[8-K] AGENUS INC Reports Material Event
Rhea-AI Filing Summary
Agenus Inc. entered into a securities purchase agreement for a private placement expected to close on July 15, 2026. The company will issue and sell 23,035,227 shares of common stock (or equivalent pre-funded warrants), Series A warrants for 21,144,277 shares at an exercise price of $4.02, and Series B warrants for 33,797,214 shares at $5.03. The combined effective purchase price per share plus accompanying warrants is $3.69, providing approximately $85 million in upfront gross proceeds and up to an additional $255 million upon full warrant exercise, for total potential gross proceeds of up to $340 million.
The financing supports a strategic prioritization of the botensilimab and balstilimab (BOT+BAL) regimen for neoadjuvant treatment of microsatellite-stable colon cancer, including the planned 850-patient Phase 3 ROBBIN trial with event-free survival as the primary endpoint. Agenus plans to discontinue financial support for the BATTMAN Phase 3 metastatic study. Based on current plans, existing cash plus net proceeds are expected to fund operations into the third quarter of 2027 without warrant exercise and through year-end 2031 if all Series A and B warrants are fully exercised. The company also agreed to add two Commodore Capital–designated directors as part of expanding its board to nine members and entered into a registration rights agreement to register resale of the shares and warrant shares.
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8-K Event Classification
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 1.01 Entry into a Material Definitive Agreement.
On July 13, 2026, Agenus Inc. (the “Company”) entered into a Securities Purchase Agreement (the “Purchase Agreement”) for a private placement (the “Private Placement”) with certain institutional and other accredited investors (each, a “Purchaser” and collectively, the “Purchasers”). The closing of the Private Placement (the “Closing”) is expected to occur on July 15, 2026, subject to the satisfaction of customary closing conditions.
Under the terms of the Purchase Agreement, the Company has agreed to issue and sell (i) 23,035,227 shares (the “Shares”) of the Company’s common stock (the “Common Stock”) (or, in lieu thereof, pre-funded warrants (“Pre-Funded Warrants”) to purchase shares of Common Stock (“Pre-Funded Warrant Shares”), with an exercise price of $0.01 per share), (ii) accompanying Series A purchase warrants (“Series A Warrants”) to purchase 21,144,277 shares of common stock (“Series A Warrant Shares”), with an exercise price of $4.02 per share and (iii) accompanying Series B purchase warrants (“Series B Warrants”) to purchase 33,797,214 shares of common stock (“Series B Warrant Shares”), with an exercise price of $5.03 per share. The combined effective purchase price per Share (or Pre-Funded Warrant to purchase one share), and accompanying Series A Warrant to purchase approximately 0.91791 shares of Common Stock and Series B Warrant to purchase approximately 1.46720 shares of Common Stock, is $3.69 (less the exercise price of the Pre-Funded Warrant, if applicable), for expected aggregate gross proceeds of approximately $85 million, before deducting Private Placement expenses, with up to an additional $255 million in gross proceeds upon exercise of the Series A Warrants and Series B Warrants, assuming the exercise in full of such warrants.
Each Pre-Funded Warrant will be exercisable at any time after the date of issuance and will not expire until exercised in full.
Each Series A Warrant will be exercisable immediately and will expire upon the earlier of the fifth anniversary of the Closing and the date that is 30 days following the day that the Company publicly discloses (either by press release or Current Report on Form 8-K) that at least 60 patients have been dosed in the Phase 3 clinical trial of the Company’s botensilimab and balstilimab combination product candidate for the neoadjuvant treatment of colon cancer. In addition, at any time prior to the expiration date, a holder of a Series A Warrant may not transfer such warrant, in whole or in part, without simultaneously transferring to the same transferee (and such transferee accepting all of the rights and obligations in respect of and agreeing to be bound by) a corresponding pro rata portion of the Series B Warrant held by such holder. At the option of the holder, the Series A Warrant may be exercised for, in lieu of shares of Common Stock, pre-funded warrants to purchase shares of Common Stock.
Each Series B Warrant will be exercisable immediately and will expire upon the earliest of (i) the fifth anniversary of the Closing, (ii) the date that is 30 days following the day that the Company publicly discloses (either by press release or Current Report on Form 8-K) pathologic response data for at least 50 patients that were dosed in the Phase 3 clinical trial of the Company’s botensilimab and balstilimab combination product candidate for the neoadjuvant treatment of colon cancer and (iii) unless the holder thereof shall at such time have exercised in full the Series A Warrant held by such holder, 12:01 a.m. (New York City time) on the date immediately following the expiration date of the Series A Warrant. In addition, at any time prior to the expiration date of the Series A Warrant, a holder of a Series B Warrant may not transfer such warrant, in whole or in part, without simultaneously transferring to the same transferee (and such transferee accepting all of the rights and obligations in respect of and agreeing to be bound by) a corresponding pro rata portion of the Series A Warrant. At the option of the holder, the Series B Warrant may be exercised for, in lieu of shares of Common Stock, pre-funded warrants to purchase shares of Common Stock.
A holder of Pre-Funded Warrants, Series A Warrants or Series B Warrants may not exercise such applicable warrant if the holder, together with its affiliates, would beneficially own more than 4.99% or 9.99% of the number of Common Stock outstanding immediately after giving effect to such exercise. A holder of Pre-Funded Warrants, Series A Warrants or Series B Warrants may increase or decrease this percentage to a percentage not in excess of 19.99% by providing at least 61 days’ prior notice to the Company. In addition, the Series A Warrants and Series B Warrants also include certain rights upon “fundamental transactions” (as described in such warrants), including that, in connection with a fundamental transaction at which the stockholders of the Company receive as consideration solely cash and/or equity securities a person or entity that are not traded on a national securities exchange, or a
fundamental transaction that is a “Rule 13e-3 transaction” (as defined in Rule 13e-3 under the Securities Exchange Act of 1934, as amended), each such holder of a Series A Warrant or Series B Warrant may require, at its option, the Company or a successor entity to purchase such warrant from such holder by paying such holder an amount in cash equal to the Black Scholes value (as described in such warrant) of the unexercised portion of such warrant on the date of the consummation of such fundamental transaction.
The Purchase Agreement contains customary representations and warranties of the Company, on the one hand, and the Purchasers, on the other hand, and customary conditions to closing. In addition, pursuant to the terms of the Purchase Agreement, the Company has also agreed to increase the size of its board of directors to nine directors (provided that, on or prior to December 31, 2027, the Company shall use its reasonable best efforts to cause the authorized number of directors to be reduced to eight), including two newly created Class III directorships under the Company’s certificate of incorporation, and, promptly following a designation notice made by Commodore Capital Master LP, cause two individuals designated by Commodore Capital Master LP to be appointed to serve as directors in the newly created Class III directorships. The Company has further agreed to take all action necessary and within its control to ensure that such designees continue to serve as directors at any time that Commodore Capital Master LP, together with its affiliates, beneficially owns at least 5% of the Company’s outstanding common stock, without giving effect to the beneficial ownership limitation provisions of any Pre-Funded Warrants held by such holders.
In addition, pursuant to the terms of the Purchase Agreement, the Company has further agreed that it shall not use the net proceeds of the Private Placement for business development purposes, for the redemption, repurchase, or other acquisition for value of any equity securities of the Company, or for the voluntary repayment, prepayment, redemption, or defeasance of any indebtedness for borrowed money of the Company prior to its stated maturity or scheduled due date.
Based on the Company’s current plans, the Company believes its existing cash and cash equivalents, together with the net proceeds from the Private Placement, will be sufficient to fund its operations and capital expenditure requirements into the third quarter of 2027 (assuming no exercise of the Series A Warrants or Series B Warrants) and through year-end 2031 (assuming the exercise in full of all Series A Warrants and Series B Warrants).
Also on July 13, 2026, the Company entered into a Registration Rights Agreement (the “Registration Rights Agreement”) with the Purchasers, which provides that the Company will register the resale of the Common Stock, the Pre-Funded Warrant Shares, Series A Warrant Shares and Series B Warrant Shares. The Company is required to prepare and file a registration statement with the Securities and Exchange Commission no later than 45 days after the date of the Closing, and to use its reasonable best efforts to have the registration statement declared effective by 90 days after the Closing, subject to certain exceptions.
The Company has also agreed to, among other things, indemnify the Purchasers, their officers, directors, agents, partners, members, managers, stockholders, affiliates, investment advisers and employees under the registration statement from certain liabilities and pay all fees and expenses (excluding any legal fees of the selling holder(s), and any underwriting discounts and selling commissions) incident to the Company’s obligations under the Registration Rights Agreement.
The securities issued and sold to the Purchasers under the Purchase Agreement will not be registered under the Securities Act of 1933, as amended (the “Securities Act”), in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act, or under any state securities laws. The Company relied on this exemption from registration based in part on representations made by the Purchasers. The securities may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. Neither this Current Report on Form 8-K (this “Form 8-K”), nor the exhibits attached hereto, is an offer to sell or the solicitation of an offer to buy the securities described herein.
The foregoing summary of the Purchase Agreement, the Registration Rights Agreement, the Pre-Funded Warrants, the Series A Warrants and the Series B Warrants does not purport to be complete and is qualified in its entirety by reference to the Purchase Agreement, the Registration Rights Agreement, the form of Pre-Funded Warrant, the form of Series A Warrant and the form of Series B Warrants, copies of which are filed as Exhibits 10.1, 10.2, 4.1, 4.2 and 4.3 to this Form 8-K, respectively, and are incorporated by reference herein.
Item 3.02 Unregistered Sales of Equity Securities.
The information contained in Item 1.01 of this Form 8-K is incorporated by reference into this Item 3.02.
Item 7.01 Regulation FD Disclosure.
On July 13, 2026, the Company made available a press release announcing the Private Placement and certain corporate updates. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K. On July 13, 2026, the Company made available on its website, www.agenusbio.com, a presentation to be used in meetings with investors in July 2026. A copy of the presentation is furnished as Exhibit 99.2 to this Form 8-K.
The information in Item 7.01 of this Form 8-K, including the information in the press release attached as Exhibit 99.1 to this Form 8-K and in the presentation attached as Exhibit 99.2 to this Form 8-K, is furnished pursuant to Item 7.01 of Form 8-K and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. Furthermore, the information in Item 7.01 of this Form 8-K, including the information in the press release attached as Exhibit 99.1 to this Form 8-K and in the presentation attached as Exhibit 99.2 to this Form 8-K, shall not be deemed to be incorporated by reference in the filings of the Company under the Securities Act.
Item 8.01 Other Events.
On July 13, 2026, in connection with the Private Placement, the Company also announced that it will conduct, and the net proceeds of the Private Placement are expected to support, a strategic prioritization of botensilimab and balstilimab (“BOT+BAL”) for the neoadjuvant treatment of microsatellite-stable (“MSS”) colon cancer, including the advancement of ROBBIN, the Company’s planned registrational Phase 3 neoadjuvant trial in MSS colon cancer. High-risk Stage II and Stage III MSS colon cancer affects an estimated 38,000 patients annually in the United States and more than 200,000 patients worldwide, representing an estimated U.S. addressable market of more than $7 billion, with no new curative-intent therapies approved in more than 20 years.
The ROBBIN clinical trial is a planned randomized global Phase 3 trial evaluating neoadjuvant BOT+BAL followed by standard of care versus standard of care alone in previously untreated high-risk Stage II and Stage III MSS colon cancer. The ROBBIN trial will enroll 850 patients, randomized 1:1, with event free survival (“EFS”) as its primary endpoint. Following interactions with the U.S. Food and Drug Administration (“FDA”), the Company has aligned on key elements of the Phase 3 trial design, including the patient population, experimental regimen, control arm, primary endpoint, and interim analysis plan.
Across NEST and UNICORN, the Company’s two independent Phase 2 studies evaluating neoadjuvant BOT+BAL in MSS colorectal cancer (“CRC”), the combination treatment has produced deep, durable responses, including pathologic response in approximately 60-70% of patients, major pathologic response (“MPR”) in approximately 35-40% of patients and pathologic complete response (“pCR”) in approximately 30% of patients. Deep pathologic responses (MPR and pCR) in the neoadjuvant setting are positively correlated with event-free survival in many tumor types, including MSS colon cancer. With median follow-up of approximately 9 to 18 months, all treated patients remained disease free. This treatment effect has continued to be observed in further results from NEST and UNICORN, and further details are anticipated to be published later this year. Together with observed circulating tumor DNA (“ctDNA”) clearance during treatment, these data support the Company’s rationale for prioritizing neoadjuvant BOT+BAL development in the registrational ROBBIN trial.
In connection with its strategic prioritization of neoadjuvant BOT+BAL in MSS colon cancer, the Company plans to discontinue financial support for the ongoing BATTMAN Phase 3 study in late-line metastatic MSS CRC. The Company expects to honor its obligations to patients currently receiving treatment and will work closely with the Canadian Cancer Trials Group and participating investigators to manage this transition responsibly.
The Company currently anticipates the following milestones with respect to the ROBBIN trial:
| • | The first patient dosed is anticipated to occur in the first quarter of 2027. |
| • | The announcement of interim pathologic response data is anticipated to occur in the second half of 2027. |
| • | The announcement of the interim analysis of EFS is anticipated to occur in the second half of 2029. |
| • | The announcement of the final analysis of EFS is anticipated to occur in the second half of 2030. |
Forward-Looking Statements
Certain statements in this Form 8-K, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the “safe harbor” provisions under the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to the Company’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business; the Company’s strategic prioritization of BOT+BAL for the neoadjuvant treatment of MSS colon cancer; the potential benefits of treatment with the Company’s product candidates, including without limitation BOT+BAL and the Company’s other balstilimab and botensilimab, zalifrelimab, AGEN1777, AGEN2373 and AGEN1571 programs; the timing of the regulatory submission, design, enrollment, indication selection, dosing, timing of initiation, progress and timing of readouts and results of the Company’s ongoing and planned clinical trials, including without limitation the Company’s Phase 2 NEST and UNICORN trials and the Company’s planned Phase 3 ROBBIN trial; anticipated safety, efficacy, potency, activity, superior response and durability outcomes with respect to the Company’s ongoing and planned clinical trials; the Company’s plans to discontinue financial support for the ongoing BATTMAN Phase 3 trial; expected regulatory timelines and filings; the Company’s commercialization plans and anticipated commercial market opportunities (including partnering and licensing opportunities); the Company’s ability to meet manufacturing demands; the closing of the Private Placement; the Company’s agreement to register the resale of the securities sold in the Private Placement; the expected amount of proceeds from the Private Placement; and the Company’s anticipated cash runway. The words “may,” “believes,” “expects,” “anticipates,” “hopes,” “intends,” “plans,” “forecasts,” “estimates,” “will,” “establish,” “potential,” “superiority,” “best in class.” These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2025, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. The Company cautions investors not to place considerable reliance on the forward-looking statements contained in this Form 8-K. These statements speak only as of the date of this Form 8-K, and the Company undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. This Form 8-K does not purport to summarize all of the conditions, risks and other attributes of an investment in the Company.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. |
Description | |
| 4.1 | Form of Pre-Funded Warrant. | |
| 4.2 | Form of Series A Warrant. | |
| 4.3 | Form of Series B Warrant. | |
| 10.1† | Form of Securities Purchase Agreement, dated July 13, 2026, by and between Agenus Inc. and each purchaser thereto. | |
| 10.2 | Form of Registration Rights Agreement, dated July 13, 2026, by and between Agenus Inc. and the other parties thereto. | |
| 99.1 | Press Release, dated July 13, 2026. | |
| 99.2 | Investor Presentation, dated July 13, 2026. | |
| 104 | The cover page from the Company’s Current Report on Form 8-K formatted in Inline XBRL. | |
| † | Exhibits and/or schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant hereby undertakes to furnish supplementally copies of any of the omitted exhibits and schedules upon request by the Securities and Exchange Commission; provided, however, that the registrant may request confidential treatment pursuant to Rule 24b-2 under the Exchange Act for any exhibits or schedules so furnished. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| AGENUS INC. | ||||||
| Date: July 13, 2026 | By: | /s/ Garo H. Armen | ||||
| Name: | Garo H. Armen | |||||
| Title: | Chief Executive Officer | |||||
Exhibit 99.1
FOR IMMEDIATE RELEASE
Agenus Announces Oversubscribed Private Placement of Up to $340 Million to Advance Registrational ROBBIN Trial of Neoadjuvant BOT+BAL in MSS Colon Cancer
| • | $85M upfront financing, along with up to $255 million upon exercise of purchase warrants, is expected to fund ROBBIN1, Agenus’ registrational Phase 3 trial of neoadjuvant botensilimab and balstilimab (BOT+BAL) in microsatellite-stable (MSS) colon cancer |
| • | Transaction is structured to fund Agenus through key value-inflection points, including interim topline pathologic response data and interim and final event-free survival (EFS) analyses, with proceeds to fund Agenus operations through year-end 2031, assuming full warrant exercise |
| • | ROBBIN target population in MSS colon cancer represents a >$7 billion addressable annual sales opportunity in the US for which no new therapies have been approved in over 20 years2,3 |
| • | To focus resources on the neoadjuvant opportunity, Agenus is discontinuing financial support for the ongoing BATTMAN Phase 3 study in late-line metastatic MSS colorectal cancer |
| • | Company to host conference call and webcast today at 8:30 a.m. ET |
LEXINGTON, Mass. July 13, 2026. Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced that it has entered into a securities purchase agreement for a private placement of approximately $85 million in upfront gross proceeds, before the deduction of private placement expenses, and up to an additional $255 million upon the full exercise of purchase warrants. The financing was led by Commodore Capital, with participation from RA Capital Management, TCGX, Invus, and Ligand Pharmaceuticals.
The net proceeds of this financing are expected to support Agenus’ strategic prioritization of botensilimab and balstilimab (BOT+BAL) for the neoadjuvant treatment of microsatellite-stable (MSS) colon cancer, including advancement of ROBBIN1, the Company’s planned registrational Phase 3 neoadjuvant trial in microsatellite-stable (MSS) colon cancer. High-risk Stage II and Stage III MSS colon cancer affect an estimated 38,000 patients annually in the US and more than 200,000 patients worldwide,2 representing an estimated US addressable annual sales opportunity of more than $7 billion, with no new curative-intent therapies approved in more than 20 years.3
As described below, under the terms of the private placement, the Company will issue shares of its common stock (or, in lieu thereof, pre-funded warrants to purchase common stock) for approximately $85 million in upfront gross proceeds, before the deduction of private placement expenses, and an accompanying “Series A” purchase warrant and “Series B” purchase warrant that, if fully exercised, would provide an additional $255 million in gross proceeds, for a combined total of up to $340 million in gross proceeds. Assuming the exercise in full of the warrants, Agenus expects the financing to fund completion of ROBBIN, with runway through year-end 2031. The private placement is expected to close on or about July 15, 2026, subject to customary closing conditions. The upfront purchase price per share, along with the exercise prices for the Series A and Series B warrants, were all priced at a premium to the market closing price per share as of Friday, July 10th, 2026.
Agenus’ Strategic Prioritization of Neoadjuvant BOT+BAL
Across NEST and UNICORN, two independent Phase 2 studies evaluating neoadjuvant BOT+BAL in MSS colorectal cancer (CRC), BOT+BAL has produced deep, durable responses, including pathologic response (PR) in approximately 60-70% of patients, major pathologic response (MPR) in approximately 35-40% of patients and pathologic complete response (pCR) in approximately 30% of patients. Deep pathologic responses (MPR and pCR) in the neoadjuvant setting are positively correlated with event-free survival in many tumor types, including MSS colon cancer.4 With median follow-up of approximately 9 to 18 months, all treated patients remained disease free. This treatment effect has persisted in updates from NEST and UNICORN, and further details are anticipated to be published later this year. Together with observed circulating tumor DNA (ctDNA) clearance during treatment, these data support Agenus’ rationale for prioritizing neoadjuvant BOT+BAL development in the registrational ROBBIN study.5,6
ROBBIN is Agenus’ planned randomized global Phase 3 trial evaluating neoadjuvant BOT+BAL followed by standard of care versus standard of care alone in previously untreated high-risk Stage II and Stage III MSS colon cancer. The ROBBIN trial will enroll 850 patients, randomized 1:1, with event free survival (EFS) as its primary endpoint. Following interactions with the US Food and Drug Administration (FDA), Agenus has aligned with the FDA on key elements of the Phase 3 design, including the patient population, experimental regimen, control arm, primary endpoint, and interim analysis plan.
“We have seen neoadjuvant and perioperative immunotherapy improve outcomes in immunologically ‘hot’ or ‘warm’ tumors such as melanoma and lung cancer, but MSS colon cancer — a ‘cold’ tumor — has resisted standard checkpoint inhibitors. BOT was engineered to overcome that resistance and has produced deep pathologic responses with no recurrences reported in the NEST and UNICORN studies. With the ROBBIN trial, we are bringing this regimen to patients with high-risk Stage II and Stage III MSS colon cancer, where treating an intact tumor gives BOT+BAL its greatest opportunity to generate a durable immune response and improve long-term outcomes,” said Dr. Steven O’Day, Chief Medical Officer of Agenus.
In connection with its strategic prioritization of neoadjuvant BOT+BAL in MSS colon cancer, Agenus plans to discontinue financial support for the ongoing BATTMAN Phase 3 study in late-line metastatic MSS CRC. Agenus will honor its obligations to patients currently receiving treatment and will work closely with the Canadian Cancer Trials Group (CCTG) and participating investigators to manage this transition responsibly. The Company remains deeply grateful to the clinicians, site teams, CCTG, and patients who have contributed to advancing BOT+BAL in late-stage disease.
“Since Agenus was founded 32 years ago, our mission has been to harness the immune system to improve outcomes and, where possible, cure cancer,” said Garo H. Armen, Ph.D., Founder, Chairman and Chief Executive Officer of Agenus. “Our plan to prioritize neoadjuvant BOT+BAL in MSS colon cancer reflects both the strength of the emerging clinical evidence and the opportunity to bring this important combination regimen to patients where it may have the greatest impact. With ROBBIN, we are advancing a randomized global trial designed to confirm the rapid and deep activity observed across the NEST and UNICORN trials.”
Upcoming ROBBIN catalysts include the following:
| • | First patient dosed: anticipated in Q1 of 2027 |
| • | Interim pathologic response data: anticipated in second half of 2027 |
| • | Interim analysis of EFS: anticipated in second half of 2029 |
| • | Final analysis of EFS: anticipated in second half of 2030 |
Conference Call and Webcast
Agenus will host a conference call and live webcast today at 8:30am ET to discuss the financing and ROBBIN trial strategy. The call will feature Myriam Chalabi, M.D., Ph.D., of the Netherlands Cancer Institute, a leading investigator in neoadjuvant immunotherapy for colorectal cancer, and Pashtoon Kasi, M.D., M.S. of City of Hope Hospital, who will provide independent clinical perspectives on the program.
To access the live webcast, please https://bit.ly/3TfulyN | Passcode: 460308
Participants may also join by dialing (309) 205-3325 and using Webinar ID: 973 3388 7478. A replay of the webcast will be available on the Agenus website at https://investor.agenusbio.com/events-and-presentations following the event.
Up To $340 Million Private Placement
Under the terms of the securities purchase agreement announced today, the Company has agreed to issue and sell (i) 23,035,227 shares of the Company’s common stock (or, in lieu thereof, pre-funded warrants to purchase shares of common stock, with an exercise price of $0.01 per share), (ii) accompanying Series A purchase warrants to purchase 21,144,277 shares of common stock, with an exercise price of $4.02 per share and (iii) accompanying Series B purchase warrants to purchase 33,797,214 shares of common stock, with an exercise price of $5.03 per share. The combined effective purchase price per share (or pre-funded warrant to purchase one share) and accompanying Series A purchase warrant to purchase approximately 0.91791 shares of common stock and Series B purchase warrant to purchase approximately 1.46720 shares of common stock, is $3.69 (less the exercise price of the pre-funded warrant, if applicable).
Each pre-funded warrant will be exercisable immediately and will not expire until exercised in full. Each pre-funded warrant will contain customary beneficial ownership limitation provisions.
Each Series A purchase warrant will be exercisable immediately and will expire upon the earlier of the fifth anniversary of the private placement closing date and the date that is 30 days following the day that the Company publicly discloses (either by press release or Current Report of Form 8-K) that at least 60 patients have been dosed in the Phase 3 clinical trial of the Company’s BOT+BAL combination product candidate for the neoadjuvant treatment of colon cancer (the “ROBBIN” trial). Each Series B purchase warrant will be exercisable immediately and will expire upon the earliest of (i) the fifth anniversary of the private placement closing date, (ii) the date that is 30 days following the day that the Company publicly discloses (either by press release or Current Report of Form 8-K) pathologic response data for at least 50 patients that were dosed with BOT+BAL in the Phase 3 clinical trial of the Company’s BOT+BAL combination product candidate for the neoadjuvant treatment of colon cancer (the “ROBBIN” trial) and (iii) unless the holder thereof shall at such time have exercised in full the Series A purchase warrant held by such holder, 12:01 a.m. (New York City time) on the date immediately following the expiration date of the Series A purchase warrant
Pursuant to the terms of the securities purchase agreement, the Company has also agreed to increase the size of its board of directors to nine directors, including two newly created Class III directorships under the Company’s certificate of incorporation, and, promptly following a designation notice made by Commodore Capital Master LP, cause two individuals designated by Commodore Capital Master LP to be appointed to serve as directors in the newly created Class III directorships.
The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws, and will be sold in a private placement pursuant to Regulation D of the Securities Act. The securities being issued in the private placement may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. Concurrently with the execution of the securities purchase agreement, the Company and the investors also entered into a registration rights agreement pursuant to which the Company has agreed to register the resale of the shares of common stock sold in the private placement and the shares of common stock issuable upon exercise of the pre-funded warrants, the Series A purchase warrants and the Series B purchase warrants sold in the private placement.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy the foregoing securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About Agenus
Agenus is a leading immuno-oncology company targeting cancer with immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches. Agenus’ headquarters are in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels.
About Botensilimab (BOT)
Botensilimab (BOT) is a human Fc enhanced multifunctional anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. BOT augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.
Approximately 1,300 patients have been treated with BOT and/or BAL in phase 1 and phase 2 clinical trials. BOT alone, or in combination with Agenus’ investigational PD-1 antibody, BAL, has shown clinical responses across nine metastatic, late-line cancers. For more information about BOT trials, visit www.clinicaltrials.gov.
About Balstilimab (BAL)
Balstilimab (BAL) is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types.
About the ROBBIN Phase 3 RCT
ROBBIN is Agenus’ planned randomized global Phase 3 trial evaluating BOT+BAL in high-risk Stage II/III MSS/pMMR colon cancer. The trial is designed to assess whether a short-course neoadjuvant BOT+BAL regimen administered before surgery can generate deep pathologic and molecular responses and improve longer-term clinical outcomes, including event-free survival.
The proposed ROBBIN design includes neoadjuvant BOT+BAL followed by surgery and guideline-directed adjuvant chemotherapy or observation based on pathologic staging, compared with the current standard of care of surgery followed by guideline-directed adjuvant chemotherapy or observation. The primary endpoint is event-free survival. Key secondary and exploratory endpoints are expected to include overall survival, circulating tumor DNA negativity, quality of life, safety, pathologic response, and other measures.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws. These forward-looking statements include, but are not limited to, express or implied statements relating to the Company’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business; the Company’s strategic prioritization of BOT+BAL for the neoadjuvant treatment of MSS colon cancer; the potential benefits of treatment with the Company’s product candidates, including without limitation BOT+BAL and the Company’s other balstilimab, botensilimab, zalifrelimab, AGEN1777, AGEN2373 and AGEN1571 programs; the timing of the regulatory submission, design, enrollment, indication selection, dosing, timing of initiation, progress and timing of readouts and results of the Company’s ongoing and planned clinical trials, including without limitation the Company’s Phase 2 NEST and UNICORN trials and the Company’s planned Phase 3 ROBBIN trial; anticipated safety, efficacy, potency, activity, superior response and durability outcomes with respect to the Company’s ongoing and planned clinical trials; the Company’s plans to discontinue financial support for the ongoing BATTMAN Phase 3 trial; expected regulatory timelines and filings; the Company’s commercialization plans and anticipated commercial market opportunities (including partnering and licensing opportunities); the Company’s ability to meet manufacturing demands; the closing of the Private Placement; the Company’s agreement to register the resale of the securities sold in the Private Placement; the expected amount of proceeds from the Private Placement; and the Company’s anticipated cash runway. The words “may,” “believes,” “expects,” “anticipates,” “hopes,” “intends,” “plans,” “forecasts,” “estimates,” “will,” “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2025, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
Investors 917-362-1370 | investor@agenusbio.com
Media 781-674-4422 | communications@agenusbio.com
References
| 1. | ROBBIN: A Phase 3 Randomized, Open-Label Study of Botensilimab Plus Balstilimab In the Neoadjuvant Setting followed by Standard of Care Versus Standard of Care Alone in Previously Untreated High-Risk Stage II and Stage III Non–MSI-H/dMMR Colon Cancer (ROBBIN Study) |
| 2. | Epidemiology analysis based on data from SEER, CDC, and Clarivate |
| 3. | André T, Boni C, Mounedji-Boudiaf L, et al. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med. 2004;350(23):2343-2351. |
| 4. | Morton D, Seymour M, Magill L, et al. Preoperative chemotherapy for operable colon cancer. J Clin Oncol. 2023;41(8):1541-1552. |
| 5. | Hissong E, et al. Neoadjuvant Botensilimab (BOT) Plus Balstilimab (BAL) in Resectable Mismatch Repair Proficient (pMMR) and Deficient (dMMR) Colorectal Cancer (CRC). Poster presented at the ASCO Gastrointestinal Cancers Symposium. January 23-25, 2025. San Francisco, CA. Abstract #207 |
| 6. | Ghelardi F, et al. Neoadjuvant botensilimab and balstilimab in colorectal cancer. Poster presented at the ASCO Gastrointestinal Cancers Symposium. January 23-25, 2025. San Francisco, CA. Poster F20 |
Exhibit 99.2 Neoadjuvant BOT+BAL in MSS Colon Cancer Agenus PIPE Financing Announcement July 13, 2026
Agenus Speakers Garo H. Armen, PhD Robin Taylor, PhD Steven O’Day, MD Zack Armen Founder, Chairman & CEO Chief Commercial Officer Chief Medical Officer VP, Corporate Dev & IR 2
Industry Thought Leaders Professor Myriam Chalabi, MD Pashtoon Kasi, MD, MS Medical Oncologist Medical Oncologist Netherlands Cancer Institute, Amsterdam NL Rad Family Chair in Gastrointestinal Oncology 2026 Innovators in Science Award City of Hope, Irvine CA 3
Forward-Looking Statements This presentation contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws. These forward- looking statements include, but are not limited to, express or implied statements relating to the Company’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business; the Company’s strategic prioritization of BOT+BAL for the neoadjuvant treatment of MSS colon cancer; the potential benefits of treatment with the Company’s product candidates, including without limitation BOT+BAL and the Company’s other balstilimab, botensilimab, zalifrelimab, AGEN1777, AGEN2373 and AGEN1571 programs; the timing of the regulatory submission, design, enrollment, indication selection, dosing, timing of initiation, progress and timing of readouts and results of the Company’s ongoing and planned clinical trials, including without limitation the Company’s Phase 2 NEST and UNICORN trials and the Company’s planned Phase 3 ROBBIN trial; anticipated safety, efficacy, potency, activity, superior response and durability outcomes with respect to the Company’s ongoing and planned clinical trials; the Company’s plans to discontinue financial support for the ongoing BATTMAN Phase 3 trial; expected regulatory timelines and filings; the Company’s commercialization plans and anticipated commercial market opportunities (including partnering and licensing opportunities); the Company’s ability to meet manufacturing demands; the closing of the Private Placement; the Company’s agreement to register the resale of the securities sold in the Private Placement; the expected amount of proceeds from the Private Placement; and the Company’s anticipated cash runway. Statements containing the words may, believes, expects, anticipates, hopes, intends, plans, will, “potential,” or the negative of these terms and other similar words or expressions, are intended to identify forward-looking statements, although not all forward- looking statements contain these identifying words. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in any forward-looking statement. These risks and uncertainties include, among others, the factors described under the Risk Factors section of Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and our subsequent Quarterly Reports on Form 10- Q filed with the Securities and Exchange Commission and made available on our website at www.agenusbio.com. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this presentation. Agenus makes no express or implied representation or warranty as to the completeness of forward-looking statements or, in the case of projections, as to their attainability or the accuracy and completeness of the assumptions from which they are derived. These statements speak only as of the date of this presentation, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Information that may be important to investors will be routinely posted on our website and social media channels. 4
Welcome Garo Armen, Ph.D. Founder, Chairman & CEO 5
Fully Funded, FDA-aligned Phase 3 Trial Testing Neoadjuvant BOT+BAL in MSS Colon Cancer, a Multi Billion-Dollar Opportunity in the US • Financing of $85M upfront and up to $340M in total, focused on BOT+BAL opportunity in high-risk Stage II 1 and Stage III MSS Colon Cancer, >$7 Billion TAM in the US • Capital will be directed to an FDA-aligned pivotal Phase 3 study (“ROBBIN”) of neoadjuvant BOT+BAL for MSS Colon Cancer (n=850, Randomized 1:1, Primary Endpoint EFS) • To focus company resources, Agenus is discontinuing support for the ongoing BATTMAN Phase 3 study • Key upcoming catalysts for ROBBIN Phase 3 Trial (Neoadjuvant BOT+BAL): • ROBBIN first patient dosed: anticipated Q1 of 2027 • Interim pathologic response data: anticipated second half of 2027 • Interim analysis of EFS: anticipated second half of 2029 • Final analysis of EFS: anticipated second half of 2030 1. Epidemiology analysis based on data from SEER, CDC, and Clarivate; assumes 38,000 eligible patient population annually * $200K for a course of neoadjuvant treatment. 6
Full PIPE Funding Expected to Cover 100% of ROBBIN Costs and All Ongoing Agenus OpEx Through EOY 2031; Transaction Structure Aligns with Key Value Inflections across ROBBIN Trial Share Price / New Shares Proceeds Anticipated Funds Agenus Funding Tranche Exercise Issued Value Inflection Point ($M) Timing through Price (Millions) Upfront $85M $3.69 23.1 ROBBIN Initiation, Regulatory Alignment Closing Q3 2027 (July 15, 2026) th Series A Warrants $85M $4.02 21.1 60 Patient Dosed in ROBBIN Q2 2027 Q1 2029 1 Series B Warrants $170M $5.03 33.8 ROBBIN Pathologic Response Rate Topline Data 2H 2027 Q4 2031 (first 50 patients treated with BOT+BAL) TOTAL $4.36 78.0 th Note: 42,680,014 Shares Outstanding as of July 10 , 2026 (pre-transaction close) 1. Assuming full approval based on projected EFS boundary crossing at the Final Analysis (80% power with 0.65 Hazard Ratio); if EFS boundary is crossed at the Interim Analysis (projected 2H 2029) then we 7 could file for full approval one year prior (1H 2030)
Colorectal Cancer (CRC) Faces Two Urgent Challenges: Rising Burden of Disease and Limited Innovation – Especially in Microsatellite Stable (MSS) Disease Most CRC lacks effective 1 Rising CRC Burden 2 immunotherapy options • Colorectal cancer (CRC) is now the • Microsatellite stable (MSS) accounts 5,6 leading cause of cancer-related death for ~85% of early-stage CRC cases 1 among Americans under 50 • No major advances in treatment of 2 6 • ~155,000 new cases annually in U.S. MSS colon cancer in >20 years 3 • ~2M new cases annually worldwide • MSS CRC remains unaddressed by 6 first-generation ICI 1. Siegel RL, et al. JAMA. 2026;335(7):632-634. 2. Siegel RL, et al. CA Cancer J Clin. 2025;75(1):10-45. 3. Bray F, et al. CA Cancer J Clin. 2024;74(3):229-263. 4. National Cancer Institute. SEER Cancer Stat Facts: 8 Colorectal Cancer. Bethesda, MD: National Cancer Institute. Available at: https://seer.cancer.gov/statfacts/html/colorect.html. 5. Buchler T. Front Oncol. 2022;12:888181. 6. Guven DC, et al. Oncologist. 2024;29(5):e580-e600.
Novel Immunotherapy Example of 100% tumor regression from Approach with BOT+BAL Neoadjuvant BOT+BAL in MSS Colon Cancer After 1 dose of BOT + 2 doses of BAL with no concurrent nor prior therapy; 1 from NEST Phase 2 trial ▪ Chemotherapy-free option ▪ Manageable safety profile ▪ Organ-sparing potential 7 weeks ▪ Safety and efficacy data from over 1,300 patients in metastatic and locally-advanced settings 9 Single-patient images; images shared with patient consent. 1. Kasi P, et al. Oral presentation at the ESMO GI Congress. Munich, Germany. 2024. Presentation #743. CONFIDENTIAL
Rationale for Strategic Pivot From Metastatic CRC to Neoadjuvant MSS Colon Cancer FROM TO Late-line, refractory metastatic CRC High-risk Stage II & Stage III MSS colon cancer BOT provides a significant benefit, but in a smaller and more No advances in treatment of this patient population in over 20 years competitive indication. since the approval of oxaliplatin. Why Now 1 2 3 4 Deeper Patient Benefit & Unprecedented Large Market with No Regulatory Alignment, Improved Potential Neoadjuvant Responses Immunotherapy Options Financing to Approval Economics with BOT+BAL with BOT+BAL High risk-stage II & Stage III MSS Improving outcomes in the ROBBIN Phase 3 trial design 52 patients in CRC treated with colon cancer has ~38,000 treated curative-intent population supports aligned with FDA feedback; BOT+BAL show deep pathologic 1 patients annually in the US strong pharmacoeconomic position responses, continued ctDNA $340M funds company through for BOT pricing clearance, and no reported projected full approval in recurrences support high likelihood neoadjuvant MSS colon cancer of success in the ROBBIN trial 1. Epidemiology analysis based on data from SEER, CDC, and Clarivate 10
Pathologic Complete Response Rates (pCR) Correlate with EFS: pCR Rates with BOT+BAL in NEST & UNICORN Provide a Strong Signal for Success in ROBBIN pCR Rate Projected EFS METHODOLOGY: Expected pCR rate in Control arm for ROBBIN = 0% Delta Hazard Ratio • 21 neoadjuvant/perioperative trials evaluated using based on FOxTROT, NeoCol, and OPTICAL control arms 1 linear regression analysis 0.0% 0.84 • Objective: To examine the relationship between pCR 2 rate delta and EFS hazard ratio (HR) across solid tumors 5.0% 0.78 10.0% 0.73 RESULTS: • Regression shows that magnitude of pCR rate predicts 15.0% 0.67 A pCR rate of ~17% correlates with a ~0.65 Hazard EFS HR. Ratio (target HR for ROBBIN trial) 20.0% 0.61 pCR Rate Delta vs EFS HR 25.0% 0.55 30.0% 0.49 If interim readout of pCR rate in ROBBIN reaches the same level as observed in NEST and UNICORN 35.0% 0.43 (~30%), this would predict a HR of ~0.50 40.0% 0.38 45.0% 0.32 50.0% 0.26 pCR Rate Delta 1. Analysis based on 21 neoadjuvant trials with paired pCR/MPR and EFS or DFS data: Checkmate-816, KEYNOTE-522, Checkmate-77T, KEYNOTE-671, AEGEAN, KEYNOTE-689, MATTERHORN, KEYNOTE-585, 11 NADIM3, GeparNuevo, SWOG S1801, NADINA, FoxTROT, OPTICAL, NeoCol, TORCH, RAPIDO, PRODIGE 23, STELLAR, PROSPECT, and CAO/ARO/AIO-12. 2. pCR rate delta defined as the difference in pathologic complete response rate between the Experimental and Control arms in each of the 21 analyzed neoadjuvant trials. Note some HRs are estimated based on study results. EFS HR
Significant Market Opportunity for BOT+BAL in Locally Advanced MSS Colon Cancer ~85,000 people are diagnosed with Stage I-III colon cancer in the US every year Exclude Stage I and • Stage I colon cancer is excluded from ROBBIN low-risk Stage II ; • 15-20% of Stage I and II Patients are MSI-H, and 8-12% of Stage III Exclude MSI-High patients are MSI-H (excluded from ROBBIN study) ~38,000 high-risk stage II + Stage III • Expected Target Product Profile with HR = 0.65: eligible • Short neoadjuvant treatment with low adverse event rate population • 3-year EFS improvement from 75% to 82% • Reduction in oxaliplatin-induced neuropathy Total US Addressable Market Opportunity for High-Risk Stage II/III MSS Colon Cancer: >$7 Billion* 1. Epidemiology analysis based on data from SEER, CDC, and Clarivate; assumes 38,000 eligible patient population annually * $200K for a course of neoadjuvant treatment. 12
Prior Neoadjuvant Studies in CRC: FOxTROT & NICHE Myriam Chalabi, MD Netherlands Cancer Institute, Amsterdam, NL 13
Current Treatment Landscape for Stage I to Stage III MSS Colon Cancer 1-4 Adjuvant Therapy Observation T1-2,N0 Observation or 6m 5FU/LV or Capecitabine T3,N0 Resectable Colon Surgery & 6m 5FU/LV or Capecitabine ROBBIN T4,N0 Eligible Cancer Pathologic Staging or FOLFOX/CAPEOX cT4a,N0 T3,N1 CAPEOX or FOLFOX or cT3,N+ 6m 5FU/LV or CT4, N+ Capecitabine T4,N1-2 1. André T, et al. J Clin Oncol. 2009;27(19):3109-3116. 2. Yothers G, et al. J Clin Oncol. 2011;29(28):3768-3774. 3. Schmoll HJ, et al. J Clin Oncol. 2015;33(32):3733-3740. 4. Grothey A, et al. N Engl J Med. 14 2018;378(13):1177-1188.
Precedent: FOxTROT Prior Neoadjuvant Chemotherapy Study for Stage II/III Colon Cancer • FOxTROT (N=1,053) established that the depth of pathologic regression is associated with improved recurrence rates 1 (notably no recurrences in patients with complete tumor regression in colon cancer) • However, the modest depth of regression achieved with neoadjuvant chemotherapy translated into only modest long- term benefit and was insufficient to change the global standard of care Pathologic Response Assessment Recurrence Rate by Pathologic Response 1. Morton D, et al. J Clin Oncol. 2023;41(8):1541-1552. 15
Precedent: NICHE pMMR/MSS Colon Cancer Cohort of Ipilimumab + Nivolumab Neoadjuvant Treatment • The NICHE study evaluated neoadjuvant ipilimumab + nivolumab ± celecoxib in 31 patients with MSS Colon Cancer 1 • 30 patients underwent surgery and were assessable for pathologic response • 10% of patients had a pCR (0% residual tumor), and 23% had a Pathologic Response (≤50% residual tumor) Recurrence over time for Pathologic Response Assessment Non-Responders (n=23) vs Responders (n=8) Responders Event-free survival at 3 years was 93%. No recurrences in patients who had a response (≥50% tumor regression) 1. Tan P. et al. Nature 2025;648:726-735. 16
NEST & UNICORN Phase 2 Studies of Neoadjuvant BOT + BAL Pashtoon Kasi, MD, MS City of Hope, Irvine, CA 17
Neoadjuvant CRC: BOT±BAL Evaluated Across Multiple Pre-Surgical Treatment Schedules 1 2 NEST (N=24) UNICORN (N=56) NEST 1 (~4 weeks to surgery) ~5 weeks to surgery BOT (75mg) BOT (75mg) BAL BAL Surgery Surgery 0 2 0 2 WEEKS WEEKS NEST 2 (~8 weeks to surgery) ~5 weeks to surgery BOT (75mg) BOT (75mg) BAL BAL BAL BAL BAL BAL Surgery Surgery 4 6 0 2 0 2 WEEKS WEEKS 1. Hissong E, et al. Neoadjuvant Botensilimab (BOT) Plus Balstilimab (BAL) in Resectable Mismatch Repair Proficient (pMMR) and Deficient (dMMR) Colorectal Cancer 18 (CRC). Poster presented at the ASCO Gastrointestinal Cancers Symposium. January 23-25, 2025. San Francisco, CA. Abstract #207 . 2. Ghelardi F, et al. Neoadjuvant botensilimab and balstilimab in colorectal cancer. Poster presented at the ASCO Gastrointestinal Cancers Symposium. January 23-25, 2025. San Francisco, CA. Poster F20
NEST Trial: Marked Tumor Reductions with 1 BOT Dose + 2-4 BAL Doses Stage II/III (Pre-Surgery and/or Chemo or “Neoadjuvant”) Patients Treated with BOT+BAL Topline Results MSI-H/ MSS/pMMR (“Cold”) (1 dose BOT + 2-4 doses BAL) dMMR a NEST-1 NEST-2 (“Hot”) ~4 weeks to surgery ~8 weeks to surgery MSS CRC (n=22 tumors) 0% 59% Pathologic Response b,2 -25% (Ipi+Nivo: 23%) Pathologic 41% Major Pathologic Response (≥50%) -50% b,2 (Ipi+Nivo: 20%) Major -75% 32% Complete Pathologic Response Pathologic b,2 (Ipi+Nivo: 10%) (≥90%) -100% Complete Pathologic (100%) MSI-H/dMMR CRC (n=4 tumors) 100% Major Pathologic Response No recurrences reported with BOT+BAL b,3 (Ipi+Nivo: 95%) (median follow-up 9–18 months) a b ClinicalTrials.gov Identifier: NCT05571293. Two patients in NEST-2 each had synchronous primary tumors (each tumor was analyzed separately for percent tumor regression). Cross-trial comparisons are descriptive; differences 19 in eligibility, assessments, and data cutoffs may confound comparisons. ; 1. Hissong E, et al. Neoadjuvant Botensilimab (BOT) Plus Balstilimab (BAL) in Resectable Mismatch Repair Proficient (pMMR) and Deficient (dMMR) Colorectal Cancer (CRC). Poster presented at the ASCO Gastrointestinal Cancers Symposium. January 23-25, 2025. San Francisco, CA. Abstract #207 . 2. Ghelardi F, et al. Neoadjuvant botensilimab and balstilimab in colorectal cancer. Poster presented at the ASCO Gastrointestinal Cancers Symposium. January 23-25, 2025. San Francisco, CA. Poster F20 . % Tumor Regression
UNICORN Trial: Consistent Demonstration of Benefit with BOT+BAL 56 Patients Treated with BOT Mono (n=28) and BOT+BAL Combo (n=28) ; Further Support for Contribution of Components MSS/pMMR (“Cold”) MSI-H/dMMR (“Hot”) BOT+BAL BOT+BAL BOT BOT 0% −25% Pathological Response (≥50%) −50% −75% Major Pathological Response (≥90%) −100% Complete Pathological Response (100%) BOT+BAL BOT BOT+BAL BOT Response Response (n=14) (n=14) (n=14) (n=14) Pathologic 100% 64% Pathologic 43% 71% 100% 36% 36% 0 Major Pathologic Major Pathologic 93% 29% 29% 0 Complete Pathologic Complete Pathologic No recurrences reported with BOT+BAL (median follow-up 6-9 months) Ghelardi F, et al. Neoadjuvant botensilimab and balstilimab in colorectal cancer. Poster presented at the ASCO Gastrointestinal Cancers Symposium. January 23-25, 20 2025. San Francisco, CA. Poster F20 Pathologic tumor regression (%)
No Disease Recurrence Reported in 38 BOT+BAL Treated Patients Across NEST and UNICORN 1 2 NEST UNICORN Event-Free Survival Event-Free Survival (N=24) (N=14) 100% 100% BOT + BAL (MSS/pMMR) 75% 75% NEST-1 Median follow-up: Median follow-up: 18.2 months (IQR 16.9–19.2 mo) 8.6 months (IQR 6.4–9.3 mo) 50% 50% NEST-2 Median follow-up: 9.0 months (IQR 8.1–9.4 mo) 25% 25% 0% 0% 0 5 10 15 20 0 3 6 9 Time (months) Time (Months) No. at risk 14 14 11 6 1. Hissong E, et al. Neoadjuvant Botensilimab (BOT) Plus Balstilimab (BAL) in Resectable Mismatch Repair Proficient (pMMR) and Deficient (dMMR) Colorectal Cancer (CRC). Poster presented at the ASCO 21 Gastrointestinal Cancers Symposium. January 23-25, 2025. San Francisco, CA. Abstract #207 . 2. Ghelardi F, et al. Neoadjuvant botensilimab and balstilimab in colorectal cancer. Poster presented at the ASCO Gastrointestinal Cancers Symposium. January 23-25, 2025. San Francisco, CA. Poster F20 EFS Probability EFS Probability
No ctDNA Recurrences Observed in NEST NEST ctDNA Levels 100% 75% pre-surgical sample post-surgical sample 50% 25% 0% 0 100 200 300 400 500 Time post treatment (days) 1. Hissong E, et al. Neoadjuvant Botensilimab (BOT) Plus Balstilimab (BAL) in Resectable Mismatch Repair Proficient (pMMR) and Deficient (dMMR) Colorectal Cancer (CRC). Poster presented at the ASCO 22 Gastrointestinal Cancers Symposium. January 23-25, 2025. San Francisco, CA. Abstract #207 ctDNA (MTM/ml)
NEST and UNICORN Safety Summary: Favorable Toxicity Profile with Low Incidence of High-Grade irAEs and No Significant Surgical Delays 1 2 NEST UNICORN BOT+BAL BOT+BAL Treatment-Related Grade 3 (n=24) Immune-mediated AE Grade ≥3 (N=28) 1 (4%) Fatigue Hyperthyroidism 1 (2%) Colitis/Diarrhea 3 (13%) No delays in surgery in any patients and 1 surgery delay (10 days) no Grade 4 AEs Among a total of 52 Patients treated with BOT + BAL: Low rate of grade ≥3 AEs One short surgical delay due to immune-mediated hyperthyroidism 1. Hissong E, et al. Neoadjuvant Botensilimab (BOT) Plus Balstilimab (BAL) in Resectable Mismatch Repair Proficient (pMMR) and Deficient (dMMR) Colorectal Cancer (CRC). Poster presented at the ASCO 23 Gastrointestinal Cancers Symposium. January 23-25, 2025. San Francisco, CA. Abstract #207 . 2. Ghelardi F, et al. Neoadjuvant botensilimab and balstilimab in colorectal cancer. Poster presented at the ASCO Gastrointestinal Cancers Symposium. January 23-25, 2025. San Francisco, CA. Poster F20
ROBBIN*: Phase 3, Randomized Controlled Study of Neoadjuvant BOT+BAL in High-Risk Stage II and Stage III MSS Colon Cancer Steven O’Day, MD Chief Medical Officer, Agenus *A Phase 3 Randomized, Open-Label Study of Botensilimab Plus Balstilimab In the Neoadjuvant Setting followed by Standard of Care Versus Standard of Care Alone in Previously Untreated High-Risk Stage II and Stage III Non–MSI-H/dMMR Colon Cancer (ROBBIN Study) 24
Setting the Stage for the ROBBIN Phase 3 Study: Neoadjuvant BOT+BAL Demonstrates Deep and Durable Responses in Stage II/III MSS CRC No Disease Recurrence Depth of Pathologic Response in MSS CRC Reported with BOT+BAL IPI/NIVO Neoadj Chemo BOT+BAL b a 1 2 (NICHE ) (NEST ) (UNICORN ) (FOxTROT ) 1,2 BOT+BAL Adjuvant Chemo a (NEST & UNICORN) (FOxTROT Control ) Complete PR 32% 29% 4% 10% (100% tumor reduction) 0% 25% Major PR 41% 36% 8% 23% recurrence recurrence (≥90% tumor reduction) at 9–18-month at 3 years Path Response 59% 71% 23% 29% follow-up (≥50% tumor reduction) a b Neoadjuvant FOLFOX in the FOxTROT trial; Morton D, et al. J Clin Oncol. 2023;41(8):1541-1552. Neoadjuvant ipilimumab and nivolumab in the NICHE trial; Tan P. et al. Nature 2025;648:726-735. Complete pathological regression (pCR) is defined as 100% tumor regression; major pathologic regression (mPR) as at least 90% tumor regression; and pathologic regression as at least 50% tumor regression. ; 1. Hissong E, et 25 al. Neoadjuvant Botensilimab (BOT) Plus Balstilimab (BAL) in Resectable Mismatch Repair Proficient (pMMR) and Deficient (dMMR) Colorectal Cancer (CRC). Poster presented at the ASCO Gastrointestinal Cancers Symposium. January 23-25, 2025. San Francisco, CA. Abstract #207 . 2. Ghelardi F, et al. Neoadjuvant botensilimab and balstilimab in colorectal cancer. Poster presented at the ASCO Gastrointestinal Cancers Symposium. January 23-25, 2025. San Francisco, CA. Poster F20
ROBBIN Phase 3: Neoadjuvant BOT+BAL in High-Risk Stage II and Stage III MSS Colon Cancer ~ 8 weeks Trial Size• N=850 BOT (1 dose; 75 mg) + SOC adjuvant chemotherapy † S BAL (3 doses; 240 mg Q2W) or observation U Patient • High Risk Stage II (cT4aN0M0) and Stage III R Population (cT3-T4Na+M0) resectable MSS colon cancer G • ECOG 0 or 1 R E • Age ≥18 years 1:1 R Y SOC adjuvant chemotherapy ~ 4 weeks † Target Primary: Event-free survival (EFS) or observation Endpoints Key Secondary: Overall survival, preservation of ctDNA clearance, and QoL †Adjuvant chemotherapy or observation in both arms to be decided by investigator per standard of care based on pathologic stage and society guidelines. Exploratory • Pathologic Response Rate Endpoints • Pathologic response correlation with Powering Assumptions EFS and OS • 80% power assuming EFS HR=0.65 • Utilization of adjuvant chemo • Biomarkers Analyses • Interim analysis for EFS at 75% Information Fraction • Final analysis for EFS at 100% Information Fraction 26
ROBBIN Phase 3 Trial Aligned with FDA Feedback The following key elements of the Phase 3 study are aligned with FDA feedback: • The proposed patient population of Stage II (cT4aN0M0) and Stage III (cT3-T4Na+M0) Colon Cancer that is not MSI-H/dMMR • The proposed experimental arm of neoadjuvant BOT and BAL followed by surgery and guideline- directed adjuvant chemotherapy based on pathologic staging • The control arm based on the current standard of care of surgery followed by guideline-directed adjuvant chemotherapy based on pathologic staging • The primary endpoint of EFS and the proposed interim analysis plan 27
Projected Timeline for ROBBIN Phase 3 Study 2026 2027 2028 2029 2030 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 ROBBIN Phase 3 RCT N = 850 (R 1:1) IA (EFS) FA (EFS) 2H’30 2H’29 FPI FDA 50 patients LPI Q1’27 Meeting BOT/BAL treated 2H’28 (for interim path response) Interim Readout (Pathologic Response Rate) 2H’27 28
Fully Funded, FDA-aligned Phase 3 Trial Testing Neoadjuvant BOT+BAL in MSS Colon Cancer, a Multi Billion-Dollar Opportunity in the US • Financing of $85M upfront and up to $340M in total, focused on BOT+BAL opportunity in high-risk Stage II and Stage III MSS Colon Cancer, >$7 Billion TAM in the US • Capital will be directed to an FDA-aligned pivotal Phase 3 study (“ROBBIN”) of neoadjuvant BOT+BAL for MSS Colon Cancer (n=850, Randomized 1:1, Primary Endpoint EFS) • To focus company resources, Agenus is discontinuing support for the ongoing BATTMAN Phase 3 study • Key upcoming catalysts for ROBBIN Phase 3 Trial (Neoadjuvant BOT+BAL): • ROBBIN first patient dosed: anticipated Q1 of 2027 • Interim pathologic response data: anticipated second half of 2027 • Interim analysis of EFS: anticipated second half of 2029 • Final analysis of EFS: anticipated second half of 2030 1. Epidemiology analysis based on data from SEER, CDC, and Clarivate; assumes 38,000 eligible patient population annually * $200K for a course of neoadjuvant treatment. 29
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