Compugen Ltd.

Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's third quarter 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 Investors 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, Head of Investor Relations and Corporate Communications. Yvonne, please go ahead.

Thank you, Yoni, and thank you all for joining us on the call today. Joining me from Compogen for the prepared remarks are Dr. Anak Cohen-Dyack, President and Chief Executive Officer, David Silberman, Chief Financial Officer, and Dr. Michelle Mahler, Chief Medical Officer. We're also delighted to be joined by Dr. Ula Dapu Yeku, Assistant Professor of Medicine, Harvard Medical School, and Director of Translational Research, Gynecologic Oncology Program, Massachusetts General Hospital, Boston, who is also an investigator on our triple IO combination ovarian cancer study, which we'll discuss today. Dr. Iran Ophira, 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 their potential outcome, the company's discovery platform, anticipated progress and plans, results and timelines for our programmes and studies, financial and accounting-related matters, as well as statements regarding our cash position. We wish to caution you 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 our SEC filings for more details on these risks, including the company's most recent annual report on Form 20F. 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 Anat.

Thank you, Yvonne, and thank you, everyone, for joining us on our third quarter 2024 call. We're fresh back from the CITI conference in Houston, Texas, where we had lots of discussions around our encouraging data presented on COM701, COM902, and Pembrolizumab in patients with platinum-resistant ovarian cancer. I'm delighted to welcome Dr. Yeku to our call today to be part of our discussion on this data and our development plans. We were able to confirm in an additional cohort of platinum-resistant ovarian cancer patients the data we previously presented supporting our triple-blockade hypothesis. We're highly encouraged by the consistency of the data between our two platinum-resistant ovarian cancer studies, demonstrating COM701-driven activity and safety in more than 40 advanced and heavily pretreated patients. While looking only at overall response rate, we recognize that the 20% range may not be considered high. However, it is important to consider that this study was in a patient population with historically poor clinical outcomes and typically not responding to immunotherapy. What stands out in the totality of this data, consistent with other data we have presented, is the durability of responses and the good tolerability of the drug combination. This was also exemplified in one of our prior studies evaluating COM701 as a single agent where we reported a disease control rate of 67% in six patients, including a partial response lasting more than 18 months in a patient treated with COM701 for 24 months. In addition, the translational data supporting a robust pharmacodynamic activation of the immune system further reinforce a COM701-driven effect. This overall data in advanced disease indicates that PVRIG has a clinical relevance in this indication and supports further development of COM701, but in a path where we would expect its unique mechanism of action to be most effective. An earlier setting of ovarian cancer where there is a significant unmet need and where the disease biology FITCOM701 mechanism of action offers such an opportunity. I will now explain the rationale supporting this. Firstly, there is a gap in care for maintenance therapy in relapsed platinum-sensitive ovarian cancer patients where safe and durable treatment options would have an advantage for women who have received prior maintenance treatments and have no options for additional maintenance treatments. COM701's durability and tolerability profiles may fit this maintenance therapy need and has the potential to be highly differentiated in this setting and consequently may face less competition. Secondly, these patients are less heavily pretreated than more advanced patients and therefore are less immunocompromised, providing the opportunity for COM701 immunotherapy to harness its unique mechanism of action to potentially increase the time to disease progression and change the trajectory of the disease. In addition, platinum-based chemotherapy has been shown to induce tertiary lymph rate structures and T-memory stem cells and, therefore, has the potential to sensitize the tumors of the patients previously treated with chemotherapy to COM701 by leveraging its unique mechanism of action on these cells. Advancing COM701 in this maintenance setting of platinum-sensitive ovarian cancer has a strong clinical and biological rationale, and it also takes into consideration the less competitive landscape. Our trials is planned to be an adaptive platform trial in relapsed platinum-sensitive ovarian cancer patients who have received at least two prior lines of platinum-based chemotherapy regimens and are not candidates to receive standards of care maintenance treatment. Our development approach will be stepwise, starting with a randomized double-blinded sub-study, initially enrolling 60 patients who will be randomized two to one to COM701 monotherapy or placebo. The primary endpoint will be median progression-free survival, where the placebo benchmark is expected to be approximately six months. Such a platform design allows for assessing COM701 as a single-agent maintenance therapy and for opening additional sub-studies in the future, providing a regulatory and commercial opportunity. Additional sub-studies would permit the evaluation of COM701 as a backbone treatment in combination with agents like NTPD1 TG checkpoints inhibitors, further testing our DENAM triplet combination hypothesis. Additional sub-studies would also permit exploring additional combination options like Bevacizumab, PARP, ADCs, or others, potentially with partners, to extract the full potential of COM701. As part of the platform design, we plan to continue employing exploratory assessments of various potential biomarker enrichment strategies. We are encouraged by the feedback from ovarian cancer experts who have been very supportive of this selected path forward. We plan to initiate the trial in Q2 2025 and expect to have data from the interim analysis of the randomized COM701 maintenance therapy arm in H2 2026. This development path ticks all the boxes we believe are important for the development of COM701. It has a strong biological and clinical rationale, may open the door for partnering options for various combinations, and enables engagement with regulatory authorities to agree on a registration path. Importantly, it also makes sense from a financial perspective, allowing a gradual investment in future additional combo arms while we focus on COM7-1 as a backbone. Cash runway, assuming no further cash inflows, is expected to suffice into 2027 and anticipated to reach potential key catalysts, including projected COM701 mono-study interim analysis and support of advancement of COM503 in the clinic, together with continued investment in our earlier pipelines. Before handing over to David to run through the financials, I want to briefly relate to the other great progress we had this quarter. Starting with COM543, our differentiated approach to harness cytokine biology to treat cancer, which is partnered with Gilead. In the third quarter, we received a $30 million milestone payment from Gilead for achieving the FDA ING clearance and we are on track to initiate the Phase 1 study in this quarter. And we were excited to see presentation of data at the World Conference of Lung Cancer and ESMO showing promising efficacy and a manageable safety profile in both lung and gastric cancer from our partner AstraZeneca's Vilvogastamix, the PD-1-TG-Bi-specific, where the TG component is derived from our FC-reduced COM902. In addition, AstraZeneca recently announced its fourth and fifth Phase III trials with rivagostomig, tropion lung 12, which will assess rivagostomig as monotherapy or in combination with ADC-DATO-DXD as adjuvant therapy in patients with high-risk early-stage resected non-squamous non-small cell and cancer, and Artemide III, which will assess relvigostomy in combination with chemo compared to pembrol and chemo in frontline non-squamous non-small cell and cancer expressing PD-L1. This broad development strategy of relvigostomy by AstraZeneca represents a significant potential revenue source for CompiGen as we're eligible for both future milestone payments and meet single-digit tiered royalties on future sales. With that, I will hand over to David for the financial update.