GRI Bio secures Australian nod for IPF treatment study

LA JOLLA, CA - GRI Bio, Inc. (NASDAQ: GRI), a clinical-stage biopharmaceutical company, has received authorization from the Australian Medicines and Healthcare products Regulatory Agency (MHRA) and the Human Research Ethics Committee (HREC) to commence a Phase 2a biomarker study in Australia. This study is part of the ongoing research into the company's lead program, GRI-0621, for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

The authorization will allow GRI Bio to expand its clinical development globally and is expected to accelerate patient enrollment in the study. The company has reported steady progress in similar trials currently underway in the U.S. and UK, with interim data anticipated in Q4 2024 and topline data expected in Q1 2025.

IPF is a severe and progressive lung disease characterized by scarring that impedes oxygen transfer to the bloodstream, leading to difficulty breathing and a significant reduction in quality of life. The average survival rate without treatment is approximately 3.5 years from diagnosis. Current IPF treatments are limited, with only two approved drugs that carry substantial side effects and do not improve survival rates.

The upcoming Australian study will be randomized, double-blind, multi-center, placebo-controlled, and will include approximately 36 subjects with IPF. Participants will be assigned in a 2:1 ratio to either receive GRI-0621 at a 4.5mg dose or a placebo, taken orally once daily for 12 weeks. A sub-study will also investigate the number and activity of NKT cells in bronchoalveolar lavage fluid. The primary endpoint is the safety and tolerability of GRI-0621, with secondary endpoints focused on changes in serum biomarkers, pharmacokinetics, and pharmacodynamics.

GRI Bio's therapeutic approach targets NKT cells, which are believed to play a pivotal role in the inflammatory and fibrotic processes of various diseases. The company's lead compound, GRI-0621, is designed to inhibit iNKT cell activity and is being developed as a novel oral therapy for IPF.

The company is also developing a pipeline of type 2 NKT agonists for systemic lupus erythematosus and has a library of over 500 proprietary compounds to support future pipeline growth. This article is based on a press release statement.

In other recent news, GRI Bio, Inc., a pharmaceutical company, has reported several significant developments. The company has received a notification from the Nasdaq Stock Market regarding non-compliance with the exchange's minimum bid price requirement, placing its listing at risk. GRI Bio has been granted a 180-day period to regain compliance, with various options being considered to resolve the issue.

In financial news, 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 also announced a public offering of over 2 million shares of common stock and Series C warrants, expected to generate about $4 million. Additionally, 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 terms of corporate governance, the company's recent shareholder meeting resulted in 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.

On the research front, GRI Bio reported positive preclinical data for its drug candidate, GRI-0621. These are the recent developments in GRI Bio's ongoing research and development efforts, financial strategies, and corporate governance.

InvestingPro Insights

As GRI Bio, Inc. (NASDAQ: GRI) embarks on its Phase 2a biomarker study in Australia, it's essential to consider the company's financial health and market performance. According to InvestingPro data, GRI Bio holds a market capitalization of $1.38 million, reflecting its size within the biopharmaceutical industry. However, the company's P/E ratio stands at -0.01, indicating that it is not generating positive earnings at the moment, a common scenario for many clinical-stage biopharmaceutical companies.

One of the InvestingPro Tips suggests that GRI Bio is quickly burning through cash, which is a critical factor for investors to consider given the company's clinical trial expenses. Moreover, the company does not pay a dividend to shareholders, which may influence investment decisions for those seeking income-producing stocks. On a more positive note, GRI Bio holds more cash than debt on its balance sheet, which could be seen as a sign of financial stability in the short term.

Market performance metrics reveal that GRI Bio's stock price has experienced significant volatility. Over the last three months, the price has fallen by 74.39%, and the six-month return is even more striking at -95.21%. These figures highlight the stock's recent performance challenges, which may be attributed to the inherent risks and long development timelines associated with biopharmaceutical research.

For those interested in deeper analysis and additional insights, InvestingPro offers more tips on GRI Bio, which can be found at the dedicated page for the company: https://www.investing.com/pro/GRI. These tips may provide further context for evaluating the company's prospects and investment potential.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.