Clinical 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].

Financial Performance - The company reported a net loss of $16,582,000 for the year ended September 30, 2024, compared to a net loss of $15,289,000 for the year ended September 30, 2023, reflecting an 8.5% increase in losses[300]. - The accumulated deficit as of September 30, 2024, was $138,736,000, with net losses of $16,582,000 and $15,289,000 for the years ended September 30, 2024, and 2023, respectively[303]. - Net cash used in operating activities for the year ended September 30, 2024, was $12,829,000, compared to $10,354,000 for 2023, reflecting a net loss of $16,582,000[312]. Expenses - Research and development expenses decreased by $1,613,000 to $6,114,000 for the year ended September 30, 2024, a reduction of 20.9% compared to $7,727,000 in 2023[296]. - Selling, general and administrative expenses increased by $2,538,000 to $9,109,000 for the year ended September 30, 2024, representing a 38.6% increase from $6,571,000 in 2023[297]. - Non-cash expenses for the year ended September 30, 2024, included stock-based compensation of $2,958,000 and depreciation and amortization of $81,000[312]. Cash Flow and Financing - The company completed a registered securities offering on August 9, 2024, raising net proceeds of approximately $3.468 million[291]. - A second registered securities offering on August 16, 2024, generated net proceeds of approximately $1.515 million[292]. - Net cash provided by financing activities for the year ended September 30, 2024, was $7,983,000, an increase from $5,865,000 in 2023, driven by proceeds from debt and common stock offerings[315]. - The company raised $5,473,000 from a common stock offering on September 29, 2023, selling 28,000,000 shares at $0.25 per share[316]. Cash Position - As of September 30, 2024, the company had cash and cash equivalents of $3,111,000 and a net working capital deficit of approximately $2,053,000[303]. - The balance of the money market account as of September 30, 2024, was $2,942,000, down from $7,836,000 in 2023[324]. - As of September 30, 2024, the company had contractual cash obligations totaling $6,490,067, including convertible notes payable of $6,095,066[317]. Operational Changes - The company launched the Generation 2 working prototype device during the year ended September 30, 2024, as part of its technology development efforts[296]. - The company reduced its headcount by nine during the year ended September 30, 2024, to manage operating expenses more effectively[296]. Internal Controls - Management concluded that internal controls over financial reporting were effective as of September 30, 2024[331]. - Management assessed the effectiveness of internal control over financial reporting as of September 30, 2024, concluding it was effective[331]. - No changes in internal controls over financial reporting were identified during the year ended September 30, 2024, that materially affected the internal control[334]. - Internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and compliance with GAAP[330]. - The internal control system is subject to inherent limitations and may not prevent or detect all misstatements[333]. - The design of the control system must consider resource constraints and the cost-benefit relationship of controls[333]. - Management's evaluation used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission[331]. - Internal controls include policies and procedures for maintaining accurate records of transactions and asset disposition[330]. - The company does not include an attestation report from its registered public accounting firm regarding internal control over financial reporting[332]. - Reasonable assurance is provided that transactions are recorded to permit the preparation of financial statements in accordance with GAAP[330]. - There were no material changes in internal controls that could affect financial reporting during the evaluation period[334].

Financial Data and Key Metrics Changes - For Q3 fiscal 2024, Know Labs reported a net loss of $4.1 million, an increase of 13.9% compared to a net loss of $3.6 million in Q3 fiscal 2023, translating to an earnings per share loss of $0.05, an improvement of 29% from the prior year [21] - Research and development expenses decreased by 28.2% year-over-year to $1.35 million from $1.88 million in Q3 fiscal 2023, primarily due to the completion of hardware and software product development milestones [21] - Selling, general and administrative expenses increased by $1.1 million to $2.49 million compared to $1.36 million for the year-ago quarter, driven by key hires and increased legal expenses [22] Business Line Data and Key Metrics Changes - The company achieved significant milestones in hardware development, including the completion of the KnowU, a wearable non-invasive continuous glucose monitoring device, which is 85% smaller than the previous prototype [7][8] - Clinical testing has progressed, with a mean absolute relative difference (MARD) of 11.8% achieved in trials, indicating the effectiveness of the device in real-world settings [9][10] Market Data and Key Metrics Changes - The company is focusing on expanding its market reach by enrolling a more diversified population in clinical trials, including individuals with Type 1 diabetes, to enhance data collection and algorithm accuracy [13] Company Strategy and Development Direction - Know Labs aims to maximize shareholder value through strategic collaborations and monetization of its intellectual property assets, while continuing to develop the KnowU for FDA approval [19][20] - The company is actively expanding its intellectual property portfolio, with over 330 patents issued, pending, and in process, reflecting a high rate of innovation [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to operate until at least December 31, 2024, following a recent capital raise of $3.445 million [23][24] - The focus remains on successful development and commercialization of the KnowU device, with an emphasis on addressing the needs of underserved populations [19][20] Other Important Information - The company has launched initiatives to reduce fixed expenses and monthly burn rate, and is exploring additional funding options to ensure operational continuity [24] - Know Labs has expanded its advisory board and joined industry advisory boards to enhance its exposure and leverage expertise in product development [18] Summary of Q&A Session Questions and Answers - There was no Q&A session during this call due to the quiet period imposed by SEC regulations following the recent capital raise [5][25]

Product Development and Technology - Know Labs is focused on developing a non-invasive continuous glucose monitor, with a working prototype currently undergoing internal and external testing[85]. - The internal clinical study showed a Mean Absolute Relative Difference (MARD) of 11.1% in measuring blood glucose levels compared to venous blood[96]. - The next iteration of the KnowU device aims for FDA clearance, with ongoing internal development and clinical research to enhance accuracy[105]. - The sensor technology has gathered billions of data points to refine machine learning algorithms for improved glucose monitoring accuracy[93]. - Preliminary tests indicate the potential for the platform to measure other analytes, such as blood alcohol and blood oxygen levels[97]. - The technology aims to provide real-time, non-invasive monitoring, differentiating it from existing continuous glucose monitors[91]. - The wearable KnowU device is designed for continuous data collection, which is essential for improving machine learning algorithm accuracy[105]. - Know Labs has developed a proprietary radio frequency and microwave spectroscopy platform with over 300 active patent assets, focusing on non-invasive continuous glucose monitoring[87][90]. - The algorithm refinement study demonstrated an improved MARD of 12.9% using a light gradient-boosting machine model, indicating competitive accuracy with FDA-cleared devices[101]. - The company plans to expand its testing with larger and more diverse populations to evaluate technology performance in real-world environments[103]. Market Strategy and Opportunities - The company is engaging strategic partners for product design, data science, and regulatory affairs to facilitate market entry[105]. - The company is exploring various market entry strategies, including direct-to-consumer and partnerships with biopharma and medical device companies[108]. - Know Labs aims to position its technology as a screening device in high diabetes incidence populations, differentiating itself from legacy continuous glucose monitor manufacturers[106]. - Each new application of the sensor technology may require its own subsequent FDA clearance, providing new monetization opportunities[118]. - The company plans to enter other clinical monitoring markets following its entry into the diabetes glucose monitoring market[117]. Financial Performance and Expenses - The company incurred approximately $5,011,000 and $6,186,000 in research and development expenses for the nine months ended June 30, 2024, and 2023, respectively[119]. - Selling, general and administrative expenses increased by $1,128,000 to $2,487,000 for the three months ended June 30, 2024, primarily due to increases in salaries, legal expenses, and stock-based compensation[133]. - Net loss for the three months ended June 30, 2024 was $4,103,000, compared to a net loss of $3,600,000 for the same period in 2023, reflecting an increase of $503,000[135]. - For the nine months ended June 30, 2024, research and development expenses decreased by $1,175,000 to $5,011,000 compared to $6,186,000 for the same period in 2023[137]. - Selling, general and administrative expenses for the nine months ended June 30, 2024 increased by $1,517,000 to $7,025,000 compared to $5,508,000 for the same period in 2023[138]. - Net loss for the nine months ended June 30, 2024 was $12,948,000, compared to a net loss of $12,354,000 for the same period in 2023, an increase of $594,000[140]. - The company anticipates recording losses from operations for the foreseeable future and believes it has enough cash to operate until October 31, 2024[143]. - The company reported a net working capital deficit of $3,987,763 as of June 30, 2024, indicating liquidity challenges[18]. - The company expects to raise additional funds through the issuance of preferred stock, convertible debentures, or equity during the remainder of 2024[144]. Patent Portfolio and Intellectual Property - The company has over 300 active patent assets and is exploring revenue generation through patent licensing opportunities[87]. - The company's patent portfolio increased from 159 to 336 year over year, reflecting a 109% growth compared to the market's 35% growth[110]. - The company has been granted 50 patents and has a total of 325 patents issued and pending, positioning it as the top worldwide IP holder in non-invasive blood glucose monitoring[120]. - The company has a strategy to expand its patent portfolio and maintain trade secrets related to its AI and ML-driven algorithms[121]. Market Context and Demographics - The global population suffering from diabetes is estimated at 579 million, projected to reach 643 million by 2030 and 784 million by 2040[113]. - Leading continuous glucose monitor (CGM) providers, Dexcom, Abbott, and Medtronic, hold 100% market share but have penetrated less than 1% of the global addressable market[113].

REGISTRATION STATEMENT UNDER S-1/A 1 knwn_s1a.htm S-1/A As filed with the Securities and Exchange Commission on August 2, 2024 Registration No. 333‑280273 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. C. 20549 Amendment No. 5 to FORM S‑1 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 I ...

REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 S-1/A 1 knwn_s1a.htm FORM S-1/A As filed with the Securities and Exchange Commission on July 24, 2024 Registration No. 333‑280273 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. C. 20549 Amendment No. 4 to FORM S‑1 Know Labs, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Nevada 3920 90‑0273142 (Primary Standard Industrial Classification Code Number) (IRS Employ ...

S-1/A 1 knwn_s1a.htm FORM S-1/A As filed with the Securities and Exchange Commission on July 22, 2024 Registration No. 333‑280273 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. C. 20549 Amendment No. 3 to 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) Nevada 3920 90‑0273142 (Primary Standard Industrial Classification Code Number) (IRS Employ ...

S-1/A 1 knwn_s1a.htm FORM S-1/A As filed with the Securities and Exchange Commission on July 9, 2024 Registration No. 333‑ 280273 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. C. 20549 Amendment No. 2 to 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) Nevada 3920 90‑0273142 (Primary Standard Industrial Classification Code Number) (IRS Employ ...

S-1/A 1 knwn_s1a.htm FORM S-1/A As filed with the Securities and Exchange Commission on July 1, 2024 Registration No. 333‑ 274080 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. C. 20549 Amendment No. 1 to 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) Nevada 3920 90‑0273142 (Primary Standard Industrial Classification Code Number) (IRS Employ ...

S-1 1 knwn_s1.htm FORM S-1 As filed with the Securities and Exchange Commission on June 17, 2024 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) (IRS Employer (State or other jurisdiction of incorporation or organization) Nevada 3920 90‑0273142 (Primary Standard Industrial Classification Code Number) Identification No.) 619 Wes ...