Sonoma Biotherapeutics and Regeneron Announce Collaboration to Discover, Develop and Commercialize Treg Cell Therapies for Autoimmune Diseases

Sonoma Biotherapeutics to receive $75 million upfront, inclusive of $45 million cash and $30 million equity investment; potential for an additional $45 million development milestone payment

Sonoma Biotherapeutics, Inc. and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced a collaboration to apply their scientific and clinical expertise and respective technology platforms to the discovery, development and commercialization of novel regulatory T cell (T_reg) therapies for autoimmune diseases. The collaboration will bring together Regeneron’s industry-leading VelociSuite^® technologies for the discovery and characterization of fully human antibodies and T cell receptors (TCRs) with Sonoma Biotherapeutics’ pioneering approach to developing and manufacturing gene-modified T_reg cell therapies.

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Under the terms of the agreement, Sonoma Biotherapeutics will receive $75 million in upfront payments, which includes a $30 million equity investment in Sonoma by Regeneron. Sonoma is also eligible to receive a $45 million development milestone payment. Regeneron and Sonoma will jointly research and develop T_reg cell therapies for ulcerative colitis, Crohn’s disease and two other undisclosed indications, with a Regeneron option for a fifth indication. The parties will equally co-fund research and development for all potential products and share equally any future commercial expenses and profits. Regeneron will have the option to lead late-stage development and commercialization on all products globally, with Sonoma retaining rights to co-promote all such products in the United States. Sonoma will also retain full ownership of its lead cell therapy candidate, SBT-77-7101, and other programs in development.

“We are thrilled to collaborate with Regeneron with the goal of developing best-in-class T_reg therapies for ulcerative colitis, Crohn's, and other diseases,” said Jeff Bluestone, Ph.D., Co-founder and Chief Executive Officer of Sonoma Biotherapeutics. “Regeneron has a track record of seeking out pioneers in their fields and forging successful partnerships. This collaboration will combine Regeneron’s proven technology and clinical expertise with Sonoma Bio’s proprietary T_reg platform and T_reg research enterprise to develop therapies that restore balance to the immune system and potentially cure disease.”

“Regeneron’s investigational pipeline includes a diverse range of cutting-edge scientific approaches, and we are pleased to expand this toolkit further through a partnership with Sonoma to explore the potential of engineered T_reg cell therapies with enhanced functionality and the ability to target specific tissues,” said George D. Yancopoulos, M.D., Ph.D., Co-Founder, President and Chief Scientific Officer of Regeneron. “Both Regeneron and Sonoma have strong foundations in basic scientific research, and by bringing together our complementary expertise, we hope to harness the power of T_regs to make further progress in the treatment of autoimmune and inflammatory diseases.”

T_reg cells act as sentinels that survey the body for unwanted immune attacks and rebalance the immune system. T_regs as a therapeutic modality potentially possess multiple therapeutic effects, within a single medicine, helping overcome the multifaceted nature of autoimmune and inflammatory disease. Emerging research shows that enhanced T_reg cells work directly at the site of inflammation and have the potential to create a durable response. This paradigm-shifting approach could possibly transform treatments for autoimmune and inflammatory diseases.

About Regeneron

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases.

Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite^® technologies, such as VelocImmune^®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

For more information, please visit www.Regeneron.com or follow @Regeneron on Twitter.

About Sonoma Biotherapeutics

Sonoma Biotherapeutics is a clinical-stage biotechnology company developing engineered regulatory T cell (T_reg) therapies to treat serious autoimmune and inflammatory diseases by restoring balance to the immune system. Founded by pioneers in T_reg biology and cell therapy, the company is employing proprietary platform technologies and approaches to develop a new generation of targeted and durable T_reg cell therapies. Sonoma Biotherapeutics is based in South San Francisco and Seattle. For more information visit sonomabio.com and follow on Twitter and LinkedIn.

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