S-1 1 know_s1.htm FORM S-1 As filed with the Securities and Exchange Commission on , 2023 Registration No.333 ‑ UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. C. 20549 FORM S‑1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Know Labs, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Nevada 3920 90‑0273142 (IRS Employer Identification No.) 500 Union Stre ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT For the transition period from _______ to ________ Commission File number 000-30262 KNOW LABS, INC. (Exact name of registrant as specified in charter) Nevada 90-0273142 (State or other jurisdiction of incorporation or organ ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT For the transition period from _______ to ________ Commission File number 000-30262 KNOW LABS, INC. (Exact name of registrant as specified in charter) Nevada 90-0273142 (State or other jurisdiction of incorporation or orga ...

Know Labs, Inc. (NYSE:KNW) Q1 2023 Earnings Conference Call February 14, 2023 4:30 PM ET Company Participants Jordyn Hujar - Chief of Staff Ron Erickson - Chairman and Chief Executive Officer Pete Conley - Senior Vice President and Chief Financial Officer Operator Greetings, and welcome to the Know Labs Fiscal Year 2023 First Quarter Earnings Conference Call and Webcast. Please note, this conference call is being recorded. I will now turn the conference call over to Jordyn Hujar, Know Labs’ Chief of Staff. ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2022 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT For the transition period from _______ to ________ Commission File number 000-30262 KNOW LABS, INC. (Exact name of registrant as specified in charter) Nevada 90-0273142 (State or other jurisdiction of incorporation or o ...

Technology Development - Know Labs, Inc. is focused on the development and commercialization of proprietary sensor technologies, specifically the Bio-RFID and ChromaID platforms, which utilize electromagnetic energy for material identification and measurement [27]. - The Bio-RFID technology has successfully demonstrated the ability to non-invasively measure blood glucose levels, addressing limitations of existing optical technologies [33]. - The company plans to market two versions of its non-invasive glucose monitoring device: the KnowU (desktop version) and the UBand (wearable version), both requiring FDA clearance [35]. - Internal laboratory testing has shown a high degree of correlation between Bio-RFID technology and leading continuous glucose monitors from Abbott Labs and DexCom [36]. - The company is also exploring additional analytes for monitoring through its devices, which will require separate FDA approvals [38]. - The ChromaID technology generates unique signatures from materials using light, enabling applications in authentication and verification [39]. - Bio-RFID technology enables real-time identification of a wide range of materials and analytes, enhancing clinical diagnostics and health monitoring [50]. - The Bio-RFID platform is expected to enter the continuous glucose monitoring market, with plans to expand into other clinical monitoring markets [59]. Regulatory and Compliance - The FDA regulates the company's medical diagnostic products, including KnowU and UBand, ensuring compliance with safety and effectiveness standards [63]. - The company believes its initial product is suitable for a de novo classification request with the FDA [79]. - Regulatory approvals are necessary for some products, and there is no assurance that such approvals will be granted, which could hinder revenue generation [130]. - International regulatory clearances are required for product sales outside the U.S., and failure to obtain these could harm business operations [131]. - The company is subject to increasingly stringent foreign governmental regulations for the manufacture and sale of medical devices, which may impact international sales [132]. Financial Performance - The company reported an accumulated deficit of $101,397,738 as of September 30, 2022, with net losses of $20,071,244 and $25,360,213 for the years ended September 30, 2022 and 2021, respectively [105]. - The company completed a public offering on September 20, 2022, selling 4,140,000 shares at $2.00 per share, generating total gross proceeds of $8,280,000 [102]. - The company anticipates needing additional financing to support technology development and ongoing operations, as it is currently operating at a loss [99]. - The potential proceeds from outstanding warrants could amount to up to $15,694,288, although there is no assurance these will be exercised [103]. - The company has limited insurance coverage, which may not cover significant claims, potentially impacting financial condition [115]. Intellectual Property - The company has been granted 27 patents and 19 design patents, with additional patents pending, supporting its intellectual property strategy [54]. - The company faces challenges in protecting its intellectual property, which could affect its competitive position and revenue [116]. Market Strategy - Know Labs, Inc. is building an internal sales and marketing team to prepare for the launch of its products and explore various market entry strategies [48]. - The competitive landscape includes large global technology companies, legacy providers, and new entrants, with Know Labs, Inc. believing its Bio-RFID technology offers a unique advantage in the market [49]. - The company aims to monetize its AI deep learning platform, exploring new applications to generate revenue for further development of its diagnostic technology [53]. Operational Challenges - The company is actively monitoring the impact of COVID-19 on its operations, which has caused supply chain delays and increased costs due to inflation [96]. - The company relies on external resources for engineering and product development, which could impact its ability to commercialize technology successfully [107]. - The company relies on key personnel, including its Chairman and CEO, and failure to retain them could adversely affect business operations [114]. - The company may face significant costs related to compliance with corporate governance and internal control requirements, which are expected to remain substantial [138]. - Cybersecurity risks pose a threat to the integrity and availability of sensitive information, necessitating ongoing investment in security measures [137]. Employee and Corporate Structure - The company has 16 full-time employees as of September 30, 2022, supplemented by consulting firms and contractors [62]. - The company has anti-takeover provisions in its bylaws designed to delay or prevent unsolicited acquisition attempts [212][215]. - The company has elected not to be governed by certain Nevada statutes that could limit third-party acquisitions of its stock [213][214]. Stock and Shareholder Information - As of September 30, 2022, the company had 48,156,062 shares of common stock issued and outstanding, with options and warrants potentially diluting future earnings per share [144]. - The company is authorized to issue up to 200,000,000 shares of common stock, which could lead to substantial dilution of existing stockholders' ownership [146]. - The market price of the company's common stock has been volatile, influenced by various market and industry factors, which may adversely affect stockholder investments [143]. - The company has never declared or paid cash dividends on its common stock and intends to retain all available funds for business operations [168].

Financial Performance - Revenue from digital asset sales for the nine months ended June 30, 2022, was $4,360,087, compared to $0 for the same period in 2021[13]. - Total operating expenses increased to $11,097,948 for the nine months ended June 30, 2022, from $8,028,208 in 2021, representing a rise of approximately 38.8%[14]. - Net loss for the nine months ended June 30, 2022, was $14,500,643, compared to a net loss of $17,763,812 for the same period in 2021, indicating an improvement of about 18.8%[14]. - Basic and diluted loss per share improved from $(0.64) in 2021 to $(0.37) in 2022 for the nine-month period[14]. - The company reported a net loss of $5,373,618 for the period ending March 31, 2021[16]. - The company reported a net loss of $5.36 million for the quarter[17]. - The nine months ended June 30, 2022, showed total segment revenue of $4,360,000, with a loss of $6,738,000, while the same period in 2021 had no revenue and a loss of $8,028,000[126]. - Other income (expense), net for the nine months ended June 30, 2022, was $(7,762,000), compared to $(9,736,000) for the same period in 2021, indicating a 20.3% improvement[197]. Assets and Liabilities - Total current assets decreased from $12,258,218 in September 2021 to $8,398,091 in June 2022, a decline of approximately 31.1%[10]. - Total liabilities decreased from $11,647,328 in September 2021 to $4,610,949 in June 2022, a reduction of approximately 60.4%[10]. - Stockholders' equity increased significantly from $1,242,163 in September 2021 to $4,919,268 in June 2022, reflecting a growth of approximately 296.5%[10]. - Cash and cash equivalents at the end of the period were $8,351,945, down from $13,870,183 at the end of the previous period[20]. - The balance as of June 30, 2022, included total assets of $1,785,715 and total liabilities of $100,699,797[18]. - As of June 30, 2022, the total convertible notes payable amounted to $2,255,066, a decrease from $9,191,155 as of September 30, 2021[78]. - The company has an accumulated deficit of $95,827,137 as of June 30, 2022[29]. Expenses - Research and development expenses for the nine months ended June 30, 2022, were $3,406,996, compared to $3,094,123 in 2021, an increase of about 10.1%[14]. - Selling, general and administrative expenses decreased from $4,934,085 in 2021 to $4,253,997 in 2022, a decline of approximately 13.8%[14]. - The company incurred depreciation and amortization expenses of $218,683 during the nine months ended June 30, 2022[20]. - Total depreciation expense for the nine months ended June 30, 2022, was $218,683, compared to $64,980 for the same period in 2021[64]. - The company incurred non-cash expenses of $9,242,544 for the nine months ended June 30, 2022, down from $12,203,424 in the same period of 2021[126]. Stock and Shares - The company reported a total of 43,802,147 shares of common stock outstanding as of June 30, 2022, compared to 35,166,551 shares as of September 30, 2021, an increase of approximately 24.6%[10]. - The company had 919,224 employee options outstanding as of June 30, 2022[18]. - As of June 30, 2022, there were 21,651,513 warrants outstanding with a weighted average exercise price of $1.003[100]. - The Company issued 863,986 shares of common stock related to warrant exercises, receiving $793,986 during the nine months ended June 30, 2022[94]. - The Company issued stock option grants totaling 3,146,000 shares to eighteen employees and consultants during the nine months ended June 30, 2022, at an average exercise price of $1.699 per share[104]. Future Outlook and Strategy - The company has plans for market expansion, focusing on increasing its user base and enhancing product offerings[17]. - Future guidance indicates a projected revenue growth of 10% year-over-year for the next quarter[17]. - The company is exploring potential mergers and acquisitions to enhance its market position and capabilities[17]. - The company anticipates recording losses from operations for the foreseeable future and believes it has enough cash to operate until June 30, 2023[29]. - The company is actively seeking partners to commercialize its electromagnetic energy technologies through its subsidiary, Particle, Inc.[27]. - The company plans to pursue additional FDA clearances for other analytes identified by its devices, although the timeline and success rate are currently uncertain[143]. Technology and Innovation - The Bio-RFID technology has successfully measured blood glucose levels non-invasively, with plans to commercialize a glucose monitoring product requiring FDA clearance[139]. - The company has developed two glucose monitoring devices: the KnowU™ for periodic monitoring and the UBand™ for continuous monitoring[140]. - The Bio-RFID technology is capable of identifying a wide range of organic and inorganic materials concurrently and in real-time, enhancing clinical diagnostics[137]. - The company has engaged a world-renowned research institution for third-party validation testing of the Bio-RFID technology, although the institution's name cannot be disclosed until peer-reviewed publication[141]. - The company is focusing on productizing its Bio-RFID technology and moving it into the marketplace[153]. Digital Assets - The company's AI Deep Learning Platform generated revenue of $4,360,087 from digital asset sales of NFTs during the nine months ended June 30, 2022[28]. - Selling and transactional costs for digital asset sales for the nine months ended June 30, 2022, were $3,437,000, with the costs associated with the AI deep learning platform's NFT sales[196]. - The company recognizes revenue from NFT sales at the point of delivery, with no obligations for returns or refunds after the sale[41]. - Revenue from digital asset sales for the nine months ended June 30, 2022, was $4,360,000, compared to $0 for the same period in 2021, representing a 100% increase[193].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT For the transition period from _______ to ________ Commission File number 000-30262 KNOW LABS, INC. (Exact name of registrant as specified in charter) Nevada 90-0273142 (State or other jurisdiction of incorporation or orga ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2021 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT For the transition period from _______ to ________ Commission File number 000-30262 KNOW LABS, INC. (Exact name of registrant as specified in charter) (State or other jurisdiction of incorporation or organization) Nevad ...

Technology Development - The company has developed proprietary biosensor technologies, including the Bio-RFID and ChromaID platforms, which utilize electromagnetic energy to identify and measure various materials and analytes [12][14]. - The Bio-RFID technology has successfully non-invasively measured blood glucose levels, with ongoing development to enhance accuracy, sensitivity, and specificity [16][18]. - Laboratory testing has shown a high degree of correlation between the Bio-RFID technology and leading continuous glucose monitors, indicating its competitive advantage in non-invasive monitoring [19]. - The AI Deep Learning Platform is integral to the company's technology, enabling accurate pattern recognition for blood glucose and other analytes, with potential future applications in health and wellness analytics [28]. - The company is focusing on the development of a non-invasive glucose monitor and aims to obtain FDA clearance for marketing this product [51]. - The company has engaged a manufacturing partner to bring its non-invasive glucose monitor to market, highlighting its commitment to product development [51]. - The company is exploring the use of its technology for medical diagnostic applications, particularly in blood glucose monitoring, which requires government regulatory approval [99]. - There is no assurance that regulatory approvals for glucose monitoring devices will be obtained, which could hinder revenue generation [101]. Intellectual Property - The company holds 20 patents and 9 design patents, with additional patents pending, ensuring a robust intellectual property portfolio to protect its innovations [29][30]. - The company has incorporated subsidiaries to focus on non-core intellectual property, allowing for diversification of its business strategy [58]. - A subsidiary, Particle, Inc., was incorporated for R&D on non-core intellectual property, with a focus on germ-inactivating light bulbs [164]. Financial Performance - The company incurred research and development expenses of $3,970,000 and $2,034,000 for the years ended September 30, 2021, and 2020, respectively, indicating a significant increase in investment in technology development [54]. - The company reported a net loss of $25,360,000 for the year ended September 30, 2021, which is an increase of 87.0% compared to the net loss of $13,563,000 for the year ended September 30, 2020 [168]. - The company's operating loss for the year ended September 30, 2021 was $10,446,000, an increase of 53.5% from the operating loss of $6,826,000 in the previous year [167]. - For the year ended September 30, 2021, the company reported net revenue of $0, a decrease of $122,000 compared to $122,000 for the year ended September 30, 2020 [169]. - The company has generated minimal revenue from its operations, with no sales reported from its Particle subsidiary as of September 30, 2021 [86][87]. - The company is currently operating at a loss and believes its cash on hand will be sufficient to fund operations through December 31, 2023 [72]. - As of September 30, 2021, the company has an accumulated deficit of $81,326,000 and reported net losses of $25,360,000 and $13,563,000 for the years ended September 30, 2021 and 2020, respectively [75]. Operational Challenges - The company is actively monitoring the impact of the COVID-19 pandemic on its operations and financial condition, which has caused disruptions in testing and validation processes [66]. - The company may need additional financing to support ongoing operations and technology development, with potential risks related to securing necessary funding [72]. - The company relies on external resources for engineering and product development, which may impact its ability to successfully commercialize its technology [79][80]. - The company faces significant competition for key personnel, which could adversely affect its ability to develop new products and maintain operations [89]. - Know Labs may face challenges in commercializing its technology if it cannot secure sales and marketing partnerships or establish effective sales capabilities [97]. Subsidiary Operations - The AI Mind subsidiary has generated revenue through the sale of NFTs, indicating a potential revenue stream from the AI Deep Learning Platform [28]. - AI Mind, Inc., another subsidiary, is exploring monetization opportunities for its AI Deep Learning Platform, including the creation of graphical images as NFTs [59]. - The Particle subsidiary is exploring strategic partnerships and distribution agreements, but its commercialization success is uncertain and may not materialize as planned [87]. - The AI Mind subsidiary commenced operations in the last calendar quarter of 2021 and generated its first revenues during the first quarter of fiscal 2022, but its future revenue generation is uncertain [88]. Financial Controls and Governance - The company has identified material weaknesses in its internal controls over financial reporting, which could affect investor confidence in its financial disclosures [84][85]. - The company has not historically employed a full-time Chief Financial Officer, relying instead on an interim CFO and a consultant, which raises concerns about its financial reporting capabilities [84]. - The company has identified a material weakness in its internal control over financial reporting due to the absence of a full-time Chief Financial Officer, with the Chairman serving as the interim CFO [204]. - As of September 30, 2021, the company's disclosure controls and procedures were deemed ineffective at the reasonable assurance level due to material weaknesses in internal controls [202]. - Management's assessment of internal control over financial reporting concluded that it was not effective as of September 30, 2021, based on the 2013 Internal Control-Integrated Framework [206]. Capital Structure - As of September 30, 2021, the company had 35,166,551 shares of common stock outstanding, with significant options and warrants that could dilute future earnings per share [117]. - Future capital raises through equity securities could dilute existing stockholders' ownership and impose restrictions on operations [123]. - The company does not anticipate paying cash dividends on its capital stock in the foreseeable future, focusing instead on retaining earnings for growth [124]. - The company has authorized 200,000,000 shares of voting common stock as of September 30, 2021, with 35,166,551 shares issued and outstanding [134]. - The company has $16,464,066 in convertible debentures, which could potentially dilute future earnings per share [135]. - The Series C Preferred Stock has a yield of 8% and a conversion price adjusted to $0.25 per share [136]. - The Series D Preferred Stock is convertible into common stock at a price of $0.25 per share and has an annual yield of 8% if dividends are declared [137]. - The company has increased the size of the stock available under the Stock Option Plan to 20,000,000 shares as of October 15, 2021 [143]. Regulatory and Compliance Risks - The company may face challenges in obtaining international regulatory clearances for its products, which could harm its business [127]. - Foreign regulatory requirements for medical devices are becoming increasingly stringent, potentially impacting the company's ability to market products internationally [128]. - The company has no unresolved SEC staff comments as of the reporting date [129]. - Anti-takeover provisions in the company's bylaws may limit the ability of another party to acquire the company, potentially affecting stock price [125]. - Cybersecurity risks pose a threat to the integrity and confidentiality of sensitive data, potentially leading to significant operational disruptions and liabilities [103].