The primary focus of the current tests has been on verifying that the iPS cells have undergone the differentiation towards the target cell and quality in a quantifiable manner. These include quantifying specific markers through qPCR and analyzing cell number and cell viability. This work will form the basis of Quality Assurance (QA) and Control (QC) methods needed for the next phase of the development, pilot production. The work to finalize the results is ongoing alongside our collaborating researchers and histology partner.

A further stage of testing is planned to be carried out over Q3 to StemCART with the aim to optimize healing capacity. These tests are an important part of the development and validation of the StemCART product. The testing project has several aims to achieve this, including evaluation of the matrix, cell quality, and healing action of the product.

About the ex-vivo testing

Beginning in January 2022, Cline has received cartilage tissue from patients undergoing orthopedic prosthetic surgery with the help of our clinical collaborators. The team then induces artificial cartilage damage to mimic joint injuries and then implants the cells and matrix together at the injury site of the tissue sample. The aim is to show that Cline's unique method successfully differentiates iPSCs into functional chondrocyte cells, that the matrix successfully supports the cells in place, and that healing of injured cartilage tissue is induced.

Next steps for StemCART

StemCART is a preclinical Advanced Therapy Medical Product (ATMP) that aims to enable treatment of cartilage damage for patients worldwide. To achieve this, Cline will continue preparing for in-human clinical trials, including scaling up production into a GMP facility, developing QA/QC methods, and the necessary safety testing and documentation for a clinical trial application. Cline envisions out-licensing StemCART to a commercial partner following successful phase I trials.

For more information, please contact:

Hanne Evenbratt, VP - Research & Development

Email: hanne.evenbratt@clinescientific.com

Phone: +46 704 88 79 23

About Cline Scientific

Cline Scientific develops advanced cancer diagnostics and regenerative medicine treatments. The company is working heavily with R&D through joint collaborations with pharmaceutical companies and academic researchers around the world. The focus is on projects in the cancer diagnostic and stem cell therapy fields since Clines nanotechnology here provides unmet solutions to critical challenges and functions. The unique patented surface nanotechnology is used in cell-based products and processes to drive projects within Life Science into and through the clinical phase.

Cline Scientific AB (publ)Phone: 031-387 55 55

Argongatan 2CEmail: info@clinescientific.com

431 53 MÖLNDAL Website: www.clinescientific.com