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.

 

Download attachmentRead full press release on Cision (external link)
2019-06-19
NextCell has treated the first patient in the ProTrans-Repeat trial
NextCell Pharma AB (NextCell) announces that earlier today the first patient was treated as part of the ProTrans-Repeat trial, which is NextCell’s second clinical trial. ProTrans-Repeat is a Phase IIa clinical trial which includes patients receiving active treatment with ProTrans and who have previously been treated in the ProTrans-1 study's dose escalation phase. This means that the participants receive their second treatment with ProTrans, just over a year after the first. The goal of the ProTrans-Repeat trial is to test whether repeated treatment can increase or maintain the effect of
NextCell Pharma AB (NextCell) announces that earlier today the first patient was treated as part of the ProTrans-Repeat trial, which is NextCell’s second clinical trial. ProTrans-Repeat is a Phase IIa clinical trial which includes patients receiving active treatment with ProTrans and who have pre...
Read moreRead more
2019-06-11
Anders Essen-Möller subscribes to his entire stakes in NextCell Pharmas right issue
The two largest owners of NextCell Pharma AB (“NextCell” or “The Company”) Anders Essen-Möller and Diamyd Medical AB, fully subscribe for their respective shares in NextCells ongoing rights issue. This means that both parties consolidate their ownership interests and that Essen-Möllers ownership in NextCell after the investments increases from approximately SEK 3.6 million to 6.0 million. Regarding the ongoing rights issue in NextCell, the principal owner Anders Essen-Möller, also the chairman of the company, has chosen to fully utilize its allotted subscription rights, which means that he
The two largest owners of NextCell Pharma AB (“NextCell” or “The Company”) Anders Essen-Möller and Diamyd Medical AB, fully subscribe for their respective shares in NextCells ongoing rights issue. This means that both parties consolidate their ownership interests and that Essen-Möllers ownership ...
Read moreRead more
2019-06-05
Selected to participate in the EIT Health Start.Smart.Global (SSG) programme.
NextCell Pharma AB (publ) ("NextCell") has been chosen as one of a select group of companies to participate in the EIT Health Start.Smart.Global (SSG) programme. The programme focusses on helping European life science SMEs successful entries into Japan and South Korea. EIT Health is a Knowledge and Innovation Community established by the European Institute for Innovation & Technology (EIT) (https://eit.europa.eu/), an independent EU body set up to promote innovation and entrepreneurship across Europe. The EIT Health Start.Smart.Global (SSG) programme, helps European life science SMEs
NextCell Pharma AB (publ) ("NextCell") has been chosen as one of a select group of companies to participate in the EIT Health Start.Smart.Global (SSG) programme. The programme focusses on helping European life science SMEs successful entries into Japan and South Korea. EIT Health is a Knowledge a...
Read moreRead more
2019-05-17
NextCell now has two parallel running clinical trials, ProTrans-1 and ProTrans-Repeat which was initiated today
NextCell Pharma AB (NextCell) announces that the initiation meeting for ProTrans-Repeat was held today at Karolinska University Hospital in Huddinge. ProTrans-Repeat is a completely independent trial and has no effect on the ProTrans-1 study. NextCell now has two ongoing clinical trials that run parallel and according to plan. ProTrans-Repeat's Principal investigator Professor Per-Ola Carlsson and the study team from Karolinska Trial Alliance, together with NextCell, went through the last practical details, which means that the new study has now been formally initiated. ProTrans-Repeat means
NextCell Pharma AB (NextCell) announces that the initiation meeting for ProTrans-Repeat was held today at Karolinska University Hospital in Huddinge. ProTrans-Repeat is a completely independent trial and has no effect on the ProTrans-1 study. NextCell now has two ongoing clinical trials that run ...
Read moreRead more
2019-05-17
Rectification: Six out of nine patients in the first part of the phase I/II trial, ProTrans-1 have completed treatment
NextCell Pharma AB (NextCell) announces that six out of the nine patients included in the dose escalation part of ProTrans-1, the trial with the drug candidate ProTrans, now have completed treatment and left the study. Earlier this week, the last of the three patients in the so-called medium-dose-cohort visited for their 12-month follow-up, the final part of the trial, which means that all three now have completed their part of the trial. In early March, the three patients in the low-dose cohort had already completed the trial. This means that six out of nine patients in the phase I part
NextCell Pharma AB (NextCell) announces that six out of the nine patients included in the dose escalation part of ProTrans-1, the trial with the drug candidate ProTrans, now have completed treatment and left the study. Earlier this week, the last of the three patients in the so-called medium-dose...
Read moreRead more
2019-05-17
Six out of nine patients in the phase-II part of the ProTrans-1 study have completed treatment
NextCell Pharma AB (NextCell) announces that six out of the nine patients included in ProTrans-1, the trial with the drug candidate ProTrans, now have completed treatment and left the study. Earlier this week, the last of the three patients in the so-called medium-dose-cohort visited for their 12-month follow-up, the final part of the trial, which means that all three now have completed their part of the trial. In early March, the three patients in the low-dose cohort had already completed the trial. This means that six out of nine patients in the phase II part have now successfully
NextCell Pharma AB (NextCell) announces that six out of the nine patients included in ProTrans-1, the trial with the drug candidate ProTrans, now have completed treatment and left the study. Earlier this week, the last of the three patients in the so-called medium-dose-cohort visited for their 12...
Read moreRead more
2019-05-15
NextCell Pharma invited speaker at the World Advanced Therapies & Regenerative Medicine Congress
NextCell Pharma AB ("NextCell") and Cellaviva have been invited to attend and speak at the 14th annual World Advanced Therapies & Regenerative Medicine Congress, which is held at the Business Design Centre, London 15 - 17 May. On 16 May, CEO Dr. Mathias Svahn will be chairing the Roundtable Discussion Session regarding hospital exemption procedures. For the duration of the conference NextCell/Cellaviva delegates will be participating in workshops, attending lectures and engaging in a variety of networking activities.  The World Advanced Therapies & Regenerative Medicine Congress is an
NextCell Pharma AB ("NextCell") and Cellaviva have been invited to attend and speak at the 14th annual World Advanced Therapies & Regenerative Medicine Congress, which is held at the Business Design Centre, London 15 - 17 May. On 16 May, CEO Dr. Mathias Svahn will be chairing the Roundtable Discu...
Read moreRead more
2019-05-09
ProTrans-Repeat, an approved clinical trial for repeated treatment of patients with diabetes
The Medical Products Agency has granted NextCell Pharma AB ("NextCell") permission to conduct the new study, ProTrans-Repeat. The study is a continuation of ProTrans-1 where patients with type-1 diabetes who participated in the dose escalation part will be asked to participate in ProTrans-Repeat. The purpose is to investigate whether repeated treatment is safe and gives increased effect on the patient's ability to produce insulin. ProTrans-Repeat is a Phase IIa clinical trial that aims to evaluate whether repeated treatment can increase or maintain the effect of ProTrans over a longer period
The Medical Products Agency has granted NextCell Pharma AB ("NextCell") permission to conduct the new study, ProTrans-Repeat. The study is a continuation of ProTrans-1 where patients with type-1 diabetes who participated in the dose escalation part will be asked to participate in ProTrans-Repeat....
Read moreRead more