Tazarotene

No decline in lung function observed at 6-week interim analysis builds upon positive safety and biomarker data Phase 2a study fully enrolled; Topline data on track for Q3 2025 Currently available treatments for IPF are limited to only two approved drugs that come with significant side-effects, limited patient compliance and no impact on survival LA JOLLA, CA, Sept. 11, 2025 (GLOBE NEWSWIRE) -- 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 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. GRI-0621 treated patients demonstrated no worsening of forced vital capacity (“FVC”) at 6 weeks compared to baseline, building upon the previously reported, six-week, positive interim serum biomarker data observed. Changes observed from baseline of biomarkers in GRI-0621 treated subjects are suggestive of an anti-fibrotic effect, with decreases in biomarkers of fibrosis formation and increases in biomarkers of fibrosis resolution, including an increase in degradation of crosslinked type III collagen found in fibrotic tissue. No safety concerns have been observed by the Independent Data Monitoring Committee (IDMC) review of the first 12 subjects at two weeks and the first 24 subjects at six weeks of treatment. IDMC has recommended to continue the study as planned. “The 6-week interim analysis pulmonary function data in patients treated with GRI-0621 shows that there has been no decline in FVC over that time,” said Toby Maher, MD, PhD, Professor of Clinical Medicine, Keck School of Medicine, USC Los Angeles. “Given the short duration of treatment and small sample size, these findings are not unexpected. We look forward to seeing longer-term data, particularly given that the biomarker findings suggest a net anti-fibrotic effect of GRI-0621 in patients with Idiopathic Pulmonary Fibrosis.” “The FVC data after 6 weeks of GRI-0621 treatment support the improvements in serum biomarkers of collagen remodeling reported earlier,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “We look forward to our topline data expected later this quarter.” 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 IDMC determined that the change from baseline in PRO-C3 of GRI-0621-treated patients compared to placebo patients was suggestive of anti-fibrotic effect. The pre-planned interim analysis for 6-week safety results demonstrated GRI-0621 (4.5mg orally once daily) to be safe and well-tolerated, and that changes in biomarkers of collagen turnover were suggestive of a decrease in collagen synthesis and an increase in collagen degradation 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. 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. For more information about the Phase 2a study, please visit clinicaltrials.gov and reference identifier NCT06331624. 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 I 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 inhibitor of iNKT cell activity 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, including additional data from the Phase 2a trial of GRI-0621, 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 and estimates about its cash and available resources and its ability to fund its planned operations through any particular date, the Company’s beliefs about the timing and outcome of regulatory approvals and potential regulatory approval pathways, the Company’s expected milestones future milestones, and the Company’s beliefs and expectations regarding the sufficiency of its existing cash and cash equivalents to fund its planned operations, its ability to raise additional funds, which may not be available to the Company on acceptable terms, or at all, and capital expenditure requirements. 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: (1) the 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 size and growth potential of the markets for the Company’s products and services, and their respective ability to serve those markets, either alone or in partnership with others; (9) the failure to achieve any milestones or receive any milestone payments under any agreements; (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 March 14, 2025 and subsequently filed reports. In particular, the data discussed in this release is interim data and additional study and additional favorable results will be needed for development of GRI-0621 to continue; this interim data may not be indicative of later or final data for this trial. 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, LLCJenene Thomas(908) 824-0775GRI@jtcir.com

Bausch Health, Canada Inc. treatment for acne vulgaris, PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide gel), now available through public drug plans of Quebec and Saskatchewan (English) LAVAL, QC, August 21, 2025 – Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), a global, diversified pharmaceutical company, today announced that PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl peroxide) gel 1.2% w/w, 0.15% w/w and 3.1% w/w, for the treatment of acne vulgaris,1 is now available to beneficiaries of the public drug plans of Quebec and Saskatchewan. This new public drug plan availability of CABTREO is in addition to that announced last month for those using the Ontario and Nova Scotia public drug plans as well as through the federal government’s Non-Insured Health Benefits (NIHB) drug plan for Indigenous populations as well as those of the Correctional Service of Canada (CSC) and Veterans Affairs Canada. CABTREO is a new Canadian-made triple-combination topical prescription treatment for acne vulgaris in patients 12 years of age and older. CABTREO is the first and only triple-combination topical treatment for acne approved by Health Canada with three mechanisms of action – an antibiotic, a retinoid and an antibacterial agent – to provide a safe and effective treatment.1 “The addition of CABTREO to the Quebec and Saskatchewan public drug plans means more Canadians now have access to this innovative acne treatment – joining those already covered under most private insurance plans,” said Amy Cairns, General Manager, Bausch Health Canada. “Acne can have a significant impact on those living with it, and there is strong demand for new treatment options, increasing the importance of public drug plan coverage.” CABTREO, a prescription product, is a topical gel that is administered once daily to affected areas of the skin. Its active ingredients are the antibiotic clindamycin phosphate, the topical retinoid adapalene and the oxidizing agent benzoyl peroxide with a broad-spectrum bactericidal activity.1 About Acne Vulgaris Acne vulgaris ("vulgaris" means "common") is the most common skin problem seen by doctors in Canada. It occurs when the pores of the skin become plugged with oil and skin cells, often causing whiteheads, blackheads, pimples or cysts to appear on the face, forehead, chest, upper back and shoulders. Acne affects about 5.6 million Canadians, or nearly 20 per cent of the population, including about 90 per cent of adolescents. About 25 per cent of teens will still have acne at age 25. Acne causes emotional distress and can cause permanent scarring.2 It can also cause skin pigmentation changes.3 CABTREO Clinical Data and Safety Information CABTREO was studied in two phase 3 multicentre, randomized, placebo controlled clinical trials in 363 patients with facial acne vulgaris. Both studies met all co-primary efficacy endpoints, including absolute change from baseline in inflammatory lesion count, absolute change from baseline in non-inflammatory lesion count, and percentage of patients achieving pre-defined treatment success. Combined efficacy results for both trials for CABTREO achieved approximately 50% treatment success and a greater than 70% reduction in both inflammatory and noninflammatory lesions at Week 12.1 The most frequent adverse reactions that may occur with CABTREO are mild to moderate application site reactions, such as skin irritation characterized by scaling, dryness, erythema, and burning/stinging. CABTREO should not be used by those who are hypersensitive to any of the ingredients in it (clindamycin phosphate, adapalene, benzoyl peroxide or to any ingredient in the formulation), patients with a history of regional enteritis (Crohn’s disease), ulcerative colitis or antibiotic-associated colitis or by pregnant women and women planning a pregnancy. CABTREO may bleach hair and coloured fabric so caution should be used when applying it near the hairline.1 Health Canada has not authorized CABTREO for pediatric use under the age of 12 years. CABTREO is for topical use only and is not for oral, ophthalmic or intravaginal use.1 About Dermatology at Bausch Health, Canada Inc. Bausch Health, Canada Inc. has one of the largest prescription dermatology businesses in Canada dedicated to helping patients in the treatment of a range of therapeutic areas, including psoriasis, actinic keratosis, acne, atopic dermatitis and other dermatoses. The Bausch Health, Canada Inc. dermatology portfolio includes several leading acne, psoriasis, anti-fungal and corticosteroid-responsive dermatoses products. CABTREO is the fourth new dermatology treatment from Bausch Health, Canada Inc. approved by Health Canada and made available to Canadians over the past four years, adding to the company's leading portfolio in this important treatment area. The other approvals were for ARAZLOTM (tazarotene lotion, 0.045% w/w), for the topical treatment of acne vulgaris in patients 10 years of age and older; BRYHALI™ (halobetasol propionate lotion 0.01% w/w), for corticosteroid-responsive dermatoses and the topical treatment of plaque psoriasis in adults; and DUOBRII™ (0.01% w/w halobetasol propionate and 0.045% w/w tazarotene) to treat adults with moderate to severe plaque psoriasis.4 All four treatments – CABTREO, ARAZLO, BRYHALI and DUOBRII – are manufactured at Bausch Health's Laval, Quebec, facility for Canada and the United States. About Bausch Health Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn. The Bausch Health Canadian prescription treatment portfolio is focused on dermatology, gastrointestinal and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada: in Laval, Quebec, and Steinbach, Manitoba. More information can be found at the Company's website at www.bauschhealth.ca. Forward-looking Statements This news release may contain forward-looking statements within the meaning of applicable securities laws, including the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may generally be identified by the use of the words “will,” “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “subject to” and variations or similar expressions. These statements are neither historical facts nor assurances of future performance, are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual and quarterly reports and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. The Company undertakes no obligation to update any of these forward-looking statements to reflect events, information or circumstances after the date of this news release or to reflect actual outcomes, unless required by law. REFERENCES 1 Bausch Health, Canada Inc., CABTREO Product Monograph,https://pdf.hres.ca/dpd_pm/00076715.PDF. 2 Canadian Dermatology Association, Acne, Quick Facts,https://dermatology.ca/public-patients/skin/acne/#:~:text=Acne%20affects%205.6%20million%20Canadians,adults%20ages%2020%20to%2040, accessed Aug. 20, 2024. 3 "What to Know about Hyperpigmentation Acne." Medical News Today, Jessica Caporuscio, April 28, 2021, https://www.medicalnewstoday.com/articles/hyperpigmentation-acne, accessed Aug. 20, 2024. 4 Bausch Health, Canada Inc., Canadian Product List, https://bauschhealth.ca/products/canadian-product-list/.