3/4/2025

speaker
Operator
Conference Call Operator

Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's fourth quarter and full year 2024 results conference call. At this time, all participants are in a listen-only mode. An audio webcast of this call is available in the investor section of Compugen's website, www.cgen.com. As a reminder, today's call is being recorded. I would now like to introduce Yvonne Naughton, Vice President, Head of Investor Relations and Corporate Communications. Yvonne, please go ahead.

speaker
Yvonne Naughton
Vice President, Head of Investor Relations and Corporate Communications

Thank you, Operator, and thank you all for joining us on the call today. Joining me from Compogen for the prepared remarks are Dr. Nat Cohen-Dyack, President and Chief Executive Officer, and David Zimmerman, Chief Financial Officer. Dr. Michelle Maller, Chief Medical Officer, and Dr. Eran Ofer, Chief Scientific Officer, will join us for the Q&A. Before we begin, we would like to remind you that during this call, the company may make projections or forward-looking statements regarding future events, business outlook, development efforts, and the potential outcome. The company's discovery platform anticipates your progress and plans, results and timelines for our programs, financial and accounting-related matters, as well as statements regarding our cash position and cash runway. We wish to continue that such statements reflect only the company's current beliefs, expectations, and assumptions, but actual results, performance, or achievements of the company may differ materially. These statements are subject to known and unknown risks and uncertainties, and we refer you to the SEC filings for more details on these risks, including the company's most recent annual 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 turn the call over to Annette.

speaker
Annette
Company Representative (Presenter)

Thank you, Yvonne, and a warm welcome to everyone joining our call today. On today's call, I will highlight some of our key achievements in 2024 and outline our strategic priorities for 2025, starting with our potential first-in-class anti-PVRIG COM701. In 2024, we presented data showing the treatment with a triple blockade of PVRIG, TGIC, and PD-1 with COM701, COM902, and pembrolizumab in platinum-resistant ovarian cancer patients who typically do not respond to immunotherapy resulted in encouraging durable responses and was well tolerated. As of mid-February 2025, a few patients remained on study treatment. The data from this study is important because it is consistent with data we previously presented and further demonstrates COM701 is active, results in durable responses, and has a good tolerability profile. Based on the totality of the data we've presented to date, including monotherapy and combination data, and with the support from ovarian cancer experts, we announced at the end of 2024 that we would advance development of COM-701 as a maintenance treatment option for patients with platinum-sensitive ovarian cancer. We believe that advancing COM701 in this maintenance setting of platinum-sensitive ovarian cancer has a strong clinical and biological rationale and represents a less competitive landscape. As part of our 2025 strategic priorities, we are on track to initiate in the second quarter of 2025 an adaptive platform trial starting with a randomized double-blinded sub-trial. The first sub-trial will evaluate single-agent COM701 as a maintenance therapy versus placebo in a total of 60 patients with platinum-sensitive ovarian cancer who are not candidates for bevacizumab or PARP inhibitors. The primary endpoint will be median progression-free survival, where the placebo benchmark is expected to be approximately six months. We believe that showing a three-month improvement over the median progression-free survival of the placebo would be clinically meaningful. We expect to share interim analysis from this sub-trial in the second half of 2026. Positive data may allow us to both engage in discussions with the regulatory authorities on a path for COM701's registration as a single agent and to extend the opportunity for COM701 to serve as a backbone for future drug combinations. Moving next to the TGIC landscape. In 2024, there have been several setbacks for the TGIC antibody class resulting in study or program discontinuations, which led to skepticism about the benefit that TG blocker combinations could bring. These study discontinuations occurred with FC-active TG antibodies. Setting aside the importance of selecting the appropriate tumor types and patient populations, then in some cases, might not have been an ideal fit for TG blockers assessment, we consistently have advocated that ST inactive antibodies may serve as the better antibody format for targeting TGs. In line with this, current clinical trials suggest that ST inactive anti-TGs may have a safety advantage in certain patient populations which could ultimately support a potential efficacy advantage due to the patient's durability on study treatment. We therefore believe that the current phase three trials conducted with FC inactive TGIT antibodies are important to confirm or refute the benefit that TGIT blocker combinations could bring. If success is achieved by one of these upcoming phase three trials, it could validate TGIT antibodies as a drug class and open new opportunities for CompiGen based on our TGIT antibody. We're one of the few companies with a clinical stage FC inactive TGIT antibody, COM902. We differentiate ourselves not only by the unique properties of COM902, but also by our clinical strategy. We continue to believe that blocking TGIT in combination with PD-L1 blockers may be effective in certain PD-L1 high tumors. But we also believe that TGIT PD-L1 blockade may need to be combined with a PGRG inhibitor to expand their use to less inflamed PD-L1 low tumors. In addition, our partner AstraZeneca has most recently initiated their seven phase three clinical trials with relvigostomy, their PD-1-tigit bispecific, the tigit component of which is derived from our COM902. Since we last reported in November 2024, AstraZeneca has initiated two phase three trials evaluating relvigostomy combinations versus standard of care. With one trial, in first-line squamous non-small cell lung cancer, expressing PD-L1, and the other trial is first-line treatment in HER2-positive gastric cancer. AstraZeneca's broad development strategy for relvigostomy to replace existing PD-1 or PD-L1 inhibitors represents a significant potential revenue source for CompiGen as were eligible for both future milestone payments and meet single digit-tiered royalties on future sales. In 2024, AstraZeneca presented promising relvigostomic data at the World Conference of Lung Cancer and ESMO showing promising efficacy and a manageable safety profile in both lung and gastrointestinal cancer. In 2025, AstraZeneca plans to share early data on the combination of relvagastamig with their ADCs. Moving next to GS0321, previously named COM503. As a reminder, GS0321, a potential first-in-class anti-IL-18 binding protein antibody licensed to Gilead, represents a novel way to harness IL-18 pathway biology for the treatment of cancer by using an antibody against IL-18 binding protein and therefore potentially avoiding the challenges presented by administration of therapeutic cytokines. The license by Gilead of GS0321 further validates our computational discovery, research, and drug development capabilities. It is also a testament to the differentiation of our antibody program targeting the IL-18 binding protein. In 2024, we also made great progress on GS0321. In the third quarter of 2024, we received a $30 million milestone payment from Gilead for achieving the SDA IND clearance. In the fourth quarter of 2024, we initiated the phase one trial for GS0321, and the first patient was dosed in early January 2025. As part of our strategic priorities in 2025, we're focused on the efficient execution of the GS0321 phase one trial. Finally, beyond our clinical stage program, our talented teams are working on multiple innovative undisclosed research programs. These efforts leverage computational predictions to identify novel ways to activate anti-tumor immunity. This work is powered by Unigen. our computational prediction discovery platform already validated by our multiple clinical stage potential first and best in class antibodies, as well as our partnerships with AstraZeneca and Gilead. It is a strategic priority for us to advance our programs to continue to feed our own pipeline. With a diverse pipeline, and strong focus on execution in 2025, we believe Comfygen is well-positioned for growth. Cash runway, assuming no further cash inflows, is expected to last into 2027, and we anticipate using this runway to advance the projected COM701 single-agent subtrial interim analysis, and to support the progression of GS0321 in the clinic, together with continued investment in our early stage research pipeline. Of course, none of this would be possible without our extraordinary team here at Compugen, who continuously performs at the highest levels of excellence. I'm excited for 2025 to be another year of advancing our efforts to make a meaningful impact on cancer patients' lives. With that, I will hand over to David for the financial update before we open the floor for Q&A.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-