Reported Earnings • May 28
First quarter 2026 earnings released First quarter 2026 results: Revenue: kr2.78m (down 19% from 1Q 2025). Net loss: kr10.4m (loss widened 27% from 1Q 2025). Revenue is forecast to grow 37% p.a. on average during the next 2 years, compared to a 15% growth forecast for the Biotechs industry in Europe. Board Change • May 21
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 3 non-independent directors. Member of Board of Advisors Eric Strati was the last director to join the board, commencing their role in 2025. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Tillkännagivande • May 08
Fujifilm Biosciences and Nextcell Pharma AB Launch Global Commercial Platform for RUO Stromal Cells and Cell Culture Media FUJIFILM Biosciences and NextCell Pharma AB announced a global commercial launch resulting from their strategic collaboration. The offering consists of FUJIFILM Biosciences’ PRIME-XV MSC Expansion XSFM medium and NextCell’s first commercial product, NextCell-Cord RUO, a research-use-only (RUO) MSC product derived from umbilical cord tissue. Some of the challenges faced in MSC research are heterogeneity of MSCs, immunocompatibility, and inefficient manufacturing. NextCell-Cord RUO provides researchers a more consistent, efficient, and accessible source of cells. The collaboration with FUJIFILM Biosciences to provide these cells with media delivers a high-quality, standardized solution for researchers working in immunology, regenerative medicine, and cell therapy development. NextCell-Cord RUO is available across all major global markets through FUJIFILM Biosciences as a standalone product or bundled with Fujifilm’s PRIME-XV MSC Expansion XSFM media, recombinant growth factors and reagents. Tillkännagivande • Apr 27
NextCell Pharma AB, Annual General Meeting, May 27, 2026 NextCell Pharma AB, Annual General Meeting, May 27, 2026, at 10:00 W. Europe Standard Time. Location: in novum-huset, floor 6 (elevator e), halsovagen 7, huddinge, Sweden Tillkännagivande • Mar 13
Nextcell Pharma AB Protrans Phase Ii Clinical Trial Accepted for Publication in Cytotherapy NextCell Pharma AB announced 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, the official journal of the International Society for Cell & Gene Therapy. The study, titled 'Umbilical Cord Mesenchymal Stromal Cells for Respiratory Complications of COVID-19 Infection (ProTrans): Phase II Randomized Clinical Trial,' reports results from ProTrans19+, a randomized, double-blind, placebo-controlled, multi-center Phase II study conducted in Canada. The trial was investigator-initiated and sponsored by McGill University Health Centre (MUHC). NextCell supported the study by supplying ProTrans. Patients were recruited at two McGill University-affiliated hospitals in Montreal: The Royal Victoria Hospital and the Jewish General Hospital. ProTrans19+ evaluated the safety and exploratory efficacy of a single intravenous infusion of ProTrans in hospitalized patients with severe COVID-19 pneumonia requiring oxygen support. The trial was discontinued early due to feasibility considerations in the context of evolving standards of care and reduced event rates during later stages of the pandemic. The study confirms the short-term safety of ProTrans in hospitalized patients receiving contemporary standard-of-care therapies. Due to limited enrollment and early termination, no definitive conclusions regarding efficacy can be drawn. Acceptance for publication in Cytotherapy reflects the scientific rigor of the study and contributes to the growing body of clinical evidence evaluating mesenchymal stromal cell therapies in inflammatory lung disease. Tillkännagivande • Mar 03
NextCell Pharma AB to Report Q1, 2026 Results on May 28, 2026 NextCell Pharma AB announced that they will report Q1, 2026 results at 9:00 AM, Central European Standard Time on May 28, 2026 Tillkännagivande • Feb 05
NextCell Pharma AB Announces Long-Term Follow-Up Data from the ProTrans- Repeat Study Showing Sustained Disease-Modifying Effects of ProTrans in Type 1 Diabetes NextCell Pharma AB announced long-term follow-up data from the ProTrans- repeat study showing sustained preservation of endogenous insulin production in patients with newly diagnosed type 1 diabetes. The data extends to approximately 6 years after the last ProTrans infusion, corresponding to 7 to 7.5 years since the first infusion. Durable effect observed 7 years from first infusion; Sustained preservation of endogenous insulin production at group level; Clear dose-dependent trends over long-term follow-up. At the latest follow-up, patients in the high-dose group demonstrate preserved endogenous insulin production at group level. Two of three patients continue to show insulin production close to baseline, while one patient shows a more pronounced decline. Intermediate-dose patients show limited preservation, whereas the low-dose group demonstrates a progressive decline over time. The durability of preserved insulin production more than 7 years after the first infusion is unexpected in type 1 diabetes and supports the conclusion that ProTrans has the potential to modify the underlying disease rather than providing only transient benefit directly after treatment. The observed dose-dependent trends further strengthen the biological rationale for ProTrans. Previously reported data from ProTrans-OBS and ProTrans- repeat demonstrated clinically meaningful preservation of endogenous insulin production five years after the last infusion. Applying the same reporting logic, the present analysis extends follow-up to six years after the last infusion in the ProTrans-Repeat study. At later timepoints, patient numbers are limited due to discontinuation, and minor numerical differences are considered likely to fall within the expected variability of the C-peptide AUC assay. Accordingly, the results are interpreted as descriptive trends at group level, consistent with earlier disclosures. Based on the strength and durability of the clinical effect observed after a single infusion, NextCell's primary objective is to bring ProTrans to patients as a single-infusion treatment, where the Company's data is most extensive, and to pursue market approval on this basis. Following market approval, NextCell intends to extend its label with the addition of paediatric patients. The Company will also explore the possibility to further optimize the treatment regimen by evaluating repeated ProTrans infusions as a strategy to maximise and prolong the therapeutic effect in selected patient populations. Tillkännagivande • Jan 21
NextCell Pharma AB has filed a Follow-on Equity Offering in the amount of SEK 15 million. NextCell Pharma AB has filed a Follow-on Equity Offering in the amount of SEK 15 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 15,000,000
Price\Range: SEK 1 Tillkännagivande • Jan 17
NextCell Pharma AB Announces Six-Year Data Demonstrating A Durable Disease-Modifying Effect of ProTrans in Type 1 Diabetes NextCell Pharma AB announced that six-year follow-up data indicate that a single infusion of ProTrans provides a long-lasting and clinically relevant preservation of endogenous insulin production in patients with newly-diagnosed type 1 diabetes. Patients treated with ProTrans continue to exhibit clinically relevant levels of stimulated C-peptide well beyond expected levels as seen with the natural course of the disease. Durable effect 6 years. Approximately 50% of insulin-producing function preserved. Strategy confirmed: a single infusion may be sufficient for clinical efficacy. Previously reported long-term data up to five years demonstrated that ProTrans-treated patients, at the group level, preserved approximately 60% of their endogenous insulin production, compared with around 15% with placebo treatment. The six-year follow-up demonstrates that this clinically meaningful separation is maintained, with ProTrans-treated patients continuing to retain around half of their baseline insulin production at the group level, years after receipt of treatment. In the placebo arm, endogenous insulin production was, as expected with disease progression, largely lost earlier, and at this late time point the number of patients completing long-term follow-up is therefore limited. The Company therefore considers the six-year data to primarily reflect durability of treatment response, rather than to serve as a basis for further quantitative group-level comparisons. In light of the clear and sustained clinical effect, the Company intends to advance ProTrans toward market approval as a single-infusion treatment for type 1 diabetes. In parallel, NextCell continues to develop ProTrans with the aim of further enhancing and prolonging the treatment effect through repeated infusions, which are being evaluated in the ongoing ProTrans-Repeat study. Results from ProTrans-Repeat, including follow-up data up to seven years, are expected to be reported shortly. Tillkännagivande • Nov 21
NextCell Pharma AB Announces CFO Changes NextCell Pharma AB announces the appointment of Eric Gustafsson as Chief Financial Officer (CFO). With extensive experience in leading financial transformations and industrial expansion phases within the pharmaceutical industry, Eric brings both strategic and operational expertise that will further strengthen NextCell's continued growth and development. Eric Gustafsson has a master's degree in economics and finance and a broad and versatile experience in finance, manufacturing and business development from the international CDMO and pharmaceutical industries. He has held several senior positions within Recipharm, including General Manager, Interim CFO for part of the European business that was divested to a new owner, and as Senior Commercial Manager in Recipharm's OSD segment. Prior to that, he has held leading financial roles at Cobra Biologics, among others. Earlier in his career, he worked in auditing at KPMG.His experience covers both strategic and operational responsibilities across manufacturing, finance, M&A and commercial development. With a deep understanding of regulated environments, quality requirements and complex production flows, Eric is well positioned to contribute to NextCell's continued growth and transition toward industrial scale operations.Eric will assume his position on 15 December 2025, succeeding Patrik Fagerholm, who is leaving the company for a new role outside the group. Tillkännagivande • Sep 20
NextCell Pharma AB Announces Step Down of Patrik Fagerholm as CFO NextCell Pharma AB ("NextCell" or the "Company") announced that the Company's CFO, Patrik Fagerholm, has decided to step down to take on a new assignment. Patrik will remain in his role throughout the notice period to ensure a smooth transition. The recruitment process to identify a successor for the CFO position has been initiated. Tillkännagivande • Jun 13
Nextcell Pharma AB Announces All Patients Successfully Treated in Protrans-Young Study NextCell Pharma AB announced that all patients in the ongoing ProTrans-Young clinical trial have now successfully been treated. This milestone marks the completion of patient dosing in the company's largest clinical study to date. ProTrans-Young is evaluating the safety and efficacy of the Company's lead cell therapy candidate, ProTrans, in paediatric and adolescent patients with recently diagnosed type 1 diabetes. ProTrans-Young is an investigator-initiated Phase II clinical trial led by Professor Per-Ola Carlsson at Uppsala University, in collaboration with Linkoping and Lund Universities. The trial began with an open-label safety phase in which six children received ProTrans, three aged 12-18 years and three aged 7-11 years, followed by three months of safety follow-up. This was followed by a randomised, placebo-controlled, double-blinded phase including 30 patients aged 12-21 years, allocated 1:1 to receive either ProTrans or placebo. One-year follow-up results for this group were reported in April 2025 and showed a positive trend in preserved insulin production. However, many patients in both arms remained in remission at the one-year mark, longer than initially expected, making it difficult to observe the full treatment effect at this stage. Based on previous adult trials, the differences between treatment groups are expected to become more pronounced over time as remission naturally ends. The final cohort of 30 patients aged 7-11 years has now also been treated, with randomisation 1:1 to receive eitherProTrans or placebo. This marks the completion of all dosing within the ProTrans-Young trial. One-year follow- up data from the full study population are expected after the summer of 2026. The ProTrans platform is based on allogeneic mesenchymal stromal cells (MSCs) selected using NextCell's proprietary algorithm to identify cells with optimal immunomodulatory function. ProTrans is being developed as an off-the-shelf, single-dose infusion therapy aimed at modulating the immune system and preserving residual beta cell function in autoimmune diabetes. Tillkännagivande • May 26
Nextcell Pharma AB Receives Us Patent for Msc Prediction Algorithm NextCell Pharma AB announced the issuance of a US patent titled "MSC Prediction Algorithm" by the United States Patent and Trademark Office (USPTO). The patent protects NextCell's innovative methodology for predicting the efficacy of mesenchymal stromal cell (MSC) therapy in individual patients, as well as the approach for determining personalised treatment options based on that prediction. The patent further reinforces NextCell's expanding portfolio of intellectual property, covering essential technologies for the production and use of MSC-based therapies in autoimmune and inflammatory diseases. The MSC Prediction Algorithm patent was granted by the USPTO on 15th April 2025. It covers the development of an algorithm to assess the in vitro (laboratory-based) efficacy of MSC therapy as a predictor of clinical effectiveness for specific patients with conditions such as type 1 diabetes. The patent also includes claims for methods to personalise treatment plans based on the evaluation of laboratory results. This latest patent strengthens NextCell's intellectual property portfolio, which already includes a granted patent for the product composition of ProTrans, the company's MSC-based drug product, as well as its use in treating immune-related disorders. The Company also has pending patent applications relating to its allogeneic MSC composition for the treatment of central nervous system disorders and COVID-19. The cornerstone of NextCell's platform is its "Allogeneic Composition" patent, which underpins ProTrans - an advanced therapy targeting autoimmune diseases such as type 1 diabetes. This patent family, covering the generation of isolated, pooled allogeneic MSC populations, has been granted in Europe, Japan, Hong Kong and Australia, with applications pending in Canada, China, Korea and the US. The broad protection provided by this patent family is key to securing NextCell's lead product and forms a critical part of its intellectual property strategy. NextCell remains committed to strengthening and expanding its IP portfolio to ensure the long-term success of its pioneering therapies for autoimmune and inflammatory diseases. This includes protecting the ProTrans platform technology as the Company advances its pipeline. The Company's IP strategy lays the groundwork for future therapies and reinforces its leadership in the development of next-generation stromal cell-based treatments. granted in: Europe, Japan, Hong Kong, Australia. Pending: Canada, China, China, Korea, US. Term: 2039.MSC Prediction Algorithm - In vitro methods to predict MSC treatment efficacy. granted in: US. Pending: Europe. Pending: Europe. Tillkännagivande • May 16
NextCell Pharma AB Announces Featured in the Future Healthcare - Focus on Diabetes Supplement of theSwedish National Media Svenska Dagbladet, Through an Article Highlighting Eight-Year-Old Hugo Wahlbeck NextCell Pharma AB announced that it 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. The article, written in collaboration with the patient advocacy group Together Against Diabetes 1 (T.A.D.1), discounts Hugo and his family's journey since his diagnosis in October 2024 and their experience participating in the clinical trial. Although the family does not know whether Hugo received ProTrans or placebo, they describe a life change for the better, with stable blood sugar levels, reduced anxiety, and significantly fewer night time alarms. ProTrans is an allogeneic cell therapy based on mesenchymal stromal cells derived from umbilical cord tissue and administered as a single intravenous infusion. The goal is to halt disease progression and preserve the patient's endogenous insulin production. Previous clinical trials in adults have demonstrated that patients receiving ProTrans maintain significantly higher levels of insulin production compared to placebo, with effects lasting for at least five years. Tillkännagivande • May 09
NextCell Pharma AB Highlights Clinical Trial Demonstrating Promising Results for Mesenchymal Stromal Cells (MSCs) in Treatment of Mild Alzheimer's Disease NextCell Pharma AB 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. NextCell has conducted preclinical development based on a selection algorithm specifically designed for applications in the central nervous system (CNS). This work forms the basis for a pending patent application regarding the use of ProTrans in the treatment of CNS and neurodegenerative diseases and expands on NextCell's pre-existing preclinical and clinical data in different diseases including type 1 diabetes and viral induced pneumonia. The specific indication(s) under evaluation for application of the CNS tailored drug product have not yet been disclosed. In a Phase 2a randomized, double-blind, and placebo-controlled study published in Nature Medicine (Rash et al., 2025), a total of 49 patients with mild Alzheimer's disease were enrolled and treated with a single or repeated intravenous dose of the MSC product laromestrocel (Lomecel-B®?). The treatment led to improved cognitive symptoms, reduced neuroinflammation, and slower brain atrophy, with no reported serious adverse events. The study appeared in Nature Medicine, one of the world's most prestigious medical journals, further underscoring its scientific importance. Lomecel-B, like ProTrans, is an allogeneic cell therapy product; however, it is derived from bone marrow mesenchymal stromAL cells (MSCs). ProTrans represents a next-generation MSC therapy, developed using highly selected cells sourced from umbilical cord tissue. Tillkännagivande • Apr 25
NextCell Pharma AB to Report Fiscal Year 2025 Final Results on Nov 06, 2025 NextCell Pharma AB announced that they will report fiscal year 2025 final results on Nov 06, 2025 Tillkännagivande • Apr 08
NextCell Presents Preliminary One-Year Results from the Older Age Group in ProTrans-Young NextCell Pharma announced preliminary one-year results from the older age group (12-21 years) in the ongoing clinical trial ProTrans-Young. The study is evaluating the safety and efficacy of the company's cell therapy, ProTrans, in preserving insulin production in young individuals newly diagnosed with type 1 diabetes, compared with placebo. The current analysis is an administrative subgroup analysis of the first 30 randomised patients, all included within six months of diagnosis - a favourable time point, as more insulin production is typically still present and can be preserved. However, variability in disease progression is greater early after diagnosis and during puberty, which at this stage makes interpretation of the treatment effect more challenging. A clearer effect is expected over time. In the open-label part of the study, the three treated patients showed an average increase in insulin production at 12 months compared to pre-treatment levels. This is in line with previous observations in studies involving adult patients. In the randomised, placebo-controlled part of the study, no substantial difference was observed between ProTrans and placebo. The spread in results was wide, resulting in large margins of error and warranting caution in interpreting the data at this early stage. Notably, three patients in the placebo group showed increased insulin production after one year, which may be attributed to the so-called honeymoon phase - a temporary period following diagnosis during which the body's natural insulin production partially recovers. This phase can last from several months to a year and varies significantly between individuals. The substantial individual variation in disease progression, along with unusually high retained insulin production in parts of the placebo group, makes it currently difficult to determine whether adolescents respond differently to treatment compared with adults. This variation is especially pronounced early after diagnosis and tends to decrease over time - particularly during adolescence, when differences are initially greatest due to puberty-related factors. The previous studies have treated adult patients later in the disease course, up to 24 months after diagnosis. A statistically significant treatment effect was observed as early as 12 months, and this effect persisted for at least five years - an outcome that may well also be seen in the adolescent group over time. Tillkännagivande • Mar 13
NextCell Pharma AB Announces Results from the Older Age Cohort in the ProTrans-Young Paediatric Study Expected in Aprilv NextCell Pharma AB announced that the last patient in the older age cohort (12-21 years) of the clinical Phase II study, ProTrans-Young, has now completed their 12-month follow-up. The collected data is currently being compiled, and an administrative subgroup analysis is planned to be presented at the IDF World Diabetes Congress in Bangkok from April 7-10. ProTrans-Young aims to evaluate the safety and efficacy of ProTrans, umbilical cord mesenchymal stromal cell treatment for newly-diagnosed type 1 diabetes in children and adolescents. The upcoming analysis represents an important interim readout of treatment response within the 12-21 year old age group. The purpose is to examine whether the treatment response in this age group follows the same trend as previously observed in adult patients. Results from the earlier ProTrans-T1D study in adults were published in 2023 in Diabetologia, the official journal of the European Association for the Study of Diabetes (EASD; Carlsson et al., 2023). It is important to note that the analysis of this subgroup will not include in-depth statistical testing, such as significance assessment using p- values. This decision has been made to ensure the statistical integrity of the study. Repeated analyses within a study can increase the risk of false-positive results, which is typically managed by adjusting the significance level (alpha). However, such an adjustment can reduce the study's ability to detect true effects. To avoid this issue, the analysis is therefore limited to an overall trend assessment at this point. Recruitment is ongoing for the younger age cohort in the ProTrans-Young study, children aged 7-11 years, with the goal of including all patients before the summer of 2025. The study is being conducted in collaboration with Uppsala University under the leadership of Professor Per-Ola Carlsson, together with co-investigators Johnny Ludvigsson at Linkoping University and Helena Elding Larsson at Lund University. Uppsala Clinical Research Center is responsible for data management. Tillkännagivande • Feb 21
NextCell Pharma AB Announces All Patients with Severe Virus-Induced Pneumonia Treated in the ProTrans V Study NextCell Pharma AB announced that all patients in the clinical trial ProTrans V, where ProTrans is used for the treatment of severe virus-induced pneumonia, have been treated. The study is being conducted at Orebro University Hospital and includes a total of nine patients, with three patients in each dose group. ProTrans V (formerly known as ProTrans19+SE) is an open-label dose-escalation study (Phase 1) in which adult patients suffering from severe pneumonia due to viral infection are treated with ProTrans. Treatment with all evaluated doses-low, medium, and high- has demonstrated a strong safety profile. The study initially focused on patients with SARS-CoV-2 infection, but was expanded to include patients with Influenza A, Respiratory Syncytial Virus (RSV), and Human Metapneumovirus. The study is being conducted At Orebro University Hospital under the leadership of Principal Investigator Dr. Josefin Sundh, Associate Professor and Senior Consultant at the Pulmonary Section, Heart-Lung Physiological Clinic, and University Lecturer at the Department of Medical Sciences, Orebro University. The full study title is: "Treatment of Respiratory Complications Associated with COVID-19, Influenza A, Metapneumovirus, Respiratory SyncyTial Virus (RSV) Infection Using Wharton's Jelly (WJ)-Umbilical Cord (UC) Mesenchymal Stromal Cells (ProTrans®): open Phase IB Clinical Trial" (EudraCT 2020-002078-29). NextCell is the Sponsor of the study, which includes nine patients with severe pneumonia caused by confirmed viral infection, who are treated with a low (3 patients), medium (3 patients), or high dose (3 patients) of ProTrans. NextCell has developed the drug candidate ProTrans, a cell therapy for the treatment of autoimmune diseases and inflammatory conditions. ProTrans is a platform technology with broad potential and application. NextCell has previously conducted several clinical studies with the cell therapy, including ProTrans-1, ProTrans-2, and the ongoing ProTrans-Young, which evaluates the treatment's safety and efficacy in type 1 diabetes, where the drug product has shown promising results in preserving the patient's own insulin production. ProTrans is based on the expansion and formulation of carefully selected umbilical cord stromal cells, optimized to suppress an overactive immune system and restore immune balance. The safe application of ProTrans in the treatment of severe pneumonia associated with viral infection demonstrates the scope of clinical application for the cell therapy. Infectious disease and the inflammatory complications thereof are a newer area for mesenchymal stromal cell therapy, where NextCell sees the potential for further development of their ProTrans product. Tillkännagivande • Dec 18
NextCell Pharma AB Reports New Results from the ProTrans-Repeat Study NextCell Pharma AB reported 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: The company 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 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 previous datasets showing that ProTrans modifies the disease progression of type 1 diabetes, long-term. Reported Earnings • Oct 25
Full year 2024 earnings released: kr1.22 loss per share (vs kr1.16 loss in FY 2023) Full year 2024 results: kr1.22 loss per share (further deteriorated from kr1.16 loss in FY 2023). Revenue: kr11.3m (down 19% from FY 2023). Net loss: kr42.0m (loss widened 5.4% from FY 2023). Over the last 3 years on average, earnings per share has fallen by 14% per year but the company’s share price has fallen by 48% per year, which means it is performing significantly worse than earnings. Tillkännagivande • Oct 04
NextCell Pharma AB Announces Drug Candidate ProTrans Highlighting in Dagens Medicin's Latest Edition Featuring Ongoing Research Advances in the Treatment of Type 1 Diabetes NextCell Pharma AB announced that their drug candidate ProTrans has been highlighted in Dagens Medicin's latest edition featuring ongoing research advances in the treatment of type 1 diabetes. ProTrans consists of mesenchymal stromal cells from the umbilical cord and has been investigated in a number of clinical studies at Uppsala University Hospital, where its potential to slow down the progression of the disease has been demonstrated. Articles in Dagens Medicin (2024-09-25) underline the need to protect insulin-producing beta cells and delay the development of type 1 diabetes, an autoimmune disease in which the body's own immune system attacks the pancreas. Stem cells from umbilical cord tissue, which form the basis of ProTrans treatment, have been shown in previous studies to be able to suppress the autoimmune attack and thereby preserve the body's natural insulin production. The ongoing study ProTrans-Young study at Uppsala University uses ProTrans to treat children and adolescents who have recently been diagnosed with type 1 diabetes. The ambition is that treatment with mesenchymal stromal cells will stop the progression of the disease with a single infusion, supporting preservation of insulin production throughout life. Mesenchymal stromal cells, which are used in ProTrans can target inflamed tissue while having a low side effect profile, making them an attractive option for the treatment of autoimmune diseases such as type 1 diabetes. Early results from studies in both adults and children look promising, and NextCell Pharma looks forward to continuing the work together with Uppsala University and other partners to evaluate ProTrans' full potential. Cellaviva is a wholly-owned subsidiary of NextCell that offers stem cell savings. Stem cells from umbilical cord blood and umbilical cord tissue (the same cells used in the manufacture of ProTrans) can be collected at birth, without any medical intervention, and saved for the possible future medical needs of the child and family. Tillkännagivande • Oct 01
NextCell Pharma AB Announces the First Children Have Been Treated in the Young Age Group of the ProTrans-Young Study NextCell Pharma AB announced that the first four children in the 7-11 year age group have been treated in the latest phase of the ProTrans-Young study. An additional four children have been screened and are expected to begin their treatment shortly. These advancements mark an important milestone in the progress of the study, which is proceeding faster than anticipated. The ProTrans-Young study is a double-blind, randomized, and placebo-controlled trial divided into two phases. In the first phase (Phase Ib), all patients, including those aged 7-18 years, were treated to ensure the safety of the treatment. The second phase (Phase IIb) includes a total of 60 children and adolescents, with 30 treated with ProTrans and 30 with placebo. The treatment of the first 30 patients aged 12-21 years has already been completed, and the safety data has been thoroughly reviewed and approved by the study's safety committee. The purpose of the ProTrans treatment is to halt the autoimmune destruction of insulin-producing cells in children and adolescents, slowing the disease progression and reduce the risk of serious complications associated with type 1 diabetes. The study aims to demonstrate that the treatment can preserve a greater portion of the body's own insulin production, which would result in improved blood sugar regulation, reduced associated illnesses and thereby a better quality of life for the young patients. Tillkännagivande • Sep 05
NextCell Pharma AB Presents New Long-Term Clinical Data at the International Society for Cell and Gene Therapy 2024 Regional Meeting NextCell Pharma AB has presented new long-term clinical data at the International Society for Cell and Gene Therapy (ISCT) 2024 Regional Meeting, held in Gothenburg, Sweden. The results show the long-term safety of the treatment, the effect of preserving the patient's own insulin production and more health benefits in patients with type 1 diabetes (T1D), such as lower BMI and blood pressure. A Single Dose of ProTrans Slows Disease Progression for More than 5 years. Patients from the Phase II trial have been monitored for over 5 years following a single dose of ProTrans. The long-term data that was presented in a press release 2024-05-28 shows that ProTrans treatment significantly slows the progression of T1D. This was described in detail at ISCT, using a non-linear regression analysis of the percentage loss of endogenous insulin production over time. The slopes of placebo-treated individuals were significantly steeper than those of ProTrans-treated individuals, indicating statistically significant differences in slowing disease progression year to year in the latter group (p). ProTrans-treated patients also exhibited a consistent trend of lower diastolic and systolic blood pressure, with significant differences emerging after 4-4.5 years compared to placebo-treated individuals (p). The findings reinforce ProTrans as a promising cell therapy for T1D, capable of slowing disease progression and supporting broader metabolic health benefits in treated individuals. NextCell Pharma also presented data on its strategy for delivering an off-the-shelf therapeutic that is accessible for patients irrespective of their geographical location. Cold chain management, standardised handling of the product and a long-term storage and stability of the product are a few of the unique features of ProTrans and how it has been developed with a commercial mindset. Reported Earnings • Jul 26
Third quarter 2024 earnings released Third quarter 2024 results: Revenue: kr2.48m (down 41% from 3Q 2023). Net loss: kr8.82m (loss narrowed 19% from 3Q 2023). Over the last 3 years on average, earnings per share has fallen by 16% per year but the company’s share price has fallen by 59% per year, which means it is performing significantly worse than earnings. New Risk • Jul 01
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 110% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr48m free cash flow). Share price has been highly volatile over the past 3 months (85% average weekly change). Earnings have declined by 22% per year over the past 5 years. Shareholders have been substantially diluted in the past year (110% increase in shares outstanding). Market cap is less than US$10m (€8.65m market cap, or US$9.27m). Minor Risk Revenue is less than US$5m (kr15m revenue, or US$1.4m). Tillkännagivande • Jun 13
Nextcell Pharma AB Receives Positive Recommendation from Data Safety Monitoring Board for Protrans-Young Study NextCell Pharma AB announces that the Data Safety Monitoring Board for the ProTrans-Young study has recommended the principal investigator, Professor Per-Ola Carlsson, to continue with treatment of children in the younger age group 7 – 11 years. This decision is based on a review of all available safety data from the 36 children and adolescents who have participated in the study so far. The recruitment of the 30 children aged 7-11 will begin in August 2024. The first part of the ProTrans-Young study is a safety part (phase Ib) where all 6 patients aged 7-18 years are treated with ProTrans. The second part of the study is randomized and placebo-controlled (phase II) and a total of 60 children and adolescents with type-1 diabetes will be treated, of which 30 with ProTrans and 30 with placebo. The first 30 patients aged 12-21 have undergone treatment and been on follow-up visits for at least 3 months. The Data Safety Monitoring Board has now reviewed the safety and recommended that the study continue with treatment of the remaining 30 patients aged 7-11. Treatment with ProTrans aims to stop the autoimmune destruction of insulin-producing cells. The children and adolescents in ProTrans-Young are treated with ProTrans within 6 months of being diagnosed with type-1 diabetes. The purpose is to be able to maintain as much of their insulin production as long as possible, even if they will continue to need extra insulin. The body's own insulin production buffers blood sugar and reduces the risk of fluctuations that can lead to serious complications. A subgroup analysis of the treatment effect of ProTrans in 30 adolescents in the age group 12-21 years, is expected to be presented in April 2025. The measure of effectiveness is the difference in endogenous insulin production between ProTrans and placebo-treated patients one year after treatment. Topline results from the entire study are expected by the end of 2026. Previous studies with ProTrans have been limited to adults, therefore only children under 18 years of age are included in the first part of the study. The other part is divided into two age groups that are commonly used in clinical trials in type 1 diabetes, 7-11 and 12-21 years respectively. The principal investigators are Professor Per-Ola Carlsson, Uppsala University and Uppsala University Hospital, with the co-investigators Professor Helena Elding Larsson, Skåne University Hospital and Professor Johnny Ludvigsson, Linköping University Hospital. The Data Safety Monitoring Board consists of Chairman Professor Ulf Smith, Sahlgrenska and Professor Mikael Rydén, Karolinska and Professor Anders Fasth, Queen Silivia Children's Hospital. Uppsala University Hospital is the sponsor of the study, which is funded by research grants. NextCell contributes with ProTrans and placebo in the study. In addition, the company will support the trial with logistics, documentation and expertise. Tillkännagivande • May 28
Nextcell Pharma AB Elects Hans-Peter Ekre as New Chairman of the Board NextCell Pharma AB announced the Hans-Peter Ekre was elected new Chairman of the Board. Reported Earnings • Apr 26
Second quarter 2024 earnings released Second quarter 2024 results: Revenue: kr2.40m (down 12% from 2Q 2023). Net loss: kr10.1m (loss narrowed 12% from 2Q 2023). Tillkännagivande • Apr 24
NextCell Pharma AB Announces Swedish Health and Social Care Inspectorate Grants Their Cellaviva Tissue Establishment Permission to Handle Amniotic Tissue NextCell Pharma AB announced that the Swedish Health and Social Care Inspectorate (IVO) has granted their Cellaviva tissue establishment permission to handle amniotic tissue. Cellaviva is the larger private stem cell bank in the Nordics. Since the launch of the cord blood bank in 2014, the company has increased the business model to include genetic tests and tissue handling services for biotech companies and hospitals. Cellaviva is expanding business-to-business activities by broadening their tissue establishment permission to include aminiotic tissues. This opens up the opportunity for handling ophthalmic products which often are produced from amniotic tissue. Discussions potential suppliers are ongoing. The business model is fee for service. Cellaviva provides a service for handling, shipping and traceability of tissues which require a tissue establishment. Tillkännagivande • Apr 20
NextCell Pharma AB, Annual General Meeting, Nov 28, 2024 NextCell Pharma AB, Annual General Meeting, Nov 28, 2024. Tillkännagivande • Apr 19
Anders Essen-Möller Resigns as Chairman of NextCell Pharma AB NextCell Pharma AB announces that its long-time Chairman of the Board, Anders Essen-Möller, after ten years of dedicated leadership, will step down from his role on May 20th, 2024 due to health reasons. Anders has been a central figure in NextCell's journey since 2014 when the Company was founded by Diamyd Medical AB together with board members Hans-Peter Ekre and Edvard Smith, as well as CEO Mathias Svahn and Lena Wikingsson. Prior to Anders' departure, the board has actively started working on identifying a suitable replacement and has assigned the nomination committee, together with NextCell's management team, the task of presenting candidates for the position of chairman before the annual general meeting on November 28, 2024. During this transition period, Hans-Peter Ekre, one of NextCell's board members, will and co-founder, to act as acting chairman of the board until the board is full and a new regular chairman can be appointed. Tillkännagivande • Mar 29
The Swedish Medical Products Agency Approves Subgroup Analysis in NextCell Pharma AB's ProTrans-Young study NextCell Pharma AB announced that the Swedish Medical Products Agency has approved an application to conduct a subgroup analysis of the treatment effect of ProTrans in 30 adolescents in the age group 12-21 years, treated in the ProTrans-Young study. Principal Investigator Professor Per-Ola Carlsson and his team treated the last patient in the age group in February 2024. The approval for the subgroup analysis by the Swedish Medical Products Agency means that the primary efficacy endpoint readout is available after 12 months. The primary efficacy endpoint is measured as a difference in endogenous insulin production compared ProTrans and placebo-treated patients one year after treatment. Results from the subgroup analysis are planned to be presented in the second quarter of 2025. ProTrans-Young started in 2022 and is an investigator-initiated clinical study led by Uppsala University together with Linkoping University and Lund University. The aim is to evaluate ProTrans for the treatment of pediatric patients with newly diagnosed type 1 diabetes. The first part of the study is an open-label safety study with 6 children aged 7 - 18 years who have recently been diagnosed with type 1 diabetes. All patients have been treated and the data safety monitoring board recommended to continue with a phase 2 part of the study in which two age groups with 30 patients in each are treated with ProTrans or placebo. The 30 patients aged 12 - 21 years have undergone treatment; the last patient was treated in February. One year of efficacy data can thus be collected in early spring 2025 and presented before summer 2025. The subgroup analysis is done for business reasons and does not affect the continuation of the study. The study's primary endpoint is the change in endogenous insulin production after 12 months, by measuring the concentration of c-peptide after a meal test. Thus, the subgroup analysis will prematurely present the change over 12 months at the group level, ProTrans compared to placebo, without assessment of statistical significance. Recruitment of 30 patients in the younger subgroup of children aged 7 - 11 years is planned after the summer this year and is expected to last until the summer of 2025. Final data from all of ProTrans-Young patients is expected to be presented in the second half of 2026. NextCell's goal is to take ProTrans to a marketing approval for the treatment of type-1 diabetes together with a partner. The subgroup analysis second quarter-2025 may lead to interesting discussions about license agreements to enable the start of pivotal study immediately after completion of the child study. Reported Earnings • Jan 26
First quarter 2024 earnings released First quarter 2024 results: Revenue: kr4.69m (up 56% from 1Q 2023). Net loss: kr9.80m (loss widened 9.8% from 1Q 2023). Tillkännagivande • Jan 24
Nextcell Pharma Announces Updates Regarding Nextcell's Clinical Trials with Protrans NextCell Pharma has several ongoing clinical trials with ProTrans. The largest ongoing study ProTrans Young, which includes 66 patients, is progressing well. All 30 patients in the older age group have been recruited and will be treated with ProTrans. In the long-term follow-up studies ProTrans-Obs and ProTrans-Repeat the first diabetes patients have now completed the studies after five years of follow-up. ProTrans-Young - completed recruitment of the older age group The study was started in 2021 and is an investigator-initiated clinical study led by Uppsala University in collaboration with Linkoping University and Lund University. The goal for this Phase 1/2 study is to evaluate ProTrans for the treatment of paediatric patients newly diagnosed with type 1 diabetes. All patients in the older age Group have now been recruited and the last patient in this age group is expected to receive treatment in February of this year. After further safety checks, 30 patients in the age group 7-11 will be recruited. That part of the study is expected to begin in August. ProTrans-Obs - patients will soon be evaluated. ProTrans-Obs is long-term follow-up of 11 patients who previously participated in ProTrans-2. The first diabetes patients will soon have completed the study after being observed for five years. During the summer, all patients will have completed the study, which can then be evaluated. Of the patients who completed ProTrans-2, 6 ProTrans-treated and 5 placebo-treated patients accepted an invitation to participate in the follow-up study ProTrans-Obs after completion of the ProTrans-2 study. In this study, the patients' own body insulin production is measured every six months, and a follow-up after three years has already been carried out. The result from this interim analysis shows a statistically significant treatment effect on the body's own insulin production at all analysed times up to three years. Drill University in Montreal, Canada, sponsored a Phase 2 trial for the treatment of patients with severe pneumonia caused by COVID-19. The aim of the study was to include 48 patients who were randomised to ProTrans (24 patients) or placebo (24 patients). The study was terminated by Drill after 19 patients were treated, due to less patients meeting the criteria for inclusion as the vaccine programme was rolled out. ProTrans-1 - completed Phase 1 study The study was started in January 2018 and completed in 2019. An open-label dose-escalation Phase 1 study in 9 patients with type 1 diabetes. ProTrans's safety and impact on the patient's own insulin production were evaluated by measuring insulin production before and one year after treatment. The study showed a) good safety, and b) a dose-dependent effect regarding preservation of the body's own insulin production one year after treatment. ProTrans-2 - completed Phase 2 study The study was started in 2019 and completed in 2020. A randomised, double-blinded placebo-controlled Phase 2 study with the main objective of evaluating effectiveness. The study included fifteen newly diagnosed patients with type 1 diabetes. The results showed that patients treated with ProTrans maintained 90% of their body's own insulin production at the time of treatment one year after treatment, compared to 53% in the placebo group. Data from this study have been published in Diabetologia, the official journal of the European Association for the Study of Diabetes (Carlsson et al. 2023 Aug;66(8):1431-1441). Reported Earnings • Oct 29
Full year 2023 earnings released Full year 2023 results: Revenue: kr14.0m (up 124% from FY 2022). Net loss: kr39.8m (loss widened 15% from FY 2022). Reported Earnings • Jul 28
Third quarter 2023 earnings released Third quarter 2023 results: Revenue: kr4.19m (up 156% from 3Q 2022). Net loss: kr10.9m (loss widened 17% from 3Q 2022). Tillkännagivande • Jul 06
NextCell Pharma AB Announces Treatment Start of Severe Pneumonia with High Dose of ProTrans NextCell Pharma AB announced that the clinical trial ProTrans 19+SE can start recruiting patients in the high dose group, which is the last dose group. Three patients treated with medium dose of ProTrans have been clinically evaluated and the data has been reviewed by the Data Safety Monitoring Board, which now allows continued treatment with high-dose ProTrans for severe pneumonia caused by COVID-19, Influenza, Human Metapneumovirus and RSV. The Data and Safety Monitoring Board has analyzed the safety aspects of the clinical trial: "Treatment of Respiratory Complications Associated with COVID-19 Infection Using Wharton's Jelly (WJ) Umbilical Cord (UC) Mesenchymal Stromal Cells {ProTrans®): open Phase IB Clinical Trial", described in EudraCT 2020-002078-29. The meeting was held on July 3 of July 2023. The members of the Board are Professor Ake Lernmark, Doctor Magnus Nisell and Professor Peter Bergman (Chairman). The Data and Safety Monitoring Board had access to full data collection forms including adverse events. ProTrans is being developed as an immunomodulatory cell therapy currently being evaluated for the treatment of patients with type 1 diabetes. However, the mechanism of immunomodulation is expected to be applicable in other autoimmune diseases and inflammatory conditions. When the condition of COVID-19 patients worsens, it is because the immune system becomes hyperactive and attacks organs, including the lungs. In this open-label phase Ib study, a total of three groups, consisting of three patients each will be treated with different doses of ProTrans. Now 6 out of 9 patients have undergone treatment and only 3 patients in the high dose group remain. Early this year, the Swedish Medical Products Agency approved the study, which initially only treated patients with severe pneumonia caused by SARS-CoV-2 infection, to also include patients with the same symptoms caused by influenza A, respiratory syncytial (RS) and human metapneumo (HMP) virus. The treatmentis designed for patients who are hospitalized and who are at high risk of needing to be put on a ventilator. ProTrans is given intravenously to reduce hyperinflammation in the lungs. The goal of the treatment is to shorten the hospital stay, rehabilitation time and to save lives. Reported Earnings • Apr 30
Second quarter 2023 earnings released Second quarter 2023 results: Net loss: kr11.4m (loss widened 12% from 2Q 2022). Reported Earnings • Jan 27
First quarter 2023 earnings released First quarter 2023 results: Net loss: kr8.92m (loss widened 38% from 1Q 2022). Tillkännagivande • Dec 22
NextCell Pharma AB Announces First Pediatric Patients Treated with ProTrans in Type-1 Diabetes Phase II Study NextCell Pharma AB supported the pediatric diabetes clinical trial conducted at Uppsala University Hospital by Principal Investigator Professor Per-Ola Carlsson with the stromal cell treatment, ProTrans. At the end of October 2022, the Data Safety and Monitoring Board recommended that phase II part of this pivotal trial should be initiated. Now the first two adolescents in the older age cohort (12-21 years) have received treatment. Recruitment of children and adolescents newly diagnosed with type-1 diabetes is underway. Patients who can participate in the study must be between 12 and 21 years of age and should have received their diagnosis in the last 6 months. Two out of a total of 30 patients have now received treatment with either ProTrans or placebo. The first part of ProTrans-Young is a safety study (phase I) where all patients have been treated at Uppsala University Hospital. Three patients aged 12-18 years first received treatment, followed by 3 patients aged 7-11 years. Safety data was reviewed by the Data Safety and Monitoring Board after all 6 patients were evaluated at the 3-month follow-up visit. The Board recommended that the study should continue with the second part, which is a randomized and placebo-controlled (phase II) study including a total of 60 children and adolescents with type-1 diabetes, 30 of whom will be treated with ProTrans and 30 with placebo. Initially, 30 patients aged 12-21 will be treated. The company can now report that the first two patients have now received treatment. After treatment and 6-month follow-up of the entire age group, the Data Safety and Monitoring Board will again review the safety data before continuing to treat the remaining 30 patients aged 7-11. The Principal Investigator is Professor Per-Ola Carlsson, Uppsala University and Uppsala University Hospital with co-investigators Professor Helena Elding Larsson, Skåne University Hospital and Professor Johnny Ludvigsson, Linköping University Hospital. The Data Safety and Monitoring Board consists of chairman Professor Ulf Smith, Sahlgrenska, Professor Mikael Rydén, Karolinska Institutet and Professor Anders Fasth, Queen Silvia'sChildren's Hospital. Uppsala University Hospital is the sponsor of the study, which is funded by third-party research grants. NextCell contributes ProTrans and placebo to the study. In addition, the company will support the trial with logistics, documentation and expert competence. No additional monetary compensation will be made. The full title of the study is: "A Double-blinded, Randomized, Parallel, Placebo-controlled trial of Wharton's Jelly-derived Allogeneic Mesenchymal Stromal Cells to treat Type I Diabetes in Children and Adolescents" (EudraCT 2020-004520-42). ProTrans is NextCell's first drug candidate based on their patent pending selection algorithm. It is an allogeneic cell therapy which means that donated cells, not the patient's own, are used. The cells are extracted from donated umbilical cord tissue and the cells are then expanded to generate large, therapeutic doses of drug product. ProTrans is defined by the selection algorithm, a method for selecting cells with suitable immunomodulatory effect that is assessed in a panel of different analyzes. The algorithm makes an overall assessment of several functional analyzes to identify optimal donors and cells for the manufacture of cell therapies. NextCell's advanced selection method has a scalable ability and guarantees high reproducibility and efficacy compared to other applications in cell therapy. The careful selection method results in cells of consistently high quality and a strong safety profile with few side effects. Board Change • Nov 16
Less than half of directors are independent No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. No highly experienced directors. 1 independent director (3 non-independent directors). Chairman Anders Essen-Möller was the last director to join the board, commencing their role in 2016. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment. Reported Earnings • Nov 06
Full year 2022 earnings released Full year 2022 results: Net loss: kr34.6m (loss widened 41% from FY 2021). Tillkännagivande • Oct 29
Nextcell Pharma AB Announces Trial with Protrans Gets Green Light for Phase Ii Part NextCell Pharma AB ("NextCell") announces that the Data Safety Monitoring Board has recommended professor Per-Ola Carlsson to continue with the phase II part of the pediatric study in type-1 diabetes with ProTrans, ProTrans-Young. NextCell Pharma AB ("NextCell") announces that the Data Safety Monitoring Board has recommended professor Per-Ola Carlsson to continue with the phase II part of the pediatric study in type-1 diabetes with ProTrans, ProTrans-Young. The first part of ProTrans-Young is a safety part (phase Ib) where all patients are treated at Uppsala University Hospital. 3 patients aged 12-18 years first receive treatment and are then followed by 3 patients aged 7-11 years. After all 6 patients have been on a 3 month follow-up examination, there is a review of data with regards to safety by the Data Safety Monitoring Board (DSMB). The DSMB has now recommended that the study continues with a second part which is randomized and placebo-controlled (phase II). A total of 60 children and adolescents with type-1 diabetes will be treated, 30 with ProTrans and 30 with placebo. Initially, 30 patients aged 12-21 in Part II will be treated and after 6 months of follow-up, the DSMB will review safety before continuing to treat the remaining 30 patients aged 7-11. The principal investigator is professor Per-Ola Carlsson, Uppsala University and Uppsala University Hospital with co-investigators Professor Helena Elding Larsson, Skåne Universitety Hospital and Professor Johnny Ludvigsson, Linköping Universitets Hospital. The Data Safety Monitoring Board consists of chairman professor Ulf Smith, Sahlgrenska and Professor Mikael Rydén, Karolinska University Hospital and Professor Anders Fasth, Queen Silivia's Children's Hospital. Uppsala University Hospital is the sponsor of the trial, which is funded by research grants. NextCell contributes to the study with ProTrans and placebo. In addition, the company will support the trial with logistics, documentation, and expert competence. No additional monetary compensation will be paid, i.e., NextCell will not pay for the study. The full title of the study is: "A Double-blinded, Randomized, Parallel, Placebo-controlled trial of Wharton's Jelly-derived Allogeneic Mesenchymal Stromal Cells to treat Type I Diabetes in Children and Adolescents" (EudraCT 2020-004520-42). Tillkännagivande • Oct 25
Nextcell Cell Therapy Shows Long-Term Effect in Two Independent Diabetes Studies "ProTrans-Repeat" and "ProTrans-Obs"- Live Presentation 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. 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 after treatment. ProTrans-2. A since 2020 completed placebo-controlled Phase-2 study 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 3.5-4 years. 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 14 patients who completed ProTrans-2, 6 ProTrans-treated and 5 placebo treated patients accepted to participate in follow-up study n ProTrans-Note after completion of the study, where they are 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 time points (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 and 30 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 for phase-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. Tillkännagivande • Oct 21
Nextcell Pharma AB Announces Protrans Cell Therapy Provides Long-Term Effect in Type-1 Diabetes with A Single Treatment NextCell Pharma AB announced that patients who 3 years ago were treated with ProTrans in the phase II study ProTrans-2 have maintained significantly higher endogenous insulin production than patients who received placebo, (63% compared to 23%). The results from the interim follow-up study ProTrans-Obs suggest that the treatment changes the course of the disease and that the effect persists over time. In 2018, the randomized double-blind phase II clinical trial, ProTrans-2 started at Karolinska University Hospital. A total of 15 patients were randomized 2:1 to treatment with ProTrans or placebo. The primary endpoint is percentage of endogenous insulin production one year after therapy and patients treated with ProTrans maintained an average of 90% compared to the placebo group who maintained 53%. The 14 patients who completed ProTrans-2 were after completion offered to participate in a follow-up study, where they are followed for another 5 years, ProTrans-Obs. Some patients abstained from participation due to long journeys, 6 patients treated with ProTrans and 5 patients who received placebo are included in the study. In ProTrans-Obs, the patients' endogenous insulin production is measured semi-annually and the latest analysis was carried out after 3 years of follow-up. In this interim analysis, ProTrans shows a statically significant treatment effect at all analyzed time points (p<0.05). NextCell announced on October 18, 2022 that patients with type-1 diabetes undergoing two high-dose treatments of ProTrans cell therapy retain significantly higher endogenous insulin production than patients treated with low and medium dose in the clinical drug trial, ProTrans-Repeat. The results from ProTrans-Obs (one treatment with ProTrans) and ProTrans-Repeat (two treatments with ProTrans) cannot be directly compared, but both studies clearly show that ProTrans has a long-term effect for the treatment of type-1 diabetes. Tillkännagivande • Oct 19
NextCell Pharma AB Announces Type-1 Diabetes Patients Receiving Two Treatments with A High Dose of Protrans Cell Therapy NextCell Pharma AB announced that type-1 diabetes patients receiving two treatments with a high dose of ProTrans cell therapy maintain a significantly higher endogenous insulin production than patients treated with low or medium doses. Type I diabetes patients enrolled in the ProTrans Repeat Study, treated with the highest dose of ProTrans, maintained a significantly higher preserved endogenous insulin production than patients treated with low and medium doses (p<0.05). On average, the 3 patients treated in each of the low, medium and high-dose cohorts have maintained 41%, 45% and 81% of their insulin production capacity at the time of treatment that is 3.5-4 years ago. In 2018, 9 patients were treated in the Phase I ProTrans-1 dose escalation study. Treatment with ProTrans demonstrated a dose-dependent therapeutic effect, with medium and high-doses maintaining a statistically significant higher insulin production than patients receiving low-dose therapy. Patients treated with low dose ProTrans reduced an average of 28% of their endogenous insulin production, compared to 6% in medium and high-dose treated patients. All the 9 patients, who participated in ProTrans-1 above, agreed to be included in a continuation study, ProTrans-Repeat. All patients received an additional treatment of ProTrans, with the same dose that they previously received (one year after the initial treatment), with evaluation subsequently performed twelve months later, that is 2 to 2.5 years after the initial treatment. The study was designed to evaluate the safety of repeated treatments. All doses were shown to be safe and did not result in any antibody responses to the allogeneic treatment. Maintained insulin production after 2 years was 94% for high, 56% for medium and 51% for low dose. An interim analysis is now presented that concludes that high-dose treatment provides the highest and longest-lasting therapeutic effect in type I diabetic patients. Maintenance of insulin production has been assessed on 3 occasions for each patient- after 1 year, 2 years and 3.5 years where the average for high dose was 96%, 94% and 81% compared to medium dose 91%, 56% and 45% and low dose 72%, 51% and 41%. The ProTrans-Repeat study is set to last for 5 years that is a total of 6-6.5 years from inclusion in ProTrans-1. Tillkännagivande • Aug 26
NextCell Pharma AB Announces ProTrans Cell Therapy to Be Granted Patent Protection Beyond Europe Next Cell Pharma AB announced that the Japan Patent Office (JPO) has issued a notice of allowance relating to the patent entitled "Allogeneic Composition" (publication number JP2020543858A). The patent describes the method of manufacturing the drug candidate ProTrans, where the selection algorithm is key for selecting optimal cells and donors. Patent protection is valid until 2039. The selection algorithm consists of a method for selecting cells with a suitable immunomodulatory effect that are assessed by a panel of different analyses. The algorithm makes an overall assessment of several functional analyses to identify optimal donors and cells for the manufacture of cell therapies. NextCell's accurate and advanced selection method has a scalable capability and guarantees high reproducibility and efficacy compared to other applications in cell therapy. The careful selection method results in consistently high -quality cells and hence a strong safety profile with few side effects. ProTrans is NextCell's first drug candidate based on the selection algorithm. It is an allogeneic cell therapy which means that donated cells, not the patient's own, are used. The cells are extracted from donated umbilical cord tissue and the cells are then multiplied to generate large amounts of cells. Cinical trials in type-1 diabetes have shown promising results for ProTrans to stop the course of the disease for 1 year in adult patients, potentially longer. Ongoing trials are now evaluating efficacy in adolescents and children newly diagnosed with type-1 diabetes. In addition, clinical trials are ongoing with patients with severe pneumonia due to COVID-19 infection, in Sweden and Canada. Reported Earnings • Jul 31
Third quarter 2022 earnings released Third quarter 2022 results: Net loss: kr9.31m (loss widened 44% from 3Q 2021). Tillkännagivande • Jun 09
NextCell Pharma AB Announces Patients in the First Part of Pediatric Diabetes Trial with Nextcell's Protrans Treated NextCell Pharma AB first part of the clinical trial with Protrans is a safety part where all patients are children with type-1 diabetes who have now received their treatment at the Uppsala University Hospital. The Data Safety and Monitoring Board consists of Professor Ulf Smith, Sahlgrenska University Hospital, Professor Mikael Rydén, Karolinska Hospital and Professor Anders Fasth, Queen Silvia Children's Hospital. They will evaluate whether it is safe to proceed to the phase II part of the study, based on 3 months of follow-up of six children. In the phase II part of the study, patients are randomized to ProTrans or placebo (1:1). First, 30 patients in the age group of 12-21 years are treated, after which - provided the recommendation of the Data Safety and Monitoring Board after six months -, another 30 patients in the age group of 7-11 years are included in the study. ProTrans is a cell therapy that balances the immune system and counteracts autoimmune type-1 diabetes. The active substance mesenchymal stromal cells, also called stem cells, are selected from umbilical cord tissue using NextCell's patent-pending selection algorithms. The principal investigators for the study are professor Per-Ola Carlsson, Uppsala University and Uppsala University Hospital with the co-investigators professor Helena Elding Larsson, Skånes University Hospital and professor Johnny Ludvigsson, Linköpings University Hospital. The second part of the study is randomized and placebo-controlled (phase II) and a total of 60 children and adolescents with type-1 diabetes will be treated, of which 30 with ProTrans and 30 with placebo. Recruitment will take place at the three participating hospitals in Uppsala, Linköping and Malmö. Tillkännagivande • May 31
The European Patent Office intends to grant a Patent to NextCell Pharma AB for Selection Algorithm NextCell Pharma AB announced that the European Patent Office (EPO) has issued an Intention to Grant notice relating to the patent entitled "Allogeneic Composition" (publication number EP3752598). The patent describes the method of manufacturing the drug candidate ProTrans, where the selection algorithm is key for selecting optimal cells and donors. Patent protection is valid until 2039. The selection algorithm consists of a method for selecting cells with a suitable immunomodulatory effect that are assessed by a panel of different analyses. The algorithm makes an overall assessment of several functional analyses to identify optimal donors and cells for the manufacture of cell therapies. NextCell's accurate and advanced selection method has a scalable capability and guarantees high reproducibility and efficacy compared to other applications in cell therapy. The careful selection method results in consistently high-quality cells and hence a strong safety profile with few side effects. ProTrans is NextCell's first drug candidate based on the selection algorithm. It is an allogeneic cell therapy which means that donated cells, not the patient's own, are used. The cells are extracted from donated umbilical cord tissue and the cells are then multiplied to generate large amounts of cells. Clinical trials in type-1 diabetes have shown promising results for ProTrans to stop the course of the disease for 1 year in adult patients, potentially longer. Ongoing trials are now evaluating efficacy in adolescents and children newly diagnosed with type-1 diabetes. In addition, clinical trials are ongoing with patients with severe pneumonia due to COVID-19 infection, in Sweden and Canada. Reported Earnings • Apr 29
Second quarter 2022 earnings released Second quarter 2022 results: Net loss: kr10.2m (loss widened 25% from 2Q 2021). Board Change • Apr 27
Less than half of directors are independent No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. No highly experienced directors. 1 independent director (3 non-independent directors). Chairman Anders Essen-Möller was the last director to join the board, commencing their role in 2016. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment. Tillkännagivande • Apr 08
NextCell Pharma AB Announces First Age Group Treated in Paediatric Diabetes Study with Protrans NextCell Pharma AB (NextCell) announced all three children in the age group 12-18 years have been treated with ProTrans. Professor Per-Ola Carlsson and the study team are now moving forward with younger patients, three children in the age group 7-11 years. The first part of the study is a safety part (phase Ib) where all patients are treated at Uppsala University Hospital. The Safety Committee consists of Chairman Professor Ulf Smith, Sahlgrenska Hospital and Professor Mikael Rydén, Karolinska University Hospital and Professor Anders Fasth, Queen Silvia Children's Hospital. They will evaluate whether it is safe to proceed to the phase II part of the study, based on 3 months of follow-up of the total of six children. In the second part of the study, patients are randomized to ProTrans or placebo (1:1). First, 30 patients in the 12-21 age group will be treated and based on safety evaluation after six months, 30 patients in the 7-11 age group will also be treated. The principal investigator is Professor Per-Ola Carlsson, Uppsala University and Uppsala University Hospital with co-investigators Professor Helena Elding Larsson, Skåne University Hospital and Professor Johnny Ludvigsson, Linköping University Hospital. The second part is randomised and placebo-controlled (phase II) and a total of 60 children and adolescents with type 1 diabetes should be treated, of which 30 with ProTrans and 30 with placebo. Recruitment will take place at the three participating hospitals in Uppsala, Linköping and Malmö. Akademiska sjukhuset is a sponsor of the study, which is funded with research grants. NextCell is contributing ProTrans and placebo in the study. In addition, the company will support the trial with logistics, documentation and expertise. Tillkännagivande • Feb 24
NextCell Pharma AB Announces Clinical Trial ProTrans19+CA Expanded to Include an Additional Site: The Jewish General Hospital In Montreal, Canada NextCell Pharma AB announces that the clinical trial ProTrans19+CA expanded to include an additional site: the Jewish General Hospital in Montreal, Canada. The hospital is one of the in Canada and is affiliated with the trial Sponsor, the Research Institute of McGill University Health Center. Patient enrolment increased due to the omicron variant, which the company envisage will be further enhanced by patient reqruitment at both sites, the Royal Victoria and Jewish General Hospital. The coronavirus pandemic has transformed over time and omicron has shown to be more contagious but associated with milder symptoms, especially for the growing proportion of vaccinated people. The number of cases were relatively low in Canada but as everywhere else, increased drastically in late 2021. ProTrans19+CA started to enroll patients in mid 2021 and 14 of the 48 patients have been treated with ProTrans to date. Tillkännagivande • Feb 22
NextCell Pharma AB Announces Pediatric Diabetes Study with ProTrans in Progress NextCell Pharma AB has previously announced a clinical trial with ProTrans™ to treat children and adolescents with type 1 diabetes. The study recently started with screening of patients. Before treatment, patients are followed for about a month and the first adolescents will soon undergo treatment. The first part of the study is a safety part (phase Ib) where all patients are treated at Akademiska university hospital. 3 patients aged 12-18 years receive treatment first and there after 3 patients aged 7-11 years. The data will then be reviewed by the Data Safety Monitoring Board, which consists of chair professor Ulf Smith, Sahlgrenska univeristy hospital and professor Mikael Rydén, Karolinska University Hospital and professor Anders Fasth, Queen Silivia Children's Hospital. Reported Earnings • Jan 29
First quarter 2022 earnings: Revenues in line with analyst expectations First quarter 2022 results: Net loss: kr6.47m (loss widened 18% from 1Q 2021). Revenue was in line with analyst estimates. Reported Earnings • Oct 31
Full year 2021 earnings released: kr0.71 loss per share (vs kr0.89 loss in FY 2020) Full year 2021 results: Net loss: kr24.6m (loss widened 39% from FY 2020). Reported Earnings • Aug 01
Third quarter 2021 earnings released Third quarter 2021 results: Net loss: kr6.46m (loss widened 34% from 3Q 2020). Tillkännagivande • Jun 11
NextCell Pharma AB Announces COVID-19 Patient Treated with ProTrans NextCell Pharma AB announced that the first patient with severe pneumonia, as a result of COVID-19 infection, has now been treated with ProTrans. The patient was hospitalized at Örebro University Hospital, where the phase 1b study ProTrans19+SE is in progress led by Principal Investigator Associate Professor Josefin Sundh. NextCell's drug candidate, ProTrans, is an immune- balancing cell therapy for the treatment of autoimmune diseases and inflammatory conditions. Patients with severe pneumonia as a result of by SARS-CoV-2 infection are at risk of rapid detioration, potentially leading to acute respiratory distress syndrome (ARDS) due to hyper-inflammation of the lungs. ProTrans is given as a peripheral infusion with the aim of reducing this hyper-inflammation. The goal of the treatment is to shorten hospital stay and time for rehabilitation, and to save lives. The study, entitled "Treatment of Respiratory Complications Associated with COVID-19 Infection Using Wharton's Jelly - Umbilical Cord Mesenchymal Stromal Cells (ProTrans): Open Phase IB Clinical Trial" is sponsored by NextCell and will include 9 patients with severe pneumonia and confirmed COVID-19 (SARS-CoV-2) infection, who will be treated with low (3 patients), medium (3 patients), or high dose (3 patients) ProTrans. NextCell will provide updates after the completion of each dose cohort, ie when all 3 patients in each dose group have received treatment. The study is registered on clinicaltrials.gov (NCT04896853). ProTrans is furthermore under evaluat for the treatment of severe pneumonia in COVID-19 infected patients in a Canadian phase 2 clinical trial with a total of 48 patients, ProTrans19+CA (NCT04869397). Tillkännagivande • May 29
NextCell Presents Their Latest Phase II Clinical Data at ISCT 2021 NextCell Pharma AB announced that they will present their findings from their Phase I/II study entitled "Wharton´s Jelly Derived Mesenchymal Stromal Cell Treatment of Adult Patients Diagnosed With Type I Diabetes" (NCT 03406585) at the International Society of Cell and Gene Therapy virtual conference 2021 (May 26-28). NextCell's CSO, Dr. Lindsay Davies will attend the meeting and present a poster entitled "Protrans Wharton's Jelly Mesenchymal Stromal Cells Preserve Beta Cell Function in Newly Diagnosed Type I Diabetes Patients - A Randomised, Double-Blinded, Placebo Controlled Phase II Trial" (Poster #111). NextCell, in collaboration with the Principal Investigator for the trial, Prof. Per-Ola Carlsson of Uppsala University Hospital, outline their study findings highlighting the therapeutic effect of a single infusion of ProTrans in maintaining beta cell function in early diagnosed, adult type I diabetics. NextCell are actively involved in the ISCT. Dr. Lindsay Davies is a member of the Commercialisation Committee, Process and Product Development Committee and the Particulate Working Group. Dr. Davies is also a mentor for Early Stage Professionals in Cell Therapy for ISCT Europe. Dr. Mathias Svahn is a member of the ISCT's Business Models and Investment Committee. Tillkännagivande • May 27
NextCell Pharma AB Announces That Both the Canadian and Swedish Covid-19 Studies Have Been Initiated and Are Now Ready to Include Patients with Severe Pneumonia Triggered by Sars-Cov-2 Infection NextCell Pharma AB announced that both the Canadian and Swedish COVID-19 studies have been initiated and are now ready to include patients with severe pneumonia triggered by SARS-CoV-2 infection. The treatment is aimed at patients who are hospitalized and with a high risk of needing ventilatory support. ProTrans is given as a peripheral infusion. With the aim of reducing hyper-inflammation within the lungs. The goal of the treatment is to shorten hospital stay and time for rehabilitation, and to save lives. ProTrans19 + CA, a randomized placebo-controlled phase-II study in Canada with a total of 48 patients. ProTrans19 + SE, an open dose escalation phase Ib study in Sweden with a total of 9 patients. Both studies are now ready to enrol. The clinical trial protocols for both the studies have been written by Professor Dominique Farge and Doctor Lindsay Davies, CSO NextCell Pharma. Some national adjustments have been made in consultation with the Principal Investigators Professor Josefin Sundh in Sweden and Associate Professor Inés Colmegna in Canada to allow cross-comparison between data sets from both studies. The Swedish trial is a phase-Ib dose escalation study, with a total of 9 patients, and a primary endpoint to evaluate safety. The Canadian trial is a phase-II study and will enrol 48 patients, randomized for treatment with ProTrans or placebo. Primary endpoint is to evaluate the efficacy of ProTrans treatment. Treatment of Respiratory Complications Associated with COVID-19 Infection Using Wharton's Jelly (WJ)-Umbilical Cord (UC) Mesenchymal Stromal Cells (ProTrans(TM)): a Randomized Phase II Controlled Clinical Trial. The trial will enrol 48 patients with severe pneumonia associated with confirmed COVID-19 (SARS-CoV-2) infection, randomised to ProTrans treatment (24 patients) or placebo (24 patients). The trial is an international collaboration between McGill University, Montreal Canada; NextCell Pharma AB, Stockholm Sweden; Saint-Louis Hospital, Paris University, France, and FamiCord Group PBKM SA, Warsaw, Poland. The core trial team designing the study are Principal Investigator Associate Professor Inés Colmegna, McGill University, co-PI Professor Dominique Farge, MATHEC, Center of Reference FAI2R, Hôpital St-Louis, IRSL, Université de Paris & adjunct Professor McGill University, co-PI Professor James Martin, McGill University, co-PI Doctor Ilan Azuelos, McGill University, co-PI Doctor Emily McDonald, McGill University and Doctor Lindsay Davies, CSO NextCell Pharma & Karolinska Institutet. Treatment of Respiratory Complications Associated with COVID-19 Infection Using Wharton's Jelly - Umbilical Cord Mesenchymal Stromal Cells (ProTrans®): Open Phase IB Clinical Trial" NextCell sponsors the study, which will include 9 patients with severe pneumonia and confirmed COVID-19 (SARS-CoV-2) infection, who will be treated with low (3 patients), medium (3 patients), or high dose (3 patients) ProTrans. The study will be performed at the University Hospital in Örebro in collaboration with the Department of Clinical Trials and Karolinska Trial Alliance. The Principal Investigator in Sweden is Professor Josefin Sundh. Tillkännagivande • May 21
Nextcelpharmama AB Recruitments Start for the Protrans Study for Treatment of Covid-19 NextCelPharmama AB announces that the Swedish COVID -19 st has been initiated and is nowow ready to include patients with severe pneumonia triggered by SARS-CoV-2 infection. The treatment is aimed at patients who are hospitalized and with a high risk of needing ventilatory support. ProTrans is given as a peripheralinfusion. With the aim of reducing hyper-inflammation within the lungs. The goal of the treatment is to shorten hospital stay and time for rehabilitation and save lifes. The study will be performed at the University Hospital in Örebro in collaboration with the Department of Clinical Trials and Karolinska Trial Alliance. The Principal Investigator in Sweden is Professor Josefin Sundh. Reported Earnings • May 01
Second quarter 2021 earnings released Second quarter 2021 results: Net loss: kr8.15m (loss widened 93% from 2Q 2020). Is New 90 Day High Low • Feb 20
New 90-day low: €1.50 The company is down 24% from its price of €1.96 on 20 November 2020. The German market is up 10.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 10.0% over the same period. Tillkännagivande • Feb 04
NextCell Pharma AB Announces Canadian Trial for ProTrans in COVID-19 NextCell Pharma AB announced that Health Canada and the McGill University Health Centre Research Ethics Board have authorized the clinical trial entitled "Treatment of Respiratory Complications Associated with COVID-19 Infection Using Wharton's Jelly (WJ)-Umbilical Cord (UC) Mesenchymal Stromal Cells (ProTrans™): a Randomized Phase II Controlled Clinical Trial". The sponsor for this trial is the Research Institute of the McGill University Health Centre. The trial will enrol 48 patients with severe pneumonia associated with confirmed COVID-19 (SARS-CoV-2) infection, randomised to ProTrans treatment (24 patients) or placebo (24 patients). The coronavirus pandemic may unfortunately be far from over. Mesenchymal stromal cell therapies have shown promise in the treatment of acute respiratory distress syndrome (ARDS), pneumonia, inflammation, and sepsis, which are among the leading causes of mortality in COVID-19 patients. The ProTrans study has been designed to evaluate whether it is possible to protect patients from developing ARDS by intervening early and breaking disease progression upon the onset of pneumonia. ProTrans is different from other MSC products in that it is developed from umbilical cords selected with a proprietary algorithm (patent pending). The trial is an international collaboration between McGill University, Montreal Canada; NextCell Pharma AB, Stockholm Sweden; Saint-Louis Hospital, Paris, France, and FamiCord Group PBKM SA, Warsaw, Poland. The core trial team designing the study are Principal Investigator Associate Professor Inés Colmegna, McGill University, co-PI Professor Dominique Farge, MATHEC, Center of Reference FAI2R, Hôpital St-Louis, IRSL, Université de Paris & adjunct Professor McGill University, co-PI Professor James Martin, McGill University, co-PI Doctor Ilan Azuelos, McGill University, and Doctor Lindsay Davies, CSO NextCell Pharma & Karolinska Institutet. NextCell Pharma will provide ProTrans to the Canadian trial site and has participated in the trial design. NextCell has successfully completed clinical trials using ProTrans for the treatment of a chronic autoimmune disease, type-I diabetes. This trial will use the same immunomodulatory capacity of ProTrans, but for treating an acute and potentially fatal viral infection. Reported Earnings • Jan 30
First quarter 2021 earnings released: kr0.23 loss per share (vs kr0.20 loss in 1Q 2020) The company reported a poor first quarter result with increased losses, weaker revenues and weaker control over costs. First quarter 2021 results: Revenue: kr1.15m (down 6.0% from 1Q 2020). Net loss: kr5.47m (loss widened 46% from 1Q 2020). Tillkännagivande • Dec 16
Nextcell Pharma AB Announces Observational Study, Protrans-Obs, receives Approval by the Swedish Ethical Review Board NextCell Pharma AB announced that an observational study, ProTrans-OBS, has been approved by the Swedish Ethical Review Board for long-term follow-up of patients previously participating in the ProTrans-2 clinical trial. The study is conducted by professor Per-Ola Carlsson, at Uppsala University. The observational study, ProTrans-OBS, is a non-interventional study, i.e. patients will not be treated with additional doses of ProTrans. Participants that completed the ProTrans-2 trial will be asked for informed consent for biannual clinical assessment of safety and efficacy for a posttrial period of 4 years. As reported, the ProTrans-Repeat study showed sustained effect and safety over 2 years, where an additional high dose ProTrans was administered after 12 months. The long-term effect of single infusion in comparison to two infusions will be evaluated by running both ProTrans-Repeat and ProTrans-OBS in parallel. The costs related to the OBS study are included in the existing budget. Tillkännagivande • Nov 18
NextCell Pharma AB Supports ProTrans Study for Children and Adolescents NextCell Pharma AB ("NextCell") has entered into an agreement with Professor Per-Ola Carlsson, at Uppsala University Hospital and Uppsala University, with the aim of contributing the stem cell product ProTransTM (ProTrans) for the treatment of children and adolescents with type 1 diabetes, within the framework of clinical drug trials. The study, which is in the planning stage, is part of NextCell's strategy to support academic groups with drugs to be able to evaluate ProTrans for a wider use. NextCell's drug candidate, ProTrans, for the treatment of type 1 diabetes is a mesenchymal stem cell treatment that prevents the breakdown of the insulin-producing beta cells. ProTrans has shown a protective effect in both phase 1 and 2 studies without giving any serious side effects, evaluated in the ProTrans-1 and ProTrans-2 studies. For safety reasons, only adult patients have been treated, although it is more common to be diagnosed with type 1 diabetes at the age of 10-12. Professor Per-Ola Carlsson is the principal investigator for all NextCell's clinical trials with ProTrans for the treatment of type 1 diabetes and will also be the principal investigator in the planned phase III study ProTrans-3. In addition, he intends, with his own research grants, to apply for and carry out a first study with children and young people, something he presented at the World Diabetes Day 2020 in Lund. NextCell's strategy is to take ProTrans to market approval for the treatment of type 1 diabetes as soon as possible, which means a continued focus on patients who meet the inclusion criteria in previous studies. In addition, the company supports investigator-initiated trials that aim to make ProTrans a possible treatment for more patients. Tillkännagivande • Nov 11
Nextcell Starts Eurostars Funded Project Bioscale NextCell Pharma AB announced that it, in cooperation with the consortium members: MyCellHub, SEFA and Scinus Cell Expansion, now officially has kicked-off the earlier announced Eurostars project. The Eurostars project Bioscale will focus on using a novel cell expansion system developed by Scinus Cell Expansion, to further test, develop and validate the involved bioprocesses used in the production of NextCell's drug candidate ProTrans™ (ProTrans).
The Eurostars programme supports innovative international projects led by R&D-performing SMEs and is co-funded by the Eurostars partner states and the EU (through Horizon 2020). In August, NextCell announced that together with three other partners it has been awarded the Eurostars project Bioscale (projectnumber E!114513). The project will run from 2020-2023 and in late October a kick-off meeting was held with all the project menbers NextCell, MyCellHub, SEFA och SCINUS Cell Expansion. NextCell has been granted €470,000 (approximately SEK 5 Million) and will cover additionally €470,000 with own contributions. This means NextCell will be participating with a total budget of €940,398. Money is allocated for further development of production methods of ProTrans and this grant is an opportunity to finance the implementation of production in a large-scale environment. The Bioscale project focuses on the stem cell expansion technology, for cost-efficient cell culture. The project will use NextCell's drug candidate ProTrans to test and validate the capabilities of the SCINUS bioreactor to provide a method for cost-efficient cell therapy production. For NextCell specifically this grant means that it will get the opportunity to, in a collaboration with other companies and with use of their competence, work on the further development and optimization of the bioprocesses involved in the production of its drug Candidate ProTrans. NextCell will integrate assays into the SCINUS workflow to optimise production of ProTrans and compare it to 2D culture. Proper planning, testing, validation and optimization of production methods will be key for taking ProTrans to the future large scale `off-the-shelf' production.