Core Viewpoint - Compugen Ltd. reported its financial results for Q1 2025, highlighting advancements in its clinical pipeline and a solid financial position that supports ongoing operations into 2027 [1][4][5]. Financial Highlights - As of March 31, 2025, Compugen had approximately $103.7 million in cash and cash equivalents, which includes proceeds from an ATM raised in January and February 2025 [4]. - The company reported revenues of approximately $2.3 million for Q1 2025, a decrease from $2.6 million in Q1 2024, primarily due to the recognition of payments from a license agreement with Gilead [8]. - R&D expenses for Q1 2025 were approximately $5.8 million, down from $6.4 million in the same period of 2024, while G&A expenses remained stable at approximately $2.4 million [9]. Clinical Developments - Compugen initiated a randomized placebo-controlled trial for COM701 maintenance therapy in patients with relapsed platinum-sensitive ovarian cancer [2][6]. - The Phase 1 trial for GS-0321, a potential first-in-class anti-IL18BP antibody licensed to Gilead, is ongoing [2][6]. - AstraZeneca expanded its rilvegostomig program to ten Phase 3 trials across various cancers, with plans to present early data at the ASCO 2025 conference [2][7]. Leadership Changes - Upcoming leadership transitions will take effect in September 2025, with Dr. Anat Cohen-Dayag becoming Executive Chair and Dr. Eran Ophir taking over as President and CEO [2][6]. Future Milestones - Compugen expects to dose the first patient in the COM701 trial and continue recruitment for GS-0321 [6]. - Data from interim analysis of COM701 is projected for H2 2026 [7].

Core Viewpoint - Compugen Ltd. is set to release its first quarter 2025 financial results on May 19, 2025, and will host a conference call for a corporate update [1]. Company Overview - Compugen is a clinical-stage cancer immunotherapy company that utilizes its predictive computational discovery platform, Unigen™, to identify new drug targets and biological pathways [3]. - The company has two proprietary product candidates in Phase 1 development: COM701, an anti-PVRIG antibody, and COM902, an antibody targeting TIGIT for solid tumors [3]. - Rilvegostomig, a PD-1/TIGIT bispecific antibody, is in Phase 3 development by AstraZeneca under a licensing agreement [3]. - GS-0321, a high affinity anti-IL-18 binding protein antibody, is also in Phase 1 development and licensed to Gilead [3]. - Compugen's therapeutic pipeline includes early-stage immuno-oncology programs aimed at enhancing anti-cancer immunity [3]. - The company is headquartered in Israel with additional offices in San Francisco, CA, and its shares are listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN [3].

Financial Data and Key Metrics Changes - As of December 31, 2024, the company had approximately $103.3 million in cash, cash equivalents, short-term bank deposits, and investments in marketable securities, which includes a $60 million upfront payment from Gilead and a $30 million milestone payment for IND clearance [23] - The company reported approximately $1.5 million in revenues for Q4 2024 and approximately $27.9 million for the full year 2024, compared to approximately $33.5 million for the same periods in 2023 [24] - R&D expenses for Q4 2024 were approximately $5.9 million, down from approximately $10.9 million in Q4 2023, while total R&D expenses for the year were approximately $24.8 million compared to $34.5 million in 2023 [25] - The net loss for Q4 2024 was approximately $6.1 million, or approximately $0.07 per share, compared to a net income of approximately $9.7 million, or approximately $0.11 per share, in Q4 2023 [26] Business Line Data and Key Metrics Changes - The company is advancing the development of COM701 as a maintenance treatment option for patients with platinum-sensitive ovarian cancer, with plans to initiate a randomized, double-blinded sub-trial in Q2 2025 [8][9] - GS-0321, a potential first-in-class anti-IL-18 binding protein antibody, has progressed with a Phase I trial initiated in early January 2025, following a $30 million milestone payment from Gilead for FDA IND clearance [18] Market Data and Key Metrics Changes - The company noted that the TIGIT antibody class faced setbacks in 2024, leading to skepticism about the efficacy of TIGIT blocker combinations, but emphasized the potential of Fc inactive anti-TIGIT antibodies [11][12] - AstraZeneca has initiated multiple Phase III trials for rilvegostomig, which is derived from the company's COM902, representing a significant potential revenue source through milestone payments and royalties [15] Company Strategy and Development Direction - The company aims to leverage its computational discovery platform, Unigen, to identify novel ways to activate antitumor immunity and advance its pipeline [19][20] - The strategic priority for 2025 includes efficient execution of clinical trials and continued investment in early-stage research, with a cash runway expected to last into 2027 [20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism for 2025, highlighting the potential impact of their clinical programs on cancer patients' lives and the importance of their extraordinary team [21] - The company is focused on advancing its programs and believes it is well-positioned for growth, despite the competitive landscape in the oncology sector [20] Other Important Information - The company has a solid balance sheet with no debt and a cash runway to support its operating plans into 2027 [22] Q&A Session Summary Question: Inquiry about AstraZeneca's Phase III study design - Management stated they cannot comment on AstraZeneca's unpublished plans but are pleased with the initiation of pivotal trials [30] Question: Expectations for near-term data from AstraZeneca - Management indicated that AstraZeneca plans to present data during 2025 from the combination of rilvegostomig with ADCs [32] Question: Design of the ovarian study and its statistical power - The study is exploratory and not powered for full pivotal trial analysis, using Bayesian statistics to evaluate improvement probabilities [37][38] Question: Balance between study arms and patient eligibility criteria - The study will enroll patients who are not recommended for standard maintenance treatments, ensuring a more well-defined patient population [42] Question: Rate of enrollment in the studies - Management expects a rapid enrollment rate due to limited clinical trials available for the specific patient population [65] Question: Interim analysis triggers and futility thresholds - The interim analysis will be event-driven and based on follow-up, with a futility boundary established for evaluation [72][73]

[Executive Summary & Corporate Update](index=1&type=section&id=Executive%20Summary%20%26%20Corporate%20Update) Compugen achieved significant 2024 progress, positioning for 2025 growth with a diverse pipeline, positive clinical data, and strong financial outlook [CEO Commentary & Strategic Highlights](index=1&type=section&id=CEO%20Commentary%20%26%20Strategic%20Highlights) Compugen's CEO highlights significant 2024 progress, positioning for 2025 growth with a diverse pipeline, key advancements, and continued AI/ML platform acceleration - Compugen is **well-positioned for growth**, building on **significant progress in 2024** with a **diverse and innovative pipeline** and a **strong focus on execution in 2025**[3](index=3&type=chunk) - Clinical data supports advancing **COM701** as a potential **first-in-class anti-PVRIG** for maintenance treatment in platinum-sensitive ovarian cancer, with an adaptive platform trial scheduled for **Q2 2025**[3](index=3&type=chunk) - AstraZeneca presented promising **rilvegostomig data** in 2024, expanded to **seven Phase 3 trials**, and plans to share early data for rilvegostomig in combination with ADCs in **2025**, representing a **significant potential revenue source** through milestone payments and **mid-single digit tiered royalties**[3](index=3&type=chunk) - A **solid financial position** with **cash runway into 2027** supports advancing the clinical and early-stage pipeline, including GS-0321 (licensed to Gilead) for which a **$30 million IND clearance milestone** was received in 2024, with the Unigen™ AI/ML platform continuing to accelerate research[4](index=4&type=chunk) [Key Corporate Highlights](index=1&type=section&id=Key%20Corporate%20Highlights) The company achieved several key milestones in Q4 and full year 2024, including positive clinical data for COM701, initiation of the first-in-human Phase 1 trial for GS-0321, expansion of AstraZeneca's rilvegostomig program, and maintaining a strong financial position with cash runway into 2027 - Clinical data presented at **SITC 2024** supports further development of **COM701**, a potential **first-in-class anti-PVRIG antibody**[5](index=5&type=chunk) - On track to initiate a randomized adaptive platform trial of **COM701 maintenance therapy** in patients with platinum-sensitive ovarian cancer, scheduled to start in **Q2 2025**[5](index=5&type=chunk) - The first patient was dosed in **Q1 2025** in the first-in-human Phase 1 solid tumor trial of **GS-0321** (previously COM503), a potential **first-in-class anti-IL18BP antibody** licensed to Gilead[5](index=5&type=chunk) - Partner AstraZeneca reported promising **rilvegostomig data** in 2024, expanded the program to **seven Phase 3 trials**, and plans to share early data for rilvegostomig in combination with ADCs in **2025**[5](index=5&type=chunk) - **Solid financial position** with **cash runway expected to fund operations into 2027**[5](index=5&type=chunk) [Financial Performance Highlights](index=2&type=section&id=Financial%20Performance%20Highlights) This section details Compugen's 2024 financial performance, covering cash, revenue, costs, operating expenses, and net income/loss [Cash Position & Runway](index=2&type=section&id=Cash%20Position%20%26%20Runway) As of December 31, 2024, Compugen held approximately $103.3 million in cash and equivalents, including significant milestone payments from Gilead and AstraZeneca, and expects its current cash to fund operations into 2027 with no debt Cash, Cash Equivalents, Short-term Bank Deposits and Investment in Marketable Securities (in millions) | As of December 31, 2024 | | :---------------------- | | 103.3 | - Cash balance includes **$60 million upfront payment** and **$30 million IND milestone payment** from Gilead, and **$15 million milestone payments** from AstraZeneca[6](index=6&type=chunk) - In January and February 2025, approximately **3.96 million shares** were sold through the ATM facility, contributing net proceeds of approximately **$8.87 million**[7](index=7&type=chunk) - Compugen expects its current cash to be sufficient to fund operating plans into **2027** and has no debt[8](index=8&type=chunk) [Revenue & Cost of Revenue Analysis](index=2&type=section&id=Revenue%20%26%20Cost%20of%20Revenue%20Analysis) Revenues for Q4 and full year 2024 significantly decreased compared to 2023, primarily due to the timing of milestone payments, while cost of revenues also decreased due to reclassification and a royalty reversal Revenues (in millions) | Period | 2024 | 2023 | | :-------- | :---- | :---- | | Q4 | $1.5 | $33.5 | | Full Year | $27.9 | $33.5 | - 2024 revenues include portions of upfront and IND milestone payments from Gilead and a **$5 million clinical milestone** from AstraZeneca, while 2023 revenues reflect a portion of Gilead's upfront payment and a **$10 million clinical milestone** from AstraZeneca[9](index=9&type=chunk) Cost of Revenues (in millions) | Period | 2024 | 2023 | | :-------- | :--- | :--- | | Q4 | $0.7 | $2.0 | | Full Year | $7.9 | $2.0 | - Cost of revenues in 2024 includes IND and Phase 1 activities and royalty payments, offset by a royalty reversal due to an exemption from the Israeli Innovation Authority for IL-18BP related income[10](index=10&type=chunk) [Operating Expenses](index=2&type=section&id=Operating%20Expenses) Research and Development (R&D) expenses decreased in 2024 due to reclassification and lower activities, partially offset by increased clinical expenses, while General and Administrative (G&A) expenses remained relatively stable Research and Development (R&D) Expenses (in millions) | Period | 2024 | 2023 | | :-------- | :---- | :---- | | Q4 | $5.9 | $10.9 | | Full Year | $24.8 | $34.5 | - The decrease in R&D expenses in 2024 was mainly due to the classification of GS-0321 expenses to cost of revenues and lower CMC and IND enabling activities for GS-0321, partially offset by an increase in clinical expenses[11](index=11&type=chunk) General and Administrative (G&A) Expenses (in millions) | Period | 2024 | 2023 | | :-------- | :--- | :--- | | Q4 | $2.2 | $2.5 | | Full Year | $9.4 | $9.7 | [Net Income/Loss & EPS](index=2&type=section&id=Net%20Income%2FLoss%20%26%20EPS) Compugen reported a net loss of $6.1 million for Q4 2024, a shift from a net income of $9.7 million in Q4 2023, with the full year 2024 net loss improving to $14.2 million from $18.8 million in 2023 Net Income (Loss) and Basic & Diluted EPS | Metric | Q4 2024 | FY 2024 | Q4 2023 | FY 2023 | | :------------------------------ | :------ | :------ | :------ | :------ | | Net Income (Loss) (in millions) | $(6.1) | $(14.2) | $9.7 | $(18.8) | | Basic and Diluted EPS (cents) | $(0.07) | $(0.16) | $0.11 | $(0.21) | [Financial Statements](index=4&type=section&id=Financial%20Statements) This section presents Compugen's condensed consolidated statements of operations and balance sheets for the specified periods [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The condensed consolidated statements of operations provide a detailed breakdown of Compugen's financial performance for the three months and full year ended December 31, 2024, compared to the same periods in 2023, covering revenues, costs, operating expenses, and net profit/loss COMPUGEN LTD. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (U.S. dollars in thousands, except for share and per share amounts) | | Three Months Ended | | Year Ended, | | | :---------------------------------------------------------------- | :----------------- | :--- | :----------- | :--- | | | December 31, | | December 31, | | | | 2024 | 2023 | 2024 | 2023 | | | Unaudited | Unaudited | | | | Revenues | 1,471 | 33,459 | 27,864 | 33,459 | | Cost of revenues | 675 | 2,004 | 7,930 | 2,004 | | Gross profit | 796 | 31,455 | 19,934 | 31,455 | | Operating expenses | | | | | | Research and development expenses | 5,911 | 10,928 | 24,810 | 34,472 | | Marketing and business development expenses | 167 | 61 | 576 | 244 | | General and administrative expenses | 2,201 | 2,482 | 9,439 | 9,731 | | Total operating expenses | 8,279 | 13,471 | 34,825 | 44,447 | | Operating profit (loss) | (7,483) | 17,984 | (14,891) | (12,992) | | Financial and other income, net | 1,370 | 735 | 5,182 | 3,208 | | Profit (loss) before taxes on income | (6,113) | 18,719 | (9,709) | (9,784) | | Tax expense | 4 | 9,006 | 4,522 | 8,970 | | Net profit (loss) | (6,117) | 9,713 | (14,231) | (18,754) | | Basic and diluted net earnings (loss) per ordinary share | (0.07) | 0.11 | (0.16) | (0.21) | | Weighted average number of ordinary shares used in computing basic | | | | | | and diluted net earnings (loss) per share | 89,538,891 | 88,415,382 | 89,528,031 | 87,633,298 | [Condensed Consolidated Balance Sheets Data](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20Data) The condensed consolidated balance sheets data presents Compugen's financial position as of December 31, 2024, and 2023, detailing assets (current and non-current), liabilities (current and non-current), and total shareholders' equity COMPUGEN LTD. CONDENSED CONSOLIDATED BALANCE SHEETS DATA (U.S. dollars, in thousands) | | December | December | | :---------------------------------------- | :------- | :------- | | | 31, | 31, | | | 2024 | 2023 | | ASSETS | | | | Current assets | | | | Cash and cash equivalents | 18,229 | 13,890 | | Restricted cash | - | 365 | | Short-term bank deposits | 61,397 | 25,053 | | Investment in marketable securities | 23,629 | 11,742 | | Trade receivables | - | 61,000 | | Other accounts receivable and prepaid expenses | 2,742 | 2,529 | | Total current assets | 105,997 | 114,579 | | Non-current assets | | | | Restricted long-term bank deposit | 343 | - | | Long-term prepaid expenses | 1,888 | 1,233 | | Severance pay fund | 3,072 | 2,977 | | Operating lease right to use asset | 2,843 | 1,329 | | Property and equipment, net | 852 | 1,216 | | Total non-current assets | 8,998 | 6,755 | | Total assets | 114,995 | 121,334 | | LIABILITIES AND SHAREHOLDERS EQUITY | | | | Current liabilities | | | | Other accounts payable, accrued expenses and trade payables | 10,080 | 14,485 | | Short-term deferred revenues | 9,632 | 11,149 | | Current maturity of operating lease liability | 448 | 632 | | Total current liabilities | 20,160 | 26,266 | | Non-current liabilities | | | | Long-term deferred revenues | 34,045 | 25,392 | | Long-term operating lease liability | 2,464 | 719 | | Accrued severance pay | 3,412 | 3,398 | | Total non-current liabilities | 39,921 | 29,509 | | Total shareholders' equity | 54,914 | 65,559 | | Total liabilities and shareholders' equity | 114,995 | 121,334 | [Company Information & Outlook](index=2&type=section&id=Company%20Information%20%26%20Outlook) This section outlines Compugen's future milestones, company overview, and important forward-looking statements [Next Planned Milestones](index=2&type=section&id=Next%20Planned%20Milestones) Compugen has outlined several key upcoming milestones, including the initiation of a randomized adaptive platform trial for COM701 in Q2 2025, AstraZeneca's plan to share early data for rilvegostomig in combination with ADCs in 2025, and projected interim analysis data for single agent COM701 in H2 2026 - **Q2 2025**: Initiation of a randomized adaptive platform trial comparing **COM701 maintenance therapy** to placebo in **60 patients** with relapsed platinum-sensitive ovarian cancer[14](index=14&type=chunk) - **2025**: Compugen's partner, AstraZeneca, plans to share early data for **rilvegostomig** in combination with their ADCs[14](index=14&type=chunk) - **H2 2026**: Data from projected interim analysis of single agent **COM701 sub-trial 1** as maintenance therapy in relapsed platinum-sensitive ovarian cancer[14](index=14&type=chunk) [About Compugen](index=3&type=section&id=About%20Compugen) Compugen is a clinical-stage therapeutic discovery and development company that utilizes its predictive computational discovery platform (Unigen™) to identify novel drug targets for cancer immunotherapies, with a pipeline including proprietary and partnered programs - Compugen is a **clinical-stage therapeutic discovery and development company** focused on cancer immunotherapies[16](index=16&type=chunk) - The company leverages its broadly applicable predictive computational discovery platform (**Unigen™**) to identify new drug targets and biological pathways[16](index=16&type=chunk) - Proprietary product candidates in Phase 1 development include **COM701** (anti-PVRIG antibody) and **COM902** (anti-TIGIT antibody)[16](index=16&type=chunk) - Partnered programs include **Rilvegostomig** (PD-1/TIGIT bispecific antibody, AstraZeneca, Phase 3) and **GS-0321** (anti-IL-18 binding protein antibody, Gilead, Phase 1)[16](index=16&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section serves as a cautionary statement, highlighting that the press release contains forward-looking statements based on current beliefs and expectations, outlining various known and unknown risks and uncertainties that could cause actual results to differ materially - The press release contains **forward-looking statements** based on current beliefs, expectations, and assumptions, identifiable by terms like 'will,' 'expects,' 'potential,' and 'intends'[17](index=17&type=chunk) - These statements involve **known and unknown risks and uncertainties** that may cause actual results to differ materially, including clinical trial failures, dependence on collaboration agreements, and the unproven nature of the computational target discovery infrastructure[17](index=17&type=chunk) - Risks are more fully discussed in Compugen's most recent Annual Report on Form 20-F filed with the SEC[17](index=17&type=chunk)