Noveome Biotherapeutics, Inc. Launches Program to Evaluate ST266 for the Treatment of the Severe Inflammatory Response Associated with COVID-19

• ST266 may significantly mitigate the frequently fatal cytokine storm observed in COVID-19 patients
• Plans to initiate human clinical trial by 4Q2020

PITTSBURGH–(BUSINESS WIRE)–Noveome Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues, today announced the launch of a new program to evaluate ST266, its lead product candidate, as a potential treatment of the severe inflammatory cytokine storm response frequently observed in the lungs of patients with COVID-19. This new program is based on a body of evidence demonstrating that ST266 significantly reduces the body’s inflammatory response in a wide range of diseases and conditions and has been shown to be safe and effective in humans. Importantly, preventing or reducing the severe cytokine storm could substantially address the shortage of ventilators. Noveome is in discussions with the FDA to expeditiously complete an IND and is currently identifying clinical sites for a Phase 1/2 safety trial, expected to initiate in the fourth quarter of 2020.

“As we continue to learn from the emerging data on COVID-19, it is clear that mitigating the cytokine storm associated with severe cases is crucial to treating this condition and improving patient outcomes. Based on our positive preclinical and clinical data, we believe that ST266 has the potential to reduce the severe inflammatory response in patients with COVID-19 and we have initiated our efforts to evaluate ST266 in these patients,” said William Golden, Noveome’s Founder, Chairman and CEO. “We look forward to addressing this crucial need with the FDA and expect to begin the trial as soon as the FDA determines that we are safe to proceed.”

“This ongoing pandemic has mobilized an unprecedented and rapid response by the biopharmaceutical industry to identify possible new therapeutic interventions and Noveome’s science has a compelling rationale to add to these efforts,” said Robert Langer, Sc.D., Massachusetts Institute of Technology Institute Professor and member of Noveome’s Board of Directors. “The body’s response to severe infection in vulnerable COVID-19 patients is a dangerous and increasingly fatal inflammatory overreaction due to a cytokine storm. ST266 has the potential to control this reaction to prevent deaths associated with COVID-19.”

About ST266

ST266 is a cell-free platform biologic containing hundreds of anti-inflammatory proteins. This collection of proteins, called a “secretome,” is made by a novel population of cells derived from the amnion, which is collected from donated, full term, Cesarean-sectioned placentas, normally discarded after birth. The ST266 secretome preserves cellular survival and/or resuscitates damaged cells. Importantly, ST266 has an established robust safety profile having treated 242 patients with no drug-related Serious Adverse Events reported.

About Noveome Biotherapeutics, Inc.

Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. Its novel platform biologic, ST266, is currently being evaluated in multiple ophthalmic indications including a Phase 1 open label clinical trial to establish the safety of ST266 when delivered intranasally to Glaucoma Suspects and a Phase 2 open-label clinical trial evaluating the efficacy of ST266 in healing Persistent Corneal Epithelial Defects (PEDs). Noveome has launched a program to test ST266 as a treatment for the severe inflammatory response seen in COVID-19 infection. To date, Noveome has received over $160 million of funding, including $129 million from the public sector (primarily the Department of Defense) and $34 million in private equity. Noveome is based in Pittsburgh, PA. For more information, please visit, www.noveome.com.

Contacts

Investor Contact:
Julie Seidel

Stern Investor Relations, Inc.

212-362-1200

[email protected]