Reported Earnings • May 11
First quarter 2026 earnings released First quarter 2026 results: Revenue: kr10.9m (down 4.6% from 1Q 2025). Net loss: kr8.12m (loss narrowed 2.8% from 1Q 2025). Revenue is forecast to grow 11% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Medical Equipment industry in Sweden. Over the last 3 years on average, earnings per share has increased by 47% per year but the company’s share price has fallen by 26% per year, which means it is significantly lagging earnings. Major Estimate Revision • Apr 22
Consensus revenue estimates decrease by 25% The consensus outlook for fiscal year 2026 has been updated. 2026 revenue forecast fell from kr72.0m to kr54.0m. EPS estimate unchanged from -kr0.06 per share at last update. Medical Equipment industry in Sweden expected to see average net income growth of 41% next year. Consensus price target of kr1.00 unchanged from last update. Share price rose 11% to kr0.87 over the past week. Annuncio • Feb 21
BrainCool AB (publ), Annual General Meeting, May 20, 2026 BrainCool AB (publ), Annual General Meeting, May 20, 2026. Reported Earnings • Feb 20
Full year 2025 earnings: EPS and revenues miss analyst expectations Full year 2025 results: kr0.15 loss per share (improved from kr0.20 loss in FY 2024). Revenue: kr45.1m (up 5.7% from FY 2024). Net loss: kr37.1m (loss narrowed 16% from FY 2024). Revenue missed analyst estimates by 20%. Earnings per share (EPS) also missed analyst estimates by 36%. Revenue is forecast to grow 28% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Medical Equipment industry in Sweden. Over the last 3 years on average, earnings per share has increased by 48% per year but the company’s share price has fallen by 36% per year, which means it is significantly lagging earnings. Major Estimate Revision • Feb 19
Consensus EPS estimates fall by 200% The consensus outlook for earnings per share (EPS) in fiscal year 2026 has deteriorated. 2026 revenue forecast decreased from kr73.0m to kr72.0m. Losses expected to increase from kr0.02 per share to kr0.06. Medical Equipment industry in Sweden expected to see average net income growth of 38% next year. Consensus price target of kr1.00 unchanged from last update. Share price rose 3.4% to kr0.50 over the past week. New Risk • Feb 18
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: kr37m Forecast net loss in 3 years: kr14m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Shareholders have been substantially diluted in the past year (56% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (kr14m net loss in 3 years). Share price has been volatile over the past 3 months (9.2% average weekly change). Market cap is less than US$100m (kr203.4m market cap, or US$22.6m). New Risk • Jan 17
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 Risk Shareholders have been substantially diluted in the past year (56% increase in shares outstanding). Minor Risks Share price has been volatile over the past 3 months (9.1% average weekly change). Market cap is less than US$100m (kr225.1m market cap, or US$24.4m). Reported Earnings • Oct 26
Third quarter 2025 earnings released Third quarter 2025 results: Revenue: kr15.0m (up 61% from 3Q 2024). Net loss: kr9.24m (loss narrowed 18% from 3Q 2024). Revenue is forecast to grow 47% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Medical Equipment industry in Sweden. Over the last 3 years on average, earnings per share has increased by 50% per year but the company’s share price has fallen by 22% per year, which means it is significantly lagging earnings. Annuncio • 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 New Risk • Oct 09
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 Swedish stocks, typically moving 12% 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 (-kr59m free cash flow). Share price has been highly volatile over the past 3 months (12% average weekly change). Minor Risks Revenue is less than US$5m (kr41m revenue, or US$4.3m). Market cap is less than US$100m (kr215.4m market cap, or US$22.8m). Reported Earnings • Aug 17
Second quarter 2025 earnings: Revenues miss analyst expectations Second quarter 2025 results: Revenue: kr7.41m (down 35% from 2Q 2024). Net loss: kr10.8m (loss narrowed 16% from 2Q 2024). Revenue missed analyst estimates by 65%. Revenue is forecast to grow 45% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Medical Equipment industry in Sweden. Over the last 3 years on average, earnings per share has increased by 47% per year but the company’s share price has fallen by 38% per year, which means it is significantly lagging earnings. New Risk • Aug 15
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 9.2% 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 Risk Less than 1 year of cash runway based on free cash flow trend (-kr72m free cash flow). Minor Risks Share price has been volatile over the past 3 months (9.2% average weekly change). Revenue is less than US$5m (kr45m revenue, or US$4.7m). Market cap is less than US$100m (kr299.0m market cap, or US$31.3m). New Risk • May 05
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: -kr72m 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 (-kr72m free cash flow). Shareholders have been substantially diluted in the past year (44% increase in shares outstanding). Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Revenue is less than US$5m (kr44m revenue, or US$4.5m). Market cap is less than US$100m (kr445.0m market cap, or US$46.3m). Buy Or Sell Opportunity • Apr 22
Now 25% undervalued Over the last 90 days, the stock has risen 29% to kr1.67. The fair value is estimated to be kr2.23, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 19% over the last 3 years. Earnings per share has grown by 35%. Revenue is forecast to grow by 151% in 2 years. Earnings are forecast to grow by 95% in the next 2 years. Buy Or Sell Opportunity • Mar 10
Now 21% undervalued Over the last 90 days, the stock has risen 24% to kr1.83. The fair value is estimated to be kr2.31, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 19% over the last 3 years. Earnings per share has grown by 35%. Revenue is forecast to grow by 151% in 2 years. Earnings are forecast to grow by 95% in the next 2 years. Annuncio • Feb 21
BrainCool AB (publ), Annual General Meeting, May 12, 2025 BrainCool AB (publ), Annual General Meeting, May 12, 2025. New Risk • Feb 20
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 9.1% 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 (-kr70m free cash flow). Earnings have declined by 4.4% per year over the past 5 years. Shareholders have been substantially diluted in the past year (44% increase in shares outstanding). Minor Risks Share price has been volatile over the past 3 months (9.1% average weekly change). Revenue is less than US$5m (kr43m revenue, or US$4.0m). Market cap is less than US$100m (kr456.1m market cap, or US$42.8m). Reported Earnings • Feb 13
Full year 2024 earnings released: kr0.17 loss per share (vs kr0.37 loss in FY 2023) Full year 2024 results: kr0.17 loss per share (improved from kr0.37 loss in FY 2023). Revenue: kr44.8m (up 63% from FY 2023). Net loss: kr44.0m (loss narrowed 28% from FY 2023). Over the last 3 years on average, earnings per share has increased by 36% per year but the company’s share price has fallen by 41% per year, which means it is significantly lagging earnings. New Risk • Jan 16
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 44% 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 (-kr71m free cash flow). Earnings have declined by 4.0% per year over the past 5 years. Shareholders have been substantially diluted in the past year (44% increase in shares outstanding). Minor Risks Revenue is less than US$5m (kr41m revenue, or US$3.6m). Market cap is less than US$100m (kr333.0m market cap, or US$29.8m). 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). Annuncio • 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. Annuncio • 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. Annuncio • 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 Annuncio • 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 • Apr 01
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). Annuncio • 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 26
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 Swedish stocks, typically moving 14% 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 (14% 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 (kr391.2m market cap, or US$37.0m). Annuncio • 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. Recent Insider Transactions • Dec 27
CEO & Director recently sold kr254k worth of stock On the 22nd of December, Martin Waleij sold around 42k shares on-market at roughly kr6.09 per share. This transaction amounted to 1.6% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Martin has been a net seller over the last 12 months, reducing personal holdings by kr309k. 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). Over the last 3 years on average, earnings per share has increased by 11% per year but the company’s share price has fallen by 7% per year, which means it is significantly lagging earnings. Annuncio • 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. Recent Insider Transactions • Oct 29
CEO & Director recently bought kr53k worth of stock On the 24th of October, Martin Waleij bought around 14k shares on-market at roughly kr3.79 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. In the last 3 months, they made an even bigger purchase worth kr62k. Martin has been a buyer over the last 12 months, purchasing a net total of kr115k worth in shares. Annuncio • 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. Annuncio • 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. Recent Insider Transactions • Sep 06
CEO & Director recently bought kr62k worth of stock On the 4th of September, Martin Waleij bought around 12k shares on-market at roughly kr5.20 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Martin's only on-market trade for the last 12 months. 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). New Risk • Aug 27
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 Swedish stocks, typically moving 12% 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 (-kr64m free cash flow). Share price has been highly volatile over the past 3 months (12% average weekly change). Earnings have declined by 4.8% per year over the past 5 years. Shareholders have been substantially diluted in the past year (146% increase in shares outstanding). Minor Risks Revenue is less than US$5m (kr24m revenue, or US$2.2m). Market cap is less than US$100m (kr715.5m market cap, or US$64.8m). Annuncio • 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. Annuncio • 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. Annuncio • 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. Annuncio • 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). Annuncio • 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. Annuncio • 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). Over the last 3 years on average, earnings per share has increased by 33% per year but the company’s share price has fallen by 30% per year, which means it is significantly lagging earnings. 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. 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). Over the last 3 years on average, earnings per share has increased by 37% per year but the company’s share price has fallen by 38% per year, which means it is significantly lagging earnings. 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). Over the last 3 years on average, earnings per share has increased by 36% per year but the company’s share price has remained flat, which means it is significantly lagging earnings. 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 30
CEO & Director recently bought kr73k worth of stock On the 25th of March, Martin Waleij bought around 11k shares on-market at roughly kr6.62 per share. In the last 3 months, they made an even bigger purchase worth kr195k. Martin has been a buyer over the last 12 months, purchasing a net total of kr579k worth in shares. Recent Insider Transactions • Mar 24
CEO & Director recently bought kr195k worth of stock On the 16th of March, Martin Waleij bought around 36k shares on-market at roughly kr5.49 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 kr507k worth in shares. Recent Insider Transactions • Mar 24
CEO & Director recently bought kr195k worth of stock On the 16th of March, Martin Waleij bought around 36k shares on-market at roughly kr5.49 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 kr507k worth in shares. Recent Insider Transactions • Mar 22
CEO & Director recently bought kr195k worth of stock On the 16th of March, Martin Waleij bought around 36k shares on-market at roughly kr5.49 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 kr507k 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. Over the last 3 years on average, earnings per share has increased by 31% per year but the company’s share price has fallen by 3% per year, which means it is significantly lagging earnings. 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. Over the last 3 years on average, earnings per share has increased by 22% per year but the company’s share price has fallen by 1% per year, which means it is significantly lagging earnings. 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). Over the last 3 years on average, earnings per share has increased by 12% 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 • Jun 22
CEO & Director recently bought kr238k worth of stock On the 17th of June, Martin Waleij bought around 35k shares on-market at roughly kr6.80 per share. This was the largest purchase by an insider in the last 3 months. This was Martin's only on-market trade for the last 12 months. Annuncio • Mar 17
BrainCool AB (publ), Annual General Meeting, Apr 15, 2021 BrainCool AB (publ), Annual General Meeting, Apr 15, 2021. Reported Earnings • Mar 01
Full year 2020 earnings released: kr0.68 loss per share (vs kr1.43 loss in FY 2019) The company reported a solid full year result with reduced losses, improved revenues and improved control over expenses. Full year 2020 results: Revenue: kr18.1m (up 62% from FY 2019). Net loss: kr37.3m (loss narrowed 35% from FY 2019). Over the last 3 years on average, earnings per share has fallen by 9% per year but the company’s share price has increased by 20% per year, which means it is well ahead of earnings. Annuncio • Feb 13
BrainCool AB (publ) Receives FDA "Breakthrough Device" Designation for Cooral® System for Prevention of Oral Mucositis BrainCool AB (publ) announced that the U.S. Food and Drug Administration (FDA) has granted "Breakthrough Device" Designation for the Cooral® System, for prevention of Oral Mucositis (OM). The FDA Breakthrough Devices Program, implemented by the FDA in 2018, replaces other fast track programs, and is intended to increase delivery of innovative medical devices that "provide for more effective treatment or diagnosis of life-threatening, or irreversibly debilitating diseases." With this designation, the FDA will provide priority review and feedback throughout the final stages of market clearance through a De Novo 510 k process, and continued support as the device enters the market in the United States. The Cooral® System, CE marked in June 2020 as an invasive medical device in the EU, has shown statistically significant evidence of its safety and effectiveness in clinical trials. A study presented at a late breaking session during the 2020 European Society for Medical Oncology's Virtual Meeting in September, is expected to be published in a major scientific journal this spring. As part of its application for FDA "Breakthrough Device" Designation, BrainCool AB (publ) was able to present already completed clinical results from the Nordic multi-center study assessing the safety and effectiveness of the Cooral® System and showing significant evidence for prevention of OM. Is New 90 Day High Low • Jan 24
New 90-day high: kr9.17 The company is up 8.0% from its price of kr8.50 on 26 October 2020. The Swedish market is up 11% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Medical Equipment industry, which is up 12% over the same period. Reported Earnings • Dec 02
Third quarter 2020 earnings released: kr0.12 loss per share The company reported a solid third quarter result with reduced losses and improved revenues and control over expenses. Third quarter 2020 results: Revenue: kr5.50m (up 55% from 3Q 2019). Net loss: kr7.07m (loss narrowed 42% from 3Q 2019). Over the last 3 years on average, earnings per share has fallen by 16% per year but the company’s share price has only fallen by 8% per year, which means it has not declined as severely as earnings. Is New 90 Day High Low • Nov 23
New 90-day low: kr7.00 The company is down 2.0% from its price of kr7.15 on 25 August 2020. The Swedish market is up 8.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Medical Equipment industry, which is up 2.0% over the same period. Annuncio • Sep 19
Braincool AB Announces Statistically Significant Late-Breaking Clinical Data At SMO Virtual Congress 2020 BrainCool AB announced late-breaking clinical results of the Cooral® System, a novel cooling device for the prevention of Oral Mucositis (OM), at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. Data was collected from a Nordic multi-center pivotal trial led by Karolinska University Hospital, Stockholm, that enrolled 182 patients with multiple myeloma or lymphoma who were scheduled to receive high-dose chemotherapy prior to hematopoietic stem cell transplantation. The abstract was presented at ESMO by Java Walladbegi, PhD, Oral Medicine, Department of Oral Medicine & Pathology, Institute of Odontology at The Sahlgrenska Academy, University of Gothenburg, Sweden. Dr. Walladbegi was project manager for the blinded, randomized investigation, which compared the efficacy of ice chips (IC) and an intra-oral cooling device (ICD; Cooral) for cryoprevention of OM. Results from the randomized trial proved that the Cooral® System was as effective as IC in terms of cryoprevention, with severe OM occurring in fewer than 10% of the cases tested. For patients with lymphoma, use of the Cooral® System showed vastly improved prevention of OM and was significantly more effective when compared to the conventional method with IC [Oral Mucositis Assessment Scale (OMAS) mean total 1.77 vs 3.08; p = 0.047]. This finding is particularly notable because lymphoma patients are treated with longer courses of chemotherapy, making severe OM a life-threatening inevitability. As for patient-reported tolerability, both diagnostic groups (myeloma and lymphoma), reported a statistically significant higher degree of tolerability when Cooral was used as compared with IC [p = 0.020]. In addition to cancer care improvements, the study indicates potential economic benefits as well. Costs for patients with severe OM in conjunction with stem cell transplantation have been estimated at more than $70,000 per patient. The data presented at ESMO are a clear indication that most of these healthcare costs can be prevented with use of the Cooral® System. Presentation of this data at ESMO paves the way for market introduction of the Cooral® System in the EU, following market clearance in early June 2020 as a class 2 invasive medical device. The device was CE marked for the EU /ESS markets as an invasive medical device this past June, and BrainCool is currently conducting a De Novo 510(k) process to obtain market clearance in the U.S. Annuncio • Sep 12
BrainCool AB (publ) to Report Q2, 2020 Results on Aug 28, 2020 BrainCool AB (publ) announced that they will report Q2, 2020 results on Aug 28, 2020