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DATE

Wednesday, May 13, 2026 at 8 a.m. ET

CALL PARTICIPANTS

  • Chief Executive Officer — Frank Bedu-Addo
  • Chief Medical Officer — Kirk Shepard
  • Chief Financial Officer — Lars Boesgaard

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TAKEAWAYS

  • Net Loss -- $7.3 million, or $0.13 per basic and diluted share, compared to $8.5 million, or $0.21 per basic and diluted share, in the prior year period.
  • Research and Development Expenses -- $3.5 million, declining from $5.8 million year over year, due to lower clinical and manufacturing costs.
  • General and Administrative Expenses -- $3.1 million, down from $3.3 million in the comparable period last year, primarily due to reduced professional fees.
  • Total Operating Expenses -- $6.5 million, versus $9.1 million in the prior year period; decline driven mainly by R&D and G&A reductions.
  • Net Interest Expense -- $0.8 million, up from $0.6 million in the comparable prior period.
  • Cash Balance -- $21.7 million as of March 31, 2026.
  • VERSATILE-003 Clinical Trial Amendment -- Protocol revised to include progression-free survival as an interim primary endpoint and shift randomization ratio from 2:1 to 1:1, enabling a reduction in targeted enrollment from 350 to 250 patients and potentially shortening trial duration and costs.
  • PDS0101 Regulatory Alignment -- Alignment with the FDA reached on the amended VERSATILE-003 protocol, with plans to restart trial enrollment at long-standing sites in the near future.
  • PDS0101 Clinical Positioning -- Only late-stage head and neck squamous cell carcinoma investigational therapy requiring five doses and using subcutaneous administration in combination with pembrolizumab.
  • PDS01ADC Pipeline Progress -- Full enrollment achieved for the colorectal cancer cohort in the Phase II PDS01ADC trial, with new data expected by year-end and Stage 1 data published in the Journal of Clinical Oncology Oncology Advances.
  • Intellectual Property Developments -- New U.S. and Japanese patents granted for PDS0101; U.S. patent combined with anticipated biologic exclusivity extends potential market protection into the 2040s, while the Japanese patent broadens key matter claims.
  • Manufacturing Readiness -- Commercial production process for PDS0101 is completed, with scale-up to commercial levels and validation activities outlined as next steps for BLA filing preparation.

SUMMARY

PDS Biotechnology Corporation (PDSB +3.45%) highlighted an amended pivotal trial protocol designed in direct consultation with the FDA, resulting in reduced trial enrollment targets and costs. Management confirmed accelerated clinical timelines following the adoption of progression-free survival as an interim primary endpoint, with expectations for more rapid data availability. The pipeline advanced with publication of Phase II Stage 1 biomarker data for PDS01ADC and the completion of colorectal cancer cohort enrollment. Expanded intellectual property protections now extend market exclusivity for PDS0101 into the 2040s, including new coverage in both the U.S. and Japan. Cash and expense management resulted in a significant reduction in net loss and operating costs compared to the previous year.

  • Site retention during the VERSATILE-003 study amendment maintained trial momentum, allowing for an immediate restart once regulatory and protocol updates are completed.
  • Manufacturing activities for PDS0101 have transitioned to process validation efforts required for biologics licensure application filing, with no changes anticipated to the established, scalable production process.
  • Management expects new data from the PDS01ADC colorectal cancer cohort to be released by year-end, following full cohort enrollment in early 2026.
  • PDS0101 and BioNTech (NASDAQ:BNTX) remain the only two late-stage clinical programs for HPV16-positive head and neck cancers, with no mention of emergent competition in the call.

INDUSTRY GLOSSARY

  • Versamune: PDS Biotechnology’s proprietary platform technology used for developing cancer immunotherapies, including PDS0101.
  • ADC (Antibody-Drug Conjugate): A biopharmaceutical consisting of an antibody chemically linked to a biologically active drug or cytotoxic compound, used to target and kill cancer cells.
  • PFS (Progression-Free Survival): The length of time during and after medication or treatment during which a patient's disease does not worsen.
  • BLA (Biologics License Application): A request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce in the U.S.
  • Cohort: A group of subjects in a clinical trial who share defining characteristics, typically enrolled during the same period in a specific study phase.

Full Conference Call Transcript

Frank Bedu-Addo: 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: 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.

Frank Bedu-Addo: 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: 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: [Operator Instructions] Our first question comes from the line of Mayank Mamtani with B. Riley Securities.

Mayank Mamtani: 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.

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

Kirk Shepard: 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.

Mayank Mamtani: 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.

Frank Bedu-Addo: 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?

Kirk Shepard: 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.

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

Joseph Pantginis: 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?

Kirk Shepard: 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.

Lars Boesgaard: 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.

Joseph Pantginis: 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?

Frank Bedu-Addo: 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.

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