Compugen Ltd. Q3 FY2024 earnings call

COM701 Data and Development - Anat Cohen-Dayag discussed encouraging data from SITC on COM701, COM902, and pembrolizumab in platinum-resistant ovarian cancer patients, with durable responses and good tolerability. - Plan to initiate a Phase 2 adaptive platform trial in relapsed platinum-sensitive ovarian cancer patients in Q2 2025, starting with a randomized double-blinded sub-study enrolling 60 patients. - COM503 progress: Received a $30 million maximum payment from Gilead for FDA IND clearance and on track to initiate Phase I study. - AstraZeneca's Rilvegostomig data: Promising efficacy and manageable safety profile in lung and gastric cancer, with AstraZeneca initiating new Phase III trials.### Michelle Mahler and Dr. Yeku Discussion - Discussed the significant unmet medical need in ovarian cancer, with COM701 study in platinum-resistant ovarian cancer showing 17% objective response rate, 46% disease control rate, and favorable safety profile. - Dr. Yeku shared anecdotes of patients experiencing pain relief and improved quality of life with COM701 treatment, and discussed the challenges of current ovarian cancer treatments like bevacizumab and PARP inhibitors.

As of September 30, 2024, Compugen had approximately $113.2 million in cash, cash equivalents, and investments compared to approximately $51.1 million as of December 31, 2023. Revenues for Q3 2024 were approximately $17.1 million. R&D expenses for Q3 2024 were $6.3 million, down from $8.3 million in Q3 2023. The company recorded a net profit of $1.3 million in Q3 2024 compared to a net loss of $9.9 million in Q3 2023.

- Cash runway is expected to fund current plans into 2027. - Plan to initiate COM701 maintenance therapy trial in Q2 2025. - Expect interim analysis of the randomized COM701 maintenance therapy arm in H2 2026. - COM503 is on track to initiate Phase I study in the current quarter.

Q: What is the number of prior platinum lines required for the proposed Phase 2 study?

A: Targeting patients who have had two prior lines of chemotherapy with platinum-containing regimens and are not candidates for standard of care maintenance treatment.

Q: What's the understanding of the proportion of patients who get to third-line and have exhausted prior Bev and/or PARP within the maintenance setting?

A: Vast majority of patients go through a platinum-sensitive phase, many having received PARP or bevacizumab in earlier lines.

Q: What was learned from trials with PD-1 or PD-L1 antagonists in this setting?

A: Earlier use of immunotherapy with checkpoints shows better responses and durability, but combinations have mixed results with associated toxicities.

Q: What's the ideal PFS for an agent to be clinically relevant in the setting and enrollment in the 60-patient study?

A: Aim for at least a 3-month improvement over control arms; engaged with key opinion leaders but GOG supports later stage development.

Q: Any development in biomarker understanding for COM701 going into the Phase 2 study and FDA feedback?

A: Looking at biomarker PVRL2 but not using it for enrichment in current Phase 2; designed trial within updated FDA guidance, no prior FDA feedback yet