The first children have been treated in the younger age group of the ProTrans-Young study

October 1, 2024

NextCell Pharma AB ("NextCell" or the "Company", Nasdaq First North Growth Market: NXTCL), announces that the first four children in the 7–11 year age group have been treated in the latest phase of the ProTrans-Young study. An additional four children have been screened and are expected to begin their treatment shortly. These advancements mark an important milestone in the progress of the study, which is proceeding faster than anticipated.

“There is a high level of interest in the study, and many are signing up from all over the country,” comments Karin Kjellström, research nurse at Uppsala University Hospital. The study aims to evaluate the efficacy and safety of ProTrans, a treatment developed to protect insulin-producing cells, which in this study is being administered for the first time to children and adolescents with newly diagnosed type 1 diabetes.

The ProTrans-Young study is a double-blind, randomized, and placebo-controlled trial divided into two phases. In the first phase (Phase Ib), all patients, including those aged 7–18 years, were treated to ensure the safety of the treatment. The second phase (Phase IIb) includes a total of 60 children and adolescents, with 30 treated with ProTrans and 30 with placebo. The treatment of the first 30 patients aged 12–21 years has already been completed, and the safety data has been thoroughly reviewed and approved by the study’s safety committee.

The purpose of the ProTrans treatment is to halt the autoimmune destruction of insulin-producing cells in children and adolescents, slowing the disease progression and reduce the risk of serious complications associated with type 1 diabetes. The study aims to demonstrate that the treatment can preserve a greater portion of the body’s own insulin production, which would result in improved blood sugar regulation, reduced associated illnesses and thereby a better quality of life for the young patients.

For more information about the study and participation, please visit: NextCell Pharma - Study Information.

Professor Per-Ola Carlsson is the principal investigator for ProTrans-Young and the study is sponsored by Uppsala University. NextCell continues to contribute ProTrans, placebo, as well as support for logistics, documentation, and expert competence. The cells used for the production of ProTrans are of the same type as the cells that the subsidiary Cellaviva collects for family stem cell banking.

For more information about NextCell Pharma, please contact
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: +46 8 735 55 95
E-mail: info@nextcellpharma.com
Website:www.nextcellpharma.com

Linkedin: https://www.linkedin.com/NextCell-Pharma
Twitter: https://twitter.com/NextCellPharma

For more information about Cellaviva, please contact
Sofie Falk Jansson, CEO Cellaviva AB
Tel: +46 8 735 20 10
E-mail: info@cellaviva.se
Website:www.cellaviva.se

Facebook: https://www.facebook.com/cellavivasverige
Instagram: https://www,instagram.com/cellaviva

Certified Adviser
FNCA Sweden AB is assigned as Certified Adviser.

About NextCell Pharma AB

NextCell is a cell therapy company in Phase II trials with the drug candidate ProTrans for the treatment of type 1 diabetes. The focus is to obtain market approval of ProTrans via a phase III trial. In addition to type 1 diabetes, ProTrans is used in two clinical trials for, in Örebro and in Montreal, Canada. Furthermore, NextCell owns 8.5% in FamicordTX, a CAR-T start-up in oncology, and 100% of Cellaviva AB, Scandinavia’s largest private stem cell bank licensed by the Swedish Health Authority (IVO) to preserve and store stem cells from umbilical cord blood and umbilical cord tissue for family use. NextCell is also a 100% owner of the daughter company, QVance which will offer quality control analytics for advanced therapy developers.

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2024-06-12

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THIS PRESS RELEASE MAY NOT BE RELEASED, PUBLISHED OR DISTRIBUTED, DIRECTLY OR INDIRECTLY IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SWITZERLAND, CANADA, HONG KONG, BELARUS, RUSSIA OR IN ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLISHING OR DISTRIBUTION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR REQUIRE REGISTATION OR OTHER MEASURES IN ADDITION TO THOSE REQUIRED BY SWEDISH LAW. SEE SECTION ”IMPORTANT INFORMATION” AT THE END OF THIS PRESS RELEASE. NextCell Pharma AB (publ) ("NextCell" or the "Company") announces that the Company has agreed to a so-called top guarantee of a total of approximately SEK 8.0 million, corresponding to approximately 20.0 percent of the transaction, from qualified investors in the Company's ongoing rights issue of units of up to approximately SEK 40.1 million before issue costs, in which the subscription period commenced on 31 May 2024 (the "Rights Issue"). With the addition of the top guarantee, the Rights Issue is now covered up to approximately 100 percent by subscription undertakings and guarantee commitments.

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THIS PRESS RELEASE MAY NOT BE RELEASED, PUBLISHED OR DISTRIBUTED, DIRECTLY OR INDIRECTLY IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SWITZERLAND, CANADA, HONG KONG, BELARUS, RUSSIA OR IN ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLISHING OR DISTRIBUTION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR REQUIRE REGISTATION OR OTHER MEASURES IN ADDITION TO THOSE REQUIRED BY SWEDISH LAW. SEE SECTION ”IMPORTANT INFORMATION” AT THE END OF THIS PRESS RELEASE. NextCell Pharma AB (publ) (”NextCell” or the “Company”) has prepared an EU Growth prospectus (the “Prospectus”) in connection with the Company’s forthcoming issue of units consisting of shares and warrants with preferential rights for existing shareholders (the “Rights Issue”), which was resolved by the Board of Directors on 24 April 2024 and approved by the Extraordinary General Meeting on 27 May 2024.

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