Positive feedback on the paediatric plan of the EMA

January 18, 2023

NextCell Pharma AB ("NextCell") has received positive comments and recommendations for the pediatric investigational plan (PIP) submitted to the Europeans Medicines Agency’s (EMA) pediatric committee (PDCO).

As previously announced, NextCell submitted a proposal in Q4 outlining how ProTrans should be developed for the treatment of children with type-1 diabetes. The agency has returned with comments and recommendations that aiming to ensure that children younger than 7 years old can also receive treatment in the future.

"The PDCO has been very helpful with the development plan and the proposed changes strengthen our proposal.  We will of course implement these before the PIP is finally submitted for approval", says Mathias Svahn, CEO.

A PIP is a development plan aimed at ensuring that all necessary safety and efficacy data are obtained through clinical studies in children, prior to application for authorisation of a medicine for pediatric usage. All applications for marketing authorisation for new medicines have to include the results of studies as described in an agreed PIP.

Only small changes have been requested by EMA, aimed at allowing even younger age groups to be treated after a possible market approval than what is treated in the ongoing pediatric study, ie children younger than 7 years. The changes do not affect the study design of the planned phase 3 study.

In addition to clinical trials, the plan also includes preclinical studies of biodistribution and toxicology. NextCell is currently reviewing the recommendations by the PDCO and amending the proposal prior to submitting for approval.

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


Certified Adviser

FNCA Sweden AB is assigned as Certified Adviser, 08-528 00 399, info@fnca.se.


About NextCell Pharma AB

NextCellis 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-19studies, 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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2018-09-11
Last day of trading in series TO 1 warrants
Today, 11th September 2018, is the last day of trading in warrants of series TO 1 issued as part of NextCell Pharma AB's ("NXTCL") listing in the spring of 2017. Last day to subscribe for shares on the basis of warrants of series TO 1 is 13th September 2018. The teaser and subscription form are available on the following websites: NXTCL (www.nextcellpharma.com (http://file///C:/Users/ErikBerggren/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/TLO3KWR6/www.nextcellpharma.com)); Sedermera Fondkommission (www.sedermera.se (http://file///C:/Users/ErikBerggren/AppData/Local/Microsoft/
Today, 11th September 2018, is the last day of trading in warrants of series TO 1 issued as part of NextCell Pharma AB's ("NXTCL") listing in the spring of 2017. Last day to subscribe for shares on the basis of warrants of series TO 1 is 13th September 2018. The teaser and subscription form are a...
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2018-09-05
Reminder to exercise your series TO 1 warrants
The subscription period for the series TO 1 warrants issued as part of NextCell Pharma AB’s ("NXTCL") issue of units during the spring of 2017 will continue until 13th September 2018. The last day for trading with the series TO 1 warrants is 11th September 2018. Holders of the series TO 1 warrants are entitled to subscribe for a new share for each warrant at a price of SEK 5.00 per share. If all of the series TO 1 warrants are exercised, 2 860 940 new shares will be issued and NXTCL is receives approximately MSEK 14.3 before issue costs. The subscription of series TO 1 warrants to be
The subscription period for the series TO 1 warrants issued as part of NextCell Pharma AB’s ("NXTCL") issue of units during the spring of 2017 will continue until 13th September 2018. The last day for trading with the series TO 1 warrants is 11th September 2018. Holders of the series TO 1 warrant...
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2018-08-28
Upcoming events and conferences for NXTCL
Stem cell company NextCell Pharma AB ("NXTCL") announces today, that CEO Mathias Svahn has been invited to speak at the annual BiotechBuilders event held today, 28th of September 2018. Mathias Svahn will also give a presentation at the Nordic Life Science Days, which will be held 10th-12th of September 2018. The BiotechBuilders event which is held today, 28th of September 2018, has invited CEO Mathias Svahn to speak about NXTCL and how the company has developed over time. The title of his presentation is: “Turning opportunity into productivity, starting a stem cell clinical trial in record
Stem cell company NextCell Pharma AB ("NXTCL") announces today, that CEO Mathias Svahn has been invited to speak at the annual BiotechBuilders event held today, 28th of September 2018. Mathias Svahn will also give a presentation at the Nordic Life Science Days, which will be held 10th-12th of Sep...
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2018-08-27
Summary of exercised warrants by Board members and senior executives in NXTCL
Stem cell company NextCell Pharma AB ("NXTCL") announces today, that members of the Board Anders Essen-Möller, Edvard Smith, Hans-Peter Ekre, Niclas Löwgren, CEO Mathias Svahn and CFO Leo Groenewegen have exercised all of their respective series TO 1 warrants. In total this means that 173 430 warrants are to be converted, corresponding to a total investment of SEK 867 150. In total, investments from the Board and Management correspond to approximately 6 percent of the total outstanding warrants. Below, each person’s amount of to be exercised series TO 1 warrants is presented: ·  Mathias
Stem cell company NextCell Pharma AB ("NXTCL") announces today, that members of the Board Anders Essen-Möller, Edvard Smith, Hans-Peter Ekre, Niclas Löwgren, CEO Mathias Svahn and CFO Leo Groenewegen have exercised all of their respective series TO 1 warrants. In total this means that 173 430 war...
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2018-08-23
NextCell's largest shareholder Diamyd Medical exercise all of its warrants
Stem cell company NextCell Pharma AB ("NXTCL") announces today, that its largest shareholder, Diamyd Medical AB, will exercise all its 296 800 series TO1 warrants. Diamyd will exercise the warrants during the subscription period which runs during the period 23rd August – 13th September 2018. This represents an investment total of SEK 1 484 000, corresponding to approximately 10 % of the outstanding warrants. The diabetes Company Diamyd Medical is one of the main owners of NextCell Pharma, with a shareholding of approximately 14 %. In addition to its current shares, Diamyd Medical also has
Stem cell company NextCell Pharma AB ("NXTCL") announces today, that its largest shareholder, Diamyd Medical AB, will exercise all its 296 800 series TO1 warrants. Diamyd will exercise the warrants during the subscription period which runs during the period 23rd August – 13th September 2018. This...
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2018-08-23
The subscription period of the series TO 1 warrants starts today
Stem cell company NextCell Pharma AB ("NXTCL") announces that today, 23rd of August 2018, marks the start of the subscription period of the series of TO 1 series warrants which were issued as part of the company's issue of units during the spring of 2017. The subscription period will end on the 13th of September 2018. Holders of the series TO 1 warrants are entitled to subscribe for a new share for each warrant at a price of SEK 5.00 per share. If all of the series TO 1 warrants are exercised, 2 860 940 new shares will be issued and NXTCL is receives approximately MSEK 14.3 before issue costs.
Stem cell company NextCell Pharma AB ("NXTCL") announces that today, 23rd of August 2018, marks the start of the subscription period of the series of TO 1 series warrants which were issued as part of the company's issue of units during the spring of 2017. The subscription period will end on the 1...
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2018-08-17
NextCell’s partner PBKM exercises its TO 1 warrants
Stem cell company NextCell Pharma AB ("NXTCL") announces today that its shareholder and partner Polski Bank Komorek Macierzystych S.A. ("PBKM") is exercising all of its 320,000 warrants. This represents an investment of MSEK 1.6, corresponding to approximately 11 % of the outstanding series TO 1 warrants. The subscription period of the series TO 1 warrants runs from 23rd of August – 13th of September 2018. PBKM is one of Europe's leading players in the field of stem cells and is also contracted for the manufacturing of NXTCL's drug candidate ProTrans. PBKM is thus an important partner of
Stem cell company NextCell Pharma AB ("NXTCL") announces today that its shareholder and partner Polski Bank Komorek Macierzystych S.A. ("PBKM") is exercising all of its 320,000 warrants. This represents an investment of MSEK 1.6, corresponding to approximately 11 % of the outstanding series TO 1 ...
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2018-08-13
An additional batch of ProTrans is released prior to use in NextCell Pharma’s ongoing clinical trial.
Stem cell company NextCell Pharma AB ("NextCell") hereby announces that it has received another batch of ProTrans for clinical use. ProTrans is manufactured according to GMP (Good Manufacturing Practices) and the stem cells are selected with the company's selection algorithm to ensure quality. The selection is carried out by NextCell and the large-scale production is then produced by supplier and shareholder Polski Bank Komorek Macierzystych S.A. ("PBKM"). The delivery is intended for use in the second part of the company's ongoing Phase I/II trial with ProTrans, which includes a total of 15
Stem cell company NextCell Pharma AB ("NextCell") hereby announces that it has received another batch of ProTrans for clinical use. ProTrans is manufactured according to GMP (Good Manufacturing Practices) and the stem cells are selected with the company's selection algorithm to ensure quality. Th...
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