NextCell presentation of Interim analysis data today at 15:00

October 27, 2022

NextCell Pharma AB ("NextCell" or the "Company") has developed a proprietary and patented platform technology where stem cells can be selected for allogeneic treatment of various specific diseases. CEO Mathias Svahn will present the results on Thursday, October 27 at 15:00 CET, which will be broadcast live via Nyhetsbytrån Direkt, link https://youtu.be/Y9BSbt31tqc.

· Thursday, October 27, CET 3:00 pm

· https://youtu.be/Y9BSbt31tqc

Below follows an update on the Company's completed and ongoing clinical trials with the drug candidate ProTrans, which has been developed for type-1 diabetes, autoimmune and inflammatory diseases.

ProTrans-1.
A 2019 completed open-label dose-escalation Phase-1 study in nine type-1 diabetes patients demonstrated a) good safety and b) dose-dependent efficacy regarding preservation of endogenous insulin production one year aftertreatment.

ProTrans-2.
A since 2020 completed placebo-controlled Phase-2study in 15 type-1 diabetes patients showed significant treatment efficacy (p<0.05), in which ProTrans-treated patients maintained 90% of their endogenous insulin production one year after treatment, versus 53% in the placebo group.

ProTrans-Repeat
is an open-label follow-up study in the patients who participated in ProTrans-1 above. The nine patients were treated, after first treatment, with an additional equal dose they had received about one-two years earlier in ProTrans-1. On October 18 this year, an interim analysis after the second treatment was presented, which concludes that treatment with the highest dose gives significant the best long-term effect regarding the preservation of one's own insulin production. On average, the three cohorts retained low-, medium-, and high-dose, 41%, 45%, and 81% of their insulin-producing ability at the first time of treatment after about 3.5-4years. The long-term effect is followed up for another two years.

ProTrans-Obs (11 patients, ongoing).
Long-term follow-up of patients who previously participated in ProTrans-2. The study lasts for 5 years and 3-year interim results are presented here: " out of 14patients who completed ProTrans-2, 6 ProTrans-treated and 5 placebo treated patients accepted to participate in follow-up study ProTrans-Note after completion of the study, where the yare followed for another 5 years. In the study, the patients' endogenous insulin production is measured semi-annually and a 3-year follow-up has been done. The results of this interim analysis show statistically significant treatment effect at all analyzed timepoints (p<0.05).

ProTrans-Young (66 patients, ongoing)
is a Phase 1/2 study where the first part is an open-label safety study with 6 children newly diagnosed with type-1 diabetes. All patients have been treated and a safety committee is expected to recommend continuation with Part 2 in early November.
The second part of the study is a randomized, placebo-controlled double-blinded study with 30 patients aged 12-21 years and30 patients aged 7-11 years.

Pediatric Investigation Plan, PIP.
‍A pediatric development plan has been submitted to the European Medicines Agency's Expert Committee on Drug Development for the Treatment of Children. The plan describes the clinical trial program until commercialization and is a requirement forphase-3 studies. The application includes ProTrans-3, a pivotal phase III study for including both adults and children that, in the event of a positive outcome, can give ProTrans marketing approval.

Protrans19+SE (9 patients,ongoing).
Swedish open-label dose escalation study (phase 1) with ProTrans for the treatment of adult patients (not type-1 diabetes), who suffered from severe pneumonia as a result of Sars-CoV-2 infection.

Protrans19+CA (48 patients,ongoing).
Canadian randomized, placebo-controlled, double-blinded (Phase 2)study for the treatment of adult patients (not diabetes), who suffered from severe pneumonia as a result of Sars-CoV-2 infection.

For more information about NextCell Pharma AB, please contact:

Mathias Svahn, CEO

Patrik Fagerholm, CFO

Tel: +46 8-735 5595

E-mail: info@nextcellpharma.com

Hemsida: www.nextcellpharma.com

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

Twitter: https://twitter.com/NextCellPharma

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 stem 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 a market approval for type-1 diabetes via a phase III study. ProTrans is evaluated in two clinical Covid-19studies, 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).

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2025-05-23

NextCell Pharma receives declarations of intent, subscription undertakings and top guarantees regarding exercise of TO2

THIS PRESS RELEASE MAY NOT BE RELEASED, PUBLISHED OR DISTRIBUTED, DIRECTLY OR INDIRECTLY IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, JAPAN, NEW ZEALAND, SOUTH AFRICA, SOUTH KOREA, SWITZERLAND, CANADA, HONG KONG, BELARUS, RUSSIA OR IN ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLISHING OR DISTRIBUTION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR REQUIRE REGISTATION OR OTHER MEASURES IN ADDITION TO THOSE REQUIRED BY SWEDISH LAW. SEE SECTION "IMPORTANT INFORMATION" AT THE END OF THIS PRESS RELEASE. NextCell Pharma AB ("NextCell" or the "Company") issued a total of 38,711,804 warrants of series TO2 (“Warrants”) within the framework of a rights issue of units during the second quarter of 2024. The exercise period for the Warrants runs until and including 30 May 2025. One (1) Warrant entitles the holder to subscribe for one (1) new share in the Company at a subscription price of SEK 1.00 per share. NextCell today announces that the Company has received declarations of intent from all of the Company’s senior executives and Board members who hold Warrants and subscription undertakings from a selection of existing Warrant holders regarding the exercise of held Warrants, totalling approximately SEK 6.9 million, corresponding to approximately 17.8 percent of the total number of outstanding Warrants. In addition, the Company has secured top guarantees from a selection of existing Warrant holders and shareholders as well as external investors corresponding to an additional approximately 30 percent of the total issue volume. The top guarantees, together with the received declarations of intent and subscription undertakings, ensure that the Company will receive minimum proceeds of approximately SEK 18.5 million, corresponding to approximately 47.8 percent of the total issue volume.

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2025-05-20

NextCell announces strategic collaboration with Fujifilm Irvine Scientific

NextCell Pharma AB’s ("NextCell" or "the Company") has entered into a strategic collaboration with Fujifilm Irvine Scientific Inc. to bring together their core competences in mesenchymal stromal cells (MSCs) and raw materials for the life science sector. The aim of the collaboration is to provide researchers and developers in the cell therapy field with an integrated offering – standardised MSC products, optimised culture media, and cryopreservation solutions.

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2025-05-19

Eric Strati Joins NextCell Pharma’s Board of Advisors to Support Commercial Strategy for ProTrans

NextCell Pharma AB ("NextCell") is pleased to announce the appointment of Eric Strati, PharmD, MBA, as a new member of its Board of Advisors, marking a strategic step as the company transitions from a development-focused organization into a pivotal phase aimed at out-licensing and commercializing its leading cell therapy product, ProTrans, for the treatment of type 1 diabetes.

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2025-05-16

The exercise period for NextCell Pharma’s warrants of series TO2 begins today

THIS PRESS RELEASE MAY NOT BE RELEASED, PUBLISHED OR DISTRIBUTED, DIRECTLY OR INDIRECTLY IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, JAPAN, NEW ZEALAND, SOUTH AFRICA, SOUTH KOREA, SWITZERLAND, CANADA, HONG KONG, BELARUS, RUSSIA OR IN ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLISHING OR DISTRIBUTION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR REQUIRE REGISTATION OR OTHER MEASURES IN ADDITION TO THOSE REQUIRED BY SWEDISH LAW. SEE SECTION "IMPORTANT INFORMATION" AT THE END OF THIS PRESS RELEASE. NextCell Pharma AB (“NextCell” or the “Company”) issued a total of 38,711,804 warrants of series TO2 (“Warrants”) within the framework of a rights issue of units during the second quarter of 2025. The exercise period for the Warrants commences today, on May 16, 2025, and continues until May 30, 2025. One (1) Warrant entitles the holder to subscribe for one (1) new share in the Company. The subscription price per share subscribed for through the exercise of Warrants has been set at SEK 1.00. Upon full utilization of all Warrants, NextCell will receive approximately SEK 38.7 million before issuance costs. The proceeds from the exercise of Warrants are mainly intended to support the completion of the ProTrans-Young study and continued clinical development, business development, and regulatory preparations for future market approval.

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2025-05-15

Eight-Year-Old Hugo – Living with Type 1 Diabetes and Participating in the ProTrans Study

NextCell Pharma AB ("NextCell") is featured in the Future Healthcare – Focus on Diabetes supplement of the Swedish national newspaper Svenska Dagbladet, through an article highlighting eight-year-old Hugo Wahlbeck, who is currently enrolled in the ongoing paediatric study with ProTrans – the Company’s leading investigational therapy for the treatment of type 1 diabetes.

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2025-05-07

Study published in Nature Medicine shows promising results in Alzheimer’s disease – supports the development of ProTrans at NextCell

NextCell Pharma AB (“NextCell” or the “Company”) highlights a recently published clinical trial demonstrating promising results for mesenchymal stromal cells (MSCs) in the treatment of mild Alzheimer’s disease. The results strengthen the scientific foundation for NextCell’s drug candidate ProTrans, which is being developed for autoimmune and inflammatory diseases. NextCell is developing the next generation of MSC therapies with a focus on selection and indication-specific tailoring using its patented platform technology.

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2025-04-25

NextCell Pharma publishes its Interim Report 2 2024/2025

NextCell Pharma AB (publ) (NXTCL or NextCell) publishes its Interim Report 2 for the period December 1, 2024 – February 28, 2025. 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.

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2025-04-24

NextCell presents detailed analysis of the administrative report from ProTrans-Young

NextCell Pharma AB’s ("NextCell" or "the Company") CSO, Lindsay Davies, has been interviewed by Flemingsberg Science regarding the analysis of the administrative topline evaluation from the older age cohort of the ProTrans-Young paediatric trial.

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NextCell presentation of Interim analysis data today at 15:00

· Thursday, October 27, CET 3:00 pm

· https://youtu.be/Y9BSbt31tqc

Below follows an update on the Company's completed and ongoing clinical trials with the drug candidate ProTrans, which has been developed for type-1 diabetes, autoimmune and inflammatory diseases.

ProTrans-1. A 2019 completed open-label dose-escalation Phase-1 study in nine type-1 diabetes patients demonstrated a) good safety and b) dose-dependent efficacy regarding preservation of endogenous insulin production one year aftertreatment.

ProTrans-2. A since 2020 completed placebo-controlled Phase-2study in 15 type-1 diabetes patients showed significant treatment efficacy (p<0.05), in which ProTrans-treated patients maintained 90% of their endogenous insulin production one year after treatment, versus 53% in the placebo group.

Protrans19+SE (9 patients,ongoing). Swedish open-label dose escalation study (phase 1) with ProTrans for the treatment of adult patients (not type-1 diabetes), who suffered from severe pneumonia as a result of Sars-CoV-2 infection.

Protrans19+CA (48 patients,ongoing). Canadian randomized, placebo-controlled, double-blinded (Phase 2)study for the treatment of adult patients (not diabetes), who suffered from severe pneumonia as a result of Sars-CoV-2 infection.

For more information about NextCell Pharma AB, please contact:

Mathias Svahn, CEO

Patrik Fagerholm, CFO

Tel: +46 8-735 5595

E-mail: info@nextcellpharma.com

Hemsida: www.nextcellpharma.com

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

Twitter: https://twitter.com/NextCellPharma

About NextCell Pharma AB

‍

ProTrans-1.
A 2019 completed open-label dose-escalation Phase-1 study in nine type-1 diabetes patients demonstrated a) good safety and b) dose-dependent efficacy regarding preservation of endogenous insulin production one year aftertreatment.

ProTrans-2.
A since 2020 completed placebo-controlled Phase-2study in 15 type-1 diabetes patients showed significant treatment efficacy (p<0.05), in which ProTrans-treated patients maintained 90% of their endogenous insulin production one year after treatment, versus 53% in the placebo group.

Protrans19+SE (9 patients,ongoing).
Swedish open-label dose escalation study (phase 1) with ProTrans for the treatment of adult patients (not type-1 diabetes), who suffered from severe pneumonia as a result of Sars-CoV-2 infection.

Protrans19+CA (48 patients,ongoing).
Canadian randomized, placebo-controlled, double-blinded (Phase 2)study for the treatment of adult patients (not diabetes), who suffered from severe pneumonia as a result of Sars-CoV-2 infection.