PDS Biotechnology Corp. Aktie

Greetings, and welcome to the PDS Biotech First Quarter 2026 Earnings Conference Call. [Operator Instructions]

It is now my pleasure to introduce your host, [ Dean Schwartz ]. Thank you. You may begin.

Thank you, operator. Good morning, everyone, and welcome to PDS Biotech's First Quarter 2026 Results and Clinical Programs update call. I'm joined on the call today by the following members of the company's management team: Dr. Frank Bedu-Addo, Chief Executive Officer; Dr. Kirk Shepard, Chief Medical Officer; and Lars Boesgaard, Chief Financial Officer.

Dr. Bedu-Addo and Dr. Shepard will provide an overview of the company's recent highlights in its clinical development program, and Mr. Boesgaard will review the financial results for the quarter ended March 31, 2026. Following management's prepared remarks, we will take questions from covering analysts.

As a reminder, during this call, we will be making 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 and cautionary statements made during this call. We assume no obligation to update any of these forward-looking statements or information.

Now I'd like to turn the call over to Dr. Bedu-Addo. Frank?

Thank you, Dean, 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 programs. This past quarter, our major focus was on advancing our clinical programs and we made significant progress.

So I will hand the call over to our Chief Medical Officer, Dr. Kirk Shepard, to provide an update. Kirk?

Thank you, Frank. During our first quarter, we adopted an amendment to our VERSATILE-003 trial, revising the design to incorporate progression-free survival as an interim primary endpoint which we believe has the potential to enable a more efficient path to accelerated approval. We also believe this amendment may shorten the trial's duration and reduce the overall costs, all while retaining overall survival as a basis for full approval in accordance with FDA requirements.

Additionally, this approach may also accelerate the availability of this promising treatment to the rapidly growing population of HPV16-positive patients in dire need of effective treatment. For patients living with HPV16-positive head and neck cancer, a disease with significant and growing unmet need, we believe PDS0101 represents a promising treatment option, and we remain focused on advancing it as efficiently as possible.

PDS0101 in combination with KEYTRUDA or pembrolizumab is the only late-stage investigational head and neck squamous cell carcinoma therapy that requires only 5 doses and also the only subcutaneous therapy. These characteristics of PDS0101, together with the tolerability and survival data reported to date, make PDS0101 a potential compelling option for these patients. Key opinion leaders at institutions such as Mayo Clinic, Dana-Farber and Yale Cancer Institute are involved in our trial.

HPV16-positive cancers are rapidly increasing in the U.S. and EU due to poor uptake of the human papillomavirus vaccine and other factors. Along with the unique pathophysiology of HPV16 cancers and the absence of approved targeted therapies, there is a significant unmet need we believe that PDS0101 is uniquely positioned to address.

Elsewhere in our program, we recently reported promising results from ongoing trials for the treatment of prostate and colorectal cancer with PDS01ADC, our novel investigational Interleukin-12 or IL-12 fused antibody drug conjugate that enhances the proliferation, potency and longevity of T cells in tumor microenvironment. In March, the Journal of Clinical Oncology, JCO, Oncology Advances published clinical and immunological biomarker data from Stage 1 of a Phase II trial, evaluating PDS01ADC in colorectal cancer with liver metastasis. We refer you to these press releases issued this morning.

Earlier in our first quarter, we also announced early results from the NCI-led trial investigating PDS01ADC at the AACR special conference on prostate cancer research. In patients with metastatic castration-resistant prostate cancer, the majority of whom received this therapy as a third-line option, the combination of PDS01ADC and docetaxel demonstrated encouraging results included in our press release this morning.

The results from these 2 trials reinforce the potential of PDS01ADC to enhance the efficacy of existing therapies across multiple solid tumor types. We remain focused on advancing PDS01ADC as a key component of our immuno-oncology pipeline.

I will now hand the call back to Frank.

Thank you, Kirk. Finally, during our first quarter, we also strengthened the intellectual property estate for PDS0101 with new patents granted in the United States and Japan. The new U.S. patent, combined with anticipated biologics exclusivity for PDS0101, extends our market protection into the 2040s. The Japanese patent adds broad composition of matter claims to existing protections across major markets.

Now I will turn it over to Lars for a review of our results for the 2026 first quarter. Lars?

Thanks, Frank, and good morning, everyone. We reported a net loss for the quarter ended March 31, 2026 of approximately $7.3 million or $0.13 per basic and diluted share. That compares to a net loss of $8.5 million or $0.21 per basic and diluted share for the quarter ended March 31, 2025.

Research and development expenses for the first quarter were $3.5 million compared to $5.8 million for the prior year period. Decrease was primarily due to lower clinical and manufacturing costs. General and administrative expenses for the first quarter were $3.1 million compared to $3.3 million for the prior year period. The decrease was primarily due to lower professional fees.

Total operating expenses for the first quarter were $6.5 million compared to $9.1 million for the prior year period. Net interest expense for the first quarter were $0.8 million compared to $0.6 million for the prior year period. The company's cash balance, as of March 31, 2026, was $21.7 million.

And with that, operator, we can open the call to questions from analysts.

[Operator Instructions] Our first question comes from the line of Mayank Mamtani with B. Riley Securities.

I appreciate the updates. On the VERSATILE-003 restart enrollment activity, could you remind us what remains sort of pending there? And is there a consideration also maybe of including subcu KEYTRUDA as a combination partner. And I don't, I think, fully follow what would be the procurement of KEYTRUDA considerations that were there last year versus what do you have today for VERSATILE-003. And then I have a follow-up.

Mayank, thanks a lot for your questions. I'll hand over to Kirk. Kirk, why don't you go ahead?

Thank you, Frank. Yes, regarding the enrollment, now that we have alignment with the FDA that we are going through the procedures of amending the protocol and going back to the sites to begin the study in the near future. We're happy to say that the sites all stayed with us during that period of a pause while we did the amendment and discussed it with the FDA. So we're very happy that we still have the momentum with us.

Regarding the possibilities of using the drug with the subcu pembrolizumab in the future, that's something that would be a possibility, but it's certainly not the target now of our research. Our research is with the pembrolizumab given IV in the usual amount that it has been in the past, but that option would remain open in the future for an entirely subcu regimen.

And then on the landscape external to you within HPV16-positive head and neck, it still seems like a relatively open white space or swim lane. Are there any emerging updates you've seen recently or you're expecting particularly from the EGFR bispecific class that you might be watching for? And then I also noticed the colorectal cancer cohort Stage 2 is now fully enrolled and you obviously published data from the Stage 1 cohort. Maybe just remind us when do you expect to have the next data update for Cohort 2. That would be very helpful.

Mayank, I'll start and I'll hand over to Kirk to add anything to it. But in terms of the HPV16 landscape, you're correct, we know that BioNTech is also in the Phase III trial. But both PDS and BioNTech remain the 2 late-stage studies in the space. So you are correct. There are very few potential opportunities for these patients at this present time.

And in terms of the colorectal cancer, yes, you are correct that we have completed enrollment into that colorectal cancer cohort of that study. And we are anticipating that by the end of the year, we should have some additional data on the full population of patients in the colorectal cancer study. Kirk, anything you want to add to that?

No, I would just refer them again to the article that was just published in our press release, but also we're very encouraged by the Stage 1 of the Phase II trial with the NCI. So we're anxious to move it on to the next trial, a controlled trial, with this therapy.

Our next question comes from the line of Joe Pantginis with H.C. Wainwright.

Great to see the recent amendment. So I wanted to actually dive into that a little bit. If you could talk about maybe a little more color on the benefits here. Obviously, Kirk, you mentioned about acceleration of the clinical time lines. I'm hoping you could hit that a little more with regard to attracting patients, anecdotes you may be getting from doctors to be able to quickly get to those reenrolling quicker.

And then next, sort of the second part of that is from Lars' standpoint, what do you believe the financial impact positively for these changes could be? And obviously, would you then look to put -- keep that money towards the filing path or put it towards a pathway sort of the ADC platform?

Yes. Thank you for your question. Regarding the amendments, as far as the protocol, of course, this all started when we did our final data cut back in September of last year. And we were very encouraged by those results. If anything, though, we needed to consider how long the trial will take because the median overall survival, I think you know, increased from around 30 months out to almost 40 months and the trial would take a long time to complete.

At the same time, too, we saw the robustness of our PFS. So we went to the FDA to discuss the possibility of a co-primary, which we have right now, having the PFS as a co-primary along with the median overall survival, which would be needed for full approval, but we'd have a chance for an accelerated review with the PFS. So we're very happy with that as far as the trial design that has come as a result of the latest results as well as discussions with the FDA.

Joe, this is Lars here. So to answer your question about the potential financial impact, the way we expect the amendment to the protocol to affect really the financial requirements for the trial is one, in terms of time and in terms of time to the interim readout in particular, so that we expect that to reduce cost, both external costs, but also our internal operating expenses simply due to that shorter time period.

And another aspect to bear in mind, Joe, is that we did -- as part of the amendment, we changed the randomization and the ratio from 2:1 to 1:1. And so that also allowed us to essentially lower the number of patients from approximately 350 to approximately 250 patients. So that also in and of itself will drive lower external costs associated with completing the trial.

Helpful detail. And then just a quick follow-up question. So look, things are late stage. They're progressing, right, very quickly. Can you talk about your manufacturing needs for Versamune and the pipeline in the near term and then heading beyond potential early commercialization?

Yes, Joe, I can talk a little bit about that. So as you know, we have a pretty straightforward manufacturing process. So in terms of scale-up and commercialization, some scale-up has been done already by the commercialization. Commercial process is already established. And so what we anticipate doing is one in parallel with the Phase III doing the traditional CMC activities, which involve validation of those processes. There may be some additional scale-up required. But since the process is now fixed and established, we would look at the validation process. We need to do a number of those validation budgets heading into the BLA filing.

So those are really the major CMC activities remaining for the program. But in terms of manufacturing itself, the processes are completed and established. So pretty straightforward path to the BLA filing as pertains to the manufacturing specifically.

We have reached the end of the question-and-answer session. I would like to turn the floor back to Frank Bedu-Addo for closing remarks.

Thank you, operator. Combined with early data from our PDS01ADC program and expanded patent protection extending into the 2040s for PDS0101, we believe we have meaningful opportunities ahead as we continue to execute against our priorities for 2026. We look forward to updating you on our progress, and thank you very much again. Have a great day.

Thank you. This concludes today's conference, and you may disconnect your lines at this time. We thank you for your participation.

Greetings, and welcome to the PDS Biotech Fourth Quarter 2025 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to turn the conference over to your host, Mike Moyer with LifeSci Advisors. Thank you. You may begin.

Thank you, operator. Good morning, everyone, and welcome to PDS Biotech's Fourth Quarter 2025 Results and Clinical Programs Update Call. I'm joined on the call today by the following members of the company's management team: Dr. Frank Bedu-Addo, Chief Executive Officer; Dr. Kirk Shepard, Chief Medical Officer; and Lars Boesgaard, Chief Financial Officer. Dr. Bedu-Addo will begin with an overview of the company's recent highlights and its clinical development program. Dr. Shepard Will review the data and rationale behind the amendment the company recently adopted to its Phase III VERSATILE-003 trial, and Mr. Boesgaard will review the financial results for the quarter ended December 31, 2025. Following management's prepared remarks, we will open the call to questions from covering analysts.

As a reminder, during this call, we will be making 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 as discussed in our filings with the SEC, including our quarterly reports on Form 10-Q and annual report on Form 10-K and cautionary statements made during this call. We assume no obligation to update any of these forward-looking statements or information.

Now I'd like to turn the call over to Dr. Bedu-Addo. Frank?

Thank you, Mike, 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 programs. The fourth quarter of 2025 capped a period of important progress for PDS Biotech, marked by meaningful advances across our clinical programs, along with financial discipline and expansion of our intellectual property portfolio. Building on the compelling top line data from our VERSATILE-002 Phase II trial, we believe the VERSATILE-003 protocol amendment we've adopted has the potential to create a more efficient path to accelerated approval. shortening the trial's duration, reducing costs and accelerating our time line to regulatory submission, while preserving overall survival as the basis for full approval.

For patients living with HPV16-positive head and neck cancer, a disease with significant and growing unmet need, we believe PDS0101 represents a genuinely promising treatment option, and we remain focused on advancing it as efficiently as possible.

In recent weeks, we also announced early results from the National Cancer Institute-led trial investigating PDS01ADC, our investigational IL-12 tumor-targeted immunocytokine at the American Association for Cancer Research, AACR, Special Conference on Prostate Cancer Research.

In patients with metastatic castration-resistant prostate cancer, the majority of whom had failed at least 2 prior treatments, the combination of PDS01ADC and standard of care docetaxel demonstrated encouraging and durable median progression-free survival or PFS of 9.6 months and a median prostate-specific antigen or PSA decline of 40%. 6 of 16 patients achieved greater than 50% PSA decline. These findings reinforce the potential of PDS01ADC as an immunocytokine that may be used to activate the immune system against multiple solid tumor types. We are encouraged by the progression-free survival and PSA declines observed in this difficult-to-treat population, and we remain focused on advancing PDS01ADC as a key component of our immuno-oncology pipeline.

Since we last spoke with you, we also strengthened the intellectual property estate for PDS0101 with new patents granted in the United States and Japan. The new U.S. patents, combined with anticipated biologics exclusivity for PDS0101 extends our market protection into the 2040s. The Japanese patent adds broad composition of matter claims to existing protections across major markets. To elaborate on progress with our VERSATILE-003 trial, in particular, the data and rationale behind the decision to amend the study protocol, I'll turn the call over to Dr. Kirk Shepard, our Chief Medical Officer. Kirk?

Thanks, Frank, and good morning, everyone. As most of you know, last August, we announced completion of our VERSATILE-002 trial with the final data further supporting the durable clinical benefit of PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. The strength of this final data and of the data in the sub-analysis, we announced in September led to our strategic decision to seek an amendment to our VERSATILE-003 trial to include progression-free survival or PFS as a primary endpoint. As you will recall, the VERSATILE-002 trial evaluated PDS0101 plus KEYTRUDA or pembrolizumab in patients with HPV16-positive head and neck cancer. A total of 53 patients were enrolled. The final data showed median overall survival was 39.3 months in patients with PD-L1 combined positive score or TPS of more than or equal to 1. The lower limit of the 95% confidence interval was 23.9 months and the upper limit was not yet estimable. The VERSATILE-002 trial is the first of patients in recurrent metastatic head and neck cancer population to report a median overall survival of almost 40 months. The PFS and survival results had important implications for the original design of our Phase III VERSATILE-003 trial. In the original trial protocol, as recommended by the FDA, median overall survival was the primary endpoint and progression-free survival was a secondary endpoint. It should be noted that the median overall survival relies on the occurrence of death events and that if a drug works well enough to prevent patient death, it may take a long time to get to the critical data readout. With further increase of the final median overall survival readout from 30 months to 39.3 months in the VERSATILE-002 trial and demonstration of the robustness of the PFS results, we felt we had an opportunity to revise the clinical design to enable a potentially faster readout and opportunity for accelerated approval using PFS as a primary endpoint. To address the potential for an extended trial duration while also abiding with the FDA's recommendation to use median overall survival as a primary endpoint, we approached the FDA to amend the protocol to convert PFS to an earlier interim primary endpoint. Following a productive dialogue with the FDA, we were pleased to announce that following the FDA's standard 30-day wait period since filing, the FDA raised no objections, and we are clear to proceed with the amended protocol. We believe this amendment provides us with an important opportunity to potentially shorten the time to regulatory submission while maintaining median overall survival as the endpoint for full FDA approval. Additionally, we also believe this approach may also accelerate the availability of this promising treatment to the rapidly growing population of HPV16-positive patients in dire need of effective therapy.

For added context, I'll point out that some additional factors that help explain why we and our investigators are so excited about our current path forward. First, PDS0101 is the only subcutaneous injection product currently in late-stage development for recurrent and/or metastatic head and neck squamous cell carcinoma, which is more convenient for the patient. Additionally, PDS0101 in combination with KEYTRUDA is the only late-stage head and neck squamous cell carcinoma therapy that requires only 5 doses. Most therapeutic approaches require over 20 doses. Our approach also presents convenient dosing intervals of 3 weeks and 6 months after the fourth dose. These characteristics of PDS0101, together with the reported tolerability and survival reported to date, make PDS0101 a compelling option for patients. It is, therefore, not surprising that several KOLs and investigators involved in our study and many of the institutions such as the Mayo Clinic, Dana-Farber and Yale Cancer Institute continue to voice their strong support for our approach. HPV16-positive cancers are rapidly increasing in the U.S. and EU due to the poor uptake of the human papillomavirus vaccine and other factors. Along with the unique pathogenesis, physiology of the HPV16-positive cancers and the absence of approved targeted therapies, there is a significant unmet need, we believe that PDS0101 is uniquely positioned to address.

With that, I'll turn the call back over to Frank.

Thank you, Kirk. To Kirk's comments, I would add that as stated by Merck, the subcutaneous version of KEYTRUDA, which was recently approved by the FDA, can be administered by a health care provider in as little as 1 minute. So a potential combination with subcutaneous PDS0101 may shorten administration time and be more convenient for patients. We are excited about the potential of this therapy for head and neck cancer patients. We are, therefore, confident in the potential of our HPV16-tailored approach and the potential of PDS0101 to ultimately provide a well-tolerated treatment without chemotherapy as an option for the growing population of HPV16-positive patients who currently have no effective therapies for this deadly disease and who will soon become the majority of head and neck cancer patients.

Now I will turn it over to Lars for a review of our financial results for the 2025 fiscal year. Lars?

Thanks, Frank, and good morning, everyone. Net loss for the year ended December 31, 2025, was approximately $34.5 million or $0.74 per basic and diluted share, which compares to a net loss of $37.6 million or $1.03 per basic and diluted share for the year ended December 31, 2024.

Research and development expenses for the year ended December 31, 2025, were $19 million compared to $22.6 million for the year ended December 31, 2024. The decrease of $3.6 million was primarily attributable to decreases in manufacturing costs of $2.5 million and personnel costs of $1.8 million. And those decreases were partially offset by an increase in clinical costs of $0.7 million.

General and administrative expenses for the year ended December 31, 2025, were $12.5 million compared to $13.8 million for 2024. The $1.3 million decrease was primarily attributable to a decrease in personnel costs.

Total operating expenses for the year ended December 31, 2025, were $31.5 million compared to $36.3 million for 2024. Net interest expense was $4.1 million for the year ended December 31, 2025, compared to $2.2 million for the year ended December 31, 2024. The change was primarily due to noncash expenses related to extinguishment of debt as well as lower interest income on our cash balances. The company's cash balance as of December 31, 2025, was $26.7 million.

And with that, operator, we can open the call to any questions.

[Operator Instructions] Our first question comes from the line of Joe Pantginis with H.C. Wainwright.

This is Josh on for Joe. So now that you have the amended protocol cleared, could you share what the revised enrollment target is going to look like and how that reduction compares to the original design?

Josh, thanks a lot. I'll hand it over to Kirk to answer your questions.

Yes, certainly. With the revised protocol, and also the increased median survival and robustness of the PFS in 002, we had a meeting with the FDA, which was a very good dialogue. And at that, we were able to shorten the trial to as much as a year as far as getting the final results. And of course, the PFS will be the interim analysis that will first be available most likely in a period of about 1.5 years. That will allow us to get an accelerated review, as you know, to make the drug available to patients. So with the decrease in the end as well as the increased results from the final analysis of the VERSATILE-002, we were able to shorten the duration with this -- a smaller end for the trial.

Great. And so now with this amended protocol, how should we expect R&D to be for 2026? Do you expect that to be a little bit lower than 2025 now with the smaller trial design?

Lars, I'll hand over to you.

Yes. So I think as far as the R&D expenses, we're not providing financial guidance per se. However, of course, once we reinitiate the trial, we do expect cost to pick up. The pickup will be commensurate with the amount of sites that we opened and patient enrollment and so forth. So it's tricky to forecast right now.

Our next question comes from the line of Mayank Mamtani with B. Riley Securities.

Could you touch on your plans to handle patients already enrolled prior to the 003 pause as part of your interim analysis and wonder if you remain blinded to those sort of patients? I assume they're continuing to dose on active drug and placebo.

And then my follow-up question to the prior question was anything you've learned last year from the execution of Phase III that could inform the enrollment pace from here? And sorry if I missed that, did you say what the sample size -- what the new sample size for the Phase III is? And are you willing to share any more details on the 2 -- it looks like you have the 2 PFS interim analysis. So I don't know what they are designed to hit on the first versus the second? If you can give any more details, that would be great.

Thanks, Mayank. Kirk, do you want to start?

Yes. Certainly, I'll [ do ]. There were many questions asked there. Well, we -- first, the patients who were started on the trial, they will all continue their treatment as indicated by the protocol. It was discussed with the FDA, and they said it was up to us as far as whether to include or not include these patients in the trial. They just wanted to be stated ahead of the protocol restart. But these patients will be on the trial as the treatment indicated. They will most likely be put in a special subset of the data that will be included for safety in the intent-to-treat data trial. So they will continue to receive their therapy. Let's see the other parts of the study. Sorry, could you repeat something else what Frank [indiscernible].

Yes. enrollment pace based on what you saw last year, and I believe there's no competitive trial now enrolling given the other trials that were accepting HPV16-positive are fully enrolled maybe.

And then if you can share with us the sample size of the new -- of the study and the interim analysis, PFS analysis that -- what are the underlying assumptions of separation between the 2 arms?

Yes. So the enrollment pace was very good and will continue to be good because we've had a very positive response from the sites that we've gone to, to run the study. As you've mentioned now, there's less competition than was when we first began the trial. so that we have a robust recruitment of sites. And we're happy to say, too, even with the pause we had while talking to the FDA, we didn't lose 1 site. They're all excited by this therapy and ready to begin again. So we're very happy about that. Also the fact that we figured out our time lines by looking at the VERSATILE-002 study, which was done at a certain rate. And now we expect even increased rate because most of the sites came back so that the VERSATILE-002 sites are now going to be involved in the 003 study, which is good because they know the workings of the protocol and the product, and we expect to have pretty brisk recruitment of the patients.

Got it. Mayank, I hope that answered your questions.

I -- sorry to push you, if you can share with us the powering assumptions for the interim PFS and the new sample size for the Phase III.

No. So we haven't made the sample size public yet, but the PFS, again, powered it high power to detect changes in -- statistically significant changes in PFS, 1 at completion of recruitment and the other about 6 months later. So both provide high power to detect statistically significant differences between the 2 arms.

Ladies and gentlemen, that will conclude our question-and-answer session. I'll turn the floor back to Dr. Bedu-Addo for any final comments.

Thank you, operator. Combined with early data from our PDS01ADC program and expanded patient protections extending into the 2040s, we believe we have meaningful opportunities ahead as we continue to execute against our priorities in 2026. We look forward to updating you on our progress. Thank you very much.

Thank you. This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.

Greetings. Welcome to the PDS Biotech's Third Quarter 2025 Earnings Conference Call. [Operator Instructions] Please note that this conference is being recorded.

At this time, I'll turn the conference over to Tom Johnson with LifeSci Advisors. Tom, you may now begin.

Thank you, operator. Good morning, everyone, and welcome to PDS Biotech's Third Quarter 2025 Results and Clinical Program Update Call. I'm joined on the call today by the following members of the company's management team Dr. Frank Bedu-Addo, Chief Executive Officer; Dr. Kirk Shepard, Chief Medical Officer; and Lars Boesgaard, Chief Financial Officer. Dr. Bedu-Addo will begin with an overview of the company's recent progress and its clinical development program. Mr. Boesgaard will review the financial results for the quarter ended September 30, 2025, 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 statements should be considered in conjunction with the cautionary statements in our press release and risk factors as discussed in our filings with the SEC, including our quarterly reports on Form 10-Q and our annual report on Form 10-K and cautionary statements made during this call. We assume no obligation to update any of these forward-looking statements or information.

Now I'd like to turn the call over to Dr. Bedu-Addo. 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 programs. During our third quarter of 2025 and recent weeks, we continued to advance PDS0101 or Versamune HPV in HPV16-positive recurrent and/or metastatic head and neck cancer. In August, we announced completion of our VERSATILE-002 trial with the final data further supporting the durable clinical benefit of PDS0101 in this patient population. The strength of this final data and of the data in sub-analysis we announced in September led to our strategic decision to seek an amendment to our VERSATILE-003 trial to include progression-free survival as a primary endpoint in addition to median overall survival. Our rationale for taking this step will be the focus of today's call.

Let's begin. Last August, we announced final top line survival data from the VERSATILE-002 Phase II clinical trial. As you will recall, the VERSATILE-002 trial evaluated PDS0101 plus KEYTRUDA or pembrolizumab in patients with HPV16-positive head in neck cancer. The final data showed median overall survival was 39.3 months, in patients with combined positive score or CPS of greater than or equal to 1. The lower limit of the 95% confidence interval was 23.9 months, and the upper limit was not yet estimable.

Importantly, the progression-free survival was 6.3 months among patients with CPS greater than or equal to 1. This PFS result is notable considering the fact that over 62% of patients in the VERSATILE-002 study had low CPS of 1 to 19. These patients have historically had significantly lower PFS results. A total of 53 patients were enrolled in the VERSATILE-002 trial. Unlike the VERSATILE-003 Phase III trial, the primary endpoint for the VERSATILE-002 trial was objective response rate or ORR. The VERSATILE-002 study included 9 censored patients who discontinued the study after the primary endpoint of ORR was reached and were, therefore, lost to follow up. To understand the potential impact of these 9 patients on PFS and MOS, a sensitivity analysis was performed in the second quarter of 2025 prior to our presentation at ASCO.

Our statistical experts obtained the survival records and disease progression status for these 9 patients. The resulting censoring analysis showed no negative impact on either PFS or MOS. The VERSATILE-002 trial is the first of patients in the recurrent and/or metastatic head and neck cancer population to report a median overall survival of almost 14 months. The PFS and survival results also have important implications for the current design of our Phase III VERSATILE-003 trial.

In the current trial protocol, median overall survival is the primary end point and progression-free survival is a secondary endpoint. However, even before our final readout of VERSATILE-002 a key concern external to PDS Biotech was the fact that MOS relies on the occurrence of death events. The concern being that if a drug works well enough to prevent patient death, it may take a long time to get to the critical data readout. With the further increased final MOS readout from VERSATILE-002 this concern was further exacerbated. To hopefully address the potential for an extended trial duration, while also abiding by the FDA's recommendation, to use MOS median overall survival as the primary endpoint, we have amended the protocol to convert PFS to a surrogate primary endpoint.

As announced, we have requested a meeting with the FDA to discuss the described amendment to the current trial protocol to include PFS as a surrogate primary endpoint independent of median overall survival, which will continue to remain as the primary endpoint for full approval. Our request to meet with the FDA to propose an amendment to VERSATILE-003 is based on careful consideration of the final data from VERSATILE-002. We believe the robust PFS data now presents us with an important opportunity to potentially shorten the time to regulatory submission while maintaining median overall survival as the endpoint for full FDA approval.

Importantly, we believe this approach may also accelerate the availability of this promising treatment to the rapidly growing population of HPV16-positive patients in dire need of effective treatment. Treatment with PDS0101 for currently enrolled patients in our VERSATILE-003 Phase III trial will continue during the temporary pause of the trial. We believe that the industry is waking up to the realization that HPV positive head and neck cancer is rapidly becoming a real problem, and several industry publications just in the last few months have reported on this developing situation.

Some of you might be familiar with independent market research published by DelveInsight on the oropharyngeal cancer market published this month. The article states that they performed interviews with KOLs at leading cancer research centers. And based on a quote from the publication with declining rates of head and neck cancers related to alcohol and tobacco, HPV has become the principal etiologic factor in oropharyngeal cancer, redefining prognostic outlooks and informing the development of tailored therapeutic approaches.

Based on established research, over 90% of HPV-positive oropharyngeal cancers, or HPV16-positive. We are, therefore, confident in the potential of our HPV16 tailored approach and the potential of PDS0101 to ultimately provide a well-tolerated treatment without chemotherapy as an option for the growing population of HPV16-positive patients who currently have no effective therapies for this daily disease, and who will soon become the majority of head and neck cancer patients. Elsewhere in our pipeline, we announced that the National Cancer Institute or NCI, presented new clinical data at the 2025 Society for Immunotherapy of Cancer SITC annual meeting. The NCI presented 3 abstracts highlighting emerging clinical and translational findings from PDS Biotechnologies novel investigational immunotherapy platforms, including PDS0101, our lead Phase III clinical stage HPV targeted immunotherapy and our tumor targeting IL-12 used antibody drug conjugate PDS01ADC.

The presented translational biomarker studies demonstrated the unique immunological properties of PDS0101 and PDS01ADC leading to antitumor immune responses and the predictability of clinical responses. PDS0101 combination immunotherapy was observed to induce broad immune activation and quantitative measurements of various blood analytes predicted clinical benefit with good accuracy. PDS01ADC monotherapy in patients with advanced solid malignancies was observed to increase blood frequencies of stem-like memory and effector CD8 and CD4 T cells that had self-renewing properties. We believe the data presented at SITC further validate the scientific underpinnings of our immunotherapy platforms and confirm that our development approach is achieving the intended immunological and clinical effects.

These findings provide a deeper understanding of how our immunotherapies are generating such promising results in advanced cancers. Earlier in the quarter, we announced that the colorectal cancer cohort of the Phase II clinical trial with PDS01ADC, met the criteria for expansion to Stage 2, following positive Stage 1 results. This trial is also being led by the National Cancer Institute. Our Phase II clinical collaborations with a National Cancer Institute, MD Anderson Cancer Center, the Mayo Clinic as well as our preclinical collaboration with NIAID allow us to focus our resources on our VERSATILE-003 Phase III clinical trial, while progressing development of our pipeline via these investigator-led studies.

Now I will turn it over to Lars for a review of our results for the third quarter of 2025. Lars?

Thanks, Frank, and good morning, everyone. We reported a net loss of $9 million or $0.19 per basic and diluted share for the 3 months ended September 30, 2025, that compared to $10.7 million or $0.29 per basic share in the prior year's quarter. Decrease in net loss was primarily due to lower operating expenses. Research and development expenses were $4.6 million for the 3 months ended September 30, 2025 compared to $6.8 million for the prior year period. The decrease was primarily due to lower manufacturing and clinical expenses and personnel costs.

General and administrative expenses were $3.6 million for the 3 months ended September 30, 2025, compared to $3.4 million for the prior year period. The increase was primarily due to higher professional fees, which were partially offset by lower personnel costs. Total operating expenses were $8.1 million for the 3 months ended September 30, 2025, compared to $10.2 million for the prior year period. Net interest expense was $0.9 million for the 3 months ended September 30, 2025, compared to $0.5 million for the prior year period. The increase was primarily due to lower interest income from our cash deposits. Our cash balance as of September 30, 2025, was $26.2 million, which compared to $41.7 million as of the beginning of the year. Yesterday, we completed the sale of $5.8 million of our common stock or prefunded warrants as well as $5.8 million company warrants for gross proceeds of approximately $5.3 million.

And with that, operator, we can open up the call for any questions.

[Operator Instructions] And our first question is from the line of Mayank Mamtani with B.Riley Securities.

I appreciate the update. So on the VERSATILE-003 protocol pause, can you touch on how you plan to handle the patients that are already enrolled and assume that they will make it to the -- this new PFS analysis that now you're going to propose to the agency? See if you could just give us an update logistically how patients enrolled will be included there? And then also, what's the new sample size, I believe you might be having some awareness of what the new protocol size would look like? And I was also curious what the net cost savings would be for you as a result of that?

Well, Mayank, thanks a lot for your question. So I think as we mentioned in the -- in the -- in the script that we just read through, we are going to continue to treat those patients who have already been enrolled on the trial -- on the study trial. In terms of incorporating them into the trial as a whole, these are not significant amendments, but these are part of the discussions that we will be having with the FDA. In terms of the new size, we have not disclosed that publicly yet. We don't want to do any of that until we have actually sat down with the FDA. We've made certain proposals to the FDA by the anticipation and the whole tier is that we will address some of those concerns by getting to those clinical trial readouts earlier than the currently designed trial will allow us to get there, right?

But I will -- I'll hand over to Kirk and see if he has anything to add to that.

No. Nothing to add, Frank. You said these discussions will take place soon. We think there are very reasonable amendments that we're asking for. We're also very happy that in reviewing these amendments and strategy for the study that the steering committee that we have as well as our investigators are with the program. They believe very much in what we're doing. And the emphasis here, as Frank said, is that these patients will be continued to receive drug on the protocol during the pause.

And are you able to share any information on what the expected PFS would be under control KEYTRUDA. It's obviously much lower than what we see relative to the OS, as you said, but just was curious what you're seeing in studies that have recently published on PFS control arm. And obviously, that feeds into your analysis for what you would power the Phase III study for?

My answer, I think I'll just reiterate something that Kirk just mentioned. These amendments and the work that's going into what we have suggested to the FDA is something that has been thoroughly discussed with the experts and principal investigators, and is very strongly supported by those experts in the field and also what we're proposing is nothing unusual in terms of clinical trial design. So we -- the goal here is to make sure that not only is it very well supported by investigators and experts in the field, but also that it is nothing unusual regarding the FDA regulations, everything we're suggesting should be -- should abide by the regulatory guidelines, right?

So we're making sure we stick with that. And in terms of the VERSATILE-003 trial, Mayank, just to make sure I address exactly what you asked, could you just repeat the last part of that section -- last part of your question?

The PFS for the control arm that you have incorporated and if that has changed relative to your prior assumption when you initially started the study?

Correct. So the PFS, as you know, in the KEYNOTE-048 study as well as the LEAP-010 study, it was 3.2 months for CPS greater than 1 in the KEYNOTE-048 study, and it was 2.8 months. in the LEAP-010 study. Now these studies were predominantly -- we assume the LEAP-010 study was predominantly HPV negative, that hasn't been published yet, but we know that the KEYNOTE-048 study was predominantly in HPV negative patients. We know that there are 2 studies that have been published that actually compared HPV-16 positive patients with HPV negative and other types of HPV infected head and neck cancer patients.

And so we know from those studies that the prognosis, if you have HPV-16 positive head and neck cancer appears to be worse than if you have HPV negative or other types of HPV positive head and neck cancer, right? And so at this point, we are conservatively assuming that the PFS in the control arm is going to be around the 3-month range, which has been reported for KEYNOTE-048 and also in the LEAP-010 study, which was 2.8 months.

That's a big delta. So Lastly, there's been a lot of strategic interest in the head and neck cancer space. A lot obviously -- on the bispecific or ADC side of things and including at ESMO, any thoughts on how you're looking at the broader landscape, especially on the HPV positive side where there's or HPV-16 positive side there is not a whole lot going on.

Right. Mayank, as you mentioned, there is quite a bit of work going on also with ADCs and so forth in head and neck cancer. But as you may know, those are really primarily targeted to HPV-negative patients. As I just mentioned, it appears that there is becoming that realization now in the industry that HPV positive head and the cancer is becoming a really serious medical problem, right? Just in the last few months, we've had several publications report on the growing incidents of HPV positive head and cancer, and this independent market research report I mentioned, specifically stated that HPV negative or the traditional head and neck cancers caused by tobacco and alcohol are on the decline and the new phase of head and neck cancer is HPV positive head and neck cancer, right. As I mentioned, we are very confident in the approach we've taken to focus on HPV-16 positive head and neck cancer, which again in oropharyngeal cancer, for example, over 90% of these HPV-positive oropharyngeal cancer are HPV-16 positive, right?

We've shown on our slide, the growing projection from some of the top medical journals such as Lancet, showing the significant increase in the prevalence of HPV-16 positive head and neck cancer. And so we are very encouraged with the results we've seen today. And we are also very encouraged that this growing population of patients will hopefully have a therapy that specifically addresses this growing type of head and neck cancer, which it appears from the expert reports could potentially be the dominant type of HPV of head and neck cancer in the next decade, right? So we continue to be pleased with the approach we've taken to really target and focus on HPV-16 positive head and neck cancer. But the majority of -- the majority of studies and the products are being developed in head and neck cancer are not focused on HPV positive head and neck cancer.

Our next question is from the line of Joe Pantginis with H.C. Wainright.

So 2 questions, if you don't mind. On 002, can you remind us or inform us on what have you, patients that have been such long-term survival, have they seen any additional therapeutic interventions? I don't believe they have? And then second, on 003, since you're looking at PFS, can you tell us about the conduct of that study with regard to physician training and awareness and to obviously have a lot more sites than 002 with regard to being able to adapt to and not make calls early based on potential pseudo progression of the tumors from the center immunotherapy.

Joe, I'll start and then I'll hand over to Kirk. Now in terms of what patients may go on after they come off the VERSATILE-002 trial, it is important to remember that at that stage, the patients are checkpoint inhibitor resistance. And in HPV-positive disease, this is published. The median overall survival is only 3 to 4 months, right? So we have to bear that in mind in this discussion, once you become checkpoint inhibitor resistance in HPV positive disease, your median overall survival is 3 to 4 months. And therefore, if you come off PDS0101 and go on to some other therapy, and all of a sudden, you see prolonged survival, then very likely, it's only reasonable to resume that, that prolonged survival came from was a result of the therapy, PDS0101 therapy, right?

Because it is very well established that if you're a checkpoint resistant, you are not going to have long survival. Right now, when patients come off the VERSATILE-002 trial, there is no FDA-approved therapy for checkpoint resistant patients. And so they will very likely go into any investigator choice chemotherapy. And that's the most likely therapy that anybody who comes of PDS0101 will go on to, right. In terms of the VERSATILE-003 design and investigators been trained in how they look at things like pseudo progression, that's something that's very important with an immunotherapy and some of the discussions that have been had with our steering committee.

So I'll hand over to Kirk to address that question.

Yes. Thank you, Frank. First of all, just a comment on the answer as far as the subsequent treatment after the protocol, you're correct. I mean there's really nothing, it's tragic that for those who are ICI resistant, that really, there's been nothing really to show that they have any survival benefit or even a high response rate. So unfortunately, we're comfortable with the fact that after the protocol, most likely any effects would be from our drug, PDS0101.

Regarding the PFS, that's a good question because it's very important as we look at these patients that the investigators are trained as far as the response. And also, this will be reviewed, as you know, by a central review from experts who will be reading the scans, et cetera. Where we've discussed this a lot, so people are sensitive to the fact that there may be pseudo progression. And so that with patients who are still clinically well and yet not determined yet as far as a response, we will continue to follow them. So this is very important and different than the 002 because now 002, remember the primary was ORR as far as response rate.

And after the patients had a response, some of them were not followed any further. We will be following these patients all along, not only for the response, but also for safety. So we're comfortable now with the training we've had and the discussions we've had with the steering committee that we will be able to properly judge these patients as far as PFS.

And also, we're very fortunate that with the current site accruals that we have, a lot of the sites are returning who were on VERSATILE-002. So they've been trained before. They are also familiar with the drug and we're very happy to know that a number of them want to be a part of now the VERSATILE-003. So we have a good core of sites that have had experience with the drug as well as judging these responses. Thanks for your question.

I appreciate all the feedback. Thanks a lot.

Thank you. At this time, I'll hand the floor back to management for further remarks.

Thank you, operator. So thank you to all for your time today. We are excited based on the strong VERSATILE-002 results and our fast-track designation about the potential for PDS0101 in head and neck cancer. Our engagement with multiple leading clinical investigators and oncology institutions has validated our approach and the long-term opportunity that we believe our HPV-16 targeted immunotherapy represents in the HPV-16 positive head and neck cancer indication. We look forward to keeping you updated on our progress, and thank you very much again.

Thank you. Ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. You may now disconnect your lines, and have a wonderful day.