Mr. Ken d'Entremont reports

FDA ACCEPTS FOR REVIEW TREOSULFAN NDA RESUBMISSION

Medexus Pharmaceuticals Inc. was informed by medac, licensor of Medexus's commercialization rights to treosulfan, that the U.S. Food and Drug Administration has accepted for review medac's April, 2024, resubmission of the new drug application for treosulfan. Medexus expects that the FDA will complete its review of the treosulfan NDA and issue a decision by Oct. 30, 2024. The treosulfan NDA seeks approval of treosulfan in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients. medac's resubmission provided additional information that had previously been requested by the FDA relating to the pivotal phase 3 clinical trial of treosulfan conducted by medac.

"We are pleased to report this positive new development in the regulatory review process," commented Ken d'Entremont, Medexus's chief executive officer. "We were encouraged to see the FDA engage with medac. We remain optimistic about the prospect of a treosulfan approval in the United States, and about treosulfan's potential in the U.S. market, because we continue to believe that treosulfan would prove to be the gold standard in this therapeutic space, as it has in Europe and Canada. If approved by the FDA, we expect that treosulfan would have a meaningful impact on Medexus's total revenue."

Medexus successfully launched treosulfan in Canada under the brand name Trecondyv in September, 2021, and since launch has gained valuable experience commercializing the product in that market. This success in Canada supports Medexus's optimism regarding treosulfan's potential positive impact in the U.S. market if and when approved.

Under the terms of a September, 2023, amendment to Medexus's February, 2021, exclusive licence agreement relating to commercialization of treosulfan in the United States, Medexus and medac now have a specified negotiation period to agree to a further amendment with respect to any adjustments to the value of unpaid regulatory and sales-based milestone payments that the parties may agree are appropriate in the prevailing circumstances. Medexus will have no obligation to make any milestone payments before the effective date of any such further amendment to the U.S. treosulfan agreement.

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.