Ms. Samira Sakhia reports

KNIGHT THERAPEUTICS ENTERS INTO EXCLUSIVE LICENSE AGREEMENT WITH SUPERNUS PHARMACEUTICALS FOR QELBREE(TM) (VILOXAZINE) IN CANADA

Knight Therapeutics Inc. has entered into an exclusive licence agreement with Supernus Pharmaceuticals Inc., a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, granting Knight the rights to seek regulatory approval and commercialize Qelbree in Canada. Qelbree is an extended-release formulation of viloxazine, a multimodal serotonergic and norepinephrine modulating agent (SNMA), a non-stimulant medication for the treatment of attention-deficit hyperactivity disorder (ADHD). Financial terms of the agreement were not disclosed.

Qelbree (viloxazine extended-release capsules) is commercially available in the United States as a prescription medicine to treat ADHD in patients six years of age and older. Based on the results of four pivotal trials, Qelbree was approved by the U.S. Food and Drug Administration in 2021 for the treatment of children six to 17 years of age and in 2022 for the treatment of adults. Qelbree is also currently being studied in several phase 4 clinical trials, the first of which is in combination with psychostimulants for the treatment of children and adolescents with ADHD (positive top-line results reported in September, 2023). A second phase 4 clinical trial in preschool-age children with ADHD is planned to commence in January, 2024. A third phase 4 clinical trial is studying the impact of Qelbree on co-morbid mood symptoms prevalent in patients with ADHD.

"This partnership represents the continued execution of our strategy of expanding our presence in CNS and entering in one of the most important segments still presenting relevant unmet medical needs," said Samira Sakhia, president and chief executive officer of Knight. "We are excited to pursue regulatory approval and bring a novel non-stimulant medication to enhance treatment of patients living with ADHD."

"Supernus was able to identify in Knight the right commercial experience and capabilities to get Qelbree approved and successfully launch it in Canada," said Jack Khattar, president and CEO of Supernus Pharmaceuticals. "Supernus is proud to support other regions and patients in need of innovative solutions to overcome the challenges of treating a complex disease such as ADHD."

About ADHD

ADHD is a neurodevelopmental disorder that affects both children and adults. The estimated prevalence of ADHD is 5 to 9 per cent in children and 3 to 5 per cent in adults. The disorder is characterized by symptoms of inattention, hyperactivity and impulsivity that can significantly impact an individual's ability to function in daily life. Although patients' symptoms of ADHD can change over time, they will generally require continued monitoring and treatment over their lifetime. Current pharmacotherapies for ADHD include amphetamine- or methylphenidate-based psychostimulants as well as long-acting non-psychostimulant options. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ADHD.

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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