Board Change • May 22
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. No highly experienced directors. Independent Director Roelof Rongen was the last director to join the board, commencing their role in 2023. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Price Target Changed • May 22
Price target decreased by 84% to US$25.00 Down from US$160, the current price target is an average from 2 analysts. New target price is 1,114% above last closing price of US$2.06. Stock is down 94% over the past year. The company is forecast to post a net loss per share of US$4.41 next year compared to a net loss per share of US$122 last year. Tillkännagivande • Apr 09
GRI Bio, Inc. Receives Notice of Allowance For UAE Patent Application Covering Novel Type 2 Diverse NKT Cell Agonists GRI Bio, Inc. announced that it has received a Notice of Allowance from the United Arab Emirates Patent Office (UAE) for UAE Patent No. P6000687/2017, titled “Prevention and Treatment of Inflammatory Conditions.” The allowed claims cover novel type 2 diverse NKT (“dNKT”) cell agonists and related methods and compositions for the prevention and treatment of inflammatory conditions, further expanding GRI Bio’s intellectual property protection for its proprietary immunomodulatory platform. These claims support therapeutic approaches targeting immune pathways implicated in inflammatory, fibrotic and autoimmune diseases and complement the Company’s existing patent portfolio. This allowance further reinforces the Company’s disciplined approach to building a global intellectual property portfolio designed to support long-term exclusivity and strategic optionality. The UAE represents a strategically significant and rapidly expanding healthcare market, serving as a gateway to the broader Middle East and North Africa (MENA) region. By securing patent protection in this region, GRI Bio strengthens its global intellectual property position for its dNKT cell agonist program and enhances its ability to support future regional partnerships, licensing opportunities and long-term commercialization strategies. The allowed application supports GRI Bio’s broader platform focused on modulating NKT cell biology, an emerging therapeutic approach designed to regulate immune responses across a range of diseases with significant unmet need. This patent further reinforces the strength and durability of the Company’s growing global intellectual property portfolio. GRI Bio remains focused on advancing its lead program, GRI-0621, while leveraging its growing chemistry platform and library of over 500 proprietary compounds to support future pipeline expansion and potential strategic partnerships. Tillkännagivande • Jan 29
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, Inc. announced additional positive data from its recently completed Phase 2a clinical study of GRI-0621 in Idiopathic Pulmonary Fibrosis ("IPF"), further strengthening potential clinical proof-of-concept and reinforcing the therapeutic differentiation of GRI-0621. Newly reported RNA-sequencing differential gene expression data demonstrate that treatment with GRI-0621 resulted in significant improvement across genes associated with lung injury, myofibroblast activation, extracellular matrix deposition, fibrosis progression, and alveolar basement membrane and epithelial repair compared to placebo. These findings represent a potential powerful and independent validation of previously reported biomarker, functional and clinical signals from the Phase 2a study. IPF is driven by ongoing epithelial injury, unchecked fibroblast activation and irreversible scarring of lung tissue. In the Phase 2a study, subjects treated with GRI-0621 demonstrated clear and significant differentially expressed genes ("DEGs") linked to key drivers of disease, supporting a mechanism consistent with fibrosis resolution and active tissue repair rather than symptomatic management. These forward-looking statements are based on the Company's current beliefs and expectations. Tillkännagivande • Jan 22
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. announced that the board of directors of the Company approved a 1-for-28 reverse stock split (the “Reverse Split”) of the Company’s common stock. The Reverse Split was approved by the stockholders of the Company at a special meeting of the Company held on January 15, 2026. The Reverse Split will legally take effect at 4:01 p.m. Eastern Time, on January 23, 2026. The Company’s common stock will open for trading under a new CUSIP number 3622AW 502 on The Nasdaq Capital Market on January 26, 2026, on a split-adjusted basis under the current ticker symbol “GRI.” The Reverse Split is intended to increase the per share trading price of the Company’s common stock to enable the Company to regain compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. Tillkännagivande • Jan 16
GRI Bio, Inc. Regains Conditional Compliance with Nasdaq Stockholders’ Equity Requirement On January 15, 2026, GRI Bio, Inc. (the “Company”) was formally notified by the Listing Qualifications Staff (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) that the Staff has determined that the Company has conditionally regained compliance with the equity requirement set forth in Nasdaq Listing Rule 5550(b)(1) which requires that companies listed on the Nasdaq Capital Market with a market value of less than $35 million and annual net income of less than $500,000 maintain stockholders’ equity of at least $2.5 million (the “Stockholders’ Equity Requirement”). As previously reported on the Company’s Current Report on Form 8-K filed on December 2, 2025, the Company had received a letter from the Staff notifying the Company that it was not in compliance with the Stockholders’ Equity Requirement based on the information provided in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025. Should the Company fail to demonstrate compliance with the Stockholders’ Equity Requirement in future Exchange Act reports, shares of the Company’s common stock may again be subject to delisting. Tillkännagivande • Jan 08
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. announced positive flow cytometry data from the Phase 2a GRI-0621-IPF-02 clinical trial evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis ("IPF"). Immune cell samples from lung bronchoalveolar lavage (BAL) fluid and peripheral blood mononuclear cells (PBMC) demonstrated iNKT inhibition and a clear immunomodulatory shift towards an anti-fibrotic profile, producing more anti-fibrotic interferon-gamma (IFN-g) and less pro-fibrotic interleukin-4 (IL-4), IL-13, IL-17A, IL-22, and transforming growth factor-beta (TGF-b). Chronically activated iNKT cells downregulate the expression of their T cell receptor (TCR). GRI-0621-treated subjects demonstrated increased TCR expression after 12 weeks of treatment compared with baseline or placebo-treated subjects receiving standard of care. T cell subsets demonstrated increased type I-associated cytokines (IFN-?) and reduced type 2 (IL-4 and IL-13) and type 3-associated cytokines (IL-17A and IL-22) in both BAL and PBMC samples. Similarly, TGF-ß was observed to be reduced after 12 weeks of GRI-0621 treatment in T cell subsets (e.g. Treg and Treg-like), B cells, monocytes, macrophages and neutrophils in BAL and PBMC samples compared to baseline or placebo-treated subjects receiving standard of care. The Company previously reported that the study met its primary endpoint, demonstrating a safety and tolerability profile differentiated from that of existing treatment options. The study also met secondary endpoints suggestive of disease-modifying activity, reversal of fibrosis and inducement of a lung repair mechanism, as well as exploratory endpoints demonstrating increased forced vital capacity (FVC) with twice as many subjects observed to have no decline in FVC compared to standard of care alone at 12 weeks of treatment. 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. Tillkännagivande • Dec 08
GRI Bio, Inc. has filed a Follow-on Equity Offering in the amount of $10 million. GRI Bio, Inc. has filed a Follow-on Equity Offering in the amount of $10 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 5,128,205
Security Name: Series F Warrants
Security Type: Equity Warrant
Securities Offered: 5,128,205
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 5,128,205 Tillkännagivande • Dec 03
Gri Bio, Inc Receives Notice of Non-Compliance with Nasdaq Listing Rules On November 26, 2025, GRI Bio, Inc. received a letter from the Listing Qualifications Department (the Staff") of The Nasdaq Stock Market LLC (Nasdaq") notifying the Company that it is not in compliance with the minimum stockholders' equity requirement for continued listing on The Nasdaq Capital Market (the Notice") based on the information provided in the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2025. Nasdaq Listing Rule 5550(b)(1) requires that companies listed on The Nasdaq Capital Market with a market value of listed securities of less than $35 million and annual net income of less than $0.5 million maintain stockholders' equity of at least $2.5 million (the Stockholders' Equity Requirement"). In accordance with Nasdaq rules, the Company was provided 45 calendar days, or until January 10, 2026, to submit a plan to regain compliance with the Stockholders' Equity Requirement (the Compliance Plan"). The Company plans to submit a Compliance Plan. If the Compliance Plan is determined to be acceptable to the Staff, the Staff would have the discretion to grant the Company an extension of 180 calendar days from the date of the Notice to regain compliance with the Stockholders' Equity Requirement. There can be no assurance that the Compliance Plan will be accepted or that, if it is, the Company will be able to regain compliance. The Notice has no immediate effect on the Company's continued listing on The Nasdaq Capital Market, subject to the Company's compliance with other continued listing requirements. If the Staff does not accept the Compliance Plan, the Staff will provide written notification to the Company that the Compliance Plan has been rejected and that the Common Stock is subject to delisting. At that time, the Company may appeal the Staff's determination to a Nasdaq Hearing Panel. Tillkännagivande • Sep 13
GRI Bio, Inc. Reports 6-Week Interim Lung Function Data in Ongoing Phase 2a Study in Idiopathic Pulmonary Fibrosis GRI Bio, Inc. reported interim 6-week lung function results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis ("IPF"). In the second interim analysis, lung function was assessed from the first 24 subjects at 6 weeks. The interim 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. Topline results from the Phase 2a biomarker study are expected in the third quarter of 2025. Additional flow cytometry and differential gene expression data are expected to be reported over the coming months. Tillkännagivande • Jul 31
Gri Bio, Inc. Reports 6-Week Interim Biomarker Data in Ongoing Phase 2A Study in Idiopathic Pulmonary Fibrosis GRI Bio, Inc. reported interim 6-week biomarker results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis ("IPF"). In the second interim analysis, biomarkers of fibrogenesis and fibrolysis, or the formation and degradation of collagen and extracellular matrix (ECM) turnover in fibrosis, were assessed from the first 24 subjects at 6 weeks. GRI-0621 treated patients demonstrated a favorable reduction in fibrogenesis biomarkers (PRO-C3 and PRO-C6) and a net fibrolytic profile shown as the ratio of collagen formation to collagen degradation (e.g., PRO-C3/CTX-III, PRO-C4/C4Ma3 and PRO-C6/C6M ratios). Taken together, GRI-0621 treated patients demonstrated increased basement membrane remodeling (C1M, C3M, C4Ma3, and C6M) and induction of a potential repair mechanism compared to patients in the control arm. Based on the available interim data reviewed, the IDMC has recommended the Phase 2a study evaluating GRI-0621 to continue as planned as there are no safety concerns seen to date and that more patient data is needed to confirm the anti-fibrotic effect of GRI-0621 treatment compared to the standard of care in the control arm and to assess whether the change in baseline of GRI-0621 patients compared to placebo patients is suggestive of pulmonary function improvement. The Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study enrolled approximately 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 will be compared with a dose of placebo following once daily oral administration for 12 weeks. Concurrently, a sub-study will examine the number and activity of NKT cells in bronchoalveolar lavage (“BAL”) fluid for up to 12 eligible subjects (across various centers). The primary endpoint for the study is safety and tolerability of oral GRI-0621 as assessed by clinical labs, vital signs and adverse events after 12 weeks of treatment. Secondary endpoints are 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 iNKT cell activation in blood after 6 weeks and 12 weeks, and from BAL fluid after 12 weeks of treatment in a sub-study. Additional exploratory endpoints for the study are to assess 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. As previously announced, the pre-planned interim analysis for 2-week safety results from the ongoing Phase 2a biomarker study demonstrated GRI-0621 (4.5mg orally once daily) to be safe and well-tolerated in the first 12 patients evaluated per protocol and the pre-planned interim analysis for 6-week safety results from the ongoing Phase 2a biomarker study demonstrated GRI-0621 (4.5mg orally once daily) to be safe and well-tolerated in the first 24 patients evaluated per protocol. The interim analysis committee recommended the study should continue as planned following each interim analysis. The interim 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. Additionally, interim biomarker results from the first 12 subjects at 2 weeks were reviewed by the IDMC and determined that the change from baseline in PRO-C3 of GRI-0621-treated patients compared to placebo patients is suggestive of anti-fibrotic effect. Based on the available interim data reviewed, the IDMC has recommended the Phase 2a study evaluating GRI-0621 to continue as planned as there are no safety concerns seen to date. Topline results from the Phase 2a biomarker study are expected in the third quarter of 2025. Additional pulmonary function test data are expected to be reported in the coming weeks, as well as flow cytometry and differential gene expression data are expected to be reported over the coming months. Tillkännagivande • Jul 14
GRI Bio, Inc., Annual General Meeting, Aug 13, 2025 GRI Bio, Inc., Annual General Meeting, Aug 13, 2025. Tillkännagivande • Jun 27
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. reported positive 6-week interim safety results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of IPF. In preliminary clinical trials to date and previous clinical trials with the oral formulation, GRI-0621 has been shown to improve fibrosis in multiple disease models and improve liver function tests and other markers of inflammation and injury in patients. The Company expects to report 6-week interim biomarker data in July 2025. Topline results from the Phase 2a biomarker study are expected in the third quarter of 2025. Tillkännagivande • May 23
GRI Bio, Inc. Presents Positive Pre-Clinical Data Demonstrating Gri-0621 Resolves Inflammation and Fibrosis in Bleomycin-Induced Fibrosis GRI Bio, Inc. announced the presentation of positive preclinical data demonstrating its lead program GRI-0621 has anti-inflammatory and anti-fibrotic effects in pulmonary fibrosis. The data was presented by Marc Hertz, PhD, Chief Executive Officer of GRI Bio in the poster titled, "Inactivation of iNKT Cells After the Inflammatory Phase Leads to Significant In inhibition of iNKT cell activity and its effect on various biomarkers in IPF patients. The presented data highlights results from biochemical, qPCR and immunohistochemistry analyses, used to investigate whether iNKT cell inactivation during the fibrotic phase resolves lung injury, fibroblast activation, and fibrosis in the murine bleomycin model of pulmonary fibrosis. Key Highlights: In a therapeutic regimen of the bleomycin-induced fibrosis model, orally administered GRI-0621 after completion of the inflammatory phase (Day 7), significantly inhibits lung injury and several important fibrotic cellular and molecular drivers of lung disease, including fibroblast activation and fibrosis. GRI-0621 demonstrated to impact key innate and adaptive cell activity, cytokine production, myofibroblast activation, and ECM deposition and fibrosis; GRI-0621 inhibition of iNKT cell activities is therapeutic in treatment models of pulmonary fibrosis and performs as well or better than the approved drug nintedanib. GRI Bio's lead program, GRI-0621, is a small molecule RAR-bg dual agonist that inhibits the activity of human iNKT cells. GRI-0621 is currently being assessed in a 12-week, double-blind, randomized, placebo-controlled study in patients with IPF to assess the safety and tolerability of GRI-0621. In addition, the effect of GRI-0621 on a number of biomarkers both from the blood and bronchoalveolar lavage (BAL) will be evaluated. These include several biomarkers associated with disease progression, NKT cell and other immune cell numbers and activity, differential gene expression, as well as pulmonary function tests. As previously announced, the pre-planned interim analysis for 2-week safety results from the ongoing Phase 2a biomarker study demonstrated GRI-0621 (4.5mg orally once daily) to be safe and well-tolerated in the first 12 patients evaluated per protocol. Hyperlipidemia, as assessed by LDL, HDL and triglyceride (TG) levels, was not seen in the 12 patients assessed at the 2-week visit. There were no meaningful changes in HDL, LDL or TG. Tillkännagivande • Apr 03
GRI Bio, Inc. has completed a Follow-on Equity Offering in the amount of $5 million. GRI Bio, Inc. has completed a Follow-on Equity Offering in the amount of $5 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,388,888
Price\Range: $3.6
Discount Per Security: $0.252
Security Name: Series E-1 Warrants
Security Type: Equity Warrant
Securities Offered: 1,388,888
Security Name: Series E-2 Warrants
Security Type: Equity Warrant
Securities Offered: 1,388,888
Security Name: Series E-3 Warrants
Security Type: Equity Warrant
Securities Offered: 1,388,888 Tillkännagivande • Apr 01
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. reported interim safety results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis ("IPF"). GRI-0621, is the Company's small molecule RAR-bg dual agonist that inhibits the activity of human Type 1 Invariant NKT cells. In preliminary clinical trials to date and previous clinical trials with the oral formulation, GRI-0621 has been shown to improve fibrosis in multiple disease models and improve liver function tests and other markers of inflammation and injury in patients. The Company expects to report interim biomarker data in second quarter of 2025. Topline results from the Phase 2a biomarker study are expected in the third quarter of 2025. Tillkännagivande • Mar 25
GRI Bio, Inc. has filed a Follow-on Equity Offering in the amount of $5 million. GRI Bio, Inc. has filed a Follow-on Equity Offering in the amount of $5 million.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Series E-1 Warrants
Security Type: Equity Warrant
Security Name: Series E-2 Warrants
Security Type: Equity Warrant
Security Name: Series E-3 Warrants
Security Type: Equity Warrant
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Security Name: Series E-1 Warrants
Security Type: Equity Warrant
Security Name: Series E-2 Warrants
Security Type: Equity Warrant
Security Name: Series E-3 Warrants
Security Type: Equity Warrant Tillkännagivande • Mar 11
GRI Bio Regains Compliance with Nasdaq’s Minimum Bid Price Rule On March 10, 2025, GRI Bio, Inc. (the Company") received a letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (Nasdaq") notifying the Company that the bid price deficiency under Nasdaq Listing Rule 5550(a)(2) (the "Minimum Bid Price Rule"), which the Company previously reported on in its Current Reports on Form 8-K filed on September 10, 2024 and Form 8-K/A filed on September 11, 2024, has been cured, and that the Company is now in compliance with the Minimum Bid Price Rule. Tillkännagivande • Feb 20
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. announced that the board of directors of the Company approved a 1-for-17 reverse stock split (the “Reverse Split”) of the Company’s common stock. The Reverse Split was approved by the stockholders of the Company at a special meeting of the Company held on February 11, 2025. The Reverse Split is intended to increase the per share trading price of the Company’s common stock to enable the Company to regain compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. Tillkännagivande • Dec 24
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. announced that European Patent Office (EPO) has issued a decision to grant notice for patent application number 19,166,502 titled, “Oxygenated Amino- or Ammonium-Containing Sulfonic Acid, Phosphonic Acid and Carboxylic Acid Derivatives and Their Medical Use.” Based on the intention to grant notice, the Company expects the EPO to issue a patent January 16, 2025. The patent claims include coverage of GRI-0803, the Company’s novel activator of human type 2 NKT cells in development for the treatment of autoimmune disorders, with an initial focus on systemic lupus erythematosus (SLE). Activation of type 2 NKT leads to a dendritic cell-mediated inhibition of iNKT cells. In the Company’s preclinical studies, type 2 NKT activating molecules, GRI-0803 and GRI-0124, were observed to inhibit both murine and human iNKT cells. Oral administration of these type 2 NKT activating molecules was observed to inhibit lupus nephritis and to significantly improve overall survival. The Company is currently focusing its available resources on GRI-0621, but, pending additional funding, the GRI-0803 IND-enabling and Phase1 program will continue in 2025. The Company is currently advancing the development of its lead program, GRI-0621, in a Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study for the treatment of IPF. Interim data from the Phase 2a biomarker study is expected in the first quarter of 2025 and topline results are expected in the second quarter of 2025. Tillkännagivande • Sep 11
GRI Bio, Inc. Receives Non-Compliance Letter from the Listing Qualifications Department of the Nasdaq Stock Market Regarding Minimum Bid Price Requirement On September 10, 2024, GRI Bio, Inc. (the Company") received a letter (the Letter") from the Listing Qualifications Department (the Staff") of The Nasdaq Stock Market, LLC (Nasdaq"), indicating that the Company no longer meets the minimum bid price requirement set in Nasdaq Listing Rule 5550(a)(2) (the Minimum Bid Price Requirement") because the closing bid price for the Company's common stock was less than $1.00 for the previous 30 consecutive business days. The Letter does not have an immediate effect on the Company's continued listing on The Nasdaq Capital Market. Under Nasdaq Listing Rule 5810(c)(3)(A), the Company has a 180-calendar day period, or until March 10, 2025 (the Compliance Date"), to regain compliance with the Minimum Bid Price Requirement. The Minimum Bid Price Requirement will be met if the Company's common stock has a minimum closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days during the 180-calendar day period, unless Nasdaq exercises its discretion to extend such 10 day period. If the Company does not regain compliance by the Compliance Date, the Company may be eligible for an additional 180-calendar day period, subject to satisfying the conditions in the applicable Nasdaq Listing Rules. If, before the Compliance Date, the Company's common stock has a closing bid price of $0.10 per share or less for ten consecutive trading days, the Staff will issue a Staff Delisting Determination under Nasdaq Listing Rule 5810 with respect to the Company's common stock. There can be no assurance that the Company will be able to regain compliance with the Minimum Bid Price Requirement. The Company is monitoring the closing bid price of its common stock and will consider options to regain compliance with the Minimum Bid Price Requirement. Tillkännagivande • Jul 24
GRI Bio, Inc., Annual General Meeting, Aug 23, 2024 GRI Bio, Inc., Annual General Meeting, Aug 23, 2024. Tillkännagivande • Jul 09
GRI Bio Regains Compliance with Nasdaq GRI Bio, Inc. (‘GRI Bio’ or the ‘Company’) announced that it received notice on July 2, 2024 from The Nasdaq Stock Market LLC (‘Nasdaq’) that the Company regained compliance with all applicable Nasdaq listing standards for continued listing on the Nasdaq Capital Market, and that the scheduled hearing before the Hearings Panel has been canceled. ‘We are very excited about this development and look forward to focusing our efforts on our core business-developing novel product candidates for the treatment of inflammatory, fibrotic and autoimmune diseases,’ said Marc Hertz, GRI Bio’s Chief Executive Officer. Tillkännagivande • Jul 02
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. announced the publication of positive preclinical data demonstrating its lead program GRI-0621 reduces the important inflammatory and fibrotic drivers in Idiopathic Pulmonary Fibrosis (IPF). The manuscript titled, "Type 1 invariant natural killer T cells drive lung fibrosis, has been published in the American Journal of Respiratory and Critical Care Medicine. IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream. The architectural destruction of the lung results in breathlessness, significant decline in quality of life and an average untreated survival of 3.5 years from diagnosis. Currently available treatments for IPF are limited with only two approved drugs that come with significant side-effects, limited compliance and no impact on survival. GRI Bio is currently advancing its lead program GRI-0621, a small molecule RAR-ß? dual agonist candidate that inhibits the activity of human iNKT cells, in a Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study for the treatment of IPF. Interim data from the Phase 2a biomarker study is expected in the third quarter of 2024 and topline results are expected in the fourth quarter of 2024. Tillkännagivande • Jun 20
GRI Bio, Inc. has filed a Follow-on Equity Offering. GRI Bio, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Warrant
Security Type: Equity Warrant
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant Tillkännagivande • May 23
GRI Bio Announces Update on Deficiency Letter from Nasdaq Regarding Minimum Stockholders’ Equity Requirement As previously reported in a Current Report on Form 8-K filed November 24, 2023, on November 22, 2023, GRI Bio, Inc. (the ‘Company’) received a deficiency letter from the Listing Qualifications Department (the ‘Staff’) of The Nasdaq Stock Market LLC (‘Nasdaq’) notifying the Company that the Company did not comply with the minimum stockholders’ equity requirement for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b) (the ‘Stockholders’ Equity Requirement’) based on the information provided in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023. The Company was provided an initial period of 180 calendar days, or until May 20, 2024, to regain compliance with the Stockholders’ Equity Requirement. On May 21, 2024, the Company received a staff determination letter (the ‘Determination Letter’) from the Staff notifying the Company that, despite reporting in excess of $2.5 million in stockholders’ equity in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, it had not regained compliance with the Stockholders’ Equity Requirement by May 20, 2024 when taking into account the Company’s historical burn rate. Accordingly, and as described in the Determination Letter, unless the Company timely requests an appeal of the determination by May 28, 2024, the Company’s securities will be subject to suspension/delisting. The Company intends to timely request an appeal of the determination to a Hearings Panel (the ‘Panel’). The appeal will automatically stay any suspension or delisting action pending the hearing before the Panel, and the Company’s common stock will remain listed on The Nasdaq Capital Market pending the outcome of the hearing before the Panel. Pursuant to Nasdaq Listing Rules, the Panel has the authority to grant an additional extension not to exceed 180 days from the Staff’s determination. Notwithstanding the foregoing, there can be no assurance that the Panel will grant the Company an additional extension period or that the Company will ultimately regain compliance with all applicable requirements for continued listing on The Nasdaq Capital Market. Tillkännagivande • May 21
GRI Bio, Inc. has filed a Follow-on Equity Offering in the amount of $0.961579 million. GRI Bio, Inc. has filed a Follow-on Equity Offering in the amount of $0.961579 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Tillkännagivande • Apr 19
GRI Bio Expands Intellectual Property Protection for Proprietary Natural Killer T (NKT) Cell Modulators with Issuance of Korea Patent GRI Bio, Inc. announced that the Korean Intellectual Property Office (KIPO) has issued a Notice of Patent Grant for Patent Application No. 10-2017-7018579 titled, "Prevention and Treatment of Inflammatory Conditions." The issued patent covers claims including compositions and methods for modulating type 2 and/or type 1 invariant NKT (iNKT) cells in the prevention and treatment of inflammatory conditions of the liver. More specifically, when issued the patent will cover the prevention and treatment of inflammatory and fibrotic conditions through the administration of a Retinoic Acid Receptor (RAR) agonist that inhibits iNKT cells and the administration of an RAR agonist that inhibits the activity of iNKT cells in a subject. GRI Bio is currently advancing its lead program GRI-0621, a small molecule RAR-ß? dual agonist candidate that inhibits the activity of human iNKT cells, in a Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study for the treatment of Idiopathic Pulmonary Fibrosis (IPF). IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream. Interim data from the Phase 2a biomarker study is expected in the first half of 2024 and topline results are expected in the second half of 2024. Tillkännagivande • Mar 05
GRI Bio, Inc. Receives MHRA Authorization to Conduct Phase 2a Biomarker Study Evaluating GRI-0621 in the United Kingdom GRI Bio, Inc. announced the authorization of its Clinical Trial Application (CTA) by the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF in the UK. The MHRA is the UK regulatory authority, a government agency, for medicines and medical devices. The MHRA is responsible for the regulation of medicines and medical devices and equipment used in healthcare and the investigation of harmful incidents. IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream. Currently available treatments for IPF are limited with only two approved drugs that come with significant side-effects, limited compliance and no impact on survival. The Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study will enroll approximately 36 subjects with IPF whom will be randomized in a 2:1 ratio for GRI-0621 4.5mg or a placebo. GRI-0621 dose of 4.5mg will be compared with a dose of placebo following once daily oral administration for 12 weeks. Concurrently, a sub-study will examine the number and activity of NKT cells in bronchoalveolar lavage (“BAL”) fluid for up to 12 eligible subjects (across various centers). An interim analysis will be performed when 24 subjects (of which approximately 8 will be placebo subjects) complete 6 weeks of treatment. The primary endpoint for the study is safety and tolerability of oral GRI-0621 as assessed by clinical labs, vital signs and adverse events after 12 weeks of treatment. Secondary endpoints are 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 iNKT cell activation in blood after 6 weeks and 12 weeks, and from BAL fluid after 12 weeks of treatment in a sub-study. An additional exploratory endpoint for the study is to assess the effect of GRI-0621 on pulmonary function at baseline and after 6 weeks and 12 weeks of treatment. Tillkännagivande • Jan 27
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. (‘GRI Bio’ or the ‘Company’) announced that the board of directors of the Company approved a 1-for-7 reverse stock split (the ‘Reverse Split’) of the Company’s common stock. The Reverse Split was approved by the stockholders of the Company at a special meeting of the Company held on January 19, 2024. The Reverse Split will legally take effect at 4:01 p.m. Eastern Time, on January 29, 2023. The Company’s common stock will open for trading under a new CUSIP number 3622AW 205 on The Nasdaq Capital Market on January 30, 2024, on a split-adjusted basis under the current ticker symbol ‘GRI.’ The Reverse Split is intended to increase the per share trading price of the Company’s common stock to enable the Company to regain compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. Tillkännagivande • Dec 22
GRI Bio, Inc. has filed a Follow-on Equity Offering in the amount of $16 million. GRI Bio, Inc. has filed a Follow-on Equity Offering in the amount of $16 million.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Security Name: Common Warrants
Security Type: Equity Warrant New Risk • Dec 06
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 16% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$4.3m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Revenue is less than US$1m. Market cap is less than US$10m (US$2.39m market cap). Tillkännagivande • Dec 05
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. announced the initiation of patient enrollment in the Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF. Patient dosing is expected imminently. Interim data from the Phase 2a biomarker study is expected in the first half of 2024 and topline results are expected in the second half of 2024. GRI is developing and repurposing GRI-0621, a type 1 invariant NKT (iNKT) antagonist, as a once-daily oral capsule for the treatment of IPF with the potential to expand into additional fibrotic indications. The Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study will enroll approximately 36 subjects with IPF whom will be randomized in a 2:1 ratio for GRI-0621 4.5mg or a placebo. GRI-0621 dose of 4.5mg will be compared with a dose of placebo following once daily oral administration for 12 weeks. Concurrently, a sub-study will examine the number and activity of NKT cells in bronchoalveolar lavage (BAL) fluid for up to 12 eligible subjects (across various centers). An interim analysis will be performed when 24 subjects (of which approximately 8 will be placebo subjects) complete 6 weeks of treatment. The primary endpoint for the study is safety and tolerability of oral GRI-0621 as assessed by clinical labs, vital signs and adverse events after 12 weeks of treatment. Secondary endpoints are 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 iNKT cell activation in blood after 6 weeks and 12 weeks, and from BAL fluid after 12 weeks of treatment in a sub-study. An additional exploratory endpoint for the study is to assess the effect of GRI-0621 on pulmonary function at baseline and after 6 weeks and 12 weeks of treatment. Tillkännagivande • Nov 29
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, Inc. announced that the U.S. Food and Drug Administration has cleared the Company's Investigational New Drug application for GRI-0621 for the treatment of IPF. The Company plans to evaluate GRI-0621 in a randomized, double-blind, multi-center Phase 2a biomarker study, on track to commence before year end. IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream. GRI is developing and repurposing GRI-0621 as a once-daily oral capsule for the treatment of IPF with the potential to expand into additional fibrotic indications. The Phase 2a, randomized, double-blind, multiple-center, placebo-controlled, parallel-design, 2-arm study will enroll approximately 36 subjects with IPF whom will be randomized in a 2:1 ratio for GRI-0621 4.5mg or a placebo. GRI-0621 dose of 4.5mg will be compared with a dose of placebo following once daily oral administration for 12 weeks. Tillkännagivande • Nov 27
GRI Bio Receives Non-Compliance Notice From Nasdaq On November 22, 2023, GRI Bio, Inc. (the “Company”) received a letter from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it is not in compliance with the minimum stockholders’ equity requirement for continued listing on The Nasdaq Capital Market (the “Notice”) based on the information provided in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023. Nasdaq Listing Rule 5550(b)(1) requires that companies listed on The Nasdaq Capital Market with a market value of listed securities of less than $35,000,000 and annual net income of less than $500,000 maintain stockholders’ equity of at least $2,500,000 (the “Stockholders’ Equity Requirement”). In accordance with Nasdaq rules, the Company was provided 45 calendar days, or until January 6, 2024, to submit a plan to regain compliance with the Stockholders’ Equity Requirement (the “Compliance Plan”). If the Compliance Plan is determined to be acceptable to the Staff, the Staff would have the discretion to grant the Company an extension of 180 calendar days from the date of the Notice to regain compliance with the Stockholders’ Equity Requirement. There can be no assurance that the Compliance Plan will be accepted or that, if it is, the Company will be able to regain compliance. The Notice has no immediate effect on the Company’s continued listing on The Nasdaq Capital Market, subject to the Company’s compliance with other continued listing requirements. If the Staff does not accept the Compliance Plan, the Staff will provide written notification to the Company that the Compliance Plan has been rejected and that the Company’s common stock is subject to delisting. At that time, the Company may appeal the Staff’s determination to a Nasdaq Hearing Panel. New Risk • Nov 17
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$4.3m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$4.3m free cash flow). Revenue is less than US$1m. Market cap is less than US$10m (US$3.15m market cap). Minor Risk Share price has been volatile over the past 3 months (14% average weekly change). New Risk • Aug 09
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.31m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$1.6m free cash flow). Negative equity (-US$3.2m). Revenue is less than US$1m. Market cap is less than US$10m (US$9.31m market cap). Minor Risk Share price has been volatile over the past 3 months (9.8% average weekly change). Tillkännagivande • May 27
GRI Bio, Inc., Annual General Meeting, Jul 07, 2023 GRI Bio, Inc., Annual General Meeting, Jul 07, 2023, at 11:00 US Eastern Standard Time. Agenda: To elect each of W. Marc Hertz and David Szekeres to the Company's Board of Directors, to serve as Class III directors until the Company's 2026 Annual Meeting of Stockholders and until such person's successor is duly elected and qualified; to ratify the appointment of Sadler, Gibb & Associates LLC as the Company's independent registered public accounting firm for the fiscal year ending December 31, 2023; and to transact such other business that is properly presented at the annual meeting and any adjournments or postponements thereof.