Earnings Call Transcript - PDSB Q1 2026

Operator, Operator

Greetings, and welcome to the PDS Biotech First Quarter 2026 Earnings Conference Call. It is now my pleasure to introduce your host, Dean Schwartz. Thank you. You may begin.

Dean Schwartz, Host / Investor Relations

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?

Frank Bedu-Addo, Chief Executive Officer

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?

Kirk Shepard, Chief Medical Officer

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 (pembrolizumab) is the only late-stage investigational head and neck squamous cell carcinoma therapy that requires only 5 doses and is also the only subcutaneous therapy. These characteristics of PDS0101, together with the tolerability and survival data reported to date, make PDS0101 a potentially 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 (IL-12) fused antibody drug conjugate that enhances the proliferation, potency and longevity of T cells in the 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 the 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 two 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.

Frank Bedu-Addo, Chief Executive Officer

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?

Lars Boesgaard, Chief Financial Officer

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. The 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 was $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, Operator

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

Mayank Mamtani, Analyst, B. Riley Securities

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

Frank Bedu-Addo, Chief Executive Officer

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

Kirk Shepard, Chief Medical Officer

Thank you, Frank. Regarding enrollment, we have alignment with the FDA and are proceeding with the protocol amendment and returning to sites to begin the study in the near future. We're happy to say that the sites stayed with us during the pause while we completed the amendment and discussed it with the FDA, so we still have momentum. Regarding the possibility of using the drug with subcutaneous pembrolizumab in the future, that is possible, but it is not our current research target. Our research is with pembrolizumab given IV at the usual dose used previously, but a fully subcutaneous regimen would remain an option for the future.

Mayank Mamtani, Analyst, B. Riley Securities

And then on the landscape external to you within HPV16-positive head and neck, it still seems like a relatively open white space. Are there any emerging updates you're watching for, particularly from the EGFR bispecific class? Also, the colorectal cancer cohort Stage 2 is now fully enrolled and you published data from the Stage 1 cohort. When do you expect the next data update for Cohort 2?

Frank Bedu-Addo, Chief Executive Officer

Mayank, I'll start and I'll hand over to Kirk to add anything. In terms of the HPV16 landscape, you're correct that BioNTech is also in a Phase III trial. Both PDS and BioNTech remain the two late-stage studies in the space, so there are very few potential options for these patients at present. Regarding the colorectal cancer cohort, we have completed enrollment into that cohort and we anticipate that by the end of the year we should have additional data on the full population of patients in the colorectal cancer study. Kirk, anything you want to add to that?

Kirk Shepard, Chief Medical Officer

No, I would just refer you again to the article that was published and the press release, and note that we are very encouraged by the Stage 1 results of the Phase II trial with the NCI. We are anxious to move this therapy into the next step, a controlled trial.

Operator, Operator

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

Joseph (Joe) Pantginis, Analyst, H.C. Wainwright

Great to see the recent amendment. I wanted to dive into that a little bit. If you could provide more color on the benefits: Kirk, you mentioned acceleration of the clinical timelines. Could you expand on patient attraction and any anecdotes from physicians about reenrolling patients quickly? And Lars, from your standpoint, what do you believe the positive financial impact of these changes could be? Would you keep those savings toward the filing path or allocate them toward the ADC platform?

Kirk Shepard, Chief Medical Officer

Yes. Regarding the amendments, this all started when we did our final data cut in September of last year and we were very encouraged by those results. We then needed to consider how long the trial would take because median overall survival increased from around 30 months to almost 40 months, which would lengthen the trial duration substantially. At the same time, we saw the robustness of our progression-free survival signal. We went to the FDA to discuss the possibility of a co-primary endpoint; we now have PFS as a co-primary along with median overall survival. Overall survival would still be needed for full approval, but PFS provides a pathway for potential accelerated review. We're very pleased with the trial design that resulted from our data and discussions with the FDA.

Lars Boesgaard, Chief Financial Officer

Joe, this is Lars. To answer your question about the potential financial impact, we expect the protocol amendment to affect financial requirements primarily by reducing time to the interim readout, which should reduce both external costs and internal operating expenses due to the shorter timeline. As part of the amendment, we changed randomization from 2:1 to 1:1, which allowed us to lower the number of patients from approximately 350 to approximately 250. That reduction in sample size will also drive lower external costs associated with completing the trial.

Joseph (Joe) Pantginis, Analyst, H.C. Wainwright

Helpful detail. One quick follow-up: things are late stage and progressing quickly. Can you talk about your manufacturing needs for Versamune and the pipeline in the near term and heading into potential early commercialization?

Frank Bedu-Addo, Chief Executive Officer

Yes, Joe, I can address that. We have a straightforward manufacturing process. In terms of scale-up and commercialization, some scale-up has already been completed and the commercial process is established. We anticipate running traditional CMC activities in parallel with the Phase III, which involve validation of those processes. There may be some additional scale-up required, but since the process is now fixed and established, we will focus on validation. We need to complete a number of validation batches heading into a BLA filing. Those are the major CMC activities remaining. In terms of manufacturing itself, the processes are completed and established, so we see a straightforward path to BLA filing from a manufacturing perspective.

Operator, Operator

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.

Frank Bedu-Addo, Chief Executive Officer

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.

Operator, Operator

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