Ms. Samira Sakhia reports

KNIGHT THERAPEUTICS ANNOUNCES REGULATORY SUPPLEMENTAL SUBMISSION OF MINJUVI (TAFASITAMAB) FOR FOLLICULAR LYMPHOMA IN ARGENTINA AND MEXICO

Knight Therapeutics Inc.'s Argentine affiliate, Laboratorio LKM S.A. and its Mexican affiliate, Grupo Biotoscana de Especialidad S.A. de C.V., have submitted a supplemental application to Anmat, the Argentinian health regulatory agency and Cofepris, the Mexican health regulatory agency, seeking approval for an additional indication for Minjuvi (tafasitamab), in combination with lenalidomide and rituximab, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one prior line of systemic therapy. Knight entered into an exclusive supply and distribution agreement with Incyte (Nasdaq: INCY) in September, 2021, for tafasitamab (commercialized as Monjuvi (tafasitamab-cxix) in the United States and Minjuvi ex-U.S.) across Latin America. 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 diffuse large B-cell lymphoma (DLBCL), who are not eligible for autologous stem cell transplantation (ASCT). 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 FL in Brazil.

"In past two years we have launched Minjuvi for the treatment of diffuse large B-cell lymphoma in Brazil, Mexico and Argentina. More recently, Minjuvi received regulatory approval for the treatment of refractory follicular lymphoma in Brazil," said Samira Sakhia president and chief executive officer of Knight Therapeutics. "We continue to advance our pipeline with the submissions for Minjuvi in both Argentina and Mexico. More importantly, Minjuvi is more than a single product. With approvals across distinct indications, it effectively represents multiple therapies within one brand, expanding the ways physicians can use Minjuvi to address different patient needs. I am proud of the progress we have made with Minjuvi and look forward to continuing our mission to bring high-quality pharmaceuticals that improve patients' health in our markets."

About Minjuvi (tafasitamab)

Minjuvi (tafasitamab) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., Monjuvi is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL).

Monjuvi is not approved and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

Additionally, Monjuvi received accelerated approval in the United States and Canada in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma and who are not eligible for autologous stem cell transplant (ASCT).

In Europe, Minjuvi (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. Additionally, Minjuvi is approved in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy in Europe.

About follicular lymphoma (FL)

FL is the most common subtype of indolent non-hodgkin lymphoma (NHL). FL typically presents with generalized painless lymphadenopathy that waxes and wanes. It commonly affects the axillary, cervical, femoral and inguinal lymph nodes. Rarely, it may appear as an asymptomatic large mediastinal mass. Roughly 20 per cent of FL patients experience B symptoms such as night sweats, fever and weight loss.

About inMIND study

The inMIND study (INCMOR 0208-301) was a phase 3, randomized, double-blind, placebo-controlled, multicentre study in participants with relapsed/refractory FL or relapsed/refractory marginal zone lymphoma (MZL) who had been previously treated with at least one prior line of systemic therapy, including an anti-CD20 antibody. Patients were randomized to receive either tafasitamab + R2 (n = 273) versus placebo + R2 (n = 275). The estimated median progression free survival (PFS; primary end point) was 22.37 months (95 per cent CI: 19.22, NE) in the tafasitamab + R2 group compared with 13.93 months (95 per cent CI: 11.53, 16.39) in the placebo + R2 group, with a HR of 0.434 (95 per cent CI: 0.324, 0.580) and a p less than 0.0001. Over all, adding tafasitamab to lenalidomide plus rituximab led to a statistically significant, clinically meaningful improvement in PFS, corresponding to a 57-per-cent lower risk of progression, relapse or death in patients with relapsed/refractory follicular lymphoma.

About Knight Therapeutics Inc.

Knight Therapeutics Inc., headquartered in Montreal, 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.

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