First combination therapy to report 29.5 months of Median Overall Survival (mOS); Standard of care Keytruda® (pembrolizumab) alone (10.8 months) and Keytruda® + chemotherapy (12.3 months) in patients with CPS 1-19* Encouraging efficacy signal observed in difficult to treat category of advanced head and neck cancer patients PRINCETON, N.J., Sept. 18, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transformi ...

PRINCETON, N.J., Sept. 02, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced that the Company will participate in the 27th Annual H.C. Wainwright Global Investment Conference, to be held in New York, NY and virtually September 8-10, 2025. Frank Bedu-Addo, Ph.D., Chief Executive Officer, and Lars Boesgaard, Chief Financial Officer, w ...

Core Insights - PDS Biotechnology Corporation announced final topline survival data from its VERSATILE-002 Phase 2 clinical trial, showing a median overall survival (mOS) of 39.3 months in patients with CPS ≥ 1, significantly outperforming the best published result of 17.9 months with standard care pembrolizumab or pembrolizumab + chemotherapy [1][2][7] Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on transforming immune system responses to cancer, particularly through its lead investigational product PDS0101 (Versamune HPV) [5] - The company is advancing its lead program in advanced HPV16-positive head and neck squamous cell cancers, with ongoing pivotal clinical trials [5] Clinical Trial Details - The VERSATILE-002 trial is an open-label, multi-center Phase 2 study evaluating the safety and efficacy of PDS0101 in combination with pembrolizumab for unresectable, recurrent or metastatic HPV16-positive head and neck squamous cell cancer [4] - The trial enrolled 53 patients, with PDS0101 administered via subcutaneous injection alongside IV infusion of pembrolizumab during the first four treatment cycles [7] Survival Data and Efficacy - The mOS of 39.3 months was achieved in patients with CPS ≥ 1, with a 95% confidence interval lower limit of 23.9 months [7] - The durable patient survival is attributed to high levels of long-lasting, multifunctional HPV16-specific CD8+ T cells induced by PDS0101, consistent across various patient demographics and clinical characteristics [7] Market Position and Future Outlook - PDS Biotech is positioned for leadership in the rapidly growing segment of HPV16-positive head and neck cancer, addressing a significant unmet medical need [3] - The combination therapy of PDS0101 and pembrolizumab is reported to be well tolerated, with no patients discontinuing due to treatment-related adverse events [3]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to _____________ Commission file number 001-37568 PDS Biotechnology Corporation (Exact name of registrant as specified in its charter) (State or othe ...

PDS Biotechnology (PDSB) Q2 2025 Earnings Call August 13, 2025 08:00 AM ET Speaker0Welcome to the PGS Biotech's Second Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce Mike Moyer with LifeSci Advisors.Thank you. You may begin.Speaker1Thank you, operator. Good morning, everyone, and welcome to PDS ...

Exhibit 99.1 PDS Biotech Reports Second Quarter 2025 Financial Results and Provides Clinical Programs Update Multiple Abstracts Presented at the 2025 American Society of Clinical Oncology Annual Meeting Conference call and webcast today at 8:00 a.m. Eastern Time PRINCETON, N.J., August 13, 2025 -- PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late- stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today provided a business ...

Core Insights - PDS Biotechnology Corporation reported a net loss of $9.4 million for Q2 2025, an increase from $8.3 million in Q2 2024, primarily due to higher net interest expenses [5][8] - The company is advancing its VERSATILE-003 Phase 3 clinical trial for PDS0101 (Versamune HPV) targeting HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma [3][11] - PDS Biotech presented three abstracts at the 2025 American Society of Clinical Oncology (ASCO) annual meeting, showcasing positive data from the VERSATILE-002 trial [10] Financial Performance - The reported net loss for Q2 2025 was $9.4 million, or $0.21 per share, compared to a loss of $8.3 million, or $0.23 per share, in Q2 2024 [5][16] - Research and development expenses decreased to $4.2 million in Q2 2025 from $4.5 million in Q2 2024, attributed to lower personnel costs [6] - General and administrative expenses also fell to $3.4 million in Q2 2025 from $4.2 million in Q2 2024, mainly due to reduced personnel costs and professional fees [7] Cash Position and Debt - As of June 30, 2025, the company's cash balance was $31.9 million, down from $41.7 million at the end of 2024 [8][15] - Long-term debt increased to $12.9 million as of June 30, 2025, compared to $9.2 million at the end of 2024 [15] Clinical Trials and Developments - The VERSATILE-003 trial is the only registrational stage trial specifically targeting HPV16-positive head and neck cancer patients [3][11] - The colorectal cancer cohort in the Phase 2 clinical trial with PDS01ADC met criteria for expansion to Stage 2 following positive Stage 1 results [10] - The company plans to publish the full data set for the VERSATILE-002 trial later this year [3]

Core Insights - PDS Biotechnology Corporation has completed patient recruitment for Stage 1 of a clinical trial for its PDS01ADC therapeutic in combination with floxuridine for metastatic colorectal cancer, leading to an expansion into Stage 2 of the study [1][2] Group 1: Clinical Trial Details - The trial is an open-label, single-center, non-randomized Phase 2 study with three cohorts: metastatic colorectal cancer, cholangiocarcinoma, and adrenocortical cancer [2] - The colorectal cancer cohort achieved the milestone of at least 6 out of 9 participants showing an objective response, allowing enrollment to continue up to 22 participants [2] - The study is conducted under a collaborative research and development agreement with the National Cancer Institute (NCI) [2] Group 2: Product Information - PDS01ADC is a fused antibody drug conjugate that targets tumor necrosis by binding to exposed DNA [3] - The investigational approach aims to minimize systemic exposure to IL-12, potentially reducing treatment-limiting toxicities [4] Group 3: Market Context - Colorectal cancer is a significant health issue, with over 930,000 deaths globally in 2020, highlighting the need for more effective treatments [4] - In the U.S., over 150,000 new cases of colorectal cancer are diagnosed annually, with 20% already metastatic at diagnosis [4]

Summary of PDS Biotechnology (PDSB) Update / Briefing June 17, 2025 Company and Industry Overview - **Company**: PDS Biotechnology (PDSB) - **Industry**: Oncology, specifically focusing on HPV16 positive recurrent metastatic head and neck squamous cell carcinoma Key Points and Arguments 1. **Clinical Trials and Data Presentation**: - PDSB presented data from the VERSATILE-two trial at the ASCO annual meeting, showing a median overall survival of **30 months** for patients treated with Versamune HPV plus pembrolizumab [3][4][39] - The ongoing VERSATILE-three trial is evaluating the combination of Versamune HPV plus pembrolizumab against pembrolizumab alone in a pivotal Phase III study [4][42] 2. **Unmet Medical Need**: - The incidence of HPV positive head and neck cancers, particularly HPV16, is rising and is projected to remain high for decades, indicating a significant unmet medical need [9][19] - HPV16 positive cancers may have worse prognoses compared to other HPV types, necessitating targeted therapies [15][19] 3. **Patient Demographics and Treatment Response**: - The patient population affected by HPV related head and neck cancer tends to be younger and has fewer comorbidities compared to those with HPV negative cancers [24][25] - The VERSATILE-two trial showed a **35.8% overall response rate** and a **77.4% disease control rate** among participants [39] 4. **Safety and Tolerability**: - The combination therapy was well tolerated, with most adverse events being grade one or two, and no deaths reported during the study [35][39] 5. **Future Directions**: - The VERSATILE-three trial aims to establish the efficacy of the combination therapy as a first-line treatment for HPV16 positive recurrent metastatic head and neck cancer [42] - A companion diagnostic tool is being developed to identify HPV16 positive patients, which will enhance treatment selection [44][65] Additional Important Insights 1. **Vaccination and Public Awareness**: - There is a need for increased public health efforts to promote HPV vaccination, especially among boys, to combat the rising incidence of HPV related cancers [72][74] - Disparities in vaccination rates, particularly in rural areas, contribute to the growing incidence of HPV related head and neck cancers [73] 2. **Competitive Landscape**: - The VERSATILE-three trial is positioned uniquely as it focuses on HPV16 positive patients, while many other ongoing studies primarily target HPV negative populations [51][52] 3. **Mechanistic Insights**: - The combination of Versamune HPV and pembrolizumab is expected to enhance immune response by generating new activated T cells, potentially improving outcomes in patients with low CPS scores [54][56] 4. **Long-term Outlook**: - The overall survival rates for patients in the VERSATILE-two trial are promising, with nearly **40% of patients alive after three years**, indicating the potential for durable responses and long-term management of the disease [38][39] This summary encapsulates the critical insights from the PDS Biotechnology briefing, highlighting the company's focus on addressing the unmet needs in HPV16 positive head and neck cancer through innovative clinical trials and therapies.

Core Viewpoint - PDS Biotechnology Corporation is hosting a virtual event to discuss the evolving treatment landscape for recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) in light of the Merck KEYNOTE-689 study and the rising incidence of HPV16-positive HNSCC in the US and Europe [1][2]. Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on innovative treatments that enhance the immune system's ability to target and eliminate cancers [7]. - The company's lead investigational therapy, Versamune® HPV, is currently in a Phase 3 clinical trial in combination with pembrolizumab for first-line treatment of recurrent/metastatic HPV16-positive HNSCC [2][7]. Event Details - The event will feature key opinion leaders, including Kevin Harrington and Katharine A. Price, who will discuss the unmet needs in treating HPV16-positive HNSCC and the distinct characteristics of HPV-positive versus HPV-negative HNSCC [1][2][3]. - A live Q&A session will follow the formal presentations, allowing for direct engagement with the experts [3]. Clinical Trials and Research - Versamune® HPV is being evaluated in multiple clinical trials, including a Phase 3 trial in combination with pembrolizumab and Phase 2 trials for various HPV16-positive cancers [2]. - The event will also address the emerging treatment landscape for first-line recurrent/metastatic HNSCC and the differentiation between HPV-positive and HPV-negative cases [2]. Speakers' Expertise - Kevin Harrington is a leading authority on metastatic head and neck cancer and has significant experience in clinical trials related to HNSCC treatments [4]. - Katharine A. Price specializes in head and neck cancers and is involved in research aimed at improving treatment access and awareness regarding HPV vaccination [5].