Latest news with #MichelleMahler
Yahoo
20-05-2025
- Business
- Yahoo
Compugen Ltd (CGEN) Q1 2025 Earnings Call Highlights: Strategic Advances Amid Revenue Decline
Cash Balance: Approximately $103.7 million as of March 31, 2025. Revenue: Approximately $2.3 million for Q1 2025, compared to $2.6 million in Q1 2024. R&D Expenses: Approximately $5.8 million for Q1 2025, compared to $6.4 million in Q1 2024. G&A Expenses: Approximately $2.4 million for both Q1 2025 and Q1 2024. Net Loss: Approximately $7.2 million or $0.08 per share for Q1 2025, compared to $7.3 million or $0.08 per share in Q1 2024. Cash Runway: Expected to fund operating plans into 2027. Warning! GuruFocus has detected 3 Warning Signs with CGEN. Release Date: May 19, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Compugen Ltd (NASDAQ:CGEN) has initiated a sub-trial for their anti-PVRIG antibody COM701 in ovarian cancer, targeting an unmet medical need. The company has a strong cash position with a runway extending into 2027, supporting their clinical and research activities. Compugen Ltd (NASDAQ:CGEN) is advancing its early-stage and clinical immuno-oncology pipeline, focusing on innovative therapies. Partnership with AstraZeneca is progressing, with multiple Phase 3 trials initiated, potentially leading to significant revenue opportunities. The company is exploring novel mechanisms of action in their early-stage pipeline, aiming to enhance anticancer immunity. Revenues for the first quarter of 2025 decreased compared to the same period in 2024. The company reported a net loss of approximately $7.2 million for the first quarter of 2025. There is uncertainty in the TIGIT landscape, with previous Phase 3 failures impacting market sentiment. The success of Compugen Ltd (NASDAQ:CGEN)'s TIGIT program is contingent on positive outcomes from upcoming Phase 3 trials. The competitive landscape in ovarian cancer is evolving, with new therapies potentially impacting Compugen Ltd (NASDAQ:CGEN)'s strategy. Q: Merck's KEYNOTE-B96 Phase 3 study in pembrolizumab for platinum-resistant ovarian cancer was successful. How might this impact your strategy in ovarian cancer? A: Michelle Mahler, Chief Medical Officer: The study is in a different setting, but it shows benefit from adding an immune checkpoint inhibitor. If our study demonstrates activity, it could open opportunities to combine COM701 in broader populations. Q: What is your interpretation of Roche's SKYCRAPER-01 data, and how does it affect your confidence in TIGIT antagonism? A: Eran Ophir, Vice President - Research, Drug Discovery: Despite the failure, we see numerical activity in TIGIT trials. The Fc active format may have contributed to high discontinuation rates. We believe Fc inactive antibodies, like ours, may offer safety and efficacy advantages. Q: Do you plan to collect data on tumor microenvironment features in the COM701 study? What PFS benefit would be clinically meaningful in the maintenance setting? A: Michelle Mahler, Chief Medical Officer: We will collect data on the tumor microenvironment but won't disclose details. An improvement of around three months in progression-free survival would be clinically meaningful. Q: Have you observed activity of COM701 in PD-L1 positive patients, and what are your thoughts on PD-1 VEGF bispecifics? A: Michelle Mahler, Chief Medical Officer: We see activity in both PD-L1 positive and negative patients. Eran Ophir, Vice President - Research, Drug Discovery: VEGF increases T cell infiltration, complementing PVRIG biology. Fc inactive TIGIT may be preferable for combinations due to safety concerns. Q: What are your thoughts on the potential synergy between TIGIT, PD-1, and VEGF inhibitors? A: Eran Ophir, Vice President - Research, Drug Discovery: VEGF can enhance T cell infiltration, aligning with PVRIG biology. While we haven't published data, combining with Fc inactive TIGIT could be advantageous due to safety profiles. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
05-03-2025
- Business
- Yahoo
Compugen Ltd (CGEN) Q4 2024 Earnings Call Highlights: Strategic Advances Amid Financial Challenges
Cash Balance: Approximately $103.3 million as of December 31, 2024. Revenue: $1.5 million for Q4 2024; $27.9 million for the full year 2024. R&D Expenses: $5.9 million for Q4 2024; $24.8 million for the full year 2024. G&A Expenses: $2.2 million for Q4 2024; $9.4 million for the full year 2024. Net Loss: $6.1 million for Q4 2024; $14.2 million for the full year 2024. Cash Runway: Expected to last into 2027. Warning! GuruFocus has detected 3 Warning Signs with CGEN. Release Date: March 04, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Compugen Ltd (NASDAQ:CGEN) presented encouraging data for COM701, showing durable responses and good tolerability in platinum-resistant ovarian cancer patients. The company plans to advance COM701 as a maintenance treatment for platinum-sensitive ovarian cancer, targeting a less competitive landscape. AstraZeneca's initiation of seven Phase 3 trials with rilvegostomig, derived from Compugen's COM902, represents a significant potential revenue source. Compugen Ltd (NASDAQ:CGEN) received a $30 million milestone payment from Gilead for GS-0321's FDA IND clearance, validating their discovery and development capabilities. The company maintains a solid financial position with a cash runway expected to last into 2027, supporting their strategic priorities and clinical advancements. Compugen Ltd (NASDAQ:CGEN) reported a net loss of approximately $14.2 million for the year ended December 31, 2024. Revenues for 2024 decreased compared to 2023, with $27.9 million reported versus $33.5 million in the previous year. The TIGIT antibody class faced skepticism due to several setbacks and program discontinuations in 2024. The ovarian cancer study is exploratory and not powered to detect significant improvements, which may limit its impact. There is uncertainty regarding the timeline and outcomes of AstraZeneca's Phase 3 trials, which could affect future revenue streams. Q: Can you confirm whether rilvegostomig will be included in AstraZeneca's Phase 3 study design for the B7-H4 DCPSAM? A: Anat Cohen-Dayag, President and CEO, stated that they cannot comment on anything not publicly disclosed by AstraZeneca. However, they are pleased with the progress of the seven pivotal trials AstraZeneca has initiated, which include testing rilvegostomig in various combinations. Q: Can we expect any near-term data from AstraZeneca that could clarify the contribution to efficacy for the TIGIT part? A: Anat Cohen-Dayag mentioned that AstraZeneca plans to present data in 2025 from the combination of rilvegostomig with ADCs. Previous data from rilvegostomig in non-small cell lung cancer and gastric cancer have shown promising efficacy and safety profiles. Q: What is the design of the ovarian study, and how is it powered to show PFS hazard ratio? A: Michelle Mahler, Chief Medical Officer, explained that the study is an exploratory Phase 1B study, not powered for a full pivotal trial. It uses Bayesian statistics to evaluate the probability of a more than three-month improvement in progression-free survival (PFS) compared to placebo. Q: Is there interest in evaluating GS-0321 in hematologic malignancies, possibly in combination with rituximab? A: Eran Ophir, VP of Research, stated that while hematological applications are interesting, the current focus is on solid tumors where they have observed unique activity in the tumor microenvironment. Q: What triggers the interim analysis in the platinum-sensitive ovarian cancer study, and is there a predefined futility threshold? A: Michelle Mahler explained that the interim analysis is triggered by a combination of event rate and follow-up duration. There is a futility boundary, and Bayesian statistics will be used to assess the probability of a three-month improvement in PFS. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
