PDS Biotechnology Corp Q2 FY2023 earnings call

• Progress on PDS0101: Filed the final VERSATILE-003 Phase III protocol. VERSATILE-002 trial had positive interim data with 87% 12-month overall survival, median progress-free survival of 10.4 months, and 71% disease control rate. Anticipate data updates on VERSATILE-002 cohorts and initiation of VERSATILE-003 Phase III trial in Q4 2023.
• PDS0301: Ongoing Phase II clinical studies, including with docetaxel in prostate cancer. Presentations at Cytokine 2023 and updates on survival data.
• Partnerships: Strong partnerships with NCI, MD Anderson, and Mayo Clinic for clinical trials, validating the science and advancing programs.

There is no detailed breakdown of financial performance by product segments as the transcript does not present separate revenue contributions or absolute financials for distinct product segments. Net loss for the three months ended June 30, 2023 was approximately $11.5 million compared to $5.8 million in the same period of 2022. Research and development costs increased to $8 million from $3.8 million, general and administrative expenses rose to $4.7 million from $3.3 million.

• Anticipate initiation of VERSATILE-003 Phase III trial in Q4 2023.
• Expect data updates on VERSATILE-002 cohorts late in Q3 2023 and final data in Q2 2024.
• Intend to file IND for PDS0103, MUC1 targeted immunotherapy, by end of 2023.
• Look forward to key data readouts and milestones in the remainder of 2023 and first half of 2024.

Q: Joe Pantginis asked about operational readiness for Phase III, targeted enrolment, and PDS0301 study with docetaxel, and influenza program.

A: Frank Bedu-Addo discussed activation of clinical sites, target enrolment between 200-300, ongoing ferret studies for influenza. Lauren Wood talked about concurrent dosing of PDS0301 and docetaxel, translational studies.

Q: Lucas Duffy asked about vision for Versamune platform and partnership with NIH.

A: Frank Bedu-Addo spoke about PDS0101 as proof of concept, plans for PDS0102 and 0103, and importance of partnerships with NCI, MD Anderson, Mayo Clinic for validation and trial progress.

Q: Kalpit Patel asked about updates for VERSATILE-002 trial and timing for Phase III submission.

A: Frank Bedu-Addo mentioned expecting updates on VERSATILE-002 later in Q3 2023 and 18-24 month accrual period for Phase III enrolment.

Q: Leland Gershell asked about accelerated approval potential for PDS0101 and timing for MUC1 study.

A: Frank Bedu-Addo discussed fast-track designation and interactions with FDA, and no timeline yet for MUC1 study data.

Q: Robert LaBoyer asked about design of VERSATILE-003 and timing for IND submission of triple combination.

A: Frank Bedu-Addo talked about primary endpoint of overall survival, and interactions with FDA for triple combination trial design.

Q: Laura Suriel asked about timing for completion of enrolment in VERSATILE-003 and data from NCI-led Phase II trial of PDS0301.

A: Frank Bedu-Addo mentioned 18-24 month enrolment period for VERSATILE-003 and Lauren Wood spoke about updated survival data before end of Q3 2023 and Cytokine 2023 presentation.