Q3 2022 GeoVax Labs Inc Earnings Call
Good afternoon, and welcome everyone to the Geovax third quarter 2022, corporate update call my.
My name is Robin will facilitate todays call.
With me are David Dodd, Chairman and CEO .
Mark Reynolds Chief Financial Officer.
Mark Newman ph D Chief Scientific officer.
Kelly Mckee M. T M P H, Chief Medical Officer, and John Sharkey Ph D Vice President business development.
At this time all participants are in a listen only mode.
Question and answer session will follow the formal presentation.
As a reminder, this conference is being recorded.
Please note. This event is being recorded and at this time I am turning the call over to Kathy do you give arena of C. G capital.
Yeah.
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 deal that can develop and manufacture vaccines with the desired characteristics in a timely manner gearboxes vaccines will be safe for human use do you have active vaccines will effectively prevent targeted infections in humans gearboxes vaccine will receive.
Regulatory approval necessary to be licensed and marketed geovax raises required capital to complete vaccine development. There is development of competitive products that may be more effective or easier to use mgo vaccine products.
We will be able to enter into favorable manufacturing and distribution agreements and other factors over which Geovax has no control.
<unk> assumes no obligation to update these forward looking statements and does not intend to do so more information about these factors is contained in geo boxes 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 Geovax David.
Yeah.
Good afternoon, and thank you for participating in the <unk> corporate update call.
The third quarter represented continued progress for <unk> as we advance the phase two clinical programs in support of good depth.
Our cancer therapy for patients with advanced head and neck cancers and G. E O C. M O four S. One our next generation COVID-19 vaccine. In addition, we continue to progress our preclinical development stage programs. We also further strengthened our balance sheet during a very difficult investment environment, especially.
So the biotech industry as a result of our successful financings. This year, we are well capitalized to complete our current phase two clinical programs, including expansion of the good depth and multi site trial and expanding the CMO for <unk> COVID-19 vaccine trial, among immuno compromised patients two additional.
All sites.
We are focused on accelerating our progress with anticipated initial data readouts over the next six to nine months. Our mission is to provide immunotherapies and vaccines that improve lives worldwide, preventing or treating some of the world's most challenging cancers and infectious diseases.
Also we recently initiated business development discussions towards ordinary and collaborations to ensure worldwide access to our products.
Value to our stakeholders, good depth and see them O. Four S wont provide significant value expansion opportunity for the company, our shareholders and our stakeholders.
As a reminder, <unk> is a cancer therapy currently in an expanded multi site valuation among patients suffering from advanced head and neck cancers. The product has received orphan drug designation from the FDA as well as the initial funding in support of the current clinical trial coming from the F. D. A.
And drugs clinical trials program.
Our focus is on accelerated and expanded patient enrollment now the additional good depth and sites are on board. Our goal is to complete patient enrollment in 2023, followed by completion of patient evaluations before the end of 'twenty 'twenty four and.
In the interim we expect to engage with the FDA regarding our results with the focus on clarifying the opportunity for an expedited biologics license application filing.
We're excited about the outlook and promise of good depth going within advanced head and neck cancers. In addition, there are promising opportunities relative to expanded use of good depth in other indications as well as application of the underlying technology in conjunction with other therapies and potential synergy with our internally developed mark wanted to your associated.
Antigen approach.
We also anticipate expanded discussions related to partnering and collaborations related to <unk>.
Sam O four as one is our leading next generation COVID-19 vaccine currently in phase two clinical development targeting both the antibody and cellular arms of the immune system with the goal of providing more robust and durable protection than the currently authorized vaccine.
This vaccine holds promise over the current authorized vaccines several critical areas of differentiation and value to various patient populations.
Our focus is on accelerating the clinical development of each of these products, including the potential for expedited regulatory review.
Meanwhile, we continue to advance other internal development programs in the past I M D filing.
We remain focused on accelerating efforts towards our milestones over the next 12 to 18 months in support of both a good depth and the CMO for S. One COVID-19 vaccine programs, we expect to report not only on the expansion of the good depth in study two additional sites, but also initial clinical data, which we are.
Anticipating reporting during the first half of 2023, we also anticipate reporting initial clinical results and support the CMO fourth S. One during the first half of 'twenty 'twenty three.
In addition, we will continue to provide updates related to the progress of our programs that are advancing their clinical staff.
Since January we have added $37 million to our balance sheet. Despite this year, representing what many consider the most challenging year in over a decade for capital development within the biotech industry.
Our successful financing supports efforts towards the completion of the current clinical programs.
We continue to receive strong interest related to investment capital, which will evaluate but we're focused on execution towards our 2022 'twenty 2022 and 'twenty 'twenty three goals of building shareholder value.
We're committed to the clinical development of the C. M O four S. One against COVID-19, specifically is an invaluable medical tool to address the continually emerging variance of concern while also providing critically important value to those with compromised immune systems.
CMO Forest, one induces immunity to Sars COVID-19 two by stimulating the immune system to produce antibodies that can block the virus and entering healthy cells. While also inducing the growth of new disease fighting T cells that can recognize and destroy infected cells.
This is an important distinction between C. M O for US one of the first generation COVID-19 vaccines.
Our vaccine includes both Sars koby to Spike and nuclear capsid proteins is immunogenic different from the current authorized vaccines, which only include the spike protein.
Inserting both of these viral genes the vaccine is able to drive the expression of both proteins within the body of the vaccine recipient.
Again. This is an important distinction as CMO for is specifically designed to induce an expanded immune response offering significant potential for improved levels of efficacy and differentiation within the field.
This vaccine design was implemented specifically to induce an expanded immune response to better combat and clear infections, regardless of the circulating Sars COVID-19 two variants.
Vaccine is the first step in the worldwide go to provide a vaccine that actually gets ahead of the variance versus having to chase the variance.
Our approach of using the spike in Nucleocapsid viral proteins was recently validated by multiple independent academic research groups in animal models using M. B, a and other vaccine platforms. Assuming continued success. This vaccine will likely reduce the requirement to continually adjust the vaccine and the.
Reliance on the repeated administration a booster doses. This is what we mean and stayed in getting ahead of the variants versus chasing the variance.
In July analysis of data from the Phase one study of CMO for its one published in the peer reviewed journal I Science show that the vaccine, which is based on the same wuhan strained as the first generation approved vaccine induced potent and the equivalent T cell cross reactivity against Delta and Omicron bearings.
These findings suggest that T cell immunity stimulated by CMO for US one may constitute a critical line of defense to provide long term protection against Sars Covid two variants.
We also believe that the multi punch approach has the potential providing a more robust and durable immune response and protection of various high risk populations, specifically immuno compromised individuals who will benefit from such a multi pronged approach, resulting in broader and more durable protection.
The vaccine is currently being evaluated in two phase III clinical trials. One is a comparative study of the backs of our vaccine is the primary vaccine versus the current F. D. A approved Pfizer vaccine and individuals that have received or are undergoing specific blood cancer therapies associated with transplantation or <unk>.
Part teeth, there therapy, which severely reduced pre existing immunity to COVID-19 vaccines clinics.
Clinical evidence indicates that such patients fail to respond optimally to the current generation vaccines and we believe that CMO for us one will prove to be more potent because there's multi allogeneic and delivered using these highly potent N V. A viral vector. We believe this will differentiate CMO for S. One from the other vaccines by inducing straw.
Home and sustained antibody T cell responses in patients who are at severe risk of COVID-19 disease due to their immuno compromised status the.
The other phase two trial underway is evaluating C. M O four S. One as a booster for healthy patients who had previously received either the Pfizer a maternal vaccine.
We believe that providing a hydrological booster rather than continued multiple shots of the same vaccine will induce more robust and durable immune responses and protection.
At our largest prime boost immunity immunizations are well studied in other fields, such as HIV and are being evaluated in multiple countries using different COVID-19 vaccine.
Our goal is to provide a vaccine that is the requirement of multiple boosters throughout a year.
Finally, I want to reinforce the concept that our internal effort to develop and advance M. B a manufacturing process based on continuously growing aliens cell lines to increase protect production consistency capacity and flexibility will mesh with the club.
Development activities in.
In total this represents the full development scope associated with that you have back to Corona virus vaccines.
Monkey Pox cases continue to increase worldwide with nations enacting procedures and policies to support of minimizing the health risks there are populations.
There is also concerned that more virulent and infectious forms monkey pox might evolve, resulting in increased spread of disease and deaths.
Axiom vector modified vaccinia, Ankara or N V E, which is utilized in numerous junior bags.
Savings, including our C. M S O for US one COVID-19 vaccine is the primary vaccine used to prevent the global global Monkey pox threat as.
As you May know N V. A is currently stockpiled and utilize to protect against both monkey pox and smallpox.
In August our colleagues at city of Hope published results demonstrating that both CMO for S. One and the synthetic M. B a use in the construct of a CMO for US one induced robust antibody in cellular immune responses against monkey pox that were durable for over six months post vaccination.
They always concluded the CMO for S. One and synthetic M. B a represent unique vaccine candidates to control the expanding global monkey pox outbreak Jia.
<unk> is evaluating development and regulatory pathways towards this opportunity as the need for expanding the M. B a vaccine availability beyond the current limited single source provider as a global and increasing concern and.
And in fact, just today, we've announced our securing the rights of the NIH N V E for use against Monkey pox in smallpox.
Now I'd like to turn the presentation over to park rentals gearbox, Chief financial office were fueled by our recent results and financial steps.
Thank you David.
Starting with our income statement. The first thing to note is the minimal amount of grant revenues reported during 2022 as compared to 2021, which is reflective of the expected wind down of our grant from the U S Army and the NIH for a loss of fever programs and our COVID-19 preclinical program as we've now focus.
Moving our attention to the clinical programs for both COVID-19.
And conduct.
We do intend to seek additional non dilutive funding for our development programs in the future I'll make that point.
R&D expenses of research and development expenses were $2 7 million for the third quarter of 2022 five.
$5 4 million for the nine month period, reflecting a substantial increase versus 2021 amounts of $1 2 million and $2 7 million respectively.
These increases were planned unexpected as they are associated with new clinical trial activity for our CMO C. M O four S. One and conducting programs, including manufacturing costs for clinical trial materials. The increase is also reflective of higher personnel and consulting costs as we staffed up earlier in the year.
General and administrative expenses were $1 2 million for the third quarter of 'twenty, two and $3 4 million for nine months period as compared to $758002 6 million in 2021 with the increases again associated with higher personnel consulting and higher patent costs.
So overall net loss for the third quarter of 2022 was four 4 million or <unk> 17 per share versus $2 million in 2020, one or 31 cents per share for.
For the nine month period, our net loss was $8 6 million in 2022 were <unk> 63 per share versus $4 8 million in 2021 or 80 cents per share again the increases during 2022, primarily associated with the ramp up of our organizational infrastructure and other costs associated with the.
CMO for S, one and conducting clinical trials.
Turning now to the balance sheet, our cash balances at September 30 were approximately $35 million as compared to 31 million at the end of last quarter and $1 4 million at the end of 2021.
The change in cash balances for 2022 was reflective of $12 million used in operating activities offset by proceeds from stock offerings in January and May with combined net proceeds to us of nearly $28 million.
And an additional $7 6 million proceeds from the exercise of warrants during the third quarter.
Our outstanding common shares now stand at $26 3 million.
In summary, we are well positioned to accelerate and advance our clinical programs with a cash runway sufficient to fund our operations and our priority programs through the end of next year.
Funding, our three ongoing phase two clinical programs and preparing for the next stages of development are the most significant use of our cash and our top financial priority.
So I'll be happy to answer any other questions on the Q&A I'll turn the call back to David now.
Thank you Mark.
My colleagues and I will now answer your questions joining us for the Q&A session are as mentioned earlier doctors Mark Newman.
Doctors, Dr. Kelly Mckeith doctors, John Sharkey, our Chief Scientific Officer, Chief Medical Officer, and Vice President of business development, respectively. I'm, Therefore, turning the call over to the operator for instructions on the Q&A period.
Thank you.
We will then be conducting a question and answer session. If you'd like to ask a question today. Please press star one from your telephone keypad and a confirmation tone will indicate your line is in the question queue do.
Can you refresh start to if you like to move your question from the queue.
For participants using speaker equipment may be necessary to pick up your handset before pressing the star keys.
One moment. Please so we poll for questions. Thank you.
Thank you.
Our first question is from the line of Jeffrey Cross with Crystal Research Associates. Please proceed with your question.
Thank you very much nice job on moving so many programs ahead and on schedule with what you had told US you are going to almost a year ago I have a few questions. The first is on the Covid immuno compromised trial you had mentioned in your announcement that you were going to be.
Expanding the number of centers can you. Please elaborate on how many centers you're planning to elaborate too and what we can expect how does that.
Sure Jeff. Thank you I. Appreciate your question I'll ask Kelly Mckee to address that Dr. Lu Qi.
Yeah, Hi, thanks for the question.
Our current plan is to expand up to somewhere between 20 and 30.
<unk> centers.
Uh huh.
It's a it's a work in progress we're making.
Slow, but steady process progress with it with in listing interested sites, but our ultimate goal is probably 20 to 30 sites.
Okay. Thank you very much.
With your expertise in N V. A right now and certainly the positive responses youre getting what is the status right now with regarding with regard to monkey pox.
Okay. Thank you I'll ask Dr. John Sharkey to address that these are point personal net chung.
Sure.
Thanks for the question there are two aspects of the Montney box at all clubs first upon the addition of a mom and Pops indication to our N V. A platform vaccine for COVID-19, and the bold and the others.
And we've been in discussion with all regulatory experts mostly outside.
And we've come to the conclusion that there is a clear regulatory pathway.
To getting both the monkey pox and the smallpox indicates an add on to what we referred to as a primary M. B a vaccine such as our COVID-19, audible or something else.
As we work through this and put it simply as the primary vaccine indication for example, COVID-19 will dictate the development timeline, but we believe in parallel we can collect the additional information required so that at the time of registration or quickly thereafter, we could add that indication.
In regards to what we announced today with the rights to the NIH N V. A poor multipart smallpox.
We're looking to develop an M D. A vaccine we know N V as effective here.
We believe that with the amount of information known about N V. A the safety profile of them be remembering that it was developed you used in the neuro compromised population.
That there should be a an abbreviated pathway and expedited pathway to getting this through with.
With the NDA in hand, we start activity the scaling up our.
Master C batches, which will allow us to move into cgmp production.
And we're being with select regulatory agencies, we're going to map out.
I said in an expedited pathway to getting this to market, but that's our intention.
Right that's very impressive.
Last question.
Hudnut centers, obviously are active can.
Can you provide some of your thoughts as to what we should expect to see as far as progress from those centers and will we expect to see you at ash.
Thank you.
Dr. <unk> would you like to answer that respond please.
Sure.
So are our ongoing.
Good depth in trial.
<unk> is now in involves three.
Academic medical centers.
The first one Stanford is the is the center of that.
Enrolled the initial five patients and we've added two more.
Of them are now under contract up and running and actively.
And patients to screen and enroll.
And we anticipate getting that that this study fully enrolled.
Hopefully by the end of the end of this year or at the latest early next year.
Great and as for Ash, I will be Oh, I'll be attending ash actually so.
Okay.
Thank you very much that's all my questions. Thank you.
The next question comes from the line of Vernon Bernardino with H C. Wainwright. Please proceed with your question.
Thank you for taking my call.
Sure.
With that we named her Vernon.
I was just curious if you can provide us with some color on.
What Joe box.
About recent results from competitors, specifically Holly perfectly to.
Compromised from a Charles.
Sure I I ask maybe Mark Newman ducked anything you'd like to start off and maybe Kelly would like that then at all and if I.
It feels something else seems to be at.
Okay.
Okay.
Yeah sure I can try so when you say news from competitors, what specifically you're talking about.
Yeah.
Well it was just a frame rate overall.
Can you read there was just some user came out.
Next I would like to buy them in fixed boxes right.
Overall the question you know how should we be approaching them.
Birmingham.
Thanks.
I mean, all of this has been done.
When that immuno compromised feature listen just wondering like what the 15 or at least how does chew bags I see that landscape for us.
Patient population, Okay, yeah sure so.
Remember the MBA was developed as a smallpox vaccine specifically for use in patients with some level of immune compromised immune systems.
So the safety and everything is unique but it's also the partners see this as a product is very effective at driving our antiviral responses, particularly T cell responses and so I think there's a somewhat of a unique niche in the way that the vectors. Judy you don't get this with you know like our mrna.
<unk> per se, there's none of the additional.
Kind of anti viral effects to it.
Beyond that have you.
Probably recall, we've been focusing on the concept of breath adverse spots and so you know the virus coronavirus, there's a lot of protein that's great. The targets, yes, yes, but you know the hand system. He gets a chance to see everything and say, we're more more closely trying to mimic a a normal response something that you would see.
If you'll be heartbreak cover on your on your own. So its induction of an antibody response, not only to ask but also the and the T cell responses as well and then you know that there's been a lot of independent research that's starting to get published kind of routinely now both in animal models and in a clinical trial.
<unk> showing that the immune responses that are more broadly targeted so S plus and can actually protect animals from infectious challenge. This was like I said coming up from independent Ah study of switches, but its really nice it's it's.
It's it's validating what we got into a phase II trial, but there's also a number of clinical trials well I've just crossed my desk yesterday our studies.
Humans that have recovered from infection showing the types of responses that are correlated and yesterday's papers Holland partner sell either be immune responses to the nucleocapsid are for these patients. So that's I think it's really lining up well we've been talking about this for about 18 months to two years.
Ours, now and and finally you know.
Getting a lot of traction and it's we kind of joke a little bit it's nice to see these animal studies validating what we already are our new letter, saying in clinical trials. So I think theres a lot of opportunities here, how it'll be used in the end it will be some regulatory questions and things to address as well.
There's always going to be that standard of care product thats out there and with each individual patient population there might be a you know a unique approach to the highway to administer the vaccine in combination says as David said heterologous prime boost or as individual products a.
Yearly boosters every feiger boosters all of those will probably have to be fine tuned.
Hi, Thank you for that kind of actually it's very helpful. And then I guess.
Have some problems with my connection so I'm sorry.
Repeat yourself with my next question, but I just wanted to know if I need it and if there were any changes to any of that occurring catalysts.
I don't believe so.
I was gonna add limit on that first issue about the immuno compromised based on the discussions we're having with you know.
With various advisors consultants, but we believe that there may very well be expedited pathways for focusing on certain immuno compromised population relative to the continued development of our COVID-19 vaccine. So the CMO for US one of them will be further.
Refining those through discussions not just amongst ourselves and consultant, but also with the F. D. A is as we go forward into 2023 and as we start sharing the initial data results that we're getting from the existing trial. So we'll keep everyone updated on that but we do believe that by focusing specifically.
On populations with immuno compromise, who are immunocompromised that there may be expedited pathways and much stronger points of differentiation for us and then obviously going toe to toe with the very large players who you know dealing with relatively healthy people are they're going to continue to have their chat.
<unk> of addressing cost variance of concern, but we do believe that there is a strong point of distinction and differentiation that will be bode very well for <unk>.
Thank you.
Thank you. The next question is from the line of Robert Leboyer with Noble capital. Please proceed with your question.
Thank you our first congratulation on congratulations on all the progress and my question was partially answered with the previous answer and I was going to ask about the current environment for Covid vaccines and requirements for approval as the vibe.
This is evolving and bearings are coming out.
Specifically in terms of what the regulatory path might be and.
In terms of size of trials next trials or any light that you can shed on next steps after the phase two data comes out for either trial.
Thank you Robert.
Thank you.
The Irish.
Our anticipation is that that will be clearer.
As we engage in discussions having data from these trials as they are coming out you know with with the F. D. A now what we will be also addressing is the advice we are receiving and we believe in it also rather strongly is that there are certain populations.
For which we may have a very compelling argument or proposal to me speak to the regulatory agencies about targeting specific populations, who clearly are not being well served are served at all by the current vaccines, even if they are modified them to chase after a new emerge.
Varian and and we plan to to focus on that very strongly as we gather the data that will begin to see in the not too distant future and we'll engage in those discussions and then as as we learn more we will keep you updated but that's sort of the basis of the pathway that we're looking at.
Yeah.
Okay. That's helpful. Thank you very much.
Thank you.
Thank you.
At this time there reach end of our question and answer session and I will hand, the floor to management for further remarks.
Thank you.
This concludes our question and answer session.
So what I'd like to do is thank everybody for participating in this update call sharing and our achievements our progress our outlook. We're quite excited about what is being achieved and what we're advancing here at <unk> and in relatively short time. It was approximately just a little over two years ago that we did the recapitalization.
NASDAQ and your interest is greatly valued and appreciated so thank you.
Going forward our focus is on.
Fusion reporting updates and progress with good depth and CMO for S. One and our other development programs as well as expansion of our capabilities our resources, our goal and focus is to build shareholder and stakeholder value.
I want to also acknowledge and thank our board of directors, our <unk> staff and the many other parties that continue to support assistant advisers towards achieving success for all of US. It is indeed, a great pleasure, serving our shareholders and being a part of this team and all of the pathway that we're pursuing.
Have a safe enjoyable day and again, thank you for your interest.
This will conclude today's conference you may disconnect. Your lines at this time. Thank you for your participation.