Agenus (AGEN) Q2 2024 earnings summary

Executive summary

• BOT/BAL demonstrated robust, durable responses in relapsed/refractory MSS colorectal cancer and other solid tumors, with interim Phase II data validating prior results and activity seen in over 1,000 patients across 10 cancer types.

• Regulatory engagement is ongoing, with positive feedback from European agencies and FDA alignment on Phase III trial design and dosing, while a Named Patient Program was launched for early access.

• The company regained rights to AGEN1777 and AGEN2373, lost BMS and Gilead as partners, and is actively exploring global partnerships and out-licensing opportunities.

• Tom Harrison joined the board, bringing healthcare and communications expertise to support strategic growth.

• National Cancer Institute's CTEP began accepting Letters of Intent for BOT clinical studies.

Financial highlights

• Ended Q2 2024 with $93.7 million in cash, up from $76.1 million at year-end 2023.

• Q2 2024 revenue was $23.5 million; six-month revenue was $51.5 million, compared to $25.3 million and $48.2 million in 2023.

• Net loss for Q2 and first half of 2024 was $54.8 million and $118.3 million, respectively.

• Cash used in operations for H1 2024 was $76.4 million, down from $118.6 million in H1 2023.

• Non-cash operating expenses were $33.5 million for Q2 and $71.8 million for H1 2024.

Outlook and guidance

• Phase III trial for BOT/BAL in r/r MSS CRC could commence within four months, with rapid enrollment expected and FDA alignment on trial design.

• Exploring subsidized global phase III trial options, potentially as low as $10 million in cost.

• Further BOT/BAL data releases are anticipated later in 2024, including results in other solid tumors.

• Additional follow-up of about six months from phase II trial needed for future FDA discussions.

• Management expects current cash and potential funding to cover liquidity needs through year-end and into 2025, but substantial doubt exists about the ability to continue as a going concern.