Ankündigung • 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. Ankündigung • 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 Ankündigung • 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. Ankündigung • 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 Ankündigung • 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. New Risk • Jan 22
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr43m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. 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 (-kr43m free cash flow). Share price has been highly volatile over the past 3 months (21% average weekly change). Earnings have declined by 13% per year over the past 5 years. Shareholders have been substantially diluted in the past year (52% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable next year (kr42m net loss next year). Revenue is less than US$5m (kr11m revenue, or US$1.2m). Market cap is less than US$100m (kr161.3m market cap, or US$17.8m). Ankündigung • 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 Ankündigung • 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. New Risk • Jan 12
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Swedish stocks, typically moving 8.3% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. 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 (-kr43m free cash flow). Earnings have declined by 13% per year over the past 5 years. Shareholders have been substantially diluted in the past year (52% increase in shares outstanding). Market cap is less than US$10m (kr80.9m market cap, or US$8.81m). Minor Risks Currently unprofitable and not forecast to become profitable next year (kr42m net loss next year). Share price has been volatile over the past 3 months (8.3% average weekly change). Revenue is less than US$5m (kr11m revenue, or US$1.2m). Ankündigung • 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. Reported Earnings • Nov 02
Full year 2025 earnings: EPS and revenues miss analyst expectations Full year 2025 results: kr0.48 loss per share (improved from kr1.03 loss in FY 2024). Revenue: kr11.1m (down 1.9% from FY 2024). Net loss: kr35.1m (loss narrowed 16% from FY 2024). Revenue missed analyst estimates by 13%. Earnings per share (EPS) also missed analyst estimates by 15%. Revenue is forecast to grow 133% p.a. on average during the next 2 years, compared to a 11% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has increased by 21% per year but the company’s share price has fallen by 52% per year, which means it is significantly lagging earnings. Ankündigung • 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. Reported Earnings • Jul 25
Third quarter 2025 earnings released Third quarter 2025 results: Revenue: kr2.26m (down 8.9% from 3Q 2024). Net loss: kr10.3m (loss widened 16% from 3Q 2024). Revenue is forecast to grow 142% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in Sweden. Ankündigung • 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. Ankündigung • 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. Ankündigung • 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. Ankündigung • 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. Reported Earnings • Apr 27
Second quarter 2025 earnings released Second quarter 2025 results: Revenue: kr3.42m (up 42% from 2Q 2024). Net loss: kr8.20m (loss narrowed 19% from 2Q 2024). Revenue is forecast to grow 129% p.a. on average during the next 3 years, compared to a 16% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has fallen by 3% per year but the company’s share price has fallen by 49% per year, which means it is performing significantly worse than earnings. Ankündigung • 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 New Risk • Apr 09
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: kr94.3m (US$9.41m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. 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 (-kr41m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Earnings have declined by 19% per year over the past 5 years. Shareholders have been substantially diluted in the past year (113% increase in shares outstanding). Revenue is less than US$1m (kr9.4m revenue, or US$942k). Market cap is less than US$10m (kr94.3m market cap, or US$9.41m). Ankündigung • 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. Ankündigung • 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. Ankündigung • 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. Reported Earnings • Jan 31
First quarter 2025 earnings released First quarter 2025 results: Revenue: kr2.86m (down 39% from 1Q 2024). Net loss: kr8.04m (loss narrowed 18% from 1Q 2024). Over the last 3 years on average, earnings per share has fallen by 11% per year but the company’s share price has fallen by 28% per year, which means it is performing significantly worse than earnings. New Risk • Jan 30
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr38m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. 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 (-kr38m free cash flow). Share price has been highly volatile over the past 3 months (15% average weekly change). Earnings have declined by 20% per year over the past 5 years. Shareholders have been substantially diluted in the past year (113% increase in shares outstanding). Minor Risks Revenue is less than US$5m (kr11m revenue, or US$1.0m). Market cap is less than US$100m (kr210.5m market cap, or US$19.1m). New Risk • Jan 13
New major risk - Revenue size The company makes less than US$1m in revenue. Total revenue: kr11m (US$1m) This is considered a major risk. Companies with a small amount of revenue are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (16% average weekly change). Earnings have declined by 20% per year over the past 5 years. Shareholders have been substantially diluted in the past year (113% increase in shares outstanding). Revenue is less than US$1m (kr11m revenue, or US$1m). Minor Risk Market cap is less than US$100m (kr204.7m market cap, or US$18.1m). Ankündigung • 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 40% per year, which means it is performing significantly worse than earnings. Ankündigung • 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. Ankündigung • 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. Ankündigung • 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 53% 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 (40% 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 (kr98.2m market cap, or US$9.27m). Minor Risk Revenue is less than US$5m (kr15m revenue, or US$1.4m). Ankündigung • 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. Ankündigung • 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). Over the last 3 years on average, earnings per share has fallen by 13% per year but the company’s share price has fallen by 57% per year, which means it is performing significantly worse than earnings. Ankündigung • 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. Ankündigung • Apr 20
NextCell Pharma AB, Annual General Meeting, Nov 28, 2024 NextCell Pharma AB, Annual General Meeting, Nov 28, 2024. Ankündigung • 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. Ankündigung • 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. New Risk • Feb 23
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Swedish stocks, typically moving 8.6% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. 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 (-kr49m free cash flow). Earnings have declined by 22% per year over the past 5 years. Market cap is less than US$10m (kr89.4m market cap, or US$8.67m). Minor Risks Share price has been volatile over the past 3 months (8.6% average weekly change). Revenue is less than US$5m (kr16m revenue, or US$1.5m). 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). Ankündigung • 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). Ankündigung • 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. New Risk • Jun 08
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Swedish stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 20% per year over the past 5 years. Revenue is less than US$1m (kr8.8m revenue, or US$814k). Minor Risks Share price has been volatile over the past 3 months (10% average weekly change). Market cap is less than US$100m (kr161.6m market cap, or US$15.0m). 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). 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). Reported Earnings • Jul 31
Third quarter 2022 earnings released Third quarter 2022 results: Net loss: kr9.31m (loss widened 44% from 3Q 2021). 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. Reported Earnings • Jan 28
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. Over the last 3 years on average, earnings per share has increased by 22% per year but the company’s share price has only increased by 4% per year, which means it is significantly lagging earnings growth. Recent Insider Transactions • Nov 13
Director recently bought kr61k worth of stock On the 11th of November, Hans-Peter Ekre bought around 8k shares on-market at roughly kr8.00 per share. This was the largest purchase by an insider in the last 3 months. This was the only on-market transaction from insiders over the last 12 months. Reported Earnings • Aug 01
Third quarter 2021 earnings released Third quarter 2021 results: Net loss: kr6.46m (loss widened 34% from 3Q 2020). Over the last 3 years on average, earnings per share has increased by 29% per year but the company’s share price has increased by 40% per year, which means it is tracking significantly ahead of earnings growth. Reported Earnings • May 01
Second quarter 2021 earnings released Second quarter 2021 results: Net loss: kr8.15m (loss widened 93% from 2Q 2020). Over the last 3 years on average, earnings per share has increased by 34% per year whereas the company’s share price has increased by 36% per year. Is New 90 Day High Low • Feb 18
New 90-day low: kr15.30 The company is down 21% from its price of kr19.35 on 20 November 2020. The Swedish market is up 9.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 9.0% over the same period. 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). Over the last 3 years on average, earnings per share has increased by 36% per year whereas the company’s share price has increased by 38% per year. Is New 90 Day High Low • Jan 30
New 90-day low: kr16.15 The company is down 15% from its price of kr19.05 on 30 October 2020. The Swedish market is up 16% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 1.0% over the same period. Is New 90 Day High Low • Jan 07
New 90-day low: kr16.80 The company is down 24% from its price of kr22.10 on 09 October 2020. The Swedish market is up 6.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 10.0% over the same period. Is New 90 Day High Low • Dec 15
New 90-day low: kr18.30 The company is down 18% from its price of kr22.40 on 15 September 2020. The Swedish market is up 6.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 6.0% over the same period. Reported Earnings • Oct 30
Full year earnings released - kr0.92 loss per share Over the last 12 months the company has reported total losses of kr17.7m, with losses narrowing by 18% from the prior year. Total revenue was kr4.17m over the last 12 months, up 111% from the prior year. Is New 90 Day High Low • Sep 26
New 90-day high: kr23.80 The company is up 90% from its price of kr12.55 on 26 June 2020. The Swedish market is up 12% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 13% over the same period.