AGEN

EX-99.1

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EX-99.1

EX-99.1

FOR IMMEDIATE RELEASE

Agenus Reports Second Quarter 2026 Results and Advances Phase 3 ROBBIN Trial of BOT+BAL in Neoadjuvant MSS Colon Cancer • Previously announced oversubscribed $85 million private placement, with up to $255 million in potential proceeds from milestone-aligned warrants, supports ROBBIN execution

• ROBBIN 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

• Previously reported NEST and UNICORN findings provided the direct clinical rationale for ROBBIN; recent advanced-disease updates reinforce the durability of BOT+BAL activity

• BOT+BAL access programs expanded across additional countries and treating institutions, contributing $6.4 million in second-quarter pre-commercial product revenue

LEXINGTON, Mass. - [DATE] - Agenus Inc. (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.

As 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.,

The 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/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.

ROBBIN addresses an estimated 38,000 newly diagnosed patients annually in the United States and more than 200,000 worldwide. Agenus estimates that this population represents an annual addressable sales opportunity of more than $7 billion.

“The financing completed in July gives us a clear path to act on the clinical evidence supporting BOT+BAL in a large, underserved patient population,” said Garo H. Armen, Ph.D., Chairman and Chief Executive Officer of Agenus. “The 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’s development milestones, we are positioned to pursue that opportunity with focus and urgency.”

Previously Announced Financing Supports ROBBIN Execution The 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.

Based on the company’s 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.

Agenus 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.

Clinical Evidence Reinforces BOT+BAL’s Differentiated Profile Previously 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.

Among 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.

Recent 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 sho

EX-99.1

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EX-99.1

EX-99.1

EX 99.1

FOR IMMEDIATE RELEASE

Agenus Reports First Quarter 2026 Financial Results and Highlights BOT+BAL Execution Across Global Access and Phase 3 Development

• Authorized access interest continues to expand across regions

• Phase 3 BATTMAN trial commenced patient enrollment in April 2026, advancing BOT+BAL into pivotal evaluation

• Zydus collaboration closed in January, delivering strategic capital, strengthening Agenus’ balance sheet and securing dedicated U.S. biologics manufacturing capacity

• Agenus continues to align operating priorities around BOT+BAL, financial discipline and commercial readiness

• SEC concluded its investigation in May 2026 with no enforcement action recommended; Related putative securities class action dismissed in its entirety by the U.S. District Court for the District of Massachusetts in March 2026

LEXINGTON, Mass. - May 11, 2026 - Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today reported financial results for the first quarter ended March 31, 2026, and provided an operational update on botensilimab plus balstilimab (BOT+BAL), the Company’s lead clinical program and one of the most clinically advanced next-generation CTLA-4/PD-1 combinations in development.

The first quarter marked a transition from foundation-building to execution for BOT+BAL. Physician engagement through regulatory-authorized access pathways continued to broaden, the Phase 3 BATTMAN trial moved into active enrollment shortly after quarter-end, and the Zydus collaboration closed, delivering strategic capital and dedicated U.S. manufacturing capacity.

BOT+BAL is designed to activate both innate and adaptive immunity and extend immunotherapy benefit into tumors that have historically shown limited responsiveness to checkpoint inhibition.

“First quarter 2026 was a defining quarter for Agenus and for BOT and BAL," said Garo H. Armen, Ph.D., Chairman and Chief Executive Officer of Agenus. "We saw continued physician requests and engagement treating patients with BOT and BAL through regulatory-authorized access pathways. Additionally, we advanced the program into Phase 3 enrollment and closed a transformative collaboration with Zydus that secured both capital and U.S. manufacturing capacity. BOT+BAL’s maturing data, particularly the durability of survival outcomes in refractory MSS colorectal cancer, continue to underpin our regulatory submissions in the United States and Europe."

EX 99.1

Key Operational Highlights Agenus is concentrating resources on BOT+BAL across three priorities: supporting physician-initiated access through regulatory-authorized pathways where permitted, advancing the Phase 3 BATTMAN trial, and building the clinical, manufacturing and operational readiness needed for the next stage of development. Continued Physician Engagement Through Regulatory-Authorized Access Pathways In parallel with clinical development, Agenus continues to support BOT+BAL access through regulatory-authorized pathways in certain countries. These programs are physician-initiated, patient-specific and governed by local regulations. In France, BOT+BAL is available under the national Autorisation d’Accès Compassionnel framework for eligible patients, with reimbursed access across MSS metastatic colorectal cancer without active liver metastases, platinum-resistant or platinum-refractory ovarian cancer, and certain advanced soft-tissue sarcomas. Outside France, BOT+BAL may be available in select countries through paid named-patient programs, which may involve out-of-pocket payment and/or special insurance arrangements depending on local requirements and individual coverage decisions. In Q1 2026, paid named-patient activity broadened to additional countries in South and Central America and Europe, reflecting continued physician interest and the unmet need for new options while regulatory review pathways advance. In April 2026, Agenus named BAP Pharma as its global partner to support BOT+BAL access programs, including France’s AAC pathway and paid named-patient programs. BAP Pharma will support program requests, case coordination, regulatory navigation, distribution logistics and related payment processing, helping Agenus build a more consistent and scalable access infrastructure. Medical Affairs Infrastructure Expanded to Support Increasing Physician Requests Agenus also expanded Medical Affairs and early-access support capabilities to respond to increasing physician-initiated interest. These capabilities support scientific exchange, access request coordination, pharmacovigilance and structured collection of real-world safety and outcomes data where applicable. Phase 3 BATTMAN Trial Active and Enrolling The global Phase 3 BATTMAN trial commenced patient enrollment in April 2026 and is evaluating BOT+BAL versus best supportive care in patients with refractory, unresectable MSS/pMMR metastatic colorectal cancer, a setting where checkpoint inhibitor

8-K

0001098972false00010989722026-03-162026-03-16

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 16, 2026

AGENUS INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware

000-29089

06-1562417

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

3 Forbes Road

Lexington, Massachusetts

02421

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: 781 674-4400

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.01 par value per share

AGEN

The Nasdaq Stock Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition. On March 16, 2026, Agenus Inc. announced its financial results for the quarter and year ended December 31, 2025. In connection with the announcement, the Company issued a press release, which is being furnished as Exhibit 99.1 to this current report on Form 8-K.

The information set forth under Item 2.02 and in Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, except as expressly set forth by specific reference in such filing. Item 9.01 Financial Statements and Exhibits. (d) Exhibit The following exhibit is furnished herewith:

99.1 Press Release dated March 16, 2026

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date:

March 16, 2026

By:

/s/ Garo H. Armen

Garo H. Armen, Chairman and CEO