Ms. Samira Sakhia reports

KNIGHT THERAPEUTICS ANNOUNCES REGULATORY SUBMISSION OF NIKTIMVO (AXATILIMAB) IN BRAZIL

Knight Therapeutics Inc.'s Brazilian affiliate, United Medical Ltda., has submitted a marketing authorization application to ANVISA, the Brazilian health regulatory agency, for Niktimvo (axatilimab) for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients six years and older.

On Aug. 4, 2025, Knight announced that it expanded its existing relationship and amended its agreement with Incyte for the exclusive rights to distribute retifanlimab (commercialized as ZYNYZ (retifanlimab) in the United States and Europe) and axatilimab (commercialized as Niktimvo (axatilimab-csfr) in the United States) in Latin America. Under the terms of the amended agreement, Incyte will be responsible for the development, manufacture and supply to Knight of retifanlimab and axatilimab, and Knight will be responsible for seeking the necessary regulatory approvals and distributing both medicines in Latin America. Knight and Incyte had entered into an exclusive supply and distribution agreement for tafasitamab (commercialized as Monjuvi (tafasitamab-cxix) in the United States) and pemigatinib (commercialized as Pemazyre in the United States) in Latin America in September, 2021.

Niktimvo received approval from the U.S. Food and Drug Administration in August, 2024, for the treatment of chronic GVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kilograms.

"For patients living with chronic graft-versus-host disease, every new treatment option can mean hope for a better quality of life", said Samira Sakhia, president and chief executive officer, Knight Therapeutics. "The submission of axatilimab in Brazil brings us closer to making that hope a reality. At Knight, our mission goes beyond expanding our portfolio. We are committed to ensuring that patients and their families have access to therapies that truly make a difference. This milestone reflects the strength of our partnership with Incyte and our shared dedication to improving lives across Latin America."

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 the Toronto Stock Exchange under the symbol GUD.

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