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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 June 30, 2025

or

☐ 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 August 1, 2025, the registrant h ad 63,525,713 shares of Class A common stock outstanding and 15,055,288 shares of Class B common stock outstanding.

|  | 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 | 21
Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 31
Item 4. | Controls and Procedures | 31
PART II | OTHER INFORMATION | 32
Item 1. | Legal Proceedings | 32
Item 1A. | Risk Factors | 32
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 32
Item 3. | Defaults Upon Senior Securities | 32
Item 4. | Mine Safety Disclosures | 32
Item 5. | Other Information | 32
Item 6. | Exhibits | 33
| Signatures | 34

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.

2

# 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;

3

•
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 this Quarterly Report on Form 10-Q, 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.

4

# 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)

|  | June 30, 2025 |  |  | December 31, 2024 |
ASSETS |  |  |  |  |  |
CURRENT ASSETS: |  |  |  |  |  |
Cash and cash equivalents |  | $ | 25,420 |  |  | $ | 37,645 |
Restricted cash |  |  | 158 |  |  |  | 28 |
Accounts receivable, less allowance of $894 and $651 as of June 30, 2025 and December 31, 2024, respectively |  |  | 5,057 |  |  |  | 5,956 |
Unbilled receivables |  |  | 1,892 |  |  |  | 2,349 |
Inventory |  |  | 4,882 |  |  |  | 5,832 |
Prepaid expenses and other current assets |  |  | 2,687 |  |  |  | 1,900 |
Total current assets |  |  | 40,096 |  |  |  | 53,710 |
Property and equipment, net |  |  | 3,122 |  |  |  | 3,122 |
Other long term assets |  |  | 2,016 |  |  |  | 2,069 |
Total assets |  | $ | 45,234 |  |  | $ | 58,901 |
LIABILITIES AND STOCKHOLDERS’ EQUITY |  |  |  |  |  |
CURRENT LIABILITIES: |  |  |  |  |  |
Accounts payable |  | $ | 2,971 |  |  | $ | 1,607 |
Deferred grant funding |  |  | 158 |  |  |  | 28 |
Deferred revenue |  |  | 1,370 |  |  |  | 1,460 |
Due to related parties |  |  | 59 |  |  |  | 61 |
Accrued expenses and other current liabilities |  |  | 3,430 |  |  |  | 5,573 |
Total current liabilities |  |  | 7,988 |  |  |  | 8,729 |
Warrant liabilities |  |  | 1,194 |  |  |  | — |
Long term deferred revenue |  |  | 914 |  |  |  | 1,054 |
Other noncurrent liabilities |  |  | 12 |  |  |  | 78 |
Total liabilities |  |  | 10,108 |  |  |  | 9,861 |
COMMITMENTS AND CONTINGENCIES (NOTE 13) |  |  |  |  |  |
STOCKHOLDERS' EQUITY |  |  |  |  |  |
Class A Common stock, $0.0001 par value per share; 600,000,000 shares authorized; 63,525,713 and 58,076,261 shares issued and outstanding at June 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 June 30, 2025 and December 31, 2024, respectively |  |  | 2 |  |  |  | 2 |
Additional paid-in capital |  |  | 348,203 |  |  |  | 343,475 |
Accumulated deficit |  |  | (313,085 | ) |  |  | (294,442 | )
Total stockholders' equity |  |  | 35,126 |  |  |  | 49,040 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |  | $ | 45,234 |  |  | $ | 58,901 |

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

##

5

HYPERFINE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited)

(in thousands, except share and per share amounts)

|  | Three Months Ended June 30, |  |  | Six Months Ended June 30, |
|  | 2025 |  |  | 2024 |  |  | 2025 |  |  | 2024 |
Sales |  |  |  |  |  |  |  |  |  |  |  |
Device |  | $ | 2,128 |  |  | $ | 2,970 |  |  | $ | 3,650 |  |  | $ | 5,674 |
Service |  |  | 568 |  |  |  | 661 |  |  |  | 1,183 |  |  |  | 1,252 |
Total sales |  |  | 2,696 |  |  |  | 3,631 |  |  |  | 4,833 |  |  |  | 6,926 |
Cost of sales |  |  |  |  |  |  |  |  |  |  |  |
Device |  |  | 1,097 |  |  |  | 1,422 |  |  |  | 2,082 |  |  |  | 2,921 |
Service |  |  | 271 |  |  |  | 406 |  |  |  | 540 |  |  |  | 848 |
Total cost of sales |  |  | 1,368 |  |  |  | 1,828 |  |  |  | 2,622 |  |  |  | 3,769 |
Gross margin |  |  | 1,328 |  |  |  | 1,803 |  |  |  | 2,211 |  |  |  | 3,157 |
Operating Expenses: |  |  |  |  |  |  |  |  |  |  |  |
Research and development |  |  | 4,541 |  |  |  | 5,959 |  |  |  | 9,578 |  |  |  | 11,529 |
General and administrative |  |  | 3,859 |  |  |  | 4,421 |  |  |  | 8,067 |  |  |  | 8,851 |
Sales and marketing |  |  | 2,523 |  |  |  | 2,269 |  |  |  | 5,063 |  |  |  | 4,273 |
Total operating expenses |  |  | 10,923 |  |  |  | 12,649 |  |  |  | 22,708 |  |  |  | 24,653 |
Loss from operations |  |  | (9,595 | ) |  |  | (10,846 | ) |  |  | (20,497 | ) |  |  | (21,496 | )
Interest income |  |  | 239 |  |  |  | 675 |  |  |  | 556 |  |  |  | 1,471 |
Change in Fair Value of Warrant Liabilities |  |  | 46 |  |  |  | — |  |  |  | 1,664 |  |  |  | — |
Other income (expense), net |  |  | 85 |  |  |  | 15 |  |  |  | (366 | ) |  |  | 21 |
Loss before provision for income taxes |  |  | (9,225 | ) |  |  | (10,156 | ) |  |  | (18,643 | ) |  |  | (20,004 | )
Provision for income taxes |  |  | — |  |  |  | — |  |  |  | — |  |  |  | — |
Net loss and comprehensive loss |  | $ | (9,225 | ) |  | $ | (10,156 | ) |  | $ | (18,643 | ) |  | $ | (20,004 | )
Net loss per common share attributable to common stockholders, basic and diluted |  | $ | (0.12 | ) |  | $ | (0.14 | ) |  | $ | (0.24 | ) |  | $ | (0.28 | )
Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted |  |  | 78,077,118 |  |  |  | 72,041,332 |  |  |  | 76,893,733 |  |  |  | 71,987,688 |

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

6

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 |
|  | 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 |

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

7

HYPERFINE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(in thousands)

|  | Six Months Ended June 30, |
|  | 2025 |  |  | 2024 |
Cash flows from operating activities: |  |  |  |  |  |
Net loss |  | $ | (18,643 | ) |  | $ | (20,004 | )
Adjustments to reconcile net loss to net cash used in operating activities: |  |  |  |  |  |
Depreciation |  |  | 512 |  |  |  | 516 |
Stock-based compensation expense |  |  | 1,492 |  |  |  | 2,206 |
Loss on disposal of property and equipment, net |  |  | — |  |  |  | 100 |
Change in fair value of warrant liabilities |  |  | (1,664 | ) |  |  | — |
Other |  |  | 15 |  |  |  | 18 |
Changes in assets and liabilities: |  |  |  |  |  |
Accounts receivable, net |  |  | 899 |  |  |  | (2,179 | )
Unbilled receivables |  |  | 457 |  |  |  | (1,179 | )
Inventory |  |  | 733 |  |  |  | (1,000 | )
Prepaid expenses and other current assets |  |  | (749 | ) |  |  | (518 | )
Prepaid inventory |  |  | — |  |  |  | 693 |
Other long term assets |  |  | (34 | ) |  |  | 46 |
Accounts payable |  |  | 1,339 |  |  |  | 867 |
Deferred grant funding |  |  | 130 |  |  |  | (621 | )
Deferred revenue |  |  | (230 | ) |  |  | 68 |
Due to related parties |  |  | (2 | ) |  |  | 5 |
Accrued expenses and other current liabilities |  |  | (1,404 | ) |  |  | (912 | )
Operating lease liabilities, net |  |  | (10 | ) |  |  | 1 |
Net cash used in operating activities |  |  | (17,159 | ) |  |  | (21,893 | )
Cash flows from investing activities: |  |  |  |  |  |
Purchases of property and equipment |  |  | (992 | ) |  |  | (216 | )
Net cash used in investing activities |  |  | (992 | ) |  |  | (216 | )
Cash flows from financing activities: |  |  |  |  |  |
Proceeds from exercise of stock options |  |  | 37 |  |  |  | 114 |
Proceeds from shares issued under “at-the-market” offering program, net of selling costs |  |  | 835 |  |  |  | — |
Proceeds from issuance of common stock and warrants, net of offering costs |  |  | 5,184 |  |  |  | — |
Net cash provided by financing activities |  |  | 6,056 |  |  |  | 114 |
Net decrease in cash and cash equivalents and restricted cash |  |  | (12,095 | ) |  |  | (21,995 | )
Cash, cash equivalents and restricted cash, beginning of period |  |  | 37,673 |  |  |  | 75,804 |
Cash, cash equivalents and restricted cash, end of period |  |  | 25,578 |  |  |  | 53,809 |
Reconciliation of cash, cash equivalents, and restricted cash reported in the balance sheets |  |  |  |  |  |
Cash and cash equivalents |  |  | 25,420 |  |  |  | 53,809 |
Restricted cash |  |  | 158 |  |  |  | — |
Total cash, cash equivalents and restricted cash |  | $ | 25,578 |  |  | $ | 53,809 |
Supplemental disclosure of noncash information: |  |  |  |  |  |
Initial measurement of warrant liabilities |  | $ | 2,858 |  |  | $ | — |
Unpaid purchase of property and equipment |  | $ | 86 |  |  | $ | 735 |
Unpaid financing issuance costs |  | $ | 2 |  |  | $ | — |

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

8

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 AI TM Software. The next-generation Swoop® system incorporates learnings from five years of real world experience features new hardware and is powered by Optive AI TM 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. All of the Company’s revenue to date has been generated from sales of the Swoop® system and related services. The Company's Optive AI TM software is currently available in the U.S., Canada, Australia and New Zealand markets. 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 and six months ended June 30, 2025.

9

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 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, the Company's inability to obtain adequate financing may result in a substantial doubt about the Company's ability to continue as a going concern.

If additional funding is required, the Company plans to obtain working capital from either debt or equity financing 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 and this could result in management concluding in the future that substantial doubt about the Company's ability to continue as a going concern exists based upon the new information.

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 six months ended June 30, 2025 are not necessarily indicative of the results to be expected for any subsequent quarter, 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 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.

10

HYPERFINE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

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

For the three months ended June 30, 2025, there were four customers that each represented 10% or more of total net revenue and contributed $402, $362, $321, and $310 of revenue, respectively. For the six months ended June 30, 2025, no ne of the customers accounted for 10% or more of total net revenue.

For the three months ended June 30, 2024, there were four customers that each represented 10% or more of total net revenue and contributed $721, $434, $394, and $378 of revenue, respectively. For the six months ended June 30, 2024, there were two customers that each represented 10% or more of total net revenue and contributed $1,146 and $721 of revenue, respectively.

As of June 30, 2025, there were three customers that each accounted for more than 10% of the Company's total accounts receivable in the amount of $1,200, $815, and $767, 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 (“SSP”) 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 November 2024, the Financial Accounting Standards Board 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, 2027, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2024-03.

11

HYPERFINE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

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

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 June 30, |  |  | Six Months Ended June 30, |
|  | Pattern of Recognition |  | 2025 |  |  | 2024 |  |  | 2025 |  |  | 2024 |
Device |  | Point in time |  | $ | 2,128 |  |  | $ | 2,970 |  |  | $ | 3,650 |  |  | $ | 5,674 |
Service |  | Over time |  |  | 568 |  |  |  | 661 |  |  |  | 1,183 |  |  |  | 1,252 |
Total revenue |  |  |  | $ | 2,696 |  |  | $ | 3,631 |  |  | $ | 4,833 |  |  | $ | 6,926 |

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:

|  | June 30, 2025 |  |  | December 31, 2024 |
Accounts receivable, net |  | $ | 5,057 |  |  | $ | 5,956 |
Unbilled receivables - current |  | $ | 1,892 |  |  | $ | 2,349 |
Unbilled receivables - non-current(1) |  | $ | 937 |  |  | $ | 825 |
Deferred revenue |  | $ | 1,370 |  |  | $ | 1,460 |
Long term deferred revenue |  | $ | 914 |  |  | $ | 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.

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 six months ended June 30, 2025 that was included in the deferred revenue balance at the beginning of the period was $430 and $829, respectively.

The amount of revenue recognized during the three and six months ended June 30, 2024 that was included in the deferred revenue balance at the beginning of the period was $489 and $879, respectively.

12

HYPERFINE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

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

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, including leases for the three and six months ended June 30, 2025 and 2024. The Company recorded service revenue from lease arrangements of $25 and $46 for the three and six months ended June 30, 2025, respectively, and of $77 and $159 for the three and six months ended June 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 $516 and $490 as of June 30, 2025 and December 31, 2024, respectively. During the three and six months ended June 30, 2025, the Company recognized $231 and $355, respectively, in expense related to the amortization of the capitalized contract costs. During the three and six months ended June 30, 2024, the Company recognized $328 and $406, respectively, in expense related to the amortization of the capitalized contract costs.

Transaction Price Allocated to Remaining Performance Obligations

As of June 30, 2025 and December 31, 2024, the Company had remaining performance obligations amounting to $5,939 and $5,644, respectively. The Company expects to recognize approximately 17% of its remaining performance obligations as revenue in fiscal year 2025, and an additional 83% in fiscal year 2026 and thereafter.

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.

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HYPERFINE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

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

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 Com pany had $25,131 and $37,451 of money market funds, demand deposit and savings accounts included in cash and cash equivalents and restricted cash as of June 30, 2025 and December 31, 2024, resp ectively. 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 June 30, 2025, and February 12, 2025, the closing date of the Offering (as defined below) and the initial warrant liability valuation date, the fair value of the warrant liabilities were $1,194 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 six months ended June 30, 2025 or 2024.

5. INVENTORIES

A summary of inventories is as follows:

|  | June 30, 2025 |  |  | December 31, 2024 |
Raw materials |  | $ | 2,463 |  |  | $ | 3,070 |
Finished goods |  |  | 2,419 |  |  |  | 2,762 |
Total inventories |  | $ | 4,882 |  |  | $ | 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.

6. PROPERTY AND EQUIPMENT, NET

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

|  | June 30, 2025 |  |  | December 31, 2024 |
Laboratory equipment |  | $ | 990 |  |  | $ | 986 |
Research devices |  |  | 1,734 |  |  |  | 1,398 |
Sales and marketing devices |  |  | 490 |  |  |  | 490 |
Computer equipment |  |  | 689 |  |  |  | 689 |
Construction in progress |  |  | 645 |  |  |  | 1,229 |
Tooling |  |  | 1,494 |  |  |  | 857 |
Trade show assets |  |  | 295 |  |  |  | 254 |
Leased devices |  |  | 181 |  |  |  | 181 |
Other |  |  | 645 |  |  |  | 595 |
|  |  | 7,163 |  |  |  | 6,679 |
Less: Accumulated depreciation and amortization |  |  | (4,041 | ) |  |  | (3,557 | )
Property and equipment, net |  | $ | 3,122 |  |  | $ | 3,122 |

Depreciation expense amounted to $283 and $512 for the three and six months ended June 30, 2025, respectively.

Depreciation expense amounted to $253 and $516 for the three and six months ended June 30, 2024, respectively.

14

HYPERFINE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

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

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 6 months in June 2025 and expires on August 31, 2026. As of June 30, 2025 and December 31, 2024, the balance of operating lease ROU assets of $254 and $341, respectively, current lease liabilities of $238 and $269, respectively, and non-current lease liabilities of $12 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 our operating lease obligations is 14 months and an annual weighted-average discount rate is 9.78%.

Future minimum commitments due under the lease agreements as of June 30, 2025 are $136 for 2025 and $114 thereafter.

8. ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

Accrued expenses and other current liabilities consist of the following:

|  | June 30, 2025 |  |  | December 31, 2024 |
Bonuses |  | $ | 1,277 |  |  | $ | 2,144 |
Contracted services |  |  | 657 |  |  |  | 1,755 |
Legal fees |  |  | 474 |  |  |  | 176 |
Payroll and related benefits |  |  | 559 |  |  |  | 756 |
Operating lease liabilities |  |  | 238 |  |  |  | 269 |
Other |  |  | 225 |  |  |  | 473 |
Total accrued expenses and other current liabilities |  | $ | 3,430 |  |  | $ | 5,573 |

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 June 30, 2025 an aggregate of 1,579,912 shares of Class A common stock have been issued and sold under the Sales Agreement, for gross proceeds of $1,737 and net proceeds o f $1,633, after deducting commissions and other offering expenses related to the ATM. During the three and six months ended June 30, 2025, 681,793 and 808,191 shares of the Company's Class A common stock have been issued and sold under the Sales Agreement, respectively, for gross proceeds of $725 and $857, respectively, and net proceeds of $687 and $815, respectively, after deducting commissions and other offering expenses related to the ATM.

15

HYPERFINE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

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

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 “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 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 six months ended June 30, 2025:

|  | Number of Options |
Outstanding at January 1, 2025 |  |  | 18,396,536 |
Granted (1) (2) (3) |  |  | 430,917 |
Exercised |  |  | (74,140 | )
Forfeited / Cancelled / Expired |  |  | (1,736,748 | )
Outstanding at June 30, 2025 |  |  | 17,016,565 |

_____________________________________________

(1) Consists of 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.

(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 o ne yea r based on continued service on the date of the next regular annual stockholders 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.

16

HYPERFINE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

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

Restricted stock unit activity

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

|  | Number of RSUs |
Outstanding at January 1, 2025 |  |  | 138,902 |
Granted (1) |  |  | 2,526,353 |
Vested |  |  | (55,846 | )
Forfeited |  |  | (41,718 | )
Outstanding at June 30, 2025 |  |  | 2,567,691 |

_____________________________________________

(1) Includes new hire grants of 183,520 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 s tock-based compensation expenses by functional line item noted within the Company's operating expenses:

|  | Three Months Ended June 30, |  |  | Six Months Ended June 30, |
|  | 2025 |  |  | 2024 |  |  | 2025 |  |  | 2024 |
Cost of sales |  | $ | 48 |  |  | $ | 24 |  |  | $ | 66 |  |  | $ | 48 |
Research and development |  |  | 367 |  |  |  | 387 |  |  |  | 712 |  |  |  | 724 |
Sales and marketing |  |  | 71 |  |  |  | 47 |  |  |  | 134 |  |  |  | 86 |
General and administrative |  |  | 61 |  |  |  | 716 |  |  |  | 580 |  |  |  | 1,348 |
|  | $ | 547 |  |  | $ | 1,174 |  |  | $ | 1,492 |  |  | $ | 2,206 |

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 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 June 30, |  |  | Six Months Ended June 30, |
|  | 2025 |  |  | 2024 |  |  | 2025 |  |  | 2024 |
Numerator: |  |  |  |  |  |  |  |  |  |  |  |
Net Loss |  | $ | (9,225 | ) |  | $ | (10,156 | ) |  | $ | (18,643 | ) |  | $ | (20,004 | )
Numerator for Basic and Dilutive EPS – Loss available to common stockholders |  | $ | (9,225 | ) |  | $ | (10,156 | ) |  | $ | (18,643 | ) |  | $ | (20,004 | )
Denominator: |  |  |  |  |  |  |  |  |  |  |  |
Common Stock |  |  | 78,077,118 |  |  |  | 72,041,332 |  |  |  | 76,893,733 |  |  |  | 71,987,688 |
Denominator for Basic and Dilutive EPS - Weighted-average common stock |  |  | 78,077,118 |  |  |  | 72,041,332 |  |  |  | 76,893,733 |  |  |  | 71,987,688 |
Basic and dilutive net loss per share |  | $ | (0.12 | ) |  | $ | (0.14 | ) |  | $ | (0.24 | ) |  | $ | (0.28 | )

17

HYPERFINE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

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

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 June 30, |  |  | Six Months Ended June 30, |
|  | 2025 |  |  | 2024 |  |  | 2025 |  |  | 2024 |
Outstanding options to purchase common stock |  |  | 17,016,565 |  |  |  | 18,501,352 |  |  |  | 17,016,565 |  |  |  | 18,501,352 |
Outstanding RSUs |  |  | 2,567,691 |  |  |  | 266,508 |  |  |  | 2,567,691 |  |  |  | 266,508 |
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 |  |  | 24,095,434 |  |  |  | 28,125,695 |  |  |  | 24,095,434 |  |  |  | 28,125,695 |

_________________________

(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.

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.

Income taxes for the three and six months ended June 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 six months ended June 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 June 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.

Subsequent to the end of the second fiscal quarter, on July 4, 2025, the One Big Beautiful Bill Act (the “OBBBA”) was enacted in the United States. The OBBBA includes significant changes to federal tax law and other regulatory provisions that may impact the Company. Since the legislation was enacted after the second fiscal quarter, its impacts are not included in the Company’s operating results for the three and six months ended June 30, 2025. The Company is currently evaluating the impact of the newly enacted tax law and its impact on the Company's forecasted annual effective tax rate in subsequent periods as required.

18

HYPERFINE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

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

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 $115 and $203 was paid during the three and six months ended June 30, 2025, respectively, and a total of approximately $120 and $248 was paid during the three and six months ended June 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 $33 and $58 during the three and six months ended June 30, 2025, respectively, and the Company paid an aggregate of $31 and $65 during the three and six months ended June 30, 2024, respectively, under the Master Services Agreement. As of June 30, 2025 and December 31, 2024 there were $59 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.

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 no t make any matching contributions to the 401(k) plan for the three or six months ended June 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 six months ended June 30, 2025, the Company completed and fulfilled grant deliverables and milestones amounting to $492 and received cash grant funding of $616. As of June 30, 2025, the Company recorded restricted cash of $158 with an offset to deferred grant funding in the Company's unaudited condensed consolidated balance sheet. As of June 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.

19

HYPERFINE, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

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

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 no t 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

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 $492 and $1,566 for the three and six months ended June 30, 2025, respectively, and $1,901 and $4,335 for the three and six months ended June 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

The Company has evaluated subsequent events through the date the condensed consolidated financial statements were issued and has determined that there were no subsequent events required to be disclosed.

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## 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 Report on Form 10-Q for the quarter ended March 31, 2025 and of this Quarterly Report on Form 10-Q, as updated and/or supplemented in subsequent filings with the SEC. Actual results may differ materially from those contained in any forward-looking statements. Unless the context otherwise requires, references to “we,” “us,” “our,” and “the Company” are intended to mean the business and operations of Hyperfine, Inc. and its consolidated subsidiaries. The unaudited condensed consolidated financial statements for the three and six months ended June 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, recent approval of new Alzheimer’s medications, 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,

21

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 AI TM 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.

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, we received CE Mark and UKCA Mark approval for the ninth-generation of software, respectively. Our Optive AI TM software is currently available in the U.S., Canada, Australia and New Zealand markets.

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 $2.7 million and $4.8 million for the three and six months ended June 30, 2025, respectively, as compared to revenues of $3.6 million and $6.9 million for the three and six months ended June 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 14 units, for the three and six months ended June 30, 2025, respectively, as compared to 13 units and 26 units, for the three and six months ended June 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,

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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. Starting in the second half of 2025, we plan to expand 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 AI TM 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, 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 six months ended June 30, 2025, we completed and fulfilled grant deliverables and milestones amounting to $0.5 million and we received cash grant funding of $0.6 million.

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Results of Operations

The following is a discussion of our results of operations for the three and six months ended June 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 June 30, |  |  | Change |  |  | Six Months Ended June 30, |  |  | Change |
($ Amounts in thousands) |  | 2025 |  |  | 2024 |  |  | % |  |  | 2025 |  |  | 2024 |  |  | % |
Sales |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Device |  | $ | 2,128 |  |  | $ | 2,970 |  |  |  | (28.4 | )% |  | $ | 3,650 |  |  | $ | 5,674 |  |  |  | (35.7 | )%
Service |  |  | 568 |  |  |  | 661 |  |  |  | (14.1 | )% |  |  | 1,183 |  |  |  | 1,252 |  |  |  | (5.5 | )%
Total sales |  |  | 2,696 |  |  |  | 3,631 |  |  |  | (25.8 | )% |  | $ | 4,833 |  |  | $ | 6,926 |  |  |  | (30.2 | )%
Cost of Sales |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Device |  |  | 1,097 |  |  |  | 1,422 |  |  |  | (22.9 | )% |  | $ | 2,082 |  |  | $ | 2,921 |  |  |  | (28.7 | )%
Service |  |  | 271 |  |  |  | 406 |  |  |  | (33.3 | )% |  |  | 540 |  |  |  | 848 |  |  |  | (36.3 | )%
Cost of sales |  |  | 1,368 |  |  |  | 1,828 |  |  |  | (25.2 | )% |  | $ | 2,622 |  |  | $ | 3,769 |  |  |  | (30.4 | )%
Gross margin |  |  | 1,328 |  |  |  | 1,803 |  |  |  | (26.3 | )% |  |  | 2,211 |  |  |  | 3,157 |  |  |  | (30.0 | )%
Operating expenses: |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Research and development |  |  | 4,541 |  |  |  | 5,959 |  |  |  | (23.8 | )% |  | $ | 9,578 |  |  | $ | 11,529 |  |  |  | (16.9 | )%
General and administrative |  |  | 3,859 |  |  |  | 4,421 |  |  |  | (12.7 | )% |  |  | 8,067 |  |  |  | 8,851 |  |  |  | (8.9 | )%
Sales and marketing |  |  | 2,523 |  |  |  | 2,269 |  |  |  | 11.2 | % |  |  | 5,063 |  |  |  | 4,273 |  |  |  | 18.5 | %
Total operating expenses |  |  | 10,923 |  |  |  | 12,649 |  |  |  | (13.6 | )% |  |  | 22,708 |  |  |  | 24,653 |  |  |  | (7.9 | )%
Loss from operations |  |  | (9,595 | ) |  |  | (10,846 | ) |  |  | (11.5 | )% |  | $ | (20,497 | ) |  | $ | (21,496 | ) |  |  | (4.6 | )%
Interest income |  |  | 239 |  |  |  | 675 |  |  |  | (64.6 | )% |  | $ | 556 |  |  | $ | 1,471 |  |  |  | (62.2 | )%
Change in fair value of warrant liabilities |  |  | 46 |  |  |  | — |  |  | NM |  |  | $ | 1,664 |  |  | $ | — |  |  | NM |
Other income (expense), net |  |  | 85 |  |  |  | 15 |  |  | NM |  |  |  | (366 | ) |  |  | 21 |  |  | NM |
Loss before provision for income taxes |  |  | (9,225 | ) |  |  | (10,156 | ) |  |  | (9.2 | )% |  | $ | (18,643 | ) |  | $ | (20,004 | ) |  |  | (6.8 | )%
Provision for income taxes |  |  | — |  |  |  | — |  |  |  |  |  |  | — |  |  |  | — |  |  |  |
Net loss and comprehensive loss |  | $ | (9,225 | ) |  | $ | (10,156 | ) |  |  | (9.2 | )% |  | $ | (18,643 | ) |  | $ | (20,004 | ) |  |  | (6.8 | )%

NM - Not meaningful

Comparison of the Three and Six Months Ended June 30, 2025 and 2024 ($ Amounts shown in tables in thousands)

Sales

|  | Three Months Ended June 30, |  |  | Change |  |  | Six Months Ended June 30, |  |  | Change |
|  | 2025 |  |  | 2024 |  |  | Amount |  |  | % |  |  | 2025 |  |  | 2024 |  |  | Amount |  |  | % |
Device |  | $ | 2,128 |  |  | $ | 2,970 |  |  | $ | (842 | ) |  |  | (28.4 | )% |  | $ | 3,650 |  |  | $ | 5,674 |  |  | $ | (2,024 | ) |  |  | (35.7 | )%
Service |  |  | 568 |  |  |  | 661 |  |  |  | (93 | ) |  |  | (14.1 | )% |  |  | 1,183 |  |  |  | 1,252 |  |  |  | (69 | ) |  |  | (5.5 | )%
Total sales |  | $ | 2,696 |  |  | $ | 3,631 |  |  | $ | (935 | ) |  |  | (25.8 | )% |  | $ | 4,833 |  |  | $ | 6,926 |  |  | $ | (2,093 | ) |  |  | (30.2 | )%

Device sales decreased by $0.8 million, or 28.4%, for the three months ended June 30, 2025 compared to the three months ended June 30, 2024. The decrease is driven primarily by a decrease in units sold partially offset by an increase in average selling price.

Service sales decreased by $0.1 million, or 14.1%, for the three months ended June 30, 2025 compared to the three months ended June 30, 2024. The decrease is driven primarily by one-time service revenue recognized in 2024 for a certain customer and higher service revenue in 2024 due to a subscription business model in prior years.

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Device sales decreased by $2.0 million, or 35.7%, for the six months ended June 30, 2025 compared to the six months ended June 30, 2024. The decrease is driven primarily by a decrease in units sold partially offset by an increase in average selling price.

Service sales decreased by $0.1 million, or 5.5%, for the six months ended June 30, 2025 compared to the six months ended June 30, 2024. The decrease is driven primarily by one-time service revenue recognized in 2024 for a certain customer and higher service revenue in 2024 due to a subscription business model in prior years.

Cost of sales

|  | Three Months Ended June 30, |  |  | Change |  |  | Six Months Ended June 30, |  |  | Change |
|  | 2025 |  |  | 2024 |  |  | Amount |  |  | % |  |  | 2025 |  |  | 2024 |  |  | Amount |  |  | % |
Device |  | $ | 1,097 |  |  | $ | 1,422 |  |  | $ | (325 | ) |  |  | (22.9 | )% |  | $ | 2,082 |  |  | $ | 2,921 |  |  | $ | (839 | ) |  |  | (28.7 | )%
Service |  |  | 271 |  |  |  | 406 |  |  |  | (135 | ) |  |  | (33.3 | )% |  |  | 540 |  |  |  | 848 |  |  |  | (308 | ) |  |  | (36.3 | )%
Total cost of sales |  | $ | 1,368 |  |  | $ | 1,828 |  |  | $ | (460 | ) |  |  | (25.2 | )% |  | $ | 2,622 |  |  | $ | 3,769 |  |  | $ | (1,147 | ) |  |  | (30.4 | )%
Percentage of revenue |  |  | 50.7 | % |  |  | 50.3 | % |  |  |  |  |  |  |  |  | 54.3 | % |  |  | 54.4 | % |  |  |  |  |  |

Cost of device sales decreased by $0.3 million, or 22.9%, for the three months ended June 30, 2025 compared to the three months ended June 30, 2024. This decrease was driven primarily by a decrease in units sold.

Cost of service sales decreased by $0.1 million, or 33.3%, for the three months ended June 30, 2025 compared to the three months ended June 30, 2024. This decrease is driven primarily by a decrease in headcount costs and infrastructure costs.

Cost of device sales decreased by $0.8 million, or 28.7%, for the six months ended June 30, 2025 compared to the six months ended June 30, 2024. This decrease was driven primarily by a decrease in units sold.

Cost of service sales decreased by $0.3 million, or 36.3%, for the six months ended June 30, 2025 compared to the six months ended June 30, 2024. This decrease is driven primarily by a decrease in headcount costs and infrastructure costs.

Research and development

|  | Three Months Ended June 30, |  |  | Change |  |  | Six Months Ended June 30, |  |  | Change |
|  | 2025 |  |  | 2024 |  |  | Amount |  |  | % |  |  | 2025 |  |  | 2024 |  |  | Amount |  |  | % |
Research and development |  | $ | 4,541 |  |  | $ | 5,959 |  |  | $ | (1,418 | ) |  |  | (23.8 | )% |  | $ | 9,578 |  |  | $ | 11,529 |  |  | $ | (1,951 | ) |  |  | (16.9 | )%

Research and development expenses decreased by $1.4 million, or 23.8%, for the three months ended June 30, 2025 compared to the three months ended June 30, 2024. This decrease was driven primarily by a decrease in salary and benefits of $1.1 million due to lower headcount and a decrease in consulting expenses of $0.2 million.

Research and development expenses decreased by $2.0 million, or 16.9%, for the six months ended June 30, 2025 compared to the six months ended June 30, 2024. This decrease was driven primarily by a decrease in salary and benefits of $2.1 million due to lower headcount and a decrease in consulting expenses of $0.5 million, partially offset by a decrease in grant fulfillment credits of $0.7 million.

General and administrative

|  | Three Months Ended June 30, |  |  | Change |  |  | Six Months Ended June 30, |  |  | Change |
|  | 2025 |  |  | 2024 |  |  | Amount |  |  | % |  |  | 2025 |  |  | 2024 |  |  | Amount |  |  | % |
General and administrative |  | $ | 3,859 |  |  | $ | 4,421 |  |  | $ | (562 | ) |  |  | (12.7 | )% |  | $ | 8,067 |  |  | $ | 8,851 |  |  | $ | (784 | ) |  |  | (8.9 | )%

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General and administrative expenses decreased by $0.6 million, or 12.7%, for the three months ended June 30, 2025 compared to the three months ended June 30, 2024. This decrease was driven primarily by a decrease in stock-based compensation of $0.7 million, partially offset by an increase in intellectual property expenses of $0.2 million.

General and administrative expenses decreased by $0.8 million, or 8.9%, for the six months ended June 30, 2025 compared to the six months ended June 30, 2024. This decrease was driven primarily by a decrease in stock-based compensation of $0.8 million.

Sales and marketing

|  | Three Months Ended June 30, |  |  | Change |  |  | Six Months Ended June 30, |  |  | Change |
|  | 2025 |  |  | 2024 |  |  | Amount |  |  | % |  |  | 2025 |  |  | 2024 |  |  | Amount |  |  | % |
Sales and marketing |  | $ | 2,523 |  |  | $ | 2,269 |  |  | $ | 254 |  |  |  | 11.2 | % |  | $ | 5,063 |  |  | $ | 4,273 |  |  | $ | 790 |  |  |  | 18.5 | %

Sales and marketing expenses increased by $0.3 million, or 11.2%, for the three months ended June 30, 2025 compared to the three months ended June 30, 2024. This increase was driven primarily by an increase in salary and benefits of $0.2 million and an increase in marketing expenses of $0.1 million.

Sales and marketing expenses increased by $0.8 million, or 18.5%, for the six months ended June 30, 2025 compared to the six months ended June 30, 2024. This increase was driven primarily by an increase in salary and benefits of $0.5 million and an increase in marketing expenses of $0.3 million.

Interest income

|  | Three Months Ended June 30, |  |  | Change |  |  | Six Months Ended June 30, |  |  | Change |
|  | 2025 |  |  | 2024 |  |  | Amount |  |  | % |  |  | 2025 |  |  | 2024 |  |  | Amount |  |  | % |
Interest income |  | $ | 239 |  |  | $ | 675 |  |  | $ | (436 | ) |  |  | (64.6 | )% |  | $ | 556 |  |  | $ | 1,471 |  |  | $ | (915 | ) |  |  | (62.2 | )%

Interest income decreased by $0.4 million, or 64.6%, for the three months ended June 30, 2025 compared to the three months ended June 30, 2024. The decrease was driven primarily by lower cash balances in money market funds and demand deposit accounts.

Interest income decreased by $0.9 million, or 62.2%, for the six months ended June 30, 2025 compared to the six months ended June 30, 2024. The decrease was driven primarily by lower cash balances in money market funds and demand deposit accounts.

Change in fair value of warrant liabilities

|  | Three Months Ended June 30, |  |  | Change |  | Six Months Ended June 30, |  |  | Change
|  | 2025 |  |  | 2024 |  |  | Amount |  |  | % |  | 2025 |  |  | 2024 |  |  | Amount |  |  | %
Change in fair value of warrant liabilities |  | $ | 46 |  |  | $ | — |  |  | $ | 46 |  |  | NM |  | $ | 1,664 |  |  | $ | — |  |  | $ | 1,664 |  |  | NM

Change in fair value of warrant liabilities for the three months ended June 30, 2025 represented a gain of $46 thousand caused by a decrease in the fair value of the warrant liabilities over the three months period. There was no similar change in fair value during the three months ended June 30, 2024 as the warrants were not outstanding during that period.

Change in fair value of warrant liabilities for the six months ended June 30, 2025 represented a gain of $1.7 million caused by a decrease in the fair value of the warrant liabilities from the initial fair value evaluation on February 12, 2025, the closing date of the Offering (as defined below) to the subsequent fair value evaluation on June 30, 2025, primarily related to changes in the price per share of our Class A common stock. There was no similar change in fair value during the six months ended June 30, 2024 as the warrants were not outstanding during that period.

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Other income (expense), net

|  | Three Months Ended June 30, |  |  | Change |  | Six Months Ended June 30, |  |  | Change
|  | 2025 |  |  | 2024 |  |  | Amount |  |  | % |  | 2025 |  |  | 2024 |  |  | Amount |  |  | %
Other income (expense), net |  | $ | 85 |  |  | $ | 15 |  |  | $ | 70 |  |  | NM |  | $ | (366 | ) |  | $ | 21 |  |  | $ | (387 | ) |  | NM

Other income (expense), net increased by $0.1 million for the three months ended June 30, 2025 compared to the three months ended June 30, 2024. This increase is mainly driven by favorable impact from foreign exchange.

Other income (expense), net decreased by $0.4 million for the six months ended June 30, 2025 compared to the three months ended June 30, 2024. This decrease is mainly driven by financing cost allocated to warrant liabilities of $0.5 million, partially offset by favorable impact from foreign exchange of $0.1 million.

Liquidity and Capital Resources

We have funded our operations primarily with proceeds from the issuance of common stock, preferred stock and warrants. We have incurred significant cash burn and recurring net losses, which includes a net loss of $18.6 million for the six months ended June 30, 2025, and an accumulated deficit of $313.1 million as of June 30, 2025. As of June 30, 2025, we had cash and cash equivalents of $25.4 million. As we continue to invest in research and development of our products and sales and marketing, we expect to continue to incur a significant cash burn 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 includes a prospectus 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 Securities, Inc. (“B. Riley”) acting as our sales agent, pursuant to the sales agreement that we entered into with B. Riley (the “Sales Agreement”) for our “at-the-market” equity program (“ATM”). We are not obligated to make any sales of Class A common stock under the Sales Agreement. As of June 30, 2025, an aggregate of 1,579,912 shares of our Class A common stock, for total gross proceeds of $1,737 thousand and net proceeds of $1,633 thousand, after deducting commissions and other offering expenses related to the ATM, have been issued and sold under the Sales Agreement. During the three and six months ended June 30, 2025, 681,793 and 808,191 shares of our Class A common stock have been issued and sold under the Sales Agreement, respectively, for gross proceeds of $725 and $857, respectively, and net proceeds of $687 and $815, respectively, after deducting commissions and other offering expenses related to the ATM.

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 “Offering”): (i) 4,511,278 shares (the “Shares”) of our Class A common stock and (ii) warrants to purchase up to 4,511,278 shares of our Class A common stock (the “Warrants”). Each Share and accompanying Warrant were sold together at a combined offering price of $1.33. The aggregate gross proceeds to from the Offering were $6.0 million before deducting the placement agent’s fees and offering expenses.

Our ability to access capital when needed is not assured and, if capital is not available when, and in the amounts needed, we could be required to delay, scale back or abandon some or all of our development programs, commercialization of our products, and other operations which could materially harm our operations, financial condition and operating results. We expect that our existing cash and cash equivalents, together with proceeds from the sales of our products and services, will enable us to conduct our planned operations for at least the next 12 months. Factors that could accelerate cash needs include: (i) delays in achieving scientific and technical milestones; (ii) unforeseen capital expenditures and fabrication costs related to manufacturing; (iii) changes we may make in our

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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 June 30, 2025, we had cash and cash equivalents of $25.4 million. Our future capital requirements may vary from those currently planned and will depend on various factors including further development costs, commercialization strategy, international expansion, and regulatory costs. 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:

|  | Six Months Ended June 30, |
(In thousands) |  | 2025 |  |  | 2024 |
Net cash used in operating activities |  | $ | (17,159 | ) |  | $ | (21,893 | )
Net cash used in investing activities |  |  | (992 | ) |  |  | (216 | )
Net cash provided by financing activities |  |  | 6,056 |  |  |  | 114 |
Net decrease in cash, cash equivalents, and restricted cash |  | $ | (12,095 | ) |  | $ | (21,995 | )

Net cash used in operating activities

For the six months ended June 30, 2025, net cash used in operating activities of $17.1 million was due primarily to a net loss of $18.6 million, partially offset by non-cash items of $0.4 million and changes in operating assets and liabilities of $1.1 million. Non-cash items were primarily stock-based compensation expense of $1.5 million and depreciation expense of $0.5 million, partially offset by gain on change in fair value of warrant liabilities of $1.7 million. Changes in operating assets and liabilities were driven primarily by a decrease in accounts receivable and unbilled receivables of $1.4 million, an increase in accounts payable of $1.3 million, a decrease in inventory of $0.7 million, partially offset a decrease in accrued expense and other current liabilities of $1.4 million primarily due to annual bonus payout and a decrease in deferred revenue of $0.2 million.

For the six months ended June 30, 2024, net cash used in operating activities of $21.9 million was due primarily to a net loss of $20.0 million and changes in operating assets and liabilities of $4.7 million, partially offset by non-cash items of $2.8 million. Non-cash items were primarily stock-based compensation expense of $2.2 million,

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depreciation expense of $0.5 million and loss on disposal of property and equipment, net of $0.1 million. Changes in operating assets and liabilities were driven primarily by an increase in accounts receivable and unbilled receivables of $3.4 million driven primarily by increased revenue, an increase in inventory of $1.0 million, a decrease in accrued expense and other current liabilities of $0.9 million driven primarily by lower bonus and salary and benefit accrual due to timing and a decreased headcount, a decrease in deferred grant funding of $0.6 million due to fulfillment of certain BMGF grant milestones, an increase in prepaid expenses and other current assets of $0.5 million, partially offset by an increase in accounts payable of $0.9 million, a decrease in prepaid inventory of $0.7 million and an increase in deferred revenue of $0.1 million.

Net cash used in investing activities

For the six months ended June 30, 2025, net cash used in investing activities of $1.0 million was from fixed assets purchased.

For the six months ended June 30, 2024, net cash used in investing activities of $0.2 million was from fixed assets purchased.

Net cash provided by financing activities

For the six months ended June 30, 2025, net cash provided by financing activities of $6.0 million which consisted primarily of proceeds from issuance and sale of the Shares and Warrants in the Offering, net of offering discounts and other costs of $5.2 million, proceeds from issuance of the Shares under the Sales Agreement of $0.8 million.

For the six months ended June 30, 2024, net cash provided by financing activities of $0.1 million was proceeds from option exercises.

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 or six months ended June 30, 2025 and 2024.

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

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 June 30, 2025.

For information on contingencies, refer to Note 13 in the notes to our unaudited condensed consolidated financial statements for the three and six months ended June 30, 2025 and 2024 included elsewhere in this Quarterly Report on Form 10-Q.

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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 Not Yet 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 2024 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 six months ended June 30, 2025 and 2024 included elsewhere in this Quarterly Report on Form 10-Q.

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## Item 3. Quantitative and Qualitative Disclosures About Market Risk

We are exposed to market risk in the ordinary course of business. Market risk represents the risk of loss that may impact our results of operations or financial position due to adverse changes in financial market prices and rates. Our market risk exposure is primarily a result of fluctuations in interest rates, inflation risk, and foreign exchange risk. We do not hold, issue or enter into any financial instruments for speculative or trading purposes. We do not have significant exposure to foreign currencies.

Interest Rate Risk

Our cash, cash equivalents and restricted cash as of June 30, 2025 consisted of $25.6 million in money market funds, demand deposit and savings accounts. Such interest-earning instruments carry a degree of interest rate risk. The goals of our investment policy are liquidity and capital preservation. We believe that we do not have any material exposure to changes in the fair value of these assets as a result of changes in interest rates due to the short-term nature of our cash equivalents. Based on our balance sheet position at June 30, 2025, the annualized effect of a 0.5 percentage point decrease in interest rates would be to decrease earnings before income taxes by $0.1 million.

Inflation Risk

We do not believe that inflation has had a material effect on our business, financial condition, or results of operations, other than its impact on the general economy. Nonetheless, if our costs were to become subject to inflationary pressures, we might not be able to fully offset such higher costs through price increases. Our inability or failure to do so could harm our business, financial condition, and results of operations.

Foreign Exchange Risk

We operate our business primarily within the United States and currently execute the majority of our transactions in U.S. dollars. We have not utilized hedging strategies with respect to such foreign exchange exposure. This limited foreign currency translation risk is not expected to have a material impact on our condensed consolidated financial statements.

## Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Our principal executive officer and principal financial officer evaluated the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of June 30, 2025. Based upon that evaluation, our principal executive officer and principal financial officer have concluded that, as of June 30, 2025, the end of the period covered by this report, our disclosure controls and procedures were effective at a reasonable assurance level to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and is accumulated and communicated to our management, including our principal executive officer and principal financial officer, or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting, identified in connection with the evaluation of such internal control that occurred during the three months ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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# PART II — OTHER INFORMATION

## Item1. Legal Proceedings

We are not currently a party to any material legal proceedings.

## Item 1A. Risk Factors

Our business, results of operations and financial condition are subject to various risks and uncertainties including the risk factors described under the caption “Risk Factors” in our 2024 Annual Report on Form 10-K and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025. There have been no material changes in our risk factors from those described in our 2024 Annual Report on Form 10-K or our Quarterly Report on Form 10-Q referenced above, other than the updates to the risk factor set forth below. We may disclose changes to risk factors or additional risk factors from time to time in our future filings with the SEC.

International trade disputes, including United States trade tariffs and retaliatory tariffs, could adversely impact our business.

Changes in United States trade policy, including recently announced or potential future tariffs, could have a material adverse impact on our business, financial condition and results of operations. The imposition of new tariffs or increases in existing tariffs on goods imported from or expected to be imported from countries where we or our suppliers operate could result in higher costs for materials or components essential to our operations. These increased costs may reduce our margins, necessitate price adjustments or impact the affordability and competitiveness of our products. Additionally, retaliatory tariffs imposed by other countries on U.S. exports could delay delivery of supplies to us and adversely affect our ability to operate or grow in certain international markets. If we are unable to effectively mitigate these risks through supply chain adjustments, pricing strategies, or other measures, our financial performance and growth trajectory could be materially affected.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

Unregistered Sales of Equity Securities and Use of Proceeds

Not applicable.

Issuer Purchases of Equity Securities

Not applicable.

## Item 3. Defaults Upon Senior Securities

Not applicable.

## Item 4. Mine Safety Disclosures

Not applicable.

## Item 5. Other Information

10b5-1 Trading Arrangements

From time to time, our officers (as defined in Rule 16a-1(f) of the Exchange Act) and directors may enter into Rule 10b5-1 or non-Rule 10b5-1 trading arrangements (as each such term is defined in Item 408 of Regulation S-K). During the three and six months ended June 30, 2025, none of our officers or directors adopted, modified or terminated any such trading arrangements.

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## Item 6. Exhibits

See Exhibit Index.

EXHIBIT INDEX

Exhibit Number |  | Exhibit Description |  | Filed Herewith |  | Incorporated by Reference herein from Form or Schedule |  | Filing Date |  | SEC File/ Reg. Number
31.1 |  | Certification of the Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |  | X |  |  |  |  |  |
31.2 |  | Certification of the Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |  | X |  |  |  |  |  |
32* |  | Certifications of the Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |  | X |  |  |  |  |  |
101.INS |  | Inline XBRL Instance Document - The instance document does not appear in the Interactive Data File because its Inline XBRL tags are embedded within the Inline XBRL document. |  | X |  |  |  |  |  |
101.SCH |  | Inline XBRL Taxonomy Extension Schema Document. |  | X |  |  |  |  |  |
104 |  | Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101). |  | X |  |  |  |  |  |

* The certifications attached as Exhibit 32 that accompany this Quarterly Report on Form 10-Q are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Hyperfine, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Form 10-Q, irrespective of any general incorporation language contained in such filing.

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# SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

|  | HYPERFINE, INC. |
Date: August 13, 2025 |  | By: /s/ Maria Sainz |
|  | Maria Sainz |
|  | President and Chief Executive Officer |
Date: August 13, 2025 |  | By: /s/ Brett Hale |
|  | Brett Hale |
|  | Chief Administrative Officer, Chief Financial Officer, Treasurer and Corporate Secretary |

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