NextCell updates on NLS days

September 28, 2022

NextCell Pharma AB ("NextCell" or the"Company") provides a status update today at the Nordic Life Science days in Malmö. NLS days is the Nordic region's largest partnering event in Life Science where NextCell's CEO Mathias Svahn will participate in meetings and give a presentation today at 14:12.

The cell therapy company NextCell Pharma AB has developed a proprietary and patented platform technology to produce mesenchymal stromal cells with properties adapted for allogeneic treatment of specific diseases.

The company's lead drug candidate, ProTrans, is being developed for the treatment of autoimmune diseases and inflammatory conditions. Efficacy and safety have been shown for the treatment of adults with type-1 diabetes (studies ProTrans 1 and 2), and here the aim is to stop the autoimmune course of the disease and thus preserve the endogenous insulin production, which the patient has left at the time of treatment. In addition to the fact that this can contribute to increased quality of life in the patients, it has been reported that remaining endogenous insulin production provides longer estimated life time, as well as reduced late complications.

In October, NextCell is expected to present the 3-year long-term effect of ProTrans from the ProTrans-OBS study.  In November, NextCell is expected to present a 3.5-year long-term effect of ProTrans from the ProTrans-Repeat study.

 

A pediatric diabetes study, ProTrans-Young, is ongoing and led by Professor Per-Ola Carlsson at Uppsala University Hospital. The first group of patients has been treated, and a safety committee's opinion is awaited in November prior to the recommendation to the start of the second part of the study, which could then include new patients in December.

 

A pediatric development plan (Pediatric Investigation Plan, PIP) is required for drug development for the treatment of children. The plan describes the clinical trial program until commercialization and is a requirement for phase 3 studies. NextCell has submitted an application, which will be considered by the European Medicines Agency's expert committee at the end of the year. The application includes ProTrans-3, a pivotal phase III study for both adults and children that, if positive, can give ProTrans marketing approval.

 

NextCell is financially stable, and with the current plan does not require additional capital needs in the coming financial year. An approved pediatric development plan is a prerequisite for applying for a pivotal study involving children and the company may seek some form of partnership before the start of a such a phase III study.

 

NextCell's GMP facility has now been completed and qualification work has begun. The purpose is to bring home the production technology to prepare future technology transfer from NextCell to one or more licensees or buyers of ProTrans. The collaboration with our contract manufacturer continues and together the companies will have production capacity that far exceeds the need for ProTrans clinical trials.

 

In addition to type-1 diabetes studies, COVID-19 studies are conducted where patients with hyperinflammation in the lungs are treated with ProTrans. The recruitment rate has slowed down as a result of the reduced number of patients affected by severe disease. The Swedish study has treated 5 out of 9 patients and the Canadian study 18 out of 48 patients. Dialogues are being conducted on how the studies can be modified to increase the rate of inclusion.

NextCell is the owner of Cellaviva, Scandinavia's largest stem cell bank for family saving of stem cells from umbilical cord blood and umbilical cord tissue. The business has shown good growth during the financial year.

For more information about NextCell Pharma AB, please contact:
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: +46 8-735 5595
E-mail: info@nextcellpharma.com
Webpage: 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 process of establishing its own GMP facility for the production of ProTrans. The GMP facility is expected to be ready for production of small 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).
 

Download attachmentRead full press release on Cision (external link)
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.
Read moreRead more
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").
Read moreRead more
2025-05-28
NextCell Pharma receives additional declarations of intent 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") 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.
Read moreRead more
2025-05-28
Angela Vollstedt joins NextCell Pharma’s Board of Advisors to Strengthen Scientific and Manufacturing Strategy Ahead of Licensing Discussions
NextCell Pharma AB ("NextCell" or "the Company") is pleased to announce the appointment of Dr. Angela Vollstedt, PhD, MBA, to its Board of Advisors, reinforcing the company’s strategic shift toward pivotal development and licensing of its lead drug candidate, ProTrans, for the treatment of type 1 diabetes. Dr. Vollstedt currently serves as Global Director of Cell & Gene Therapies Portfolio Management at Novartis, where she leads cross-functional teams in the development, scaling, and commercialisation of advanced therapies.
Read moreRead more
2025-05-26
NextCell Receives US Patent for MSC Prediction Algorithm
NextCell Pharma AB ("NextCell" or "the Company") is pleased to announce the issuance of a US patent titled “MSC Prediction Algorithm” by the United States Patent and Trademark Office (USPTO). The patent protects NextCell’s innovative methodology for predicting the efficacy of mesenchymal stromal cell (MSC) therapy in individual patients, as well as the approach for determining personalised treatment options based on that prediction.
Read moreRead more
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.
Read moreRead more
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.
Read moreRead more
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.
Read moreRead more