PDS Biotechnology(US:PDSB)2025-11-13 21:08Clinical Trials and Research - The Company initiated the VERSATILE-003 Phase 3 clinical trial for PDS0101 (Versamune® HPV) in HPV16-positive first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma, aiming to enroll 351 patients[94]. - The colorectal cancer cohort of the Phase 2 trial with PDS01ADC met pre-defined criteria for expansion to stage 2 following positive stage 1 results[94]. - The estimated 12-month overall survival rate for the ICI naïve cohort in the VERSATILE-002 trial was 87.1%, significantly higher than the published results of 36-50% for approved ICIs used alone[105]. - The median progression-free survival (PFS) in the ICI naïve cohort was reported at 10.4 months, compared to published results of 2-3 months for approved ICIs[105]. - The disease control rate in the ICI naïve cohort was 70.6%, with a confirmed and unconfirmed objective response rate of 41.2%[105]. - The Company plans to investigate a triple combination of PDS0101 + PDS01ADC + pembrolizumab as a first-line treatment in HPV16-positive recurrent/metastatic HNSCC[107]. - The Company has requested a meeting with the FDA to seek an expedited pathway for the VERSATILE-003 trial, proposing to include progression-free survival as an early primary endpoint[96]. - The Company completed enrollment in the ICI naïve arm of the VERSATILE-002 trial in May 2023 and filed an amended IND with the FDA in Q3 2023[102]. - The Company reported that 60% of patients in the VERSATILE-002 trial had a CPS score of 1-19, indicating a generally weaker response to Keytruda®[105]. - The Company announced a temporary pause to VERSATILE-003 during the FDA's review of the proposed changes to the trial's design[96]. - Median Overall Survival (mOS) was 30 months, with a lower 95% confidence interval of 19.7 months; published mOS for pembrolizumab is 12-18 months[111]. - Objective Response Rate (ORR) of 36% (19/53); published ORR for pembrolizumab is 19-25%[111]. - Disease Control Rate (DCR) is 77% (41/53)[111]. - Median Progression-Free Survival (mPFS) was 6.3 months overall; 14.1 months for patients with CPS≥20[116]. - 75% of immune checkpoint inhibitor (ICI) naïve patients remain alive at 36 months; published median overall survival in similar patients is 7-11 months[117]. - Significant tumor shrinkage with confirmed ORR of 75% in HPV16-positive immune checkpoint inhibitor naïve patients; historically published result is 11-24%[122]. - Earlier and greater proportion of ctDNA clearance with PDS0101 plus chemoradiation (CRT) vs. SOC CRT alone (81.3% clearance after 3 weeks vs. 30.3% with SOC, p=0.0018)[123]. - Decrease in PSA levels was seen in all patients at all three tested doses of PDS01ADC, with 61% of patients having at least a 60% decrease in PSA levels[129]. - The combination of PDS0101 and Keytruda® appeared to be well tolerated, with 11% of patients experiencing Grade 3 treatment-related adverse events[110]. - 21% of patients had deep tumor responses and shrinkage of 90-100%[111]. Financial Performance - As of September 30, 2025, the company reported net losses of $26.9 million and $29.7 million for the nine months ended September 30, 2025 and 2024, respectively, with an accumulated deficit of $209.0 million[131][138]. - The company had $26.2 million in cash and cash equivalents as of September 30, 2025[132]. - Research and development expenses decreased to $4.6 million for the three months ended September 30, 2025, down from $6.8 million for the same period in 2024, representing a 33% decrease[142][143]. - General and administrative expenses increased to $3.6 million for the three months ended September 30, 2025, up from $3.4 million in 2024, a 6% increase[142][144]. - Total operating expenses for the three months ended September 30, 2025, were $8.1 million, a decrease of 20% from $10.2 million in 2024[142]. - The net loss for the three months ended September 30, 2025, was $9.0 million, a 16% improvement from the $10.7 million loss in 2024[142]. - For the nine months ended September 30, 2025, research and development expenses totaled $14.6 million, down 19% from $18.0 million in 2024[146][147]. - The company sold 2,237,941 shares of common stock for a net value of $3.0 million during the nine months ended September 30, 2025[152]. - The company expects significant increases in research and development expenses as it advances its clinical candidates and prepares for potential commercial launches[140]. - The company has not generated any revenues from commercial product sales and does not expect to do so in the near future[138]. - The company received $24.6 million in net proceeds from a Loan and Security Agreement with Horizon Technology Finance Corporation[153]. - Approximately $0.9 million was received from the net sale of tax benefits for tax year 2022[154]. - The company raised approximately $11 million in gross proceeds from the February 2025 Offering, with net proceeds of approximately $10.05 million[156]. - As of September 30, 2025, the company had $26.2 million in cash and cash equivalents, primarily used for operating expenses and research and development[159]. - Net cash used in operating activities was $24.0 million for the nine months ended September 30, 2025, a decrease from $26.8 million in 2024[165]. - The company anticipates continued losses as it develops and seeks regulatory approvals for its product candidates, with no product revenue generated to date[168]. - The company has substantial doubt about its ability to continue as a going concern for at least 12 months from the issuance of its financial statements[162]. - Net cash provided by financing activities decreased by $11.4 million for the nine months ended September 30, 2025, primarily due to a decrease in proceeds from the Loan and Security Agreement[167]. - The company plans to fund operations through existing cash and additional equity and/or debt financing, but there is uncertainty regarding the availability of such financing[161]. - The company has no material non-cancelable purchase commitments with service providers, operating on a cancelable basis[172].