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NextCell Pharma’s updated growth strategy

February 27, 2024

NextCell Pharma AB ("NextCell" or the "Company") today announces that the Company has decided to implement strategic changes. The new strategic direction means, amongst other things, that Cellaviva will become a wholly owned subsidiary and that the company's GMP facility will have new sources of revenue. The strategic changes will also result in cost savings as a result of staff reduction.

NextCell develops the cell therapy drug ProTrans for the treatment of type 1 diabetes. ProTrans is now being evaluated in NextCell's largest study to date, ProTrans Young (the paediatric study), a clinical trial that is progressing according to plan. In addition, a five year follow-up of previous studies with ProTrans will be carried out this year, which will provide the Company with valuable longitudinal data.

"It is our conviction that the results from these clinical trials will be sufficient to be able to sign an agreement to out-license ProTrans for type-1 diabetes. To better position NextCell for the future, we have decided on important strategic changes," comments NextCell Pharma's CEO Matthias Svahn.

Cellaviva becomes a subsidiary

Cellaviva is Scandinavia's largest private stem cell bank and the business has shown a strong growth over the past five years. In addition, the range has been broadened with a number of new products and services, both for consumers and companies. During the second half of 2023, it was announced that Cellaviva had entered into an agreement to distribute tissue products to clinics, which was possible thanks to the permission from IVO to operate tissue establishments in Sweden. The fact that Cellaviva will become a wholly owned subsidiary in the first step means that the business will have a clearer focus with its own dedicated management team with the task of increasing sales and achieving profitability.

Developing the GMP facility for more revenue sources

NextCell's GMP facility for manufacturing the drug ProTrans has been completed. Today, the drug ProTrans for the paediatric study is manufactured by NextCell's partner, contract manufacturer PBKM. The new facility has an excellent capacity and the Company has decided to commission the facility according to cleanroom grade D. This means that NextCell will have a new source of revenue through use of the facility for manufacturing cells for research purposes that will be sold to researchers and biotech companies. The study drug ProTrans will continue to be manufactured by PBKM, which is a cost-effective solution. As part of the new direction, NextCell has decided on staff reductions, which is expected to result in cost savings and streamlined activities.

For more information about NextCell Pharma, please contact
Mathias Svahn, CEO
Patrik Fagerholm, CFO
Tel: +46 8 735 55 95
E-mail: info@nextcellpharma.com
Website:www.nextcellpharma.com

Linkedin: https://www.linkedin.com/NextCell-Pharma
Twitter: https://twitter.com/NextCellPharma

For more information about Cellaviva, please contact
Sofie Falk Jansson, Head of Cellaviva
Tel: +46 8 735 20 10
E-mail: info@cellaviva.se
Website:www.cellaviva.se

Facebook: https://www.facebook.com/cellavivasverige
Instagram: https://www,instagram.com/cellaviva

Certified Adviser
FNCA Sweden AB is assigned as Certified Adviser.

About NextCell Pharma AB

NextCell is a cell therapy company in Phase 2 trials with the drug candidate ProTrans for the treatment of type 1 diabetes. The focus is to obtain market approval of ProTrans via a Phase 3 trial. In addition to type 1 diabetes, ProTrans is used in two clinical trials for COVID-19, in Örebro and in Montreal, Canada. The company is in the process of establishing its own GMP-facility for the production of ProTrans. Furthermore, NextCell owns 8.5% in FamicordTX, a CAR-T start-up in oncology, and 100% of Cellaviva, Scandinavia’s largest private stem cell bank licensed by the Swedish Health Authority (IVO) to preserve and store stem cells from umbilical cord blood and umbilical cord tissue for family use.

 

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2021-07-30
NextCell Pharma publishes Interim Report 3 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. Third quarter (2020-03-01 until 2021-05-31) · Operating income amounted to SEK 905 750 (750 512). · Operating result amounted to SEK -6 457 514 (-4 833 332). · 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 ...
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2021-06-22
NextCell enters CAR-T joint venture
NextCell Pharma AB (“NextCell”) today announces a joint venture together with their long-term collaborator and contract manufacture organisation, Polski Bank Komórek Macierzystych (PBKM, FamiCord Group). NextCell has acquired ~10 % of shares in the newly started company FamiCordTx through a directed equity issue, raising the capital with 0,5 MEuro in cash. FamiCordTx has exclusively licensed a patent pending CAR-T technology and the tech transfer is completed, and the production of CAR-T cell therapy is awaiting ATMP manufacturing approval before production of CAR-T for clinical trial use can
NextCell Pharma AB (“NextCell”) today announces a joint venture together with their long-term collaborator and contract manufacture organisation, Polski Bank Komórek Macierzystych (PBKM, FamiCord Group). NextCell has acquired ~10 % of shares in the newly started company FamiCordTx through a direc...
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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.
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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 ...
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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 ...
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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,
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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...
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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...
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