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).

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

2024-07-25

NextCell publishes its Interim Report 3 2023/2024

NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 3 for the period September 1, 2023 – May 31, 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

2024-07-03

NextCell carries out a directed issue of units to guarantors in connection with the completed 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. The Board of Directors of NextCell Pharma AB (publ) (“NextCell” or the “Company”) has today, based on the authorisation from the Annual General Meeting on 30 November 2023, resolved on a directed issue of 894,329 units to guarantors who provided guarantee commitments in the rights issue of units resolved upon by the Board of Directors on 24 April 2024 (the “Right Issue”), in accordance with guarantee agreements entered into (the “Remuneration Issue”). Each (1) unit consists of one (1) newly issued share and one (1) warrant of series TO2. The subscription price in the Remuneration Issue is SEK 1.50 per unit and payment is made by offsetting the guarantors’ claims on the Company.

Read more Read more

2024-06-17

NextCell’s rights issue oversubscribed

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”) hereby announces the outcome of the Company’s rights issue of units, consisting of shares and warrants of series TO2, with preferential rights for the Company’s existing shareholders, which was announced through a press release on 24 April 2024 (the “Rights Issue”). The outcome of the Rights Issue shows that 34,747,218 units, corresponding to approximately 91.9 percent of the Rights Issue, were subscribed for with the support of unit rights. In addition, applications for subscription of 22,636,886 units without the support of unit rights have been submitted, corresponding to approximately 59.9 percent of the Rights Issue. Together, subscriptions of units with the support of unit rights and applications for subscription of units without the support of unit rights correspond to approximately 151.7 percent of the Rights Issue. The Rights Issue is therefore oversubscribed and NextCell will from the Rights Issue receive approximately SEK 40.1 million before deduction of issue costs.

Read more Read more

2024-06-12

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

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.

Read more Read more

2024-06-11

The Board of Directors and management sign in addition to subscription commitments

NextCell Pharma AB (publ) ("NextCell" or the "Company") carries out a rights issue of units of up to approximately SEK 40.1 million, which is covered to approximately 100 percent by subscription and guarantee commitments. The company's Board of Directors, management and key employees, who have previously entered into subscription commitments of up to a total of approximately SEK 1.5 million, have now announced that they will register their interest in subscribing for units for a total of approximately SEK 3.3 million, corresponding to 8.2 percent of the rights issue.

Read more Read more

2024-06-10

NextCell publishes supplement to the prospectus regarding the rights issue

Read more Read more

2024-06-05

Cellaviva becomes an independent company under NextCell Pharma

Cellaviva, the stem cell bank operated by NextCell Pharma AB, has announced its transition to an independent company. This strategic move will enable Cellaviva to further focus on its core mission of providing expectant parents with the opportunity to preserve and store valuable stem cells collected from the placenta and umbilical cord. These cells, which would otherwise be discarded post-birth, offer significant potential for future medical treatments and therapies.

Read more Read more

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