[8-K] GRI Bio, Inc. Reports Material Event

Rhea-AI Filing Summary

GRI Bio (Nasdaq: GRI) furnished an 8-K under Item 7.01 disclosing a press release that reports interim safety results from its Phase 2a study of GRI-0621 for idiopathic pulmonary fibrosis. The disclosure is provided solely for Regulation FD purposes and is expressly not deemed “filed” under the Exchange Act. No efficacy data, financial metrics, or guidance updates were included. Exhibit 99.1 contains the full press release; no other material items were reported.

Insights

Clinical Development Analyst

Safety milestone reached; efficacy still unknown, so risk profile unchanged.

The company’s decision to release interim safety data indicates the trial has cleared a key tolerability checkpoint, allowing enrollment to continue without protocol amendments. However, the 8-K provides no numerical adverse-event rates or discontinuation figures, preventing assessment of comparative safety versus standard of care. Investors should watch for upcoming efficacy or biomarker read-outs before reassessing probability-of-success assumptions. The fact that the information is furnished, not filed, limits legal liability and underscores management’s caution. Overall, the announcement confirms progress but does not materially de-risk the program.

Biotech Equity Analyst

Disclosure advances timeline but lacks detail to shift valuation.

Reaching an interim safety checkpoint is a necessary step toward a potential Phase 2b/3 pivot, yet the filing omits any quantitative data that could influence discounted cash-flow models. Without clarity on treatment-emergent serious adverse events or dose-limiting toxicities, sell-side coverage is unlikely to adjust success probabilities or peak-sales estimates. The neutral presentation—furnished under Reg FD, not filed—suggests management aims to maintain informational symmetry without triggering re-guidance. Near-term share movement will hinge on subsequent efficacy updates rather than this safety note.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549 FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 26, 2025

GRI BIO, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-40034

82-4369909

(State or other jurisdiction

(Commission File Number)

(IRS Employer Identification No.)

of incorporation)

2223 Avenida de la Playa, #208

La Jolla, CA 92037

(Address of principal executive offices and zip code)

(619) 400-1170

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

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

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.

Emerging Growth Company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

On June 26, 2025, GRI Bio, Inc. (the "Company") issued a press release announcing its interim safety results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of idiopathic pulmonary fibrosis. A copy of this press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.

The information in this report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying Exhibit 99.1 shall not be deemed incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof regardless of any general incorporation language in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.						Description
99.1						Press Release issued by GRI Bio, Inc., dated June 26, 2025.
104						Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: June 26, 2025

GRI BIO, INC.

By:

/s/ Leanne Kelly

Name:

Leanne Kelly

Title:

Chief Financial Officer