Yahoo

Compugen Ltd (CGEN) (Q2 2026) Earnings Call Highlights: Advancing COM701 with Strong Cash ...

Trade CGEN on Coinbase

This article first appeared on GuruFocus .

  • Cash Position:Approximately $125.3 million in cash equivalents, short-term bank deposits, and marketable securities as of June 30, 2026.

  • Revenue:Approximately $2.6 million for Q2 2026, compared to $1.3 million in Q2 2025.

  • R&D Expenses:Approximately $6.3 million for Q2 2026, compared to $5.6 million in Q2 2025.

  • G&A Expenses:Approximately $2.3 million for Q2 2026, compared to $2.2 million in Q2 2025.

  • Net Loss:Approximately $7.0 million, or $0.07 per basic and diluted share, for Q2 2026, compared to a net loss of $7.3 million, or $0.08 per share, in Q2 2025.

  • Cash Runway:Expected to fund operating plans into 2029, assuming no further cash inflows.

Release Date: August 03, 2026

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

Positive Points

  • Compugen Ltd ( NASDAQ:CGEN ) is advancing its wholly-owned COM701 program with the MyOvarian trial on track for an interim analysis by Q1 2027, targeting a high unmet need in platinum-sensitive ovarian cancer.

  • AstraZeneca's continued investment in rilvegostomig, including a new Phase III trial in urothelial carcinoma, underscores confidence in the asset and its potential to generate milestones and royalties for Compugen Ltd ( NASDAQ:CGEN ).

  • New data from AstraZeneca's GEMINI hepatobiliary study showed a median overall survival of 16.8 months in first-line biliary tract cancer, exceeding historical benchmarks of less than 13 months.

  • Compugen Ltd ( NASDAQ:CGEN ) maintains a solid cash position of $125.3 million, with a runway expected to fund operations into 2029, supporting ongoing clinical and pipeline activities.

  • The company's AI-driven platform, Unigen, continues to deliver innovative targets, with GS0321 (licensed to Gilead) progressing as planned in Phase I dose escalation, offering additional upside through milestones and royalties.

Negative Points

  • Compugen Ltd ( NASDAQ:CGEN ) revised its estimated median PFS for the placebo control arm in the MyOvarian trial down to approximately four months, reflecting a more heavily pretreated patient population and potentially higher hurdle for demonstrating COM701's benefit.

  • The MyOvarian trial is not powered to show a statistical difference, and the interim analysis relies on a relatively small sample size (40 patients on COM701 vs. 20 on placebo), which may limit the strength of conclusions.

  • No regulatory interactions with the FDA have occurred for the MyOvarian trial, and the path to approval remains uncertain, with the company only noting alignment with Project Front Runner guidelines.

  • Phase III readouts for rilvegostomig are not expected until after 2027, meaning potential milestones and royalties from AstraZeneca are likely several years away.

  • The company's net loss of $7 million in Q2 2026, while slightly improved year-over-year, reflects ongoing R&D and G&A expenses with no near-term product revenue, relying on partnerships for cash inflows.

Q & A Highlights

Q: What is the company's updated expectation for the placebo control arm in the MyOvarian trial, and what data supports this revised assumption? A: Michelle Mahler, Chief Medical Officer, explained that the company has adjusted its estimate for the placebo control arm's median progression-free survival (PFS) to approximately four months. This revision is based on emerging data from two European trials (Tadova and OREO) in relapsed platinum-sensitive ovarian cancer, which showed a median PFS of 2.8 months in their control arms. While those trials included more heavily pre-treated patients (including those with liver metastases and stable disease), the company believes the actual benchmark for its trial lies between the historical 5.5 months from PARP inhibitor registration trials and the 2.8 months from these newer studies, leading to the ~4-month estimate.

Q: Has the company had any interactions with the FDA regarding a potential expedited or accelerated approval path for COM701 based on the MyOvarian trial? A: Michelle Mahler, Chief Medical Officer, stated that the company has not yet had a formal meeting with the FDA. However, the trial was designed in alignment with FDA guidelines, including the Project Front Runner initiative and the use of a Bayesian trial design. The company is confident that with robust data, it will be able to have productive regulatory engagements to discuss potential approval pathways.

Q: With AstraZeneca now running 12 Phase III trials for rilvegostomig, which study might yield the earliest data readout, and does the new trial change the milestone schedule? A: Eran Ophir, President and CEO, clarified that the addition of the new Phase III trial (Tropion-Urothelial 04) does not alter the existing agreement terms or the milestone schedule. Regarding data readouts, the company can only refer to AstraZeneca's public guidance, which indicates that formal Phase III readouts are expected after 2027. While interim analyses could occur earlier, the official timeline for late-stage data remains post-2027.

Q: Could the MyOvarian trial data readout potentially occur before the end of 2026, and what biomarkers will be evaluated alongside the PFS outcome? A: Eran Ophir, President and CEO, confirmed that the company is maintaining its guidance for an interim analysis by Q1 2027, despite the updated placebo assumptions. Michelle Mahler, Chief Medical Officer, added that PFS is the primary readout, and there is no specific biomarker selection strategy. The trial excludes patients with liver metastases, and exploratory biomarker analyses will be conducted when the data is unblinded.

Q: What is the company's level of confidence in the revised four-month placebo PFS assumption, and what is known about the patient populations in the cited trials? A: Michelle Mahler, Chief Medical Officer, detailed that the two referenced trials (Tadova and OREO) were European studies that did not cap prior lines of treatment, included patients with stable disease, and allowed enrollment of patients with liver metastases. These factors made the populations more heavily pre-treated than the MyOvarian trial. Eran Ophir, President and CEO, emphasized that while the placebo assumption is important for planning, the critical comparison is the randomized, blinded data from the trial itself, which will definitively assess COM701's monotherapy activity.

Q: What is the current status of the GS0321 (COM503) Phase I trial, and are there plans to present dose-escalation data? A: Eran Ophir, President and CEO, noted that due to the partnership arrangement with Gilead, the company cannot disclose specific details. However, he confirmed that the trial is progressing as planned, with dose escalation ongoing in both monotherapy and combination with a PD-1 inhibitor, as well as backfill cohorts in monotherapy. He indicated that it is still early for data disclosure, as 18 months into a Phase I study is typically too soon for reporting.

Q: How does the company define "clinically meaningful success" for the MyOvarian trial's interim analysis? A: Eran Ophir, President and CEO, explained that success is defined as COM701 helping patients remain progression-free for at least six months after platinum-based chemotherapy. Achieving this threshold would maintain patients' platinum-sensitive status for longer, delay the transition to platinum-resistant disease, and provide a valuable recovery break from chemotherapy, thereby improving quality of life and preserving additional treatment options.

Q: What is the company's cash position and expected runway following the second quarter of 2026? A: David Silberman, Chief Financial Officer, reported that the company ended Q2 2026 with approximately $125.3 million in cash, equivalents, and marketable securities. Assuming no further cash inflows, this runway is expected to fund operating plans into 2029, supporting the advancement of the MyOvarian trial, the GS0321 clinical program, and continued investment in the early-stage pipeline.

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

Mobilize your Website
View Site in Mobile | Classic
Share by: