LA JOLLA, CA - GRI Bio, Inc. (NASDAQ: GRI), a biotechnology firm focused on inflammatory and fibrotic diseases, has presented new preclinical data suggesting its lead drug candidate, GRI-0621, could play a significant role in treating Idiopathic Pulmonary Fibrosis (IPF). The findings were shared during the 8th Annual Antifibrotic Drug Development Summit held in Boston, MA, from November 19-21.
The company's Chief Executive Officer, Marc Hertz, PhD, delivered a talk at the summit, highlighting the potential of GRI-0621 to reduce inflammatory and fibrotic markers in IPF. This condition, characterized by lung scarring and a progressive decline in lung function, currently has limited therapeutic options.
In studies, GRI-0621, an oral small molecule RAR-βγ dual agonist, has shown to inhibit pro-inflammatory cytokines and fibrogenic factors such as TGF-β. It also reduced the accumulation of neutrophils and the activation of fibroblasts, which are key players in the development of fibrosis.
Additionally, a poster presented at the summit detailed the involvement of Type 1 Invariant Natural Killer T (iNKT) cells in lung fibrosis and how GRI-0621 can inhibit these cells, leading to improved inflammatory and fibrotic conditions in a preclinical model.
GRI Bio is currently advancing GRI-0621 through a Phase 2a clinical trial with IPF patients. The study aims to examine the drug's effect on iNKT cell activity and other key biomarkers. Interim data from the biomarker study is anticipated in the first quarter of 2025, with topline results expected in the second quarter of 2025.
This press release statement serves as the basis for this report, which aims to provide a factual overview of GRI Bio's recent developments without endorsing the claims or predicting the outcome of ongoing studies. The company's progress in the field of IPF treatment reflects its commitment to addressing unmet medical needs and advancing potential therapeutic solutions.
In other recent news, GRI Bio, a biotech firm, has made significant strides in expanding its financial capabilities and advancing its lead program, GRI-0621. The company successfully exercised warrants, raising approximately $0.8 million and extending its financial runway into mid-Q1 2025. This move will bolster the development of GRI-0621, an investigational treatment for Idiopathic Pulmonary Fibrosis (IPF).
Ascendiant Capital has initiated coverage on GRI Bio with a Buy rating, reflecting confidence in the company's approach to treating diseases with immune response irregularities. In addition to securing a patent in Japan for its Natural Killer T (NKT) cell modulators, GRI Bio has also received authorization from Australian regulatory authorities to commence a Phase 2a biomarker study for GRI-0621.
Financially, GRI Bio 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. It also announced a public offering of over 2 million shares of common stock and Series C warrants, expected to generate about $4 million.
Despite these positive developments, GRI Bio has been notified by the Nasdaq Stock Market regarding non-compliance with the exchange's minimum bid price requirement, placing its listing at risk. However, the company has been granted a 180-day period to regain compliance. These recent developments underscore GRI Bio's ongoing efforts in research, financial strategies, and corporate governance.
InvestingPro Insights
As GRI Bio, Inc. (NASDAQ: GRI) advances its promising drug candidate GRI-0621 for Idiopathic Pulmonary Fibrosis, investors should consider some key financial metrics and insights from InvestingPro.
According to InvestingPro data, GRI Bio's market capitalization stands at a modest $1.87 million, reflecting its early-stage status in drug development. The company's price-to-book ratio of 0.51 suggests that the stock is trading below its book value, which could indicate potential undervaluation if the company's clinical trials prove successful.
However, it's crucial to note that GRI Bio is currently not profitable, with an adjusted operating income of -$8.06 million for the last twelve months as of Q3 2023. This aligns with an InvestingPro Tip indicating that analysts do not anticipate the company will be profitable this year, which is common for biotechnology firms in the research and development phase.
Another InvestingPro Tip highlights that GRI Bio is quickly burning through cash, a critical factor for investors to monitor given the capital-intensive nature of drug development. Despite this, the company holds more cash than debt on its balance sheet, providing some financial flexibility as it progresses through clinical trials.
The stock's performance has been volatile, with a strong 27.52% return over the last three months, contrasting sharply with a 51.59% decline over the past month. This volatility is typical for small-cap biotech stocks, especially as they approach significant clinical milestones.
For investors seeking a more comprehensive analysis, InvestingPro offers 13 additional tips for GRI Bio, providing a deeper understanding of the company's financial health and market position.
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