GRI Bio, Inc. (GRI) SEC Filings

GRI Bio, Inc. is soliciting stockholder votes for its virtual 2026 annual meeting on November 4, 2026. The ballot includes electing W. Marc Hertz, Ph.D. and David Szekeres as Class III directors through the 2029 annual meeting; ratifying WithumSmith+Brown, PC as independent auditor for fiscal 2026; a proposal to increase shares available for issuance under the 2018 Equity Incentive Plan by 546,529 shares and extend its evergreen provision to January 1, 2036; and authority to adjourn or postpone if additional proxies are needed. The board recommends FOR each proposal.

There were 2,186,115 common shares outstanding and entitled to vote as of September 22, 2026. The meeting will be held by live audio webcast at 11:00 a.m. Eastern Time, with voting available online, by telephone, by mail or during the meeting. Reported 2025 total compensation was $1,027,220 for CEO W. Marc Hertz, $584,722 for CFO Leanne Kelly and $579,087 for Chief Scientific Officer Vipin Kumar. The board has five directors, three determined independent, and the chair and CEO roles are separate.

GRI Bio, Inc. (GRI) reported new Phase 2a data for its lead IPF candidate GRI-0621, an oral RARβ/γ agonist, from the randomized, double-blind, placebo-controlled 12‑week GRI‑0621‑IPF‑02 study in 35 idiopathic pulmonary fibrosis patients. The study met its primary objective of safety and tolerability and generated translational biomarker and lung function signals.

Across four independent modalities (RNA sequencing, serum ECM biomarkers, spectral flow cytometry and clinical readouts), GRI-0621 showed direction‑consistent signals supporting nine mechanistic pillars, including immune re‑balancing, fibrolysis, basement‑membrane repair, re‑epithelialization, FVC stabilization, antitussive effect and GI protection. At Week 12, placebo‑adjusted FVC change from baseline was +99 mL overall and +139 mL on background standard antifibrotic therapy, with 39% of treated patients achieving an FVC increase ≥30 mL versus 20% on placebo and a 60% relative reduction in patients with ≥10% FVC decline.

GRI-0621 was well tolerated with no serious treatment‑emergent adverse events in the active arm, fewer cough, dyspnea and diarrhea events than placebo despite higher nintedanib use, and no hepatic, lipid, visual, auditory or neuropsychiatric safety signals. GRI Bio states that the totality of Phase 2a data supports advancing GRI‑0621 into a longer‑duration, 52‑week study.

GRI Bio, Inc. is a clinical-stage biopharmaceutical company developing immunology-based therapies, led by GRI-0621 for idiopathic pulmonary fibrosis (IPF). For the quarter ended June 30, 2026, it reported a net loss of $1.6 million, narrower than the prior-year period, with operating expenses of $1.6 million driven by reduced research and development spending following completion of a Phase 2a trial of GRI-0621. For the six-month period, the net loss was $3.6 million.

Cash and cash equivalents were $10.9 million as of June 30, 2026, and the accumulated deficit was $55.3 million. The company raised capital mainly through an at-the-market program, selling 1,688,546 shares in the first half of 2026 for $8.2 million in gross proceeds, and additional 2025 public offerings with common stock and warrants. Management believes existing cash funds operations through the second quarter of 2027 under a limited development plan, but states there is substantial doubt about its ability to continue as a going concern without additional financing.

GRI-0621 received FDA Orphan Drug Designation for IPF on June 18, 2026, following a Phase 2a trial that met its primary safety endpoint and showed supportive biomarker and functional trends. The company also continues early work on GRI-0803 for autoimmune diseases. GRI remains a smaller reporting and emerging growth company and discloses an ongoing material weakness in internal controls, with revised controls in place but not yet operating for a sufficient period. A new, stayed Nasdaq Market Value of Listed Securities requirement, if implemented, could pose delisting risk because the company’s MVLS is currently below the proposed threshold.

GRI Bio, Inc. share ownership is updated by three reporting persons — Mitchell P. Kopin, Daniel B. Asher, and Intracoastal Capital LLC — who jointly report beneficial ownership of 93,005 shares of common stock as of June 30, 2026. This stake equals approximately 4.99% of the common stock, calculated using 1,770,838 shares outstanding as of May 12, 2026 plus shares issuable under certain warrants. The position consists of 90,475 shares issuable upon exercise of Intracoastal Warrant 1 and 2,530 shares issuable upon exercise of Intracoastal Warrant 2. All 93,005 shares are held with shared voting and dispositive power and no sole power. Additional warrant shares are subject to blocker provisions that prevent exercises resulting in beneficial ownership above 4.99%, so 942 shares from Intracoastal Warrant 2 and 3,472 shares from Intracoastal Warrant 3 are excluded from the reported amount. Without these blockers, total beneficial ownership could be 97,419 shares.

GRI Bio, Inc. reported that the U.S. Food and Drug Administration has granted Orphan Drug Designation to its lead candidate GRI-0621 (tazarotene) for treating idiopathic pulmonary fibrosis, a progressive and ultimately fatal lung disease. This designation is a key regulatory milestone that can support development and potential commercialization.

The status may provide GRI-0621 with potential eligibility for seven years of U.S. market exclusivity upon approval, possible tax credits on qualified clinical expenses, waiver of certain FDA fees and enhanced interaction with the FDA. GRI-0621, a once-daily oral RARβ/γ-selective agonist, previously met primary, secondary and exploratory endpoints in a 35‑patient Phase 2a trial in idiopathic pulmonary fibrosis, most of whom received standard antifibrotic therapy.

GRI Bio, Inc. reported first quarter 2026 results and highlighted new Phase 2a data for its IPF drug candidate GRI-0621. Cash and cash equivalents were approximately $11.0 million as of March 31, 2026, up from about $8.2 million at year-end 2025, which the company expects will fund operations into the second quarter of 2027.

In the 35-patient Phase 2a IPF trial, GRI-0621 added to standard of care showed zero cough versus 25% on placebo, a 76% reduction in dyspnea (4% vs. 17%), no weight loss versus 17% on placebo, and a 61% reduction in diarrhea (13% vs. 33%), with no serious adverse events in the active arm. Exploratory data showed a +99 mL FVC improvement overall and +139 mL in patients on background antifibrotics.

Research and development expenses fell to about $0.4 million from $1.6 million a year earlier as the Phase 2a trial concluded, while general and administrative expenses were approximately $1.6 million versus $1.4 million. Net loss narrowed to roughly $2.0 million from $3.0 million, and the company raised about $6.8 million in gross proceeds through its at-the-market facility.

GRI Bio, Inc. files an Amendment No. 2 to a Schedule 13G/A reporting beneficial ownership. The filing states that, as of March 31, 2026, the Reporting Persons are each deemed to beneficially own 90,475 shares of common stock issuable upon exercise of a warrant held by Intracoastal, representing 5.9% of the company on the stated basis. The filing cites 1,445,029 shares outstanding as of January 29, 2026 used to calculate the percentage and discloses two additional warrants each for 3,472 shares that contain 4.99% blocker provisions. The filing is signed by Mitchell P. Kopin and Daniel B. Asher.

GRI Bio, Inc. reported a Q1 2026 net loss of $1.998M, narrowing from $3.046M a year earlier, as research and development spending fell to $0.361M from $1.64M after completing a Phase 2a trial of lead drug GRI-0621. General and administrative expenses rose to $1.642M, reflecting higher public company costs.

The company ended March 31, 2026 with $11.048M in cash and cash equivalents, helped by $6.8M of gross proceeds from an at-the-market stock program during the quarter. Management believes this cash funds operations into the second quarter of 2027 but warns it is insufficient to complete a Phase 2b trial of GRI-0621 without substantial additional capital. The filing states there is “substantial doubt” about GRI Bio’s ability to continue as a going concern absent new financing.

GRI Bio, Inc. shareholders Intracoastal Capital LLC, Mitchell P. Kopin, and Daniel B. Asher filed an amended Schedule 13G reporting their beneficial ownership of the company’s common stock. The filing focuses on their combined position and the structure of that holding.

As of the close of business on December 31, 2025, the reporting persons may have been deemed to beneficially own 1,097,858 shares of common stock, or 9.99% of the class. This includes 229,347 shares held by Intracoastal and 868,511 shares issuable upon exercise of one warrant. The ownership percentage is based on 10,121,060 shares outstanding as of December 19, 2025 plus the warrant shares counted for this calculation.

The filing explains that additional shares are potentially issuable under several warrants but are currently blocked from exercise by provisions that cap beneficial ownership at 9.99% for one warrant and 4.99% for three others. The investors certify that the securities were not acquired for the purpose of changing or influencing control of GRI Bio.