On August 7, 2023 Compugen Ltd., a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported its financial results for the second quarter ended June 30, 2023 and provided a corporate update on key events since the start of 2023 (Press release, Compugen, AUG 7, 2023, View Source [SID1234634869]).
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"In the first half of the year, we continued to execute on our goals," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "Patient enrollment is advancing in our two proof-of-concept studies with our unique triple immunotherapy combination approach and initial findings are expected by the end of the year. We presented new clinical data in metastatic endometrial cancer at ASCO (Free ASCO Whitepaper) in June showing durable responses, including in a patient failing immunotherapy which is consistent with data we previously presented in other hard to treat tumors. The totality of our data to date, suggest that our COM701 based combinations have the potential to offer a treatment option with a favorable safety profile for hard-to-treat patients, across the spectrum of PD-L1 expression levels, including in patients who are anti-PD-1 refractory, pointing to a potential COM701 mediated mechanism of action."
Dr. Cohen-Dayag added, "Our immediate focus is on expanding our data in two indications, platinum resistant ovarian cancer and microsatellite stable colorectal cancer, while continuing to invest in biomarker discovery, which is important to efficiently set our development path forward. We believe that the therapeutic potential of COM701 and COM902 as part of the DNAM-1 axis may be much broader than these two indications."
Dr. Cohen-Dayag concluded, "In the second half of the year we are planning to present new and follow up data with our COM701 combinations including in ovarian and breast cancer as well as additional data on our COM503 lead pre-clinical program. Additionally, we are delighted to see the continued advancement in the development of rilvegostomig derived from COM902 by our partner AstraZeneca."
Corporate Update:
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March 2023: First patient dosed in microsatellite stable colorectal cancer study; enrollment is on track to complete by year end.
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CIMT May 2023: Presentation of data on lead pre-clinical asset COM503, an anti- IL-18BP antibody, designed to induce a potent anti-tumor response and pronounced localized tumor microenvironment immune modulation by unleashing natural IL-18 activity in the tumor and potentially overcoming the challenges of administering a cytokine therapeutic.
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June 2023: First patient dosed in platinum resistant ovarian cancer study. Enrollment to date is slower than anticipated, however we believe that we can catch up on enrollment with the planned activation of additional sites.
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June 2023: Win at the European Patent Office (EPO), which ruled to uphold the Company’s broad PVRIG patent for the treatment of cancer reflecting the strength of Compugen’s patent strategy in novel target discovery. The EPO ruling is subject to appeal.
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ASCO June 2023: Presentation of data from triple immunotherapy combination (COM701+ nivolumab + BMS anti-TIGIT) in microsatellite stable endometrial cancer study showing durable partial responses in patients who failed standard of care, including pembrolizumab and lenvatinib.
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ASCO June 2023: Presentation of clinical data by partner AstraZeneca on rilvegostomig, a PD-1/TIGIT bispecific derived from COM902, establishing its safety and pharmacokinetic profile and showing anti-tumor activity in checkpoint inhibitor experienced NSCLC patients who typically do not respond to immunotherapy.
Next Planned Milestones in H2 2023:
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Report initial findings from ongoing triple combination (COM701+COM902+ pembrolizumab) proof-of-concept studies in microsatellite stable colorectal and platinum resistant ovarian cancer by end of the year.
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Presentation of new translational data and initial biomarker data from platinum resistant ovarian cancer studies evaluating COM701 + nivolumab ± BMS anti-TIGIT.
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Presentation of longer-term patient follow up from platinum resistant ovarian cancer study evaluating COM701 + nivolumab + BMS anti-TIGIT.
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Presentation of new data from the metastatic breast cancer cohort expansion study of patients treated with COM701 and nivolumab.
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Presentation of data from COM503 lead pre-clinical program.
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Rilvegostomig (PD-1/TIGIT bispecific derived from COM902): AstraZeneca continues to advance the development of rilvegostomig in multiple trials, including a Phase 2 trial in checkpoint inhibitor naïve NSCLC and a Phase 2 trial in hepatobiliary cancer. AstraZeneca disclosed plans to initiate a Phase 3 trial with rilvegostomig this year.
Financial Results
As of June 30, 2023, cash, cash equivalents and cash investments were approximately $66.5 million, compared with approximately $83.7 million as of December 31, 2022. The Company expects its existing cash and cash related balances to be sufficient to fund its operating plan into at least the end of 2024, based on current plans. During the three months ended June 30, 2023, the Company sold approximately 1.6 million ordinary shares under its "at-the-market offering" (ATM) facility pursuant to a sales agreement entered with Leerink Partners on January 31, 2023, for aggregate gross proceeds of approximately $1.6 million.
Compugen has no debt.
R&D expenses for the second quarter ended June 30, 2023, were approximately $7.8 million, up from $6.8 million for the comparable period in 2022. The increase is mainly due to end of the amortization of the deferred participation in R&D expenses following the termination of the agreement with Bristol Myers Squibb in the third quarter of 2022, and an increase in preclinical and CMC activities associated with COM503, offset by a decrease in clinical trial expenses, headcount and currency exchange effect.
General and administrative expenses for the second quarter ended June 30, 2023, were approximately $2.4 million down from approximately $2.6 million for the comparable period in 2022.
Net loss for the second quarter ended June 30, 2023, was approximately $9.3 million, or $0.11 per basic and diluted share, compared with a net loss of approximately $9.1 million, or $0.11 per basic and diluted share, for the comparable period in 2022.