PDS Biotechnology Corporation

Greetings and welcome to the PDS Biotech fourth quarter 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.

Thank you, operator. Good morning, everyone, and welcome to PDS Biotech's fourth quarter 2025 results and clinical programs update call. I'm joined on a call today by the following members of the company's management team. Dr. Frank Badu-Addo, Chief Executive Officer, Dr. Kirk Shepard, Chief Medical Officer, and Lars Bosgaard, Chief Financial Officer. Dr. Badu-Addo will begin with an overview of the company's recent highlights in its clinical development program. Dr. Shepard will review the data and rationale behind the amendment the company recently adopted to its Phase III Versatile 003 trial, and Mr. Bosgaard will review The financial results for the quarter ended December 31st, 2025. Following management's prepared remarks, we will open the call to 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 statement 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. Badua Do, Frank.

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 Biotech, 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 Bursetel 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. For patients living with HPV16-positive head and neck cancer, a disease with significant and growing unmet need, we believe PDS-0101 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-01-ADC, 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 filled at least two prior treatments, the combination of PDS-01-ADC and standard-of-care docetaxel demonstrated encouraging and durable median progression pre-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. These findings reinforce the potential of PDS01-ADC 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 PDS01-ADC as a key component of our immuno-oncology pipeline. Since we last spoke with you, we also strengthened the intellectual property estate for PDS01-01 with new patents granted in the United States and Japan. The new U.S. patent, combined with anticipated biologics exclusivity for PDS-0101, 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 Shepherd, our Chief Medical Officer. Kirk?