GRI Bio, Inc. GRI
We are a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing innovative therapies that target serious diseases associated with dysregulated immune responses leading to inflammatory, fibrotic and autoimmune disorders. Our goal is to be an industry leader in developing therapies to treat these diseases and to improve the lives of patients suffering from such diseases.
Our product candidate, GRI-0621, is an oral inhibitor of type 1 invariant Natural Killer T (iNKT) cells. The active pharmaceutical ingredient in GRI-0621, tazarotene, is a synthetic retinoid acid receptor-beta and gamma selective agonist. Tazarotene is approved in the United States for topical treatment of psoriasis and acne. While there are no approved oral formulations of tazarotene, as of December 31, 2025, it has been evaluated in over 1,700 patients as an oral product for up to 52-weeks. We are developing GRI-0621 for the treatment of severe fibrotic lung diseases such as idiopathic pulmonary fibrosis (IPF), a life-threatening progressive fibrotic disease of the lung that affects approximately 140,000 people in the United States, with up to 40,000 new cases per year in the United States. Some estimate that IPF affects 3 million globally. While there are currently two approved therapies for the treatment of lung fibrosis, neither has been associated with improvements in overall survival, and both therapies have been associated with significant side effects leading to poor therapeutic adherence. In preliminary and topline data from our trials to date with GRI-0621, and earlier trials with oral tazarotene, we have observed GRI-0621 to be well-tolerated and to inhibit iNKT cell activity in subjects. We and others have shown that activated iNKT are upregulated in IPF, primary sclerosing cholangitis (PSC), metabolic dysfunction-associated steatohepatitis (MASH), alcoholic liver disease (ALD), systemic lupus erythematosus (SLE), multiple sclerosis (MS), ulcerative colitis (UC) patients as well as other indications. In these patients activated iNKT cells are correlated with more severe disease.
Valuation FY2025 figures against the last close
Annual financial statements
Income statement
| Fiscal year | FY2025 | FY2024 | FY2023 | FY2022 | FY2021 | FY2020 | FY2019 |
|---|---|---|---|---|---|---|---|
| Revenue | — | — | — | — | $0 | $100.0K | — |
| R&D | $6.8M | $3.8M | $3.2M | $242.0K | $5.2M | $3.7M | — |
| SG&A | $5.2M | $4.5M | $8.2M | $2.0M | $4.1M | $1.2M | — |
| Total operating expenses | $12.0M | $8.2M | $11.4M | $2.2M | $9.3M | $4.9M | — |
| Operating income | -$12.0M | -$8.2M | -$11.4M | -$2.2M | -$9.3M | -$4.8M | — |
| Pre-tax income | -$12.0M | -$8.2M | — | — | — | — | — |
| Income tax | $3.0K | $2.0K | — | — | — | — | — |
| Net income | -$12.0M | -$8.2M | -$13.0M | -$3.2M | -$9.3M | -$4.8M | — |
| EPS, basic | -121.80 | -1,545.55 | -5,018.09 | -24.95 | -1.42 | -1.07 | — |
| EPS, diluted | -121.80 | -1,545.55 | -5,018.09 | -24.95 | -1.42 | -1.07 | — |
| Shares, diluted (wtd. avg.) | 98,162 | 6,547 | 2,598 | 128,994 | 6.5M | 4.5M | — |
Balance sheet
| Fiscal year | FY2025 | FY2024 | FY2023 | FY2022 | FY2021 | FY2020 | FY2019 |
|---|---|---|---|---|---|---|---|
| Cash and equivalents | $8.2M | $5.0M | $1.8M | $9.0K | $90.0K | $109.0K | $3.8M |
| Short-term investments | — | — | — | $0 | $3.8M | $0 | — |
| Total current assets | $8.6M | $5.6M | $2.9M | $312.0K | $8.1M | $674.0K | — |
| Property, plant and equipment | $3.0K | $4.0K | $8.0K | $4.0K | $0 | $2.0K | — |
| Total assets | $8.7M | $5.7M | $3.0M | $383.0K | $8.3M | $955.0K | — |
| Accounts payable | $1.8M | $897.0K | $1.4M | $1.3M | $918.0K | $1.2M | — |
| Total current liabilities | $2.6M | $1.6M | $2.7M | $2.0M | $2.4M | $2.2M | — |
| Total liabilities | $2.7M | $1.7M | $2.7M | $2.0M | $2.5M | $2.4M | — |
| Retained earnings | -$51.7M | -$39.7M | -$31.5M | -$18.5M | -$21.9M | -$12.6M | — |
| Total equity | $6.0M | $4.0M | $259.0K | -$1.6M | -$4.8M | -$1.5M | $3.2M |
Cash flow
| Fiscal year | FY2025 | FY2024 | FY2023 | FY2022 | FY2021 | FY2020 | FY2019 |
|---|---|---|---|---|---|---|---|
| Operating cash flow | -$10.2M | -$8.6M | -$9.0M | -$1.1M | -$8.3M | -$3.7M | — |
| Depreciation and amortisation | $4.0K | $4.0K | $4.0K | $3.0K | — | — | — |
| Stock-based compensation | $793.0K | $148.0K | $388.0K | $25.0K | $626.0K | $154.0K | — |
| Capital expenditure | $3.0K | $0 | $8.0K | $3.0K | $0 | $2.0K | — |
| Investing cash flow | -$3.0K | $0 | -$8.0K | -$3.0K | -$3.8M | -$2.0K | — |
| Financing cash flow | $13.4M | $11.8M | $10.8M | $1.0M | $15.7M | -$4.0K | — |
Figures as tagged in each year's own filing, in US dollars. A year restated by a later filing shows the restated figure. Capital expenditure, dividends and buybacks are cash out, shown positive. A line the filer does not report is not listed. Latest from accession 0001824293-26-000033.
Plot the figures US dollars
- Revenue
- Gross profit
- Net income
| Fiscal year | FY2019 | FY2020 | FY2021 | FY2022 | FY2023 | FY2024 | FY2025 |
|---|---|---|---|---|---|---|---|
| Revenue | — | $100.0K | $0 | — | — | — | — |
| Gross profit | — | — | — | — | — | — | — |
| Net income | — | -$4.8M | -$9.3M | -$3.2M | -$13.0M | -$8.2M | -$12.0M |
Recent filings and events
- Other event The catch-all. The company chose to disclose something that fits no other item, so the content is whatever it says it is. Item 8.01
- Results announced The quarterly or annual earnings release. Arrives four times a year from almost every company here. Item 2.02
- Other event Item 8.01
- Results announced Item 2.02
- Annual report filed A new 10-K. The figures and the business description on this site come from it. Form 10-K
- Material agreement signed The company entered an agreement outside the ordinary course of business - a large contract, a credit facility, a merger agreement. Item 1.01
- Other event Item 8.01
- Shareholder rights changed The terms attaching to the shares themselves have changed. Item 3.03
- Charter or fiscal year changed A change to the company's governing documents, or to when its year ends. Item 5.03
- Other event Item 8.01
- Delisting notice The exchange has told the company it no longer meets the rules for staying listed - usually price, market cap, or filings that are late. Item 3.01
- Shareholder vote The results of the annual meeting or a special vote. Item 5.07
Item numbers are Form 8-K's own, and a filing date is up to four business days after the thing it reports. The same feed across the whole market.
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