PDS Biotechnology Q4 2025 Earnings Report

PDS Biotechnology EPS Results

• Actual EPS: -$0.14
• Consensus EPS: -$0.20
• Beat/Miss: Beat by +$0.06
• 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: Q4 2025
• Date: 3/30/2026
• Time: Before Market Opens
• Conference Call Date: Monday, March 30, 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 Q4 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: The company amended VERSATILE-003 to make PFS an earlier interim primary endpoint after the FDA raised no objections, aiming to shorten trial duration and enable a potential accelerated approval with a PFS readout expected in about 1–1.5 years.
• Positive Sentiment: Final VERSATILE-002 topline showed a median overall survival of 39.3 months in PD-L1 CPS ≥1 patients, which management cites as robust evidence supporting the phase III amendment and durable clinical benefit.
• Positive Sentiment: Early NCI-led data for PDS-01ADC plus docetaxel in metastatic castration-resistant prostate cancer reported a median PFS of 9.6 months and a median PSA decline of 40% (6 of 16 patients >50% PSA decline), reinforcing the program’s potential across solid tumors.
• Positive Sentiment: The company secured new U.S. and Japanese patents for PDS0101 and expects biologics exclusivity, which together extend market protection into the 2040s and strengthen the intellectual property estate.
• Negative Sentiment: Financially, PDS reported a 2025 net loss of $34.5 million and held $26.7 million in cash at year-end, a level that may pressure runway and necessitate additional financing.

Presentation

[Operator]

Greetings, and welcome to the PDS Biotechnology Q4 2025 Earnings Call. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. 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.

[Mike Moyer, Managing Director at LifeSci Advisors]

Thank you, operator. Good morning, everyone, and welcome to PDS Biotechnology's Q4 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 in its clinical development program. Dr. Shepherd will review the data and rationale behind the amendment the company recently adopted to its phase III VERSATILE-003 trial. 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.

[Mike Moyer, Managing Director at LifeSci Advisors]

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, CEO at PDS Biotechnology]

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 Biotechnology, 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 timeline to regulatory submission while preserving overall survival as the basis for full approval.

[Frank Bedu-Addo, CEO at PDS Biotechnology]

For patients living with HPV-16 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 a National Cancer Institute-led trial investigating PDS-01ADC, 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 two prior treatments, the combination of PDS-01ADC 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%. Six of 16 patients achieved greater than 50% PSA decline.

[Frank Bedu-Addo, CEO at PDS Biotechnology]

These findings reinforce the potential of PDS-01ADC 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 PDS-01ADC 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. 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. 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.

[Frank Bedu-Addo, CEO at PDS Biotechnology]

Kirk.

[Kirk Shepard, CMO at PDS Biotechnology]

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 HPV-16-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 HPV-16-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 CPS of more than or equal to one.

[Kirk Shepard, CMO at PDS Biotechnology]

The lower limit of the 95% confidence interval was 23.9 months, and the upper limit was not yet estimatable. The VERSATILE-002 trial is the first of patients in the 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.

[Kirk Shepard, CMO at PDS Biotechnology]

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 standard 30-day wait period since filing, the FDA raised no objections, and we are clear to proceed with the amended protocol.

[Kirk Shepard, CMO at PDS Biotechnology]

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 HPV-16 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 five doses. Most therapeutic approaches require over twenty doses.

[Kirk Shepard, CMO at PDS Biotechnology]

Our approach also presents convenient dosing intervals of three weeks and six 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 at the institutions such as the Mayo Clinic, Dana-Farber, and Yale Cancer Institute continue to voice their strong support for our approach. HPV-16 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, pathophysiology of the HPV-16 positive cancers and the absence of approved targeted therapies, there's a significant unmet need we believe that PDS0101 is uniquely positioned to address.

[Kirk Shepard, CMO at PDS Biotechnology]

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

[Frank Bedu-Addo, CEO at PDS Biotechnology]

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 healthcare provider in as little as one minute. 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 HPV-16 tailored approach and the potential of PDS0101 to ultimately provide a well-tolerated treatment without chemotherapy as an option for the growing population of HPV-16 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.

[Frank Bedu-Addo, CEO at PDS Biotechnology]

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

[Lars Boesgaard, CFO at PDS Biotechnology]

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. Those decreases were partially offset by an increase in clinical cost of $0.7 million.

[Lars Boesgaard, CFO at PDS Biotechnology]

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 non-cash 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 were $26.7 million.

[Lars Boesgaard, CFO at PDS Biotechnology]

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

[Operator]

Thank you. If you'd 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 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. We ask that you each keep to one question and one follow-up. Thank you. Our first question comes from the line of Joe Pantginis with H.C. Wainwright. Please proceed with your question.

[Josh Korsen, Analyst at H.C. Wainwright]

Hi, this is Josh on for Joe. Thanks for taking our questions. Now that you have the amended protocol cleared, could you share what the revised enrollment target's gonna look like and how that reduction compares to the original design?

[Lars Boesgaard, CFO at PDS Biotechnology]

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

[Kirk Shepard, CMO at PDS Biotechnology]

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. At that we were able to shorten the trial to as much as a year as far as getting the final results. Of course, the PFS will be the interim analysis that will first be available most likely in a period of about a year and a half. That will allow us, if we get an accelerated review, as you know, to make the drug available to patients.

[Kirk Shepard, CMO at PDS Biotechnology]

With the decrease in the N, as well as the increased results from the final analysis of the VERSATILE-002, we're able to shorten the duration with the smaller N for the trial.

[Josh Korsen, Analyst at H.C. Wainwright]

Great. Thank you. 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?

[Frank Bedu-Addo, CEO at PDS Biotechnology]

Lars, I'll hand over to you.

[Lars Boesgaard, CFO at PDS Biotechnology]

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

[Josh Korsen, Analyst at H.C. Wainwright]

Okay. Thank you so much.

[Operator]

Thank you. Our next question comes from the line of Mayank Mamtani with B. Riley Securities. Please proceed with your question.

[Mayank Mamtani, Senior Managing Director at B. Riley Securities]

Yes, good morning, team. Thanks for taking our questions. Could you touch on your plans to handle patients already enrolled prior to the VERSATILE-003 pause as part of your interim analysis? Wonder if you remain blinded to those set of patients. I assume they're continuing to dose on active drug and placebo. 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? Sorry if I missed that, did you say what the new sample size for the phase III is?

[Mayank Mamtani, Senior Managing Director at B. Riley Securities]

Are you willing to share any more details on, you know... It looks like you have the two PFS interim analysis, so I don't know what they're designed to hit on the first versus the second. If you can give any more details, that would be great.

[Lars Boesgaard, CFO at PDS Biotechnology]

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

[Kirk Shepard, CMO at PDS Biotechnology]

Yeah, certainly. There's many questions asked there. 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 want it to be stated ahead of the protocol restart. These patients will be on the trial as their 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. They will continue to receive their therapy. Let's see the other parts of the study. Sorry, could you repeat something else or Frank perhaps-

[Mayank Mamtani, Senior Managing Director at B. Riley Securities]

Yeah. Enrollment pace based on what you saw last year and I believe there's no competitive trial now enrolling, you know, given the other trials that were accepting HPV-16 positive, you know, are fully enrolled, maybe. Then if you can share with us the sample size of the study and the interim analysis, PFS analysis that, you know, what are the underlying assumptions of separation between the two arms?

[Kirk Shepard, CMO at PDS Biotechnology]

Yeah. 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. We're happy to say, too, even with the pause we had while talking to the FDA, we didn't lose one site. They're all excited by this therapy and ready to begin again. We're very happy about that.

[Kirk Shepard, CMO at PDS Biotechnology]

Also the fact that we figured out our timelines 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 gonna be involved in a VERSATILE-003 study, which is good because they know the workings of the protocol and the product, and we expect to have pretty, you know, brisk recruitment of the patients.

[Mayank Mamtani, Senior Managing Director at B. Riley Securities]

Got it. Thank you.

[Frank Bedu-Addo, CEO at PDS Biotechnology]

Mayank, I hope that answered your questions.

[Mayank Mamtani, Senior Managing Director at B. Riley Securities]

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.

[Frank Bedu-Addo, CEO at PDS Biotechnology]

No. We haven't made the sample size public yet, but the PFS, again, powered with high power to detect statistically significant changes in PFS, one at completion of recruitment and the other about six months later. Both provide high power to detect statistically significant differences between the two arms.

[Mayank Mamtani, Senior Managing Director at B. Riley Securities]

Okay, great. Thank you, Frank and Kirk.

[Kirk Shepard, CMO at PDS Biotechnology]

You're welcome.

[Operator]

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

[Frank Bedu-Addo, CEO at PDS Biotechnology]

Thank you. 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.

[Operator]

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

Participants

Executives

• Frank Bedu-Addo, CEO
• Kirk Shepard, CMO
• Lars Boesgaard, CFO

Analysts

• Josh Korsen, Analyst at H.C. Wainwright
• Mayank Mamtani, Senior Managing Director at B. Riley Securities
• Mike Moyer, Managing Director at LifeSci Advisors