H.C. Wainwright maintains Buy on GRI Bio stock, $10 target

On Monday, H.C. Wainwright reaffirmed a Buy rating and a $10.00 price target on GRI Bio, Inc. (NASDAQ:GRI) shares, following the company’s announcement of positive interim safety data from its Phase 2a study of GRI-0621 for idiopathic pulmonary fibrosis (IPF). The stock, currently trading at $1.33, has faced significant headwinds, declining nearly 79% over the past six months. InvestingPro analysis reveals 12 additional investment insights for GRI Bio, including key metrics on valuation and financial health. The study’s interim analysis, conducted at two weeks, showed that the drug was safe and well-tolerated in the initial 12 patients. No instances of hyperlipidemia, such as abnormal levels of LDL, HDL, or triglycerides, were reported, with all lipid levels remaining within normal ranges.

The interim analysis committee has recommended that the study proceed without modifications. H.C. Wainwright views these findings as a positive development for GRI Bio and its GRI-0621 treatment, considering the safety concerns associated with currently approved IPF therapies. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 3.43, and its cash position exceeds its debt obligations, providing financial flexibility for continued clinical development. Analyst Matthew Keller highlighted the significance of the drug’s safety profile, which is supported by prior studies involving over 1,700 patients treated with oral tazarotene, a component related to GRI-0621.

The ongoing Phase 2a trial aims to further establish the safety and efficacy of GRI-0621. The absence of hyperlipidemia is particularly noteworthy, as it is a common side effect of many drugs. The encouraging safety data thus far may help mitigate risks for future data releases and distinguish GRI-0621 within the treatment landscape for IPF, according to Keller.

Looking ahead, H.C. Wainwright anticipates additional updates from the trial, including interim biomarker data expected in the second quarter of 2025, and topline Phase 2a results projected for the third quarter of 2025. The firm’s reiterated Buy rating and price target reflect confidence in the potential of GRI-0621 and its prospects in the ongoing study. Based on InvestingPro Fair Value analysis, the stock appears to be undervalued at current levels, though investors should note that analysts don’t expect profitability this year. The next earnings report is scheduled for May 15, 2025, which could provide additional insights into the company’s financial position and clinical progress.

In other recent news, GRI Bio, Inc. has announced a $5 million public offering of common stock and Series Warrants, with H.C. Wainwright & Co. serving as the exclusive placement agent. The proceeds from this offering are earmarked for product development, working capital, and general corporate purposes. Additionally, GRI Bio reported interim safety results from its Phase 2a study of GRI-0621, a potential treatment for Idiopathic Pulmonary Fibrosis, with no safety concerns noted, allowing the trial to continue as planned. The company has also secured two global patents, enhancing its intellectual property portfolio, which supports its focus on inflammatory, fibrotic, and autoimmune diseases. Moreover, GRI Bio has regained compliance with Nasdaq’s minimum bid price requirement, marking a positive development in maintaining its stock listing. In a recent virtual meeting, stockholders approved a reverse stock split, which aims to boost the per-share trading price and attract broader market interest. This approval gives the board discretion to determine the exact ratio of the split, which could range from one-for-two to one-for-twenty-three. These developments underscore GRI Bio’s ongoing efforts to advance its product pipeline and strengthen its market position.

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