PDS Biotechnology Corporation

Greetings and welcome to the PDS Biotech first quarter 2026 earnings conference call. At this time, all participants are on a listen-only mode. A question and answer session will follow the phone presentation. If anyone can require operator assistance, please press star zero on your telephone keypad. 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 Baduado, Chief Executive Officer, Dr. Kirk Shepherd, Chief Medical Officer, and Lars Boasgaard, Chief Financial Officer. Dr. Baduado and Dr. Shepherd will provide an overview of the company's recent highlights in its clinical development program and Mr. Bosgaard 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. Badu 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 Shepherd, 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 the 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. PDS-0101 in combination with Keytruda or pembrolizumab is the only late-stage investigational head and neck squamous cell carcinoma therapy that requires only five doses and also the only subcutaneous therapy. These characteristics of PDS-0101 together with the tolerability and survival data reported to date make PDS-0101 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. HPV 16 positive cancers are rapidly increasing in the US and EU due to poor uptake of the human papillomavirus vaccine and other factors. Along with unique pathophysiology of HPV 16 cancers and the absence of approved targeted therapies, there's a significant unmet need we believe that PDS-0101 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 PDS-01-ADC, 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 one of a phase two trial evaluating PDS01 ADC and 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 AHCR 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 doxotaxel demonstrated encouraging results included in our press release this morning. The results from these two trials reinforce the potential of PDS01-ADC to enhance the efficacy of existing therapies across multiple solid tumor types. We remain focused on advancing PDS01-ADC 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 PDS 0101 with new patents granted in the United States and Japan. The new U.S. patent combined with anticipated biologics exclusivity for PDS 0101 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 13 cents per basic and diluted share. That compares to a net loss of $8.5 million, or 21 cents 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 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. Thank you.

We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing these star keys.

One moment, please, while we poll for questions. Our first question comes from the line of .

Please proceed with your question.

Yes. Good morning, Dean. Thanks for taking our questions and 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 SubQ Keytruda as a combination partner? I don't think fully follow what would be the procurement of Key Truda considerations that, you know, were there last year versus what you have today for versus 2003. And then I have a follow-up.

Hi, 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 sub-Q, 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 sub-Q regimen.

Thank you. And then on the landscape external to you within HPV16 positive, head and neck, you know, 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, you know, particularly from the EGFR by specific class that, you know, you might be watching for? And then I also noticed the colorectal cancer cohort you know, stage two is now fully enrolled and you obviously published data from the stage one cohort. Maybe just remind us when do you expect to have the next data update for cohort two? That would be very helpful.

Okay, 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 a phase three trial. But both PDS and BioNTech remain the two 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'd 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 this stage one of the phase three trial with the NCI. So we're anxious to move it on to the next trial, a controlled trial with this therapy.

Thanks so much, team. Thank you.

Our next question comes from the line of Joe Panagenis with AC Wainwright. Please proceed with your question.

Hey, guys. Good morning. Thanks for taking the questions, and 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 timelines. I'm hoping you could hit that a little more with regard to, you know, attracting patients, anecdotes you may be getting from doctors to be able to, you know, quickly get to those, re-enrolling quicker. And then next, sort of the second part of that is, you know, from Lars's standpoint, you know, what do you believe the financial impact positively for these changes could be? And obviously, would you then look to put you know, keep that money towards the filing path or, you know, 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 would 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.

Hey 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, you know, 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 costs, both external costs, but also our internal operating expenses simply due to that shorter time period. Another aspect to bear in mind, Joe, is that we did, as part of the amendment, we changed the randomization and the ratio from two to one to one to one. 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 details. Thank you. And then just a quick follow-up question. So, look, things are late stage. They're progressing very quickly. Can you talk about your manufacturing needs, you know, for Versamune and the pipeline, you know, 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 in commercialization, some scale up has been done already by the commercialization. Commercial process is already established. And so what we anticipate doing is once in parallel with the phase three, 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 batches heading into the BLA filing. So those are really the major TMC 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.

Thanks for all the details, guys.

No problem.

Thank you. And we have reached the end of the question and answer session. I would like to turn the floor back to Frank Beduado for closing remarks.

Thank you, operator. Combined with early data from our PDS01-ADC program and expanded patent protections extending into the 2040s for PDS01-01, 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.