PDS Biotechnology(PDSB)2024-11-14 21:05Clinical Trial Results - The combination of Versamune®HPV and PDS01ADC resulted in a median overall survival of approximately 20 months in a Phase 2 trial for ICI resistant patients, compared to historical median survival of 3-4 months[93]. - In November 2023, updated survival data showed a 75% survival rate at 36 months for ICI naïve patients in the NCI-led Phase 2 trial involving Versamune®HPV, PDS01ADC, and an investigational immune checkpoint inhibitor[100]. - The VERSATILE-002 Phase 2 clinical trial has completed enrollment for both ICI naïve and ICI resistant arms, evaluating the efficacy and safety of Versamune®HPV in combination with Keytruda®[102]. - The company presented data at the 2023 American Society of Clinical Oncology showing a 41.2% confirmed and unconfirmed response rate in patients treated with Versamune®HPV and Keytruda®, compared to approximately 19% for approved ICIs[106]. - The estimated 12-month overall survival rate for the ICI naïve cohort was 87.1%, compared to published results of 36-50% for approved ICIs used alone[110]. - The median progression-free survival (PFS) for the ICI naïve cohort was 10.4 months, while published results for approved ICIs as monotherapy are 2-3 months[110]. - The confirmed overall response rate (ORR) for the ICI naïve cohort was 41.2%, with 26.5% of patients having confirmed responses[110]. - The 24-month overall survival rate for the combination of Versamune® HPV and Keytruda® was 74%, significantly higher than the published rate of less than 30% for approved ICIs[112]. - The median overall survival for the ICI naïve cohort with CPS > 1 was 30 months, compared to published results for ICIs of 7-18 months[113]. - The confirmed overall response rate (ORR) for the ICI naïve cohort was 34%, exceeding the published results of less than 20% for comparable patients receiving ICIs[113]. - The median overall survival (mOS) was reported as 30 months, with a lower 95% confidence interval of 19.7 months, while published mOS for pembrolizumab is 12-18 months[118]. - The disease control rate (DCR) was 77%, with 21% of patients experiencing deep tumor responses and shrinkage of 90-100%[118]. - The company announced a two-part registrational trial focused on the double combination of Versamune® HPV and pembrolizumab for first-line treatment in HPV16-positive recurrent/metastatic HNSCC[114]. - The company plans to initiate a registrational study in first-line treatment in HPV16-positive recurrent/metastatic HNSCC with the double combination of Versamune® HPV and pembrolizumab[116]. - 100% of patients treated with Versamune® HPV and CRT had an objective response, and 89% demonstrated a complete response on Day 170[127]. - The combination of Versamune® HPV and CRT resulted in 81.3% ctDNA clearance after 3 weeks compared to 30.3% with SOC CRT alone (p=0.0018)[128]. - 91.7% ctDNA clearance was observed at 5 weeks with Versamune® HPV plus CRT versus 53.1% with SOC (p=0.0179)[128]. Financial Performance - The company reported net losses of 32.0 million for the nine months ended September 30, 2024 and 2023, respectively[145]. - As of September 30, 2024, the company had 6.8 million for Q3 2024, up from 3.4 million for Q3 2024, down from 10.2 million, a decrease of 3% from 18.0 million, down 11% from 10.9 million, a decrease of 11% from 10.7 million, a slight improvement from a net loss of 19.4 million during the nine months ended September 30, 2024[162]. - Interest expense increased to 0.8 million in the same period of 2023[156]. - Net cash used in operating activities increased to 25.2 million in the same period of 2023, reflecting a 29.0 thousand for the nine months ended September 30, 2024, compared to 20.0 million for the nine months ended September 30, 2024, up from $5.6 million in the same period of 2023, primarily from the sale of common stock[178]. - The company has not generated any product revenue to date and does not expect to do so until regulatory approval and commercialization of product candidates are achieved[179]. - The company anticipates continued losses as it develops and seeks regulatory approvals for its product candidates, with expected increases in losses as operations continue[179]. - There is substantial doubt about the company's ability to continue as a going concern for at least 12 months from the issuance of the financial statements due to reliance on available financial resources[180]. - The company plans to finance its cash needs through equity or debt financings, collaborations, or strategic alliances, but there is no assurance that financing will be available on acceptable terms[180]. - The company has no material non-cancelable purchase commitments with service providers, operating on a cancelable purchase order basis[183]. - The company is exposed to interest rate risk due to a floating interest rate under its Loan and Security Agreement, but historical fluctuations in interest rates have not materially impacted its operations[190]. - Inflation has not had a material effect on the company's business, financial condition, or results of operations during the three months ended September 30, 2024[191]. Product Development and Pipeline - The proprietary combination of Versamune®HPV and PDS01ADC is designed to enhance T cell proliferation and longevity in the tumor microenvironment, addressing limitations of current therapies[93]. - The company executed an exclusive global license agreement with Merck KGaA for the tumor targeting IL-12 fused antibody drug conjugate, M9241, now known as PDS01ADC, in December 2022[93]. - In February 2023, the company completed a Type B meeting with the FDA regarding the clinical protocol for a potential registrational trial for the triple combination therapy[94]. - The investigational universal flu vaccine, PDS0202, demonstrated broad neutralization across multiple influenza strains, providing protection in animal studies presented in September 2023[95]. - The company has a growing pipeline of targeted cancer and infectious disease immunotherapies based on its Versamune® T cell activator technology[91]. - Interim data showed a decrease in PSA levels in all patients treated with PDS01ADC, with 61% experiencing at least a 60% decrease[137]. - The company is exploring the use of PDS01ADC in combination with other Versamune® based clinical candidates[139].