NextCell publishes opinion piece with ISCT

October 11, 2022

NextCell Pharma AB (”NextCell” or ”Company”)published an opinion piece on particulates in cell and gene therapy products with the International Society for Cell and Gene Therapy’s Process Development, Manufacturing and Analytics Committee last week in the journal Cytotherapy.

NextCell Pharma AB is a cell therapy company working in the development and commercialization of the mesenchymal stromal cell therapy product, ProTrans. This product, with its proprietary platform technology, is in clinical development for the treatment of autoimmune conditions, such as type I diabetes and inflammatory conditions such as viral pneumonia.

 

NextCell’s CEO, Mathias Svahn and CSO, Lindsay Davies are active members of the International Society for Cell and Gene Therapy (ISCT), the leading global society for the development and commercialization of advanced therapeutics. Dr Davies is a member of both the ISCT Commercialization Committee and Process Development, Manufacturing and Analytics Committee and an ISCT mentor for early stage professionals entering the cell therapy space. The Process Development, Manufacturing and Analytics working group brings together scientists and cell and gene therapy companies, in all stages of commercial development, to discuss current issues in the advanced therapy arena and lead forward thinking in these novel and evolving areas of clinical development.

 

“It has been great to work with such a diverse and knowledgeable group of scientists and business developers from across the globe to discuss ways of addressing and supporting cell and gene therapy development. The NextCell team is committed to actively participating in advancing knowledge and understanding, promoting regulatory change and thereby ensure wider accessibility of safe cell and gene therapies for patients”, says Dr Davies.

 

Last week Lindsay Davies and the Process Development, Manufacturing and Analytics Committee published an opinion piece in the journal Cytotherapy. The piece entitled, “Particulates are everywhere, but are they harmful in cell and gene therapies?” addresses the potential issue of evaluating particulate matter in cell and gene therapy products, and the need for regulations to differentiate this distinct class of drugs from other, more traditional pharmaceutical products.

 

The published article can be accessed, for free, at https://authors.elsevier.com/a/1fpxZ5DBIBTE%7EZ until November
16, 2022.

For more information about NextCell Pharma AB, please contact:
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: 08-735 5595
E-mail: info@nextcellpharma.com
Homepage: www.nextcellpharma.com
 
LinkedIn: https://www.linkedin.com/company/15255207/
Twitter: https://twitter.com/NextCellPharma

 

About NextCell Pharma AB:
NextCell is a phase II cell therapy company with the drug candidate ProTrans for the treatment of type 1 diabetes. The focus is to take ProTrans to market approval via a Phase III study. ProTrans is in addition to diabetes, used in two clinical trials for Covid-19, in Örebro and Montreal (Canada). The company is in the processes of establishing its own GMP facility for production of ProTrans. The GMP facility is expected to be ready for production of smaller quantities of ProTrans in 2023. NextCell furthermore owns 8,5% in FamicordTX, a CAR-T start-up in oncology and 100 % of Cellaviva, Scandinavia's largest stem cell bank for family saving 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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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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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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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 that the Company has received additional non-binding declarations of intent regarding the exercise of warrants of series TO2 (“Warrants”). The new declarations correspond to approximately SEK 5.5 million, equivalent to approximately 14.1 percent of the total number of outstanding Warrants. In total, the Company has now received declarations of intent, subscription undertakings, and guarantee commitments amounting to approximately SEK 24.0 million, corresponding to approximately 61.9 percent of the total issue volume.
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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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