GRI Bio（GRI）株式概要臨床段階のバイオ医薬品会社であるGRIバイオ社は、米国において炎症性疾患、線維化疾患、自己免疫疾患につながる疾患を標的とした治療法の発見、開発、商品化に注力している。 詳細GRI ファンダメンタル分析スノーフレーク・スコア評価1/6将来の成長0/6過去の実績0/6財務の健全性4/6配当金0/6リスク分析過去1年間で株主の希薄化は大幅に進んだ 収益が 100 万ドル未満 ( $0 )キャッシュランウェイが1年未満である 意味のある時価総額がありません ( $3M )+1 さらなるリスクすべてのリスクチェックを見るGRI Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair ValueUS$Current PriceUS$2.20該当なし内在価値ディスカウントEst. Revenue$PastFuture-13m12016201920222025202620282031Revenue US$1.0Earnings US$0.2AdvancedSet Fair ValueView all narrativesGRI Bio, Inc. 競合他社AzitraSymbol: NYSEAM:AZTRMarket cap: US$3.2mCalidi BiotherapeuticsSymbol: NYSEAM:CLDIMarket cap: US$2.6mEnsysce BiosciencesSymbol: NasdaqCM:ENSCMarket cap: US$2.9mOragenicsSymbol: NYSEAM:OGENMarket cap: US$2.5m価格と性能株価の高値、安値、推移の概要GRI Bio過去の株価現在の株価US$2.2052週高値US$80.3652週安値US$1.97ベータ-0.771ヶ月の変化-12.70%3ヶ月変化-11.65%1年変化-93.71%3年間の変化-99.90%5年間の変化n/aIPOからの変化-99.90%最新ニュースお知らせ • Apr 09GRI Bio, Inc. Receives Notice of Allowance For UAE Patent Application Covering Novel Type 2 Diverse NKT Cell AgonistsGRI 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.お知らせ • Jan 29Gri Bio, Inc. Delivers Compelling New Phase 2A Gene Expression Data Demonstrating Improvements in Key Drivers of Fibrosis and Lung Repair in IPFGRI 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.お知らせ • Jan 22GRI Bio Announces Reverse Stock Split to Regain Compliance with the Minimum Bid Price Requirement for Continued Listing on the Nasdaq Capital MarketGRI 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.お知らせ • Jan 16GRI Bio, Inc. Regains Conditional Compliance with Nasdaq Stockholders’ Equity RequirementOn 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.お知らせ • Jan 08GRI Bio, Inc. Announces Additional Positive Data from Phase 2A Study in Idiopathic Pulmonary Fibrosis, Strengthening Clinical Proof-Of-Concept for GRI-0621GRI 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.お知らせ • Dec 13+ 1 more updateGRI Bio, Inc. Announces Positive Topline Data from its Phase 2a Study in Idiopathic Pulmonary FibrosisGRI 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.最新情報をもっと見るRecent updatesお知らせ • Apr 09GRI Bio, Inc. Receives Notice of Allowance For UAE Patent Application Covering Novel Type 2 Diverse NKT Cell AgonistsGRI 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.お知らせ • Jan 29Gri Bio, Inc. Delivers Compelling New Phase 2A Gene Expression Data Demonstrating Improvements in Key Drivers of Fibrosis and Lung Repair in IPFGRI 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.お知らせ • Jan 22GRI Bio Announces Reverse Stock Split to Regain Compliance with the Minimum Bid Price Requirement for Continued Listing on the Nasdaq Capital MarketGRI 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.お知らせ • Jan 16GRI Bio, Inc. Regains Conditional Compliance with Nasdaq Stockholders’ Equity RequirementOn 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.お知らせ • Jan 08GRI Bio, Inc. Announces Additional Positive Data from Phase 2A Study in Idiopathic Pulmonary Fibrosis, Strengthening Clinical Proof-Of-Concept for GRI-0621GRI 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.お知らせ • Dec 13+ 1 more updateGRI Bio, Inc. Announces Positive Topline Data from its Phase 2a Study in Idiopathic Pulmonary FibrosisGRI 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.お知らせ • Dec 08GRI 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お知らせ • Dec 03Gri Bio, Inc Receives Notice of Non-Compliance with Nasdaq Listing RulesOn 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.お知らせ • Sep 13GRI Bio, Inc. Reports 6-Week Interim Lung Function Data in Ongoing Phase 2a Study in Idiopathic Pulmonary FibrosisGRI 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.お知らせ • Jul 31Gri Bio, Inc. Reports 6-Week Interim Biomarker Data in Ongoing Phase 2A Study in Idiopathic Pulmonary FibrosisGRI 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.お知らせ • Jul 14GRI Bio, Inc., Annual General Meeting, Aug 13, 2025GRI Bio, Inc., Annual General Meeting, Aug 13, 2025.お知らせ • Jun 27GRI Bio, Inc. Reports Positive 6-Week Interim Safety Results from its Ongoing Phase 2a Study Evaluating GRI-0621 for Treatment of Idiopathic Pulmonary FibrosisGRI 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.お知らせ • May 23GRI Bio, Inc. Presents Positive Pre-Clinical Data Demonstrating Gri-0621 Resolves Inflammation and Fibrosis in Bleomycin-Induced FibrosisGRI 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.お知らせ • May 08+ 1 more updateGri Bio Continues to Drive Enrollment in Ongoing Phase 2A Study of Gri-0621 in Idiopathic Pulmonary FibrosisGRI Bio, Inc. announced that enrollment for the 6 week interim analysis is complete with 24 of the 36 planned patients randomized in its ongoing Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis ("IPF"). The Company expects to report interim biomarker data from the first 12 patients enrolled in Second Quarter 2025. Topline results from the Phase 2a biomarker study are expected in the third quarter of 2025.お知らせ • Apr 03GRI 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お知らせ • Apr 01GRI Bio, Inc. Reports Encouraging Interim 2-Week Safety Results from Ongoing Phase 2A Study of Gri-0621 in Idiopathic Pulmonary FibrosisGRI 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.お知らせ • Mar 25GRI 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お知らせ • Mar 11GRI Bio Regains Compliance with Nasdaq’s Minimum Bid Price RuleOn 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.お知らせ • Feb 20GRI Bio Announces Reverse Stock Split to Regain Compliance with the Minimum Bid Price Requirement for Continued Listing on the Nasdaq Capital MarketGRI 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.お知らせ • Dec 24GRI Bio, Inc. Announces European Patent Office Issued A Decision to Grant Notice for Patent Covering GRI-0803 and Its Library of 500+ Proprietary CompoundsGRI 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.お知らせ • Sep 11GRI Bio, Inc. Receives Non-Compliance Letter from the Listing Qualifications Department of the Nasdaq Stock Market Regarding Minimum Bid Price RequirementOn 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.お知らせ • Jul 24GRI Bio, Inc., Annual General Meeting, Aug 23, 2024GRI Bio, Inc., Annual General Meeting, Aug 23, 2024.お知らせ • Jul 09GRI Bio Regains Compliance with NasdaqGRI 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.お知らせ • Jul 02GRI Bio, Inc. Announces Publication of Positive Preclinical Data from Lead Program GRI -0621 in the American Journal of Respiratory and Critical Care MedicineGRI 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.お知らせ • Jun 20GRI 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お知らせ • May 23GRI Bio Announces Update on Deficiency Letter from Nasdaq Regarding Minimum Stockholders’ Equity RequirementAs 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.お知らせ • May 21GRI 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お知らせ • Apr 19GRI Bio Expands Intellectual Property Protection for Proprietary Natural Killer T (NKT) Cell Modulators with Issuance of Korea PatentGRI 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.お知らせ • Mar 05GRI Bio, Inc. Receives MHRA Authorization to Conduct Phase 2a Biomarker Study Evaluating GRI-0621 in the United KingdomGRI 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.お知らせ • Jan 27GRI Bio Approves 1-for-7 Reverse Stock Split to Regain Compliance with the Minimum Bid Price Requirement for Continued Listing on The Nasdaq Capital MarketGRI 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.お知らせ • Dec 22GRI 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 WarrantNew Risk • Dec 06New major risk - Share price stabilityThe 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).お知らせ • Dec 05GRI Bio, Inc. Commences Patient Enrollment in Phase 2a Biomarker Study Evaluating Lead Program GRI-0621 for Treatment of Idiopathic Pulmonary FibrosisGRI 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.お知らせ • Nov 29GRI Bio, Inc. Announces FDA Clearance of IND for Lead Program GRI-0621, a Type 1 Invariant NKT Antagonist for the Treatment of Idiopathic Pulmonary FibrosisGRI 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.お知らせ • Nov 27GRI Bio Receives Non-Compliance Notice From NasdaqOn 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 17New major risk - Financial positionThe 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 09New major risk - Market cap sizeThe 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).お知らせ • May 27GRI Bio, Inc., Annual General Meeting, Jul 07, 2023GRI 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.株主還元GRIUS BiotechsUS 市場7D2.3%-3.0%-0.3%1Y-93.7%32.9%26.7%株主還元を見る業界別リターン: GRI過去 1 年間で32.9 % の収益を上げたUS Biotechs業界を下回りました。リターン対市場: GRIは、過去 1 年間で26.7 % のリターンを上げたUS市場を下回りました。価格変動Is GRI's price volatile compared to industry and market?GRI volatilityGRI Average Weekly Movement9.9%Biotechs Industry Average Movement10.9%Market Average Movement7.2%10% most volatile stocks in US Market16.2%10% least volatile stocks in US Market3.2%安定した株価: GRI 、 US市場と比較して、過去 3 か月間で大きな価格変動はありませんでした。時間の経過による変動: GRIの 週次ボラティリティ は、過去 1 年間で18%から10%に減少しました。会社概要設立従業員CEO（最高経営責任者ウェブサイト20094W. Hertzwww.gribio.comGRI Bio, Inc.は臨床段階のバイオ医薬品企業であり、米国において炎症性疾患、線維化疾患、自己免疫疾患につながる疾患を対象とした治療法の発見、開発、商業化に注力している。同社の主要製品候補は経口1型ナチュラルキラーT細胞阻害剤であるGRI-0621であり、特発性肺線維症などの重篤な線維性肺疾患の治療薬として第IIa相臨床試験中である。また、同社のポートフォリオには、自己免疫疾患の治療薬として前臨床開発中の新規経口2型ナチュラルキラーT細胞作動薬GRI-0803、500種類以上の化合物からなる独自のライブラリー、炎症性免疫反応のバランスをとるためのGRI-0124およびGRI-0729が含まれる。以前はGlycoregimmune, Inc.として知られていた。GRIバイオ社は2009年に設立され、カリフォルニア州LAホヤに本社を置いている。もっと見るGRI Bio, Inc. 基礎のまとめGRI Bio の収益と売上を時価総額と比較するとどうか。GRI 基礎統計学時価総額US$3.18m収益（TTM）-US$10.91m売上高(TTM)n/a0.0xP/Sレシオ-0.3xPER（株価収益率GRI は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計GRI 損益計算書（TTM）収益US$0売上原価US$0売上総利益US$0その他の費用US$10.91m収益-US$10.91m直近の収益報告Mar 31, 2026次回決算日該当なし一株当たり利益（EPS）-7.55グロス・マージン0.00%純利益率0.00%有利子負債／自己資本比率0%GRI の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/05/21 02:24終値2026/05/21 00:00収益2026/03/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋GRI Bio, Inc. 2 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。2 アナリスト機関Edward WooAscendiant Capital Markets LLCMatthew KellerH.C. Wainwright & Co.
お知らせ • Apr 09GRI Bio, Inc. Receives Notice of Allowance For UAE Patent Application Covering Novel Type 2 Diverse NKT Cell AgonistsGRI 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.
お知らせ • Jan 29Gri Bio, Inc. Delivers Compelling New Phase 2A Gene Expression Data Demonstrating Improvements in Key Drivers of Fibrosis and Lung Repair in IPFGRI 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.
お知らせ • Jan 22GRI Bio Announces Reverse Stock Split to Regain Compliance with the Minimum Bid Price Requirement for Continued Listing on the Nasdaq Capital MarketGRI 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.
お知らせ • Jan 16GRI Bio, Inc. Regains Conditional Compliance with Nasdaq Stockholders’ Equity RequirementOn 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.
お知らせ • Jan 08GRI Bio, Inc. Announces Additional Positive Data from Phase 2A Study in Idiopathic Pulmonary Fibrosis, Strengthening Clinical Proof-Of-Concept for GRI-0621GRI 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.
お知らせ • Dec 13+ 1 more updateGRI Bio, Inc. Announces Positive Topline Data from its Phase 2a Study in Idiopathic Pulmonary FibrosisGRI 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.
お知らせ • Apr 09GRI Bio, Inc. Receives Notice of Allowance For UAE Patent Application Covering Novel Type 2 Diverse NKT Cell AgonistsGRI 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.
お知らせ • Jan 29Gri Bio, Inc. Delivers Compelling New Phase 2A Gene Expression Data Demonstrating Improvements in Key Drivers of Fibrosis and Lung Repair in IPFGRI 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.
お知らせ • Jan 22GRI Bio Announces Reverse Stock Split to Regain Compliance with the Minimum Bid Price Requirement for Continued Listing on the Nasdaq Capital MarketGRI 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.
お知らせ • Jan 16GRI Bio, Inc. Regains Conditional Compliance with Nasdaq Stockholders’ Equity RequirementOn 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.
お知らせ • Jan 08GRI Bio, Inc. Announces Additional Positive Data from Phase 2A Study in Idiopathic Pulmonary Fibrosis, Strengthening Clinical Proof-Of-Concept for GRI-0621GRI 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.
お知らせ • Dec 13+ 1 more updateGRI Bio, Inc. Announces Positive Topline Data from its Phase 2a Study in Idiopathic Pulmonary FibrosisGRI 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.
お知らせ • Dec 08GRI 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
お知らせ • Dec 03Gri Bio, Inc Receives Notice of Non-Compliance with Nasdaq Listing RulesOn 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.
お知らせ • Sep 13GRI Bio, Inc. Reports 6-Week Interim Lung Function Data in Ongoing Phase 2a Study in Idiopathic Pulmonary FibrosisGRI 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.
お知らせ • Jul 31Gri Bio, Inc. Reports 6-Week Interim Biomarker Data in Ongoing Phase 2A Study in Idiopathic Pulmonary FibrosisGRI 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.
お知らせ • Jul 14GRI Bio, Inc., Annual General Meeting, Aug 13, 2025GRI Bio, Inc., Annual General Meeting, Aug 13, 2025.
お知らせ • Jun 27GRI Bio, Inc. Reports Positive 6-Week Interim Safety Results from its Ongoing Phase 2a Study Evaluating GRI-0621 for Treatment of Idiopathic Pulmonary FibrosisGRI 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.
お知らせ • May 23GRI Bio, Inc. Presents Positive Pre-Clinical Data Demonstrating Gri-0621 Resolves Inflammation and Fibrosis in Bleomycin-Induced FibrosisGRI 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.
お知らせ • May 08+ 1 more updateGri Bio Continues to Drive Enrollment in Ongoing Phase 2A Study of Gri-0621 in Idiopathic Pulmonary FibrosisGRI Bio, Inc. announced that enrollment for the 6 week interim analysis is complete with 24 of the 36 planned patients randomized in its ongoing Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis ("IPF"). The Company expects to report interim biomarker data from the first 12 patients enrolled in Second Quarter 2025. Topline results from the Phase 2a biomarker study are expected in the third quarter of 2025.
お知らせ • Apr 03GRI 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
お知らせ • Apr 01GRI Bio, Inc. Reports Encouraging Interim 2-Week Safety Results from Ongoing Phase 2A Study of Gri-0621 in Idiopathic Pulmonary FibrosisGRI 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.
お知らせ • Mar 25GRI 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
お知らせ • Mar 11GRI Bio Regains Compliance with Nasdaq’s Minimum Bid Price RuleOn 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.
お知らせ • Feb 20GRI Bio Announces Reverse Stock Split to Regain Compliance with the Minimum Bid Price Requirement for Continued Listing on the Nasdaq Capital MarketGRI 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.
お知らせ • Dec 24GRI Bio, Inc. Announces European Patent Office Issued A Decision to Grant Notice for Patent Covering GRI-0803 and Its Library of 500+ Proprietary CompoundsGRI 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.
お知らせ • Sep 11GRI Bio, Inc. Receives Non-Compliance Letter from the Listing Qualifications Department of the Nasdaq Stock Market Regarding Minimum Bid Price RequirementOn 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.
お知らせ • Jul 24GRI Bio, Inc., Annual General Meeting, Aug 23, 2024GRI Bio, Inc., Annual General Meeting, Aug 23, 2024.
お知らせ • Jul 09GRI Bio Regains Compliance with NasdaqGRI 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.
お知らせ • Jul 02GRI Bio, Inc. Announces Publication of Positive Preclinical Data from Lead Program GRI -0621 in the American Journal of Respiratory and Critical Care MedicineGRI 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.
お知らせ • Jun 20GRI 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
お知らせ • May 23GRI Bio Announces Update on Deficiency Letter from Nasdaq Regarding Minimum Stockholders’ Equity RequirementAs 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.
お知らせ • May 21GRI 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
お知らせ • Apr 19GRI Bio Expands Intellectual Property Protection for Proprietary Natural Killer T (NKT) Cell Modulators with Issuance of Korea PatentGRI 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.
お知らせ • Mar 05GRI Bio, Inc. Receives MHRA Authorization to Conduct Phase 2a Biomarker Study Evaluating GRI-0621 in the United KingdomGRI 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.
お知らせ • Jan 27GRI Bio Approves 1-for-7 Reverse Stock Split to Regain Compliance with the Minimum Bid Price Requirement for Continued Listing on The Nasdaq Capital MarketGRI 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.
お知らせ • Dec 22GRI 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 06New major risk - Share price stabilityThe 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).
お知らせ • Dec 05GRI Bio, Inc. Commences Patient Enrollment in Phase 2a Biomarker Study Evaluating Lead Program GRI-0621 for Treatment of Idiopathic Pulmonary FibrosisGRI 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.
お知らせ • Nov 29GRI Bio, Inc. Announces FDA Clearance of IND for Lead Program GRI-0621, a Type 1 Invariant NKT Antagonist for the Treatment of Idiopathic Pulmonary FibrosisGRI 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.
お知らせ • Nov 27GRI Bio Receives Non-Compliance Notice From NasdaqOn 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 17New major risk - Financial positionThe 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 09New major risk - Market cap sizeThe 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).
お知らせ • May 27GRI Bio, Inc., Annual General Meeting, Jul 07, 2023GRI 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.
