Breakthrough multiplication of blood stem cells

April 26, 2023

NextCell Pharma AB (“NextCell” or the “company") announces that the FDA has approved a product of multiplied stem cells from umbilical cord blood. It is a breakthrough that could lead to increased interest in saving stem cells for private use, where Cellaviva is the market leader in Scandinavia. Cellaviva is a part of NextCell with offices in Stockholm and Copenhagen.

On April 17, 2023, the US Food and Drug Administration (FDA) approved the first product with expanded stem cells from umbilical cord blood. In the clinical trial that led to the approval, the number of stem cells was expanded an average of 60 times by cell culture.

"Multiplication or expansion of blood-forming stem cells is a significant achievement. The new method opens the door for the use of even smaller collections of cord blood in clinical practice." says Professor Edvard Smith, Medical Director of NextCell Pharma and Cellaviva.

Stem cells from umbilical cord blood have been used in healthcare for the treatment of over 80 different conditions, such as leukaemias, lymphoma and sickle cell anaemia, for more than 30 years. It has also been shown that in regenerative medicine, treatment with stem cells from umbilical cord blood provides clinical benefits for patients. More than 60,000 patients have already been treated with umbilical cord blood.

In addition to the above-mentioned already approved therapies, over 3,000 research studies are currently underway in various fields around the world to discover the full potential of stem cells. Umbilical cord blood is the source of the youngest, most powerful and most readily available stem cells. They can also be easily collected and stored after birth, to be used later in life. Due to the limited blood volume and number of stem cells isolated from umbilical cord blood; critics have pointed out that an average unit of umbilical cord blood is only sufficient for patients weighing up to 40-50 kg. The FDA's groundbreaking decision to approve expanded, also known as multiplied, umbilical cord blood means that this restriction is no longer a concern.

The product approved by the FDA is manufactured by Gamida under the name Omisirge (also known as omidubicel or NiCord).

Link to FDA press release:
https://www.fda.gov/news-events/press-announcements/fda-approves-cell-therapy-patients-blood-cancers-reduce-risk-infection-following-stem-cell

Link to the scientific article about the study:
https://doi.org/10.1182/blood.2021011719

For more information about NextCell Pharma, please contact
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: +46 8 735 5595
E-mail: info@nextcellpharma.com

Websites:
NextCell Pharma AB: www.nextcellpharma.com
Cellaviva Sverige: www.cellaviva.se
Cellaviva Danmark: www.cellaviva.dk

LinkedIn: https://www.linkedin.com/company/15255207/
Twitter: https://twitter.com/NextCellPharma

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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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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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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