Compugen Ltd.

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

Thank you, Operator, and thank you all for joining us on the call today. Joining me from Comfygen for the prepared remarks are Dr. Anak Cohen-Dyack, President and Chief Executive Officer, and Alberta Sessa, Chief Financial Officer. Dr. Michelle Mallard, Chief Medical Officer, and Dr. Irwan Uffir, 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 outlooks, development efforts and their potential outcome, the company's discovery platform, anticipated progress and plans, results and timelines for our programmes, 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 the SEC filings for more details on these risks, including the company's most recent annual report on Form 20S. The company undertakes no obligation to update projections and forward-looking statements in the future. With that, I now turn the call over to Anat.

Thank you, Yvonne, and thank you, everyone, for joining us on our first quarter 2024 call. Today, I will cover the significant progress we have made across our pipeline in the first quarter of this year, and I will then move to our planned catalysts through the rest of 2024. But before I go there, I thought I would start on a question which we frequently get asked. Is Compugen an AI company? And the answer is yes. Compugen is a pioneer in computational discovery of novel drug targets, and not just in theory, but in practice. which is a significant differentiator. We successfully moved our newly discovered drug targets from computer prediction to drug discovery to preclinical and clinical trials, continuously feeding our own pipeline with potential significant opportunities to address cancer immunotherapy resistance. The Gilead deal on CON543 highlights the most recent assets discovered through our computational discovery capabilities. Our discovery platform is a validated AI ML-powered platform. This platform is the engine fueling our competitive advantage and pipeline and has already delivered multiple fully-owned clinical programs, multiple validating strategic partnerships, and multiple early stage undisclosed assets, which are expected to feed our future pipeline and the opportunity to deliver long-term value creation. We plan to speak more on our discovery platform at future events, so now I will move to the focus of today's call. In the first quarter of the year, we again executed on our promises. Firstly, At the annual ASCO conference in June, we will present preliminary antitumor activity of COM701 in combination with COM902 and pembrolizumab in patients with MSS-CRC and liver metastasis from our ongoing proof-of-concept study. Secondly, we completed enrollment of more than 20 patients in our platinum reticence ovarian cancer study, and we're on track to report initial findings in the fourth quarter of this year. Thirdly, the progress we have made unlocking novel biology of new drug targets and in diversifying our approach to address cancer immunotherapy resistance was reflected by our presentations at the Keystone Symposium and the American Association of Cancer Research Conference in March and April this year along with the publication of our COM503 and PVRIG papers in cancer immunology research. At both conferences, we presented data supporting the unique biology of PVRIG, suggesting its role in sensitizing tumors to the other immune checkpoints, TG10PD1, and additionally, data supporting the therapeutic potentials of our high-affinity potential first-in-class antialiating binding protein antibody, COM543, showing its activity is localized to the tumor macroenvironment with the potential advantage of a wider therapeutic window than systemically delivered cytokines. Finally, in the first quarter of 2024, our partner AstraZeneca continue to rapidly advance the development of rilvagastamig. We're delighted that they are initiating a second phase 3 trial, tropion lung 10, in non-squamous, non-small-cell and cancer. The study will assess rilvagastamig as monotherapy and in combination with DATO-DXD, a TROP2-directed ADC being developed in collaboration with Daichi Sankyo, compared to pembrolizumab as first-line treatment for patients with advanced or metastatic non-squamous lung cancer with high PD-L1 expression. As a reminder, we recently received a $10 million smartphone payment upon dosing of the first patient in the phase three study of the first indication, biliary tract cancer. Under this agreement, we're eligible to receive development milestone payments for the first and second indication. The progress into a second phase three trial addressing a major indication such as non-squamous non-small cell and cancer reinforces our partnering strategy to broaden opportunities for our pipeline and brings us closer to realizing additional future milestone payments and royalties. As a reminder, The TGIT component of relvagastamig is derived from our potential best-in-class anti-TGIT COM902, and both relvagastamig and COM902 fall in the FC-reduced inactive function camp. Moving on now to what's planned for the rest of the year. 2024 is planned to be a catalyst-rich year for us, with multiple data readouts and updates expected from our diversified portfolio. At ASCO in June, we plan to present data from our ongoing proof-of-concept study in MSS-CRC patients, including those with liver metastasis, who have been treated with the IIIO combination of COM701, COM902, and pembrolizumab. MSS-CRC, and in particular, such patients with liver metastasis, represents significant unmet medical need and the hard-to-treat patient population. At CITIC in 2022, we presented data from our first cohort of 22 patients treated with a dual combination of COM701 and Evolumab, and we were the first and only company to report responses to IO in this population of patients with liver metastasis. reporting a 12% overall response rate and stable disease in addition to immune activation supporting PVRIG biology and COM701 mechanism of action. Although this indication was not initially selected based on dominant PVRIG pathway expression levels, following this encouraging clinical data, and with an aim to assess the strength of our findings in liver metastasis patients in a larger cohort, we initiated our ongoing study in 20 patients with MSS CRC and added our anti-TGIC COM902 to the drug combination to see if we could improve on the responses seen with a dual combination. Recorded was rapid, reflecting the significant unmet needs and we enrolled the last patient in September 23. The data will be presented at the upcoming ASCO on June 1st, with a data cutoff date of April 5th, 24, and remains supportive of COM71-mediated activity and safety, with some patients continuing treatment as the data cutoff date. However, With the totality of the data we have in hand, we believe that an IO-IO approach is not the way forward in this notoriously IO-resistant patient population of MSS CRC with liver metastasis. Yet, the total clinical activity observed to date in the two evaluated cohorts suggest the effects are COM71-mediated and due to the unique biology of PVRIG, may warrant further evaluation of COM701 with other agents in MSS-CRC. Therefore, the door remains open for other COM701 combinations in this patient population. However, this will not be the focus of our internal resources at this time. It is important to note that observations made in tumors which are biologically distinct from each other, such as MSS-CRC and platinum-resistant ovarian cancer, are not considered indicative of each other. With this, I will remind you that we have reported more dominant PVRIG pathway expression levels in ovarian cancer. This brings us to our next catalyst. The next catalyst for our triple combination will be the presentation of our data in platinum-resistant ovarian cancer for which we have completed enrollment. Data presentation is on track for the fourth quarter of 2024 and our plan is to present this data at a medical conference. We believe the totality of the data we have reported to date in platinum-resistant ovarian cancer patients is encouraging compared to the current standard of care. Based on the data we reported at ESMO-IO in December 2022 from the first cohort of 20 platinum-resistant ovarian cancer patients treated with triple combination, investigators were excited to report durable shrinking or stabilization of tumors in some of their patients who had previously progressed on all available treatment options. We presented a 20% overall response rate with some patients responding for over 16 months, which is favorable considering median duration of response for single-agent chemotherapy is around three to four months, and in ADCs, is around 6.9 months. Responses were achieved in the hard-to-treat high-grade serous adenocarcinoma patients along with the favorable safety profile. We also presented preliminary biomarker data showing an association between PVRL2 expression and clinical benefit. Of note, we also previously presented data showing COM7-1 monotherapy activity in a patient with ovarian cancer whose tumor microenvironment was immune desert. This patient had a partial response of more than 18 months. For the ongoing study, we plan to present data in the fourth quarter of the year, including the baseline characteristics, safety, overall response rate, disease control rate, preliminary data on duration of responses, and potentially biomarker data. Data showing clinical benefit in platinum-resistant ovarian cancer is expected to allow us to pursue the next studies towards a path to registration, which, depending on data, may employ a predictive biomarker enrichment strategy. In addition, we're also on track to submit the IND for COM503 in the second half of this year and expect that IND clearance for which we're eligible for $30 million maximum payments from Gilead, will be achieved in 2024. With that expectation, we're in advanced stages of planning the Phase 1 study. Finally, in the second half of this year, AstraZeneca expects data from their Phase 1 to Artemide 1 trial in non-small cell cancer in the frontline setting. Before passing over to Alberto to go through the financials, I would like to take this opportunity to warmly thank him for his commitment and leadership since he joined us in 2022. Alberto has been a great partner to me and the rest of the team here at Compugen. David Silverman will take over the reins from Alberto as Chief Financial Officer effective August 15th. David has experience in the healthcare industry as chief financial officer of a biotech company traded on the NASDAQ, and I'm looking forward to introducing you to David when he joins. I also want to emphasize that while benefiting from our solid cash position to enhance and advance CompuGen to additional milestones, we're also financially disciplined. We have two potential first- or best-in-class unrestricted assets, along with multiple undisclosed early-stage assets, with the possibility to address a significant admin need in immuno-oncology. In addition, we have two strong validating strategic pharma partners, Gilead and AstraZeneca, on rilvogastamig and COM503, respectively, and from whom were eligible to receive future milestone and royalty payments. With that, I will hand over to Alberto for the financial update.