Registration No. 333-276205 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GRI BIO, INC. As filed with the Securities and Exchange Commission on January 31, 2024. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (Primary Standard Industrial Classification Code Number) Delaware 2834 82-4369909 (I.R.S. Employer Identification Number) 2223 Avenida de la Playa, #208 ...

As filed with the Securities and Exchange Commission on January 30, 2024. Registration No. 333-276205 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) (State or other jurisdiction of (Primary Standard Industrial Classification Code Number) Delaware 2834 82-4369909 (I.R.S. Employer Identification Number) 2223 Avenida de la Playa, #208 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 As filed with the Securities and Exchange Commission on December 21, 2023. Registration No. 333- GRI BIO, INC. (Exact name of registrant as specified in its charter) (Name, address, including zip code, and telephone number, including area code, of agent for service) Copies to: Adam Lenain, Esq. Melanie Ruthrauff Levy, Esq. Jason Miller, Esq. Mintz, Levin, Cohn, Ferris, Glo ...

As filed with the Securities and Exchange Commission on December 4, 2023. Registration No. 333-274972 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 PRE-EFFECTIVE AMENDMENT NO. 1 TO FORM S-3 ON FORM S-1 REGISTRATION STATEMENT (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 82-4369909 UNDER THE SECURITIES ACT OF 1933 GRI BIO, INC. (Exact name of registrant as specified in its charter) (I.R.S. Employ ...

Product Development - GRI Bio's lead product candidate, GRI-0621, has been evaluated in over 1,700 patients for up to 52 weeks, targeting severe fibrotic lung diseases like idiopathic pulmonary fibrosis (IPF), which affects approximately 140,000 people in the U.S. annually [95] - GRI Bio plans to initiate a Phase 2a trial in 36 IPF patients in the second half of 2023, with topline results expected in the second half of 2024 [95] - The company intends to file an IND for GRI-0803, targeting systemic lupus erythematosus (SLE), in the first half of 2024 [96] Financial Performance - Total operating expenses for the three months ended September 30, 2023, were $2.4 million, compared to $0.2 million in 2022, resulting in a loss from operations of $2.4 million [110] - The net loss for the nine months ended September 30, 2023, was $11.0 million, compared to a net loss of $0.9 million in 2022, indicating a significant increase in losses [122] - As of September 30, 2023, the company had an accumulated deficit of $29.5 million and $3.5 million in cash [130] Expenses - Research and development expenses increased to $1.2 million for the three months ended September 30, 2023, compared to $0.1 million in the same period of 2022, reflecting a $1.1 million rise primarily due to GRI-0621 development costs [111] - General and administrative expenses rose to $1.3 million for the three months ended September 30, 2023, from $0.1 million in 2022, with a $1.2 million increase attributed to professional fees and personnel expenses [112] - Research and development expenses increased to $2.2 million for the nine months ended September 30, 2023, compared to $0.2 million in 2022, reflecting a $2.0 million rise primarily due to GRI-0621 development costs [117] - General and administrative expenses rose to $7.2 million in 2023 from $0.4 million in 2022, a $6.8 million increase mainly due to professional fees related to the Merger and increased personnel expenses [118] Cash Flow - Net cash used in operating activities was $3.4 million for the nine months ended September 30, 2023, compared to $0.2 million in 2022, reflecting a $3.2 million increase in cash outflow [125] - Net cash provided by financing activities was $6.9 million for the nine months ended September 30, 2023, primarily from proceeds of $12.3 million from the Equity SPA [127] - The company anticipates that existing cash and cash equivalents will be sufficient to fund operations into the first quarter of 2024 [131] Warrant Liability - The change in fair value of warrant liability was a decrease of $0.1 million during the three months ended September 30, 2023 [113] - The change in fair value of warrant liability was a decrease of $0.2 million during the nine months ended September 30, 2023 [119] - The Series T Warrants issued in connection with the Merger are not currently subject to forced exercise due to unmet equity conditions [132] Corporate Actions - GRI Bio completed a merger with Vallon Pharmaceuticals on April 21, 2023, changing its name to GRI Bio, Inc. [97] - The company issued warrants to purchase 1,269,210 shares at an initial exercise price of $13.51 per share as part of the merger financing [99] - The company expects to continue incurring significant operating losses and will need substantial additional funding to support ongoing operations and clinical trials [132]

Financial Performance - The total operating expenses for the three months ended June 30, 2023, were $5.9 million, compared to $0.2 million in 2022, resulting in a loss from operations of $5.9 million [105]. - The net loss for the three months ended June 30, 2023, was $6.7 million, compared to a net loss of $0.3 million in the same period of 2022 [105]. - The total operating expenses for the six months ended June 30, 2023, were $6.9 million, compared to $0.4 million in 2022, leading to a loss from operations of $6.9 million [110]. - The net loss for the six months ended June 30, 2023, was $8.9 million, compared to a net loss of $0.6 million in the same period of 2022 [110]. - Net losses for the six months ended June 30, 2023, were $8.9 million, compared to $0.6 million for the same period in 2022, resulting in an accumulated deficit of $27.4 million [115]. Research and Development - Research and development expenses increased to $0.9 million for the three months ended June 30, 2023, compared to $0.1 million in the same period of 2022, reflecting a $0.8 million increase primarily due to GRI-0621 development costs [106]. - Research and development expenses for the six months ended June 30, 2023, were $1.0 million, up from $0.1 million in 2022, with a $0.9 million increase primarily due to GRI-0621 development [111]. - GRI-0621 is being developed for severe fibrotic lung diseases, with a Phase 2a trial expected to initiate in the second half of 2023 and topline results anticipated in the second half of 2024 [93]. - GRI-0803 is being developed for autoimmune disorders, with an IND filing expected in the first half of 2024 for initial trials targeting systemic lupus erythematosus [94]. Expenses and Costs - General and administrative expenses rose to $5.1 million for the three months ended June 30, 2023, from $0.1 million in 2022, with a $3.8 million increase attributed to professional fees related to the merger [107]. - General and administrative expenses for the six months ended June 30, 2023, were $5.9 million, compared to $0.3 million in 2022, with a $4.5 million increase related to merger-associated professional fees [112]. - The increase in interest expense, net, was $2.1 million for the six months ended June 30, 2023, compared to $0.2 million in 2022, attributed to the Bridge Notes [114]. - Cash flows from operating activities showed a net outflow of $2.1 million for the six months ended June 30, 2023, compared to an outflow of $0.1 million in 2022 [117]. Cash and Financing - Cash and cash equivalents as of June 30, 2023, totaled $4.8 million, with a net cash increase of $4.79 million during the six months [116]. - Net cash provided by financing activities was $6.9 million, primarily due to $12.3 million from the Equity SPA, offset by merger-related costs and liabilities [119]. - The company has financed working capital through common stock, warrants, convertible notes, and promissory notes since inception [116]. - The company expects to incur significant additional costs related to planned clinical trials and product development, indicating a need for substantial future funding [122]. - The company anticipates that existing cash and cash equivalents will be sufficient to fund operations for twelve months post-merger, excluding Series T Warrant Exercises [123]. Going Concern - There is substantial doubt about the company's ability to continue as a going concern if adequate additional funding is not secured [124]. - The company is classified as an "emerging growth company" and intends to rely on exemptions from certain disclosure requirements [128].

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 March 31, 2023 ☐ 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 _________________ ...

Table of Contents UNITED STATES ________________________________ 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, 2022 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 SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 | Delaware | 82-4369909 | | --- | --- | | (State or other jurisdiction of | ...