Agenus (AGEN) Q2 2024 earnings summary

Executive summary

• BOT/BAL demonstrated robust and durable responses in relapsed/refractory MSS colorectal cancer, with interim Phase II data confirming prior results and supporting broad solid tumor activity across multiple cancer types and stages.

• Over 1,000 patients treated across 10 cancer types, with high demand for compassionate use and strong advocacy from key opinion leaders.

• Positive initial feedback from European regulators and ongoing engagement with global authorities, including FDA alignment on Phase III trial design and dosing.

• Named Patient Program launched to provide early access to BOT/BAL for eligible patients.

• Regained full rights to AGEN1777 and AGEN2373 from BMS and Gilead, but recent partnership terminations eliminate future milestone and royalty revenue from those programs.

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 H1 2024 was $54.8 million and $118.3 million, including significant non-cash expenses.

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

• Closed first tranche of a $75 million royalty financing with Ligand, providing near-term liquidity.

Outlook and guidance

• Planning to initiate a Phase III trial for BOT/BAL within four months, with potential to enroll inside a year due to high patient demand 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 anticipated later in 2024, including results beyond MSS CRC.

• Additional follow-up of about six months needed for more mature Phase II data before further FDA engagement.

• 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.