New Risk • Jun 02
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 161% 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 Debt is not well covered by operating cash flow (currently running at an operating cash loss). Share price has been highly volatile over the past 3 months (14% average weekly change). High level of non-cash earnings (503% accrual ratio). Shareholders have been substantially diluted in the past year (161% increase in shares outstanding). Minor Risks Negative equity (-€4.8m). Market cap is less than US$100m (€33.6m market cap, or US$39.1m). Board Change • May 20
Insufficient new 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. 3 highly experienced directors. Independent Director Jacquelien Ten Dam was the last director to join the board, commencing their role in 2020. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • May 20
Mauna Kea Technologies Announces Terms of Claire Biot and Jacquelien Ten Dam Come to an End Mauna Kea Technologies announced that if approved by shareholders, Richard Di Benedetto will replace Claire Biot and Randall Stanicky will replace Jacquelien Ten Dam, as their respective terms come to an end. Announcement • May 01
Mauna Kea Technologies SA, Annual General Meeting, Jun 04, 2026 Mauna Kea Technologies SA, Annual General Meeting, Jun 04, 2026. Location: 9 rue d enghien, paris France Announcement • Mar 12
Mauna Kea Technologies Announces Major Milestone for Cellvizio in Pancreatic Cysts with Climb Study Selected for Asge Presidential Plenary Session At Ddw 2026 Mauna Kea Technologies announced that the CLIMB study (Confocal Laser Endomicroscopy as an IMaging Biomarker, ClinicalTrials.gov ID: NCT03492151) will be presented at the ASGE (American Society for Gastrointestinal Endoscopy) Presidential Plenary Session on Sunday, May 3, 2026, one of the most prestigious sessions of the Digestive Disease Week (DDW) 2026 conference, to be held from May 2 to 5, 2026 in Chicago, Illinois. This prospective multicenter study (over 500 patients across 14 U.S. centers) led by Dr. Somashekar (Som) Krishna, Professor of Medicine and Director of Advanced Endoscopy at The Ohio State University Wexner Medical Center, demonstrates the superiority of EUS-nCLE (Endoscopic Ultrasound-guided needle-based Confocal Laser Endomicroscopy using Cellvizio) for the multimodal diagnosis of pancreatic cystic lesions (PCLs), particularly IPMNs (intraductal papillary mucinous neoplasms), a common type of premalignant or malignant cyst. EUS-nCLE confirms unmatched diagnostic accuracy compared to standard methods (cyst fluid analysis: CEA, amylase, cytology, glucose), thanks to accurate cellular-level visualization which can improve patient management and outcomes. This selection for the ASGE Presidential Plenary Session highlights the major clinical impact of Cellvizio and positions it as a key tool for the evolution of PCL management. Dr. Krishna and his team illustrate academic excellence surrounding Cellvizio with 9 accepted works (6 lectures, 3 posters) covering: Precise real-time diagnosis (e.g., serous cystadenomas) and reduction of inappropriate surgeries via multimodal approaches; Artificial intelligence for automated detection and classification of cysts from EUS-nCLE videos; Medico-economic analyses favoring EUS-RFA (Endoscopic Ultrasound-guided Radiofrequency Ablation) vs. surgical resection. Announcement • Feb 04
Mauna Kea Technologies Appoints Benoit Chardon as Fractional Chief Commercial Officer Mauna Kea Technologies announced the appointment of Benoit Chardon as Fractional Chief Commercial Officer dedicated to CellTolerance. Benoit Chardon, who has served as Senior Strategic Advisor since 2024 and played a pivotal role in shaping CellTolerance's value proposition, branding, go-to-market strategy, and initial commercial rollout (Europe, Australia, and other regions), is appointed Fractional Chief Commercial Officer dedicated to CellTolerance. With over 20 years of proven leadership in healthcare, weight loss, and medical aesthetics, Benoit Chardon has developed scalable playbooks for revenue development and value creation. Under his leadership, a dedicated, outsourced commercial and marketing team will drive CellTolerance scaling with the following key priorities for 2026: accelerating new account acquisition and lead generation; securing strategic partnerships with leading clinics and distributors; rolling out standardized, high-quality commercial, clinical, and patient-experience frameworks to ensure consistent execution and sustainable clinic growth. Announcement • Jan 22
Mauna Kea Technologies SA to Report Fiscal Year 2025 Results on Apr 09, 2026 Mauna Kea Technologies SA announced that they will report fiscal year 2025 results at 5:40 PM, Central European Standard Time on Apr 09, 2026 Announcement • Nov 22
Mauna Kea Technologies Receives NMPA Regulatory Approval in China for its Next-Generation Cellvizio® Platform Mauna Kea Technologies SA announces that it has obtained approval from the National Medical Products Administration (NMPA) in China for the import and commercialization of its next-generation Cellvizio (Gen 3) platform. This registration was processed and obtained directly by Mauna Kea Technologies S.A. and is valid for five years until November 2030. It authorizes the use in China of the Gen 3 platform in conjunction with the Company's full range of confocal probes (GastroFlex™ N, ColoFlex™ N, CholangioFlex™ N, AlveoFlex™ N, AQ-Flex™ 19 N). The Cellvizio® Gen 3 system is the Company's most advanced platform and is a distinct asset not included in the previous agreements under the Joint Venture with Tasly. By securing this approval directly, Mauna Kea reinforces its portfolio of proprietary assets in China. China represents an important market for interventional endoscopy, with strong demand for precision diagnostic technologies. With this essential regulatory authorization now in place, Mauna Kea is currently evaluating its options for the commercialization of the next-generation Cellvizio® platform to Chinese hospitals, aiming to make this cutting-edge technology available to practitioners and patients as effectively as possible. Announcement • Jul 22
Mauna Kea Technologies Strengthens Its Role in the AI-Based Endomicroscopic Imaging Ecosystem with Its 14th Patent Granted in the U.S Mauna Kea Technologies announced that it has been granted the 14th U.S. patent for real-time AI-based enhancement of Confocal Laser Endomicroscopy (CLE) image sequences, continuing to expand its intellectual property portfolio in the field of artificial intelligence. With this new technological asset, which focuses on the cognitive interface between doctors and machines, Mauna Kea Technologies is reinforcing its position at the heart of all rapid developments in centers of excellence in AI applied to Cellvizio imaging. This latest milestone builds upon the Company's recent advancements, including the previously announced major AI breakthrough with Cellvizio for risk stratification of malignant pancreatic cystic lesions. By strengthening its platform's core technology, Mauna Kea technologies is positioning itself as an essential partner and catalyst for the entire AI research and development ecosystem, enabling third parties to build high-value applications on the Cellvizio platform. Announcement • Jun 02
Mauna Kea Technologies Announces Major AI Breakthrough with Cellvizio in Pancreatic Cystic Lesion Risk Stratification Mauna Kea Technologies announced a significant advancement with the results of a landmark study published in the peer-reviewed journal Pancreatology. The research, titled “Towards Automating Risk Stratification of Intraductal Papillary Mucinous Neoplasms: Artificial Intelligence Advances Beyond Human Expertise with Confocal Laser Endomicroscopy”, demonstrates that Artificial Intelligence (AI) model combined with Cellvizio needle-based confocal laser endomicroscopy (nCLE) technology significantly outperforms human experts in risk stratification of Intraductal Papillary Mucinous Neoplasms (IPMNs), a common type of pancreatic cyst. The study aimed to compare the performance of 16 nCLE human experts with a novel AI algorithm (nCLE-AI) specifically designed for the sub-classification of a type of pancreatic cystic lesion with malignant potential. These findings build on the CLIMB study data presented this year at DDW, which demonstrated strong diagnostic performance of needle-based confocal laser endomicroscopy in differentiating benign from malignant or pre-malignant pancreatic cysts. Indeed, the latest results from the CLIMB study -spanning 17 endosonographers across 14 centers - have further reinforced the significantly superior diagnostic accuracy of Endoscopic Ultrasound-guided nCLE (EUS-nCLE) compared to the current standard of care. The results of the study on risk stratification associated with IPMNs cysts with malignant potential, detailed in the table below, show that the nCLE-AI model combined with revised Fukuoka Criteria achieves an Area Under the Curve (AUC) of 0.85, with a sensitivity of 78% and a specificity of 78%. This performance is significantly superior to that of human experts using the same criteria (AUC 0.64; p<0.01) and represents an improvement over the nCLE-AI model alone (p=0.02), clearly demonstrating the superiority of the AI-augmented approach for enhancing the detection of malignant cysts that need immediate intervention. The AI model continues to improve rapidly with additional nCLE sequences and data. The prevalence of pancreatic cystic lesions in the adult asymptomatic population ranges from 2.4% to 24.3%. The large majority of pancreatic cystic lesions are discovered through incidental imaging, and it is estimated that 40% of cysts with no risk of carcinogenesis are operated on unnecessarily. More accurate classification methods, including risk stratification, are therefore needed earlier in the patient’s diagnostic workup. Conventional diagnostic testing involves performing an endoscopic ultrasound (EUS) and then collecting and testing the cyst fluid through fine needle aspiration (FNA). In some advanced facilities, next generation sequencing (NGS) of cellular DNA may be performed to provide additional data. Although most facilities employ a combination of a range of conventional diagnostic methods, sensitivity, specificity, and accuracy remain insufficient, potentially exposing patients to misclassified cysts and unneeded surgical procedures. Announcement • Mar 04
Mauna Kea Technologies's Cellvizio Now Recommends in New European Society of Gastrointestinal Endoscopy Technical Guideline for Pancreatic Cyst Diagnosis Mauna Kea Technologies announced that the European Society of Gastrointestinal Endoscopy (ESGE) has issued a recommendation for the use of needle-based confocal laser endomicroscopy (nCLE) with Cellvizio®? for the characterization of pancreatic cyst lesions (PCLs)1. This recognition highlights the potential of nCLE to enhance the accuracy of pancreatic cyst diagnoses in centers with adequate expertise, supporting its integration into standard clinical practice. ESGE suggests the use of nCLE to differentiate between mucinous and non-mucinous pancreatic cysts, acknowledging the technology's ability to provide real-time, high-resolution imaging of tissue and vascular structures. The recommendation is based on a large body of clinical evidence demonstrating nCLE's diagnostic accuracy compared to conventional endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) alone. Several multi-center studies have reported high diagnostic accuracy with nCLE, including one study presented at Digestive Disease Week®? 2024 demonstrating very high sensitivity and diagnostic accuracy of EUS-nCLE for classifying mucinous vs. non-mucinous PCLs of 98% and 97%, respectively, compared to 77% and 80% for CEA +cytology + glucose. Additionally, cost-benefit analyses demonstrate that integrating nCLE into PCL management reduces unnecessary surgeries by 23% and decreases overall clinical costs by 13%. This recognition from ESGE marks a turning point, underscoring the critical role that nCLE with Cellvizio can play in transforming pancreatic cyst diagnosis. For patients, this means fewer unnecessary surgeries on indeterminate cysts, faster and more accurate diagnoses, and ultimately better outcomes. For healthcare providers, integrating nCLE into routine practice represents a major leap forward in precision medicine. With pancreatic cysts affecting millions worldwide and current diagnostic tools leaving too much uncertainty, this recommendation paves the way for large-scale deployment and will be a key driver in securing reimbursement across several countries. 2025 is off to a strong start and is set to be a milestone year for this indication. Some highly anticipated results from the CLIMB study - the largest clinical study for this indication - conducted in 14 centers in the United States, set to be unveiled at Digestive Disease week®? 2025, will definitively establish technology as the gold standard worldwide for pancreatic cyst characterization. Announcement • Jan 28
Mauna Kea Technologies Announces Promising Results in New Application Combining Robotics and Cellvizio®? for Precision Surgery in Head and Neck Cancers Mauna Kea Technologies announced very promising results in a new surgical indication published in a recent case series in Oral Oncology Reports. Surgeons at the University of Alabama at Birmingham (Birmingham, Alabama) have demonstrated the clinical feasibility and potential advantages of using the Cellvizio confocal laser endomicroscopy (CLE) platform during transoral robotic surgery (TORS) in combination with the da Vinci SP robotic surgical system by Intuitive to enhance the precision of margin assessment for head and neck cancers. Head and neck cancers present unique surgical challenges, particularly in achieving clear margins while minimizing tissue loss to preserve critical functions such as swallowing and speech. Positive surgical margins – meaning cancer remains in the patient’s body after resection – occur in up to 15-20% of TORS procedures according to the study and are associated with a significantly increased risk of cancer recurrence. The Cellvizio CLE platform directly addresses these challenges by providing high-resolution, real-time imaging of cellular structures and architecture. Cellvizio allows surgeons to visually delineate tumor boundaries intraoperatively, facilitating precise resection while sparing healthy tissue. This study focused on the application of Cellvizio in assessing mucosal margins during TORS for cancers of the larynx, hypopharynx and oropharynx. Announcement • Jan 16
Mauna Kea Technologies SA, Annual General Meeting, Jun 05, 2025 Mauna Kea Technologies SA, Annual General Meeting, Jun 05, 2025. Announcement • Oct 17
Mauna Kea Technologies Announces New Positive Clinical Results for Cellvizio in Food Intolerance Mauna Kea Technologies announced that new clinical data demonstrating the value of Cellvizio® in the detection, understanding, and treatment of food intolerances leading to gut barrier dysfunction in patients suffering from Irritable Bowel Syndrome (IBS), were presented at UEG Week 2024, the world's largest gastroenterology congress. In this study, 119 patients suffering from IBS were screened using Cellvizio® during a food challenge to detect primary and food-induced gut barrier dysfunctions. Of these patients, 62% showed a response to a food challenge in the form of an impaired intestinal barrier. Patients with identified dysfunctions were treated with a multimodal approach, including an elimination diet of the problematic foods identified by the unique imaging provided by Cellvizio®. After approximately six months, 71% of patients who returned for a follow-up procedure using Cellvizio® showed improvement in barrier integrity, with 46% achieving full stabilization. Clinical outcomes included significant improvements in IBS severity, quality of life, and psychological well-being, with particular relief from abdominal pain, cramping, and stool irregularities. Reported Earnings • Oct 17
First half 2024 earnings released First half 2024 results: Revenue: €4.27m (down 40% from 1H 2023). Net loss: €4.69m (down 267% from profit in 1H 2023). Revenue is forecast to grow 8.0% p.a. on average during the next 3 years, compared to a 6.1% growth forecast for the Medical Equipment industry in Germany. Announcement • Oct 16
Mauna Kea Technologies Sa Reaffirms Sales Guidance for the Year 2024 Mauna Kea Technologies SA reaffirmed sales guidance for the year 2024. 2024 guidance set over +20% organic sales growth, excluding licensing income. Announcement • Sep 16
Mauna Kea Technologies Announces Positive Clinical Results in Lung Cancer Obtains with Cellvizio Mauna Kea Technologies announced the publication in the peer-reviewed Journal of Thoracic Disease of new ground-breaking clinical results demonstrating the efficacy of its needle-based Confocal Laser Endomicroscopy (nCLE) technology for the characterization of peripheral lung cancer and preparation of surgical resection. This study, conducted by the team of Professor Stephane Renaud at the University Hospital of Nancy, evaluated the use of Cellvizio's nCLE platform in combination with Electromagnetic Navigation Bronchoscopy (ENB) to characterize suspicious pulmonary nodules and prepare them for surgical resection when needed. The results highlight the potential of nCLE to rapidly and accurately identify malignant lesions while minimizing the risks associated with traditional diagnostic methods including ionizing radiation. The study included 30 patients with suspicious pulmonary nodules with a median size of 16 mm. The findings revealed a sensitivity of 96.43% and a specificity of 100% in characterizing malignant lesions, based on previously published nCLE image classification. The median time of contact with the suspicious lesions was just 5 minutes with no major complications reported, demonstrating the technology's efficiency in clinical practice. Additionally, the use of nCLE also improved the quality and quantity of tissue sampling, thus enabling molecular and genomics analyses, which have become essential tools for the choice and planning of treatments. Announcement • Jul 26
Mauna Kea Technologies SA to Report First Half, 2024 Results on Oct 30, 2024 Mauna Kea Technologies SA announced that they will report first half, 2024 results on Oct 30, 2024 Announcement • Jun 13
Mauna Kea Technologies SA to Report First Half, 2024 Results on Oct 02, 2024 Mauna Kea Technologies SA announced that they will report first half, 2024 results on Oct 02, 2024 New Risk • May 03
New major risk - Negative shareholders equity The company has negative equity. Total equity: -€17m This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risks Negative equity (-€17m). Earnings are forecast to decline by an average of 31% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€7.5m net loss in 2 years). Share price has been volatile over the past 3 months (7.8% average weekly change). Shareholders have been diluted in the past year (33% increase in shares outstanding). Market cap is less than US$100m (€24.6m market cap, or US$26.5m). Announcement • Apr 27
Mauna Kea Technologies SA Provides Sales Guidance for the Year 2024 Mauna Kea Technologies SA provided sales guidance for the year 2024. 2024 guidance set over +20% organic sales growth, excluding licensing income. New Risk • Apr 15
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2023. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 68% per year for the foreseeable future. Minor Risks Negative equity (-€16m). Latest financial reports are more than 6 months old (reported June 2023 fiscal period end). Share price has been volatile over the past 3 months (9.8% average weekly change). Shareholders have been diluted in the past year (38% increase in shares outstanding). Market cap is less than US$100m (€24.4m market cap, or US$26.0m). Board Change • Jan 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 3 experienced directors. 2 highly experienced directors. Independent Director Jacquelien Ten Dam was the last director to join the board, commencing their role in 2020. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Dec 22
Mauna Kea Technologies SA ADR - Sponsored to Be Deleted from OTC Equity Mauna Kea Technologies SA American Depositary Receipts - Sponsored (France) will be deleted from OTC Equity effective December 21, 2023, due to ADR /GDR Program Terminated. New Risk • Nov 28
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 9.4% 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 Share price has been highly volatile over the past 3 months (9.4% average weekly change). Earnings are forecast to decline by an average of 28% per year for the foreseeable future. Minor Risks Negative equity (-€16m). Currently unprofitable and not forecast to become profitable over next 2 years (€6.9m net loss in 2 years). Shareholders have been diluted in the past year (9.2% increase in shares outstanding). Market cap is less than US$100m (€20.8m market cap, or US$22.8m). Announcement • Nov 14
Mauna Kea Technologies SA announced that it expects to receive €6 million in funding from Telix Pharmaceuticals Limited Mauna Kea Technologies SA announced a private placement of 11,911,852 common shares at a price of €0.5037 per share for gross proceeds of €6,000,000 on November 13, 2023. The transaction included participation from new investor Telix Pharmaceuticals Limited. Announcement • Nov 02
Mauna Kea Technologies Announces First Patient Enrolled in the Pivotal CLEVER Clinical Trial in Peripheral Lung Cancer Mauna Kea Technologies announced the first patient enrollment in the multi-center randomized controlled trial (RCT) entitled "Confocal Laser Endomicroscopy VERification" (CLEVER, NCT06079970)1 in collaboration with the Amsterdam University Medical Centers (UMC) for the diagnosis and management of peripheral lung lesions. In the framework of this trial, over 200 patients will be enrolled across 7 sites in Europe and the U.S. until end of second quarter 2025. Lung cancer is the world's leading cause of cancer deaths claiming over 1.8 million lives every year - more than colorectal, breast, and prostate cancers combined. The rise in lung cancer screening and the increased use of chest-computed tomography (CT) has generated a surge in the detection of suspected malignant lung lesions globally, increasing the need for more effective and efficient diagnostic methods. Over 80% of these incidental lesions develop in the peripheral bronchi and are not easily visualized or accessed during conventional bronchoscopy. Adding nCLE as an adjunctive technique offers a potential solution by providing real-time feedback on the correct positioning of biopsy twazers or needles (tool-in-lesion) and collecting the right cells samples (lesion-in-tool). Breakeven Date Change • Oct 25
No longer forecast to breakeven The analyst covering Mauna Kea Technologies no longer expects the company to break even during the foreseeable future. The company was expected to make a profit of €8.19m in 2025. New forecast suggests the company will make a loss of €6.40m in 2025. New Risk • Oct 25
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 28% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 28% per year for the foreseeable future. Minor Risks Negative equity (-€16m). Currently unprofitable and not forecast to become profitable over next 2 years (€6.9m net loss in 2 years). Share price has been volatile over the past 3 months (6.6% average weekly change). Shareholders have been diluted in the past year (9.2% increase in shares outstanding). Market cap is less than US$100m (€24.7m market cap, or US$26.2m). New Risk • Oct 03
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 German stocks, typically moving 6.1% 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 Risk Earnings are forecast to decline by an average of 28% per year for the foreseeable future. Minor Risks Negative equity (-€16m). Currently unprofitable and not forecast to become profitable over next 2 years (€6.9m net loss in 2 years). Share price has been volatile over the past 3 months (6.1% average weekly change). Shareholders have been diluted in the past year (9.0% increase in shares outstanding). Market cap is less than US$100m (€26.3m market cap, or US$27.6m). Reported Earnings • Oct 02
First half 2023 earnings released: EPS: €0.063 (vs €0.14 loss in 1H 2022) First half 2023 results: EPS: €0.063 (up from €0.14 loss in 1H 2022). Revenue: €7.14m (up 93% from 1H 2022). Net income: €2.80m (up €9.01m from 1H 2022). Profit margin: 39% (up from net loss in 1H 2022). Revenue is expected to decline by 2.3% p.a. on average during the next 3 years, while revenues in the Medical Equipment industry in Germany are expected to grow by 6.3%. Over the last 3 years on average, earnings per share has increased by 34% per year but the company’s share price has fallen by 17% per year, which means it is significantly lagging earnings. New Risk • Sep 29
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 28% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 28% per year for the foreseeable future. Minor Risks Negative equity (-€16m). Currently unprofitable and not forecast to become profitable over next 2 years (€6.9m net loss in 2 years). Shareholders have been diluted in the past year (9.0% increase in shares outstanding). Market cap is less than US$100m (€28.0m market cap, or US$29.6m). Announcement • Sep 19
Mauna Kea Technologies and Endoscopy Institute of Hawaii Achieve 1,200 Procedure Milestone Mauna Kea Technologies announced that Jeong Kim, M.D., and the Endoscopy Institute of Hawaii (EIH) clinical team have completed more than 1,200 Cellvizio procedures for the diagnosis and interventional treatment of gastric disease, a condition which can lead to gastric cancer. EIH is part of the Covenant Physician Partners network of facilities and physicians which operates more than 85 leading healthcare centers across the United States. Dr. Kim, the lead gastroenterologist at EIH, is a specialist providing care for a broad range of digestive illnesses such as detection of stomach and colon cancer, gastroesophageal reflux disease (GERD), inflammatory bowel disease (IBD), and liver disease. His focus on minimally invasive endoscopy led Dr. Kim to add the Cellvizio program to his facility in January 2020. Since then, he has used Cellvizio on more than 1,200 patients, primarily for the screening and detection of GIM, which is a known precursor to gastric cancer and is highly prevalent in certain populations such as patients of Asian descent and among patients with specific risk factors like diet, lifestyle, or family history of gastric disease. Mapping GIM is a burdensome clinical challenge, given the large size of the stomach and the need to adequately visualize the gastric mucosa to rule out suspicious lesions and determine GIM extent. Dr. Kim has developed his own adjunctive protocol used in tandem with the standard protocol to provide the best care to his patients. His total procedure time takes only 10 to 12 minutes for a full visual inspection with Cellvizio, including completing multiple gastric biopsies using the Sydney Protocol. Breakeven Date Change • Sep 06
No longer forecast to breakeven The analyst covering Mauna Kea Technologies no longer expects the company to break even during the foreseeable future. The company was expected to make a profit of €8.19m in 2025. New forecast suggests the company will make a loss of €6.40m in 2025. Announcement • Jan 13
Mauna Kea Technologies SA Announces the Publication of Results of the First in Human Clinical Study Combining Robotic-Assisted Bronchoscopy and Needle-Based Confocal Laser Endomicroscopy for Lung Cancer Mauna Kea Technologies SA announced that the results of the first in human clinical study combining nCLE and robotic-assisted bronchoscopy (Clinicaltrials.gov: NCT04441749) have been published in the international peer-reviewed journal Respirology(1) . This clinical study, co-funded by the Lung Cancer Initiative at Johnson & Johnson(2), combines needle-based confocal laser endomicroscopy and robotic-assisted bronchoscopy using both Cellvizio(R) and the Monarch(TM) Platform from Ethicon(3) for the diagnosis of peripheral lung nodules. Twenty patients with a median lung nodule size of 14.5mm (range 8-28mm) were enrolled. This study demonstrated that robotic-assisted bronchoscopic nCLE-imaging in small peripheral lung lesions is feasible and safe and provides real-time feedback on correct needle positioning. Bronchoscopic nCLE-imaging provided tool-in-nodule confirmation in 19 of 20 patients (95%) whereas corresponding rapid on-site evaluation (ROSE) confirmed representative material in only 9 of 20 patients (45%) and no complications were reported during the study. With nCLE real-time in vivo cellular imaging feedback, the needle was repositioned in 45% of the patients (9/20 patients) to reach a diagnostic yield across all nodule sizes and locations of 80%. Of the 17 patients with malignancy, 16 (94%) had the final diagnosis of lung cancer confirmed by nCLE imaging, including two patients with negative TBNA and biopsies. Breakeven Date Change • Nov 16
No longer forecast to breakeven The 2 analysts covering Mauna Kea Technologies no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of €4.06m in 2024. New consensus forecast suggests the company will make a loss of €9.18m in 2024. Announcement • Nov 01
Mauna Kea Technologies SA Announces Success of Clinical Trial on Prediction of Remission in Patients with Inflammatory Bowel Disease (IBD) and its Publication in Gastroenterology Mauna Kea Technologies announced the success of a long term prospective clinical study on the prediction of major adverse outcomes for patients suffering from Inflammatory Bowel Disease (IBD) using Confocal Laser Endomicroscopy with Cellvizio®. Final results of the ERIca trial (Erlangen Remission in IBD, clinicaltrials.gov NCT05157750) are now published in the peer-reviewed journal Gastroenterology, the journal of the American Gastroenterological Association, in the article “Intestinal barrier healing is superior to endoscopic and histologic remission for predicting major adverse outcomes in IBD: the prospective ERIca trial”. Endoscopy is the key technique for the surveillance of patients suffering from IBD, with patients undergoing surveillance colonoscopy every one to two years. Endoscopic and histologic remission, characterized by visual assessment of the colon and analysis of random biopsies, have emerged as key therapeutic goals in the management of IBD that are associated with favorable long-term disease outcomes. In this study, the authors prospectively compared the predictive value of intestinal barrier healing visualized dynamically and functionally in real time with Confocal Laser Endomicroscopy (Cellvizio®) versus endoscopic and histologic remission for predicting long-term disease behavior in a large cohort of IBD patients in clinical remission. Key clinical results: Between 2017 and 2019, a total of 296 IBD patients were screened for eligibility. Out of these, 181 IBD patients (100 with Crohn’s Disease (CD) and 81 with Ulcerative Colitis (UC)) patients were finally eligible and included in the study, with a mean follow-up of 25 months for UC and 35 months for CD. Endoscopic and histologic disease activity as well as barrier healing were prospectively assessed along established scores. During subsequent follow-up, patients were closely monitored for clinical disease activity and the occurrence of major adverse outcomes (MAO): disease flares, IBD-related hospitalization or surgery, initiation or dose escalation of systemic steroids, immunosuppressants, small molecules or biological therapy. The authors found that Barrier Healing assessed with Confocal Laser Endomicroscopy was far superior to endoscopic and histologic remission for predicting MAO-free survival in both UC and CD: For patients suffering from UC and with Barrier Healing in the Colon confirmed with Cellvizio, the MAO-free survival probability was 81% compared to 47.7% - 64.7% for all other predictors. For patients suffering from CD and with Barrier Healing in the Colon confirmed with Cellvizio, the MAO-free survival probability was 70.4% compared to 43.9% - 50% for all other endoscopic and histologic predictors. When Barrier Healing was confirmed in the Ileum, this probability reached 100% compared to 43.9% - 50% for all other predictors. Announcement • Oct 05
Mauna Kea Technologies SA Announces the Appointment of Sacha Loiseau as Chief Executive Officer Mauna Kea Technologies SA announces the appointment of Sacha Loiseau, Founder and current Chairman of the Board of Mauna Kea Technologies, to serve also as Chief Executive Officer, replacing interim CEO Nicolas Bouvier effective immediately. Mr. Sacha Loiseau will thus concurrently hold the positions of Chairman and Chief Executive Officer of Mauna Kea Technologies. A graduate of École Polytechnique and a Ph.D. in Astrophysics, Sacha Loiseau co-founded Mauna Kea Technologies and served as its CEO for more than 18 years, taking the company public in July 2011 on Euronext. He has served as Mauna Kea Technologies Chairman of the Board of Directors since October 2018. In addition, Sacha holds other non-executive roles in leading medtech startups: he is Chairman of the Board of Therapixel and SeqOne Genomics, Board Member at Lifen, Gleamer and MDoloris. Sacha is also a Venture Partner with Elaia, a top tier DeepTech European Venture Capital firm. Announcement • Sep 16
Mauna Kea Technologies SA to Report First Half, 2022 Final Results on Oct 20, 2022 Mauna Kea Technologies SA announced that they will report first half, 2022 final results on Oct 20, 2022 Breakeven Date Change • Apr 27
No longer forecast to breakeven The 2 analysts covering Mauna Kea Technologies no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of €4.06m in 2024. New consensus forecast suggests the company will make a loss of €9.40m in 2024. Breakeven Date Change • Apr 23
No longer forecast to breakeven The 2 analysts covering Mauna Kea Technologies no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of €4.06m in 2024. New consensus forecast suggests the company will make a loss of €9.40m in 2024. Announcement • Apr 13
Mauna Kea Technologies Announces First of Its Kind U.S. FDA 510(k) Clearance for Use of Cellvizio in a New Category of Molecular Imaging-guided Endoscopic, Laparoscopic, Needle-Based Procedures Mauna Kea Technologies announced a new U.S. FDA 510(k) clearance (K220477) for the use of the Cellvizio 100 Series platform with a molecular imaging agent, the first of its kind, for real-time in vivo visualization during endoscopic, laparoscopic, and needle-based procedures. This U.S. FDA clearance is for a new clinical indication for the use of Cellvizio to perform fluorescence imaging of tissues that have taken up the drug Pafolacianine, marketed under the trade name CYTALUX™ and manufactured by On Target Laboratories, consistent with its approved use and administration labeling. Additionally, the clearance includes a new clinical indication for the use of Cellvizio to perform fluorescence imaging and visualization of ICG (indocyanine green), either intravenously or interstitially, consistent with ICG approved use and administration labeling. The 510(k) includes all Cellvizio Confocal Miniprobes™ across all cleared clinical indications. The pioneering category of medical procedures expanded through this new clearance – Molecular Image-guided Procedures (MIP) – is designed to provide Cellvizio the unique clinical ability to visualize tissues to which the molecular agents bind, allowing the potential for real-time visualization of cancer at the cellular level during minimally invasive interventions. The use of MIP during bronchoscopic lung biopsy may improve the diagnostic accuracy of biopsies while reducing the number of procedures, time, and complications associated with obtaining a diagnosis. The clearance represents Mauna Kea’s 20thU.S. FDA 510(k) for the Cellvizio® p/nCLE platform and reflects Mauna Kea Technologies’ ongoing work with the U.S. FDA to build a unique range of indications for Cellvizio: imaging of the internal microstructure of tissues including, but not limited to, the identification of cells, vessels and their organization or architecture; imaging blood flow in vascular areas, including microvasculature and capillaries; and for the near-infrared version of Cellvizio, fluorescence angiography and visualization of the lymphatic system, including lymphatic vessels and lymph nodes with ICG and fluorescence imaging of tissues that have taken up the CYTALUX drug. This latest clearance also reflects the U.S. FDA’s success in implementing portions of the 21st Century Cures Act and thus facilitating the availability of safe and effective device/drug combination products to healthcare professionals for improved patient care. Announcement • Feb 24
Mauna Kea Technologies SA Announces Start of Enrollment in Peripheral Lung Cancer Multi-Center Clinical Trial Mauna Kea Technologies announces that, as part of its collaboration with the Lung Cancer Initiative at Johnson & Johnson, initial enrollment of patients has begun in a prospective, multi-center, open-label, single-arm clinical feasibility study sponsored by LCI. The study will combine nCLE and robotic-assisted bronchoscopy, using both Cellvizio and the Monarch Platform from Auris Health Inc., a subsidiary of Ethicon Inc., part of the Johnson & Johnson Medical Devices Companies, to assess the capability of nCLE to accurately confirm needle position for the diagnosis of peripheral lung nodules. The primary objective of this study, named CLEAR is to evaluate the ability of nCLE to confirm successful navigation of the biopsy needleduring peripheral lung nodule procedures, as confirmed by cone beam CT. The secondary objectives are to evaluate the reproducibility of using nCLE across multiple facilities and to evaluate the ability of nCLE to diagnose malignancy vs. non-malignancy, including exploring diagnostic yield at the index procedure. This study will include up to 75 patients with peripheral lung nodules in at least 3 U.S. centers. Announcement • Jan 07
Mauna Kea Technologies SA announced that it has received $12.8 million in funding from Lightspeed China Partners, Qiming Weichuang Venture Capital Management (Shanghai) Company Limited, Shanghai Ivy Investment Holdings Co., Ltd. Mauna Kea Technologies SA announced that it has received $12,800,000 in a round of funding led by new investor Lightspeed China Partners on January 5, 2022. The transaction included participation from Qiming Weichuang Venture Capital Management (Shanghai) Company Limited and Shanghai Ivy Investment Holdings Co., Ltd. Reported Earnings • Sep 26
First half 2021 earnings released The company reported a solid first half result with improved revenues and control over costs, although losses were not reduced. First half 2021 results: Revenue: €3.90m (up 23% from 1H 2020). Net loss: €6.70m (flat on 1H 2020). Announcement • Aug 25
Mauna Kea Technologies Receives U.S. FDA 510(k) Clearance of its Next-Generation Cellvizio® Platform Combined with a Fluorescent Contrast Agent Mauna Kea Technologies announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its next-generation Cellvizio® platform and all associated Confocal Miniprobes™ for a new clinical indication for visualization of blood flow when used in conjunction with a fluorescent dye, fluorescein, as a drug-device combination (K212322). This marks the 19thU.S. FDA 510(k) clearance of the Cellvizio® p/nCLE platform. The next-generation Cellvizio® platformhas already been cleared by U.S. FDA 510(k) for the vizualisation of the internal microstructure of tissues including, but not limited to, the identification of cells and vessels and their organization or architecture (K193416). Building upon the success of the previous models, the new generation of Cellvizio equips physicians with the most advanced cellular imaging technology to improve patients’ lives. The platform includes several new features: an all-new workflow for endoscopic, bronchoscopic, or operating environments via integrated connectivity; enhanced capabilities enabling artificial intelligence (AI) for assisted pattern recognition; and a small footprint and slim profile allowing easy maneuverability within the procedure room. The Cellvizio® real-time in vivo cellular imaging platform is used in the fields of gastroenterology, pulmonology, and urology during endoscopic procedures, as well as laparoscopic and robot-assisted surgeries. Announcement • Jul 24
Mauna Kea Technologies SA Provides Earnings Guidance for the Twelve Months Ending December 31, 2021 Mauna Kea Technologies SA provided earnings guidance for the twelve months ending December 31, 2021. For the period, the company expected to increase sales in the range of 25% to 30% year-over-year. Announcement • Jun 15
Mauna Kea Technologies Unveils Its Next-Generation Cellvizio® Platform Mauna Kea Technologies unveiled the next-generation Cellvizio platform, which has already received both 510(k) clearance (K193416) from the U.S. Food and Drug Administration (FDA) and CE marking. Built with enhanced capabilities, this entirely new system uses the company’s proprietary Confocal Laser Endomicroscopy (CLE) advanced imaging technology to deliver cellular and molecular imaging virtually anywhere in the human body, and will be available for purchase in the second half of 2021. Building upon the success of the previous models, the new generation of Cellvizio equips physicians with the most advanced cellular imaging technology to improve patients’ lives. The platform includes several new features: an all-new workflow integration for endoscopic, bronchoscopic, or operating environments via integrated connectivity; enhanced capabilities enabling artificial intelligence (AI) for assisted pattern recognition; and a small footprint and slim profile allowing easy maneuverability within the procedure room. Reported Earnings • May 09
Full year 2020 earnings released The company reported a decent full year result with reduced losses and improved control over expenses, although revenues were weaker. Full year 2020 results: Revenue: €7.94m (down 6.7% from FY 2019). Net loss: €12.8m (loss narrowed 16% from FY 2019). Announcement • Feb 10
Mauna Kea Technologies: Cellvizio® Combined with Artificial Intelligence Outperforms Standard of Care for Pancreatic Cyst Diagnosis and Risk Stratification Mauna Kea Technologies announced the publication of a peer-reviewed study on pancreatic cystic lesion (PCL) risk stratification using artificial intelligence (AI) models for nCLE image classification and the publication of a new peer-reviewed meta-analysis on endoscopic ultrasound (EUS) guided nCLE for PCL evaluation. The majority of PCLs incidentally found in the population represent intraductal papillary mucinous neoplasms (IPMNs), a precursor of pancreatic adenocarcinoma. Current standard of care relies on a combination of clinical history, imaging, EUS features, and cyst fluid cytology for identification of IPMNs with advanced neoplasia. Today, approximately half of the IPMNs that undergo surgical resection are ultimately found to have low- or intermediate-grade dysplasia. To avoid unnecessary resections of indolent lesions considering the high post-operative morbidity (30%) and mortality (2.1%) rates, more accurate methods to diagnose IPMNs are crucial to guide patient management including surgical decisions. The first study, entitled “High performance in risk stratification of intraductal papillary mucinous neoplasms by confocal laser endomicroscopy image analysis with convolutional neural networks,” published in the peer-reviewed journal Gastrointestinal Endoscopy (2020, DOI: 10.1016/j.gie.2020.12.054), reported the successful development and application of AI algorithms for nCLE diagnosis and risk stratification of IPMNs. The authors demonstrated that deep learning models derived from nCLE images, were more accurate in diagnosing and risk stratifying advanced neoplasia in IPMNs compared with current standard diagnosis and society guidelines. A second publication entitled “Needle-based Confocal Laser Endomicroscopy (nCLE) for Evaluation of Pancreatic Cystic Lesions: A Systematic Review and Meta-analysis,” was published in the Journal of Clinical Gastroenterology (2020, DOI: 10.1097/MCG.0000000000001468). Seven studies enrolling 324 patients were included and the authors evaluated pooled diagnostic, accuracy, sensitivity, specificity, and odds ratio. The authors concluded that “nCLE appears to be an effective and safe technique for the diagnostic evaluation of PCLs.” Indeed, nCLE was associated with a sensitivity of 85%, a specificity of 99%, a diagnostic accuracy of 99%, and a post-procedure pancreatitis rate of 1%. Is New 90 Day High Low • Jan 09
New 90-day high: €1.55 The company is up 20% from its price of €1.29 on 09 October 2020. The German market is up 8.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Medical Equipment industry, which is up 9.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €2.78 per share. Announcement • Dec 19
Mauna Kea Technologies Announces Board Changes Mauna Kea Technologies announced the cooptation by the Board of Ms. Jacquelien Ten Dam as an Independent Director, effective immediately. Ms. Ten Dam replaces Dr. Jennifer Tseng, who tendered her resignation from the Board after 3 years of service. This cooptation will be subject to the approval of the Ordinary General Meeting of Mauna Kea Technologies, which will be voting on the financial statements for the fiscal year ending December 31, 2020, to be held in 2021. Jacquelien Ten Dam studied Biomedical Sciences before joining Kempen, a leading European investment bank, where she advised life science firms on strategy, M&A and capital market transactions. After a stint at Picnic, a start-up company in the digital retail industry, Jacquelien joined Mimetas as Chief Financial Officer. Announcement • Dec 17
Telix Pharmaceuticals Limited and Mauna Kea Technologies Announces Exclusive Scientific and Clinical Research Collaboration Telix Pharmaceuticals Limited and Mauna Kea Technologies announced an exclusive scientific and clinical research collaboration in the field of molecular imaging guided urologic oncology. The Telix and Mauna Kea scientific and clinical research collaboration is called the “Imaging and Robotics in Surgery (IRiS) Alliance,” or “IRiS Alliance,” and was created to further develop the combined technological capabilities of both companies. The IRiS Alliance was formed based on the belief that the use of cancer-specific Positron Emission Tomography (PET) imaging agents, including dual-modality tracers that combine PET and fluorescent (optical) techniques, in conjunction with confocal laser endomicroscopy, may significantly improve surgical techniques and clinical outcomes in patients with urologic cancers. The IRiS Alliance aims to demonstrate that pre-operative planning, intra-operative guidance, surgical margin assessment and other surgical parameters may be improved by combining these modalities. The initial focus of the IRiS Alliance is to develop and evaluate the use of Telix’s dual-modality PET and optical imaging tracers, together with Mauna Kea’s unique near-infrared version of the Cellvizio endomicroscopy platform to facilitate fluorescence-guided surgical interventions for prostate and kidney cancers. Is New 90 Day High Low • Oct 31
New 90-day low: €1.00 The company is down 15% from its price of €1.18 on 31 July 2020. The German market is down 4.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Medical Equipment industry, which is down 1.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €5.82 per share. Is New 90 Day High Low • Oct 12
New 90-day high: €1.51 The company is up 25% from its price of €1.22 on 14 July 2020. The German market is up 2.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Medical Equipment industry, which is up 2.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €7.25 per share. Is New 90 Day High Low • Sep 23
New 90-day low: €1.04 The company is down 17% from its price of €1.25 on 25 June 2020. The German market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Medical Equipment industry, which is down 1.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €5.99 per share. 