MONTREAL, December 19, 2025 – ExCellThera Inc. (ExCellThera), a world leader in blood stem cell expansion and metabolic fitness, and its wholly owned subsidiary Cordex Biologics, announced the publication in the journal Transplantation and Cell Therapy of results from a retrospective effectiveness analysis comparing outcomes of adult patients with blood cancers who received Zemcelpro® (UM171 Cell Therapy) with those treated with conventional allogeneic hematopoietic stem cell transplants.  In this real-world analysis using matched-controlled data from the European Society for Blood and Marrow Transplantation (EBMT), Zemcelpro® demonstrated improved outcomes compared with several conventional donor source transplants. The publication is available at: Comparison of Outcomes after UM171-Expanded Cord Blood and Six Conventional Donor Source Transplants: A Matched Analysis from the EBMT Registry.

“This matched-controlled real-world analysis provides clinically relevant context on short and long-term clinical outcomes with Zemcelpro® in patients suffering from life-threatening blood cancers who need a suitable source of stem cells for a potentially curative allogeneic hematopoietic stem cell transplant. More specifically, we observed significant improvement in graft-versus-host disease and relapse-free survival, or GRFS, over conventional graft sources like haploidentical transplants,” said Guy Sauvageau, MD, PhD, Founder and Chief Scientific Officer. “These results are consistent with those previously reported in another analysis of similar design conducted using control cohorts from the CIBMTR.”

“This is another important achievement for the company’s most advanced therapy soon to be commercialized,” said Pierre Caudrelier, MD, Chief Medical Officer. “With a GRFS at 2-years hazard ratio of 0.37 to 0.45 in favour of Zemcelpro® compared with standard-of-care allografts, the product has the potential to deliver clinically meaningful long-term benefits over commonly used graft sources.”

Conditional marketing authorization has recently been granted by the European Commission to Zemcelpro® for the treatment of adults with haematological malignancies requiring an allogeneic haematopoietic stem cell transplantation following myeloablative conditioning for whom no other type of suitable donor cells is available.

The timing of Zemcelpro® availability in individual countries will depend on several factors, including the completion of national reimbursement procedures. In the meantime, Cordex Biologics is working closely with national health authorities to enable early access for eligible patients ahead of the reimbursement process, and is engaging with leading stem cell transplantation centers to establish a network of treatment centers for the future administration of Zemcelpro®. Cordex Biologics is also actively seeking strategic partnerships to support and accelerate the commercialization of Zemcelpro® in Europe and other international markets.

About the study

Overall, 22 Phase 1/2 adult patients receiving Zemcelpro® were pair-matched to 308 patients from six separate control cohorts identified in the EBMT observational database, using exact matching and propensity score criteria. Primary endpoints assessed included neutrophil recovery, platelet recovery, non-relapse mortality, progression-free survival, overall survival, and GRFS, a composite of graft versus host disease (GVHD)-free and relapse-free survival. Secondary endpoints included incidence of relapse/progression of disease, acute and chronic GVHD.

Neutrophil engraftment was significantly faster among patients treated with Zemcelpro® (median of 18 days) compared to non-manipulated cord blood (CB) recipients (22 days) and 10/10 matched unrelated donor (MUD) – bone marrow (BM) recipients (23 days). GRFS was significantly higher at 2 years in UM171 Cell Therapy recipients compared to 10/10 MUD – peripheral blood controls, 9/10 MMUD controls, haploidentical and matched sibling donor (MSD) controls, and appeared higher compared to CB and 10/10 MUD – bone marrow controls without reaching statistical significance. Please refer to the publication for the complete study results.

About Zemcelpro®

Zemcelpro®, also known as UM171 Cell Therapy, is a novel personalized cryopreserved haematopoietic stem cell transplantation product containing two components, namely UM171-expanded CD34+ cells (dorocubicel) and unexpanded CD34- cells, each derived from the same cord blood unit.

Zemcelpro®, developed by Cordex Biologics, a wholly owned subsidiary of ExCellThera, has been evaluated in 120 patients with haematologic malignancies in clinical trials in the United States, Europe and Canada. Zemcelpro® has received orphan drug designation and regenerative medicine advanced therapy (RMAT) designations from the FDA as well as orphan medicinal product designation, advanced therapy medicinal product (ATMP) classification and priority medicines (PRIME) designation from the EMA.

Zemcelpro® has been tested in Phase 2 trials in patients with high and very high-risk acute leukemias and myelodysplasias who have limited treatment options with low survival outcomes and high incidence of relapse under the current standard of care, including patients with patients with TP53 mutations or other genetic abnormalities, patients requiring a second transplant, and patients with refractory or active disease. A pivotal Phase 3 trial in this patient population will be initiated as soon as possible.

The use of Zemcelpro® in other patient populations, including pediatric patients and patients with non-malignant haematological diseases, is also being investigated.

For complete product information, including Warnings and Precautions for Use and Adverse Reactions (and their appropriate management), please refer to the EU Summary of Product Characteristics (SmPC) for Zemcelpro®.

The product safety and efficacy have not yet been established by other regulatory agencies, such as the U.S. FDA, the MHRA and Health Canada.

About ExCellThera and UM171 Technology

ExCellThera is a world leader in enhanced blood stem cell therapies. ExCellThera’s proprietary Enhance™ platform for cell expansion and metabolic fitness is designed to deliver a greater dose of functional therapeutic stem cells by expanding haematopoietic stem cells (HSCs) from any source and counteracting the effects of culture or gene editing induced stress. ExCellThera partners with biopharmas to help them develop best-in-class cell and gene therapies by leveraging the technologies that form the Enhance™ platform, including the proprietary molecule UM171 which has a first-in-class mechanism of action for ex vivo expansion and metabolic fitness of HSCs. For additional information, visit excellthera.com, and follow us on LinkedIn.

Zemcelpro® is a registered trademark of ExCellThera or its related companies.