The paediatric diabetes study gets the green light to treat the age group 7 – 11 years

June 12, 2024

NextCell Pharma AB (publ) ("NextCell") announces that the Data Safety Monitoring Board for the ProTrans-Young study has recommended the principal investigator, Professor Per-Ola Carlsson, to continue with treatment of children in the younger age group 7 – 11 years. This decision is based on a review of all available safety data from the 36 children and adolescents who have participated in the study so far. The recruitment of the 30 children aged 7-11 will begin in August 2024.

The first part of the ProTrans-Young study is a safety part (phase Ib) where all 6 patients aged 7-18 years are treated with ProTrans. 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. The first 30 patients aged 12-21 have undergone treatment and been on follow-up visits for at least 3 months. The Data Safety Monitoring Board has now reviewed the safety and recommended that the study continue with treatment of the remaining 30 patients aged 7-11.

Information in Swedish about the clinical trial and participation can be found at: https://www.nextcellpharma.com/studie

Treatment with ProTrans aims to stop the autoimmune destruction of insulin-producing cells. The children and adolescents in ProTrans-Young are treated with ProTrans within 6 months of being diagnosed with type-1 diabetes. The purpose is to be able to maintain as much of their insulin production as long as possible, even if they will continue to need extra insulin. The body's own insulin production buffers blood sugar and reduces the risk of fluctuations that can lead to serious complications.

A subgroup analysis of the treatment effect of ProTrans in 30 adolescents in the age group 12-21 years, is expected to be presented in April 2025. The measure of effectiveness is the difference in endogenous insulin production between ProTrans and placebo-treated patients one year after treatment. Topline results from the entire study are expected by the end of 2026. Previous studies with ProTrans have been limited to adults, therefore only children under 18 years of age are included in the first part of the study. The other part is divided into two age groups that are commonly used in clinical trials in type 1 diabetes, 7-11 and 12-21 years respectively.

The principal investigators are Professor Per-Ola Carlsson, Uppsala University and Uppsala University Hospital, with the co-investigators Professor Helena Elding Larsson, Skåne University Hospital and Professor Johnny Ludvigsson, Linköping University Hospital. The Data Safety Monitoring Board consists of Chairman Professor Ulf Smith, Sahlgrenska and Professor Mikael Rydén, Karolinska and Professor Anders Fasth, Queen Silivia Children's Hospital.

The complete title of the clinical trial 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).

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

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, Head of Cellaviva
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 that is in phase 2 studies with the drug candidate ProTrans for the treatment of type 1 diabetes. The focus is to obtain market approval of ProTrans via a phase 3 study. ProTrans is manufactured utilizing the patented platform technology for selection of optimal cells with potency to treat inflammatory disorders including autoimmune diseases. NextCell owns Cellaviva, the largest stem cell bank in the Nordics and QVance, a quality analysis CRO company in start up.

Download attachment Read full press release on Cision (external link)

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.

Read more Read more

2024-05-31

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.

Read more Read more

2024-05-30

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.

Read more Read more

2024-05-28

Single treatment with ProTrans demonstrates long-term therapeutic effect over 5 years

NextCell Pharma AB ("NextCell" or the "Company") today announces that patients who were treated with a single dose of ProTrans five years ago in the randomized, placebo-controlled phase II study ProTrans-2 have retained significantly higher endogenous insulin production than patients who received placebo. ProTrans treated patients maintained 57% of their endogenous insulin production compared to 15% in the placebo group. The results are in line with NextCell’s previously reported three year data and demonstrates that ProTrans offers a disease-modifying treatment with long-lasting clinically relevant effect.

Read more Read more

2024-05-27

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

At the Extraordinary General Meeting of NextCell Pharma AB (publ) (“NextCell” or the “company”) on 27 May 2024, the following resolutions were made. All resolutions were in accordance with the proposals presented, which are described in detail in the general meeting documents available on the company’s website, www.nextcellpharma.com.

Read more Read more

2024-04-25

NextCell publishes its Interim Report 2 2023/2024

NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 2 for the period September 1, 2023 – Februari 29, 2024. The report is available on the company’s website: https://www.nextcellpharma.com/en/investors#financial-report. NextCells share is traded on Nasdaq First North Growth Market under the ticker "NXTCL". The amount in brackets refers to the corresponding period in the previous year.

Read more Read more

2024-04-24

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.

Read more Read more

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.

Read more Read more