Full Year 2024 PDS Biotechnology Corp Earnings Call and Business Update
Good morning, and welcome to P. D S Biotechs fourth quarter full year 2024 earnings conference call.
Operator: Good morning and welcome to PDS Biotech's fourth quarter and full year 2024 earnings conference call. At this time, all participants are currently in listen-only mode.
At this time all participants are currently in listen only mode.
Operator: Following the formal presentation, we'll open the call up for a question and answer session.
Following the formal presentation, we'll open the call up for a question and answer session.
Tom Johnson: At this time, I would now like to turn the conference over to Tom Johnson, LifeSci Advisors. Please go ahead. Thank you, Operator.
Tom Johnson: At this time I would now like to turn the conference over to Tom Johnson lifestyle Advisors. Please go ahead Sir.
Tom Johnson: Thank you operator, good morning, everyone and welcome to the Tds Biotech 2024 results clinical program update call on.
Tom Johnson: Good morning, everyone, and welcome to the PDS Biotech's 2024 Results and Clinical Program Update Call.
Tom Johnson: I'm joined on the call today by the following members of the company's management team, Dr. Frank Beduado, Chief Executive Officer, Dr. Kirk Shepard, Chief Medical Officer, and Lars Boesgaard, Chief Financial Officer. Dr. Beduado will begin with an overview of the company's recent progress in its clinical development program.
Speaker Change: I'm joined on the call today by the following members of the company's management team Dr. Frank Bennett with Dow Chief Executive Officer, Dr. Curt Shepherd, Chief Medical Officer, and <unk>, Chief Financial Officer, Dr. <unk> <unk> will begin with an overview of the company's recent progress in its clinical development program. Mr. <unk> will review the financial results for 2024.
Tom Johnson: Mr. Boesgaard will review the financial results for the 2024 fiscal year, and Dr. Shepard will then join the call to help address questions from covering analysts. As a reminder, during this call, we will make forward-looking statements which are subject to various risks and uncertainties that could cause our actual results to differ materially from these statements. Any such statements should be considered in conjunction with cautionary statements in our press releases and risk factors discussed in our filings with the SEC, including our quarterly reports on Form 10-Q and annual report on Form 10-K.
Tom Johnson: Fiscal year <unk>.
Tom Johnson: Have to shuffle would join the call to help address questions from our covering analysts.
Tom Johnson: As a reminder, during this call we will make forward looking statements, which are subject to various risks and uncertainties that could cause our actual results to differ materially from these statements.
Tom Johnson: Any such statements should be considered in conjunction with cautionary statements in our press releases and risk factors discussed in our filings with the SEC, including our quarterly reports on Form 10-Q, and annual report on Form 10-K, and these cautionary statements made during this call we.
Tom Johnson: And these cautionary statements made during this call. We assume no obligation to update any of these hardworking statements or information.
Tom Johnson: We assume no obligation to update any of these forward looking statements or information.
Frank Beduado: Now, I'd like to turn the call over to Dr. Bedua Du. Frank? Thank you, Tom, and good morning, everyone. It's our pleasure to speak with you again and to provide this brief update on our progress in advancing our clinical program. 2024 and the first weeks of 2025 have been busy and productive.
Speaker Change: Now I'd like to turn the call over to Dr. <unk>.
Tom Johnson: Frank.
Frank: Thank you Tom and good morning, everyone.
Frank: It's our pleasure to speak with you again and to provide this brief update on our progress in advancing our clinical programs.
Frank: 2024, and the first weeks of 2025 have been busy and productive.
Frank Beduado: led by the initiation of our versatile 003 phase three clinical trial of versamune HPV plus pembrolizumab compared to pembrolizumab as a potential treatment for first-line recurrent and or metastatic HPV 16 positive head and neck squamous cell carcinoma, HNSCC, or head and neck cancer. Patients with HPV-16 positive head and neck cancer represent a large, fast-growing population in need of targeted therapies to treat the underlying cause of the cancer. It is projected that by the mid-2030s, HPV-16 positive head and neck cancer could be the most prevalent type of head and neck cancer in the United States and Europe.
Frank: Led by the initiation of our versatile zero-zero three phase III clinical trial.
Frank: The diverse immune HPV, plus pembrey lithium up compared to Pembina loser map as a.
Frank: <unk> treatment for first line recurrent or metastatic HPV 16 positive head and neck squamous cell carcinoma, H N S C C or had any cancer.
Frank: Patients with HPV 16 positive head and neck cancer represents a large.
Frank: Fast growing population.
Frank: Need of targeted therapies to treat the underlying cause of the cancer.
Frank: It is projected that by the mid 2030.
Frank: HPV 16 positive head and neck cancer could be the most prevalent type of head and neck cancer in the United States and Europe.
Frank: Okay.
Frank Beduado: Considering the strength and durability of the clinical responses observed in our versatile 002 phase two study, we are pleased to get this registrational trial underway and are confident in the potential of our innovative combination of Versamune HPV and Pembrolizumab to improve patient outcomes and enhance the standard of care. In the coming weeks, we expect to continue to activate additional clinical sites and look forward to the continued progression of this trial. As we announced previously, the Versatile 003 trial design includes approximately 350 patients. The two-arm registrational trial design has been given the go-ahead by the U.S.
Frank: Considering the strength and durability of the clinical responses observed in our versatile 002 phase II study. We are pleased to get this registrational trial underway and are confident in the potential of our innovative combination of various immune HPV and pembina is the map to improve patient outcomes.
Frank: And hence the standard of care.
Frank: In the coming weeks, we expect to continue to activate additional clinical sites and look forward to the continued progression of this trial.
Frank: As we announced previously diverse the towels zero-zero three trial design includes approximately 350 patients.
Frank: The two arm Registrational trial design has been given the go ahead by the U S food and drug administration F D. A.
Frank Beduado: Food and Drug Administration, FDA. The two arms of the trial include a treatment arm of the versamune HPV pembrolizumab combination versus the control arm of pembrolizumab only. Patients are enrolled in a 2-to-1 randomization. Median overall survival is the primary endpoint. The trial design is informed by the observed durability of the clinical responses in our versatile 002 phase 2 clinical trial seen over the last year with the most recent data presented at the European Society for Medical Oncology, ESMO, Congress in September.
Frank: The two arms of the trial include a treatment arm of diverse immune HPV Pembina Zimmer combination.
Frank: Versus the control arm of <unk> only.
Frank: Patients are enrolled in a 221 randomization.
Frank: Median overall survival is the primary endpoint.
Frank: The trial design is informed by the observed durability of the clinical responses in our versatile zero-zero two phase II clinical trial seen over the last year with the most recent data presented at the European Society for medical Oncology ESMO Congress in September.
Frank: Okay.
Frank Beduado: These data demonstrated the following. Median overall survival has remained at 30 months over the last two data cuts. and the lower limit of the 95% confidence interval improved to approximately 20 months. The best published median overall survival for Pembrolizumab is 17.9 months. Promising durability and long-lasting anti-tumor immune responses were demonstrated with improvement in all clinical response outcomes between the data presented in June of 2023 at the American Society of Clinical Oncology ASCO Conference and September of 2024 at ESMO, a period of a little over a year. Objective response rate improved from 26 percent to 36 percent.
Frank: These data demonstrated the following.
Frank: Median overall survival.
Frank: It remained at 30 months over the last two data cuts.
Frank: And the lower limit of the 95% confidence interval improved to approximately 20 months.
Frank: The best published median overall survival for Pembina lithium up 17.9 months.
Frank: Promising durability and long lasting anti tumor immune responses were demonstrated with improvement in all clinical response outcomes between the data presented in June of 2023 at the American Society of clinical oncology <unk> Conference ends.
Frank: In September of 'twenty 'twenty four at ESMO, a period of a little over a year.
Frank: Objective response rate improved from 26% to 36%.
Frank Beduado: Published objective response rate for Pembrolizumab is 19 to 25 percent. disease control rate improved from 70% to 77%. the number of patients with complete or near-complete responses of 90 to 100% tumor shrinkage increased from 6% to 21%. the number of patients with complete responses increased from 3% to 9%. The most common treatment-related adverse events overall were grade 1 and grade 2 transient injection site reactions. Treatment-related adverse events of grade three and higher were seen in nine out of 87 patients, or 10% of immune checkpoint inhibitor-naive and immune checkpoint inhibitor-resistant patients in the trial. there was only one grade four treatment-related adverse event.
Frank: Published objective response rate for Penn realism up it's 19% to 25%.
Frank: Disease control rate improved from 70% to 77%.
Frank: The number of patients with complete or near complete responses of 90% to 100% tumor shrinkage increase from 6% to 21%.
Frank: The number of patients with complete responses increased from 3% to 9%.
The most common treatment related adverse events overall were grade one grade two transient injection site reactions.
Frank: Treatment related adverse events of grade three and higher were seen in nine out of 87 patients or 10% of it.
Frank: Immune checkpoint inhibitor naive and immune checkpoint inhibitor resistant patients in the trial.
Frank: There was only one grade four treatment related adverse events.
Frank: The encouraging patient survival and clinical responses, coupled with promising tolerability athene in diverse styles. The residual two clinical trial underscore.
Frank Beduado: The encouraging patient survival and clinical responses, coupled with promising tolerability as seen in the Versatile 002 clinical trial, underscores our belief in the potential of the combination to be the first HPV-targeted immunotherapy for head and neck cancer, and a significant advancement in the treatment of the growing population of patients with HPV-16 positive head and neck cancer.
Frank: Underscores our belief in the potential of the combination to be the first HPV targets immune immunotherapy for head and neck cancer.
Frank: And a significant advancement in the treatment of the growing population of patients with HPV 16 positive head and neck cancer.
Frank: Elsewhere in our pipeline, we were pleased to announce FDA clearance of our investigational new drug I N D application for the combination of various immune Mark one and.
Frank Beduado: Elsewhere in our pipeline, we were pleased to announce FDA clearance of our investigational new drug IND application for the combination of versamune MOC1 and PDS-01-ADC to treat metastatic colorectal cancer. This is a significant development for the company, as several highly prevalent solid tumors are MOC1 positive, including non-small cell lung cancer, ovarian cancer, breast cancer, liver cancer, and others.
Frank: And P D S O one ADC to treat metastatic colorectal cancer.
Frank: This is a significant development for the company.
Frank: Several highly prevalent solid tumors, a mock one positive, including non small cell lung cancer.
Frank: Ovarian cancer breast cancer liver cancer and others.
Frank: We are pleased to announce that we continue our strong relationship with the National Cancer Institute and this phase one two clinical trial is scheduled to be run under our collaborative research and development agreement with the National Cancer Institute.
Frank Beduado: We are pleased to announce that we continue our strong relationship with the National Cancer Institute, and this Phase I-II clinical trial is scheduled to be run under our collaborative research and development agreement with the National Cancer Institute. PDS Biotech will continue to focus our efforts on progressing the BIRSTYLE-003 Phase 3 clinical trial.
Frank: P. D. S. Biotech will continue to focus our efforts on progressing the <unk> thousand and received a three phase III clinical trial.
Frank: Last October data from our immune <unk> phase II clinical study evaluating versus immune HPV with chemo radiation to treat locally advanced cervical cancer were presented at the American Society for radiation oncology.
Frank Beduado: Last October, data from our Immunoserve Phase 2 clinical study evaluating versamune HPV with chemoradiation to treat locally advanced cervical cancer were presented at the American Society for Radiation Oncology ASTRO annual meeting. The presented data demonstrated promising survival. clinical activity, and a compelling safety profile.
Frank: Annual meeting.
Frank: The presented data demonstrated promising survival.
Frank: Clinical activity and the compelling safety profile.
Frank: Based on research and continued and various HPV positive cancers conducted by P. D S biotech and by independent researchers who recognize its potential.
Frank Beduado: Based on research and continued in various HPV positive cancers conducted by PDS Biotech and by independent researchers who recognize its potential, versamine HPV appears to work in combination with a variety of therapeutic agents to generate clinical responses and promote improved survival in patients with a favorable safety profile.
Frank: <unk> HPV appears to work in combination with a variety of therapeutic agents to generate clinical responses and promote improved survival in patients with a favorable safety profile.
Frank: Also last October the rationale and trial design for the National Cancer Institute led study evaluating our IL 12 fused antibody drug conjugates Pds <unk> ADC in combination with Astellas and <unk> versus tends a lot tonight alone for the treatment of recurrent prostate.
Frank Beduado: Also last October, the rationale and trial design for the National Cancer Institute-led study evaluating our IL-12 fused antibody drug conjugate, PDS-01-ADC, in combination with astellasenzalatamide versus enzalatamide alone for the treatment of recurrent prostate cancer was discussed during an oral presentation at the 12th annual meeting of the International Cytokine and Interference Society, Cytokines 2024 in Seoul, South Korea.
Frank: Cancer was discussed during an oral presentation of the <unk> annual meeting of the international cytokine and interference Society cytokines 2020 full in Seoul, South Korea.
Speaker Change: The presentation was given by Ravi a Madonna M D had prostate cancer clinical research section section.
Frank Beduado: The presentation was given by Ravi A. Madan, MD, Head, Prostate Cancer Clinical Research Section, Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, part of the U.S. National Institutes of Health.
Speaker Change: Genitourinary Malignancies branch center for cancer Research National Cancer Institute part of the U S National Institutes of health.
Speaker Change: Now I will turn it over to Lars for a review of our results for 2022 2024, sorry Lars.
Lars Boesgaard: Now I will turn it over to Lars for review of our results for 2022, 2024, sorry, Lars. Thank you, Frank, and good morning, everyone. A net loss for the year ended December 31, 2024, was approximately $37.6 million or $1.03 per basic and diluted share. This compares to a net loss of $42.9 million or $1.39 per basic and diluted share for the prior year period. The reduced net loss was primarily the result of decreased operating expenses, which were partially offset by increased net interest. Research and development expenses for 2024 were $22.6 million compared to $27.8 million in 2023.
Lars: Thank you Frank and good morning, everyone.
Speaker Change: Net loss for the year ended December 31, 2024 was approximately $37 $6 million or $1.03 per basic and diluted share.
Speaker Change: Here's to a net loss of $42 $9 million or $1.39 per basic and diluted share for the prior year period.
Speaker Change: The reduced net loss was primarily the result of decreased operating expenses, which were partially offset by increased net interest expense.
Speaker Change: Research and development expenses for 2024 were $22 $6 million compared to $27 8 million in 2023.
Lars Boesgaard: The decrease of $5.2 million was primarily attributable to decreases in clinical costs of $4.1 million, personnel costs of $1 million, and professional fees of $0.1 million. General and administrative expenses for 2024 were $13.8 million, compared to $15.3 million in 2020. The $1.5 million decrease was primarily attributable to decreases in professional fees of $1.3 million and facilities costs of $0.2 million. Total operating expenses for 2024 were $36.3 million, which compared to $43 million in 2020. Net interest expense was $2.2 million for 2024 compared to $1.3 million in 2023. This change was due to increased debt interest and lower interest income on the company's cash balance.
Speaker Change: The decrease of $5 $2 million was primarily attributable to decreases in clinical costs of $4 1 million personnel cost of $1 million and professional fees of $1 million.
Speaker Change: General and administrative expenses for 2024 were $13 8 million compared to $15 3 million in 2023.
Speaker Change: The $1 5 million decrease was primarily attributable to decreases in professional fees of $1 3 million in facilities cost of Seaworld.
Speaker Change: Zero point $2 million.
Speaker Change: Total operating expenses for 2024 were $36 $3 million, which compared to $43 million in 2023.
Speaker Change: Net interest expense was $2 2 million for 2024 compared to $1 3 million in 2023.
Speaker Change: This change was due to increased debt interest and lower interest income on the companys cash balances.
Lars Boesgaard: On February 27, 2025, we announced an up to $22 million registered direct offer. The securities purchase agreements with new and existing healthcare-focused institutional investors included 11 million upfront gross proceeds with up to an additional 11 million dollars of aggregate gross proceeds upon cash exercise in full of warrants issued to the investor.
Speaker Change: On February 27, 2025, we announced an up to $22 million registered direct offering.
The securities purchase agreements with new and existing health careful with institutional investors included $11 million upfront gross proceeds with up to an additional $11 million of aggregate gross proceeds upon cash exercise in full of warrants issued to the investors.
Speaker Change: Yeah.
Speaker Change: The Companys cash balance as of December 31, 2024 was $41 7 million a debt balance of course does not include the aforementioned direct offering which we completed in February.
Lars Boesgaard: The company's cash balance as of December 31, 2024, was $41.7 million, and that balance, of course, does not include the aforementioned direct offering, which we concluded in February.
Lars Boesgaard: With that, I'll just turn the call back to the office. Thank you.
Speaker Change: With that I'll, just turn the call back to the.
Speaker Change: To the operator.
Speaker Change: Thank you we will now be conducting a question and answer session.
Operator: We'll now be conducting a question and answer session. If you would like to ask a question at this time, you may press star 1 from your telephone keypad and a confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to withdraw your question from the queue. Since this one's using speaker equipment, it may be necessary to pick up your handset before pressing the star key. One moment, please, while we poll for the first. Thank you.
Speaker Change: If you'd like to ask a question at this time you May press star one from your telephone keypad, a confirmation tone will indicate your line is in the question queue.
Speaker Change: You May press star two if you'd like to withdraw your question from the queue.
Speaker Change: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Or no. Please poll for the first question. Thank you.
Speaker Change: Thank you and the first question comes from the line of Joe <unk> with H C. Wainwright. Please proceed with your questions.
Joe Pantginis: And the first question comes from the line of Joe Pantginis with H.C. Wainwright. Hey guys, good morning. Thanks for taking the questions. So first, I wanted to get a sense of the enrollment trajectory for VersaMune-003. And I guess, well, projected timelines, number one, and I know that might be hard to project since it's very early, but the sites that you're targeting, what kind of balance are you looking at with regard to sites that are familiar with VersaMune-003?
Joe: Hey, guys. Good morning, Thanks for taking the questions. So.
Joe: So first I wanted to get a sense of the enrollment trajectory for various immuno <unk> III.
Joe: And I guess, well projected timelines number one and I know that might be hard to project. Since it's very early but the sites that you're targeting what kind of balance are you looking at with regard to sites that are familiar with various immune versus new sites that might require.
Frank Beduado: versus new sites that might require, you know, some level Thank you, Joe, for the question.
Joe: Some level of a learning curve.
Kirk: Thank you Joe for the question Kirk I'll hand that question over to you.
Kirk Shepard: Kirk, I'll hand that question over to you. Yes. So we're happy that, as you know, we initiated the first site this month, and we're happy also to say that sites that were involved. Almost all of them from the Phase 2 trial are reengaged with us now with Phase 3. And as I think you referred to in your question, this helps out a lot as far as their familiarity with the drug. I think their belief in the good results. And so that's really sped us along quite a bit. As far as the patient accrual in the future, I mean, you're right, that'll be determined by how fast we bring these sites on.
Joe: Yes.
Joe: So we're happy that as you know we initiated the first site. This month and we are happy also to say that.
Joe: The sites that were involved almost all of them from the phase II trial are reengage with us now with phase III and as I think you referred to in your question. This helps out a lot as far as their familiarity with the drug I think their belief in the good results and so that's really spurred us along quite a bit.
Joe: As far as the patient accrual in the future I mean, youre right that will be determined by how fast we bringing sites saw it and so far we're tracking very well.
Joe Pantginis: And so far, we're tracking very well. And of course, how well each of the sites do. That's helpful. Thanks.
Joe: And of course, how well each of the sites do perform.
Joe: No. That's helpful. Thanks, and I guess, you know is largely describing too.
Lars Boesgaard: And I guess, you know, as Lars was describing, too, in this day and age, you guys are... in a good position to have a decent cash balance. So I guess, you know, as people look to study completion and pipeline development, you know, how do you view the current funding environment for your?
Joe: In this day and age you guys are.
Joe: I guess in a good position to have a.
Joe: A decent cash balance so I guess.
Speaker Change: As people look to study completion and pipeline development you know how do you view the current funding environment for your current studies.
Joe: Yeah.
Lars Boesgaard: Lars, I'll hand that over to you. Sure, hey Joe, thanks for the question. Yeah, you're right, as I mentioned, we did raise 11 million recently and definitely the current funding environment and market conditions are difficult and challenging. So we're quite pleased that we were able to raise the funds in a way that enables us to start the trial. And so we're progressing as Kirk just mentioned. But of course, I think it should be clear also that we currently don't have enough raised or on the balance sheet for that matter to complete the trial. So our plan is to raise necessary capital in a stepwise manner as we make progress with our phase three trial.
Joe: So I'll hand that over to you.
Joe: Sure Hey, Joe Thanks for the question.
Joe: Yes, you are right as I mentioned, we did race 11 million recently and definitely the current funding environment and market conditions are difficult and challenging. So we are quite pleased that we were able to raise the funds in a way that enables us to start the trial.
Joe: And so we're progressing.
Speaker Change: As Kirt just mentioned.
Speaker Change: But of course I think it should be clear also that we currently don't have enough.
Speaker Change: <unk> raised on the balance sheet for that matter to complete the trial.
Speaker Change: So our plan is to raise necessary capital in a stepwise manner as we make progress with our phase III trial and our plan is to essentially make use of all options available to us which includes equity and non dilutive sources, such as that and we will continue to balance our funding needs against dialer.
Lars Boesgaard: And our plan is to essentially make use of all options available to us, which includes equity and non-diluted sources such as debt. And we will continue to balance our funding needs against dilution of current shareholders. No, that's totally fair. I appreciate that. And when you said...
Speaker Change: <unk> current shareholders.
Speaker Change: No that's totally fair I appreciate that and when you said potentially non dilutive options I guess, maybe I'll throw the potential of business development into the mix and you know what do you think that role it might play in being able to bring even pipeline programs forward.
Lars Boesgaard: and Dilutive.
Lars Boesgaard: Transcripts provided by Transcription Outsourcing, LLC. So, sorry, so in terms of non-dilutive, right, I think that includes, as I mentioned, debt, but it includes all various sources, right? So we don't necessarily want to get ahead of ourselves in terms of talking about specific, you know, partnerships or specific collaborations. Suffice to say, and I think it's also important, as Frank alluded to in his prepared remarks, that most of our pipeline beyond the Phase 3 are essentially IITs in which our, you know, our funding is very limited, and the funding needs are very limited as far as we're concerned.
Speaker Change: So sorry.
Speaker Change: So in terms of non dilutive right I think that includes as I mentioned that but it includes all old various sources right. So we don't necessarily want to.
Speaker Change: Get ahead of ourselves in terms of talking about specific partnerships or specific collaborations suffice to say that I think I think it's also it's also important to us as Frank alluded to in his prepared remarks.
Speaker Change: That most of our pipeline beyond the phase III are essentially <unk> in which all were all of our funding is very limited.
Speaker Change: Funding needs are very limited as far as we're concerned we're focused solely on on versatile all three with regard to two hour our funding needs.
Lars Boesgaard: So we're focused solely on Versatile O3 with regard to our, you know, our funding needs. Absolutely fair. Appreciate it.
Speaker Change: Totally fair I appreciate all the comments guys.
Speaker Change: The next question is from the line of Mike Montana with B Riley Securities. Please proceed with your question.
Mayank Mamtani: The next question is from the line of Mayank Mamtani with B Raleigh Securities. Yes, good morning team. Thanks for taking our questions and pleased to see the Phase 3 Versatile 003 trial kicked off. I see you say impressively there are multiple interim readouts built in the study and your total patient sample size came in a bit lower than perhaps what you had originally thought.
Mike Montana: Yes, good morning team, thanks for taking our questions and please to see the phase III versus kind of the <unk> trial kicked off.
Mike Montana: Seamlessly deploy an interim readout in the study and your total patient sample size give me a little bit lower than perhaps what you would obviously Todd.
Kirk Shepard: We would love to hear the rationale for that and also obviously any color you can give on how you've built in these OS interims. And then I have a Hi, Mayank. Thanks a lot for your question. So, yes, you are correct that the trial size was initially over 400. As I alluded to in my remarks, we have seen significant durability of the responses and also significant improvement of all the clinical outcomes over the last year and good durability of the median overall survival, which is going to be our primary readout for this trial. So, based upon the durability of the responses and the increases in those responses, we are able to go back to our statisticians.
Mike Montana: Love to hear the rationale for that and also to see any color you can give on.
Mike Montana: And these wins.
Mike Montana: <unk>.
Mike Montana: And then I have one.
Speaker Change: Hi, Mike. Thanks, a lot for your question. So yes, you are correct that the trial size was initially over 400 as I alluded to in my in my remarks, we have seen significant durability of the responses and also significant improvement of all the clinical.
Mike Montana: Outcomes over the last year.
Mike Montana: And good good durability of the median overall survival, which is simple which is going to be our primary readout for this trial. So based upon that the durability of the responses and the increases in dose responses, we're able to go back to our statisticians.
Kirk Shepard: to tighten the trial design based on the fact that we had a lot more confidence in those numbers due to the prolonged follow-up of those patients. And so that took it from over 400 patients down to 350 patients with the same power, by the way. So we retained the statistical power. That amended IND was then presented to the FDA, who gave us the go-ahead with this redesigned trial. And so, as you know, median overall survival, as you mentioned, is our primary data readout. And so, the goal here, based upon the data we've seen in Adverse Dialysis 002, which is highly encouraging, was to give us the opportunity, if we are able to replicate these results in the Phase 3 clinical trial, give us that opportunity to be able to discuss results early on with the FDA.
Mike Montana: Two tightened the trial design based.
Mike Montana: Based on the fact that we had a lot more confidence in those numbers due to the prolonged follow up of those patients and so that took it from over 400 patients down to 350 patients with the same power by the way. So we retained the statistical power.
Mike Montana: That amended <unk>, what's been presented to the FDA, who gave US to go ahead with this.
Mike Montana: With this redesigned trial.
Mike Montana: And so as you know median overall survival as you've mentioned is our <unk>.
Mike Montana: Primary data readout and so the goal here based upon the data we've seen in a burst thousand resilient too which is highly encouraging.
Mike Montana: Just to give us the opportunity.
Mike Montana: If we were able to replicate these results in the phase III clinical trial gave us that opportunity to be able to discuss results early on with the FDA and so our design built into interim data readouts.
Kirk Shepard: And so, our design built in two interim data readouts. The first interim data readout will come approximately six months after full enrollment into the trial. And these endpoints are based on specific death events. So, they're based on a certain number of death events occurring by that time. And then, 12 months after that, we give ourselves another interim data readout. And so, really, what this trial design does, based on median overall survival, which has been really durable, is to give us that opportunity to have early discussions with the FDA regarding potential accelerated approval, pending what the data readouts look like at that specific time.
Mike Montana: The first interim data readout will come approximately six months after full enrollment into the trial and these endpoints are based on specific death death events. So they based on a certain number of death events occurring by that time, and then 12 months after that we gave ourselves.
Mike Montana: Or interim data readout, and so really what this trial design dos based on median overall survival, which has been really durable is to give us that opportunity to have early discussions with the FDA regarding potential potential accelerated approval pending what the data when the data readouts looked like.
Mike Montana: At that specific time.
Kirk Shepard: Kirk, is there anything you'd like to add to that? No, Frank, I think you covered it well. Yeah, I think the important thing is that we do have a good opportunity, the first interim analysis, to go back to the FDA with the survival data for hopefully an accelerated review and then an approval.
Mike Montana: I'm Kirk is there anything you'd like to add to that.
Mike Montana: Yeah.
Mike Montana: No Frank I think you covered it well I think the important thing is that we do have a good opportunity. The first interim analysis to go back to the FDA with a survival data for hopefully an accelerated review and then an approval, but no I have nothing to add what you said before.
Mayank Mamtani: But no, I have nothing to add to what you said before. Yeah, so what we see on clintrials.gov, 2029, essentially you're saying that the time frame for first readout could be maybe half of that period, if I had to compare.
Mike Montana: Okay.
Speaker Change: Yes, so what we see on <unk> Gov, Duane Duane nine essentially you are saying the timing.
Mike Montana: Frame for first readout could be maybe half of that period.
Speaker Change: To kind of.
Kirk Shepard: get to the bottom line here. Yeah, as Lars said, I don't think we want to get ahead of ourselves. And also, as Kirk said, it will take us a few months to understand the enrollment rates, how these sites enroll patients. Because as you know, really, the timeline for a clinical trial is absolutely dependent on how the trial recruitment rates, right? So it will take us a few months to get a good handle on how quickly these patients are coming in. The good thing, as Kirk mentioned, is the fact that most of our versatile 002 sites are interested in participating and are participating in this phase three clinical trial.
Speaker Change: Get to the bottom line hedge of Frank Yes.
Speaker Change: Yes.
Speaker Change: Our philosophy I don't think we want to get ahead of ourselves and also okay. Kirk said, we will it will take a few months to understand the enrollment rates. How these sites enrolling patients because as you know really the timeline for our clinical trial is absolutely dependent on how the trial recruitment rates right. So it will take us a few months too.
Speaker Change: Get a good handle on how quickly these patients are coming in the good thing as Kirk mentioned is the fact that most of our various styles 002 sites.
Speaker Change: Interested in participating and participate are participating in this phase III clinical trial. So we're hopeful that that familiarity with the trial design with the with the.
Kirk Shepard: So we are hopeful that that familiarity with the trial design, with the process of enrolling patients will help speed up the process and also the really promising data which has been generated in the phase two, which has given a lot of these investigators quite a bit of confidence in both the trial design and the Versamune HPV product itself. So we are hopeful that we'll have a pretty rapid enrollment, but it will take us a few months to get a handle around what the projected timelines could be.
Speaker Change: The process of enrolling patients will help speed up the process and also the really promising data, which has been generated in the phase II, which has given a lot of these investigators quite a bit of confidence in the in the both the trial design and that and the.
Speaker Change: And diverse immune HPV product itself. So we are hopeful that we will have at a pretty rapid enrollment, but it will take us a few months to get a handle around what the project projected timelines could be.
Mayank Mamtani: Yeah, that was quite evident in your December KVAL event.
Speaker Change: Yes that was great evidence.
Speaker Change: December cave element.
Mayank Mamtani: Just switching gears quickly on the initial tumor indications of priority for the MUC1 candidate. And it seems like you're doing a PDS01-ADC combination strategy here, at least within CRC.
Speaker Change: Just switching gears quickly on the initial dealer indications a priority for the muck, one candidate and it seems like Youre doing.
Speaker Change: BDSI, one ADC combination strategy here with at least with NCIC and just.
Frank Beduado: And just maybe higher level, you know, is the work on IL-12-ADC head and neck on pause now. And you're letting these ISPs sort of drive data generation activity, including obviously in the prostate setting that you have with Xtandi. Thanks again for taking the time. Thanks a lot, Mayank. Very good question.
Speaker Change: Just maybe higher level.
Speaker Change: Is the work on IL 12, ADC in head and neck on pause now and Youre letting these isps out of drive data generation activity, including obviously in the prostate setting.
Speaker Change: That you have with extending thanks again for taking our questions.
Mike Montana: Well, thanks, a lot Mike.
Speaker Change: Good question so.
Frank Beduado: So, you're right that today our focus is on the Versatile 003, and that is where the company is applying our capital. But to the point you made, we have actually been very successful in partnering with the National Cancer Institute and other top-tier academic institutions, right? So, those institutions are able to independently progress some of these Phase II trials, including what we're doing with the MAC-1 and PDS-01-ADC. So, the combination is based on the preclinical, published preclinical studies that were done by the NCI, where they looked at various combinations with a versamine-based product, as well as PDS-01-ADC, and also with checkpoint inhibitors.
Speaker Change: Youre right that today, our focus is on diverse styles zero-zero, three and that is where the company is applying our capital.
Speaker Change: But to the point you made we have actually been very successful in partnering with the National Cancer Institute and other top tier academic institutions right. So those institutions are able to independently progress some of these phase II trials.
Speaker Change: Including what we're doing with the Mark one and Pds <unk> ADC. So this the.
Speaker Change: The combination is based on the preclinical published preclinical studies that were done by the NCI, where they looked at various combinations with diverse mean based products as well as PD S O one ADC and off.
Speaker Change: With checkpoint inhibitors, and we saw very strong synergy between diverse immune based product and Pds <unk> ADC. So as you know <unk> adcs the tumor targeting IL 12.
Frank Beduado: And we saw a very strong synergy between the versamine-based product and PDS-01-ADC. So, as you know, PDS-01-ADC is a tumor targeting IL-12. What IL-12 does is it activates T-cells, but by getting it into the tumor specifically, we're able to really activate those T-cells within the tumor microenvironment itself. Right? So we believe this is a highly promising combination, so does the National Cancer Institute. And there are a number of tumor types that express, highly express, MOC1. We've selected colorectal cancer as the first target to demonstrate that proof of concept in that Phase 1 and Phase 1-2 human clinical trial.
Speaker Change: What IL 12 Das is it activates T cells, but by getting it into the tumor specifically, we're able to really activate those T cells within the tumor environment microenvironment itself right. So we believe this is a highly promising combination. So that's the national cancer Institute and there are a number of tumor.
Speaker Change: Types that express highly express mock one we've selected colorectal cancer as the first targets to demonstrate.
Speaker Change: That proof of concept in the phase one phase <unk> human clinical trial, but then that then allows us to progress into multiple tumor types, Jeff very similar to what we've done with our various immune HPV right. So as loss mentioned when we talk about non dilutive funding funding we have done this quite effectively.
Frank Beduado: But then that then allows us to progress into multiple tumor types, just very similar to what we've done with adverse immune HPV. Right? So as Lars mentioned, when we talk about non-dilutive funding, we have done this quite effectively with a number of programs to progress all these programs in cervical cancer, the triple combination, all types of HPV cancers, and now MOC1 with our collaborators who are putting their capital to work to progress these programs for us. And then you mentioned the triple combination.
Speaker Change: With a number of programs to progress all of these programs in cervical cancer.
Speaker Change: Triple combination all types of HPV, Kansas and now Mark one with our collaborators who are putting their capital to work to progress. These programs for US and then you mentioned the triple combination.
Frank Beduado: With the triple combination, our current plan is to follow what we deem to be potentially the simplest regulatory strategy, which will also feed into our product lifecycle management strategy for both Versamune and PDS-01-ADC. So one scenario is to get the Versamune HPV plus PEMBRO approved. So once that doublet is approved, we can then add PDS-01-ADC to that approved combination to develop a second-generation product that may treat patients who are both checkpoint inhibitor-naive in addition to those who are checkpoint inhibitor-resistant. As you know, in the recent JAMA Oncology publication that we announced, we see extremely promising survival results both in checkpoint inhibitor-naive and checkpoint inhibitor-resistant patients.
Speaker Change: With a triple combination our current plan is to follow what we deem to be potentially the simplest regulatory strategy, which will also feed into our product lifecycle management strategy for both versus immune and Pds <unk> ADC. So one scenario to get diverse HPV plus Pembroke approved.
Speaker Change: So once that once the doublets. It's approved we can then add Pds <unk> ADC to that approved combination to develop a second generation product that may treat patients who are both checkpoint inhibitor naive. In addition to those who are checkpoint inhibitor resistance as you know in their recent jump Jama oncology.
Speaker Change: <unk> publication that we announced we see extremely promising survival results both in checkpoint inhibitor naive and checkpoint inhibitor resistant patients and we see this across the board.
Mayank Mamtani: And we see this across board with all types of HPV-related cancers, right? In that publication, they show data from anal cancer, cervical cancer, vaginal vulva, in addition to head and neck cancer. So these present us with some real opportunities as we develop the product and also potentially get the second-generation product out there after the doublet has been successfully approved. Mayank, I hope this answered your question. Yes, there were multiple parts. Thank you for taking all of them. and I'll hop back in the queue.
Speaker Change: All types of HPV related cancers, writing about publication they showed data from anal cancer cervical cancer vaginal revolver. In addition to head and neck cancer. So these presented some with some real opportunities as we as we develop the product and also potentially get the second generation product out there after the doublets.
Speaker Change: Has been successfully approved.
Speaker Change: I hope this answered your question.
Speaker Change: Yes.
Speaker Change: But thank you for taking all of them.
Speaker Change: Hop back into queue.
Speaker Change: No problem.
Mayank Mamtani: No problem.
Speaker Change: Thank you.
James Molloy: The next question is from the line of James Molloy with Alliance Global Partners. Good morning. Thank you very much for taking my questions.
Speaker Change: The next question is from the line of James Molloy with Alliance Global Partners. Please proceed with your question.
James Molloy: Hey, good morning, Thank you very much taking my questions.
James Molloy: Just to follow up on the last point, Frank, so the phase three triple, would that even start before the phase two double trial wraps up, or is that something that we'll wait for, the phase two double trial data before going into the phase, starting the phase three triple? Hey, James. So now what I just said, we're looking for, we're doing this as part of our anticipated project, product lifecycle management strategy, and also following the simplest regulatory strategy. So the simplest regulatory strategy would be to get the doublet approved. Once that doublet is approved, we can then add the IL-12 on top of that approved doublet.
Speaker Change: Follow up on that last point, Frank So the triple the phase III triple.
Speaker Change: That was that without even start before the phase II double trial wraps up or is that something that will wait for the <unk>.
Speaker Change: These two double trial data before going into the phase starting to phase III triple.
James Molloy: Hi, James.
Speaker Change: Just said.
Speaker Change: We're looking for we're doing this as part of our anticipated project product lifecycle management strategy and also following the simplest regulatory strategy. So the simplest regulatory strategy would be to get the doublet approved.
Speaker Change: Once the doublets is approved we can then of the IL 12 on top of that approved doublet. It simplifies the regulatory pathway of having multiple investigational products involved in the trial right and so based upon our discussions with the FDA and suggestions that have been made we see.
Frank Beduado: It simplifies the regulatory pathway of having multiple investigational products involved in the trial, right? And so based upon our discussions with the FDA and suggestions that have been made, we see this as potentially the simplest regulatory strategy and also a good product lifecycle management strategy in head and neck cancer specifically, right? The initial focus is on checkpoint inhibitor-naive patients, but once we add IL-12 on top of that, potentially this could address both ICI-naive and ICI-resistant patients based upon the data that was recently published in JAMA Oncology.
Speaker Change: This as potentially the simplest regulatory strategy and also a good product lifecycle management strategy in head and neck cancer, specifically right. The initial focus is on checkpoint inhibitor naive patients, but once we add IL 12 on top of that potentially this could address both ICI naive and ICI resist.
Speaker Change: <unk> patients based upon the data that was recently published in Jama oncology.
Speaker Change: Perfect. Thank you very much.
James Molloy: Perfect.
James Molloy: Thank you very much.
Frank Beduado: And then, Walt, the expectation for the MUC1 sort of kicking off and sort of the next cut point for potential data, and then the TARP, the Phase I TARP, is that still on track for potential IND in 2025? No, so let's start with the MOC 1. So with the MOC 1, as I mentioned, that is going to be led by the National Cancer Institute. And so the IND has been successfully filed and we've had the green light from the FDA. And so right now, what we would do would be we will be dependent on the National Cancer Institute's timelines.
Speaker Change: And then you are welcome.
Speaker Change: The expectation for a mark one.
Speaker Change: Sort of kicking off kicking off in sort of the next kept cut point for potential data and then the TARP. The phase one topic, that's still on track for potential R&D in 2025.
Speaker Change: So let's start with the moc, one so with the Moc one as I mentioned that is going to be led by the National Cancer Institute.
Speaker Change: So I'll.
Speaker Change: I N D has been successfully filed and we've had the green light from the FDA and so right now what we would do would be will be dependent on the national cancer institutes timelines and.
Frank Beduado: And so we will wait to hear from them in terms of their intended start date. Right. So, again, we don't want to put any start dates out there until they have been confirmed by the National Cancer Institute. They will be leading the trial while we focus on the versatile 003 trial design. Very similar approach to triple. Understood.
Speaker Change: And so we will wait to hear from them in terms of the intended start date right. So again, we don't want to put any start dates out there until they have been confirmed by the National Cancer Institute, They will be leading the trial, while we focus on the <unk> III trial design.
Speaker Change: Okay, Great and then just similar approach to triple.
Frank Beduado: And then is the TARP, the 102-IND and TARP expressed in Kansas, is that still potentially on for 25? Or is that also NCI-led? No, the TARP, the TARP, right now we're focusing on the Mach 1 and the reverse immune HPV. We have not presented any timelines yet for the TARP. The TARP, as you know, is the focus there is prostate cancer. Approximately 95 and higher percent of prostate cancers express the TARP antigen. But for now, once we get a better handle on how the Mach 1 is progressing and the VERSTYLE 003, we'll then provide some guidance on how we intend to progress the TARP program.
Speaker Change: Understood and then is the <unk>.
Speaker Change: Is the TARP.
Speaker Change: Why don't you.
Speaker Change: And TARP expressing cancers is that still potentially on.
Speaker Change: And for 25 years that also NCI led.
Speaker Change: No the top the top right now we foresee we focusing on the Mark one and the verse immune HBV, we have not presented any timelines yet for the top the top as you know is the focus there is prostate cancer approximated 95, and high higher percent of prostate cancers Express the top antigen.
Speaker Change: But for now once we get a better handle on how the <unk> is progressing.
Speaker Change: And diverse styles 003 will then provide some guidance on how we intend to progress the top program, but we have not provided any guidance to date on progression of the top program. Today I'll focus is diverse mean HPV and also now handing them off one over under our creator to the National Cancer Institute for further develop.
Frank Beduado: But we have not provided any guidance to date on progression of the TARP program.
Frank Beduado: Today our focus is the VERSTYLE HPV and also now handing the Mach 1 over under our crater to the National Cancer Institute for further development. Great. Thank you very much for taking the questions. You're welcome. Thank you.
Speaker Change: <unk>.
Speaker Change: Alright, Thank you very much for taking my questions.
Speaker Change: Youre welcome.
Speaker Change: Thank you.
Frank Beduado: At this time, I'll turn the floor back to Dr. Bedouin for closing. Thank you very much, operator. So in closing, we are very pleased to have initiated the Versatile 003 Registrational Trial this quarter. This study is the first phase three clinical trial specifically in the growing population of HPV-16 positive head and neck cancer. We are excited, based on the strong Verstyl-002 results and our fast-track designation, about the potential for versamine HTB-HPV to be the first product of its kind on the market in head and neck cancer. We expect to provide final results from our ongoing Phase 2 Versatile 002 study later this year.
Speaker Change: At this time I will turn the floor back to Dr. <unk> for closing remarks.
Speaker Change: Thank you very much operator.
Speaker Change: So in closing we are very pleased to have initiated the <unk> 003, Registrational trials this quarter.
Speaker Change: This study is the first phase III clinical trial, specifically in the growing population of HPV 16 positive head and neck cancer.
Speaker Change: We are excited based on the strong burst out the reserve to results and our fast track designation.
Speaker Change: About the potential for <unk> H, two b HPV to be the first product of its kind on the market in head and neck cancer.
Speaker Change: We expect to provide final results from our ongoing phase II various styles and resumed to study later this year.
Speaker Change: Our engagement with investors and clinical investigators has validated our approach and the long term opportunity that we believe the HPV 16 targeted immunotherapy presents in the HPV 16 positive head and neck cancer indications.
Frank Beduado: Our engagement with investors and clinical investigators has validated our approach and the long-term opportunity that we believe the HPV-16 targeted immunotherapy presents in the HPV-16 positive head and neck cancer indication. We look forward to keeping you updated on our progress. Thank you very much. Thank you.
Speaker Change: We look forward to keeping you updated on our progress. Thank you very much.
Speaker Change: Thank you. This will conclude today's conference disconnect. Your lines at this time, we thank you for your participation.
Operator: This will conclude today's conference. We disconnect your lines at this time. We thank you for your participation.
Speaker Change: Okay.