Financial Results - GRI Bio, Inc. reiterated its financial results for the fiscal year 2025 on February 4, 2026[4]. Company Classification - The company is classified as an emerging growth company under the Securities Act of 1933[3]. Recent Highlights - A press release summarizing key recent highlights was issued, which is attached as Exhibit 99.1[4].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 or ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-40034 GRI BIO, INC. (Exact name of registrant as specified in its charter) | Delaware | | 82-4369909 | | --- | --- ...

As filed with the Securities and Exchange Commission on December 9, 2025. Registration No. 333-291999 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GRI BIO, INC. (Exact name of registrant as specified in its charter) (Primary Standard Industrial Classification Code Number) Delaware 2834 82-4369909 (I.R.S. Employer Identification Number) 2223 Avenida de la Playa, #208 La Jolla, CA 92037 (619) 400-117 ...

As filed with the Securities and Exchange Commission on December 8, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GRI BIO, INC. (Exact name of registrant as specified in its charter) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) (State or other jurisdiction of incorporation or organization) 2223 Avenida de la Playa, #208 La Jolla, CA 92037 ...

Product Development - GRI-0621, the lead product candidate, has been evaluated in over 1,700 patients for up to 52 weeks, targeting severe fibrotic lung diseases like idiopathic pulmonary fibrosis (IPF), which affects approximately 140,000 people annually in the U.S.[77] - The company expects to release topline results from the Phase 2a biomarker study of GRI-0621 by the end of November 2025[78] - The FDA has cleared the Investigative New Drug application for GRI-0621, allowing the initiation of clinical trials in the U.S., U.K., and Australia[78] - The company 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)[79] - The company plans to complete IND-enabling studies for GRI-0803 in 2026, pending additional funding[80] - The company is preparing for planned clinical trials of GRI-0621 and GRI-0803, which will require substantial financial resources[113] Financial Performance - Total operating expenses for the three months ended September 30, 2025, were $3.4 million, up from $2.1 million in 2024, resulting in a loss from operations of $3.4 million[94] - The company reported a net loss of $3.4 million for the three months ended September 30, 2025, compared to a net loss of $2.1 million in 2024[94] - The net loss for the nine months ended September 30, 2025, was $9.3 million, compared to a net loss of $6.3 million in 2024, reflecting a 48% increase in losses[104] - Cash used in operating activities was $7.2 million for the nine months ended September 30, 2025, compared to $6.6 million in 2024, indicating a 9.1% increase in cash outflow[106] - Interest income for the nine months ended September 30, 2025, was $16,000, a decrease of 15.8% from $19,000 in 2024[103] - General and administrative expenses rose to $4.1 million for the nine months ended September 30, 2025, an increase of 20.6% from $3.4 million in 2024[101] - Research and development expenses increased to $5.2 million for the nine months ended September 30, 2025, up 80.8% from $2.9 million in 2024[100] Funding and Capital - The company has raised $6.2 million in gross proceeds from the At The Market Offering, selling 1,680,099 shares at a weighted-average price of $3.67 per share[86] - Net cash provided by financing activities was $6.2 million for the nine months ended September 30, 2025, down from $9.6 million in 2024, a decrease of 35.4%[107][108] - The company expects to incur significant operating losses for the foreseeable future and will need to secure additional funding to continue operations[115] - The company plans to raise capital through additional issuances of equity securities and/or debt arrangements[115] Expense Analysis - Research and development expenses increased to $1.8 million for the three months ended September 30, 2025, compared to $1.1 million in the same period of 2024, reflecting a $0.5 million rise in GRI-0621 registration development costs[95] - General and administrative expenses rose to $1.6 million for the three months ended September 30, 2025, from $1.0 million in 2024, primarily due to a $0.5 million increase in personnel expenses[96] - As of September 30, 2025, the company had $4.1 million in cash and an accumulated deficit of $49.0 million[104][113]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ____________________________________ FORM 10-Q ____________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_________to_________ Commission File Number: 001-40034 __________________ ...

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ____________________________________ FORM 10-Q ____________________________________ (Mark One) ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_________to_________ Commission File Number: 001-40034 _________________ ...

[GRI Bio Reports First Quarter 2025 Financial Results and Corporate Update](index=1&type=section&id=GRI%20Bio%20Reports%20First%20Quarter%202025%20Financial%20Results%20and%20Corporate%20Update) GRI Bio reported Q1 2025 results, highlighting positive interim Phase 2a data for GRI-0621 in IPF and extended cash runway [Corporate Update and Recent Highlights](index=1&type=section&id=Corporate%20Update%20and%20Recent%20Highlights) GRI Bio reported Q1 2025 results, highlighting positive interim Phase 2a data for GRI-0621 in IPF and extended cash runway - The ongoing Phase 2a trial of lead program **GRI-0621** is showing encouraging progress based on **positive interim safety and biomarker data** from the first 12 patients[3](index=3&type=chunk) - Key recent achievements include **positive interim trial data**, **completion of patient enrollment** for the 6-week interim analysis (n=24), securing **new patents** in Europe and Japan, and closing a **$5.0 million public offering**[5](index=5&type=chunk) - The company's cash runway is expected to fund operations through **Q3 2025**[1](index=1&type=chunk) [Clinical Program Update](index=1&type=section&id=Clinical%20Program%20Update) This section details the clinical development of GRI-0621 for IPF, including its mechanism, positive Phase 2a interim results, and future milestones [GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF)](index=1&type=section&id=GRI-0621%20for%20Idiopathic%20Pulmonary%20Fibrosis%20%28IPF%29) GRI-0621 is an oral, small molecule iNKT cell inhibitor for IPF, showing potential to improve fibrosis and favorable safety in Phase 2a - IPF is a **rare, chronic, progressive pulmonary disease** with **limited treatment options** that have significant side-effects and no impact on overall survival[5](index=5&type=chunk)[6](index=6&type=chunk) - GRI-0621 is a **small molecule RAR-βɣ dual agonist** that **inhibits the activity of human iNKT cells**, which play a key role in inflammation and fibrosis[6](index=6&type=chunk) [Phase 2a Trial Interim Results](index=2&type=section&id=Phase%202a%20Trial%20Interim%20Results) Interim analysis of GRI-0621's Phase 2a study showed a positive safety profile and encouraging biomarker data, leading to study continuation - A 2-week safety analysis in the first 12 patients showed GRI-0621 (4.5mg orally once daily) to be **safe and well-tolerated**, with **no hyperlipidemia observed** (no meaningful changes in HDL, LDL, or triglyceride levels)[7](index=7&type=chunk) - Interim biomarker results from the first 12 subjects at 2 weeks showed a change in **PRO-C3 levels** suggestive of an **anti-fibrotic effect** compared to placebo[8](index=8&type=chunk) - Based on the interim data, the **IDMC recommended the Phase 2a study continue as planned**, citing **no safety concerns**[8](index=8&type=chunk) [Expected GRI-0621 Upcoming Milestones](index=2&type=section&id=Expected%20GRI-0621%20Upcoming%20Milestones) GRI Bio anticipates reporting further key data from the GRI-0621 Phase 2a trial in upcoming quarters of 2025, serving as critical catalysts GRI-0621 Phase 2a Trial Milestones | Timeline | Milestone | | :--- | :--- | | Q2 2025 | Report 6-week interim results from Phase 2a biomarker study | | Q3 2025 | Report topline results from Phase 2a biomarker study | [Summary of Financial Results for First Quarter 2025](index=2&type=section&id=Summary%20of%20Financial%20Results%20for%20First%20Quarter%202025) This section summarizes GRI Bio's Q1 2025 financial performance, including net loss, expenses, and cash position [Q1 2025 Financial Performance](index=2&type=section&id=Q1%202025%20Financial%20Performance) In Q1 2025, GRI Bio reported a $3.0 million net loss, increased expenses, and extended its cash runway through Q3 2025 after a $5.0 million offering Key Financial Metrics (Millions USD) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net Loss | $3.0 million | N/A | | Research & Development Expenses | $1.6 million | $0.9 million | | General & Administrative Expenses | $1.4 million | $1.0 million | - As of March 31, 2025, the company held approximately **$3.3 million** in cash and cash equivalents[11](index=11&type=chunk) - Subsequent to the quarter's end, the company raised an additional **$5.0 million** in gross proceeds from a public offering, extending its cash runway through **Q3 2025**[11](index=11&type=chunk)[12](index=12&type=chunk) [Corporate Information](index=3&type=section&id=Corporate%20Information) This section provides an overview of GRI Bio's therapeutic focus and includes a standard disclaimer regarding forward-looking statements [About GRI Bio, Inc.](index=3&type=section&id=About%20GRI%20Bio%2C%20Inc.) GRI Bio is a clinical-stage biopharmaceutical company targeting NKT cells for inflammatory, fibrotic, and autoimmune diseases, with lead program GRI-0621 for IPF - GRI Bio's therapeutic approach is to **target NKT cells**, which are key regulators in the inflammatory cascade, to interrupt disease progression[13](index=13&type=chunk) - The company's pipeline includes **GRI-0621** (an **iNKT inhibitor for IPF**) and **novel type 2 dNKT agonists for systemic lupus erythematosus**[13](index=13&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section cautions that the press release contains forward-looking statements subject to risks, and interim data may not be representative of final results - The press release contains **forward-looking statements** concerning clinical trial timelines, product candidate potential, and financial performance, which are subject to **inherent risks and uncertainties**[14](index=14&type=chunk) - The company specifically warns that the **interim data** discussed may **not be indicative of later or final data** for the trial, as additional clinical testing is required[15](index=15&type=chunk)

As filed with the Securities and Exchange Commission on March 26, 2025. Registration No. 333-286072 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GRI BIO, INC. (Exact name of registrant as specified in its charter) Delaware 2834 82-4369909 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) Ad ...

As filed with the Securities and Exchange Commission on March 24, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GRI BIO, INC. (Exact name of registrant as specified in its charter) Delaware 2834 82-4369909 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 2223 Avenida de la Playa, # ...