Q2 2023 GeoVax Labs Inc Earnings Call
Good day My name is Jordan and I'll be your conference operator today at this time I would like to welcome everyone to the <unk> second quarter earnings Conference call.
I'll turn the call over to Gabrielle.
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 weather.
That's been developed and manufactured product candidates with the desired characteristics in a timely manner and such products will be safe for human use.
With vaccines will effectively prevent targeted infections in humans.
These product candidates will receive regulatory approval necessary to be licensed and marketed.
Gearbox raises required capital to complete development of its products, there's development of competitive products that may be more effective or easier to use geovax with products.
You would actually be able to enter into favorable manufacturing and distribution agreements and other factors over which drove that has no control. She had actually seems no obligation to update these forward looking statements and does not intend to do so more information about these factors is contained in G. Abaxis filings with the Securities and Exchange Commission.
Including those set forth at risk factors and gearboxes Form 10-K. It is now my pleasure to introduce the chairman and CEO of Geovax David.
David.
Good afternoon, and thank you just putting in the GFX corporate update call.
This year, we've expanded patient enrollment in support of a good depth in phase two clinical trial and the two phase III trials for G. E O CMO for S. One as well as announcing the initiation of the third phase III clinical program evaluating this next generation COVID-19 vaccine as a booster among patients.
Chronic lymphocytic leukemia.
We also recently expanded our rights related to see them all four of US wanted to include <unk>.
Okay parks in smallpox further differentiating our COVID-19 vaccine.
While the clinical development progress and good depth and CMO for S. One we've made our priority. We are also focused on G. E O M D. A.
Vaccine against Monkey pox in smallpox as well as the implementation of the transformative N V. A continuous cell line manufacturing process.
During the second quarter, we progressed each of these priority initiatives.
Currently we are funded into 2024, and we anticipate further strengthening our balance sheet as a result of supportive stop activities business development initiatives and non dilutive opportunities related to government and NGO funding.
As recently announced interim data from the current the depth and clinical program was presented in July at the American Association for cancer Research and the American head and Neck Society Joint conference on head and neck cancers.
We are pleased and encouraged by the results, noting no dose limiting toxicities or serious adverse events definitely attributable to treatment with impaired growth in targeted lesions observed in the majority of the patients.
We anticipate completion of the current clinical programs shortly and we are already planning the next stage of clinical development relative to this promising therapy.
There are approximately 67000, new cases of head and neck cancers annually in the U S and approximately 13000 deaths. This represents our initial targeted patient population.
Why there are approximately 900000, new cases of head and neck cancers annually and approximately 400000 deaths.
Suffering from advanced head and neck cancer represent a critical unmet medical need.
We are excited about the outlook and promise of good depth in therapy against numerous tumors chapters, we perceive significant opportunity addressing various tumors as model therapy as well as the potential combos administering.
Administering good depth and in conjunction with other therapies, such as immune checkpoint inhibitors, we anticipate publication of compelling preclinical evaluation of conducting usually combination with ICI later this year.
Relative to commercialization, we anticipate partnering and collaboration to support a worldwide use for which business development activities have been initiated we hold worldwide rights for the use of good depth in all indications.
The vast array of unmet medical needs within oncology represents significant opportunities for <unk> to advance novel approaches addressing various cancer patient needs worldwide increase.
Increasingly we are participating in various oncology conferences, some of which we expect good depth in presentations and.
With others good depth in partnering discussions.
G E O C M O four S. One or a next generation COVID-19 vaccine differentiates from the currently authorized COVID-19, vaccines and targeting both antibody and cellular arms of the immune system focused on providing a more robust and durable protection to the current vaccines.
This is critically important in addressing the high risk populations of immune compromised individuals for whom the current vaccines monoclonal antibody therapies are inadequate.
Such populations include those with various blood cancers renal disease sickle cell anemia, HIV positive autoimmune diseases, such as lupus and those are immune suppressive therapy in general patient groups with a blade immune systems unable to respond adequately to approved mrna vaccines are at such high.
High risk.
In the U S. There are approximately 12 to 15 million of immune compromised individuals worldwide. There are an estimated 200 plus million. This is a major critical need for next generation COVID-19 vaccines to support such individuals and we believe the CMO for S. One is the leading next generation vaccine in clinical development.
Uh huh.
During second quarter, the White House announced project next year is $5 billion initiative. The follow on from operation Warped speed seeking COVID-19 vaccines with enhanced breadth of protection against variants that improve durability being particularly interested in novel vaccine candidates already on.
Clinical trials.
We believe the CMO for S. One it was a leading example, xyratex generation COVID-19 vaccine, we have considerable interest both domestically and internationally and participating in our clinical development program.
We believe that an opportunity for an expedited regulatory path likely exist due to our focus on high risk populations unserved by the current COVID-19 vaccine and monoclonal antibody therapies.
We anticipate partnering and collaborations in support of worldwide commercialization of distribution.
Regarding project Nextgen, all we can say at this time is that we're deeply involved in the process and discussions we hope Brian further updates soon.
For the remainder of 'twenty to 'twenty three we are focused on accelerating efforts in support of the depth and CMO for S. One phase II clinical programs.
R M B a vaccine specific for M Fox in smallpox into development and further advancement of our program focus on improved NBA manufacturing processes. We also anticipate opportunities to add additional capital in support of these programs accelerating the pace of progress and reporting a milestone milestone payments.
Now I'd like to turn the presentation over to Mark rentals, <unk>, Chief Financial Officer for a review of our recent results and financial status Mark.
Thank you David.
Starting with our income statement I will focus on the comparative figures for the six month periods of 2023 versus <unk> 22, we.
We had no active grants during 2023, so far so we reported no grant revenues as compared to a small amount in 'twenty. Two I will note. However that as David suggested we are actively seeking additional non dilutive funding from both our preclinical and clinical development programs and we expect this may potentially be a very important.
One of our financing mix in the future.
Research and development expenses were $7 5 million in 2023 versus $2 6 million in 'twenty two.
With the increase primarily associated with clinical trial activity for the CMO for us one in conducting programs, including manufacturing costs uncle trial materials.
Increase is also reflective of higher personnel costs as we brought on two additional executive level employees, this year, which added depth to our regulatory and quality control functions.
General and administrative expenses were $2 9 million in 2023 versus $2 1 million in 'twenty, two with the increase mostly associated with higher personnel consulting and patent costs.
So overall net loss for the first six months of 2023 was approximately $10 million or <unk> 38 per share versus $4 7 million in 2022, or <unk> 47 per share again with the increase being driven by the CMO for us one and conduct in clinical trial activity.
Turning now to the balance sheet, our cash balances at June 30 were approximately $18 million as compared to $27 6 million at the end of 'twenty two.
The change in the cash balances is reflective of $9 8 million used in operating activities. There were no significant financing or investing activities. So far during 2023 our.
Our outstanding common shares stand at $26 4 million.
Funding, our four ongoing phase II clinical programs is the most significant use of our cash and our top financial priority.
But I'll note that the recently initiated fourth trial that being for CLO.
It is being fully funded primarily through non dilutive sources with <unk>, providing some relatively minor support for analytical costs.
Our cash runway is sufficient to fund these programs through the milestones are expected to occur through the end of this year and into early 2024.
So I'll be happy to answer any questions during the Q&A and I'll turn the call back now to David.
Thank you Mark.
My colleagues and I will now answer your questions joining us for the Q&A session are doctors, Mark Newman, Kelly with key and John Sharkey, Our Chief Scientific Officer, Chief Medical Officer, and Vice President of business development, respectively. I will now turn the call over to the operator for the instructions on the question and answer period.
Yeah.
At this time I would like to remind everyone in order to ask a question Press Star then the number one on your telephone keypad, we'll pause for just a moment to compile the Q&A roster.
Your first question.
Comes from the line of.
Robert Leboyer from noble capital markets.
Hi, and congratulations on all the progress that you've made in the past quarter Mike.
My question has to do with your your mention of a combination trial with <unk>.
The checkpoint inhibitors.
And I was wondering if there was any data that was going to be presented or any plans for the rest of the year you had mentioned.
Expansion of <unk>.
The current trials and completing enrollment but.
Was wondering if there was any intention to start another arm or.
What the potential.
For combination therapy is right now.
Sure. Robert This is David I'll answer and then Kelly, if you want to add anything else.
What I would say right now that's in preclinical work, we're supporting that work.
Evaluation or adapt to and in conjunction with <unk>.
There is a manuscript that's in <unk>.
But again this is preclinical work that we.
Great that manuscript.
It will be published yet.
Our understanding is and yet this year.
And we'll continue to value weighted but at this time, we're not working in the clinic and in any combo therapy. We're focused right now on the current clinical profile, Kevin do you want to add anything to that.
Sure.
I mean, one of the one of the really exciting things about <unk> is that its mechanism of action is essentially tumor agnostic with respect to solid cancers solid tumor cancers, and so I think we have an opportunity.
To sort of survey the cancer landscape, if you will and target a number of different.
Tumor types.
In that regard.
We're exploring sort of next steps in the head and neck cancer space.
But we're also in discussions with some academic investigators who has expressed an interest in.
In.
Looking at the depth and in breast cancer patients and if they if we proceed in that direction I think the the likely opportunity will be for us to go in with a combination.
<unk> and checkpoint inhibitor trial, the design of which is again sort of in early the early phases of discussion. So really can't go into details on that but that's probably going to be our next non agent and neck cancer target.
Great.
Okay. Thank you very much.
Thank you Rob.
Your next question comes from the line of Kumar <unk> from Roth capital.
Yes.
Hi, Thanks for taking my questions.
So I admired equation about the booster fans.
In.
Baird.
When can we expect data from this trial.
We will be have any interim data from this trial.
Kumar are you asking about the healthy volunteer booster or the booster for the CLI patients.
Asking about the Seattle times.
Okay, Kelly you want to address that please.
Yeah. So so that the CML trial just began enrolling.
Couple of weeks ago, and so it's still in the early phases of study.
The expectation based on our discussions with the principal investigator at the city of Hope Medical Center and their team is it will have that trial fully enrolled within about a six month period.
Now the primary readout is a month or so after the second vaccination, which is three months. After the first explanation. So you sort of you sort of do the math and I think you're likely to see.
At least in the initial <unk>.
Do you.
Of outcomes of immunologic outcomes and safety outcomes.
Sometime towards the end of 2020 for early 2025.
The study itself is as a follow up period of the year. So it won't be completed tour.
12 months after it's fully enrolled so whenever that time point hits.
Does that answer your question.
Yeah, what I'm trying to get into areas like will you be waiting for the all of these 80 patients to be Angola, or will you be releasing some data out.
Let us say a date out something like 40 patients or something like that will you be providing the thing update in the interim.
Well you know again remember this is an investigator initiated study and so the you know the sort of operational control of this trial is under the investigator himself.
We are fully informed of progress as it as the trial proceeds but as to when specific data will be forthcoming.
Can't answer that at this time.
Okay.
And with regard to this madness grip youre preparing with the checkpoint inhibitor.
Hmm.
What kind of preclinical models are being used there.
It also.
Is that expectation like how how got update will be sequenced with the checkpoint plus Julius corrupting and then followed by the checkpoint inhibitor.
Yeah.
So that so the so the manuscript is being prepared by our academic collaborators.
And this is based on their work in a mouse model a mouse tumor model and the specific details of that.
<unk> disclosed but.
It will guide the design of our clinical trial I think you can we can say that with some with some confidence.
Okay, and mostly this data was being head and neck cancer models as well as the best kind of set of models that are starting to see my understanding is that correct.
Aye.
Okay.
Not sure I haven't seen the draft manuscript, so I'm not sure exactly what is being put in there, but I do know that they have.
Data from at least breast cancer.
Our breast cancer tumor model.
And additional tumors, but im not sure what additional tumors Azhar John Sharkey do you have that information.
Yeah, Hey, komara. They my understanding is they've looked at a couple of different tumor or tumor type they've looked at a glioblastoma. The Kelly said they've looked at a breast cancer.
Which ones are going to include in that public case, and we're just not aware privy to until we see the.
The first draft of this preparation and internal circulation with vendor institution at the current time.
Okay. Okay.
And with regard to the head and neck.
Has all of the 10 patients being enrolled in the trials.
Or can you share with regards to that.
No we're still a couple of patient short of our target enrollment target.
<unk>.
And.
We.
Yeah.
I know you're at your what you really want to know when we can have Vinny Vinny complete enrollment.
We're hoping that that's going to take place before the end of the year. This is we found this to be a very very difficult patient population to enroll for a whole variety of reasons.
But we're confident that we'll be able to close out. This study by the end of the year.
Great. Thanks, so much for taking my questions.
Sure <unk>, let me just add on the C. O L study I did want to point out that the vaccinations have already begun it was just recently a couple of weeks ago, we announced the initiation of it but there is there appears to be a.
Strong building I'll call it Q.
Hello patients interested in this so.
The vaccinations, who have already started and.
Theres quieter.
Screaming buildup.
Background and so.
Concept for this.
This being fully enrolled within six months.
I mean, it'll be six months I mean, we'll have to monitor the pace of it because it is an investigator initiated trial.
Our anticipation is that we will be learning of data as we go through it not simply waiting till the pool.
Our completed.
Okay great.
Again, if you would like to ask a question Press Star then the number one on your telephone keypad.
Your next question comes from Jeffrey Cross Crystal Research Associates.
Thank you very much.
Two of my questions were already answered, leaving just one.
With regard to the CMO for US one in the omicron variance.
This is actually.
I would think of technology, while Covid has died down given smallpox and some of the issues. They are having in other countries.
Are you seeing good response following that data that you presented showing both the T cell response as well as an immune response.
Yes, I'll ask Mark Newman, who would like to weigh in on those because we've seen very promising and encouraging response with our vaccine against the omicron Delta basically all the way through the SB five foot Mark.
Yes sure. Thank you David you know we have samples in the freezer from the phase one and then we have what would be called the safety lead in our the sentinels and the.
<unk>.
Blood cancer studies that are evaluated in real time, and so one of the things you always do is go back and look at your samples and ask why okay.
How did it work against the Wuhan, where we started and how does it work against Delta how does it work against all Macau and in fact, what we're finding is and this has been presented a couple of vaccine meetings is we're getting great booster responses, even in the cancer treatment patients and in fact, I would say surpassing you know initial.
Patients. This includes an increase in antibody responses that neutralize the variance is it from you know from the the original rule through the Delta and into some of the AUM of crowds, including our old crowd about would be a one point too and I want a one five so we're always a little.
I would say behind maybe three to four.
Weeks behind it takes that long to make the new construct stuff, but it's it's it's very promising data and that we're seeing neutralization across to these other variants and of course, we're seeing T cell recognition to both the SME and maintained at a high level that was actually a predictable because.
As the virus is not very Yang the T cell epitopes as much as that's varying the portion that the antibodies is recognizing.
So yeah, it's all pointing in the right direction.
Now on the you know looking at the such populations with the various blood cancers et cetera, as well as sickle cell.
Not widely recognized while the sickle cell population in the United States in Boston 200000, the sickle cell population in India is estimated to be $28 million. So that is an area. I think you would have a lot of interest for not only partnering but a lot of interest for patient population trading because it's such a large market for them.
That's true numerous groups within <unk>.
I will call the immune compromised populations.
People are still being sequestered in the United States, who are CLO patients people being sequestered in other parts of the world, whereas the rest of US no. We don't we barely remember wearing masks. It seems like we've gone about our lives, but there are these populations who have these medical conditions for for whom the current vaccines a monoclonal.
Antibodies are in adequate and theyre, not leaving they're not back to normal lives Theres still sequestered being kept indoors and that's why we saw a strong response and interest with the announcement of the initiation of the C O L booster crop.
Perfect. Thank you very much for the updates.
Thank you.
There are no further questions at this time I would like to turn the call back over to the presenters.
Thank you. Thank you everyone for participating in this corporate update and sharing our achievements progress and outlook.
We're quite excited about what we're learning with these products the depth them as is.
<unk> to show promise and encouragement not just in head and neck.
But in the application of other areas, where we think there's broad based opportunities there.
We will keep you updated as more data comes in and as we learn more about.
CMO for US one is Mark Newman mentioned it.
<unk> probably expectations in terms of the promise of what we're looking forward to.
We're highly encouraged with the interest we've received from from various parties about that product and the opportunity. The broad based use of it again, we'll keep you updated as more data comes on the same thing as we progress with our MTA vaccine to become the first U S based supplier.
Such a vaccine and helped the world supply et cetera, and then of course, our manufacturing process improvements. So we'll keep you updated our focus is only accelerating to these milestone catalyst our goal is to deliver critically needed vaccines and immunotherapies to build shareholder and stakeholder value.
Providing highly motivated and career development opportunities for our team.
We take that very seriously.
Knowledge and thank our board of directors, our staff and the many other parties that support the advise counsel and assistance as we move forward well. Thank you for your answers. So please circle back if you have further questions. We appreciate your time attention and interest.
Have a good day.
This concludes today's conference call you may now disconnect.
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Okay.
Okay.
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Yeah.