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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2020-10-29
Study design and plan for the recently approved COVID-19 study with ProTrans
NextCell Pharma AB (“NextCell” or “the Company”) announced last week that a clinical trial with the stem cell therapy product ProTrans for the treatment of patients with COVID-19 has been approved. A total of nine patients will be treated within this phase 1b study, called "ProTrans 19+". The company provides an update prior to the initiation of the study. · ProTrans 19+ will treat COVID-19 patients with NextCell's lead candidate ProTrans. The study will be performed at the University Hospital in Örebro in collaboration with the Department of Clinical Trials and Karolinska Trial Alliance.
NextCell Pharma AB (“NextCell” or “the Company”) announced last week that a clinical trial with the stem cell therapy product ProTrans for the treatment of patients with COVID-19 has been approved. A total of nine patients will be treated within this phase 1b study, called "ProTrans 19+". The com...
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2020-10-21
ProTrans stem cells approved for clinical trials in COVID-19 patients
NextCell Pharma AB ("NextCell") today announces that the application for clinical trial of COVID-19 patients with the drug candidate ProTrans has been approved by both the Ethics Committy and the Swedish Medical Product Agency. The study will be conducted at the University Hospital in Örebro in collaboration with the Department of Clinical Trials and Karolinska Trial Alliance. ProTrans is developed as an immunomodulatory stem cell therapy presently evaluated in clinical trials treating patients with type-1 diabetes. However, the mechanism of immunomodulation is expected to be applicable in
NextCell Pharma AB ("NextCell") today announces that the application for clinical trial of COVID-19 patients with the drug candidate ProTrans has been approved by both the Ethics Committy and the Swedish Medical Product Agency. The study will be conducted at the University Hospital in Örebro in c...
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2020-10-14
NextCell presents at “Investerarjakten”
NextCell Pharma AB (“NextCell”) will today at 15:00 present at Investerarjakten. Viewers have the possibility to ask questions directly to CEO Mathias Svahn. The event is broadcast live on Studio Direct's youtube channel, the facebook group Aktier and on Investerarbrevet.se between 13:00-17:00. In September, NextCell published positive data for its Phase II study, ProTrans-2. The patients with type 1 diabetes treated with a dose of the stem cell drug ProTrans had maintained a statistically significantly higher insulin production after 12 months compared with the patients treated with placebo
NextCell Pharma AB (“NextCell”) will today at 15:00 present at Investerarjakten. Viewers have the possibility to ask questions directly to CEO Mathias Svahn. The event is broadcast live on Studio Direct's youtube channel, the facebook group Aktier and on Investerarbrevet.se between 13:00-17:00. ...
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2020-09-10
Presentation of the positive results from ProTrans-2
NextCell Pharma AB ("NextCell") announced earlier this week that the clinical diabetes trial ProTrans-2 had met the primary endpoints. On the occation of that, the principal investigator Professor Per-Ola Carlsson together with NextCell will hold a webcast presentation today, Thursday 10 September at 16.00. The result from the clinical trial ProTrans-2 said that patients treated with a single dose ProTrans show a statistically significant improved preservation of insulin production over 12 months, compared to patients treated with placebo (p-value < 0.05). Today, on Thursday the 10th of
NextCell Pharma AB ("NextCell") announced earlier this week that the clinical diabetes trial ProTrans-2 had met the primary endpoints. On the occation of that, the principal investigator Professor Per-Ola Carlsson together with NextCell will hold a webcast presentation today, Thursday 10 Septembe...
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2020-09-08
ProTrans shows significant effect in Diabetes
NextCell Pharma AB ("NextCell") today announces that the ProTrans-2 clinical trial met the primary endpoint. Patients treated with a single dose ProTrans show a statistically significant improved preservation of insulin production over 12 months, compared to patients treated with placebo (p-value < 0.05). A total of 15 patients were included in the ProTrans-2 trial. They were randomized to receive either ProTrans (n=10), NextCell’s proprietary stem cell therapy, or placebo (n=5). Treatment was blinded, ensuring that neither patients or their physicians knew whether they had received active
NextCell Pharma AB ("NextCell") today announces that the ProTrans-2 clinical trial met the primary endpoint. Patients treated with a single dose ProTrans show a statistically significant improved preservation of insulin production over 12 months, compared to patients treated with placebo (p-value...
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2020-08-03
NextCell announces Eurostars grant for developing an innovative cell therapy production platform
NextCell Pharma AB (“NextCell” or the “Company”) announces today that the Company together with 3 partner organizations have been awarded a €1.6M Eurostars grant of which NextCell’s share is €470,000. The aim of the project entitled Bioscale, is to optimise automated bioreactors to manufacture the drug candidate ProTrans. The SCINUS expansion system presents cost-efficient cell culturing, designed for standardised cell therapy production, leading to improved quality consistency and reduced cost. · NextCell has been granted €470,000 of a Eurostar grant totalling €1.6M. The total budget of the
NextCell Pharma AB (“NextCell” or the “Company”) announces today that the Company together with 3 partner organizations have been awarded a €1.6M Eurostars grant of which NextCell’s share is €470,000. The aim of the project entitled Bioscale, is to optimise automated bioreactors to manufacture th...
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2020-07-31
NextCell Pharma AB publishes its interim report for September 2019 - May 2020
NextCell Pharma AB (publ) (NXTCL) today announces that its Interim report for the period September 1, 2019 - May 31, 2020 now is available on the company’s website: https://www.nextcellpharma.com/en/investors#financial-report Nine months (2019-09-01 until 2020-05-31) · Operating income amounted to SEK 3 191 314 (1 273 201). · Operating result amounted to SEK -12 803 349 (-13 477 202). · Earnings per share* amounted to SEK -1,11 (-1,17). · Cash and bank amounted to SEK 5 612 952 (2 249 092). In addition, after the end of the period, in June 2020, the Company received an
NextCell Pharma AB (publ) (NXTCL) today announces that its Interim report for the period September 1, 2019 - May 31, 2020 now is available on the company’s website: https://www.nextcellpharma.com/en/investors#financial-report Nine months (2019-09-01 until 2020-05-31) · Operating income amounted...
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2020-07-06
NextCell approved for trading on Nasdaq First North
NextCell Pharma AB (publ) (“NextCell” or “the Company”) announces that Nasdaq Stockholm AB today has approved their application for trading on Nasdaq Stockholm First North. The last day for trading on Spotlight is Tuesday, July 21, 2020 and the first day for trading on Nasdaq First North is Wednesday, July 22, 2020. The shares in NextCell will be traded with unchanged ticker (NXTCL) and ISIN code (SE0009723125) and shareholders in NextCell need not take any action in connection with the list change. "The list change is a natural step in our development and is expected to attract a broader
NextCell Pharma AB (publ) (“NextCell” or “the Company”) announces that Nasdaq Stockholm AB today has approved their application for trading on Nasdaq Stockholm First North. The last day for trading on Spotlight is Tuesday, July 21, 2020 and the first day for trading on Nasdaq First North is Wedne...
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