ProTrans and NextCell gain international attention

August 8, 2023

Results from Professor Per-Ola Carlsson, Principal Investigator for NextCell’s Phase-I/II study with ProTrans stromal cells for Type 1 Diabetes are now published and featured in the Up-front section of the current issue of Diabetologia. The article was selected by the Editor as worthy of special attention, for its high quality and interest to the diabetes field. Furthermore, the article has already been cited in an International scientific journal.

 “We are proud that our work is recognized and appreciated by the Editor. This will further increase the international exposure of NextCell”, says Mathias Svahn, CEO

Diabetologia, the official journal of the European Association for the Study of Diabetes (EASD) summarizes the importance of the study on their website:

Umbilical cordderived mesenchymal stromal cells preserve endogenous insulin production in type 1 diabetes: a Phase I/II randomised doubleblind placebocontrolled trial
Per-Ola Carlsson, Daniel Espes, Sofia Sisay, Lindsay C. Davies, C. I. Edvard Smith and Mathias G. Svahn

Mesenchymal stromal cells (MSCs) have been shown to modulate the immune system and dampen inflammatory and autoimmune responses in numerous diseases. In this issue, Carlsson et al (https://doi.org/10.1007/s00125-023-05934-3) report their findings from a Phase I/II dose escalation and double-blind placebo-controlled clinical trial investigating the Wharton’s jelly MSC drug product, ProTrans, for the treatment of new-onset type 1 diabetes. In the dose escalation safety study, the authors demonstrate that ProTrans can be safely administered intravenously with no serious adverse events. A fixed dose of 200 million MSCs preserved the production of endogenous insulin and reduced exogenous insulin replacement compared with placebo 1 year after treatment. The authors conclude that a single treatment with ProTrans could potentially delay type 1 diabetes disease progression, thereby reducing the associated complications and improving quality of life.”

In the international scientific journal, Frontiers in Cell and Developmental Biology (June 2023), Hana Drobiova and coworkers list advantages of using stem or stromal cells from the umbilical cord, such as ProTrans, enabling the use of WJ-MSCs as therapeutic agents in regenerative medicine. In particular Professor Carlsson’s clinical trials using allogenic WJ-MSCs to investigate their safety and efficacy are highlighted

The clinical trial with ProTrans is a collaboration with Professor Per-Ola Carlsson, Principal Investigator at Uppsala University and Karolinska Trial Alliance, Karolinska University Hospital, Huddinge, Sweden (Clinicaltrials.gov identifier NCT03406585).

The article is available as open access at https://pubmed.ncbi.nlm.nih.gov/37221247/

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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2018-10-31
Publication of year-end report
NextCell Pharma AB (”NXTCL”, “NextCell”) today, released its year-end report for book year 2017/2018 (September 2017 – August 2018). Twelve Months (2017-09-01 until 2018-08-31)  · Net sales amounted to SEK 655 413 (517 203). · Operating result amounted to SEK –14 032 294 (-13 245 206).                   · Result per share amounted to SEK -0,61 (-0,64). · Cash and bank amounted to SEK 3 115 876 (16 600 937). · Solidity amounted to 59 (88) %. · Net sales amounted to SEK 127 868 (198 765). · Operating result amounted to SEK -3 422 282 (-4 757 996).
NextCell Pharma AB (”NXTCL”, “NextCell”) today, released its year-end report for book year 2017/2018 (September 2017 – August 2018). Twelve Months (2017-09-01 until 2018-08-31)  · Net sales amounted to SEK 655 413 (517 203). · Operating result amounted to SEK –14 032 294 (-13 245 206).      ...
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2018-10-25
The Safety Committee recommends proceeding with part 2 of the stem cell trial in type 1 diabetes
The stem cell company NextCell Pharma AB ("NXTCL") today announced that the Data and Safety Monitoring Board recommends Professor Per-Ola Carlsson Academic Hospital, Uppsala University and NXTCL to proceed with the second part of the clinical trial with ProTrans. Patients with type 1 diabetes aged 18-40 years old who had the disease for a maximum of 2 years and who have some own insulin production are candidates to be included in the study. The second part of the ProTrans trial is a Phase-II study with the aim to further evaluate the efficacy and safety of ProTrans. The efficacy of the
The stem cell company NextCell Pharma AB ("NXTCL") today announced that the Data and Safety Monitoring Board recommends Professor Per-Ola Carlsson Academic Hospital, Uppsala University and NXTCL to proceed with the second part of the clinical trial with ProTrans. Patients with type 1 diabetes age...
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2018-10-01
NXTCL’s Cellaviva brand is expanding into Denmark
NextCell Pharma AB ("NXTCL") announced today, that the Cellaviva brand will expand its operations into Denmark. As of 1st October 2018, Cellaviva will offer family stem cell banking there. The idea of family saving of stem cells is already an established business in Denmark and NXTCL estimates that its entrance into Denmark will allow for a doubling of annual sales for Cellaviva. The establishment fits within the existing budget and does not affect NXTCL's capital requirements. Cellaviva has now decided to expand its operations to Denmark as of 1st October 2018. The company holds all the
NextCell Pharma AB ("NXTCL") announced today, that the Cellaviva brand will expand its operations into Denmark. As of 1st October 2018, Cellaviva will offer family stem cell banking there. The idea of family saving of stem cells is already an established business in Denmark and NXTCL estimates th...
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2018-09-20
Redeemed warrants are now registered with the Swedish Companies Registration Office
NextCell Pharma AB ("NXTCL") announced today, 20th September 2018, that the exercised series TO 1 warrants, whose subscription period ended on 13th September 2018, have now been registered with the Swedish Companies Registration Office. A total of 2 720 931 new shares have been registered, which means that the number of shares in NXTCL after registration amounts to 11 226 356. The share capital amounts to SEK 2 301 402.98. Conversion of interim shares to shares is expected to take place on 28th September 2018. Different agents may take a different amount of time to convert, which means that
NextCell Pharma AB ("NXTCL") announced today, 20th September 2018, that the exercised series TO 1 warrants, whose subscription period ended on 13th September 2018, have now been registered with the Swedish Companies Registration Office. A total of 2 720 931 new shares have been registered, which ...
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2018-09-17
NXTCL is allocated approximately SEK 12.9 million through redemption of warrants
During the period 23rd August – 13th September 2018, holders of series TO 1 warrants in NextCell Pharma AB ("NXTCL") have been able to subscribe for shares on the basis of their warrants. In total 2 720 931 warrants of series TO 1 were exercised, which means a subscription rate of 95.11 percent. NXTCL is therefore allocated approx. SEK 13.6 million before issue costs, which are estimated to amount to approx. SEK 0.7 million. CEO Mathias Svahn comments "I would like to thank all of those who have shown - and continue to show - their interest and trust in the stem cell company NXTCL. We
During the period 23rd August – 13th September 2018, holders of series TO 1 warrants in NextCell Pharma AB ("NXTCL") have been able to subscribe for shares on the basis of their warrants. In total 2 720 931 warrants of series TO 1 were exercised, which means a subscription rate of 95.11 percent. ...
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2018-09-11
NextCell to present status of ongoing clinical trial at the Nordic Life Science Days
Stem cell company NextCell Pharma AB ("NXTCL") today presents a status update of its ongoing Phase I/II trial with ProTrans for the treatment of type 1 diabetes. Two out of three patients in the high dose cohort have now undergone treatment and the third patient is scheduled for treatment later this week. NXTCL's clinical trial is divided into two parts, the first part is a three-step dose escalation phase with three patients in each cohort, a total of nine patients. The second part of the trial is randomized, double-blind and placebo-controlled, with ten patients receiving ProTrans and five
Stem cell company NextCell Pharma AB ("NXTCL") today presents a status update of its ongoing Phase I/II trial with ProTrans for the treatment of type 1 diabetes. Two out of three patients in the high dose cohort have now undergone treatment and the third patient is scheduled for treatment later t...
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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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