Release Date: November 12, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Compugen Ltd (NASDAQ:CGEN) reported encouraging data from their studies on COM701, COM902, and pembrolizumab in patients with platinum-resistant ovarian cancer, showing durable responses and good tolerability.
• The company received a $30 million milestone payment from Gilead for achieving FDA IND clearance for COM503, indicating strong progress in their partnership.
• Compugen Ltd (NASDAQ:CGEN) has a strong cash position with approximately $113.2 million, expected to fund operations into 2027, providing financial stability.
• The company plans to initiate a new trial in Q2 2025, targeting relapsed platinum-sensitive ovarian cancer patients, which could open new regulatory and commercial opportunities.
• Compugen Ltd (NASDAQ:CGEN) is eligible for future milestone payments and royalties from AstraZeneca's development of bispecific antibodies, representing a significant potential revenue source.

Negative Points

• The overall response rate in the platinum-resistant ovarian cancer study was only 17%, which may be considered low despite the challenging patient population.
• The company faces competition in the ovarian cancer treatment landscape, particularly in maintenance therapy for relapsed platinum-sensitive patients.
• There are concerns about the toxicity and side effects of current treatments like Bevacizumab and PARP inhibitors, which Compugen Ltd (NASDAQ:CGEN) aims to address with their therapies.
• The development of biomarkers for patient selection remains challenging, with no current enrichment strategy for COM701 in the platinum-resistant setting.
• The company's future success is heavily reliant on the outcomes of ongoing and planned clinical trials, which carry inherent risks and uncertainties.

Q & A Highlights

• Warning! GuruFocus has detected 2 Warning Signs with CGEN.

Q: Could you remind me of the number of prior platinum lines required for the proposed phase two study? A: Michelle Maler, Chief Medical Officer: We will target patients who have had two prior lines of chemotherapy with platinum-containing regimens. Patients must have had maintenance with Bevacizumab or a Parp inhibitor and not be candidates for additional maintenance therapy with BEV or Parp. This primarily addresses third-line patients, but there may be exceptions in the second line.

Q: What is your understanding of the proportion of patients who get to third line, are still platinum-sensitive, and have exhausted prior BEV and/or PARP within the maintenance setting? A: Dr. Ola Dapu Yeu, Assistant Professor of Medicine: Most patients will progress through a platinum-sensitive phase. Many patients with stage four disease on diagnosis would have received Bevacizumab. In the first platinum-sensitive setting, most patients would have been exposed to either PARP or Bevacizumab.

Q: Is there an opportunity to build on combination therapies after understanding the single-agent activity of COM701? A: Anat Cohen-Dayag, President and CEO: Yes, this is a great opportunity to start with a single agent, which may open a path for monotherapy. It also opens the door for combination therapies, allowing us to have a COM701-centric design.

Q: What did we learn from trials with PD-1 or PDL-1 antagonists in this setting? A: Dr. Ola Dapu Yeu: Monotherapy is not effective. Combinations with other immune checkpoints or chemotherapy have shown mixed effects. Earlier use in less sick patients shows better responses and durability. However, combinations come with toxicities.

Q: What would be the ideal PFS to suggest that an agent is clinically relevant in the platinum-sensitive setting? A: Dr. Ola Dapu Yeu: Clinically, anything above six months is meaningful. Achieving an 8-9 month PFS would maintain patients as platinum-sensitive, allowing for reinduction with platinum and potentially better outcomes.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.