On November 8, 2022 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a broad pipeline targeting cancers and infectious disease, reported financial results for the third quarter of 2022 (Press release, Agenus, NOV 8, 2022, View Source [SID1234623371]).

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"Botensilimab has demonstrated impressive clinical responses in nine cold, treatment-resistant tumor types with strong durability, and we look forward to presenting expanded data in colorectal, ovarian, lung and sarcoma cohorts at a plenary session at SITC (Free SITC Whitepaper) followed by our R&D event this Saturday," said Garo Armen, PhD, Chairman and Chief Executive Officer of Agenus. "In light of these compelling clinical data, we have expanded our leadership team to accelerate the development and seek registration of botensilimab with the aim of delivering this potentially transformative new therapy to patients across multiple tumor types."

Clinical update on botensilimab, Agenus’ innate and adaptive immune stimulator, to be presented in a plenary session of the SITC (Free SITC Whitepaper) Annual Meeting

New data on multiple expansion cohorts from the Phase 1 study of botensilimab in cold (immunotherapy-resistant) tumors will be presented at an oral plenary session on novel immunotherapies on Saturday, November 12th at 10:50am ET.
Two additional SITC (Free SITC Whitepaper) presentations will include new data on the mechanisms underpinning botensilimab’s differentiated and enhanced anti-tumor immunity.
Initiated Phase 2 ACTIVATE trials in advanced MSS colorectal cancer and melanoma

ACTIVATE-Colorectal is a global, randomized, open-label, dose-optimization study evaluating the safety and efficacy of botensilimab as monotherapy and in combination with balstilimab in advanced refractory MSS CRC patients.
ACTIVATE-Melanoma is a global, randomized, open-label, multi-cohort, dose-optimization study evaluating the safety and efficacy of botensilimab as a single agent in advanced refractory melanoma who have failed prior PD-1 +/- CTLA-4 therapy.
An additional Phase 2 study in pancreatic cancer is anticipated to begin later in 2022.
Expanded clinical and regulatory leadership team to accelerate botensilimab development

Patricia Carlos named Chief Regulatory, Quality, and Safety Officer. Patricia brings over 20 years of regulatory affairs leadership experience, directing programs from investigational new drug application to commercialization including prior regulatory and quality leadership roles at Arcus Biosciences, BeiGene, Medivation, Gilead Sciences, and Bayer.
Todd Yancey, MD named Senior Global Clinical Development, Medical Affairs and Commercial Advisor. Todd brings over 40 years of combined clinical and industry experience, including prior global clinical and commercial leadership roles at Beigene, BioMarin, Medivation, Onyx, Genentech, and Amgen.
Continued to advance clinical pipeline through company-led studies and corporate partnerships

Dosed first patient in Phase 1 study of AGEN1571 (ILT2 antagonist) as a monotherapy and in combination with botensilimab and/or balstilimab in participants with advanced solid tumors.
Combination study with AGEN2373 (CD137 agonist) and botensilimab in melanoma patients who have relapsed or are refractory to prior anti-PD-1 therapy continues to enroll.
Update on the Phase 2 trial of AGEN1423, an anti-CD73-TGFβ-trap bifunctional antibody in combination with balstilimab (anti-PD-1) in advanced pancreatic cancer will be presented at SITC (Free SITC Whitepaper).
BMS launched a Phase I/II study of BMS-986442 (a TIGIT bispecific discovered by Agenus, also known as AGEN1777) in combination with nivolumab +/- chemotherapy in patients with advanced solid tumors and non-small cell lung cancer.
Merck has initiated a randomized Phase II study evaluating MK-4830 (a candidate ILT4 antagonist discovered by Agenus) in combination with pembrolizumab and chemotherapy in ovarian cancer; additional Phase II studies are ongoing in NSCLC, small cell lung cancer, esophageal cancer, MSI-H colorectal cancer, renal cell carcinoma, and melanoma.
Incyte has initiated a randomized Phase II study evaluating INCAGN02385 (LAG-3) and INCAGN02390 (TIM-3), both discovered by Agenus, in combination with anti-PD-1 in 1L squamous cell carcinoma of the head and neck; additional Phase II studies are ongoing in melanoma, endometrial cancer, and urothelial carcinoma.
Third Quarter 2022 Financial Results
We ended our third quarter 2022 with a cash, cash equivalent, and short-term investment balance of $218.2 million as compared to $238.3 million and $306.9 million on June 30, 2022, and December 31, 2021, respectively. Cash used in operations was $32.2 million for the quarter ended September 30, 2022, and $128 million for the nine-months then ended.

We recognized revenue of $22.8 million and incurred a net loss of $56.7 million, or $0.19 per share, for the third quarter ended September 30, 2022. For the nine-months ended September 30, 2022, we recognized revenue of $69.6 million and incurred a net loss of $156.6 million, or $0.54 per share.

Non-cash operating expenses for the third quarter and nine-months ended September 30, 2022, were $22.2 million and $62.8 million respectively.

Webcast
A webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website at View Source and via View Source

"The Road Taken" R&D Event
Agenus will host an in-person and virtual R&D event ("The Road Taken") on Saturday, November 12th from 2:00 p.m. to 5:00 p.m. ET at the Prudential Tower in Boston, MA. The event will feature insights from leading cancer immunologists who will share their collective and individual expertise on the current and future state of cancer immunotherapy, including a deep dive into the botensilimab data presented at SITC (Free SITC Whitepaper). Institutional investors, research analysts, and key opinion leaders are invited to attend the event in-person and can RSVP by emailing [email protected]. To register for the live webcast, please click here.