NextCell publishes its Interim Report 2 2022/2023

April 27, 2023

NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 2 for the period December 1, 2022 – February 28, 2023 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.



 

Second quarter (2022-12-01 until 2023-02-28)

  • Operating income amounted to 2,734 (1,840) TSEK, of which Cellaviva counted for 2,106 (1,279) TSEK.
     
  • Operating result amounted to -11,408 (-10,212) TSEK.
     
  • Earnings per share* amounted to -0.33 (-0.30) SEK.
     
  • Cash and bank amounted to 77,617 (118,170) TSEK.
     
  • Solidity** amounted to 89.3 (92.7) %


First half year (2022-09-01 until 2023-02-28)

  • Operating income amounted to 5,747 (3,187) TSEK of which Cellaviva counted for 4,244 (2,616) TSEK.
     
  • Operating result amounted to -20,327 (-16,684) TSEK.
     
  • Earnings per share* amounted to -0.59 (-0.49) SEK.


*Earnings per share: Profit for the period divided by average number of shares. Average number of shares for the second quarter 2022/2023: 34,379,523 (34,379,523)
 shares. Number of shares in NextCell as of
February 28, 2022: 34,379,523 (34,379,523) shares.
**Solidity: Own capital's share of the sheet total.

Significant events in the second quarter

  • NextCell announced at the end of March that the first two adolescents in the older age cohort (12-21 years) had undergone treatment in the phase II part of the childhood diabetes study.
  • The company announced in mid-January that it had received positive comments and recommendations on the draft pediatric plan (PIP) previously submitted to the European Medicines Agency's pediatric unit (PDCO).
  • NextCell announced at the end of January that it is expanding the ProTrans study in COVID-19 to the treatment of severe pneumonia caused by flu, RS and HMP virus.


Significant events after the reporting period

  • NextCell announced at the end of March that the results of the clinical phase I/II study in type 1 diabetes had been accepted for publication in the peer-reviewed journal Diabetologia, the official journal of the European Association for the Study of Diabetes
  • The company announced late April that the FDA has approved a product of multiplied stem cells from umbilical cord blood. It is a breakthrough that could lead to increased interest in saving stem cells for private use, where Cellaviva is the market leader in Scandinavia.

This disclosure contains information that NextCell Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 27-04-2023 07:30 CET.

For more information about NextCell Pharma, please contact
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: +46 8 735 5595
E-mail: info@nextcellpharma.com

Websites:
NextCell Pharma AB: www.nextcellpharma.com
Cellaviva Sverige: www.cellaviva.se
Cellaviva Danmark: www.cellaviva.dk

LinkedIn: https://www.linkedin.com/company/15255207/
Twitter: https://twitter.com/NextCellPharma

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).

Download attachmentRead full press release on Cision (external link)
2021-06-17
Advisory meeting with the European Medicines Agency
NextCell Pharma AB (“NextCell” or “the Company”) announces that a scientific advisory meeting with the European Medicines Agency (EMA) has been held regarding ProTrans and the path forward to a possible market approval. The focus was the design of the phase III study ProTrans-3, which NextCell intends to submit an application for later this year.
NextCell Pharma AB (“NextCell” or “the Company”) announces that a scientific advisory meeting with the European Medicines Agency (EMA) has been held regarding ProTrans and the path forward to a possible market approval.
Read moreRead more
2021-06-10
COVID-19 patient treated with ProTrans
NextCell Pharma AB (“NextCell” or “the Company”) announces that the first patient with severe pneumonia, as a result of COVID-19 infection, has now been treated with ProTrans. The patient was hospitalized at Örebro University Hospital, where the phase 1b study ProTrans19+SE is in progress led by Principal Investigator Associate Professor Josefin Sundh. NextCell's drug candidate, ProTrans, is an immune- balancing cell therapy for the treatment of autoimmune diseases and inflammatory conditions. Patients with severe pneumonia as a result of by SARS-CoV-2 infection are at risk of rapid
NextCell Pharma AB (“NextCell” or “the Company”) announces that the first patient with severe pneumonia, as a result of COVID-19 infection, has now been treated with ProTrans. The patient was hospitalized at Örebro University Hospital, where the phase 1b study ProTrans19+SE is in progress led by ...
Read moreRead more
2021-06-08
Article about Gene and Cell Therapy
Professor Edvard Smith, CMO NextCell Pharma AB ("NextCell" or the "Company") has written a review article in the Swedish Medical Journal (Läkartidningen) entitled "Gene therapy now comes in many medical specialties", together with Associate Professor Pontus Blomberg, Director of Operations; both at the Department of Laboratory Medicine, Karolinska Institutet; Karolinska Centre for Cell Therapy, Karolinska University Hospital, Stockholm. The main message of the article is that the development of gene therapy has been rapid, and more and more preparations are reaching patients and in many
Professor Edvard Smith, CMO NextCell Pharma AB ("NextCell" or the "Company") has written a review article in the Swedish Medical Journal (Läkartidningen) entitled "Gene therapy now comes in many medical specialties", together with Associate Professor Pontus Blomberg, Director of Operations; both ...
Read moreRead more
2021-05-28
NextCell presents their latest phase II clinical data at ISCT 2021
NextCell Pharma AB (“NextCell”) announces today that they will present their findings from their Phase I/II study entitled “Wharton´s Jelly Derived Mesenchymal Stromal Cell Treatment of Adult Patients Diagnosed With Type I Diabetes” (NCT 03406585) at the International Society of Cell and Gene Therapy virtual conference 2021 (May 26[th]-28[th]). NextCell’s CSO, Dr. Lindsay Davies will attend the meeting and present a poster entitled “Protrans Wharton’s Jelly Mesenchymal Stromal Cells Preserve Beta Cell Function in Newly Diagnosed Type I Diabetes Patients – A Randomised, Double-Blinded,
NextCell Pharma AB (“NextCell”) announces today that they will present their findings from their Phase I/II study entitled “Wharton´s Jelly Derived Mesenchymal Stromal Cell Treatment of Adult Patients Diagnosed With Type I Diabetes” (NCT 03406585) at the International Society of Cell and Gene The...
Read moreRead more
2021-05-26
Study start for ProTrans in COVID-19
NextCell Pharma AB (“NextCell”) announces today that both the Canadian and Swedish COVID-19 studies have been initiated and are now ready to include patients with severe pneumonia triggered by SARS-CoV-2 infection. The treatment is aimed at patients who are hospitalized and with a high risk of needing ventilatory support. ProTrans is given as a peripheral infusion. With the aim of reducing hyper-inflammation within the lungs. The goal of the treatment is to shorten hospital stay and time for rehabilitation, and to save lives. · ProTrans19 + CA, a randomized placebo-controlled phase-II study
NextCell Pharma AB (“NextCell”) announces today that both the Canadian and Swedish COVID-19 studies have been initiated and are now ready to include patients with severe pneumonia triggered by SARS-CoV-2 infection. The treatment is aimed at patients who are hospitalized and with a high risk of ne...
Read moreRead more
2021-05-21
Recruitment start for the ProTrans study for treatment of COVID-19
NextCell Pharma AB (“NextCell”) announces today that the Swedish COVID-19 stuy has been initiated and is now ready to include patients with severe pneumonia triggered by SARS-CoV-2 infection. The treatment is aimed at patients who are hospitalized and with a high risk of needing ventilatory support. ProTrans is given as a peripheralinfusion. With the aim of reducing hyper-inflammation within the lungs. The goal of the treatment is to shorten hospital stay and time for rehabilitation and save lifes. The study will be performed at the University Hospital in Örebro in collaboration with the
NextCell Pharma AB (“NextCell”) announces today that the Swedish COVID-19 stuy has been initiated and is now ready to include patients with severe pneumonia triggered by SARS-CoV-2 infection. The treatment is aimed at patients who are hospitalized and with a high risk of needing ventilatory suppo...
Read moreRead more
2021-04-29
NextCell Pharma publishes Interim Report 2 2020/2021
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 2 for the period September 1, 2020 - February 28, 2021 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. Second quarter (2020-12-01 until 2021-02-28) · Operating income amounted to SEK 1 007 846 (1 364 645). · Operating result amounted to SEK -8 148 299 (-4 228 449). · Earnings
NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 2 for the period September 1, 2020 - February 28, 2021 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 ...
Read moreRead more
2021-04-27
Presentation of the pediatric diabetes study tomorrow Wednesday
NextCell Pharma AB (“NextCell”) has invited Professor Per-Ola Carlsson to present study design and rational for the pediatric study, ProTrans-Young. The trial, recently approved, is a phase I / II study with a total of 66 patients with newly diagnosed type-1 diabetes. The presentation will be broadcasted tomorrow, Wednesday April 28, at 14:00. Afterwards, there is an opportunity to ask questions to Professor Carlsson and NextCell's CEO and CSO. https://youtu.be/kE4POLMlXWA.
NextCell Pharma AB (“NextCell”) has invited Professor Per-Ola Carlsson to present study design and rational for the pediatric study, ProTrans-Young. The trial, recently approved, is a phase I / II study with a total of 66 patients with newly diagnosed type-1 diabetes. The presentation will be br...
Read moreRead more