PHILADELPHIA, PA, April 21, 2023 (GLOBE NEWSWIRE) — GRI Bio, Inc. (NASDAQ: VLON), today announced the completion of the previously announced merger between Vallon Pharmaceuticals, Inc. and GRI Bio, Inc., a privately held biotechnology company. The combined company will operate under the name “GRI Bio, Inc.” and will focus on advancing GRI Bio’s innovative pipeline of NKT cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases.
The shares of the Company’s common stock, previously trading on The Nasdaq Capital Market under the ticker symbol “VLON,” will commence trading on The Nasdaq Capital Market, on a post-reverse split adjusted basis, under the ticker symbol “GRI”, effective April 24, 2023. The Company’s common stock is now represented by a new CUSIP number, 3622AW 106.
“This marks a transformational moment for the Company and an important step into what we believe is a bright future for the Company. With the completion of the merger and concurrent investment, we are well positioned to realize multiple upcoming catalytic clinical and regulatory milestones that we believe will drive value in the near and long term,” added Marc Hertz, PhD, the new Chief Executive Officer of the Company.
Innovative Approaches for the Treatment of Inflammatory, Fibrotic and Autoimmune Diseases
GRI Bio is a clinical stage biotechnology company focused on fundamentally changing the way inflammatory disease is treated by targeting NKT immune cells earlier in the inflammatory chain than the current standard of care, to interrupt disease progression more effectively. GRI Bio’s lead program, GRI-0621 is a small molecule RAR-βɣ dual agonist that inhibits the activity of human Type I, or invariant, NKT (“iNKT”) cells. In in vitro studies and after 28 days dosing in the study GRI-0621-201 (NCT02949375), oral dosing of GRI-0621 has been shown to inhibit iNKT cells in patients and improve fibrosis in multiple disease models. GRI Bio is planning to launch a Phase 2a biomarker study evaluating GRI-0621 for the treatment of idiopathic pulmonary fibrosis (“IPF”) with data expected in the second quarter of 2024.
GRI Bio’s second asset in development, GRI-0803, is a novel activator of human Type 2 NKT 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.
About the Transaction
Under the terms of the merger agreement, the Company acquired 100% of the outstanding equity interests of Private GRI, by means of reverse triangular merger of a wholly owned subsidiary of the Company with and into Private GRI, with Private GRI surviving as a wholly owned subsidiary of the Company. In connection with the closing of the merger, the Company changed its name to “GRI Bio, Inc.”
As of the closing of the merger, the equity holders of Private GRI immediately before the merger own approximately 85% of the outstanding equity of the Company, and the equity holders of the Company immediately before the merger own approximately 15% of the outstanding equity of the combined company.
As previously announced, in connection with the execution of the merger agreement, Altium Capital (“Altium”) agreed to invest approximately $15 million, of which $2.5 million was previously invested and an additional $12.25 million was invested immediately prior to the closing of the merger. The combined company is expected to use the proceeds from the financings to fund the advancement of GRI Bio’s NKT development pipeline targeting multiple inflammatory, fibrotic and autoimmune indications into mid-2024 with an initial focus on IPF.
Advisors
Ladenburg Thalmann & Co. Inc. acted as the exclusive financial advisor and Thompson Hine LLP served as legal counsel to Vallon Pharmaceuticals, Inc. Evolution Venture Partners LLC acted as the exclusive strategic advisor with securities offered through Ecoban Securities Corporation and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. served as legal counsel to GRI Bio, Inc.
About GRI Bio, Inc.
GRI Bio is a clinical stage biopharmaceutical company focused on fundamentally changing the way inflammatory, fibrotic and autoimmune diseases are treated. GRI’s therapies are designed to target the activity of NKT cells, which are key regulators earlier in the inflammatory cascade, to interrupt disease progression and restore the immune system to homeostasis. NKT cells are innate-like T cells that share properties of both NK and T cells and are a functional link between the innate and adaptive immune responses. Type I iNKT cells play a critical role in propagating the injury, inflammatory response, and fibrosis observed in inflammatory and fibrotic indications. GRI’s lead program, GRI-0621, is an inhibitor of iNKT cell activity and is being developed as a novel oral therapeutic for the treatment of IPF, a serious disease with significant unmet need. The Company is also developing a pipeline of novel Type 2 NKT agonists for the treatment of systemic lupus erythematosus. Additionally, with a library of over 500+ proprietary compounds, GRI has the ability to fuel a growing pipeline.
