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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2025-06-13

All Patients Successfully Treated in ProTrans-Young Study

NextCell Pharma AB ("NextCell" or the "Company") announces today that all patients in the ongoing ProTrans-Young clinical trial have now successfully been treated. This milestone marks the completion of patient dosing in the company’s largest clinical study to date. ProTrans-Young is evaluating the safety and efficacy of the Company’s lead cell therapy candidate, ProTrans, in paediatric and adolescent patients with recently diagnosed type 1 diabetes.

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2025-06-02

NextCell Pharma announces outcome of exercise of TO2 and resolves on directed share issues to guarantors

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, 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 (“NextCell” or the “Company”) today announces the outcome of the exercise of warrants of series TO2 (the “Warrants”), which were issued in connection with the Company’s rights issue of units during the second quarter of 2024. In total, 24,945,532 Warrants have been exercised, corresponding to approximately 64.4 percent of the total number of outstanding Warrants, for subscription of 24,945,532 shares at subscription price of SEK 1.00 per share. As a result, guarantee commitments of 11,614,000 shares, corresponding to approximately SEK 11.6 million, have been utilized. Thus, the board of directors of the Company has resolved on a directed issue of 11,614,000 shares (the “Directed Issue”) to the investors who had provided guarantee commitments. Through the exercise of Warrants and the Directed Issue, the Company will receive total proceeds of approximately SEK 36.6 million before deduction of issue-related costs. Furthermore, the board of directors has resolved on a set-off issue of 1,742,100 shares to the guarantors to pay the guarantee compensation (the "Remuneration Issue").

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2025-05-28

NextCell Pharma receives additional declarations of intent regarding exercise of TO2

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2025-05-28

Angela Vollstedt joins NextCell Pharma’s Board of Advisors to Strengthen Scientific and Manufacturing Strategy Ahead of Licensing Discussions

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2025-05-26

NextCell Receives US Patent for MSC Prediction Algorithm

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2025-05-23

NextCell Pharma receives declarations of intent, subscription undertakings and top guarantees regarding exercise of TO2

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, 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 ("NextCell" or the "Company") issued a total of 38,711,804 warrants of series TO2 (“Warrants”) within the framework of a rights issue of units during the second quarter of 2024. The exercise period for the Warrants runs until and including 30 May 2025. One (1) Warrant entitles the holder to subscribe for one (1) new share in the Company at a subscription price of SEK 1.00 per share. NextCell today announces that the Company has received declarations of intent from all of the Company’s senior executives and Board members who hold Warrants and subscription undertakings from a selection of existing Warrant holders regarding the exercise of held Warrants, totalling approximately SEK 6.9 million, corresponding to approximately 17.8 percent of the total number of outstanding Warrants. In addition, the Company has secured top guarantees from a selection of existing Warrant holders and shareholders as well as external investors corresponding to an additional approximately 30 percent of the total issue volume. The top guarantees, together with the received declarations of intent and subscription undertakings, ensure that the Company will receive minimum proceeds of approximately SEK 18.5 million, corresponding to approximately 47.8 percent of the total issue volume.

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2025-05-20

NextCell announces strategic collaboration with Fujifilm Irvine Scientific

NextCell Pharma AB’s ("NextCell" or "the Company") has entered into a strategic collaboration with Fujifilm Irvine Scientific Inc. to bring together their core competences in mesenchymal stromal cells (MSCs) and raw materials for the life science sector. The aim of the collaboration is to provide researchers and developers in the cell therapy field with an integrated offering – standardised MSC products, optimised culture media, and cryopreservation solutions.

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2025-05-19

Eric Strati Joins NextCell Pharma’s Board of Advisors to Support Commercial Strategy for ProTrans

NextCell Pharma AB ("NextCell") is pleased to announce the appointment of Eric Strati, PharmD, MBA, as a new member of its Board of Advisors, marking a strategic step as the company transitions from a development-focused organization into a pivotal phase aimed at out-licensing and commercializing its leading cell therapy product, ProTrans, for the treatment of type 1 diabetes.

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