5/6/2020

speaker
Conference Operator
Moderator

Thank you, Operator, and thank you for joining us today.

speaker
Ilana
Investor Relations

With me from Compugen are Dr. Anat Cohen-Dayag, President and CEO, Dr. Henry Attaway, Chief Medical Officer, and Ari Krushen, CFO and COO. Before we begin, I would like to read the following regarding forward-looking statements. During the course of this conference call, the company may make projections and other forward-looking statements regarding future events or future business outlook, our development efforts and their outcome, our discovery platform, Anticipated progress and timeline for our programs, financing, 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 expectations and that actual events or results may differ materially. You are kindly referred to the risk factors and cautionary language contained in the documents the company filed with the Securities and Exchange Commission, including the company's most recent annual report, and Form 20-F filed on February 24, 2020. The company undertakes no obligation to update projections and forward-looking statements in the future. I will now turn the call over to Anat. Anat?

speaker
Dr. Anat Cohen-Dayag
President and CEO

Thank you, Ilana. Good morning and good afternoon, everyone, and welcome to our first quarter 2020 corporate and financial update. As Ilana mentioned, Today on the call, I have with me Dr. Henry Adewoy, our Chief Medical Officer, who will provide updates on our clinical progress. We also have Ari Krashen, our CFO and COO, who will review our financial statements and positions. In the past two months, we have experienced a new reality, brought about by the COVID-19 pandemic, which impacted every aspect of our lives, both private and professional. Our highest priority during this time has been and continues to be the safety and health of our employees while doing our best to meet our goals. Most of our employees are currently working remotely, though almost all of our lab scientists continue to work in our R&D laboratories under strict safety guidelines. We have reviewed our most critical activities and implemented mitigation plans to minimize the impact on our clinical programs, which I will discuss in more detail shortly, as well as our early-stage pipeline program. Simultaneously with preparing for escalating scenarios nationwide or company-wide, We're now implementing measures which are intended to allow for smooth and efficient recovery once normalization is declared. At this time, we're not experiencing significant delays in our plans, and despite the ongoing challenges associated with the COVID-19 global pandemic, the first quarter of 2020 has been one of significant and continued accomplishments for CompuGem. We reported additional encouraging data from our Phase 1 COM701 dose escalation study, both as monotherapy and in combination with Odevo. This further supports the potential of our overall science-driven clinical strategy. In addition, we have advanced COM902, our anti-clinic antibody to the clinic, announcing the first patient dose in April. This marks a third target program discovered computationally by us that is now in clinical studies. Earlier in the quarter, we also announced an important strategic step by spending our ongoing collaboration with Bristol-Mare-Squid to include a Phase I-II-III combination study testing COM701 with BMS of DIVO, and their investigational TIGIT inhibitor. This study will enable us to directly test our hypothesis of an intersection between the PDR-IG, TIGIT and PD-1 pathways in which the simultaneous blockade of these three pathways has the potential to synergistically enhance antitumor immune response in selected patient populations Not responsive or refractory to PD-1 blockers alone. As a brief reminder, our intelligent discoveries on the existence of two parallel and complementary pathways in the genome-immune oncology axis lay the foundation for our current progress. Our lead program, COM701, originated from our computational discovery of PVRIG as a novel immune checkpoint and newly discovered inhibitory pathway in the genome axis. This finding was added to a prior discovery by us and by others, suggesting that STIGIT, our COM902 target, is an additional inhibitory pathway that is part of the genome axis. Our research and preclinical data indicate that these two pathways are parallel and complementary inhibitory pathways in the genome axis and have further strengthened our belief that in certain tumor types and patient populations, where the two pathways are operative, there may be a need to block both PTRID and TATIC in order to enhance potent anti-tumor immune response. Our preclinical data supports recent scientific findings by others indicating a molecular intersection between the genome exit and the PD-1 pathway, thus suggesting that various drug combinations that address PDRG, TGIT, and PD-1 may be required to target these three pathways in different cancer patient populations and in cancer indications. While in some of the patients, blocking the PD-1 pathway will be sufficient, in others, the blockade of one or two of the other inhibitory pathways with or without PD-1 blockade may be required to generate potent immunotherapy treatment responses. Before Henry provides detailed clinical updates, I'd like to spend a little more time highlighting our accomplishments and what is to come in 2020. Last week, we presented updated data at the ASTR virtual meeting, which further supports the safety and antitumor activity of COM701 as a monotherapy and expands our data to include also COM701 in combination with Opdivo. As before, we believe our results, which now include two confirmed partial responses, in addition to the high percentage of disease control rate and some durable responses of over six months across treatment arms, are particularly compelling as they were achieved in a dose escalation setting in a highly refractory patient population. We have completed the monotherapy dose escalation, and we're now working on completing the combination dose escalation. And importantly, we look forward to beginning our biomarker-informed monotherapy expansion cohort, which are expected in Q2. Our monotherapy expansion cohort will include indications we believe are most likely to respond to COM701, and these were selected based on our analysis of denim acid biomarker expression profiles and our clinical data. In this monotherapy expansion study, biopsies will be collected before and on COM7-1 treatment to allow retrospective analysis of our denim acid biomarker approach. Additionally, we remain on track to begin our Phase 1-2 triple combination study, testing COM701 with BNS of Devo and their investigational TG inhibitor in the second half of this year. Moving to our TG program, we were pleased to announce first patient dose in our Phase 1 dose escalation trial of COM902 in patients with advanced malignancies. This would enable us to clinically evaluate dual blockade of PDRIG and TIGIT inhibitory pathways in the genome axis. We are encouraged by the biopharma industry's increasing interest in TIGIT. The potential clinical validation of the TIGIT pathway, combined with our encouraging signals of antitumor activity of COM701 as a monotherapy and in combination with PD-1 inhibitor further substantiates our hypothesis of the relevance of the DENAM axis and the PDR-IG pathway in immunology. This also serves as evidence in our view of the potential power and validity of our computational discovery platform. Having access to the only clinical stage PDR-IG asset to our knowledge highly differentiates us on testing the clinical relevance of these Xs, and we look forward to driving our three parallel clinical studies in 2020, COM701 monotherapy, COM701-OVIVO, Antibiotic Inhibitor-Triple Combination Therapy, and COM902 dose escalation. Furthermore, in early Q1, We provided certain anticipated milestones and data readouts. At this time, despite the COVID-19 pandemic, we do not expect delays in our earlier guidance. We still plan to initiate and complete enrollment in our COM701 monotherapy expansion cohort with initial data expected to be disclosed in the first half of 2021. disclose initial data from our COM902 dose escalation study in 2021, and initiate our triple combination study with BMS in the second half of 2020. Having said that, we're monitoring the situation on an ongoing manner, and we will share with you any material changes in our outlook, if these may arise. While some of our sites are directing resources to COVID-19, overall to date we have not observed significant impact on patient enrollment and monitoring. This could be for a number of reasons. First, the patient population we are enrolling is comprised of patients with advanced disease who have exhausted all available standards of care therapies. We are still in stages in which we are recruiting a very small number of patients. In addition to these two aspects, we believe that the number of clinical sites participating in our studies, our careful selection of a mix of academic and dedicated Phase I clinical trial sites that see only patients with advanced cancer, and the diligence of the clinical investigators all contribute to our current position. But again, this may change, and we are in daily communication with the site and are actively monitoring the situation. We have also continued our steady progress in strengthening our intellectual property portfolio, aiming to keep the position of our assets as strong as possible. Adding to our previously granted composition of matter and use patent in the US and Europe, we are announcing Q1, a European patent for the use of any anti-PGRID antibody that activates T-cells and or NK-cells in the treatment of cancer, an additional European composition of matter patent for COM701 and backup antibodies for use in the treatment of cancer, and the U.S. Patent for methods of screening of anti-PDRG antibodies that inhibit the binding of PDRG and PDRL2. We were proud to recently announce the publication of preclinical data originating from our collaboration with Bayer on Bay 190-5254, a first-in-class immuno-oncology therapeutic antibody targeting IDR2. which we discovered computationally and which is currently being evaluated by Bayer in a Phase 1 study in advanced solid tumor. We believe this also serves as important validation of the power of our platform to computationally identify untapped drug targets while also establishing ILDR2 as a new immune checkpoint and a drug target being pursued in clinical studies. The recent accomplishments have contributed to COMPIGEN's dramatic evolution over the past several quarters. We transitioned to a clinical stage company with a growing body of encouraging data that support our unique approach as a target discovery and drug development biotech company employing cutting-edge Computational Biology to discover new biological pathways and novel drug targets to develop first-class drug candidates. This quarter, and despite challenging market conditions, we were pleased to announce an approximately $79 million public offering that we believe is testament to the growing confidence in our company, and the power of our approach and capabilities. Our strengthened cash balance empowers us to continue our strong execution, pursue our strategic clinical plans and advance our early stage programs to propel our company forward. Before turning the call over to Henry, I would like to add that I'm very proud of our employees and Grateful for their dedication. These recent accomplishments and our tremendous progress over the past several quarters were made possible due to their hard work, drive, faith and commitment for which I'm incredibly grateful, particularly given the extraordinary circumstances we're now facing. Under these circumstances, we remain focused on advancing our pipeline program and maintain positive momentum to achieve our long-term goals. I look forward to providing updates throughout the year. And with this, I will now turn the call over to Henry. Henry?

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