Ms. Samira Sakhia reports

KNIGHT THERAPEUTICS ANNOUNCES SUPPLEMENTAL REGULATORY SUBMISSION FOR MINJUVI (TAFASITAMAB) IN BRAZIL

Knight Therapeutics Inc. has submitted a supplemental application to ANVISA, the Brazilian health regulatory agency, seeking approval for an additional indication for Minjuvi (tafasitamab) in combination with lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma or high-grade B-cell lymphoma. The supplemental application for the additional indication was selected for review under Project Orbis.

"This supplemental submission to ANVISA marks an important step in our efforts to expand Minjuvi's potential in earlier lines of therapy in Brazil," said Samira Sakhia, president and chief executive officer of Knight. "Patients with previously untreated DLBCL and HGBL continue to face significant unmet medical needs. We are encouraged by the clinical data supporting the addition of tafasitamab and look forward to working with regulators under Project Orbis to bring this potential new first-line treatment option to patients as quickly as possible."

In September, 2021, Knight entered into an exclusive supply and distribution agreement with Incyte for the exclusive rights to distribute tafasitamab (commercialized as Monjuvi in the United States and Minjuvi ex-U.S.). Knight has launched Minjuvi in Brazil, Mexico and Argentina for use in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL, who are not eligible for autologous stem cell transplantation. In March, 2026, Knight announced the approval and launch of Minjuvi in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma in Brazil.1 Also in March, 2026, Knight submitted Minjuvi for the same indication in Argentina and Mexico.

This supplemental submission to ANVISA builds on those approvals, seeking a first-line indication for Minjuvi based on results from the phase 3 frontMIND trial.

About Knight Therapeutics Inc.

Knight Therapeutics, headquartered in Montreal, Canada, is a pharmaceutical company focused on acquiring, 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.

We seek Safe Harbor.