Board Change • Jun 10
No independent directors There are 3 new directors who have joined the board in the last 3 years. Of these new board members, none were independent directors. The company's board is composed of: 3 new directors. No experienced directors. No highly experienced directors. No independent directors (3 non-independent directors). Director Annelie Vikner is the most experienced director on the board, commencing their role in 2025. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Lack of experienced directors. Aankondiging • Feb 21
BrainCool AB (publ), Annual General Meeting, May 20, 2026 BrainCool AB (publ), Annual General Meeting, May 20, 2026. Aankondiging • Oct 24
BrainCool AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 42.231865 million. BrainCool AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 42.231865 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 84,463,730
Price\Range: SEK 0.5
Transaction Features: Rights Offering Aankondiging • Feb 21
BrainCool AB (publ), Annual General Meeting, May 12, 2025 BrainCool AB (publ), Annual General Meeting, May 12, 2025. Reported Earnings • Nov 03
Third quarter 2024 earnings released Third quarter 2024 results: Revenue: kr9.18m (up 93% from 3Q 2023). Net loss: kr11.3m (loss widened 3.8% from 3Q 2023). Reported Earnings • Aug 16
Second quarter 2024 earnings released Second quarter 2024 results: Revenue: kr11.7m (up 38% from 2Q 2023). Net loss: kr12.8m (flat on 2Q 2023). Aankondiging • Jun 26
Braincool AB (Publ) Approves Board Appointments BrainCool AB (publ) announced that annual general meeting held on June 26, 2024, Klaus Bratlie, Jens Lindberg and Michelle Hessius were elected as new members of the board of directors for the period until the end of the next annual general meeting. Aankondiging • May 29
BrainCool AB (publ) Announces Roger Henriksson Declines Re-Election as Board Member BrainCool AB (publ) announced that Roger Henriksson has declined re-election as board member but will remain as a senior advisor to the Company. New Risk • May 22
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 56% 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 Share price has been highly volatile over the past 3 months (30% average weekly change). Earnings have declined by 1.9% per year over the past 5 years. Shareholders have been substantially diluted in the past year (56% increase in shares outstanding). Minor Risks Revenue is less than US$5m (kr33m revenue, or US$3.1m). Market cap is less than US$100m (€45.4m market cap, or US$49.3m). Aankondiging • May 18
BrainCool AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 85.763172 million. BrainCool AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 85.763172 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 77,966,520
Price\Range: SEK 1.1
Transaction Features: Rights Offering Aankondiging • Apr 17
BrainCool AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 85.763172 million. BrainCool AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 85.763172 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 77,966,520
Price\Range: SEK 1.1
Transaction Features: Rights Offering Reported Earnings • Mar 31
Full year 2023 earnings released Full year 2023 results: Revenue: kr30.9m (up 2.7% from FY 2022). Net loss: kr61.3m (loss widened 34% from FY 2022). Aankondiging • Mar 27
Braincool AB (Publ) Announces Karolinska Starts the Clinical Study PRINCESS 2 with BrainCool's Product RhinoChill® System BrainCool AB (publ) announced that Karolinska Institutet/University Hospital on March 27, 2024 will start the recruitment of patients for the large and groundbreaking clinical study PRINCESS 2, which is based on BrainCool's product RhinoChill®? System. RhinoChill®? System enables a unique cooling method for early and ultra-fast cooling of the brain. This means that as of tomorrow, a number of Swedish physician manned emergency vehicles (Sw. Akutlakarbilar) are equipped with BrainCool's product Rhino Chill®? System. Thus, RhinoChill®? System is now used in practice for acute treatment of cardiac arrest in the daily Swedish emergency care within the framework of this study. As soon as one of the equipped vehicles reaches a patient with cardiac arrest, the patient will be treated with RhinoChill®? System. New Risk • Mar 21
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 10% a week. This is considered a major risk. Share price volatility 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. It may also indicate 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. 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 (-kr92m free cash flow). Share price has been highly volatile over the past 3 months (10% average weekly change). Earnings have declined by 1.9% per year over the past 5 years. Minor Risks Shareholders have been diluted in the past year (9.4% increase in shares outstanding). Revenue is less than US$5m (kr22m revenue, or US$2.1m). Market cap is less than US$100m (€53.2m market cap, or US$57.8m). Aankondiging • Jan 05
BrainCool AB (publ) and University of Freiburg Announces Start of Pivotal Clinical Trial (Cottis 2) for Combined Target Temperature Management and Thrombectomy After Ischemic Stroke BrainCool AB announced the start of the pivotal (phase 3) clinical trial COTTIS 2 after approval from the German pharmaceutical agency ("The BfArM"). COTTIS 2 is an EU funded multicenter randomized controlled clinical trial of a total of 400 patients led by the University of Freiburg, Germany. The objective of the COTTIS 2 study is planned to evaluate the efficiency of combining cooling treatment of patients undergoing thrombectomy. Two interim analyses are planned after 100 and 200 patients. The study follows the COTTIS 1 study (Ref. 1) which proved that this novel cooling treatment was safe and feasible, and associated with very strong data on survival with very good functional outcomes. Treating stroke remains one of the grand challenges of medicine. It is the second leading cause of death worldwide and the leading cause of neurological disability, greater than all dementias combined, including Alzheimer's. BrainCool's ultra early cooling solution is by far the most promising solution for protecting the brain after a stroke. Securing national approval from BfArM in Germany to commence COTTIS 2 as a non-CE trial, based on MDR, marks an important milestone in journey to make this treatment accessible to patients in the near future. COTTIS aims to enhance patient outcomes by minimizing the occurrence and severity of brain damage associated with strokes. In COTTIS-1, 68% of patients treated with thrombectomy in combination with hypothermia achieved a favorable score of 0-2 on the mRS scale within 3 months. Comparatively, retrospective studies on only thrombectomy-treated patients at the University Hospital of Freiburg revealed a 35% rate of mRS 0-2 after 3 months when patients arrived directly at the hospital for the procedure, and 30% for those transferred from another hospital. The results suggest a remarkable achievement, with a doubling in the number of patients showing good neurological function compared to typical survivors. Thrombectomy, a minimally invasive surgical procedure, involves the removal of blood clots from arteries, significantly improving outcomes for stroke patients. Thrombectomy stands as one of the most efficacious treatments in medicine, with a potential to prevent disability in one patient with stroke for every 2.3 patients treated. However, the majority of the patients undergoing thrombectomy still experience major disabilities. The study participants are randomized into two groups, with 200 patients in each group. The intervention group will receive cooling treatment with BrainCool's products combined with thrombectomy and will be compared with a control group receiving the current standard treatment (thrombectomy with/without thrombolysis) of today. The primary endpoint and objective of the study is to measure the proportion of survivors with good neurological function (mRS 0-2), with the aim of showing a statistically significant difference corresponding to an effective size difference of 14%, in terms of survival with good neurological function (defined as mRS 0 - 2). Two interim analyzes are planned after 100 and 200 patient. The pre-specified cut-off value for ending the study earlier, requires a p-value of p<0.0025. The thrombectomy technique employed in the early phases of ischemic stroke, coupled with periinterventional procedures, offers an opportunity to apply hypothermia within the optimal time frame identified through initial animal experiments and subsequently a human clinical trial encompassning 22 patients - COTTIS 1. RhinoChill®? System facilitates the administration of hypothermia in the initial stages of ischemic stroke, preceding reperfusion, and during a specified period post-reperfusion. Consequently, it becomes feasible to impact crucial elements of the pathophysiological cascade following ischemic stroke and reperfusion. The findings from COTTIS 1 strongly indicate that two-thirds of patients survived with good neurological recovery, suggesting a positive outcome associated with this procedure. Reported Earnings • Dec 01
Third quarter 2023 earnings released Third quarter 2023 results: Revenue: kr5.04m (down 31% from 3Q 2022). Net loss: kr10.9m (loss narrowed 4.4% from 3Q 2022). Aankondiging • Nov 29
Braincool AB (Publ) Announces New Clinical Study Evaluating Early Hypothermia Treatment After Cardiac Arrest with the Braincool System and Rhinochill System BrainCool AB (publ) announced that a clinical study with BrainCool products has been published in JCM (impact factor 3.9) by researchers at the Center for Cardiac arrest Research at Karolinska Institute (Ref 1). The study evaluated the RhinoChill®? System to initiate early cooling treatment immediately after arrival at the hospital instead of waiting until patients arrived in the intensive care unit. The research group at Karolinska Institute has shown for the first time that it is possible that RhinoChill®?, as the only method on the market, can deliver effective and continuous cooling that can be started in the emergency department and continue during transport to and in connection with X-rays and advanced heart examinations. When patients arrived in theintensive care unit, the BrainCool™? System was used for systemic cooling for 24 hours. Karolinska Institute, with support from BrainCool AB, is also running the European multicenter study PRINCESS2 to study ultra-early cooling with RhinoChill®? in patients who suffer cardiac arrest outside the hospital. Aankondiging • Oct 28
American Medical Association Approves New Current Procedural Terminology Code for Cryotherapy Using BrainCool's Cooral System BrainCool AB (publ) announced that the American Medical Association (AMA) formally announced the approval of a new Current Procedural Terminology (CPT®) code for cryotherapy - using the company' s Cooral® System - in patients undergoing chemotherapy. The new code CPT 3 will be released on January 1, 2024, and become effective on July 1 2024. The new code has several positive implications for BrainCool and its product Cooral® System. It opens for reimbursement for Cooral® System from Medicare - the U. S public health care system. Reimbursement in this case does not require a U. S-based clinical trial over a period of 5 years. This implies that BrainCool can bring forward the official launch of Cooral® System on the U. S market to mid 2024 instead of 2025/26. Reimbursement will facilitate a more rapid penetration of the market and provide more clinical evidence of Cooral´s benefits to other players than Medicare in the market such as the major private insurers. The benefits include alleviating pain to patients undergoing chemotherapy and reducing cost. The medical costs for treating oral mucositis are estimated at approximately 25,000 USD per patient. BrainCool will in the long-term benefit in seeking to establish a reimbursement framework also for the private insurance sector. As previously announced, BrainCool will establish a robust U. S structure with a randomized, controlled trial with U. S patients only. The focus is on patients affected by lymphoma that are also treated with stem cell transplants. The clinical trial will encompass 80-100 patients with the first patient enrolled in the first quarter of 2024. The study is expected to be completed by the end of 2025. The new CPT code is unique as there previously was no code at all for treating oral mucositis with cryotherapy. The application process for the code was very smooth and there were no objections on the path to approval. Aankondiging • Sep 23
BrainCool AB (publ) Announces New CPT Code from AMA for Cooral® System supports Pathway to Reimbursement in the U.S BrainCool AB reported that the American Medical Association (AMA) have announced the approval of a new Current Procedural Terminology (CPT®) code for reduction of complications associated with oral mucositis in patients undergoing chemotherapy, thereby creating a clear path for reimbursement of the Cooral® System. The new CPT code, an action resulted from the AMA CPT Editorial Panel's September 21st - 23rd 2023 meeting, will become effective for use in 2024, and establishing a pathway for widespread adoption and reimbursement. Worth highlighting is that the code application was included by the CPT Committee as a `consent' application. Meaning the application was approved without further discussions and a vote. Reported Earnings • Aug 28
Second quarter 2023 earnings released Second quarter 2023 results: Revenue: kr9.37m (up 4.9% from 2Q 2022). Net loss: kr12.7m (loss widened 7.2% from 2Q 2022). Aankondiging • Jul 29
Braincool AB (Publ) Introduces Minichill in Japan BrainCool AB (publ) introduced MiniChill in Japan, the next generation RhinoChill technology. The company has committed to provide products (with limited revenue of EUR 6,000) for an animal-based clinical trial/study, focusing on selective brain cooling using the updated Rhinochill technology. The clinical trial will be initiated at Nagoya University, at the Department of Emergency and Critical Care, with Dr. Mitsuaki Nishikimi as trial leader. Funding for the trial has been made possible through support from the ZOLL Foundation. In this study, MiniChill, the new generation RhinoChill, will be used. This innovative product was developed under the COOLHEAD project, which received an EU grant from Eurostars in 2019. MiniChill represents significant progress and reduces the weight of today's product from 13 kg to only 5 kg. The improvement is a direct response to valuable feedback from the PRINCESS study, in which the ambulance service and EMS highlighted the size and weight as a limiting factor during emergency situations. BrainCool welcomed this feedback and created the next generation RhinoCill (MiniChill), now three times lighter, making it easier to adapt to different situations and easier to transport. Design and functionality have mainly been retained. Some adjustments have been made to the electronic components and the alarm, to match the appropriate medical device standards. The main objective of the Japanese study is to collect crucial data for selective brain cooling in a 'cardiac arrest model'. The process of selective brain cooling involves targeting specific brain regions to protect them from damage during a cardiac arrest. This is achieved by inducing rapid brain cooling while keeping the body warm using an endovascular catheter. The study results could be a game changer and lead to major medical advances, especially with regard to neuroprotection in the intensive care for heart disease. Aankondiging • Jul 27
Braincool AB (Publ) Announces New Patent Application for Rhinochill Technology Paves the Way for New Possibilities BrainCool AB (publ) announced that the patent application for a newly developed technology resulting in updated cooling systems of RhinoChill, has reduced its weight significantly, from 13 kg to only 5 kg. Even the size has been reduced. The development of the product has been fully financed within the framework of two EU grants. The clinical results of the Princess 2 also apply to the new lighter generation of the device. The new generation of RhinoChill will be evaluated in collaboration with Karolinska Institutet (1) in a substudy to Princess 2, with the aim of: evaluating the effectiveness and feasibility of the compact RhinoChill version in a real clinical setting. further validating its potential applications and overall performance. BrainCool and Karolinska will seek additional funding to support the substudy and the final stages of product development leading to market approval. The new lightweight generation RhinoChill, creates new possibilities and will also target new areas such as: traumatic brain injuries (TBI) in the military market. the growing medical problem of heat stroke caused by climate change. BrainCool's goal is to introduce a new standard of care with cooling technology in public settings, schools and sports facilities, similar to the implementation of defibrillators/AEDs. Aankondiging • Jul 15
BrainCool AB (publ) Receives Patent Approval for "Shivering" in the EU for the Product BrainCool System BrainCool AB (publ) received a patent approval for "shivering" in the EU for the product BrainCool™ System. The final step for patent protection of the BrainCool System has been completed with the approval of technology to manage shivering during cooling in the EU. The patent for addressing 'shivering' has already been approved in the USA, Sweden, Japan, South Korea, and China. Aankondiging • Jun 15
Braincool AB (Publ) Announces International Clinical Study with Rhinochill®System of Patients with Sudden Cardiac Arrest Obtain Ethical Approval BrainCool AB (publ) has been notified by Karolinska Institutet about the clinical study, PRINCESS 2, has now have received ethical approval both from the ethical committee and the national body (Swedish Medical Agency (Svenska Läkemedelsverket - LMV), The clinical trial is to study the neuroprotective effect of ultra-early cooling on cardiac arrest. On the 28th of March 2023, BrainCool announced that the company will supply Karolinska with its product RhinoChill®System for the study. The order is worth 3 million SEK over a three-year period. Karolinska Institutet will now be able to start recruiting patients for the study that will cover up to 924 patients. The approval should then automatically apply to other EU-states after or in parallel with applications for ethical approval of the clinical study. The ethical approval application is made by the specific hospital implementing the trial and approved by a regional agency in each EU-state. Reported Earnings • Jun 01
First quarter 2023 earnings released First quarter 2023 results: Revenue: kr4.34m (down 58% from 1Q 2022). Net loss: kr15.6m (loss widened 71% from 1Q 2022). Aankondiging • May 04
BraincCool Launches New Commercialization Strategy for Its Breakthrough Product Cooral ®System Aiming for Reimbursement in the U.S BrainCool AB (publ) launches a new commercialization strategy in the U.S for the new cryotherapy product Cooral ®System supporting patients undergoing treatment for cancer. Cooral ® Systems is one of the first breakthrough medical products that has obtained marketapproval in the U.S. If the strategy is successful, it will create substantial value not only for the patients but also for BrainCool and its shareholders. In parallel, a global marketing strategy will be developed. BrainCool has developed Cooral ®Systems over the past few years to address the severe problem with oral mucositis (OM) that may affect patients under cancer treatment. A large -multi-clinical study demonstrated the efficacy of the Cooral device to reduce the incidence of OM in patients undergoing chemotherapy and in October 2022 Cooral® System obtained De Novo 510 k approval with a Breakthrough designation from FDA in the U.S. The approval applies for all chemotherapy regimens that may lead to OM and is not restricted to any specific chemo agent or cancer indication. There is a strong support for using the new cryotherapy product preventing and mitigating OM frommajor oncology societies in the US such as the International Society of Oral Oncology, AmericanSociety of Clinical Oncology, and the Oncology Nursing Society. Aankondiging • Jan 30
BrainCool AB (publ) to Report Fiscal Year 2022 Results on Feb 28, 2023 BrainCool AB (publ) announced that they will report fiscal year 2022 results on Feb 28, 2023 Reported Earnings • Dec 02
Third quarter 2022 earnings released: kr0.17 loss per share (vs kr0.12 loss in 3Q 2021) Third quarter 2022 results: kr0.17 loss per share (further deteriorated from kr0.12 loss in 3Q 2021). Revenue: kr7.30m (down 7.9% from 3Q 2021). Net loss: kr11.4m (loss widened 49% from 3Q 2021). Board Change • Nov 16
No independent directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 2 experienced directors. 1 highly experienced director. No independent directors (3 non-independent directors). CEO & Director Martin Waleij was the last director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Insufficient board refreshment. Aankondiging • Nov 01
BrainCool AB (publ) to Report Q3, 2022 Results on Nov 30, 2022 BrainCool AB (publ) announced that they will report Q3, 2022 results on Nov 30, 2022 Aankondiging • Oct 18
BrainCool AB (publ) Announces FDA approval of Cooral BrainCool AB (publ) has reached an important milestone in its oncology project with the product Cooral System. The company has now received market approval from the US Food and Drug Administration for counteracting chemotherapy-induced oral mucositis, a common and serious side effect of cancer treatment. Reported Earnings • Sep 03
Second quarter 2022 earnings released: kr0.18 loss per share (vs kr0.13 loss in 2Q 2021) Second quarter 2022 results: kr0.18 loss per share (down from kr0.13 loss in 2Q 2021). Revenue: kr8.93m (up 24% from 2Q 2021). Net loss: kr11.9m (loss widened 43% from 2Q 2021). Reported Earnings • Jun 03
First quarter 2022 earnings released: kr0.14 loss per share (vs kr0.12 loss in 1Q 2021) First quarter 2022 results: kr0.14 loss per share (down from kr0.12 loss in 1Q 2021). Revenue: kr10.4m (up 48% from 1Q 2021). Net loss: kr9.12m (loss widened 28% from 1Q 2021). Aankondiging • May 02
BrainCool AB (publ) to Report Q1, 2022 Results on May 31, 2022 BrainCool AB (publ) announced that they will report Q1, 2022 results on May 31, 2022 Board Change • Apr 27
No independent directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 2 experienced directors. 2 highly experienced directors. No independent directors (4 non-independent directors). CEO & Director Martin Waleij was the last director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Insufficient board refreshment. Recent Insider Transactions • Mar 24
CEO & Director recently bought €19k worth of stock On the 16th of March, Martin Waleij bought around 36k shares on-market at roughly €0.53 per share. This was the largest purchase by an insider in the last 3 months. Martin has been a buyer over the last 12 months, purchasing a net total of €49k worth in shares. Recent Insider Transactions • Mar 24
CEO & Director recently bought €19k worth of stock On the 16th of March, Martin Waleij bought around 36k shares on-market at roughly €0.53 per share. This was the largest purchase by an insider in the last 3 months. Martin has been a buyer over the last 12 months, purchasing a net total of €49k worth in shares. Recent Insider Transactions • Mar 22
CEO & Director recently bought €19k worth of stock On the 16th of March, Martin Waleij bought around 36k shares on-market at roughly €0.53 per share. This was the largest purchase by an insider in the last 3 months. Martin has been a buyer over the last 12 months, purchasing a net total of €49k worth in shares. Reported Earnings • Mar 03
Full year 2021 earnings: Revenues and EPS in line with analyst expectations Full year 2021 results: kr0.61 loss per share (up from kr0.68 loss in FY 2020). Revenue: kr27.5m (up 73% from FY 2020). Net loss: kr38.8m (loss widened 3.9% from FY 2020). Revenue was in line with analyst estimates. Reported Earnings • Dec 02
Third quarter 2021 earnings: Revenues and EPS in line with analyst expectations Third quarter 2021 results: kr0.12 loss per share (up from kr0.12 loss in 3Q 2020). Revenue: kr7.93m (up 44% from 3Q 2020). Net loss: kr7.63m (loss widened 7.9% from 3Q 2020). Revenue was in line with analyst estimates. Reported Earnings • Aug 28
Second quarter 2021 earnings released: kr0.13 loss per share (vs kr0.15 loss in 2Q 2020) The company reported a solid second quarter result with improved revenues and control over costs, although losses increased. Second quarter 2021 results: Revenue: kr7.20m (up 72% from 2Q 2020). Net loss: kr8.29m (loss widened 8.4% from 2Q 2020). Reported Earnings • Jun 04
First quarter 2021 earnings released: kr0.12 loss per share (vs kr0.24 loss in 1Q 2020) The company reported a solid first quarter result with reduced losses, improved revenues and improved control over expenses. First quarter 2021 results: Revenue: kr7.02m (up 98% from 1Q 2020). Net loss: kr7.12m (loss narrowed 39% from 1Q 2020). 
