GRI Bio (NASDAQ: GRI) Participates in Virtual Investor “What This Means” Segment Highlighting Positive Preclinical Data from Idiopathic Pulmonary Fibrosis (IPF) and Systemic Lupus Erythematosus (SLE) Programs
GRI Bio (NASDAQ: GRI) has participated in a Virtual Investor 'What This Means' segment, showcasing positive preclinical data from its Idiopathic Pulmonary Fibrosis (IPF) and Systemic Lupus Erythematosus (SLE) programs. The data was presented at the 2024 American Thoracic Society International Conference and the 14th International Congress on Autoimmunity.
Key personnel, including CEO Marc Hertz, discussed the implications of these findings for the company's IPF program (GRI-0621) and SLE development programs (GRI-0803 and GRI-0124). The company reiterated 2024 as a pivotal year, with significant milestones expected, such as interim and topline results from Phase 2a biomarker studies for GRI-0621, and completion of IND-enabling studies and initial clinical trials for GRI-0803.
The Virtual Investor segment is now available online for further insights.
- Positive preclinical data for IPF and SLE programs presented at major conferences.
- CEO and other key officers provided detailed insights, enhancing transparency.
- Upcoming milestones set for 2024, including Phase 2a biomarker study results for GRI-0621.
- GRI-0803 expected to complete IND-enabling studies and file IND by Q3 2024.
- No mention of current revenue or financial performance.
- Dependent on successful completion of clinical trials, which carry inherent risks.
- Future milestones may be subject to delays or negative outcomes.
- No immediate clinical data supporting market authorization.
Insights
GRI Bio's announcement of positive preclinical data in its programs for Idiopathic Pulmonary Fibrosis (IPF) and Systemic Lupus Erythematosus (SLE) is noteworthy. This development involves Natural Killer T (NKT) cell modulators, a novel approach in treating these challenging diseases. Preclinical data is an early, yet critical step in drug development, indicating that the therapy might be effective and safe in animal models. Investors should be cautiously optimistic, as this data will need to be validated in human trials. Importantly, the expected upcoming milestones throughout 2024, especially around Phase 2a and Phase 1 trials, will be pivotal. These results will provide clearer insights into the drug's efficacy and safety in humans, significantly impacting the company's valuation and investor sentiment.
From a financial perspective, GRI Bio's reiteration of 2024 as a 'year of data' is essential. Investors should monitor the timeline closely, especially the interim and topline results from the Phase 2a biomarker study of GRI-0621 expected in Q3 and Q4 2024, respectively. Positive results here could lead to increased investor confidence and potential partnerships or funding opportunities. However, the biotechnology sector is inherently risky and negative trial results might lead to significant stock volatility. Understanding the company's cash runway and funding needs will be important as they advance these programs through expensive clinical trials.
Data recently presented at the 2024 American Thoracic Society International Conference and the 14th International Congress on Autoimmunity
Company reiterates 2024 as year of data
Click here to watch the “What This Means” segment
LA JOLLA, CA, May 22, 2024 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio,” “we,” “our,” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (NKT) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced the release of a Virtual Investor “What This Means” segment.
Watch the “What This Means” video here
As part of this “What This Means” segment, Marc Hertz, PhD, Chief Executive Officer, Albert Agro, PhD, Chief Medical Officer and Vipin Kumar Chaturvedi, PhD, Chief Scientific Officer of GRI Bio discuss the encouraging preclinical data that was recently presented and what this means for its IPF program, GRI-0621, and SLE development programs, GRI-0803 and GRI-0124. Additionally, the Company reiterated its expected upcoming milestones and 2024 as a year of data.
Expected GRI-0621 Upcoming Milestones
- Q3 2024: Report interim data from Phase 2a biomarker study
- Q4 2024: Report topline results from Phase 2a biomarker study
Expected GRI-0803 Upcoming Milestones
- Q3 2024: Complete IND-enabling studies
- Q3 2024: File IND and launch Phase 1a/b
- Q4 2024: Report Phase 1a single ascending dose (SAD) study topline results
- Q4 2024: Report Phase 1b multiple ascending dose (MAD) study topline results
The Virtual Investor "What This Means" segment featuring GRI Bio is now available here. Additional videos from the "What This Means" series are available on demand at www.virtualinvestorco.com.
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 Bio’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 1 invariant (iNKT) cells play a critical role in propagating the injury, inflammatory response, and fibrosis observed in inflammatory and fibrotic indications. GRI Bio’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 idiopathic pulmonary fibrosis, 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 Bio has the ability to fuel a growing pipeline.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions. These forward-looking statements are based on the Company’s current beliefs and expectations. Forward-looking statements include, but are not limited to, statements regarding: the Company’s expectations with respect to development and commercialization of the Company’s product candidates, the timing of initiation or completion of preclinical studies, clinical trials and availability of resulting data or other milestones, the potential benefits and impact of the Company’s preclinical studies, clinical trials and product candidates and any implication that the data or results observed in preclinical studies or earlier studies or trials will be indicative of results of later studies or clinical trials, any implication that the Company’s product candidates will perform similarly to other candidates or approved therapies, the Company’s beliefs and expectations regarding future financial performance, and the Company’s beliefs about the timing and outcome of regulatory approvals and potential regulatory approval pathways. Actual results may differ from the forward-looking statements expressed by the Company in this press release and consequently, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including, without limitation: (1) the inability to maintain the listing of the Company’s common stock on Nasdaq and to comply with applicable listing requirements; (2) changes in applicable laws or regulations; (3) the inability of the Company to raise financing in the future; (4) the success, cost and timing of the Company’s product development activities; (5) the inability of the Company to obtain and maintain regulatory clearance or approval for its respective products, and any related restrictions and limitations of any cleared or approved product; (6) the inability of the Company to identify, in-license or acquire additional technology; (7) the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently developing; (8) the size and growth potential of the markets for the Company’s products and services, and their respective ability to serve those markets, either alone or in partnership with others; (9) the failure to achieve any milestones or receive any milestone payments under any agreements; (10) inaccuracy in the Company’s estimates regarding expenses, future revenue, capital requirements and needs for and the ability to obtain additional financing; (11) the Company’s ability to protect and enforce its intellectual property portfolio, including any newly issued patents; and (12) other risks and uncertainties indicated from time to time in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including the risks and uncertainties described in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K filed with the SEC on March 28, 2024 and subsequently filed reports. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.
Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
GRI@jtcir.com
FAQ
What recent data did GRI Bio present for its IPF and SLE programs?
What are the expected milestones for GRI Bio in 2024?
When will GRI Bio report interim data from the Phase 2a biomarker study for GRI-0621?
What are the next steps for GRI-0803 in 2024?
