LA JOLLA, CA - GRI Bio, Inc. (NASDAQ: GRI), a biotechnology firm specializing in Natural Killer T (NKT) cell modulators for treating inflammatory, fibrotic, and autoimmune diseases, today announced it has been granted a patent by the Japan Patent Office. The patent, concerning the prevention and treatment of inflammatory conditions, strengthens the company's intellectual property portfolio in a significant pharmaceutical market.
The patent, application No. 2023-000750, encompasses compositions and methods for modulating type 2 and type 1 invariant NKT cells. It specifically includes the use of a Retinoic Acid Receptor agonist to inhibit these cells, with the aim of treating various inflammatory, fibrotic, and autoimmune conditions.
Japan, holding the title of the world's third-largest pharmaceutical market, valued at around $106 billion in 2021, presents a lucrative territory for GRI Bio. The country has a high life expectancy and an increasing number of chronic disease cases, such as Idiopathic Pulmonary Fibrosis (IPF) and Systemic Lupus Erythematosus (SLE), which are similar in prevalence to the United States.
GRI Bio's CEO, Marc Hertz, PhD, expressed confidence in the company's approach to addressing unmet medical needs within this market. The company is advancing its lead program, GRI-0621, a small molecule RAR-βδ dual agonist candidate, through a Phase 2a study for the treatment of IPF. This disease is characterized by progressive lung scarring that impedes oxygen transfer to the bloodstream. Interim data from the study is expected in Q4 2024, with topline results anticipated in Q1 2025.
The company's pipeline also includes novel type 2 NKT agonists for the treatment of systemic lupus erythematosus and boasts over 500 proprietary compounds that could fuel further developments.
This announcement is based on a press release statement and contains forward-looking statements regarding the development and potential of GRI Bio's product candidates. These statements are subject to risks and uncertainties, and there is no assurance that the trials will be successful or that the products will be approved for commercial use. The company does not assume any obligation to update the information as per the applicable laws.
In other recent news, GRI Bio, a clinical-stage biopharmaceutical company, has received authorization from Australian regulatory authorities to commence a Phase 2a biomarker study for its lead program, GRI-0621, aimed at treating Idiopathic Pulmonary Fibrosis. This approval is expected to accelerate patient enrollment and expand the company's clinical development globally. Meanwhile, GRI Bio has been notified by the Nasdaq Stock Market about its non-compliance with the minimum bid price requirement, and the company is considering various options to regain compliance within the granted 180-day period.
In financial developments, GRI Bio has expanded its at-the-market offering program, allowing for the issuance of an aggregate of $2,644,609 worth of the company's common stock. The company has also announced a public offering of over 2 million shares of common stock and Series C warrants, predicted to generate about $4 million. Moreover, GRI Bio initiated a 1-for-13 reverse stock split, reducing the total outstanding shares from approximately 6.6 million to about 508,091 shares.
In corporate governance news, a recent shareholder meeting saw the election of a director, approval of common stock issuances, and an equity plan amendment. The company also regained compliance with Nasdaq's listing standards, canceling a previously scheduled hearing with the Nasdaq Hearings Panel. These are recent developments in GRI Bio's ongoing research and development efforts, financial strategies, and corporate governance.
InvestingPro Insights
GRI Bio's recent patent grant in Japan marks a significant milestone for the company, potentially opening doors to a lucrative pharmaceutical market. However, investors should be aware of some critical financial metrics and trends highlighted by InvestingPro.
According to InvestingPro data, GRI Bio's market capitalization stands at a modest $1.31 million USD, reflecting its current developmental stage. The company's financial position shows some concerning trends. An InvestingPro Tip indicates that GRI is "quickly burning through cash," which is not uncommon for biotech firms in the research and development phase but requires careful monitoring.
Another InvestingPro Tip reveals that GRI "holds more cash than debt on its balance sheet," which could provide some financial flexibility as it advances its clinical programs. However, this should be viewed in the context of the company's cash burn rate.
The stock's performance has been challenging, with InvestingPro data showing a significant price decline over various timeframes. The 1-year price total return as of the most recent data stands at -99.68%, indicating substantial investor skepticism or market challenges.
Looking ahead, InvestingPro notes that GRI's next earnings date is expected on November 14, 2024. This will be a crucial event for investors to assess the company's progress on its clinical programs and financial health.
For a more comprehensive analysis, InvestingPro offers additional tips and metrics that could provide deeper insights into GRI Bio's financial situation and market position. Investors interested in a fuller picture might consider exploring the 12 additional tips available on the InvestingPro platform.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.