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 late 2024. Borrowing $100 million against future royalties, as a % of future royalties, to keep going for now.

Basic data (GAAP):

Revenue was $28 million, down % sequentially from $84 million and up % from $23 million year-earlier.

Net income was negative $63 million, down sequentially from negative $49 million, and up from negative $71 million year-earlier.

Earnings per share, diluted, (EPS) were negative $3.04, down sequentially from negative $2.60 and up from negative $4.31 year-earlier.

Guidance:

none

Conference Highlights:

CEO Garo Armen stated: "We are thrilled to announce a significant $100 million royalty financing agreement with Ligand, a milestone that investors have eagerly anticipated. This capital infusion is pivotal for advancing the development and market readiness of our BOT/BAL treatment. The BOT/BAL combination has consistently demonstrated deep and durable responses in cold solid tumors, especially in our advanced studies of relapsed/refractory MSS CRC. With the promising results we have seen, and additional data from our ongoing Phase 2 study, we plan to engage with the FDA in the second half of 2024. Pending the outcomes of these discussions, we aim to commence the submission of a Biologics License Application under the accelerated approval provision for BOT/BAL in refractory MSS CRC NLM." Loan allows Agenus to keep Bot/Bal or bring in partners. Could add $100 million more in a syndicated transaction with other parties, several of which we are talking with. Has requests for an unprecented number of investigator-sponsored trials.

In Q2 2024 entered a $100 million royalty financing agreement, backed by potential bot/bal royalies, with Ligand Pharmaceuticals (LGND). Did not state interest rate, but likely high. Will get an initial $75 million, with an option for Ligand to invest an additional $25 million. " In return for the initial $75 million payment, Ligand will receive 18.75% of the future royalties and 31.875% of the future milestone payments related to six of Agenus’ clinical-stage partnered oncology programs, including BMS-986442 (Bristol Myers Squibb), AGEN2373 (Gilead Sciences), INCAGN2385 and INCAGN2390 (Incyte), MK-4830 (Merck), and UGN-301 (UroGen Pharma). Ligand’s portion of the milestones related to these six programs has the potential to exceed $400 million, with royalties in the low single digits. In addition, Ligand will also receive a 2.625% royalty on future global net sales generated by BOT/BAL."

In Q1 executed to reverse stock split, 20:1. That regained Nasdaq listing requirements.

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. Hopes to submit a BLA to the FDA in 2H 2024. In June will make a psoter presentation at ASCO. There are also investigator-sponsored trials underway.

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.

Manufacturing preparations for a launch continue.

Trying to minimize expenses to conserve cash.

Revenue consisted of $0 million R&D; $27.8 million non-cash royalty (QS-21); $0.2 million other.

Cost of sales was $0 million. Research and development expense was $44 million. General and administrative expense was $17 million. Cost of service revenue $0.1 million. Other loss $1 million. Non-cash interest expense of $30 million.

Cash and equivalents balance ended at $53 million, down sequentially from $76 million. In January 2024 received (?) a $25 million milestone payment from Bristol. Cash used in operations was $38.2 million.

Q&A selective summary:

Confirm number of patients treated at Phase 2 dose? Working on a compelling data package for the FDA. The Phase 2 randomized study included. We have a significant number of patients on bot/bal, at 2 doses, enough to talk to the FDA given the unmet need.

Bot/Bal in melanoma and pancreatic? Fixated on CRC right now. With additional financial resources these programs will come back into focus.

Study details? Will not discuss details until after presenting to the FDA, and even then prefer to present the data at a major medical meeting.

FDA request is going in as we speak. Guess could get meeting scheduled for the end of July.

We have minimum follow up advice from our regulatory advisors for the data follow up period, leading the the BLA filing.

We have over 50 ISP requests for trial, we are focussing on a handful of trials that would help with significant data and potential approval in several indications. There is a great deal of interest in sarcoma because of the activity we have seen so far.

Financing, bot/bal vs. other programs? In Ligand press release. We can now pursue bot/bal on our own or can pursue it worldwide with partners.

Agenus web site

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