Know Labs(KNW)2024-05-16 03:16Financial Data and Key Metrics Changes - For Q2 fiscal 2024, Know Labs reported an operating loss of $4.73 million, a slight improvement from an operating loss of $4.81 million in Q2 fiscal 2023, representing a reduction of 1.7% [44] - The earnings per share loss improved to $0.07 from $0.10 in the prior year, marking a 30% improvement before preferred stock dividends [44] - Research and development expenses decreased by 15.1% year-over-year to $2.18 million from $2.56 million in Q2 fiscal 2023, attributed to reduced personnel and external consultant costs [46] - Selling, general, and administrative expenses increased by 13.7% to $2.55 million from $2.24 million in the year-ago period, reflecting key hires and increased legal expenses [47] - Cash and cash equivalents as of March 31, 2024, were $4.71 million, down from $8.02 million at the end of September 30, 2023 [48] - Shareholder equity for Q2 fiscal 2024 was negative $1.75 million compared to $3.74 million in fiscal 2023 [51] Business Line Data and Key Metrics Changes - The company has made significant progress in hardware development, completing the portable Generation 1 prototype for non-invasive glucose monitoring and announcing the KnowU, a wearable continuous glucose monitoring device [6][8] - Clinical trials have shown a Mean Absolute Relative Difference (MARD) of 11.1% in glucose monitoring accuracy, with consistent performance across various glycemic ranges [19][23] Market Data and Key Metrics Changes - The company aims to expand its clinical trials to include a more diverse population, particularly individuals with type 1 diabetes, to enhance data collection in critical glycemic ranges [24] - The wearable nature of the KnowU device is expected to facilitate continuous data collection, which is essential for improving algorithm accuracy [25] Company Strategy and Development Direction - Know Labs is focused on developing a non-invasive glucose monitoring solution that enhances the quality of life for diabetes patients, with a commitment to making the technology accessible and affordable [42] - The company is actively pursuing joint development agreements with medical device manufacturers and pharmaceutical companies to expand its market reach [53] - Intellectual property remains a core focus, with over 300 patents issued or pending, reinforcing the company's competitive position in non-invasive blood glucose monitoring [30][31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's progress and the potential for the KnowU device to revolutionize diabetes management [42] - The company is preparing for a pre-submission meeting with the FDA to discuss the KnowU device and its clinical trial results [74] Other Important Information - Know Labs has entered into a funding agreement for up to $12 million to accelerate development across its core work streams [37] - The company showcased its technology at the ATTD conference and received an emerging technology grant, highlighting its innovative approach [34] Q&A Session All Questions and Answers Question: What is the status of the wrist-worn device similar to a smartwatch? - The KnowU device is significantly smaller than the Generation 1 prototype, and miniaturization efforts are ongoing to achieve a watch-like form factor [59][60] Question: When can investors expect to see the results of the 100 study? - The company shifted focus to testing with the Gen 2 KnowU after satisfactory data was collected from 30 participants, and interim results have been presented at conferences [62][63] Question: What is the company's approach to international markets? - The hiring of Chris Somogyi as President International will focus on global opportunities and monetization of the intellectual property [64] Question: Are non-invasive technology a trade secret or patent? - The company holds 332 patent assets in 18 jurisdictions, with significant trade secrets that are a crucial part of its intellectual property strategy [70][71]