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

Our operations have consumed substantial amounts of cash since inception. We expect to use our cash resources to develop and further commercialize our products, develop new products, and for working capital and general corporate purposes. We may require additional capital to further develop and commercialize our products and to develop new products. In addition, our operating plans may change as a result of many factors that may currently be unknown to us, and we may need to seek additional funds sooner than planned. We may seek additional capital through debt financings, equity financings, partner financings, and/or technology licensing agreements.

the impact of political instability and military conflict, such as the conflicts in Ukraine and the Middle East, which hashave resulted in instability in the global financial markets and export controls, and which has contributed to the increased cost of the magnet that is a key custom-made component in our Swoop® system and is manufactured by a single source supplier in Europe, and could result in further supply impacts on our business and have a material adverse impact on our sales in affected markets; and general industry, economic and market conditions and other factors, including factors unrelated to our operating performances or the operating performance of our competitors.

We have developed, and are engaged in the development of,of MRI solutions. We are commercializing our Swoop® system to address limitations of current imaging technologies. Our success will depend on the acceptance of our products and services in the United States and international healthcare markets. The marketplace may not be receptive to our products and services over competing products, including conventional MRI systems used in hospitals and imaging centers and physicians’ offices, and we may be unable to compete effectively. Factors that could affect our ability to successfully further commercialize our current products and services and to commercialize any potential future products and services include:

Revenue from non-U.S. countries was 51%23% of total revenue for the year ended December 31, 2024.2025. We believe that a substantial percentage of our future revenue will come from international sources as we continue to commercialize our products and services, having received marketing authorization for brain imaging in several countries, including the European Union (CE Mark), the United Kingdom (UKCA Mark), Canada, AustraliaAustralia, New Zealand and New Zealand.India. We expect to continue to seek regulatory authorization for our products in additional jurisdictions, and we seek to expand our sales and marketing opportunities internationally. Our success will depend, in part, upon our ability to succeed in differing legal, regulatory, economic, social and political conditions by developing, implementing and maintaining policies and strategies that are effective in each location where we do business. We have limited experience operating internationally and engaging in international business involves a number of difficulties and risks, including:

Additionally, the imposition of substantial tariffs by the United States on imports from various countries, including China, Canada, and Mexico, and the possible countermeasures by these countries could increase costs, disrupt the global supply chain, and create additional operational challenges. For example, in April 2025, the U.S. government announced a 10% tariff on product imports from almost all countries and individualized higher tariffs on certain other countries. In October 2025 the U.S. government announced a 100% tariff on all product imports from China, bringing the total rate of a 130% tariff on China effective November 2025. Several tariff announcements have been followed by announcements of limited exemptions and temporary pauses. These actions have increased costs, caused substantial uncertainty and volatility in financial markets and may result in retaliatory measures on U.S. goods. The uncertainty surrounding future trade relationships and the potential for increased market volatility and currency exchange rate fluctuations along with tariffs and trade regulations could have an adverse effect on our business.

We have undertaken internal restructuring activities in the past that could result in disruptions to our business or otherwise materially harm our results of operations or financial condition.

On January 28, 2025, we implemented an organizational restructuring designed to decrease our costs and create a more streamlined organization to support our business priorities. As a result, we terminated approximately 14% of our global workforce. The restructuring affectsaffected employees predominantly in technical positions and iswas largely focused on internally-facing roles as we evolveevolved from development stage to commercial stage. There can be no assurance that our restructuring will achieve the cost savings, operating efficiencies or other benefits that we may have initially expected. If our restructuring fails to achieve some or all of the expected benefits therefrom, our cash resources may not last as long as estimated and our business, results of operations and financial condition could be materially and adversely affected.

Our future success depends on our ability to attract, recruit, train, retain, motivate and integrate key personnel, including the Founder of Legacy Hyperfine and Liminal and our director, Dr. Jonathan Rothberg, our Chairperson, R.Daniel ScottJ. Huennekens,Wolterman, and our President and Chief Executive Officer, Maria Sainz, as well as other members of our management team and our research and development, manufacturing, software engineering and sales and marketing personnel. As our development and commercialization plans and strategies develop, we will need additional managerial, operational, sales, marketing, financial, legal and other resources. Competition for qualified personnel in the health technology and medical device industry is intense. Due to this intense competition, we may be unable to attract and retain the qualified personnel necessary for the development of our business or to recruit suitable replacement personnel.

We believe that our management team must be able to act decisively to apply and adapt our business model in the rapidly changing markets in which we compete. In addition, we rely upon technical and scientific employees orand third-party contractors to effectively establish, manage and grow our business. Consequently, we believe that our future viability will depend largely on our ability to attract and retain highly skilled managerial, sales, scientific and technical personnel. In order to do so, we may need to pay higher compensation or fees to our employees or consultants than we currently expect, and such higher compensation payments may have a negative effect on our operating results. Competition for experienced, high-quality personnel is intense, and we cannot assure investors that we will be able to recruit and retain such personnel. Our growth depends, in particular, on attracting and retaining highly-trained sales personnel with the necessary technical background and ability to understand our products and services at a technical level to effectively identify and sell to potential new customers and develop new products. Because of the technical nature of our products and the dynamic market in which we compete, any failure to attract, recruit, train, retain, motivate and integrate qualified personnel could materially harm our operating results and growth prospects.

Our long term strategy is to increase our international presence. We received marketing authorization for brain imaging in several countries, including the European Union (CE Mark), the United Kingdom (UKCA Mark), Canada, AustraliaAustralia, New Zealand and New Zealand.India. This strategy may include establishing and maintaining physician outreach and education capabilities outside of the United States and expanding our relationships with international customers. Doing business internationally involves a number of risks, including:

establishment registration, device listing and ongoing compliance with the QSRquality management system requirements;

Before a new medical device, or a significant modification of a medical device, including a new use of or claim for an existing product, can be marketed in the United States, we must first receive either 510(k) clearance or premarket approval (“PMA”) from the FDA, unless an exemption applies. In the 510(k) clearance process, the FDA must determine that a proposed device is “substantially equivalent” to a device legally on the market, known as a “predicate” device, with respect to intended use, technology and safety and effectiveness, in order to clear the proposed device for marketing. Clinical data is sometimes required to support substantial equivalence. Legacy Hyperfine received 510(k) clearance from the FDA for its portable MRI system in 2020. In February and October 2023, the Company received 510(k) clearances from the FDA for its Swoop® system AI-powered software. The combination of these two software updates, incorporated deep-learning based denoising in the post-processing of images for crisper images, and improved image quality for all Swoop® system sequences. In July 2024, we received 510(k) clearance from the FDA of the ninth-generation AI-powered Swoop® system software. ThisIn latestMay software2025, updatewe releasedreceived to510(k) dateclearance significantlyfrom reducesthe scanFDA timesfor acrossour multipletenth-generation MRAI-powered sequencessoftware, withoutOptive sacrificingAI™ imagesoftware, quality.in late May 2025, we received 510(k) clearance for our new next-generation Swoop® system powered by Optive AITM software, and in December 2025 we received 510(k) clearance for our eleventh-generation AI-powered software. In October 2024 and February 2025, we received CE Mark and UKCA Mark approval for our ninth generation of software, respectively. In August 2025, we received both CE Mark and UKCA Mark approvals for our Optive AI™ software. In December 2025, we received regulatory approval in India from the CDSCO, authorizing commercialization of the first-generation Swoop® system throughout India. Outside of the United States, the first-generation Swoop® system has received marketing authorization for brain imaging in several countries, including the European Union (CE Mark), the United Kingdom (UKCA Mark), Canada, AustraliaAustralia, New Zealand and New Zealand. In October 2024 and February 2025, the Company received CE Mark and UKCA Mark approval for the latest generation of software.India. All of our revenue to date has been generated from sales of the Swoop® system and related services.

We may be required to obtain a new 510(k) clearance or a PMA approval for significant post-market modifications to our products, including any modifications made to our commercially marketed devices.

Obtaining 510(k) clearance or a PMA approval for medical devices can be expensive and time-consuming, and entails significant user fees, unless an exemption is available. The FDA’s process for obtaining 510(k) clearance usually takes three to 12 months, but it can last longer. In the PMA approval process, the FDA must determine that a proposed device is safe and effective for its intended use based, in part, on extensive data, including but not limited to, technical, nonclinical, clinical trial, manufacturing and labeling data. The process for obtaining a PMA is more costly and uncertain and approval can take anywhere from at least one year to, in some cases, multiple years from the time the application is initially filed with the FDA. Modifications to products that are approved through a PMA application generally require further FDA approval. Some of our future products may require approval through the PMA approval.process. In addition, the FDA may demand that we obtain a PMA prior to marketing future changes of our existing products. Further, we may not be able to obtain additional 510(k) clearances or PMAs for new products or for modifications to, or additional indications for, our products in a timely fashion or at all. Delays in obtaining future clearances or approvals could adversely affect our ability to introduce new or enhanced products in a timely manner, which in turn could harm our revenue and future profitability.

In order to conduct a clinical investigation involving human subjects for the purpose of demonstrating the safety and effectiveness of a medical device, if necessary, for a PMA application or 510(k) notification, a company must, among other things, apply for and obtain institutional review board (“IRB”) approval of the proposed investigation. In addition, if the clinical study involves a “significant risk” (as defined by the FDA) to human health, the sponsor of the investigation must also submit and obtain FDA approval of an investigational device exemption (“IDE”) application and follow applicable IDE regulations. Unless IDE-exempt, nonsignificant risk devices are still subject to certain abbreviated IDE requirements, but an IDE application is not required if such abbreviated requirements are met. We may not be able to obtain any necessary FDA and/or IRB approval to undertake clinical trials in the United States for future devices we develop and intend to market in the United States. If we do obtain such approvals, the FDA may find that our studies do not comply with the IDE or other regulations governing clinical investigations or the data from any such trials may not support clearance or approval of the investigational device. Moreover, certainty that clinical trials will meet desired endpoints, produce meaningful or useful data and be free of unexpected adverse effects, or that the FDA will accept the validity of foreign clinical study data (if applicable) cannot be assured, and such uncertainty could preclude or delay market clearance or authorizations resulting in significant financial costs and reduced revenue.

We are also subject to numerous post-marketing regulatory requirements, which include quality management system regulations related to the manufacture of our devices, labeling regulations and medical device reporting (“MDR”) regulations. The last of these regulations requires us to report to the FDA if our devices cause or contribute to a death or serious injury, or malfunction in a way that would likely cause or contribute to a death or serious injury if the malfunction recurred. If we fail to comply with present or future regulatory requirements that are applicable to us, we may be subject to enforcement action by the FDA, which may include any of the following sanctions:

In order for us to market our products in countries outside of the United States, we must comply with extensive safety and quality regulations in other countries regarding the quality, safety and efficacy of our products. These regulations, including the requirements for marketing authorizations,authorization, and the time required for regulatory review, vary from country to country. Failure to obtain regulatory authorization in any foreign country in which we plan to market our products may harm our ability to generate revenue and harm our business. Marketing authorization requirements vary between countries and can involve additional product testing and additional administrative review periods. The time required to obtain marketing authorization in other countries might differ from that required to obtain FDA clearance or other marketing authorization. The regulatory process in other countries may include all of the risks detailed above regarding FDA clearance in the United States. Regulatory authorization of a product in one country does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory authorization in one country may negatively impact the regulatory process in others. Failure to obtain regulatory authorization in other countries or any delay or setback in obtaining such authorization could have the same adverse effects described above regarding FDA clearance or approval in the United States.

The primary regulatory environment in Europe is that of the European Economic Area (“EEA”), which is comprised of the Member States of the European Union, plus Iceland, Liechtenstein and Norway. In 2023, our first-generation Swoop® system received approval in the European Union (CE Mark). In October 2024, our latest generation of AI-powered Swoop® system software received CE approval under the European Medical Device Regulation (MDR, EU No. 2017/745). The Medical Device Regulation became fully effective on May 26, 2021. The Medical Device Regulation includes elements intended to strengthen the conformity assessment procedures, assert greater control over notified bodies and their standards, increase overall system transparency, and impose more robust device vigilance requirements on manufacturers and distributors. These new requirements may have an effect on the way we design and manufacture product and products candidates and conduct our business in the EEA. For example, as a result of the continuing transition towards the Medical Device Regulation, Notified Body review times have lengthened, and product introductions or modifications could be delayed or canceled, which could adversely affect our ability to grow our business.

When producing and distributing commercial medical device products, we, our contract manufacturer, and certain of our component suppliers are required to comply with the FDA’s Qualityquality Systemmanagement Regulationsystem (“QSR”),requirements, and starting on February 2, 2026 the new QSMR, which is a complex regulatory framework that covers the procedures and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage, shipping and servicing of our devices. Compliance with applicable regulatory requirements is subject to continual review and is monitored rigorously through periodic, sometimes unannounced, inspections by the FDA. We cannot assure investors that our facilities or our third-party manufacturers’ or suppliers’ facilities would pass any future quality system inspection. Failure by us or our third-party manufacturers or component suppliers to adhere to QSRquality management system requirements/QMSR requirements or take adequate and timely corrective action in response to an adverse quality system inspection finding could delay production of our products and lead to fines, difficulties in obtaining marketing authorizations for our products, recalls, or enforcement actions, including but not limited to injunctive relief or consent decrees, or other consequences, which could have a material adverse effect on our business, financial condition or results of operations. Any such failure, including the failure of our current or any future contract manufacturers to achieve and maintain the required high manufacturing standards, could result in further delays or failures in product testing or delivery, cost overruns, increased warranty costs or other problems that could harm our business and prospects.

In addition, any of our products shipped internationally are also required to comply with applicable quality standards and regulatory requirements, including the International Organization for Standardization (“ISO”) quality system standards as well as European Directives and norms in order to produce products for sale in the EU. In addition, many countries such as Canada and Japan have very specific additional regulatory requirements for quality assurance and manufacturing. If we fail to continue to comply with current good manufacturing practice requirements, as well as ISO or other regulatory standards, we may be required to cease all or part of our operations until we comply with these regulations. Maintaining compliance with multiple regulators adds complexity and cost to our manufacturing and compliance processes.

While we believebelieve, and strive to ensure that our business arrangements with third parties and other activities and programs comply with all applicable laws, these laws are complex, and our activities may be found not to be compliant with one or more of these laws, which may result in significant civil, criminal and/or administrative penalties, fines, damages and exclusion from participation in government healthcare programs. Even an unsuccessful challenge or investigation into our practices could cause adverse publicity, and be costly to respond to, and thus could have a material adverse effect on our business, financial condition and results of operations. Our compliance with Medicare and Medicaid regulations may be reviewed by federal or state agencies, including the Office of Inspector General for the U.S. Department of Health and Human Services (“HHS-OIG”), CMS, and the Department of Justice, or may be subject to whistleblower lawsuits under federal and state false claims laws. To ensure compliance with Medicare, Medicaid and other regulations, government agencies conduct periodic audits of the Company to ensure compliance with various supplier standards and billing requirements.

We are subject to complex and evolving U.S. and foreign laws and regulations regarding privacy, data protection, artificial intelligence, and other matters. Many of these laws and regulations are subject to change and uncertain interpretation, and could result in claims,claims or monetary penalties, changes to our business practices, monetary penalties, increased cost of operations, or declines in customer growth or engagement, or otherwise harm our business.

In addition, foreign data protection, privacy, and other laws and regulations can be more restrictive than those in the United States. Data localization laws in some countries generally mandate that certain types of data collected in a particular country be stored and/or processed within that country. We could be subject to audits in Europe and around the world, particularly in the areas of consumer and data protection, as we continue to grow and expand our operations. Legislators and regulators may make legal and regulatory changes, or interpret and apply existing laws, in ways that make our products less useful to customers, require us to incur substantial costs, expose us to unanticipated civil or criminal liability, or cause us to change our business practices. These changes or increased costs could negatively impact our business and results of operations in material ways. For example, the GDPR imposes requirements in the EEA relating to, among other things, consent to process personal data of individuals, the information provided to individuals regarding the processing of their personal data, the security and confidentiality of personal data, notifications in the event of data breaches and use of third-party processors. GDPR also imposes restrictions on the transfer of personal data from the EEA to third countries likethat thehave Unitednot States.been found to provide adequate protection to such personal data. If we fail to comply with these standards, we could be subject to criminal penalties and civil sanctions, including fines and penalties and amounts could be significant.

In addition, the GDPR, which took effect in May 2018, governs the collection and use of personal data of EEA residents. The GDPR, and its equivalents in the United Kingdom and Switzerland, are wide-ranging in scope, impose requirements relating to the consent of the individuals to whom the personal data relates, the information provided to the individuals regarding the processing of their personal data, the security and confidentiality of the personal data, data breach notification and the use of third-party processors in connection with the processing of the personal data. The GDPR also imposes strict rules on the transfer of personal data out of the EEA to third countries likethat thehave Unitednot States,been found to provide adequate protection to such personal data, enhances enforcement authority and imposes large penalties for noncompliance, including the potential for fines of up to 20 million euros or 4% of the annual global revenues of the infringer, whichever is greater. While we strive to comply with the GDPR and its UK and Swiss equivalents, as applicable, there can be no assurance that as our operations evolve, our efforts to comply or to remain in compliance will be fully successful.

Various courts, including the U.S. Supreme Court, have rendered decisions that impact the scope of patentability of certain inventions or discoveries relating to life sciences and medical technology. Specifically, these decisions stand for the proposition that patent claims that recite laws of nature, natural phenomena, and abstract ideas are not themselves patentable unless those patent claims have sufficient additional features that provide practical assurance that the processes are genuine inventive applications of those laws, phenomena, and abstract ideas rather than patent drafting efforts designed to monopolize the law of nature, natural phenomenon, or abstract idea itself. What constitutes a “sufficient” additional feature is somewhat uncertain. Furthermore, in view of these decisions, since December 2014, the USPTO has published and continues to publish revised guidelines for patent examiners to apply when examining process claims for patent eligibility.

We may not be aware of all third-party intellectual property rights potentially relating to our products. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until approximately 18 months after filing or, in some cases, not until such patent applications issue as patents. We might not have been the first to make the inventions covered by each of our pending patent applications and we might not have been the first to file patent applications for these inventions. To determine the priority of these inventions, we may have to participate, as applicable, in interference proceedings, derivation proceedings or other post-grant proceedings declared by the USPTO, or other similar proceedings in non-U.S. jurisdictions that could result in substantial cost to us and the loss of valuable patent protection. The outcome of such proceedings is uncertain. No assurance can be given that other patent applications will not have priority over our patent applications. In addition, changes to the patent laws of the United States allow for various post-grant opposition proceedings that have not been extensively tested, and their outcome is therefore uncertain. Furthermore, if third parties bring these proceedings against our patents, regardless of the merit of such proceedings and regardless of whether we are successful, we could experience significant costs and our management may be distracted.

WeIn currentlythe future, we may rely on licenses from third parties, and in the future may rely on additional licenses from other third parties, and if we lose any of thesesuch licenses, then we may be subjected to future litigation.

We are, and may in the future become,become a party to license agreements that grant us rights to use certain intellectual property, including patents and patent applications, typically in certain specified fields of use. We may need to obtain additional licenses from others to advance our research, development and commercialization activities.

Our success may depend in part on the ability of our licensors and any future licensors to obtain, maintain andor enforce patent protection for our licensed intellectual property. Without protection for the intellectual property we may license, other companies might be able to offer substantially identical products and technologies for sale, which could materially adversely affect our competitive business position and harm our business, financial condition, results of operations and prospects.

OurAny currentfuture license agreements impose,we andenter future agreementsinto may impose,impose various diligence, commercialization, milestone payment, royalty, insurance and other obligations on us and require us to meet development timelines, or to exercise commercially reasonable efforts to develop and commercialize licensed products, in order to maintain the licenses. If we fail to comply with these obligations, our licensor(s) may have the right to terminate our license, in which event we would not be able to develop or market products or technology covered by the licensed intellectual property. Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations and prospects.

If we do not prevail in such disputes, we may lose any or all of our rights under such license agreements, experience significant delays in the development and commercialization of our products and technologies, or incur liability for damages, any of which could have a material adverse effect on our business, financial condition, results of operations, and prospects. In addition, we may seek to obtain additional licenses from our licensor(s) and, in connection with obtaining such licenses, we may agree to amend our existing licenses in a manner that may be more favorable to the licensor(s), including by agreeing to terms that could enable third parties, including our competitors, to receive licenses to a portion of the intellectual property that is subject to our existing licenses and to compete with our products.

In addition, theany future agreements under which we currently and in the futuremay license intellectual property or technology from third parties arewill be complex and certain provisions in such agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations and prospects. Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize any affected products or services, which could have a material adverse effect on our business, financial condition, results of operations and prospects.

We have in the past experienced material weaknesses in our internal controls over financial reporting that have required us to expend substantial time and effort to remediate. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of a company’s annual or interim financial statements will not be prevented or detected and corrected on a timely basis. During the years ended December 31, 2023 and 2022, we undertook remediation measures related to the previously identified material weakness in internal control over financial reporting, which we believe allowed us to successfully remediate and strengthen our internal control over financial reporting. During the second quarter of 2023, we completed testing of the operating effectiveness of the controls and concluded that the material weaknesses were remediated as of June 30, 2023. Based on theseour remediation measures, we believe that the previously reported material weaknesses have been remediated. However,While completionwe ofundertook remediationremedial proceduresmeasures forin the past related to previously identified material weaknessesweakness, doessuch measures do not provide assurance that our process and controls will continue to operate properly or that our financial statements will be free from error.

Upon exercise or conversion, the shares underlying the Warrants and outstanding options may be resold into the public market. In the case of outstanding securities that have exercise or conversion prices that are below the market price of our Class A common stock from time to time, our stockholders would experience dilution upon the exercise or conversion of these securities. Any such resales into the public market could place downward pressure on the price of our Class A common stockstock.

The Nasdaq Stock Market has established continued listing requirements, including a requirement to maintain a minimum closing bid price of at least $1.00 per share. In May 2024,2024 and April 2025, we received written noticenotices from Nasdaq notifying us that, because the closing bid price for our Class A common stock had fallen below $1.00 per share for 30 consecutive business days, we no longer met the minimum bid price requirement for continued inclusion on The Nasdaq Global Market. On July 24, 2024,2024 and August 6, 2025, respectively, we received written notice from Nasdaq that we were back in compliance with the bid price requirement. Although we have since regained compliance with the bid price requirement and our Class A common stock continues to trade on The Nasdaq Global Market, there can be no assurance that we will be able to maintain compliance with the bid price requirement or other Nasdaq requirements in the future. If we are not able to maintain compliance with Nasdaq requirements, our Class A common stock may be delisted from Nasdaq, which could have a material adverse effect on us and our stockholders, including by reducing the liquidity of our shares and having a material adverse effect on our ability to raise capital or complete a strategic transaction.

The dual class structure of our common stock has the effect of concentrating voting power with Jonathan M. Rothberg, Ph.D., the Founder of Legacy Hyperfine and Liminal and a member of our board of directors, which will limitlimits an investor’s ability to influence the outcome of important transactions, including a change in control.

We are an “emerging growth company” within the meaning of the Securities Act, as modified by the JOBS Act, and we may take or continue to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of 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. As a result, our stockholders may not have access to certain information they may deem important. We couldexpect beto remain classified as an emerging growth company foruntil upDecember to31, five years, although circumstances could cause us to lose that status earlier, including if the market value of our Class A common stock held by non-affiliates is $700 million or more as of the last business day of the most recently completed second fiscal quarter, in which case we would no longer be an emerging growth company as of2026, the end of thatthe fiscal year.year following the fifth anniversary of the completion of our initial public offering. We cannot predict whether investors will find our securities less attractive because we will rely on these exemptions. If some investors find our securities less attractive as a result of our reliance on these exemptions, the trading prices of our securities may be lower than they otherwise would be, there may be a less active trading market for our securities and the trading prices of our securities may be more volatile.

We are an innovative health technology business with a mission to revolutionize patient care globally through accessible, affordable, clinically relevant artificial intelligence (“AI”)-powered portable ultra-low-field (“ULF”) magnetic resonance (“MR”) brain imaging. Our Swoop® Portable MR Imaging® System (“Swoop® system”) produces high-quality images at a significantly lower magnetic field strength than conventional magnetic resonance imaging (“MRI”) scanners. Our Swoop® system is designed to transform brain MR for the patient, the clinician and the provider, enabling a highly differentiated experiencepatient-friendly for patients,experience, timely imaging for clinicians, and favorable economics for hospital administrators. The Swoop® system is a portable, ULF MRI device for producing images that display the internal structures of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. Healthcare professionals can use the Swoop® system to make effective clinical diagnoses and decisions in various care settings where conventional MRI devices are inaccessible and/or when they are not readily available. The easy-to-use interface and portable design of our Swoop® system make it easilysafely and readily accessible anywhere in a hospital, clinic, physician’s office, or patient care site and it does not require any special facilities accommodationsaccommodations. norThe easy to use, iPad-based interface makes its operation easy to learn and it does not require specialized personnel to operate safely. ULF MR does not expose patients to harmful ionizing radiation and compares favorably in this regard to X-ray computed tomography (“CT”) or positron emission tomography (“PET”).

The demand for MR imaging has been increasing due to the aging population and the rising prevalence of neurological, neurodegenerative, and cardiovascular conditions, recentand approval of new Alzheimer’s medications, as well asalso the trends towards decentralized healthcare in mature, as well as low- and middle-income countries. Healthcare professionals and insurers recognize MR imaging as an effective, non-invasive diagnostic tool for evaluation and ongoing monitoring.monitoring of patients at risk of or with neurological conditions. The Swoop® system is the next generationnext-generation brain imaging devicescanner designed to increase access to MRI in a cost-effective manner. We believe our market opportunity is significant across the multiple sites of care where the Swoop® system brings clinical and economic value. We estimate in the United States alone that our total addressable market for Swoop® system device placements is more than $16 billion.

Despite their advantages, many healthcare institutions worldwide lack the facilities, specialized operators,technicians, and capital necessary to acquire, maintain, and staff expensive conventional MRI devices. The Swoop® system is the first FDA-cleared, portable, ULF, MR brain imaging system andthat is capable of providing imaging at multiple sites of care, such as intensive care units,units clinics,(“ICUs”), emergency departmentsdepartments, procedural rooms, clinics or physicians’ offices, and can inform the timely detection, diagnosis, monitoring, and treatment of acute and chronic neurological conditions inside and outside the hospital. We designed the Swoop® system to address the limitations of conventional imagingMRI technologies and make brain MR imaging accessible nearly anytimeanywhere andin anywherea timely manner, closer to the patient, across professional healthcare settings. We believe the adoption of the Swoop® system by healthcare professionals has potential clinical and economic benefits throughout healthcare communities in both high and low resource settings.

The Swoop® system is AI-powered and integrates deep learning, Optive AITM, a form of AI in the reconstruction pipeline of the sequences. We offer T1, T2, diffusion-weighted Imagingimaging (“DWI”), and fluid-attenuated inversion recovery (“FLAIR”) sequences.sequences, in both fast and high resolution modes. Scanning time varies based on protocols but on average a full brain scan takes around 25 minutes. The integration of deep learning does not require any additional steps from the user. As a result, deep learning can enhance the image quality and, consequently, the diagnostic value of images generated at ULF. TheOur algorithmsOptive AITM models are designed to improve ULF image quality, while reducing the impact of scan artifacts. The imagesOptive createdAITM withmodels these algorithms wereare validated by expert radiologists. The Swoop® system is used clinically every day as the first mover in the field of AI-powered portable MRI, and the installinstalled base continues to expand.expand globally. The learnings from this market experience have served to improve our hardware, software, AI, and denoising algorithms resulting in the image quality and performance improvements of our product over the nineeleven generations of software since our initial clearance. As we move forward, we are continuously investing in improving our AI-powered image quality and leveraging each imaging-focused software release to further improve the Swoop® system performance. Furthermore, we have established a strong proprietary position in ULF MRI and as of February 15, 2025,2026, we possess a portfolio of 185197 issued patents worldwide and 150additional 160 U.S. and foreign patents applications pending.

Total revenues were $12.9$13.6 million for the year ended December 31, 2024,2025, an increase of $1.9$0.7 million, or 17%,5.2%, from the year ended December 31, 2023,2024, primarily driven by increasesan increase in Swoop®average systemselling units sold and service revenues.price. See "Results of Operations - Sales" below for further information. Total Swoop® system net units sold were 4838 units for the year ended December 31, 2024,2025, ana increasedecrease of 1110 units, or 30%,20.8%, from the year ended December 31, 2023.2024. We launched our next-generation Swoop® system powered by Optive AITM software in mid-2025.

Our results have included revenue from the United States and outside the United States. Our Swoop® system received initial 510(k) clearance from the FDA in 2020. Initially, we have been focused on executing contracts with U.S. hospitals and hospital systems. We have built a direct sales and field support organization in the United States who are working in strong collaboration to increase adoption, support successful implementations and support routine use at expanded customer sites. InWe 2025,are we plan to expandexpanding our commercial focus beyond our initial call point of critical care in the hospital into hospital emergency departments, hospital-based neurology clinics and outside the hospital in neurology offices. This commercial expansion is supported by the product launch of our next-generation Swoop® system powered by our Optive AITM software.

The countries outside of the United States in which we have begun commercializing our first-generation Swoop® system include Canada, certain European and Middle Eastern markets, Australia, New Zealand and New Zealand.India. We obtained a Medical Device License issued by Health Canada, UKCA Mark certification in the United Kingdom, CE Mark in the EU, and regulatory authorization in Australia and New Zealand. The Swoop® system CE markMark and UKCA markMark approval of the latestninth-generation AI-powered Swoop® system software in October 2024 and February 2025, and CE Mark and UKCA Mark approval for our Optive AITM software in August 2025, enables a broader Europeaninternational commercial expansion of the Swoop® system, bringing cutting-edge brain imaging technology to new global markets. Further we are executing on a global expansion strategy, broadening access to MR brain imaging in regions with large populations, low penetration of MRI, and significant unmet healthcare needs. In December 2025, we received regulatory approval in India from the CDSCO, authorizing commercialization of the first-generation Swoop® system throughout India.

Our commitment to the vision of providing affordable and accessible imaging that enables earlier detection and timely management of health conditions worldwide is furthermore advanced by grant funding from the BMGF.Bill and Melinda Gates Foundation (“BMGF”). Through our engagement with the BMGF, we have deployed the Swoop® system in low-middle income settings without readily-accessible MRI technology. During 2020 and 2021, we were awarded multiple grants totaling $4.9 million from the BMGF for the provision and equipping of sites with our portable MR brain imaging system to enable the performance of a multi-site study focused on optimizing diagnostic image quality. These grants were designed to provide data to validate the use of the Swoop® system in measuring the impact of maternal anemia, malnutrition, infection and birth related injury. These grants were designed to support the deployment of a total of 25 Swoop® system devices and other services to investigators, which commenced in the spring of 2021 and was completed by February 2024. In May 2023, we were awarded an additional $3.4 million grant from the BMGF to continue to develop a scalable approach to measuring neurodevelopment via low-field MRI in neonates, infants, and young children in low-to-middle income countries through February 2026. In November 2025, we were awarded a further $3.7 million grant from the BMGF to support continued technical innovation using our AI-powered portable MRI platform, which a focus on neonatal brain imaging and objective assessment of neurodevelopment in resource constrained settings through March 2028. This funding supports ongoing collaboration with academic and clinical partners to advance AI-based image processing and analysis capabilities designed to improve image quality and diagnostic reliability in neonatal and early childhood imaging. During the year ended December 31, 2024,2025, we completed and fulfilled grant deliverables and milestones amounting to $1.7$1.3 million and we received cash grant funding of $1.1$2.2 million.

Research and development costs consist of production costs for prototype, test and pre-production units, lab supplies, clinical study cost, consulting and personnel costs, including salaries, stock-based compensation, bonuses and benefit costs. Most of our research and development expenses are related to developing new products and services as well as to enhancing our current product and software capabilities. Consulting expenses are related to research and development activities as well as clinical and regulatory activities. Fabrication services include certain third-party engineering costs. Research and development expenses are expensed as incurred. We expect to continue to make substantial investments in research and development.

Sales and marketing costs primarily consist of personnel costs and benefits including stock-based compensation, advertising and promotional costs, as well as costs for conferences, meetings, and other events. We will seekexpect to controlmake investments in sales and marketing expensesas while continuing towe promote our brand through marketing and advertising initiatives and expand our market presence and awareness.awareness across our multiple commercial growth opportunities.

Device sales increased by $1.7$0.9 million, or 19.5%,9.1%, for the year ended December 31, 20242025 compared to the year ended December 31, 2023.2024. The increase in device sales revenue iswas mainlydriven dueprimarily by an increase in average selling price partially offset by a decrease in units sold.

Cost of deviceService sales increaseddecreased by $0.9$0.3 million, or 20.7%,11.3%, for the year ended December 31, 20242025 compared to the year ended December 31, 2023.2024. ThisThe increasedecrease in service sales revenue was driven primarily by increasedthe unitsexpiration sold.of the subscription service contracts from prior years and the transition to new service and support contracts at a lower annual price and other service contract adjustments.

Cost of servicedevice sales decreasedincreased by $0.2$0.4 million, or 11.0%,6.8%, for the year ended December 31, 20242025 compared to the year ended December 31, 2023.2024. This decreaseincrease iswas driven primarily by higher cost per unit, increased depreciation due to anew decreasetooling inand personnel-relatedfixtures costsand drivenhigher tariffs on products sold partially offset by lower headcountunits and increased efficiency.sold.

InterestCost incomeof service sales decreased by $1.4$0.6 million, or 35.1%34.6%, for the year ended December 31, 20242025 compared to the year ended December 31, 2023.2024. TheThis decrease was driven primarily by alower personnel-related costs due to lower interest ratesheadcount and lower cashinfrastructure balances in money market funds and demand deposit accounts.costs.

OtherResearch incomeand (expense),development netexpenses haddecreased aby decrease$5.0 in other income of $23 thousand,million, or 65.7%,22.4%, for the year ended December 31, 20242025 compared to the year ended December 31, 2023.2024. This decrease in other income was driven primarily by a $4.5 million decrease in netsalary realizedand gainbenefits onincluding foreignstock-based currenciescompensation ofdue approximatelyto $67lower thousandheadcount and a $0.8 million decrease in consulting expenses, partially offset by ana increase$0.3 million lower in interestgrant incomefulfillment from customer financing and other of approximately $44 thousand.credits.

We have funded our operations primarily with proceeds from the issuance of common andstock, preferred stock.stock and warrants. We have incurred significant cash burn and recurring net losses, which includes a net loss of $40.7$35.6 million for the year ended December 31, 2024,2025, and an accumulated deficit of $294.4$330.0 million as of December 31, 2024.2025. As of December 31, 2024,2025, we had cash and cash equivalents of $37.6$35.1 million. As we continue to invest in research and development of our products and sales and marketing, we expect to continue to incur negative cash burnflows from operations and recurring net losses for the foreseeable future until such time that our product and services sales generate enough gross profit to cover our operating expenses. However, we can provide no assurance that our product and service sales will generate a net profit in the future or that our cash resources will be sufficient to continue our commercialization and development activities.

In November 2023, we filed a shelf registration statement on Form S-3 (the “Shelf Registration Statement”) with the SEC pursuant to which we registered for sale up to $150 million of any combination of our Class A common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that we may determine. OurThe shelfShelf registrationRegistration statement on Form S-3Statement also included a prospectus covering up to an aggregate of $50.0 million in shares of Class A common stock that we could issue and sell from time to time, through B. Riley Securities, Inc. (“B. Riley”), acting as our sales agent, pursuant to the Sales Agreement for our “at-the-market” equity program (“ATM”). In December 2025, the Sales Agreement with B. Riley was amended and restated to add BTIG, LLC (“BTIG”) as an additional sales agent and we filed a new prospectus supplement covering up to an aggregate of $50.0 million in shares of Class A common stock that we may issue and sell from time to time, through B. Riley and BTIG acting as our sales agent,agents. The offering of our Class A common stock pursuant to the Salesprospectus Agreement,supplement fordated ourNovember “at-the-market”22, equity2023 programwas (“ATM”).also terminated such that no further offers or sales will be made pursuant to such prospectus supplement, effective as of December 29, 2025. We are not obligated to make any sales of Class A common stock under the Sales Agreement.ATM. As of December 31, 2024,2025, aan totalaggregate of 771,7213,464,325 shares of our Class A common stock,stock for total gross proceeds of $881 thousand and net proceeds of $828 thousand, after deducting commissions and other offering expenses related to the ATM, havehad been issued and sold under the Sales Agreement.Agreement, for gross proceeds of $4.3 million, before deducting commissions and other offering expenses, resulting in net proceeds of $4.2 million, after deducting commissions and other offering expenses. We issued and sold an aggregate of 2,692,604 shares of Class A common stock under the Sales Agreement during the year ended December 31, 2025 for gross proceeds of $3.5 million, before deducting commissions and other offering expenses, resulting in net proceeds of $3.4 million, after deducting commissions and other expenses.

On February 11,12, 2025, we enteredclosed intothe transactions pursuant to a securities purchase agreement with Certain institutional investors (the Investors,“Investors”), pursuant toin which we agreed to issueissued and sell,sold, in a registered direct offering by us directly to the Investors (the Shares“"February 2025 Offering”): (i) 4,511,278 shares of our Class A common stock and (ii) warrants to purchase up to 4,511,278 shares of our Class A common stock (the Warrants.“Warrants”). Each Shareshare and accompanying Warrant were sold together at a combined offering price of $1.33. The aggregate gross proceeds to from the February 2025 Offering were $6.0 million before deducting the placement agent’s fees and estimatedoffering expenses, and net proceeds of $5.2 million, after deducting placement agent's fees and offering expenses.

Our ability to access capital when needed is not assured and, if capital is not available when, and in the amounts needed, we could be required to delay, scale back or abandon some or all of our development programs, commercialization of our products, and other operations which could materially harm our operations, financial condition and operating results. We expect that our existing cash and cash equivalents, together with proceeds from the sales of our products and services, will enable us to conduct our planned operations for at least the next 12 months. Factors that could accelerate cash needs include: (i) delays in achieving scientific and technical milestones; (ii) unforeseen capital expenditures and fabrication costs related to manufacturing; (iii) changes we may make in our business or commercialization and hiring strategy; (iv) costs of running a public company; (v) higher inflation and increases in product transportation and labor costs; (vi) the effects of the tariffs; and (vivii) other items affecting our forecasted level of expenditures and use of cash resources including potential acquisitions.

We expect to use our fundscash to further invest in the development of our products and services, commercial expansion, and for working capital and general corporate purposes.

For the year ended December 31, 2024,2025, net cash used in operating activities of $38.8$27.9 million was due primarily to a net loss of $40.7$35.6 million, non-cash items of $5.6$3.2 million and changes in operating assets and liabilities of $3.6$4.3 million. Non-cash items were primarily stockconsisted basedof stock-based compensation expense of $4.4$2.8 million, depreciation expense of $1.0$1.1 million, change in fair value of warrant liabilities of $0.8 million and loss on disposal of property and equipment of $0.2$0.1 million. Changes in operating assets and liabilities were driven primarily by an increase in accounts payable of $2.4 million, a decrease in accounts receivable and unbilled receivables of $4.2$1.8 million, an increase in deferred grant funding of $0.9 million, a decrease in prepaid expenses and other current assets of $0.4 million, an increase in accrued expense and other current liabilities of $0.6$0.3 million, and a decrease in deferred grant funding of $0.6 million, partially offset by a decrease in inventory and prepaid inventory of $1.3 million, an increase in accounts payable of $0.4 million,million and a decrease in other long term assets of $0.3$0.2 million, and partially offset by an increase in inventory of $1.5 million and a decrease in deferred revenue of $0.2 million.

For the year ended December 31, 2023,2024, net cash used in operating activities of $41.8$38.8 million was due primarily to a net loss of $44.2$40.7 million, non-cash items of $6.0$5.6 million and changes in operating assets and liabilities of $3.6 million. Non-cash items were primarily stockconsist basedof stock-based compensation expense of $4.7$4.4 million andmillion, depreciation expense of $1.1$1.0 million, and loss on disposal of property and equipment of $0.2 million. Changes in operating assets and liabilities were driven primarily by an increase in inventory of $2.2 million due to increased inventory units-on-hand, an increase in accounts receivable and unbilled receivables of $1.1$4.2 million due to increased revenue,million, a decrease in accrued expensesexpense and other current liabilities of $0.7$0.6 million, anand increasea decrease in unbilleddeferred receivablesgrant funding of $0.5 million, an increase in prepaid inventory of $0.4 million and an increase of other long term assets of $0.2$0.6 million, partially offset by a decrease in prepaid expensesinventory and prepaid inventory of $1.3 million, an increase in accounts payable of $0.4 million, and a decrease in other currentlong term assets of $1.5$0.3 million mainly due to the timing of directors and officers liability insurance prepayment.million.

For the year ended December 31, 2024,2025, net cash provided by financing activities of $1.0$27.5 million consistingconsisted primarily of proceeds from the issuance of Class A common stock under the Sales Agreement of $0.8$3.4 million, proceeds from the issuance of Class A common stock and Warrants in the February 2025 Offering of $5.2 million, proceeds from the issuance of Class A common stock in the October 2025 Offering of $18.4 million, proceeds from issuance of Class A common stock in connection with Warrant exercises of $0.3 million and proceeds from stock options exercises of $0.2 million.

For the year ended December 31, 2023,2024, net cash provided by financing activities of $0.2$1.0 million wasconsisted primarily of proceeds from optionthe exercises.issuance of Class A common stock under the Sales Agreement of $0.8 million and proceeds from stock options exercises of $0.2 million.

Through our engagement with the BMGF, we have deployed and continue to deploy the Swoop® system in low-middle income settings without readily-accessible MRI technology. The multiple grants provided by our research partnership with the BMGF, which commenced funding in the spring of 2020, support the deployment of 25 Swoop® system and accessories to investigators. The ongoing investigation is designed to provide data to validate the potential use of the Swoop® system in measuring the impact of maternal anemia, malnutrition, infection, and birth-related injury. In May 2023, we were awarded an additional three-year grant from the BMGF to continue to develop a scalable approach to measuring neurodevelopment via ULF brain imaging in neonates, infants, and young children in low-to-middle income countries. In November 2025, we were awarded an additional grant from the BMGF to support continued technical innovation using our AI-powered portable MRI Platform, which a focus on neonatal brain imaging and objective assessment of neurodevelopment in resource-constrained settings, with funding extending into March 2028.

Our stock-based compensation program includes restricted stock unitunits and stock option grants to our employees, directors and consultants. Stock options are granted at exercise prices not less than the estimated fair market value of our common stock at the dates of grant. For purposes of restricted stock unit grants, the grant date fair value is calculated as the fair market value of the stock on the date of grant.

The following discussion and analysis provides information which management believes is relevant to an assessment and understanding of our condensed consolidated results of operations and financial condition. The discussion should be read in conjunction with the unaudited condensed consolidated financial statements and notes thereto contained in this Quarterly Report on Form 10-Q and the consolidated financial statements and notes thereto for the year ended December 31, 2025 contained in our 2025 Annual Report on Form 10-K. This discussion contains forward-looking statements and involves numerous risks and uncertainties, including, but not limited to, those described in the “Risk Factors” sections of our 2025 Annual Report on Form 10-K, as updated and/or supplemented in subsequent filings with the SEC. Actual results may differ materially from those contained in any forward-looking statements. Unless the context otherwise requires, references to “we,” “us,” “our,” and “the Company” are intended to mean the business and operations of Hyperfine, Inc. and its consolidated subsidiaries. The unaudited condensed consolidated financial statements for the three and six months ended MarchJune 31,30, 2026 and 2025, respectively, present the financial position and results of operations of Hyperfine, Inc. and its wholly owned subsidiaries.

Our Swoop® system received initial 510(k) clearance for brain imaging from the U.S. Food and Drug Administration (the “FDA”) in 2020. In July 2024, we received 510(k) clearance from FDA of the ninth-generation AI-powered Swoop® system software. The ninth-generation software significantly reduces scan times across multiple MR sequences without sacrificing image quality. In May 2025, we received 510(k) clearance from the FDA for our tenth-generation AI-powered software, Optive AI™ software. The tenth-generation software enhances each stage of image processing from noise cancellation and image acquisition to reconstruction and post processing and produces brain images with greater clarity, uniformity and sharper anatomical detail.

Total revenues were $3.9 million and $7.8 million for the three and six months ended MarchJune 31,30, 2026, anrespectively, increaseas compared to revenue of $1.8$2.7 million,million orand 83%,$4.8 frommillion for the three and six months ended MarchJune 31,30, 2025, respectively, primarily driven by an increase in units sold and an increase in average selling price. See “Results of Operations - Sales” below for further information. Total Swoop® system units sold were 1012 units and 22 units for the three and six months ended MarchJune 31,30, 2026, anrespectively, increaseas ofcompared 4to 8 units and 14 units, or 67%, fromfor the three and six months ended MarchJune 31,30, 2025.2025, respectively. We launched our next-generation Swoop® system powered by Optive AITM software in mid-2025.

Our results have included revenue from the United States and outside the United States. Our Swoop® system received initial 510(k) clearance from the FDA in 2020. Initially, we have been focused on executing contracts with U.S. hospitals and hospital systems. We have built a direct sales and field support organization in the United States whothat are workingworks in strong collaboration to increase adoption, support successful implementations and support routine use at customer sites. We are expanding our commercial focus beyond our initial call point of critical care in the hospital into hospital emergency departments, hospital-based neurology clinics and outside the hospital in neurology offices. This commercial expansion is supported by the product launch of our next-generation Swoop® system powered by our Optive AITM software.

The countries outside of the United States in which we have begun commercializing our first-generation Swoop® system include Canada, certain European and Middle Eastern markets, Australia, New Zealand and India. We obtained a Medical Device License issued by Health Canada, UKCA Mark in the United Kingdom, CE Mark in the EU, and regulatory authorization in Australia and New Zealand. The Swoop® system CE Mark and UKCA Mark approval of the ninth-generation AI-powered Swoop® system software in October 2024 and February 2025, and CE Mark and UKCA Mark approval for our Optive AITM software in August 2025, enablesenable a broader international commercial expansion of the Swoop® system, bringing cutting-edge brain imaging technology to new global markets. The Swoop® system received CE Mark and UKCA Mark approval in March 2026 for both the next-generation Swoop® scanner and the latest version of our Optive AI™ software, enabling commercialization in Europe of the exceptional low-field MRI image quality recently commercialized in the United States. FurtherFurther, we are executing on a global expansion strategy, broadening access to MR brain imaging in regions with large populations, low penetration of MRI, and significant unmet healthcare needs. In December 2025, we received regulatory approval in India from the CDSCO, authorizing commercialization of the first-generation Swoop® system throughout India.

Our commitment to the vision of providing affordable and accessible imaging that enables earlier detection and timely management of health conditions worldwide is furthermore advanced by grant funding from the Bill and Melinda Gates Foundation (“BMGF”). Through our engagement with the BMGF, we have deployed the Swoop® system in low-middle income settings without readily-accessible MRI technology. During 2020 and 2021, we were awarded multiple grants totaling $4.9 million from the BMGF for the provision and equipping of sites with our portable MR brain imaging system to enable the performance of a multi-site study focused on optimizing diagnostic image quality. These grants were designed to provide data to validate the use of the Swoop® system in measuring the impact of maternal anemia, malnutrition, infection and birth relatedbirth-related injury. These grants were designed to support the deployment of a total of 25 Swoop® system devices and other services to investigators, which commenced in the spring of 2021 and was completed by February 2024. In May 2023, we were awarded an additional $3.4 million grant from the BMGF to continue to develop a scalable approach to measuring neurodevelopment via low-field MRI in neonates, infants, and young children in low-to-middle income countries through February 2026. In November 2025, we were awarded a further $3.7 million grant from the BMGF to support continued technical innovation using our AI-powered portable MRI platform, with a focus on neonatal brain imaging and objective assessment of neurodevelopment in resource constrainedresource-constrained settings through March 2028. This funding supports ongoing collaboration with academic and clinical partners to advance AI-based image processing and analysis capabilities designed to improve image quality and diagnostic reliability in neonatal and early childhood imaging. During the three and six months ended MarchJune 31,30, 2026, we completed and fulfilled grant deliverables and milestones amounting to $0.5$0.6 million.million and $1.1 million, respectively.

Comparison of the Three and Six Months Ended MarchJune 31,30, 2026 and 2025 ($ Amounts shown in tables in thousands)

Device sales increased by $1.7$1.0 million, or 114.0%,49.0%, for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. The increase was driven primarily by an increase in units sold and increase in average selling price.sold.

Cost of deviceService sales increased by $0.7$0.2 million, or 67.1%,29.2%, for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. ThisThe increase was driven primarily by increasedcontinued costsgrowth associatedin withthe higherinstalled salesbase volume.as well as non-recurring revenue items.

InterestDevice incomesales decreasedincreased by $0.1$2.8 million, or 19.9%,76.1%, for the threesix months ended MarchJune 31,30, 2026 compared to the threesix months ended MarchJune 31,30, 2025. The decreaseincrease was driven primarily by loweran effectiveincrease yieldsin onunits our money market fundssold and demandan depositincrease accounts, partially offset by higherin average investableselling cash balances.price.

InterestService expensesales increased by $0.1$0.2 millionmillion, or 16.7%, for the threesix months ended MarchJune 31,30, 2026 compared to the threesix months ended MarchJune 31,30, 2025. The increase was driven primarily by interestcontinued incurredgrowth onin the Loaninstalled Agreementbase (as definedwell below)as enterednon-recurring intorevenue in March 2026, including stated interest and non-cash amortization of debt discount and issuance costs.items.

OtherCost incomeof (expense),device netsales decreasedincreased by $0.5 millionmillion, or 46.1%, for the three months ended MarchJune 31,30, 2026 compared to the three months ended MarchJune 31,30, 2025. This decreaseincrease was mainlydriven drivenprimarily by financingincreased costs allocatedassociated towith warranthigher liabilitiessales during the three months ended March 31, 2025.volume.

We have funded our operations primarily with proceeds from the issuance of common stock, preferred stock, and warrants and the establishment of a debt facility. We have incurred significant cash burn and recurring net losses, which includesinclude a net loss of $8.6$9.3 million and $17.9 million for the three and six months ended MarchJune 31,30, 2026, respectively, and an accumulated deficit of $338.6$347.9 million as of MarchJune 31,30, 2026. As of MarchJune 31,30, 2026, we had cash and cash equivalents of $40.8$43.5 million. As we continue to invest in research and development of our products and sales and marketing, we expect to continue to incur negative cash flows from operations and recurring net losses for the foreseeable future until such time that our product and services sales generate enough gross profit to cover our operating expenses. However, we can provide no assurance that our product and service sales will generate a net profit in the future or that our cash resources will be sufficient to continue our commercialization and development activities.

In November 2023, we filed a shelf registration statement on Form S-3 (the “Shelf Registration Statement”) with the SEC pursuant to which we registered for sale up to $150 million of any combination of our Class A common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that we may determine. The Shelf Registration Statement also included a prospectus covering up to an aggregate of $50.0 million in shares of Class A common stock that we could issue and sell from time to time, through B. Riley Securities, Inc. (“B. Riley”), acting as our sales agent, pursuant to the Sales Agreement for our “at-the-market” equity program (“ATM”). In December 2025, the Sales Agreement with B. Riley was amended and restated (“Amended Sales Agreement”) to add BTIG, LLC (“BTIG”) as an additional sales agent and we filed a new prospectus supplement covering up to an aggregate of $50.0 million in shares of Class A common stock that we may issue and sell from time to time, through B. Riley and BTIG acting as our sales agents. The offering of our Class A common stock pursuant to the prospectus supplement dated November 22, 2023 was also terminated such that no further offers or sales will be made pursuant to such prospectus supplement, effective as of December 29, 2025. We are not obligated to make any sales of Class A common stock under the ATM. Prior to the termination of the prospectus supplement dated November 22, 2023, effective as of December 29, 2025, we had issued and sold an aggregate of 3,464,325 shares of our Class A common stock under the Sales Agreement, for total gross proceeds of $4.4 million, before deducting commissions and other offering expenses, and net proceeds of $4.2 million, after deducting such commissions and expenses. As of MarchJune 31,30, 2026, an aggregate of 678,0127,809,779 shares of Class A common stock had been issued and sold under the Amended Sales Agreement, for gross proceeds of $0.8$11.7 million, before deducting commissions and other offering expenses, resulting in net proceeds of $0.8$11.4 million, after deducting commissions and other offering expenses. We issued and sold an aggregate of 678,0127,131,767 shares and 7,809,779 shares of Class A common stock under the Amended Sales Agreement during the three and six months ended MarchJune 31,30, 20262026, respectively, for gross proceeds of $0.8$10.8 million and $11.7 million, before deducting commissions and other offering expenses, respectively, resulting in net proceeds of $0.8$10.6 million and $11.4 million, after deducting commissions and other expenses.expenses, respectively.

Borrowings under the term loan bear interest at a variable rate equal to the prime rate plus 4.25%, subject to a minimum interest rate of 10.75%. The term loan provides for interest-only payments for 48 months from the closing date, followed by equal monthly payments of principal and interest through the maturity date of March 18, 2031. Our obligations under the Loan Agreement are guaranteed by our wholly owned subsidiaries and are secured by substantially all of our assets, subject to customary exceptions, including that intellectual property is excluded from the collateral at closing and until the first funding of any additional loan tranche following the Closing Date. The Loan Agreement contains customary affirmative and negative covenants, including limitations on additional indebtedness and certain other transactions. As of March 31, 2026, we were in compliance with all applicable covenants.

As of MarchJune 31,30, 2026, we had cash and cash equivalents of $40.8$43.5 million. Our future capital requirements may vary from those currently planned and will depend on various factors including further development costs, commercialization strategy, regulatory developments, supply constraints, manufacturing costs and international expansion. If we need additional funds and are unable to obtain funding on a timely basis, we may need to curtail significantly our product development and commercialization efforts to provide sufficient funds to continue our operations, which could adversely affect our business prospects.

For the threesix months ended MarchJune 31,30, 2026, net cash used in operating activities of $9.0$16.3 million was due primarily to a net loss of $8.6$17.9 million and changes in operating assets and liabilities of $1.6$1.4 million, partially offset by non-cash items of $1.1$3.0 million. Non-cash items were primarily stock-based compensation expense of $0.6$1.6 million and depreciation expense of $0.3 million andmillion, loss on change in fair value of warrant liabilities of $0.2$0.8 million, depreciation expense of $0.5 million and amortization of debt discount and issuance costs of $0.1 million. Changes in operating assets and liabilities were driven primarily by a decrease in accounts payable of $1.6 million, a decrease in accrued expenses and other current liabilities of $1.7$0.9 million reflecting the timing of annual employee bonus payments, an increase in prepaid expenses and other current assets of $1.4$0.7 million primarily related to the timing of annual insurance premium renewals, a decrease in deferred grant funding of $0.5 million and an increase in other long term asset of $0.1 million, partially offset by a decrease in accounts receivable and unbilled receivables of $0.8$0.7 million, an increase in deferred grant funding of $0.3 million, a decrease in inventory of $0.8$0.3 millionmillion, a decrease in other long-term assets of $0.2 million, and an increase in accountsdeferred payablerevenue of $0.5$0.2 million.

For the threesix months ended MarchJune 31,30, 2025, net cash used in operating activities of $9.2$17.1 million was due primarily to a net loss of $9.4$18.6 millionmillion, andpartially offset by non-cash items of $0.4 million,million partially offset byand changes in operating assets and liabilities of $0.6$1.1 million. Non-cash items were primarily stock-based compensation expense of $1.5 million and depreciation expense of $0.5 million, partially offset by gain on change in fair value of warrant liabilities of $1.6 million, partially offset by stock-based compensation expense of $0.9 million and depreciation expense of $0.2$1.7 million. Changes in operating assets and liabilities were driven primarily by a decrease in inventory of $1.2 million, a decrease in accounts receivable and unbilled receivables of $1.0$1.4 million, an increase in accounts payable of $0.6$1.3 million, anda an increasedecrease in deferred fundinginventory of $0.4$0.7 million, partially offset by a decrease in accrued expenseexpenses and other current liabilities of $1.4 million primarily due to annual bonus payout and ana increasedecrease in prepaiddeferred expenses and other current assetsrevenue of $1.2$0.2 million, primarily due to the timing of payment of the directors and officers liability insurance.million.

For the threesix months ended MarchJune 31,30, 2026, net cash used in investing activities of $0.2$0.3 million was from fixed assets purchased.

For the threesix months ended MarchJune 31,30, 2025, net cash used in investing activities of $0.5$1.0 million was from fixed assets purchased.

For the threesix months ended MarchJune 31,30, 2026, net cash provided by financing activities was $14.5$25.3 million which consisted primarily of proceeds from issuance of debt net of debt issuance costs of $13.6 million, proceeds from the issuance of Class A common stock under the Amended Sales Agreement of $0.8$11.4 million and proceeds from stock options exercises of $42$0.3 thousand.million.

For the threesix months ended MarchJune 31,30, 2025, net cash provided by financing activities of $5.6$6.0 million which consisted primarily of proceeds from issuance and sale of the shares and February 2025 Warrantswarrants in the February 2025 Offering, net of offering discounts and other costs of $5.4$5.2 million, proceeds from issuance of the shares under the Sales Agreement of $0.1$0.8 million and proceeds from stock option exercises of $33 thousand.million.

We sponsor a 401(k) defined contribution plan covering all eligible U.S. employees. Contributions to the 401(k) plan are discretionary. We did not make any matching contributions to the 401(k) plan for the three and six months ended MarchJune 31,30, 2026 or 2025.

Through our engagement with the BMGF, we have deployed and continue to deploy the Swoop® system in low-middle income settings without readily-accessible MRI technology. The multiple grants provided by our research partnership with the BMGF, which commenced funding in the spring of 2020, support the deployment of 25 Swoop® systemsystems and accessories to investigators. The ongoing investigation is designed to provide data to validate the potential use of the Swoop® system in measuring the impact of maternal anemia, malnutrition, infection, and birth-related injury. In May 2023, we were awarded an additional three-year grant from the BMGF to continue to develop a scalable approach to measuring neurodevelopment via ULF brain imaging in neonates, infants, and young children in low-to-middle income countries. In November 2025, we were awarded an additional grant from the BMGF to support continued technical innovation using our AI-powered portable MRI platform, with a focus on neonatal brain imaging and objective assessment of neurodevelopment in resource-constrained settings, with funding extending into March 2028.

We had no other significant contractual obligations as of MarchJune 31,30, 2026.

For information on contingencies, refer to Note 14 in the notes to our unaudited condensed consolidated financial statements for the three and six months ended MarchJune 31,30, 2026 and 2025 included elsewhere in this Quarterly Report on Form 10-Q.

A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our unaudited condensed consolidated financial statements and notes thereto for the three and six months ended MarchJune 31,30, 2026 and 2025 included elsewhere in this Quarterly Report on Form 10-Q.