Know Labs(US:KNW)2025-02-14 21:00Clinical Technology Development - The company announced the interim results of a clinical study showing a Mean Absolute Relative Difference (MARD) of 11.1% in non-invasive blood glucose measurement using its proprietary RF sensor technology [143]. - The KnowU™ non-invasive wearable continuous glucose monitor prototype device has been developed and is undergoing internal clinical testing [133]. - The latest iteration of the KnowU® device is significantly smaller and aims to enable continuous data collection for improved accuracy in glucose monitoring [156]. - A proof-of-principle study demonstrated 100% accuracy in quantifying three different analytes in vitro using the company's sensor technology [145]. - The sensor technology has been validated against leading continuous glucose monitors, showing a high degree of correlation [143]. - The company is focused on refining its algorithms to improve accuracy and is building a team for commercialization efforts [153]. - The company is focused on developing sensor solutions that can be integrated across multiple applications and industries, with a particular emphasis on healthcare [170]. Intellectual Property and Licensing - The company has over 300 active patent assets and launched the Know Labs Technology Licensing (KTL) initiative to generate revenue through patent licensing [135]. - The company aims to expand its technology applications beyond medical diagnostics, leveraging its intellectual property for various industries [139]. - The KTL initiative is expected to attract licensing partners across diverse fields, enhancing the company's revenue potential [154]. - The company has over 330 patents globally, positioning it as a leader in RF spectroscopy and related innovations [164]. - The company aims to expand its patent portfolio and has retained organizations to perform patent-related work, reflecting a commitment to innovation and competitive advantage [165]. Financial Performance - Research and development expenses for the three months ended December 31, 2024, were $802,000, a decrease of 46.1% from $1,487,000 in 2023 [189]. - Total operating expenses for the same period were $2,767,000, down 20.9% from $3,498,000 in 2023 [189]. - The company incurred a total other expense of $1,899,000 for the three months ended December 31, 2024, compared to an income of $51,000 in 2023, reflecting a variance of -3823.5% [189]. - Net loss for the three months ended December 31, 2024 was $4,666,000, compared to a net loss of $3,447,000 for the same period in 2023, representing an increase of 35.4% [195]. - Selling, general and administrative expenses decreased by $46,000 to $1,965,000 for the three months ended December 31, 2024, compared to $2,011,000 for the same period in 2023 [192]. - Other expense, net for the three months ended December 31, 2024 was $1,899,000, a significant increase from other income of $51,000 in the same period of 2023 [193]. - As of December 31, 2024, the company had cash and cash equivalents of $1,032,000 and a net working capital deficit of approximately $4,167,000 [198]. - The accumulated deficit as of December 31, 2024 was $143,434,000, with net losses of $4,666,000, $16,582,000, and $15,289,000 for the three months ended December 31, 2024 and the years ended September 30, 2024 and 2023, respectively [198]. - Net cash used in operating activities for the three months ended December 31, 2024 was $1,898,000, down from $3,393,000 in the same period of 2023 [203]. - The company intends to seek additional cash via equity and debt offerings due to substantial doubt about its ability to continue as a going concern [199]. - On December 12, 2024, the company entered into subscription agreements for a registered direct offering of 1,250,000 units, generating approximately $300,000 in gross proceeds [201]. - Contractual cash obligations as of December 31, 2024 totaled $5,735,590, with $5,263,895 due within one year [208]. Internal Controls and Compliance - As of December 31, 2024, the company's disclosure controls and procedures are effective at the reasonable assurance level [221]. - There were no changes in internal controls over financial reporting during the three months ended December 31, 2024, that materially affected the internal control over financial reporting [223]. - Internal control over financial reporting may not prevent or detect misstatements due to inherent limitations [222]. Market Opportunity - The global population suffering from diabetes is estimated at 579 million, expected to reach 643 million by 2030 and 784 million by 2040, with current CGM providers holding 100% market share but penetrating less than 1% of the global addressable market [168]. - The company showcased its Generation 1 prototype and received strong interest in its non-invasive continuous glucose monitor, particularly in high diabetes incidence populations [157].