Mauna Kea Technologies Announces Largest Annual Pancreatic Cyst Consortium at Digestive Disease Week ® 2025
PARIS & BOSTON--(BUSINESS WIRE)--Regulatory News:
Mauna Kea Technologies (Euronext Growth: ALMKT), inventor of Cellvizio ®, the multidisciplinary probe and needle-based confocal laser endomicroscopy (p/nCLE) platform, today announced completion of the largest annual pancreatic cyst consortium held at the Digestive Disease Week ® (DDW) Conference in San Diego, California, on Monday May 5, 2025. The detailed program is available on the Mauna Kea Technologies website at the following link:
https://www.landing.maunakeatech.com/hubfs/ddw/DDW_2025_Consortium_Agenda.pdf
The consortium brought together more than 75 physicians from across the United States with a focus on cutting-edge advancements in the diagnosis, classification, risk stratification, and treatment of pancreatic cystic lesions and pancreatic cancer. Attendance tripled compared to the 2024 meeting, reflecting the growing interest among the medical community in this field. Central to the discussions was the growing impact of endoscopic ultrasound with Cellvizio needle-based Confocal Laser Endomicroscopy (EUS-nCLE) in enabling earlier and more accurate diagnoses and clinical decisions before any therapy begins, with the goal of increasing non-surgical treatment options.
The consortium was led by Dr. Somashekar (Som) Krishna, MD, MPH, Professor of Medicine and Director of Advanced Endoscopy at The Ohio State University Wexner Medical Center and principal investigator of the CLIMB 1 study. It was co-sponsored by 9 leading medical device and pharmaceutical products companies, demonstrating strong cross-industry commitment to advancing care for the millions of patients affected by pancreatic cystic lesions worldwide.
"This year's consortium marks a turning point in how the medical community and the industry approach pancreatic cyst management and treatment,' said Sacha Loiseau, Ph.D., Chairman and Chief Executive Officer of Mauna Kea Technologies. 'Bringing together more than 75 top physicians and 9 committed industry partners shows that the ecosystem around EUS-nCLE, RFA 2, and AI is maturing rapidly - and with it, our ability to change the standard of care for patients facing pancreatic lesions. A clear momentum is building around this application, driven by the recent endorsement of nCLE in European clinical guidelines and the surge of interest we're now seeing in the United States at DDW. We're proud to help lead this transformation and deeply grateful to our collaborators and clinical pioneers who are making it possible. With Cellvizio, we are targeting one of the largest unmet clinical issues in gastroenterology - and changing the trajectory for many patients at risk of pancreatic cancer.'
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About Pancreatic Cysts
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.
About Digestive Disease Week ®
Digestive Disease Week ® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW was an in-person and online meeting from May 3-6, 2025. The meeting showcases more than 5,600 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.
About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company that manufactures and sells Cellvizio ®, the real-time in vivo cellular imaging platform. This technology uniquely delivers in vivo cellular visualization which enables physicians to monitor the progression of disease over time, assess point-in-time reactions as they happen in real time, classify indeterminate areas of concern, and guide surgical interventions. The Cellvizio ® platform is used globally across a wide range of medical specialties and is making a transformative change in the way physicians diagnose and treat patients. For more information, visit www.maunakeatech.com.
Disclaimer
This press release contains forward-looking statements about Mauna Kea Technologies and its business. All statements other than statements of historical fact included in this press release, including, but not limited to, statements regarding Mauna Kea Technologies' financial condition, business, strategies, plans and objectives for future operations are forward-looking statements. Mauna Kea Technologies believes that these forward-looking statements are based on reasonable assumptions. However, no assurance can be given that the expectations expressed in these forward-looking statements will be achieved. These forward-looking statements are subject to numerous risks and uncertainties, including those described in Chapter 2 of Mauna Kea Technologies' 2024 Annual Report filed with the Autorité des marchés financiers (AMF) on April 30, 2025, which is available on the Company's website (www.maunakeatech.fr), as well as the risks associated with changes in economic conditions, financial markets and the markets in which Mauna Kea Technologies operates. The forward-looking statements contained in this press release are also subject to risks that are unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not currently consider material. The occurrence of some or all of these risks could cause the actual results, financial condition, performance or achievements of Mauna Kea Technologies to differ materially from those expressed in the forward-looking statements. This press release and the information contained herein do not constitute an offer to sell or subscribe for, or the solicitation of an order to buy or subscribe for, shares of Mauna Kea Technologies in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The distribution of this press release may be restricted in certain jurisdictions by local law. Persons into whose possession this document comes are required to comply with all local regulations applicable to this document.
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1 ClinicalTrials.gov: NCT03492151
2 Radiofrequency Ablation
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Otsuka Pharmaceutical Co., Ltd.'s global website is accessible at About Visterra Visterra is a biologics research and early-stage clinical development biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with immune-mediated kidney diseases and other hard-to-treat diseases. Its proprietary Hierotope® platform enables the design and engineering of precision biologics-based product candidates that specifically bind to, and modulate, key disease targets that are not adequately addressed by traditional therapeutic approaches. The platform also includes Fc engineering capabilities for half-life extension, bispecific antibodies and antibody-drug conjugates (ADCs). Visterra's pipeline includes programs targeting kidney diseases, immunologically-driven diseases and infectious diseases. Visterra is an indirect subsidiary of Otsuka Pharmaceutical Co., Ltd. For more information, visit References Otsuka Pharmaceutical Development & Commercialization, Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN). Thompson A, Carroll K, Inker LA, et al. Proteinuria Reduction as a Surrogate End Pointin Trials of IgA Nephropathy. Clin J Am Soc Nephrol. 2019;14(3): Mathur M, Barratt J, Suzuki Y, et al. Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VIS649 (Sibeprenlimab), an APRIL-Neutralizing IgG2 Monoclonal Antibody, in Healthy Volunteers. Kidney Int Rep. 2022;7(5):993-1003. Chang S, Li XK. The Role of Immune Modulation in Pathogenesis of IgA Nephropathy ( Cheung CK, Barratt J, Liew A, Zhang H, Tesar V, Lafayette R. The role of BAFF and April in IGA nephropathy: Pathogenic mechanisms and targeted therapies. Frontiers in nephrology. February 1, 2024. Mathur M, Barratt J, Chacko B, et al. A Phase 2 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy Patients. NEJM. 2023 Gharavi, Ali G, et al. 'Aberrant Iga1 Glycosylation Is Inherited in Familial and Sporadic IGA Nephropathy.' Journal of the American Society of Nephrology : JASN, U.S. National Library of Medicine, May 2008, Kant, Sam, et al. 'Advances in Understanding of Pathogenesis and Treatment of Immune-Mediated Kidney Disease: A Review - American Journal of Kidney Diseases.' American Journal of Kidney Diseases, Apr. 2022, Pitcher, D. Braddon, et. al Long-term outcomes in IGA nephropathy. Clinical journal of the American Society of Nephrology : CJASN. Lai K. Iga nephropathy. Nature reviews. Disease primers. 2016 Cheung, Chee Kay & Boyd, JKF & Feehally, J.. (2012). Evaluation and management of IgA nephropathy. Clinical Medicine. 12. s27-s30. 10.7861/clinmedicine.12-6-s27.
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Unless otherwise noted, all translations from Renminbi to U.S. dollars and from U.S. dollars to Renminbi are made at a rate of RMB7.2567 to US$1.00, the exchange rate on March 31, 2025, set forth in the H.10 statistical release of the Federal Reserve Board. The Company makes no representation that the Renminbi or U.S. dollars amounts referred could be converted into U.S. dollars or Renminbi, as the case may be, at any particular rate or at all. About Burning Rock Burning Rock Biotech Limited (NASDAQ: BNR), whose mission is to guard life via science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of i) NGS-based therapy selection testing for late-stage cancer patients, and ii) cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage. 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Such statements are based upon management's current expectations and current market and operating conditions, and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and many of which are beyond Burning Rock's control. Forward-looking statements involve risks, uncertainties and other factors that could cause actual results to differ materially from those contained in any such statements. All information provided in this press release is as of the date of this press release, and Burning Rock does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law. Non-GAAP Measures In evaluating the business, the Company considers and uses non-GAAP measures, such as non-GAAP gross profit and non-GAAP gross margin, as supplemental measures to review and assess operating performance. The presentation of these non-GAAP financial measures is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with accounting principles generally accepted in the United States of America ('U.S. GAAP'). The company defines non-GAAP gross profit as gross profit excluding depreciation and amortization. The company defines non-GAAP gross margin as gross margin excluding depreciation and amortization. The company presents these non-GAAP financial measures because they are used by management to evaluate operating performance and formulate business plans. The company believe non-GAAP gross profit and non-GAAP gross margin excluding non-cash impact of depreciation and amortization reflect the company's ongoing business operations in a manner that allows more meaningful period-to-period comparisons. Contact: IR@ Selected Operating Data As of March 31, 2024 June 30, 2024 September 30, 2024 December 31, 2024 March 31, 2025 In-hospital Channel: Pipeline partner hospitals(1) 28 29 30 29 30 Contracted partner hospitals(2) 59 59 61 63 63 Total number of partner hospitals 87 88 91 92 93(1) Refers to hospitals that are in the process of establishing in-hospital laboratories, laboratory equipment procurement or installation, staff training or pilot testing using the Company's products. (2) Refers to hospitals that have entered into contracts to purchase the Company's products for use on a recurring basis in their respective in-hospital laboratories the Company helped them establish. Kit revenue is generated from contracted hospitals. Selected Financial Data For the three months ended Revenues March 31, 2024 June 30, 2024 September 30, 2024 December 31, 2024 March 31, 2025 (RMB in thousands) Central laboratory channel 47,614 48,773 39,984 39,278 38,296 In-hospital channel 57,387 59,872 63,769 43,464 57,687 Pharma research and development channel 20,622 26,888 24,891 43,280 37,099 Total revenues 125,623 135,533 128,644 126,022 133,082 For the three months ended Gross profit March 31,2024 June 30,2024 September 30,2024 December 31,2024 March 31,2025 (RMB in thousands) Central laboratory channel 37,002 38,424 33,262 33,153 32,191 In-hospital channel 39,192 44,058 46,580 29,563 43,895 Pharma research and development channel 9,500 12,956 12,004 26,706 21,315 Total gross profit 85,694 95,438 91,846 89,422 97,401 For the three months ended Share-based compensation expenses March 31,2024 June 30,2024 September 30,2024 December 31,2024 March 31,2025 (RMB in thousands) Cost of revenues 596 464 289 520 308 Research and development expenses 12,287 12,008 3,180 3,202 1,800 Selling and marketing expenses 508 1,232 1,917 1,353 1,025 General and administrative expenses 55,990 54,407 4,732 2,937 1,413 Total share-based compensation expenses 69,381 68,111 10,118 8,012 4,546 Burning Rock Biotech Limited Unaudited Condensed Statements of Comprehensive Loss (in thousands, except for number of shares and per share data) For the three months ended March 31,2024 June 30,2024 September 30, 2024 December 31,2024 March 31, 2025 March 31, 2025 RMB RMB RMB RMB RMB US$ Revenues 125,623 135,533 128,644 126,022 133,082 18,340 Cost of revenues (39,929 ) (40,095 ) (36,798 ) (36,600 ) (35,681 ) (4,918 ) Gross profit 85,694 95,438 91,846 89,422 97,401 13,422 Operating expenses: Research and development expenses (65,985 ) (64,952 ) (49,150 ) (52,203 ) (40,389 ) (5,566 ) Selling and marketing expenses (46,856 ) (48,907 ) (48,411 ) (46,730 ) (40,888 ) (5,635 ) General and administrative expenses (98,681 ) (92,794 ) (32,874 ) (37,289 ) (31,303 ) (4,314 ) Impairment loss on long-lived assets (35,127 ) Total operating expenses (211,522 ) (206,653 ) (130,435 ) (171,349 ) (112,580 ) (15,515 ) Loss from operations (125,828 ) (111,215 ) (38,589 ) (81,927 ) (15,179 ) (2,093 ) Interest income 4,038 3,187 3,173 1,814 2,581 356 Other income (expense), net 434 (82 ) 1 4,353 (652 ) (90 ) Foreign exchange (loss) gain, net (13 ) 262 (129 ) (220 ) (26 ) (4 ) Loss before income tax (121,369 ) (107,848 ) (35,544 ) (75,980 ) (13,276 ) (1,831 ) Income tax expenses (180 ) (190 ) (201 ) (5,314 ) (224 ) (31 ) Net loss (121,549 ) (108,038 ) (35,745 ) (81,294 ) (13,500 ) (1,862 ) Net loss attributable to Burning Rock Biotech Limited's shareholders (121,549 ) (108,038 ) (35,745 ) (81,294 ) (13,500 ) (1,862 ) Net loss attributable to ordinary shareholders (121,549 ) (108,038 ) (35,745 ) (81,294 ) (13,500 ) (1,862 ) Loss per share for class A and class B ordinary shares: Class A ordinary shares - basic and diluted (1.19 ) (1.05 ) (0.35 ) (0.79 ) (0.13 ) (0.02 ) Class B ordinary shares - basic and diluted (1.19 ) (1.05 ) (0.35 ) (0.79 ) (0.13 ) (0.02 ) Weighted average shares outstanding used in loss per share computation: Class A ordinary shares - basic and diluted 85,219,188 85,271,858 85,902,670 86,036,286 90,291,658 90,291,658 Class B ordinary shares - basic and diluted 17,324,848 17,324,848 17,324,848 17,324,848 17,324,848 17,324,848 Other comprehensive income (loss), net of tax of nil: Foreign currency translation adjustments 590 940 (4,054 ) 6,009 (72 ) (10 ) Total comprehensive loss (120,959 ) (107,098 ) (39,799 ) (75,285 ) (13,572 ) (1,872 ) Total comprehensive loss attributable to Burning Rock Biotech Limited's shareholders (120,959 ) (107,098 ) (39,799 ) (75,285 ) (13,572 ) (1,872 ) Burning Rock Biotech LimitedUnaudited Condensed Consolidated Balance Sheets(In thousands) As of December 31, 2024 March 31,2025 March 31,2025 RMB RMB US$ ASSETS Current assets: Cash and cash equivalents 519,849 495,145 68,233 Restricted cash 2,313 2,261 312 Accounts receivable, net 152,013 159,463 21,974 Contract assets, net 13,855 17,178 2,367 Inventories, net 62,625 65,424 9,016 Prepayments and other current assets, net 25,963 22,072 3,042 Total current assets 776,618 761,543 104,944 Non-current assets: Property and equipment, net 47,152 41,162 5,672 Operating right-of-use assets 53,188 43,804 6,036 Intangible assets, net 421 386 53 Other non-current assets 7,926 7,822 1,078 Total non-current assets 108,687 93,174 12,839 TOTAL ASSETS 885,305 854,717 117,783 Burning Rock Biotech LimitedUnaudited Condensed Consolidated Balance Sheets (Continued)(in thousands) As of December 31,2024 March 31,2025 March 31,2025 RMB RMB US$ LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable 33,747 35,938 4,952 Deferred revenue 117,895 117,200 16,151 Accrued liabilities and other current liabilities 89,498 76,198 10,501 Customer deposits 592 592 82 Current portion of operating lease liabilities 24,567 22,524 3,104 Total current liabilities 266,299 252,452 34,790 Non-current liabilities: Non-current portion of operating lease liabilities 27,754 19,814 2,730 Other non-current liabilities 10,425 10,649 1,467 Total non-current liabilities 38,179 30,463 4,197 TOTAL LIABILITIES 304,478 282,915 38,987 Shareholders' equity: Class A ordinary shares 124 124 17 Class B ordinary shares 21 21 3 Additional paid-in capital 5,002,255 5,005,991 689,844 Treasury stock (63,264 ) (62,453 ) (8,606 ) Accumulated deficits (4,200,261 ) (4,213,761 ) (580,672 ) Accumulated other comprehensive loss (158,048 ) (158,120 ) (21,790 ) Total shareholders' equity 580,827 571,802 78,796 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY 885,305 854,717 117,783 Burning Rock Biotech LimitedUnaudited Condensed Statements of Cash Flows(in thousands) For the three months ended March 31,2024 March 31,2025 March 31,2025 RMB RMB US$ Net cash generated from (used in) operating activities 19,062 (23,527 ) (3,242 ) Net cash used in investing activities (812 ) (1,531 ) (211 ) Net cash used in financing activities (74 ) - - Effect of exchange rate on cash, cash equivalents and restricted cash 5,739 302 43 Net increase in (decrease) cash, cash equivalents and restricted cash 23,915 (24,756 ) (3,410 ) Cash, cash equivalents and restricted cash at the beginning of period 498,247 522,162 71,955 Cash, cash equivalents and restricted cash at the end of period 522,162 497,406 68,545 Burning Rock Biotech LimitedReconciliations of GAAP and Non-GAAP Results For the three months ended March 31,2024 June 30,2024 September 30,2024 December 31,2024 March 31,2025 (RMB in thousands) Gross profit: Central laboratory channel 37,002 38,424 33,262 33,153 32,191 In-hospital channel 39,192 44,058 46,580 29,563 43,895 Pharma research and development channel 9,500 12,956 12,004 26,706 21,315 Total gross profit 85,694 95,438 91,846 89,422 97,401 Add: depreciation and amortization: Central laboratory channel 1,919 1,226 1,277 1,010 562 In-hospital channel 1,524 824 798 623 290 Pharma research and development channel 3,856 4,417 3,846 2,534 2,412 Total depreciation and amortization included in cost of revenues 7,299 6,467 5,921 4,167 3,264 Non-GAAP gross profit： Central laboratory channel 38,921 39,650 34,539 34,163 32,753 In-hospital channel 40,716 44,882 47,378 30,186 44,185 Pharma research and development channel 13,356 17,373 15,850 29,240 23,727 Total non-GAAP gross profit 92,993 101,905 97,767 93,589 100,665 Non-GAAP gross margin： Central laboratory channel 81.7% 81.3% 86.4% 87.0% 85.5% In-hospital channel 70.9% 75.0% 74.3% 69.5% 76.6% Pharma research and development channel 64.8% 64.6% 63.7% 67.6% 64.0% Total non-GAAP gross margin 74.0% 75.2% 76.0% 74.3% 75.6%Sign in to access your portfolio
