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Subject: Product/Service

Direct Biologics Announces First Patient Dosed with ExoFlotm in a Phase 1 Clinical Trial for Medically Refractory Ulcerative Colitis


Direct Biologics, LLC, a late-stage biotechnology company leveraging its regenerative medicine platform using extracellular vesicles (EVs) derived from bone marrow mesenchymal stem cells (MSCs) to address multiple disease indications, announces that the first patient has been dosed in its Phase 1 clinical trial evaluating ExoFlotm for the treatment of patients with medically refractory ulcerative colitis (UC).

"The initiation of our ulcerative colitis clinical study is an important milestone as it marks the beginning of Direct Biologics' clinical trial program for inflammatory bowel disease, a chronic condition with no known cure," said Amy Lightner, Chief Medical Officer of Direct Biologics. "ExoFlo's safety profile, combined with its anti-inflammatory, immunomodulatory and regenerative properties, make it an ideal next generation candidate for ulcerative colitis. This has the potential to fulfill a critical, unmet need for the thousands of patients suffering from this chronic condition."

This open-label Phase 1 study (NCT05176366) is designed to evaluate the safety and efficacy of ExoFlo for the treatment of medically refractory UC. The trial is expected to enroll 10 patients, aged 18-75 years, who have had a diagnosis of medically refractory UC of at least six months duration and have failed at least one monoclonal antibody therapy. The ten patients enrolled will be randomized to treatment with intravenous ExoFlo every month or every other month over the course of one year.

The primary objective for this trial is to evaluate the safety of intravenous ExoFlo in patients with moderate to severe UC. The secondary objective is to evaluate the efficacy of intravenous ExoFlo in inducing clinical remission, clinical response, and improvement in patient reported outcomes. This is measured by changes in laboratory values including C-reactive protein and fecal calprotectin, and changes in validated clinical and endoscopic scoring systems.

About Ulcerative Colitis

Ulcerative colitis is an idiopathic chronic inflammatory disease of the colon and rectum, which continues to increase in incidence for unknown reasons, resulting in a significant burden to the healthcare system. UC is characterized by persistent mucosal inflammation of the colon and rectum with a chronic remitting and relapsing behavior, which leaves patients on chronic immunosuppression and recurrent hospitalizations to treat the symptoms, but without an ability to cure the disease. Despite the ever-growing armamentarium of immunosuppressive medications, up to 30% of patients still require a colectomy for medically refractory disease. Thus, the current treatment paradigm presents a significant unmet need as observed by frequent hospitalizations, lost jobs, morbidity related to medical and surgical treatment, and a significantly impaired quality of life.

About Direct Biologics

Direct Biologics is a late-stage biotechnology company leveraging a regenerative medicine platform which uses extracellular vesicles (EVs) secreted from mesenchymal stem cells to address multiple disease indications. Direct Biologics' mission is to be the global leader in regenerative medicine through discovery, innovation, advancement of science, and treatment of patients in a safe and effective manner. Our therapeutic product candidate, ExoFlo, is designed to be a scalable, reproducible, and effective next-generation biologic that leverages our proprietary EV platform technology designed to reduce inflammation, modulate the immune system, and restore tissue through cellular regeneration. Direct Biologics is currently conducting the global Phase 3 EXTINGUISH clinical trial of ExoFlo for the treatment of hospitalized adults with moderate-to-severe acute respiratory distress syndrome (ARDS). In addition, the Company has initiated Phase 1 clinical trials with ExoFlo for the treatment of ulcerative colitis and Crohn's disease, and expanded access trials in solid abdominal organ transplantation, and severe COVID-19 ARDS patients. Direct Biologics intends to pursue additional clinical applications including perianal fistulizing Crohn's disease and necrotizing enterocolitis. Headquartered in Austin, Texas, Direct Biologics also has an R&D facility at the Center for Novel Therapeutics on the campus of University of California at San Diego, and operations and order-fulfillment center in San Antonio, Texas. For more information, please visit www.directbiologics.com and follow us on Twitter @directbiologics.


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