Update on the ongoing clinical trials

NextCell Pharma AB (NextCell) is today providing a status update regarding its two ongoing clinical trials, presented at the Nordic Life Science days in Malmö. All patients in ProTrans-1 were treated by June 2019 and 8 out of 9 patients in the dose escalation part have already left the trial after 12 months follow-up. The ProTrans-Repeat has included 5 out of 18 patients.

NextCell is conducting two parallel clinical trials with the drug candidate ProTrans, with the aim to treat type-1 diabetes. A single dose of ProTrans is given and the patients own ability to produce insulin is compared before treatment and one year after treatment.

Today, in the morning about 11 PM, NextCell will present at the Nordic Life Science days in Malmö . Yesterday, NextCell was also invited to a panel discussion about advanced medicinal therapy products, together with representatives from Novo Nordisk, Immunicum, Pfizer, Novartis, HealthCap and Arctic Fund Management

ProTrans-1

ProTrans-1 is the first trial, initiated in January 2018. The trial is a randomized, placebo-controlled phase I/II trial and aims to collect efficacy and safety data regarding treatment of type-1 diabetes patients, who have been diagnosed less years than two years ago.

As previously communicated all patients in the ProTrans-1 trial have been included in the trial. As of today’s, date, eight out of nine patients in phase I, the dose escalation part, have completed treatment. Last visit, last patient is scheduled for September 24, which means that all patients in the dose escalation part will leave the trial before the end of September. The phase II part, which is randomized, placebo-controlled and double blinded, all patients have now been treated. The 12 month follow-up is the last visit and the last patient, last visit is expected to be during summer 2020.

ProTrans-Repeat 

ProTrans Repeat, which was initiated in May 2019, is a continuation trial of ProTrans-1 dose escalation part with the aim of maximizing data collection on repeated treatment, i.e. to find out whether repeated treatment can increase or maintain the effect of ProTrans over a longer period of time with retained safety. This repeat-dose trial includes nine of the patients who have originally been included in the dose escalation phase of the ProTrans-1 trial as well as another nine patients that serve as a control group, a total of 18 patients.

So far, four patients have been treated as part of the repeat-dose trial. Furthermore, one patient in the control group has been included as of today, meaning that a total of five out of 18 patients have been included into the trial.

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For more information about NextCell Pharma AB, please contact:

Mathias Svahn, CEO

Sofia Fredrikson, CFO

Phone: 08-735 5595

E-mail: info@nextcellpharma.com

www.nextcellpharma.com

About NextCell Pharma AB:

Stem cells are expected to change the way how many of today's life-threatening diseases are treated. NextCell

Pharma AB develops ProTrans, a drug candidate consisting of stem cells for the primary treatment of autoimmune and inflammatory diseases as well as for use in kidney transplants. ProTrans consists of selected stem cells derived from the umbilical cord tissue with NextCell's patent pending selection algorithm. NextCell operates the stem cell bank Cellaviva, which is Sweden's first and only IVO-approved biobank for family-saving of stem cells from umbilical cord blood and umbilical cord tissue.

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