Seraxis’ manufacturing suite completes GMP quality system audit ahead of SR-02 IND filing and transplantation of pancreatic clusters to patients with Type 1 Diabetes.

Seraxis’ manufacturing suite completes GMP quality system audit ahead of SR-02 IND filing and transplantaCon of pancreaCc clusters to paCents with Type 1 Diabetes GMP-compliant manufacturing puts SR-02 on track to be industry’s second clinical- stage stem cell derived pancrea?c islet transplant program. The third-party auditor’s FDA six-system approach yielded no cri?cal nor major observa?ons of Seraxis’ quality system for the produc?on of GMP-grade organs from pancreas-derived stem cells. Dr. William Rust, CEO, will present further data on the development of SR-02 and follow-on immune-cloaked SR-03 on Monday, January 8 at 10:30am PST at Biotech Showcase in San Francisco. Germantown, MD, January 4, 2024. Seraxis, Inc., a regenera/ve medicine company developing a pancrea/c islet replacement therapy to transform the lives of pa/ents with Type 1 and insulin- requiring Type 2 diabetes, today announced the comple/on of a comprehensive third-party on- site Good Manufacturing Prac/ce (GMP) audit of Seraxis’ QMS, cleanroom, cell growing produc/on process and QC laboratory, conducted in advance of Seraxis’ planned IND submission of the pancrea/c clusters candidate SR-02 for the intended treatment of insulin- dependent diabetes. The independent audit followed the FDA six-system approach and concluded that Seraxis’ proprietary manufacturing process is in compliance with GMP audit standards, regula/ons and internal wriPen procedures. “The manufacturing of an exquisite cluster of living cells – essen/ally the produc/on of a replacement human organ – is a tremendously nuanced and intricate feat of biological engineering,” said Seraxis’ Chief Opera/ng Officer, Carole Welsch, PhD. “We are proud that our team has created a clinical-scale cleanroom produc/on facility and quality system that pass muster with a rigorous audit comparable to a possible future FDA inspec/on associated with our upcoming IND filings.” “Seraxis’ stem cell line SR1423 was derived from pancrea/c cells and retain the epigene/c fingerprint of islets so, by design, they efficiently expand and generate replacement islet clusters. This characteris/c eliminates purifica/on steps, enabling Seraxis to manufacture product on a clinical scale for both the SR-02 program and the follow-on immune-cloaked SR-03 program in our Germantown facility,” added CEO Will Rust. Dr . Rust will be presen/ng Seraxis’ recent candidate development data in a presenta/on at Biotech Showcase on Monday, January 8, in a 10:30am (PST) session. The presenta/on will be posted to www.seraxis.com shortly therea‘er . ABOUT SERAXIS Seraxis is bringing transforma/ve cures to the millions of people worldwide struggling with the management and life-threatening complica/ons of T1D and insulin-requiring T2D. Seraxis’ lead program, SR-02, is a novel, off-the-shelf islet replacement therapy slated to enter clinical tes/ng with immunosuppressive therapy in 2024 in pa/ents with severe recurrent hypoglycemia. A follow-on diabetes program, SR-03, is a version of the Seraxis pancrea/c clusters altered to be unrecognized by the immune system for use without chronic immune suppression by the broader popula/on of T1D and insulin-requiring T2D. Seraxis’ underlying proprietary technology enables the crea/on of a pipeline of novel stem cell- derived therapies origina/ng from single donated organs for other indica/ons. The company’s lead therapeu/c program, SR-02, is manufactured from a stem cell line derived from a human donor pancreas. These cells preferen/ally re-differen/ate into pancrea/c clusters containing all the endocrine cells of the na/ve pancrea/c islet, and with safety, potency, and manufacturing advantages over embryonic and induced pluripotent stem cells. Seraxis is backed by Frazier Life Sciences, Polaris Partners, Eli Lilly, the JDRF T1D Fund and independent investors. Seraxis manufactures its best-in-class therapeu/c pancrea/c clusters using scalable, clinically compliant processes in its cGMP facility located in Maryland’s I-270 Biotech Corridor . For more informa/on, please visit www.seraxis.com.

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