On November 12, 2024 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported financial results for the third quarter ended September 30, 2024, and provided a corporate update (Press release, Compugen, NOV 12, 2024, View Source [SID1234648164]).
"A highlight of the third quarter was the presentation of our validating COM701, COM902, pembrolizumab combination data in heavily pre-treated platinum resistant ovarian cancer (PROC) patients at SITC (Free SITC Whitepaper) last week," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "We are highly encouraged that this study confirms previously presented data supporting COM701 mediated durable responses with a good tolerability profile in advanced heavily pre-treated patients. Feedback received from ovarian cancer experts supports advancing development of COM701 in an earlier disease setting. There is a need for durable and well tolerated treatment options in relapsed platinum sensitive ovarian cancer (PSOC) patients who have received prior maintenance treatment and have no options for additional maintenance therapy. These patients are less immune compromised, than more advanced patients, providing the opportunity to harness the unique mechanism of action of COM701 to potentially change the disease trajectory and improve progression free survival. In addition, since there is no established treatment for these women, targeting this patient population to evaluate COM701’s single agent activity and as a potential backbone for future combination treatments, presents a regulatory and commercial opportunity. We look forward to initiating an adaptive platform trial, starting with sub-study 1 randomizing patients with relapsed PSOC to single agent COM701 maintenance treatment or placebo in the second quarter of 2025. Since the median progression free survival of these patients is around 6 months, and this is a less competitive space than PROC for enrollment, we project having data from the interim analysis of sub-study 1 in the second half of 2026."
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Dr. Cohen-Dayag continued, "In the third quarter of 2024, we received a $30 million milestone payment from our partner Gilead following achieving FDA IND clearance for COM503, a differentiated antibody approach to harness cytokine biology for cancer therapeutics. We are on track to initiate a Phase 1 clinical trial for COM503 in advanced solid tumors, in the fourth quarter of 2024."
Dr. Cohen-Dayag added, "Our partner, AstraZeneca, continued to advance development of rilvegostoming, their PD-1/TIGIT bispecific of which the TIGIT component is derived from COM902. In September 2024, AstraZeneca presented clinical data showing promising efficacy and a manageable safety profile in trials evaluating rilvegostomig monotherapy in lung cancer and in combination with chemotherapy in gastric cancer at the WCLC and ESMO (Free ESMO Whitepaper), respectively. They also initiated two additional Phase 3 trials bringing the total number of ongoing Phase 3 trials to five. We are eligible for future milestones and mid-single-digit tiered royalty payments, presenting a significant potential revenue source for the Company."
Next Planned Milestones
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Q4 2024- on track to initiate Phase 1 study of COM503 in solid tumors
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Q2 2025- plan to initiate an adaptive platform trial starting with sub-study 1, randomizing patients with relapsed platinum sensitive ovarian cancer ineligible for PARPi or bevacizumab to single agent COM701 maintenance treatment or placebo
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H2 2026- data from projected COM701 interim analysis from sub-study 1
Third Quarter 2024 Financial Highlights
Cash: As of September 30, 2024, Compugen had approximately $113.2 million in cash, cash equivalents, short-term bank deposits, long term restricted bank deposits, restricted cash and cash investments, compared with approximately $51.1 million as of December 31, 2023. Cash includes a $30 million milestone payment for COM503 IND clearance achieved in July 2024, which was subject to a 15% withholding tax and a $5 million clinical milestone payment from AstraZeneca. Compugen expects that its cash and cash related balances will be sufficient to fund its current operating plans into 2027. The Company has no debt.
Revenues: Compugen reported approximately $17.1 million in revenues for the third quarter ended September 30, 2024, compared to no revenues for the comparable period in 2023. The revenues reported reflect the recognition of a portion of the upfront and milestone payments from the license agreement with Gilead.
R&D expenses for the third quarter ended September 30, 2024, were approximately $6.3 million, a decrease from $8.3 million for the comparable period in 2023. The decrease is mainly due to the classification of COM503 R&D activities to cost of revenues coupled with lower COM503 expenses, mainly related to CMC.
G&A expenses for the third quarter ended September 30, 2024, were approximately $2.6 million, compared to approximately $2.3 million for the comparable period in 2023.
Net Profit for the third quarter ended September 30, 2024, was approximately $1.3 million, or $0.01 per basic and diluted share, compared with a net loss of approximately $9.9 million, or $0.11 per basic and diluted share, for the comparable period in 2023.