AGEN — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-11

• Agenus is a clinical-stage biotechnology company focused on discovering and developing immunotherapies for cancer and infectious disease. Our primary business is immuno-oncology ("I-O"), where we are advancing antibody-based programs to activate innate and adaptive immunity, overcome tumor immune ev…

• The first quarter of 2026 and the period shortly thereafter included several developments that materially advanced our strategic priorities: continued expansion of physician engagement through regulatory-authorized access pathways and the appointment of an exclusive global access distribution partne…

• In France, BOT/BAL is available under the national Autorisation d'Accès Compassionnel ("AAC") framework for eligible patients in MSS metastatic colorectal cancer without active liver metastases (added September 2025), platinum-resistant or platinum-refractory ovarian cancer (added January 2026), and…

• In April 2026, the global Phase 3 BATTMAN (CCTG CO.33) trial commenced patient enrollment. Conducted together with the Canadian Cancer Trials Group ("CCTG") and participating cooperative groups, BATTMAN is evaluating BOT plus BAL versus best supportive care in approximately 830 patients with refract…

• 100 sites in Canada, France, Australia and New Zealand, and is intended to support potential regulatory filings in the United States and the European Union.

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• We are a clinical-stage biotechnology company specializing in discovering and developing therapies to activate the body's immune system against cancer and infections. Our pipeline includes immune-modulatory antibodies, vaccine adjuvants (via SaponiQx, Inc. ("SaponiQx")), and adoptive cell therapies …

• Our I-O portfolio is driven by several platforms and programs, which we plan to utilize individually and in combination:

• Multiple antibody discovery platforms, including proprietary display technologies, to identify future antibody candidates.

• Antibody candidate programs, including our lead assets, botensilimab ("BOT") (a multifunctional immune cell activator and human Fc-enhanced CTLA-4 blocking antibody, also known as AGEN1181) and balstilimab ("BAL") (a PD-1 blocking antibody).

• Our saponin-based vaccine adjuvant platform, primarily centered around our STIMULON™ cultured plant cell (“cpc”) QS-21 adjuvant (“STIMULON cpcQS-21”).

Text added vs the prior filing · source: 10-Q · 2026-05-11

• We had cash and cash equivalents at March 31, 2026 of $35.0 million, which are exposed to the impact of interest rate changes, and our interest income fluctuates as interest rates change. Additionally, in the normal course of business, we are exposed to fluctuations in interest rates as we seek debt…

• There has been no material change to our interest rate exposure and our approach toward interest rate and foreign currency exchange rate exposures, as described in our Annual Report on Form 10-K for the year ended December 31, 2025.

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• currencies. We do not currently employ specific strategies, such as the use of derivative instruments or hedging, to manage these exposures. Our currency exposures vary but are primarily concentrated in the British Pound, in large part due to our subsidiary, Agenus UK Limited, a company with operati…

• We had cash and cash equivalents at September 30, 2025 of $3.5 million, which are exposed to the impact of interest rate changes, and our interest income fluctuates as interest rates change. Additionally, in the normal course of business, we are exposed to fluctuations in interest rates as we seek d…

• There has been no material change to our interest rate exposure and our approach toward interest rate and foreign currency exchange rate exposures, as described in our Annual Report on Form 10-K for the year ended December 31, 2024.

Text added vs the prior filing · source: 10-Q · 2026-05-11

• Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this report are effective at a level that provides such reasonable assurances.

• There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the three months ended March 31, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over…

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the three months ended September 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control …

Text added vs the prior filing · source: 10-Q · 2026-05-11

• On May 4, 2026, the U.S. Securities and Exchange Commission (the "SEC") informed the Company that it has concluded its investigation as to the Company and does not intend to recommend an enforcement action against the Company. The investigation originated in September 2024, when the Company received…

• On March 24, 2026, the U.S. District Court for the District of Massachusetts (the "Court") granted the Company's motion to dismiss the putative securities class action captioned In re Agenus Inc. Securities Litigation, No. 1:24-cv-12299, in its entirety, ruling in favor of the Company and the indivi…

• On April 15, 2026, the lead plaintiff filed a Notice of Appeal to the U.S. Court of Appeals for the First Circuit in a case captioned Olsen v. Agenus, Inc., et al., No. 26-01421. The First Circuit requires the parties to participate in a mandatory settlement conference, which is scheduled for May 26…

• The Company has also been served with four derivative actions filed in the Court between November 2024 and January 2025 by purported stockholders. These actions name certain of the Company's executives and directors and allege that defendants made false or misleading statements and omissions of mate…

• The Company is not currently a party to any other material legal proceedings. From time to time, the Company may be subject to various legal proceedings and claims that arise in the ordinary course of business. Regardless of outcome, litigation can have a material adverse effect on the Company becau…

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• In September 2024, a putative securities class action lawsuit captioned In re Agenus Inc. Securities Litigation, No. 1:24-cv-12299, was filed in the U.S. District Court for the District of Massachusetts (the “Court”) against the Company and certain of its executives and directors. The Court appointe…

• The Company has been served with four derivative actions filed in the Court between November 2024 and January 2025 by purported stockholders. The actions name certain of the Company’s executives and directors and allege that defendants made false or misleading statements and omissions of material fa…

• In September 2024, the Company received a subpoena from the Boston Regional Office of the U.S. Securities and Exchange Commission (the “SEC”) seeking records relating to certain of our product candidates, correspondence with the FDA, public disclosure, and other matters. We have produced records pur…

• We are not currently a party to any other material legal proceedings. From time to time, we may be subject to various legal proceedings and claims that arise in the ordinary course of our business activities. Regardless of the outcome, litigation can have a material adverse effect on us because of d…

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• Christine M. Klaskin, VP, Finance, Principal Financial Officer, Principal Accounting Officer of the Company, has informed the Company that after nearly 30 years with the Company she will be retiring effective December 31, 2025. Ms. Klaskin will continue as a consultant to the Company.