CytoAgents Receives Fourth Grant From National Institutes of Health to Advance Research on Cytokine Release Syndrome

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PITTSBURGH--(BUSINESS WIRE)--Oct 1, 2025--

CytoAgents, Inc., a clinical-stage biotechnology company developing a safe and effective preventative treatment for cytokine release syndrome (CRS) and the neurotoxicity immune effector cell-associated neurotoxicity syndrome (ICANS), announced today that it has been awarded a $2.25 million National Institutes of Health (NIH) grant, the fourth NIH grant totaling $7.85 million in five years.

This most recent grant funding will accelerate the development of its lead drug candidate, CTO1681, an investigational new drug that uses a novel approach to prevent and mitigate CRS and ICANS frequently seen with multiple myeloma patients receiving CAR T-Cell Therapy. This is an area of significant unmet medical need as the majority of patients undergoing CAR T treatment for their cancer experience CRS and associated neurotoxicity.

“We are appreciative of the ongoing support from the National Cancer Institute of the NIH; this funding will help to expand into the multiple myeloma patient population receiving CAR T-Cell therapy at risk for CRS and ICANS,” said Teresa Whalen, RPh, CEO of CytoAgents. “Through better management of toxicities, our goal is to move these patients from the inpatient academic medical center setting, into the outpatient and then into the community setting. This approach is how the full potential of CAR T Cell and T-Cell Engager therapies will be unlocked.”

“We are deeply honored to receive a fourth NIH grant, which further validates the importance and potential of our research at CytoAgents,” said Arthur P. Bertolino MD, Ph.D., MBA, Chief Medical Officer at CytoAgents. “Our team is committed to leveraging this support to expand into the multiple myeloma patient population in pursuit of a universal preventative therapy for CRS and ICANS.”

CytoAgents is developing innovative pharmaceutical products to treat CRS associated with life-threatening conditions, diseases, and disorders. CRS, also called cytokine storm, is caused by excessive cytokine production and can be triggered by a variety of diseases and treatments. Certain advanced immunotherapies such as CAR T-Cell and Bispecific Antibody Therapies suffer from high incidences of associated CRS. The Company expects that effective CRS management will support greater accessibility to and broader adoption of these highly effective therapies.

CytoAgents is currently enrolling patients in a Phase 1b/2a clinical trial evaluating CTO1681 to treat CRS in lymphoma patients receiving CAR T-Cell Therapy. The clinical trial is being conducted at multiple U.S. sites and investigates the safety, tolerability, and efficacy of different doses of CTO1681. This latest grant will support expanding into an additional patient population.

“CAR T has transformed the treatment paradigm for the multiple myeloma patient population; it is imperative to find a solution to prevent CRS and ICANS which will allow us to treat and cure more patients with CAR T-cell therapy,” said Stanley M. Marks, MD, Medical Oncologist and Chairman of CytoAgents, Inc.

This Small Business Innovation Research (SBIR) grant is non-dilutive funding from the National Cancer Institute of the National Institutes of Health under Award Number R44CA295189 and will support the research of CTO1681. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About CytoAgents

CytoAgents, Inc. is a clinical-stage therapeutics company developing CTO1681, an oral, small molecule immune modulator for the prevention of Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). By effectively preventing these life-threatening complications experienced by oncology patients treated with CAR T-Cell Therapy, CytoAgents is working to enable safer, widescale adoption of these breakthrough therapies. CTO1681 is currently in Phase 1b/2a for oncology patients receiving CAR T-Cell therapy with plans to expand into additional immunotherapies, autoimmune, and other therapeutic categories. www.cytoagents.com

Forward Looking Statements

Some of the statements in this press release may be forward-looking statements or statements of future expectations based on currently available information. Such statements are naturally subject to risks and uncertainties. Factors such as the development of general economic conditions, future market conditions, unusual catastrophic loss events, changes in the capital markets, changes in governmental regulations and other circumstances may cause the actual events or results to be materially different from those anticipated by such statements. CytoAgents does not make any representation or warranty, express or implied, as to the accuracy, completeness, or updated status of such statements. CytoAgents will not be liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages.

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CONTACT: Media Contact:

Rachel Ford Hutman for CytoAgents

301-801-5540

[email protected]

KEYWORD: UNITED STATES NORTH AMERICA PENNSYLVANIA

INDUSTRY KEYWORD: ONCOLOGY HEALTH CLINICAL TRIALS RESEARCH SCIENCE PHARMACEUTICAL BIOTECHNOLOGY

SOURCE: CytoAgents, Inc.

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PUB: 10/01/2025 09:02 AM/DISC: 10/01/2025 09:04 AM

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