Analyst Conference Summary

Biotechnology

conference date: March 14, 2023 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2022 (Q4, fourth quarter 2022)

Forward-looking statements

Overview: First Phase 3 trial for botensilimab to launch in 2023.

Basic data (GAAP):

Revenue was $28 million, up sequentially from $23 million and up 40% from $20 million year-earlier.

Net income was negative $74 million, down sequentially from negative $57 million, and down from $68 million year-earlier.

Earnings per share, diluted, (EPS) were negative $0.24, down sequentially from negative $0.19 and down from $0.26 year-earlier.

Guidance:

Cash runway through Q2 2024, longer if milestones or deals are achieved.

Conference Highlights:

CEO Garo Armen stated: "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. 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 microsatellite stable colorectal cancer (MSS CRC) and other priority indications." Botensilimab has shown strong results in both cold and hot refractory and difficult to treat cancers. Believes can continue to generate non-dilutive cash from partnerships. Plans Phase 3 studies in colorectal, melanoma, and pancreatic cancers. Could make regulatory submission for approval in 2024.

Dr. Steven O'Day, Chief Medical Officer, said "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. Botensilimab's clinical activity in advanced and refractory cancers has generated considerable interest from experts worldwide."

Next-Gen CTLA-4 agent, botensilimab (AGEN1181) reported updated data as SITC in November 2022 and at ASCO-GI and ESMO-GI in Q1 2023. Most recent Phase 2 MSS CRC data showed 12-month overall survival rate of 63%, including 81% for patients with no active liver metastases, and 40% for patients with active liver metastases, indicating clinical benefit across all patient populations. That compared with standard of care 12-month overall survival rate of approximately 25%, inclusive of patients with and without active liver metastases. Phase 2 updated Ovarian cancer showed overall response rate of 26% and disease control rate of 63%, much better than comparators. Sarcoma data showed 46% overall response rate. R/R NSCLC data showed a 50% overall response rate and 75% disease control rate. All trials will coninue, with melanoma and pancreatic cancer Phase 2 trials expectd to complete enrollment in 2023. Had initiated Phase 2 trials for advanced refractory MSS colorectal cancer and for melanoma patients who failed prior PD1 and/or CTLA4 therapy in Q3 2022. A trial in pancreatic cancer began in December 2022. Botensilimab is designed to delete T-regs and increase priming. It also overcomes the genetic polymorphism displayed by about 40% of the target cancers (which makes Yervoy unresponsive). Both monotherapy and combination therapy were well-tolerated. Next data update will be in March for the ovarian cohort.

The first patient was dosed with AGEN 1571 in July 2022, alone and then combined with botensilimab and/or balstilimab, in solid cancers. It is an ILT2 inhibitor that targets tumor associated macrophages, which promote resistance to PD-1 and CTLA-4 therapy. Preclinical data was presented at AACR 2022 in April. Another Phase 1 study is planned.

The combination study of AGEN2373 (CD137 agonist) and botensilimab in melanoma patients who have relapsed or are refractory to PD1 therapy continues to enroll.

AGEN2373, a CD137 agonist, partnered with Gilead, is enrolling a Phase 1b sudty in R/R melanoma, combined with botensilimab. Received a $5 million milestone from Gilead in 2022.

AGEN1571, an ILT2 antagonist, began a Phase 1 dose-escalating and expansion study in patients with advanced solid tumors. The study will evaluate safety and tolerability as a single agent and in combination with botensilimab and balstilimab.

In Q3 2022 Bristol Myers launched a Phase I/II study of BMS-986442 (a TIGIT bispecific discovered by Agenus, was AGEN1777) in combination with nivolumab or chemotherapy in patients with advanced solid tumors and non-small cell lung cancer.

In Q3 Merck initiated a Phase II study of 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.

In Q3 Incyte initiated a Phase II study of 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.

Bali/Zali combination will continue to be developed for possible use in ex-US territories.

Incyte therapies licensed from Agenus continue to advance in the clinic.

Shingrix is the most effective shingles vaccine; GSK commercial sales have exceeded projections. Agenus licensed GSK QS-21 Stimulon, a component of Shingrix. Non-cash royalties were $0 million in Q2 2021, down from $8 million year-earlier. It is also a component of GSK's Mosquirix vaccine, against malaria, which has received regulatory approval in Africa. SaponiQx subsidiary was launched to provide SQ-21 and next-generation agents, collaborating with Phyton Biotech and Ginkgo Bioworks. Will use a plant-cell based technology. SQ-21 Stimulon is also a component of the GSK RSV vaccine that now has a PDUFA for May 2, 2023.

The platform includes the capability of identifying patients likely to respond to therapies before those therapies are administered in clinical trials.

Revenue consisted of $4 million R&D; $18 million non-cash royalty; $6 million other.

Cost of sales was $0 million. Research and development expense was $53 million. General and administrative expense was $25 million. Cost of service revenue $8 million. Other expense $4 million. Non-cash interest expense of $18 million. Loss related to debt $2 million.

Cash and equivalents balance ended at $193 million, down sequentially from $218 million. $ million cash used in operations. No debt.

Q&A selective summary:

Size of NSCLC cohort before larger trial? Looking at response rates, decided to expand the cohort to at least 30 patients. Should get that in a few months. Then will decide on next steps. The results so far were on a very small patient sample.

Colorectal arms re contribution of components? Bot and combination, does not see a need for PD1 monotherapy, as its effect is likely zero in the setting.

Collaboration milestones possible this year? Yes, but will not quantify yet. They would be significant sums.

Phase 3 CRC target population? Is same as Phase 2, hopes to see same robust responses.

We are looking at potential partnerships in NSCLC, where they might use their own PD1 agent in combination.

Our CTLA4 is a multi-function CTLA4, not just an improved CTLA4. We engineered several new capacities like recruiting new immune cells and stimilation of memory cells.

Melanoma or pancreatic data this year? We should have some internally by the end of the year, when we make a public report depends, but could be Q1 2024 at a major conference.

Cash runway? With no additional milestones (unlikely) or partnerships, should make it to Q2 2024. But we believe we will bring in additional cash from one or more sources.

Confirmed responses require 2 scans.

We do see side effects, we have programs to manage indications of toxicity, which can be associated with efficacy benefits.

Agenus web site

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