Analyst Conference Summary

Biotechnology

conference date: August 9, 2022 @ 5:30 AM Pacific Time
for quarter ending: June 30, 2022 (Q2, second quarter 2022)

Forward-looking statements

Overview: Plans Phase 2 trials of botensilimab for colorectal, melanoma, and pancreatic cancers by end of 2022.

Basic data (GAAP):

Revenue was $21 million, down sequentially from $26 million and up from $11 million year-earlier.

Net income was negative $49 million, up sequentially from negative $51 million, and up from negative $84 million year-earlier.

Earnings per share, diluted, (EPS) were negative $0.17, up sequentially from negative $0.19, and up from negative $0.37 year-earlier.

Guidance:

none

Conference Highlights:

CEO Garo Armen stated: "Agenus’ presentation of botensilimab/balstilimab combination data in MSS colorectal cancer at ESMO GI was received with great enthusiasm by many thought leaders and clinicians in the fields of GI cancers and immuno-oncology. Treatment-resistant MSS CRC patients lack effective options, with the standard of care offering only a 1-2% response rate and an expected median survival ranging from 6 to 7 months. Our results could potentially change the treatment paradigm and offer hope to a significant number of patients with limited options. We are working closely with regulators and advisors to expedite botensilimab’s development in pursuit of global registrations across multiple cancers."

Next-Gen CTLA-4 agent, botensilimab (AGEN1181), in Q2 2022 presented updated data at ESMO showing clinical activity in microsatellite stabler colorectal cancer. Combined botensilimab and balstilimab for MSS CRC had a 24% ORR and 73% disease control rate in heavily pretreated MSS CRC (cold tumors, PDL1 negative). 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.

The first patient was dosed with AGEN 1571 in July 2022. It is an ILT2 inhibitor that targets tumor associated macrophages, which promote resistance to PD-1 and CTLA-4 therapy. ILT4 antagonist is licensed to Merck as MK4830. 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.

In Q2 2022 earned a $25 million sales-based milestone for QS-21 Stimulon component of Shingrix vaccine by GSK, to be received in 2H 2022.

Looking for innovative financing and more partnerships while reducing expenses.

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.

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.

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 $45 million. General and administrative expense was $19 million. Cost of service revenue $2 million. Other income $9 million. Non-cash interest expense of $14 million. Adjustment of fair value $0.4 million.

Cash and equivalents balance ended at $238 million, down sequentially from $263 million. $43 million cash used in operations. No debt.

Q&A summary:

ILT2 program? Bal/Bot combination with 1571 is promissing because high levels of ILT2 correspond to non-responders in IO therapy. Combination potentiates immune activation. Potentially best and first in class program. ILT4 antibody is with Merck.

Melanona cohort? We will release data at an upcoming major conference.

Potential milestone revenue in 2022? No comment on deal structures or milestones, except the QW-21 $25 million already announced.

Trial design? 3 randomized trials to start soon, details during ESMO week.

Nivo LAG3 approval affect on melanoma space? LAG3 is a very different target. Now 3 first line options. Will address each of the cohorts.

Agenus web site

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