On November 7, 2023 Compugen Ltd., a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported financial results for the third quarter ended September 30, 2023, and provided a corporate update (Press release, Compugen, NOV 7, 2023, View Source [SID1234638116]).
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"In the second half of 2023, we continue to execute, and are delighted to see the continued advancement in the development of rilvegostomig derived from COM902 by our partner AstraZeneca who has progressed it into Phase 3 as adjuvant therapy for biliary tract cancer after resection in combination with chemotherapy," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "We completed patient enrollment in our microsatellite stable colorectal cancer proof-of-concept study with our unique triple immunotherapy combination and we are on track to report data in the first half of 2024. We presented new clinical data at SITC (Free SITC Whitepaper) last week reinforcing previous data suggesting COM701 mediated anti-tumor activity in patients typically not responding to immunotherapy. For the first time, we presented initial data showing the association between baseline PVRL2 levels and clinical benefit, suggesting the potential of PVRL2 as a predictive biomarker to help enrich for patients who may derive benefit from COM701 combinations in certain indications. This initial finding has potential to inform future direction of our studies employing a biomarker driven strategy."
Dr. Cohen-Dayag, added, "At SITC (Free SITC Whitepaper), during both oral and poster presentations, we presented data supporting our approach to harness IL-18 biology to fight cancer and address the challenges that led to past failures by others with the systemic dosing of cytokines. Our data suggest that our potentially first-in-class anti-IL18BP antibody approach has a leading edge in inhibiting tumor growth, while avoiding peripheral toxicity associated with administration of a recombinant IL-18 cytokine."
Dr. Cohen-Dayag concluded, "Moving into next year, we look forward to presenting data in the first half of 2024 from our proof-of-concept study in metastatic colorectal cancer and completing enrollment of up to 20 patients from our platinum resistant ovarian cancer proof-of-concept study and to present data in 2024. Additionally, we are on track for IND filing in 2024."
Corporate Update:
Q4 2023: Rilvegostomig, AstraZeneca’s PD-1/TIGIT bi-specific derived from Compugen’s COM902 progressed into Phase 3 as adjuvant therapy for biliary tract cancer after resection in combination with chemotherapy.
Q4 2023: Microsatellite stable colorectal cancer study; enrollment of 20 patients complete.
Q3-Q4 2023 : Activation of additional sites in platinum resistant ovarian cancer study resulting in increase in enrollment. However, enrollment completion of up to 20 patients will move into 2024.
SITC 2023: Presentation of new translational data and initial biomarker data from platinum resistant ovarian cancer studies evaluating COM701 + nivolumab ± BMS anti-TIGIT, supporting a COM701 mediated clinical benefit and initial data to suggest PVRL2 as a potential biomarker to help enrich for patients who may derive benefit from COM701 combinations.
SITC 2023: Presentation of longer-term patient follow up from platinum resistant ovarian cancer study evaluating COM701 + nivolumab + BMS anti-TIGIT showing clinically meaningful durable responses, with a trend that compares favorably to standard of care.
SITC 2023: Presentation of new data from the metastatic breast cancer cohort expansion study of patients treated with COM701 and nivolumab, another indication showing clinical benefit in patients typically not responding to immunotherapy with initial data showing that baseline PVRL2 levels are higher in patients with clinical benefit supporting the findings in platinum resistant ovarian cancer patients.
SITC 2023: Presentation of new data from COM503, Compugen’s lead pre-clinical program, showing sufficient levels of tumor IL-18 to provoke anti-tumor activity following antibody blockade of IL-18BP with potential favorable therapeutic window compared to recombinant cytokines.
ESMO October 2023: Presentation of additional 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
Report data from ongoing triple combination (COM701 + COM902 + pembrolizumab) proof-of-concept study in microsatellite stable colorectal in H1 2024.
Complete enrollment of up to 20 patients and present data from ongoing triple combination (COM701 + COM902 + pembrolizumab) proof-of-concept study platinum resistant ovarian cancer in 2024.
File IND for COM503 in 2024
Financial Results
As of September 30, 2023, cash, cash equivalents and cash investments were approximately $57.5 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 current operating plan at least through the end of 2024. During the three months ended September 30, 2023, the Company sold approximately 0.1 million ordinary shares under its "at-the-market offering" (ATM) facility pursuant to a sales agreement entered into with Leerink Partners on January 31, 2023, with an average price of approximately $1.30 per share.
Compugen has no debt.
R&D expenses for the third quarter ended September 30, 2023 were approximately $8.3 million, a decrease from $9.3 million for the comparable period in 2022. The decrease is mainly due to lower expenses associated with CMC activities, offset by an increase in clinical trial expenses and the 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.
General and administrative expenses for the third quarter ended September 30, 2023, were approximately $2.3 million, a decrease from approximately $2.6 million for the comparable period in 2022.
Net loss for the third quarter ended September 30, 2023 was approximately $9.9 million, or $0.11 per basic and diluted share, compared with a net loss of approximately $11.7 million, or $0.14 per basic and diluted share, for the comparable period in 2022.
Full financial tables are included below
Conference call and webcast information
The Company will hold a conference call today, November 7, 2023, at 8:30 AM ET to review its third quarter 2023 results. To access the live conference call by telephone, please dial 1-866-744-5399 from the U.S., or +972-3-918-0644 internationally. The call will be available via live webcast through Compugen’s website, located at the following link. Following the live webcast, a replay will be available on the Company’s website.