IPF Phase 2a results and cash runway update for GRI Bio (NASDAQ: GRI)
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
GRI Bio, Inc. reported first quarter 2026 results and highlighted new Phase 2a data for its IPF drug candidate GRI-0621. Cash and cash equivalents were approximately $11.0 million as of March 31, 2026, up from about $8.2 million at year-end 2025, which the company expects will fund operations into the second quarter of 2027.
In the 35-patient Phase 2a IPF trial, GRI-0621 added to standard of care showed zero cough versus 25% on placebo, a 76% reduction in dyspnea (4% vs. 17%), no weight loss versus 17% on placebo, and a 61% reduction in diarrhea (13% vs. 33%), with no serious adverse events in the active arm. Exploratory data showed a +99 mL FVC improvement overall and +139 mL in patients on background antifibrotics.
Research and development expenses fell to about $0.4 million from $1.6 million a year earlier as the Phase 2a trial concluded, while general and administrative expenses were approximately $1.6 million versus $1.4 million. Net loss narrowed to roughly $2.0 million from $3.0 million, and the company raised about $6.8 million in gross proceeds through its at-the-market facility.
Positive
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Negative
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Insights
GRI pairs encouraging IPF Phase 2a signals with a modestly improved cash runway.
GRI Bio presents Phase 2a data suggesting GRI-0621 may improve tolerability when added to current IPF standard of care, with lower cough, dyspnea, weight loss and diarrhea, plus favorable exploratory lung function trends and no serious adverse events in the active arm.
Financially, quarterly net loss narrowed to about $2.0 million from $3.0 million, helped by lower R&D after completing the trial, while cash rose to roughly $11.0 million and was supplemented by $6.8 million in at-the-market proceeds. Management indicates this supports operations into Q2 2027.
The overall picture is an early-stage IPF program with supportive safety and biomarker data and a defined, but finite, runway. Subsequent company filings may detail Phase 2b design, additional capital plans, and regulatory interactions in the United States and Europe.
8-K Event Classification
3 items: 2.02, 8.01, 9.01
3 items
Item 2.02
Results of Operations and Financial Condition
Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Cash and cash equivalents: $11.0 million
Cash and cash equivalents prior period: $8.2 million
ATM gross proceeds: $6.8 million
+5 more
8 metrics
Cash and cash equivalents
$11.0 million
As of March 31, 2026; funding into Q2 2027
Cash and cash equivalents prior period
$8.2 million
As of December 31, 2025; baseline comparison
ATM gross proceeds
$6.8 million
Raised through At The Market facility in Q1 2026
Research and development expense
$0.4 million
Three months ended March 31, 2026
General and administrative expense
$1.6 million
Three months ended March 31, 2026
Net loss
$2.0 million
Quarter ended March 31, 2026
Phase 2a trial size
35 patients
GRI-0621 in idiopathic pulmonary fibrosis
Exploratory FVC change
+99 mL overall; +139 mL SOC subset
At 12 weeks vs placebo plus standard of care
Key Terms
Phase 2a, idiopathic pulmonary fibrosis, Natural Killer T (NKT) cells, At The Market facility, +2 more
6 terms
Phase 2a medical
"Phase 2a data show zero cough and 60% lower treatment-related diarrhea"
Phase 2a is an early stage in testing a new medical treatment or drug, where the main goal is to assess its safety and find the right dosage. For investors, this stage indicates whether the treatment shows initial promise before moving on to larger, more definitive studies; progress here can influence expectations for future development and potential success.
idiopathic pulmonary fibrosis medical
"GRI-0621’s differentiated therapeutic potential in idiopathic pulmonary fibrosis (IPF)"
Idiopathic pulmonary fibrosis is a chronic lung disease in which the air‑carrying tissue becomes progressively thickened and scarred for no identifiable reason, making the lungs stiff and less able to move oxygen—similar to a sponge that hardens and loses its pores. It matters to investors because it is life‑limiting with limited effective treatments, so clinical trial outcomes, regulatory approvals, pricing and reimbursement decisions can strongly affect the commercial value of therapies and the financial prospects of companies developing treatments.
Natural Killer T (NKT) cells medical
"advancing an innovative pipeline of Natural Killer T (NKT) cell modulators"
Natural killer T (NKT) cells are a small group of immune cells that act like hybrid security guards, combining features of two frontline defenders to spot infected or cancerous cells and call in stronger responses. Investors care because therapies or tests that harness or measure NKT cells can drive drug development, clinical trial results, regulatory decisions, or diagnostic advances, all of which can significantly affect a biotech company’s value.
At The Market facility financial
"Strengthened the balance sheet through the Company’s At The Market facility"
IND-enabling activities regulatory
"Advancing GRI-0803 toward IND-enabling activities to expand the pipeline"
IND-enabling activities are the lab tests, animal studies and manufacturing checks a company performs to demonstrate a new drug is reasonably safe and can be produced reliably before filing an Investigational New Drug (IND) application to begin human trials. For investors these steps are a key milestone because completing them reduces safety and regulatory risk, requires substantial time and funding, and signals that a program is ready to move from early development into clinical testing—like building a foundation before constructing a house.
RARβ/γ selective agonist medical
"GRI-0621, the Company’s once-daily oral RARβ/γ selective agonist"
A rarβ/γ selective agonist is a drug-like molecule that specifically binds to and turns on two subtypes of retinoic acid receptors (beta and gamma), which help control genes involved in cell growth, differentiation and tissue repair. For investors, this selectivity matters because targeting only those receptor subtypes can increase the chance of therapeutic benefit while lowering side effects—similar to dimming two specific lights rather than rewiring an entire circuit—which can improve clinical and commercial prospects.
Earnings Snapshot
Net loss: $2.0 million
Quarter ended March 31, 2026
Net loss
$2.0 million
Compared to $3.0 million for the same period in 2025
Research and development expense
$0.4 million
Compared to $1.6 million for the same period in 2025
General and administrative expense
$1.6 million
Compared to $1.4 million for the same period in 2025
Cash and cash equivalents
$11.0 million
Compared to $8.2 million as of December 31, 2025
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549 FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 14, 2026
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction | (Commission File Number) | (IRS Employer Identification No.) | ||||||||||||
| of incorporation) | ||||||||||||||
(Address of principal executive offices and zip code)
(619 ) 400-1170
(Registrant’s telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
The Nasdaq Capital Market | ||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging Growth Company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On May 14, 2026, GRI Bio, Inc. (the “Company”) issued a press release (the “Press Release”) announcing its financial results for the three months ended March 31, 2026 and summarizing key recent highlights. A copy of the Press Release containing this information is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 2.02 and Exhibit 99.1 is being furnished and, except as otherwise set forth in this Current Report on Form 8-K, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying Exhibit 99.1 shall not be deemed, except as otherwise set forth in this Current Report on Form 8-K, incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof regardless of any general incorporation language in such filing.
Item 8.01 Other Events.
The section of the Press Release entitled “Phase 2a Data – GRI-0621 in IPF” is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |||||||
| 99.1 | Press Release issued by GRI Bio, Inc., dated May 14, 2026. | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: May 14, 2026 | GRI Bio, Inc. | |||||||
| By: /s/ Leanne Kelly | ||||||||
| Leanne Kelly | ||||||||
| Chief Financial Officer | ||||||||
Exhibit 99.1
GRI Bio Reports First Quarter 2026 Financial Results, New Data Reinforcing Differentiated Profile of GRI-0621 in Idiopathic Pulmonary Fibrosis and Highlights Continued Advancement of Differentiated Immune-Modulating Pipeline
Phase 2a data show zero cough and 60% lower treatment-related diarrhea than placebo despite higher nintedanib use in the active arm – suggesting GRI-0621 may mitigate nintedanib-related GI-toxicities when used in combination
Advancing GRI-0803 toward IND-enabling activities to expand the pipeline across autoimmune indications with high unmet need
LA JOLLA, CA, May 14, 2026 -- GRI Bio, Inc. (NASDAQ: GRI) (“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 reported financial results for the quarter ended March 31, 2026 and provided a corporate update.
“The growing body of Phase 2a clinical, translational and biomarker data continues to reinforce GRI-0621’s differentiated therapeutic potential in idiopathic pulmonary fibrosis (IPF),” said Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “Additional analyses in the Phase 2a study show that GRI-0621 delivered zero cough, reduced dyspnea, zero weight loss and approximately 60% less treatment-related diarrhea when added to standard of care versus standard of care alone, with no serious adverse events in the active arm – directly addressing the tolerability burdens that drive discontinuations of current IPF therapies. These data, together with improvements in lung function and consistent evidence of immune modulation, anti-fibrotic activity, and epithelial repair, give us confidence in the program. With approximately $11.0 million in cash as of March 31, 2026, supporting planned operations into the second quarter of 2027, we believe we are positioned to continue advancing GRI-0621 towards pivotal studies and progressing GRI-0803 toward IND-enabling activities with disciplined execution.”
Phase 2a Data – GRI-0621 in IPF
GRI-0621, the Company’s once-daily oral RARβ/γ selective agonist, was evaluated in a randomized, double-blind, placebo-controlled Phase 2a trial (GRI-0621-IPF-02; NCT06331624) in 35 patients with IPF, approximately 80% of whom were on background standard-of-care (SOC) antifibrotics. The trial met its primary safety and tolerability endpoint, with continued analyses of translational and biomarker endpoints supporting previously reported findings. Key results include:
•Safety and tolerability: GRI-0621 was observed to reduce important clinical features of IPF (cough/shortness of breath) and SOC-associated toxicities (diarrhea). Zero cough was observed in the active arm vs. 25% in the placebo arm; a 76% reduction in dyspnea (4% vs. 17% placebo arm); no weight loss (vs. 17% placebo arm); and a 61% reduction in diarrhea (13% vs. 33% placebo arm), despite 67% more nintedanib use in the active vs. placebo arm (nintedanib is known to be associated with higher rates of diarrhea compared to pirfenidone); no serious adverse events were reported in the active arm, and a single SAE was reported in the placebo arm.
•Exploratory pulmonary function: +99 mL FVC improvement overall, and +139 mL in the SOC combination subset, versus placebo + SOC at 12 weeks.
•MOA: Evidence across multiple, independent measures, including serum proteomics (17 analytes), whole-blood RNA-sequencing and flow cytometry suggest disease-modifying benefits, including immune rebalancing (Th2→Type 1 switch), active fibrolysis, basement membrane repair and epithelial regeneration.
•Patents: The company has filed additional patent applications based, in part, on these data.
First Quarter 2026 Pipeline and Corporate Highlights
•Advanced clinical development planning activities for GRI-0621 to support potential regulatory pathways in both the United States and Europe.
•Progressed GRI-0803, the Company’s type 2 diverse Natural Killer T (dNKT) agonist program for autoimmune diseases, toward IND-enabling activities.
•Strengthened the balance sheet through the Company’s At The Market facility, generating approximately $6.8 million in gross proceeds during the first quarter of 2026.
First Quarter 2026 Financial Results
Cash and cash equivalents totaled approximately $11.0 million as of March 31, 2026, compared to approximately $8.2 million as of December 31, 2025. Based on the Company’s current operating plan, GRI Bio believes existing cash resources will be sufficient to fund planned operating expenses and capital expenditure requirements into the second quarter of 2027.
Research and development expenses were approximately $0.4 million for the three months ended March 31, 2026, compared to approximately $1.6 million for the same period in 2025. The decrease was primarily related to lower expenses due to the completion of the Company’s Phase 2a clinical trial of GRI-0621 in 2025.
General and administrative expenses were approximately $1.6 million for the three months ended March 31, 2026, compared to approximately $1.4 million for the same period in 2025.
Net loss for the quarter ended March 31, 2026, was approximately $2.0 million, compared to approximately $3.0 million for the same period in 2025.
About GRI Bio, Inc.
GRI Bio is a clinical-stage biopharmaceutical company focused on fundamentally changing the way inflammatory, fibrotic and autoimmune diseases are treated. GRI Bio’s therapies are designed to target the activity of Natural Killer T (“NKT”) cells, which are key regulators earlier in the inflammatory cascade, to interrupt disease progression and restore the immune system to homeostasis. NKT cells are innate-like T cells that share properties of both NK and T cells and are a functional link between the innate and adaptive immune responses. Type 1 invariant NKT (“iNKT”) cells play a critical role in propagating the injury, inflammatory response, and fibrosis observed in inflammatory and fibrotic indications. GRI Bio’s lead program, GRI-0621, is an RARβ/γ-selective agonist shown to inhibit the activity of key immune cells, such as iNKT cells, and is being developed as a novel oral therapeutic for the treatment of idiopathic pulmonary fibrosis, a serious disease with significant unmet need. The Company is also developing a
pipeline of novel type 2 diverse NKT (“dNKT”) agonists for the treatment of systemic lupus erythematosus. Additionally, with a library of over 500 proprietary compounds, GRI Bio has the ability to fuel a growing pipeline.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions. These forward-looking statements are based on the Company’s current beliefs and expectations. Forward-looking statements include, but are not limited to, statements regarding: the Company’s expectations with respect to development and commercialization of the Company’s product candidates, the timing of initiation or completion of clinical trials and availability of resulting data, the potential benefits and impact of the Company’s clinical trials and product candidates and any implication that the data or results observed in preclinical trials or earlier studies, topline or interim data or trials will be indicative of results of later studies or clinical trials or final data, the Company’s beliefs and expectations regarding potential shareholder value and future financial performance, the Company’s beliefs about the timing and outcome of regulatory approvals and potential regulatory approval pathways, the Company’s expected future milestones, shareholder value and the length of time the Company’s current resources will fund its planned operations (which current estimate assumes only initial preparatory activities for GRI-0621 as substantial additional capital or resources will be required to fund a Phase 2b clinical trial of GRI-0621). Actual results may differ from the forward-looking statements expressed by the Company in this press release and consequently, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including, without limitation risks related to: (1) the Company’s inability to maintain the listing of the Company’s common stock on The Nasdaq Capital Market and to comply with applicable listing requirements; (2) changes in applicable laws or regulations; (3) the inability of the Company to raise financing in the future; (4) the success, cost and timing of the Company’s product development activities; (5) the inability of the Company to obtain and maintain regulatory clearance or approval for its respective products, and any related restrictions and limitations of any cleared or approved product; (6) the inability of the Company to identify, in-license or acquire additional technology; (7) the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently developing; (8) the accuracy of the estimated size and growth potential of the markets for the Company’s products and services, and its ability to serve those markets, either alone or in partnership with others; (9) that later data or clinical trials may be inconsistent with or contrary to data and observations to date, including that later data may not indicate a patient benefit, modulate toxicities or validate a mechanism of action; (10) inaccuracy in the Company’s estimates regarding expenses, future revenue, capital requirements and needs for and the ability to obtain additional financing; (11) the Company’s ability to protect and enforce its intellectual property portfolio, including any newly issued patents and its ability to obtain any expected patent term extensions, adjustments, exclusivities or disclaimers; and (12) other risks and uncertainties indicated from time to time in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including the risks and uncertainties described in the
“Risk Factors” section of the Company’s most recent Annual Report on Form 10-K filed with the SEC on January 30, 2026 and subsequently filed reports. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.
Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
GRI@jtcir.com
FAQ
How much cash does GRI Bio (GRI) have after Q1 2026?
GRI Bio ended the quarter with about $11.0 million in cash and cash equivalents as of March 31, 2026, up from roughly $8.2 million at December 31, 2025, providing funding into the second quarter of 2027 under its current plan.
What were GRI Bio’s Q1 2026 research and development expenses?
Research and development expenses were approximately $0.4 million for the three months ended March 31, 2026, compared with about $1.6 million for the same period in 2025, mainly reflecting completion of the Phase 2a clinical trial of GRI-0621.
What net loss did GRI Bio (GRI) report for Q1 2026?
GRI Bio reported a net loss of approximately $2.0 million for the quarter ended March 31, 2026, compared to about $3.0 million for the prior-year quarter, indicating a narrower loss driven in part by reduced R&D spending after trial completion.
What key Phase 2a IPF results did GRI Bio announce for GRI-0621?
In the 35-patient Phase 2a IPF trial, GRI-0621 showed zero cough in the active arm versus 25% on placebo, reduced dyspnea, no weight loss, substantially less diarrhea, and no serious adverse events in treated patients, alongside favorable exploratory lung function changes.
How long does GRI Bio expect its cash to fund operations?
Based on its current operating plan, GRI Bio believes existing cash resources will fund planned operating expenses and capital needs into the second quarter of 2027, assuming only initial preparatory activities for further development of GRI-0621.
How much did GRI Bio raise through its At The Market facility in Q1 2026?
GRI Bio strengthened its balance sheet by generating approximately $6.8 million in gross proceeds via its At The Market equity facility during the first quarter of 2026, adding to its cash position for pipeline advancement and corporate activities.