Financial 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]

Financial Performance - The net loss for the three months ended March 31, 2024, was $5.40 million, compared to a net loss of $4.93 million for the same period in 2023, reflecting an increase in losses of approximately 9%[13]. - The company reported a net loss of $3.446 million for the year ending December 31, 2023[15]. - The company reported a net loss of $8,844,288 for the six months ended March 31, 2024, compared to a net loss of $8,753,061 for the same period in 2023[18]. - The company reported a net loss of $5,496,273 for the three months ended March 31, 2024, compared to a net loss of $4,930,202 for the same period in 2023, reflecting an increase in loss of approximately 11.4%[11]. - The company anticipates recording losses from operations for the foreseeable future and believes it has enough cash to operate until October 31, 2024[180]. Assets and Liabilities - As of March 31, 2024, total assets decreased to $4.94 million from $8.27 million as of September 30, 2023, representing a decline of approximately 40%[9]. - Current liabilities increased to $5.06 million from $4.52 million, marking an increase of about 12%[9]. - The accumulated deficit increased to $130.85 million as of March 31, 2024, from $121.84 million as of September 30, 2023, an increase of approximately 7%[9]. - The total stockholders' deficit equity decreased to $(1.75) million as of March 31, 2024, from $3.74 million as of September 30, 2023[9]. - Total liabilities increased to $6,692,122 as of March 31, 2024, compared to $4,521,985 as of September 30, 2023, marking an increase of approximately 48.0%[9]. Revenue and Expenses - Research and development expenses for the three months ended March 31, 2024, were $2.18 million, down from $2.56 million in the same period of 2023, a decrease of about 15%[13]. - Selling, general and administrative expenses rose to $2.55 million for the three months ended March 31, 2024, compared to $2.24 million in the prior year, an increase of approximately 14%[13]. - The total operating expenses for the three months ended March 31, 2024, were $4.73 million, slightly down from $4.81 million in the same period of 2023, a decrease of about 2%[13]. - The total cash used in operating activities was $7,047,684, compared to $6,340,649 in the prior year[18]. - Total current assets decreased to $4,709,690 as of March 31, 2024, down from $8,023,716 as of September 30, 2023, representing a decline of approximately 41.0%[9]. Stock and Equity - The weighted average shares of common stock outstanding increased to 81,766,128 for the three months ended March 31, 2024, compared to 48,207,937 in the same period of 2023[13]. - The company has authorized 205,000,000 shares of capital stock, including 200,000,000 shares of voting common stock[22]. - The company issued common stock worth $8.830 million, demonstrating ongoing capital raising efforts[15]. - The company issued 453,492 shares of common stock to six directors at $0.434 per share, totaling $196,816 in expenses for the quarter ended March 31, 2024[79]. - The company has 82,512,166 shares of common stock issued and outstanding as of March 31, 2024[78]. Research and Development - The company is focused on developing proprietary sensor technology utilizing radio and microwave spectroscopy[23]. - The company launched a Generation 2 working prototype device for non-invasive blood glucose monitoring during the three months ended March 31, 2024, which is ready for commercialization pending FDA clearance[24]. - Research and development expenses for the six months ended March 31, 2024, were approximately $3.66 million, compared to $4.31 million for the same period in 2023[4]. - The company has gathered billions of data points to refine its AI and ML algorithms for improved accuracy in glucose monitoring[120]. - Know Labs aims to expand its sensor technology to other non-invasive medical diagnostic applications following FDA clearance of the glucose monitor[114]. Market and Competitive Landscape - The global population suffering from diabetes is estimated at 579 million, projected to reach 643 million by 2030 and 784 million by 2040[2]. - Leading continuous glucose monitor (CGM) providers hold 100% market share but have penetrated less than 1% of the global addressable market[3]. - The competitive landscape includes major players like Dexcom, Abbott, and Medtronic, which have significantly greater financial resources and market recognition[10]. - Know Labs has received strong interest in its technology for early diabetes detection, particularly in high-incidence populations[133]. - The company is expanding its market presence in Asia, targeting a 15% market share by the end of the fiscal year[5].

Amendment No. 1 to FORM S‑1 S-1/A 1 know_s1a.htm S-1/A (Exact name of registrant as specified in its charter) As filed with the Securities and Exchange Commission on April 9, 2024 Registration No. 333‑ 278326 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Know Labs, Inc. UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. C. 20549 Nevada 3920 90‑0273142 (Primary Standard Industrial Classification Code Number) (IRS Employer Identification No.) 500 Union Street, Suite 810 Seattle, Washing ...

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) S-1 1 know_s1.htm FORM S-1 As filed with the Securities and Exchange Commission on March 28, 2024 Nevada 3920 90‑0273142 (Primary Standard Industrial Classification Code Number) (IRS Employer Identification No.) 500 Un ...

Financial Data and Key Metrics Changes - For Q1 fiscal '24, the company reported a net loss of $3.45 million, an improvement of 9.8% compared to a net loss of $3.82 million in Q1 fiscal '23, translating to an earnings per share loss of $0.04, better than the prior year EPS of $0.08, reflecting a 50% improvement before preferred stock dividends [45][46] - Selling, general and administrative expenses for Q1 '24 were $2.01 million, an increase of 5.6% from $1.91 million in the same period last year, primarily due to increased salaries from key new hires [13] - Research and development expenses for Q1 fiscal '24 were $1.48 million, a decrease of 14.7% year-over-year from $1.74 million in Q1 fiscal '23, attributed to reduced personnel and external consultant costs [30] Business Line Data and Key Metrics Changes - The company is focused on four core work streams: hardware development, clinical trials and data collection, algorithm development, and intellectual property [6][7][9] - The hardware work stream has seen significant progress with the completion of the portable Gen 1 prototype for non-invasive glucose monitoring [6] - Clinical trials are ongoing with up to 100 participants, focusing on diabetes and pre-diabetes populations to collect critical data [7] Market Data and Key Metrics Changes - The company is preparing to present at the International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) in Florence, Italy, which is expected to enhance awareness and networking opportunities within the medical community [10][11] Company Strategy and Development Direction - The company aims to refine its algorithm to achieve a mean absolute relative difference (MARD) of 10% or less, focusing on accuracy across varying glycemic ranges [27] - Intellectual property remains a core focus, with 264 patents issued, pending, and in process, reinforcing the company's innovation strategy [9] - The company is exploring revenue opportunities outside the FDA pathway, particularly in international markets and potential licensing of its platform technology [53][55] Management's Comments on Operating Environment and Future Outlook - Management acknowledges a competitive landscape with established players like Dexcom and Abbott Labs, emphasizing the need for vigilance and innovation [36] - The company has made adjustments to fixed expenses, significantly reducing its core monthly burn rate, and believes it has sufficient cash to operate until at least June 30, 2024 [31] - Management is optimistic about upcoming developments and expects to share updates on the non-invasive glucose monitor soon [39] Other Important Information - The company has added new members to its Board of Directors and medical advisory board to enhance its expertise in core work streams [28] - A non-cash charge of $792,000 was recorded in Q1 fiscal '24, primarily related to stock-based compensation [30] Q&A Session Summary Question: Can you address the burn rate and any unusual expenditures? - The incremental spend has been about $200,000 to $300,000 a month, with a one-time expense of close to $1 million for auditors and counsel related to financing [16] Question: What is the status of joint development agreements? - The company is moving forward with several joint development agreements, which are critical for future success, but details are constrained by non-disclosure agreements [50] Question: How does the company view the competitive landscape? - The company sees a competitive marketplace with established players and new entrants, but believes it has a competitive edge due to its intellectual property [36][51] Question: Will the second-generation device be shown in Italy? - The company is actively exploring revenue opportunities without FDA clearance and is considering the potential for its technology in less developed markets [53][54]

Financial Performance - The company reported a net loss of $3,446,624 for the three months ended December 31, 2023, compared to a net loss of $3,822,859 for the same period in 2022, indicating an improvement of about 9.8%[12]. - Basic and diluted loss per share improved from $(0.08) in Q4 2022 to $(0.04) in Q4 2023[12]. - The company generated net cash used in operating activities of $3,392,647 for the three months ended December 31, 2023, compared to $2,917,417 for the same period in 2022, indicating an increase in cash outflow of about 16.3%[16]. - The company anticipates recording losses from operations for the foreseeable future and will need to raise additional funds to support its operations[24]. - The company has an accumulated deficit of $125,351,000 as of December 31, 2023[163]. Assets and Liabilities - Total current assets decreased from $8,023,716 as of September 30, 2023, to $4,821,477 as of December 31, 2023, representing a decline of approximately 40.5%[8]. - The company had total liabilities of $3,787,220 as of December 31, 2023, down from $4,521,985 as of September 30, 2023, representing a decrease of about 16.3%[8]. - Total stockholders' equity decreased from $3,743,912 as of September 30, 2023, to $1,225,889 as of December 31, 2023, a decline of approximately 67.3%[8]. - Cash and cash equivalents decreased from $8,023,716 at the beginning of the period to $4,821,477, a decrease of approximately 40.5%[8]. - Current liabilities decreased from $4,521,985 to $3,787,220, a reduction of about 16.3%[8]. Research and Development - Research and development expenses for the three months ended December 31, 2023, were $1,486,388, down from $1,743,051 in the same period of 2022, reflecting a decrease of approximately 14.7%[11]. - The company is focused on the development of a wearable device for non-invasive blood glucose monitoring, with a Generation 1 prototype already announced and work ongoing for Generation 2[23]. - Know Labs has developed a Generation 1 working prototype for a non-invasive blood glucose monitoring device, which is currently undergoing internal clinical testing[102]. - The company aims to achieve FDA clearance for its non-invasive blood glucose monitor, with ongoing studies comparing its technology to leading continuous glucose monitors showing a high degree of correlation[112]. - Recent studies have demonstrated the accuracy of Know Labs' Bio-RFID sensor technology, achieving a Mean Absolute Relative Difference (MARD) of 12.9% and 11.3% in quantifying blood glucose levels compared to established devices[117][118]. Capital and Financing - The company raised net proceeds of $5,472,791 from the sale of 28,000,000 shares of common stock at a price of $0.25 per share on September 29, 2023[165]. - The company has outstanding warrants that could potentially generate proceeds of up to $16,008,327 if exercised[27]. - The company is currently working on capital fundraising transactions to secure additional financing[26]. - The company believes it has enough cash to operate until at least June 30, 2024, but substantial doubt exists about its ability to continue as a going concern[25]. - The company has made staffing adjustments that have significantly reduced its monthly burn rate[24]. Stock and Equity - The weighted average shares of common stock outstanding increased from 48,187,339 in Q4 2022 to 81,094,007 in Q4 2023, an increase of approximately 68.3%[12]. - As of December 31, 2023, the company had 81,346,524 shares of common stock issued and outstanding, with various options and warrants outstanding that could dilute future earnings per share[42]. - The company issued 883,061 shares of common stock at a price of $0.25 per share, resulting in net proceeds of $203,105 after expenses[65]. - The company has a total of 28,220,473 stock options outstanding with an average exercise price of $0.907 as of December 31, 2023[75]. - The company recorded $699,246 in compensation expense related to stock options for the three months ended December 31, 2023[75]. Operational Efficiency - Total operating expenses decreased from $3,648,122 in Q4 2022 to $3,497,634 in Q4 2023, a reduction of about 4.1%[11]. - Selling, general and administrative expenses increased by $106,000 to $2,011,000 for the three months ended December 31, 2023, compared to $1,905,000 for the same period in 2022[158]. - The total depreciation expense for the three months ended December 31, 2023, was $18,724, a significant decrease of 81.9% compared to $103,160 for the same period in 2022[48]. - The company recognized total lease costs of $62,000 for the three months ended December 31, 2023, compared to $82,000 for the same period in 2022, reflecting a decrease of 24.4%[50]. - The company incurred expenses of $1,486,000 and $1,743,000 for development activities for the three months ended December 31, 2023, and 2022, respectively[132].

Financial Data and Key Metrics Changes - For FY 2023, the company reported a net loss of $15.29 million, a reduction of 23.8% compared to a net loss of $20.07 million in FY 2022, translating to an earnings per share loss of $0.41, an improvement from the previous year's loss of $0.50 [64][66] - Research and development expenses increased by 43.5% year-over-year, totaling $7.73 million in FY 2023 compared to $5.39 million in FY 2022, driven by engineering services and development costs for the Generation 1 device [34] - Selling, general, and administrative expenses decreased by 19.1% to $6.57 million in FY 2023 from $8.12 million in FY 2022, reflecting cost-reduction initiatives [66] Business Line Data and Key Metrics Changes - The company achieved a significant improvement in technology accuracy, reducing the Mean Absolute Relative Difference (MARD) from 20.6% to 11.3%, positioning it closer to FDA-cleared devices [12][21] - The Generation 1 device was revealed in June 2023, designed for remote data collection and research purposes, while the Generation 2 device is expected to be more than 50% smaller and presented to the FDA for clinical trials [11][47] Market Data and Key Metrics Changes - The company reported a portfolio growth rate that is at least four times higher than the average patent market growth rate for noninvasive blood glucose monitoring, with over 250 patents issued, pending, or in process [13][109] - The company is currently conducting trials with up to 100 participants and plans to scale testing to 500-1,000 participants to enhance data diversity and generalizability [28][90] Company Strategy and Development Direction - The company aims to develop the first FDA-cleared, truly noninvasive glucose monitoring device, with a broader vision to transform medical diagnostics through non-invasive means [63] - Strategic partnerships are being pursued with biopharma, medical device manufacturers, and consumer electronics partners to accelerate product development and commercialization [94] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in having enough cash to operate until at least June 30, 2024, while planning to raise additional funds through equity and convertible debentures [73] - The company acknowledged the challenges in capital markets but emphasized the importance of aligning resources to critical functions such as clinical and product development [110] Other Important Information - The company plans to present results from its current clinical study at the Advanced Technologies and Treatments for Diabetes (ATTD) Conference in Florence, Italy, in 2024 [44] - The company has reduced its monthly burn rate from $1.2 million to approximately $700,000, indicating improved financial management [14] Q&A Session Summary Question: What progress has been made with the Gen 1 prototype device? - The Gen 1 device has allowed for expanded testing outside the lab, facilitating data collection and testing [38] Question: What is the path to FDA clinical trials, including key milestones and timing? - Management indicated that they are working with urgency towards FDA submission and will share timelines as confidence in them increases [40] Question: What sort of joint development agreements can be expected in the future? - Management noted that these agreements can take time and they cannot speculate on the duration or form of these agreements [68]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: September 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to _____________ Commission File No. 001-37479 KNOW LABS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of i ...

S-1/A 1 know_s1a.htm FORM S-1/A As filed with the Securities and Exchange Commission on September 25, 2023 Registration No.333 ‑274350 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Know Labs, Inc. (Exact name of registrant as specified in its charter) Nevada 3920 90‑0273142 (State or other jurisdiction of incorporation or organization) UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. C. 20549 AMENDMENT No. 2 to FORM S‑1 (Primary Standard Industrial Classification Code Number) (IRS E ...

S-1/A 1 know_s1a.htm FORM S-1/A As filed with the Securities and Exchange Commission on September 19, 2023 Registration No.333 ‑274350 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) Nevada 3920 90‑0273142 (IRS Employer (State or other jurisdiction of incorporation or organization) Cavas S. Pavri, Esq. ArentFox Schiff LLP 1717 K S ...