GRI Bio (GRI) issues press release on new Phase 2a IPF trial data

Rhea-AI Filing Summary

GRI Bio, Inc. filed a report noting that it has released additional data from its Phase 2a clinical trial of GRI-0621 in patients with idiopathic pulmonary fibrosis. The company announced these clinical findings through a press release dated January 28, 2026.

The press release is included as Exhibit 99.1, meaning the detailed trial information and outcomes are provided in that attached document rather than in the body of this report.

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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): January 28, 2026

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 January 28, 2026, GRI Bio, Inc. (the “Company”) issued a press release announcing additional data from the Company’s Phase 2a clinical trial investigating GRI-0621 in patients diagnosed with idiopathic pulmonary fibrosis. The press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 8.01 by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.						Description
99.1						Press Release issued by GRI Bio, Inc., dated January 28, 2026.
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: January 28, 2026

GRI BIO, INC.

By:

/s/ Leanne Kelly

Name:

Leanne Kelly

Title:

Chief Financial Officer

FAQ

What did GRI Bio, Inc. (GRI) disclose in this 8-K filing?

GRI Bio disclosed that it issued a press release with additional data from its Phase 2a trial of GRI-0621 in idiopathic pulmonary fibrosis. The detailed information is contained in Exhibit 99.1 attached to the report.

What clinical program is highlighted by GRI Bio, Inc. (GRI) in this filing?

The filing highlights GRI Bio’s Phase 2a clinical trial evaluating GRI-0621 in patients diagnosed with idiopathic pulmonary fibrosis. The company announced additional data from this study in a press release dated January 28, 2026, attached as Exhibit 99.1.

How did GRI Bio, Inc. (GRI) communicate its new clinical data?

GRI Bio communicated the new clinical data through a press release issued on January 28, 2026. That press release, describing additional Phase 2a data for GRI-0621 in idiopathic pulmonary fibrosis, is filed as Exhibit 99.1 to the current report.

Which exhibit in the GRI Bio, Inc. (GRI) 8-K contains the trial data details?

Exhibit 99.1 contains the detailed information, as it is the press release issued by GRI Bio on January 28, 2026. The press release presents the additional data from the Phase 2a trial of GRI-0621 in idiopathic pulmonary fibrosis.

Does this GRI Bio, Inc. (GRI) filing include financial statements?

The filing lists only exhibits, including a press release and an inline XBRL cover page data file. It does not present financial statements, focusing instead on additional clinical trial data for GRI-0621 in idiopathic pulmonary fibrosis.