Analyst Conference Summary

Biotechnology

conference date: May 10, 2022 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2022 (Q1, first quarter 2022)

Forward-looking statements

Overview: Plans Phase 2 trials of botensilimab for colorectal, melanoma, and pancreatic cancers.

Basic data (GAAP):

Revenue was $26 million, up sequentially from $20 million and up from $12 million year-earlier.

Net income was negative $51 million, up sequentially from negative $68 million, and down from negative $54 million year-earlier.

Earnings per share, diluted, (EPS) were negative $0.19, up sequentially from negative $0.26, and down from negative $0.27 year-earlier.

Guidance:

none

Conference Highlights:

CEO Garo Armen stated: "In the current challenging environment for the biotech industry, we are prioritizing our most promising clinical programs, including botensilimab combinations, as well as preclinical programs with the highest potential for engagement from collaborators. Needless to say, we are also taking decisive steps to contain costs across the board despite our reasonable cash position." Biotech sentiment in the stock market as very negative. Across partnerships, Agenus is eligible for $2.8B in milestones plus royalties and the option to participate in development and commercialization for certain programs.

Next-Gen CTLA-4 agent, botensilimab (AGEN1181), in Q4 2021 presented data at SITC showing durable responses in 9 cold cancer types in over 100 heavily pretreated patients. Phase 2 studies are now planned in melanoma, colorectal, and pancreatic cancers. 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. Building internal infrastrucure to support a launch, including manufacturing sites in Emeryville and Vacaville. Actively working with FDA to finalize plans for Phase 2 studies.

Plans to get AGEN 1571 into the clinic is 2022. It targets tumor associated macrophages, which promote resistance to PD-1 and CTLA-4 therapy. It is licensed to Merck. Preclinical data was presented at AACR 2022 in April. Another Phase 1 study is planned.

AGEN2373 generated from Gilead a $5 million milestone was received in April 2022. It targets CD137. Phase 1b combination study will be with botensilimab ongoing in melanoma patients who have relapsed or are refractory to prior anti-PD-1 therapy. Gilead has an exclusive option to license AGEN2373, while Agenus can opt-in for a 50:50 profit share and US co-commercialization rights. Possibly up to $570 million in future milestones.

Looking for innovative financing and more partnerships.

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

Initiated a comprehensive review to elminate nonessential spending in Q2 2022.

AGEN1777 is licensed to Bristol-Myers.

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 $17.6 million in Q1 2021, up from $8.5 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.

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

Cost of sales was $0 million. Research and development expense was $42 million. General and administrative expense was $19 million. Cost of service revenue $1 million. Other income $0 million. Non-cash interest expense of $15 million. Adjustment of fair value $0.5 million.

Cash and equivalents balance ended at $263 million, down sequentially from $307 million. $53 million cash used in operations. No debt.

Q&A summary:

ILT2? AGEN1571 goes beyond ILT2 to include T, NK, and NKT activation. AACR data shows it to be best in class. Tumors chosen will depend on which ones respond to ILT2 agents. Myeloid space is important, as is lymphoid. Phase 1 will look broadly at tumor types including ovarian and liver. Because botensilimab showed the advantage of FC activation, so we have hopes for combinations with 1571.

Botensilimab trial design? Regulatory environment has changed. We needed to make sure that the trial designs would be meaningful. The trials will be randomized to either standard of care or within the drug we are studying. We are laser focussed on this program given the remarkable activity from the Phase 1 program. We will test as a single agent for melanoma. Colorectal will be combined with PD1 agent. Pancreas is a cold tumor, will look at botensilimab combined with chemotherapy. That way we will cover the three major pathways.

Target for op ex savings? Not quantified, but hopefully over 10%. Will not compromise the deliveries in our high priority programs.

Phase 2 botensilimab trial launch times? All 3 expected to commence in Q3 2022. Delay was due to need to confer with FDA. But trial design is finalized.

We have no current plans to issue stock to raise funds.

Which melanoma second-line patient types will you enroll? LAG3 failures? We believe we have not just a CTLA4 drug but a broader one, so we will see which failure scenarios it can rescue.

SITC upcoming data? Phase 1 bot trial continues to expand. So we will have more data later this year, but we have not announced which conference that will be at. Because of the good results we have seen a greatly expanded enrollment in the Phase 1 trials.

Agenus web site

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