Group 1 - Halper Sadeh LLC is investigating Know Labs, Inc. for potential violations of federal securities laws related to its sale to Goldeneye 1995 LLC [1] - Heliogen, Inc. is set to be sold to Zeo Energy Corp, with securityholders expected to receive shares valued at approximately $10 million based on a share price of $1.5859 [2] - The firm may seek increased consideration for shareholders and additional disclosures regarding the proposed transactions [3] Group 2 - Shareholders are encouraged to contact Halper Sadeh LLC to discuss their legal rights and options at no charge [4] - Halper Sadeh LLC represents investors globally who have experienced securities fraud and corporate misconduct, recovering millions for defrauded investors [4]

Financial Performance - Net loss attributable to common shareholders for the three months ended March 31, 2025, was $3,602,698, compared to a net loss of $5,496,273 for the same period in 2024, reflecting a reduction of approximately 34.4%[12] - The company reported a net loss of $3.446 billion for the quarter[16] - The net loss for the six months ended March 31, 2025, was $8,244,544, compared to a net loss of $8,844,288 for the same period in 2024, indicating a decrease in losses by approximately 6.8%[20] - The net loss for the three months ended March 31, 2025, was $3,579,000, a 33.7% improvement compared to a net loss of $5,398,000 for the same period in 2024[198] - The net loss for the six months ended March 31, 2025, was $8,245,000, a 6.8% improvement compared to a net loss of $8,844,000 for the same period in 2024[206] Assets and Liabilities - Total current assets decreased to $443,913 in 2025 from $3,110,755 in 2024, representing a decline of approximately 86.7%[9] - Total liabilities increased to $6,807,734 in 2025 from $5,820,629 in 2024, marking an increase of about 17%[9] - Total stockholders' deficit increased to $(5,883,549) in 2025 from $(2,156,201) in 2024, representing a decline of approximately 172.5%[9] - As of December 31, the balance sheet showed total assets of $17.858 billion, with liabilities of $16.161 billion[16] - The balance as of March 31 shows a total of $17.858 billion in assets, indicating stability in financial position[16] Expenses - Research and development expenses for the six months ended March 31, 2025, were $1,220,309, down from $3,661,633 in 2024, indicating a decrease of about 66.7%[12] - Selling, general and administrative expenses for the three months ended March 31, 2025, were $1,789,315, compared to $2,550,848 in 2024, a decrease of approximately 29.9%[12] - Interest expense for the six months ended March 31, 2025, was $2,557,844, compared to $740,251 in 2024, an increase of approximately 245.5%[12] - The company incurred advertising and marketing costs of $10,000 for the three months ended March 31, 2025, compared to $58,866 in the same period of the previous year[42] - The total depreciation expense for the three months ended March 31, 2025, was $7,162, compared to $19,643 for the same period in 2024[59] Stock and Equity - The basic and diluted loss per share for the three months ended March 31, 2025, was $(1.24), compared to $(2.69) for the same period in 2024, showing an improvement of about 54.9%[12] - The weighted average shares of common stock outstanding for the three months ended March 31, 2025, were 2,909,985, compared to 2,044,153 in 2024, an increase of approximately 42.3%[12] - The company issued options totaling 6.616 million shares, indicating ongoing employee incentives[16] - The total stock expenses were reported at $9.860 million, highlighting the company's commitment to shareholder value[16] - The company has a total of 5.594 million warrants outstanding, which could impact future equity dilution[16] Strategic Initiatives - The company is focusing on market expansion and new product development to drive future growth[16] - The company is exploring strategic acquisitions to enhance its market position and product offerings[16] - Know Labs announced the development of the KnowU™ non-invasive wearable continuous glucose monitor prototype, which is currently undergoing internal clinical testing[128] - The company is in discussions with potential biopharma, medical device, and consumer electronics partners regarding joint development agreements to accelerate development and commercial launch[159] - The KTL initiative aims to license Know Labs' intellectual property to corporate partners and academic institutions, fostering innovation across various industries[157] Compliance and Future Outlook - Future guidance suggests a cautious outlook due to current market conditions and competitive pressures[16] - The company has substantial doubt about its ability to continue as a going concern, as it may require additional financing to support its operations[34] - The NYSE American lifted the trading suspension of the company's common stock on March 5, 2025, after the stock traded above the low selling price threshold[189] - The company has a target completion date of March 27, 2026, to regain compliance with the NYSE American's continued listing standards[190] - Know Labs received notification from the NYSE American regarding non-compliance with minimum stockholders' equity requirements, and submitted a plan to regain compliance by March 27, 2026[186] Research and Development - The Company is focused on the development of a non-invasive blood glucose monitoring device, with a working prototype launched in the previous fiscal year[28] - The internal clinical research study showed a Mean Absolute Relative Difference (MARD) of 11.1% in measuring blood glucose levels using the proprietary RF dielectric sensor[139] - The sensor technology has demonstrated a high degree of correlation with leading continuous glucose monitors, providing a non-invasive alternative[138] - A study indicated that the technology achieved 93.37% accuracy in classifying glycemic status compared to venous blood glucose values[145] - The company is focused on refining its algorithms and expanding testing to ensure accurate glucose value estimation across diverse populations[147]

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].

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].

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].