• Partnership will support Resolution’s pivotal clinical program in 2027, as well as future commercial preparedness for RTX001, its lead asset in patients with end-stage liver disease (ESLD)
• Primary goal is to ensure patients can access treatment in the community setting, where the majorityof decompensated patients are managed
• RTX001 has the potential to be the first treatment that demonstrates a clear and durable improvement in transplant free survival for ESLD patients

Resolution Therapeutics Limited (“Resolution” or “Company”), a clinical-stage biopharmaceutical company pioneering Regenerative Macrophage Therapy (RMT) in inflammatory and fibrotic diseases, today announced apartnership with the Blood Centers of America, Inc. (BCA) to ensure broad patient access to its pivotal clinical program for RTX001, its lead asset in end-stage liver disease (decompensated cirrhosis), in the U.S.

Today, liver transplantation is the only disease-modifying treatment option for ESLD patients. However, transplants are severely limited by lack of access to a transplant center, donor availability, and the complexity and cost of surgery, leaving many U.S. patients with no alternative beyond symptom management. These patients often experience debilitating symptoms that make it difficult for them to travel long distances, somost decompensated patients are managed in the community setting.

Regenerative Macrophage Therapy is a distinct class of cell therapy that rewires the microenvironment to become permissive to regeneration. Resolution Therapeutics has entered a strategic partnership with BCA to ensure patients can receive care in the community setting. BCA will serve as one of Resolution’s preferred providers of cell collection and processing services for pivotal study sites that require such support. BCA is a network of members centers that provide geographic reach across the United States.

BCA and its member blood centers are known for their expertise in managing blood collection and processing for (autologous) cell therapy trials, including regulatory credentials and operational expertise to provide wrap-around services.

Amir Hefni, Chief Executive Officer of Resolution Therapeutics, said: “RTX001 is intentionally designed and manufactured to address the historical limitations impacting cell therapy adoption ina community-based setting. Our partnership with the Blood Centers of America, Inc. willensure patients can receive treatment with the doctor they trust, close to home.”

Bill Block, Chief Executive Officer of Blood Centers of America, Inc. said: “BCA is a cooperative of independent organizations which, in aggregate, are the largest collector and provider of blood-derived components for transfusion or further manufacture of therapeutic products in the United States. BCA is proud to partner with both healthcare organizations and biopharmaceutical companies, leveraging its national footprint to improve patient care. 

Our partnership with Resolution Therapeutics will rely on the national patient apheresis footprint of our members, as well as their product handling and storage capabilities, to support participating healthcare organizations to treat end-stage liver disease with their highly innovative cell therapy in regions where such care might not otherwise be available.”

RTX001, an experimental treatment, is a repeat-dose regimen administered via a peripheral IV, and requires no pre-conditioning or bridging therapy, and no lymphodepletion. This differentiates RTX001 from other cell therapy modalities, which are challenging to administer in a community setting due to inherent complexities. To date, early phase clinical studies of RTX001 have shown no significant safety signals, and no need for prolonged monitoring.

Resolution plans to initiate a pivotal study for RTX001 in patients with end-stage liver disease across the U.S. in 2027, following a pre-IND meeting between Resolution and the FDA. Subsequently, the Company will finalize the pivotal study design and specific clinical trial site selection.

Beyond RTX001, Resolution is also developing RMTs in additional inflammatory and fibrotic indications, including lung fibrosis, and is actively accelerating the development of its in vivo Regenerative Macrophage Therapy. These programs are in preclinical evaluation.