Page 1

Mauna Kea Technologies PRESS RELEASE MAUNA KEA TECHNOLOGIES REPORTS FIRST HALF 2021 FINANCIAL RESULTS - - Paris and Boston , September 23 , 2021 5.45 PM CEST Mauna Kea Technologies ( Euronext : MKEA ) inventor of CellvizioⓇ , the multidisciplinary probe and needle - based confocal laser endomicroscopy ( p / nCLE ) platform , today announced first half 2021 financial results for the six months ended June 30 , 2021 . First Half 2021 Financial Summary : • • • • • Total revenue * for the first half of 2021 increased € 0.7 million , or 22 % year - over - year , to € 3.9 million As previously reported , total sales for the first half of 2021 increased € 1.2 million , or 58 % year - over - year , to € 3.3 million Current operating loss for the first half of 2021 increased € 0.1 million , or 2 % year - over - year , to € 6.1 million Net loss for the first half of 2021 was € 6.7 million , compared to € 6.7 million in the prior year period As of June 30 , 2021 , the Company had a cash balance of € 3.4 million and total debt obligations of € 28.2 million , compared to € 8.6 million of cash and € 27.0 million of total debt obligations , as of December 31 , 2020 . Recent Operating Highlights : • • On July 6 , 2021 , the Company announced completion of enrollment of the observational clinical study combining nCLE and robotic - assisted bronchoscopy , using both Cellvizio and the Monarch® Platform from Auris Health , Inc. , part of Johnson & Johnson Medical Devices Companies , for the diagnosis of peripheral lung nodules ( Clinicaltrials.gov : NCT04441749 ) . On August 24 , 2021 , the Company announced that it 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 marked the 19th U.S. FDA 510 ( k ) clearance of the CellvizioⓇ p / nCLE platform . • On September 20 , 2021 , the Company announced that it entered into a new research collaboration agreement with the Lung Cancer Initiative ( " LCI " ) at Johnson & Johnson ¹ to advance the validation of Cellvizio as a real- time biopsy guidance tool during robotic - assisted bronchoscopy to potentially reduce the near - miss rate of peripheral lung cancer . • - On September 20 , 2021 , the Company announced the execution of equity subscription agreements with Johnson & Johnson Innovation – JJDC , Inc. ( JJDC ) , one of the Company's existing shareholders , and a leading US - based healthcare fund , Armistice Capital Master Fund Ltd. The net proceeds from this offering are expected to be approximately € 11.5 million . The Company estimates that the net proceeds of the offering , as well as any additional drawings on the equity line that the company has with Kepler Cheuvreux , as the case may be , will enable it to finance its activities and strategy until the end of the third quarter of 2022 . Management Commentary : " Our first half of 2021 financial results reflect solid execution and improvement in the global operating environment , ” stated Robert L. Gershon , Chief Executive Officer of Mauna Kea Technologies . Our new targeting strategy in the U.S. Gl market focused on high - volume upper GI clinicians continues to result higher utilization per system and we continue to support our Gl customers in our primary global markets outside the U.S. " 1 The legal entity of the Lung Cancer Initiative at Johnson & Johnson is Johnson & Johnson Enterprise Innovation Inc. * Total revenue for the first half of 2020 included € 337,000 in research tax credits and € 615,000 in U.S. government grants , compared to € 350,000 in research tax credits and € 198,000 in BPI grant on the PERSEE project in 2021 . 1