Agenus Reports Fourth Quarter and Full Year 2022 Financial Results and Outlines 2023 Objectives

LEXINGTON, Mass., March 14, 2023 (GLOBE NEWSWIRE) -- Agenus Inc. (Nasdaq: AGEN), an immuno-oncology company with a pipeline of immunological agents targeting cancer and infectious disease, today provided a corporate update and reported financial results for the fourth quarter and full year 2022.

"Agenus has entered 2023 with strong momentum across our extensive and diverse clinical pipeline of immuno-oncology programs. Our anchor programs, botensilimab (Fc-enhanced, multi-functional anti-CTLA-4) and balstilimab (anti-PD-1), show exciting potential in combination to treat a broad spectrum of treatment-resistant cancers," said Garo Armen, PhD, Chairman, and Chief Executive Officer of Agenus. "With the growing body of data demonstrating robust, consistent, and durable efficacy signals from a trial of over 300 patients across nine metastatic, late-line cancers, we are expediting the expansion of our botensilimab/balstilimab development program in MSS CRC and other priority indications.”

"The number of patients with solid tumors resistant to a variety of therapies, including current immunotherapies, is substantial. Existing treatment options for these patients after failure of initial standard treatments are limited and largely ineffective, resulting in a short overall survival rate," said Dr. Steven O'Day, Chief Medical Officer of Agenus. "Botensilimab’s clinical activity in advanced and refractory cancers has generated considerable interest from experts worldwide."

Botensilimab’s clinical results have been presented at a late-breaking oral session at the American Society of Clinical Oncology (ASCO GI) in 2023, and in plenary sessions at the European Society for Medical Oncology (ESMO-GI), Connective Tissue Oncology Society (CTOS), the Society for Immunotherapy of Cancer (SITC) 2022 annual meetings, as well as at a company-hosted R&D Event ('The Road Taken'). The latest clinical study results, including those of the botensilimab and botensilimab/balstilimab combination, demonstrate durable responses and significant benefits compared to that reported for standard of care and other investigational therapies in patients with treatment-resistant tumors.

Since SITC, a total of 4 out of 8 evaluable NSCLC patients have showed objective responses, consistent with the 50% overall response rate reported at SITC 2022.

As of December 31, 2022, we had a cash, cash equivalent and short-term investment balance of $193 million, compared to $218 million and $307 million on September 30, 2022, and December 31, 2021, respectively. For the fourth quarter ended December 31, 2022, we recognized revenue of $28 million and incurred a net loss of $74 million (including non-cash expenses of $33 million) or $0.24 per share. For the year ended December 31, 2022, we recognized revenue of $98 million and incurred a net loss of $231 million (including non-cash expense of $96 million), or $0.78 per share. Revenue includes revenue under our collaboration agreements, revenue related to non-cash royalties earned, milestones received, and revenue from Agenus owned CROs.

A webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website athttps://investor.agenusbio.com/events-and-presentationsand viahttps://edge.media-server.com/mmc/p/p9dyor73.

References1 Mayer et al. NEJM 20152 Grothey et al. Lancet 20133 Chen et al. JAMA Oncol. 20204 Overman et al. ASCO 20165 https://clinicaltrials.gov/ct2/show/results/NCT019283946 Hinchcliff et al. Gynecologic Oncology 20217 D’Angelo et al. Lancet Oncology 20188 Somaiah et al. Lancet Oncology 20229 https://clinicaltrials.gov/ct2/show/results/NCT0275051410 Fisher et al. ASCO 2019

About Botensilimab

Botensilimab is a novel, multifunctional CTLA-4 investigational antibody that has been designed to extend clinical benefits to “cold” and refractory tumors that do not respond to standard of care or investigational therapies. In addition to binding to the CTLA-4 receptor, its Fc enhanced structure induces a memory immune response, downregulates regulatory T cells, and delivers better priming and activation of T cells, thereby amplifying immune responses.

In a Phase 1b clinical study of more than 300 patients, botensilimab has demonstrated clinical responses in nine solid tumor cancers, either alone or in combination with Agenus’ PD-1 antibody, balstilimab. Agenus is conducting global, randomized Phase 2 trials in microsatellite-stable colorectal cancer (MSS CRC), pancreatic cancer, and melanoma as part of its ACTIVATE trial program. A global Phase 3 trial in MSS CRC is expected to launch in 2023.

About Agenus

Agenus is a clinical-stage immuno-oncology company focused on the discovery and development of therapies that engage the body's immune system to fight cancer and infections. The Company's vision is to expand the patient populations benefiting from cancer immunotherapy by pursuing combination approaches that leverage a broad repertoire of antibody therapeutics, adoptive cell therapies (through its subsidiary MiNK Therapeutics), and adjuvants (through its subsidiary SaponiQx). The Company is equipped with a suite of antibody discovery platforms and a state-of-the-art GMP manufacturing facility with the capacity to support clinical programs. Agenus is headquartered in Lexington, MA. For more information, please visit www.agenusbio.com and our Twitter handle @agenus_bio. Information that may be important to investors will be routinely posted on our website and Twitter.

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 relating to our technologies, therapeutic candidates, and capabilities, for instance, statements regarding therapeutic benefit and efficacy, mechanism of action, potency, durability, and safety and tolerability profile of our therapeutic candidates, both alone and in combination with each other and/or other agents; statements regarding future plans, including research, clinical, regulatory, and commercialization plans; and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "will" 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: www.agenusbio.com. 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.

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