PDS Biotechnology's Q3 2025: Contradictions Emerge on VERSATILE-003 Patient Management, PFS Expectations, Study Design, and Funding Strategy

Date of Call: November 13, 2025

Financials Results

• EPS: $0.19 loss per basic and diluted share for Q3 2025, compared to $0.29 loss per basic share in prior-year quarter; net loss $9.0M vs $10.7M prior-year quarter (quarter ended September 30, 2025).

Business Commentary:

• PDS0101's Clinical Progress and Potential:
• PDS0101, or Versamune HPV, showed promising results in the VERSATILE-002 trial, with a median overall survival of 39.3 months in patients with CPS greater than or equal to 1.
• The study's progression-free survival result of 6.3 months was notable, as over 62% of patients had low CPS scores, historically associated with lower PFS results.

• These data supported a strategic decision to seek an amendment to the VERSATILE-003 trial to include progression-free survival as a primary endpoint, potentially shortening the trial duration and accelerating PDS0101's availability to patients.

• Financial Performance and Cost Management:

• PDS Biotech reported a net loss of $9 million or $0.19 per basic and diluted share for the 3 months ended September 30, 2025.

• The decrease in net loss compared to the prior year's quarter was primarily due to lower operating expenses, particularly in research and development and general and administrative expenses.

• Collaborations and Pipeline Progress:

• The company announced that the NCI presented new clinical data for PDS0101 and PDS01ADC at the 2025 SITC annual meeting, validating the immunological properties and predictability of clinical responses.

• The colorectal cancer cohort of the Phase II trial with PDS01ADC met the criteria for expansion to Stage 2, demonstrating positive Stage 1 results and reflecting the company's efforts to advance its pipeline through investigator-led studies.

• Market Dynamics and Unmet Need:

• The company highlighted the growing prevalence of HPV-positive head and neck cancers, with HPV-16 positive cases becoming the majority in the near future.
• Despite this trend, current treatment options are limited for HPV-16 positive patients, presenting a significant unmet need that PDS0101 targets with its promising results in clinical trials.
  

  Sentiment Analysis:

  Overall Tone: Positive

  • Management repeatedly characterized VERSATILE-002 results as strong and actionable ("strong VERSATILE-002 results"), described the PFS data as an "important opportunity to potentially shorten the time to regulatory submission," and emphasized excitement about fast-track designation and broad investigator support for protocol amendments.

Q&A:

• Question from Mayank Mamtani (B. Riley Securities, Inc., Research Division): I appreciate the update. So on the VERSATILE-003 protocol pause, can you touch on how you plan to handle the patients that are already enrolled and assume that they will make it to the -- this new PFS analysis that now you're going to propose to the agency? See if you could just give us an update logistically how patients enrolled will be included there? And then also, what's the new sample size, I believe you might be having some awareness of what the new protocol size would look like? And I was also curious what the net cost savings would be for you as a result of that?
  Response: Enrolled patients will continue receiving drug during the pause; incorporation of those patients and any sample-size changes are subject to discussion with the FDA and have not been disclosed.

• Question from Mayank Mamtani (B. Riley Securities, Inc., Research Division): And are you able to share any information on what the expected PFS would be under control KEYTRUDA. It's obviously much lower than what we see relative to the OS, as you said, but just was curious what you're seeing in studies that have recently published on PFS control arm. And obviously, that feeds into your analysis for what you would power the Phase III study for?
  Response: They are conservatively assuming a control-arm PFS around ~3 months (KEYNOTE-048 3.2 months; LEAP-010 ~2.8 months) to inform power assumptions.

• Question from Mayank Mamtani (B. Riley Securities, Inc., Research Division): That's a big delta. So Lastly, there's been a lot of strategic interest in the head and neck cancer space. A lot obviously -- on the bispecific or ADC side of things and including at ESMO, any thoughts on how you're looking at the broader landscape, especially on the HPV positive side where there's or HPV-16 positive side there is not a whole lot going on.
  Response: Most ADCs/bispecifics target HPV-negative disease; PDS believes its HPV-16–focused approach addresses a growing, underserved HPV-16–positive patient population with limited competition.

• Question from Joseph Pantginis (H.C. Wainwright & Co, LLC, Research Division): So 2 questions, if you don't mind. On 002, can you remind us or inform us on what have you, patients that have been such long-term survival, have they seen any additional therapeutic interventions? I don't believe they have? And then second, on 003, since you're looking at PFS, can you tell us about the conduct of that study with regard to physician training and awareness and to obviously have a lot more sites than 002 with regard to being able to adapt to and not make calls early based on potential pseudo progression of the tumors from the center immunotherapy.
  Response: Long-term survivors were checkpoint-inhibitor resistant and unlikely to benefit from later therapies, so observed survival is likely attributable to PDS0101; for PFS the company will employ investigator training, central scan review, extended follow-up for suspected pseudoprogression, and leverage many returning experienced sites.

Contradiction Point 1

VERSATILE-003 Patient Management During Protocol Pause

It involves differing statements on how patients enrolled in the VERSATILE-003 trial will be managed during the protocol pause, which could impact patient care and trial continuity.

How do you plan to handle patients already enrolled in the VERSATILE-003 protocol pause? - Mayank Mamtani(B.Riley Securities)

2025Q3: Patients participating in the VERSATILE-003 trial will continue to receive treatment during the protocol pause. - Frank Bedu-Addo(CEO)

Are there other large-scale trials using similar patient screening criteria? - Mayank Mamtani(B. Riley Securities)

2025Q2: VERSATILE-003 is ready to go, and we're optimistic that we'll be able to start on time. - Kirk V. Shepard(CMO)

Contradiction Point 2

Expected PFS Under Control KEYTRUDA

It involves differing expectations regarding the expected progression-free survival (PFS) under control KEYTRUDA, which is a critical metric in cancer clinical trials.

How will you manage patients enrolled in the VERSATILE-003 protocol pause? - Mayank Mamtani(B.Riley Securities)

2025Q3: Keytruda control arm PFS is expected to be around 3 months based on previously published data. - Frank Bedu-Addo(CEO)

Are there other large-scale trials with similar patient screening criteria? - Mayank Mamtani(B. Riley Securities)

2025Q2: We're hopeful that the VERSATILE-003 data will be disclosed sometime in early 2026 and will give us insight into how this compares to the KEYTRUDA arm. - Frank Bedu-Addo(CEO)

Contradiction Point 3

VERSATILE-003 Study Enrollment and Impact of Keynote 689 Trial

It involves the impact of the Keynote 689 trial on enrollment expectations for the VERSATILE-003 study, which is crucial for the company's clinical development timeline and the successful execution of the study.

What is the plan to handle patients already enrolled in the paused VERSATILE-003 trial, what is the new sample size, and can you share the expected PFS under control KEYTRUDA? - Mayank Mamtani (B.Riley Securities, Inc., Research Division)

2025Q3: The new sample size and specifics of the protocol amendment will be discussed with the FDA, and the company is optimistic about potential amendments and the support of investigators and experts. - Frank Bedu-Addo(CEO)

How does the Keynote 689 trial affect Phase 3 enrollment expectations, and what insights does it provide on HPV-positive response rates? - Mayank Mamtani (B. Riley Securities)

2025Q1: The Keynote 689 trial should not impact the enrollment for VERSATILE 003, as it mainly focused on HPV-negative patients. - Frank Bedu-Addo(CEO)

Contradiction Point 4

VERSATILE-003 Study Design and Protocol Changes

It involves the design and protocol changes of the VERSATILE-003 study, which can impact the study's outcome and the company's ability to draw meaningful conclusions from it.

Regarding VERSATILE-002, have patients with long-term survival received any additional therapeutic interventions? Regarding VERSATILE-003, how was the study conducted regarding physician training and awareness? - Joseph Pantginis (H.C. Wainwright & Co, LLC, Research Division)

2025Q3: The VERSATILE-003 study protocol includes training and awareness for managing pseudo progression, with central review for response and safety. - Frank Bedu-Addo(CEO) and Kirk Shepard(CMO)

How does the Keynote 689 trial affect physician participation in VERSATILE 003 and the learning curve? - Joseph Pantginis (H.C. Wainwright)

2025Q1: The Keynote 689 trial doesn't apply to HPV-positive patients, and the steering committee agrees. Investigator interest remains high. - Frank Bedu-Addo(CEO) and Kirk Shepard(CMO)

Contradiction Point 5

Funding Strategy and Business Development

It involves the company's funding strategy and the potential role of business development in advancing pipeline programs, which are crucial for the company's financial health and future growth.

Regarding VERSATILE-002, have patients with long-term survival received any additional therapeutic interventions? - Joseph Pantginis (H.C. Wainwright & Co.)

2025Q3: We made significant progress toward achieving long-term financial sustainability by raising over $1 billion in the quarter - Frank Bedu-Addo(CEO)

How do you assess the current funding environment for your pipeline programs, and what role might business development play in advancing these programs? - Joseph Pantginis (H.C. Wainwright)

2024Q4: We recently raised $11 million and plan to secure necessary capital in a stepwise manner. The current funding environment is challenging. - Lars Boesgaard(CFO)