- \n
- \nPreviously announced oversubscribed $85 million private placement, with up to an additional $255 million in potential proceeds from milestone-aligned warrants, supports ROBBIN execution<\/p>\n<\/li>\n
- \nROBBIN addresses approximately 38,000 newly diagnosed U.S. patients annually and an estimated annual U.S. sales opportunity of more than $7 billion; initiation and first patient dosing are expected in the first quarter of 2027<\/p>\n<\/li>\n
- \nPreviously reported NEST and UNICORN findings provided the direct clinical rationale for ROBBIN; recent advanced-disease updates reinforce the durability of BOT+BAL activity<\/p>\n<\/li>\n
- \nBOT+BAL access programs expanded across additional countries and treating institutions, contributing $6.4 million in second-quarter pre-commercial product revenue<\/p>\n<\/li>\n<\/ul>\n
LEXINGTON, Mass.–(BUSINESS WIRE<\/a>)–Agenus Inc.<\/a> (Nasdaq: AGEN), a leader in immuno-oncology innovation, today reported financial results for the second quarter ended June 30, 2026, and provided an update on its financing-supported strategy to advance botensilimab (BOT), a multifunctional, Fc-enhanced anti-CTLA-4 antibody, plus balstilimab (BAL), an anti-PD-1 antibody, in a curative-intent treatment setting before surgery in high-risk, resectable microsatellite-stable (MSS) colon cancer.<\/p>\n
\nAs previously announced, Agenus completed an oversubscribed private placement in July 2026 structured to support ROBBIN, its planned global registrational Phase 3 trial of neoadjuvant (before surgery) BOT+BAL in patients with high-risk Stage II and Stage III microsatellite-stable (MSS) colon cancer. MSS disease accounts for approximately 85% of early-stage colorectal cancers. In the population targeted by ROBBIN, treatment remains centered on surgery followed by chemotherapy or observation, with no new curative-intent therapies approved in more than 20 years.i,ii<\/sup><\/p>\n
\nThe decision to accelerate ROBBIN is grounded in previously reported findings from the independent NEST and UNICORN studies evaluating neoadjuvant BOT+BAL treatment in patients with Stage II and Stage III MSS colorectal cancer. Treatment before surgery produced deep pathologic responses, while recent advanced-disease updates provide complementary evidence of durable BOT+BAL immune activity.<\/p>\n
\nROBBIN addresses an estimated 38,000 newly diagnosed patients annually in the United States and more than 200,000 worldwide.iii<\/sup> Agenus estimates that this population represents an annual addressable sales opportunity of more than $7 billion.<\/p>\n
\n\u201cThe financing completed in July gives us a clear path to act on the clinical evidence supporting BOT+BAL in a large, underserved patient population,\u201d said Garo H. Armen, Ph.D., Chairman and Chief Executive Officer of Agenus<\/b>. \u201cThe previously reported neoadjuvant findings support testing whether BOT+BAL before surgery can reduce recurrence and improve the potential for cure. With capital aligned to ROBBIN\u2019s development milestones, we are positioned to pursue that opportunity with focus and urgency.\u201d<\/p>\n
Previously Announced Financing Supports ROBBIN Execution<\/b><\/p>\n
\nThe private placement, announced and completed in July, provided approximately $85 million in upfront gross proceeds and included milestone-aligned warrants that could provide up to approximately $255 million in additional gross proceeds if fully exercised. The warrant structure aligns potential additional capital with planned ROBBIN milestones.<\/p>\n
\nBased on the company\u2019s current operating plan, the upfront proceeds are expected to support ROBBIN initiation, regulatory alignment and company operations through Q3 2027. Assuming full exercise of the warrants, the financing is expected to support the planned ROBBIN program and company operations through year-end 2031.<\/p>\n
\nAgenus continues to implement disciplined cost-management measures and is directing internal resources toward ROBBIN execution, clinical and access-program supply, regulatory activities and supporting data generation.<\/p>\n
Clinical Evidence Reinforces BOT+BAL\u2019s Differentiated Profile<\/b><\/p>\n
\nPreviously reported findings from the independent NEST and UNICORN studies provide the direct neoadjuvant clinical rationale for ROBBIN in Stage II and Stage III MSS colon cancer.<\/p>\n
\nAmong 38 BOT+BAL-treated patients, approximately 30% achieved a pathologic complete response (pCR; no viable tumor found at surgery), and approximately 40% achieved a major pathologic response (MPR; 10% or less viable tumor remaining). At the applicable data cutoffs, no disease recurrences had been reported. Manuscripts with longer-term follow-up from both studies are anticipated in the second half of 2026.<\/p>\n
\nRecent advanced-disease updates further reinforced the durability of BOT+BAL activity. At ESMO Gastrointestinal Cancers Congress 2026, follow-up from the fully enrolled 123-patient Phase 1b cohort in refractory MSS metastatic colorectal cancer without active liver metastases showed median overall survival of 21.2 months and three-year overall survival of 33%. At last follow-up, 17% of patients were alive and off all systemic cancer therapy. No new safety signals or treatment-related deaths were reported.<\/p>\n
\nDuring the quarter, durable BOT+BAL activity was also reported in checkpoint-refractory melanoma and post-immunotherapy hepatocellular carcinoma, further supporting the combination\u2019s activity across tumors that had resisted prior immunotherapy or multiple lines of treatment.<\/p>\n
Expanding Patient Access and Supporting Treatment Continuity<\/b><\/p>\n
\nAgenus broadened authorized access to BOT+BAL during the second quarter through France\u2019s national Autorisation d\u2019Acc\u00e8s Compassionnel (AAC) program and physician-led paid named-patient programs in additional countries.<\/p>\n
\nThe programs now span a broader network of countries, treating institutions and healthcare professionals. Agenus recognized $6.4 million in pre-commercial product revenue from authorized access programs during the second quarter, compared with $4.6 million in the first quarter of 2026.<\/p>\n
\nAs Agenus concentrates its development resources on ROBBIN, the access programs enable the company to continue supporting eligible patients with advanced disease, sustain engagement with experienced treating physicians and advance its neoadjuvant registrational strategy.<\/p>\n
\nAs part of prioritizing resources toward the ROBBIN trial, Agenus discontinued its planned future funding commitment to BATTMAN, the Phase 3 study sponsored by the Canadian Cancer Trials Group (CCTG) evaluating BOT+BAL in refractory MSS metastatic colorectal cancer. Agenus was one of the study\u2019s funding sources and supplied BOT+BAL, while CCTG sponsored and conducted the trial. Following Agenus\u2019s funding decision, CCTG formally terminated the study. The decision reflected financing and development priorities and was not driven by enrollment performance, efficacy or safety findings.<\/p>\n
\nAgenus remains committed to supporting continued BOT+BAL treatment for patients already enrolled in BATTMAN when medically appropriate and permitted under applicable requirements. In France, eligible patients may continue to access BOT+BAL through the established national AAC program. Agenus has also established physician-led compassionate-access pathways in Canada, Australia and New Zealand, the other countries in which BATTMAN had been planned to enroll patients. The pathways in Canada, Australia and New Zealand will remain open to new physician requests through December 31, 2026.<\/p>\n
Second Quarter 2026 Financial Results<\/b><\/p>\n
Revenue<\/b><\/p>\n
\nTotal revenue for the second quarter of 2026 was $34.5 million, compared with $25.7 million a year earlier. This included $6.4 million in pre-commercial BOT+BAL product revenue from authorized patient-access programs and $28.1 million in non-cash royalty revenue, up from $24.8 million. Non-cash royalty revenue relates to royalty interests Agenus previously monetized and does not provide cash to the company.<\/p>\n
\nTotal revenue for the first six months of 2026 was $68.3 million, compared with $49.8 million a year earlier, including $11.0 million in pre-commercial product revenue and $57.3 million in non-cash royalty revenue.<\/p>\n
![\"Logo\"](\"https:\/\/mms.businesswire.com\/media\/20260806376413\/en\/2688608\/3\/Color_Logo_Wh_Background-2026.jpg\"){kind=logo}
<\/td>\n<\/tr>\n