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 cord‑derived mesenchymal stromal cells preserve endogenous insulin production in type 1 diabetes: a Phase I/II randomised double‑blind placebo‑controlled 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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2020-12-15

ProTrans Observation Study for long term efficacy in diabetes

NextCell Pharma AB (“NextCell” or “the Company”) today announces that an observational study, ProTrans-OBS, has been approved by the Swedish Ethical Review Board for long-term follow-up of patients previously participating in the ProTrans-2 clinical trial. The study is conducted by professor Per-Ola Carlsson, at Uppsala University. The observational study, ProTrans-OBS, is a non-interventional study, i.e. patients will not be treated with additional doses of ProTrans. Participants that completed the ProTrans-2 trial will be asked for informed consent for biannual clinical assessment of

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2020-12-10

ProTrans demonstrates effect at 2 years after repeated treatments

NextCell Pharma AB ("NextCell") today announces that the ProTrans-Repeat trial met its primary safety endpoint. There were no severe adverse events recorded during the 12-month follow-up period after a second dose of ProTrans™ (ProTrans). Furthermore, a strong tendency of sustained efficacy was observed in the three patients receiving high dose ProTrans. · Primary safety endpoint met · Tendency of sustained efficacy observed for high dose patients · 2-year preservation of insulin production significantly higher for patients treated with high dose as compared to low dose ProTrans-

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2020-12-03

NextCell Pharma publishes prospectus relating to the rights issue

The Board of Directors of NextCell Pharma AB ("NextCell" or the “Company”) has prepared a prospectus (the “Prospectus”) relating to the new issue of shares with preferential rights for existing shareholders of approximately SEK 150 million (the Rights Issue”), which was resolved by the Board of Directors on 26 November 2020 pursuant to the authorisation from the annual general meeting. The Prospectus has today been approved and registered by the Swedish Financial Supervisory Authority. NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE

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2020-11-20

The Board of Directors of NextCell Pharma intends on resolving on a fully guaranteed preferential rights issue of approximately SEK 150 million

The Board of Directors of NextCell Pharma AB (“NextCell” or the “Company”) today announces its intention to resolve on a fully guaranteed rights issue of up to approximately SEK 150 million with preferential rights for the Company’s existing shareholders (the “Rights Issue”). The Board of Directors’ intent to resolve on the Rights Issue requires that the shareholders at the Annual General Meeting on 24 November 2020 authorizes the Board of Directors to resolve on share issues. In the notice convening the Annual General Meeting, which was published by press release on 23 October 2020, the

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2020-11-16

NextCell supports ProTrans study for children and adolescents

NextCell Pharma AB (“NextCell”) has entered into an agreement with Professor Per-Ola Carlsson, at Uppsala University Hospital and Uppsala University, with the aim of contributing the stem cell product ProTrans™ (ProTrans) for the treatment of children and adolescents with type 1 diabetes, within the framework of clinical drug trials. The study, which is in the planning stage, is part of NextCell's strategy to support academic groups with drugs to be able to evaluate ProTrans for a wider use. NextCell's drug candidate, ProTrans, for the treatment of type 1 diabetes is a mesenchymal stem cell

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2020-11-09

NextCell has formally kicked-off its Eurostars funded project ‘ Bioscale ’

NextCell Pharma AB (“NextCell” or the “Company”) announces today that it, in cooperation with the consortium members: MyCellHub, SEFA and Scinus Cell Expansion, now officially has kicked-off the earlier announced Eurostars project. The Eurostars project Bioscale will focus on using a novel cell expansion system developed by Scinus Cell Expansion, to further test, develop and validate the involved bioprocesses used in the production of NextCell’s drug candidate ProTrans™ (ProTrans). · NextCell has been granted €470,000 of a Eurostar grant totalling €1.6M. The total budget of the project is €2.

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2020-10-30

NextCell publishes its Year-End Report

NextCell Pharma AB (publ) (NXTCL) publishes its Year-End Report for the period September 1, 2019 - August 31, 2020 The report is available on the company’s website: https://www.nextcellpharma.com/en/investors#financial-report NextCells share is traded on Nasdaq First North Growth Market under the ticker "NXTCL". The amount in brackets refers to the corresponding period in the previous year. Twelve months (2019-09-01 until 2020-08-31) ● Operating income amounted to SEK 4 166 123 (1 964 132). ● Operating result amounted to SEK -17 680 697 (-17 997 787). ● Earnings per share* amounted

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2020-10-29

Study design and plan for the recently approved COVID-19 study with ProTrans

NextCell Pharma AB (“NextCell” or “the Company”) announced last week that a clinical trial with the stem cell therapy product ProTrans for the treatment of patients with COVID-19 has been approved. A total of nine patients will be treated within this phase 1b study, called "ProTrans 19+". The company provides an update prior to the initiation of the study. · ProTrans 19+ will treat COVID-19 patients with NextCell's lead candidate ProTrans. The study will be performed at the University Hospital in Örebro in collaboration with the Department of Clinical Trials and Karolinska Trial Alliance.

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