SEATTLE--(BUSINESS WIRE)--Know Labs, Inc. (NYSE American: KNW), a leading developer of non-invasive diagnostics technology released this morning an overview of its Form 10-K annual report for its fiscal year ending September 30, 2024, and provided reassurance regarding its progress over the past year, its plans and the state of its financial stability in light of its auditor required going concern opinion.
Know Labs (the “Company”) issued a press release on November 15, 2024, regarding the receipt of an audit opinion with a going concern explanation from its independent registered public accounting firm. The filing of that press release is a requirement of the NYSE American Exchange, pursuant to its Company Guide Section 610(b), which requires public announcement of the receipt of an audit opinion containing a going concern paragraph. This announcement does not represent any change or amendment to the Company’s financial statements or to its annual report on Form 10-K for the year ended September 30, 2024. The going concern explanation states that the Company did not have enough funds on its year-end balance sheet on September 30, 2024, for operations during the next twelve months. Know Labs has received audit opinions with a going concern explanation in previous quarter-end and annual filings.
Management feels confident in its ability to access capital and continue operations as they execute the Company’s plans and strategic initiatives. The Company emphasized that it has available a previously filed and effective S-3 shelf offering which provides ready access to capital and allows the Company to raise that capital without a new filing with the SEC.
Regarding the 10-K filing, the Company reported a net loss of $16 million for FY2024, however $5 million of that was non-cash charge to earnings due to GAAP mandated derivative accounting for options and warrants.
For FY2024, cash used in operations was $12.8 million -- of that $6.1 million was spent in R&D, resulting in:
- Development and completion of the 2nd generation KnowU™ wearable continuous glucose monitor (CGM) in a record 8 months (a product program which typically takes much longer).
- Development and completion of companion mobile app with a world class tier one app developer for major medical device companies.
- Filing and prosecution of 68 new patent filings, resulting in a total of 332 active patent assets – establishing Know Labs as the global leader in non-invasive glucose monitoring IP.
- Publication in leading peer-reviewed publications of 3 clinical studies demonstrating 93% accuracy in determining glycemic levels.
- March 2024 presentation at ATTD, the world’s largest diabetes tech conference, in Florence, Italy of an 11% MARD in a mixed cohort (N=130 hypo/normal/hyperglycemic).
- Establishment of a Skunkworks project in May 2024 to monetize our patent portfolio through strategic joint venture and patent licensing.
- Announcement in October 2024 of Know Labs’ Smart Steering Wheel project and engagement of the Stanbridge Group, a leading automotive consulting company, to establish strategic joint ventures with leading automakers and OEMs in the automotive supply chain to engage in R&D around implanting Know Labs’ sensor in steering wheels and other places in automobiles. There is growing interest among automotive OEMs in medical IOT sensors to monitor driver health & wellness, and physiology.
- We are under NDA with several major companies to develop strategic joint-venture partnerships around clinical collaboration, technology, and product development.
- Significant -42% reduction in cash burn from $1.2 million per month to $700,000 per month, as Gen 2 hardware and mobile app are complete, and new patent filings have leveled off with Know Labs commanding an industry leading IP position.
- Added a new Chief Science Officer and a new interim Chief Technology Officer with significant research, development and strategic experience.
For more information on Know Labs, visit www.knowlabs.co and for an easy to follow overview of the Company, its technology and strategic direction please take a look at the latest presentation which can be found at this link.
About Know Labs, Inc.
Know Labs, Inc. is a public company whose shares trade on the NYSE American Exchange under the stock symbol “KNW.” The Company’s platform technology uses spectroscopy to direct electromagnetic energy through a substance or material to capture a unique molecular signature. The technology is designed to able to integrate into a variety of wearable, mobile or bench-top form factors. The Company believes that this patented and patent-pending technology makes it possible to effectively identify and monitor analytes that could only previously be performed by invasive and/or expensive and time-consuming lab-based tests. The Company’s first expected application of the technology will be in a product marketed as a non-invasive glucose monitor. The device is designed to provide the user with accessible and affordable real-time information on blood glucose levels. This product will require U.S. Food and Drug Administration clearance prior to its introduction to the market.
Safe Harbor Statement
This release contains statements that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements appear in a number of places in this release and include all statements that are not statements of historical fact regarding the intent, belief or current expectations of Know Labs, Inc., its directors or its officers with respect to, among other things: (i) financing plans; (ii) trends affecting its financial condition or results of operations; (iii) growth strategy and operating strategy; and (iv) performance of products. You can identify these statements by the use of the words “may,” “will,” “could,” “should,” “would,” “plans,” “expects,” “anticipates,” “continue,” “estimate,” “project,” “intend,” “likely,” “forecast,” “probable,” “potential,” and similar expressions and variations thereof are intended to identify forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond Know Labs, Inc.’s ability to control, and actual results may differ materially from those projected in the forward-looking statements as a result of various factors. These risks and uncertainties also include such additional risk factors as are discussed in the Company’s filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended September 30, 2024, Forms 10-Q and 8-K, and in other filings we make with the Securities and Exchange Commission from time to time. These documents are available on the SEC Filings section of the Investor Relations section of our website at www.knowlabs.co. The Company cautions readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. The Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made.
