ProTrans and NextCell gain international attention

August 8, 2023

Results from Professor Per-Ola Carlsson, Principal Investigator for NextCell’s Phase-I/II study with ProTrans stromal cells for Type 1 Diabetes are now published and featured in the Up-front section of the current issue of Diabetologia. The article was selected by the Editor as worthy of special attention, for its high quality and interest to the diabetes field. Furthermore, the article has already been cited in an International scientific journal.

“We are proud that our work is recognized and appreciated by the Editor. This will further increase the international exposure of NextCell”, says Mathias Svahn, CEO

Diabetologia, the official journal of the European Association for the Study of Diabetes (EASD) summarizes the importance of the study on their website:

“Umbilical cord‑derived mesenchymal stromal cells preserve endogenous insulin production in type 1 diabetes: a Phase I/II randomised double‑blind placebo‑controlled trial
Per-Ola Carlsson, Daniel Espes, Sofia Sisay, Lindsay C. Davies, C. I. Edvard Smith and Mathias G. Svahn

Mesenchymal stromal cells (MSCs) have been shown to modulate the immune system and dampen inflammatory and autoimmune responses in numerous diseases. In this issue, Carlsson et al (https://doi.org/10.1007/s00125-023-05934-3) report their findings from a Phase I/II dose escalation and double-blind placebo-controlled clinical trial investigating the Wharton’s jelly MSC drug product, ProTrans, for the treatment of new-onset type 1 diabetes. In the dose escalation safety study, the authors demonstrate that ProTrans can be safely administered intravenously with no serious adverse events. A fixed dose of 200 million MSCs preserved the production of endogenous insulin and reduced exogenous insulin replacement compared with placebo 1 year after treatment. The authors conclude that a single treatment with ProTrans could potentially delay type 1 diabetes disease progression, thereby reducing the associated complications and improving quality of life.”

In the international scientific journal, Frontiers in Cell and Developmental Biology (June 2023), Hana Drobiova and coworkers list advantages of using stem or stromal cells from the umbilical cord, such as ProTrans, enabling the use of WJ-MSCs as therapeutic agents in regenerative medicine. In particular Professor Carlsson’s clinical trials using allogenic WJ-MSCs to investigate their safety and efficacy are highlighted

The clinical trial with ProTrans is a collaboration with Professor Per-Ola Carlsson, Principal Investigator at Uppsala University and Karolinska Trial Alliance, Karolinska University Hospital, Huddinge, Sweden (Clinicaltrials.gov identifier NCT03406585).

The article is available as open access at https://pubmed.ncbi.nlm.nih.gov/37221247/

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, 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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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.

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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.

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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.

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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.

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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.

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2024-06-10

NextCell publishes supplement to the prospectus regarding the rights issue

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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.

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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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