Q4 2023 GeoVax Labs Inc Earnings Call
[music].
Unknown Executive: www. GeoVaxLabs.com Good afternoon and welcome everyone to the GeoVax fourth quarter 2023 corporate update. My name is Desiree, and I will be David Dodd, chairman. Mark Reynolds.
Good afternoon, and welcome everyone to the Geo Vax fourth quarter of 2023 corporate update call.
My name is exaggerated and I will facilitate todays call with me are David Dodd, Chairman and CEO, Mark <unk>, Chief Financial Officer, Dr. Mark Newman, Chief Scientific Officer, Dr. Kennedy, Mckee, Chief Medical Officer, and softer Chinese Sharkey Vice President business.
Unknown Executive: Financial Ops for Mark Newman, Scientific Office. Dr. Kelly McKee, unclear for medical Oracle Oracle Heart Has Heart Has Heart immunizations immunizations new new and Dr. John Sharkey, Vice President, Business Development. At this time, all participants are on a list. Question and answer session will follow the formal presentation. As a reminder, this conference, At this time, I am turning the call over to Max Gattaca of Stern. Thanks.
At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded at this time I am turning the call over to Max that about a third of IR.
Thank you ladies.
Unknown Executive: Please note the following: certain statements in this presentation may constitute forward-looking statements, within the meaning of the private security, for Unknown Speaker 0, Subject to Uncertainty. Actual results. Gary O'Leary, statements due to a variety of factors. GeoVax can develop Desire Characteristics in a Timely Manner, such products will be safe for human use.
Please note the following certain statements in this presentation may constitute forward looking statements within the meaning of the private Securities Litigation reform.
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.
<unk> develops and manufactures product candidates with the desired characteristics in a timely manner.
Such products will be safe for human use.
Unknown Executive: GeoVax's vaccines will effectively prevent targeted infections in humans. Additionally, GeoVax's product candidates will receive regulatory approvals necessary to be licensed and marketed. GeoVax raises the required capital to complete the development of its products. However, there is the development of competitive products that may be more effective or easier to use than GeoVax's products. GeoVax will be able to enter into favorable manufacturing and distribution agreements and other factors over which it has no control.
<unk> vaccines will effectively prevent targeted infections and coupons.
<unk> product candidate will receive regulatory approvals necessary to be licensed and marketed.
Vas raises required capital to complete development of its products.
There is development of competitive products that may be more affected margins here. He has done to your fastest products.
<unk> will be able to enter into a favorable manufacturing and distribution agreements.
And other factors over what's Geovax has no control.
David Alan Dodd: GeoVax assumes no obligation to update these forward-looking statements and does not intend to do so. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission, including those Step 4 at-risk factors and GeoVax's Form 10-K. It is now my pleasure to introduce the chairman and CEO of GeoVax, David Dodd. Good afternoon, and thank you for participating in the GeoVax Corporate Update Call. Last year, and more specifically during the fourth quarter, we successfully advanced our developments, focused on the two phase two clinical stage products, while also advancing other critically important initiatives. Today, we'll discuss the progress, status, and plans related to GADEPTIN, currently in development as a therapy against advanced head and neck cancer, and GEO-CM04S1, our next generation COVID-19 vaccine. Our goal is to develop innovative cancer therapies and infectious disease vaccines addressing critically important unmet medical needs, pursuing initial indications that support expedited registration pathways. We anticipate worldwide development, commercialization, and distribution via business partnerships and collaboration. Following my comments, Mark Reynolds, our CFO, will provide an update on our financials, and then your questions will be addressed.
<unk> assumes no obligation to update these forward looking statements and does not intend to do so.
More information about these factors is contained.
<unk> filings with the Securities and Exchange Commission.
<unk> those step four risk factors angioplasty this Form 10-K.
It is now my pleasure to introduce the chairman and CEO of GFS EBITDA.
Good afternoon, and thank you for participating in the <unk> corporate update call.
Last year more specifically during the fourth quarter, we successfully advanced our development is focused on the toothpaste in clinical stage products, while also advancing other critically important initiatives.
They will discuss the progress status and plans relates to good Daphne currently in development as a therapy, I guess Vance head and neck cancer and CEO Sam for US one our next generation COVID-19 vaccine.
Our goal is to develop innovative cancer therapies. Thank you Suzy.
Vaccines addressing critically important unmet medical needs pursuing initial indications.
<unk> expedited registration pathways.
We anticipate worldwide development commercialization and distribution via business partnerships and collaborations.
Following my comments Mark <unk>, our CFO will provide an update of our financials and then your questions will be addressed.
David Alan Dodd: At year-end, we announced the closure of enrollment for the Phase 1-2 trial of Godeftin among advanced head and neck cancer patients. This initial targeted patient population represents those who are in in-state care, the 15,000 in the U.S. and 400,000 worldwide. These patients represent a critical unmet medical need because many are unable to swallow food and have difficulty speaking.
At year end, we announced the closure of enrollment for the phase one slides two trial is good depth, among advanced head and neck cancer patients.
This initial targeted patient population represents those who are in stage cure. The 15000 in the U S and 400000 worldwide. These patients represent a critical unmet medical need.
Many are unable to swallow food and have difficulty speaking typically they have exhausted existing therapies and the standard of care and are receiving palliative care.
David Alan Dodd: Typically, they have exhausted existing therapies and the standard of care and are receiving palliative care. Our goal has been to provide an improved end-stage quality of life for these patients by shrinking and or eliminating various targeted tumors and to provide clinical evidence supporting advancement of this therapy in earlier stage disease. As you may recall, this trial was funded by the FDA under the Orphan Drugs Clinical Trials Program. Last July, initial clinical data results were presented at the AACR-AHNS conference in Montreal. That presentation noted that administration of gadeptin was shown to be safe and feasible, reflecting stabilization and or reduction in the size of treated tumors. We expect to report the final results of this trial during the first half of 2024, followed by discussing our plans for further evaluation of gadeptin in patients with advanced head and neck cancer. Our strategy also considers cadeptin therapy for earlier stage HNSTC with less tumor burden, including a role similar to neoadjuvant or cytoreductive radiotherapy in combination with checkpoint blockade inhibition.
Our goal has been to provide an improved any stage quality of life in these patients by shrinking <unk>, eliminating various targeted tumors and to provide clinical evidence supporting advancement of this therapy in earlier stage disease as.
As you May recall this trial was funded by the FDA under the orphan drug clinical trials program.
Last July initial clinical data results were presented at the ACR a H <unk> conference in Montreal that presentation noted that administration of good depth and was shown to be safe and feasible, reflecting stabilization and or reduction in size of treated <unk>.
We expect to report the final results of this trial during first half 2024, followed by discussing our plans for further evaluation.
In patients with advanced head and neck cancer <unk>.
Our strategy also considers good depth in therapy for earlier stage, HMS AC with less tumor burden.
<unk> a role similar to neo adjuvant are saddled with Dr Radio therapy in combination with checkpoint blockade and ambition.
David Alan Dodd: We also anticipate discussions with the FDA during 2024 related to an expedited path to registration. The vast array of unmet medical needs within oncology represents significant opportunities for GeoVax to advance novel approaches addressing various cancer patient needs worldwide. We refer to cadeptin as tumor agnostic, meaning that its mechanism of action will enable us to address a variety of solid tumors, both cancerous and benign.
We also anticipate discussions with the FDA during 2024 related to an expedited path to registration.
The vast array of unmet medical needs with an oncology represent significant opportunities for <unk> to advance novel approaches addressing various cancer patient needs worldwide.
We refer to good depth in his tumor agnostic, meaning that its mechanism of action will enable us to address a variety of solid tumors, both cancers and whatnot.
David Alan Dodd: We hold worldwide rights for all indications of this technology, and we're participating in various oncology and partnering conferences, some of which we will present conducting clinical data and with others to conduct partnering discussions. GEO-CM04S1, our next-generation COVID-19 vaccine, aims to provide a more practical, public-health-friendly COVID-19 vaccine solution than that offered by currently-approved vaccines by stimulating a robust and durable immune response across multiple virus variants as a result of targeting both the antibody and cellular arms of the immune system and through the use of a proven safe and efficient replication-efficient vaccine delivery platform. This is critically important in addressing the high-risk populations of immune-compromised individuals for whom the current vaccines and monoclonal antibody therapy are inadequate. The immune profile generated following receipt of StemO4 S1s also positions it well for more general use as a heterologous booster to current mRNA vaccines, providing a more robust, durable, functional response against emerging variants, potentially without the need for the continuous vaccine reconfiguration that appears necessary with the mRNA vaccine.
We hold worldwide rights for all indications of this technology and we are participating in various oncology and partnering conferences and some of which we will present clinical data and with others to conduct partnering discussions GE.
<unk> CMO for <unk>, our next generation COVID-19 vaccine aimed to provide a more practical public health friendly COVID-19 vaccine solution.
That awkward with currently approved vaccines by stimulating a robust and durable immune response across multiple virus variants as a result of targeting both the antibody and cellular arms of the immune system and through the use of a proven safe and efficient replication deficient vaccine delivery platform.
This is critically important addressing the high risk populations are immune compromised individuals for whom the current vaccine and monoclonal antibody therapies are inadequate.
The immune profile generated following receipt of CMO for Epsilon also positions us well for a more general use is ahead of our launch of the booster to current mrna vaccines, providing a more robust durable functional response against emerging various potentially without the need for the continuous vaccine reconfiguration. It appears.
Sorry, with the mrna vaccine.
David Alan Dodd: Three Phase II clinical trials are underway with CMO-4S1, two of which address the high-risk populations of immunocompromised patients. The other Phase 2 trial is evaluating our vaccine as a booster following prior receipt of an mRNA vaccine. We hope to demonstrate that our COVID-19 vaccine successfully addresses the current unmet need among the millions of immunocompromised patients while also demonstrating the vaccine is a more robust, durable, universal booster for the current authorized vaccine. Last September, we completed enrollment in our Phase 2 trial assessing CMO4S1 as a booster for the mRNA vaccines. This trial involved 63 healthy adults who had previously received the Pfizer or Moderna mRNA vaccine. The immunological responses measured throughout the study included both neutralizing antibodies against SARS-CoV-2 variants and specific T cell responses.
Three phase III clinical trials are underway with CMO for US one two of which address a high risk populations of immuno compromised patients. The other phase II trials are valid and widening our vaccine as a booster following prior receipt of an mrna vaccine we.
We hope to demonstrate that our COVID-19 vaccine successfully address the current unmet needs among the millions of immuno compromised patients. While also demonstrating the vaccine is a more robust durable universal booster for the current authorized vaccine.
Last September we completed enrollment in our phase II trial assessing CMO for US one is they booster for the mrna vaccines. This trial involves 63 healthy adults who had previously received the Pfizer of Madura mrna vaccine.
Immunological responses measured throughout the study include both neutralizing antibodies against Sars Cov, two variants and specific T cell responses.
David Alan Dodd: Earlier this month, we reported positive interim data from this trial indicating no serious adverse events and statistically significant increases in neutralizing antibodies against multiple SARS-CoV-2 variants ranging from the original Wuhan strain through Delta and the highly virulent Omicron XBB 1.5, as well as demonstrating robust cellular immune responses. Additional testing against the current variant of concern, the JN1 variant, is currently underway. Final results from this trial are anticipated during the fourth quarter of this year, reflecting the 12-month monitoring of these patients. Previously, we discussed that in the U.S., there are approximately 15 million immunocompromised individuals. Worldwide, there are an estimated 240 million.
Earlier this month, we reported positive interim data from this trial, indicating no serious adverse events and statistically significant increases in neutralizing antibodies against multiple charts <unk> variants ranging from the original Wuhan strain through Delta in the highly virulent omicron SBB, one five as well as <unk>.
Construction robust cellular immune responses.
Testing I guess the current variant of concern the Jan one Barrett is currently underway.
Final results from this trial are anticipated during the fourth quarter of this year, reflecting the 12 month monitoring of these patients.
Previously we've discussed in the U S. There are approximately $15 million of immuno compromised individuals worldwide. There are an estimated over $240 million.
David Alan Dodd: Such populations include those with various blood cancers, renal disease, autoimmune diseases such as lupus, transplant patients, and others with disease or therapy-induced immunosuppression. Many of these patients are limited in their ability to respond adequately to the approved mRNA vaccines, placing them at significantly increased risk of severe COVID-9 infection, hospitalization, and potential death. Recently, it was reported in JAMA on February 15th that the number of immunocompromised adults in the U.S. has been updated, indicating a population of 23 million versus the previous estimate of 15 million. There is a major critical need for next-generation COVID-19 vaccines to support such individuals, and we believe that CMO4S1 is the leading next-generation vaccine in clinical development to support the needs of immunocompromised patients. During 2023, initial data from the stem cell transplant trial were presented at several international conferences, including the World Vaccine Congress in Washington, D.C. In addition, results were published this past September in the peer-reviewed journal Vaccine. These findings demonstrated robust immunogenicity, illustrating the vaccine's ability to strongly induce both antibody and T-cell responses, essential for conferring protection, particularly in immunocompromised individuals.
Such populations include those with various blood cancers renal disease autoimmune diseases, such as lupus.
Transplant patients and others with disease or therapy induced immunosuppression.
Many of these patients are limited in their ability to respond adequately to the approved mrna vaccine, placing nimbus significantly increased risk for severe COVID-19 infection hospitalization and potential death.
Recently it was reported in Jama on February 15 that the number of immuno compromised adults in the U S has been updated indicating a population of $23 million versus a previous estimate of 15 mill.
There is a major critical need for next generation COVID-19, vaccines and supports us individual and we believe the CMO for US one is the leading next generation vaccine in clinical development and support the needs of immuno compromised patients.
During 2023 initial data from stem cell transplant trial was presented at several international conferences, including the World vaccine Congress in Washington D C.
In addition results were published this past September in the peer reviewed journal vaccines.
Finally, as demonstrated robust immunogenicity illustrating the vaccine's ability to strongly induced both antibody and T cell responses are central for conferring protection, particularly in immuno compromised individuals.
Vaccines article also highlighted the unique feature of CMO for us one providing protective immune levels from the ancestral Wuhan strength all the way through what I mentioned earlier, the highly parallel omicron SBB one five variants.
David Alan Dodd: The Vaccines article also highlighted the unique feature of CMO4S1 providing protective immune levels from the Ancestral Wuhan strain all the way through what I mentioned earlier, the highly virulent Omicron XBB1.5 variant. Initial patient enrollments into this trial occurred at the City of Hope Medical Center in California. More recently, however, additional sites have been added as we seek to accelerate the pace of trial enrollment. In addition to the patients initially enrolled from City of Hope, there are now four additional sites actively recruiting patients into this critically important Phase II trial. The four expansion sites include the Fred Hutchinson Cancer Center in Seattle, University of Massachusetts Medical Center in Worcester, Mass., Wake Forest Baptist Medical Center in Winston-Salem, North Carolina, and Eastern Carolina Medical Center in Benson, North Carolina.
Initial patient enrollments into this trial occurred as the city of Hope Medical Center in California.
More recently, however, additional sites have been added as we seek to accelerate the pace of trial enrollment.
In addition to the patients initially enroll city of hope there are now four additional sites actively recruiting patients into this critically important phase III trial.
The four expansion sites include the Fred Hutchinson Cancer Center in Seattle University of Massachusetts Medical Center in Worcester Mass Wake Forest Baptist Medical Center in was the sale of North Carolina, and Eastern Carolina Medical Center and best in North Carolina.
While we are currently focused on optimizing patient enrollment from these sites we've seen.
Interest both domestically internationally and participating in this clinical study.
Following the initiation of patient enrollment in the immuno compromised DLL trial last August this investigator initiated trials continue to recruit and enroll patients more recently expanding to additional city of hope locations.
<unk> trials designed to evaluate CMO for Epsilon among approximately 80 CLO patients directly comparing with the Pfizer impact mrna vaccine.
David Alan Dodd: While we are currently focused on optimizing patient enrollment from these sites, we've seen considerable interest, both domestically and internationally, in participating in this clinical study. Following the initiation of patient enrollment in the immunocompromised CLL trial last August, this investigator-initiated trial has continued to recruit and enroll patients, more recently expanding to additional City of Hope locations. The trial is designed to evaluate CM04S1 among approximately 80 CLL patients directly comparing it with the Pfizer-BioNTech mRNA vaccine. Typically, these patients are unable to generate adequate levels of protective antibodies following mRNA vaccination due to their underlying hematologic malignancy placing them at extreme risk of developing clinically severe COVID-19. As a consequence, many of these patients have remained homebound more than three years since the pandemic began.
Typically these patients are unable to generate adequate levels protective antibodies following mrna vaccination due to their underlying hematologic malignancy, placing them at extreme risk of developing clinically severe COVID-19.
As a consequence many of these patients remain homebound more than three years since the pandemic began.
We are optimistic the CMO for US one can offer these individuals the protection from these buyers that they so desperately need results from an interim analysis of the ongoing trial are anticipated during the first half 2024.
Relative to developing CMO for us one among immuno compromised patients, we believe that an opportunity for an expedited regulatory path.
Due to our focus on such high risks Unserved populations.
Now I'd like to comment regarding project Nextgen last April the White House announced this $5 billion initiatives to follow on from operation Warped speed shaking COVID-19 vaccines with enhanced breadth with protection against various and improve durability, particularly interested a novel vaccine candidate.
<unk> already in clinical trials, we believe the CMO for US one is a prime example of the desired next generation COVID-19 vaccine.
David Alan Dodd: We are optimistic that CMO4S1 can offer these individuals the protection from these viruses that they so desperately need. Results from an interim analysis of the ongoing trial are anticipated during the first half of 2024. Relative to developing CMO4S1 among immunocompromised patients, we believe that an opportunity exists for an expedited regulatory path due to our focus on such high-risk, unserved populations.
Regarding project Nexgen, we continue with active discussions related to formal participation in this program.
$5 billion set aside for funding there remains over $3 billion still to be awarded beyond noting that we remain in active discussion.
Regarding participation.
At this time.
Finally related to CMO for US one, we anticipate partnering and collaboration and additional clinical and research efforts in support of worldwide commercialization of distributions.
David Alan Dodd: Now, I'd like to comment on Project NextGen. Last April, the White House announced this $5 billion initiative to follow on from Operation Warp Speed, seeking COVID-19 vaccines with enhanced breadth of protection against variants and improved durability, particularly interested in novel vaccine candidates already in clinical trials. We believe CMO4S1 is a prime example of the desired next-generation COVID-19 vaccine. Regarding Project NextGen, we continue with active discussions related to formal participation in this program. Of the $5 billion set aside for funding, over $3 billion remains to be awarded.
Active initiatives are underway in this area.
Overall, we are addressing opportunities that provide us the basis for achieving leadership within those targeted patient areas in commercial markets. Our current clinical stage products, good depth and CMO for US one our focus on patient populations currently unserved by existing vaccines and therapies, we believe that.
The potential of achieving product leadership in addressing the therapeutic and vaccine needs of these respective populations exists and we're focused in that area.
David Alan Dodd: Beyond noting that we remain in active discussions and negotiations regarding participation, we can't comment at this time. Finally, related to CMO4S1, we anticipate partnering and collaborations and additional clinical and research efforts in support of worldwide commercialization and distribution. Active initiatives are underway in this area. Overall, we're addressing opportunities that provide us the basis for achieving leadership within those targeted patient areas and commercial markets. Our current clinical stage products, Cadefin and CMO4S1, are focused on patient populations currently unserved by existing vaccines and or therapies. We believe that the potential for achieving product leadership and addressing the therapeutic and vaccine needs of these respective populations exists, and we're focused on that area. Also, GEO MVA, our vaccine against mumps and smallpox, is intended to disrupt an existing global monopoly in that important area, providing us with a leadership position as the first U.S.-based supplier of such a vaccine.
Also geo MBA, our vaccine against and Fox a smallpox is intended to disrupt and existing global monopoly in that important area, providing us a leadership position as the first U S based supplier such a vaccine.
We're confident that we're on a course that will build significant shareholder and stakeholder value, while delivering critically important differentiated products to improve lives worldwide.
During this year, we'll report further progress our results from our CMO for US one phase III programs and for good depth and 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 further plans regarding next steps related to evaluate <unk> as combination therapy used in conjunction with immune checkpoint inhibitors.
Relative to our MBA vaccine against and parts of smallpox, we anticipate reporting our regulatory path and plans related to advancing that product towards registration.
Finally, we anticipate further updates related to our advanced MBA manufacturing process targeted to enable <unk> to effectively produce and distribute NBA based vaccines in response to real time market needs worldwide.
To summarize our various clinical stage products. Good Devlin CMO for US one an MBA represent clinically important areas of medical need largely unserved by current products and standard of care we.
David Alan Dodd: We're confident that we're on a course that will build significant shareholder and stakeholder value while delivering critically important differentiated products to improve lives worldwide. During this year, we'll report further progress and results from our CMO4S1 Phase II programs. And for GADEPTIN, we expect to report the final results from the current trial and our plans for the expanded Phase II trial.
We are pleased with the consistent encouraging results, we're seeing from our clinical trials more we believe that expedited path to registration are feasible for these products from potential commercial perspective. These product opportunities represent an estimated annual U S revenue potential of almost $30 billion now thats not.
Sales forecast, but rather a reflection of the significance of the need to address these critically important areas.
David Alan Dodd: We also expect to report further plans regarding next steps related to evaluating GADEPTIN as combination therapy used in conjunction with immune checkpoint inhibitors. As for our MVA vaccine against mPox and smallpox, we anticipate reporting our regulatory path and plans related to advancing that product toward registration. Finally, we anticipate further updates related to our advanced MVA manufacturing process targeted to enable GeoVax to effectively produce and distribute MVA-based vaccines in response to real-time market needs worldwide. To summarize our various clinical stage products, GADEPIN, CMO-4S1, and MVA represent clinically important areas of medical needs, largely unserved by current products and standards of care. We are pleased with the consistent and encouraging results we're seeing from our clinical trials. More than we believe, the expedited paths to registration are feasible for these products. From a potential commercial perspective, these product opportunities represent an estimated annual U.S. revenue potential of almost $30 billion.
Expanding this to a worldwide basis in conjunction with partners and collaborators as to the confidence that we have relative to the outlook for <unk>, our shareholders and stakeholders.
Now I'd like to turn the presentation over to Mark <unk> <unk>, Chief Financial Officer for a review of our recent results and financial status Mark. Thank you David I'll start the financial review with our income statement. We had no active grants during 2023. So we reported no grant revenues this year as compared to a small amount.
In 2022.
However, as David Davis as noted we are having ongoing discussions with Florida relative to project next year with an award where do we made this would become a very important component of our financing mix going forward as well as a catalyst for other financing efforts, but there is no award to date. So these are definitely forward looking statements.
Research and development expenses were $20 7 million in 2023 versus $9 1 million in 2022, an increase of $11 6 million.
This increase is primarily associated with accelerated clinical trial activity for a CMO for us one and <unk> programs, including manufacturing costs for clinical trial materials.
<unk> also includes costs associated with the <unk> manufacturing technology license from provides them, which will be an important to the future commercialization and partnering activities for all of our MVA based vaccines.
Mark W. Reynolds: Now, that's not a sales forecast, but rather a reflection of the significance of the need to address these critically important areas. Expanding this on a worldwide basis in conjunction with partners and collaborators adds to the confidence that we have relative to the market for GeoVax, our shareholders, and stakeholders. Now I'd like to turn the presentation over to Mark Reynolds, GeoVax's Chief Financial Officer, for a review of our recent results and financial status.
General and administrative expenses were $6 million and 23 versus $5 million in 2022, with the increase mostly associated with higher legal and patent costs Investor relations expenses consulting fees and personnel costs.
Interest income was 776023 versus just 7022, reflecting increasing interest rates available through our money market accounts. So overall net loss for 23 was 26 5 million or $14 29 per share versus $14 million.
Mark W. Reynolds: Thank you, David. I'll start the financial review with our income statement. We had no active grants during 2023, so we reported no grant revenues this year as compared to a small amount in 2022.
2022, or $12 36 per share again, with the increase being driven by clinical trial programs.
Now to the balance sheet.
Mark W. Reynolds: However, as David has noted, we are having ongoing discussions with BARDA relative to Project NextGen. If an award were to be made, this would become a very important component of our financing mix going forward, as well as a catalyst for other financing efforts. But there has been no award to date, so these are definitely forward-looking statements. Research and development expenses were $20.7 million in 2023 versus $9.1 million in 2022, an increase of $11.6 million.
Our cash balances at December 31 of 23 were approximately $6 5 million as compared to $27 6 million at the end of 2022.
The change in our cash balances is reflective of 25 million used in operating activities, partially offset by $4 1 million in net proceeds from the exercise more.
Since this past December.
Outstanding common shares currently stand at $2 2 million following the reverse split we executed in January this year, which flows back into full Nasdaq compliance.
Our ongoing phase II clinical programs for CMO Forest, one and good afternoon will continue to be the most significant use of our cash for 2024, we.
Mark W. Reynolds: This increase is primarily associated with the accelerated clinical trial activity for our CMO4S1 and Gadeptin programs, including manufacturing costs for clinical trial materials. The increase also includes costs associated with the AGE1 cell line manufacturing technology licensed from ProBiogen, which will be important to the future commercialization and partnering activities for all of our MVA-based vaccines. General administrative expenses were $6,023,000 versus $5,022,000, with the increase mostly associated with higher legal and patent costs, investor relations expenses, consulting fees, and personnel costs.
We don't expect this prioritization of our spending change if we receive a project Nextgen award from BARDA is any incremental spending from that program will be funded by the award we do expect to raise additional capital to fund programs in 2024, and we intend to do that in conjunction with positive news flow.
Be happy to answer questions during the Q&A and.
I will 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 of our doctors Mark Gilman, Kelly Mckee 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 instructions on the question asked.
Pierre.
We will now begin the question and answer session to ask a question you May Press Star then one on your telephone keypad.
Mark W. Reynolds: Interest income was $776,023, versus just $7,022, reflecting increasing interest rates available through our money market account. So overall, the net loss for 23 was $26.5 million, or $14.29 per share, versus $14 million in 2022, or $12.36 per share, again, with the increase being driven by the clinical trial program. Now to the balance sheet, our cash balances at December 31st of 23 were approximately $6.5 million as compared to $27.6 million at the end of 2022. The change in the cash balances is reflective of $25 million used in operating activities, partially offset by $4.1 million in net proceeds from the exercise of warrants this past December.
If youre using a speakerphone please pick up your handset before pressing the keys.
Your question. Please press Star then two.
At this time, we will pause momentarily to assemble our roster.
The first question comes from the line of James Molloy.
With Alliance Global Partners. Your line is open.
Hello. This is <unk> on for Jim Malloy. Thank you for taking my questions.
So with the positive interim.
Interim results that you have any kind of it for the phase two trial Coalbed booster vaccine in healthy volunteers, you anticipate similar efficacy against the newer in Jan one <unk> and what other findings might you be expecting from this chart once full topline results are gathered.
Sure. Thank you. This is David Thank you for years.
Question.
And I'll I'll make some comments and then I'll ask counting of Kaye, our chief Medical officer he'd like to add in but we're very pleased with the initial results that we've seen of the trial is fully enrolled.
Mark W. Reynolds: outstanding common shares currently stand at $2.2 million following the reverse split we executed in January this year, which brought us back into full NASDAQ compliance. Funding our ongoing Phase II clinical programs for CMO4S1 and Gadeptin will continue to be the most significant use of our cash for 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 programs in 2024, and we intend to do that in conjunction with positive news flows.
We'll be tracking these patients through September of this year and then we will see the final results.
Right now we have no reason to believe that our vaccine would not continue to address the variance included in Jan one as it has all the others, but until our testing is completed we have no data to support that statement, but we are very pleased that whereas.
The mrna vaccines have had to be reconfigured as new variance of concern have emerged as the delta of the various armour from the SBB, one five et cetera, remember the bivalence et cetera that our vaccine without any reconfiguration has continued to demonstrate strong protective immunity.
David Alan Dodd: I'll be happy to answer questions during the Q&A, and I'll turn the call back to David. Thank you, Mark. My colleagues and I will now answer your questions. Joining us for the Q&A session are Drs. Mark Newman, Kelly McKee, and John Sharkey, our Chief Scientific Officer, Chief Medical Officer, and Vice President of Business Development, respectively.
We believe that's because of this dual approach of targeting both the antibody as well as the cellular immunity, but I'll ask Kelly, if you'd like to add anything to that.
Okay.
Thanks, David I think you pretty much covered the waterfront on that one.
Yes, we don't have any reason to.
Back to that.
Debt.
Unknown Executive: I'll now turn the call over to the operator for instructions on the question and answer period. We will now begin the question and answer session. To ask a question, you may press star, then 1 on your telephone. If you are using a speakerphone, please pick up your handset before pressing the button. If the right question is answered, please press star.
Neutralization of Jan one will be significantly different from anything that we've seen with the other omicron variously tested but the.
The proof is going to be in the testing and we'll have to wait till those test results come back.
Yes.
Got it and then offset for that in Canada.
The additional indications might you consider for a combination therapy alongside <unk> and checkpoint inhibitors and do you currently have any clinical development plans for this program.
David Alan Dodd: At this time, we will pause momentarily to assemble our. The first question comes from the line of James Molloy, with Alliance Global Partners. Unknown Speaker 0, Hello, this is Laura Surrell on behalf of Jim Malloy. Thank you for taking, So, with the positive interim results that you already gathered for the phase two trial of your COVID booster vaccine in healthy volunteers, do you anticipate similar efficacy against the newer JN1 COVID variant, and what other findings might you be expecting? for Topline Results. Thank you. This is David Dodd.
Kelly would you like to address.
Sure so facilities as well as sort of.
I noted earlier this.
This technology is.
Is should be tumor agnostic.
The mechanism the mechanism of action is such that any solid tumor should be responsive to.
To do the treatment and so we are right now sort of exploring what other tumor types would be most amenable to two to this approach sort of as a next step beyond.
David Alan Dodd: I'll make some comments and then I'll ask Kelly McKee, our Chief Medical Officer, if he'd like to add anything. But we're very pleased with the initial results that we've seen; the trial is fully enrolled, and it will be tracking these patients through September of this year, and then we'll see the final result.
Head and neck cancer.
Head and neck cancer was initially chosen for a number of reasons not the least of which was the accessibility.
Of head and neck tumors to needle injections, which is sort of the requisite for step in this.
David Alan Dodd: Right now, we have no reason to believe that our vaccine has not continued to address the variants, including JN1, as it has all the others. So until our testing is completed, we have no data to support that statement. But we are very pleased that whereas the mRNA vaccines have had to be reconfigured as new variants of concern have emerged, such as the Delta, the VariSomicron, the X. 1.5, etc.
These treatment regimens and so.
Sure.
As we sort of look at other tumor types that might be amenable to two needle injection approach.
Some of the some of the advanced.
Breast tumors come up.
As prime candidates and we are in active discussions with a group at Emory.
While looking at.
Hey, good afternoon.
Certain.
David Alan Dodd: Remember the bivalence, etc. That our vaccine without any reconfiguration has continued to demonstrate strong protective immunity. We believe that's because the dual approach of targeting both the antibody as well as the cellular.
Breast tumor advanced breast tumor metastatic breast tumor types. The design of that is still under discussion and any timing for <unk>.
So the start is such a trial.
So Lee is added in the future at some point, but we are talking to people about.
Kelly T. McKee: But I'll ask Kelly if he'd like to add anything. Thanks, David. I think you pretty much covered the waterfront on that.
Got it thank you for taking the questions.
Thank you.
Our next question comes from the line of Jeffrey Cross with Crystal Research. Your line is open.
Kelly T. McKee: Yeah, we don't have any reason to expect that neutralization of JN1 will be significantly different from anything that we've seen with the other Omicron variants we've tested, but you know, the proof's going to be in the testing, and we'll have to wait until those test results come back. And then also for your deducting candidate, what additional indications might you consider for a combination therapy alongside immune checkpoint inhibitors? And do you currently have any clinical development plans for this program? Kelly, would you like to address the class? Sure. So, as was sort of noted earlier, this technology is, um, is, should be tumor agnostic. The mechanism of action is such that any solid tumor should be responsive to the treatment.
Thank you very much the BARDA agreement for other companies has been extremely valuable in terms of market cap appreciation when we looked at some of those other companies.
The additions to the market capitalization of thinking about just the increase in the stock price has been very powerful for them.
All of the discussions going on that front and do things continue to proceed in the direction that you would like them to be.
Thus far where we're very pleased with the discussions.
We'd love to have and have received an award letter yesterday or even today that hasn't occurred but they are.
Very positive they are encouraging.
And.
We try not to.
To try to model or give out and certainly we don't think the impact of receiving an award it'll be very positive. It certainly won't be negative, but we're not speculating what the range of that might be but like everyone else and we're aware of the value or participating in being selected to award net.
Kelly T. McKee: And so we are right now sort of exploring what other tumor types would be most amenable to this approach sort of as a next step beyond head and neck cancer. Head and neck cancer was initially chosen for a number of reasons, not the least of which was the accessibility of head and neck tumors to needle injections, which is sort of the requisite first step in these treatment regimens.
Program and I'll, just say that that we have had.
<unk> ongoing and involve discussions.
Kelly T. McKee: And so, as we sort of look at other tumor types that might be amenable to a needle injection approach, some of the some of the advanced breast tumors sort of come up as prime candidates. And we're in active discussions with a group at Emory about a trial looking at GADEP in certain breast tumors, advanced breast tumor, metastatic breast tumor types. The design of that is still sort of under discussion, and any timing for the start of such a trial is sort of way out in the future at some point, but we are talking. I got it.
By and large our most encouraging.
Okay. Thank you very much and with regard to adapt and we have not seen any other trials significantly advance in that area ahead of providing results that we've seen from your product is there any new technology that you see on the horizon that you sell to is additional threats or would you feel still feel as confident with your technology.
As you have been given the results you've been able to achieve so far.
I would say and then I'll ask if either Kelly or Mark Newman wish to add in but I'm not aware of any other you know theres a lot of work that's going on for head and neck cancer, because that's an important.
<unk> has over 70000, new cases every year now and we're seeing now 16000 deaths that ladder is what we're addressing it.
Unknown Executive: Thank you for taking the question. Our next question comes from the line of Jeffrey Kraws with Crystal Research. Your line is open.
At least as our initial indication.
David Alan Dodd: Thank you very much. The Bartho agreement for other companies has been extremely valuable in terms of market cap appreciation when we, Some of those other companies. As additions to the market, price has been very powerful. How are the discussions going on that front? And will things continue to proceed?
I would say the the advanced technology may well be the combination therapy of the good depth in technology in conjunction with the immune checkpoint inhibitors that may be what would be the next stage advanced technology, but our goal right now is to complete the evaluation.
David Alan Dodd: Thus far, we're very pleased with the discussion. We'd love to have received an award letter yesterday or even today, but that hasn't happened, but they are very positive, they're encouraging. And, you know, we try not to try to model or give out awards, certainly.
<unk> of the book.
What we hope to be able to announce show yet this half and then to lay out our plans for going forward.
And keep everybody updated but we're not aware of any other technology thats directly coming after what we're focused on right now we see a lot of good ideas and approaches for earlier stage solid tumors.
David Alan Dodd: We don't think the impact of receiving an award will be very positive, it certainly won't be negative, but we're not speculating what the range of that might be. But like everyone else, we're aware of the value of participating and being selected for that program. And I'll just say that we have had continued, ongoing, involved discussions that are, by and large, most encouraging. Okay, thank you very much.
But in the end they may very well be highly complementary and there may be synergies those technologies with good afternoon.
Okay. If no other so we can go over the next question.
Next question comes from the line of Robert <unk> with Noble capital markets. Your line is open.
David Alan Dodd: And with regard to GADEPTAN, we have not seen any other trials significantly advanced in that area ahead of providing results that we've seen from your product. Is there any new technology that you see on the horizon that you feel has additional threats, or do you still feel as confident with your technology as you have been given the results you've been able to achieve? I would say and then I'll ask if it's either. Kelly there are more, wish to add in, but I'm not aware of any others.
I had a question on good depth in the clinical trials I was hoping you could just clarify a little bit of.
The plans you had mentioned expansion of the phase two <unk>.
<unk> event.
And combinations with checkpoint inhibitors are these going to be separate trials.
Beginning in sequence.
Arms, one trial or.
David Alan Dodd: You know, there's a lot of work that's going on for head and neck at www.geovax.com, leases our initial in the case. I would say the next stage advanced technology may well be the combination therapy of the GADEPTEN technology in conjunction with the immune checkpoint inhibitors, that may be what would be the next stage advanced technology. But our goal right now is to complete the evaluation of the... What we hope to be able to announce this half is then to lay out our plans for going forward and keep everybody updated, but we're not aware of any other technology that's directly coming after what we're focused on right now. We see a lot of good ideas and approaches for earlier stage solid tumors.
Just any.
Any clarification on how you are looking at all of these potential combinations of <unk>.
Sure I'll ask Kelly that pick up on this one.
Yes.
Yes.
Yes.
You're sort of focusing on exactly.
The dilemma that we face and and and and it's a it's a topic thats under active discussion as we speak.
Yeah.
We were very encouraged by what we've seen with our with our.
With our phase one and phase one two.
Trials up to this point at least particularly in terms of the mechanism of action and translating that into it into.
Our response to that.
We anticipated seeing.
Kelly T. McKee: And, you know, in the end, they may very well be highly complementary. There may be synergy between those technologies and cadets. If no others have done so, we can go to the next question, which comes from the line of Robert LeBoyer with Noble Capital Markets, your line. I had a question about Gudeptin and the clinical trial. Blah, blah, blah, and Hewdman. Expansion of the Phase-D program in the U.S. Let's start with a brief introduction; are these going? separate file.
In these patients and so the next question. The question then becomes where do we go from here.
We are we put together a and advisory committees.
Yes.
Consisting of a number of head and neck cancer oncologists in head and neck cancer surgeons.
With whom we are scheduled to meet towards the end of April to discuss exactly.
The question that you asked I mean, what's what's the most logical next step this is a very.
Although this is David indicated that theres not a lot of competition.
Kelly T. McKee: The sequence, for the arms of one trial, clarification on how you're looking. Good. I'll ask Kelly to pick up the phone. Yeah, that's a good idea. That you're sort of focusing on exactly the dilemma that we face, and it's a topic that's under active discussion as we speak. We're very encouraged by what we've seen with our phase one and phase one, two trials up to this point, particularly in terms of the sort of mechanism of action and translating that into a response that we anticipated seeing in these patients. And so, you know, the next question, the question then becomes, where do we go from here? We have put together an advisory committee consisting of a number of head and neck cancer oncologists and head and neck cancer surgeons with whom we're scheduled to meet towards the end of April to discuss exactly. The question that you asked, I mean, what's the most logical next step? You know, this is a very, although there's, as David indicated, there's not a lot of competition, with regard to our specific case, www.geovax.com. Well, Kelly's having some phone difficulties, but I think we were saying that, www.globalonenessproject.org overlay check progressed into earlier stages. All of these things are here.
With regard to our specific technology.
Okay.
Okay.
Yes.
Okay.
Having some phone difficulties, but I think we're saying that specifically.
Specific with our technology, we don't see a lot of competition, but there is a lot going on this addressing solid tumors and I'd say very marvell all good ideas of Eric.
Checkpoint inhibitors should this be an add on should this be.
A mono therapy to which we then.
Overlay a checkpoint inhibitor.
Should we progressed into earlier stage disease. All of these questions I think they are sort of interrelated and we're going to be heavily reliant on the advice of our advisory can be sort of guide us into where we go next but the short answer to your question is we do.
Don't really know at this point in time.
Okay, Yeah, that's that's totally fair and relying on them.
Hitting the.
Surgeons.
<unk> you.
Oh good good course of action. So I will ask you to speculate and I'll just wait for the update after you have that meeting with them.
Thanks.
Kelly T. McKee: We'll be sure to answer your questions. We don't really know. OK, yeah, that's there. Advice, a good course that I want to, Transcribed by https://otter.ai, Okay, thanks. They were. Unknown Speaker 0.
Yes.
They all make sense to me, but.
It's their opinion accounts more.
So yes.
Just in terms of the M pox and the NBA manufacturing process.
That's not something where you have a clinical trial or.
Presentation of the conference are there any milestones or announcements that we should be looking for that would signal progress in the manufacturing.
Unknown Executive: . Just in terms of the MPOC, The NBA Manufacturer, If that's not a trial, are there any milestones or targets looking for that would signal progress with the Mark? Yes, John Sharkey, would you pick up on that? Sure. Hey, Robert.
Process for.
Towards the market in that program.
Yes, John Sharkey would you pick up on that please.
Sure.
Hey, Robert Nice talking with you again.
John Sharkey: It's nice talking to you. Yeah. Unknown Speaker.
Yes.
Remember.
John Sharkey: MBA, in our manufacturing environment, is like a lot of our other vaccines. So as we move forward to implement our MVA production for our different vaccine candidates, such as O4S1 and others at ABL, that platform will also be useful for MBA. Regarding specific MVA milestones, we remain highly confident and optimistic that there is an expedited pathway forward to bring an MVA vaccine for monkeypox and smallpox to the marketplace. We are advancing our discussions with regulators to map that out.
NBA in our in our manufacturing environment is like a lot of our other vaccine. So as we move forward to implement RMB eight production for our different vaccine candidates such as <unk> and others at ADL that platform will be useful also for NBA <unk>.
Regarding specific NBA milestones, we remain highly confident and optimistic that there is an expedited pathway forward to bring.
NBA vaccine for multi box of small parts to the marketplace.
We are advancing our discussions with.
Regulators to map that out.
John Sharkey: And I would expect that we would be updating the market once we have agreement on the plan towards a registration. As always, you never get, yes, do this, and you'll get it, but you do get agreement on how to move something forward. I would expect we would be bringing that forward and sharing with the market here, earlier probably would have said, Okay, great. Thank you. The next question comes from the line by Jason Kolbert with Dawson, your life.
And I would expect that we would be updating the market. Once we have agreement on the plan.
Towards a registration as always you never yet, yes, do this and Youll get it but you get agreement on how to move something forward I would expect we would be bringing that forward and ensuring would.
The market this year.
Earlier, probably been later.
Okay, great. Thank you very much for that.
Next question comes from the line of Jason Kolbert with Dawson James Your line is open.
David Alan Dodd: Hi guys, it was good to see you recently. I'd like to ask you a little bit about financing. We're in a very tough environment for microcaps. They've been under a lot of pressure.
Hi, guys that good seeing you recently.
I'd like to ask you a little bit about financing we're in a very tough environment for micro caps, they've been under a lot of pressure.
Mark W. Reynolds: How do you anticipate raising capital over the coming years? I asked Mark Reynolds. I'll toss that easy answer question to him. The simple answer, Jason, is we'll raise funds opportunistically. You know, every biotech CEO will tell you we'll raise as much money when and wherever we can. You know, we have said in our public filings that we've got cash runway through into Q2 of this year, so you could expect to see some fundraising activity within that time frame. And if you, can you narrow in with me on that time frame, what do you think might be catalysts that could help drive the stock?
How do you anticipate raising capital over the coming year.
As Marc <unk> said easy quite answer question to him.
The simple answer Jason is broke will raise funds opportunistically.
Every biotech CEO will tell you will raise raise as much money when and wherever we can.
Sure.
We have we have said in our public filings that we've got cash run way through.
Into Q2 of.
This year, so you could expect to see some fundraising activity with that within that timeframe.
And if you can you narrow in with me on that time frame, what you think might be catalysts that could help drive the stock.
Mark W. Reynolds: There will be some continued data flow from the trials. But the most significant item, which is the elephant in the room, is the Project NextGen award from BARDA. You know, we can't count on that because, you know, that's definitely a forward-looking statement to say that we're even contemplating that award. But we're very confident in that regard. So, I think that would be a significant catalyst for us to look at funding and remind me how big that award could be and whether that award goes beyond just time and materials. Apply it.
It's going to be some continued data flow from the trials, it's going to be the most significant item, which is the elephant in the room is the project next Gen Award from BARDA.
We we can't count on that because it's definitely forward looking statement to say that we even or even contemplating that award.
But we're very confident in that regard so I think that that would be a significant catalyst for us to look at fundraising upon.
And remind me how big that award could be and whether that award goes beyond just like a time and materials or is it supply just can you go into that a little bit.
Mark W. Reynolds: Can you go into that a little bit? David, do you want to take that question? Now you can go ahead with it. Yeah, so the type of award that we expect may come would be a mod, I'll call it a modest amount directly to the company, but the value of the award would be immensely greater than what we would receive directly. You call it the bio book.
Okay.
Based on David do you want to take that question.
Now you can go ahead, yes.
So.
It's the type of award that we expect May com.
Would be a mod I'll call it a modest amount and directly to the company.
But the value of the awards would be immensely more than what we would receive directly.
All at the bio box.
David Alan Dodd: The benefit to the company could be in the hundreds of millions. But again, that's a forward-looking statement. We'll have to defer to the. Winner Nifty Award. Thank you very much. It looks like a pretty important cattle.
The benefit to the company because it could be in the hundreds of millions of dollars, but again, that's a forward looking statement will have to defer to see when we entered 50 award comes how it's structured.
Okay. Thank you very much.
It looks like a pretty important catalyst.
David Alan Dodd: Yeah, it is, Jason. Let me just add that the way that these awards have been coming is that there's a direct award to the company, and that's for the planning of phase two. And then it may, then there'll be a direct payment to the CRO that's gonna be supporting the clinical program, and that can be up to 300 million dollars in value.
It is Jason let me just add on the way that these awards have been coming as a direct award to the company.
And thats for the planning and with Phase two and then May then.
There will be a direct payments to the <unk> is going to be supporting the clinical program and that can be.
300 plus million dollars in value.
David Alan Dodd: So when you see these awards announced, you'll see some of them announce that they've received this initial award of $10 million directly, but the value that they're receiving is 350 million. So that's how it's been reflected in various programs. That's really helpful. Thank you, David. Our next question comes from the line of Vernon Bernardino with HC Wainwright. Your line.
When you see these awards and now you'll see some of them, we'll announce where they've received this initial award of $10 million directly but the value that they're receiving is $350 million. So.
That's how it's been reflected in various press releases.
Yes, that's really helpful. Thank you David.
Yes.
Okay.
Our next question comes from the line of Brennan Bernardino with H C. Wainwright. Your line is open.
David Alan Dodd: Hi David and team. Thanks for taking my question. You probably saw that ACIP recommended persons over 65 years of age should receive an additional dose of COVID vaccine. Does the recommendation or any of the language from the meeting change your thinking as far as strategy, market opportunity, or priority? Not at all.
Hi, David and team Thanks for taking my question.
You probably saw.
You bet.
Recommended person over 65 years of age should receive an additional dose of a COVID-19 vaccine.
So is the recommendation and are any of them.
Language from the meeting change your thinking as far as strategy market opportunity or priorities.
Not at all if anything it underscores where we differentiate.
David Alan Dodd: If anything, it underscores where we differentiate because what has been going on is we've all noticed and we're seeing, you know, reports from the CDC and others that the famous efficacy of 95% and et cetera seems to be more like about 50%, depending on how you measure efficacy. And we're seeing that durability, which is why we're having to see so many boosters continuously being added, is that the durability of the existing vaccines appears to be somewhere between two to four or two to six months. I mean, it just is not durable versus what was originally communicated, which was that they would be good for a year.
Because what has been going on as we've all noticed that we're seeing.
Reports from the CDC and others.
The the famous efficacy of 95% et cetera seem to be more of like about 50%, depending how you how you measure efficacy and we're seeing that durability, which is why we're having to see so many boosters continuously being added.
Is that the durability of the existing vaccines appears to be somewhere between two to four 2% to six months I mean, it just is not the durability versus what was originally communicated which was that it would be good for a year and and yet we're seeing right now with the data that we're getting out of our trials durability and X.
David Alan Dodd: And yet, with the data that we're getting out of our trials, durability in excess of eight months. So, we are right now seeing data that demonstrate that our durability is about two times X of what is being noted in the clinical use of the current vaccine. There are increasingly more and more publications and statements addressing the needs of the elderly, depending on how you define the elderly, but also those with compromised immune systems. It's well accepted that this latter group of people have depleted immune systems because of various medical conditions, and they are at the highest risk of severe disease, hospitalization, and the risk of death.
SaaS of of eight months. So we right now are seeing data that demonstrate that our durability is about a two X of what is being noted in the clinical the clinical use of the current vaccines.
Increasingly more and more publications and state months in addressing the needs of the elderly depending on how you define the elderly but also.
Those with compromised immune systems is well accepted that that latter group of people will have depleted.
Immune systems, because various medical conditions that they are at the highest risk of severe disease hospitalization and the risk of that and this is again, where we see with our construct is coming in and having a strong focus on not only on the antibody side, but also on the cellular side, giving what we are.
David Alan Dodd: And this is, again, where we see with our construct of coming in and having a strong focus on not only on the antibody side, but also on the cellular side, given what we're seeing right now, gives us a broader, almost very agnostic. Unknown Speaker, Unknown Attendee, Unknown Speaker, Unknown Attendee, Unknown Speaker, is progressing through its clinical trials, there's increasingly more and more evidence of why Project NextGen is such a critical program that the White House announced last year because it's the recognition that what is out there is inadequate in many different ways. Now, as a follow-up, I didn't attend or view the proceedings. I didn't see any mention as far as immunocompromised individuals.
Seeing right now gives us a broader almost very agnostic.
Our immune response, but also greater durability, we think that as our product is is progressing through its clinical trials. There is increasingly more and more evidence of wide project Nexgen is such a critical program that the White House announced last year because it is the recognition that what is out there is that many dip.
Arent ways.
Now as a follow up I didn't.
Attend or view the proceedings.
I think Jamie mentioned as far as immunocompromised individuals did you gain any insight from the AC.
David Alan Dodd: Did you gain any insight from the ACIP meeting about immunocompromised individuals and booster shots? Not at the recent meeting, but it's been so well underlined by the CDC, by the WHO, and others that the highest risk groups are those with compromised immune systems. Okay, yes, and I'm definitely excited for that kind of trial as well. Thanks for taking my question and my follow-up. I'm looking forward to the progress this year. Thank you so much.
CIP meeting about immune compromised individuals and booster shots.
Not in the recent meeting, but it's been so well underscored by the CDC by the <unk> and others.
The highest risk groups are those with compromised immune systems.
Yeah.
Okay, Yes.
We are excited for that clinical trial as well. Thanks for taking my question and then my follow up.
We're comfortable with the progress in this year.
Thank you so much.
David Alan Dodd: Again, if you have a question, please press star, then we'll answer it. There are no further questions at this time. This concludes our question and answer session. I would like to turn the conference back over to David Dodd for any questions.
Again, if you have a question. Please press Star then one.
There are no further questions at this time. This concludes our question and answer session I would like to turn the conference back over to David Dodd for any closing remarks.
David Alan Dodd: Thank you, and thank you, everyone. We really appreciate your participation in this Corporate Update Call and in joining us and sharing the achievements, progress, and our out... Indeed, your interest is greatly appreciated. I want to especially acknowledge and thank our Board of Directors, Advisors, our GeoVax staff, and the many other parties. Support and Advise Us Towards Achieving Success. In achieving our success, we're committed to providing meaningful career development opportunities for highly competitive, quality-oriented individuals seeking to disrupt the current paradigm of cancer therapy, infectious disease vaccines, and redefining how success is defined in addressing various patient populations. For all of us, it's been a great pleasure serving our shareholders, our stakeholders, and being part of the. Wish everyone a safe evening and a wonderful rest of the week. Now concluded. Thank you for attending today's presentation. You may now go to, www.globalonenessproject.org
Thank you and thank you everyone really appreciate your participation in this corporate update call.
And joining us and sharing the achievements progress and our outlook and indeed your interest is greatly appreciated.
I would especially acknowledge and thank our board of directors and advisers are <unk> staff and the many other parties that continue to support and advise us towards achieving success.
In achieving our success, we're committed to providing meaningful career development opportunities for highly competitive quality oriented individuals seeking to disrupt the current paradigm with cancer therapies infectious disease vaccine and redefining how success is defined and addressing various patient populations for.
For all of US it's been a great pleasure, serving our shareholders our stakeholders of being part of this journey I wish everyone, a safe evening and a wonderful rest of the week. Thank you.
Now concluded. Thank you for attending today's presentation you may now disconnect.
[music].
Sure.
Okay.