NDRA 10-K & 10-Q changes, risk factors and insider trading

Investing in our common stock involves a high degree of risk. You should carefully consider the following risks and all other information contained in this Annual Report, including our financial statements and the related notes, before investing in our securities. The risks and uncertainties described below are not the only ones we face but include the most significant factors currently known by us that make investing in our securities speculative or risky. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, also may become important factors that affect us. If any of the following risks materialize, our business, financial condition and results of operations could be materially harmed. In that case, the trading price of our securities could decline, and you may lose some or all of your investment. The risks and uncertainties described below reflect the Company’s beliefs and opinions as to factors that could materially and adversely affect the Company and its securities in the future. References to past events are provided by way of example only and are not intended to be a complete listing or a representation as to whether or not such factors have occurred in the past or their likelihood of occurring in the future.

We are experiencing financial and operating challenges. We have only generated limited revenues to date and have a history of losses from operations. As of December 31, 2024,2025, we had an accumulated deficit of $103.4$110.4 million. Our independent registered public accounting firm, in its report on our financial statements for the year ended December 31, 2024,2025, has raised substantial doubt about our ability to continue as a going concern. To remain viable, we will require additional capital in the near term to proceed with the commercialization of our planned TAEUS applications and to meet our growth targets. Our near-term capital needs include supporting the hiring of personnel, payroll and benefits, continued scientific and potential product research and development, clinical studies to support ouran FDA deDe novoNovo submission, expenses associated with the development of relationships with strategic partners, intellectual property development and prosecution, funding the costs of seeking regulatory approval of TAEUS applications, expanding our sales and marketing infrastructure, capital expenditures, working capital, responses to business opportunities, and general and administrative expenses.

We are actively exploring additional sources of liquidity and may seek to raise such capital through, among other means, public or private equity offerings (including sales of our common stock under our at-the-market equity offering program), debt financings, corporate collaborations and/or licensing arrangements. However, general market conditions or the market price of our common stock may not support these capital raising transactions on terms favorable to us, or at all. If we are unable to obtain adequate financing or financings on terms satisfactory to us when we require it, we will be forced to undertake capital preservation measures that may include delaying or reducing our product development programs and commercialization efforts, materially curtailing or eliminating our operations, selling or disposing of our rights or assets, pursuing a sale or other strategic transactions, or undergoing restructuring or insolvency proceedings. Factors that could limit our ability to raise additional capital after this offering include, among other matters:

To date, we have financed our operations through the net proceeds from offerings offeringsof shares of common and preferred stock, warrants and convertible notes. Our future funding requirements will depend on many factors, including, but not limited to:

We may not be able to successfully execute our TAEUS business model.

In August 2024, we announced a new management team and laid out strategic steps to become a more actionable and predictable company as we work towards bringing the Company’s TAEUS technology to market. We are a company with limited operating history and we may not have the necessary resources, expertise and experience to successfully execute our TAEUS business model on a global scale, such as obtaining the necessary approvals or clearances from the regulatory agencies of our target markets. Our ability to execute our model is dependent on a number of factors, including the ability of our senior management team to execute our model, our ability to incentivize, train and support international distribution partners in different geographic regions, our ability to begin or maintain our pace of product development, manufacturing and commercialization, our ability to meet the changing needs of the medical imaging market, and the ability of our employees to perform at a high-level. If we are unable to execute our model, or if our model does not drive the growth that we anticipate, or if our TAEUS market opportunity is not as large as we have estimated, it could adversely affect our business and our prospects.

If the Company’s products are used by non-licensed or untrained practitioners, it could result in product misuse and adverse treatment outcomes, which could harm the Company’s reputation and the Company’s business. The Company’s products may be purchased or operated by physicians with varying levels of training, and in many states, by non-physicians, including [nurse practitioners and] technicians.non-physicians. Outside the U.S., many jurisdictions do not require specific qualifications or training for purchasers or operators of its products. The Company will not be able to supervise the procedures performed with the Company’s applications, nor does the Company require that direct medical supervision occur that is determined by state law. The Company and its distributors intend to offer but do not require product training to the purchasers or operators of the Company’s products. In addition, the Company may sell its systems to companies that rent its systems to third parties and that provide a technician to perform the procedures. The lack of training and the purchase and use of its products by non-physicians may result in product misuse and adverse treatment outcomes, which could harm the Company’s reputation and its business, and, in the event these actions result in product liability litigation, distract management and subject the Company to liability, including legal expenses.

We discontinued our initial pre-clinical Nexus 128 product in 2019 and our TAEUS liver device has previously obtained CE mark approvalcertification but has not yet been fully commercialized. This limited commercial experience makes it difficult to evaluate our business, predict our future results or forecast our financial performance and growth. If our assumptions regarding the risks and uncertainties we face, which we use to plan our business, are incorrect or change due to circumstances in our business or our markets, or if we do not address these risks successfully, our operating and financial results could differ materially from our expectations and our business could suffer.

We have formed, and may in the future form or seek, strategic alliances and collaborations or enter into licensing arrangements, and we may not realize the benefits of such alliances, collaborations or licensing arrangements.

Our competitors include producers of CT and MRI systems that include multi-nationalmultinational corporations such as Royal Philips, Siemens AG and Fujifilm Corporation, many of whom also manufacture and sell ultrasound equipment. In the MASLD diagnosis market we will compete with makers of surgical biopsy tools, such as Cook Medical and Sterylab S.r.l. In the thermal ablation market, we will compete with manufacturers of surgical temperature probes, such as Medtronic plc and St. Jude Medical, Inc. These competitors and other potential competitors have substantially greater financial, technical and other resources, such as larger R&D staff, more robust manufacturing capabilities and more experienced marketing and manufacturing organizations. These competitors may succeed in developing, acquiring or licensing on an exclusive basis, products that are more effective or less costly than TAEUS applications that we may develop, or achieve earlier patent protection, regulatory approval, product commercialization and market penetration than us. Additionally, technologies developed by our competitors may render our potential product candidates uneconomical or obsolete, and we may not be successful in marketing our product candidates against those of our competitors.

We are exposed to the risk of fraud, misconduct or other illegal activity by our employees, independent contractors, consultants, commercial partners and vendors. Misconduct by these parties could include intentional, reckless and negligent conduct that fails to: comply with the FD&C Act and similar laws of other countries, or the rules and regulations of the FDA and other similar foreign regulatory bodies; provide true, complete and accurate information to the FDA and other similar foreign regulatory bodies; comply with manufacturing standards we establish; comply with healthcare fraud and abuse laws in the United States and similar foreign fraudulent misconduct laws; or report financial information or data accurately or to disclose unauthorized activities to us. For any products for which we obtain regulatory approval and begin commercializing in Europe or the United States, respectively, our potential exposure under such laws will increase significantly, and our costs associated with compliance with such laws are also likely to increase. In particular, the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices. Our sales team in the European Union marketing our TAEUS liver probe are subject to these laws, as well as regulations that restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commissions, certain customer incentive programs and other business arrangements generally. It is not always possible to identify and deter misconduct by employees and other parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions.

Public health crises, such as COVID-19 or other similar pandemics in the future,crises can adversely impact our business, including our pre-sales activities, clinical trials and ability to obtain regulatory approvals.

We are currently in a transitional period, where our existing certified products will be required to continue to comply with applicable medical device directives (including the Medical Devices Directive and the Active Implantable Medical Devices Directive) and with the Medical Device Regulation to obtain CE mark certification in order to continue or commence marketing medical devices. The CE mark is applied following certification from a Notified Body or declaration of conformity. It is an international symbol of adherence to quality assurance standards and compliance with applicable European Medical Devices Directives or the MDR, as the case may be. CE mark approvals issued prior to May 26, 2021 for Class IIa medical devices will, subject to certain conditions (including, among others, continued compliance with the MDR, no significant changes to design or intended purpose, a quality management system, and engagement with a notified body to obtain conformity assessment), remain valid until December 31, 2028. In March 2020, we received CE mark approval for our TAEUS FLIP (Fatty Liver Imaging Probe) System. The CE marking indicates that TAEUS complies with all applicable regulations in the EU, and other CE mark geographies, including the 27 EU member states. We believe that future TAEUS applications will qualify for sale in the European Union as Class IIa medical devices. The MDR requires a clinical evaluation for all medical devices and clinical trials for selected medical devices to be (re-)certified under the rules of the MDR. Depending on the classification of our applications, future CE mark certifications or recertification of our applications may require additional clinical evaluations or trials, as the case may be.

Although our common stock is traded on the Nasdaq Capital Market, the volume of trading has historically been limited. Our average daily trading volume of our shares from January 1, 20242025 to December 31, 2024 (on an adjusted basis taking into account the August Reverse Split and November Reverse Split)2025 was approximately 98,294531,026 shares. Thinly tradedThinly-traded stock can be more volatile than stock trading in a more active public market. While we have made efforts to increase trading in our stock, we cannot predict the extent to which an active public market for our common stock will develop or be sustained. Therefore, a holder of our common stock who wishes to sell his or her shares may not be able to do so immediately or at an acceptable price.

Sales and marketing expenses consist primarily of headcount and consulting costs,costs. andWe marketinghave andsignificantly tradeshow expenses. Currently,reduced our sales and marketing effortsexpenses areas primarilypart business development - generating awareness through meetings with research institutions,of our websitecost andreduction attendancemeasures. In the event we obtain FDA approval of keyour industryTAEUS meetingsliver and conferences. As of December 31, 2024, we had a full-time sales engineer in France and a part-time, contracted, business development executive in Germany. Upon FDA approval,device, we will seek to expand our sales & marketing efforts, primarily by adding a direct sales force and related expenses and costs.

General and administrative expenses consist primarily of salaries and related expenses for our management and personnel, and professional fees, such as for accounting, consulting and legal services. In 2024, general and administrative expenses also included a $2.4 million inventory reserve discussed further in Results of Operations.

Excluding this one-time charge, we anticipate that our general and administrative expenses will increase in the future as we support our continued research and development activities, expand our sales and marketing operations, and continue as a public company. These increases would likely include increased costs related to the hiring of personnel, including compensation and employee-related expenses, including stock-based compensation, and fees to outside consultants, lawyers and accountants, among other expenses. Additionally, weWe anticipate continued costs associated with being a public company, including expenses related to services associated with maintaining compliance with The Nasdaq Capital Market and SEC requirements, directors and officers insurance, increased legal and accounting costs and investor relations costs.

Management makes estimates that affect certain accounts including inventory reserve, deferred income tax assets, accrued expenses, fair value of equity instruments, warrant liability and reserves for any other commitments or contingencies. Any adjustments applied to estimates are recognized in the period in which such adjustments are determined.

The Company’s 2016 Omnibus Incentive Plan (the “Omnibus Plan”) permits the grant of stock options and other stock awards to our employees, consultants and non-employee members of our board of directors. Each January 1 the pool of shares available for issuance under the Omnibus Plan automatically increases by an amount equal to the lesser of (i) the number of shares necessary such that the aggregate number of shares available under the Omnibus Plan equals 25% of the number of fully-diluted outstanding shares on the increase date (assuming the conversion of all outstanding shares of preferred stock and other outstanding convertible securities and exercise of all outstanding options and warrants to purchase shares) and (ii) if the board of directors takes action to set a lower amount, the amount determined by the board. OnIn Januaryaddition, 1,on December 9, 2025, the stockholders approved the Second Amendment to the Omnibus Plan (the “Omnibus Plan Amendment The Omnibus Plan Amendment increased the pool of shares available for issuance by 3,200,000 shares of common stock. Due to these increases, the pool of shares issuable under the Omnibus Plan automaticallyshares increased by 178,033 shares from 1,738 shares to 179,4743,048,799 shares.shares Asas of December 31, 2024,2025. priorIn to such increase, there were 1,441 shareslight of commonthe stockincrease remaining available for issuance undereffected by the Omnibus Plan.Plan Amendment, no automatic increase to the pool was effected as of January 1, 2026.

Research and development expenses were $1,849,996 for the year ended December 31, 2025, as compared to $3,190,293 for the year ended December 31, 2024, as compared to $5,003,695 for the year ended December 31, 2023, a decrease of $1,813,402$1,340,297 or 36%. 42%. The costs include primarily wages, fees, consultants, contractors and equipment for the development of our TAEUS product line. Research and development expenses decreased from the prior year as we completed development of our initial TAEUS product and began focusing our spending on ensuringsmall thetrials clinicalto trials.test our results.

Our general and administrative expenses for the year ended December 31, 20242025 were $7,055,814,$3,723,635, compared to $4,696,486$7,055,814 for the year ended December 31, 2023,2024, ana increasedecrease of $2,359,328,$3,332,179, or 50%. 47%.

The primary driver of this increasedecrease was our inventory reserve. In 2024, in connection with a strategic shift under the direction of our new management team, we determined that we needed to redesign our TAEUS liver system to require less space, be simpler to use and be more cost effective. As a result, we performed a thorough assessment of the valuation of inventory as of December 31, 2024 and determined to record a non-cash charge to reserve against all inventory, as it may not be usable in connection with our redesigned system. This reserve totaled $2,525,179 as of December 31, 2024. Our reserve was $138,045$0 as of December 31, 2023.2025.

Other expenses were $690,800$1,264,309 for the year ended December 31, 20242025 primarily driven by changes in fair value of digital assets, non-cash warrant expense, changes in fair value of warrant liability and gain on settlement on warrant exercise.

For the year ended December 31, 2023,2024, we had other income expense of $460,485 which was$690,800 primarily thedriven resultby non-cash warrant expense, changes in fair value of thewarrant Employer Retention Tax Credit for employee retention in 2021liability and 2022gain on settlement on warrant exercise.

Since inception, we have incurred losses and expect to continue to incur losses for the foreseeable future. As of December 31, 2024,2025, we had an accumulated deficit of $103,438,099$110,465,509 and had $3,229,480 $762,365 in cash. To date we have funded our operations through private and public sales of our securities and will need to raise additional funds in order to execute on our business plan, fully commercialize our TAEUS technology, and generate revenues. IfIn 2026, we areimplemented cost unablereduction measures, including a reduction in headcount and prioritization of development activities over clinical ones, to obtainextend our adequateoperating financingrunway orand financingsfocus resources on product improvements and regulatory strategy for our TAEUS liver application. These actions are expected to impact the timing of certain development activities, including delaying the timing of a future De Novo submission to the FDA relating to our TAEUS liver application. Additionally, in March 2026, we announced that the nearBoard termhad oninitiated termsa satisfactoryprocess to us,evaluate a orrange atof all,strategic wealternatives mayincluding, bebut forcednot limited to undertakestrategic additionalinvestments, measures,mergers, whichbusiness maycombinations, include delayingin-licensing or collaboration reducingarrangements, ourasset product development programs and commercialization efforts, materially curtailingsales, or eliminating our operations, selling or disposing of our rights or assets, pursuing sale or othermerger strategicof transactions,the or undergoing restructuring or insolvency proceedings.Company.

We need additional capital to allow us to continue to execute our clinical trials and commercialization plans through the 20252026 and beyond. We are considering potential financing options that may be available to us, including sales of our common stock through our at-the-market sales program (the “ATM Program”) with Ascendiant Lucid Capital Markets, LLC.LLC, which are limited due to registration statement rules relating to public float. Except for the ATM Program, we have no commitments to obtain any additional funds, and there can be no assurance funds will be available in sufficient amounts or on acceptable terms. If we are unable to obtain sufficient additional financing in a timely fashion and on terms acceptable to us, our financial condition and results of operations may be materially adversely affected and we may not be able to continue operations or execute our stated commercialization plan.

During the year ended December 31, 2024,2025, we used $7,400,547 $5,182,558 of cash in operating activities primarily as a result of our net loss of $11,507,947,$7,027,410, offset by a non-cash charge for inventory reserve of $2,387,134, share-based compensation of $329,409, $571,924, the net effect of warrants of $799,284 (which includes warrant expense of $7,323,685, changeschange in fair value of warrant liability of ($3,447,737$319,537), andfair gainvalue onof settlementvested onadvisory warrantwarrants exerciseof $665,030, digital asset staking compensation of ($3,076,664)$5,121), changes in fair value of digital assets of $995,161, amortization of right of use assets of 159,683,$113,249, depreciation expense of $46,489, fixed assets write-off of $8,808,$44,045, and net changes in operating assets and liabilities of $134,079.$22,616.

During the year ended December 31, 2023,2024, we used $9,548,775 $7,400,547 of cash in operating activities primarily as a result of our net loss of $10,060,250,$11,507,947, offset by a non-cash charge for inventory reserve of $2,387,134, share-based compensation of $996,430,$571,924, the net effect of warrants of $799,284 (which includes warrant expense of $7,323,685, changes in fair value of warrant liability of ($3,447,737) and gain on settlement on warrant exercise of ($3,076,664)), amortization of right of use assets of $151,725, inventory reserve of $138,045,$159,683, depreciation expense of $123,726,$46,489, fixed assets write-off of $24,868,$8,808, and net changes in operating assets and liabilities of $(923,319).$134,079.

We have not completed the commercialization of any of our TAEUS technology platform applications. WeTo the extent we continue the development and commercialization of our TAEUS technology, we would expect to continue to incur significant expenses for the foreseeable future. We anticipate that our expenses may increase as we:

It is possible that we will not achieve the progress that we expect because the actual costs and timing of completing the development and regulatory approvals for a new medical device are difficult to predict and are subject to substantial risks and delays. We have no committed external sources of funds except for the February 2024 ATM Agreement, Program, the use of which is limited due to registration statement rules relating to public float. We do not expect that our existing cash will be sufficient for us to complete the commercialization of our TAEUS application or to complete the development of any other TAEUS application and we will need to raise additional capital for those purposes. As a result, we will need to finance our future cash needs through public or private equity offerings, debt financings, corporate collaboration and licensing arrangements or other financing alternatives. Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors, including the factors discussed in the Risk Factors section of this Annual Report on Form 10-K. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect.

Until we can generate a sufficient amount of revenue from our TAEUS platform applications, if ever, we expect to finance future cash needs through public or private equity offerings, debt financings or corporate collaborations and licensing arrangements. Additional funds may not be available when we need them on terms that are acceptable to us, or at all. If adequate funds are not available, we may be required to delay, reduce the scope of or eliminate one or more of our research or development programs or our commercialization efforts or perhaps even cease the operation of our business. To the extent that we raise additional funds by issuing equity securities, our stockholders may experience additional dilution, and debt financing, if available, may involve restrictive covenants. To the extent that we raise additional funds through collaborations and licensing arrangements, it may be necessary to relinquish some rights to our technologies or applications or grant licenses on terms that may not be favorable to us. We may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time. As described above under “Near-Term Liquidity and Capital Resources,” the Board initiated a process to review strategic alternatives for the Company.

ThereOther than as set forth below, there have been no material changes to our Risk Factors as therein previously reported.

As used in this Quarterly Report on Form 10-Q (this “Form 10-Q”), unless the context otherwise requires, the terms “we,” “us,” “our,” “ENDRA” and the “Company” refer to ENDRA Life Sciences Inc., a Delaware corporation, and its direct and indirect subsidiaries. The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our historical financial statements and related notes thereto in this Form 10-Q. This Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “would,” “seek,” “intend,” “plan,” “estimate,” “anticipate” or other comparable terms. All statements other than statements of historical facts included in this Form 10-Q, including those regarding our strategies, prospects, financial condition, operations, costs, plans and objectives, are forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding expectations for revenues, cash flows and financial performance, the anticipated results of our development efforts and the timing for receipt of required regulatory approvals and product launches. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in, or implied by, the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: our limited commercial experience, limited cash and history of losses; our ability to obtain adequate financing to fund our business operations in the future; our ability to achieve profitability; delays and changes in regulatory requirements, policy and guidelines, including potential delays in submitting required regulatory applications or other submissions with respect to U.S. Food and Drug Administration (“FDA”) or other regulatory agency approval; our ability to obtain and maintain required CE mark certifications and secure required FDA and other governmental approvals for our Thermo-Acoustic Enhanced Ultrasound (“TAEUS”) applications; our ability to develop any commercially feasible applications based on our TAEUS technology; market acceptance of our technology; the effect of macroeconomic conditions on our business; results of our human studies, which may be negative or inconclusive; our ability to find and maintain development partners; our reliance on third parties, collaborations, strategic alliances and licensing arrangements to complete our business strategy; the amount and nature of competition in our industry; our ability to protect our intellectual property; potential changes in the healthcare industry or third-party reimbursement practices; our ability to comply with regulation by various federal, state, local and foreign governmental agencies and to maintain necessary regulatory clearances or approvals; our ability to regain compliance with Nasdaq listing standards; our ability to successfully execute on our digital asset treasury strategy; risks related to regulatory developments regarding digital assets and digital asset markets, which could adversely affect our business, financial condition, and results of operations; the volatile and unpredictable cycles in the digital asset industry; in the accounting treatment of digital assets; our dependence on our senior management team; the consummation of the Company’s proposed merger (the “Merger”) of its subsidiary with Noble Africa LLC, a wholly-owned subsidiary of ASP Isotopes, Inc. and intermediate holding Company for Renergen Limited (“Renergen”); the outcomes of various strategies and projects undertaken by Renergen; the potential impact of laws or government regulations or policies in South Africa or elsewhere; Renergen’s future capital requirements and sources and uses of cash; Renergen’s ability to obtain funding for its operations and future growth, including debt funding for Phase 2 of the Virginia Gas Project; Renergen’s reliance on the efforts of third parties; Renergen’s ability to complete Phase 1 and 2 of the Virginia Gas Project; the financial terms of any current and future commercial arrangements; Renergen’s ability to complete certain transactions and realize anticipated benefits from acquisitions and contracts; Renergen’s ability to comply with the terms of the loan and credit facilities of Renergen’s subsidiary Tetra4; the ability of Renergen and its subsidiaries to retain and hire key personnel; the volatility of LNG and liquid helium prices; Renergen’s success in discovering, estimating and developing natural gas and helium reserves; actions of competitors or regulators; limitations in the availability of, and costs of, supplies, materials, contractors and services that may delay the drilling or completion of wells or make such wells more expensive; the amount and timing of future development costs; uncertainties inherent in estimating quantities of natural gas and helium reserves and projecting future rates of production and timing of development activities; risks relating to the lack of capital available on acceptable terms to finance Renergen’s continued growth; the competitive nature of Renergen’s industry; the risk that the conditions to the closing or consummation of the proposed transactions are not satisfied, including the failure to timely obtain approval of the proposed Merger from ENDRA stockholders, if at all; the risk that the proposed financings are not completed in a timely manner, if at all; uncertainties as to the timing of the consummation of the proposed transactions and the ability of each of ENDRA and Noble to consummate the proposed transactions; risks related to ENDRA’s continued listing on Nasdaq until closing of the proposed transactions and the combined company’s ability to remain listed following the closing of the proposed transactions; the ability to obtain debt financing on terms that are favorable, or at all; the risk that Renergen does not receive funding from the U.S. DFC or Standard Bank SA or that such funding is delayed; risks related to ENDRA’s ability to correctly estimate its respective operating expenses and its respective expenses associated with the proposed transactions, as applicable, pending the closing of the proposed transactions, as well as uncertainties regarding the impact any delay in the closing would have on the anticipated cash resources of ENDRA, and other events and unanticipated spending and costs that could reduce ENDRA’s cash resources; risks related to the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the proposed transactions; the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the merger agreement; the effect of the announcement or pendency of the proposed Merger on ENDRA’s or Renergen’s business relationships, operating results and business generally; costs related to the proposed Merger; risks related to the market price of ENDRA’s common stock relative to the value suggested by the proposed Merger; the outcome of any legal proceedings that may be instituted against ENDRA, Noble or any of their respective directors, managers, or officers related to the proposed transactions; costs of the proposed transactions and unexpected costs, charges or expenses resulting from the proposed transactions; changes in regulatory requirements and government incentives; risks associated with the possible failure to realize, or that it may take longer to realize than expected, certain anticipated benefits of the proposed transactions, including with respect to future financial and operating results, legislative, regulatory, political and economic developments, and those uncertainties and factors; and the risk of involvement in litigation, including securities class action litigation, that could divert the attention of the management of ENDRA or the combined company, harm the combined company’s business and may not be sufficient for insurance coverage to cover all costs and damages; and the other risks and uncertainties described in the Risk Factors section of our Annual Report on Form 10-K for the period ended December 31, 2025, as filed with the Securities and Exchange Commission (“SEC”) on March 31, 2026, and in the Management’s Discussion and Analysis of Financial Condition and Results of Operations section of this Form 10-Q. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

No revenue has been generated by our TAEUS technology, which we have not commercially sold as of MarchJune 31,30, 2026.

The Company’s 2016 Omnibus Incentive Plan (the “Omnibus Plan”) permits the grant of stock options and other share-based awards to its employees, consultants and non-employee members of the board of directors. Each January 1 the pool of shares available for issuance under the Omnibus Plan automatically increases by an amount equal to the lesser of (i) the number of shares necessary such that the aggregate number of shares available under the Omnibus Plan equals 25% of the number of fully-diluted outstanding shares on the increase date (assuming the conversion of all outstanding shares of preferred stock and other outstanding convertible securities and exercise of all outstanding options and warrants to purchase shares) and (ii) if the board of directors takes action to set a lower amount, the amount determined by the board. On January 1, 2025, the pool of shares issuable under the Omnibus Plan automatically increased by 178,033. In addition, on December 9, 2025, the stockholders of ENDRA Life Sciences Inc. (the “Company”) approved the Second Amendment to the Company’s 2016 Omnibus Incentive Plan (the “Omnibus Plan Amendment”) at the 2025 Annual Meeting of the Company’s Stockholders (the “Annual Meeting”). That Amendment increased the pool of shares available for issuance by 3,200,000 shares of common stock. Due to these increases, the pool of shares issuable under the Omnibus Plan shares increased from 1,738 shares to 3,048,7993,379,771 shares as of December 31, 2025. In light of the increase effected by the Omnibus Plan Amendment, no automatic increase to the pool was effected as of March 31,January 1, 2026. As of MarchJune 31,30, 2026, there were 3,019,525 shares of common stock remaining available for issuance under the Omnibus Plan.

Three months ended MarchJune 31,30, 2026 and 2025

We had no revenue during the three months ended MarchJune 31,30, 2026 and 2025.

We had no cost of goods sold during the three months ended MarchJune 31,30, 2026 and 2025.

Research and development expenses were $776,410$233,665 for the three months ended MarchJune 31,30, 2026, as compared to $528,685$381,061 for the three months ended MarchJune 31,30, 2025, ana increasedecrease of $247,725,$147,396, or or 47%.39%. The costs include primarily wages, fees, equipment and third-party costs for the development of our TAEUS product line. Research and development expenses increaseddecreased from the prior year as we complete development of our initial TAEUS product and began focusing our spending on clinical trials and commercialization of the product that has been developed.product.

Sales and marketing expenses were $4,278$5,813 for the three months ended MarchJune 31,30, 2026, as compared to $68,991$68,834 for the three months ended MarchJune 31,30, 2025, a decrease of $64,713,$63,021, or 94%.92%. The costs include primarily headcount and pre-selling activities for our TAEUS product line. Sales and marketing expenses decreased largely due to continued reductions in expenses resulting from our restructuring in the second quarter of 2024 and first quarter of 2026. Currently, our marketing efforts are through our website and attendance of key industry meetings.

Our general and administrative expenses for the three months ended MarchJune 31,30, 2026 were $1,393,060,$1,243,778, compared to $871,606$851,195 for the three months ended MarchJune 31,30, 2025, an increase of $521,454,$392,583, or 60%.46%. Our wage and related expenses for the three months ended MarchJune 31,30, 2026 were $779,125,337,240, compared to $368,607$239,866 for the three months ended MarchJune 31,30, 2025. Wage and related expenses in the three months ended MarchJune 31,30, 2026 included $574,451$228,429 of stock compensation expense related to the issuance and vesting of options and RSUs for the three months ended MarchJune 31,30, 2026. Our professional fees, which include legal, audit, and investor relations, for the three months ended MarchJune 31,30, 2026 were $387,231,$721,203, compared to $305,860$413,954 for the three months ended MarchJune 31,30, 2025.

Other expenseincome of $862,315$1,643,200 for the three months ended MarchJune 31,30, 2026 was primarily due to changes in fair value of warrant liability and digital assets. Other expenseincome was $432,952$75,178 for the the three months ended MarchJune 31,30, 2025, an increase of $429,363,$1,568,022, or 99%,2086%, due to changes in fair value of warrant liability and digital assets. assets. For the three months ended MarchJune 31,30, 2026, there were changes in fair value of warrant liability of $(8,85766,702) and changes,changes in fair value of digital assets of $859,761.$1,700,247, and digital asset staking compensation of $9,700.

As a result of the foregoing, for the three months ended MarchJune 31,30, 2026, we recorded a net lossincome of $1,311,433,$159,944, compared to a net loss of $1,036,330$1,225,912 for the three months ended MarchJune 31, 30, 2025.

We are experiencing financial and operating challenges. Since inception, we have incurred losses and expect to continue to incur losses for the foreseeable future. As of MarchJune 31,30, 2026, we had an accumulated deficit of $111,776,942$111,616,998 and had $356,462$5,539,946 in cash.cash, approximately $3.8 million of which is subject to restrictions on use pursuant to a deposit account control agreement acceptable to the Company and LHE LNG Holdings, LLC (the “Purchaser”), an affiliate of ASP Isoptopes Inc. (as described below). To date we have funded our operations through private and public sales of our securities and will need to raise additional funds in order to execute on our business plan, fully commercialize our TAEUS technology, and generate revenues. In the threesix months ended MarchJune 31,30, 2026, we implemented cost reduction measures, including a reduction in headcount and prioritization of development activities over clinical ones, to extend our operating runway and focus resources on product improvements and regulatory strategy for our TAEUS liver application. These actions are expected to impact the timing of certain development activities, including delaying the timing of a future De Novo submission to the FDA relating to our TAEUS liver application. Additionally, in March 2026, we announced that the Board had initiated a process to evaluate a range of strategic alternatives including, but not limited to strategic investments, mergers, business combinations, in-licensing or collaboration arrangements, asset sales, or sale or merger of the Company.

WeIf we do not consummate the Merger, we may be required to return all or a portion of the proceeds from the May 2026 Private Placement to LHE and we would need additional capital to allow us to continue to execute our clinical trials and commercialization plans through 2026 and beyond. WeIf arewe consideringdo not consummate the Merger, we will consider additional potential financing options that may be available to us, including sales of our common stock through our at-the-market sales program (the “ATM Program”) with Lucid Capital Markets, LLC,LLC (“Lucid”), which are limited due to registration statement rules relating to public float. Except for the ATM Program, we have no commitments to obtain any additional funds, and there can be no assurance funds will be available in sufficient amounts or on acceptable terms. If we are unable to obtain sufficient additional financing in a timely fashion and on terms acceptable to us, our financial condition and results of operations may be materially adversely affected and we may not be able to continue operations or execute our stated commercialization plan.

The consolidated financial statements included in this Form 10-Q have been prepared assuming we will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. As reflected in the accompanying consolidated financial statements, during the threesix months ended MarchJune 31,30, 2026, we incurred net losses of $1,311,433$1,151,489 and used cash in operations of $1,119,650.$2,047,210. In light of our cash balance as of June March 31,30, 2026, if we do not consummate the Merger, we will need to raise additional capital in order to fund operations through the next twelve twelve months, and prior to any ability to fund operations from revenue generated from the sale of our products. The financial statements do do not include any adjustments that might be necessary should we be unable to continue as a going concern.

During the threesix months ended MarchJune 31,30, 2026, we used $1,119,650$2,047,210 of cash in operating activities primarily as a result of our net loss of $1,311,433,$1,151,489, offset by share-based compensation of $574,451,$1,116,355, amortization of right of use assets of $30,223,61,232, depreciation expense of $9,492,$17,648, change in fair value of warrant liability of $8,857,$75,559, digital asset staking compensation of $(11,06020,760), change in fair value of digital assets of $(859,7612,560,008) and net changes in operating assets and liabilities of $439,581.$487,234.

During the threesix months ended MarchJune 31,30, 2026, we weused $18,670 in investing activities related to purchases of fixed assets and received $450,000$2,685,775 in proceeds from the sale of digital intangible assets. During the threesix months ended MarchJune 31,30, 2025, we used $17,280 in investing activities related to purchases of fixed assets.

During the threesix months ended MarchJune 31,30, 2026, our our financing activities provided $263,747$4,157,686 in proceeds from issuances of common stock. During the threesix months ended MarchJune 31,30, 2025, our financing financing activities provided $145,803$1,003,218 in proceeds from issuances of common stock.

It is possible that we will not achieve the progress that we expect because the actual costs and timing of completing the development and regulatory approvals for a new medical device are difficult to predict and are subject to substantial risks and delays. We have no committed external sources of funds except for our at-the-marketATM offering programProgram with Lucid Capital Markets, LLC,Lucid, the use of which may be limited due to registration statement rules relating to public float. Our existing cash will not be sufficient for us to complete the commercialization of our TAEUS application, or to complete the development of any other TAEUS application and we will need to raise substantial additional capital for those purposes. As a result, if we do not consummate the Merger, we will need to finance our future cash needs through public or private equity offerings, debt financings, corporate collaboration and licensing licensing arrangements or other financing alternatives. Our forecast of our financial resources is a forward-looking statement and involves risks risks and uncertainties, and actual results could vary as a result of a number of factors, including the factors discussed in the Risk Factors Factors section of our Annual Report on Form 10-K for the year ended December 31, 2025. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect.

Until we can generate a sufficient amount of revenue from our TAEUS platform applications, if ever, if we do not consummate the Merger, we expect to finance future cash needs through public or private equity offerings, debt financings or corporate collaborations and licensing arrangements. Additional funds may not be available when we need them on terms that are acceptable to us, or at all. If adequate funds are not available, we may be required to cease the operation of our business. To the extent that we raise additional funds by issuing equity securities, our stockholders may experience additional dilution, and debt financing, if available, may involve restrictive covenants. To the extent that we raise additional funds through collaborations and licensing arrangements, it may be necessary to relinquish some rights to our technologies or applications or grant licenses on terms that may not be favorable to us. We may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time. As described above under “Near-Term Liquidity and Capital Resources,” the Board initiated a process to review strategic alternatives for the Company.

At MarchJune 31,30, 2026, the Company did not have any transactions, obligations or relationships that could be considered off-balance sheet arrangements.