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 [3] - The company's lead program, GRI-0621, is an oral therapeutic aimed at inhibiting iNKT cell activity for the treatment of idiopathic pulmonary fibrosis, addressing a significant unmet medical need [3] - GRI Bio 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 [3] Event Participation - Marc Hertz, PhD, CEO of GRI Bio, will participate in a fireside chat at A.G.P.'s Annual Healthcare Company Showcase on May 21, 2025, at 2:40 PM ET [1] - The event will be accessible via a live webcast on the company's website [2]

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The company's Q1 2025 financial statements show decreased cash and assets, increased liabilities, a higher net loss, and subsequent capital raising [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) As of March 31, 2025, the company's cash, total assets, and stockholders' equity decreased, while total liabilities increased Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $3,281 | $5,028 | | Total current assets | $3,930 | $5,615 | | Total assets | $4,042 | $5,739 | | **Liabilities & Equity** | | | | Total current liabilities | $2,779 | $1,636 | | Total liabilities | $2,837 | $1,707 | | Total stockholders' equity | $1,205 | $4,032 | [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) For Q1 2025, the company reported a net loss of $3.0 million, up from $1.9 million in Q1 2024, driven by increased operating expenses Quarterly Operating Results (in thousands, except per share data) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $1,640 | $933 | | General and administrative | $1,411 | $962 | | **Total operating expenses** | **$3,051** | **$1,895** | | **Loss from operations** | **($3,051)** | **($1,895)** | | **Net loss** | **($3,046)** | **($1,887)** | | Net loss per share, basic and diluted | ($5.80) | ($101.05) | [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) In Q1 2025, net cash used in operations decreased, but financing activities shifted to usage, leading to a net cash decrease Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Cash used in operating activities | ($1,736) | ($2,203) | | Cash (used in) provided by financing activities | ($11) | $4,486 | | **Net (decrease) increase in cash** | **($1,747)** | **$2,283** | | Cash and cash equivalents at end of period | $3,281 | $4,091 | [Notes to Unaudited Interim Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Interim%20Consolidated%20Financial%20Statements) Notes detail the company's biopharmaceutical focus, significant going concern doubt, and recent financing activities including an April 2025 public offering - The company is a clinical-stage biopharmaceutical firm developing therapies for inflammatory, fibrotic, and autoimmune disorders. Its lead product, **GRI-0621**, targets idiopathic pulmonary fibrosis (**IPF**), while **GRI-0803** targets autoimmune disorders like **lupus** and **MS**[21](index=21&type=chunk) - There is **substantial doubt** about the company's ability to continue as a **going concern**. Existing cash of **$3.3 million** (as of March 31, 2025) is projected to fund operations only through the **third quarter of 2025**, necessitating additional capital raising[23](index=23&type=chunk)[28](index=28&type=chunk)[29](index=29&type=chunk) - In **April 2025**, the company executed a **public offering**, raising gross proceeds of **$5.0 million** through the sale of common stock, pre-funded warrants, and several series of common stock warrants[65](index=65&type=chunk) - The company has engaged in multiple financing activities, including a **February 2024 offering** (net proceeds **$4.4M**), a **May 2024 At-The-Market (ATM) offering** (gross proceeds **$3.6M** as of Q1 2025), a **June 2024 offering** (net proceeds **$3.2M**), and an **October 2024 warrant repricing**[24](index=24&type=chunk)[25](index=25&type=chunk)[26](index=26&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses GRI-0621 development, increased Q1 2025 net loss from higher expenses, and critical funding needs due to going concern doubt [Overview and Recent Developments](index=19&type=section&id=Overview%20and%20Recent%20Developments) The company is advancing GRI-0621 for IPF, with GRI-0803 on hold; recent developments include a reverse stock split and a $5.0 million capital raise - The company is advancing its lead product, **GRI-0621**, in a **Phase 2a study** for **IPF**, with interim data anticipated in **Q2 2025** and topline results in **Q3 2025**[72](index=72&type=chunk) - Development of the second product candidate, **GRI-0803** for **lupus** and **MS**, is **on hold** pending additional funding, with plans to file an **IND in 2025** if capital is secured[73](index=73&type=chunk) - A **1-for-17 reverse stock split** was effected in **February 2025**, and the company regained **Nasdaq compliance** in **March 2025**[74](index=74&type=chunk)[79](index=79&type=chunk) - In **April 2025**, the company entered into a securities purchase agreement for gross proceeds of **$5.0 million**[75](index=75&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Q1 2025 saw R&D expenses increase by $0.7 million and G&A expenses by $0.4 million, leading to a higher net loss of $3.0 million Comparison of Operating Results (in thousands) | Expense Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $1,640 | $933 | +$707 | | General and administrative | $1,411 | $962 | +$449 | | **Net loss** | **($3,046)** | **($1,887)** | +($1,159) | - The **$0.7 million increase** in **R&D expenses** was mainly due to increased costs for the **GRI-0621** registration development program[87](index=87&type=chunk) - The **$0.4 million increase** in **G&A expenses** was primarily due to a **$0.3 million rise** in **personnel expenses** (including stock compensation) and a **$0.2 million increase** in **professional fees**[88](index=88&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces significant liquidity challenges with limited cash, an accumulated deficit, and a critical need for additional funding, raising substantial doubt about its going concern ability - The company had **$3.3 million** in cash and an accumulated deficit of **$42.8 million** as of March 31, 2025[91](index=91&type=chunk)[97](index=97&type=chunk) - Existing cash and cash equivalents are expected to fund operating expenses and capital requirements only through the **third quarter of 2025**[98](index=98&type=chunk) - The company will need to obtain **substantial additional funding** to continue operations. Failure to secure financing may force it to **delay or discontinue development programs or cease operations entirely**[99](index=99&type=chunk)[100](index=100&type=chunk) Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in Operating activities | ($1,736) | ($2,203) | | Net cash (used in) provided by Financing activities | ($11) | $4,486 | [Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This disclosure is not applicable as the company qualifies as a smaller reporting company - Disclosure is **not required** as the company is a **smaller reporting company**[105](index=105&type=chunk) [Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls were ineffective due to a material weakness in accounting for a warrant repricing, with a remediation plan underway - Management concluded that disclosure controls and procedures were **not effective** as of March 31, 2025[108](index=108&type=chunk) - A **material weakness** was identified related to the **inaccurate accounting** for a **warrant repricing transaction**, specifically the computation of the **non-cash deemed dividend**[109](index=109&type=chunk) - A **remediation plan** has been implemented, involving the engagement of **third-party experts** and **refinement of internal communication and documentation processes** for complex transactions[110](index=110&type=chunk)[112](index=112&type=chunk) [PART II. OTHER INFORMATION](index=29&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings, nor is it aware of any pending or threatened actions - The company is **not currently involved** in any **material legal proceedings**[115](index=115&type=chunk) [Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred to the risk factors previously disclosed in the company's Annual Report on Form 10-K - **No material changes** from the risk factors disclosed in the Annual Report[116](index=116&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=29&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or issuer purchases were reported during the period - **None reported**[117](index=117&type=chunk) [Other Information](index=29&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during the quarter - **No directors or officers** adopted or terminated **Rule 10b5-1 trading arrangements** during the quarter[120](index=120&type=chunk) [Exhibits](index=30&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including officer certifications and documents incorporated by reference

[GRI Bio First Quarter 2025 Financial Results and Corporate Update](index=1&type=section&id=GRI%20Bio%20First%20Quarter%202025%20Financial%20Results%20and%20Corporate%20Update) [Corporate and Clinical Highlights](index=1&type=section&id=Recent%20Highlights) GRI Bio reported positive interim Phase 2a data for GRI-0621 in IPF, strengthened intellectual property, and extended its cash runway with a $5.0 million public offering - Reported **positive interim 2-week safety and biomarker results** from the ongoing Phase 2a study of GRI-0621 for IPF[1](index=1&type=chunk)[3](index=3&type=chunk)[5](index=5&type=chunk) - **Completed patient enrollment for the 6-week interim analysis (n=24)** and has enrolled over two-thirds of the total trial participants[1](index=1&type=chunk)[5](index=5&type=chunk) - **Strengthened its global intellectual property portfolio** with the granting of patents in Europe and Japan[5](index=5&type=chunk) - Closed a **$5.0 million public offering**, extending the company's cash runway[5](index=5&type=chunk)[11](index=11&type=chunk) [Clinical Program Update: GRI-0621 for IPF](index=1&type=section&id=Clinical%20Program%20Update) The Phase 2a study of GRI-0621 for IPF demonstrated safety and tolerability in early patients, with interim biomarker data suggesting an anti-fibrotic effect - GRI-0621 is a **small molecule RAR-βɣ dual agonist** designed to inhibit iNKT cell activity for treating IPF, a chronic progressive pulmonary disease with limited treatment options[5](index=5&type=chunk)[6](index=6&type=chunk) - A pre-planned interim analysis of the first 12 patients showed GRI-0621 (4.5mg orally once daily) to be **safe and well-tolerated**, with **no hyperlipidemia** observed at the 2-week visit[7](index=7&type=chunk) - Interim biomarker results from the first 12 subjects showed a change from baseline in PRO-C3 that is **suggestive of an anti-fibrotic effect**, leading the IDMC to recommend the study continue as planned[8](index=8&type=chunk) [Upcoming Milestones](index=2&type=section&id=Expected%20GRI-0621%20Upcoming%20Milestones) GRI Bio anticipates reporting significant data from its Phase 2a trial of GRI-0621 in the second and third quarters of 2025, marking key catalysts for the program - **Q2 2025**: Report **6-week interim results** from the Phase 2a biomarker study[11](index=11&type=chunk) - **Q3 2025**: Report **topline results** from the Phase 2a biomarker study[9](index=9&type=chunk)[11](index=11&type=chunk) [First Quarter 2025 Financial Results](index=2&type=section&id=Summary%20of%20Financial%20Results%20for%20First%20Quarter%202025) GRI Bio reported a **$3.0 million net loss** for Q1 2025, with increased R&D and G&A expenses, and an extended cash runway through Q3 2025 after a **$5.0 million public offering** Key Financial Metrics | Financial Metric | Q1 2025 | | :--- | :--- | | Net Loss | $3.0 million | | Cash and Cash Equivalents (as of Mar 31) | $3.3 million | Operating Expenses | Expense Category | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research & Development | $1.6 million | $0.9 million | | General & Administrative | $1.4 million | $1.0 million | - The company's existing cash, supplemented by a subsequent **$5.0 million public offering**, is expected to fund operations and capital expenditures through **Q3 2025**[1](index=1&type=chunk)[11](index=11&type=chunk)[12](index=12&type=chunk) [Company Overview](index=3&type=section&id=About%20GRI%20Bio%2C%20Inc.) GRI Bio is a clinical-stage biopharmaceutical company developing NKT cell-targeted therapies for inflammatory, fibrotic, and autoimmune diseases, with lead program GRI-0621 for IPF - GRI Bio is a **clinical-stage biopharmaceutical company** focused on modulating **Natural Killer T (NKT) cells** to treat inflammatory, fibrotic, and autoimmune diseases[2](index=2&type=chunk)[13](index=13&type=chunk) - The lead program, **GRI-0621**, is an **oral inhibitor** of type 1 invariant NKT (iNKT) cell activity being developed for **Idiopathic Pulmonary Fibrosis (IPF)**[13](index=13&type=chunk) - The company's pipeline also includes **novel type 2 diverse NKT (dNKT) agonists** for **systemic lupus erythematosus** and is supported by a **proprietary library of over 500 compounds**[13](index=13&type=chunk)

Core Insights - GRI Bio, Inc. reported positive interim results from its ongoing Phase 2a study of GRI-0621 for treating Idiopathic Pulmonary Fibrosis (IPF), indicating safety and potential anti-fibrotic effects [1][2][8] - The company has completed patient enrollment for the 6-week interim analysis with 24 patients and has over two-thirds of enrollment completed for the overall trial [1][8] - GRI Bio's cash runway is expected to fund operations through Q3 2025, bolstered by a recent public offering that raised $5 million [11] Clinical Program Update - GRI-0621 is a small molecule RAR-βɣ dual agonist that inhibits the activity of human invariant NKT (iNKT) cells, showing promise in improving fibrosis and liver function in preliminary trials [5][12] - The interim analysis demonstrated that GRI-0621 (4.5mg orally once daily) was safe and well-tolerated, with no significant changes in lipid levels among the first 12 patients evaluated [6][7] - The Independent Data Monitoring Committee (IDMC) recommended the continuation of the Phase 2a study based on the observed safety and biomarker data [7][8] Financial Results - For Q1 2025, GRI Bio reported a net loss of $3 million, with research and development expenses of $1.6 million and general and administrative expenses of $1.4 million [10] - As of March 31, 2025, the company had approximately $3.3 million in cash and cash equivalents, which, along with the recent public offering, is expected to support operations through Q3 2025 [11] Upcoming Milestones - Topline results from the Phase 2a biomarker study are anticipated in Q3 2025, with a 6-week interim results report expected in Q2 2025 [9][14]

Core Insights - The Independent Data Monitoring Committee (IDMC) has recommended the continuation of the Phase 2a study for GRI-0621, indicating no safety concerns in the reviewed data [1][2][4] - GRI Bio has completed patient enrollment for the 6-week interim analysis with 24 subjects and has over two-thirds of the total enrollment completed for the overall trial [1][3] - Interim biomarker results suggest an anti-fibrotic effect of GRI-0621 compared to placebo, with topline data expected in Q3 2025 [2][5] Company Overview - GRI Bio, Inc. is a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for treating inflammatory, fibrotic, and autoimmune diseases [1][6] - The lead program, GRI-0621, is an oral therapeutic aimed at treating idiopathic pulmonary fibrosis (IPF), a disease with significant unmet medical needs [6] Study Details - The Phase 2a study is a randomized, double-blind, placebo-controlled trial enrolling approximately 36 subjects with IPF, randomized in a 2:1 ratio for GRI-0621 (4.5mg) or placebo [3] - The primary endpoint is the safety and tolerability of GRI-0621 after 12 weeks, with secondary endpoints including changes in serum biomarkers and pharmacokinetics [3][4] Interim Analysis Findings - The interim analysis showed that GRI-0621 was safe and well-tolerated in the first 12 patients, with no significant changes in lipid levels [4] - The IDMC's recommendation to continue the study is based on the absence of safety concerns and the encouraging trend in anti-fibrotic effects observed [2][4]

Core Insights - GRI Bio, Inc. has completed enrollment for a Phase 2a study evaluating GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF), with 24 out of 36 planned patients enrolled [1][2] - The company is on track to report interim biomarker data from the first 12 patients imminently, with topline results expected in Q3 2025 [1][4] - The Phase 2a study is designed as a randomized, double-blind, placebo-controlled trial, comparing GRI-0621 (4.5mg) to a placebo over 12 weeks [2][3] Company Overview - GRI Bio is a clinical-stage biopharmaceutical company focused on treating inflammatory, fibrotic, and autoimmune diseases through Natural Killer T (NKT) cell modulators [5][6] - The lead program, GRI-0621, is an inhibitor of iNKT cell activity, aimed at addressing the significant unmet need in IPF treatment [6] Study Details - The study will enroll approximately 36 subjects with IPF, randomized in a 2:1 ratio for GRI-0621 or placebo [2] - Primary endpoints include safety and tolerability, while secondary endpoints focus on changes in serum biomarkers and pharmacokinetics [2][3] - An interim analysis will be conducted after 24 subjects complete 6 weeks of treatment, with safety results from the first 12 patients showing no significant adverse effects [3]

Core Insights - GRI Bio, Inc. is advancing a pipeline of Natural Killer T (NKT) cell modulators aimed at treating inflammatory, fibrotic, and autoimmune diseases [1][3] - The company will present its research on the inactivation of iNKT cells and its effects on fibroblast activation and fibrosis at the 2025 ATS International Conference [2] Company Overview - GRI Bio is a clinical-stage biopharmaceutical company focused on innovative treatments for inflammatory, fibrotic, and autoimmune diseases [3] - The company's lead program, GRI-0621, is an inhibitor of iNKT cell activity, targeting 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 has a library of over 500 proprietary compounds to support its pipeline [3]

LA JOLLA, CA, April 02, 2025 (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 the closing of its previously announced public offering of an aggregate of 1,388,888 shares of its common stock (or common stock equivalents in lieu thereof), Series E-1 warrants to purchase up to 1,388,888 shares of co ...

GRI Bio, Inc.’s (GRI) shares plummeted 36.9% on April 1 after the company announced the pricing of a public offering of stock of $5 million.Earlier in the day, the stock surged after the company reported positive interim safety results from its ongoing phase IIa study evaluating pipeline candidate GRI-0621 for the treatment of idiopathic pulmonary fibrosis (IPF).Last month, the company received notice from The Nasdaq Stock Market LLC stating that it regained compliance with Nasdaq’s “minimum bid price rule. ...

LA JOLLA, CA, April 01, 2025 (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 the pricing of a public offering of an aggregate of 1,388,888 shares of its common stock (or common stock equivalents in lieu thereof), Series E-1 warrants to purchase up to 1,388,888 shares of common stock, short-term ...