Compugen(US:CGEN)2019-11-11 17:37Financial Data and Key Metrics Changes - As of September 30, 2019, the company had approximately $48 million in cash and cash-related accounts, an increase from approximately $37 million at the end of Q2 2019, attributed to proceeds from the ATM facility amounting to approximately $15.5 million [38] - R&D expenses for Q3 2019 decreased by approximately 45%, totaling $4.3 million compared to $7.8 million in the same period of 2018, primarily due to reduced preclinical activities related to COM902 and cost reduction measures [39] - The net loss for Q3 2019 was $6.5 million or $0.10 per share, compared to a net loss of $3.1 million or $0.05 per share for Q3 2018, which included $7.8 million in revenue from a milestone achieved with Bayer [40] Business Line Data and Key Metrics Changes - The company reported initial clinical data for COM701, showing that 69% of the 13 patients in the study had a best time point response of stable disease, with 83% of microsatellite stable colorectal cancer patients achieving the same response [13][31] - The ongoing Phase I study of COM701 is progressing, with the company currently enrolling patients in the eighth dose cohort at a higher dose of 20 mg/kg on a Q4 weekly dosing schedule [35][36] Market Data and Key Metrics Changes - The company is focusing on specific tumor types for the expansion cohort based on PVRL2 expression data, including lung, breast, ovarian, and endometrial cancers, which are believed to have high PVRL2 expression [17] - The initial clinical data presented at the Annual Meeting of the Society for Immunotherapy of Cancer indicated that COM701 is the only PVRIG inhibitor currently in clinical testing, positioning the company uniquely in the market [9] Company Strategy and Development Direction - The company aims to advance COM701 through its next phases of development, including a combination therapy with Opdivo and a monotherapy expansion cohort [16][36] - The company has made significant progress with COM902, its anti-TIGIT antibody, and plans to initiate a Phase I trial for COM902 in early 2020 [20][21] - The company is committed to leveraging its computational discovery platform to develop differentiated clinical programs that may expand cancer immunotherapy treatment options [23] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the emerging safety profile and initial signs of antitumor activity for COM701, particularly in a challenging patient population [7][25] - The company believes its current cash resources are sufficient to support activities through the second quarter of 2021 without additional cash inflows [41] - Management emphasized the importance of urgency in advancing clinical programs while maintaining a responsible approach to development [50] Other Important Information - The company has reached a significant milestone with three programs based on new drug targets discovered internally set to be evaluated in the clinic in 2020 [22] - The company is aware of other entities working on PVRIG antibodies and is focused on maintaining urgency in its program development [49] Q&A Session Summary Question: Anticipation of protocol amendments for COM701 trial - Management indicated it is premature to discuss potential amendments to the protocol for the expansion cohort but acknowledged the data presented [42][44] Question: Design of COM902 trial - The design will be a standard rules-based approach, combining a hybrid single subject design and 3 plus 3, but specifics on combining with COM701 will depend on COM902's safety profile [43][45] Question: Duration of clinical benefit and prior I-O treatment - The disease control rate was 69%, with durations of response ranging from 85 to 370 days, and some patients had prior treatment refractory disease [52][53] Question: Biomarker data indicating tumor response - Currently, there are no pre-treatment biopsies available, but future expansion cohorts will require biopsies to assess the tumor microenvironment [58][60] Question: Reason for choosing indications for dose expansion cohorts - The selected indications were based on high expression levels of PVR, PVRL2, and PD-L1, with clinical data now influencing future decisions [63][64]