02.

About NextCell

NextCell is a Swedish biopharmaceutical company located in Huddinge, adjacent to the Karolinska University Hospital. NextCell is one company running two business areas with the same core – stem cells from umbilical cord. NextCell is focusing on research and development of novel stem cell therapies and is also running a tissue establishment and biobank, classified as healthcare provider.

Business concept

NextCell's business concept is to develop and commercialize mesenchymal stem cell products based on the Company's proprietary selection algorithm, primarily for the treatment of autoimmune diabetes, as well as other types of autoimmune diseases.

The lead candidate ProTrans, has in addition to successful completion of its safety study, shown efficacy in restoring the patient’s own insulin production. Further, NextCell operates Cellaviva, the largest private stem cell bank in the Nordic region. Cellaviva offer expectant parents store stem cells from their newborn children for future medical needs.

History

NextCell was founded in 2014 by CEO Dr. Mathias Svahn, two of the board members; professor Edvard Smith and Hans-Peter Ekre, and Dr. Lena Degling Wilkingsson. The company was originally called Cellaviva AB and it started Sweden’s first family saving stem cell bank.

At the beginning of 2014, Diamyd Medical AB became one of the company’s principal owners, and in late 2014 the company was granted a licence by Sweden’s Health and Social Care Inspectorate (IVO). The service for family saving of umbilical cord blood (hematopoietic stem cells or HSCs) was launched on the market in September 2015. In 2016 a decision was made to expand the operation and also conduct drug development and stem cell research, and at this point the company changed name to NextCell Pharma AB.

In 2016 a decision was made to expand the operation and also conduct drug development and stem cell research, and at this point the company changed name to NextCell Pharma AB.

The decision to expand was made when the company, through its Cellaviva activities, found an effective method for harnessing mesenchymal stem cells, isolating and cultivating them. Mesenchymal stem cells are found in various tissues, for instance the bone marrow. The majority of existing studies have been done on stem cells from bone marrow, an approach which involves painful, extensive procedures. There are therefore advantages to using the umbilical cord instead, as NextCell does. In late 2016 the company’s auxiliary Cellaviva also launched an option to save the tissue-forming mesenchymal stem cells, which means Cellaviva today banking both blood stem cells and tissue-forming stem cells. NextCell applied and started a clinical trial of its candidate drug ProTrans™ in late 2017.

Market

The market for stem cell treatment of autoimmune diabetes is expected to be extensive. At present there are some 40 million people with autoimmune Type 1 diabetes. An estimated 130,000 in the age of 18 -40 years are diagnosed every year world wide, corresponding to the inclusion criteria in ProTrans-1.

Type 1 Diabetes is an autoimmune disease that effects the body’s ability to produce insulin, a hormone necessary for stabilizing blood sugar levels. Current only available treatment is insulin. ProTrans treatment approach is different. It aims to restore the body’s own inherent ability to produce insulin.

Type 1 diabetes accounts for USD 14.9bn in health care costs yearly in the US (Children’s hospital Los Angeles). Type 1 diabetes is, opposed to Type 2, often diagnosed early in life, creating an even larger effect on life quality and health economics. Approximately 1.25 million Americans suffer from the condition and the global prevalence is growing.

  • An estimated 130 000 people in the age of 18-40 years world wide are diagnosed with type-1 diabetes every year, corresponding to the inclusion criteria in ProTrans-1 trial.
  • Likely price per treatment are $50,000 - $80,000
  • Market potential is $5 - 10 billion
ProTrans is particularly suitable for a licensing business model and Market potential is estimated to USD 5-10 billion per year and NextCell has received a pilot order of USD 40 000 to a British based biotech company.

Organisation

Management

Mathias Svahn
CEO
Ph.D. and co-founder, background as scientific manager at KI and country medical manager at Roche.
Sofia Fredrikson
CFO
MsC, Prior experience as a public accountant.  Responsible for the financial operations.
Edvard Smith
Medical director
MD, professor, co-founder and medically responsible for NextCell Pharma AB and Cellaviva.
Sofie Falk Jansson
Marketing & Sales director
experienced marketeer within business to consumer.
Maria Hägg
QA/RA manager
Ph.D. Background from clinical grade cell production and advanced therapeutic medicinal products (ATMP).

Board

Anders Essen-Möller
Chairman of the board
Board member and founder of Diamyd Medical AB and Synectics Medical AB
Camilla Myhre Sandberg
Board member
Independent board member with a marketing background in cell therapy and regenerative medicine, CEO at Miris Holding AB.
Edvard Smith
Board member
Professor of molecular genetics. His research has resulted in the identification of several disease genes and to new treatments.
Hans-Peter Ekre
Board member
Background as investment manager at Karolinska Development and R&D manager at Pharmacia, Astra and Biotech companies.
Pingis Hadenius
Board member
Economist and entrepreneur. Co-founder of i.a. Löwengrip AB, Nordic Tech House AB and Flattered AB.

Medical Advisers

Edvard Smith
MD
Professor in Molecular Genetics at the Department of Laboratory Medicine, Karolinska University Hospital and Karolinska Institutet, Huddinge, Sweden.
Gunvor Ekman-Ordeberg
MD
professor in Obstetrics and gynecology at Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden.
Per-Ola Carlsson
MD
professor in Medical Cell biology and experimental endocrinology at the Department of Medical Sciences, Transplantation and Regenerative medicine, Akademiska University Hospital, Uppsala, Sweden.
Timo Otonkoski
MD
Professor of Medical Stem Cell Research, Children’s Hospital and Biomedicum Stem Cell Center, Program of Molecular Neurology, University of Helsinki, Helsinki, Finland
Xiao-Dong Chen
MD
Professor and VA Research Health Scientist; Chief, Regenerative Medicine Program; Department of Physiology, University of Texas Health Science Center, San Antonio, USA

Company Structure

NextCell Pharma AB has no shareholdings and is not part of a corporate group. The company has one auxiliary company; Cellaviva.