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.

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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.

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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).

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