GRI

EX-99.1

2 ex991_pressreleaseq126earn.htm

EX-99.1

Document

Exhibit 99.1

GRI Bio Reports First Quarter 2026 Financial Results, New Data Reinforcing Differentiated Profile of GRI-0621 in Idiopathic Pulmonary Fibrosis and Highlights Continued Advancement of Differentiated Immune-Modulating Pipeline

Phase 2a data show zero cough and 60% lower treatment-related diarrhea than placebo despite higher nintedanib use in the active arm – suggesting GRI-0621 may mitigate nintedanib-related GI-toxicities when used in combination

Advancing GRI-0803 toward IND-enabling activities to expand the pipeline across autoimmune indications with high unmet need

LA JOLLA, CA, May 14, 2026 -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (NKT) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced reported financial results for the quarter ended March 31, 2026 and provided a corporate update.

“The growing body of Phase 2a clinical, translational and biomarker data continues to reinforce GRI-0621’s differentiated therapeutic potential in idiopathic pulmonary fibrosis (IPF),” said Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “Additional analyses in the Phase 2a study show that GRI-0621 delivered zero cough, reduced dyspnea, zero weight loss and approximately 60% less treatment-related diarrhea when added to standard of care versus standard of care alone, with no serious adverse events in the active arm – directly addressing the tolerability burdens that drive discontinuations of current IPF therapies. These data, together with improvements in lung function and consistent evidence of immune modulation, anti-fibrotic activity, and epithelial repair, give us confidence in the program. With approximately $11.0 million in cash as of March 31, 2026, supporting planned operations into the second quarter of 2027, we believe we are positioned to continue advancing GRI-0621 towards pivotal studies and progressing GRI-0803 toward IND-enabling activities with disciplined execution.”

Phase 2a Data – GRI-0621 in IPF

GRI-0621, the Company’s once-daily oral RARβ/γ selective agonist, was evaluated in a randomized, double-blind, placebo-controlled Phase 2a trial (GRI-0621-IPF-02; NCT06331624) in 35 patients with IPF, approximately 80% of whom were on background standard-of-care (SOC) antifibrotics. The trial met its primary safety and tolerability endpoint, with continued analyses of translational and biomarker endpoints supporting previously reported findings. Key results include:

•Safety and tolerability: GRI-0621 was observed to reduce important clinical features of IPF (cough/shortness of breath) and SOC-associated toxicities (diarrhea). Zero cough was observed in the active arm vs. 25% in the placebo arm; a 76% reduction in dyspnea (4% vs. 17% placebo arm); no weight loss (vs. 17% placebo arm); and a 61% reduction in diarrhea (13% vs. 33% placebo arm), despite 67% more nintedanib use in the active vs. placebo arm (nintedanib is known to be associated with higher rates of diarrhea compared to pirfenidone); no serious adverse events were reported in the active arm, and a single SAE was reported in the placebo arm.

•Exploratory pulmonary function: +99 mL FVC improvement overall, and +139 mL in the SOC combination subset, versus placebo + SOC at 12 weeks.

•MOA: Evidence across multiple, independent measures, including serum proteomics (17 analytes), whole-blood RNA-sequencing and flow cytometry suggest disease-modifying benefits, including immune rebalancing (Th2→Type 1 switch), active fibrolysis, basement membrane repair and epithelial regeneration.

•Patents: The company has filed additional patent applications based, in part, on these data.

First Quarter 2026 Pipeline and Corporate Highlights

•Advanced clinical development planning activities for GRI-0621 to support potential regulatory pathways in both the United States and Europe.

•Progressed GRI-0803, the Company’s type 2 diverse Natural Killer T (dNKT) agonist program for autoimmune diseases, toward IND-enabling activities.

•Strengthened the balance sheet through the Company’s At The Market facility, generating approximately $6.8 million in gross proceeds during the first quarter of 2026.

First Quarter 2026 Financial Results

Cash and cash equivalents totaled approximately $11.0 million as of March 31, 2026, compared to approximately $8.2 million as of December 31, 2025. Based on the Company’s current operating plan, GRI Bio believes existing cash resources will be sufficient to fund planned operating expenses and capital expenditure requirements into the second quarter of 2027.

Research and development expenses were approximately $0.4 million for the three months ended March 31, 2026, compared to approximately $1.6 million for the same period in 2025. The decrease was primarily related to lower expenses due to the completion of the Com

val-20260204FALSE000182429300018242932026-02-042026-02-04

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): February 4, 2026

GRI BIO, INC.

(Exact name of registrant as specified in its charter)

Delaware001-4003482-4369909 (State or other jurisdiction(Commission File Number)(IRS Employer Identification No.) of incorporation)

2223 Avenida de la Playa, Suite 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 2.02 Results of Operations and Financial Condition. On February 4, 2026, GRI Bio, Inc. (the “Company”) issued a press release reiterating its financial results for the fiscal year 2025 and summarizing key recent highlights. A copy of the Company’s press release containing this information is being furnished as Exhibit 99.1 to this Current Report on Form 8-K. 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 99.1Press Release issued by GRI Bio, Inc., dated February 4, 2026.

104Cover 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: February 4, 2026GRI Bio, Inc. By: /s/ Leanne Kelly Leanne Kelly Chief Financial Officer

val-20250515FALSE000182429300018242932025-05-152025-05-15

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): May 15, 2025

GRI BIO, INC.

(Exact name of registrant as specified in its charter)

Delaware001-4003482-4369909 (State or other jurisdiction(Commission File Number)(IRS Employer Identification No.) of incorporation)

2223 Avenida de la Playa, Suite 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 2.02 Results of Operations and Financial Condition. On May 15, 2025, GRI Bio, Inc. (the Company) issued a press release announcing its financial results for the three months ended March 31, 2025, and provided a business update. 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 99.1Press Release issued by GRI Bio, Inc., dated May 15, 2025.

104Cover 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: May 15, 2025GRI Bio, Inc. By: /s/ Leanne Kelly Leanne Kelly Chief Financial Officer