Analyst Conference Summary



conference date: March 1, 2022 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2021 (Q4, fourth quarter 2021)

Forward-looking statements

Overview: 1181 now named botensilimab.

Basic data (GAAP):

Revenue was $20 million, down sequentially from $252 million and down from $31 million year-earlier.

Net income was negative $68 million, up sequentially from negative $177 million, and down from negative $38 million year-earlier.

Earnings per share, diluted, (EPS) were negative $0.26, up sequentially from negative $0.72, and down from negative $0.20 year-earlier.



Conference Highlights:

CEO Garo Armen stated: "We made several important advancements in 2021. Our Phase 1 data presentation at SITC 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 and D team continues to advance novel discoveries, with our macrophage targeting program expected to enter the clinic this year " 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.

For the full year 2021 Agenus received $220 million in upfront and milestone payments from its partners.

In Q3 2021 Bristol-Myer dosed the first patient with AGEN1777, triggering a $20 million milestone. BMS plans to use it in high-priority indications like non-small cell lung cancer.

Merck continues to advance MK-4830, targeting myeloid cells across cancers including pancreatic, lung, renal, breast, ovarian, gastric and glioblastoma.

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

AGEN2373, a CD137 agent and checkpoint agonist, showed good results at ASCO 2021. Will combine in trial with 1181 for melanoma.

Balstilimab and zalifrelimab development continues for combination therapies.

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 $15 million in Q4 2021. 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 $53 million. General and administrative expense was $22 million. Cost of service revenue $1 million. Other income $3 million. Non-cash interest expense of $16 million. Adjustment of fair value $2 million.

Cash and equivalents balance ended at $307 million, up sequentially from $262 million. No debt.

Q&A summary:

Bal Zal cervical combo any path forward? Because of agency guidance changes we do not see a single arm or randomized trial path. Even though we showed clear benefit in our trial. Competitors have also pulled PLAs from trial. We will not pursue Bal + Zal in cervical cancer.

Botensilimab path to approval? In melanoma we can test as a single agent in two settings, where current standard is 15% and we hope to hit 25% effectiveness. Also patients who failed prior lines, where response rates bar is low and unmet need is high. KOLs are energized by our Phase 1 melanoma data. Pancreatic will begin in second line setting, but could move to first line later.

Saponin internasal vaccine? We have a promising QS-7 agent and have developed plant based cell lines to improve yields. We hope to have GMP quantities late in 2022, which could allow discussions with potential partners.

Given the new regulatory environemnt, we do not see it worth taking chances with single arm trials. Our trials will be randomized, even in populations with unmet need. It is highly likely large randomized Phase 3 trials will be necessary for approval, but will discuss results with the FDA.

1571 mechanism? Not releasing yet.

Partner timelines? We can't say, but enrollment is progressing in all these trials, so there might be some data this year.

Will the Phase 2 planned trials be randomized? In melanoma will be single arm, discussing the other trial designs with the FDA.

Agenus web site

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Disclaimer: My analyst call summaries may include both our condensations of statements made by company representatives and my own analysis. They are not covered by any warranty. I cannot guarantee anything said by company representatives is true. I try not to make errors, but it is possible. This is journalism, not investment advice.

Copyright 2022 William P. Meyers