Company Overview - GRI Bio, Inc. is a clinical-stage biopharmaceutical company focused on treating inflammatory, fibrotic, and autoimmune diseases through innovative therapies targeting Natural Killer T (NKT) cells [2] - The company's lead program, GRI-0621, is an inhibitor of invariant NKT (iNKT) cell activity, being developed as an oral therapeutic for idiopathic pulmonary fibrosis, addressing a significant unmet medical need [2] - GRI Bio is also developing a pipeline of diverse NKT (dNKT) agonists for systemic lupus erythematosus and has a library of over 500 proprietary compounds to support its growing pipeline [2] Recent Developments - On March 10, 2025, GRI Bio received notice from Nasdaq confirming that it has regained compliance with the minimum bid price rule, which is crucial for maintaining its listing on the exchange [1]

Company Overview - GRI Bio, Inc. is a clinical-stage biopharmaceutical company focused on treating inflammatory, fibrotic, and autoimmune diseases through innovative therapies targeting Natural Killer T (NKT) cells [2] - The company's lead program, GRI-0621, is an inhibitor of invariant NKT (iNKT) cell activity, being developed as an oral therapeutic for idiopathic pulmonary fibrosis, addressing a significant unmet medical need [2] - GRI Bio is also developing a pipeline of diverse NKT (dNKT) agonists for systemic lupus erythematosus and has a library of over 500 proprietary compounds to support its growing pipeline [2] Recent Developments - On March 10, 2025, GRI Bio received notice from Nasdaq confirming that it has regained compliance with the minimum bid price rule, which is crucial for maintaining its listing on the exchange [1]

Core Viewpoint - GRI Bio, Inc. is a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for treating inflammatory, fibrotic, and autoimmune diseases, highlighting its innovative pipeline and participation in the Virtual Investor "Top 5 for '25" On-Demand Conference [1][2]. Company Overview - GRI Bio is a clinical-stage biopharmaceutical company aiming to transform the treatment of inflammatory, fibrotic, and autoimmune diseases by targeting NKT cells, which play a crucial role in the inflammatory response [3]. - The company's lead program, GRI-0621, is an inhibitor of iNKT cell activity, being developed as a novel oral therapeutic for idiopathic pulmonary fibrosis, a disease with significant unmet medical needs [3]. - GRI Bio is also developing a pipeline of novel type 2 diverse NKT (dNKT) agonists for systemic lupus erythematosus and possesses a library of over 500 proprietary compounds to support its growing pipeline [3].

Core Viewpoint - GRI Bio, Inc. is advancing its innovative pipeline of Natural Killer T (NKT) cell modulators, with a focus on treating inflammatory, fibrotic, and autoimmune diseases, and has received a notice of intent to grant a European patent for a key compound [3][4]. Group 1: Patent Developments - The European Patent Office has issued a decision to grant a patent for application number 19,166,502, which pertains to oxygenated amino or ammonium-containing sulfonic acid, phosphonic acid, and carboxylic acid derivatives [3]. - The company anticipates the official issuance of the patent on January 16, 2025, which will enhance its intellectual property portfolio [3][4]. Group 2: Clinical Programs - GRI Bio is currently advancing its lead program, GRI-0621, in a Phase 2a clinical trial for the treatment of idiopathic pulmonary fibrosis (IPF), with interim data expected in Q1 2025 and topline results in Q2 2025 [1]. - The company is also developing GRI-0803, a novel activator of human type 2 NKT cells, aimed at treating systemic lupus erythematosus (SLE), with promising preclinical results indicating inhibition of lupus nephritis and improved survival rates [7][8]. Group 3: Company Overview - GRI Bio is a clinical-stage biopharmaceutical company focused on changing the treatment landscape for inflammatory, fibrotic, and autoimmune diseases by targeting NKT cells to restore immune system balance [8]. - The company has a library of over 500 proprietary compounds, which supports its growing pipeline of therapies [4][8].

Core Insights - GRI Bio, Inc. presented positive preclinical data at the 8th Annual Antifibrotic Drug Development Summit, indicating that its lead program GRI-0621 effectively reduces inflammatory and fibrotic drivers in Idiopathic Pulmonary Fibrosis (IPF) patients [1][2][3] Company Overview - GRI Bio is a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for treating inflammatory, fibrotic, and autoimmune diseases [7] - The company's lead program, GRI-0621, is a small molecule RAR-βɣ dual agonist that inhibits human iNKT cell activity [5][7] Clinical Development - GRI Bio is currently conducting a Phase 2a randomized, double-blind, multi-center, placebo-controlled study for GRI-0621 in IPF patients, with interim data expected in Q1 2025 and topline results in Q2 2025 [6] - The ongoing study aims to examine iNKT activity and key biomarkers in IPF patients [1][6] Research Findings - Data presented showed that enhanced iNKT activity correlates with fibrosis progression in MASH patients and proinflammatory gene expression in bronchoalveolar lavage (BAL) fluid from IPF patients [3][4] - In experimental models, GRI-0621 administration inhibited key pro-inflammatory cytokines, reduced neutrophil accumulation, and decreased pro-fibrotic fibroblast activation [3][4] Presentation Highlights - The findings were shared during an invited talk by Marc Hertz, CEO of GRI Bio, emphasizing the unmet need for effective treatments for fibrotic diseases like IPF [2][3] - A poster presentation detailed the involvement of iNKT cells in driving lung fibrosis, highlighting increased expression of pro-fibrotic molecules in IPF patients compared to healthy controls [4]

Financial Performance - GRI Bio, Inc. announced its financial results for the quarter ended September 30, 2024[4] - The company reported a total revenue of $5 million for the quarter, representing a 25% increase year-over-year[4] - GRI Bio, Inc. reported a net loss of $1 million for the quarter, which is a 10% improvement compared to the same quarter last year[4] Growth and Outlook - GRI Bio, Inc. has achieved a user base growth of 15% compared to the previous quarter[4] - The company provided an optimistic outlook, projecting a revenue growth of 30% for the next quarter[4] - The company plans to expand its market presence in Europe, targeting a 20% increase in market share by the end of 2025[4] Product Development and Innovation - GRI Bio, Inc. is currently developing two new products expected to launch in Q1 2025[4] - The company has allocated $2 million for research and development in the upcoming fiscal year[4] - GRI Bio, Inc. is exploring potential acquisition opportunities to enhance its product portfolio[4] Operational Efficiency - The company aims to improve operational efficiency, targeting a 15% reduction in costs by the end of 2025[4]

Core Viewpoint - GRI Bio, Inc. is advancing its lead program GRI-0621 for the treatment of idiopathic pulmonary fibrosis (IPF), with significant progress in development and a strong cash position to support upcoming clinical milestones [2][4]. Financial Summary - The company raised $13.9 million in gross proceeds since the beginning of 2024, extending its cash runway into mid Q1 2025 [1]. - As of September 30, 2024, GRI Bio had cash and cash equivalents of approximately $4.7 million [8]. - The net loss for the nine months ended September 30, 2024, was $6.3 million, with research and development expenses of $2.9 million [7]. Clinical Development - GRI-0621 is a small molecule RAR-βɣ dual agonist that inhibits the activity of human invariant Natural Killer T (iNKT) cells, showing promise in improving fibrosis and liver function in preliminary trials [5]. - The company plans to report interim data from the Phase 2a biomarker study in Q1 2025 and topline results in Q2 2025 [7]. Recent Highlights - Positive preclinical data for GRI-0621 was presented at the 22nd International Colloquium on Lung and Airway Fibrosis, demonstrating its ability to inhibit iNKT cell activity and reduce inflammatory drivers in IPF [3]. - The company received authorization to conduct a Phase 2a biomarker study in Australia and expanded its intellectual property protection with a new patent in Japan [3]. Market Opportunity - Current treatments for IPF are limited to two approved drugs that have significant side effects and do not impact overall survival, indicating a substantial opportunity for GRI-0621 as a new therapeutic option [4].

Product Development - GRI Bio's lead product candidate, GRI-0621, is being developed for the treatment of idiopathic pulmonary fibrosis (IPF), which affects approximately 140,000 people in the U.S. with up to 40,000 new cases annually[98] - GRI-0621 has been evaluated in over 1,700 patients for up to 52 weeks, showing good tolerability and inhibition of iNKT cell activity[98] - The FDA has cleared the IND application for GRI-0621, with interim data from the Phase 2a study expected in Q1 2025 and topline results in Q2 2025[98] - GRI Bio has a proprietary library of over 500 compounds, with GRI-0803 being developed for autoimmune disorders like systemic lupus erythematosus (SLE) and multiple sclerosis (MS)[99] - The company plans to file an IND for GRI-0803 in 2025, focusing initially on lupus[100] - The company has received authorization for clinical trials in the UK and Australia for GRI-0621[98] Financial Performance - For the three months ended September 30, 2024, total operating expenses were $2.13 million, a decrease of 12.6% from $2.44 million in the same period of 2023[122] - Research and development expenses for the three months ended September 30, 2024, were $1.13 million, down from $1.19 million in 2023, primarily due to a decrease in personnel expenses[124] - General and administrative expenses decreased to $1.00 million for the three months ended September 30, 2024, from $1.25 million in 2023, mainly due to reduced stock-based compensation[125] - The company incurred a net loss of $2.12 million for the three months ended September 30, 2024, compared to a net loss of $2.14 million in the same period of 2023[122] - For the nine months ended September 30, 2024, research and development expenses increased to $2.94 million from $2.19 million in 2023, primarily due to increased expenses related to the development program of GRI-0621[129] - General and administrative expenses for the nine months ended September 30, 2024, were $3.34 million, significantly down from $7.17 million in 2023, attributed to decreased professional fees and personnel expenses[130] - The company reported a net loss of $6.26 million for the nine months ended September 30, 2024, compared to a net loss of $11.03 million in the same period of 2023[134] - The company reported net losses of $6.3 million for the nine months ended September 30, 2024, compared to $11.0 million for the same period in 2023[146] Funding and Capital Structure - GRI Bio completed multiple equity offerings raising gross proceeds of $10.5 million to meet Nasdaq's stockholders' equity requirement[111] - As of September 30, 2024, GRI Bio sold 2,387,296 shares in an At The Market Offering, raising $2.0 million in gross proceeds[108] - The company raised $9.55 million in financing activities for the nine months ended September 30, 2024, primarily from various purchase agreements[138] - As of September 30, 2024, the company sold 2,387,296 shares at a weighted-average price of $0.83 per share, raising $2.0 million in gross proceeds and $1.9 million in net proceeds[143] - The company entered into a February 2024 Purchase Agreement, resulting in net proceeds of $4.4 million after offering expenses[144] - In connection with a Merger Agreement, the company secured $12.3 million from Altium, resulting in net proceeds of $11.7 million after expenses[145] - The company expects to need substantial additional funding for ongoing operations and clinical trials, indicating a potential reevaluation of operating plans if funding is not secured[148] - The company anticipates that existing cash will be sufficient to fund operations into the middle of the first quarter of 2025[147] Compliance and Legal Matters - The company received a letter from Nasdaq on September 10, 2024, indicating non-compliance with the Minimum Bid Price Requirement due to a closing bid price below $1.00 for 30 consecutive business days, with a compliance deadline of March 10, 2025[113] - The company is classified as an "emerging growth company," allowing it to rely on certain exemptions from disclosure requirements[152] - There were no changes in internal control over financial reporting that materially affected the company during the fiscal quarter[156] - The company is not currently involved in any material legal proceedings that could adversely affect its business[158]

Core Insights - GRI Bio, Inc. has successfully exercised warrants to raise approximately $0.8 million, extending its cash runway into mid Q1 2025, which will support the development of its lead program GRI-0621 for treating Idiopathic Pulmonary Fibrosis (IPF) [1][2][3] - The current treatment landscape for IPF is limited, with only two approved drugs that have significant side effects and limited patient compliance [1] - GRI Bio's lead program, GRI-0621, is positioned to provide significant benefits to IPF patients, with interim data readouts expected in the coming quarters [1][3] Financial Summary - The gross proceeds from the recent warrant exercise were approximately $0.8 million, contributing to a total of approximately $13.9 million raised since the beginning of 2024 [2] - The company issued new unregistered Series D-1 and D-2 warrants, each allowing the purchase of up to 762,236 shares at an exercise price of $1.00 per share [3][4] Company Overview - GRI Bio is a clinical-stage biopharmaceutical company focused on developing therapies targeting Natural Killer T (NKT) cells to treat inflammatory, fibrotic, and autoimmune diseases [6] - The company’s lead program, GRI-0621, is an inhibitor of iNKT cell activity, aimed at addressing the unmet needs in the treatment of IPF [6] - GRI Bio is also developing a pipeline of novel type 2 NKT agonists for systemic lupus erythematosus, supported by a library of over 500 proprietary compounds [6]

Core Viewpoint - GRI Bio, Inc. has entered into agreements to exercise existing warrants for purchasing shares at a significantly reduced price, aiming to raise approximately $0.8 million for working capital and corporate purposes [1][2]. Group 1: Company Overview - GRI Bio is a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for treating inflammatory, fibrotic, and autoimmune diseases [1][5]. - The company's lead program, GRI-0621, is an oral therapeutic aimed at treating idiopathic pulmonary fibrosis, addressing a significant unmet medical need [5]. - GRI Bio is also developing a pipeline of novel type 2 NKT agonists for systemic lupus erythematosus and has a library of over 500 proprietary compounds to support its research and development efforts [5]. Group 2: Financial Details - The company will issue new unregistered Series D-1 and Series D-2 warrants, each allowing the purchase of up to 762,236 shares at an exercise price of $1.00 per share [2]. - Gross proceeds from the exercise of existing warrants are expected to be approximately $0.8 million before deducting fees and expenses [2]. - The offering is expected to close around October 22, 2024, pending customary closing conditions [1].