Ms. Samira Sakhia reports

KNIGHT THERAPEUTICS ANNOUNCES HEALTH CANADA APPROVAL FOR WYNZORAtrademark TO TREAT PSORIASIS VULGARIS

Health Canada has approved Knight Therapeutics Inc.'s Wynzora, a white uniform cream containing 0.05 milligram/gram of calcipotriol (CAL) and 0.5 mg/g of betamethasone dipropionate (BDP), indicated for the topical treatment of psoriasis vulgaris in adults and adolescents aged 12 to 17 years for up to eight weeks.

Knight obtained the Canadian rights to Wynzora through its June, 2025, acquisition of the assets of Paladin Pharma Inc. In November, 2024, Paladin had entered into a licence agreement with MC2 Therapeutics (MC2) to commercialize Wynzora in Canada. MC2 is a private pharmaceutical company based in Horsholm, Denmark, and in Guildford, United Kingdom.

"By uniting two proven mechanisms in a once-daily cream, Wynzora addresses the twin challenges of adherence and symptom control. Health Canada's approval expands the treatment landscape with an evidence-based, practical therapy that can improve quality of life without adding monitoring burden," said Dr. Charles Lynde, MD, dermatologist at The Lynde Institute for Dermatology in Markham, Ont.

"We are proud to introduce Wynzora to patients in Canada, offering an innovative treatment option for psoriasis vulgaris that combines efficacy with convenience. This launch underscores our commitment to improving quality of life for Canadian patients, while continuing our broader mission to bring innovative therapies to all markets we serve," said Samira Sakhia, president and chief executive officer, Knight Therapeutics.

About Wynzora

Wynzora is a cream-based fixed dose combination of CAL and BDP for topical treatment of psoriasis vulgaris developed by MC2. Wynzora has a broad mode of action by targeting keratinocyte proliferation and differentiation and inhibiting expression of pro-inflammatory hallmark cytokines such as IL-23, IL-17A/F and TNF-alpha. In Wynzora, the combination of CAL and BDP has greater anti-inflammatory and anti-proliferative effects than either component alone. Wynzora is uniquely enabled by MC2's formulation and drug delivery system PAD Technology, allowing an effective convenient-to-use aqueous formulation. MC2 obtained approval of Wynzora in the United States by the Food and Drug Administration on July 20, 2020, and Wynzora was approved in the first country in Europe on July 9, 2021.

The Health Canada approval is based on the results of two randomized, investigator-blind, vehicle-controlled eight-week trials (MC2-01-C2 and MC2-01-C7) in adults. CAL/BDP gel/suspension was included as an active comparator, and the trials were designed to show superiority to vehicle and non-inferiority of Wynzora to CAL/BDP (50 mcg/g CAL and 0.5 mL/g BDP) gel/suspension.

The primary efficacy end point in trial MC2-01-C2 was the proportion of subjects in each treatment group with treatment success at week 8, defined as a minimum two-point decrease from baseline to week eight on the Physician Global Assessment (PGA) scale of disease severity on the trunk and limbs. This was the secondary end point trial MC2-01-C7. The primary efficacy end point in trial MC2-01-C7 was the percentage change in modified Psoriasis Area and Severity Index (mPASI) on the body (trunk and/or limbs) from baseline to week 8. This was the secondary end point for trial MC2-01-C2.1

Results from both primary and secondary efficacy end points in both MC2-01-C2 and MC2-01-C7 demonstrated that Wynzora had superior efficacy compared with vehicle (p less than 0.0001) for all confirmatory efficacy end points in treating psoriasis on the body (trunk and/or limbs). Wynzora demonstrated a statistically significant, greater PGA treatment success and mean percentage change from baseline in mPASI at week 8 compared with the vehicle. In addition, Wynzora was non-inferior to CAL/BDP gel/suspension at week 8 for PGA treatment success. The most frequently reported adverse reactions were "application site reactions" including application site irritation, pain, pruritus, eczema, exfoliation, telangiectasia and folliculitis. All reported adverse reactions were seen at a frequency below 1 per cent.

About psoriasis

Psoriasis is a chronic, immune-mediated inflammatory disease of the skin. It is often characterized by sharply demarcated, scaly dull-red plaques, particularly on the extensor parts of limbs and on the scalp. An estimated one million Canadians and 125 million people worldwide, are affected by psoriasis. Chronic plaque psoriasis (psoriasis vulgaris) is the most common type and accounts for 80 per cent to 90 per cent of cases. The severity of disease may vary among patients, ranging from mild to moderate to severe. The clinical course of psoriasis is unpredictable, with fluctuating severity overtime.

Common symptoms of psoriasis include itching, redness, flaking and scaling. Itch is considered one of the most bothersome symptoms, with patients reporting itch reduction the most important treatment goal. Yet, the disease burden of psoriasis extends far beyond the physical dermatological symptoms. Psoriasis is considered a systemic inflammatory disorder, similar to rheumatoid arthritis, Crohn's disease and systemic lupus erythematosus.

About Knight Therapeutics Inc.

Knight Therapeutics, headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight's Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics' shares trade on Toronto Stock Exchange under the symbol GUD.

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