Mr. Ken d'Entremont reports

MEDEXUS AND PAN-CANADIAN PHARMACEUTICAL ALLIANCE (PCPA) SUCCESSFULLY COMPLETE NEGOTIATIONS FOR TRECONDYV (TREOSULFAN FOR INJECTION) IN CANADA

Earlier in November, 2024, Medexus Pharmaceuticals has successfully completed a negotiation process with the pan-Canadian Pharmaceutical Alliance (pCPA) seeking to make Trecondyv (treosulfan for injection) accessible to publicly funded drug programs and patients in Canada. The pCPA is an independent organization whose membership includes the provincial, territorial and federal governments.

Reaching this important milestone on Nov. 4, 2024, was the result of a collaborative negotiation process with pCPA and followed a publication of final recommendations on reimbursement from Quebec's L'Institut National d'Excellence en Sante et en Services Sociaux on March 6, 2024, and from Canada's Drug Agency (formerly CADTH) on March 18, 2024, based on Medexus's July, 2023, submissions to those agencies.

"We are very encouraged by this additional vote of confidence in treosulfan," said Richard Labelle, Medexus's chief operating officer. "Approximately three-quarters of transplant centres across Canada are already using treosulfan, which is consistent with the strong year-over-year unit demand growth we saw as of Sept. 30, 2024. This latest development emphasizes the need to move quickly through the subsequent steps to public reimbursement of Trecondyv and is yet another important indicator of this product's prospects and potential, both in the Canadian market and, if and when approved by the FDA [U.S. Food and Drug Administration], the U.S. market as well."

The next step in the public reimbursement process will be for participating government organizations to make their respective final decisions on public reimbursement for their regions. Medexus is committed to continuing to work with 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.

"Clinicians should always make the best choice possible for their patients, so we are very pleased with this new development as it will hopefully result in greater physician access to this treatment option across Canada," added Dr. Ivan Pasic from Toronto's Princess Margaret Hospital.

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 with 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 through 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 (SOCs) of gastrointestinal disorders, general disorders and administration site conditions, and musculoskeletal and connective tissue disorders. TEAEs of at least CTCAE (Common Terminology Criteria for Adverse Events) 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. Over all, TEAEs were reported by 92.6 per cent of patients in the treosulfan treatment group.

Treosulfan is approved by Health Canada for sale and use in Canada only and is not intended for export outside Canada. Medexus makes no representation that treosulfan is appropriate for or authorized for sale to or use by persons who are not located in Canada. Treosulfan is currently the subject of a regulatory review process with the U.S. FDA. Medexus holds exclusive commercialization rights to treosulfan in Canada and 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.

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