Analyst Conference Summary

Biotechnology

conference date: May 12, 2025 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2025 (Q1, first quarter 2025)

Forward-looking statements

Overview: No funding for further Bot/Bal development yet. Cash crisis, but says near a collaboration that will infuse cash.

Basic data (GAAP):

Revenue was $24.1 million, down sequentially from $26.8 million and down from $28.0 million year-earlier.

Net income was negative $ million, up sequentially from negative $46.8 million, and up from negative $ million year-earlier.

Earnings per share, diluted, (EPS) were negative $1.03, up sequentially from negative $2.04 and up from negative $3.04 year-earlier.

Guidance:

none

Conference Highlights:

CEO Garo Armen stated: "Agenus has received 4 formal transaction proposals, including an Emeryville facility sale, a signifant equity investment at a big premium, and two Bot/Bal licensing deals." Believes first announcement could be in a few days up to a few weeks. Meanwhile facing significant financial strain, needs substantial funds to pursue Bot/Bal Phase 3. Is reducing costs by externalizing development. Believes Bot/Bal has groundbreaking or even revolutionary potential. Believes the regulatory environment under Kennedy actually favors Agenus.

Agenus requested a Type B meeting with the FDA, asking for accelerated approval (before Phase 3 trial). Has data on over 1200 Bot/Bal patients and over 2 year follow ups. Dr. Richard Goldberg, an internationally recognized leader in GI cancer treatment and research, joined Agenus as Chief Development Officer to support the advancement of Bot/Bal for patients.

Agenus is pursuing potential out-licensing transactions for Bot/Bal and several of its other pipeline assets. Includes AGEN1777 (Tigit), previously licensed to Bristol Myers Squibb, and AGEN2373 (CD137), for which the Gilead option period expired. The cash is needed for getting through the Phase 3 Bot trial. Will likely partner Bot/Bal.

In Q1 2025 more data for Bot/Bal was presented as ASCO-GI in January 2025, and in April at the AACR (American Association for Cancer Research). Good data reported in colorectal cancer, TNBC, and sarcoma. 100 percent of dMMR (mismatch repair deficient) CRC patients, at the higher does, achieved a partial Complete Response. Bot/Bal has now validated durable responses in previously unresponsive cold tumors.

Agenus has engaged with the European Medicines Authority and has agreed to the protocol for the Phase 3 pivotal study in MSS CRC.

Agenus is receiving many compassionate use requests for Bot/Bal.

Agenus is prepared to issue and sell stock, if necessary, to finance it until Bot/Bal approval. May also sell its real estate, soon, possibly worth $70 million.

Bot/Bal is advancing in 3 ISTs in MSS CRC. Results from European trials expected in early 2025.

Trying to minimize expenses to conserve cash. Believes annual cash burn will be reduced to $50 million by 2H 2025.

Revenue mainly consisted of non-cash royalty from (QS-21).

Not stated in press release, should be on 10-Q. Cost of sales was $0 million. Research and development expense was $ million. General and administrative expense was $ million. Cost of service revenue $ million. Other loss $ million. Non-cash interest expense of $ million. Non-cash fair value adjustment negative $ million.

Cash and equivalents balance ended at $18.5 million, down sequentially from $40.4 million. Cash used in operations was $25.6 million.

Q&A selective summary:

Longer term Bot/Bal, OS point reached? Median follow up for Phase 1 is 18 months, Phase 2 is 12 months. Some patients now beyond 4 years with no progression. Believes with longer term follow up, studies show survival benefit, should allow for approval. Will present more data at a major upcoming conference.

Will also talk to FDA about the design of a randomized Phase 3 trial.

Response rates to approved products are quite low, so Bot/Bal responses are 2x or higher.

Non CRC plans? The quickest way to get approval is in colorectal. Two varieties, one in refractory. The other is neoadjuvent, MSI high or microsatellite stable patients.

Timing of Type B meeting? Path is clear.

EU? CHMP interaction incredibly productive. Agreed on dose, components, two-arm randomized trial for approval.

Emeryville value? Totality of value will reflect the premium for U.S. drug manufacturing facilities.

The two agreements submitted to us are global. Two additional agreements are geography specific. Global agreements would underwrite the full development of Bot/Bal.

We have not yet engaged with the new FDA leadership. That is what the Type B meeting is for.

Agenus web site

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