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Interim Report 1 2019/2020

Cellaviva Sverige - January 31, 2020 - 0 comments

NextCell Pharma AB today publish the Interim Report 1 for the period September 1 – November 30, 2019.

“NextCell”, “NXTCL” or “Company” refer to NextCell Pharma AB with organization number 556965-8361.The amount in brackets refers to the corresponding period in the previous year. Note that the Company’s fiscal year is September 1-August 31. 

First quarter (2019-09-01 until 2019-11-30)

  • Operating income amounted to SEK 1 222 087 (73 745).
  • Operating result amounted to SEK -3 755 926 (-5 440 809).     
  • Earnings per share* amounted to SEK -0,20 (-0,38).
  • Cash and bank amounted to SEK 15 715 418 (10 403 405).
  • Solidity** amounted to 84,6 (59,2) %.

*Result per share: operating results divided by the average number of shares. Average number of shares for the first quarter of 2019/2020: 19 144 092 (8 505 425) shares. Number of shares in NextCell as per November 30th, 2019: 19 144 092 shares (8 505 425).

** Equity ratio: shareholders’ equity of the balance sheet total.

CEO comments

The financial year 2019/2020 has started well. The first quarter shows strong growth in Cellaviva. Sales is up and the quarter’s income corresponds to the income of last year’s first three quarters together. The clinical trials are ongoing, and all patients have, by now, been treated with ProTrans. The treatment has already been proven to be safe and after the end of the period ProTrans’s therapeutic effect has also been shown.

In 2018, the first nine Type-1 diabetes patients were treated with ProTrans stem cells in the dose scaling part (phase-1) of the ProTrans-1 study. After a 12 months follow-up, they did left the ProTrans-1 study and subsequently also agreed to undergo another treatment in NextCell’s second clinical trial, ProTrans-Repeat. We are extremely grateful for their commitment and confident in the fact that all nine chose to get a prepeated treatment.

In December, data from the dose escalation section of ProTrans-1 were analyzed. The study design was intended only to evaluate safety at three different doses of ProTrans; therefore, no control patients were included. Nevertheless, we could see a statistically significant difference between low dose and medium or high dose in terms of efficacy.

Patients treated with medium or high dose ProTrans have, one year after treatment, better preserved their ability to produce insulin compared to those receiving low dose (P <0.05). The effect of treatment is measured as a comparison between the patient’s own insulin production before treatment and one year after treatment. The natural course of action for this patient group is an insulin production drop by about 20-40% during the measurement period, comparable to the course of patients who received a low dose. Low doses are unlikely to have any effect, while the higher doses appear to be able to stop the reduction of insulin production during at least the 12 months studied.

The promising effect means that we are stepping up preparations for the next phase in the clinical trial program. The ProTrans-1 trial will be completed in July after last patient has been on the last visit. Later in the summer, phase II data can be analyzed, ie comparison of the 10 patients treated with high-dose ProTrans and the 5 patients who received placebo. My hope is that we will submit an application for a larger Phase IIb study by the end of 2020, a study that may lead to conditional market approval.

Cellaviva has experienced strong growth over the past year. Our presence in Denmark has increased and we now have offices in both Stockholm and Copenhagen. Cellaviva is Scandinavia’s largest stem cell bank and we have customers from all over the Nordic region.

The sales increase is the result of a long-term strategy to spread the knowledge about stem cells through digital channels and with the help of ambassadors. Cellaviva has also been helped by NextCell’s clinical trials. We are not only a stem cell bank, but we are also developing treatments based on the same types of stem cells. It shows the importance of stem cell sparing and will hopefully also help people with diabetes get effective treatment for their disease.

NextCell is doing well! 2020 will be an eventful year and I am grateful to be able to share the journey with you.

Mathias Svahn, Ph.D.

CEO NextCell Pharma AB

Significant events during the first quarter of 2019/2020

  • The last patient and last visit for ProTrans-1 Phase-1, the dose scaling part, was completed at the end of September. The Phase-I part of the study is now complete.
  • The last patient in the ProTrans-Repeat study’s active treatment group received treatment at the beginning of October. This means that all treatments with ProTrans for the two ongoing studies are now complete.
  • NextCell opens, in October 2019, a new office in Copenhagen. The Copenhagen office is primarily intended to be a hub for the Danish Cellaviva business with the opportunity to host customers, trainings and more. The Copenhagen office also enables increased exposure and presence for NextCell in the Öresund region.
  • NXTCL publishes a notice to attend the Annual General Meeting. Notice with suggested resolutions is available on the Company´s website (www.nextcellpharma.com). Entrepreneur Pingis Hadenius will be proposed as a new member of the Board.

Significant events after the reporting period

  • NextCell announces in early December that an interim analysis of the dose escalation study (phase 1 part of ProTrans-1), which is a safety study, shows that after one year, the six patients treated with high and medium doses have retained their insulin production significantly better (P <0.01) than the three patients who received a low dose of ProTrans. No serious side effects have been reported.
  • NXTCL holds its Annual General Meeting. Communique with a summary of decided resolutions is available on the Company´s website (www.nextcellpharma.com).
  • NextCell announces, in mid-December, that the Swedish Medical Products Agency (Läkemedelsverket) has extended the company’s wholesale license. In October, the Swedish Medical Products Agency carried out a routine inspection of NextCell’s operations, which resulted in the license being extended for another five years.

Two business areas based on the same technology

Stem cells are a revolutionary medical treatment for today’s severe and incurable diseases. NextCell develops an umbilical cord stem cell based drug candidate, ProTrans, primarily for the treatment of autoimmune and inflammatory diseases.

NextCell also operates Cellaviva, Scandinavia’s largest stem cell bank of umbilical cord blood and umbilical cord tissue stem cells for familial use. The umbilical cord is a rich source of young and viable stem cells that can be collected by non-invasive methods. The stem cells are harvested from the umbilical cord after birth, making valuable use of dispensable material.

ProTrans™ is developed by NextCell using the company’s selection algorithm (patent pending). ProTrans is a stem cell product consisting of young healthy mesenchymal stem cells from the umbilical cord with both a regenerative and an immunosuppressive effect.

Cellaviva™ is NextCell’s product name for banking of stem cells for familial use. We offer future parents a service to collect their child’s stem cells and save them in our biobank for future use.

Stay up to date with the latest development in NextCell Pharma

LinkedIn: https://www.linkedin.com/company/15255207/

Twitter: https://twitter.com/NextCellPharma

For more information about NextCell Pharma AB, please contact:

Mathias Svahn, CEO

Sofia Fredrikson, CFO

Phone: 08-735 5595

E-mail: info@nextcellpharma.com