PDS Biotechnology(US:PDSB)2025-11-13 14:00Financial 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]