GlobeNewswire Inc | Oct 29, 2020 07:45AM EDT

October 29, 2020

-- Balstilimab rolling BLA filing and FDA review underway -- COVID-19 trial open with patients in screening for iNKT Cell Therapy -- New data and clinical responses with AGEN1181 to be presented at SITC on NOV11

LEXINGTON, Mass., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate and optimize immune response to cancers and infections, todayprovided a corporate update and reported financial results for the third quarter of 2020.

-- Balstilimab BLA filing initiated and FDA review is underway; data presented at ESMOBalstilimab (PD-1) monotherapy trial achieves response rates of 19% in PD-L1 positive tumors and 14% in PD-L1 positiveand negative tumors combinedBalstilimab (PD-1) + zalifrelimab (CTLA-4) combination trial achieves response rates of 27% in PD-L1 positive tumors and 22% in PD-L1 positive and negative tumors combinedMedian duration of response of 15.4 months demonstrated for monotherapy; median duration of response in the combination trial has not yet been reached -- Allogeneic iNKT cell therapy: patients with COVID-19in screeningiNKT cells have unique properties to combat cancer and infectionsiNKT cells regulate harmful inflammation while also preventing reinfectioniNKT cancer clinical trial expected to commence in 4Q2020 -- Seven AGEN programs to be presented at SITCAGEN1181: new data and responses of AGEN1181 aloneand with balstilimabZalifrelimab: clinical activity in refractory rare tumorsBalstilimab +/- zalifrelimab: improving treatment of cervical cancer patients with pseudo-progressionAGEN2373: anti-CD137 antibody designed for optimal safely and efficacyAGEN1777: Fc-enhanced TIGIT bispecific for optimal anti-tumor actioniNKT cell therapy: cancer killing with unmodified iNKTs as well as CAR-iNKTsAGEN VISION platform: identification of biomarkers and new targets, prediction of responders -- Partnered programMK-4830 presented at ESMOMK-4830 (ILT4 agonist licensed to Merck) shows benefit as a monotherapy and in combo with anti-PD-1 with 11 responses (2CR, 9PRs)Agenus already received $10M in milestones and is eligible to receive an additional $85M -- Launch of balstilimab access program with RottapharmAgenus provides balstilimab to Rottapharm for clinical testing with CR6086, a potent and selective prostaglandin EP4 receptor antagonist, in patients with advanced metastatic colorectal cancer; trial expected to commence by end of 2020

Third Quarter Financial Results

We ended the third quarter of 2020 with a cash balance of $114 million as compared to $62 million at December 31, 2019.

For the third quarter ended September 30, 2020, our cash used in operations was $32 million. Net loss for the quarter was $52 million or $0.28 per share which includes non-cash expenses of $18 million. This compares to cash used in operations for the same period in 2019 of $28 million and a net loss of $46 million, or $0.33 per share, which included $9 million of non-cash expenses.

Our cash used in operations for the nine months ended September 30, 2020 was $104 million with a net loss of $145 million or $0.87 per share compared to cash provided by operations of $13 million and a net loss for the same period in 2019 of $81 million or $0.58 per share.

For the nine-month period ended September 30, 2020, we recognized revenue of $57 million which includes revenue related to the upfront license fee from our transaction with Betta in addition to non-cash royalties earned. For the same period in 2019 we recorded revenue of $116 million which includes revenue related to the upfront license fee from our transaction with Gilead in addition to non-cash royalties earned.



Financial Highlights(in thousands, except per share data)(unaudited) September 30, December 31, 2020 2019 Cash and cash $ 114,144 $ 61,808 equivalents Three months ended September Nine months ended September 30, 30, 2020 2019 2020 2019 Revenues,research and $ 4,287 $ 5,751 $ 24,284 $ 81,022 developmentRevenues,non-cash 8,947 12,204 29,950 30,073 royaltyRevenues, 1,599 1,985 2,672 4,453 otherTotal 14,833 19,940 56,906 115,548 Revenue Research anddevelopment 32,134 46,132 107,047 131,506 expensesGeneral andadministrative 14,380 11,512 39,188 33,723 expensesCost ofservice 911 - 1,545 - revenueOther expense 940 (437 ) 2,806 (552 )(income)Non-cashinterest 15,918 10,791 44,109 30,400 expenseLoss onmodification - - 2,720 - of debtNon-cashcontingentconsideration 2,196 (1,781 ) 4,652 1,180 fair valueadjustmentNet loss $ (51,646 ) $ (46,277 ) $ (145,161 ) $ (80,709 ) Net loss pershareattributable to $ (0.28 ) $ (0.33 ) $ (0.87 ) $ (0.58 )Agenus Inc.commonstockholders Cash (used in)provided by $ (31,626 ) $ (27,785 ) $ (103,506 ) $ 13,098 operations



Call Access

To access the live call, dial (833) 614-1394 (US) or (914) 987-7115 (International)

The call will also be webcast and will be accessible from the Company websites Events & Presentations page at https://investor.agenusbio.com/events-and-presentationsor via https://edge.media-server.com/mmc/p/mbkjgw8w. A replay will be available after the call.

About AgenusAgenus 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. 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 AgenTus Therapeutics subsidiary), and proprietary cancer vaccine platforms. 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 StatementsThis press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding clinical development and regulatory plans and timelines, anticipated corporate milestones, new clinical data and program updates to be presented at SITC and the anticipated commencement of Agenus clinical collaboration with Rottapharm. 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. 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.

ContactAgenus Inc.Caroline Bafundo212-994-8209Caroline.bafundo@agenusbio.com