TG Therapeutics Announces Global License Agreement with Precision BioSciences for the Development and Commercialization of Precision’s Allogeneic CD19 CAR T Cell Therapy Program for the Treatment of Autoimmune Diseases

US IND filing targeted for mid-2024

NEW YORK, Jan. 09, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), “the Company,” today announced that it has entered into an agreement with Precision BioSciences, Inc. (NASDAQ GS: DTIL) to acquire a worldwide license to Precision’s Azercabtagene Zapreleucel (azer-cel), an allogeneic CD19 CAR T cell therapy program for autoimmune diseases and all other non-oncology indications. Azer-cel is an allogeneic (off the shelf) CAR T program and the Company has near-term plans to evaluate the program in multiple autoimmune indications, with an investigational new drug (IND) filing targeted for mid-2024.

Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “We are excited to expand our autoimmune portfolio and leverage our robust drug development and commercialization expertise in partnering with Precision on this CAR T program. We look forward to exploring azer-cel’s potential to be a meaningful therapy for patients with various autoimmune disorders with a target IND filing mid-2024.”

“We are excited to partner with TG Therapeutics to extend the therapeutic opportunity for our allogeneic CAR T product azer-cel to address unmet medical needs in autoimmune conditions and other diseases beyond oncology. TG Therapeutics has a strong track record of development, regulatory and commercial success in the multiple sclerosis space, and we believe they will bring their expertise to the development of azer-cel for autoimmune diseases,” said Michael Amoroso, President and Chief Executive Officer of Precision BioSciences.

Under the terms of the agreement, TG Therapeutics will receive exclusive worldwide rights to develop and commercialize azer-cel in non-oncology indications, and in exchange, Precision will receive upfront and potential near-term economics valued at $17.5 million. The upfront payment of $7.5 million will consist of cash and the purchase of Precision common stock by TG Therapeutics at a 100% premium to the 30-day VWAP prior to purchase. Precision will also receive $2.5 million in deferred consideration due within 12 months as an equity investment in Precision’s common stock at a 100% premium to the then 30-day VWAP prior to purchase. Upon the achievement of certain near-term clinical milestones, Precision will receive an additional $7.5 million payment, consisting of cash and the purchase of Precision common stock by TG at a 100% premium to the then current 30-day VWAP. Precision is also eligible to receive up to $288 million in additional payments based on the achievement of certain clinical, regulatory, and commercial milestones, in addition to high-single-digit to low double-digit royalties on net sales.