Patients in the first part of pediatric diabetes trial with NextCell’s ProTrans treated

June 8, 2022

The cell therapy company NextCell Pharma AB ("NextCell") today announces that all six children in the first part of the study have now been treated with ProTrans. Patients will be monitored during the summer after which the safety of treatment will be evaluated by an independent Data Safety and Monitoring Board.

The first part of the clinical trial with Protrans is a safety part where all patients are children with type-1 diabetes who have now received their treatment at the Uppsala University Hospital. The Data Safety and Monitoring Board consists of Professor Ulf Smith, Sahlgrenska University Hospital, Professor Mikael Rydén, Karolinska Hospital and Professor Anders Fasth, Queen Silvia Children's Hospital. They will evaluate whether it is safe to proceed to the phase II part of the study, based on 3 months of follow-up of six children.

In the phase II part of the study, patients are randomized to ProTrans or placebo (1:1). First, 30 patients in the age group of 12-21 years are treated, after which - provided the recommendation of the Data Safety and Monitoring Board after six months -, another 30 patients in the age group of 7-11 years are included in the study. ProTrans is a cell therapy that balances the immune system and counteracts autoimmune type-1 diabetes. The active substance mesenchymal stromal cells, also called stem cells, are selected from umbilical cord tissue using NextCell's patent-pending selection algorithms.

The principal investigators for the study are professor Per-Ola Carlsson, Uppsala University and Uppsala University Hospital with the co-investigators professor Helena Elding Larsson, Skånes University Hospital and professor Johnny Ludvigsson, Linköpings University Hospital. The second part of the study is randomized and placebo-controlled (phase II) and a total of 60 children and adolescents with type-1 diabetes will be treated, of which 30 with ProTrans and 30 with placebo. Recruitment will take place at the three participating hospitals in Uppsala, Linköping and Malmö.

Uppsala University Hospital is the sponsor of the study, which is funded by research grants. NextCell contributes with ProTrans and placebo. In addition, the company will support the trial with logistics, documentation and cell therapy expertise.

Full name 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).

For more information about NextCell Pharma AB, please contact
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: 08-735 5595
E-mail: info@nextcellpharma.com

Websites:
www.nextcellpharma.com
www.cellaviva.se
www.cellaviva.dk
LinkedIn: https://www.linkedin.com/company/15255207/
Twitter: https://twitter.com/NextCellPharma
Instagram: https://www.instagram.com/cellaviva/

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

About NextCell Pharma AB
NextCell is a phase II cell therapy company with the drug candidate ProTrans for the treatment of type 1 diabetes. The focus is to take ProTrans to market approval via a Phase III study. ProTrans is in addition to diabetes, used in two clinical trials for Covid-19, in Örebro and Montreal (Canada). The company is in the processes of establishing its own GMP facility for production of ProTrans. The GMP facility is expected to be ready for production of smaller quantities of ProTrans in 2023. NextCell furthermore owns 8,5% in FamicordTX, a CAR-T start-up in oncology and 100% of Cellaviva, Scandinavia's largest stem cell bank for family saving 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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2024-06-04

NextCell procures top guarantee in ongoing 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") 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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Bulletin from the Extraordinary General Meeting of NextCell Pharma AB (publ)

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Notice of Extraordinary General Meeting in NextCell Pharma AB (publ)

The shareholders of NextCell Pharma AB (publ), Reg. No. 556965-8361 (”NextCell” or the ”company”), are hereby summoned to an Extraordinary General Meeting on Monday, 27 May 2024, 10:00 CEST, in the Novum building, floor 6 (elevator E), Hälsovägen 7, SE-141 57 Huddinge, Sweden.

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2024-04-24

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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