Compugen (CGEN) Q3 2026 Earnings Call Transcript

DATE

Mon, Nov. 9, 2026

CALL PARTICIPANTS

• President and Chief Executive Officer - Eran Ophir
• Chief Financial Officer - David Silberman
• Head of Investor Relations and Corporate Communications - Lindsey Trickett
• Chief Medical Officer - Michelle Mahler

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TAKEAWAYS

• Revenue -- $3.8 million, reflecting the recognition of portions of both the upfront and milestone payments from the Gilead license agreement.
• Net Loss -- $5.8 million, representing a decrease from a net loss of $7 million in the prior year.
• Net Loss Per Share -- $0.06 per basic and diluted share, compared with a loss of $0.07 per share in the third quarter of 2025.
• Cash Position -- $117.5 million as of Sept. 30, 2026, including cash, cash equivalents, short-term deposits, and marketable securities.
• Cash Runway -- expected into 2029, assuming no further cash inflows.
• Research and Development Expenses -- $5.8 million, remaining consistent with the $5.8 million reported in the third quarter of 2025.
• General and Administrative Expenses -- $2.3 million, compared to $2.2 million in the comparable period of 2025.
• MAIA-Ovarian Enrollment -- 62 patients, following the completion of global enrollment for the randomized trial evaluating COM701 as maintenance monotherapy.
• MAIA-Ovarian Data Timeline -- high-level results are expected by the end of the first quarter of 2027.
• Trial Randomization -- 2:1 ratio for patients receiving either COM701 or placebo in the MAIA-Ovarian study.
• Six-month Progression-Free Rate -- a critical measure for the MAIA-Ovarian trial, reflecting the opportunity to extend the platinum-free interval.
• Placebo PFS Assumption -- approximately 4 months, based on historical benchmarks for relapsed platinum-sensitive ovarian cancer populations.
• ARTEMIDE-Biliary01 Timeline -- high-level results from the AstraZeneca-partnered rilvegostomig study are anticipated in the second half of 2027.
• Biliary Trial Size -- 760 participants, evaluating rilvegostomig plus chemotherapy as adjuvant treatment for biliary tract cancer.
• Partnered Phase 3 Count -- 12 ongoing studies for rilvegostomig across multiple cancer indications including lung and gastric cancers.
• Rilvegostomig Milestones -- $195 million in remaining regulatory and commercial milestone payments available to the company.
• Rilvegostomig Royalties -- up to mid-single-digit tiered percentages on worldwide sales.
• GS-0321 Payments -- $90 million in gross payments received from Gilead to date under the license agreement.
• GS-0321 Milestones -- $758 million in potential additional milestone payments from Gilead.
• GS-0321 Royalties -- tiered ranges from single digits to low double digits on future sales.
• AstraZeneca BLA Milestone -- $25 million, triggered upon Biologics License Application acceptance for rilvegostomig.
• Operating Loss -- $6.8 million, compared with an operating loss of $7.9 million in the third quarter of 2025.

SUMMARY

Compugen Ltd. (NASDAQ:CGEN) reported progress across its clinical pipeline and the expansion of its discovery engine during the third quarter. Management highlighted the completion of enrollment for the MAIA-Ovarian trial and reiterated that data results remain on track for early 2027. The company stated that strategic partnerships with AstraZeneca and Gilead continue to advance, with rilvegostomig currently being evaluated in 12 ongoing Phase 3 trials and GS-0321 proceeding through Phase 1 dose escalation. The introduction of UnigenX represents a strategic move into tumor-associated antigens to support the development of next-generation drug targets such as T-cell engagers. The company maintained its projected cash runway into 2029 based on its current balance of cash and marketable securities.

• CEO Ophir stated that "2027 is expected to be a data-rich year for Compugen" given the anticipated readouts for both wholly owned and partnered programs.
• Dr. Yeku of Massachusetts General Hospital noted that COM701 is differentiated by its safety profile and potential to prolong the platinum-free interval while maintaining quality of life for ovarian cancer patients.
• AstraZeneca reported overall survival data for rilvegostomig in first-line non-small cell lung cancer that compared favorably with historical benchmarks.
• The UnigenX platform identifies both single targets and target combinations aiming to increase specificity and coverage for targeted immune activation.
• Gilead continues to evaluate GS-0321 in monotherapy and combination studies, though clinical data disclosure timelines are subject to Gilead's discretion.
• Management noted that the next milestone in the AstraZeneca collaboration is Biologics License Application acceptance, which would trigger a $25 million payment.

INDUSTRY GLOSSARY

• PVRIG: Poliovirus receptor-related immunoglobulin domain-containing protein, a novel immune checkpoint target identified by the company.
• TIGIT: T-cell immunoreceptor with Ig and ITIM domains, an immune checkpoint protein involved in cancer immunotherapy.
• IL-18BP: Interleukin-18 binding protein, a natural inhibitor of the cytokine IL-18 that regulates immune responses.
• T-cell engager: A therapeutic modality designed to direct a patient's T cells to selectively target and kill tumor cells.
• Multiomics: A biological analysis approach that integrates multiple data sets, such as genomics and transcriptomics, to identify drug targets.
• Platinum-free interval: The duration of time between the completion of platinum-based chemotherapy and the recurrence of cancer.

Full Conference Call Transcript

Operator: Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's Third Quarter 2026 Results Conference Call. [Operator Instructions] An audio webcast of this call is available in the Investors section of Compugen's website, www.cgen.com. As a reminder, today's call is being recorded. With us from the Compugen team are Dr. Eran Ophir, President and CEO; and David Silberman, Chief Financial Officer. Dr. Michelle Mahler, Chief Medical Officer, will join for the Q&A. To begin today's call is Lindsey Trickett, Compugen's Head of Investor Relations and Corporate Communications. Go ahead, Lindsey.

Lindsey Trickett: Thank you, operator. Good morning, and good afternoon, everyone, and welcome to Compugen's Third Quarter 2026 Financial Results Conference Call. With us today are Dr. Eran Ophir, President and CEO; and David Silberman, Chief Financial Officer. Dr. Michelle Mahler, our Chief Medical Officer, will join for the Q&A portion of the call. Before we get started, I want to remind you that during the call, we may make projections or forward-looking statements regarding future events, business outlook, development efforts and their potential outcome, company's discovery platform, anticipated progress and plans, results and time lines for our programs, including disclosure of clinical data, financial and accounting-related matters as well as statements regarding both our cash position and cash runway.

We wish to caution you that such statements reflect only the company's current beliefs, expectations and assumptions and that actual results, performance or achievements may differ materially. These statements are subject to known and unknown risks and uncertainties, and we refer you to our SEC filings for more details on these risks, including our most recent report on Form 20-F. The company undertakes no obligation to update projections and forward-looking statements in the future. And with that, I'll now turn it over to Eran. Go ahead.

Eran Ophir: Thank you, Lindsey, and good morning, everyone. This quarter, I would like to highlight 3 areas of progress. First, we have completed enrollment in MAIA-Ovarian, our global randomized trial evaluating COM701, a potential first-in-class anti-PVRIG antibody as maintenance monotherapy in patients with second- and third-line relapsed platinum-sensitive ovarian cancer, and we remain on track to report data by the end of the first quarter of 2027. Second, partnered programs, GS-0321 and rilvegostomig continue to advance with the Phase III readout from AstraZeneca now anticipated in the second half of 2027 from the ARTEMIDE-Biliary01 trial. Third, we recently introduced UnigenX, which has been designed to expand our target discovery capabilities into tumor-associated antigens.

These developments reflect our strategy of advancing our wholly owned lead assets, benefiting from the progress of our partnered programs and building the next generation of our pipeline. As you can see, 2027 is expected to be a data-rich year for Compugen, and we look forward to keeping you updated. So I'll begin with COM701, our wholly owned potential first-in-class anti-PVRIG antibody. MAIA-Ovarian is fully enrolled, and we remain on track to report results by the end of the first quarter of 2027. The blinded placebo-controlled trial includes 62 patients, randomized 2:1 to receive either COM701 or placebo.

It was designed to evaluate COM701 as maintenance monotherapy in patients with second- and third-line relapsed platinum-sensitive ovarian cancer, a setting with no approved maintenance treatment option and significant unmet need. At our October 5 virtual KOL event, Dr. Yeku of Harvard and Massachusetts General Hospital highlighted 3 considerations in this setting, which includes the importance of extending the platinum-free interval, the limitations of currently available maintenance options and the need to balance efficacy, tolerability and treatment sequencing. Specifically, Dr. Yeku mentioned that emerging ADC competition in this disease setting may have limitations as maintenance drugs, mostly due to their chemotherapy-like side effects.

And COM701 is differentiated by its safety profile and its potential to prolong the platinum-free interval while maintaining quality of life. We appreciate everyone who attended the event and the perspective Dr. Yeku shared from his real-world experience managing patients with ovarian cancer. A replay of the event is available on our website. In evaluating MAIA-Ovarian trial, we will consider the totality of the data, including the magnitude and durability of separation between COM701 and placebo arms. As we heard from Dr. Yeku as well as from our scientific advisers, the platinum-free interval is critically important in ovarian cancer.

Patients who relapse within 6 months after platinum-based chemotherapy are generally considered to have platinum-resistant disease, a setting that has a poor prognosis with fewer treatment options. We believe that the proportion of patients who remain progression-free at 6 months will be an important measure because it reflects the opportunity to extend the platinum-free interval. If successful, COM701 could delay the need for subsequent treatment and provide patients with a longer chemotherapy-free interval while maintaining more potential subsequent treatment options, outcomes that are meaningful in this setting. Regarding our expectations from the placebo arm, 2 recent studies in relapsed platinum-sensitive ovarian cancer reported median progression-free survival of less than 3 months in their control arms.

Those populations were similar but not directly comparable with MAIA and are generally more heavily pretreated, including treated with PARP inhibitors, bevacizumab or both. So taking those differences into account, our working assumption is that median progression-free survival in the MAIA placebo arm may be approximately 4 months. The actual outcome eventually will depend on the characteristics of the enrolled and treated populations on the study. We continue to expect and look forward to sharing the MAIA-Ovarian data with you by the end of first quarter of 2027. I will now turn to our partnered programs, which provide the potential for more than $1 billion in future milestone payments and royalties.

So let's start with rilvegostomig, which is a potential immuno-oncology backbone for AstraZeneca. Rilvegostomig is being studied in 12 ongoing Phase III trials across indications, including non-small cell lung cancer, biliary tract cancer and gastric cancer. One of those 12 Phase III studies, ARTEMIDE-Biliary01, is now anticipated to have high-level results in the second half of next year. ARTEMIDE-Biliary01 is assessing rilvegostomig plus investigator choice of chemotherapy compared to chemotherapy alone as adjuvant treatment in 760 participants with biliary tract cancer who are at risk of recurrence after surgery. In addition, this quarter, AstraZeneca reported at the World Conference on Lung Cancer, the first overall survival data from the Phase II ARTEMIDE-01 in first-line PD-L1 positive non-small cell lung cancer.

Results showed overall survival, which compares favorably with historical benchmarks. These data support the ongoing Phase III lung cancer development program for rilvegostomig. Furthermore, the results showed that rilvegostomig was generally well tolerated with no Grade IV or higher treatment-related adverse events and lower rates of both Grade III adverse events and discontinuations. As a reminder, Compugen is eligible to receive up to $195 million in regulatory and commercial-based milestones, and up to mid-single-digit royalties on rilvegostomig worldwide sales. Next, GS-0321, formerly known as COM503, which is our potentially first-in-class anti-IL-18 binding protein antibody licensed to Gilead. The program is designed to harness cytokine biology for the treatment of cancer while potentially overcoming limitations associated with direct cytokine administration.

The ongoing Phase I dose escalation trial continues to advance and is on track. Compugen has received gross payments totaling $90 million from Gilead under the agreement and is eligible to receive up to $758 million in additional milestone payments plus tiered royalties ranging from single digits to low double digits. Turning to our early pipeline. Unigen is our AI-powered discovery engine for identifying novel immuno-oncology drug targets by connecting computational prediction, biological validation and clinical learning. Over the years, we have identified multiple drug targets like TIGIT, PVRIG and IL-18BP and have taken them into the clinic as part of our internal pipeline or through collaborations.

At our October 5 investor event, we introduced a strategic expansion of our discovery engine into targeted immune activation modalities such as T-cell engagers, where there is a high unmet need for novel cancer-specific targets. This expansion called UnigenX was built with the aim of identifying novel tumor-associated antigens that could enable highly selective immune targeting of tumor cells. We believe our differentiation in this area is based on our rich multi-omics data sets, our deep understanding of the desired multiparameter target profile and our long-term experience in identifying novel drug targets. UnigenX can identify both single targets and target combinations aiming to increase both specificity and coverage.

This expanded capability has the potential to generate multiple TAA-driven opportunities across solid tumor indications and modalities, enhance our internal pipeline and support future potential partnerships. To summarize, we expect 2027 to be an exciting year for Compugen with randomized data anticipated from our wholly owned lead asset COM701, anticipated rilvegostomig Phase III high-level results in biliary tract cancer and the continued application of our discovery capabilities to build the next generation of programs. With that, I will turn the call over to David to review the financial results.

David Silberman: Thanks, Eran, and thank you all for joining us today. We finished the third quarter of 2026 with a solid balance sheet. Cash runway, assuming no further cash inflows is expected to fund our operating plans into 2029. Going into the details, I will start with our cash balance. As of September 30, 2026, we had approximately $117.5 million in cash, cash equivalents, short-term bank deposits and investments in marketable securities. Revenues for the third quarter of 2026 were approximately $3.8 million compared to approximately $1.9 million of revenue for the comparable period in 2025.

The revenues in the third quarters of 2026 and 2025 reflect the recognition of portions of both the upfront payment and the IND milestone payment from the license agreement with Gilead. Expenses in the third quarter of 2026 were in line with our plans. R&D expenses for the third quarters of 2026 and 2025 were approximately $5.8 million in each quarter. G&A expenses were approximately $2.3 million for the third quarter of 2026 compared to $2.2 million for the third quarter of 2025.

Net loss for the third quarter of 2026 was approximately $5.8 million or $0.06 per basic and diluted share compared to a net loss of approximately $7 million or $0.07 per basic and diluted share in the third quarter of 2025. With that, I will hand over to the operator to open the call for questions.

Operator: [Operator Instructions] The first question is from Daina Graybosch of Leerink Partners.

Bill Ling: Bill on for Daina. Can you talk about the difference between Unigen and UnigenX? Can you maybe just help us set some expectations for when we might see some new clinical candidates? It seems like you had some in mind on your last call. And I guess just a quick point of clarification. I was wondering, is this focusing more on neoantigens or maybe like peptides presented on HLAs?

Eran Ophir: Thanks. So UnigenX is an expansion of Unigen. It relies on all the databases, our mapping of the tumor microenvironment, the multi-omics approaches and the experience to identify novel drug targets and expanding it into the discovery of tumor-associated antigens, which are specific proteins expressed on the surface of tumor cells and not normal tissues that could be a specific target for modalities like T-cell engagers. So we all heard just recently when you have a good and clean target like DLL3, then you can get really significant results even in solid tumors with T-cell engagers.

And the challenge we are taking ourselves is to exploit all our experience in the platform we built along years, Unigen, now using UnigenX to identify more such targets to enable specific tumor targeting with T-cell engagers and potentially also other modalities.

Operator: The next question is from Leland Gershell of Oppenheimer.

Leland Gershell: Just a couple from us. First, I wanted to ask, Eran, with the ARTEMIDE-Biliary01 readout coming up now second half of next year, does that itself trigger a payment? Can you share? And if so, how much?

Eran Ophir: So what we said previously when we monetized a small portion of our royalties to AstraZeneca was that the next milestone is BLA acceptance. And for that milestone in that deal, we added $25 million in addition to what was there. So the next milestone is BLA acceptance, meaning if the Biliary01 is positive and if AstraZeneca submits to regulatory upon approval of the receiving of the package, then this will trigger the next milestone.

Leland Gershell: Got it. Okay. And then just a quick question on GS-0321. So that as the Phase I continues to dose escalate. Can you say if a biologically active dose has been established here? And also for this, what milestone needs to be reached before the first clinical disclosure in that program?

Eran Ophir: So due to the nature of the collaboration with Gilead, we are unfortunately unable to give guidance on the specifics of the stage we are and when we'll disclose data. The study is ongoing in monotherapy and in combination since the beginning of last year. So it has been a while, and we are obviously, we'll discuss with Gilead what will be the right time to disclose the clinical data itself, but it eventually will require the approval of Gilead, which owns the assets.

Operator: [Operator Instructions] This concludes the Q&A session and Compugen's investors conference call. Thank you for your participation. You may go ahead and disconnect.

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