Here are a few analogies to describe GRI Bio:

• An early-stage Vertex Pharmaceuticals, but specialized in developing novel treatments for inflammatory and autoimmune diseases.
• A specialized biotech focused on a new therapeutic approach (NKT cell modulation), similar to how CRISPR Therapeutics focuses on gene-editing for various diseases.

• GRI-0128: A clinical-stage therapeutic candidate designed as an NKT cell activator for the treatment of psoriasis and other autoimmune diseases.
• GRI-0621: A therapeutic candidate developed as an NKT cell activator for the treatment of severe asthma.
• GRI-0803: An NKT cell activator therapeutic candidate currently in development for Systemic Lupus Erythematosus (SLE) and other autoimmune diseases.
• GRI-0414: A pre-clinical NKT cell activator therapeutic candidate being developed for the treatment of Type 1 Diabetes.

GRI Bio (symbol: GRI) is a clinical-stage biotechnology company focused on developing an innovative class of Natural Killer T (NKT) cell modulators for various autoimmune, inflammatory, and fibrotic diseases.

Due to its stage of development, GRI Bio does not currently have "major customers" in the traditional sense of companies or individuals purchasing commercial products. The company's primary activities are research and development, aiming to advance its drug candidates through preclinical and clinical trials.

As a clinical-stage biotech, GRI Bio's business model is centered on developing promising drug candidates. If successful in their clinical development, these candidates would typically be licensed to or acquired by larger pharmaceutical companies for late-stage development, regulatory approval, and commercialization. Therefore, GRI Bio's "customers" are primarily potential future strategic partners within the global pharmaceutical and biotechnology industry, rather than existing companies or individuals currently purchasing products.

Since these are potential future partners and not current customers with ongoing sales agreements for commercial products, specific customer names and symbols cannot be identified at this time.

Marc Hertz, PhD President, Chief Executive Officer and Director

Marc Hertz has a distinguished career in the biopharmaceutical industry, currently serving as the President and Chief Executive Officer of GRI Bio. He previously held leadership roles including Chairman of Multimeric Biotherapeutics, Managing Director of Bird Rock Biotech Consultancy, and CEO of Pharmexa Inc. Dr. Hertz co-founded Multimeric Biotherapeutics, Inc. in 2008 and GlycoRegImmune, Inc.. With over 20 years of experience in biotech R&D, business development, and executive leadership, he also directed company strategy, investor relations, and participated in multiple rounds of public fundraising at Pharmexa-Epimmune, Inc..

Leanne Kelly Chief Financial Officer

Leanne Kelly brings over 20 years of experience in financial management, reporting, and regulatory compliance across life science, technology, and e-Commerce sectors, with a foundation in public accounting. She began her career as a Senior Auditor at KPMG LLP. Her past roles include SEC Accountant at Luminant Worldwide, Controller at Lamina Ceramics, Chief Financial Officer at Genaera Corporation, and President of her own consulting firm, Kelly Consulting Limited. She also served as Controller at Iroko Pharmaceuticals, LLC, Senior Vice President of Finance at Conventus-Flower Orthopedics, Controller and Executive Director of Global Financial Reporting at Optinose, Inc., and Chief Financial Officer of Vallon Pharmaceuticals, Inc., which completed a merger with GRI Bio. Ms. Kelly is a licensed CPA.

Vipin Kumar Chaturvedi, PhD Chief Scientific Officer

Vipin Kumar Chaturvedi is a co-founder of GRI Bio, Inc.. His extensive academic background includes a BS in Biology from Kanpur University, an MSc in Biochemistry, Molecular Biology, and Immunology, and a PhD in Biochemistry. He completed research fellowships at Harvard University and California Institute of Technology. Dr. Chaturvedi's research, often conducted at the University of California San Diego's Division of Gastroenterology, focuses on identifying and characterizing cellular and molecular mechanisms in immune regulation mediated by innate-like NK T cell subsets, as well as regulatory CD4 and CD8 T cell subsets in inflammatory and autoimmune diseases. He also investigates how the gut microbiome influences these immune regulatory mechanisms to control inflammation.

Albert Agro, PhD Chief Medical Officer

Albert Agro is a co-founder of GRI Bio Inc., where he was instrumental in the company's IPO, NASDAQ listing, and securing $30 million in financing to advance its NKT cell modulator platform. He is currently the CEO of Jocasta Neuroscience Inc. and previously served as CEO and President of Sublimity Therapeutics Ltd., an Irish biotech company, where he raised over $75 million for clinical programs. Dr. Agro has held numerous executive positions, including CEO of Colomba Therapeutics and Versanum, and Chief Medical Officer (CMO) at KalGene Inc., Cynapsus, Ironshore Pharma, Trillium Therapeutics Inc., and Stem Cell Therapeutics. He also served as EVP of Clinical Development at TransTech Pharma. Notably, Cynapsus, where he was CMO, was acquired by Sunovion for $850 million. He maintains a professorship at McMaster University and holds board positions with Diamond Therapeutics, Imunexus Ltd, and SE Health.

The key risks for GRI Bio (GRI) are primarily centered around the inherent challenges of being a clinical-stage biopharmaceutical company, particularly concerning its lead product candidate, GRI-0621. These risks include:

1. Clinical Trial Success: As a clinical-stage biopharmaceutical company, GRI Bio's business success is heavily dependent on the favorable outcomes of its ongoing and future clinical trials, especially for its lead candidate, GRI-0621, which is being developed for idiopathic pulmonary fibrosis (IPF). While interim safety results for GRI-0621 have been positive, these are preliminary, and there is no guarantee that additional or final results will demonstrate sufficient efficacy or safety to advance the product further or secure approval. The failure of clinical trials would significantly impede the company's ability to bring products to market.
2. Ability to Raise Future Financing: GRI Bio faces significant risks related to its ability to secure future financing to fund its operations and product development. The company has a history of raising capital through public offerings to maintain its liquidity and advance its pipeline. Its cash runway has been noted as limited, emphasizing a continued reliance on external funding. Furthermore, there have been concerns regarding the company's ability to maintain its Nasdaq listing, which is often tied to financial compliance and could impact its access to capital markets.
3. Regulatory Approvals: The company faces the critical risk of obtaining and maintaining regulatory approvals for its product candidates. The regulatory process for new pharmaceutical drugs is extensive, expensive, and uncertain, and there is no assurance that GRI Bio's candidates will receive the necessary clearances or approvals from regulatory bodies, which is essential for commercialization and revenue generation.

GRI Bio (symbol: GRI) is a clinical-stage biopharmaceutical company focused on inflammatory, fibrotic, and autoimmune diseases. The addressable markets for their main product candidates are as follows:

GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF)

• The global idiopathic pulmonary fibrosis treatment market was estimated to be between USD 3.12 billion and USD 4.54 billion in 2024. [cite: 1, 3, 4, 5 (previous search output)]
• Projections indicate the global market is expected to reach between USD 5.46 billion by 2030 and USD 8.6 billion by 2033, with Compound Annual Growth Rates (CAGR) ranging from 6.8% to 9.2% during the forecast periods. [cite: 1, 3, 4, 5 (previous search output)]
• The IPF market across the top 7 markets (U.S., EU4, UK, and Japan) was valued at USD 3,805.2 million in 2024 and is projected to reach USD 7,451.4 million by 2035. [cite: 2 (previous search output)] The U.S. has the largest patient pool and represents the largest market for IPF treatment. [cite: 2 (previous search output)]
• North America dominated the global market with a revenue share of 37.5% in 2024. [cite: 1 (previous search output)]

GRI-0803 for Systemic Lupus Erythematosus (SLE)

• The global systemic lupus erythematosus (SLE) drugs market was valued between USD 2.24 billion and USD 3.97 billion in 2024.
• The global market for SLE drugs is projected to grow to between USD 3.66 billion by 2030 and USD 11.70 billion by 2035, with CAGRs ranging from 5.54% to 10.91% during the forecast periods.
• North America is reported as the largest market for SLE drugs. In 2024, North America held approximately 43.64% of the systemic lupus erythematosus market share.

GRI-0124 for Primary Sclerosing Cholangitis (PSC)

• The global primary sclerosing cholangitis (PSC) market was valued between USD 151.07 million (for the 7 major markets) and USD 337 million in 2024.
• The global market is expected to grow to between USD 298.6 million by 2032 and USD 661 million by 2032, with CAGRs ranging from 7.6% to 8.0% during the forecast periods.
• North America dominated the global primary sclerosing cholangitis market in terms of revenue share and is expected to maintain its dominance.

ADAIR and ADMIR for Attention-Deficit/Hyperactivity Disorder (ADHD)

• The global attention deficit hyperactivity disorder (ADHD) therapeutics market size was calculated between USD 13.7 billion and USD 35.17 billion in 2024.
• Forecasts indicate the global market is expected to reach between USD 19.6 billion by 2032 and USD 76.96 billion by 2033, with CAGRs ranging from 3.6% to 9.09% during the forecast periods.
• North America leads the ADHD therapeutics market.

1. Successful Clinical Development and Potential Commercialization of GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF): GRI Bio's lead drug candidate, GRI-0621, is a novel oral therapeutic targeting Type 1 invariant Natural Killer T (iNKT) cells for the treatment of Idiopathic Pulmonary Fibrosis (IPF). IPF represents a significant unmet medical need with a $1.5 billion market ripe for innovation. The company anticipates reporting 6-week interim biomarker data from its Phase 2a study in Q2 2025 and topline results from the Phase 2a biomarker study in Q3 2025. Positive results from these trials are crucial, as they could validate GRI-0621's dual anti-inflammatory and anti-fibrotic mechanism, which directly addresses the underlying pathology of IPF, potentially offering superior efficacy and tolerability compared to existing treatments. Should the trials prove successful, this would pave the way for further clinical development, regulatory approvals, and ultimately, the commercial launch and sales of GRI-0621, driving substantial revenue growth.
2. Advancement and Potential Future Commercialization of Pipeline Candidates in Other Inflammatory, Fibrotic, and Autoimmune Diseases: Beyond GRI-0621, GRI Bio is also developing a pipeline of novel type 2 diverse NKT (dNKT) agonists, including GRI-0803 and GRI-0124, for the treatment of systemic lupus erythematosus (SLE). While GRI-0621 is the primary focus, positive preclinical data has been reported for these SLE programs. The continued progress of these additional candidates through preclinical and clinical development, potentially leading to new product launches, could diversify GRI Bio's revenue streams in the future, particularly as development of GRI-0803 is planned to continue in 2025, contingent on additional funding.
3. Strategic Partnerships and Licensing Agreements: As a clinical-stage biotechnology company, GRI Bio's future revenue could significantly benefit from strategic partnerships and licensing agreements. The company has already engaged in collaborations, such as with the NIHR Respiratory Translational Research Collaboration, to advance its NKT regulation technology. Such collaborations, or future licensing deals related to their innovative NKT cell modulator technology or specific drug candidates, could generate upfront payments, milestone payments triggered by development achievements, and potential royalties on future product sales.
4. Expansion and Protection of Intellectual Property Portfolio: While not a direct revenue generator, the continuous strengthening of GRI Bio's global intellectual property (IP) portfolio is a critical enabler of future revenue growth. The company has been granted patents in Europe and Japan covering GRI-0803 and its extensive library of over 500 proprietary compounds. A robust IP portfolio protects their innovations, enhances the value of their drug candidates, and provides a competitive advantage, which is essential for attracting partners, securing favorable licensing terms, and ensuring market exclusivity upon commercialization.

Share Issuance

• GRI Bio closed a public offering in April 2025, generating approximately $5.0 million in gross proceeds through the issuance of common stock and warrants.
• The Series Warrants issued in April 2025, if fully exercised, could yield approximately $13.3 million in additional gross proceeds for the company.
• The company has raised approximately $13.9 million in total gross proceeds from financings since the beginning of 2024, including $0.8 million from the exercise of existing warrants in October 2024.

Inbound Investments

• GRI Bio raised approximately $13.9 million in gross proceeds through various financings, including public offerings and warrant exercises, since the beginning of 2024.
• A $5.0 million public offering in April 2025 involved the issuance of common stock and warrants, with participation from healthcare-focused institutional investors.

Capital Expenditures

• Research and development expenses, a key area of capital allocation for GRI Bio, were $3.2 million for the year ended December 31, 2023, a significant increase from $0.2 million in 2022.
• The primary focus of the increased research and development expenditures in 2023 was the advancement of the GRI-0621 development program, along with personnel, consulting fees, and intellectual property expenses.
• The net proceeds from recent offerings are intended to be used for product candidate development, working capital, and general corporate purposes.