Eran Ophir
Analyst · Leerink Partners
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.
