First pediatric patients treated with ProTrans in type-1 diabetes phase II study

December 21, 2022

NextCell Pharma AB ("NextCell") supports the pediatric diabetes clinical trial conducted at Uppsala University Hospital by Principal Investigator Professor Per-Ola Carlsson with the stromal cell treatment, ProTrans. At the end of October 2022, the Data Safety and Monitoring Board recommended that phase II part of this pivotal trial should be initiated. Now the first two adolescents in the older age cohort (12-21 years) have received treatment.
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Recruitment of children and adolescents newly diagnosed with type-1 diabetes is underway. Patients who can participate in the study must be between 12 and 21 years of age and should have received their diagnosis in the last 6 months. Two out of a total of 30 patients have now received treatment with either ProTrans or placebo.

"The study is progressing according to plan; I have a fantastic study team. The children, and not least their parents, are knowledgeable and very interested, which is inspiring," says Professor Per-Ola Carlsson.

The first part of ProTrans-Young is a safety study (phase I) where all patients have been treated at Uppsala University Hospital. Three patients aged 12-18 years first received treatment, followed by 3 patients aged 7-11 years. Safety data was reviewed by the Data Safety and Monitoring Board after all 6 patients were evaluated at the 3-month follow-up visit. The Board recommended that the study should continue with the second part, which is a randomized and placebo-controlled (phase II) study including a total of 60 children and adolescents with type-1 diabetes, 30 of whom will be treated with ProTrans and 30 with placebo. Initially, 30 patients aged 12-21 will be treated. We can now report that the first two patients have now received treatment. After treatment and 6-month follow-up of the entire age group, the Data Safety and Monitoring Board will again review the safety data before continuing to treat the remaining 30 patients aged 7-11.

The Principal Investigator is Professor Per-Ola Carlsson, Uppsala University and Uppsala University Hospital with co-investigators Professor Helena Elding Larsson, Skåne University Hospital and Professor Johnny Ludvigsson, Linköping University Hospital. The Data Safety and Monitoring Board consists of chairman Professor Ulf Smith, Sahlgrenska, Professor Mikael Rydén, Karolinska Institutet and Professor Anders Fasth, Queen Silvia’s Children's Hospital.

Uppsala University Hospital is the sponsor of the study, which is funded by third-party research grants. NextCell contributes ProTrans and placebo to the study. In addition, the company will support the trial with logistics, documentation and expert competence. No additional monetary compensation will be made.

The full title of the study is: "A Double-blinded, Randomized, Parallel, Placebo-controlled trial of Wharton's Jelly-derived Allogeneic Mesenchymal Stromal Cells to treat Type I Diabetes in Children and Adolescents"(EudraCT 2020-004520-42).

About ProTrans:

ProTrans is NextCell's first drug candidate based on their patent pending selection algorithm. It is an allogeneic cell therapy which means that donated cells, not the patient's own, are used. The cells are extracted from donated umbilical cord tissue and the cells are then expanded to generate large, therapeutic doses of drug product.

ProTransis defined by the selection algorithm, a method for selecting cells with suitable immunomodulatory effect that is assessed in a panel of different analyzes. The algorithm makes an overall assessment of several functional analyzes to identify optimal donors and cells for the manufacture of cell therapies. NextCell’s advanced selection method has a scalable ability and guarantees high reproducibility and efficacy compared to other applications in cell therapy. The careful selection method results in cells of consistently high quality and a strong safety profile with few side effects.

For more information about NextCell Pharma AB, please contact:

Mathias Svahn, CEO

Patrik Fagerholm, CFO

Tel: +46 8-735 5595

E-mail: info@nextcellpharma.com

Webpage: www.nextcellpharma.com

LinkedIn: https://www.linkedin.com/company/15255207/

Twitter: https://twitter.com/NextCellPharma

Certified Adviser

‍‍FNCA Sweden AB is assigned as Certified Adviser, 08-528 00 399, info@fnca.se.

About NextCell Pharma AB

NextCell is a cell therapy company in clinical phase II. The company has developed a proprietary and patented platform technology to produce mesenchymal stromal cells adapted for allogeneic treatment of various autoimmune and immunological diseases. The drug candidate ProTrans is now being tested for the treatment of type-1 diabetes as well as respiratory complications caused by Sars-CoV-2 infection. The focus is to take ProTrans to market approval for type-1 diabetes via a phase III study. ProTrans is evaluated in two clinical COVID-19 studies, in Sweden and Canada. NextCell is working on completing its own GMP facility for the manufacture of ProTrans. The GMP facility is expected to be ready for manufacturing smaller quantities of ProTrans in 2023. NextCell also owns 8.5% of FamicordTX, a start-up company in CAR-T and oncology, and 100%of Cellaviva, Scandinavia's largest stem cell bank for family savings of stem cells from umbilical cord blood and umbilical cord tissue with permission from the Swedish Health and Social Care Inspectorate (IVO).

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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. 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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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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The Board of Directors of NextCell resolves on a rights issue of units of approximately SEK 40.1 million, subject to approval by an Extraordinary General Meeting

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, 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. The Board of Directors of NextCell Pharma AB (publ) (”NextCell” or the ”Company”) has today, subject to subsequent approval by an Extraordinary General Meeting in the Company on 27 May 2024, resolved on a new issue of no more than 37,817,475 units, with preferential rights for existing shareholders, of approximately SEK 40.1 million (the ”Rights Issue”). Each unit consists of one (1) share and one (1) warrant of series TO2 free of charge. Upon full exercise of the warrants, the Company may receive an additional of up to approximately SEK 113.5 million before deduction of issue costs, provided full subscription of the Rights Issue. The Rights Issue is covered to approximately 80 percent by guarantee commitments and subscription undertakings as well as declarations of intent, corresponding to approximately SEK 32.1 million. The purpose of the Rights Issue is primarily to provide the Company with additional capital to enable an out-licensing of the Company’s drug candidate ProTrans™ for the treatment of type 1 diabetes.

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