UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2025 OR ENDRA LIFE SCIENCES INC. (Exact name of registrant as specified in its charter) Delaware 26-0579295 (State of incorporation) (I.R.S. Employer Identification No.) 3600 Green Court, Suite 350, Ann Arbor, MI 48105-1570 (Address of principal executive of ice) (Zip code) (734) 335-046 ...

EX-99.1 2 endra_ex991.htm PRESS RELEASE EXHIBIT 99.1 ENDRA Life Sciences Provides a Business Update and Reports First Quarter 2025 Financial Results ANN ARBOR, Mich. (May 15, 2025) – ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo-Acoustic Enhanced UltraSound (TAEUS®), today provided a business update and reported financial results for the three months ended March 31, 2025. Business Update Incorporating Liver Diagnostics into the Management of Metabolic Disease ENDRA recently announced a strate ...

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]

EXHIBIT 99.1 ENDRA Life Sciences Reports Fourth Quarter and Full-Year 2024 Financial Results and Provides a Business Update ANN ARBOR, Mich. (March 31, 2025) – ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo-Acoustic Enhanced UltraSound (TAEUS®), today reported financial results for the fourth quarter and full-year ended December 31, 2024, and provided a business update. EX-99.1 2 endra_ex991.htm PRESS RELEASE Business Update ENDRA made significant progress against many of the new initiatives d ...

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].

Financial Performance - The net loss for the three months ended September 30, 2024, was $2,354,090, compared to a net loss of $3,100,836 for the same period in 2023[148]. - The net loss for the nine months ended September 30, 2024, was $7,358,943, an improvement from a net loss of $8,600,714 for the same period in 2023[155]. - As of September 30, 2024, the company had an accumulated deficit of $99,289,095 and $4,745,187 in cash, indicating financial challenges[156]. - The company used $5,884,842 of cash in operating activities during the nine months ended September 30, 2024, primarily due to the net loss[160]. - Other income (expense) decreased by $1,300,776 or 281% to $(838,535) for the nine months ended September 30, 2024, compared to $462,241 for the same period in 2023[154]. Expenses - Research and development expenses decreased by 51% to $794,444 for the three months ended September 30, 2024, compared to $1,632,849 for the same period in 2023[143]. - Sales and marketing expenses decreased by 66% to $83,157 for the three months ended September 30, 2024, compared to $243,332 for the same period in 2023[144]. - General and administrative expenses decreased by 49% to $631,413 for the three months ended September 30, 2024, compared to $1,252,881 for the same period in 2023[145]. - Research and development expenses decreased by $1,872,009 or 42% to $2,552,336 for the nine months ended September 30, 2024, compared to $4,424,345 for the same period in 2023[151]. - Sales and marketing expenses decreased by $187,952 or 28% to $484,769 for the nine months ended September 30, 2024, compared to $672,721 for the same period in 2023[152]. - General and administrative expenses decreased by $482,586 or 12% to $3,483,303 for the nine months ended September 30, 2024, compared to $3,965,889 for the same period in 2023[153]. TAEUS Technology and Development - No revenue has been generated by the TAEUS technology as of September 30, 2024[128]. - The company plans to continue incurring research and development expenses as it pursues FDA approval for the NAFLD TAEUS system[130]. - The first-generation TAEUS application is designed to quantify fat in the liver and stage progression of nonalcoholic fatty liver disease (NAFLD)[123]. - The company anticipates completing necessary clinical studies by the fourth quarter of 2024 or first quarter of 2025 for a new de novo request to the FDA[126]. - The company expects to incur significant expenses as it advances the engineering design and development of its TAEUS technology and seeks regulatory approvals[166]. - The company may need to raise substantial additional capital to complete the commercialization of its NAFLD TAEUS application and other TAEUS applications[167]. Sales and Marketing - The company has restructured its European sales operations to align with near-term sales prospects and plans to expand sales representation in the EU[131]. - The company received CE mark approval for the TAEUS FLIP System in March 2020, enabling marketing in the European Union[125]. Financing Activities - Financing activities provided $1,148,470 from issuances of common stock and $5,368,363 from issuance of warrants during the nine months ended September 30, 2024[164].

Financial Performance - The net loss for Q3 2024 was $2.4 million, an improvement from a net loss of $3.1 million in Q3 2023, despite including a non-cash charge of $911,000 related to warrants[10] - Net loss for September 2024 was $(2,354,090), a decrease from $(3,100,836) in September 2023, representing an improvement of about 24.0%[17] - Net loss per share for September 2024 was $(9.54), compared to $(706.20) in September 2023, showing a significant reduction[17] Operating Expenses - Operating expenses in Q3 2024 decreased by 52% to $1.5 million compared to $3.1 million in Q3 2023, primarily due to reductions in general and administrative spending[9] - Year-over-year expenses for Q3 2024 were reduced by 54%, primarily from general and administrative reductions[9] - Total operating expenses were $1,509,014 in September 2024, down from $3,129,062 in September 2023, reflecting a reduction of about 51.8%[17] - The operating loss for September 2024 was $(1,509,014), compared to $(3,129,062) in September 2023, indicating an improvement of approximately 51.8%[17] Cost Reductions - The company achieved $3.1 million in annualized savings through cost-cutting initiatives and resource refocusing[7] - Research and development expenses decreased to $794,444 in September 2024 from $1,632,849 in September 2023, a reduction of approximately 51.3%[17] - Sales and marketing expenses fell to $83,157 in September 2024 compared to $243,332 in September 2023, representing a decline of about 65.8%[17] - General and administrative expenses decreased to $631,413 in September 2024 from $1,252,881 in September 2023, a decrease of approximately 49.7%[17] Cash Position - Cash and cash equivalents as of September 30, 2024, were $4.7 million, up from $2.8 million at the end of 2023[10] Clinical Developments - Nearly 40 subjects were enrolled in clinical evaluation sites over the past two months to assess TAEUS' liver fat measurement capabilities against MRI-PDFF[3] - A TAEUS system was activated at LMU University Hospital in Germany for a post-market clinical study to assess liver fat measurement capabilities[4] - A study on TAEUS technology in patients with high BMI was accepted for presentation at AASLD's The Liver Meeting 2024, highlighting its potential in challenging assessments[5] - The company is focused on securing clinical data for a new De Novo regulatory filing with the FDA, prioritizing subject recruitment at pilot clinical evaluation sites[8] Intellectual Property - ENDRA's intellectual property portfolio expanded to 82 issued patents globally during Q3 2024, enhancing protection for the TAEUS system[6] Other Income and Expenses - Other income increased to $65,528 in September 2024 from $28,226 in September 2023, reflecting a growth of approximately 132.5%[17] - Total other expenses resulted in $(845,076) in September 2024, compared to $28,226 in September 2023, indicating a significant change in expense structure[17] Shareholder Information - Weighted average common shares outstanding increased to 246,816 in September 2024 from 4,391 in September 2023, indicating a substantial increase in share count[17]

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].

Financial Data and Key Metrics Changes - The company raised $7.3 million in net proceeds from the sale of common stock and warrants in a public offering during the quarter [15] - As of June 30, 2024, cash and cash equivalents stood at $6.4 million, providing a cash runway into the first half of 2025 [15] - Total operating expenses decreased to $2.2 million from $3 million for the same period in 2023, primarily due to declines in research and development and sales and marketing expenses [15][16] - Year-over-year, R&D expenses decreased by $684,000 or 49%, while sales and marketing costs decreased by $85,000 or 34% [16] Business Line Data and Key Metrics Changes - The company is shifting resources and spending from development to clinical activities, focusing on executing a statistically powered multi-center prospective clinical trial [8][16] - Initial data collection for the clinical program is limited to three pilot sites, with data already acquired on 25 subjects [13] Market Data and Key Metrics Changes - The company is revisiting its go-to-market strategy for the TAEUS liver device, indicating that hepatology may not be the primary target market [10] Company Strategy and Development Direction - The company plans to implement six specific changes to enhance operations, including a stronger operating team, a new approach with the FDA, and improved financial execution [5][11] - The strategic direction will focus on adding more value to customers beyond the liver fat test, aiming to become a metabolic disease biomarker company [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the technology and market opportunity, anticipating improved performance following the implementation of the six initiatives [21] - The goal is to complete the clinical study this year and initiate a pivotal study early next year, with a submission targeted for mid-2025 [19] Other Important Information - The company has issued five additional patents during the second quarter, bringing the total to 81 issued patents globally [13][14] - The management team has been enhanced with experienced operators to navigate the company through its critical phase [6][7] Q&A Session Summary Question: How quickly will the new strategic path be implemented? - Management indicated a clear priority for the next 9 to 12 months, focusing on completing the clinical study and preparing for regulatory submission [17] Question: Is there a specific time in 2025 for the FDA application? - Management stated that the goal is to complete the clinical study this year and submit the application by mid-2025, although no specific date was provided [19]

Financial Performance - The net loss for the three months ended June 30, 2024, was $2,229,153, an improvement from a net loss of $2,557,132 for the same period in 2023[87]. - The net loss for the six months ended June 30, 2024, was $5,004,853, an improvement from a net loss of $5,499,878 for the same period in 2023[91]. - As of June 30, 2024, the accumulated deficit was $96,935,005, with cash reserves of $6,400,732, indicating a need for additional funding to support operations[92]. - Other income significantly dropped to $6,541 for the six months ended June 30, 2024, from $434,015 for the same period in 2023, primarily due to the completion of the Employer Retention Tax Credit[91]. Expenses - Research and development expenses decreased by 49% to $716,366 for the three months ended June 30, 2024, compared to $1,400,182 for the same period in 2023[85]. - Sales and marketing expenses decreased by 34% to $162,952 for the three months ended June 30, 2024, compared to $247,773 for the same period in 2023[85]. - General and administrative expenses increased slightly by 0% to $1,351,535 for the three months ended June 30, 2024, compared to $1,346,610 for the same period in 2023[86]. - Research and development expenses for the six months ended June 30, 2024, were $1,757,892, a decrease of 37% from $2,791,496 for the same period in 2023[88]. - Sales and marketing expenses decreased by $27,777, or 6%, to $401,612 for the six months ended June 30, 2024, compared to $429,389 for the same period in 2023[20]. - General and administrative expenses increased by $138,882, or 5%, to $2,851,890 for the six months ended June 30, 2024, compared to $2,713,008 for the same period in 2023[90]. - Cash used in operating activities was $4,227,613 for the six months ended June 30, 2024, compared to $4,775,442 for the same period in 2023[95]. Future Plans - The company plans to continue incurring research and development expenses as it focuses on the commercialization of the TAEUS product[79]. - The company anticipates completing necessary clinical studies by Q4 2024 or Q1 2025 and submitting a new de novo request to the FDA in the first half of 2025[77]. - The company is building a small sales and marketing team to support global ultrasound distributors and plans to expand sales efforts in the U.S. post-FDA approval[80]. - The company plans to advance the engineering design and development of its TAEUS technology, which will incur significant expenses in the foreseeable future[98]. - The company is considering financing options, including sales of common stock, to support its commercialization plans for the TAEUS technology[93]. Regulatory and Compliance - The company received CE mark approval for the TAEUS FLIP System in March 2020, allowing marketing in the European Union[76]. - A material weakness in internal control over financial reporting was identified due to insufficient personnel resources within the accounting function[103]. Financing Activities - Financing activities generated $1,148,470 from common stock issuances and $6,687,248 from warrant exercises during the six months ended June 30, 2024[97].