ProTrans cell therapy provides long-term effect in type-1 diabetes with a single treatment

October 20, 2022

NextCell Pharma AB ("NextCell" or the "Company") today announces that patients who 3 years ago were treated with ProTrans in the phase II study ProTrans-2 have maintained significantly higher endogenous insulin production than patients who received placebo, (63% compared to 23%).The results from the interim follow-up study ProTrans-Obs suggest that the treatment changes the course of the disease and that the effect persists overtime.

In 2018, the randomized double-blind phase II clinical trial, ProTrans-2 started at Karolinska University Hospital. A total of 15 patients were randomized 2:1 to treatment with ProTrans or placebo. The primary endpoint is percentage of endogenous insulin production one year after therapy and patients treated with ProTrans maintained an average of 90% compared to the placebo group who maintained 53%.

The 14 patients who completed ProTrans-2 were after completion offered to participate in a follow-up study, where they are followed for another 5 years, ProTrans-Obs. Some patients abstained from participation due to long journeys, 6 patients treated with ProTrans and 5patients who received placebo are included in the study. In ProTrans-Obs, the patients' endogenous insulin production is measured semi-annually and the latest analysis was carried out after 3 years of follow-up. In this interim analysis, ProTrans shows a statically significant treatment effect at all analyzed timepoints (p<0.05).

NextCell announced on October 18, 2022 that patients with type-1 diabetes undergoing two high-dose treatments of ProTrans cell therapy retain significantly higher endogenous insulin production than patients treated with low and medium dose in the clinical drug trial, ProTrans-Repeat. The results from ProTrans-Obs (one treatment with ProTrans)and ProTrans-Repeat (two treatments with ProTrans) cannot be directly compared, but both studies clearly show that ProTrans has a long-term effect for the treatment of type-1 diabetes.

 

This information is the information that NextCell Pharma AB is required to disclose under the EU Market Abuse Regulation. The information was provided by the below contactperson for publication on 20th October 2022, 13.30 CET.

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
Hemsida: 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

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 in2023. 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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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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