GeoVax Labs - Q2 2024

Transcript

Operator (participant)

Good afternoon, and welcome, everyone, to the GeoVax Q2 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, PhD, Chief Scientific Officer; Kelly McKee, MD, MPH, Chief Medical Officer; and John Sharkey, PhD, Vice President, Business Development. At this time, all participants are in a listen-only mode. A Q&A 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 AQ.

Max Gadicke (Head of Investor Relations)

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 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, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax's 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 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 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-K. It is now my pleasure to introduce the Chairman and CEO of GeoVax, David Dodd.

David Dodd (Chairman and CEO)

Thank you, Max. Good afternoon, and thank you for participating in the Q2 2024 GeoVax Corporate Update Call. Following my comments, Mark Reynolds, our CFO, will provide an update of our financials, and then your questions will be addressed. The Q2 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 2b 10,000-patient trial, comparing our vaccine to an FDA-authorized mRNA vaccine. This program is already underway, with our having already initiated billings to BARDA, as Mark will further discuss during the financial review. We're delighted to be partnered with Allucent as our CRO for the Project NextGen trial, as Allucent is our existing CRO, supporting both our CM04S1 and Gedeptin clinical trials.

In addition, during Q2, we conducted a comprehensive review of the Gedeptin phase 1b/2a trial in conjunction with the Gedeptin Clinical Advisory Committee, deciding to proceed with the implementation of a phase 2 trial, evaluating Gedeptin in combination with an immune checkpoint inhibitor as therapy for patients with squamous cell head and neck cancer. Thus far, clinical evaluation of Gedeptin therapy has demonstrated sufficient tumor stabilization or reduction activity to support plans to advance clinical development of Gedeptin in such an expanded phase 2 clinical trial. These two events and decisions represent significant milestones for GeoVax. Today, we'll discuss the progress, status, and plans related to GEO-CM04S1 and Gedeptin, as well as provide updates on our other programs, including our progress in the advanced MVA manufacturing process.

Our goal is to successfully develop innovative cancer therapies and infectious disease vaccines, addressing critically important unmet medical needs, pursuing initial indications to support expedited registration pathways. We anticipate establishing business partnerships and collaborations in support of worldwide development, commercialization, and distribution. Last December, we announced the closure of enrollment for the Phase 1a/2b trial of Gedeptin 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. This represents 17,000 in the U.S. and over 400,000 individuals worldwide. Our goal is to obtain clinical evidence supporting advancement of this therapy, including in patients with earlier-stage disease. You recall this trial was funded by the FDA under the Orphan Drugs Clinical Trials Program.

The Allucent comprehensive review of the results from the phase 1 and the most recent phase 1a/2b trial of Gedeptin concluded that Gedeptin has demonstrated acceptable safety and efficacy to support continued development of a phase 2 trial in first-recurrent head and neck cancer. The primary goal of this trial will be to establish efficacy of neoadjuvant Gedeptin therapy combined with an immune checkpoint inhibitor in squamous cell head and neck cancer. The company has initiated the necessary planning activities, including protocol development, manufacturing, and CRO selection, with the trial activation anticipated during the H1 of 2025. We believe that the Gedeptin mechanism of action will enable us to address a variety of solid tumors, both cancerous and benign. We hold worldwide rights for all indications of this technology, and we are participating in various oncology and partnering conferences.

We anticipate funding the expanded phase II trial through a combination of internal funding, potential partnering, and potential non-dilutive funding resources. During the Q&A session, we welcome the opportunity to further discuss our plans for the expanded phase II trial. Our big news during Q2, however, was the announcement of the BARDA Project NextGen award of almost $400 million, supporting GEO-CM04S1 and a 10,000-patient comparative trial against an FDA-authorized mRNA vaccine. This announcement and award represent a highly significant event in the evolution of our company, which we believe represents a strong validation of our MVA technology and expertise. The vetting process was lengthy and rigorous, but we remained confident throughout, and we're delighted to be part of the Project NextGen vaccine program. Our aim with GEO-CM04S1 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 and cellular arms of the immune system against multiple virus antigens. This distinction is critically important in addressing the high-risk populations of immune-compromised individuals for whom the current vaccines and monoclonal antibody therapies are typically inadequate. This represents the key differentiation between our vaccine and the first-generation approved vaccines. Our vaccine utilizes a proven, safe, and efficient delivery platform, Modified Vaccinia Ankara, or MVA, which does not replicate in mammalian cells. The safety of MVA has been well established and accepted by regulatory authorities worldwide, especially among patients with weakened immune systems as well as among pregnant women.

That our vaccine platform, MVA, is also a stand-alone vaccine authorized for protection against mpox and smallpox, is a unique feature with critically important clinical benefits, providing a significant differentiator for GEO-CM04S1, especially as a preferred COVID-19 vaccine in regions endemic to mpox. A current example is within the Democratic Republic of the Congo, or DRC, where there is a threatening outbreak underway. Also, the CDC recently issued a warning of continued mpox threats and risks within the U.S. We believe that GEO-CM04S1 offers an immune profile optimal for more general use as a heterologous booster to current mRNA vaccines, providing a more robust, durable, and broadly functional immune response against emerging variants, potentially without the need for the continuous vaccine reconfiguration that appears necessary with the mRNA vaccine.

In fact, the HHS press release announcing our Project NextGen award specifically highlighted our award as providing the potential for a COVID-19 vaccine that provides broader protection, meaning encompassing a wider array of variants, and the potential for increased durability than that evidenced by the current authorized vaccines. The clinical data thus far from our current phase 2 studies is supportive of this potential. Relative to GEO-CM04S1, we anticipate partnering and collaborations in additional clinical and research efforts, and in support of worldwide commercialization and distribution. Active initiatives are underway in these areas. As mentioned earlier, we are delighted to be partnered with Allucent for this phase 2b trial, and we recognize the BARDA funding provided to both GeoVax and Allucent to ensure successful operational execution of this critically important study.

As you recall, three phase 2 clinical trials are underway with GEO-CM04S1, two of which address the high-risk populations of immunocompromised patients. The other phase 2 trial evaluates our vaccine as a heterologous booster among healthy adults following prior receipt of an mRNA vaccine. Overall, we hope to demonstrate that our COVID-19 vaccine successfully addresses the current unmet needs among the tens of millions of immunocompromised patients, while also demonstrating the vaccine as a more robust, durable booster vaccine used in conjunction with mRNA vaccines. I won't delve further into these specific trials at this time, but we welcome any questions you may have during our Q&A session. With the announcement of our Project NextGen award last month and the progress in our other phase 2 clinical studies, our activity related to partnering and collaborations has increased.

We believe that GEO-CM04S1 represents significant promise as a critically needed and important part of the COVID-19 vaccine armamentarium for public health worldwide. During the remainder of 2024, we anticipate continued expanded discussions in advancing business development negotiations. In summary, we are focused on addressing opportunities that provide a basis for achieving leadership within differentiated patient areas and commercial markets. Our current clinical stage products, Gedeptin and GEO-CM04S1, are focused on patient populations currently underserved or unserved by existing therapies and/or vaccines. GEO-MVA, our vaccine candidate against mpox and smallpox, is intended to disrupt the current monopoly in that important area, providing us a leadership as the first U.S.-based supplier of such a vaccine. This may also provide GeoVax our initial step into revenue generation due to the significant governmental interest in U.S.-based supply chains versus overdependence on non-U.S. suppliers.

The strong sentiment in favor of such onshoring initiative remains a major national legislative focus and interest. We're confident that we're on a course that will build significant shareholder and stakeholder value, while delivering critically important differentiated products to improve lives worldwide. Finally, we anticipate providing continued updates related to our advanced MVA manufacturing process, targeted to enable GeoVax to effectively produce and distribute MVA-based vaccines in response to real-time market needs. Overall, our various lead stage products, Gedeptin, GEO-CM04S1, and MVA, represent critically important areas of medical need, largely unserved or underserved by current products and standard of care. We are pleased with the consistent, encouraging results we're seeing from our clinical studies. Moreover, we believe that expedited paths to registration are feasible for these products. From a commercial perspective, these product opportunities represent an estimated annual US revenue potential of over $40 billion.

I'll underscore that this isn't a sales forecast, but rather a reflection of the significance of the need to address these critically important areas of healthcare, both clinically and commercially. Expanding this to a worldwide basis in conjunction with partners and collaborators adds to the confidence we have relative to the outlook for GeoVax, our shareholders, and stakeholders. Now, I'd like to turn the presentation over to Mark Reynolds, GeoVax Chief Financial Officer, for a review of our recent results and financial status. Mark?

Mark Reynolds (CFO)

Thank you, David. Starting with our income statement, I'll focus most of my comments on the comparative figures for the six-month period of 2024 versus 2023. During the quarter ended June 30, we reported $301,000 of revenues associated with the BARDA Project NextGen award. There were no comparable revenues reported during 2023. This represents our first billing to BARDA under the contract, which began on June 12, so there's little more than half a month worth of billing there. This is a cost reimbursement contract, so future revenues will directly correlate with our billable personnel time and the incremental expenses we incur. Research and development expenses were $8.7 million during the first six months of 2024, versus $7.5 million in 2023, representing an increase of roughly $1.2 million, or 15%.

This year-over-year increase is primarily associated with the cost of conducting our clinical trials, including manufacturing costs for clinical trial materials, as well as some supportive studies. General administrative expenses were $2.5 million in 2024 versus $2.9 million in 2023, representing a decrease of $400,000 or 13%, mostly associated with lower stock-based compensation expense and a mix of other costs as well. Other income net was $31,000 in 2024, as compared to $484,000 in 2023, primarily reflecting lower interest income due to lower cash balances invested through money market accounts. So overall, net loss for the first six months of 2024 was approximately $11 million, or $4.68 per share, versus $10 million in 2023, or $5.66 per share.

Again, with the increase in the net loss being driven by the GEO-CM04S1 and the Gedeptin clinical trial activity. Turning now to the balance sheet. Our cash balances at June 30 were $1.6 million, as compared to $6.5 million at December 31. Reflective of $7.6 million used in operating activities, partially offset by $2.7 million in financing transactions, together with some buildup in our payables and accrual balances. We also completed an additional raise in July with net proceeds of $2.8 million, which is not reflected in the current balance sheet that you see. Our outstanding common shares currently stand at 5.3 million, following the recent financings. As David mentioned, the BARDA Project NextGen award was the most significant event during the Q2, and it's our top priority going forward in terms of operational focus.

But that entire clinical program is fully funded by BARDA through the awards to GeoVax and to Allucent, our CRO partner. The total federal support for this program will total, we expect, between $367 million and $388 million over the next several years. In terms of our funding needs, the ongoing non-BARDA Phase II clinical programs for Gedeptin and GEO-CM04S1 will continue to be the most significant use of our cash in the foreseeable future. We are currently developing our capital formation plans to fund these programs through the next several valuation inflection points. I'll be happy to answer any questions during the Q&A period, and I'll turn the call back over to David.

David Dodd (Chairman and CEO)

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

Operator (participant)

We will now begin Q&A session. 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 time, we will pause momentarily to assemble our roster. For our first question, we have Robert LeBoyer with Noble Capital Markets. Please go ahead.

Robert LeBoyer (Analyst)

Good afternoon, and thank you, and congratulations on all the great progress in the H1 of the year. One of the things that was mentioned was that the Gedeptin trial is in squamous cell carcinoma of the head and neck, and there was a mention of a variety of solid tumors. So I was wondering if there was anything else that you could tell us on any additional indications in preclinical or planned IND filings there?

David Dodd (Chairman and CEO)

Thank you, Robert. I hope people can hear me. I've been out of the conference call for quite a while. But anyway, I'm gonna ask, Kelly McKee, our Chief Medical Officer, to address that. Kelly? No. Robert, can you hear me okay?

Robert LeBoyer (Analyst)

I was having some technical difficulties a little earlier, but you're loud and clear right now.

David Dodd (Chairman and CEO)

Okay. Because I missed over two-thirds of this, so I guess Kelly is on there, so still some technical difficulties. Well, we initially, you know, we're studying the advanced head and neck cancer. We did that with the phase 1 and then the phase 1a and 2b. Then we had this, our review with our clinical advisory committee in late April, and we've determined that the next target for the phase 2 study will be the study approximately. It will be decided as we go through and finalize the protocol, but approximately 36 patients. It'll be Gedeptin in combination with the immune checkpoint inhibitor, and it will target those with first recurrent head and neck cancer.

Now, we also have been receiving proposals or interest that we also look at triple-negative breast cancer, and we also look at earlier stage cancers. Now, right now, our focus is not on any of those others. It really is towards advancing with the phase 2 trial, as we recently announced. I think it was last week we announced what the plans are for that. But we do anticipate that the Gedeptin technology, the therapy, will be applicable to a variety of solid tumors, as long as, again, they're needle accessible, which is virtually all of them with today's technology.

We 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 the planning activities that we've already initiated, the manufacturing, the development of protocols, so that we'll be prepared, as we get towards an end of that late second, maybe the beginning of the Q3 next year to activate this phase two trial. Does that answer your question well enough?

Robert LeBoyer (Analyst)

That was a great answer. But-

David Dodd (Chairman and CEO)

Thank you.

Robert LeBoyer (Analyst)

gave me some of the details I was, I was hoping for. If I could just ask a second question.

David Dodd (Chairman and CEO)

Sure.

Robert LeBoyer (Analyst)

Is it too early to ask if the accounting for the funding from NextGen, the $24 million, has been determined yet, or?

David Dodd (Chairman and CEO)

Determined yet.

Robert LeBoyer (Analyst)

Any hint as to what the accounting treatment is going to be on those?

David Dodd (Chairman and CEO)

Mark? Okay, go ahead.

Mark Reynolds (CFO)

I'll answer that. You know, we're treating this as revenue. You know, it's, it's a cost reimbursement program, so as we expend the co-, expend the external cost for the study, and as we incur the personnel time, we bill BARDA for that with a, with a slight markup for fringe benefits and for some overhead rates. So, you know, as the costs are incurred, is when the revenue is, is recognized. You know, so for the 10-Q that we just filed, you know, the, the project didn't start until June twelfth. And so, you know, we, we billed a small amount for the month of June. I think we reported $301,000 in the, in the income statement, but that, that will build over time.

But, you know, the big value here is in the money that's going to the CRO, and that does not flow through our financial statements at all. The money goes directly to the CRO, so you won't see that reflected in our revenues.

Robert LeBoyer (Analyst)

Of course. Thank you very much.

David Dodd (Chairman and CEO)

You're welcome.

Robert LeBoyer (Analyst)

Thank you.

Operator (participant)

Your next question comes from the line of Jason Kolbert with EF Hutton. Please go ahead.

Jason Kolbert (Managing Director and Senior Healthcare Analyst)

Hey, David, you're right. You cut out about a third of the way through, so we missed everything you were saying. And I did want to hear you discuss the financials, in terms of what the pro forma cash is, today, and, you know, understand how you're gonna manage the cash burn going forward. And I understand BARDA really has nothing to do with this, right? BARDA is just a pass-through on the income statement.

David Dodd (Chairman and CEO)

Mark, do you want to?

Mark Reynolds (CFO)

Jason, I'll address that. In fact, I don't know if the web live stream is still available or not, but I've flipped back in the slides to cover some of this. I mean, we did have some across the board technical difficulties here, where the stream just went down for some reason, so

Jason Kolbert (Managing Director and Senior Healthcare Analyst)

Exactly.

Mark Reynolds (CFO)

So anyway, as I just answered with Robert, for the quarter, we reported $300,000 in revenues from the, the BARDA contract. And as I said, you know, the, the money will, will start flowing. In fact, you know, for the-

Jason Kolbert (Managing Director and Senior Healthcare Analyst)

Well, my question. So, so I really wasn't asking about the BARDA award. I was really asking about the cash balance on the balance sheet, and how you perceive the spending, outside of BARDA, right? Independent of BARDA.

Mark Reynolds (CFO)

Mm-hmm.

Jason Kolbert (Managing Director and Senior Healthcare Analyst)

Whatever you receive from BARDA, you're gonna spend.

Mark Reynolds (CFO)

Right.

Jason Kolbert (Managing Director and Senior Healthcare Analyst)

But outside of that, or just tell me a little bit about what you're thinking in terms of your current pro form a cash, what you have ballpark on the balance sheet today, and what the plan's gonna be, you know, to run the company over the coming year. Thanks.

Mark Reynolds (CFO)

Okay. Well, the bottom line is that even with the BARDA funding, we're gonna need to raise money. That's a given, because the BARDA contract obviously doesn't cover the other programs we've got ongoing, the other clinical trials for GEO-CM04S1 and the planned Gedeptin trial, and plus our ongoing corporate overhead and burn. So we will be raising funds. You know, we're not at liberty yet to say how or how much and the timing of all that, that's in development. We are in discussions with several different bankers in that regard.

But what I can say is that by BARDA funding a complete clinical pathway for at least one significant program for GEO-CM04S1, that gives us some flexibility to, you know, turn the spigot on and off, so to speak, on some, on some of the other programs. Now, we wanna accelerate as fast as we can, obviously, but that's gonna be dependent on the availability of capital resources and, and the fundraising efforts. And, you know, that's, you know, still to be determined.

Jason Kolbert (Managing Director and Senior Healthcare Analyst)

But Mark, where I was really going was what is the impact of the BARDA award in terms of your flexibility of, fundraising instruments? I know, we all know you can raise equity, right? I'm just wondering if there might be a more or a less dilutive approach. Have you considered debt? I noticed one of my other companies who was dealing with a depressed stock price actually did something really smart. You know, they did a debt offering, and,

Mark Reynolds (CFO)

Uh-huh

Jason Kolbert (Managing Director and Senior Healthcare Analyst)

I'm not a big fan of that, except that you have such a securitized asset-

Mark Reynolds (CFO)

Mm-hmm

Jason Kolbert (Managing Director and Senior Healthcare Analyst)

With BARDA, that I would think you, it would, you know, open up some new financial levers for you. That's what I think so.

Mark Reynolds (CFO)

I understand now. The issue I have with debt is, I'm not opposed to debt in the right circumstances. The issue we have with taking on debt for where we are now is that, you know, you mentioned the word securitize. Okay, that's, you know, that's one form, you know, one way to get some debt done is securitizing assets. But then that hamstrings you on sometimes with you know, strategic opportunities for corporate licensing and whatever, if you have some lien on your assets or your patents. And, you know, outside of that, if you're looking at unsecured debt, then you're where we are, you're looking at usually a convertible feature that's built in there, and I'm really not a fan of those.

Jason Kolbert (Managing Director and Senior Healthcare Analyst)

Gotcha. Okay, that's helpful. But you do you feel comfortable with the offers you're getting that, you'll be able to continue to develop Gedeptin and in terms of the timeline you've already represented to the street?

Mark Reynolds (CFO)

Absolutely. 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 gonna weather through it. We will find the funds to continue the programs, and I think that there's a lot of upside here.

Jason Kolbert (Managing Director and Senior Healthcare Analyst)

Well, I mean, this is what Dave, David does. This is what you're really good at, so I'm glad you're at the helm for that. All right, thanks, guys. I really appreciate it. Thank you.

Mark Reynolds (CFO)

Thank you, Jason.

Operator (participant)

Your next question comes from the line of Jeff Kraws with Crystal Research. Please go ahead.

Jeff Kraws (Analyst)

Thank you very much. And, sorry, you had your technical difficulties on the call. The questions that basically have been asked that I was gonna ask, although I will say I concur with your thoughts on the financial aspects and not using debt, because I think that does limit your ability to do many things. On the GEO-CM04S1 and the development, given that it does allow you to throttle back on the cash or move forward on the cash when you do your raise, with your other programs, what is the anticipated speed that you think that product will complete its enrollment? And, what is the timing, do you think, that those trials will conclude? And is there a lot of competition to attract those patients?

Obviously, with Gedeptin, you have an easier time recruiting, but just wanted to hear your thoughts on recruitment with this, and it's great that obviously it's funded, but I wanted to hear your timing on that also.

Mark Reynolds (CFO)

Sure. Kelly, are you on? Would you like to address that?

Kelly McKee (CMO)

I finally got back on. Sorry about that.

Jeff Kraws (Analyst)

Thank you.

Kelly McKee (CMO)

So to talk about the recruitment,

So we've the ongoing trial that we have in patients with blood cancers that have received cell transplants. We have two or three sites currently active, two of which have been enrolling fairly briskly. Now, briskly-

Jeff Kraws (Analyst)

Good.

Kelly McKee (CMO)

You have to put that into context, but we've, they've been enrolling over several, a couple of patients a month, which is pretty much what we projected them to do. And we're planning to activate two additional sites here in the States. And that trial, we intend to continue probably for the next year, while we are preparing to launch a follow-on study, which will be an international trial that will involve sites in the U.S., Canada, and the U.K. The U.K., we've been in serious discussions with about this follow-on trial, and they're very, very enthusiastic about enrolling patients. We've had discussions with patient groups over there who are clamoring for the opportunity to participate in that trial.

So, you know, with regard to projected recruitment challenges, I think they're gonna diminish over time, as we mature the current trial and get the rollover into the next trial, within the next year or two.

Jeff Kraws (Analyst)

Okay. Thank you. And Jeff?

David Dodd (Chairman and CEO)

Jeff, this is David.

Jeff Kraws (Analyst)

Yes.

David Dodd (Chairman and CEO)

Let me just add, relative to the Project NextGen, you know, there are 5 vaccines that have been provided Project NextGen awards. Each one is gonna conduct 10,000-patient trial, and there's estimated 100 sites in each trial. So there's a lot of competition out there for patients, but they're healthy adults, and so we think that'll go well. We're thrilled at how fast this is moving for us on our behalf. We made the announcement on June the eighteenth, and here we are, what? A month and a half passed, and of the 100 sites, there's currently 80 confirmed sites that have already been identified and signed on to this. And others, there are additional ones, but they just haven't completed the confirmation process.

So, from what I understand, that the Allucent, Kelly, and others are, is that we're anticipating that it'll enrollment will take about six months, which is pretty fast, to say the least of that. And, we're following for, I think it's, for a year, whatever it is. But basically, this will go very nicely, and we're off to an incredibly fast, successful start of this program. I could not be more thrilled and delighted at the pace that things are going. That's where it is, and that may help you understand it also.

Jeff Kraws (Analyst)

Great. Thank you very much, David.

David Dodd (Chairman and CEO)

You're welcome.

Operator (participant)

This concludes our Q&A session. I would like to turn the conference back over to David Dodd for any closing remarks.

David Dodd (Chairman and CEO)

Okay. Thank you. Thank you, everyone, for participating in today's update, re-reviewing our progress, our achievements, and our outlook. We believe that this past quarter, Q2, represented a watershed in the GFX development as a result of the Project NextGen Award and our decision to proceed with an expanded Gedeptin Phase 2 clinical trial. Your interest is greatly appreciated, and we look forward to ongoing interactions. As always, we want to acknowledge and thank our board of directors and advisors, our GFX staff, and the many other parties, entities that continue to support us towards achieving success. 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, including those external partners who continue to contribute to the progress success underway at GFX.

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 by our development and commercialization of novel, critically needed cancer therapies and infectious disease vaccines. Have a safe and enjoyable day. Thank you.

Operator (participant)

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