PDS Biotechnology Q1 2026 Earnings Report

PDS Biotechnology EPS Results

• Actual EPS: -$0.13
• Consensus EPS: -$0.15
• Beat/Miss: Beat by +$0.02
• One Year Ago EPS: N/A

PDS Biotechnology Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

PDS Biotechnology Announcement Details

• Quarter: Q1 2026
• Date: 5/13/2026
• Time: Before Market Opens
• Conference Call Date: Wednesday, May 13, 2026
• Conference Call Time: 8:00AM ET

PDS Biotechnology (NASDAQ:PDSB) Group, Inc. is a clinical‐stage immunotherapy company focused on the development of targeted treatments for oncology and infectious diseases. The company’s proprietary Amplivant™ adjuvant platform leverages Toll-like receptor 3 activation to prime antigen‐presenting cells, directing robust immune responses against defined tumor and viral antigens. Its lead therapeutic vaccine candidate, PDS‐0101, is designed to treat HPV16‐positive cancers and is being evaluated both as a monotherapy and in combination with checkpoint inhibitors in ongoing Phase 1/2 clinical trials.

Beyond its HPV‐focused program, PDS Biotechnology is advancing a diversified pipeline of immunotherapies incorporating its Amplivant platform. The company’s research initiatives include both off‐the‐shelf vaccines targeting shared tumor antigens and personalized approaches that present patient‐specific neoantigens. By integrating novel adjuvant technology with established cancer targets, PDS Biotechnology aims to generate durable T-cell responses and improve clinical outcomes in multiple solid tumor indications.

Founded in 2007 and headquartered in San Diego, California, PDS Biotechnology conducts its research, translational studies, and early clinical development across facilities in the United States. The company partners with academic centers and biopharmaceutical organizations to advance its product candidates through global clinical trials. Under the leadership of CEO Bruce D. Montgomery and an experienced management team, PDS Biotechnology is dedicated to translating its platform innovations into next-generation immunotherapies for patients with cancer and chronic viral infections.

PDS Biotechnology Q1 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: PDS Biotechnology amended VERSATILE-003 to use progression-free survival as an interim primary endpoint, which management believes could speed an accelerated approval path and shorten the trial’s duration.
• Positive Sentiment: The company said the amended design also reduces costs by lowering the trial size from about 350 patients to 250 and changing the randomization ratio to 1:1:1.
• Positive Sentiment: Management highlighted continued momentum in PDS0101, saying the therapy remains a differentiated late-stage option in HPV-16 positive head and neck cancer because it is subcutaneous and requires only five doses.
• Positive Sentiment: The company reported encouraging updates from its PDS01ADC program in both colorectal and prostate cancer, including published biomarker data and early clinical results that support broader immuno-oncology potential.
• Neutral Sentiment: First-quarter 2026 results showed a net loss of $7.3 million versus $8.5 million a year ago, with cash of $21.7 million at quarter-end and lower operating expenses year over year.

Presentation

[Operator]

Greetings and welcome to the PDS Biotechnology 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 formal presentation. If any needs to 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.

[Dean Schwartz, Associate at LifeSci Advisors]

Thank you, operator. Good morning, everyone, and welcome to PDS Biotechnology'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, the 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'll 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.

[Dean Schwartz, Associate at LifeSci Advisors]

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, CEO at PDS Biotechnology]

Thank you, Dean. 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. We made significant progress. I will hand the call over to our Chief Medical Officer, Dr. Kirk Shepard, to provide an update. Kirk.

[Kirk Shepard, Chief Medical Officer at PDS Biotechnology]

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.

[Kirk Shepard, Chief Medical Officer at PDS Biotechnology]

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.

[Kirk Shepard, Chief Medical Officer at PDS Biotechnology]

PDS0101 in combination with KEYTRUDA or pembrolizumab is the only late-stage investigational head and neck squamous cell carcinoma therapy that requires only full 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 potential compelling option for these patients. The opinion leaders at institutions such as Mayo Clinic, Dana-Farber, and Yale Cancer Center are involved in our trial. HPV16-positive cancers are rapidly increasing in the U.S. and E.U. 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 PDS0101 is uniquely positioned to address.

[Kirk Shepard, Chief Medical Officer at PDS Biotechnology]

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 the tumor microenvironment. In March, the Journal of Clinical Oncology JCO Oncology Advances published clinical and immunological biomarker data from stage I 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.

[Kirk Shepard, Chief Medical Officer at PDS Biotechnology]

In patients with metastatic castration-resistant prostate cancer, the majority of whom receive 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, CEO at PDS Biotechnology]

Thank you, Kirk. Finally, during our first quarter, we also strengthened the intellectual property estate for PDS0101 with new patents granted in the U.S. 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, CFO at PDS Biotechnology]

Thanks, Frank, 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 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.

[Lars Boesgaard, CFO at PDS Biotechnology]

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

[Operator]

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 Mayank Mamtani with B. Riley Securities. Please proceed with your question.

[Mayank Mamtani, Analyst at B. Riley Securities]

Yes. Good morning, team. 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? Is there a consideration also, maybe, of including subcu KEYTRUDA as a combination partner? I don't painfully follow what would be the procurement of KEYTRUDA considerations that, you know, were there last year, versus what do you have today for VERSATILE-003? I have a follow-up.

[Frank Bedu-Addo, CEO at PDS Biotechnology]

Hi, 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 at PDS Biotechnology]

Thank you, Frank. Yes, regarding the enrollment, now that we have alignment with the FDA, 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 pause while we did the amendment and discussed it with the FDA. We're very happy that we still have the momentum with us.

[Kirk Shepard, Chief Medical Officer at PDS Biotechnology]

Regarding the possibilities of using the drug with the subcu pembrolizumab in the future, that's something that would be a possibility, 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, that option would remain open in the future for an entirely subcu regimen.

[Mayank Mamtani, Analyst at B. Riley Securities]

Thank you. 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 bispecific class that, you know, you might be watching for? Then I also noticed the colorectal cancer cohort, you know, 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, CEO at PDS Biotechnology]

Hey, Mayank, I'll start. I'll hand over to Kirk to add anything to it. In terms of the HPV16 landscape, you're correct. We know that BioNTech is also in a phase III trial. Both PDS and BioNTech remain the two late-stage studies in the space. You are correct. There are very few potential opportunities for these patients at this present time. In terms of the colorectal cancer, yes, you are correct that we have completed enrollment into that colorectal cancer cohort of that study. 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?

[Kirk Shepard, Chief Medical Officer at PDS Biotechnology]

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

[Mayank Mamtani, Analyst at B. Riley Securities]

Thanks so much, team.

[Operator]

Thank you. Our next question comes from the line of Joe Pantginis with H.C. Wainwright. Please proceed with your question.

[Joe Pantginis, Analyst at H.C. Wainwright]

Hey, guys. Good morning. Thanks for taking the questions. Great to see the recent amendment. 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 the 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. Next, sort of the second part of that is, you know, from Lars' standpoint, you know, what do you believe the financial impact positively for these changes could be?

[Joe Pantginis, Analyst at H.C. Wainwright]

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 path, ADC platform?

[Kirk Shepard, Chief Medical Officer at PDS Biotechnology]

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. 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.

[Kirk Shepard, Chief Medical Officer at PDS Biotechnology]

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. 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, CFO at PDS Biotechnology]

Hey, Joe. This is Lars here. 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. 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 2 to 1 to 1 to 1.

[Lars Boesgaard, CFO at PDS Biotechnology]

That also allowed us to essentially lower the number of patients from approximately 350 to approximately 250 patients. That also, in and of itself, will drive lower external costs associated with completing the trial.

[Joe Pantginis, Analyst at H.C. Wainwright]

Helpful details. Thank you. Just a quick follow-up question. Things are late-stage. They're progressing right, pretty 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?

[Frank Bedu-Addo, CEO at PDS Biotechnology]

Yes, Joe, I can talk a little bit about that. As you know, we have a pretty straightforward manufacturing process. In terms of scale-up and commercialization, some scale-up has been done already, but the commercial process is already established. What we anticipate doing is, once 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 batches heading into the BLA filing. Those are really the major CMC activities remaining for the program.

[Frank Bedu-Addo, CEO at PDS Biotechnology]

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.

[Joe Pantginis, Analyst at H.C. Wainwright]

Thanks for all the details, guys.

[Frank Bedu-Addo, CEO at PDS Biotechnology]

No problem.

[Operator]

Thank you. 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, CEO at PDS Biotechnology]

Thank you, operator. Combined with early data from our PDS01ADC program and expanded patent protections 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. 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.

Participants

Executives

• Frank Bedu-Addo, CEO
• Kirk Shepard, Chief Medical Officer
• Lars Boesgaard, CFO

Analysts

• Dean Schwartz, Associate at LifeSci Advisors
• Joe Pantginis, Analyst at H.C. Wainwright
• Mayank Mamtani, Analyst at B. Riley Securities