Hyperfine, Inc.

The following is a discussion of our results of operations for the periods shown below, and our accounting policies are described under"Summary of Significant Accounting Policies"in Note 2 to our unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.

Comparison of the three and nine months ended September 30, 2026 and 2025 ($ Amounts shown in tables in thousands)

NM - Not meaningful

Sales

Device sales increased by $2.4 million, or 81.4%, for the three months ended September 30, 2026 compared to the three months ended September 30, 2025. The increase was driven primarily by an increase in units sold and an increase in average selling price.

Service sales increased by $0.2 million, or 31.3%, for the three months ended September 30, 2026 compared to the three months ended September 30, 2025. The increase was driven primarily by continued growth in the installed base.

Device sales increased by $5.1 million, or 78.4%, for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025. The increase was driven primarily by an increase in units sold and an increase in average selling price.

Service sales increased by $0.4 million, or 21.3%, for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025. The increase was driven primarily by continued growth in the installed base.

Cost of sales

Cost of device sales increased by $1.0 million, or 72.4%, for the three months ended September 30, 2026 compared to the three months ended September 30, 2025. This increase was driven primarily by increased costs associated with higher sales volume.

Cost of service sales was relatively flat for the three months ended September 30, 2026 compared to the three months ended September 30, 2025.

Cost of device sales increased by $2.1 million, or 62.4%, for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025. This increase was driven primarily by increased costs associated with higher sales volume.

Cost of service sales was relatively flat for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025.

Gross profit and gross margin

Gross profit increased by $1.5 million, or 83.0%, to $3.4 million for the three months ended September 30, 2026, compared to $1.8 million for the three months ended September 30, 2025. Gross margin increased to 56.7% for the three months ended September 30, 2026 from 53.8% for the three months ended September 30, 2025. The increase in gross margin was primarily attributable to higher sales volumes and average selling prices, which outpaced growth in cost of sales.

Gross profit increased by $3.3 million, or 80.9%, to $7.3 million for the nine months ended September 30, 2026, compared to $4.1 million for the nine months ended September 30, 2025. Gross margin increased to 53.3% for the nine months ended September 30, 2026 from 49.1% for the nine months ended September 30, 2025. The increase in gross margin was primarily attributable to higher sales volumes and average selling prices, which outpaced growth in cost of sales.

Research and development

Research and development expenses were relatively flat for the three months ended September 30, 2026 compared to the three months ended September 30, 2025.

Research and development expenses decreased by $2.0 million, or 14.7%, for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025. This decrease was driven primarily by a $1.1 million decrease in salaries and benefits, including stock-based compensation, due to lower headcount and a $0.9 million increase in grant fulfillment credits.

General and administrative

General and administrative expenses decreased by $0.1 million, or 2.4%, for the three months ended September 30, 2026 compared to the three months ended September 30, 2025. This decrease was driven primarily by a $0.5 million decrease in allowance for credit losses, partially offset by a $0.4 million increase in salaries and benefits, including stock-based compensation.

General and administrative expenses decreased by $0.1 million, or 1.1%, for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025. This decrease was driven primarily by a $0.8 million decrease in allowance for credit losses, partially offset by a $0.7 million increase in salaries and benefits, including stock-based compensation.

Sales and marketing

Sales and marketing expenses were relatively flat for the three months ended September 30, 2026 compared to the three months ended September 30, 2025.

Sales and marketing expenses were relatively flat for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025.

Loss from operations

Loss from operations decreased by $1.7 million, or 18.6%, for the three months ended September 30, 2026 compared to the three months ended September 30, 2025. The improvement reflected an 83.0% increase in gross profit, while total operating expenses decreased by 1.2%, as sales growth and gross margin expansion outpaced operating expenses.

Loss from operations decreased by $5.1 million, or 17.4%, for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025. The improvement reflected an 80.9% increase in gross profit and a 5.5% decrease in total operating expenses, including lower research and development expenses, as sales growth and gross margin expansion outpaced operating expenses.

Interest income

Interest income was relatively flat for the three months ended September 30, 2026 compared to the three months ended September 30, 2025.

Interest income was relatively flat for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025.

Interest expense

Interest expense increased by $0.5 million for the three months ended September 30, 2026 compared to the three months ended September 30, 2025. The increase was driven primarily by interest incurred on the Loan Agreement (as defined below) entered into in March 2026, including stated interest and non-cash amortization of debt discount and issuance costs.

Interest expense increased by $1.2 million for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025. The increase was driven primarily by interest incurred on the Loan Agreement entered into in March 2026, including stated interest and non-cash amortization of debt discount and issuance costs.

Change in fair value of warrant liabilities

Change in fair value of warrant liabilities increased by $3.8 million for the three months ended September 30, 2026 compared to the three months ended September 30, 2025. This increase was driven by non-cash change in fair value of warrant liabilities related to warrants issued in connection with the February 2025 Offering.

Change in fair value of warrant liabilities increased by $1.3 million for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025. This increase was driven by non-cash change in fair value of warrant liabilities related to warrants issued in connection with the February 2025 Offering.

Other income (expense), net

Other income (expense), net was relatively flat for the three months ended September 30, 2026 compared to the three months ended September 30, 2025.

Other income (expense), net increased by $0.4 million for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025. This increase was mainly driven by financing costs allocated to warrant liabilities during the nine months ended September 30, 2025.

Liquidity and Capital Resources

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 include a net loss of $6.0 million and $23.9 million for the three and nine months ended September 30, 2026, respectively, and an accumulated deficit of $353.9 million as of September 30, 2026. As of September 30, 2026, we had cash and cash equivalents of $37.9 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 (the “Sales Agreement”) for our “at-the-market” equity program (“ATM”). In December 2025, the Sales Agreement with B. Riley was amended and restated (the “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 September 30, 2026, an aggregate of 7,809,779 shares of Class A common stock had been issued and sold under the Amended Sales Agreement, for gross proceeds of $11.7 million, before deducting commissions and other offering expenses, resulting in net proceeds of $11.4 million, after deducting commissions and other offering expenses. We issued and sold an aggregate of 7,809,779 shares of Class A common stock under the Amended Sales Agreement during the nine months ended September 30, 2026, for gross proceeds of $11.7 million, before deducting commissions and other offering expenses, resulting in net proceeds of $11.4 million, after deducting commissions and other offering expenses. No shares of our Class A common stock were issued or sold under the Amended Sales Agreement during the three months ended September 30, 2026.

On November 9, 2026, we plan to file a shelf registration statement on Form S-3 with the SEC to replace our existing shelf registration statement on Form S-3 (File No. 333-275449), which was declared effective on November 22, 2023 and is scheduled to expire on November 22, 2026 (the “Prior Shelf”), pursuant to which we expect to register for sale up to $150.0 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 “2026 Shelf”), which is the same aggregate amount registered under the Prior Shelf. The 2026 Shelf is expected to include a prospectus supplement covering up to an aggregate of $50.0 million in shares of Class A common stock, which amount is included within, and not in addition to, the $150.0 million registered under the 2026 Shelf, that we may issue and sell from time to time, through B. Riley and BTIG, acting as our sales agents, pursuant to the Amended Sales Agreement, consistent with the at-the-market program under the Prior Shelf. Upon effectiveness of the 2026 Shelf, the Prior Shelf will be deemed terminated and will no longer be available for sales of securities.

On February 12, 2025, we closed the transactions pursuant to a securities purchase agreement with certain institutional investors (the “Investors”), in which we issued and sold, in a registered direct offering directly to the Investors (the “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 “February 2025 Warrants”). Each share and accompanying February 2025 Warrant were sold together at a combined offering price of $1.33. The aggregate gross proceeds from the February 2025 Offering were $6.0 million before deducting the placement agent’s fees and offering expenses, and the net proceeds were $5.2 million, after deducting the placement agent's fees and offering expenses.

On October 17, 2025, we closed an underwritten public offering (the “October 2025 Offering”), in which we issued and sold 14,000,000 shares of our Class A common stock at a public offering price of $1.25 per share, pursuant to an Underwriting Agreement (the “Underwriting Agreement”) with Lake Street Capital Markets, LLC, as the underwriter. On October 17, 2025, we received gross proceeds of $17.5 million from the October 2025 Offering, before deducting underwriting discounts and commissions and other offering expenses, and net proceeds of approximately $15.8 million, after deducting underwriting discounts and commissions and other offering expenses.

Under the terms of the Underwriting Agreement, the underwriter was granted a 30-day option to purchase up to an additional 2,100,000 shares of Class A common stock at the public offering price, less underwriting discounts and commissions (the “Underwriter Option”). The underwriter exercised the Underwriter Option on October 21, 2025, and on October 23, 2025 we received additional gross proceeds of $2.6 million and additional net proceeds of approximately $2.4 million, after deducting underwriting discounts and commissions and other offering expenses.

In the aggregate, we issued and sold 16,100,000 shares of Class A common stock in the October 2025 Offering. Our aggregate gross proceeds from the October 2025 Offering, including the gross proceeds from the exercise of the Underwriter Option, were $20.1 million, and aggregate net proceeds were approximately $18.2 million, after deducting underwriting discounts and commissions and other offering expenses.

On March 18, 2026 (the “Closing Date”), we entered into a Loan and Security Agreement (the “Loan Agreement”) with Horizon Technology Finance Corporation pursuant to which we obtained a senior secured term loan facility with aggregate principal availability of up to $40.0 million. At closing, we borrowed $15.0 million, and the remaining $25.0 million is available to draw prior to December 31, 2027, subject to the satisfaction of certain conditions set forth in the Loan Agreement. The proceeds from the term loan are intended to be used for working capital and general corporate purposes.

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 September 30, 2026, we were in compliance with all applicable covenants.

In connection with the Loan Agreement, we issued warrants to purchase up to an aggregate of 562,500 shares of Class A common stock at an exercise price of $1.20 per share (the “Initial Warrants”), which are immediately exercisable, and warrants to purchase up to an aggregate of 520,835 shares of Class A common stock at an exercise price of $1.20 per share (the “Additional Warrants”), which are exercisable only upon the funding of future loan tranches. All of these warrants expire seven years from the Closing Date.

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 (vii) other items affecting our forecasted level of expenditures and use of cash resources including potential acquisitions.

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

Our future cash requirements will depend on many factors, including market adoption of our products; the cost and timing of establishing additional sales, marketing and distribution capabilities; the cost of our research and development activities; our ability to enter into and maintain collaborations; the cost and timing of potential future regulatory clearances or approvals for our products; and the effect of competing technological and market developments. We cannot assure you that we will be able to obtain additional funds on acceptable terms, or at all. If we raise additional funds by issuing equity or equity-linked securities, our stockholders may experience dilution. Future debt financing, if available, may involve covenants restricting our operations or our ability to incur additional debt. Any debt or equity financing that we raise may contain terms that are not favorable to us or our stockholders. If we raise additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish some rights to our technologies or our products, or grant licenses on terms that are not favorable to us. If we do not have or are not able to obtain sufficient funds, we may have to delay development or commercialization of our products. We also may have to reduce marketing, customer support or other resources devoted to our products and services or cease operations.

Cash

As of September 30, 2026, we had cash and cash equivalents of $37.9 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.

Cash flows

The following table summarizes our cash flows for the periods indicated:

Net cash used in operating activities

For the nine months ended September 30, 2026, net cash used in operating activities of $22.4 million was due primarily to a net loss of $23.9 million and changes in operating assets and liabilities of $1.3 million, partially offset by non-cash items of $2.8 million. Non-cash items were primarily stock-based compensation expense of $2.5 million, depreciation expense of $0.8 million and amortization of debt discount and issuance costs of $0.2 million, partially offset by gain on change in fair value of warrant liabilities of $0.7 million. Changes in operating assets and liabilities were driven primarily by a decrease in accounts payable of $2.4 million, an increase in prepaid expenses and other current assets of $1.0 million primarily related to the timing of annual insurance premium renewals, and a decrease in deferred grant funding of $0.2 million, partially offset by an increase in accrued expenses and other current liabilities of $1.0 million reflecting the timing of annual employee bonus payments, a decrease in inventory of $0.7 million, a decrease in other long-term assets of $0.3 million, and an increase in deferred revenue of $0.3 million.

For the nine months ended September 30, 2025, net cash used in operating activities of $22.7 million was due primarily to a net loss of $29.7 million, partially offset by non-cash items of $3.7 million and changes in operating assets and liabilities of $3.2 million. Non-cash items were primarily stock-based compensation expense of $2.1 million, depreciation expense of $0.8 million, loss on change in fair value of warrant liabilities of $0.6 million and loss on disposal of property and equipment of $0.1 million. Changes in operating assets and liabilities were driven primarily by an increase in accounts payable of $2.1 million, a decrease in accounts receivable and unbilled receivables of $2.0 million and an increase in deferred grant funding of $0.4 million, partially offset by an increase in prepaid expenses and other current assets of $0.8 million, an increase in inventory of $0.2 million, a decrease in accrued expenses and other current liabilities of $0.2 million, and a decrease in deferred revenue of $0.1 million.

Net cash used in investing activities

For the nine months ended September 30, 2026, net cash used in investing activities of $0.3 million was from fixed assets purchased.

For the nine months ended September 30, 2025, net cash used in investing activities of $1.1 million was from fixed assets purchased.

Net cash provided by financing activities

For the nine months ended September 30, 2026, net cash provided by financing activities was $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 $11.4 million and proceeds from stock option exercises of $0.3 million.

For the nine months ended September 30, 2025, net cash provided by financing activities was $8.2 million which consisted primarily of proceeds from the issuance and sale of the shares and warrants in the February 2025 Offering, net of offering discounts and other costs of $5.2 million, net proceeds from the issuance of Class A common stock under the Sales Agreement of $2.9 million and proceeds from stock option exercises of $0.1 million.

Contractual obligations

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 nine months ended September 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® systems 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.

Our purchase commitments and obligations include all open purchase orders and contractual obligations in the ordinary course of business, including commitments with contract manufacturers and suppliers, for which we have not received the goods or services. A majority of these purchase obligations are due within a year. Although open purchase orders are considered enforceable and legally binding, the terms generally allow us the option to cancel, reschedule, and adjust our requirements based on our business needs prior to the delivery of goods or performance of services.

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

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

Critical Accounting Policies and Significant Judgments and Estimates

Our management's discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, as well as the reported revenue generated, and expenses incurred during the reporting periods. Our estimates are based on our historical experience and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about items that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Except as described in Note 2 “Summary of Significant Accounting Policies – Recently Issued Accounting Pronouncements Adopted”, to our unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q, there have been no material changes to our critical accounting policies and estimates as compared to the critical accounting policies and estimates disclosed in our 2025 Annual Report on Form 10-K.

Recently Issued Accounting Pronouncements

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 nine months ended September 30, 2026 and 2025 included elsewhere in this Quarterly Report on Form 10-Q.