Analyst Conference Summary

Biotechnology

conference date: May 07, 2024 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2023 (Q1, first quarter 2024)

Forward-looking statements

Overview: First FDA submission for approval could come in mid 2024.

Basic data (GAAP):

Revenue was $ million, up % sequentially from $84 million and up % from $ million year-earlier.

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

Earnings per share, diluted, (EPS) were negative $, up sequentially from negative $0.13 and up from negative $ year-earlier.

Guidance:

Conference Highlights:

CEO Garo Armen stated: ""

Agenus is pursuing immediate prospects for additional cash infusions, but not stock issuance. Agenus is in the process of selling two non-strategic assets plus the partial sale of other milestones and royalties due to Agenus from partnered programs. These three sales are expected to close by the end of the first half of 2024. This should provide funding through the end of 2024, into 2025. In addition Agenus is in advanced discussions for a potential structured financing for BOT/BAL as well as a potential corporate collaboration with a large pharma or biotech company.

The bot/bal combo received FDA Fast Track designation for patients with metastatic colorectal cancer that is not MSI-H/dMMR and who do not have liver metastases, and who were previously treated with standard combination chemotherapy, anti-VEGF and anti-EGFR if RAS wild type (refractory MSS mCRC NLM). The Phase 2 trial completed enrollment in October 2023. Strong Phase 1 clinical data reported, but detailed Phase 2 data will not be reported until after an FDA meeting in May. Data was also presented in neoadjuvant CRC in January 2024.

Next-Gen CTLA-4 agent, botensilimab (AGEN1181) reported updated data at with or without balstilimab (BAL), is broadly effective in treating five advanced solid tumors: colorectal, pancreatic, lung, melanoma, and sarcoma. Over the past 12 months, clinical data on BOT/BAL has been featured in six oral or plenary sessions at major cancer conferences and published in peer-reviewed medical and scientific journals. Data readouts for the ACTIVATE-Pancreatic, ACTIVATE-Melanoma, and the Phase 1b trial in non-small cell lung cancer (NSCLC) are expected throughout 2024.

In second line pancreatic cancer, a Phase 2 random study update is expected in 1H 2024, with a possible sBLA filing in 2025.

There has also been positive indicators in the trials for neoadjuvant CRC, refractory melanoma, NSCLC, and advanced sarcomas.

Revenue consisted of $ million R&D; $ million non-cash royalty (QS-21); $ million other.

Cost of sales was $0 million. Research and development expense was $ million. General and administrative expense was $ million. Cost of service revenue $ million. Other income $ million. Non-cash interest expense of $ million. Fair value adjustment $ million.

Cash and equivalents balance ended at $ million, down sequentially from $76 million. In January 2024 received a $25 million milestone payment from Bristol. No debt.

Q&A selective summary:

Agenus web site

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