Compugen Reports First Quarter 2025 Results
- Strong cash position of $103.7M with runway extending into 2027
- AstraZeneca expanded rilvegostomig program to 10 Phase 3 trials, potentially generating milestone payments and royalties
- Advancement of COM701 maintenance therapy trial in ovarian cancer
- Ongoing development of first-in-class GS-0321 with Gilead
- No debt on balance sheet
- Revenue declined to $2.3M in Q1 2025 from $2.6M in Q1 2024
- Continued net losses of $7.2M in Q1 2025
- Leadership transition could create temporary operational uncertainty
Insights
Compugen advancing immunotherapy pipeline with promising partnerships while maintaining solid financial position for continued R&D into 2027.
Compugen's Q1 2025 update reveals encouraging progress across multiple clinical programs targeting novel immune checkpoints. The initiation of the randomized placebo-controlled trial evaluating COM701 as maintenance therapy in platinum-sensitive ovarian cancer represents a significant clinical milestone. Maintenance therapy approaches have become increasingly important in ovarian cancer management, where extending progression-free intervals is crucial for patient outcomes.
The ongoing development of GS-0321 (previously COM503), a potential first-in-class anti-IL18BP antibody licensed to Gilead, targets an innovative pathway in cancer immunotherapy. IL-18 binding protein acts as a natural inhibitor of pro-inflammatory IL-18, and neutralizing it could potentially enhance anti-tumor immune responses—representing a novel approach beyond established checkpoint pathways.
Most notably, AstraZeneca's expanded rilvegostomig program now encompasses ten Phase 3 trials across multiple cancer types. The TIGIT inhibitor component derived from Compugen's COM902 positions the company to benefit substantially should this bispecific therapy demonstrate efficacy. The upcoming ASCO presentations on rilvegostomig combinations in lung and biliary tract cancers will provide crucial efficacy signals for this program.
The planned leadership transition, with current CEO Dr. Cohen-Dayag moving to Executive Chair and CSO Dr. Ophir ascending to CEO, appears designed to maintain continuity while positioning the company for its next development phase. This structured transition suggests confidence in the company's strategic direction and pipeline progress.
With
Compugen shows solid financial position with promising partnership-driven revenue potential from AstraZeneca's expanding TIGIT program.
Compugen's Q1 financial results demonstrate a stable position with
The company's operating expenses remain well-controlled with R&D at
The most significant value driver for Compugen is their partnership with AstraZeneca, which has expanded the rilvegostomig program to ten Phase 3 trials across multiple cancer indications. This represents one of the largest Phase 3 programs in the competitive TIGIT space. As Compugen is eligible for milestone payments and
The company's use of its ATM facility in early 2025 has bolstered its cash position without significantly diluting shareholders. This strategic capital raise, combined with milestone payments from partnerships, has created a financial foundation that supports both clinical advancement and continued computational discovery platform development.
The leadership transition planned for September 2025, with the current CEO moving to Executive Chair and the CSO becoming CEO, represents a thoughtful succession approach that maintains institutional knowledge while potentially bringing fresh perspectives to commercialization strategies as programs mature.
- Initiated platform trial of COM701 maintenance therapy in patients with platinum sensitive ovarian cancer in Q2 2025
- Recruitment ongoing in the first in human Phase 1 trial of GS-0321 (previously COM503), a potential first-in-class anti-IL18BP antibody licensed toGilead
- PartnerAstraZeneca expanded their rilvegostomig program to ten Phase 3 trials across lung, gastrointestinal and endometrial cancers and plans to share early data for rilvegostomig at ASCO
- Solid financial position with cash runway expected to fund operations into 2027
- Key leadership transitions to take effect in September 2025
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"We continued to advance our diverse innovative clinical and early-stage pipeline," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We initiated and activated the first site in our randomized placebo-controlled trial evaluating single agent COM701 maintenance therapy in patients with relapsed platinum sensitive ovarian cancer (sub-trial 1).We are working diligently to dose the first patient and activate additional sites. In addition, we continue to advance our Phase 1 trial for GS-0321 a potential first-in-class anti-IL18BP antibody licensed to Gilead."
Dr. Cohen-Dayag continued, "We are encouraged by the progress our partner AstraZeneca is making with its rilvegostomig program which is notably the largest ongoing Phase 3 program in the TIGIT space. Rilvegostomig is a PD-1/TIGIT bispecific antibody, the TIGIT component of which is derived from COM902. AstraZeneca has increased the number of its Phase 3 trials with rilvegostomig to ten trials across lung, gastrointestinal and endometrial cancers. At the upcoming ASCO 2025 conference, as part of poster presentations, AstraZeneca plans to share early data for rilvegostomig in combination with the ADC Datroway in first-line advanced non-small-cell-lung cancer and in combination with chemotherapy in first-line advanced biliary tract cancer. AstraZeneca's broad development strategy for rilvegostomig to replace existing PD(L)-1 inhibitors represents a significant potential revenue source for Compugen as we are eligible for both future milestone payments and mid-single digit tiered royalties on future sales."
Dr. Cohen-Dayag added, "Our solid financial position with a cash runway expected to fund our operations into 2027 allows us to advance our innovative clinical and early-stage pipeline. Additionally, it enables us to continue to leverage our AI/ML powered predictive computational discovery platform, Unigen�, to accelerate our research efforts supporting our early-stage pipeline. We are also excited about the upcoming leadership changes which will come into effect in September 2025. I will assume the newly created role of Executive Chair of the Board of Directors, and Dr. Eran Ophir, currently Chief Scientific Officer, will become President and Chief Executive Officer and will join the Board of Directors. We believe this combination of leadership ensures a solid foundation for the Company's next phase of growth."
Next Planned Milestones
- ASCO 2025:Compugen's partner, AstraZeneca, plans to present early data as poster presentations from two ongoing Phase 2 rilvegostomig trials:
- First-lineDato-DXd + rilvegostomig in advanced or metastatic non-small cell lung cancer: Results from TROPION-Lung04 (cohort 5)
- First-line rilvegostomig plus chemotherapy in advanced biliary tract cancer: Primary analysis of GEMINI-Hepatobiliary sub-study 2 (cohort A)
- H2 2026:data from projected interim analysis of single agent COM701 sub-trial 1 as maintenance therapy in relapsed platinum sensitive ovarian cancer
First Quarter 2025 Financial Highlights
Cash: As of March 31, 2025, Compugen had approximately
Compugen expects that its cash and cash-related balances will be sufficient to fund its operating plans into 2027. This does not include any additional cash inflows. The Company has no debt.
Revenue: Compugen reported approximately
R&D expensesfor the first quarter of 2025 were approximately
G&A expenseswere approximately
Net loss for the first quarter of 2025 was approximately
Full financial tables are included below.
Conference Call and Webcast Information
The Company will hold a conference call today, May 19, 2025, at 8:30 AM ET to review its first quarter 2025 results. To access the conference call by telephone, please dial 1-866-744-5399from
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Compugenis a clinical-stage therapeutic discovery and development company utilizing its broadly applicable predictive computational discovery platform (Unigen�) to identify new drug targets and biological pathways for developing cancer immunotherapies. Compugen has two proprietary product candidates in Phase 1 development: COM701, a potential first-in-class anti-PVRIG antibody and COM902,a potential best-in-class antibody targeting TIGIT for the treatment of solid tumors. Rilvegostomig, a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical stage anti-TIGIT antibody, COM902, is in Phase 3 development by AstraZeneca through a license agreement for the development of bispecific and multispecific antibodies.GS-0321 (previously COM503), a potential first-in-class, high affinity anti-IL-18 binding protein antibody, which is in Phase 1 development is licensed to Gilead. In addition, the Company's therapeutic pipeline of early-stageimmuno-oncology programs consists of research programs aiming to address various mechanisms to enhance anti-cancer immunity. Compugenis headquartered in
Forward-Looking Statement
This press release contains "forward-looking statements" within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended, and the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on the current beliefs, expectations, and assumptions of Compugen. Forward-looking statements can be identified using terminology such as "will," "may," "expects," "anticipates," "believes," "potential," "plan," "goal," "estimate," "likely," "should," "confident," and "intends," and similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include, but are not limited to, statements regarding our expectations to dose the first patient and activate additional sites in our randomized placebo-controlled trial evaluating single agent COM701 maintenance therapy in patients with relapsed platinum sensitive ovarian cancer (sub-trial 1); statements regarding the advancement of Phase 1 trial for GS-0321, statements regarding the potential capabilities of GS-0321, a potential first-in-class anti-IL18BPB antibody licensed to Gilead; statements regarding the progress of AstraZeneca with its rilvegostomig program; statements regarding the timing of any data announcement by AstraZeneca regarding two ongoing Phase 2 rilvegostomig trials (including the ASCO 2025 presentation); statements regarding the capability of rilvegostomig to replace existing PD(L)-1 inhibitors; statements regarding rilvegostomig as a significant potential revenue source for Compugen, and Compugen's potential receipt of future milestone payments and mid-single-digit tiered royalties on future sales; statements to the effect that our cash and cash-related balances will be sufficient to fund our operating plans into 2027; statements that our cash position will enable us to continue to leverage our AI/ML-powered predictive computational discovery platform, Unigen�, to accelerate our research efforts supporting our early-stage pipeline; and statements regarding our upcoming leadership changes and our belief that the upcoming leadership changes ensure a solid foundation for the Company's next phase of growth. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance, or achievements of Compugen to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Among these risks: the clinical trials of any product candidates that Compugen, or any current or future collaborators, may develop may fail to satisfactorily demonstrate safety and efficacy to the FDA, and Compugen, or any collaborators, may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of these product candidates; Compugen's business model is substantially dependent on entering into collaboration agreements with third parties and Compugen may not be successful in generating adequate revenues or commercializing aspects of its business model; Compugen's approach to the discovery of therapeutic products is based on its proprietary computational target discovery infrastructure, which is unproven clinically; general market, political and economic conditions in the countries in which Compugen operates, including
Company contact:
Yvonne Naughton, Ph.D.
Head of Investor Relations and Corporate Communications
:[email protected]
Tel: +1(628)241-0071
COMPUGEN LTD. | |||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||
( | |||||||
Three Months Ended | |||||||
March 31, | |||||||
2025 | 2024 | ||||||
Unaudited | Unaudited | ||||||
Revenues | 2,284 | 2,559 | |||||
Cost of revenues | 2,400 | 2,102 | |||||
Gross profit (loss) | (116) | 457 | |||||
Operating expenses | |||||||
Research and development expenses | 5,773 | 6,410 | |||||
Marketing and business development expenses | 139 | 91 | |||||
General and administrative expenses | 2,367 | 2,448 | |||||
Total operating expenses | 8,279 | 8,949 | |||||
Operating loss | 8,395 | 8,492 | |||||
Financial and other income, net | 1,245 | 1,228 | |||||
Loss before taxes on income | 7,150 | 7,264 | |||||
Taxes on income | 31 | 3 | |||||
Net loss | 7,181 | 7,267 | |||||
Basic and diluted net loss per ordinary share | (0.08) | (0.08) | |||||
Weighted average number of ordinary shares | 92,308,225 | 89,505,618 | |||||
COMPUGEN LTD. | ||||
CONDENSED CONSOLIDATED BALANCE SHEETS DATA | ||||
( | ||||
March 31, | December 31, | |||
2025 | 2024 | |||
Unaudited | ||||
ASSETS | ||||
Current assets | ||||
Cash and cash equivalents | 14,575 | 18,229 | ||
Short-term bank deposits | 56,480 | 61,397 | ||
Investment in marketable securities | 32,690 | 23,629 | ||
Other accounts receivable and prepaid expenses | 3,148 | 2,742 | ||
Total current assets | 106,893 | 105,997 | ||
Non-current assets | ||||
Restricted long-term bank deposit | 336 | 343 | ||
Long-term prepaid expenses | 1,636 | 1,888 | ||
Severance pay fund | 2,870 | 3,072 | ||
Operating lease right to use asset | 2,759 | 2,843 | ||
Property and equipment, net | 949 | 852 | ||
Total non-current assets | 8,550 | 8,998 | ||
Total assets | 115,443 | 114,995 | ||
LIABILITIES AND SHAREHOLDERS EQUITY | ||||
Current liabilities | ||||
Other accounts payable, accrued expenses and trade payables | 10,944 | 10,080 | ||
Short-term deferred revenues | 9,626 | 9,632 | ||
Current maturity of operating lease liability | 423 | 448 | ||
Total current liabilities | 20,993 | 20,160 | ||
Non-current liabilities | ||||
Long-term deferred revenues | 31,767 | 34,045 | ||
Long-term operating lease liability | 2,348 | 2,464 | ||
Accrued severance pay | 3,227 | 3,412 | ||
Total non-current liabilities | 37,342 | 39,921 | ||
Total shareholders' equity | 57,108 | 54,914 | ||
Total liabilities and shareholders' equity | 115,443 | 114,995 | ||
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SOURCE Compugen Ltd.