Long-term Effects with Repeated ProTrans Treatment After 6 Years

NextCell Pharma AB reports new results from the ProTrans-Repeat study, where type 1 diabetes patients have been followed for 5 years after receiving two doses of the stromal cell product ProTrans, in total 6 years after the first infusion. The results show that two out of three patients in the high-dose group increased their insulin production by 23% and 34% respectively. Long-term Effectiveness and Safety ProTrans-1, a dose-escalation study completed in 2019, demonstrated that ProTrans treatment is safe and that higher doses of the drug product provides therapeutic efficacy. Patients who received the highest dose of 200 million cells, demonstrated a significant preservation of their insulin production one year after treatment compared to those who received lower doses. In the follow-up study, ProTrans-Repeat, patients from ProTrans-1 were treated with an additional dose of ProTrans 1–1.5 years after the initial infusion. Earlier interim analyses showed that the high-dose group retained, on average, 81% of their insulin production 3.5–4 years after the first dose, compared to 41% and 45% in the low- and medium-dose groups. Results After 6 Years We now demonstrate that 6 years after the first infusion, the high-dose group (n=3) retained, on average, 91% of their insulin production. Two patients increased their production by 23% and 34%, while the third experienced a decline. In the low- and medium-dose groups, retained insulin production after 6 years averaged 26% and 47%, respectively. "The results from the ProTrans-Repeat study are highly encouraging, showing that repeated treatment can preserve and even improve insulin production over 6 years. This strengthens ProTrans’ potential as a safe and effective therapy for modifying the progression of type 1 diabetes", says Mathias Svahn, CEO. A summary of insulin production as a percentage of baseline is provided below: Timepoint (years) Low Dose Medium Dose High Dose Controls 0 100% 100% 100% 100% 1 72% 91% 96% 72% 3.5 41% 45% 81% 36% 6 26% 47% 91% N/A The control patients were included when the ProTrans-Repeat trial began, 1–1.5 years after other patients. Their type 1 diabetes diagnoses varied between 2 months and more than 2 years prior to inclusion. Connection to Previous Findings These data reinforce earlier findings on ProTrans’ long-term effectiveness. In October 2023, NextCell reported that a single treatment with ProTrans could slow disease progression for over 5 years. These new results suggest that repeated treatment can further enhance long-term outcomes, particularly with higher doses. While later timepoints lack statistical significance due to the small group sizes, a clear trend is evident and in line with our previous datasets showing that ProTrans modifies the disease progression of type 1 diabetes, long-term. In September 2023, we reported that ProTrans is immunologically safe when used for repeated treatments. The combination of long-term efficacy and safety highlights ProTrans’ potential as a groundbreaking treatment for autoimmune diseases such as type 1 diabetes. 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 17-12-2024 12:50 CET. For more information about NextCell Pharma, please contact Mathias Svahn, CEO Patrik Fagerholm, CFO Tel: +46 8 735 5595 E-mail: [email protected] Websites : NextCell Pharma AB: www.nextcellpharma.com Cellaviva Sverige: www.cellaviva.se Cellaviva Danmark: www.cellaviva.dk QVance AB: www.qvance.se LinkedIn: https://www.linkedin.com/company/15255207/ Twitter: https://twitter.com/NextCellPharma The company's shares are listed on the Nasdaq First North Growth Market. FNCA AB is assigned as Certified Adviser. About NextCell Pharma AB NextCell is a cell therapy company in Phase II 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 III trial. In addition to type 1 diabetes. NextCell owns Cellaviva AB, 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. NextCell also owns QVance which will offer quality control analytics for advanced therapy developers. Furthermore, NextCell owns 8.5% in FamicordTX, a CAR-T start-up in oncology. Download attachment Read full press release on Cision (external link) 2026-08-27 Interim Report second quarter 2026 NextCell Pharma AB (publ) (“NextCell” or the “Company”) publishes its Interim report for the second quarter 2026. The report is available on the company´s website: www.nextcellpharma.com. NextCells share is traded on Nasdaq First North Growth Market under the ticker "NXTCL". The amount in brackets refers to the corresponding period last year. Please note that, as of 2025, the Company’s financial year corresponds to the calendar year. 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The amount in brackets refers to the corresponding period last year. Please note that, as of 2025, the Company’s financial year corresponds to the calendar year. Read more Read more 2026-05-27 NextCell Pharma AB (publ) Annual General Meeting 2026 On Wednesday, 27 May 2026, the Annual General Meeting of NextCell Pharma AB (publ), reg. no. 556965-8361 (“NextCell” or the “Company”), was held. A summary of the resolutions adopted at the Annual General Meeting is set out below. All resolutions were adopted with the required majority. For more detailed information regarding the content of the resolutions, reference is made to the notice convening the Annual General Meeting and the complete proposals for resolutions, which have previously been published and are available on the Company’s website, www.nextcellpharma.com. Read more Read more 2026-05-06 NextCell and FUJIFILM Biosciences Launch New Commercial Platform Comprised of RUO Stromal Cells and Cell Culture Media NextCell Pharma AB ("NextCell" or "the Company") today announces that in collaboration with FUJIFILM Biosciences, NextCell-Cord RUO cells have been commercially launched. Read more Read more 2026-05-04 NextCell Pharma publishes Annual Report 2024/2025 NextCell Pharma AB (publ) (“NextCell” or the “Company”) publishes its Annual Report for the extended financial year September 1, 2024 – December 31, 2025. The Annual Report is available in Swedish as an appendix to this press release or on the company's website: www.nextcellpharma.com. NextCells share is traded on Nasdaq First North Growth Market under the ticker "NXTCL". Read more Read more 2026-05-04 NextCell Pharma publishes Annual Report 2024/2025 NextCell Pharma AB (publ) (“NextCell” or the “Company”) publishes its Annual Report for the extended financial year September 1, 2024 – December 31, 2025. The Annual Report is available in Swedish as an appendix to this press release or on the company's website: www.nextcellpharma.com. NextCells share is traded on Nasdaq First North Growth Market under the ticker "NXTCL". Read more Read more 2026-03-13 ProTrans Phase II COVID-19 Trial Accepted for Publication in Cytotherapy NextCell Pharma AB (“NextCell” or the “Company”) announces that the Phase II clinical trial evaluating ProTrans® (allogeneic Wharton’s Jelly-derived mesenchymal stromal cells) for respiratory complications associated with COVID-19 has been accepted for publication in Cytotherapy (https://www.isct-cytotherapy.org/article/S1465-3249(26)00736-X/abstract), the official journal of the International Society for Cell & Gene Therapy. 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