CGEN Compugen Ltd.

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Compugen Ltd. Q3 F2026 Earnings Call Transcript

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Operator
Conference Call Operator
Ladies and gentlemen, thank you for joining us today. Welcome to CompuGen's third quarter 2026 results conference call. At this time, all participants are in listen-only mode. 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, Compugence Head of Investor Relations and Corporate Communications. Go ahead, Lindsey.
Lindsey Trickett
Head of Investor Relations and Corporate Communications
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 timelines for our program, 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.
Dr. Eran Ophir
President and Chief Executive Officer
Thank you, Lindsey. Good morning, everyone. This quarter, I would like to highlight three areas of progress. First, we have completed enrollment in myovarian, a global randomized trial evaluating COM-701, a potential first-in-class anti-PVRG 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, patent programs GS0321, Andrew Vygostamek, continue to advance with the Phase III readout from AstraZeneca, now anticipated in the second half of 2027 from Artemide-Bilary-015. Third, we recently introduced UNIGEN-X, 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 partner 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-class anti-pivergy antibody. Maya O'Brien 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 to 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 needs. At our October 5th virtual care allowance, Dr. Yeku of Harvard and Massachusetts General Hospital highlighted three 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 COM7-1 is differentiated by its safety profile as its potential to prolong the platinum-free interval while maintaining quality of life. We appreciate everyone who attended the event and the perspective of Dr. Yerko shared from his real-world experience managing patients with ovarian cancer. A replay of the event is available on our website. In evaluating my 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 from our scientific advisors, the platinum-free interval is critically important in ovarian cancer. Patients who relapse within six months after platinum-based chemotherapy are generally considered to have platinum-resistant disease, a setting that has a poorer prognosis with fewer treatment options. We believe that the proportion of patients who remain progression-free at six 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 , while maintaining more potential subsequent treatment options, outcomes that are meaningful in this setting. Regarding our expectations from the placebo arm, two recent studies in relapsed platinum-sensitive ovarian cancer reported median progression-free survival of less than three months in their control arms. Those populations were similar, but not directly comparable with Maya, and are generally more heavily pretreated, including pretreated with PARP, inibitors, bevacizumab, or both. So taking those differences into account, our working assumption is that median progression-free survival in the myoplasma arm may be approximately four 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 myovarian data with you by the end of the first quarter of 2027. I will now turn to our parted programs, which provide the potential for more than $1 billion in future milestone payments and royalties. So let's start with Rilvogostomic, which is a potential immuno-oncology backbone for AstraZeneca. Rilvogostomic is being studied in 12 ongoing Arthamide Billary 01 is now anticipated to have high-level results in the second half of next year. Arthamide Billary 01 is assessing Rilvogostamig plus investigator choice of chemotherapy compared to chemotherapy alone as adjuvant treatment and 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 Artemis-01 in first-line PDA1-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 levigostomy. Furthermore, the results show that levigostomy was generally well-tolerated, with no Grade IV or higher treatment-related adverse events, and low 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 Rilpocostamix worldwide sets. Next, GS0321, formerly known as COM503, which is our potentially first-in-class anti-isolating 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 1 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 TGIT, PVIRG, and IL-TNBP, and have taken them into the clinic as part of our internal pipeline or through collaborations. At our October 5th investor events, we introduced a strategic expansion of our discovery engine into targeted immune activation modalities such as T-cell engagers, where there is an high-animate need for novel cancer-specific targets. This expansion called UNIGEN-X 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 datasets, our deep understanding of the desired multi-parameter target profile, and are 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 TA-driven opportunities across solid tumor indications and modalities, enhance our internal pipeline, and support for future potential partnerships. To summarize, we expect Thanks Eran, and thank you all for joining us today.
David Silberman
Chief Financial Officer
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 7 cents per basic and diluted chair in the third quarter of 2025. With that, I will hand over to the operator to open the call for questions.
Operator
Conference Call Operator
Thank you. Ladies and gentlemen, at this time, we will begin the question and answer session. If you have a question, please press star 1. If you wish to decline from the pooling process, please press star 2. If you are using speaker equipment, kindly leave the answer before pressing the number. Please stand by while we pull for your questions. The first question is from Diana Graybush of Learing Partners. Please go ahead.
Bill
Analyst, Leerink Partners
Hey, good morning, guys. Thanks for the question. I've got Bill on for Dana. Can you talk about the difference between Unigine and UGIN-X? Can you maybe just help us? I've 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 new antigens or maybe like peptides presented on HLAs? Thank you.
Dr. Eran Ophir
President and Chief Executive Officer
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 on 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 the years, Unigen, now using UnigenX to identify more such targets to enable specific tumor targeting with T-cell engagers and potentially also other modalities.
Bill
Analyst, Leerink Partners
Thank you.
Operator
Conference Call Operator
The next question is from Leland Gershel of Hopeniner. Please go ahead.
Leland Gershell
Analyst
Great. Good morning. Thank you very much for this update and taking our questions. Just a couple from us. First, I want to ask Eran, with the Artemidae Billiardia 01 readout coming up now second half of next year, does that itself trigger a payment? Can you share? And if so, how much?
Dr. Eran Ophir
President and Chief Executive Officer
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 billary 01 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
Analyst
Got it. Okay, thanks. And then just a quick question on GSO321, so that as the phase one 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 from that program?
Dr. Eran Ophir
President and Chief Executive Officer
So due to the nature of the collaboration with Gilead, we are unfortunately unable to give guidance on the specifics of If there are any additional questions, please press star 1.
Operator
Conference Call Operator
If you wish to cancel your request, please press star 2. Please stand by while we pull for more questions. This concludes the Q&A session and Compugens investors conference call. Thank you for your participation. You may go ahead and disconnect.