ENDRA Life Sciences(NDRA)
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ENDRA Life Sciences(NDRA) - 2024 Q4 - Annual Report
2025-03-31 12:51
Financial Performance - The net loss for 2024 was $11,507,947, compared to a net loss of $10,060,250 in 2023, reflecting an increase in losses of approximately 14.4%[330] - For the year ended December 31, 2023, the net loss was $10,060,250, compared to a net loss of $11,507,947 for the year ended December 31, 2024, indicating a decrease in losses[336] - The total income (loss) before income taxes for 2024 was $(11,507,947), compared to $(10,060,250) for 2023[421] - The Company has not generated any product revenue to date and expects to incur significant expenses and operating losses as it advances product candidates[428] Assets and Liabilities - Total current assets increased to $3,433,665 in 2024 from $3,032,812 in 2023, representing a growth of approximately 13.2%[327] - Total liabilities rose to $1,891,996 in 2024 compared to $1,095,157 in 2023, indicating an increase of about 72.6%[327] - The accumulated deficit grew to $(103,438,099) in 2024 from $(91,930,152) in 2023, an increase of approximately 12.5%[327] - The total stockholders' equity as of December 31, 2023, was $5,658,989, down from $2,560,366 as of December 31, 2024[333] - As of December 31, 2024, the company recorded inventory reserves totaling $2,525,179, compared to $138,045 as of December 31, 2023, indicating a significant increase in inventory devaluation reserves[365] - The Company had a balance of 180,707 warrants outstanding as of December 31, 2024, with a weighted average exercise price of $85.38[397] Expenses - Research and development expenses decreased to $3,190,293 in 2024 from $5,003,695 in 2023, a reduction of about 36.2%[329] - General and administrative expenses increased significantly to $7,055,814 in 2024 from $4,696,486 in 2023, marking an increase of approximately 50.5%[329] - The total operating expenses for 2024 were $10,817,147, slightly higher than $10,520,735 in 2023, an increase of about 2.8%[329] - The Company incurred rent expenses of $203,265 and $218,815 for the years ended December 31, 2024 and 2023, respectively[413] Cash Flow and Financing - Cash and cash equivalents at the end of the period increased to $3,229,480 for the year ended December 31, 2024, compared to $2,833,907 for the year ended December 31, 2023[336] - The cash flows from financing activities provided $7,808,917 in 2024, compared to $7,518,305 in 2023, reflecting an increase in financing[336] - The Company plans to raise additional capital through equity sales and borrowing to fund future operations, including R&D and commercialization efforts[362] - The net proceeds from the Offering on June 5, 2024, amounted to $7,338,333 after deducting offering expenses[377] Stock and Shares - The company reported a weighted average of 202,106 common shares for 2024, compared to 3,636 shares in 2023, indicating a substantial increase in shares outstanding[330] - The Company issued a total of 530,971 shares of common stock during the year ended December 31, 2024, with 495,476 shares from cashless exercise of Series B Warrants[376] - The Company executed two reverse stock splits in 2024, with ratios of one-for-50 and one-for-35, affecting the number of shares and exercise prices[370][371] Audit and Compliance - The company has not identified any critical audit matters in the current period audit of the financial statements[325] - The Company has no unrecognized tax benefits as of December 31, 2024 and 2023, and no penalties or interest were recorded in income tax expense for these years[425] Operational Challenges - The company has expressed substantial doubt about its ability to continue as a going concern due to recurring losses and negative cash flows[320] - The company had no pending orders for the sale of a TAEUS system as of December 31, 2024, indicating potential challenges in sales[364] Tax and Deferred Assets - The expected tax at statutory rates for 2024 was $(2,416,700), reflecting a 21% rate[420] - The net deferred tax assets (liabilities) were $24,573,700 as of December 31, 2024, with a full valuation allowance recorded due to uncertainty in realizing these assets[422] - The domestic U.S. net operating loss carryforward increased from $62,032,405 at December 31, 2023 to $72,521,129 at December 31, 2024[423] - The Company's total state net operating losses increased from $74,926,792 at December 31, 2023 to $84,972,922 at December 31, 2024[423]
ENDRA Life Sciences(NDRA) - 2024 Q4 - Annual Results
2025-03-31 12:49
[ENDRA Life Sciences 2024 Q4 and Full-Year Financial Report](index=1&type=section&id=ENDRA%20Life%20Sciences%202024%20Q4%20and%20Full-Year%20Financial%20Report) [Business Update](index=1&type=section&id=Business%20Update) In late 2024, ENDRA Life Sciences significantly advanced its TAEUS® Liver device's FDA regulatory path, accelerated clinical data collection, revised its strategy, and implemented substantial cost reductions [FDA Regulatory Process and Product Refinement](index=1&type=section&id=FDA%20Regulatory%20Process%20and%20Product%20Refinement) In Q4 2024, the company refocused resources to advance the TAEUS® Liver device's FDA regulatory path, gathering data to optimize design and prepare for a pivotal De Novo trial - ENDRA is prioritizing the advancement of its TAEUS Liver device on its FDA regulatory path, focusing on data collection to optimize design and prepare for a pivotal clinical trial necessary for a De Novo submission[2](index=2&type=chunk) - The TAEUS device is undergoing continuous development, with enhancements to its hardware and software to improve both accuracy and usability[2](index=2&type=chunk) [Acceleration of Clinical Data Collection](index=1&type=section&id=Acceleration%20of%20Clinical%20Data%20Collection) Two new clinical sites activated in October 2024 have scanned over 110 subjects, providing crucial data across diverse liver disease states for product optimization and De Novo submission - Two new clinical sites have acquired TAEUS scan data from over **110 subjects**, which is being assessed against the gold standard MRI-PDFF test[2](index=2&type=chunk) - The new data covers a wider range of liver disease states, with about **20% of subjects** having moderate and severe steatosis (S2 and S3), which is foundational for regulatory, clinical, and commercial success[2](index=2&type=chunk) [Revised Regulatory Strategy](index=1&type=section&id=Revised%20Regulatory%20Strategy) ENDRA revised its TAEUS Liver device regulatory strategy to a prospective, multicenter clinical trial with approximately 250 subjects, planning pre-submission FDA engagement for alignment - The company will conduct a prospective, multicenter pivotal trial with approximately **250 subjects** for its De Novo submission, a change from previous plans to use retrospective data[2](index=2&type=chunk) - ENDRA plans a pre-submission engagement with the FDA to align on study design, sample size, hypothesis, and statistical analyses before initiating the trial[2](index=2&type=chunk) [Cost Reduction Initiatives](index=1&type=section&id=Cost%20Reduction%20Initiatives) Significant cost reductions in H2 2024 lowered average monthly cash burn from $0.8 million in 2023 to $0.5 million in Q4 2024, with further reductions expected Reduction in Monthly Cash Used for Operations | Period | Average Monthly Cash Used | | :--- | :--- | | Full Year 2023 | $0.8 million | | Q4 2024 | $0.5 million | | Q2 & Q3 2025 (Expected) | $0.35 million | [New Operating Team Achievements](index=1&type=section&id=New%20Operating%20Team%20Achievements) Since late Q3 2024, ENDRA's new operating team has focused the business on the De Novo submission, defined a new strategy, and significantly reduced cash burn - The new operating team has achieved several key objectives since Q3 2024: - Focused the business on the new multicenter clinical study for the De Novo submission[2](index=2&type=chunk) - Defined a new mission, product strategy, and business model[2](index=2&type=chunk) - Executed a business optimization that significantly reduced monthly cash burn[2](index=2&type=chunk) - Implemented a more cohesive FDA De Novo strategy[2](index=2&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) ENDRA significantly reduced cash used in operations in 2024, though net loss increased due to $3.1 million in one-time non-cash charges, indicating underlying operational improvement [Fourth Quarter 2024 Financial Results](index=2&type=section&id=Fourth%20Quarter%202024%20Financial%20Results) In Q4 2024, cash used in operations decreased to $1.5 million, but net loss increased to $4.2 million primarily due to $3.3 million in one-time non-cash items Q4 Financial Performance Comparison | Metric | Q4 2024 | Q4 2023 | Change | | :--- | :--- | :--- | :--- | | Cash Used in Operations | $1.5 million | $2.2 million | ($0.7 million) | | Operating Expenses | $4.3 million | $1.5 million | +$2.8 million | | Net Loss | $4.2 million | $1.5 million | +$2.7 million | - The increase in Q4 2024 net loss was primarily due to a **$3.3 million swing** from one-time non-cash items, including a **$2.3 million inventory charge** in 2024 and a **$1.0 million gain** from reversing bonuses in 2023[5](index=5&type=chunk)[11](index=11&type=chunk) [Full-Year 2024 Financial Results](index=2&type=section&id=Full-Year%202024%20Financial%20Results) Full-year 2024 cash used in operations decreased to $7.4 million, while net loss increased to $11.5 million primarily due to $3.1 million in non-cash charges Full-Year Financial Performance Comparison | Metric | FY 2024 | FY 2023 | Change | | :--- | :--- | :--- | :--- | | Cash Used in Operations | $7.4 million | $9.5 million | ($2.1 million) | | Total Operating Expenses | $10.8 million | $10.5 million | +$0.3 million | | Net Loss | $11.5 million | $10.1 million | +$1.4 million | - Excluding **$3.1 million** in one-time, non-cash items (inventory and warrant charges), the company's financial performance showed notable improvement in 2024[7](index=7&type=chunk) [Financial Position](index=2&type=section&id=Financial%20Position) As of the end of the fiscal year 2024, ENDRA Life Sciences held $3.2 million in cash and cash equivalents on its balance sheet - As of December 31, 2024, the Company had **$3.2 million** in cash and cash equivalents[8](index=8&type=chunk) [Financial Statements](index=3&type=section&id=Financial%20Statements) The consolidated financial statements for 2024 detail a decrease in total assets to $4.5 million, an increase in liabilities, and a net loss of $11.5 million [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) As of December 31, 2024, the balance sheet shows total assets decreased to $4.5 million, total liabilities increased to $1.9 million, and stockholders' equity decreased to $2.6 million Consolidated Balance Sheet Summary (as of Dec 31) | Account | 2024 | 2023 | | :--- | :--- | :--- | | Cash | $3,229,480 | $2,833,907 | | Total Assets | $4,452,362 | $6,754,146 | | Total Liabilities | $1,891,996 | $1,095,157 | | Total Stockholders' Equity | $2,560,366 | $5,658,989 | [Consolidated Statements of Operations](index=4&type=section&id=Consolidated%20Statements%20of%20Operations) For 2024, total operating expenses were $10.8 million, resulting in a net loss of $11.5 million or ($56.94) per share, reflecting increased shares outstanding Consolidated Statement of Operations Summary (Year Ended Dec 31) | Account | 2024 | 2023 | | :--- | :--- | :--- | | Total operating expenses | $10,817,147 | $10,520,735 | | Operating loss | ($10,817,147) | ($10,520,735) | | Net Loss | ($11,507,947) | ($10,060,250) | | Net loss per share | ($56.94) | ($2,766.85) | | Weighted average common shares | 202,106 | 3,636 | [About ENDRA Life Sciences & Forward-Looking Statements](index=2&type=section&id=About%20ENDRA%20Life%20Sciences%20%26%20Forward-Looking%20Statements) ENDRA Life Sciences develops TAEUS® technology for steatotic liver disease, with the report containing forward-looking statements subject to inherent risks and uncertainties - ENDRA's core focus is the development of its TAEUS® technology for measuring liver fat to assess and monitor steatotic liver disease, a condition affecting over **two billion people globally**[9](index=9&type=chunk) - The report contains forward-looking statements regarding future plans, including FDA submissions, product launches, and financial projections, which are subject to inherent risks and uncertainties[10](index=10&type=chunk)
What Makes ENDRA Life Sciences (NDRA) a New Strong Buy Stock
ZACKS· 2025-01-28 18:06
Core Viewpoint - ENDRA Life Sciences Inc. (NDRA) has received an upgrade to a Zacks Rank 1 (Strong Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][4][6]. Earnings Estimates and Revisions - The Zacks rating system focuses on the consensus measure of EPS estimates from sell-side analysts, which reflects the changing earnings picture of a company [2]. - For the fiscal year ending December 2024, ENDRA Life Sciences is expected to earn -$47.46 per share, representing a 98.3% change from the previous year's reported number [9]. - Over the past three months, the Zacks Consensus Estimate for ENDRA Life Sciences has increased by 95.1%, indicating a strong upward trend in earnings estimates [9]. Impact of Institutional Investors - Changes in a company's future earnings potential, as indicated by earnings estimate revisions, are strongly correlated with near-term stock price movements, largely due to institutional investors adjusting their valuations based on these estimates [5]. - Institutional investors typically react to changes in earnings estimates, leading to significant buying or selling actions that affect stock prices [5]. Zacks Rating System - The Zacks Rank stock-rating system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [8]. - The upgrade of ENDRA Life Sciences to Zacks Rank 1 places it in the top 5% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [11].
ENDRA Life Sciences(NDRA) - 2024 Q2 - Quarterly Results
2024-08-23 20:06
Financial Performance - ENDRA Life Sciences reported a net loss of $2.23 million for Q2 2024, compared to a net loss of $2.56 million in Q2 2023, representing a 13% improvement year-over-year[12]. - Operating expenses decreased by 26% year-over-year, from $2.99 million in Q2 2023 to $2.23 million in Q2 2024, primarily due to reduced research and development expenses[4][12]. - The company reported a significant reduction in annualized operating expenses by $3.1 million compared to the prior-year second quarter[3]. Capital and Cash Position - The company raised approximately $8.0 million in gross proceeds from a public offering, enhancing its cash position to $6.4 million as of June 30, 2024[3][5]. - Cash and cash equivalents increased from $2.83 million at the end of 2023 to $6.4 million by June 30, 2024, reflecting successful capital raising efforts[10][5]. - Total current assets rose to $6.71 million as of June 30, 2024, up from $3.03 million at the end of 2023[10]. Intellectual Property and Technology Development - ENDRA expanded its intellectual property portfolio to 81 issued patents globally, with five additional patents granted in Q2 2024[3]. - The company initiated new pilot clinical trials at two North American sites and plans to start one in Europe to support the TAEUS technology's clinical value[2]. - The acting CEO emphasized the priority of securing clinical data for a new De Novo regulatory filing with the FDA, while revisiting the go-to-market strategy for TAEUS[4]. - ENDRA's TAEUS technology aims to provide non-invasive assessments of fatty tissue in the liver, addressing a market need affecting over two billion people globally[7].
Why Is ENDRA Life Sciences (NDRA) Stock Up 36% Today?
Investor Place· 2024-06-17 12:11
Core Viewpoint - ENDRA Life Sciences (NASDAQ:NDRA) stock has experienced a significant increase following an investment from S.H.N. Financial Investments Ltd, which now holds a 9.99% stake in the company [1][8]. Group 1: Stock Performance - NDRA stock is up 35.8% as of Monday morning, although it has declined 93.5% year-to-date as of the previous Friday's close [5]. - Heavy trading activity is noted, with over 52 million shares traded on Monday morning, significantly above the average daily trading volume of approximately 12.2 million shares [9]. Group 2: Investment Details - S.H.N. Financial Investments Ltd has acquired 1.2 million shares and also holds pre-funded warrants for an additional 6,721,648 shares, which are exercisable within 60 days [4][8]. - The investment firm is limited to a 9.99% stake in NDRA stock, and this stake was taken without any intent to influence control of the company [4][9]. - Additional warrants held by S.H.N. Financial Investments Ltd include 12,286,154 Series A Warrants and 12,286,154 Series B Warrants, along with 4,364,506 shares available upon the exercise of other pre-funded warrants [7].
ENDRA Life Sciences(NDRA) - 2024 Q1 - Earnings Call Transcript
2024-05-15 00:30
Financial Data and Key Metrics Changes - For the quarter ended March 31, 2024, operating expenses decreased to $2.8 million from $2.9 million for the same period in 2023, primarily due to lower research and development expenses [7][15] - The net loss in the first quarter of 2024 was $2.8 million or $0.26 per share, compared to a net loss of $2.9 million or $0.93 per share in the first quarter of 2023 [15] Business Line Data and Key Metrics Changes - Research and development expenses decreased year-over-year by approximately $350,000 as the development of the initial TAEUS product was completed [15] - Sales and marketing expenses increased by approximately $57,000, mainly due to higher consulting fees [15] - General and administrative expenses increased by approximately $134,000, mainly due to higher professional fees [15] Market Data and Key Metrics Changes - The prevalence of liver disease affects over 2 billion people globally, highlighting the need for accessible diagnostic tools [4] - Major insurers are requiring adherence to specific prescribing authorization criteria for new liver disease therapies, emphasizing the complexity of managing this disease [13][25] Company Strategy and Development Direction - The company is focused on leveraging clinical partner sites in Europe and the US to build clinical evidence and achieve successful adoption of its technology [17] - ENDRA is engaging closely with the FDA to advance its regulatory submission in the US [17] - The company aims to explore collaborations and strategic pathways to expand the applications of its TAEUS platform beyond liver disease [26] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of building a body of clinical evidence to support commercial success and the need for precision in diagnosis and treatment of liver disease [11][13] - The company is actively preparing for an in-person pre-submission meeting with the FDA to discuss clinical trial design [27][28] - Management expressed optimism about the advancements in diagnosing and managing liver disease, which provide opportunities for ENDRA [25] Other Important Information - Cash and cash equivalents were $1.1 million as of March 31, 2024, with the company raising $420,000 in gross proceeds from the sale of common stock [30] - ENDRA has issued eight new patents this year, bringing its total to 80 issued patents worldwide, reinforcing its competitive edge [26] Q&A Session Summary Question: Is the company considering expansion into other parts of Asia? - Management indicated that while there is a distribution agreement in Vietnam, the focus will be on establishing a strong presence in Europe and the US before expanding into Asia [19][34] Question: What are the next steps following the FDA meeting? - Management expressed anticipation for the outcomes of the FDA meeting and the next steps in the regulatory process [28][35]
ENDRA Life Sciences(NDRA) - 2024 Q1 - Quarterly Report
2024-05-14 20:26
Revenue and Financial Performance - No revenue has been generated by the TAEUS technology as of March 31, 2024[85]. - The net loss for the three months ended March 31, 2024, was $2,775,700, compared to a net loss of $2,942,746 for the same period in 2023[101]. - For the three months ended March 31, 2024, the company incurred net losses of $2,775,700 and used cash in operations of $2,144,312[105]. - Cash used in operating activities for the same period in 2023 was $2,506,847, with a net loss of $2,942,746[107]. - As of March 31, 2024, the accumulated deficit was $94,705,852, with cash reserves of $1,134,701[102]. Expenses - Research and development expenses decreased by 25% to $1,041,526 for the three months ended March 31, 2024, compared to $1,391,314 for the same period in 2023[98]. - Sales and marketing expenses increased by 31% to $238,660 for the three months ended March 31, 2024, compared to $181,616 for the same period in 2023[99]. - General and administrative expenses rose by 10% to $1,500,355 for the three months ended March 31, 2024, compared to $1,366,398 for the same period in 2023[100]. Funding and Capital Needs - The company is considering financing options, including sales of common stock, to continue executing its commercialization plans[103]. - The company anticipates needing to raise substantial additional capital to complete the commercialization of its NAFLD TAEUS application and other TAEUS applications[113]. - The company has no committed external sources of funds and may need to finance future cash needs through public or private equity offerings, debt financings, or corporate collaborations[114]. - The company raised $419,967 from common stock issuances and $77,419 from warrant exercises during the three months ended March 31, 2024[110]. Future Plans and Development - The company plans to submit a new de novo request to the FDA in the first half of 2025 after completing necessary clinical studies by the fourth quarter of 2024[84]. - The company expects to incur significant expenses as it advances the engineering design and development of its TAEUS technology and seeks regulatory approvals for its NAFLD TAEUS application[112]. - The company expects to hire a small internal marketing team to support channel partners and clinical customers for its NAFLD TAEUS application[112]. - The company is building a sales and marketing team to support global ultrasound distributors and plans to expand its sales representation in the EU and the US[88]. Other Financial Information - As of March 31, 2024, the company did not have any off-balance sheet transactions[115]. - The company used $27,000 in investing activities related to purchases of fixed assets during the three months ended March 31, 2024[108]. - The financial statements do not include adjustments that might be necessary if the company is unable to continue as a going concern[105].
ENDRA Life Sciences(NDRA) - 2024 Q1 - Quarterly Results
2024-05-14 20:17
Financial Performance - Net loss for Q1 2024 was $2.8 million, or $0.26 per share, compared to a net loss of $2.9 million, or $0.93 per share in Q1 2023[5]. - Operating expenses for Q1 2024 were $2.8 million, a decrease from $2.9 million in Q1 2023, primarily due to lower research and development expenses[4]. - Research and development expenses for Q1 2024 were $1.04 million, down from $1.39 million in Q1 2023[17]. - The company reported a net cash used in operating activities of $2.14 million for Q1 2024, compared to $2.51 million in Q1 2023[20]. Cash Position - Cash and cash equivalents as of March 31, 2024, were $1.1 million, down from $2.8 million at the end of Q1 2023[6]. - Total assets decreased to $5.06 million as of March 31, 2024, from $6.75 million at the end of Q1 2023[15]. - Total current liabilities increased to $1.22 million as of March 31, 2024, compared to $0.90 million at the end of Q1 2023[15]. Product Development - The first TAEUS system was installed in the UK at King's College Hospital for clinical evaluation, with a study expected to include approximately 75 subjects[10]. - ENDRA is preparing for a pre-submission meeting with the FDA to align on clinical study design and statistical analysis for the TAEUS system[3]. Intellectual Property - The company expanded its intellectual property portfolio to 80 issued patents globally, with eight additional patents granted in Q1 2024[10].
ENDRA Life Sciences(NDRA) - 2023 Q4 - Annual Report
2024-03-28 20:38
Financial Performance - As of December 31, 2023, the total assets of ENDRA Life Sciences Inc. were $6.75 million, a decrease from $9.27 million in 2022, representing a decline of approximately 27%[309] - The company reported a net loss of $10.06 million for the year ended December 31, 2023, compared to a net loss of $13.18 million in 2022, indicating an improvement of about 24%[312] - Total operating expenses for 2023 were $10.52 million, down from $13.16 million in 2022, reflecting a reduction of approximately 20%[312] - The net loss for the year ended December 31, 2023, was $10,060,250, compared to a net loss of $13,179,092 for the year ended December 31, 2022, representing a 23.5% improvement[317] - The company had a total income loss before income taxes of $9,996,700 for the year ended December 31, 2023, compared to a loss of $13,179,100 in 2022[379] Cash and Liquidity - Cash and cash equivalents decreased to $2.83 million as of December 31, 2023, from $4.89 million in 2022, a decline of approximately 42%[309] - Cash used in operating activities for 2023 was $9,548,775, a decrease from $12,769,371 in 2022, indicating a 25.5% reduction in cash outflow[317] - The company experienced a net decrease in cash of $2,055,191 in 2023, compared to a decrease of $4,572,436 in 2022, indicating improved cash management[317] Research and Development - Research and development expenses decreased to $5.00 million in 2023 from $6.55 million in 2022, a reduction of about 24%[312] - Research and development expenses for the year ended December 31, 2023, were $5,003,695, down from $6,554,194 in 2022, reflecting a 23.6% decrease[332] - The company continues to develop technology for non-invasive tissue characterization to enhance patient access to safe diagnosis and treatment[318] Accumulated Deficit and Liabilities - The company has an accumulated deficit of $91.93 million as of December 31, 2023, compared to $81.87 million in 2022, indicating an increase in losses[310] - The Company reported a cumulative net loss of $91,930,152 since inception[343] - Total accounts payable and accrued liabilities decreased from $1,523,012 in 2022 to $700,754 in 2023[349] Capital and Equity - The weighted average common shares outstanding increased to 6.36 million in 2023 from 2.89 million in 2022, reflecting a growth of approximately 120%[312] - Proceeds from the issuance of common stock in 2023 amounted to $6,483,393, compared to $8,399,512 in 2022, a decline of 22.8%[317] - The Company issued a total of 7,221,047 shares of common stock during the year ended December 31, 2023, raising aggregate net proceeds of $7,498,352[355] - A total of 1,583,500 shares of common stock were issued upon warrant exercises, generating net proceeds of $1,014,859 during the year ended December 31, 2023[361] - The Company issued 202,020 shares of restricted common stock valued at $200,485 to PatentVest for services related to its patent portfolio[360] Going Concern and Future Plans - The company has expressed substantial doubt about its ability to continue as a going concern due to recurring losses and negative cash flows from operations[301] - The company plans to advance the engineering design and development of its TAEUS technology and expand marketing efforts for its NAFLD TAEUS application[298] - ENDRA Life Sciences Inc. aims to hire a small internal marketing team to support channel partners and clinical customers for its NAFLD TAEUS application[298] - The Company plans to raise additional capital through equity securities and borrowing to fund future operations[343] Taxation and Compliance - The Company does not have any unrecognized tax benefits as of December 31, 2023 and 2022[383] - No income tax returns are currently under examination for the years 2020 and after[383] - The Company is subject to taxation in multiple states and foreign jurisdictions[383] - Foreign income tax returns after 2020 remain open to examination[383] - The company recorded a full valuation allowance for deferred tax assets due to uncertainty in realizing these assets as of December 31, 2023[381] Other Financial Metrics - The company recognized an inventory reserve of $138,045, which is 5% of the inventory, resulting in a net carrying value of inventory of $2,622,865 as of December 31, 2023[325] - Inventory as of December 31, 2023, was valued at $2,622,865, with a reserve of 5% or $138,045[346][347] - The Company had working capital of $2,129,717 as of December 31, 2023[343] - The Company’s fixed assets, net, decreased from $235,655 in 2022 to $111,782 in 2023[348] - The company incurred rent expenses of $218,815 for the year ended December 31, 2023, compared to $213,912 in 2022[370] - The company has a long-term lease obligation of $192,062 as of December 31, 2023[370] - The Toronto-Dominion Bank loan balance remained at CAD 40,000 as of December 31, 2023, with conditions for partial forgiveness[350] - The Toronto-Dominion Bank Loan was repaid in full after December 31, 2023[385] Stock Options and Warrants - The fair value of stock options granted in 2023 was estimated at $1,017,534, with a volatility rate of 105% to 107%[358] - The company had 1,514,715 potentially dilutive shares as of December 31, 2023, compared to 410,358 in 2022[334] - The company has a total of 882,349 warrants outstanding as of December 31, 2023, with a weighted average exercise price of $1.58[362] - The company reduced the exercise price of certain warrants from $1.40 to $0.70 in December 2023[361] Consulting and Agreements - The company entered into a consulting agreement with a director, compensating him at a rate of $150 per hour for commercialization services[364] - There are no changes or disagreements with accountants on accounting and financial disclosure[386]
ENDRA Life Sciences(NDRA) - 2023 Q4 - Annual Results
2024-03-28 20:10
Financial Performance - Operating expenses in Q4 2023 were $1.5 million, a decrease of 54.5% compared to $3.3 million in Q4 2022[3] - Net loss for Q4 2023 was $1.5 million, or $0.17 per share, compared to a net loss of $3.3 million, or $1.04 per share, in Q4 2022[5] - Full year 2023 operating expenses totaled $10.5 million, down 20.4% from $13.2 million in 2022[6] - Full year 2023 net loss was $10.1 million, or $1.58 per share, compared to a net loss of $13.2 million, or $4.56 per share, in 2022[6] Cash Position - Cash and cash equivalents as of December 31, 2023, were $2.8 million, down from $4.9 million at the end of 2022[7] - Cash at the end of the year was $2,833,907, a decrease from $4,889,098 at the beginning of the year[22] Investment and Financing Activities - Net cash used in investing activities was $(24,721) compared to $(202,577) in the previous year[22] - Proceeds from issuance of common stock amounted to $6,483,393, a decrease from $8,399,512 year-over-year[22] - Net cash provided by financing activities totaled $7,518,305, down from $8,399,512 in the prior year[22] - Interest paid during the year was $44,985, compared to $59,113 in the previous year[22] - Stock dividend payable decreased to $840 from $7,790 year-over-year[22] - Right of use asset decreased to $354,091 from $505,816 in the previous year[22] Product Development and Market Engagement - The first TAEUS system was installed in the UK at King's College Hospital for clinical evaluation, with a study expected to include approximately 75 subjects[4] - The FDA's review of ENDRA's De Novo request for the TAEUS liver system is ongoing, with an in-person meeting scheduled for Q2 2024[4] - ENDRA expanded its intellectual property portfolio to 75 issued patents globally, including seven additional patents in Q4 2023[4] - A new ICD-10-CM code for NAFLD was issued, facilitating standardized billing and promoting advanced diagnostic technologies like the TAEUS system[4] - ENDRA showcased the TAEUS system at four major clinical conferences, enhancing awareness and engagement with potential customers[4]