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

Rhea-AI Filing Summary

GRI Bio, Inc. filed a Form 8-K dated 31 July 2025 to disclose that it has issued a press release (Ex. 99.1) announcing interim biomarker data from its ongoing Phase 2a study of GRI-0621 in idiopathic pulmonary fibrosis (IPF). No numerical biomarker results, safety or efficacy data were included in the filing itself; investors must review the referenced press release for specifics. The company affirms its listing of common stock (ticker GRI) on Nasdaq and notes no other material transactions or financial updates. The item is reported under Item 8.01 – Other Events; therefore it is considered informational rather than financial.

Positive

• Phase 2a interim biomarker data announced, indicating continued clinical progress for lead candidate GRI-0621.

Negative

• No quantitative biomarker, safety, or efficacy data disclosed, limiting investors’ ability to gauge clinical significance.

Insights

Biotechnology Analyst

TL;DR: Filing flags clinical progress but omits data; market impact limited until results known.

The 8-K simply notifies investors that interim biomarker data from the Phase 2a IPF trial are now public via a separate press release. While a mid-stage readout often represents a key de-risking step, the absence of any quantitative biomarker or safety figures prevents assessment of effect size or regulatory relevance. As such, the disclosure is procedural and offers minimal insight into GRI-0621’s clinical value or timeline. Impact on valuation should be modest until data details emerge.

Regulatory Affairs Specialist

TL;DR: Standard Item 8.01 notice; maintains compliance, bears no immediate regulatory consequence.

GRI Bio uses the 8-K to ensure prompt disclosure of potentially material clinical information, aligning with SEC and FDA best-practice transparency. However, because the filing lacks the actual biomarker metrics, it neither advances the dossier with regulators nor triggers additional reporting obligations. Investors awaiting pivotal efficacy or safety endpoints will need fuller clinical reports later in the study cycle.

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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): July 31, 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 8.01 Other Events.

On July 31, 2025, GRI Bio, Inc. (the "Company") issued a press release announcing its interim biomarker data from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of idiopathic pulmonary fibrosis. A copy of this press release is filed as Exhibit 99.1 to this report and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.						Description
99.1						Press Release issued by GRI Bio, Inc., dated July 31, 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: July 31, 2025

GRI BIO, INC.

By:

/s/ Leanne Kelly

Name:

Leanne Kelly

Title:

Chief Financial Officer

FAQ

What did GRI (GRI Bio) announce in the Form 8-K?

The company disclosed that it issued a press release with interim biomarker data from its Phase 2a study of GRI-0621 for IPF.

Does the filing include actual biomarker results?

No. The 8-K references the press release (Ex. 99.1) but does not contain specific biomarker figures.

Which trial is affected by this announcement?

GRI-0621’s ongoing Phase 2a trial for idiopathic pulmonary fibrosis.

Is there any financial guidance or earnings data in this filing?

No financial metrics or guidance were provided; the filing is solely an Item 8.01 ‘Other Events’ notice.

Where can investors find the detailed data?

Investors should review Exhibit 99.1, the press release dated 31 July 2025, for detailed interim biomarker results.