Mr. Ken d'Entremont reports

GRAFAPEX (TREOSULFAN) FOR INJECTION RECEIVES CMS APPROVAL OF NEW TECHNOLOGY ADD-ON PAYMENT (NTAP) FOR ELIGIBLE CASES IN CMS'S FISCAL YEAR 2026

The U.S. Centers for Medicare & Medicaid Services has approved new technology add-on payment reimbursement for eligible cases involving the use of Medexus Pharmaceuticals Inc.'s Grafapex (treosulfan) for injection for CMS's fiscal year 2026, which runs from Oct. 1, 2025, to Sept. 30, 2026.

The NTAP program is designed to provide temporary supplemental reimbursement to institutions that use designated new higher-cost medical technologies in the first few years after introduction to the market. To receive NTAP approval, designated technologies must demonstrate substantial clinical improvement in the diagnosis or treatment of Medicare beneficiaries compared with existing alternatives.

Starting Oct. 1, 2025, eligible procedures involving the use of Grafapex will be eligible for additional reimbursement through the NTAP program. Cases involving the use of Grafapex that are eligible for NTAP will be identified by ICD-10-PCS codes XW03388 or XW04388, and will benefit from a maximum NTAP of $21,411 for CMS's fiscal year 2026. The Grafapex approval was one of only five for CMS's fiscal year 2026 under the new technology add-on payment traditional pathway, out of the 13 applications considered by CMS.

"This development is an important reimbursement milestone for Grafapex," said Virginie Bernier PhD, vice-president, hemato-oncology, at Medexus. "We appreciate CMS's support of Grafapex, first through its approval of transitional pass-through status under Medicare's hospital outpatient prospective payment system and assignment of a permanent HCPCS Level 2 coding system, J code, for reporting and billing, and now with inclusion in the NTAP program. Together, these actions will help ensure Medicare beneficiaries can more consistently receive Grafapex in both inpatient and outpatient settings."

Medexus continues to see a positive response to Grafapex since the U.S. commercial launch of the product in February, 2025. As of June 30, 2025, nine large commercial payers, together covering an estimated 48 million patient lives, and 14 individual health care institutions, representing 8 per cent of the 180 transplant centres in the United States, have made positive formulary inclusion determinations, a promising indicator of the product's commercial potential, with progress to date consistent with company expectations. An additional 29 commercial payers have added Grafapex on their prior authorization lists. Wholesaler data as of June 30, 2025, show that 37 of the 180 transplant centres have already ordered Grafapex for procedures in their institutions, which is likewise consistent with company expectations regarding initial institutional uptake and patient-level demand for the product.

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 hematology and hematology-oncology, and allergy, dermatology and rheumatology.

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