Financial Data and Key Metrics Changes - The net loss for the year ended December 31, 2025, was approximately $34.5 million or $0.74 per basic and diluted share, compared to a net loss of $37.6 million or $1.03 per basic and diluted share for the year ended December 31, 2024, indicating an improvement in financial performance [15] - Research and development expenses for the year ended December 31, 2025, were $19 million, down from $22.6 million in 2024, primarily due to decreases in manufacturing and personnel costs [15] - General and administrative expenses decreased to $12.5 million in 2025 from $13.8 million in 2024, reflecting a reduction in personnel costs [16] Business Line Data and Key Metrics Changes - The company reported encouraging early results from the PDS-01ADC trial, showing a median progression-free survival (PFS) of 9.6 months and a 40% decline in prostate-specific antigen (PSA) levels in patients with metastatic castration-resistant prostate cancer [5][6] - The VERSATILE-002 trial demonstrated a median overall survival of 39.3 months for patients with HPV-16 positive head and neck cancer, marking a significant clinical achievement [9] Market Data and Key Metrics Changes - The company highlighted the growing unmet need for effective therapies in HPV-16 positive cancers, which are rapidly increasing in the U.S. and EU due to low vaccination rates [12] - The company’s PDS0101 is positioned as the only subcutaneous injection product in late-stage development for recurrent and/or metastatic head and neck squamous cell carcinoma, offering a more convenient treatment option [11] Company Strategy and Development Direction - The company is focused on advancing PDS0101 as a promising treatment option for HPV-16 positive head and neck cancer, with an amended protocol for the VERSATILE-003 trial aimed at accelerating approval timelines [4][10] - The strategic decision to amend the VERSATILE-003 trial to include PFS as a primary endpoint is expected to shorten trial duration and reduce costs while maintaining overall survival as a basis for full approval [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of PDS0101 to provide a well-tolerated treatment option for the growing population of HPV-16 positive patients, emphasizing the lack of effective therapies currently available [14] - The company anticipates meaningful opportunities ahead as it continues to execute its priorities in 2026, supported by early data from the PDS-01ADC program and expanded patient protections [38] Other Important Information - The company has strengthened its intellectual property portfolio with new patents granted in the U.S. and Japan, extending market protection for PDS0101 into the 2040s [6] Q&A Session Summary Question: What will the revised enrollment target look like for the amended protocol? - The trial duration has been shortened to about a year for final results, with PFS being the interim analysis available in approximately a year and a half [20] Question: How should R&D expenses be expected for 2026 with the smaller trial design? - While specific financial guidance was not provided, R&D costs are expected to increase as the trial is reinitiated and patient enrollment begins [23] Question: How will patients already enrolled prior to the VERSATILE-003 pause be handled? - Patients who started on the trial will continue their treatment as indicated by the protocol, and they will be included in a special subset of the data for safety analysis [27] Question: What are the powering assumptions for the interim PFS and the new sample size for the phase III? - The sample size has not been made public yet, but the PFS is powered to detect statistically significant changes, with two analyses planned [34]

Financial Data and Key Metrics Changes - The net loss for the year ended December 31, 2025, was approximately $34.5 million or $0.74 per basic and diluted share, compared to a net loss of $37.6 million or $1.03 per basic and diluted share for the year ended December 31, 2024, indicating an improvement in financial performance [15] - Research and development expenses for the year ended December 31, 2025, were $19 million, down from $22.6 million in 2024, primarily due to decreases in manufacturing and personnel costs [15] - General and administrative expenses decreased to $12.5 million in 2025 from $13.8 million in 2024, reflecting a reduction in personnel costs [16] Business Line Data and Key Metrics Changes - The company reported encouraging early results from the PDS-01ADC trial, showing a median progression-free survival (PFS) of 9.6 months and a 40% median decline in prostate-specific antigen (PSA) levels in patients with metastatic castration-resistant prostate cancer [5][6] - The VERSATILE-002 trial demonstrated a median overall survival of 39.3 months for patients with HPV-16 positive head and neck cancer, marking a significant clinical achievement [9] Market Data and Key Metrics Changes - The company highlighted the growing unmet need for treatments in HPV-16 positive cancers, which are rapidly increasing in the U.S. and EU due to low vaccination rates [12] - The amendment to the VERSATILE-003 trial protocol aims to accelerate the availability of PDS0101 to the growing population of HPV-16 positive patients [11] Company Strategy and Development Direction - The company is focused on advancing PDS0101 as a promising treatment option for HPV-16 positive head and neck cancer, with a strategic amendment to the VERSATILE-003 trial to include PFS as a primary endpoint [4][10] - The company has strengthened its intellectual property portfolio with new patents granted in the U.S. and Japan, extending market protection into the 2040s [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of PDS0101 to provide a well-tolerated treatment option without chemotherapy for HPV-16 positive patients, who currently lack effective therapies [14] - The company anticipates meaningful opportunities ahead as it continues to execute its priorities in 2026, particularly with the early data from the PDS-01ADC program [38] Other Important Information - The company emphasized the convenience of PDS0101 as a subcutaneous injection requiring only five doses, compared to over twenty doses for most therapeutic approaches [12] Q&A Session Summary Question: What will the revised enrollment target look like for the amended protocol? - The trial duration has been shortened to about a year for final results, with the interim analysis for PFS expected in approximately a year and a half [20] Question: How should R&D expenses be expected for 2026 with the smaller trial design? - While specific financial guidance was not provided, R&D costs are expected to increase once the trial is reinitiated, commensurate with site openings and patient enrollment [23] Question: How will patients already enrolled prior to the VERSATILE-003 pause be handled? - Patients who started on the trial will continue their treatment as indicated by the protocol, and they will be included in a special subset of the data for safety [27] Question: What is the expected enrollment pace based on last year's execution? - The enrollment pace is expected to be robust due to positive responses from sites and less competition compared to when the trial first began [29] Question: Can you share the powering assumptions for the interim PFS and the new sample size for the phase III? - The sample size has not been made public yet, but the PFS is powered to detect statistically significant changes, with two interim analyses planned [34]

Financial Data and Key Metrics Changes - The net loss for the year ended December 31, 2025, was approximately $34.5 million or $0.74 per share, compared to a net loss of $37.6 million or $1.03 per share for the year ended December 31, 2024, indicating an improvement in financial performance [15] - Research and development expenses decreased to $19 million in 2025 from $22.6 million in 2024, primarily due to reductions in manufacturing and personnel costs [15] - General and administrative expenses also decreased to $12.5 million in 2025 from $13.8 million in 2024, reflecting a reduction in personnel costs [16] Business Line Data and Key Metrics Changes - The company reported encouraging early results from the PDS-01ADC trial, showing a median progression-free survival (PFS) of 9.6 months and a 40% decline in prostate-specific antigen (PSA) levels in patients with metastatic castration-resistant prostate cancer [5][6] - The VERSATILE-002 trial demonstrated a median overall survival of 39.3 months for patients with HPV-16 positive head and neck cancer, marking a significant clinical achievement [9] Market Data and Key Metrics Changes - The company highlighted the growing unmet need for treatments in HPV-16 positive head and neck cancer, which is rapidly increasing in the U.S. and EU due to low vaccination rates [12] - The amendment to the VERSATILE-003 trial protocol aims to accelerate the regulatory submission process, addressing the urgent need for effective therapies in this patient population [11] Company Strategy and Development Direction - The company is focused on advancing PDS0101 as a promising treatment option for HPV-16 positive head and neck cancer, with a strategic amendment to the VERSATILE-003 trial to include PFS as a primary endpoint [4][10] - The company has strengthened its intellectual property portfolio, extending market protection for PDS0101 into the 2040s, which is expected to enhance its competitive position [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of PDS0101 to provide a well-tolerated treatment option without chemotherapy for the growing population of HPV-16 positive patients [14] - The company anticipates meaningful opportunities ahead as it continues to execute its priorities in 2026, with a focus on clinical development and regulatory progress [38] Other Important Information - The company has received new patents in the U.S. and Japan for PDS0101, enhancing its market exclusivity and competitive edge [6] - The cash balance as of December 31, 2025, was reported at $26.7 million, providing a financial cushion for ongoing operations [16] Q&A Session Summary Question: What will the revised enrollment target look like for the amended protocol? - The trial duration has been shortened to about a year for final results, with the interim analysis for PFS expected in approximately a year and a half [20] Question: How should R&D expenses be expected for 2026 with the smaller trial design? - While specific financial guidance was not provided, R&D costs are expected to increase as the trial is reinitiated and sites are opened [23] Question: How will patients already enrolled prior to the VERSATILE-003 pause be handled? - Patients will continue their treatment as indicated by the protocol and will be included in a special subset for safety analysis [27] Question: What is the expected enrollment pace based on last year's execution? - The enrollment pace is expected to be robust due to positive responses from sites and reduced competition in the market [28] Question: Can you share the powering assumptions for the interim PFS and the new sample size for the phase III? - The sample size has not been made public yet, but the PFS analysis is powered to detect statistically significant changes [34]

Filed Phase 3 Amendment Incorporates PFS as Interim Primary Endpoint Expected to Shorten Trial Duration and Reduce Costs Conference Call and Webcast Today at 8:00 am Eastern Time PRINCETON, N.J., March 30, 2026 (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 provided a business and clinical programs update and reported financial results for the ...

Core Viewpoint - PDS Biotechnology Corporation is set to host a conference call and webcast on March 30, 2026, to report its financial results for the year ended December 31, 2025, and provide updates on clinical programs and corporate developments [1]. Group 1: Conference Call Details - The conference call is scheduled for March 30, 2026, at 8:00 a.m. Eastern Time [2]. - Dial-in numbers include 1-877-704-4453 for domestic calls and 1-201-389-0920 for international calls [2]. - The event will be archived on PDS Biotech's website for six months following the live webcast [2]. Group 2: Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on enhancing the immune system's ability to target and eliminate cancers [3]. - The company has initiated a pivotal clinical trial for its lead program targeting advanced HPV16-positive head and neck squamous cell cancers [3]. - PDS0101, the lead investigational targeted immunotherapy, is being developed in combination with a standard immune checkpoint inhibitor and in a triple combination with PDS01ADC, an IL-12 fused antibody drug conjugate [3].

Financial Data and Key Metrics Changes - The company reported a net loss of $9 million or $0.19 per basic and diluted share for Q3 2025, compared to a net loss of $10.7 million or $0.29 per basic share in the prior year's quarter, indicating a decrease in net loss primarily due to lower operating expenses [15][16] - Research and development expenses were $4.6 million for Q3 2025, down from $6.8 million in the prior year, attributed to lower manufacturing and clinical expenses [16] - General and administrative expenses increased to $3.6 million in Q3 2025 from $3.4 million in the prior year, mainly due to higher professional fees [16] - Total operating expenses were $8.1 million for Q3 2025, down from $10.2 million in the prior year [17] - Cash balance as of September 30, 2025, was $26.2 million, down from $41.7 million at the beginning of the year [17] Business Line Data and Key Metrics Changes - The VERSATILE-002 trial showed a median overall survival of 39.3 months for patients with a combined positive score (CPS) of greater than or equal to one, with a progression-free survival (PFS) of 6.3 months among these patients [5][6] - The company plans to amend the VERSATILE-003 trial to include PFS as a primary endpoint alongside median overall survival, based on the strong data from VERSATILE-002 [8][9] Market Data and Key Metrics Changes - The company highlighted that HPV-positive head and neck cancer is becoming a significant medical issue, with over 90% of HPV-positive oropharyngeal cancers being HPV-16 positive [11][30] - Recent market research indicates a growing incidence of HPV-positive head and neck cancer, with traditional causes like tobacco and alcohol declining [30] Company Strategy and Development Direction - The company is focusing on HPV-16 positive head and neck cancer, believing it will become the dominant type of head and neck cancer in the next decade [30][31] - The company is engaging with the FDA to discuss amendments to the VERSATILE-003 trial protocol, aiming to potentially shorten the time to regulatory submission while maintaining median overall survival as an endpoint for full approval [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of PDS0101 as a well-tolerated treatment option for HPV-16 positive patients, who currently lack effective therapies [11][30] - The management noted that the industry is recognizing the growing problem of HPV-positive head and neck cancer, which is reflected in recent publications and market research [10][30] Other Important Information - The National Cancer Institute presented new clinical data at the 2025 Society for Immunotherapy of Cancer meeting, validating the scientific basis of the company's immunotherapy platforms [12][13] - The colorectal cancer cohort of the phase two clinical trial with PDS01ADC met criteria for expansion to stage two following positive results [13] Q&A Session Summary Question: How will the company handle patients already enrolled in the VERSATILE-003 trial during the protocol pause? - The company will continue to treat patients already enrolled in the trial and will discuss their incorporation into the trial with the FDA [20][22] Question: What is the expected PFS for the control Keytruda? - The company conservatively assumes that the PFS in the control arm will be around three months, based on previous studies [26][27] Question: How is the company addressing physician training and awareness regarding pseudoprogression in the VERSATILE-003 study? - The company has trained investigators to recognize pseudoprogression and will conduct central reviews of scans to ensure accurate assessments [39][40]

Core Viewpoint - PDS Biotechnology Corporation has completed the VERSATILE-002 Phase 2 trial for PDS0101 in combination with pembrolizumab, showing promising results that lead the company to seek an expedited approval pathway in the ongoing VERSATILE-003 Phase 3 trial [1][2][3]. Clinical Update - The VERSATILE-002 trial demonstrated a median overall survival (mOS) of 39.3 months for patients with CPS ≥ 1, with a 95% confidence interval lower limit of 23.9 months [4]. - Progression-free survival (PFS) was reported at 6.3 months for the same patient group [4]. - The company plans to amend the ongoing VERSATILE-003 trial to potentially reduce its size while maintaining statistical power, with mOS remaining the primary endpoint for full FDA approval [4][3]. Financial Results - For Q3 2025, the company reported a net loss of $9.0 million, or $0.19 per share, a decrease from a net loss of $10.7 million, or $0.29 per share, in Q3 2024 [5][16]. - Research and development expenses were $4.6 million, down from $6.8 million in the same quarter of the previous year, attributed to lower manufacturing and clinical expenses [6][16]. - General and administrative expenses increased to $3.6 million from $3.4 million year-over-year, primarily due to higher professional fees [7][16]. Cash Position - As of September 30, 2025, the company's cash balance was $26.2 million, a decrease from $41.7 million as of December 31, 2024 [8][15]. - The company raised approximately $5.3 million by selling 5,800,000 shares and accompanying warrants on November 12, 2025 [9]. Additional Clinical Developments - The National Cancer Institute presented new clinical data at the 2025 Society for Immunotherapy of Cancer Annual Meeting, highlighting the immunological properties of PDS0101 and PDS01ADC [4]. - Preliminary results from the colorectal cancer cohort of the Phase 2 clinical trial with PDS01ADC met the criteria for expansion to Stage 2, confirming at least 6 of 9 objective responses [4].

Core Insights - PDS Biotechnology Corporation announced positive clinical and translational data for its investigational immunotherapies PDS0101 and PDS01ADC at the 2025 Society for Immunotherapy of Cancer Annual Meeting, highlighting their potential in treating advanced cancers [1][3][13] Group 1: Clinical Data and Presentations - The studies were conducted under a collaborative research and development agreement with the National Cancer Institute, featuring one rapid oral abstract and two poster presentations at SITC 2025 [2] - PDS0101 demonstrated strong clinical activity across three phase 2 trials, establishing a link between immune signatures and clinical response, supporting future biomarker-guided optimization [6][4] Group 2: Mechanisms of Action - PDS01ADC reprograms natural killer (NK) cells to enhance their cancer-killing capabilities and promotes the generation of stem cell-like killer T cells and memory T cells, contributing to long-lasting anti-tumor activity [8][11] - Analysis of 50 patients with advanced HPV16-positive cancers showed significant immune activation and increases in pro-inflammatory cytokines, which are crucial for T cell recruitment and potency [9] Group 3: Future Development and Trials - PDS Biotech is advancing PDS0101 in a phase 3 clinical trial in combination with Keytruda for HPV16-positive recurrent/metastatic head and neck cancer, while PDS01ADC is being evaluated in multiple phase 2 trials for various cancer types [13][17] - The findings from SITC 2025 strengthen the scientific foundation of the company's immunotherapy platforms and support ongoing regulatory and clinical milestones [13][17]

Core Insights - PDS Biotechnology Corporation announced that the National Cancer Institute (NCI) will present new clinical data at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting, focusing on its investigational immunotherapy platforms [1][4] - The presentations will include three abstracts that highlight clinical and translational findings related to PDS Biotech's immunotherapy candidates, including PDS0101 and PDS01ADC [1][4] Company Overview - PDS Biotechnology is a late-stage immunotherapy company dedicated to transforming immune system responses to cancer [4] - The company is advancing its lead program, PDS0101, in pivotal clinical trials for treating advanced HPV16-positive head and neck squamous cell cancers [5] Clinical Data Presentation - The NCI will present three abstracts at SITC, including: 1. Early changes in serum proteomic profiles predicting anti-tumor activity in patients with advanced HPV-associated malignancies [3] 2. A tumor-targeting IL-12 immunocytokine therapy that increases peripheral natural killer (NK) cells associated with enhanced tumor cell lysis [3] 3. Increases in peripheral memory T cells with self-renewing properties in patients treated with IL-12 immunocytokine therapy [3] Leadership Commentary - The CEO of PDS Biotechnology expressed optimism about the collaboration with NCI and the potential of their platforms to enhance immune system recognition and elimination of cancer [2]