Agenus — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for Q3 2026 was $31.5 million, up from $30.2 million in Q3 2025.
• Pre-commercial product revenue was $6.0 million in Q3 2026, compared to $6.4 million in Q2 2026 and $0 in Q3 2025.
• Non-cash royalty revenue was $25.5 million in Q3 2026, down from $28.1 million in Q2 2026 and $29.1 million in Q3 2025.
• Year-to-date (YTD) revenue for the first nine months of 2026 was $99.7 million, up from $80.0 million in the same period in 2025.
• YTD pre-commercial product revenue was $17.0 million.
• YTD non-cash royalty revenue was $82.7 million.
• Operating income was $11.4 million in Q3 2026, a reversal from an operating loss of $4.6 million in Q3 2025; YTD operating income was $37.8 million compared to a loss of $34.6 million in 2025.
• Net income was $2.8 million in Q3 2026 and $41.4 million YTD 2026, compared to net income of $63.9 million and $7.5 million respectively in the prior year periods.
• Cash, cash equivalents, and short-term investments were $86.9 million at September 30, 2026, up from $18.7 million at June 30, 2026 and $3.5 million at September 30, 2025.

Guidance and Future Outlook:

• The ROBBIN Phase 3 trial is on track for first patient enrollment in Q1 2027.
• An interim pathologic response assessment for the first 100 patients enrolled in ROBBIN is anticipated in Q4 2027.
• Anticipated Series A Warrants milestone (60 patients enrolled in ROBBIN) is expected in Q2 2027.
• Anticipated Series B Warrants milestone (interim pathologic response assessment) is expected in the second half of 2027.
• Upfront proceeds from the July private placement are expected to support ROBBIN initiation, regulatory activities, and operations through Q3 2027.
• Assuming full exercise of warrants, financing is expected to support the ROBBIN program and company operations through year-end 2031.
• Additional clinical publications and updates, along with potential additional regulatory submissions, are anticipated in 2027.

Business Segments and Product Lines:

• BOT+BAL (botensilimab and balstilimab) is the primary focus, currently in the ROBBIN Phase 3 registrational trial for high-risk Stage II and III microsatellite-stable (MSS) colon cancer.
• ROBBIN is designed to enroll approximately 850 patients with event-free survival as the primary endpoint.
• NEST study (published in Clinical Cancer Research) reported approximately 32% pathologic complete response (pCR) in MSS tumors with no recurrences at median follow-up of 32.2 months (NEST-1) and 23.5 months (NEST-2).
• UNICORN study (published in Nature Medicine) reported 29% pCR and 36% major pathologic response in MSS cohorts, with no recurrences at 19.2 months median follow-up.
• Phase 1b C-800-01 program showed 33% three-year overall survival in heavily pretreated MSS metastatic colorectal cancer patients without active liver metastases.
• Phase 1b C-800-01 recurrent ovarian cancer cohort demonstrated 48% estimated overall survival at three years.
• NEOASIS study in dMMR colon cancer showed 72% pCR and 83% major pathologic response following six weeks of BOT+BAL.
• Armenia granted the first worldwide marketing authorizations for Botvymo (botensilimab) and Evamplix (balstilimab) for MSS metastatic colorectal cancer without active liver metastases.
• France's AAC program provides fully reimbursed access for MSS metastatic colorectal cancer, platinum-resistant/refractory ovarian cancer, and advanced soft-tissue sarcomas.
• Physician-initiated named-patient programs provide access in select countries in Europe and South/Central America.

Market and Competitive Landscape:

• MSS disease accounts for approximately 85% of early-stage colorectal cancers.
• ROBBIN addresses an estimated 38,000 newly diagnosed U.S. patients annually, representing an estimated annual U.S. total addressable market exceeding $7 billion.
• No new curative-intent therapies have been approved for MSS colon cancer patients in over two decades.
• BOT+BAL is being developed to expand immunotherapy benefits to "cold" tumors and MSS disease populations that generally respond poorly to standard of care.

Risks and Challenges:

• Armenian marketing authorizations are conditional and valid for one year, subject to renewal based on annual clinical updates.
• BOT+BAL remains investigational outside Armenia and is not approved by the U.S. FDA.
• Recognized revenue from pre-commercial access programs can vary with country-specific pricing, reimbursement, taxation, distribution arrangements, and timing.
• Forward-looking statements regarding clinical timelines, regulatory filings, and financing are subject to risks and uncertainties that could cause actual results to differ materially.

Management Commentary and Tone:

• CEO Garo H. Armen stated the company has moved from planning ROBBIN to mobilizing investigators and activating sites globally.
• Management expressed confidence in the potential of BOT+BAL to change outcomes for MSS colon cancer patients, citing strong investigator engagement in Madrid and São Paulo.
• The company prioritizes bringing BOT+BAL earlier in the treatment of cancer to prevent recurrence and increase the potential for cure.
• Management highlighted the importance of the Armenia marketing authorization as a step to bring treatment options to patients with advanced disease who need it today.

Other Key Points:

• A July oversubscribed private placement provided approximately $85 million in upfront gross proceeds.
• The private placement includes milestone-aligned warrants that could provide up to approximately $255 million in additional gross proceeds if fully exercised.
• No new safety concerns were identified in the neoadjuvant studies; 98% of patients in UNICORN underwent surgery on schedule.
• The company has robust end-to-end development capabilities including commercial and clinical cGMP manufacturing facilities.
• BAP Pharma serves as Agenus' global partner for the French AAC pathway and named-patient access programs.