive, quality oriented members of our team. We're seeking to disrupt the current paradigm of both cancer therapies, infectious disease, vaccines and redefining how the success is in fact defined in addressing various patient population.

Speaker 2

So I want to wish everyone a wonderful day. Thank you, and we look forward to keeping you updated as we go forward. Thank you.

Operator

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

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