TIGIT

FDA Grants Fast Track designation for BOT/BAL in metastatic, refractory colorectal cancer (CRC) patients who have failed 1st and 2nd line standard of care treatments Data from Phase 1 of BOT/BAL in refractory CRC showed durable ORR of 24% in patients with non-active liver metastases (NLM); Completed enrollment of randomized Phase 2 trial (n=230) Clinical data sets path for expansion opportunities in pancreas, lung, neoadjuvant CRC, and melanoma LEXINGTON, Mass.--(BUSINESS WIRE)-- Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, today provided a corporate update and reported financial results for the fourth quarter and full year 2023. “In 2023, Agenus made significant advances across our BOT/BAL development program. Our first target indication is metastatic, refractory colorectal cancer that is not MSI-H/dMMR, for which we are focused on pursuing accelerated approval,” said Garo Armen, Ph.D., Chief Executive Officer. “We are also pursuing multiple strategies to capitalize the company through this important path in our efforts to bring BOT and BOT/BAL to the forefront of solid tumor cancer treatment. Our vision is to maximize BOT's utility to benefit patients in combination with other immune therapies as well as current standards of care for patients with both early and late-stage tumors.” 2023 Highlights on Botensilimab Colorectal Cancer: Received Fast Track designation for patients with metastatic colorectal cancer that is not MSI-H/dMMR and who do not have liver metastases, and who were previously treated with standard combination chemotherapy, anti-VEGF and anti-EGFR if RAS wild type (“refractory MSS mCRC NLM”) Completed enrollment of patients with refractory MSS mCRC NLM in a Phase 1 (n=150) and randomized Phase 2 (n=230) in October 2023. Clinical data reported by Agenus in October 2023 revealed: Among the 70 efficacy evaluable ("EE") patients in the refractory MSS mCRC NLM treatment setting, a 24% RECIST v1.1 response rate was observed in those treated with the BOT/BAL combination. Based on literature review, the response rate in a similar population treated with standard of care therapies ranges from 1% to 6.1%1, 2. The 12-month overall survival (OS) rate is 74% with median OS not yet reached. Topline data from the ongoing Phase 2 study are expected in 2H 2024. The most common safety observations are immune-related diarrhea and colitis, which are managed in accordance with standard therapies. Grade 3 treatment related diarrhea/colitis occurred in approximately 14% of patients. Neoadjuvant CRC: Clinical data presented at ASCO-GI January 2024: In an investigator sponsored trial (IST) led by Dr. Pashtoon Kasi at Weill-Cornell Medicine, patients diagnosed with resectable localized colon or rectal cancer were treated with one dose of BOT and two doses of BAL approximately 4 weeks prior to planned surgery. After surgery, pathologic analysis reported significant tumor shrinkage. 3/3 patients (100%) with MSI-H CRC experienced major pathological responses (>90% tumor shrinkage) in less than 4 weeks, while 6/9 (67%) MSS CRC patients had tumor shrinkage of 50% or more. IST is expanding to 24 patients with an extended follow-up time (6-8 weeks); Agenus plans to prioritize neoadjuvant development and is evaluating study designs for subsequent pivotal trials. 2L Metastatic Pancreatic: In patients with metastatic pancreatic cancer who have failed or don’t respond to FOLFIRINOX (2L Pancreatic) and received treatment with BOT in combination with gemcitabine+nab-paclitaxel, significant tumor marker reductions were observed in 4 of 5 patients, all with liver metastases. Two (2) of the 4 patients achieved PRs at 16 weeks (target lesion reductions of 47% (confirmed) and -37% (pending confirmation). Two other patients showed stable disease at their first 8-week scan with tumor reductions of -20% and -13%. A Phase 2 randomized study is in progress, with preliminary data expected to be available mid-year. CTLA-4/PD-1 Relapsed Refractory Advanced Melanoma (“2L+ Melanoma”): Phase 1b expansion cohort in 2L+ Melanoma reported a 30% ORR and 60% disease control rate (n=10; 2/8 BOT responses and 1/2 BOT/BAL responses); all patients had failed anti-PD-1 therapy and 8/10 had failed both anti-PD-1/CTLA-4 therapy. In the Phase 2 study in 2L+ Melanoma, data from the fully enrolled BOT monotherapy arm and a cohort of patients on BOT/BAL (n=30) are anticipated in 2H2024. Refractory Non-Small Cell Lung Cancer (NSCLC): In the PD(L)-1 refractory cohort, a 56% ORR and an 89% disease control rate were observed in patients treated with the BOT/BAL combination (n=9). In a TKI-refractory cohort, 2 out of 7 patients experienced complete confirmed objective responses after treatment with BOT/BAL*. Advanced Sarcomas: Updated findings from a Phase 1b study of 41 efficacy evaluable patients treated with BOT/BAL showed durable responses with an ORR of 20%, a median response duration of 19.4 months (iRECIST), and a 6-month progression-free survival rate of 40%. A higher ORR was observed by dose level, with 29% at 2 mg/kg BOT compared to 15% at 1 mg/kg BOT. Refractory Ovarian: In a total of 24 evaluable patients treated with BOT/BAL, with a median of four prior lines of therapy, an overall response rate of 33% was observed. The disease control rate was 67% and the median Duration of Response (DOR) was not yet reached. Finance $25 million milestone payment from BMS triggered by the commencement of a Phase 2 study with BMS-986442 in December 2023. Advancing in our discussions on monetizing non-strategic assets, royalty monetization, and project financing, with the potential to yield $100-200 million in cash proceeds. Currently we are in active discussions with several potential biopharma partners for potential co-development and co-commercialization of BOT/BAL. Fourth Quarter and Full Year 2023 Financial Results For the year ended December 31, 2023, we recognized revenue of $156 million and incurred a net loss of $257 million, or $0.69 per share. For the fourth quarter ended December 31, 2023, we recognized revenue of $84 million and incurred a net loss of $49 million or $0.13 per share. Revenue primarily includes revenue under our collaboration agreements, including milestones achieved, and revenue related to non-cash royalties earned. We ended the year with a $76.1 million cash balance; subsequent to which in January 2024 we received the $25 million milestone payment from BMS triggered by the commencement of a Phase 2 study with BMS-986442, the AGENUS discovered TIGIT bispecific antibody. Additionally, we've progressed in monetizing non-strategic assets and future milestones and royalties from ongoing partnerships. These efforts are expected to yield significant cash proceeds by mid 2024. Accordingly, we anticipate being funded through 2024. In parallel, we're pursuing potential partnership discussions with several biopharmaceuiticsl parties to further expand our cash resources. December 31, 2023 2022 Cash, cash equivalents and short-term investments $ 76,110 $ 193,358 Three months ended December 31, Year ended December 31, 2023 2022 2023 2022 Revenues, research and development $ 30,249 $ 3,755 $ 38,764 $ 16,975 Revenues, non-cash royalty 53,038 18,284 114,572 45,285 Revenues, royalty sales milestone - - - 25,250 Revenues, other 514 6,347 2,978 10,514 Total Revenue 83,801 28,386 156,314 98,024 Research and development expenses 66,723 53,279 234,569 186,691 General and administrative expenses 21,177 25,036 78,739 81,007 Cost of service revenue 260 7,693 3,111 10,568 Other income (193 ) (3,918 ) (2,663 ) (10,944 ) Non-cash interest expense 44,574 18,326 100,551 62,955 (Gain) loss related to debt - 1,937 - (782 ) Non-cash contingent consideration fair value adjustment (158 ) 135 (556 ) (815 ) Net loss $ (48,582 ) $ (74,102 ) $ (257,437 ) $ (230,656 ) Net loss per share attributable to Agenus Inc. common stockholders $ (0.13 ) $ (0.24 ) $ (0.69 ) $ (0.78 ) Cash used in operations $ 40,590 $ 47,338 $ 224,202 $ 175,373 Non-cash operating expenses $ 56,455 $ 32,777 $ 139,015 $ 96,286 Conference Call Date: March 14th, 2024, 8:30 a.m. ET To access dial-in numbers, please register here. Conference ID: 73242 Webcast A live webcast and replay of the conference call will be accessible on the company’s website at and via . References 1 Prager et. al NEJM 2023 2 Grothey et al. Lancet 2013 * Investigator reported, subject to change About Botensilimab Botensilimab is an investigational multifunctional anti-CTLA-4 immune activator (antibody) designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Approximately 900 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316. About Agenus Agenus is a leading immuno-oncology company targeting cancer and infectious diseases with a comprehensive pipeline of immunological agents. The company’s mission is to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx). Agenus is headquartered in Lexington, MA. For more information, visit or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding a its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed with the Securities and Exchange Commission and available on our website at . Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

HOLON, Israel, March 11, 2024 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced that it has been selected to give two oral presentations at the Keystone Symposium on Cancer Immunotherapy: Beyond Immune Checkpoint Blockade and Overcoming Resistance, taking place March 17-21, 2024, in Whistler, Canada. "We are delighted to be selected to give two oral presentations at the upcoming Keystone Symposium on Cancer Immunotherapy this year," said Anat Cohen-Dayag, Ph.D., President, and CEO of Compugen. "We believe our selection to present at a Keystone Symposium reflects the significant discovery, research and development taking place at Compugen as we are working to advance our vision to transform patient lives by developing first-in class therapeutics based on our computational target discovery platform." The abstracts are available on the publication section of Compugen's website . The presentations and posters will be made available on , on the day of presentation. About Compugen Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable predictive computational discovery capabilities to identify new drug targets and biological pathways for developing cancer immunotherapies. Compugen has developed two proprietary product candidates: 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. Compugen also has a clinical stage partnered program, rilvegostomig (previously AZD2936), a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical stage anti-TIGIT antibody, COM902, in Phase 3 development by AstraZeneca through a license agreement for the development of bispecific and multispecific antibodies. In addition, Compugen's therapeutic pipeline of early-stage immuno-oncology programs consists of programs aiming to address various mechanisms of immune resistance, of which the most advanced program, in IND enabling studies is COM503, which is licensed to Gilead. COM503 is a potential first-in-class, high affinity antibody which blocks the interaction between IL-18 binding protein and IL-18, thereby freeing natural IL-18 in the tumor microenvironment to inhibit cancer growth. Compugen is headquartered in Israel, with offices in San Francisco, CA. Compugen's shares are listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN. Company contact: Yvonne Naughton, Ph.D. Head of Investor Relations and Corporate Communications Email: ir@cgen.com Tel: +1 (628) 241-0071 View original content: SOURCE Compugen Ltd. Company Codes: TelAviv:CGEN, Berlin:CW9, Dusseldorf:CW9, NASDAQ-NMS:CGEN

WATERTOWN, Mass. and GOSSELIES, Belgium, March 06, 2024 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, today announced the appointment of Jill DeSimone to its Board of Directors, effective March 7, 2024, where she will serve on the Company’s audit committee. “Expanding our board with industry leaders and oncology veterans with commercial, scientific, and corporate portfolio strategy experience is of the utmost importance for iTeos. After the recent appointment of Servier’s David Lee, we are thrilled to welcome Jill DeSimone to our Board of Directors during an important time in iTeos’ evolution. Jill and David’s unique insights will be of tremendous value to our organization as we continue on our path to becoming a late-stage biopharmaceutical company,” said Michel Detheux, Ph.D., president and chief executive officer of iTeos. “By leveraging its comprehensive knowledge of tumor biology, iTeos has advanced a portfolio of promising therapeutic candidates addressing key immunological pathways involved in the development of cancer,” said Ms. DeSimone. “I look forward to working with the iTeos leadership team and offering my global business and commercial insights to help the company achieve its goal of bringing transformational therapies to patients living with cancer.” With over 40 years of global business expertise in life sciences, Ms. DeSimone is recognized for her role as President of U.S. Oncology at Merck & Co., Inc., where she established the company’s oncology division, growing it from less than $500 million in annual revenue to $9 billion in eight years. Additionally, she led three key product launches and more than 45 indication launches, including Keytruda®, the fastest growing product in the company’s history. Prior to joining Merck, Ms. DeSimone was Senior Vice President of Global Women’s Health at Teva Pharmaceutical Industries, Ltd. She began her career at Bristol Myers Squibb and held roles of increasing responsibility culminating as the Senior Vice President of U.S. Oncology, a role in which she helped launch the first FDA-approved CTLA-4 immune checkpoint inhibitor, Yervoy®. Ms. DeSimone currently serves as a board member for Affini-T Therapeutics, Inc., Kinnate Biopharma Inc., Oncternal Therapeutics, Inc., Praxis Precision Medicine, Inc., as well as the Florida Cancer Specialists Foundation, a nonprofit organization that delivers non-medical aid for individuals undergoing treatment for cancer, and Swim Across America, a foundation that awards grants to cancer research and patient programs. She earned a B.S. in Pharmacy from Northeastern University and completed a fellowship with the Wharton School of the University of Pennsylvania. About iTeos Therapeutics, Inc.iTeos Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients. iTeos Therapeutics leverages its deep understanding of tumor immunology and immunosuppressive pathways to design novel product candidates with the potential to restore the immune response against cancer. The Company’s innovative pipeline includes three clinical-stage programs targeting novel, validated immuno-oncology pathways designed with optimized pharmacologic properties for improved clinical outcomes, including the TIGIT/CD226 axis and the adenosine pathway. iTeos Therapeutics is headquartered in Watertown, MA with a research center in Gosselies, Belgium. Internet Posting of InformationiTeos routinely posts information that may be important to investors in the 'Investors' section of its website at www.iteostherapeutics.com. The Company encourages investors and potential investors to consult our website regularly for important information about iTeos. Forward-Looking StatementsThis press release contains forward-looking statements. Any statements that are not solely statements of historical fact are forward-looking statements. Words such as “believe,” “anticipate,” “plan,” “expect,” “will,” “may,” “intend,” “prepare,” “look,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements relating to the potential benefits of product candidates; the value our new board members bring to iTeos; and iTeos’ path to becoming a late-stage biopharmaceutical company. These forward-looking statements involve risks and uncertainties, many of which are beyond iTeos’ control. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: market conditions; challenges and uncertainties inherent in product research and development and manufacturing limitations; the data for our product candidates may not be sufficient for obtaining regulatory approval to move into later stage trials or to commercialize products; iTeos may not be able to execute on its business plans, including meeting its expected or planned regulatory milestones and timelines, research and clinical development plans, and bringing its product candidates to market, for various reasons, some of which may be outside of iTeos’ control, including possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner, negative developments in the field of immuno-oncology, such as adverse events or disappointing results, including in connection with competitor therapies, and regulatory, court or agency decisions such as decisions by the United States Patent and Trademark Office with respect to patents that cover our product candidates; and those risks identified under the heading “Risk Factors” in iTeos’ Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company which you are encouraged to review. Statements regarding the Company’s cash runway do not indicate when or if the Company may access the capital markets. Any of the foregoing risks could materially and adversely affect iTeos’ business, results of operations and the trading price of iTeos’ common stock. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. iTeos does not undertake any obligation to publicly update its forward-looking statements other than as required by law. For further information, please contact: Investor Contact:Carl MauchiTeos Therapeutics, Inc.carl.mauch@iteostherapeutics.com Media Contact:media@iteostherapeutics.com