[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). |

Drug Development and Trials - GRI-0621 is being developed for the treatment of idiopathic pulmonary fibrosis (IPF), affecting approximately 140,000 people in the U.S. with 40,000 new cases annually[35]. - The FDA has cleared the IND application for GRI-0621, with a Phase 2a trial expected to enroll approximately 36 patients, and topline results anticipated in Q3 2025[49]. - GRI-0803 is being developed for autoimmune disorders, particularly systemic lupus erythematosus (SLE), which affects 160,000 to 200,000 patients in the U.S.[36]. - The company plans to file an IND for GRI-0803 in 2025, targeting SLE in Phase 1a and 1b trials[49]. - GRI-0621 has shown preliminary data indicating it is well-tolerated and inhibits iNKT cell activity in patients[35]. - GRI-0621 is an oral gel capsule formulation developed for the treatment of idiopathic pulmonary fibrosis (IPF), differentiating itself by targeting the dysfunctional immune response rather than just symptoms[59]. - Enrollment for a Phase 2a trial of GRI-0621 in IPF patients commenced in December 2023, targeting approximately 36 patients over a twelve-week period[85]. - GRI-0803 is being developed for lupus nephritis related to systemic lupus erythematosus (SLE), which affects 160,000 to 200,000 patients in the U.S.[87]. - GRI-0803 has shown promise in preclinical studies by inhibiting iNKT cells and improving overall survival in lupus nephritis models[91]. - The Phase 1 trial for GRI-0803 is planned to initiate upon completion of the toxicology program, with an IND filing anticipated in 2025[101]. - The Single Ascending Dose (SAD) trial will evaluate up to six doses of GRI-0803 in cohorts of 12 subjects, with safety as the primary endpoint[104]. - The Multiple Ascending Dose (MAD) trial will follow the SAD trial, examining four doses of GRI-0803, with safety and multi-dose pharmacokinetics as primary endpoints[105]. Market and Competitive Landscape - The company aims to maximize the commercial value of its product candidates by retaining worldwide development and commercial rights[49]. - GRI-0621 and GRI-0803 are positioned to address significant unmet medical needs in fibrotic and autoimmune diseases[47]. - Current therapies for IPF do not improve overall survival, highlighting the unmet need for effective treatments[52]. - Current SLE treatments, including hydroxychloroquine and corticosteroids, have limitations and safety concerns, highlighting the need for new therapeutic strategies[88][89]. - The competitive landscape includes large biotechnology firms such as AstraZeneca and Bristol-Myers Squibb, which have significant resources and established market presence[106]. Regulatory and Compliance - Regulatory compliance is critical, with the FDA overseeing the drug approval process, which requires substantial time and financial resources[120]. - The FDA has a ten-month review period for standard NDAs and six months for priority reviews, with potential extensions for additional information[140]. - The FDA requires annual progress reports and IND safety reports during clinical trials, especially for serious adverse events[134]. - The Prescription Drug User Fee Act (PDUFA) mandates substantial fees for NDA submissions, which are adjusted annually and may include exemptions for small businesses[137]. - The FDA may require a risk evaluation and mitigation strategy (REMS) to ensure the benefits of a drug outweigh its risks, which must be submitted for approval[146]. - The FDA may accept foreign clinical trial data if conducted under Good Clinical Practices (GCPs) and applicable to the U.S. population[143]. - The FDA requires at least two adequate and well-controlled clinical investigations to establish the effectiveness of a new product, although a single trial with confirmatory evidence may suffice under certain conditions[148]. - The FDA can designate products for expedited development if they address unmet medical needs, including fast track, breakthrough therapy, and priority review designations[153][156]. - The accelerated approval pathway allows drugs to be approved based on surrogate endpoints that predict clinical benefit, with post-marketing studies required to verify effectiveness[158]. - The FDA imposes ongoing regulations on approved drugs, including recordkeeping, periodic reporting, and compliance with current Good Manufacturing Practices (cGMPs)[163][165]. Intellectual Property and Exclusivity - The company has filed patent applications representing six patent families, with 12 issued U.S. patents and 75 issued foreign patents as of February 28, 2025[111]. - The company expects to rely on data exclusivity and patent term extensions to protect its products post-approval[119]. - Orphan drug designation grants seven years of exclusivity upon FDA approval for the indication, preventing approval of other marketing applications for the same drug[185]. - Patent term extensions can restore up to five years for patents lost during product development and FDA review, but cannot extend beyond 14 years from the product's approval date[188]. Data Privacy and Compliance - The California Consumer Privacy Act (CCPA) and the California Privacy Rights Act (CPRA) impose strict regulations on personal data, increasing compliance costs and potential liabilities[228]. - The GDPR, effective since May 2018, imposes stringent requirements on the processing of personal data, including health data, which may lead to increased operational costs for compliance[229]. - The UK GDPR, implemented post-Brexit, aligns closely with the EU GDPR, potentially resulting in similar compliance costs and risks for companies operating in the UK[230]. - Legislative changes in various states, including the "My Health My Data" Act in Washington, are increasing the complexity of compliance regarding health data privacy[226]. - The evolving landscape of data privacy laws in the U.S. and abroad may create significant compliance challenges and increase the risk of regulatory enforcement actions[224]. - Non-compliance with data protection laws may lead to significant penalties and enforcement actions, affecting the company's reputation and business operations[232]. - The number of government investigations related to data security incidents is on the rise, which could strain resources and generate negative publicity[232]. - Companies must ensure third-party service providers comply with GDPR requirements to mitigate risks of data breaches and non-compliance[231]. Financial and Market Impact - Total worldwide sales of nintedanib and pirfenidone reached $4.3 billion in 2022, despite only about 10% adoption among IPF patients[64]. - Heightened scrutiny over drug pricing has resulted in proposed legislation aimed at increasing transparency and reforming reimbursement methodologies, which could adversely affect sales and financial conditions[218]. - The U.S. government has implemented the Inflation Reduction Act, requiring drug manufacturers to pay rebates if prices increase faster than inflation, impacting revenue from Medicare-covered drugs[219]. - Starting in 2026, CMS will negotiate prices for select single-source Part D drugs, which may lead to decreased revenue for those products[219].

[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)

As filed with the Securities and Exchange Commission on June 26, 2024. Registration No. 333-280323 Delaware 2834 82-4369909 (I.R.S. Employer Identification Number) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Amendment No. 2 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GRI BIO, INC. (Exact name of registrant as specified in its charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 222 ...

(Primary Standard Industrial Classification Code Number) As filed with the Securities and Exchange Commission on June 25, 2024. Registration No. 333-280323 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 (I.R.S. Employer (State or other jurisdiction of incorporation or organization) 2223 Avenida de la Playa, ...

As filed with the Securities and Exchange Commission on June 18, 2024. 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) (State or other jurisdiction of incorporation or organization) Delaware 2834 82-4369909 (Primary Standard Industrial Classification Code Number) 2223 Avenida de la Playa, #208 La Jolla, CA 92037 (619) 400-1170 (Ad ...

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 | | --- | --- | ...