Announcement • Dec 13

+ 1 more update

GRI Bio, Inc. Announces Positive Topline Data from its Phase 2a Study in Idiopathic Pulmonary Fibrosis

GRI Bio, Inc. announced positive topline data from the Phase 2a GRI-0621-IPF-02 clinical trial evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis. The study met its primary endpoint and secondary endpoints demonstrating that GRI-0621 was well tolerated over a 12-week treatment period, consistent with earlier studies evaluating over 1,700 subjects treated for up to a year. Subjects treated with GRI-0621 also displayed improvements in serum biomarkers of collagen turnover suggesting fibrosis resolution and induction of an alveolar basement membrane repair mechanism. Study Met Its Primary Endpoint, Demonstrating a Safety Profile Differentiated From Existing Treatment Options No safety or tolerability concerns were observed in the subjects enrolled at 12 weeks of treatment, with dry skin, dry lips, muscle and joint pain as the most common adverse events reported. There were no increases in cough (0% in the GRI-0621-treated arm compared to 25% in the placebo arm) or gastrointestinal disorders reported in the GRI-0621 arm compared to the placebo arm (diarrhea reported in 13% versus 33%, respectively). 80% of the subjects enrolled were taking background pirfenidone or nintedanib. Study Met Secondary Endpoints Suggestive of Disease-Modifying Activity, Reversing Fibrosis and Inducing a Lung Repair Mechanism Subjects treated with GRI-0621 also displayed improvements in serum biomarkers of collagen turnover, suggesting fibrosis resolution and induction of an alveolar basement membrane repair mechanism. PRO-C6, a biomarker of type VI collagen synthesis, was observed to decrease from baseline (-3%) in GRI-0621 treated subjects and increase (+12%) in subjects treated with placebo and standard of care. C6M, a biomarker of type VI collagen degradation, was observed to increase from baseline (+6%) in GRI-0621 treated subjects and decrease (-3%) in subjects treated with placebo and standard of care. The type VI collagen remodeling rate shifted from fibrogenic (+10%; continued worsening of fibrosis) in placebo-treated subjects to fibrolytic (-7%; resolution of fibrosis), suggestive of GRI-0621 inducing resolution of fibrosis in treated subjects compared to continued worsening of fibrosis in subjects treated with placebo and standard of care. Destruction of the alveolar basement membrane is a hallmark of IPF, and type IV collagen synthesis, and repair of the basement membrane, is a crucial step in lung tissue repair. PRO-C4, a biomarker of type IV collagen synthesis, was observed to increase from baseline (+9%) in GRI-0621 treated subjects and decrease (-2%) in subjects treated with placebo and standard of care. C4Ma3, a biomarker of type IV collagen degradation, was observed to decrease in GRI-0621 treated subjects compared to subjects treated with placebo and standard of care (10% vs 24%, respectively). The type IV collagen remodeling rate shifted from fibrolytic (-16%; continued destruction of the basement membrane) in placebo-treated subjects to neutral (0%) in GRI-0621 treated subjects, suggestive of GRI-0621 inducing a lung tissue repair mechanism and repair of the alveolar basement membrane compared to placebo-treated subjects. Interestingly, the alveolar basement membrane repair mechanism is supported by differential gene expression data of AT1 cell re-epithelialization of the basement membrane. GRI-0621 was observed to significantly reduce DLK1 (-6.46 LogFC; FDR 0.0003), a gene involved in lung epithelial AT2 cell fate plasticity and regeneration of alveolar AT1 cells (Sawhney, et al. (2025) Nat Commun 16, 8924; Li, et al. (2025) Resp Res26 188), another critical step in alveolar basement membrane repair, compared to subjects treated with placebo and standard. Reductions in neutrophil and macrophage activity (immune cell biomarkers upregulated in IPF and associated with disease progression) and downregulation of genes associated with fibrosis, disease progression and mortality were also observed in patients treated with GRI-0621 compared to placebo-treated subjects. Study Met Exploratory Endpoints Demonstrating Increased Forced Vital Capacity, With Twice as Many Subjects Observed to Have No Decline in FVC Compared to Standard of Care at 12 Weeks Placebo-adjusted changes from baseline in FVC increased by 99 ml in the GRI-0621-treated arm and a 139 ml increase in the subset taking both GRI-0621 and standard of care compared to placebo plus standard of care. Spirometry is subject to large visit-to-visit variability and is dependent on the individual’s effort, often resulting in data outliers. To minimize the impact of outliers in the dataset, a post hoc data analysis was performed excluding the datapoints with the largest gain or loss in FVC over 12 weeks from both arms. The results of this analysis demonstrated an increase in placebo-adjusted change from baseline in FVC of 54 ml in the GRI-0621-treated arm and an increase of 81 ml in the subset taking both GRI-0621 and standard of care. Overall, 39% of GRI-0621 treated subjects experienced an increase in FVC at 12 weeks compared to 80% of subjects who experienced a decline in FVC at 12 weeks in the placebo-treated arm. The Phase 2a, randomized, double-blind, multinational, multi-center, placebo-controlled, parallel-design, 2-arm study enrolled 35 subjects with IPF who were randomized in a 2:1 ratio for GRI-0621 4.5mg or a placebo. GRI-0621 dose of 4.5mg was compared with a dose of placebo following once daily oral administration for 12 weeks. Concurrently, a sub-study examined the number and activity of immune cells in bronchoalveolar lavage (“BAL”) fluid in 8 subjects (across various centers). The primary endpoint for the Phase 2a study was safety and tolerability of oral GRI-0621 as assessed by clinical labs, vital signs and adverse events after 12 weeks of treatment. Secondary endpoints were baseline changes in serum biomarkers collected at week 6 and week 12; an assessment of the pharmacokinetics (PK) of GRI-0621 at the week 12 visit of treatment (steady state); and a determination of the pharmacodynamic activity of oral GRI-0621 as measured by inhibition of immune cell activation in blood after 6 weeks and 12 weeks, and from BAL fluid after 12 weeks of treatment in the sub-study. Additional exploratory endpoints for the study included assessment of the effect of GRI-0621 on pulmonary function at baseline and after 6 weeks and 12 weeks of treatment and flow cytometry and differential gene expression at various time points. These results show that GRI-0621’s receptor selectivity is consistent with the toxicity profile observed in earlier studies evaluating oral tazarotene in over 1,700 patients treated for up to 52 weeks.

Biotechs Industry Growth	17.04%
Revenue growth rate	n/a
Return on equity	-93.96%
Net Margin	n/a
Last Earnings Update	30 Jun 2026

Date	Earnings	G+A Expenses	R&D Expenses
30 Jun 26	-10	6	4
31 Mar 26	-11	5	6
31 Dec 25	-12	5	7
30 Sep 25	-13	5	6
30 Jun 25	-12	5	5
31 Mar 25	-11	5	4
31 Dec 24	-10	4	4
30 Sep 24	-8	4	4
30 Jun 24	-8	5	4
31 Mar 24	-13	8	4
31 Dec 23	-13	8	3
30 Sep 23	-13	9	2
30 Jun 23	-12	8	1
31 Mar 23	-5	3	0
31 Dec 22	-3	2	0
30 Sep 22	-1	1	0
31 Dec 21	-2	1	0

Data	Last Updated (UTC time)
Company Analysis	2026/09/09 17:52
End of Day Share Price	2026/09/09 00:00
Earnings	2026/06/30
Annual Earnings	2025/12/31

Package	Data	Timeframe	Example US Source ^*
Company Financials	10 years	Income statement Cash flow statement Balance sheet	SEC Form 10-K SEC Form 10-Q
Analyst Consensus Estimates	+3 years	Forecast financials Analyst price targets	Analyst Research Reports Blue Matrix
Market Prices	30 years	Stock prices Dividends, Splits and Actions	ICE Market Data SEC Form S-1
Ownership	10 years	Top shareholders Insider trading	SEC Form 4 SEC Form 13D
Management	10 years	Leadership team Board of directors	SEC Form 10-K SEC Form DEF 14A
Key Developments	10 years	Company announcements	SEC Form 8-K

Analyst	Institution
Edward Woo	Ascendiant Capital Markets LLC
Matthew Keller	H.C. Wainwright & Co.

GRI Bio Past Earnings Performance

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Recent updates

GRI Bio Presents New Phase 2a Data at ERS 2026 Defining GRI-0621's Mechanism of Action in IPF Across Nine Mechanistic Pillars

New major risk - Revenue and earnings growth

New minor risk - Share price stability

Insufficient new directors

Price target decreased by 84% to US$25.00

GRI Bio, Inc. Receives Notice of Allowance For UAE Patent Application Covering Novel Type 2 Diverse NKT Cell Agonists

Gri Bio, Inc. Delivers Compelling New Phase 2A Gene Expression Data Demonstrating Improvements in Key Drivers of Fibrosis and Lung Repair in IPF

GRI Bio Announces Reverse Stock Split to Regain Compliance with the Minimum Bid Price Requirement for Continued Listing on the Nasdaq Capital Market

GRI Bio, Inc. Regains Conditional Compliance with Nasdaq Stockholders’ Equity Requirement

GRI Bio, Inc. Announces Additional Positive Data from Phase 2A Study in Idiopathic Pulmonary Fibrosis, Strengthening Clinical Proof-Of-Concept for GRI-0621

GRI Bio, Inc. Announces Positive Topline Data from its Phase 2a Study in Idiopathic Pulmonary Fibrosis

GRI Bio, Inc. has filed a Follow-on Equity Offering in the amount of $10 million.

Gri Bio, Inc Receives Notice of Non-Compliance with Nasdaq Listing Rules

GRI Bio, Inc. Reports 6-Week Interim Lung Function Data in Ongoing Phase 2a Study in Idiopathic Pulmonary Fibrosis

Gri Bio, Inc. Reports 6-Week Interim Biomarker Data in Ongoing Phase 2A Study in Idiopathic Pulmonary Fibrosis

GRI Bio, Inc., Annual General Meeting, Aug 13, 2025

GRI Bio, Inc. Reports Positive 6-Week Interim Safety Results from its Ongoing Phase 2a Study Evaluating GRI-0621 for Treatment of Idiopathic Pulmonary Fibrosis

GRI Bio, Inc. Presents Positive Pre-Clinical Data Demonstrating Gri-0621 Resolves Inflammation and Fibrosis in Bleomycin-Induced Fibrosis

Gri Bio Continues to Drive Enrollment in Ongoing Phase 2A Study of Gri-0621 in Idiopathic Pulmonary Fibrosis

GRI Bio, Inc. has completed a Follow-on Equity Offering in the amount of $5 million.

GRI Bio, Inc. Reports Encouraging Interim 2-Week Safety Results from Ongoing Phase 2A Study of Gri-0621 in Idiopathic Pulmonary Fibrosis

GRI Bio, Inc. has filed a Follow-on Equity Offering in the amount of $5 million.

GRI Bio Regains Compliance with Nasdaq’s Minimum Bid Price Rule

GRI Bio Announces Reverse Stock Split to Regain Compliance with the Minimum Bid Price Requirement for Continued Listing on the Nasdaq Capital Market

GRI Bio, Inc. Announces European Patent Office Issued A Decision to Grant Notice for Patent Covering GRI-0803 and Its Library of 500+ Proprietary Compounds

GRI Bio, Inc. Receives Non-Compliance Letter from the Listing Qualifications Department of the Nasdaq Stock Market Regarding Minimum Bid Price Requirement

GRI Bio, Inc., Annual General Meeting, Aug 23, 2024

GRI Bio Regains Compliance with Nasdaq

GRI Bio, Inc. Announces Publication of Positive Preclinical Data from Lead Program GRI -0621 in the American Journal of Respiratory and Critical Care Medicine

GRI Bio, Inc. has filed a Follow-on Equity Offering.

GRI Bio Announces Update on Deficiency Letter from Nasdaq Regarding Minimum Stockholders’ Equity Requirement

GRI Bio, Inc. has filed a Follow-on Equity Offering in the amount of $0.961579 million.

GRI Bio Expands Intellectual Property Protection for Proprietary Natural Killer T (NKT) Cell Modulators with Issuance of Korea Patent

GRI Bio, Inc. Receives MHRA Authorization to Conduct Phase 2a Biomarker Study Evaluating GRI-0621 in the United Kingdom

GRI Bio Approves 1-for-7 Reverse Stock Split to Regain Compliance with the Minimum Bid Price Requirement for Continued Listing on The Nasdaq Capital Market

GRI Bio, Inc. has filed a Follow-on Equity Offering in the amount of $16 million.

New major risk - Share price stability

GRI Bio, Inc. Commences Patient Enrollment in Phase 2a Biomarker Study Evaluating Lead Program GRI-0621 for Treatment of Idiopathic Pulmonary Fibrosis

GRI Bio, Inc. Announces FDA Clearance of IND for Lead Program GRI-0621, a Type 1 Invariant NKT Antagonist for the Treatment of Idiopathic Pulmonary Fibrosis

GRI Bio Receives Non-Compliance Notice From Nasdaq

New major risk - Financial position

New major risk - Market cap size

GRI Bio, Inc., Annual General Meeting, Jul 07, 2023

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