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

In our December 31, 20242025 consolidated financial statements, we have concluded and stated our recurring losses from operations, recurring cash flows used in operations and the requirement we raise additional capital in order to fund our ongoing operations beyond March 2026 2027 raise substantial doubt regarding our ability to continue as a going concern. Additionally, our independent registered public accounting firm’s report on our consolidated financial statements includes an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern. Our plans to address this going concern risk include pursuing further financings in addition to the recently completed offering of our Registered Direct Offering (in which we realized net proceeds of approximately $14.5 million) and pursuing additional offerings of debt and/or equity securities. The consolidated financial statements do not include any adjustments that might result from our inability to consummate such offerings or our ability to continue as a going concern. Moreover, there is no assurance if we consummate additional offerings, we will raise sufficient proceeds in such offerings to pay our financial obligations as they become due. These factors raise substantial doubt about our ability to continue as a going concern.

In August 2024, we entered into an a ninth amendment to the management services agreementMSA with PAVmed (the “MSA”),PAVmed, pursuant to which PAVmed may elect to receive payment of the monthly fee under the management services agreement in cash or in shares of our common stock valued at a price based on the current market price, subject to a floor price and a maximum number of shares. Under the amendment, the monthly fee due from the Company to PAVmed was increased from $0.83 million to $1.05 million.million In(the accordanceparties withalso entered in a tenth amendment to the MSA andin December 2025, to provide for a one-time increase in the PBERA,monthly fee by an additional $1.2 million, to cover certain one-time employee-related expenses paid by PAVmed on January 26, 2024, PAVmed elected to receive payment of $4.675 million of fees and reimbursements accrued under the MSA and the PBERA through the issuance of 3,331,771 sharesbehalf of the Company’s common stock.Company). To the extent PAVmed elects for us to satisfy our obligations under the MSA and PBERA in shares of our common stock in the future, the interest of other shareholders of the Company would be diluted. Currently, under the terms of its outstanding convertible debt, PAVmed is required to elect to receive such payments in cash.

Furthermore, we have issued and expect to continue to issue equity awards, including stock options, under our 2018 Long-Term Incentive Equity Plan (the “Lucid Diagnostics Inc. 2018 Equity Plan”) and our Employee Stock Purchase Plan (the “Lucid Diagnostics Inc. ESPP”). In addition, inMay March2025, 2022,the weCompany entered into a committedControlled equityEquity facilityOffering with an affiliate of Cantor. Under the terms of the facility, Cantor has committed to purchase up to $50 million in shares of our common shares stock from time to time at the our requestAgreement (althoughATM) thisbetween facilityus terminates onand AugustMaxim 1,Group 2025, which is the first of the month following the 36-month anniversary of the effective date of the registration statement for the same). In November 2022, we also entered into an “at-the-market offering”LLC for up to $6.5$25.0 million of our common stock that may be offered and sold underfrom time to time (replacing a Controlledsimilar Equity Offering Agreement between us and Cantor (although effective as of March 4, 2025, the Company terminated the prospectus supplement for this offering and as a result,facility the Company willhad notpreviously makemaintained anywith sales of common stock in this offering unless and until a new prospectus or prospectus supplement is filedCantor). Also in November 2022, we entered into the PBERA with PAVmed, pursuant to which PAVmed will continue to pay certain payroll and benefit-related expenses on our behalf and we will reimburse PAVmed, in cash or, subject to approval by each of our boards of directors, in shares of our common stock valued at a price based on the current market price, subject to a floor price and a maximum number of shares.

Our future capital requirements depend on many factors, including our research, development, and sales and marketing activities. We intend to continue to make investments to support our business growth. Because we have not generated significant revenue or cash flow to date, and despite our recently having raised net proceeds of approximately $14.5 million in connection with our consummation in February 2025 of a registered direct offering, and $18.3 million in connection with the issuance in November 2024 of the 2024 Convertible Notes, we may require additional funds to:

Under our existing management services agreement and payroll and benefit expense reimbursement agreement with PAVmed, PAVmed may determine the form and timing of our satisfaction of our obligations under such agreements. To the extent PAVmed elects for this obligation to be paid in cash (which it is currently required to do under the terms of its convertible debt),cash, that would increase our need to raise additional capital. In this regard, because of the challenges PAVmed has faced in terms of raising capital itself, PAVmed has become highly dependent on us to fund its operations, primarily through electingelected for the payment in cash by us of our obligations under our management services agreement with PAVmed. PAVmed as means for funding its operations.

Our products may never achieve market acceptance.acceptance, despite our investment of significant time and resources to drive adoption.

Long-term adoption of our products as well as payment and coverage for them may depend on their recommendation in clinical practice guidelines. These include professional society guidelines published by gastroenterology specialty societies, such as the American College of Gastroenterology (ACG),ACG, the American Gastroenterological Association (AGA),AGA, and the American Society for Gastrointestinal Endoscopy ("ASGE"), internal medicine and family practice societies such as the American College of Physicians ("ACP") and American Academy of Family Physicians ("AAFP"), and oncology societies such as the American Cancer Society ("ACS"). These also include federal agencies and federally funded affiliates such as the U.S. Preventative Services Task Force (“USPSTF”) and the Agency for Healthcare Research & Quality (“AHRQ”). The recommendations in these clinical practice guidelines may shape payors’ coverage decisions.

Initially,For the foreseeable future, we will not directly manufacture our products and will rely on third parties to do so for us. If our manufacturing and distribution agreements are not satisfactory, we may not be able to develop or commercialize products as planned. In addition, we may not be able to contract with third parties to manufacture our products in an economical manner. Furthermore, third-party manufacturers may not adequately perform their obligations, may delay clinical development or submission of products for regulatory approval or otherwise may impair our competitive position. We may not be able to enter into or maintain relationships with manufacturers that comply with good manufacturing practices. If a product manufacturer fails to comply with good manufacturing practices, we could experience significant time delays or we may be unable to commercialize or continue to market the products. Changes in our manufacturers could require costly new product testing and facility compliance inspections. In the United States, failure to comply with good manufacturing practices or other applicable legal requirements can lead to federal seizure of violative products, injunctive actions brought by the federal government, and potential criminal and civil liability on the part of a company and its officers and employees. Because of these and other factors, we may not be able to replace our manufacturing capacity quickly or efficiently in the event that our manufacturers are unable to manufacture our products at one or more of their facilities. As a result, the sales and marketing of our products could be delayed or we could be forced to develop our own manufacturing capacity, which could require substantial additional funds and personnel and compliance with extensive regulations.

The manufacturing processes for our products have not yet been tested at large-scale commercial levels, and it may not be possible to manufacture or process these materials in a cost-effective manner.

Our ability to successfully carry out our business plan is dependent upon the efforts of our key personnel. We cannot assure you that any of our key personnel will remain with us for the immediate or foreseeable future. The unexpected loss of the services of our key personnel could have a detrimental effect on us. We may also be unable to attract and retain additional key personnel in the future. We are limited in shares available for issuance under our long-term incentive plan,evenplan, even taking into account the shareholder-approved annual increases, which could limit our ability to attract and retain key personnel. An inability to attract and retain key personnel may impact our ability to continue and grow our operations.

Despite our initiative to establish a robust cash-pay program, long-term successful commercialization of our EsoGuard test and EsoCheck device, and of any other product or service we develop, license or acquire depends, in large part, on the availability of adequate reimbursement from private or governmental third-party payors.

EsoGuard’s PLA code 0114U has been granted “gapfill” determination through the CMS CLFS process, allowing us to engage directly with Medicare Administrative Contractor (“MAC”) Palmetto GBA, whose Molecular Diagnostics Program (“MolDx”) performs technical assessment of molecular diagnostic tests on behalf of itself and other MACs. Although CMS granted EsoGuard final Medicare payment determination of $1,938.01, effective January 1, 2021, we have not received a final Medicare local coverage determination from MolDx. Most recently, in May 2023, a final Local Coverage Determination (“LCD”) L39256, entitled “Molecular Testing for Detection of Upper Gastrointestinal Metaplasia, Dysplasia, and Neoplasia” became effective on the CMS website by MAC Palmetto GBA. (A substantially identical LCD was published by Noridian Healthcare Solutions, the MAC whose geographic jurisdiction covers our CLIA laboratory in Lake Forest, CA.) The LCD outlines criteria for future coverage that MolDX expects upper gastrointestinal precancer and cancer molecular diagnostic tests to meet. These criteria include active GERD with at least two risk factors, as well as evidence of analytic validity, clinical validity, and clinical utility. Although the LCD indicated that it found that no currently existing test has fulfilled all these criteria, it indicated that it will “monitor the evidence and may revise this determination based on the pertinent literature and society recommendations.” In November 2024, we announced that we submitted to MolDx our complete clinical evidence package in support of a request for reconsideration of the non-coverage language in the LCD to secure Medicare coverage for EsoGuard. However, there can be no assurance that MolDx will determine that we meet the criteria for coverage as specified in the LCD. If we are not granted coverage, or if a determination is substantially delayed, that could have a material adverse effect on our ability to commercialize EsoGuard.

In addition, we and our cleared or approved products will be subject to extensive and ongoing regulatory requirements by FDA and other regulatory authorities with regard to the labeling, packaging, adverse event reporting, storage, advertising, promotion and recordkeeping for our products. We and our contract manufacturers also will be required to comply with current good manufacturing practice (“cGMP”) regulations regarding the manufacture of our products, which include requirements related to quality control and quality assurance as well as the corresponding maintenance of records and documentation. Further, regulatory authorities must approve these manufacturing facilities before they can be used to manufacture medical devices, and these facilities are subject to continual review and periodic inspections by FDA and other regulatory authorities for compliance with cGMP regulations. Operations at these facilities could be interrupted or halted if FDA or other governmental agency deems the findings of such inspections unsatisfactory.

If FDA determines that our labeling, advertising, promotional materials, or user training materials, or representations made by our personnel, include the promotion of an off-label use for the device, or that we have made false or misleading or inadequately substantiated promotional claims, or claims that could potentially change the regulatory status of the product, the agency could take the position that these materials have misbranded our devices and request that we modify our labeling, advertising, or user training or promotional materials and/or subject us to regulatory or legal enforcement actions, including the issuance of an Untitled Letter or a Warning Letter, injunction, seizure, recall, adverse publicity, civil penalties, criminal penalties, or other adverse actions. It is also possible that other federal, state, or foreign enforcement authorities might take action if they consider our labeling, advertising, promotional, or user training materials to constitute promotion of an unapproved use, which could result in significant fines, penalties, or other adverse actions under other statutory authorities, such as laws prohibiting false claims for reimbursement. In that event, we would be subject to extensive fines and penalties and our reputation could be damaged and adoption of the products would be impaired. Although we intend to refrain from statements that could be considered off-label promotion of our products, FDA or another regulatory agency could disagree and conclude that we have engaged in off-label promotion. In addition, any such off-label use of our products may increase the risk of injury to patients, and, in turn, the risk of product liability claims, and such claims are expensive to defend and could divert our management’s attention and result in substantial damage awards against us.

Many aspects of our business, beyond the specific elements described above, are subject to complex, intertwined, costly and/or burdensome federal and state health care laws and regulations which may open to interpretation and be subject to varying levels of discretionary enforcement. If we fail to comply with these laws and regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected.

Even though we do not and do not expect to control referrals of healthcare services or bill directly to Medicare, Medicaid or other third-party payors, certain federal and state healthcare laws and regulationsregulations, including those pertaining to fraud and abuse and patients’ rightsrights, are and will be applicable to our business. We could be subject to healthcare fraud and abuse and patient privacy regulation by both the federal government and the states in which we conduct our business. The regulations that may affect our ability to operate include, without limitation:

Billing for diagnostic and laboratory services is a complex process. Laboratories bill many different payors including patients, private insurance companies, Medicare, Medicaid, concierge medicine practices and employer groups, all of which have different billing requirements. We are continuing to work with third-party payors to cover and reimburse EsoGuard tests. If we are unsuccessful, we may not receive payment for EsoGuard tests we perform for patients on a timely basis, if at all, and we may not be able to provide services for patients with certain healthcare plans. We may face lawsuits by government or commercial payors if they believe they have overpaid us for our EsoGuard test services. Commercial payors may also audit our claims submitted to them, which audits could be costly and time-consuming, and may result in our having to return to payors any amounts they determined should not have been reimbursed. We may face write-offs of doubtful accounts, disputes with payors and patients, and long collection cycles. We may face patient dissatisfaction, complaints or lawsuits, including to the extent EsoGuard tests are not fully covered by insurers and patients become responsible for all or part of the price of the test. As a result, patient compliance in fulfilling prescriptions for EsoGuard could be adversely affected. To the extent patients express dissatisfaction with our billing practices to their physicians, those physicians may be less likely to prescribe EsoGuard for other patients, and our business would be adversely affected. Likewise, any such dissatisfaction expressed by the businesses or organization with whom we partner for our testing events could result in reputational harm within the communities in which we operate.

Further, changes in regulatory requirements and guidance may occur, both in the United States and in foreign countries, and we may need to amend clinical study protocols to reflect these changes. Amendments may require us to resubmit our clinical study protocols to an IRB for reexamination, which may impact the costs, timing or successful completion of a clinical study. In light of widely publicized events concerning the safety risk of certain drug and medical device products, regulatory authorities, members of Congress, the Governmental Accounting Office, medical professionals and the general public have all raised concerns about potential safety issues. These events have resulted in the recall and withdrawal of medical device products, revisions to product labeling that further limit use of products and establishment of risk management programs that may, for instance, restrict distribution of certain products or require safety surveillance or patient education. The increased attention to safety issues may result in a more cautious approach by FDA or other regulatory authorities to clinical studies and the medical device approval process. Adverse event data from clinical studies may receive greater scrutiny with respect to product safety, which may make FDA or other regulatory authorities more likely to terminate or suspend clinical studies before completion, or require longer or additional clinical studies that may result in substantial additional expense and a delay or failure in obtaining approval or approval for a more limited indication than originally sought.

PAVmed owns approximately 46% 27.5% as of December 31, 20242025 and 35%27.1% as of March 20,23, 20252026 of our issued common stock (with such percentage inclusive of shares of our common stock underlying granted but unvested restricted stock awards), but excluding the voting power of any convertible securities. Presently, Although presently PAVmed controls less than 50% of the combined voting power of our common stock and our convertible securities andsecurities, for as long as PAVmed is our largest shareholder, PAVmed will have significant influence in the election of all the members of our board of directors. In addition, as long as PAVmed continues to control more of our voting securities than any of our other shareholders, PAVmed will also have significant influence over any other action that requires shareholder approval. If PAVmed does not provide any requisite consent allowing us to take any such action when requested, we may not be able to engage in the related activities if we do not get the required consent from our other shareholders and, as a result, our business and our operating results may be harmed.

As a result of the exercise by the holder of PAVmed’s convertible debt and preferred stock of its rights under the agreements governing thosethat instruments,instrument, such holder could acquire voting control of the Company.

PAVmed currently has approximately $6.6 $15.0 million convertibleof debt outstanding, which matures in DecemberFebruary 2025, and has from time to time been in default of the financial covenants thereunder, although PAVmed has received a waiver of those financial covenants through December 31, 2025.2029. While the holder of such indebtedness has agreed in the past to waive any suchnon-compliance non-compliance,with the terms of other debt it has held, there can be no assurance that it will do so in the future. If the debtholder elects to accelerate PAVmed’s indebtedness rather than waiving any such non-compliance, it is likely PAVmed will not have sufficient cash on hand to pay the amounts due on an acceleration, in which case it may be required to satisfy its obligations through the transfer of its shares of common stock of the Company to such debtholder.

In any such event, the applicable holder in turn would be entitled to exercise the voting control with respect to any shares of our common stock that it acquires from, or controls through, PAVmed and may do so in a manner that could vary significantly from that of PAVmed.

We cannot assure you that such services are not available at lower cost from third parties. Any payments made to PAVmed will reduce our cash flow and profits. Currently,In under our MSA,2025, the annual fees payablepaid to PAVmed areunder $12.6the MSA were $13.8 million.

Our common stock is listed on the Nasdaq Capital Market. We are required to meet certain financial and liquidity criteria to maintain the listing of our common stock on Nasdaq (and we while we are currently in compliance with such requirements, from time to time we have failed otto comply with the Nasdaq’s minimum bid price requirement). If we violate the Nasdaq continued listing requirements or fail to meet any of Nasdaq’s continued listing standards, our common stock may be delisted. In addition, while we have no present intention to do so, our Board of Directors may determine that the cost of maintaining our listing on a national securities exchange outweighs the benefits of such listing.

We are obligated to pay dividends in shares of our common stock to the holders of shares of our Series BB-1 Preferred Stock and Series B-1 Preferred Stock, which stock dividendsdividend will dilute our existing shareholders.

Each holder of our Series B Preferred Stock and Series B-1 Preferred Stock is entitled to receive, on the one-year and two-year anniversaries anniversary of the issuance thereof, a dividend payable in shares of our common stock equal to 20% of the number of shares of common stock issuable upon conversion of the shares of preferred stock it then holds. Such stock dividendsdividend would be accelerated upon a mandatory conversion of our preferred stock in connection with certain change of control transactions. Such dividendsdividend will dilute the holdings of our existing stockholders.

As a public company, we will incur significant legal, accounting and other expenses that we would not incur as a private company. We will be subject to the reporting requirements of the Securities Exchange Act of 1934, as amended, the other rules and regulations of the Securities and Exchange Commission, or “SEC,” and the rules and regulations of Nasdaq. The expenses that will be required in order to adequately prepare for being a public company will be material, and compliance with the various reporting and other requirements applicable to public companies will require considerable time and attention of management. For example, the Sarbanes-Oxley Act and the rules of the SEC and national securities exchanges have imposed various requirements on public companies, including requiring establishment and maintenance of effective disclosure and financial controls. Our management and other personnel will need to devote a substantial amount of time to these compliance initiatives. These rules and regulations will continue to increase our legal and financial compliance costs and will make some activities more time-consuming and costly, and could also make it more difficult for us to attract and retain qualified personnel to serve on our Board of Directors, our board committees, or as executive officers.

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, or the JOBS Act, which was enacted in April 2012. For as long as we continue to be an emerging growth company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. We could be an emerging growth company for up to five years, although circumstances could cause us to lose that status earlier. We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year following the fifth anniversary of the completion of our initial public offering, offering (i.e., December 31, 2026), (2) the last day of the fiscal year in which we have total annual gross revenue of at least $1.07 billion, (3) the date on which we are deemed to be a large accelerated filer, which means the market value of our common stock that is held by non-affiliates exceeds $700.0 million as of the prior June 30th, and (4) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period. We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may suffer or be more volatile.

WeLucid areDiagnostics is a commercial-stage,commercial-stage cancer prevention medical diagnostics technology companycompany. Lucid is focused on the millions of patients with gastroesophageal reflux disease (“GERD”), also known as chronic heartburn, who are at risk of developing esophageal precancer and cancer, specifically highly lethal esophageal adenocarcinoma (“EAC”).

We believe that our flagship product, the EsoGuard Esophageal DNA Test, performed on samples collected with the EsoCheck Esophageal Cell Collection Device, constitutes the first and only commercially available diagnostic test capable of serving as a widespread testing tool forwith the early detectiongoal of esophageal precancer,preventing includingEAC Barrett’sdeaths, Esophagusthrough (“BE”), in at-risk patients. Earlyearly detection of esophageal precancer allows patients to undergo appropriate monitoring and treatment, as indicated by clinical practice guidelines, in anat-risk effortGERD to prevent progression to esophageal cancer.patients.

EsoCheck is an FDA 510(k) cleared and CE Mark clearedcertified noninvasive swallowable balloon capsule catheter device capabledesigned for in-office targeted sampling of sampling surface esophageal cells in a less than five-minute two minute long office procedure. It consists of a vitamin pill-sizedsized rigidsemi-rigid plastic capsule tethered to a thin silicone catheter from which a soft inflatable silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal. We believe this proprietary Collect+Protect™ technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling.

EsoGuard and EsoCheck are based on patented technology licensed by Lucid from Case Western Reserve University (“CWRU”). EsoGuard and EsoCheck have been developed to provide an accurate, non-invasive, patient-friendly testtesting for the early detection of EAC and BE, including dysplastic BE and related precursors pre-cursors to EAC in patients with gastroesophageal reflux disease (“GERD”), commonly known as chronic heartburn, acid reflux, or just reflux.GERD.

In November 2024, we submitted to MolDx our complete clinical evidence package in support of a request for reconsideration of the non-coverage language in the LCDLCD, to secure Medicare coverage for EsoGuard. The EsoGuard clinical evidence package included six new peer-reviewed publications: three clinical validation studies (two in the intended use population, one case control), two clinical utility studies, and one analytical validation study. The current LCD provides clear coverage criteria consistent with the American College of Gastroenterology (ACG)ACG, guidelines for esophageal precancer testing. The package was submitted as part of a request for reconsideration of the non-coverage language in the LCD to secure Medicare coverage for EsoGuard.

On March 13, 2025, the Company announced that Highmark Blue Cross Blue Shield, an independent licensee of the Blue Cross and Blue Shield Association, has issued a positive coverage policy for non-invasive screening of esophageal precancer and cancer in New York state. The new policypolicy, willwhich coverbecame effective as of May 26, 2025, covers EsoGuard in patients who meet established criteria for esophageal precancer testing consistent with professional society guidelines.

On September 11, 2025, the Company closed on the September 2025 Offering. The net proceeds of the September 2025 Offering, after deducting the estimated placement agent’s fees and other expenses of the$1.8 Offering,million, was approximately $14.5$27.0 million. The Company intends to use the net proceeds from the September 2025 Offering for working capital and other general corporate purposes.

Suspension of ATM Facility

General and administrative expenses consist primarily of professional fees for accounting, tax, audit and legal services (including those fees incurred as a result of our being a public company), consulting fees, employees costs involved in third-party payor reimbursement, expenses associated with obtaining and maintaining patents within our intellectual property portfolio, and certain employee costs, along with the portion of the MSA Fee allocated to general and administrative expenses.

The year ended December 31, 20242025 as compared to year ended December 31, 20232024 - continued

In November 2024, we submitted to MolDx our complete clinical evidence package in support of a request for reconsideration of the non-coverage language in the local coverage determination, or (“LCD,LCD”) to secure Medicare coverage for EsoGuard. The EsoGuard clinical evidence package included six new peer-reviewed publications: three clinical validation studies (two in the intended use population, one case control), two clinical utility studies, and one analytical validation study. The current LCD provides clear coverage criteria consistent with the American College of Gastroenterology, or (“ACG,ACG”) guidelines for esophageal precancer testing. The package was submitted as part of a request for reconsideration of the non-coverage language in the LCD to secure Medicare coverage for EsoGuard.

As part of the LCD reconsideration process, MolDx-participating Medicare Administrative Contractors convened a Contractor Advisory Committee, or (“CAC,CAC”) Meeting regarding the LCD on September 4, 2025. At the meeting, eleven experts, including physicians across multiple specialties (GI, primary care, pathology), major society guideline co-authors (ACG,American AGACollege (asof definedGastroenterology, below)American Gastroenterological Association) and industry leaders (American Foregut Society, American Society for Gastrointestinal Endoscopy), participated in this extensive discussion of the unmet clinical need with respect to early detection of esophageal precancer and the strength of the EsoGuard clinical validity and clinical utility data.

Subsequent to March 31, 2026, onOn April 24, 2026, the Company closed on the sale of 18,000,000 shares of its common stock at a price of $1.00 per share in a registered direct offering. The net proceeds of the offering, after deducting approximately $1.2 million of the underwriting discount and other estimated expenses, was approximately $16.8 million.

On May 30, 2025, the Company entered into an “at-the-market offering” (“ATM”) for up to $25.0 million of its common stock that may be offered and sold under a Controlled Equity Offering Agreement between the Company and Maxim Group LLC. In the threesix months ended MarchJune 31,30, 2026, the Company sold 4,161,747 shares through theirthe ATM equity facility for net proceeds of approximately $5.3 million, after payment of 3% commissions,commissions or approximately $0.2 million.

Other income and expense, net, consists principally of changes in fair value of our convertible notenotes and losses on extinguishment of debt upon repayment of such convertible note.notes.

All dollar amounts in this Management’s Discussion and Analysis of Financial Condition and Results of Operations are presented as dollars in millions, except for share and per share amounts.

The three months ended MarchJune 31,30, 2026 as compared to the three months ended MarchJune 31,30, 2025

In the three months ended MarchJune 31,30, 2026, revenue was approximately $1.3$1.5 million as compared to $0.8$1.2 million for the corresponding period in the prior year. The $0.5$0.3 million increase principally relates to the increase in consideration received for the performance of the EsoGuard tests.

In the three months ended MarchJune 31,30, 2026, the cost of revenue was relatively level at approximately $1.6$1.4 million,million as compared to $1.5 million for the corresponding period in the prior year. The $0.1 million decrease principally relates to a decrease in compensation costs.

In the three months ended MarchJune 31,30, 2026, sales and marketing costs were approximately $5.0$5.8 million as compared to $4.1$4.0 million for the corresponding period in the prior year. The net increase of $0.9$1.8 million was principally related to:

In the three months ended MarchJune 31,30, 2026, general and administrative costs were approximately $5.4$5.8 million as compared to $6.2$5.6 million for the corresponding period in the prior year. The net decreaseincrease of $0.8$0.2 million was principally related to:

In the three months ended MarchJune 31,30, 2026, research and development costs were approximately $1.2 million, compared to $1.4$1.3 million for the corresponding period in the prior year. The net decrease of $0.2$0.1 million was principally related to a decrease in development costs, particularly in clinical trial activities and outside professional and consulting fees.:

In the three months ended MarchJune 31,30, 2026, the amortization of acquired intangible assets remained relatively level at approximately $0.1 million, as compared to the corresponding period in the prior year.

In the three months ended MarchJune 31,30, 2026,2026 and 2025, the sequential increasechange in the fair value of our convertible notes of approximately $1.8$1.0 million and $6.9 million, respectively, is reflected as other expenseincome in the Statement of Operations,Operations (see Note 10, Debt, to our accompanying unaudited condensed consolidated financial statements). The 2024convertible Convertible Notesnotes were initially measured at the issue-date estimated fair value and are subsequently remeasured at estimated fair value as of each reporting period end date.

We are subject to all of the risks and uncertainties typically faced by medical device and diagnostic companies that devote substantially all of their efforts to the commercialization of their initial products and services. We experienced a net loss of approximately $13.9$25.6 million and used approximately $12.1$23.4 million of cash in operations during the threesix months ended MarchJune 31,30, 2026. Financing activities provided $5.5$22.3 million of cash during the threesix months ended MarchJune 31,30, 2026. We ended the quarter with cash on-hand of $27.9$33.4 million as of MarchJune 31,30, 2026. We expect to continue to experience recurring losses and negative cash flow from operations, and will continue to fund our operations with debt and/or equity financing transactions, which in accordance with management’s plans may include conversions of our existing debt to equity and refinancing our existing debt obligations to extend the maturity date. The Company’sOur ability to continue operations 12 months beyond the issuance of the accompanying financial statements will depend upon generating substantial revenue that is conditioned on obtaining positive third-party reimbursement coverage for itsour EsoGuard Esophageal DNA Test from both government and private health insurance providers, and increasing revenue through contracting directly with self-insured employers, and upon raising additional capital through various potential sources including equity and/or debt financings or refinancing existing debt obligations. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the accompanying unaudited condensed consolidated financial statements are issued.

On April 24, 2026, the Company closed on the sale of 18,000,000 shares of its common stock at a price of $1.00 per share (the “Offering”).share. The net proceeds of the offering, after deducting approximately $1.2 million of the underwriting discount and other estimated expenses, was approximately $16.8 million.

On May 30, 2025, the Company entered into an “at-the-market offering” (“ATM”) for up to $25.0 million of its common stock that may be offered and sold under a Controlled Equity Offering Agreement between the Company and Maxim Group LLC. In the threesix months ended MarchJune 31,30, 2026, the Company sold 4,161,747 shares through its at-the-market equity facility for net proceeds of approximately $5.3 million, after payment of 3% commissionscommissions, ofor approximately $0.2 million.

On November 22, 2024, the Company closed on the sale of $21.975 million in principal amount of 2024 Convertible Notes.Notes, as defined in Note 10, Debt, to our accompanying unaudited condensed consolidated financial statements. Each 2024 Convertible Note has a 12.0% annual stated interest rate, a contractual maturity date of five years from the date of issuance, and a contractual conversion price of $1.00 per share of the Company’s common stock (subject to adjustment in certain circumstances). Under the 2024 Convertible Notes, the Company is subject to certain customary affirmative and negative covenants, including certain financial covenants. The Company was in compliance with all covenants as of MarchJune 31,30, 2026. See Note 10, Debt, for more information.

The discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the amounts reporting in our unaudited condensed consolidated financial statements and accompanying notes. On an ongoing basis, we evaluate our estimates and judgements. In accordance with U.S. GAAP, we base our estimates on historical experience and on various other factors that are believed to be appropriate under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. Our critical accounting estimates are as disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 as filed with the SEC on March 25, 2026. There have been no material changes to our critical accounting estimates in the threesix months ended MarchJune 31,30, 2026.