Q3 2023 GeoVax Labs Inc Earnings Call

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Okay.

Speaker 1: Good afternoon and welcome everyone to the GeoBacks third quarter 2023 corporate update.

Good afternoon, and welcome everyone to the <unk> third quarter 2023, corporate update call. My name is Martin deep and I wont fulfilled states, you'll still take todays call with me are David Dodd, Chairman and CEO, Mark Reynolds Chief Financial Officer.

Speaker 1: My name is Mandeep and I will facilitate today's call. With me are David Dodd, Chairman and CEO , Mark Reynolds, Chief Financial Officer.

Speaker 1: 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. The 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 Gidegi Kalawis.

How old are you Mickey M D M P H, Chief Medical Officer, and John Sharp.

Vice President business development at this time, all participants are in a listen only mode.

A question 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 Geeky of Stern IR.

Yeah.

Okay.

Okay.

Thank you.

Please note the following.

Speaker 2: Certain statements in this presentation may constitute forward-looking statements within the meanings of the Private Securities Litigation Reform Act.

Certain statements in this presentation may constitute forward looking statements within the meaning of the private Securities Litigation Reform Act.

Speaker 2: These statements are based on management's current expectations and are subject to uncertainty and changes in circumstance.

These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances.

Speaker 2: Actual results may differ materially from those included in these statements due to a variety of factors, including whether geobacks can develop and manufacture its product candidates with the desired characteristics in a timely manner and such products will be safe for human use.

Actual results may differ materially from those included in these statements due to a variety of factors including weather.

<unk> 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 2: GeoVax's vaccines will effectively prevent targeted infections in humans.

<unk> vaccines will effectively prevent targeted infections in humans.

Speaker 2: Q of access product candidates will receive regulatory approvals necessary to be licensed and marketed.

<unk> product candidates will receive regulatory approvals necessary to be licensed and marketed.

Speaker 2: GeoVax raises required capital to complete development of its products.

Geovax raises required capital to complete development of its products.

Speaker 2: There is development of competitive products that may be more effective or easier to use than GeoVac's products.

There is development of competitive products that may be more effective or easier to use and geovax with products.

Speaker 2: Geovax will be able to enter into favorable manufacturing and distribution agreements and other factors over which Geovax has no control.

<unk> will be able to enter into the favorable manufacturing and distribution agreements and other factors over which Geovax has no control.

Speaker 2: GeoVest assumes no obligation to update these forward-looking statements and does not intend to do so.

<unk> assumes no obligation to update these forward looking statements and does not intend to do so.

Speaker 2: 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 .

More information about these factors is contained in <unk> filings with the Securities and Exchange Commission, including those set forth at risk factors in <unk> Form 10-K.

Speaker 2: It is now my pleasure to introduce the Chairman and CEO of GeoVax, David Dodd.

It is now my pleasure to introduce the chairman and CEO of <unk> David Dodd.

Speaker 3: Good afternoon, and thank you for participating in the GFX Corporate Update call.

Good afternoon, and thank you for participating in the GFX corporate update call.

Speaker 3: This year, and more specifically during the third quarter, we have successfully advanced the progress of our developments focused on the two Phase II clinical stage products while also advancing other critically important initiatives.

This year and more specifically during the third quarter, we have successfully advanced the progress of our development is focused on the two phase III clinical stage products, while also advancing other critically important initiatives.

Speaker 3: Today we'll address the progress, status, and plans related to Godestin currently in development as a therapy against advanced head and neck cancer and GEO-CM04S1, our next generation COVID-19 vaccine.

They will address the progress status and plans related to get depth in currently in development as a therapy against advanced head and neck cancer and CEO CMO for us one.

Generation COVID-19 vaccine.

Speaker 3: 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 to improve lives worldwide.

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 to improve lives worldwide.

Speaker 3: Following my comments, Mark Reynolds, our CFO , will provide an update of our financials, and then your questions will be addressed.

Following my comments Mark Reynolds, our CFO will provide an update of our financials and then your questions will be addressed.

Speaker 3: Our strategy at GI of Access to Develop Innovative Cancer Therapies and Infectious Disease Vaccines that provide meaningful differentiation addressing clearly important unmet medical needs pursuing the initial indications that support expedited registration pathway.

Our strategy is do you have access to develop innovative cancer therapies in infectious disease vaccines that provide meaningful differentiation addressing important unmet medical needs pursuing initial indications.

For expedited registration pathways.

Speaker 3: We anticipate worldwide development, commercialization, distribution via business partnerships and collaboration.

We anticipate worldwide development commercialization and distribution via business partnerships and collaborations.

Speaker 3: 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.

Other words, our strategy is reflected as elevate differentiate accelerate and collaborate.

It is this strategy that dictates our activities now and continuing through 2024.

Speaker 3: We are focused on our priorities in order to successfully implement our strategy.

We are focused on our priorities in order to successfully implement our strategy.

Speaker 3: 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.

It is critically important that we advanced group catalysts and milestones that demonstrate the differentiated value of our developments, while strengthening the confidence and support from our investors and other key stakeholders.

Speaker 3: In addition, we're addressing opportunities that provide us a basis for achieving leadership within those targeted patient areas and commercial marks.

In addition, we're addressing opportunities that provide us a basis for achieving leadership within those targeted patient areas in commercial markets.

Speaker 3: That's why our current clinical-states products, Godetton and GEOCMO4S1, provide us the potential of achieving leadership in those respective populations.

Why our current clinical stage products, good depth and Geo's CMO for US one provide us the potential of achieving leadership in those respective populations.

Speaker 3: These represent areas where much larger competitors either aren't addressing such patients, perhaps due to their relatively small size of those opportunities, such as the case where advanced head and neck cancer, or their technologies are inadequate to address the respective patient populations, such as immutile compromised patients relative to the current authorized COVID-19 vaccine.

These represent areas, where our much larger competitors, either arent addressing such patients perhaps due to their relatively small size of those opportunities such as the case for advanced head and neck cancer or their technologies are in adequate to address the respective patient populations such as immuno compromised.

Patients relative to the current authorized COVID-19 vaccine.

Speaker 3: Also, GEO, NVA, our vaccine against inbox and smallpox, is intended to disrupt existing monopole in that important area, providing this leadership as the first US-based supplier such a vaccine. I'll reiterate this since we hold worldwide rights for our products, we're highly focused and engaged in discussions to ensure worldwide access and commercialization.

Also geo NBA, our vaccine against imports from smallpox isn't intended to disrupt the existing monopoly in that important area, providing us leadership as the first U S based suppliers such a vaccine.

I'll reiterate this since we hold worldwide rights for our products, we are highly focused and engaged in discussions to ensure worldwide access in commercialization.

Speaker 3: Finally, we realized that adaptability, the changing market conditions, emerging competitors, other challenges, is required to achieve and maintain sustainability and success.

Finally, we realized and adaptability to changing market conditions emerging competitors. Other challenges is required to achieve and maintain sustainability and success.

Speaker 3: The principles of focused leadership and adaptability are the foundation for implementing our strategy and progressing to successful growth and development.

The principles of focused leadership and adaptability are the foundation for implementing our strategy and progressing its successful growth and development. This.

Speaker 3: This is not only relevant to our portfolio development activities, but also relative to our financing strategy, which includes equity proceeds, non-deluted funding opportunities, and capital resulting from business development activities.

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 3: We believe that having this multi-fraung strategy relative to capital development provides us the ability to continue to support our development priorities in the current challenging economic market environment.

We believe that having a 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.

Speaker 3: The VASVARIA UNMET medical needs with an 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 a GEDEPT in clinical data and with others to conduct partnering discussion.

The vast array of unmet medical needs with an 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 a good that's been clinical data and with others.

Conduct partnering discussions.

Speaker 3: Godefnid 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.

Good afternoon is based on a novel patented technology for the treatment of solid tumors through a gene therapy strategy known as gene directed enzyme pro drug therapy or <unk>.

D E P T.

Speaker 3: NGD's EPT, a vector is used to selectively transduce tumor cells with a non-human June with expresses an enzyme that can convert a non-toxic prodrogue into a highly toxic anti-tumor compound inside.

And Judy <unk>, a vectors used to selectively transduce tumor cells with a nonhuman June which expresses an enzyme that can convert a nontoxic pro drug and so a highly toxic anti tumor compound inside too.

Speaker 3: The death in his 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.

Good afternoon, as tumor agnostic, meaning that it provides the opportunity to address a variety of solid tumors, either cashless or benign we hold worldwide rights for all indications of this technology or as we call. It this pipeline technology.

Speaker 3: 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.

Annually in the U S. There are 67000, new cases of head and neck cancers with approximately 15000 deaths worldwide. There are approximately 900000, new cases of head and neck cancers annually and approximately 400000 deaths alright.

Speaker 3: Our initial targeted patient population for the application of Gideffin represents those who are in-stage care to 15,000 in the US and the 400,000 worldwide. These patients represent a critical unmet medical need. Money are unable to swallow food and difficulty speaking. Most have exhausted existing therapies and standard of care. Typically, they are receiving palliative care.

Our initial targeted patient population for the application of <unk> represents those who are in stage care to 15000 in the U S and the 400000 worldwide.

These patients represent a critical unmet medical need.

Many are unable to swallow food and have difficulty speaking most have exhausted existing therapies and standard of care.

Typically they are receiving palliative care.

Speaker 3: Our goal is to provide an improved in-stage quality of life by reducing and or eliminating various targeted tools.

Our goal is to provide an improved in stage quality of life by reducing and are eliminating various targeted tumors.

Speaker 3: The current protocol entails of the five treatment cycles, each consisting of three infratumal injections of cadet and over two days, followed by infusion of approval of who dare being phosphate once daily for three days.

The current protocol in sales up to five treatment cycles, each consisting of three and for tomorrow in fractions of good depth in over two days followed by infusion of a probe.

Dara being phosphate once daily for three days.

Speaker 3: The Phase I Doh Fransley study demonstrated that treating a tumor with a single cycle of good death and followed by fluid Arabine infusions was well tolerated with evidence of a reduction tumor size in patients with solid tumor.

As one dose ranging study demonstrated that treating a tumor with a single cycle of good depth, followed by Fludarabine infusions was well tolerated with evidence of a reduction in tumor size in patients with solid tumors.

Speaker 3: As a result of that study, the FDA is funding the current trial under the Orphan Drugs Clinical Trial Taiwan.

As a result of that study the FDA is funding the current trial under the orphan drug clinical trials program.

Speaker 3: In July , initial data from the current multi-site trial was presented at the AACR, AHNS, International Conference in Montreal. That presentation included results from the initial aid of the targeted 10 patients enrolled. As noted in the press release issued at that time, administration of Godetna was shown to be safe and feasible.

Yeah.

In July of initial data from the current multi site trial was presented at the ACR Aaas and.

<unk> International conference in Montreal.

That presentation included results from the initial eight of the targeted 10 patients enrolled.

As noted in the press release issued at that time administration of <unk> was shown to be safe and feasible.

Speaker 3: We expect to complete this initial trial by the end of Q1 2024. Then to review our recommendations for an expanded base to trial with the FDA, focus on an expedited path to registration.

We expect to complete this initial trial by the end of Q1 2024, then to review our recommendations for an expanded phase II trial with the FDA focused on an expedited path to registration.

Speaker 3: In the interim, we are discussing partnerships and collaborations in support of worldwide development and commercialization of gadaptin against very solid tumors, both as monotherapy and as combination therapy in conjunction with immune checkpoint inhibitors.

The interim we are discussing partnerships and collaborations in support of worldwide development and commercialization of good afternoon against various solid tumors, both as monotherapy and as combination therapy in conjunction with immune checkpoint inhibitors.

Turning now to COVID-19.

Speaker 3: CMO for S1, our next generation COVID-19 vaccine differentiates from the current authorized COVID-19 vaccines and targeting both the antibody and cellular arms of the immune system, focusing on providing a more robust and more durable protection than the current vaccine.

CMO for <unk>, our next generation COVID-19 vaccine differentiates from the current authorized COVID-19 vaccines and targeting both the antibody and cellular arms of the immune system, focusing on providing a more robust and more durable protection in the current vaccines.

Speaker 3: This is critically important in addressing the high risk populations of immune compromised individuals, those for whom the current vaccines and monoclonal antibody therapies are inadequate.

This is critically important dressing the high risk populations of immune compromised individuals those for whom the current vaccines a monoclonal antibody therapies are inadequate.

Speaker 3: Such populations include those of various blood cancers, renal disease, sickle cell anemia, HIV positive, autoimmune diseases such as lupus, and those on immune to pressive therapy. In general, patient groups with a bladed immune systems unable to respond adequately to the approved mRNA vaccines are at such a high risk.

Such populations include those with various blood cancers renal disease sickle cell anemia, HIV positive autoimmune diseases, such as lupus and those on immune suppressive therapy.

General patient groups with a blade immune systems unable to respond adequately to the approved mrna vaccines are at such a high risk.

Speaker 3: In the U.S., there are approximately 15 million immune-compromised individuals. Worldwide, there are an estimated 240-plus million.

In the U S. There are approximately $15 million immune compromised individuals worldwide. There are an estimated 240 plus million dollars.

Speaker 3: There's a major critical need for next generation COVID-19 vaccines to support such individuals. And we believe that CMO 4S1 is the leading next generation vaccine currently in clinical development.

There was a major critical need for next generation COVID-19 vaccines and support such individuals when we believe the CMO for US one is the leading next generation vaccine currently in clinical development.

Speaker 3: During second quarter of this year, the White House announced Project NextGen, a $5 billion initiative to follow on from Operation Warp Speed, seeking COVID-19 vaccines with enhanced breadth of protection against variants and improved durability, being particularly interested in novel vaccine candidates already in clinical trials.

During second quarter of this year, the White House announced project next year.

$5 billion initiatives the follow on from operation Warped speed.

<unk> COVID-19 vaccine with enhanced breadth of protection against the variance and improves durability being particularly interested a novel vaccine candidates already in clinical trials.

Speaker 3: We believe that CMO4S1 is a prime example of the desired next-generation COVID-19 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-19 vaccines and monoclonal antibody therapy.

We believe that CMO for US one is a prime example of the desired next generation COVID-19 vaccine.

We have considerable interest both domestically and internationally and participating in our clinical development program we.

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.

Speaker 3: Also, we anticipate partnering and collaborations in support of worldwide commercialization and distribution.

Also we anticipate partnering and collaborations in support of worldwide commercialization and distribution.

Speaker 3: Regarding Project NextGen, we are currently in active discussions related to formal participation in this initiative.

Regarding project Nextgen.

We are currently in active discussions related to fall participation in this initiative.

Speaker 3: Of the $5 billion funding, so far $1.9 billion has been awarded, resulting in $3.1 billion remaining to be awarded. Project NextGen leadership has indicated their expectation to award the full $5 billion, with additional awards to be announced by year end. We hope to provide further updates soon.

Of the $5 billion funding.

So far $1 $9 billion has been award, resulting in $3 1 billion remaining to be awarded.

Nextgen leadership has indicated their expectation to award the full $5 billion with additional awards to be announced by year end, we hope provide further updates soon.

Speaker 3: For the remainder of 2023 and 2024, we are focused on accelerating efforts in support of the GADEPTEN and CMO4S1 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 focused on the advanced MVA manufacturing system.

For the remainder of 2023 and 2024, we're focused on accelerating efforts in support of the <unk> and CMO for US one phase II clinical programs as well as advancing our NBA vaccine specific to imports and a small portion of the development and further progress of our program focused on the advanced.

NBA manufacturing system.

Speaker 3: In 2024, this will include the further reporting of results from our CMO4S1 Phase 2 programs, including results from the Healthy Volunteer Booster Trial, completion of enrollment and results from the Immunocompromised DLL Trial, and additional site initiations and further results from our Immunocompromised Stem Cell Transplant Trial.

In 2024. This will include the further reporting our results from our CMO for S. One phase III programs, including results from the healthy volunteer booster trial completion of enrollment in our results from the immuno compromised DLL trial and additional site initiations are further results from our immuno compromised.

Stem cell transplant trial.

Speaker 3: For GADEPTIN 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 steps related to evaluating GADEPTIN as combination therapy used in conjunction with immune checkpoint inhibitors.

So a good depth and in 2024, we expect to report the final results from the current trial and our plans for the expanded phase II trial. We also expect to report plans regarding the next steps related to evaluating <unk> combination therapy used in conjunction with immune checkpoint inhibitors.

Speaker 3: Relative to GEO MVA against MPOCS and smallpox, we anticipate reporting in 2024 a regulatory path and plans related to advancing that product towards registration.

Relative to CEO MBA against <unk> smallpox, we anticipate reporting in 2020 for a regulatory path and plans related to advancing that product towards registration.

Speaker 3: Finally, next year, we'll continue to provide updates related to our advanced MBA manufacturing process targeted to enable GFX to effectively produce and distribute MBA-based vaccines in response to real-time market needs. 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.

Finally next year, we will continue to provide updates related to our advanced MBA manufacturing process targeted to enable <unk> to effectively produce and distribute MVA based vaccines in response to real time market needs now I would like to turn the presentation over to Mark rentals, <unk> Chief Financial Officer.

A review of our recent results and financial status Mark.

Speaker 4: Thank you, David. I'll start the financial review with our income statements.

Thank you David.

I'll start the financial review with our income statements.

Speaker 4: We had no active grants during 2023, so we reported no grant revenues 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 of our financing mix in the future.

We had no active grants during 2023, so we reported no grant revenues as compared to a small amount in 2022.

As David has noted we are having ongoing discussions with regard project Nextgen, If an award worthy made by BARDA.

Geovax this could become a very important component of our financing mix in the future.

Speaker 4: In this regard, though, I'll state that there is no award to date and there are no guarantees that it 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.

In this regard there I'll state that there is no award date and there are no guarantees that we'll be one so I'll refer everyone back.

The forward looking statements disclaimer at the beginning of this call as Oliver comments regarding project Nextgen are forward looking statements.

Speaker 4: Research and development expenses were $6.9 million and $14.5 million for the three-month and nine-month periods in 2023 versus $2.7 million and $5.4 million, respectively, in 2022.

Research and development expenses were $6 9 million and $14 5 million for the three month and nine month periods in 2023.

<unk> $2 7 million and $5 4 million respectively in 2022.

Speaker 4: These increases are primarily associated with clinical trial activity for the CMO-4S1 and GADEPTEN programs, which includes manufacturing costs for clinical trial materials.

These increases are primarily associated with the clinical trial activity for the CMO for US one in conducting programs, which includes manufacturing costs clinical trial materials.

Speaker 4: The increase is also reflective of higher personnel costs as we brought on two additional executive-level employees in early 2023, adding depth to our regulatory and quality control functions.

The increase was also reflected the higher personnel costs as we brought on two additional executive level employees in early 2023, adding depth to our regulatory and quality control functions.

Speaker 4: General administrative expenses were $1.7 million and $4.6 million for the three-month and nine-month periods in 2023 versus $1.2 million and $3.4 million in 2022, with the increases mostly associated with higher personnel consulting costs, patent costs, and investor relations costs.

General and administrative expenses were $1 7 million and $4 6 million for the three months and nine month periods in 2023 versus $1 2 million and $3 4 million in 2022 with the increase is mostly associated with higher personnel and consulting costs patent costs and investor.

Relations expenses.

Speaker 4: Interest income was $675,023 versus just $4,020 reflecting increasing interest rates available through our Money Market Act.

Interest income was 675023 versus just 4000 in 2022, reflecting increasing interest rates available through our money market accounts.

Speaker 4: So, overall net loss for the nine-month period of 23 was approximately 18 million or 69 cents per share versus 8.6 million in 2022 or 63 cents per share. Again, with the increase being driven by the CMO4S1 and cadeptin clinical trial.

Overall net loss for the nine months period of 23 was approximately 18 million or <unk> 69 per share.

Versus $8 6 million in 2022, or <unk> 63 per share again with the increase being driven by the CMO forest one in cadet to clinical trial activity.

Speaker 4: Turning now to the balance sheet, our cash balances at September 30 were approximately 12.7 million. That's compared to 27.6 million at the end of 2022. The change in our cash balances is reflective of 14.9 million used in operating activities. There were no significant financing or investing activities so far during 2023. Our outstanding common shares currently stand at 26.7 million.

Turning now to the balance sheet and our cash.

Cash balances at September 30 were approximately $12 7 million as compared to $27 6 million at the end of 2022.

The change in our cash balances as reflective of $14 9 million used in operating activities. There were no significant financing or investing activities. So far during 2023.

Our outstanding common shares currently stands at $26 7 million.

Speaker 4: So, going forward, funding our ongoing Phase II clinical programs for CMO4S1 and Gadeptin will continue to be the most significant use of our cash going into 2024. We don't expect this prioritization of our spending to change if we receive a Project Next Gen award from BARDA, as any incremental spending for that program will be funded by the award. 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.

So going forward funding, our ongoing phase II clinical programs for <unk>, one and <unk> will continue to be the most significant use of our cash going into 'twenty four.

We don't expect this prioritization of our spending to change if we receive a project next Gen Award from BARDA is any incremental spending for that program will be funded by the award.

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.

Speaker 4: I'll be happy to answer any questions for the Q&A, and I'll now turn the call back to David.

I'm happy to answer any questions for the Q&A and I'll now turn the call back to David.

Speaker 3: Thank you, Mark. My colleagues and I will now answer your question.

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 Charkhi, Our Chief Scientific Officer, Chief Medical Officer, and Vice President of business development, respectively.

Speaker 3: Joining us for the Q&A session are Drs. Mark Newman, Kelly McKee, and John Charkey, our Chief Scientific Officer, Chief Medical Officer, and Vice President of Business Development, respectively.

Speaker 3: I'll now turn the call over to the operator for instructions on the question and answer period.

I'll now turn the call over to the operator for instructions on the question answered here.

Speaker 1: We will now begin the question and answer session. To ask a question, you may press star one on your telephone.

We will now begin the question and answer session to ask a question you May Press Star then one on your telephone keypad.

Speaker 1: If you are using the speakerphone, please pick up your handset before pressing the key.

Using a speaker phone please pickup your handset before pressing the keys to withdraw your question. Please press Star then one.

Speaker 1: To withdraw your question, please press star then 1. At this time, we will pause momentarily to assemble our raw

At this time, we will pause momentarily to assemble our roster.

Speaker 1: Our first question comes from Jason Colbert with Dawson Jeans. Please go ahead.

Our first question comes from Jason Kolbert with Dawson James. Please go ahead.

Speaker 5: Hi, guys. Congratulations on all the progress. I have kind of a tangential question, but I think it's important.

Hi, guys. Congratulations on all the progress I have kind of a 10 gentle question, but I think it's important.

Speaker 5: There have been a tremendous number of COVID reinfections, people who had COVID.

There had been a tremendous number of Covid reinfection people, who had COVID-19.

Speaker 5: uh recovered from it and now they're getting it again and I noticed that the emergency use authorization is now approved for Pfizer's PaxLavid and PaxLavid is getting prescribed quite a lot so I'm just wondering how this

Recovered from it and now they're getting it again and I noticed that the emergency use authorization is now approved for Pfizer's tax lavette impactful of it is getting prescribed quite a lot.

Just wondering how this impacts the.

Speaker 5: the marketplace, and does it impact immune-compromised patients at all?

The marketplace and does it impact immune compromised patients at all.

Speaker 3: Thank you Jason. What I'll do is I'll make a couple comments on my thoughts on this and then Kelly I'll ask if you'd like to add to it but

Thank you Jason on 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 but.

Speaker 3: It first of all 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 mark on antibodies, either in the shield or packs low that so I think that's unchanged. There's still a tremendous need.

First of all I will say that I don't think it impacts the immuno compromised at all because it's been shown that they are not responding well to the monoclonal antibodies either <unk> or <unk>. So I think that's unchanged. There is still a tremendous need for a vaccine such as ours that will address their needs because they've been unmet.

Speaker 3: for a vaccine such as hours that will address their needs because they've been unmet since the beginning of the introduction of the vaccines. So I think from that standpoint, there's just really no impact. If anything, it's further underscores the importance of what we have in development. Kelly, do you wanna ask?

Since the beginning of the introduction of the vaccine so, though so I think from that standpoint.

There's just really no impact if anything further under underscores the importance of what we have done development Kelly do you want to add anything there.

Speaker 6: Yeah, 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 at the, in the first stages of the pandemic for sure.

Yes.

Just a couple of thoughts I mean first of all as far as the impact on the vaccine market overall.

Thank everybody sort of recognizes that.

Sure.

The mrna vaccine.

Sales have been considerably lower than they were.

And the first stages of the pandemic for sure.

Speaker 6: And 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 parse those issues efficiently.

And and.

There are so many factors that impact that and.

This sort of issue of recurrent infections are breakthrough and sanctions.

It's only a component of that so I'm not sure you can sort of parse those issues.

Efficiently.

Speaker 6: As far as, you know, the impact on the immunocompromised population, I mean, we're sort of talking apples and oranges. Paxil is a therapeutic, of course, and, you know, 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 severe.

Far as is the impact on the immuno compromised population I mean were sort of talking apples and oranges <unk> therapeutic of course.

And we get a vaccine to offering.

By anybody's measure if we can prevent people from getting sick.

Particularly for those two.

From getting severely yield, we're better off and having to rely on it.

Speaker 6: we're better off than having to rely on a therapeutic and antiviral therapeutic that, number one, isn't 100% effective, and number two, has 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 painkillers. So, you know,

On the therapeutic and antiviral therapeutic that number one isn't 100% of effective and number two is.

Some substantial.

Sort of side effects that.

You prefer not to deal with not the least of which is the sort of long COVID-19 syndrome that seems to sort of.

Appear in people after they have stopped taking place so.

Speaker 6: I, I, it shouldn't, it shouldn't impact us at all.

Aye.

It shouldnt it shouldn't impact us at all.

Speaker 6: and whether it has what the influence is on the wider, you know, vaccine landscape, I can't really.

And whether it hasnt.

What the influences on the wider.

Yes.

Vaccine landscape I can't really.

I don't know.

Speaker 5: Well, I was just, you know, what I see in the real world is a very large segment of the population does not want to get a fourth, fifth, and sixth mRNA booster. They they're hearing that, you know, Paxlevid does have some side effects, metallic taste in the mouth principally, but, you know, it's pretty effective at knocking virus down, but you're right. There is a lag and

I was just what I see in the real World is a very large segment of the population does not want to get our fourth fifth and sixth mrna booths there.

There are you hearing that tax law, but it does have some side effects metallic taste in the mouth, principally but it's pretty effective at knocking virus down, but youre right. There is a lag and I think a segment of the population would really like an mrna alternative and I'm really wondering.

Speaker 5: I think a segment of the population would really like an mRNA alternative. And I'm really wondering is that might that not be a market segment that in addition to immune compromised patients kind of becomes very attractive to you?

Is that it might that not be a market segment. In addition to immune compromised patients kind of becomes very attractive CEO.

Speaker 7: Well, I think you could be a good guy.

Okay.

Go ahead, Kelly I'm, sorry, I was just going to say I mean, when you say they prefer an mrna option I think <unk> kind of what they had currently available.

Speaker 6: 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, you know, currently available to them. You know, one of the, one of the, the big advantage that I think our vaccine offers.

One of the one.

The big advantage that I think are.

<unk> offers is sort of an alternative approach to immunization.

Speaker 6: is sort of an alternative approach to immunization where we can provide sort of broad, durable immune protection that won't require, that shouldn't, I should say, require frequent...

Are we.

Can provide sort of a broad durable.

On EMEA and protection that is.

That won't require this shouldn't I should say require.

Frequent.

Speaker 6: you know once, twice a year boosting in order to maintain immune and immune protective status.

Yes.

Once twice a year boosting in order to maintain.

And.

Immune protective status.

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 its the healthy volunteers receiving our vaccine as a booster I think that data. They made the demonstrative of sort of what Kevin was just touching on it may be.

Speaker 3: And 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

Speaker 3: for what Kelly was just touching on. Maybe that our breadth of protection and the durability that's delivered from this dual-anogen approach is going to give something that will be of value that they're not receiving from the mRNA.

But that our breadth of protection and the durability that's delivered.

This dual antigen approach is going to give something that will be a value that they are not receiving from the mrna.

Speaker 5: You know, in a prior life I was involved in pharmaceutical sales. So a year from now, before you hire a pharmaceutical sales manager, you should give me a call.

On a prior life I was involved in pharmaceutical sales. So a year from now before you hire a pharmaceutical sales manager you should give me a call.

Speaker 5: Okay, we'll do this. All right, guys, thank you so much. Thank you.

Okay, we will do that alright.

Alright, guys. Thank you so much thank you.

Speaker 1: Again, if you have a question, please press star then

Again, if you have a question. Please press Star then one.

Okay.

Speaker 1: Just concludes our question and answer session. I would now turn to conference fact over to David Dodd for any closing remarks.

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

Speaker 3: Well, thank you for everyone who worked 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. And I 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. That reflects our focus towards building significant general stakeholders.??

Well, thank you for everyone, who aren't that many questions.

We have a new sales manager coming out a year from now I guess, but anyway I want to thank everyone for participating in the call. We appreciate your interest and I would just say that again to reiterate our strategy. We're focused on is to innovate differentiate to accelerate to the market and to do this while collaborating that.

Our focus towards building significant shareholder value.

Speaker 3: I want to acknowledge and thank our Board of Directors, our staff and the many other parties that can support advisors towards achieving success. We're committed to providing meaningful career development opportunities for 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 this success is in fact defined and addressing various patient populations.

<unk>.

To acknowledge and thank our board of directors, our staff and the many other parties that continue to support advise us towards achieving success, we're committed to providing meaningful career development opportunities for highly competitive quality oriented members of our team we're seeking disrupt the current paradigm of both cancer therapies.

Infectious disease vaccines and redefining how the success is in fact defined in addressing various patient populations.

Speaker 3: So I want to wish everyone a wonderful day. Thank you and we look forward to keeping up data as we go forward. Thanks.

I want to wish everyone a one off.

Thank you and we look forward to keeping update as we go forward. Thank you.

Speaker 1: The conference is now concluded. Thank you for attending today's presentation. You may now dis-

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

[music].

Yes.

Okay.

Okay.

Okay.

Sure.