NextCell presents detailed analysis of the administrative report from ProTrans-Young

April 24, 2025

NextCell Pharma AB’s ("NextCell" or "the Company") CSO, Lindsay Davies, has been interviewed by Flemingsberg Science regarding the analysis of the administrative topline evaluation from the older age cohort of the ProTrans-Young paediatric trial.

On 7th April 2025, NextCell Pharma released a press release announcing the topline data from its administrative analysis of the older age cohort from the ProTrans-Young paediatric clinical trial. The study is evaluating the safety and efficacy of the company’s cell therapy, ProTrans, in preserving insulin production in young individuals newly diagnosed with type 1 diabetes, compared with placebo. The current analysis is of the first 30 randomised patients, all included within six months of diagnosis – a favourable time point, as more insulin production is typically still present and can be preserved.

In her interview with Flemingsberg Science, Dr Davies discussed the data achieved and how the company is interpreting the findings. “We are strongly encouraged by the dataset. It is important to remember the aims of this trial in asking the questions of can we safely treat children with ProTrans and secondly can we target the disease earlier in its development than we have previously. We can absolutely say that the drug product is safe for children and early indications are that yes, we can target earlier in the disease than previously thought”. Lindsay cited the top line data that no severe adverse side effects had been reported within the Phase I arm of the study and that in the Phase II older age cohort the data already demonstrated strong trends that a clinical effect was evident in preserving insulin production in ProTrans treated individuals.

She added, “It is important to not directly compare the data to our earlier trial in adults at this point. We need to consider that this is a live cell therapy dependent on an immune modulating effect that is going to be impacted by the immune system and biochemistry of the treated individual. We are interestingly already seeing trends related to sex, with females demonstrating a 19% loss in insulin with ProTrans treatment compared to 25% loss in the placebo group and males averaging a loss of 22% insulin with ProTrans treatment compared to 28% in the placebo group. Earlier intervention means that it will take longer to see the clear impact of the treatment compared to placebo – this is why this study will run for 5 years to monitor the evolution of the disease. To already see differences and trends is fantastic!”

Lindsay’s interview with Natasha Bank, Cluster Manager at Fleminsgberg Science can be watched at the following link https://youtu.be/XxUGNZ8pCP4.

For more information about NextCell Pharma AB, please contact:

Mathias Svahn, CEO

Patrik Fagerholm, CFO

Tel: 0+46 8-735 5595

E-mail: info@nextcellpharma.com

Website: www.nextcellpharma.com

 

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

Twitter: https://twitter.com/NextCellPharma


For information about Cellaviva, please contact:

Sofie Falk Jansson, CEO

Tel: 08-735 2010

E-mail: info@cellaviva.se

Website: www.cellaviva.se

 

Facebook: https://www.facebook.com/cellavivasverige

Twitter: https://www.instagram.com/cellaviva/

Certified Adviser
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.

Download attachmentRead full press release on Cision (external link)
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 moreRead 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 moreRead 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 moreRead 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 moreRead more
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”).
Read moreRead 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 moreRead 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 moreRead 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 moreRead more