Access the “What This Means” segment here LA JOLLA, CA, Feb. 17, 2026 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” 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 that it participated in a Virtual Investor “What This Means” segment. As part of the segment, Marc Hertz, PhD, President, Chief Executive Officer and Director of GRI Bio, discuss ...

Summary of Conference Call on GRI Bio Company Overview - **Company**: GRI Bio - **Industry**: Biopharmaceuticals, specifically focusing on treatments for inflammatory, fibrotic, and autoimmune diseases [2][3] Core Points and Arguments Pipeline and Lead Programs - GRI Bio is advancing a pipeline of immune modulators targeting inflammatory, fibrotic, and autoimmune diseases [3] - The lead program, **GRI-0621**, is an oral RAR beta gamma agonist aimed at treating idiopathic pulmonary fibrosis (IPF) [3][4] - A second program, **GRI-0803**, targets regulatory T-cells and is focused on systemic lupus erythematosus (SLE) [15] Phase 2A Study Results - GRI Bio recently reported positive Phase 2A data for GRI-0621 in IPF, a chronic progressive pulmonary disease with a median survival of 3-5 years [4][5] - The study involved 35 subjects, with a 2:1 randomization between active and control arms, and 80% of subjects were on background therapy with approved drugs [5][6] - Primary endpoints were safety and tolerability, with secondary endpoints focusing on biomarkers and exploratory endpoints on lung function [6] Efficacy and Safety - GRI-0621 was found to be safe and well-tolerated, with no overlapping gastrointestinal toxicities compared to standard care [6][7] - Positive trends were observed in biomarkers related to collagen turnover and immunomodulation, suggesting potential disease-modifying activities [8] - Lung function data showed a 95% increase in subjects preserving or increasing forced vital capacity (FVC) and a 60% decrease in subjects experiencing significant decline in FVC [9][14] Comparison with Current Treatments - Current approved drugs for IPF slow disease progression but do not significantly impact survival and have serious side effects, leading to high discontinuation rates [5][17] - GRI Bio aims to not only slow decline but potentially reverse disease progression, indicating true disease-modifying potential [17][19] Future Directions and Partnerships - GRI Bio is preparing for a Phase 2B study and is open to strategic partnerships to support the next stage of development [20] - The company is also advancing the GRI-0803 program, with plans to file an IND for SLE later this year [21] Additional Important Information - The biopharmaceutical market for IPF treatments is substantial, with current drugs generating over $4 billion annually despite their limitations [5] - The company has a library of about 500 proprietary compounds, indicating a robust pipeline for future development [4] - The focus on biomarkers and their correlation with clinical outcomes is a key aspect of GRI Bio's strategy, providing confidence in the potential for meaningful clinical impacts [17]

Core Viewpoint - GRI Bio, Inc. is participating in the Corporate Connect Webinar Series hosted by Webull Financial on February 10-11, 2026, to discuss its innovative pipeline of immune cell modulators for treating inflammatory, fibrotic, and autoimmune diseases [1][2]. Company Overview - GRI Bio is a clinical-stage biopharmaceutical company focused on transforming the treatment of inflammatory, fibrotic, and autoimmune diseases through therapies targeting Natural Killer T (NKT) cells [3]. - The company's lead program, GRI-0621, is an RARβγ agonist aimed at inhibiting iNKT cell activity and is being developed as an oral therapeutic for idiopathic pulmonary fibrosis, a disease with significant unmet needs [3]. - GRI Bio is also developing a pipeline of novel type 2 diverse NKT (dNKT) agonists for systemic lupus erythematosus and has a library of over 500 proprietary compounds to support its growing pipeline [3]. Webinar Details - The presentation will take place on February 11, 2026, at 1:00 PM EST, led by Marc Hertz, PhD, the President and CEO of GRI Bio [2].

Financial Results - GRI Bio, Inc. reiterated its financial results for the fiscal year 2025 on February 4, 2026[4]. - The financial statements and exhibits are not deemed "filed" under the Securities Exchange Act of 1934[5]. Company Classification - The company is classified as an emerging growth company under the Securities Act of 1933[3]. Press Release - A press release summarizing key recent highlights was issued, which is attached as Exhibit 99.1[4]. Data Presentation - The report includes a Cover Page Interactive Data File embedded within the Inline XBRL document[6].

Core Insights - GRI Bio, Inc. reported a cash position of $8.2 million as of December 31, 2025, and raised an additional $6.5 million in January 2026, strengthening its balance sheet to fund operations into Q1 2027 [1][4] - The company announced strong Phase 2a clinical data for GRI-0621 in idiopathic pulmonary fibrosis (IPF), reinforcing its clinical proof-of-concept and therapeutic differentiation [1][8] - GRI-0803, focused on autoimmune indications with high unmet need, is advancing through IND-enabling activities [1][8] Financial Summary - For the year ended December 31, 2025, GRI Bio reported a net loss of $12 million, with research and development expenses increasing to $6.8 million from $3.8 million in 2024, primarily due to the registration development program of GRI-0621 [5] - General and administrative expenses rose to $5.2 million in 2025 from $4.5 million in 2024, mainly due to increased personnel costs [6] Recent Highlights - The company raised approximately $14.5 million in gross proceeds in December 2025 and January 2026, ensuring a strong cash position to fund operations into Q1 2027 [8] - Positive Phase 2a topline data from the completed clinical study of GRI-0621 in IPF was announced, along with additional data demonstrating suppression of pro-fibrotic immune phenotypes [8] - New RNA-sequencing gene expression data was generated, showing a direct impact on the core biology of fibrosis and lung repair [8] - Plans to progress GRI-0803 into IND-enabling studies were advanced, expanding the company's pipeline in autoimmune diseases [8]

FDA Approvals & Rejections - Intellia Therapeutics has received FDA approval to resume its MAGNITUDE-2 Phase 3 trial for nexiguran ziclumeran (nex-z) targeting hereditary transthyretin amyloidosis with polyneuropathy, increasing target enrollment from 50 to 60 patients [2][4] - Outset Medical's next-generation Tablo Hemodialysis System has been granted FDA 510(k) clearance, making it the first dialysis device to meet enhanced cybersecurity standards, with shipping expected to begin in Q2 2026 [6][7] - OKYO Pharma has received positive feedback from the FDA for its Phase 2b/3 trial design for Urcosimod, a candidate for neuropathic corneal pain, with plans to start the trial in the first half of 2026 [8][9] - REGENXBIO has faced clinical holds on its RGX-111 and RGX-121 gene therapy programs due to a case of CNS tumor in a child treated with RGX-111, although no similar findings were reported in other patients [10][11] - Almirall has received NMPA approval for Seysara in China for treating moderate-to-severe acne vulgaris, expanding its dermatology portfolio in the region [12][13] Clinical Trials - Breakthroughs - Aprea Therapeutics reported early clinical activity for APR-1051 in endometrial cancer, achieving a 50% reduction in target lesion size in a patient with PPP2R1A-mutated uterine serous carcinoma [19][21] - Fractyl Health's Revita demonstrated positive results in weight maintenance after GLP-1 drug discontinuation, showing a 4.5% weight regain compared to 7.5% in the sham group [22][24] - Ascletis Pharma announced positive Phase 3 results for Denifanstat in moderate-to-severe acne vulgaris, focusing on long-term safety in a trial with 240 patients [25][26] - GRI Bio reported new gene expression data from its Phase 2a study of GRI-0621 in idiopathic pulmonary fibrosis, showing significant improvements in lung injury and fibrosis progression [27][28] - Cardiff Oncology announced encouraging results from its Phase 2 trial of Onvansertib in RAS-mutated metastatic colorectal cancer, with a well-tolerated regimen and plans to advance to a registrational program [31][32] - Genentech's CT-388 Phase 2 trial for obesity showed a significant placebo-adjusted weight loss of 22.5% at 48 weeks, with a high percentage of participants achieving significant weight loss [34][36] - Sarepta Therapeutics reported positive three-year results from its EMBARK study for ELEVIDYS in Duchenne muscular dystrophy, showing significant slowing of disease progression in treated patients [38][41] Deals - YD Bio Limited has signed a letter of intent to acquire Safe Save Medical for approximately $26.87 million, aiming to enhance its capabilities in advanced cellular therapeutics [14][15][17]

Financial Performance and Concerns - The company has incurred significant net losses since inception and expects to continue incurring substantial losses for the foreseeable future[26]. - Management has expressed substantial doubt about the company's ability to continue as a going concern, with independent auditors highlighting this uncertainty[26]. - The company has identified material weaknesses in internal controls over financial reporting, which could impair the accuracy of financial statements[30]. - Future sales and issuances of securities may lead to dilution of stockholder ownership and potential declines in share price[30]. - The January 2026 Reverse Stock Split may have negatively impacted stock price and liquidity of common stock[30]. Capital Requirements and Development Challenges - The company requires substantial additional capital to finance operations, particularly to complete a Phase 2b clinical trial of GRI-0621[26]. - The company is highly dependent on the success of product candidates GRI-0621 and GRI-0803, which require significant additional development before seeking regulatory approval[26]. - Clinical development is lengthy, complex, and expensive, with uncertain outcomes that may not be predictable from early-stage trials[26]. Market and Operational Risks - The company may face challenges in obtaining adequate reimbursement or insurance coverage for approved product candidates, limiting marketability and revenue generation[26]. - The company relies on third parties for clinical trials and manufacturing, and failures in these collaborations could adversely affect business[27].

Core Insights - GRI Bio, Inc. announced positive data from its Phase 2a clinical study of GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF), indicating potential disease-modifying effects and therapeutic differentiation [1][10] Gene Expression and Mechanism - RNA-sequencing data showed significant improvement in genes related to lung injury, myofibroblast activation, and fibrosis progression in GRI-0621 treated subjects compared to placebo, validating previous biomarker findings [2][4] - The treatment demonstrated modulation of differentially expressed genes (DEGs) linked to key disease drivers, supporting a mechanism of fibrosis resolution and tissue repair rather than mere symptomatic management [3][4] Lung Regeneration Evidence - GRI-0621 treatment was associated with repair of the alveolar basement membrane and transition of AT2 to AT1 epithelial cells, indicating true lung regeneration rather than just slowing disease progression [5][6] - Earlier data indicated changes in type IV collagen serum biomarkers, suggesting an alveolar repair mechanism, which is now supported by new gene expression findings [6] Consistency Across Data - The new results reinforce previously announced topline data, showing that GRI-0621 treatment led to decreased neutrophil activity, reduced synthesis of fibrillar collagens, and lower levels of pro-fibrotic cytokines [8][9] - The treatment was well-tolerated, differentiating it from existing options that primarily slow disease decline while having significant side effects [7][10] Clinical Study Outcomes - The Phase 2a study met its primary endpoint with favorable safety and tolerability, and multiple secondary endpoints indicative of disease-modifying activity were achieved [12] - Improvements were noted in forced vital capacity (FVC), with twice as many GRI-0621-treated subjects experiencing no decline in FVC at 12 weeks compared to standard care [12]

Core Insights - GRI Bio, Inc. has received U.S. Patent No. 12,528,775, enhancing its intellectual property protection for its immunomodulator compounds targeting inflammatory, fibrotic, and autoimmune diseases [1][2][3] Intellectual Property - The newly issued patent includes claims for a distinct class of proprietary compounds characterized by linked molecular structures forming pyrrolidine, piperidine, or azepane ring systems, which are a significant advancement over previous patents [2] - This patent strengthens GRI Bio's intellectual property estate, providing independent protection for a valuable subset of its chemistry platform [3] Product Development - GRI Bio is focused on advancing its lead program, GRI-0621, which is an RARβγ agonist aimed at treating idiopathic pulmonary fibrosis, a disease with significant unmet medical needs [4][5] - The company is also developing a pipeline of novel type 2 diverse NKT (dNKT) agonists for systemic lupus erythematosus, supported by a library of over 500 proprietary compounds [5]

Summary of GRI Bio Inc. Extraordinary General Meeting Company Overview - **Company Name**: GRI Bio Inc. - **Stock Symbol**: NasdaqCM: GRI - **Meeting Date**: January 15, 2026 Key Points Discussed Meeting Attendance and Quorum - A total of **4,874,725 shares** were present, representing **48.16%** of the outstanding voting stock, confirming a quorum for the meeting [2] Proposals Voted Upon 1. **Amendment Proposal**: - Approval of an amendment to the Amended and Restated Certificate of Incorporation to effect a **reverse stock split** of the company's Common Stock at a ratio between **1 for 2** and **1 for 30**. - The exact ratio will be determined by the Board of Directors, and they have the discretion to abandon the proposed amendment [3] 2. **Adjournment Proposal**: - Approval for the adjournment of the special meeting to a later date if necessary, to allow further solicitation and voting of proxies in case there are insufficient votes for the amendment proposal [4] Voting Process - Voting was conducted via proxy and electronic ballot, with an option for stockholders to vote during the meeting [5] - Preliminary results indicated that both the amendment and adjournment proposals received the requisite votes for approval [5] Conclusion of Meeting - Both proposals were declared duly approved, with final voting results expected to be reported on Form 8-K to the SEC within four business days [6] - The meeting concluded with appreciation expressed to stockholders for their participation [6][7] Additional Important Information - The meeting was attended by key executives including the CEO, CFO, and legal counsel, indicating a structured approach to governance and compliance [1] - The ability for the Board to abandon the reverse stock split proposal highlights a level of flexibility in corporate governance [3]