Mr. Ken d'Entremont reports

MEDEXUS AND ONTARIO'S PROVINCIAL HEALTH SERVICES SUCCESSFULLY COMPLETE AGREEMENTS FOR PUBLIC REIMBURSEMENT OF TRECONDYV (TREOSULFAN FOR INJECTION) IN ONTARIO, CANADA

Medexus Pharmaceuticals Inc. recently completed listing agreements with Ontario's Ministry of Health (Ontario public drug programs) and Ontario Health (Cancer Care Ontario) for Trecondyv (treosulfan for injection). The Ontario public drug programs will now reimburse eligible claims made for Trecondyv, subject to satisfaction of any relevant conditions set out in the agreements.

"This important development is another reimbursement milestone following the successful completion of the pCPA negotiation process for Trecondyv," said Richard Labelle, Medexus's chief operating officer. "It further demonstrates our commitment to seeking and quickly achieving public reimbursement of Trecondyv across Canada, and is yet another important indicator of the prospects and potential of our treosulfan products -- both Trecondyv in the Canadian market and, in the U.S. market, Grafapex (treosulfan) for injection, which was recently approved by the FDA."

The next step in the Trecondyv public reimbursement process will be for other remaining government organizations to make their respective final decisions on public reimbursement for their regions or jurisdictions. Medexus is committed to continuing to work with these other participating provincial, territorial and federal government organizations to make Trecondyv available as soon as possible through public drug plans for the patients who need it.

About Trecondyv (treosulfan for injection)

Treosulfan is part of a preparative regimen for allogeneic hematopoietic stem cell transplantation, to be used in combination with fludarabine, used in treating eligible patients with acute myeloid leukemia and myelodysplastic syndromes.

Final study results and analysis of the pivotal phase 3 clinical trial of treosulfan conducted by medac GmbH, which was published in the American Journal of Hematology, concluded that the study demonstrates clinically relevant superiority of treosulfan over a widely applied "reduced-intensity conditioning" busulfan regimen with regard to its primary end point, event-free survival. The publication also includes favourable conclusions on two key secondary end points, finding that overall survival with treosulfan was superior compared to busulfan and that non-relapse mortality for patients in the treosulfan arm was lower than for patients in the busulfan arm. For more information about the study and the publication, including a link to the full publication, see Medexus's June 6, 2022, press release, available via the Investors section of Medexus's corporate website.

During the phase 3 clinical trial of treosulfan, treatment emergent adverse events (TEAEs) were most commonly reported in the system organ classes, or SOCs, of "gastrointestinal disorders," "general disorders and administration site conditions," and "musculoskeletal and connective tissue disorders". TEAEs of at least CTCAE Grade III were reported by 54.8 per cent of patients in the treosulfan treatment group. Severe adverse events were reported by 8.5 per cent of patients in the treosulfan treatment group. Overall, TEAEs were reported by 92.6 per cent of patients in the treosulfan treatment group.

Trecondyv (treosulfan for injection) is approved by Health Canada for sale and use in Canada only and is not intended for export outside Canada.

About Grafapex (treosulfan) for injection

On Jan. 22, 2025, Medexus was informed that the U.S. Food and Drug Administration approved Grafapex (treosulfan) for injection, an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients one year of age and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Grafapex is approved by the FDA for sale and use in the United States only and is not intended for export outside the United States. Medexus makes no representation that Grafapex is appropriate for, or authorized for sale to or use by, persons who are not located in the United States.

About Medexus Pharmaceuticals Inc.

Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions. Medexus's current focus is on the therapeutic areas of oncology, hematology, rheumatology, auto-immune diseases, allergy and dermatology.

We seek Safe Harbor.