Mauna Kea Technologies reports first half 2021 financial results

Mauna Kea Technologies 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 & Johnson¹ 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.