Agenus Inc. Q2 FY2025 earnings call

• Colorectal cancer is a critical crisis with high mortality, especially affecting younger adults. • BOT/BAL immunotherapy shows promising results in patients, including late-stage (42% 2-year survival rate in MSS colorectal cancer patients) and early-stage cancers, with durable responses and manageable side effects. • Highlighted regulatory challenges delaying access to treatments and the need for regulatory reform, citing FDA Commissioner Dr. Makary's reformist agenda. • Introduction of MiNK Therapeutics and their iNKT cell therapy, which bridges innate and adaptive immunity, showing potential in cancer and severe inflammatory/infectious diseases. • Progress on Zydus collaboration, including clearance of Hart-Scott-Rodino (HSR) and upcoming treasury department hurdle for closing the transaction.

No detailed breakdown of product segment financial performance and revenue contribution % provided in the transcript.

• Anticipation of closing the Zydus collaboration soon after clearing remaining regulatory hurdles. • Expectation of timely execution of Phase III trials (BATTMAN trial) and sharing of data at ESMO and beyond, including more data on refractory and neoadjuvant settings.

• Regulatory challenges continuing to delay access to innovative treatments like BOT/BAL. • Uncertainties in the approval process for BOT/BAL, including previous FDA requirements for 3-arm trials causing delays. • Potential impact of tariffs and logistical issues on the Zydus collaboration, though the Zydus facility is expected to mitigate some tariff-related risks.

Q: Can you share some additional resources that CCTG provides the partnership? And what does the monetary commitment look like in order to execute the study?

A: The CCTG has a long history of executing clinical trials, is an academic cooperative group capable of doing Phase I to III trials, leverages funding from sources like the Canadian Cancer Society and other grants, with a 10:1 leverage ratio.

Q: Why has the study since the completion of the Phase II been delayed by approximately 18 months?

A: The FDA initially insisted on a 3-arm trial, which was deemed unethical and slow to accrue patients; it took about a year for the FDA to change to a 2-arm trial.

Q: What's coming next at ESMO and beyond?

A: Launch of the BATTMAN Phase III trial, sharing more data on refractory settings and neoadjuvant approaches, with ongoing reporting of neoadjuvant study data.

Q: Did India tariffs impact the Zydus deal or Phase III development?

A: The impact is positive as Zydus's U.S. facility avoids tariffs on goods shipped from India, benefiting the collaboration.