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] Upcoming Presentation - GRI Bio will present at the Webull Financial Corporate Connect Webinar Series: Biotech/MedTech from August 19-21, 2025, with a specific presentation scheduled for August 20, 2025, at 2:20 PM ET [1] - The presentation will be led by Marc Hertz, PhD, who serves as the President, Chief Executive Officer, and Director of GRI Bio [1]

PART I. FINANCIAL INFORMATION This section provides the unaudited interim consolidated financial information for GRI Bio, Inc., covering financial statements, management's discussion, market risk, and internal controls [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents GRI Bio, Inc.'s unaudited interim consolidated financial statements, including the balance sheets, statements of operations, changes in stockholders' equity, and cash flows for the periods ended June 30, 2025 and 2024. It also includes detailed notes explaining the company's organization, liquidity, accounting policies, and specific financial line items [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets%20as%20of%20June%2030%2C%202025%20%28unaudited%29%20and%20December%2031%2C%202024) This table presents the unaudited consolidated balance sheets of GRI Bio, Inc. as of June 30, 2025, and December 31, 2024 | Metric | June 30, 2025 (unaudited) (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :--------------------------------------- | :------------------------------- | | Cash and cash equivalents | $5,122 | $5,028 | | Total current assets | $5,576 | $5,615 | | Total assets | $5,675 | $5,739 | | Total current liabilities | $2,309 | $1,636 | | Total liabilities | $2,353 | $1,707 | | Total stockholders' equity | $3,322 | $4,032 | [Consolidated Statements of Operations](index=4&type=section&id=Consolidated%20Statements%20of%20Operations%20%28unaudited%29%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024) This table details the unaudited consolidated statements of operations for the three and six months ended June 30, 2025 and 2024 | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $1,879 | $877 | $3,520 | $1,811 | | General and administrative | $1,018 | $1,380 | $2,429 | $2,342 | | Total operating expenses | $2,897 | $2,257 | $5,949 | $4,153 | | Loss from operations | $(2,897) | $(2,257) | $(5,949) | $(4,153) | | Net loss | $(2,892) | $(2,250) | $(5,938) | $(4,137) | | Net loss per share, basic and diluted | $(1.31) | $(61.85) | $(4.33) | $(150.32) | [Consolidated Statements of Changes in Stockholders' Equity](index=5&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity%20%28unaudited%29%20for%20the%20six%20months%20ended%20June%2030%2C%202025%20and%202024) This table outlines the unaudited consolidated statements of changes in stockholders' equity for the six months ended June 30, 2025 and 2024 | Metric (in thousands) | Balance, December 31, 2024 | Stock-based compensation | Issuance of common stock and prefunded warrants in financing | Issuance of common stock | Net loss | Balance, June 30, 2025 | | :-------------------- | :------------------------- | :----------------------- | :----------------------------------------------------------- | :----------------------- | :------- | :--------------------- | | Additional Paid-in Capital | $43,772 | $220 | $4,143 | $825 | — | $49,000 | | Accumulated Deficit | $(39,740) | — | — | — | $(5,938) | $(45,678) | | Total Stockholders' Equity | $4,032 | $261 | $4,143 | $825 | $(5,938) | $3,322 | [Consolidated Statements of Cash Flows](index=6&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows%20%28unaudited%29%20for%20the%20six%20months%20ended%20June%2030%2C%202025%20and%202024) This table summarizes the unaudited consolidated statements of cash flows for the six months ended June 30, 2025 and 2024 | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(5,938) | $(4,137) | | Cash used in operating activities | $(4,902) | $(4,344) | | Cash provided by financing activities | $4,996 | $8,889 | | Net increase in cash and cash equivalents | $94 | $4,545 | | Cash and cash equivalents at end of period | $5,122 | $6,353 | [Notes to Unaudited Interim Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Interim%20Consolidated%20Financial%20Statements) This section provides detailed explanatory notes to the unaudited interim consolidated financial statements [1. Organization and Description of Business](index=8&type=section&id=1.%20ORGANIZATION%20AND%20DESCRIPTION%20OF%20BUSINESS) This note describes GRI Bio, Inc.'s business as a clinical-stage biopharmaceutical company and its product candidates - GRI Bio, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for inflammatory, fibrotic, and autoimmune disorders[21](index=21&type=chunk) - The lead product candidate, GRI-0621, is an oral inhibitor of type 1 iNKT cells, being developed for severe fibrotic lung diseases like idiopathic pulmonary fibrosis (IPF)[21](index=21&type=chunk) - The company also has GRI-0803, a novel oral agonist of type 2 dNKT cells, in its portfolio for autoimmune disorders such as Systemic Lupus Erythematosus Disease (SLE) and multiple sclerosis (MS)[21](index=21&type=chunk) - The company effected reverse stock splits on January 29, 2024 (one-for-seven), June 17, 2024 (one-for-thirteen), and February 21, 2025 (one-for-seventeen)[22](index=22&type=chunk) [2. Liquidity](index=8&type=section&id=2.%20LIQUIDITY) This note discusses the company's liquidity position, operating losses, cash resources, and future funding requirements - The company has incurred operating losses since inception, resulting in an accumulated deficit of **$45,678 thousand** as of June 30, 2025[23](index=23&type=chunk) - As of June 30, 2025, the company had approximately **$5,122 thousand in cash**[23](index=23&type=chunk) - The company believes its existing cash will fund operations into the fourth quarter of 2025, but requires additional capital to continue as a going concern[29](index=29&type=chunk)[30](index=30&type=chunk) | Financing Activity | Date | Net Proceeds (in thousands) | | :----------------- | :--- | :-------------------------- | | February 2024 Offering | Feb 1, 2024 | $4,389 | | ATM Offering (cumulative) | As of June 30, 2025 | $4,292 | | June 2024 Offering | June 26, 2024 | $3,172 | | October 2024 Warrant Repricing | Oct 21, 2024 | $609 | | April 2025 Offering | April 1, 2025 | $4,020 | [3. Basis of Presentation and Summary of Significant Accounting Policies](index=9&type=section&id=3.%20BASIS%20OF%20PRESENTATION%20AND%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note outlines the basis of financial statement presentation and key accounting policies applied by the company [Principles of Consolidation](index=9&type=section&id=Principles%20of%20Consolidation) This section explains the consolidation principles applied to GRI Bio, Inc. and its subsidiary - The consolidated financial statements include GRI Bio, Inc. and its wholly-owned subsidiary, GRI Bio Operations, Inc., with all intercompany balances and transactions eliminated[33](index=33&type=chunk) [Use of Estimates](index=9&type=section&id=Use%20of%20Estimates) This section details the management's use of estimates and assumptions in preparing the financial statements - Preparation of financial statements requires management to make estimates and assumptions, particularly for valuation of share options, warrants, deferred tax assets, accrued expenses, and operating lease incremental borrowing rates[34](index=34&type=chunk) [Fair Value Measurements](index=11&type=section&id=Fair%20Value%20Measurements) This section describes the company's fair value measurements for financial instruments, particularly liability classified warrants - The company's financial instruments, excluding liability classified warrants, approximate fair value due to short-term maturity[37](index=37&type=chunk) - May 2022 Warrants are classified as a Level 3 liability due to unobservable significant valuation assumptions and are revalued at each reporting date[38](index=38&type=chunk)[39](index=39&type=chunk) [Deferred Stock Issuance Costs](index=11&type=section&id=Deferred%20Stock%20Issuance%20Costs) This section explains the accounting treatment for costs incurred in connection with proposed securities offerings - Deferred stock issuance costs are incremental costs directly attributable to proposed securities offerings and are charged against gross proceeds upon closing[40](index=40&type=chunk) [Net Loss Per Common Share](index=11&type=section&id=Net%20Loss%20Per%20Common%20Share) This section details the calculation of basic and diluted net loss per common share, noting anti-dilutive securities - Basic and diluted net loss per common share are the same due to net losses, making potentially dilutive securities anti-dilutive[41](index=41&type=chunk) | Common Stock Equivalents Excluded from Diluted EPS | June 30, 2025 | June 30, 2024 | | :--------------------------------- | :------------ | :------------ | | Stock options | 21,270 | 142 | | Warrants | 4,623,292 | 311,956 | | Total | 4,644,562 | 312,098 | [Recent Accounting Pronouncements](index=12&type=section&id=Recent%20Accounting%20Pronouncements) This section discusses the impact of recently adopted accounting pronouncements on the company's financial reporting - The company adopted ASU No. 2023-07, Segment Reporting, effective for fiscal years beginning after December 15, 2023, enhancing disclosures about significant segment expenses[44](index=44&type=chunk) [4. Property and Equipment](index=12&type=section&id=4.%20PROPERTY%20AND%20EQUIPMENT) This note provides details on the company's property and equipment, including cost, accumulated depreciation, and depreciation expense | Property and Equipment (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Computer equipment | $21 | $21 | | Furniture and fixtures | $13 | $13 | | Total cost | $34 | $34 | | Accumulated depreciation | $(32) | $(30) | | Net property and equipment | $2 | $4 | - Depreciation expense was **$1 thousand** for the three months ended June 30, 2025 and 2024, and **$2 thousand** for the six months ended June 30, 2025 and 2024[45](index=45&type=chunk) [5. Accrued Expenses](index=12&type=section&id=5.%20ACCRUED%20EXPENSES) This note presents a breakdown of accrued expenses as of June 30, 2025, and December 31, 2024 | Accrued Expenses (in thousands) | June 30, 2025 | December 31, 2024 | | :------------------------------ | :------------ | :---------------- | | Research and development | $550 | $342 | | General and administrative | $73 | $12 | | Payroll and related | $337 | $337 | | Total accrued expenses | $960 | $691 | [6. Stockholders' Equity](index=13&type=section&id=6.%20STOCKHOLDERS%27%20EQUITY) This note details changes in stockholders' equity, including various securities purchase agreements and warrant activities [February 2024 Securities Purchase Agreement](index=13&type=section&id=February%202024%20Securities%20Purchase%20Agreement) This section describes the terms and proceeds from the February 2024 issuance of common stock and warrants - On February 1, 2024, the company issued common stock, pre-funded warrants, and common warrants for net proceeds of **$4,389 thousand**[47](index=47&type=chunk) - All February 2024 Pre-Funded Warrants and Series A-1 Warrants have been exercised as of June 30, 2025[48](index=48&type=chunk)[49](index=49&type=chunk) [May 2024 At The Market Offering](index=13&type=section&id=May%202024%20At%20The%20Market%20Offering) This section details the shares sold and net proceeds generated from the May 2024 At The Market (ATM) Offering - As of June 30, 2025, the company sold **908,172 shares** of common stock in the ATM Offering at a weighted-average price of **$5.01 per share**, generating net proceeds of **$4,292 thousand**[51](index=51&type=chunk) - During the quarter ended June 30, 2025, **582,554 shares** were sold for gross proceeds of **$941 thousand** and net proceeds of **$825 thousand**[51](index=51&type=chunk) [June 2024 Securities Purchase Agreement](index=14&type=section&id=June%202024%20Securities%20Purchase%20Agreement) This section outlines the terms and proceeds from the June 2024 issuance of common stock and warrants - On June 26, 2024, the company issued common stock, pre-funded warrants, and common warrants for net proceeds of **$3,172 thousand**[52](index=52&type=chunk) - All June 2024 Pre-Funded Warrants have been exercised in full as of June 30, 2025[53](index=53&type=chunk) - The company issued warrants to Wainwright to purchase **9,002 shares** of common stock in connection with the June 2024 Offering[54](index=54&type=chunk) [October 2024 Repricing Letter Agreement](index=14&type=section&id=October%202024%20Repricing%20Letter%20Agreement) This section describes the repricing and exercise of Series B Common Warrants in October 2024 - On October 21, 2024, certain Series B Common Warrants were exercised at a reduced price of **$17.00 per share**, generating net proceeds of **$202 thousand**[55](index=55&type=chunk)[56](index=56&type=chunk) - Holders received new unregistered Series D-1 and D-2 common warrants, and Wainwright received warrants to purchase **3,140 shares**[55](index=55&type=chunk) [April 2025 Securities Purchase Agreement](index=15&type=section&id=April%202025%20Securities%20Purchase%20Agreement) This section details the terms and proceeds from the April 2025 issuance of common stock and warrants - On April 1, 2025, the company issued common stock, pre-funded warrants, and Series E common stock warrants for net proceeds of **$4,020 thousand**[58](index=58&type=chunk) - All April 2025 Pre-Funded Warrants have been exercised in full as of June 30, 2025[59](index=59&type=chunk) - Wainwright received warrants to purchase **97,222 shares** of common stock as compensation for placement agent services[60](index=60&type=chunk) [Warrants](index=15&type=section&id=Warrants) This section provides a table summarizing the company's outstanding warrants, including exercise prices and expiration dates | Number of Shares | Exercise Price per Share | Expiration Date | | :--------------- | :----------------------- | :-------------- | | 210 | $243.10 | August 2025 | | 1,388,888 | $3.20 | January 2026 | | 9 | $464,100.00 | February 2026 | | 128,577 | $31.11 | March 2026 | | 44,839 | $17.00 | April 2026 | | 1,388,888 | $3.20 | October 2026 | | 16 | $43,548.05 | May 2027 | | 1 | $0.01 | July 2027 | | 3 | $94,970.33 | April 2028 | | 210 | $243.10 | February 2029 | | 9,002 | $38.8875 | June 2029 | | 128,577 | $31.11 | September 2029 | | 44,839 | $17.00 | October 2029 | | 3,140 | $21.25 | October 2029 | | 1,388,888 | $3.20 | April 2030 | | 97,222 | $4.50 | April 2030 | [7. Stock-Based Compensation](index=16&type=section&id=7.%20STOCK-BASED%20COMPENSATION) This note details the company's stock-based compensation plan, expenses, and stock option activity - The Amended and Restated 2018 Equity Incentive Plan allows for granting stock options, restricted stock, and other equity-based awards[64](index=64&type=chunk) | Stock-Based Compensation Expense (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $0 | $0 | $25 | $0 | | General and administrative | $41 | $37 | $236 | $74 | | Total | $41 | $37 | $261 | $74 | | Stock Option Activity (Six Months Ended June 30, 2025) | Number of options | Weighted-average exercise price | | :----------------------------------------------------- | :---------------- | :------------------------------ | | Outstanding at December 31, 2024 | 142 | $4,376.92 | | Granted | 21,128 | $11.66 | | Outstanding at June 30, 2025 | 21,270 | $40.80 | | Exercisable at June 30, 2025 | 21,208 | $30.83 | - As of June 30, 2025, all outstanding and exercisable stock options were out of the money, with **$174 thousand** in unrecognized compensation cost expected to be recognized over **0.78 years**[66](index=66&type=chunk) [8. Segment Reporting](index=17&type=section&id=8.%20SEGMENT%20REPORTING) This note explains the company's single reportable segment and how the CODM assesses performance - The company operates as a single reportable segment: biotechnology research, focused on developing products for inflammatory diseases[68](index=68&type=chunk) - The Chief Operating Decision Maker (CODM) assesses performance based on R&D and G&A expenses, consolidated net loss, and cash flows, using cash forecast models for resource allocation[69](index=69&type=chunk)[70](index=70&type=chunk) [9. Commitments and Contingencies](index=18&type=section&id=9.%20COMMITMENTS%20AND%20CONTINGENCIES) This note outlines the company's employment contracts and a separation agreement with a former CEO - The company has employment contracts with officers providing for severance and benefit continuation upon certain terminations, with potential equity award acceleration post-change in control[71](index=71&type=chunk) - A Separation and Release Agreement with the former CEO, David Baker, included salary and COBRA benefits continuation for **18 months** and a lump sum bonus payment[72](index=72&type=chunk) [10. Subsequent Events](index=18&type=section&id=10.%20SUBSEQUENT%20EVENTS) This note describes significant events occurring after the reporting period, including the OBBBA enactment - The One Big Beautiful Bill Act (OBBBA) was enacted on July 4, 2025, and is not currently expected to materially impact the company's effective tax rate or cash flows in the current fiscal year[73](index=73&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and results of operations for the three and six months ended June 30, 2025 and 2024. It covers the company's business overview, recent financing activities, detailed analysis of operating expenses, and a discussion of liquidity and capital resources, highlighting the ongoing need for additional funding [Overview](index=19&type=section&id=Overview) This section provides an overview of GRI Bio's business, product candidates, and clinical development progress - GRI Bio is a clinical-stage biopharmaceutical company developing therapies for inflammatory, fibrotic, and autoimmune disorders[76](index=76&type=chunk) - The lead product candidate, GRI-0621, an oral iNKT cell inhibitor, is in a Phase 2a biomarker study for idiopathic pulmonary fibrosis (IPF), with enrollment completed in July 2025 and topline results expected in Q3 2025[77](index=77&type=chunk) - GRI-0803, a novel oral dNKT cell agonist, is being developed for autoimmune disorders like SLE and MS, with further development contingent on additional funding and an IND application planned for 2026[78](index=78&type=chunk)[79](index=79&type=chunk) [Recent Developments](index=20&type=section&id=Recent%20Developments) This section highlights recent financing activities, including the April 2025 Securities Purchase Agreement and ATM Offering [April 2025 Securities Purchase Agreement](index=20&type=section&id=April%202025%20Securities%20Purchase%20Agreement) This section details the net proceeds from the April 2025 public offering of common stock and warrants - On April 1, 2025, the company completed a public offering, issuing common stock and various warrants, generating net proceeds of **$4.0 million**[80](index=80&type=chunk) [May 2024 At The Market Offering](index=20&type=section&id=May%202024%20At%20The%20Market%20Offering) This section summarizes the shares sold and net proceeds generated from the May 2024 ATM Offering - As of June 30, 2025, the company sold **908,172 shares** in the ATM Offering for **$4.5 million** gross proceeds and **$4.3 million** net proceeds[83](index=83&type=chunk) - The company increased the aggregate offering price for shares under the ATM Offering to **$1.8 million** on May 23, 2025[82](index=82&type=chunk) [Financial Operations Overview](index=20&type=section&id=Financial%20Operations%20Overview) This section provides an overview of key financial operation components, including R&D, G&A, warrant liability, and interest income [Research and Development Expenses](index=20&type=section&id=Research%20and%20Development%20Expenses) This section describes the components of R&D expenses and their expected future trends - R&D expenses primarily include personnel costs, third-party contractor fees for research, clinical trials, and drug manufacturing, and are expected to increase with planned clinical and preclinical activities[84](index=84&type=chunk)[85](index=85&type=chunk) [General and Administrative Expenses](index=21&type=section&id=General%20and%20Administrative%20Expenses) This section outlines the components of G&A expenses and their expected future trends - G&A expenses consist mainly of compensation, professional fees (legal, accounting), travel, and facilities, and are expected to increase due to public company compliance and additional personnel[86](index=86&type=chunk)[87](index=87&type=chunk) [Warrant Liability](index=21&type=section&id=Warrant%20Liability) This section explains the accounting treatment for May 2022 Warrants classified as a liability - May 2022 Warrants are recorded as a liability at fair value, with changes recognized in the consolidated statements of operations[88](index=88&type=chunk) [Interest Income](index=21&type=section&id=Interest%20Income) This section describes the source of the company's interest income - Interest income is derived from cash and cash equivalents held with institutional banks[89](index=89&type=chunk) [Results of Operations](index=21&type=section&id=Results%20of%20Operations) This section presents a comparative analysis of the company's financial results for the reported periods [Comparison of the Three Months Ended June 30, 2025 and 2024](index=21&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section compares key financial metrics for the three months ended June 30, 2025 and 2024 | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (YoY) | | :-------------------- | :------------------------------- | :------------------------------- | :----------- | | Research and development | $1,879 | $877 | +$1,002 | | General and administrative | $1,018 | $1,380 | -$362 | | Total operating expenses | $2,897 | $2,257 | +$640 | | Net loss | $(2,892) | $(2,250) | -$(642) | - The **$1.0 million** increase in R&D expenses was primarily due to a **$0.9 million** increase in the GRI-0621 development program and a **$0.1 million** increase in personnel expenses[91](index=91&type=chunk) - The **$0.4 million** decrease in G&A expenses was mainly due to a reduction in professional fees and public company expenses[92](index=92&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=22&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section compares key financial metrics for the six months ended June 30, 2025 and 2024 | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (YoY) | | :-------------------- | :----------------------------- | :----------------------------- | :----------- | | Research and development | $3,520 | $1,811 | +$1,709 | | General and administrative | $2,429 | $2,342 | +$87 | | Total operating expenses | $5,949 | $4,153 | +$1,796 | | Net loss | $(5,938) | $(4,137) | -$(1,801) | - The **$1.7 million** increase in R&D expenses was primarily due to a **$1.6 million** increase in the GRI-0621 development program and a **$0.1 million** increase in personnel expenses[95](index=95&type=chunk) - The **$0.1 million** increase in G&A expenses was mainly due to a **$0.3 million** increase in personnel expenses (including stock-based compensation), offset by a **$0.2 million** decrease in public company expenses[96](index=96&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash flows, financing activities, and future funding requirements [Cash Flows from Operating Activities](index=23&type=section&id=Cash%20Flows%20from%20Operating%20Activities) This section analyzes the cash used in operating activities for the reported periods - Cash used in operating activities increased by **$0.6 million**, from **$4.3 million** in H1 2024 to **$4.9 million** in H1 2025, primarily due to a **$1.8 million** increase in net loss[101](index=101&type=chunk) [Cash Flows from Financing Activities](index=23&type=section&id=Cash%20Flows%20from%20Financing%20Activities) This section details the cash provided by financing activities, including various offerings - Net cash provided by financing activities was **$5.0 million** for H1 2025, mainly from the April 2025 Offering (**$5.0 million**) and ATM Offering (**$0.9 million**), offset by **$0.9 million** in stock issuance costs[102](index=102&type=chunk) - Net cash provided by financing activities was **$8.9 million** for H1 2024, primarily from the February 2024 Offering (**$9.5 million**) and ATM Offering (**$1.0 million**), offset by **$1.6 million** in stock issuance costs[103](index=103&type=chunk) [April 2025 Securities Purchase Agreement](index=23&type=section&id=April%202025%20Securities%20Purchase%20Agreement) This section summarizes the net proceeds from the April 2025 Offering and associated expenses - The April 2025 Offering generated net proceeds of **$4.0 million** after deducting **$1.0 million** in offering expenses[104](index=104&type=chunk) [May 2024 At The Market Offering](index=23&type=section&id=May%202024%20At%20The%20Market%20Offering) This section details the net proceeds and shares sold through the May 2024 ATM Offering - As of June 30, 2025, the ATM Offering generated **$4.3 million** in net proceeds from the sale of **908,172 shares** at a weighted-average price of **$5.01 per share**[105](index=105&type=chunk) [February 2024 Securities Purchase Agreement](index=24&type=section&id=February%202024%20Securities%20Purchase%20Agreement) This section outlines the net proceeds from the February 2024 Offering and associated expenses - The February 2024 Offering resulted in net proceeds of **$4.4 million** after deducting **$1.1 million** in offering expenses[106](index=106&type=chunk) [Future Funding Requirements](index=24&type=section&id=Future%20Funding%20Requirements) This section addresses the company's need for additional capital and its going concern considerations - The company expects existing cash to fund operations into Q4 2025 but requires substantial additional funding for ongoing operations and clinical trials, raising substantial doubt about its ability to continue as a going concern[108](index=108&type=chunk)[109](index=109&type=chunk) - Future funding is planned through equity issuances and/or debt arrangements, with potential operational reductions if financing is not secured[109](index=109&type=chunk) [Off-Balance Sheet Arrangements](index=24&type=section&id=Off-Balance%20Sheet%20Arrangements) This section confirms the absence of material off-balance sheet transactions or obligations - The company is not party to any off-balance sheet transactions, guarantees, or obligations other than those from normal business operations[110](index=110&type=chunk) [Critical Accounting Policies and Estimates](index=24&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section highlights the reliance on management's estimates and assumptions in financial reporting - The financial statements rely on management's estimates and assumptions, which are evaluated continuously, and actual results may differ[111](index=111&type=chunk) [Emerging Growth Company Status](index=24&type=section&id=Emerging%20Growth%20Company%20Status) This section explains the company's status as an emerging growth company and related exemptions - The company is an 'emerging growth company' (EGC) under the JOBS Act, allowing it to rely on exemptions from certain disclosure requirements[113](index=113&type=chunk) - Exemptions include reduced executive compensation disclosure, no non-binding stockholder advisory votes, and exemption from auditor attestation on internal control over financial reporting[113](index=113&type=chunk)[121](index=121&type=chunk) - The company will remain an EGC until the earliest of reaching **$1.235 billion** in gross revenues, December 31, 2026, issuing over **$1.0 billion** in nonconvertible debt, or becoming a large accelerated filer[114](index=114&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that quantitative and qualitative disclosures about market risk are not applicable to the company as a smaller reporting company - Quantitative and Qualitative Disclosures About Market Risk are not applicable to the company as a smaller reporting company[115](index=115&type=chunk) [Item 4. Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details management's evaluation of the company's disclosure controls and procedures, identifying a material weakness related to warrant repricing computation. It outlines remediation efforts and discusses the inherent limitations of control systems [Management's Evaluation of our Disclosure Controls and Procedures](index=26&type=section&id=Management%27s%20Evaluation%20of%20our%20Disclosure%20Controls%20and%20Procedures) This section details the CEO and CFO's evaluation of disclosure controls and identified material weakness - The CEO and CFO concluded that disclosure controls and procedures were not effective as of June 30, 2025, due to a material weakness[117](index=117&type=chunk) - The material weakness was related to the inaccurate computation of the non-cash deemed dividend associated with the repricing of Series B Common Warrants[118](index=118&type=chunk) - Remediation plans include engaging third-party professionals for accounting expertise and enhancing documentation and communication processes with auditors[119](index=119&type=chunk) [Changes in Internal Control over Financial Reporting](index=27&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section reports on remediation efforts for the material weakness and other control changes - Remediation measures for the identified material weakness were implemented during the fiscal quarter, with no other material changes to internal control over financial reporting[122](index=122&type=chunk) [Limitations of Effectiveness of Control](index=27&type=section&id=Limitations%20of%20Effectiveness%20of%20Control) This section discusses the inherent limitations of any system of internal controls - Any system of controls provides only reasonable, not absolute, assurance and can be circumvented by individual acts, collusion, or management override[123](index=123&type=chunk) PART II. OTHER INFORMATION This section covers other information including legal proceedings, risk factors, equity sales, defaults, and exhibits [Item 1. Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) This section confirms that the company is not currently involved in any material legal proceedings, nor is it aware of any pending or threatened legal actions that could significantly impact its business or financial condition - The company is not currently a party to any material legal proceedings and is unaware of any pending or threatened legal actions that could adversely affect its business, operating results, or financial condition[125](index=125&type=chunk) [Item 1A. Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) This section states that there have been no material changes to the risk factors previously disclosed in the company's Annual Report - There have been no material changes from the risk factors previously disclosed in the Annual Report[126](index=126&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=28&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section reports that there were 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 purchases of equity securities[127](index=127&type=chunk) [Item 3. Defaults Upon Senior Securities](index=28&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section indicates that there were no defaults upon senior securities during the reporting period - There were no defaults upon senior securities[128](index=128&type=chunk) [Item 4. Mine Safety Disclosures](index=28&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that there are no mine safety disclosures applicable to the company - There are no mine safety disclosures[129](index=129&type=chunk) [Item 5. Other Information](index=28&type=section&id=Item%205.%20Other%20Information) This section confirms that no Rule 10b5-1 trading arrangements were adopted or terminated by the company's directors or officers during the three months ended June 30, 2025 - During the three months ended June 30, 2025, none of the company's directors or officers adopted or terminated "Rule 10b5-1 trading arrangements" or "non-Rule 10b5-1 trading arrangements"[130](index=130&type=chunk) [Item 6. Exhibits](index=29&type=section&id=Item%206.%20Exhibits) This section provides a comprehensive list of exhibits filed with the Quarterly Report, including organizational documents, warrant forms, compensation policies, and certifications - The exhibits include the Amended and Restated Certificate of Incorporation, Amended and Restated Bylaws, various warrant forms (Pre-Funded, Series E, Placement Agent), Form of Securities Purchase Agreement, Amended and Restated Non-Employee Director Compensation Policy, Form of Restricted Stock Unit Agreement, and certifications from the Principal Executive Officer and Principal Financial Officer[132](index=132&type=chunk) [Signatures](index=31&type=section&id=Signatures) This section contains the required signatures, confirming the due authorization and filing of the report on behalf of GRI Bio, Inc - The report was signed on August 14, 2025, by Leanne M. Kelly, Chief Financial Officer (Principal Financial and Accounting Officer) of GRI BIO, INC[139](index=139&type=chunk)[140](index=140&type=chunk)

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 [3] - The company is in the clinical stage and aims to fundamentally change treatment approaches for these diseases [3] Recent Developments - GRI Bio participated in a Virtual Investor segment where CEO Marc Hertz discussed interim biomarker data from a Phase 2a study in Idiopathic Pulmonary Fibrosis (IPF) [2] - The interim data was collected over a 6-week period, indicating progress in the ongoing study [2] Product Pipeline - GRI Bio's lead program, GRI-0621, is an inhibitor of iNKT cell activity, being developed as an oral therapeutic for IPF, which has significant unmet medical needs [3] - The company is also developing a pipeline of novel type 2 diverse NKT (dNKT) agonists aimed at treating systemic lupus erythematosus [3] - GRI Bio possesses a library of over 500 proprietary compounds, which supports the expansion of its product pipeline [3]

Core Insights - GRI Bio, Inc. is a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for treating inflammatory, fibrotic, and autoimmune diseases [1][3] - The company’s lead program, GRI-0621, is an oral therapeutic aimed at treating 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] Company Overview - GRI Bio is a clinical-stage biopharmaceutical company aiming to change the treatment landscape for inflammatory, fibrotic, and autoimmune diseases [3] - The company’s therapies target NKT cells, which play a crucial role in the inflammatory response and disease progression [3] - The company’s focus on NKT cells positions it uniquely in the biopharmaceutical industry, linking innate and adaptive immune responses [3] Leadership Insights - Dr. Marc Hertz, the President and CEO, shared his dedication to the company and insights into its development programs during a recent investor conference [2]

Core Insights - GRI Bio, Inc. has completed patient enrollment for its Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (IPF) [1][2] - The company is on track to report 6-week interim biomarker results in July 2025, with topline data expected in Q3 2025 [1][6] - GRI-0621 is being developed as a novel oral therapeutic targeting Natural Killer T (NKT) cells, which play a critical role in inflammatory and fibrotic diseases [8] Company Overview - GRI Bio is a clinical-stage biopharmaceutical company focused on treating inflammatory, fibrotic, and autoimmune diseases through NKT cell modulation [8] - The lead program, GRI-0621, is an inhibitor of iNKT cell activity aimed at addressing the unmet needs in IPF treatment [8] Study Design and Results - The Phase 2a study is a randomized, double-blind, placebo-controlled trial enrolling approximately 35 subjects, with a 2:1 randomization for GRI-0621 (4.5mg) versus placebo [3] - Primary endpoint focuses on safety and tolerability after 12 weeks, while secondary endpoints include changes in serum biomarkers and pharmacokinetics [3] - Interim safety results from the first 12 and 24 patients indicated that GRI-0621 is safe and well-tolerated, with no significant changes in lipid levels observed [4][5] Future Expectations - The company anticipates reporting 6-week interim biomarker data in July 2025, followed by topline results in Q3 2025 [6]

Core Insights - The Independent Data Monitoring Committee (IDMC) has recommended the continuation of the study for GRI-0621, indicating no safety concerns in the reviewed data [1][3] - Interim results show GRI-0621 to be safe and well-tolerated in the first 24 patients evaluated, with no adverse events related to hyperlipidemia [3][4] - The company expects to report 6-week interim biomarker data in July 2025, with topline results anticipated in Q3 2025 [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][7] - GRI-0621 is a small molecule RAR-βɣ dual agonist that inhibits the activity of human Type 1 Invariant NKT (iNKT) cells, showing promise in improving fibrosis and liver function in preliminary trials [2][7] - The ongoing Phase 2a study is randomized, double-blind, and placebo-controlled, enrolling approximately 36 subjects with idiopathic pulmonary fibrosis (IPF) [4][5] Study Details - The Phase 2a study evaluates GRI-0621 at a dose of 4.5mg orally once daily for 12 weeks, with a primary endpoint focused on safety and tolerability [4][5] - Secondary endpoints include changes in serum biomarkers at weeks 6 and 12, pharmacokinetics assessment, and pharmacodynamic activity of GRI-0621 [4][5] - The study also includes a sub-study examining NKT cell activity in bronchoalveolar lavage fluid [4]

Core Insights - GRI Bio, Inc. presented positive preclinical data at the 2025 ATS International Conference, indicating that GRI-0621 has potential anti-inflammatory and anti-fibrotic effects in pulmonary fibrosis [1][2][3] - The ongoing Phase 2a study of GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF) is expected to provide interim analysis results in Q2 2025 [1][3] Company Overview - GRI Bio is a biotechnology company focused on developing Natural Killer T (NKT) cell modulators for treating inflammatory, fibrotic, and autoimmune diseases [1][10] - The lead program, GRI-0621, is a small molecule RAR-βɣ dual agonist that inhibits human iNKT cell activity and is currently in a 12-week, double-blind, randomized, placebo-controlled study for IPF [6][10] Clinical Study Details - The Phase 2a study aims to assess the safety and tolerability of GRI-0621, along with its effects on various biomarkers associated with disease progression [6][7] - Interim results from the first 12 patients indicated that GRI-0621 (4.5mg orally once daily) was safe and well-tolerated, with no significant changes in lipid levels [7][9] Research Findings - The presented data included biochemical, qPCR, and immunohistochemistry analyses, demonstrating that iNKT cell inactivation during the fibrotic phase can significantly inhibit fibroblast activation and fibrosis in a murine model [4][8] - GRI-0621 showed therapeutic effects in reducing lung injury and impacting key cellular and molecular drivers of lung disease, performing comparably or better than the approved drug nintedanib [8][9] Future Expectations - The interim analysis committee has recommended the continuation of the Phase 2a study, with topline results expected in Q3 2025 [9]

Summary of GRI Bio Conference Call Company Overview - **Company**: GRI Bio - **Focus**: Clinical stage biotech company targeting inflammatory fibrotic and autoimmune diseases through regulation of invariant natural killer T (NKT) cells [2][5] Core Program - **Lead Program**: GRI o six two one (GRI621) - **Type**: Small molecule inhibitor of type one invariant NKT cells - **Indication**: Treatment of idiopathic pulmonary fibrosis (IPF) - **Current Stage**: Phase 2a study with top line data expected in Q3 2025 [6][17] Mechanism of Action - **NKT Cells**: Critical lymphocytes involved in chronic inflammation and fibrosis - Inhibition of NKT cells shown to be therapeutic across various preclinical models of fibrosis [8][9] - Increased NKT cell activity correlates with worsening fibrotic disease, suggesting potential as a biomarker [9][12] Clinical Trial Details - **Trial Design**: - 36 patients, randomized 2:1 (GRI621 vs. placebo) - Duration: 12 weeks, with patients allowed to continue background therapy [18][19] - Primary endpoints: Safety, tolerability, pharmacokinetics, biomarkers of fibrosis, and pulmonary function tests [19][25] - **Enrollment Status**: Approximately 80% enrolled [20] Interim Results - **Recent Findings**: Positive recommendation from the Independent Data Monitoring Committee (IDMC) for continued trial [24] - **Early Data**: Indication of antifibrotic signal observed in initial 12 patients after two weeks [24] Challenges in IPF Treatment - **Current Landscape**: - Existing treatments (nantenadib and profinidone) slow lung function decline but do not improve overall survival [32] - Significant side effects limit patient compliance [32] - **Focus on Upstream Targets**: GRI Bio aims to address earlier stages in the inflammatory cascade rather than late-stage targets like TGF beta [33][34] Market Potential - **Market Size**: IPF is an orphan indication; nantenadib generated approximately $4 billion in sales last year [38] - **Competitive Landscape**: Other drugs in development face challenges, including drug-drug interactions and tolerability issues [39][40] Future Considerations - **Regulatory Pathways**: Potential for expedited approval due to existing safety data from other indications [47] - **Pipeline Opportunities**: GRI Bio is developing additional programs, including GRI o eight zero three (GRI803) targeting systemic lupus erythematosus [49][50] Conclusion - GRI Bio is positioned to address significant unmet needs in the treatment of IPF through innovative targeting of NKT cells, with ongoing clinical trials and a robust pipeline of future therapies [52]

Summary of GRI Bio Conference Call Company Overview - **Company**: GRI Bio - **Focus**: Clinical stage biotech company targeting inflammatory fibrotic and autoimmune diseases through regulation of NKT cells [2][5] Lead Program - **Product**: GRI o six two one - **Type**: Type one invariant natural killer T cell antagonist - **Indication**: Treatment of idiopathic pulmonary fibrosis (IPF) - **Current Stage**: Phase 2a study with top line data expected in Q3 2025 [6][18] Mechanism of Action - **NKT Cells**: Critical lymphocytes involved in chronic inflammation and fibrosis - **Therapeutic Approach**: Inhibiting NKT cell activity to interrupt disease progression and restore immune homeostasis [5][8] - **Biomarker Potential**: Increased NKT cells correlate with worsening fibrotic disease, suggesting their role as a useful biomarker [9][39] Clinical Trial Details - **Trial Design**: - 36 patients, 2:1 randomization (24 on GRI o six two one, 12 on placebo) - Duration: 12 weeks, with primary endpoints focusing on safety and tolerability [16][18] - **Enrollment Status**: Approximately 80% enrolled, with interim data expected in Q2 2025 [18][22] Data and Results - **Interim Analysis**: Positive recommendation from the Independent Data Monitoring Committee (IDMC) after 12 patients completed two weeks [21] - **Early Signals**: Antifibrotic signal observed in pro-collagen type III (pro C3) after two weeks [21][26] Market Context - **Market Size**: IPF is an orphan indication; Nintanadib, one of the approved drugs, generated approximately $4 billion in sales last year [35] - **Challenges**: Current treatments slow disease progression but do not improve overall survival; significant side effects limit patient compliance [29][30] Competitive Landscape - **Current Treatments**: Nintanadib and Perfinetone are the two approved drugs, both with limitations in efficacy and tolerability [35][36] - **Future Positioning**: GRI o six two one aims to address the disease earlier in the inflammatory cascade compared to existing therapies [30][31] Regulatory Considerations - **Expedited Approval**: Potential for a single registration trial due to existing safety data from other indications [43][44] Pipeline Opportunities - **Future Programs**: GRI o eight zero three targeting type two NKT cells for systemic lupus erythematosus; additional 500 compounds in the library for future development [46][47] Conclusion - GRI Bio is positioned to potentially disrupt the IPF treatment landscape with GRI o six two one, focusing on early intervention in the inflammatory process and leveraging NKT cells as biomarkers for disease progression [5][39]

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 [4] - The company's lead program, GRI-0621, is an inhibitor of iNKT cell activity, being developed as a novel oral therapeutic for idiopathic pulmonary fibrosis, addressing a significant unmet medical need [4] - 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 growing pipeline [4] Upcoming Event - Marc Hertz, PhD, CEO of GRI Bio, will participate in the Virtual Investor Closing Bell Series on May 28, 2025, at 4:00 PM ET, providing a corporate overview and business outlook [1][2] - The event will allow investors and interested parties to submit questions live, with the company aiming to answer as many as possible within the time allowed [2] Webcast Information - A live video webcast of the event will be available on the company's website, with a replay accessible for 90 days following the live event [3]