Analyst Conference Summary

Biotechnology

conference date: November 11, 2024 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2023 (Q3, third quarter 2024)

Forward-looking statements

Overview: Sounds like botensilimab will need a Phase 3 trial. But money is tight, looking for financing.

Basic data (GAAP):

Revenue was $25.1 million, up sequentially from $23.5 million and up from $24.3 million year-earlier.

Net income was negative $67.2 million, down sequentially from negative $55 million, and down from negative $64.5 million year-earlier.

Earnings per share, diluted, (EPS) were negative $3.08, down sequentially from negative $2.52 and up from negative $3.29 year-earlier.

Guidance:

none

Conference Highlights:

CEO Garo Armen stated: "BOT/BAL represents one of the most significant advancements in cancer immunotherapy, showing remarkable results in MSS colorectal cancer where previous treatments have fallen short. Its potential extends beyond this challenging cancer type, with promising efficacy seen in the neoadjuvant setting and other hard-to-treat cancers. While we are excited by these achievements, we remain mindful of the financial challenges that come with advancing such breakthrough therapies. We are focused on strategic initiatives, including asset monetization and operational efficiencies, to strengthen our financial position and continue driving forward. We are confident in our path and unwavering in our commitment to deliver innovative treatments that redefine patient care and create long-term value for our patients and shareholders." Working to reduce cash spend. Facing significant financial strain, needs substantial funds to pursue Bot/Bal Phase 3.

Agenus is pursuing potential out-licensing transactions for several of its 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. May even partner Bot/Bal. Believes a signicant transaction can be completed "in the near term.".

New analyses presented at the ESMO October 2024 meeting highlighted BOT/BAL activity in metastatic CRC across challenging sites of metastatic disease, including MSS CRC, sarcomas and other difficult cancers.

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.

Revenue consisted of $0 million R&D; $23 million non-cash royalty (QS-21); $1 million other.

Cost of sales was $0 million. Research and development expense was $41 million. General and administrative expense was $17 million. Cost of service revenue $0.1 million. Other loss $0.5 million. Non-cash interest expense of $36 million. Non-cash fair value adjustment negative $2 million.

Cash and equivalents balance ended at $45 million, down sequentially from $94 million. Cash used in operations was $130 million for year to Q3 end. $7.1 million was raised after the end of Q3 under the stock issuance agreement

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. Received an initial $75 million in May 2024. " 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."

Q&A selective summary:

Phase 3 design, timeline? We have EMA and FDA feedback. But we need a strategic partnership to finance it. We are talking to potential pharma customers, or could fund it if we can license a different antibody.

Investigator trial designs? The ESMO data for MSS CRC was very strong. Another is looking at Bot/Bal for CRC in the neoadjuvant setting. Third is from Netherlands, broad solid tumor range including CRC.

Phase 2 R/R CRC? Data continues to mature. Should present in early 2025.

Any more data on melanoma, pancreas. etc., in the near term? At ESMO we presented data on sarcoma. As the data matures it gets more compelling. Physicians who see the data are keen to have Bot/Bal become available for patients. In particular melanoma and pancreas data is mature and should become available in 2025.

Agenus web site

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