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)

[Form 8-K Current Report](index=1&type=section&id=Form%208-K%20Current%20Report) This Form 8-K reports GRI Bio, Inc.'s financial results for the year ended December 31, 2024, and related exhibits [Item 2.02 Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) GRI Bio, Inc. announced its financial results for the year ended December 31, 2024, and a business update via a press release, which is furnished but not filed with the SEC - The company issued a press release on **March 17, 2025**, announcing financial results for the fiscal year ending **December 31, 2024**, and a business update[5](index=5&type=chunk) - The press release (Exhibit 99.1) is designated as **"furnished" rather than "filed"** with the SEC, impacting legal liability[6](index=6&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=2&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section details the exhibits accompanying the Form 8-K filing, primarily the press release containing the company's financial results and business update Exhibits Filed | Exhibit No. | Description | | :--- | :--- | | 99.1 | Press Release issued by GRI Bio, Inc., dated March 17, 2025. | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |

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, 2024 or (Exact name of registrant as specified in its charter) | Delaware | 82-4369909 | | --- | --- | | (State or other jurisdiction of | (I.R.S. Employer Identification No.) | | incorporation and organization) | | | 2223 Avenida de la Playa, #208, La Jolla, CA 92037 | (619 ...

[Form 8-K Current Report](index=1&type=section&id=Form%208-K%20Current%20Report) [Registrant Information](index=1&type=section&id=Registrant%20Information) This section provides basic corporate information for GRI Bio, Inc., including its address, stock exchange listing, and its classification as an emerging growth company - GRI Bio, Inc. is a Delaware-incorporated company with principal executive offices located at 2223 Avenida de la Playa, 208, La Jolla, CA 92037[2](index=2&type=chunk) Stock Registration Details | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :--- | :--- | :--- | | Common Stock, par value $0.0001 per share | GRI | The Nasdaq Capital Market | - The company is identified as an 'Emerging Growth Company' under SEC rules[4](index=4&type=chunk) [Item 2.02 Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) On November 14, 2024, GRI Bio, Inc. issued a press release, furnished as Exhibit 99.1, announcing its financial results for the quarter ended September 30, 2024, along with a business update. The information is explicitly 'furnished' and not 'filed' for liability purposes under the Securities Exchange Act - The company announced its financial results for the quarter ended September 30, 2024, via a press release on November 14, 2024[5](index=5&type=chunk) - The information, including the press release (Exhibit 99.1), is being 'furnished' and not 'filed' with the SEC, which has implications for legal liability under the Securities Exchange Act of 1934[6](index=6&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=2&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists the exhibits filed with the Form 8-K, which include the press release detailing the financial results and an interactive data file for reporting List of Exhibits | Exhibit No. | Description | | :--- | :--- | | 99.1 | Press Release issued by GRI Bio, Inc., dated November 14, 2024 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | [Signatures](index=3&type=section&id=Signatures) The report was formally authorized and signed on November 14, 2024, by the company's Chief Financial Officer, Leanne Kelly - The report was signed on behalf of GRI Bio, Inc. on November 14, 2024[10](index=10&type=chunk) - The signatory was Leanne Kelly, in her capacity as Chief Financial Officer[11](index=11&type=chunk)

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 September 30, 2024 ☐ 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 _____________ ...

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents GRI Bio, Inc.'s unaudited interim consolidated financial statements as of June 30, 2024, reflecting increased cash and equity from financing and continued operating losses [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) Total assets increased to **$7.0 million** from **$3.0 million** by June 30, 2024, driven by cash, with stockholders' equity rising to **$4.7 million** Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2024 (unaudited) | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $6,353 | $1,808 | | Total current assets | $6,884 | $2,934 | | **Total assets** | **$7,031** | **$2,956** | | **Liabilities & Equity** | | | | Total current liabilities | $2,216 | $2,697 | | **Total liabilities** | **$2,312** | **$2,697** | | **Total stockholders' equity** | **$4,719** | **$259** | | **Total liabilities and stockholders' equity** | **$7,031** | **$2,956** | [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) Net losses significantly reduced to **$2.3 million** (Q2) and **$4.1 million** (H1) in 2024, driven by lower general and administrative expenses Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $877 | $880 | $1,811 | $997 | | General and administrative | $1,380 | $5,054 | $2,342 | $5,926 | | **Loss from operations** | **($2,257)** | **($5,934)** | **($4,153)** | **($6,923)** | | **Net loss** | **($2,250)** | **($6,746)** | **($4,137)** | **($8,896)** | | Net loss per share | ($4.92) | ($239.37) | ($8.82) | ($433.14) | [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Cash used in operations was **$4.3 million**, offset by **$8.9 million** from financing, resulting in **$6.4 million** cash at period-end Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2024 | 2023 | | :--- | :--- | :--- | | Cash used in operating activities | ($4,344) | ($2,119) | | Cash used in investing activities | $0 | ($8) | | Cash provided by financing activities | $8,889 | $6,917 | | **Net increase in cash** | **$4,545** | **$4,790** | | **Cash at end of period** | **$6,353** | **$4,799** | [Notes to Unaudited Interim Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Interim%20Consolidated%20Financial%20Statements) Notes detail business, liquidity, merger, and accounting policies, highlighting focus on therapies, financing reliance, and going concern doubt - GRI Bio is a clinical-stage biopharmaceutical company focused on therapies for diseases associated with dysregulated immune responses. Its lead product candidate, GRI-0621, is an oral inhibitor for idiopathic pulmonary fibrosis (IPF)[19](index=19&type=chunk) - The company has incurred operating losses since its 2009 inception, with an accumulated deficit of **$35.7 million** as of June 30, 2024. Its ability to continue as a going concern is dependent on raising additional capital[23](index=23&type=chunk)[35](index=35&type=chunk) - The company completed a reverse merger with Vallon Pharmaceuticals, Inc. on April 21, 2023, which was accounted for as a reverse recapitalization[20](index=20&type=chunk)[51](index=51&type=chunk) - The company has conducted multiple reverse stock splits, including a **1-for-7 split** in January 2024 and a **1-for-13 split** in June 2024[21](index=21&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses business, financing, and liquidity, focusing on GRI-0621 advancement, with current cash projected to fund operations only into Q1 2025 [Overview and Recent Developments](index=25&type=section&id=Overview%20and%20Recent%20Developments) GRI-0621 advances in Phase 2a for IPF with Q4 2024 interim data expected, following 2024 financing rounds and Nasdaq compliance regain - The company's lead candidate, GRI-0621, is being evaluated in a Phase 2a biomarker study for idiopathic pulmonary fibrosis (IPF), with interim data expected in **Q4 2024** and topline results in **Q1 2025**[90](index=90&type=chunk) - Development of the second product candidate, GRI-0803 for autoimmune disorders like lupus, is limited pending additional funding[91](index=91&type=chunk)[92](index=92&type=chunk) - In 2024, the company executed multiple financing agreements, including a securities purchase agreement in February for net proceeds of **$4.4 million**, an At The Market (ATM) offering initiated in May, and another securities purchase agreement in June for net proceeds of **$3.2 million**[94](index=94&type=chunk)[96](index=96&type=chunk)[98](index=98&type=chunk)[126](index=126&type=chunk)[128](index=128&type=chunk) - The company regained compliance with Nasdaq listing requirements for minimum stockholders' equity and minimum bid price in **July 2024** after receiving deficiency notices[100](index=100&type=chunk)[101](index=101&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) R&D expenses increased by **$0.8 million** in H1 2024, while G&A decreased by **$3.6 million**, leading to a net loss improvement to **$4.1 million** Comparison of Operating Results for the Six Months Ended June 30 (in thousands) | Expense Category | 2024 | 2023 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $1,811 | $997 | +$814 | Increased expenses for the GRI-0621 development program | | General and administrative | $2,342 | $5,926 | -$3,584 | Decreased professional fees (legal, accounting, banking) following the 2023 Merger | | **Net Loss** | **($4,137)** | **($8,896)** | **+$4,759** | Primarily due to lower G&A expenses and absence of prior-year interest expense | [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) With **$6.4 million** cash and **$35.7 million** accumulated deficit, current funds are projected to last only into Q1 2025, raising going concern doubt - The company had **$6.4 million** in cash as of June 30, 2024[121](index=121&type=chunk) - Cash provided by financing activities was **$8.9 million** for the first six months of 2024, mainly from stock and warrant issuances[124](index=124&type=chunk) - Management projects that existing cash and cash equivalents will fund operations only into the **first quarter of 2025**[131](index=131&type=chunk) - The company's financial condition raises substantial doubt about its ability to continue as a going concern, and it will need to obtain substantial additional funding[132](index=132&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable as the company is a smaller reporting company - Disclosure is not required as the company qualifies as a smaller reporting company[137](index=137&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2024, with no material changes in internal control - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of **June 30, 2024**[141](index=141&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[142](index=142&type=chunk) [PART II. OTHER INFORMATION](index=37&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company reports no material legal proceedings pending or threatened against it[144](index=144&type=chunk) [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes 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 have occurred[145](index=145&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities or issuer purchases of equity securities during the period - There were no unregistered sales of equity securities or issuer repurchases during the quarter[146](index=146&type=chunk) [Item 5. Other Information](index=37&type=section&id=Item%205.%20Other%20Information) During the three months ended June 30, 2024, none of the company's directors or officers adopted or terminated a Rule 10b5-1 trading arrangement - No directors or officers adopted or terminated a Rule 10b5-1 trading arrangement in the second quarter of 2024[148](index=148&type=chunk) [Item 6. Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including certifications by the Principal Executive Officer and Principal Financial Officer - The report includes a list of exhibits filed, such as corporate governance documents, warrant forms, the At The Market Offering Agreement, and officer certifications required by the Sarbanes-Oxley Act[149](index=149&type=chunk)

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents GRI Bio, Inc.'s unaudited interim consolidated financial statements for Q1 2024, highlighting net loss and equity changes [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) Total assets increased to **$4.6 million** by March 31, 2024, with decreased liabilities and significantly improved equity Consolidated Balance Sheet Highlights (in thousands) | Metric | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $4,091 | $1,808 | | Total current assets | $4,428 | $2,934 | | Total assets | $4,587 | $2,956 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $1,680 | $2,697 | | Total liabilities | $1,789 | $2,697 | | Total stockholders' equity | $2,798 | $259 | | Total liabilities and stockholders' equity | $4,587 | $2,956 | [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) Net loss decreased to **$1.9 million** in Q1 2024 due to lower interest expense, despite increased R&D costs Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Research and development | $933 | $116 | | General and administrative | $962 | $872 | | **Total operating expenses** | **$1,895** | **$988** | | Loss from operations | ($1,895) | ($988) | | Interest income (expense), net | $6 | ($1,162) | | **Net loss** | **($1,887)** | **($2,150)** | | Net loss per share, basic and diluted | ($0.46) | ($15.04) | [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Cash used in operations increased to **$2.2 million** in Q1 2024, offset by **$4.5 million** from financing, for a **$2.3 million** net increase Consolidated Statements of Cash Flows Highlights (in thousands) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Cash used in operating activities | ($2,203) | ($579) | | Cash provided by financing activities | $4,486 | $1,030 | | **Net increase in cash and cash equivalents** | **$2,283** | **$451** | | Cash and cash equivalents at end of period | $4,091 | $460 | [Notes to Unaudited Interim Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Interim%20Consolidated%20Financial%20Statements) Notes detail business, liquidity, and accounting policies, highlighting a public offering and going concern doubt - The company is a **clinical-stage biopharmaceutical firm** focused on diseases related to dysregulated immune responses. Its lead product candidate is **GRI-0621** for **idiopathic pulmonary fibrosis (IPF)**[20](index=20&type=chunk) - In February 2024, the company raised net proceeds of **$4.4 million** (**$4,389 thousand** after deducting **$1,110 thousand** in expenses) through a public offering of common stock, pre-funded warrants, and common warrants[27](index=27&type=chunk)[61](index=61&type=chunk) - Management has concluded there is **substantial doubt** about the company's ability to continue as a **going concern** for one year, as existing cash is only sufficient to fund operations into the **third quarter of 2024**[29](index=29&type=chunk)[30](index=30&type=chunk) - The **April 2023 merger** with **Vallon Pharmaceuticals** was accounted for as a **reverse recapitalization**, with **GRI Operations** as the accounting acquirer[21](index=21&type=chunk)[44](index=44&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses business, financing, Nasdaq compliance, Q1 2024 results, and liquidity issues raising going concern doubt [Overview](index=22&type=section&id=Overview) GRI Bio is a clinical-stage biopharmaceutical company developing therapies for immune disorders, with lead candidate GRI-0621 in Phase 2a - Lead product candidate **GRI-0621** is being developed for **idiopathic pulmonary fibrosis (IPF)**. Enrollment for a **Phase 2a biomarker study** began in **December 2023**[77](index=77&type=chunk) - The company expects **interim data** from the **GRI-0621 Phase 2a trial** in **Q3 2024** and **topline results** in **Q4 2024**[77](index=77&type=chunk) - The second product candidate, **GRI-0803**, is being developed for **autoimmune disorders**, with an initial focus on **lupus (SLE)**. An **IND filing** is planned for the **second half of 2024**[78](index=78&type=chunk) [Recent Developments](index=24&type=section&id=Recent%20Developments) Recent developments include a **$4.4 million** public offering, a reverse stock split, and ongoing Nasdaq compliance challenges - On **February 1, 2024**, the company raised net proceeds of **$4.4 million** through a **public offering** of stock and warrants[80](index=80&type=chunk) - A **1-for-7 reverse stock split** was effected on **January 29, 2024**, to address **Nasdaq compliance**[82](index=82&type=chunk) - The company received a **Nasdaq deficiency notice** for not meeting the **$2.5 million minimum stockholders' equity requirement**. While compliant as of **March 31, 2024**, the company notes the proceeds will likely be **insufficient to maintain long-term compliance**[84](index=84&type=chunk)[85](index=85&type=chunk) - The company also received a **Nasdaq bid price deficiency notice** for its stock trading **below $1.00**. The reverse stock split did not resolve this, and the company has until **July 3, 2024**, to regain compliance[86](index=86&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) Net loss decreased to **$1.9 million** in Q1 2024 from **$2.2 million** in Q1 2023, driven by lower interest expense despite increased R&D Comparison of Operations (in thousands) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Research and development | $933 | $116 | | General and administrative | $962 | $872 | | Interest income (expense) | $6 | ($1,162) | | **Net loss** | **($1,887)** | **($2,150)** | - The **$0.8 million** increase in R&D expenses was mainly due to a **$0.5 million** increase in costs for the **GRI-0621 program**[99](index=99&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2024, the company had **$4.1 million** cash, but reserves are only sufficient into Q3 2024, raising going concern doubt - As of **March 31, 2024**, the company had **$4.1 million** in cash and an accumulated deficit of **$33.4 million**[105](index=105&type=chunk)[112](index=112&type=chunk) - Based on the current operating plan, existing cash and cash equivalents are projected to fund operations only into the **third quarter of 2024**[113](index=113&type=chunk) - The company needs to raise **substantial additional capital** and acknowledges there is **substantial doubt** about its ability to continue as a **going concern**. Failure to secure funding may force it to **delay, scale back, or cease operations**[114](index=114&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=32&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 - **Not applicable** to a **smaller reporting company**[120](index=120&type=chunk) [Item 4. Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of March 31, 2024, with no material changes to internal controls - The **Chief Executive Officer** and **Chief Financial Officer** concluded that as of **March 31, 2024**, the company's disclosure controls and procedures were **effective**[124](index=124&type=chunk) - **No material changes** to the company's **internal control over financial reporting** occurred during the **first quarter of 2024**[125](index=125&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings, nor aware of any pending or threatened actions - The company reports **no material legal proceedings**[127](index=127&type=chunk) [Item 1A. Risk Factors](index=35&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**[128](index=128&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=35&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales or issuer purchases of equity securities during the period - **None reported**[129](index=129&type=chunk) [Item 5. Other Information](index=35&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during Q1 2024 - **No directors or officers** adopted or terminated **Rule 10b5-1 trading arrangements** during the quarter[132](index=132&type=chunk) [Item 6. Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including officer certifications and interactive data files

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, 2023 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 | | --- | --- | ...