Vallon and GRI Bio Strike a Merger Deal, Joining Forces for Innovative NKT Cell Regulators

Vallon Pharmaceuticals, a Philadelphia-based clinical-stage biopharmaceutical company, announced on Tuesday that it has entered into a merger agreement with GRI Bio, Inc., a privately held biotechnology company focused on transforming treatments of inflammatory diseases. 

According to the agreement, GRI Bio will merge with a wholly-owned subsidiary of Vallon in an all-stock transaction, which is expected to close in the first quarter of 2023. Following the closing of the Merger, the combined company is expected to operate under the name “GRI Bio, Inc.” and will focus on advancing the innovative pipeline of NKT cell regulators for the treatment of inflammatory, fibrotic and autoimmune diseases.

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GRI Bio’s Portfolio in Inflammatory, Fibrotic and Autoimmune Diseases

Natural killer T (NKT) cells are lymphocytes that express both a T-cell receptor (TCR), characteristic of adaptive immunity, and surface receptors for NK cells, which are part of the innate immune response. These cells influence diverse immune responses, including the surveillance for tumors, the maintenance of self-tolerance and the regulation of autoimmune diseases. In particular, type I NKT (NKT I) cells play a critical role in initiating and propagating the inflammatory response, injury and fibrosis observed in idiopathic pulmonary fibrosis (IPF) and other fibrotic indications.

GRI Bio’s lead program, GRI-0621 is an inhibitor of NKT I cells and is being developed as a novel oral therapeutic for IPF. GRI Bio is planning to launch a Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF with data expected in the second quarter of 2024.

GRI-0803, another GRI Bio’s asset in development, is a novel activator of human type II NKT (NKT II) cells in development for the treatment of autoimmune disorders, with an initial focus on systemic lupus erythematosus. GRI Bio expects to launch a Phase 1 study in 2023. Additionally, GRI Bio has a library of 500+ proprietary compounds to fuel a growing pipeline targeting a number of high value indications with unmet need.

Additional Investment on Top of Merger

Concurrently with the execution of the Merger Agreement, Altium Capital has agreed to invest approximately $15 million at the close of the Merger and committed to an additional $10 million future investment in the combined company.

David Baker, Chief Executive Officer of Vallon, commented, “GRI Bio provides an exciting opportunity for value creation by advancing a potentially deep pipeline leveraging its innovative NKT regulator technology. The combined company will be well positioned with the potential to address shortcomings that exist with current therapeutic treatments targeting inflammation and fibrosis across a number of high-value indications.”

“We believe the proposed Merger and Financing will mark a transformational evolution for GRI Bio. These transactions, including the additional Altium investment, will provide us with the necessary capital to propel GRI Bio forward in a meaningful way and to fund our planned operations into mid-2024, with the goal of realizing multiple catalytic clinical and regulatory milestones,” added Marc Hertz, PhD, Chief Executive Officer of GRI Bio.

Author

Richard Chau