On March 1, 2022 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies and adjuvants designed to activate immune response to cancers and infections, reported financial results for the fourth quarter and full year 2021 (Press release, Agenus, MAR 1, 2022, View Source [SID1234609252]).

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"We made several important advancements in 2021," said Garo Armen, PhD, Chief Executive Officer of Agenus. "Our Phase 1 data presentation at SITC (Free SITC Whitepaper) demonstrated the best-in-class potential of our flagship program, botensilimab, consistent with its Fc-enhanced design. We partnered our Fc-enhanced TIGIT bispecific with BMS to accelerate its development in high priority indications such as NSCLC. This year, we expect to launch several new botensilimab studies to unlock its franchise potential. In parallel, our R&D team continues to advance novel discoveries, with our macrophage targeting program expected to enter the clinic this year."

Botensilimab is the first anti-CTLA-4 antibody to demonstrate clinical responses across 9 cold, treatment-resistant cancers; Phase II studies planned in melanoma, colorectal, and pancreatic cancers

Phase 1 data from >100 patients treated with botensilimab, as monotherapy or in combination with our PD-1 antibody, balstilimab, presented at SITC (Free SITC Whitepaper).

Based on these data, Agenus plans to commence Phase 2 trials in melanoma, MSS-colorectal, and pancreatic cancers in order to:

Demonstrate superiority to ipilimumab, which has been approved and extensively studied in melanoma; new melanoma response to botensilimab monotherapy observed since SITC (Free SITC Whitepaper) presentation in a patient who progressed on prior ipilimumab treatment.

Build upon potential best-in-class signal in MSS-colorectal cancer; among 20 patients in our Phase I study, we observed a 20% response rate for the botensilimab/balstilimab combination compared to a reported 1% response rate for a first generation CTLA-4/PD-(L)1 combination.

Establish botensilimab as superior combination agent for chemotherapy in cold tumors, by evaluating botensilimab in combination with standard of care chemotherapy in pancreatic cancer.

Positive data in these studies can unlock the franchise potential of botensilimab, supporting further development in indications where first-generation CTLA-4 has been approved or demonstrated benefit, as well as expansion into indications where botensilimab has shown benefit but other CTLA-4 agents have not.

Internal infrastructure build underway to support botensilimab development and potential launch: Emeryville site designed to manufacture inventory worth >$10B in annual sales.

AGEN1571 is entering clinical development in 2022

AGEN1571 targets tumor associated macrophages, which promote resistance to PD-1 and CTLA-4 therapy.

The importance of this target class has been validated by Merck’s ILT4 antagonist, discovered by Agenus, which has shown durable responses in PD-1 resistant cancers.

6 clinical-stage programs advancing through strategic partnerships; $220M in upfront and achieved milestone payments received in 2021

AGEN1777 (Fc-enhanced TIGIT bispecific) was licensed to BMS for $220M in upfront and achieved milestones plus $1.36B in future milestones and royalties. BMS plans to advance AGEN1777 in high priority tumor indications including NSCLC.

Merck is advancing a myeloid cell-targeting antibody, MK-4830, discovered by Agenus, across a range of cancers – including pancreatic, lung, renal, breast, ovarian, gastric and glioblastoma.

Incyte is advancing four clinical stage partnered programs, including a combination trial evaluating our TIM-3 and LAG-3 antagonists with PD-1 in PD-1 r/r melanoma.

Across our partnerships, we are eligible for $2.8B in milestones plus royalties, as well as the option to participate in development and commercialization for certain programs.

Cell therapy subsidiary, MiNK Therapeutics, launched via an IPO

MiNK Therapeutics launched a successful IPO to support clinical development of its allogeneic cell therapies.

Clinical programs are underway in solid tumors and multiple myeloma.

SaponiQx to generate GMP grade QS-21 STIMULON adjuvant from proprietary plant cell culture manufacturing process in 2022 to enable partner clinical studies

QS-21 STIMULON is a proven adjuvant in GSK’s shingles vaccine (SHINGRIX), with durability lasting >9 years.

While data supports broad applicability across >20 disease settings, supply is limited by a complicated extraction process from a Chilean soap bark tree.

SaponiQx’s plant cell culture method of manufacturing offers a more sustainable, scalable, and cost-effective supply of QS-21 STIMULON.

GMP grade material from this manufacturing process is expected to be available this year to enable partner clinical trials.

SaponiQx is also developing next-generation adjuvants designed to increase mucosal immunity through intranasal delivery, critical for addressing respiratory pandemic threats such as COVID-19.

Fourth Quarter and Full Year 2021 Financial Results

We ended the year 2021 with a cash and short-term investment balance of $307 million as compared to $100 million at December 31, 2020.

We recognized revenue of $296 million and $88 million for the years ended December 31, 2021, and 2020, respectively, which includes revenue related to upfront license fees received, non-cash royalties earned, and revenue recognized under our collaboration agreements.

Our cash provided by operations for the year ended December 31, 2021, was $10 million with a reported net loss of $29 million or $0.11 per share compared to cash used in operations of $139 million and a net loss for the year ended 2020 of $183 million or $1.05 per share. Non-cash operating expenses for the year ended December 31, 2021, were $49 million compared to $37 million for the year ended 2020.

Net loss for the fourth quarter ended 2021 was $68 million or $0.26 per share compared to a net loss for the same period in 2020 of $38 million, or $0.20 per share. For the fourth quarter ended December 31, 2021, our cash used in operations was $23 million compared to $36 million for the same period in 2020.

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