Compugen Ltd.

Ladies and gentlemen, thank you for joining us today. Welcome to CompuGen's fourth quarter and full year 2023 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 Compogen for the prepared remarks are Dr. Anatko Ndiaye, President and Chief Executive Officer, and Alberta Sessa, Chief Financial Officer. Dr. Michelle Mahler, Chief Medical Officer, and Dr. Iran 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 will 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 programs, financial and accounting-related matters, as well as statements regarding our cash positions. 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 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 thanks to everyone for joining our call today. Before we discuss the full year and fourth quarter highlights, I want to start by welcoming the new addition to our management team, Michelle Mahler, who took over the role of Chief Medical Officer on March 1st, 2024. I'm really excited to welcome Michelle, an oncologist by training with extensive experience in leading clinical developments in both biotech and pharma companies in and outside of the U.S. Michel is an excellent fit for CompuGen and will be a great partner to me and a collaborator to the whole team as we work together on executing our programs to accelerate value creation. I would like to take this opportunity to thank Henry for his major contributions and commitment to CompuGen and his leadership. Henry has been instrumental for the successful transition of CompiGen from a preclinical to clinical stage company and creating the growth opportunities in front of us. Moving now to the highlights of 2023. Our successes in 2023 and in the last quarter in particular position us well as we advance into 2024 and are expected to play an important role in the exciting future I envision for Configen. Firstly, at the end of the year, we executed a preclinical licensing deal with Gilead for a total deal value of up to $848 million, including a $60 million upfront payment and $30 million near-term milestone payment, and with additional single-digit to low double-digit royalties on future NET sales. The license by Gilead of COM543, for which we are expected to lead phase one development, further validates our computational discovery, research, and development capabilities. It is also a testament to the differentiation of our antibody program, targeting the IL-18 binding protein. The DEEP process was competitive which reflects the significant interest in the IL-18 space and highlights the potential of our COMFY4-3 differentiated antibody approach. As a reminder, COMFY4-3, a potential first-in-class anti-IL-18 binding protein antibody, 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. Secondly, focusing on execution and advancing the development of our clinical stage assets, we initiated two proof-of-concept clinical studies with our differentiated COM701 combinations in platinum-resistant ovarian cancer and metastatic microsatellite-stable colorectal cancer. We completed enrollment in the ongoing MSS-CRC study, and we significantly ramped up the enrollment of our ongoing PROC study, with enrollment of at least 20 patients expected by the end of the first quarter of 2024. In addition, We presented new data at scientific conferences throughout 2023, including preliminary evidence supporting the association between the biomarker PVRL2 and clinical benefit intended to guide the next step in our development path for COM701 combination. Thirdly, in the fourth quarter of 2023, our partner AstraZeneca advanced revagostamine, their PD-1 TGIC bispecific, the TGIC component of which is derived from Compugen's COM902, into phase 3 development in biliary tract cancer. Dosing of the first patient in this phase 3 trial entitled us to a milestone payment and brings Compugen one step closer to a potentially marketed drug, AstraZeneca's broad clinical investigation of this asset across multiple indications and across various lines of treatment and combinations increases our probability of realizing future milestone payments and royalties. Finally, the cash received from our licensing deal with Gilead and milestone met by AstraZeneca in 2023 allow us to move into 2024 with a solid balance sheet. The additional cash we receive and the cash we expect to receive upon IMD clearance of COM 543 is expected to extend our cash runway from the end of 2024 into 2027 and potentially accelerate value creation by enabling us to invest in enhancing our discovery capabilities and advancing our diversified portfolio, including our differentiated COM701, COM902 I-O combination strategy, the phase one development of COM503, and our early stage innovative pipeline. This is an exciting time for Compugen. This is a good segue for me to move to what to expect from us in 2024. 2024 is planned to be a catalyst-rich year for us with multiple data readouts and updates expected from our diversified portfolio. In 2024, we plan to share data from our ongoing proof-of-concept studies, MSS-CRC, and platinum-resistant ovarian cancer. These are particularly challenging indications to treat and have historically failed to respond to immunotherapy. While we believe that these indications represent a very high bar, we have previously presented encouraging clinical data supported by immune activation, suggesting that the unique biology of PVRIG enables NTPD-1 activity in these challenging indications. The goal of these studies is to further substantiate our clinical findings, including our initial biomarker results, to potentially enable us to move forward with a biomarker-enriched development strategy. Regarding MSS-CRC, In the first cohort of 22 patients treated with COM701 in combination with nivolumab, we showed an encouraging overall response rate of 12% and stable diseases in patients with liver metastasis, a patient population which historically has not responded to other drugs. For the ongoing proof-of-concept study, our objective is to understand if there could be an additional benefit of adding an anti-TG to the dual combination and further evaluate the combination in the liver metastasis patient population, which represents approximately 70% of the patient population in the evaluated line of treatment. The ongoing study, fully recruited in 2023, at a speed which we believe reflects the significant unmet needs. Data presentation from this ongoing study is planned for the first half of 2024, with the aim to be presented at a medical conference. You can expect to see baseline characteristics, including safety, overall response rate, disease control rate, duration of response, and translational data. In patients with platinum-resistant ovarian cancer, based on the data from the first cohorts of 20 patients treated with triple combinations, there was a lot of excitement from investigators reporting durable shrinking or stabilization of tumors in some of their patients who had previously progressed on all available treatment options. We believe The totality of the data reported in these patients is encouraging compared to the current standard of care. We presented a 20% overall response rate with patients responding for over 16 months, which is favorable, considering median duration of response for single-agent chemotherapy is around 3 to 4 months, and in ADCs is around 6.9 months. Responses were also achieved in the hard-to-treat high-grade serous adenocarcinoma patients along with a favorable safety profile. For the ongoing study in platinum-resistant ovarian cancer, we are delighted to report that our investigators are active on recruitment and we expect to complete recruitment of at least 20 patients this quarter and and plan to present in the fourth quarter of 2024. Again, our preference will be to present at a medical conference. For this ongoing study, you can expect to see baseline characteristics and data for at least 20 patients, including safety, overall response rate, disease control rate, duration of responses, and preliminary biomarker data. Moving now to COM503. Rapid execution on both COM543 IMD clearance and Phase 1 development is a priority for us, and we're incentivized by Gilead on this priority. We greatly value the partnership with Gilead, and together we're well advanced on the Phase 1 trial design and feel confident that we can initiate Phase 1 shortly after we gain IMD clearance. were on track for IMD submission in the second half of 2024 with subsequent initiation of the Phase I study following IMD clearance. Finally, in the second half of 2024, AstraZeneca expects data from their Phase I-II Artemide I trial in non-small cell cancer in frontline setting and their Phase II Gemini trial in hepatobiliary cancer. Before handing over to Alberto to go through our financials, I want to emphasize that we will continue to be financially disciplined while benefiting from our solid cash position to enhance and advance our company. We're strategic with how we deploy our resources, and this will include two main priorities. One, advancing our clinical stage programs, COM701 and COM902 combinations, and COM503 upon initiation of its clinical study, and two, investing in COMPIGEN's core competitive advantage, the integration of our computational discovery platform with innovative research and drug development capabilities. In terms of COM701 combinations, Advancing our ongoing studies will be data and biology driven. In PROC, we believe data showing durable responses and additional biomarker correlations are expected to allow us to move ahead employing a predictive biomarker enrichment strategy. As a result of the evolving platinum-resistant ovarian cancer treatment landscape, we see the opportunity for COM701 combinations to be used as a treatment option in two patient populations, those progressing on ADCs and those ineligible for ADCs. In MSS-CRC, the bar is very high due to the many failures and the non-responsive nature of the liver metastasis patient population. We believe the data showing an overall survival advantage over standard of care would be encouraging. Our study in MSS CRC is still ongoing, as some of the patients enrolled only in September 23, and based on data from the overall and the liver metastasis patient populations, we will determine the next steps. Based on the encouraging safety and efficacy data generated to date with our COM701 combinations across indications, we believe there is an opportunity to collaborate with potential partners to bring COM701 combinations to patients across a broad range of indications, generating a potentially large opportunity. For the second main priority, we will continue to invest in the engine powering our core competitive advantage. We're skilled and highly experienced in integrating cutting-edge computational capabilities with groundbreaking immunology research and drug development expertise to discover novel drug targets. Investing to enhance our computational discovery platform from computer predictions to early-stage programs we believe will enable us to progress the generation of novel drug candidates the next come 5.3. And finally, our focus remains on non-dilutive funding for which we have demonstrated in 2023 we can successfully execute on. With that, I turn the call over to Alberto.