Single treatment with ProTrans demonstrates long-term therapeutic effect over 5 years

NextCell Pharma AB ("NextCell" or the "Company") today announces that patients who were treated with a single dose of ProTrans five years ago in the randomized, placebo-controlled phase II study ProTrans-2 have retained significantly higher endogenous insulin production than patients who received placebo. ProTrans treated patients maintained 57% of their endogenous insulin production compared to 15% in the placebo group. The results are in line with NextCell’s previously reported three year data and demonstrates that ProTrans offers a disease-modifying treatment with long-lasting clinically relevant effect. ProTrans Placebo 1 year 89% (± 10%) 53% (± 34%) 2 years 71% (± 21%) 33% (± 26%) 3 years 63% (± 33%) 23% (± 19%) 4 years 66% (± 41%) 14% (± 12%) 5 years 57% (± 29%) 14% (± 13%) Table 1: Maintenance of endogenous insulin production per year after a single infusion of ProTrans, mean value for each treatment arm + standard deviation. NextCell's Chief Scientific Officer, Dr. Lindsay Davies, will present the data and explain how a single dose of ProTrans can provide such a long-lasting effect. The presentation will be available at https://www.redeye.se/events/1012070/nextcell-pharma from Wednesday 29 May at 09:00 CET. In 2018, the randomized double-blinded phase II study ProTrans-2 started at Karolinska University Hospital. A total of 15 patients were randomized 2:1 for treatment with one infusion of ProTrans or placebo control. The primary endpoint was the percentage of retained endogenous insulin production capacity one year after treatment, with patients treated with ProTrans maintaining an average of 89% compared to placebo controls which maintained 53%. The 14 patients who completed ProTrans-2 were invited, after completion of the study, to participate in a non-interventional follow-up study where they would be followed for an additional 5 years, ProTrans-Obs. In total 6 patients treated with ProTrans and 5 patients who received placebo completed the study. In ProTrans-Obs, the patients' endogenous insulin production capability was measured. ProTrans treatment demonstrated a statistically significant effect (p<0.05) compared to placebo. No serious adverse reactions related to treatment have been reported. The company continues to analyses the data and will present more detailed results in the coming weeks. 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 28-05-2024 14:15 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 LinkedIn: https://www.linkedin.com/company/15255207/ Twitter: https://twitter.com/NextCellPharma Certified Adviser FNCA Sweden AB is assigned as Certified Adviser. About NextCell Pharma AB NextCell is a cell therapy company that is in phase 2 studies 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 study. ProTrans is manufactured utilizing the patented platform technology for selection of optimal cells with potency to treat inflammatory disorders including autoimmune diseases. NextCell owns Cellaviva, the largest stem cell bank in the Nordics and QVance, a quality analysis CRO company in start up. 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. Read more Read more 2026-08-18 NextCell Selected for EU-Japan Biotech Business Mission and Strengthens Presence in Hong Kong NextCell Pharma AB ("NextCell" or the "Company") has been selected as the only Swedish company to participate in the EU-Japan Biotech Business Mission 2026. In parallel, the Company is strengthening its local presence in Hong Kong by establishing an office and becoming a member of the Hong Kong-Shenzhen Innovation and Technology Park (HSITP), effective 1 September. NextCell will also participate as a Founding Partner in the Nordic Future Health Pavilion at BIOHK 2026, held 9–12 September. Read more Read more 2026-05-28 Interim Report first quarter 2026 NextCell Pharma AB (publ) (“NextCell” or the “Company”) publishes its Interim report for the first 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. 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. Read more Read more Next Site links 01. Our product portfolio 02. About NextCell 03. Investors 04. News 05. Contact Contact Hälsovägen 7, 141 57 Huddinge, Sweden [email protected] +46 (0)8 735 55 95 © Copyright 2021 NextCell Pharma AB Integrity policy Cookie Policy Cookie preferences Cookie consent preferences Cookies are small text files used to store small information. Cookies are stored on your device as the site loads into your browser. 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