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CytoAgents’ Phase 1 Trial Results Show “Cytokine Release Syndrome” Drug Candidate Safe

PITTSBURGH–()–CytoAgents, Inc., a clinical stage biotechnology company, announced today that its lead drug candidate, GP1681, has successfully completed Phase 1 clinical trials with a strong safety profile. Building on these positive results, the company also announced the close and oversubscription of an initial equity round and is now positioned to raise a larger Series A round in early 2022 to enable two Phase II trials. CytoAgents is developing innovative pharmaceutical products to treat life-threatening conditions, diseases and disorders associated with Cytokine Release Syndrome, or CRS. Commonly referred to as cytokine storm and clinically known as hypercytokinemia, CRS is a potentially lethal condition associated with a range of diseases and treatments.

As part of the close of the initial equity round, Dr. Stanley Marks, Chairman UPMC Hillman Cancer Center and Chief of the Division of Hematology and Oncology, and John Friedman, Founder and Managing Partner at Easton Capital Group, will both join the CytoAgents board of directors.

“With the positive Phase 1 trial results, an oversubscribed equity round, solid scientific and business strategies, and the addition of Dr. Marks and John Friedman to our board, CytoAgents has built tremendous momentum in a relatively short time,” said Teresa Whalen, RPh, CEO of CytoAgents. “The mortality, economic burden and strain on our overall healthcare system as a consequence of cytokine storm is devastating, and GP1681 is positioned to be a new, breakthrough therapy to meet this threat head-on.”

The successful Phase 1 study assessed the safety and tolerability and multiple ascending doses of GP1681 in healthy adults and was conducted in partnership with a contract research organization and clinical trial unit in Australia. The safety data presented in the final clinical study report supports further human clinical development of GP1681 used to treat the excessive inflammatory response triggered by many diseases and therapies. The upcoming Phase II studies will first target CRS triggered by CAR T-cell therapy in oncology. The second will focus on COVID-19-related CRS, where GP1681 has the potential to effectively treat patients regardless of the viral variant they carry.

“As someone who has dedicated my life to cancer treatment, patient advocacy and innovation, I’m highly motivated to solve the CRS problem associated with CAR T-cell therapy” noted Dr. Stanley Marks. “GP1681 could not only treat but perhaps prevent CRS altogether. Reducing this life-threatening side effect will allow us to treat and cure more patients with CAR T-cell therapy.”

“I’ve always found that treatments with the potential to address an unmet need associated with a broad range of disease states are very attractive from a commercialization perspective,” said John Friedman. “I have had great success investing in companies with breakthrough therapies that can expand across multiple indications, and I believe CytoAgents has the potential to be another such opportunity.”

CytoAgents has been awarded Phase II SBIR grants, totaling of $3.6 million in non-dilutive funding from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health, under Award Numbers 1R44AI152726-01 and 1R44AI157719-01 to advance the research of GP1681, as well as recent funding from the Richard King Mellon Foundation’s Pandemic Solutions Package to jump-start COVID-19 response strategies.

About CytoAgents

CytoAgents is a privately held, clinical-stage biotechnology company focused on the development of innovative pharmaceutical products for the treatment of life-threatening symptoms associated with Cytokine Release Syndrome (CRS), an overreaction of the immune system causing systemic inflammation. There are many causes of CRS and our mission is to develop a broadly accessible treatment for multiple indications of high unmet need, including oncology CAR T-cell therapy, COVID-19, and respiratory epidemics. Using a novel, host-directed approach, our lead compound, GP1681, targets the underlying cause of life-threatening CRS, by modulating the body’s natural immune response to sickness or disease. We are committed to developing first-in-class, best-in-class products that meet a major medical need now and into the future. 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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