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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

_________________

FORM 10-Q

_________________

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES

EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2025

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES

EXCHANGE ACT OF 1934

For the transition period from ___________to_________

Commission File Number: 001-39949

_________________

Hyperfine, Inc.

(Exact name of registrant as specified in its charter)

_________________


Delaware		98-1569027
(State or other jurisdiction of incorporation or organization)		(IRS Employer Identification No.)
351 New Whitfield Street Guilford, Connecticut		06437
(Address of principal executive offices)		(Zip Code)

(866) 796-6767

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:


Title of Each Class	Trading Symbol(s)	Name of each exchange on which registered
Class A common stock, $0.0001 Par Value Per Share	HYPR	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer ☐	Accelerated filer ☐
Non-accelerated filer ☒	Smaller reporting company ☒
	Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of November 3, 2025, the registrant had 82,113,369 shares of Class A common stock outstanding and 15,055,288 shares of Class B common stock outstanding.

TABLE OF CONTENTS


		Page
	Cautionary Statement Regarding Forward-Looking Statements	3
PART I	FINANCIAL INFORMATION	5
Item 1.	Financial Statements	5
	Condensed Consolidated Balance Sheets (unaudited)	5
	Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)	6
	Condensed Consolidated Statements of Changes in Stockholders’ Equity (unaudited)	7
	Condensed Consolidated Statements of Cash Flows (unaudited)	8
	Notes to Condensed Consolidated Financial Statements (unaudited)	9
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	22
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	33
Item 4.	Controls and Procedures	33
PART II	OTHER INFORMATION	34
Item 1.	Legal Proceedings	34
Item 1A.	Risk Factors	34
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	34
Item 3.	Defaults Upon Senior Securities	34
Item 4.	Mine Safety Disclosures	34
Item 5.	Other Information	34
Item 6.	Exhibits	35
	Signatures	36

All brand names or trademarks appearing in this report are the property of their respective holders. Use or display by us of other parties’ trademarks, trade dress, or products in this report is not intended to, and does not, imply a relationship with, or endorsements or sponsorship of, us by the trademark or trade dress owners. Unless the context requires otherwise, references in this report to the “Company,” “we,” “us,” and “our” refer to Hyperfine, Inc. and its wholly-owned subsidiaries, including Hyperfine Operations, Inc., and Liminal Sciences, Inc., as the case may be.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that relate to future events or our future financial performance regarding, among other things, the plans, strategies and prospects, both business and financial, of the Company. These statements are based on the beliefs and assumptions of our management team. Although we believe that our plans, intentions and expectations reflected in or suggested by these forward-looking statements are reasonable, we cannot assure you that we will achieve or realize these plans, intentions or expectations. Forward-looking statements are inherently subject to risks, uncertainties and assumptions. Generally, statements that are not historical facts, including statements concerning possible or assumed future actions, business strategies, events or results of operations, are forward-looking statements. These statements may be preceded by, followed by or include the words “believes,” “estimates,” “expects,” “projects,” “forecasts,” “may,” “will,” “should,” “seeks,” “plans,” “scheduled,” “anticipates” or “intends” or similar expressions. Forward-looking statements contained in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:

•

the success, cost and timing of our product development activities;

•

the commercialization and adoption of our existing products and the success of our future product offerings, including the degree to which our products and services are accepted and used by healthcare professionals;

•

the potential attributes and benefits of our products and services, including the clinical evidence supporting those benefits, and our ability to generate clinical evidence of the benefits of our products and services;

•

our ability to obtain and maintain regulatory approval for our products, and any related restrictions and limitations of any approved product;

•

our intellectual property rights;

•

our ability to identify, in-license or acquire additional technology;

•

our ability to maintain our existing licensing, manufacturing and supply agreements and to obtain adequate supply of products;

•

our ability to compete with other companies currently marketing or engaged in the development of magnetic resonance imaging technologies, many of which have greater financial and marketing resources than us;

•

the size and growth potential of the markets for our products and services, and the ability of our products and services to serve those markets, either alone or in partnership with others;

•

our expansion plans and our ability to grow and manage growth profitably;

•

the pricing of our products and services and reimbursement for medical procedures conducted using our products and services;

•

changes in applicable laws or regulations;

•

our history of losses and our ability to continue as a going concern;

•

our estimates regarding expenses, revenue, capital requirements and needs for additional financing;

•

our ability to raise financing in the future and the effects of future raises;

•

our future performance, including our financial performance and performance obligations;

•

our success in retaining or recruiting, or changes required in, our officers, key employees or directors;

•

intense competition and competitive pressures from other companies in the industry in which we operate;

•

market conditions and global and economic factors, such as inflation, geopolitical conflicts, and instability;

•

the effect of legal, tax and regulatory changes;

•

anticipated National Institutes of Health funding pressures; and

•

the expected effect from U.S. export controls and tariffs.

These and other risks and uncertainties are described in greater detail under the caption “Risk Factors” in Item 1A of Part I of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (the “2024 Annual Report on Form 10-K”), filed with the Securities and Exchange Commission (the “SEC”) on March 17, 2025, in Item 1A of Part II of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 13, 2025, and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC on August 13, 2025, as updated and/or supplemented in subsequent filings with the SEC. The risks described under the heading “Risk Factors” are not exhaustive. New risk factors emerge from time to time, and it is not possible to predict all such risk factors, nor can we assess the impact of all such risk factors on our business or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements, which speak only as of the date hereof. All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by the foregoing cautionary statements. We undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

PART I — FINANCIAL INFORMATION

Item 1. Financial Statements

HYPERFINE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

(in thousands, except share and per share amounts)


	September 30, 2025			December 31, 2024
ASSETS
CURRENT ASSETS:
Cash and cash equivalents	$	21,564		$	37,645
Restricted cash		466			28
Accounts receivable, less allowance of $1,163 and $651 as of September 30, 2025 and December 31, 2024, respectively		4,886			5,956
Unbilled receivables		1,423			2,349
Inventory		5,838			5,832
Prepaid expenses and other current assets		2,726			1,900
Total current assets		36,903			53,710
Property and equipment, net		2,745			3,122
Other long term assets		1,863			2,069
Total assets	$	41,511		$	58,901
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable	$	3,710		$	1,607
Deferred grant funding		466			28
Deferred revenue		1,435			1,460
Due to related parties		45			61
Accrued expenses and other current liabilities		4,512			5,573
Total current liabilities		10,168			8,729
Warrant liabilities		3,497			—
Long term deferred revenue		974			1,054
Other noncurrent liabilities		—			78
Total liabilities		14,639			9,861
COMMITMENTS AND CONTINGENCIES (NOTE 13)
STOCKHOLDERS' EQUITY
Class A Common stock, $0.0001 par value per share; 600,000,000 shares authorized; 65,429,923 and 58,076,261 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively		6			5
Class B Common stock, $0.0001 par value per share; 27,000,000 shares authorized; 15,055,288 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively		2			2
Additional paid-in capital		350,968			343,475
Accumulated deficit		(324,104	)		(294,442	)
Total stockholders' equity		26,872			49,040
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$	41,511		$	58,901

The accompanying notes are an integral part of these condensed consolidated financial statements.

HYPERFINE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited)

(in thousands, except share and per share amounts)


	Three Months Ended September 30,						Nine Months Ended September 30,
	2025			2024			2025			2024
Sales
Device	$	2,891		$	3,033		$	6,541		$	8,707
Service		546			610			1,729			1,862
Total sales		3,437			3,643			8,270			10,569
Cost of sales
Device		1,328			1,359			3,410			4,280
Service		261			376			801			1,224
Total cost of sales		1,589			1,735			4,211			5,504
Gross margin		1,848			1,908			4,059			5,065
Operating Expenses:
Research and development		4,048			5,865			13,626			17,394
General and administrative		4,152			4,510			12,219			13,361
Sales and marketing		2,568			2,496			7,631			6,769
Total operating expenses		10,768			12,871			33,476			37,524
Loss from operations		(8,920	)		(10,963	)		(29,417	)		(32,459	)
Interest income		187			585			743			2,056
Change in Fair Value of Warrant Liabilities		(2,303	)		—			(639	)		—
Other income (expense), net		17			52			(349	)		73
Loss before provision for income taxes		(11,019	)		(10,326	)		(29,662	)		(30,330	)
Provision for income taxes		—			—			—			—
Net loss and comprehensive loss	$	(11,019	)	$	(10,326	)	$	(29,662	)	$	(30,330	)
Net loss per common share attributable to common stockholders, basic and diluted	$	(0.14	)	$	(0.14	)	$	(0.38	)	$	(0.42	)
Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted		79,028,987			72,678,622			77,613,306			72,219,681

The accompanying notes are an integral part of these condensed consolidated financial statements.

HYPERFINE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (Unaudited)

(in thousands, except share amounts)


	Class A Common Stock				Class B Common Stock				Additional			Accumulated			Total Stockholders'
	Shares		Amount		Shares		Amount		Paid-in Capital			Deficit			Equity
Balance, December 31, 2024		58,076,261		5		15,055,288		2		343,475			(294,442	)		49,040
Net loss		—		—		—		—		—			(9,418	)		(9,418	)
Issuance of restricted stock, net		29,135		—		—		—		—			—			—
Exercise of stock options		41,390		—		—		—		33			—			33
Shares issued under “at-the-market” (ATM) Sales Agreement, net		126,398		—		—		—		129			—			129
Issuance of common stock and warrants, net of offering costs		4,511,278		1		—		—		2,384			—			2,385
Issuance of common stock in connection with warrant exercise		100		—		—		—		—			—			—
Stock-based compensation expense		—		—		—		—		945			—			945
Balance, March 31, 2025		62,784,562		6		15,055,288		2		346,966			(303,860	)		43,114
Net loss		—		—		—		—		—			(9,225	)		(9,225	)
Issuance of restricted stock, net		26,608		—		—		—		—			—			—
Exercise of stock options		32,750		—		—		—		4			—			4
Shares issued under “at-the-market” (ATM) Sales Agreement, net		681,793		—		—		—		686			—			686
Stock-based compensation expense		—		—		—		—		547			—			547
Balance, June 30, 2025		63,525,713	$	6		15,055,288	$	2	$	348,203		$	(313,085	)	$	35,126
Net loss		—		—		—		—		—			(11,019	)		(11,019	)
Shares issued under “at-the-market” (ATM) offering program, net		1,554,726		—		—		—		2,056			—			2,056
Issuance of restricted stock		20,166		—		—		—		—			—			—
Exercise of stock options		329,318		—		—		—		92			—			92
Stock-based compensation expense		—		—		—		—		617			—			617
Balance, September 30, 2025		65,429,923	$	6		15,055,288	$	2	$	350,968		$	(324,104	)	$	26,872


	Class A Common Stock				Class B Common Stock				Additional			Accumulated			Total Stockholders'
	Shares		Amount		Shares		Amount		Paid-in Capital			Deficit			Equity
Balance, December 31, 2023		56,840,989	$	5		15,055,288	$	2	$	338,114		$	(253,722	)	$	84,399
Net loss		—		—		—		—		—			(9,848	)		(9,848	)
Issuance of restricted stock, net		41,007		—		—		—		—			—			—
Exercise of stock options		70,670		—		—		—		55			—			55
Stock-based compensation expense		—		—		—		—		1,032			—			1,032
Balance, March 31, 2024		56,952,666		5		15,055,288		2		339,201			(263,570	)		75,638
Net loss		—		—		—		—		—			(10,156	)		(10,156	)
Issuance of restricted stock, net		34,915		—		—		—		—			—			—
Exercise of stock options		144,121		—		—		—		105			—			105
Stock-based compensation expense		—		—		—		—		1,174			—			1,174
Balance, June 30, 2024		57,131,702	$	5		15,055,288	$	2	$	340,480		$	(273,726	)	$	66,761
Net loss		—		—		—		—		—			(10,326	)		(10,326	)
Shares issued under “at-the-market” (ATM) offering program, net		728,188		—		—		—		785			—			785
Issuance of restricted stock		33,568		—		—		—		(1	)		—			(1	)
Stock-based compensation expense		—		—		—		—		1,103			—			1,103
Balance, September 30, 2024		57,893,458	$	5		15,055,288	$	2	$	342,367		$	(284,052	)	$	58,322

The accompanying notes are an integral part of these condensed consolidated financial statements.

HYPERFINE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(in thousands)


	Nine Months Ended September 30,
	2025			2024
Cash flows from operating activities:
Net loss	$	(29,662	)	$	(30,330	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		809			775
Stock-based compensation expense		2,109			3,308
Loss on disposal of property and equipment, net		120			156
Change in fair value of warrant liabilities		639			—
Other		22			6
Changes in assets and liabilities:
Accounts receivable, net		1,070			(3,611	)
Unbilled receivables		926			(1,322	)
Inventory		(221	)		(579	)
Prepaid expenses and other current assets		(802	)		(324	)
Prepaid inventory		—			693
Other long term assets		51			(9	)
Accounts payable		2,112			193
Deferred grant funding		438			(402	)
Deferred revenue		(105	)		97
Due to related parties		(16	)		(8	)
Accrued expenses and other current liabilities		(221	)		949
Operating lease liabilities, net		(10	)		(2	)
Net cash used in operating activities		(22,741	)		(30,410	)
Cash flows from investing activities:
Purchases of property and equipment		(1,122	)		(375	)
Net cash used in investing activities		(1,122	)		(375	)
Cash flows from financing activities:
Proceeds from exercise of stock options		130			160
Proceeds from shares issued under “at-the-market” offering program, net of selling costs		2,906			805
Proceeds from issuance of common stock and warrants, net of offering costs		5,184			—
Net cash provided by financing activities		8,220			965
Net decrease in cash and cash equivalents and restricted cash		(15,643	)		(29,820	)
Cash, cash equivalents and restricted cash, beginning of period		37,673			75,804
Cash, cash equivalents and restricted cash, end of period		22,030			45,984
Reconciliation of cash, cash equivalents, and restricted cash reported in the balance sheets
Cash and cash equivalents		21,564			45,765
Restricted cash		466			219
Total cash, cash equivalents and restricted cash	$	22,030		$	45,984
Supplemental disclosure of noncash information:
Initial measurement of warrant liabilities	$	2,858		$	—
Unpaid purchase of property and equipment	$	5		$	571

The accompanying notes are an integral part of these condensed consolidated financial statements.

HYPERFINE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

(all amounts are in thousands, except share and per share amounts)

1. ORGANIZATION AND DESCRIPTION OF BUSINESS

Hyperfine, Inc. (together with its subsidiaries, as applicable, “Hyperfine” or the “Company”), formerly known as HealthCor Catalio Acquisition Corp. (“HealthCor”), was incorporated as a Cayman Islands exempted company on November 18, 2020. The Company’s legal name became Hyperfine, Inc. in connection with the closing (the “Closing”) of the business combination with HealthCor on December 22, 2021 (the “Closing Date”). In connection with the Closing, Hyperfine, Inc., a Delaware corporation (“Legacy Hyperfine”), and Liminal Sciences, Inc., a Delaware corporation (“Liminal”), merged with and into separate wholly owned subsidiaries of HealthCor and became wholly-owned subsidiaries of the Company (the “Mergers”), and changed their names to Hyperfine Operations, Inc. and Liminal Operations, Inc., respectively. Liminal subsequently changed its name to Liminal Sciences, Inc.

The Company is 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. The Swoop® Portable MR Imaging® System (“Swoop® system”) produces high-quality images at a lower magnetic field strength than conventional magnetic resonance imaging (“MRI”) scanners. The Swoop® system is designed to transform brain MR for the patient, the clinician and the provider, enabling a highly differentiated experience for patients, 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 or when they are not readily available. The easy-to-use interface and portable design of the Company's Swoop® system make it easily and readily accessible anywhere in a hospital, clinic, physician office, or patient care site and it does not require any special facilities accommodations nor 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 or positron emission tomography.

The Company’s 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, the Company received 510(k) clearance from the 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, the Company received 510(k) clearance from the FDA of its 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 the result is brain images with greater clarity, uniformity and sharper anatomical detail.

A very important milestone for Hyperfine was obtaining 510(k) clearance from the FDA in late May 2025, for its new next generation Swoop® system powered by Optive AITM software. The next-generation Swoop® system incorporates learnings from five years of real world experience features new hardware and is powered by Optive AITM software. The next-generation Swoop® system features innovations specifically engineered to deliver the highest signal-to-noise ratio, which, when paired with the Optive AI™ software, achieves exceptional image quality for low-field MRI, including improved resolution and uniformity, as well as faster acquisition times.

Outside of the United States, the Swoop® system has received marketing authorization for brain imaging in several countries, including the European Union (“CE Mark”), the United Kingdom (UK Conformity Assessment (“UKCA Mark”)), Canada, Australia and New Zealand. In October 2024 and February 2025, the Company received CE Mark and UKCA Mark approval for the ninth-generation of software, respectively. In August 2025, the Company received both CE Mark and UKCA Mark approvals for the Optive AITM software. The Company's Optive AITM software is currently available in the United States, Canada, United Kingdom, Australia and New Zealand markets. All of the Company’s revenue to date has been generated from sales of the Swoop® system and related services. The Company has an indirect wholly-owned subsidiary in the United Kingdom that did not have any significant operations during 2024 nor during the three or nine months ended September 30, 2025.

HYPERFINE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

(all amounts are in thousands, except share and per share amounts)

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation and Principles of Consolidation

The accompanying condensed consolidated financial statements include the accounts of the Company and have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the accounting disclosure rules and regulations of the Securities and Exchange Commission (the “SEC”) on a going concern basis, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. However, the Company has limited revenues and a history of negative working capital. The Company’s existing capital resources, including the net proceeds from the recent offerings described below are expected to be sufficient to fund the Company’s operations for at least twelve months from the issuance date of these condensed consolidated financial statements. Unless and until the Company is able to generate a sufficient amount of revenue and generate positive operating cash flows, the Company expects to finance future cash needs through public and/or private offerings of equity securities and/or debt financings. If the Company is not able to obtain additional financing and/or substantially increase revenue from sales, in the longer term, it could result in a substantial doubt about the Company's ability to continue as a going concern.

Management believes the net proceeds from the recent offering described under Note 15 – “Subsequent Events” and the Company’s anticipated revenue, provides an opportunity to continue as a going concern. If additional funding is required, the Company plans to obtain working capital from either debt or equity financings from the sale of common stock, preferred stock, and/or convertible debentures. There can be no assurance that the Company will be able to obtain such working capital on acceptable terms or at all which could result in management concluding in the future that there is substantial doubt about the Company's ability to continue as a going concern.

The financial statements do not include any adjustments to the amount and classification of assets and liabilities that may be necessary should the Company not continue as a going concern.

These condensed consolidated financial statements should be read in conjunction with the financial statements and notes included in the Company’s audited consolidated financial statements as of and for the years ended December 31, 2024 and 2023. The condensed consolidated balance sheet as of December 31, 2024 included herein was derived from the audited consolidated financial statements as of that date.

The accompanying unaudited condensed consolidated financial statements reflect all normal recurring adjustments necessary to present fairly the financial position, results of operations, and cash flows for the interim periods. The results for the three and nine months ended September 30, 2025 are not necessarily indicative of the results to be expected for the year ending December 31, 2025 or any other period.

Except as described elsewhere in this Note 2 under the heading “Recently issued accounting pronouncements not yet adopted,” there have been no material changes to the Company’s significant accounting policies as described in the audited consolidated financial statements as of December 31, 2024 and 2023.

Risks and Uncertainties

The Company is subject to risks and uncertainties caused by events with significant geopolitical and macroeconomic impacts, including, but not limited to, the conflicts in Ukraine and the Middle East, inflation, tariffs and actions taken to counter such impacts. The Company relies on a single source manufacturer and single source suppliers for the supply of its products. Disruption from the manufacturer or suppliers has and would have a negative impact on the Company’s business, financial position and results of operations in its consolidated financial statements. The Company continues to critically review its liquidity and anticipated capital requirements in light of the significant uncertainty created by geopolitical and macroeconomic conditions.

Concentrations of Credit Risk

The Company's cash and cash equivalents are deposited with several major financial institutions. At times, deposits in these institutions exceed the amount of insurance provided on such deposits. The Company reduces this risk by maintaining such deposits with high quality financial institutions that management believes are creditworthy and the

HYPERFINE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

(all amounts are in thousands, except share and per share amounts)

Company monitors this credit risk and makes adjustments to the concentrations as necessary. The Company has not experienced any losses in such accounts and does not believe that it is exposed to any significant risk of loss on these balances.

For the three months ended September 30, 2025, there were four customers that each represented 10% or more of total net revenue and contributed $884, $451, $442, and $374 of revenue, respectively. For the nine months ended September 30, 2025, there was one customer that represented 10% or more of total net revenue and contributed $884 of revenue.

For the three months ended September 30, 2024, there were two customers that each represented 10% or more of total net revenue and contributed $395 and $369 of revenue, respectively. For the nine months ended September 30, 2024, there was one customer that represented 10% or more of total net revenue and contributed $1,264 of revenue.

As of September 30, 2025, there were three customers that each accounted for more than 10% of the Company's total accounts receivable in the amount of $1,226, $927 and $815, respectively. As of December 31, 2024, there were three customers that each accounted for more than 10% of the Company's total accounts receivable in the amount of $1,439, $815, and $720, respectively.

Use of Estimates

The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions about future events that affect the amounts reported in its condensed consolidated financial statements and accompanying notes. Future events and their effects cannot be determined with certainty. On an ongoing basis, management evaluates these estimates and assumptions. Significant estimates and assumptions included:

•

Revenue recognition, including determination of the timing and pattern of satisfaction of performance obligations, determination of the standalone selling price of performance obligations;

•

Allowance for credit losses;

•

Net realizable value (the selling price as well as estimated costs of disposal and transportation) of inventory, and demand and future use of inventory;

•

Valuation allowances with respect to deferred tax assets;

•

Assumptions underlying the fair value used in the calculation of stock-based compensation expense; and

•

Warrant liabilities valuation.

The Company bases these estimates on historical and anticipated results and trends and on various other assumptions that the Company believes are reasonable under the circumstances, including assumptions as to future events. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates, and any such differences may be material to the Company’s condensed consolidated financial statements.

Recently Issued Accounting Pronouncements Not Yet Adopted

In September 2025, the Financial Accounting Standards Board (“FASB”) issued ASU 2025-06, “Intangibles - Goodwill and Other-Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software” (“ASU 2025-06”). ASU 2025-06 amends the existing standard to remove all references to prescriptive and sequential software development project stages. Under this guidance, eligible software development costs will begin capitalization when (i) management has authorized and committed to funding the software project and (ii) it is probable that the project will be completed and the software will be used to perform the function intended. In evaluating whether it is probable the project will be completed, management is required to consider whether there is significant uncertainty associated with the development activities of the software. This guidance is effective for fiscal years beginning after December 15, 2027, and for interim periods beginning after December 15, 2027, with early adoption permitted. ASU 2025-06 may be applied on a prospective basis, a modified basis for

HYPERFINE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

(all amounts are in thousands, except share and per share amounts)

in-process projects, or a retrospective basis. The Company is currently evaluating the impact of adopting ASU 2025-06.

In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40) (“ASU 2024-03”): Disaggregation of Income Statement Expenses, requiring public entities to disclose additional information about specific expense categories in the notes to the financial statements on an interim and annual basis. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and for interim periods beginning after December 15, 2026, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2024-03.

3. REVENUE RECOGNITION

Disaggregation of Revenue

The Company disaggregates revenue from contracts with customers by product type. The Company believes that these categories best represent the payor types by nature, amount, timing and uncertainty of its revenue streams. The following table summarizes the Company’s disaggregated revenues:


		Three Months Ended September 30,				Nine Months Ended September 30,
	Pattern of Recognition	2025		2024		2025		2024
Device	Point in time	$	2,891	$	3,033	$	6,541	$	8,707
Service	Over time		546		610		1,729		1,862
Total revenue		$	3,437	$	3,643	$	8,270	$	10,569

Contract Balances

Contract balances represent amounts presented in the condensed consolidated balance sheets when either the Company has transferred goods or services to the customer, or the customer has paid consideration to the Company under the contract. These contract balances include trade accounts receivable and deferred revenue. Deferred revenue represents consideration received from customers at the beginning of the subscription period for services that are transferred to the customer over the respective subscription period. The accounts receivable balances represent amounts billed to customers for goods and services where the Company has an unconditional right to payment of the amount billed.

The following table provides information about receivables and deferred revenue from contracts with customers:


	September 30, 2025		December 31, 2024
Accounts receivable, net	$	4,886	$	5,956
Unbilled receivables - current	$	1,423	$	2,349
Unbilled receivables - non-current(1)	$	862	$	825
Deferred revenue	$	1,435	$	1,460
Long term deferred revenue	$	974	$	1,054

______________________

(1) Recorded in other long term assets in the Company’s consolidated balance sheets. Unbilled receivables - non-current is based on the billing schedules for future billings beyond one year.

The Company recognizes a receivable when it has an unconditional right to payment. Typical payment terms require the Company's customers to pay the Company within 30 days of invoice and up to less than one year based on the terms agreed upon with the respective customer.

HYPERFINE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

(all amounts are in thousands, except share and per share amounts)

Accounts Receivable, Unbilled Services, and Deferred Revenue

Accounts receivable are recorded at net realizable value. Unbilled receivables arise when performance obligations are satisfied for which revenue has been recognized but the customers have not been billed. Contractual provisions and payment schedules may or may not correspond to the timing of the performance of services under the contract.

Deferred revenue is a contract liability that consists of customer payments received in advance of performance and billings in excess of revenue recognized, net of revenue recognized from the balance at the beginning of the period.

The amount of revenue recognized during the three and nine months ended September 30, 2025 that was included in the deferred revenue balance at the beginning of the period was $421 and $1,106, respectively.

The amount of revenue recognized during the three and nine months ended September 30, 2024 that was included in the deferred revenue balance at the beginning of the period was $475 and $1,172, respectively.

Timing of Billing and Performance

Difference in the timing of revenue recognition and associated billings and cash collections result in recording of billed accounts receivable, unbilled accounts receivable (including contract assets), and deferred revenue on the consolidated balance sheet. Amounts are billed in accordance with the agreed-upon contractual terms, resulting in recording unbilled accounts receivable in instances where the right to bill is contingent solely on the passage of time, and contract assets in instances where the right to consideration is conditional on something other than the passage of time.

Revenue from Leasing Arrangements

Revenue from leasing arrangements is not subject to the revenue standard for contracts with customers and remains separately accounted for under ASC 842, “Leases” including leases for the three and nine months ended September 30, 2025 and 2024. The Company recorded service revenue from lease arrangements of $0 and $46 for the three and nine months ended September 30, 2025, respectively, and of $44 and $203 for the three and nine months ended September 30, 2024, respectively. The Company records revenue from the sale of hardware devices under sales-type leases as device revenue in an amount equal to the present value of minimum lease payments at the inception of the lease. Sales-type leases also produce financing income, which is included in device revenue in the consolidated statements of operations and comprehensive loss and is recognized at effective rates of return over the lease term.

Costs of Obtaining or Fulfilling Contracts

The Company incurs incremental costs of obtaining contracts with customers. Incremental costs of obtaining contracts, which include commissions paid as a result of obtaining contracts with customers, are capitalized to the extent that the Company expects to recover such costs. Capitalized costs are amortized in a pattern that is consistent with the Company’s transfer to the customer of the related goods and services. Such costs are recorded in Other long term assets and were $558 and $490 as of September 30, 2025 and December 31, 2024, respectively. During the three and nine months ended September 30, 2025, the Company recognized $340 and $695, respectively, in expense related to the amortization of the capitalized contract costs. During the three and nine months ended September 30, 2024, the Company recognized $408 and $814, respectively, in expense related to the amortization of the capitalized contract costs.

Transaction Price Allocated to Remaining Performance Obligations

As of September 30, 2025 and December 31, 2024, the Company had remaining performance obligations amounting to $6,156 and $5,644, respectively. The Company expects to recognize approximately 9% of its remaining performance obligations as revenue in fiscal year 2025, and an additional 91% in fiscal year 2026 and thereafter.

HYPERFINE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

(all amounts are in thousands, except share and per share amounts)

4. FAIR VALUE OF FINANCIAL INSTRUMENTS

Fair value estimates of financial instruments are made at a specific point in time, based on relevant information about financial markets and specific financial instruments. As these estimates are subjective in nature, involving uncertainties and matters of significant judgment, they cannot be determined with precision. Changes in assumptions can significantly affect estimated fair value.

The Company measures fair value as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The Company utilizes a three-tier hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value:

Level 1 — Valuations based on quoted prices in active markets for identical assets or liabilities that an entity has the ability to access.

Level 2 — Valuations based on quoted prices for similar assets or liabilities, quoted prices for identical assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable data for substantially the full term of the assets or liabilities.

Level 3 — Valuations based on inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

The carrying value of cash and cash equivalents, accounts payable and accrued expenses and other current liabilities approximates their fair values due to the short-term or on demand nature of these instruments.

Cash is measured at fair value on a recurring basis using Level 1 inputs. The Company had $22,030 and $37,451 of money market funds, demand deposit and savings accounts included in cash and cash equivalents and restricted cash as of September 30, 2025 and December 31, 2024, respectively. These assets were valued using quoted prices in active markets and accordingly were classified as Level 1. Other liabilities include warrant liabilities that are measured at fair value on a recurring basis using Level 3 inputs. As of September 30, 2025 and February 12, 2025, the closing date of the February 2025 Offering (as defined below) and the initial warrant liability valuation date, the fair value of the warrant liabilities were $3,497 and $2,858, respectively.

The Company had no assets or liabilities classified using Level 2 inputs and there were no transfers between fair value measurement levels during the three and nine months ended September 30, 2025 or 2024.

5. INVENTORIES

A summary of inventories is as follows:


	September 30, 2025		December 31, 2024
Raw materials	$	2,008	$	3,070
Finished goods		3,830		2,762
Total inventories	$	5,838	$	5,832

Manufacturing overhead costs primarily include management’s best estimate and allocation of the labor costs incurred related to acquiring finished goods from the Company’s contract manufacturer. Labor costs include wages, taxes and benefits for employees involved in warehousing, logistics coordination, material sourcing, and production planning activities.

HYPERFINE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

(all amounts are in thousands, except share and per share amounts)

6. PROPERTY AND EQUIPMENT, NET

Property and equipment, net, are recorded at historical cost and consist of the following:


	September 30, 2025			December 31, 2024
Laboratory equipment	$	1,027		$	986
Research devices		1,823			1,398
Sales and marketing devices		400			490
Computer equipment		689			689
Construction in progress		373			1,229
Tooling		1,502			857
Trade show assets		295			254
Leased devices		181			181
Other		632			595
		6,922			6,679
Less: Accumulated depreciation and amortization		(4,177	)		(3,557	)
Property and equipment, net	$	2,745		$	3,122

Depreciation expense amounted to $297 and $809 for the three and nine months ended September 30, 2025, respectively.

Depreciation expense amounted to $259 and $775 for the three and nine months ended September 30, 2024, respectively.

7. RIGHT-OF-USE (“ROU”) ASSETS AND LEASES LIABILITIES

The Company has operating leases for its corporate offices, including its Palo Alto, California lease agreement which expires on April 30, 2026 and a warehouse lease agreement in Guilford, Connecticut which was extended by six months in June 2025 and expires on August 31, 2026. As of September 30, 2025 and December 31, 2024, the balance of operating lease ROU assets of $186 and $341, respectively, current lease liabilities of $182 and $269, respectively, and non-current lease liabilities of $0 and $78, respectively, are included in the Company's condensed consolidated balance sheets in other long term assets, accrued expenses and other current liabilities, respectively.

The weighted-average remaining lease term associated with the measurement of the Company's operating lease obligations is 11 months and an annual weighted-average discount rate is 9.78%.

Future minimum commitments due under the lease agreements as of September 30, 2025 are $68 for 2025 and $115 thereafter.

8. ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

Accrued expenses and other current liabilities consist of the following:



	September 30, 2025		December 31, 2024
Bonuses	$	1,874	$	2,144
Contracted services		928		1,755
Legal fees		290		176
Payroll and related benefits		981		756
Operating lease liabilities		182		269
Other		257		473
Total accrued expenses and other current liabilities	$	4,512	$	5,573

HYPERFINE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

(all amounts are in thousands, except share and per share amounts)

9. STOCKHOLDERS' EQUITY

Common Stock At-the-Market (ATM) Offering Program

On November 9, 2023, the Company filed a $150,000 shelf registration statement on Form S-3, which became effective on November 22, 2023, and includes a prospectus covering up to an aggregate of $50,000 in shares of Class A common stock that the Company may issue and sell from time to time, through B. Riley Securities, Inc. (“B. Riley”) acting as its sales agent, pursuant to the sales agreement that the Company entered into with B. Riley in November 2023 (the “Sales Agreement”), for its “at-the-market” (“ATM”) equity program. The shelf registration statement is effective for three years and permits the Company to sell, from time to time, up to $150,000 in aggregate value of its Class A common stock, preferred stock, debt securities, warrants, and/or units. The shelf registration statement is intended to provide the Company with flexibility to access additional capital when market conditions are appropriate.

As of September 30, 2025, an aggregate of 3,134,638 shares of Class A common stock have been issued and sold under the Sales Agreement, for gross proceeds of $3,862 and net proceeds of $3,689, after deducting commissions and other offering expenses related to the ATM. During the three and nine months ended September 30, 2025, 1,554,726 and 2,362,917 shares of the Company's Class A common stock, respectively, were issued and sold under the Sales Agreement, for gross proceeds of $2,124 and $2,981, respectively, and net proceeds of $2,049 and $2,870, respectively, after deducting commissions and other offering expenses related to the ATM.

Common Stock and Common Stock Warrants

On February 12, 2025, the Company closed the transactions pursuant to a securities purchase agreement with certain institutional investors (the “Investors”), in which the Company issued and sold, in a registered direct offering by the Company directly to the Investors (the “February 2025 Offering”): (i) 4,511,278 shares (the “Shares”) of the Company’s Class A common stock and (ii) warrants to purchase up to 4,511,278 shares of the Company’s Class A common stock (the “Warrants”). Each Share and accompanying Warrant were sold together at a combined offering price of $1.33. Each Warrant has an exercise price of $1.33 and expires on the five-year anniversary of the initial issuance date. The aggregate gross proceeds to the Company from the February 2025 Offering were $6,000 before deducting the placement agent’s fees and offering expenses. The incremental issuance costs allocated to warrant liabilities were recorded as expenses in the Company's condensed consolidated statements of operations in line item “other (expense) income, net”.

Equity Incentive Plan

The Company's 2021 Equity Incentive Plan (the “Plan”) is administered by the Company's board of directors and its compensation committee of the board of directors, which may grant restricted stock units (“RSUs”) and options to purchase shares either as incentive stock options or non-qualified stock options, and other stock-based awards. The option and RSU grants are subject to certain terms and conditions, and privileges as set forth in the Plan.

Stock option activity

The following table summarizes the changes in the Company’s outstanding stock options for the nine months ended September 30, 2025:


	Number of Options
Outstanding at January 1, 2025		18,396,536
Granted (1) (2) (3)		430,917
Exercised		(936,351	)
Forfeited / Cancelled / Expired		(2,043,228	)
Outstanding at September 30, 2025		15,847,874

_____________________________________________

(1) Includes new hire employee grants of stock options to purchase 111,500 shares of the Company's Class A common stock. The grants vest 25% on the first anniversary date of the grant with the remainder vesting equally over the remaining 36 months, subject to the employee’s continued service to the Company through the applicable vesting dates.

HYPERFINE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

(all amounts are in thousands, except share and per share amounts)

(2) Includes the annual equity grants to three of the Company’s nonemployee directors of non-qualified stock options to purchase 79,200 shares of the Company’s Class A common stock, effective as of May 20, 2025, for an aggregate of stock options to purchase 237,600 shares of the Company’s Class A common stock. The grants will vest on the date of the Company's next regular annual stockholders meeting, subject to the directors’ continued service to the Company through the vesting date. The previous chairperson of the Company’s board of directors and one of the nonemployee directors chose to voluntarily forfeit their 2025 annual equity grants.

(3) Includes a grant of non-qualified stock options to purchase 81,817 shares of the Company’s Class A common stock granted to Mr. Wolterman, the new chairperson of the Company’s board of directors, effective as of June 5, 2025, which vest on the date of the Company’s next regular annual stockholders meeting, subject to Mr. Wolterman’s continued service to the Company through the vesting date. During the vesting term of the option, Mr. Wolterman will not receive cash compensation for his service as chairperson of the board of directors.

In general, employee awards will vest based on continued service, which is generally over four years. Nonemployee director awards generally will vest in one year based on continued service on the date of the next regular annual stockholder meeting. The grant date fair value of the award will be recognized as stock-based compensation expense over the requisite service period. The grant date fair value was determined using similar methods and assumptions as those previously disclosed by the Company.

Restricted stock unit activity

The following table summarizes the changes in the Company’s outstanding RSUs for the nine months ended September 30, 2025:


	Number of RSUs
Outstanding at January 1, 2025		138,902
Granted (1)		2,540,753
Vested		(76,160	)
Forfeited		(68,468	)
Outstanding at September 30, 2025		2,535,027

_____________________________________________

(1) Includes new hire grants of 197,920 RSUs, annual employee grants of 1,742,833 RSUs, and grants to executive officers of 600,000 RSUs. The grants will vest 25% approximately on the anniversary date of the grant with the remainder vesting equally over the remaining 12 quarters, subject to the employee’s continued service to the Company through the applicable vesting dates.

The following table presents details of stock-based compensation expenses by functional line item noted within the Company's operating expenses:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2025		2024		2025		2024
Cost of sales	$	30	$	18	$	96	$	66
Research and development		209		383		921		1,107
Sales and marketing		47		49		181		135
General and administrative		331		652		911		2,000
	$	617	$	1,102	$	2,109	$	3,308

10. NET LOSS PER SHARE

Basic net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock of the Company outstanding during the period. Diluted net loss per share is computed by giving effect to all common equivalent shares of the Company, including outstanding stock options, RSUs, Earn-Out Shares (as defined below) and warrants to purchase Class A common stock (described below), to the extent dilutive. Basic and diluted

HYPERFINE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

(all amounts are in thousands, except share and per share amounts)

net loss per share was the same for each period presented as the inclusion of all common equivalent shares of the Company outstanding would have been anti-dilutive.

The following table presents the calculation of basic and diluted net loss per share for the Company’s common stock:


	Three Months Ended September 30,						Nine Months Ended September 30,
	2025			2024			2025			2024
Numerator:
Net Loss	$	(11,019	)	$	(10,326	)	$	(29,662	)	$	(30,330	)
Numerator for Basic and Dilutive EPS – Loss available to common stockholders	$	(11,019	)	$	(10,326	)	$	(29,662	)	$	(30,330	)
Denominator:
Common Stock		79,028,987			72,678,622			77,613,306			72,219,681
Denominator for Basic and Dilutive EPS - Weighted-average common stock		79,028,987			72,678,622			77,613,306			72,219,681
Basic and dilutive net loss per share	$	(0.14	)	$	(0.14	)	$	(0.38	)	$	(0.42	)

Since the Company was in a net loss position for all periods presented, net loss per share attributable to Class A and Class B common stockholders was the same on a basic and diluted basis, as the inclusion of all common equivalent shares outstanding would have been anti-dilutive. Anti-dilutive common equivalent shares were as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2025		2024		2025		2024
Outstanding options to purchase common stock		15,847,874		18,713,397		15,847,874		18,713,397
Outstanding RSUs		2,535,027		224,849		2,535,027		224,849
Earn-Out Shares (1)		—		9,357,835		—		9,357,835
Warrants to purchase common stock		4,511,178		—		4,511,178
Total anti-dilutive common equivalent shares		22,894,079		28,296,081		22,894,079		28,296,081

_________________________

(1) The Company would issue to holders of Legacy Hyperfine and Liminal securities as of immediately prior to the effective time of the Mergers, in accordance with their pro rata share, up to 10,000,000 shares of Class A common stock as earn-out consideration (the “Earn-Out Shares”) net of forfeitures, if at any time during the period between the Closing Date of December 22, 2021 and the third anniversary of the Closing Date (the “Earn-Out Period”), (i) the last share price of the Class A common stock was greater than or equal to $15.00 for any 20 trading days within any 30 consecutive trading day period, or (ii) there was a transaction that would result in shares of Class A common stock being converted or exchanged into the right to receive cash or other consideration having a value greater than or equal to $15.00. During the Earn-Out Period, if there was a transaction (other than for stock splits, stock dividends, special cash dividends, reorganizations, recapitalizations or similar transactions affecting the Class A common stock) that would result in the shares of Class A common stock being converted or exchanged into the right to receive cash or other consideration having a value less than $15.00, then the right to receive Earn-Out Shares would terminate. As of December 22, 2024, the Earn-Out Shares expired as a result of the vesting conditions not being achieved.

See Note 15—Subsequent Events for further discussion of the Company's Class A common stock issued subsequent to September 30, 2025 in connection with the October 2025 Offering (as defined below).

11. INCOME TAXES

The Company accounts for income taxes under ASC 740, “Income Taxes” (“ASC 740”). ASC 740 requires the recognition of deferred tax assets and liabilities for both the expected impact of differences between the financial statement and tax basis of assets and liabilities and for the expected future tax benefit to be derived from tax loss and tax credit carry forwards. ASC 740 additionally requires a valuation allowance to be established when it is more likely than not that all or a portion of deferred tax assets will not be realized.

HYPERFINE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

(all amounts are in thousands, except share and per share amounts)

Income taxes for the three and nine months ended September 30, 2025 are recorded at the Company’s estimated annual effective income tax rate, subject to adjustments for discrete events, if they occur. The Company’s estimated annual effective tax rate was 0.0% for each of the three and nine months ended September 30, 2025. The primary reconciling items between the federal statutory rate of 21.0% for these periods and the Company’s overall effective tax rate of 0.0% were related to the effects of deferred state income taxes, research and development credits, stock-based compensation, and the valuation allowance recorded against the full amount of its net deferred tax assets.

A valuation allowance is required when it is more likely than not that some portion or all of the Company’s deferred tax assets will not be realized. The realization of deferred tax assets depends on the generation of sufficient future taxable income during the period in which the Company’s related temporary differences become deductible. The Company has recorded a full valuation allowance against its net deferred tax assets as of September 30, 2025 and 2024 since management believes that based on the earnings history of the Company, it is more likely than not that the benefits of these assets will not be realized.

On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted in the United States. The OBBBA makes permanent key elements of the Tax Cuts and Jobs Act, including 100% bonus depreciation, domestic research cost expensing, and the business interest expense limitation. ASC 740 requires the effects of changes in tax rates and laws on deferred tax balances to be recognized in the period in which the legislation is enacted. The Company has evaluated the new legislation and has determined to continue the current treatment of capitalizing and amortizing its domestic Internal Revenue Code Section 174 expenditures. As a result of the Company’s net operating loss carryforwards and full valuation allowance against the Company’s net deferred tax assets, the Company does not expect this treatment to have a significant effect on the Company’s financial statements. Management will continue to monitor and evaluate the tax effects of the OBBBA on the Company’s financial statements, including the effect on the Company’s effective tax rate and deferred tax assets during the remainder of 2025 and in future periods. However, the Company does not expect the other provisions contained within the OBBBA to result in any significant effects on its financial statements.

12. RELATED PARTY TRANSACTIONS

The Company utilizes and subleases office and lab space in Connecticut, which is being leased from an unrelated landlord by 4Catalyzer Corporation (“4C”), which is owned by a related party. The Company pays rent to 4C on a month-to-month basis. A total of approximately $161 and $364 was paid during the three and nine months ended September 30, 2025, respectively, and a total of approximately $138 and $386 was paid during the three and nine months ended September 30, 2024, respectively.

Hyperfine entered into a Master Services Agreement (the “Master Services Agreement”) with 4C effective as of July 7, 2021 pursuant to which Hyperfine may engage 4C to provide services such as general administration, facilities, information technology, financing, legal, human resources and other services, through future statements of work and under terms and conditions to be determined by the parties with respect to any services to be provided. The Company paid an aggregate of $32 and $90 during the three and nine months ended September 30, 2025, respectively, and the Company paid an aggregate of $33 and $98 during the three and nine months ended September 30, 2024, respectively, under the Master Services Agreement. As of September 30, 2025 and December 31, 2024 there were $45 and $61 due to 4C, respectively, for expenses paid on the Company's behalf. These payables are included in due to related parties on the condensed consolidated balance sheet.

HYPERFINE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

(all amounts are in thousands, except share and per share amounts)

13. COMMITMENTS AND CONTINGENCIES

Commitments

The Company sponsors a 401(k) defined contribution plan covering all eligible U.S. employees. Contributions to the 401(k) plan are discretionary. The Company did not make any matching contributions to the 401(k) plan for the three or nine months ended September 30, 2025 or 2024.

During 2020 and 2021, the Company was awarded multiple grants totaling $4,910 from the Bill & Melinda Gates Foundation (“BMGF”) for the provision and equipping of sites with the Company’s 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. All of 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, the Company was awarded an additional $3,354 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. The funds were accounted for as restricted cash with a corresponding credit to deferred grant funding. Any grant funds, plus any interest income, that have not been used for, or committed to, the project must be returned promptly to the BMGF upon expiration of or termination of the agreement. During the nine months ended September 30, 2025, the Company completed and fulfilled grant deliverables and milestones amounting to $802 and received cash grant funding of $1,233. As of September 30, 2025, the Company recorded restricted cash of $466 with an offset to deferred grant funding in the Company's unaudited condensed consolidated balance sheet. As of September 30, 2025, and December 31, 2024, there were no grant fund amounts that were required to be returned under the terms of the project.

Purchase Commitments

The Company’s 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 the Company has 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 the Company the option to cancel, reschedule, and adjust its requirements based on the Company’s business needs prior to the delivery of goods or performance of services.

Contingencies

The Company is, from time to time, a party to litigation that arises in the normal course of its business operations. The Company is not presently a party to any litigation for which it believes a loss is probable requiring an amount to be accrued or a possible loss contingency requiring disclosure.

The Company has indemnification obligations under some agreements that the Company enters into with other parties in the ordinary course of business, including business partners, investors, contractors, and the Company’s officers, directors and certain employees. The Company has agreed to indemnify and defend the indemnified party against claims and related losses suffered or incurred by the indemnified party from actual or threatened third-party claims because of the Company’s activities or non-compliance with certain representations and warranties made by the Company. It is not possible to determine the maximum potential loss under these indemnification provisions due to the Company’s limited history of prior indemnification claims and the unique facts and circumstances involved in any particular case. The Company has not recorded any liability under such indemnification provisions within its condensed consolidated balance sheets. The Company is not aware of any claims or other circumstances that would give rise to material payments from the Company under such indemnification provisions.

14. REPORTABLE SEGMENTS AND GEOGRAPHIC INFORMATION

HYPERFINE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

(all amounts are in thousands, except share and per share amounts)

The Company operates in one business segment, which includes all activities related to production, supply, service and commercialization of the Swoop® system. The determination of a single business segment is consistent with the consolidated financial information regularly provided to the Company’s chief operating decision maker (“CODM”). The Company’s CODM is its Chief Executive Officer, who reviews consolidated net loss to measure segment profit or loss, allocate resources, and assess performance. Further, the CODM is regularly provided with and utilizes consolidated functional expenses, as presented in the accompanying consolidated statements of operations, and total assets at the consolidated level, as included in the consolidated balance sheets herein, to manage the Company’s operations.

All of the Company’s long-lived assets are located in the United States. Non-U.S. revenue is attributed to revenue from customer located in foreign countries. Other than revenue recognized in non-U.S. countries of $831 and $2,397 for the three and nine months ended September 30, 2025, respectively, and $1,156 and $5,254 for the three and nine months ended September 30, 2024, respectively, all of the revenues during these periods were earned in the United States. Since the Company has a single reportable segment, all required financial segment information is provided in the consolidated financial statements.

15. SUBSEQUENT EVENTS

October 2025 Offering

On October 17, 2025, the Company closed an underwritten public offering (the “October 2025 Offering”), in which the Company issued and sold 14,000,000 shares of the Company’s 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, the Company received gross proceeds of $17,500 from the October 2025 Offering, before deducting underwriting discounts and commissions and other offering expenses, and net proceeds of approximately $16,000, after deducting underwriting discounts and commissions and other offering expenses.

Under the terms of the Underwriting Agreement, the underwriter had 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”). On October 21, 2025, the underwriter notified the Company that it was exercising the Underwriter Option. On October 23, 2025, the Company received additional gross proceeds of $2,625 from the exercise of the Underwriter Option, before deducting underwriting discounts and commissions and other offering expenses, and additional net proceeds of approximately $2,400, after deducting underwriting discounts and commissions and other offering expenses.

The Company’s aggregate gross proceeds from the October 2025 Offering, including the gross proceeds from the exercise of the Underwriter Option, were $20,125, before deducting underwriting discounts and commissions and other offering expenses. The Company's aggregate net proceeds from the October 2025 Offering, including the net proceeds from the exercise of the Underwriter Option, were approximately $18,400, after deducting underwriting discounts and commissions and other offering expenses.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

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, 2024 contained in our 2024 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 2024 Annual Report on Form 10-K, our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025 and June 30, 2025, 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 nine months ended September 30, 2025 and 2024, respectively, present the financial position and results of operations of Hyperfine, Inc. and its wholly owned subsidiaries.

Overview

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 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 experience for patients, 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 or when they are not readily available. The easy-to-use interface and portable design of our Swoop® system make it easily and readily accessible anywhere in a hospital, clinic, physician office, or patient care site and it does not require any special facilities accommodations nor 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 or positron emission tomography.

The demand for MR imaging has been increasing due to the aging population and the rising prevalence of neurological, neurodegenerative, and cardiovascular conditions, as well as the trends towards decentralized healthcare in mature, as well as low- and middle-income countries. Healthcare professionals and insurers recognize imaging as an effective, non-invasive diagnostic tool for evaluation and ongoing monitoring of patients at risk of or with neurological conditions. The Swoop® system is the next generation brain imaging device 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, 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 that is capable of providing imaging at multiple sites of care, such as intensive care units, clinics, emergency departments 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 imaging technologies and make brain MR imaging accessible nearly anytime and anywhere across professional healthcare settings. We believe the adoption of the Swoop® system by healthcare professionals has the potential to offer clinical and economic benefits throughout healthcare communities in both high and low resource settings.

The Swoop® system is AI-powered and integrates deep learning, a form of AI in the reconstruction pipeline of T1, T2, diffusion-weighted Imaging, and fluid-attenuated inversion recovery sequences. 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. The algorithms are designed to improve ULF image quality, while reducing the impact of scan artifacts. The images created with these algorithms were 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 install base continues to expand. 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 ten 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.

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 of 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 the result is brain images with greater clarity, uniformity and sharper anatomical detail.

A very important milestone for us was obtaining 510(k) clearance from the FDA in late May 2025, for our new next generation Swoop® system powered by Optive AITM software. The next-generation Swoop® system incorporates learnings from five years of real-world experience, features new hardware and is powered by Optive AI™ software. The next-generation Swoop® system features innovations specifically engineered to deliver the highest signal-to-noise ratio, which, when paired with the Optive AI™ software, achieves exceptional image quality for low-field MRI, including improved resolution and uniformity, as well as faster acquisition times.

Key Performance Metrics

Management reviews and analyzes several key performance metrics including total revenues and total Swoop® system units sold. These metrics are reviewed and analyzed to evaluate our business performance, identify trends affecting our business, allocate capital, and make strategic decisions.

Total revenues were $3.4 million and $8.3 million for the three and nine months ended September 30, 2025, respectively, as compared to total revenues of $3.6 million and $10.6 million for the three and nine months ended September 30, 2024, respectively, primarily driven by decreases in Swoop® system units sold offset by an increase in average selling price. See "Results of Operations - Sales" below for further information. Total Swoop® system units sold were 8 units and 22 units, for the three and nine months ended September 30, 2025, respectively, as compared to 13 units and 39 units, for the three and nine months ended September 30, 2024, respectively.

Factors Affecting Results of Operations

The following factors have been important to our business and we expect them to impact our results of operations and financial condition in future periods:

Technical innovation

We have developed our Swoop® system through extensive research and development activities. Moreover, our team is dedicated to clinical support programs designed to integrate the Swoop® system into an array of diverse healthcare environments, workflow, and applications. We believe that, from our commercial and clinical experience, we are gaining invaluable insights into the Swoop® system’s clinical utility. We believe these learnings will enable us to further improve our product and develop new services and tools in the future. We are continuously improving our image quality and imaging capabilities. Building upon this foundation and our expertise in ULF brain imaging, we plan to develop new imaging applications, broadening the range of clinical uses for our proprietary technology.

Additionally, we are leveraging our strengths in AI and cloud technology to explore the Swoop® system’s role as a brain imaging clinical decision support platform. While these technical innovations may increase our research and development expenses, we expect them to have a positive impact on our results of operations and profitability in the future.

Commercialization efforts of the Swoop® system

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 customer sites. We have begun 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 Optive AITM software.

Expand sales in international markets

The countries outside of the United States in which we have begun commercializing our Swoop® system include Canada, certain European markets, Australia, and New Zealand. 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, enables a broader European 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.

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 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. During the nine months ended September 30, 2025, we completed and fulfilled grant deliverables and milestones amounting to $0.8 million and we received cash grant funding of $1.2 million.

Results of Operations

The following is a discussion of our results of operations for the three and nine months ended September 30, 2025 and 2024. 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.


	Three Months Ended September 30,				Change			Nine Months Ended September 30,				Change
($ Amounts in thousands)	2025		2024		%			2025		2024		%
Sales
Device	$	2,891	$	3,033		(4.7	)%	$	6,541	$	8,707		(24.9	)%
Service		546		610		(10.5	)%		1,729		1,862		(7.1	)%
Total sales		3,437		3,643		(5.7	)%	$	8,270	$	10,569		(21.8	)%
Cost of Sales
Device		1,328		1,359		(2.3	)%	$	3,410	$	4,280		(20.3	)%
Service		261		376		(30.6	)%		801		1,224		(34.6	)%
Cost of sales		1,589		1,735		(8.4	)%	$	4,211	$	5,504		(23.5	)%
Gross margin		1,848		1,908		(3.1	)%		4,059		5,065		(19.9	)%
Operating expenses:
Research and development		4,048		5,865		(31.0	)%	$	13,626	$	17,394		(21.7	)%
General and administrative		4,152		4,510		(7.9	)%		12,219		13,361		(8.5	)%
Sales and marketing		2,568		2,496		2.9	%

Hyperfine, Inc. 10-Q