Treatment start of severe pneumonia with high dose of ProTrans

July 5, 2023

NextCell Pharma AB ("NextCell" or the "Company") announces that the clinical trial ProTrans 19+SE (also called Protrans V) can start recruiting patients in the high dose group, which is the last dose group. Three patients treated with medium dose of ProTrans have been clinically evaluated and the data has been reviewed by the Data Safety Monitoring Board, which now allows continued treatment with high-dose ProTrans for severe pneumonia caused by COVID-19, Influenza, Human Metapneumovirus and RSV.

The Data and Safety Monitoring Board has analyzed the safety aspects of the clinical trial: "Treatment of Respiratory Complications Associated with COVID-19 Infection Using Wharton's Jelly (WJ) Umbilical Cord (UC) Mesenchymal Stromal Cells {ProTrans®): open Phase IB Clinical Trial", described in EudraCT 2020-002078-29.

The meeting was held on Monday 3 of July 2023. The members of the Board are Professor Åke Lernmark, Doctor Magnus Nisell and Professor Peter Bergman (Chairman). The Data and Safety Monitoring Board had access to full data collection forms including adverse events.

ProTrans is being developed as an immunomodulatory cell therapy currently being evaluated for the treatment of patients with type 1 diabetes. However, the mechanism of immunomodulation is expected to be applicable in other autoimmune diseases and inflammatory conditions. When the condition of COVID-19 patients worsens, it is because the immune system becomes hyperactive and attacks organs, including the lungs. In this open-label phase Ib study, a total of three groups, consisting of three patients each will be treated with different doses of ProTrans. Now 6 out of 9 patients have undergone treatment and only 3 patients in the high dose group remain.

Early this year, the Swedish Medical Products Agency approved the study, which initially only treated patients with severe pneumonia caused by SARS-CoV-2 infection, to also include patients with the same symptoms caused by influenza A, respiratory syncytial (RS) and human metapneumo (HMP) virus. The treatment is designed for patients who are hospitalized and who are at high risk of needing to be put on a ventilator. ProTrans is given intravenously to reduce hyperinflammation in the lungs. The goal of the treatment is to shorten the hospital stay, rehabilitation time and to save lives.

The principal investigator of the study is Associate Professor Josefin Sundh, Örebro University Hospital. The protocol was written by Professor Dominique Farge, St. Louis Hospital in France, and Dr. Lindsay Davies, CSO NextCell Pharma. The steering committe consists of chairman Professor Farge and members Professor Edvard Smith (NextCell) and Dr Tomasz Oldak (PBKM).

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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CSO Lindsay Davies Co-Chairs ISCT Europe 2024 Meeting

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

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

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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

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