SBT-77-7101 / Sonoma Biotherap - LARVOL DELTA

Sonoma Biotherapeutics Receives $45 Million Milestone Payment from Regeneron under Ongoing Collaboration (Businesswire) - "Sonoma Biotherapeutics, Inc...announced today that it has received a $45 million milestone payment from Regeneron Pharmaceuticals, Inc., under the terms of its active collaboration to discover, develop and commercialize engineered Treg therapies for autoimmune diseases....Under the terms of the agreement, Sonoma Bio received $75 million in upfront payments, which included a $30 million equity investment in Sonoma Bio by Regeneron. Sonoma Bio was also eligible to receive an additional $45 million development milestone payment, which has now been achieved. Sonoma Bio continues to retain full ownership of its lead Treg cell therapy candidate, SBT-77-7101, and other programs in development."

Financing • Hidradenitis Suppurativa • Immunology • Rheumatoid Arthritis

Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Sonoma Biotherapeutics, Inc. | Trial completion date: Jun 2026 ➔ Sep 2026 | Initiation date: Jun 2024 ➔ Sep 2024 | Trial primary completion date: Jun 2026 ➔ Sep 2026

Trial completion date • Trial initiation date • Trial primary completion date • Dermatology • Hidradenitis Suppurativa • Immunology

Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Sonoma Biotherapeutics, Inc.

New P1 trial • Dermatology • Hidradenitis Suppurativa • Immunology

Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Sonoma Biotherapeutics, Inc.

New P1 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Sonoma Biotherapeutics to Present Preclinical Data from Novel Treg Cell Therapy at Symposium on Hidradenitis Suppurativa Advances (Businesswire) - "Sonoma Biotherapeutics, Inc...will present preclinical data from its autologous chimeric antigen receptor (CAR) Treg product candidate for the treatment of hidradenitis suppurativa (HS) at the 8th Annual Symposium on Hidradenitis Suppurativa Advances (SHSA). The meeting takes place October 13-15th in Phoenix, Arizona....'Our 7101 program targets citrullinated proteins, a hallmark of many autoimmune diseases, including rheumatoid arthritis and HS. Our results show that we can engineer CAR Tregs directly from HS patients’ cells that can target these proteins. This represents a novel therapeutic approach to restore the balance of the immune system to treat HS.'"

Preclinical • Hidradenitis Suppurativa • Immunology

Sonoma Biotherapeutics Raises $265 Million in an Oversubscribed Series B Financing to Translate the Promise of Cell Therapy into Curative Medicines for Autoimmune and Other Inflammatory Diseases (Businesswire) - “Sonoma Biotherapeutics…announced an oversubscribed $265 million Series B financing. Proceeds from the financing will be used to advance Sonoma Bio’s Treg cell therapy platform and a novel Teff conditioning biologic into the clinic to treat multiple, severe autoimmune and inflammatory diseases and to further invest in and scale up manufacturing operations in order to support supply for initial clinical studies…SBT-77-7101 CAR-Treg cells adapt the clinically proven paradigm of CAR-Teff cells in cancer…”

Financing • Oncology