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GRI BIO INC

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GRI Bio

GRI Bio Inc is a clinical-stage biotech company focused on discovering, developing, and commercializing therapies targeting serious diseases associated with dysregulated immune responses that to inflammatory, fibrotic, and autoimmune disorders. GRI Bio's program, GRI-0621, is a small molecule RAR-beta and gamma dual agonist that inhibits the activity of human NKT I cells, returning the immune system to homeostasis. It is also an oral formulation of tazarotene, a synthetic RAR-beta and gamma selective agonist for the topical treatment of psoriasis and acne. The company's other product candidate GRI-0803 is a novel oral agonist of type 2 Natural Killer T (type 2 NKT) cells which can be a potential treatment for autoimmune disorders.

GRI Bio Inc

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GRI Bio Reports Interim Biomarker Results From Phase 2a Study Evaluating GRI-0621 In Idiopathic Pulmonary Fibrosis; Independent Data Monitoring Committee Recommended Study Continue As Planned, As No Safety Concerns Were Seen In The Data Reviewed

Enrollment completed for the 6-week interim analysis with 24 of the 36 planned patients now enrolled&nbsp;
Company on track to report interim biomarker data from the first 12 patients imminently
Completion of patient enrollment and topline results expected Q3 2025

News

GRI Bio Completes Enrollment With 24 Of 36 Planned Patients Randomized In Its Ongoing Phase2a Study Evaluating GRI-0621 For Idiopathic Pulmonary Fibrosis

HC Wainwright &amp; Co. analyst Joseph Pantginis reiterates GRI Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GRI#NASDAQ">GRI</a>) with a Buy and maintains $10 price target.

Price Target

Reiteration

Analyst Ratings

HC Wainwright & Co. Reiterates Buy on GRI Bio, Maintains $10 Price Target

WIIM

GRI Bio shares are trading lower after the company announced a $5 million public price offering.

Offerings

GRI Bio Prices $5.0M Public Offering Of 1,388,888 At $3.60

GRI Bio, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GRI#NASDAQ">GRI</a>) stock is trading on Tuesday with a strong session volume of 6.9 million compared to an average volume of 17.35K, as per data <a href="https://www.benzinga.com/pro/feature/newsfeed" target="_blank" rel="noreferrer noopener">from Benzinga Pro</a>.
GRI Bio reported interim safety results from its ongoing Phase 2a study evaluating GRI-0621 for <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">Idiopathic Pulmonary Fibrosis (IPF)</a>.
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 <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/g44584630/gri-bio-reports-encouraging-interim-2-week-safety-results-from-ongoing-phase-2a-study-of-gri-0621-" rel="noreferrer noopener">and injury in patients</a>.
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 (high cholesterol) was not seen in the 12 patients assessed at the 2-week visit.
There were no meaningful changes in cholesterol levels in patients receiving GRI-0621, and all subjects remained within normal ranges.
The interim analysis committee recommended the study should continue as planned.
The interim results show that GRI-0621&#8217;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.
The company expects to report interim biomarker data in Q2 2025. Topline results from the Phase 2a biomarker study are expected in the third quarter of 2025.
Price Action: GRI stock is up 95.9% at $6.27 at the last check Tuesday.
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Why Is Nano Cap GRI Bio Stock Skyrocketing On Tuesday?

GRI Bio Shares Resumed Trade And Then Again Halted On Circuit Breaker To The Downside, Stock Now Up 154.1%

&nbsp;GRI Bio, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GRI#NASDAQ">GRI</a>) ("GRI Bio" or the "Company"), a biotechnology company advancing an innovative pipeline of Natural Killer T ("NKT") cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today reported interim safety results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis ("IPF"). &nbsp;
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 ere no meaningful changes in HDL, LDL or TG levels in patients receiving GRI-0621, and all subjects remained within normal ranges. The interim analysis committee recommended the study should continue as planned. 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. &nbsp;

GRI Bio Reported Interim 2-Week Safety Results From Ongoing Phase 2a Study of GRI-0621 in Idiopathic Pulmonary Fibrosis

GRI Bio Expands Intellectual Property Portfolio With Granting of Two Global Patents in Europe and Japan

<h3>Gainers</h3>
<ul>
<li>vTv Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VTVT#NASDAQ">VTVT</a>) shares increased by 65.2% to $24.53 during Monday's regular session. The market value of their outstanding shares is at $64.0 million. </li>
<li>Monogram Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MGRM#NASDAQ">MGRM</a>) stock increased by 52.35% to $3.55. The company's market cap stands at $121.8 million. As per the news, the Q4 earnings report came out 3 days ago. </li>
<li>Regencell Bioscience (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RGC#NASDAQ">RGC</a>) stock rose 46.67% to $18.51. The market value of their outstanding shares is at $240.8 million. </li>
<li>Scienture Holdings (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SCNX#NASDAQ">SCNX</a>) stock moved upwards by 42.95% to $2.13. The company's market cap stands at $18.3 million. </li>
<li>Hyperfine (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HYPR#NASDAQ">HYPR</a>) shares increased by 34.92% to $1.24. The market value of their outstanding shares is at $96.0 million. As per the news, the Q4 earnings report came out today. </li>
<li>CervoMed (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CRVO#NASDAQ">CRVO</a>) shares moved upwards by 28.11% to $8.25. The company's market cap stands at $68.1 million. As per the press release, Q4 earnings came out today. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>Revelation Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REVB#NASDAQ">REVB</a>) stock declined by 19.7% to $2.73 during Monday's regular session. The market value of their outstanding shares is at $2.4 million. </li>
<li>bioAffinity Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIAF#NASDAQ">BIAF</a>) stock declined by 17.93% to $0.3. The market value of their outstanding shares is at $4.6 million. </li>
<li>Palisade Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PALI#NASDAQ">PALI</a>) stock decreased by 14.88% to $0.85. The company's market cap stands at $2.5 million. </li>
<li>Plus Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PSTV#NASDAQ">PSTV</a>) stock decreased by 12.7% to $0.59. The market value of their outstanding shares is at $3.4 million. </li>
<li>NRX Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NRXP#NASDAQ">NRXP</a>) shares declined by 12.56% to $2.06. The market value of their outstanding shares is at $34.7 million. The company's, Q4 earnings came out today. </li>
<li>GRI Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GRI#NASDAQ">GRI</a>) stock declined by 12.14% to $5.26. The company's market cap stands at $2.7 million. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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12 Health Care Stocks Moving In Monday's Intraday Session

Summary of Financial Results for Full Year 2024 &nbsp;
Net loss was $8.2 million for the year ended December 31, 2024.
Research and development expenses were $3.8 million and $3.2 million for the years ended December 31, 2024 and 2023, respectively. The $0.6 million increase in research and development expenses was primarily due to increased expenses related to the registrational development program of GRI-0621.
General and administrative expenses were $4.5 million and $8.2 million for the years ended December 31, 2024 and 2023, respectively. The $3.7 million decrease was primarily due to a decrease of $3.4 million in accounting, legal, investment banking and other fees related to the merger with Vallon Pharmaceuticals, Inc. in April 2023.
As of December 31, 2024, the Company had cash and cash equivalents of approximately $5.0 million. Based on the Company's current operating plan, the Company believes that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into the second quarter of 2025.

Earnings

GRI Bio Reports As Of December 31, 2024, The Company Had Cash And Cash Equivalents Of ~$5M; Cash Runway Expected To Fund Operations Into Q2 2025, Including Interim Data Readout From GRI-0621

GRI Bio, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GRI#NASDAQ">GRI</a>) ("GRI Bio" or the "Company"), a biotechnology company advancing an innovative pipeline of Natural Killer T ("NKT") cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced that it received notice on March 10, 2025 from The Nasdaq Stock Market LLC ("Nasdaq") stating that the Company regained compliance with Nasdaq Listing Rule 5550(a)(2), also known as the "minimum bid price rule."

GRI Bio Regains Compliance With Nasdaq's Minimum Bid Price Rule

Trading Halt: Halted at 7:50:00 p.m. ET - Trading Halt: Halt News Pending

GRI Bio shares are trading lower after the company announced a 1-for-17 reverse stock split.

GRI's common stock is expected to begin trading on a post-split adjusted basis on February 24, 2025
LA JOLLA, CA, Feb. 19, 2025 (GLOBE NEWSWIRE) -- <a href="https://www.globenewswire.com/Tracker?data=MzcPI4Nne-gM9Y7IcrvoQNVonsr-sxSgaMIIl8GMorqA_B5Lg8fWbPdlBY6JIGy97U4a6Zc22KT2nbZICLkmUw==">GRI Bio, Inc.</a> (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GRI#NASDAQ">GRI</a>) ("GRI Bio" or the "Company"), a biotechnology company advancing an innovative pipeline of Natural Killer T ("NKT") cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced that the board of directors of the Company approved a&nbsp;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 will legally take effect at 4:01 p.m. Eastern Time, on February 21, 2025. The Company's common stock will open for trading under a new CUSIP number 3622AW 403 on The Nasdaq Capital Market on February 24, 2025, 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.

Stock Split

GRI Bio Announces 1-For-17 Reverse Stock Split, Expected To Begin Trading On A Post-Split Adjusted Basis On February 24, 2025

<h3>Gainers</h3>
<ul>
<li>Anitra (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/AZTR#AMEX">AZTR</a>) stock moved upwards by 89.1% to $0.53 during Tuesday's pre-market session. The company's market cap stands at $6.5 million. </li>
<li>Evaxion Biotech (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EVAX#NASDAQ">EVAX</a>) stock increased by 60.83% to $3.86. The company's market cap stands at $24.1 million. </li>
<li>Achilles Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACHL#NASDAQ">ACHL</a>) stock rose 22.32% to $1.37. The market value of their outstanding shares is at $58.5 million. </li>
<li>Invivyd (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IVVD#NASDAQ">IVVD</a>) stock moved upwards by 19.81% to $1.27. The company's market cap stands at $151.9 million. </li>
<li>Aclarion (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACON#NASDAQ">ACON</a>) stock rose 18.79% to $7.9. The market value of their outstanding shares is at $8.0 million. </li>
<li>Kymera Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KYMR#NASDAQ">KYMR</a>) stock rose 16.91% to $45.0. The market value of their outstanding shares is at $2.9 billion. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>Universe Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/UPC#NASDAQ">UPC</a>) stock decreased by 28.4% to $0.3 during Tuesday's pre-market session. The company's market cap stands at $2.5 million. </li>
<li>HCW Biologics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HCWB#NASDAQ">HCWB</a>) stock fell 19.33% to $0.51. The company's market cap stands at $22.8 million. </li>
<li>LifeStance Health Gr (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LFST#NASDAQ">LFST</a>) stock decreased by 12.93% to $7.0. The market value of their outstanding shares is at $2.6 billion. </li>
<li>Omega Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OMGA#NASDAQ">OMGA</a>) stock decreased by 12.34% to $0.42. The company's market cap stands at $23.2 million. </li>
<li>GRI Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GRI#NASDAQ">GRI</a>) shares declined by 12.04% to $0.55. The company's market cap stands at $4.9 million. </li>
<li>IMAC Hldgs (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BACK#NASDAQ">BACK</a>) shares decreased by 11.92% to $0.67. The market value of their outstanding shares is at $1.3 million. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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Strengthening Global Patent Portfolio For NKT Cell Modulators Targeting Inflammatory And Autoimmune Diseases

GRI Bio Secures European Patent Approval For GRI-0803 And 500+ Proprietary Compounds

HC Wainwright &amp; Co. analyst Joseph Pantginis initiates coverage on GRI Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GRI#NASDAQ">GRI</a>) with a Buy rating and announces Price Target of $10.

Initiation

HC Wainwright & Co. Initiates Coverage On GRI Bio with Buy Rating, Announces Price Target of $10

Ascendiant Capital analyst Edward Woo maintains GRI Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GRI#NASDAQ">GRI</a>) with a Buy and raises the price target from $12 to $13.

Ascendiant Capital Maintains Buy on GRI Bio, Raises Price Target to $13

GRI Bio Highlights GRI-0621's Potential To Reduce Inflammation And Hepatic Fibrosis In Idiopathic Pulmonary Fibrosis, With Positive Preclinical Data Presented At AFDD Summit And Phase 2 Topline Data Expected In Q2 2025

Press Releases

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

GRI Bio Reports Full Year 2024 Financial Results and Reiterates Expected Clinical Data Readouts in 2025 for Ongoing Phase 2a Study of GRI-0621 in Idiopathic Pulmonary Fibrosis ("IPF")

GRI Bio Participates in a Virtual Investor CEO Connect Segment

GRI Bio Bolsters Intellectual Property Portfolio with Granting of Two Global Patents for Europe and Japan

GRI Bio Reports Encouraging Interim 2-Week Safety Results from Ongoing Phase 2a Study of GRI-0621 in Idiopathic Pulmonary Fibrosis ("IPF")

GRI Bio Announces Pricing of $5.0 Million Public Offering

GRI Bio Announces Closing of $5.0 Million Public Offering

GRI Bio Announces Abstract Selected for Poster Discussion Session at the 2025 American Thoracic Society (ATS) International Conference

GRI Bio Continues to Drive Enrollment in Ongoing Phase 2a Study of GRI-0621 in Idiopathic Pulmonary Fibrosis ("IPF")

GRI Bio's Interim Biomarker Data Demonstrate Positive Trend Towards Anti-Fibrotic Effect of GRI-0621 in First Twelve Patients of Ongoing Phase 2a Study in Idiopathic Pulmonary Fibrosis ("IPF")

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