Results from the Older Age Cohort in the ProTrans-Young Paediatric Study Expected in Aprilv

March 13, 2025

NextCell Pharma AB ("NextCell" or "the Company") announces that the last patient in the older age cohort (12–21 years) of the clinical Phase II study, ProTrans-Young, has now completed their 12-month follow-up. The collected data is currently being compiled, and an administrative subgroup analysis is planned to be presented at the IDF World Diabetes Congress in Bangkok from April 7–10.

ProTrans-Young aims to evaluate the safety and efficacy of ProTrans, umbilical cord mesenchymal stromal cell treatment for newly-diagnosed type 1 diabetes in children and adolescents. The upcoming analysis represents an important interim readout of treatment response within the 12–21 year old age group. The purpose is to examine whether the treatment response in this age group follows the same trend as previously observed in adult patients. Results from the earlier ProTrans-T1D study in adults were published in 2023 in Diabetologia, the official journal of the European Association for the Study of Diabetes (EASD; Carlsson et al., 2023).

It is important to note that the analysis of this subgroup will not include in-depth statistical testing, such as significance assessment using p-values. This decision has been made to ensure the statistical integrity of the study. Repeated analyses within a study can increase the risk of false-positive results, which is typically managed by adjusting the significance level (alpha). However, such an adjustment can reduce the study’s ability to detect true effects. To avoid this issue, the analysis is therefore limited to an overall trend assessment at this point.

Recruitment is ongoing for the younger age cohort in the ProTrans-Young study, children aged 7–11 years, with the goal of including all patients before the summer of 2025.

The study is being conducted in collaboration with Uppsala University under the leadership of Professor Per-Ola Carlsson, together with co-investigators Johnny Ludvigsson at Linköping University and Helena Elding Larsson at Lund University. Uppsala Clinical Research Center is responsible for data management.

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

The company's shares are listed on the Nasdaq First North Growth Market. RedEye 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. NextCell owns 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 also owns QVance which will offer quality control analytics for advanced therapy developers. Furthermore, NextCell owns 8.5% in FamicordTX, a CAR-T start-up in oncology.

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2024-06-10

NextCell publishes supplement to the prospectus regarding the rights issue

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 today published a supplement (the “Supplement”) to the EU Growth prospectus, which was approved and registered by the Swedish Financial Supervisory Authority and published on 30 May 2024 (the “Prospectus”). The Supplement has been prepared due to the fact that the Company on 4 June 2024 announced through a press release that the Company had agreed to a so-called top guarantee of a total of approximately SEK 8.0 million in the ongoing rights issue of units in the Company (the “Rights Issue”).

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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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The subscription period in NextCell’s rights issue commences today

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. Today, 31 May 2024, the subscription period in NextCell Pharma AB (publ)’s (“NextCell” or the “Company”) rights issue of units, which was announced on 24 April 2024 (the “Rights Issue”), commences. The subscription period in the Rights Issue runs until 14 June 2024. Please note, however, that nominees may have a final response date for subscription in the Rights Issue that falls before 14 June 2024.

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NextCell publishes prospectus in connection with the rights issue of units of approximately SEK 40.1 million

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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Bulletin from the Extraordinary General Meeting of NextCell Pharma AB (publ)

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