SEC Form 10-Q filed by Hyperfine Inc.

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, 2024

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, 2024, the registrant had 57,567,341 shares of Class A common stock outstanding and 15,055,288 shares of Class B common stock outstanding.

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TABLE OF CONTENTS

 

		Page
	Cautionary Statement Regarding Forward-Looking Statements	3
PART I	FINANCIAL INFORMATION	5
Item 1.	Financial Statements	5
	Condensed Consolidated Balance Sheets (unaudited)	5
	Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)	6
	Condensed Consolidated Statements of Changes in Stockholders’ Equity (unaudited)	7
	Condensed Consolidated Statements of Cash Flows (unaudited)	8
	Notes to Condensed Consolidated Financial Statements (unaudited)	9
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	21
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	30
Item 4.	Controls and Procedures	30
PART II	OTHER INFORMATION	31
Item 1.	Legal Proceedings	31
Item 1A.	Risk Factors	31
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	31
Item 3.	Defaults Upon Senior Securities	31
Item 4.	Mine Safety Disclosures	31
Item 5.	Other Information	31
Item 6.	Exhibits	32
	Signatures	33

 

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., (“Legacy Hyperfine”), and Liminal Sciences, Inc., (“Liminal”), as the case may be.

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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:

 

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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, 2023, in Item 1A of Part II of this Quarterly Report on Form 10-Q, and in other filings that we make with the Securities and Exchange Commission (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.

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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, 2024				December 31, 2023
ASSETS
CURRENT ASSETS:
Cash and cash equivalents		$	53,809			$	75,183
Restricted cash			—				621
Accounts receivable, less allowance of $308 and $321 as of June 30, 2024 and December 31, 2023, respectively			5,368				3,189
Unbilled receivables			2,121				942
Inventory			7,465				6,582
Prepaid expenses and other current assets			2,262				2,391
Total current assets			71,025				88,908
Property and equipment, net			3,429				2,999
Other long term assets			2,156				2,292
Total assets		$	76,610			$	94,199
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable		$	2,238			$	1,214
Deferred grant funding			—				621
Deferred revenue			1,425				1,453
Due to related parties			66				61
Accrued expenses and other current liabilities			5,056				5,419
Total current liabilities			8,785				8,768
Long term deferred revenue			1,064				968
Other noncurrent liabilities			—				64
Total liabilities			9,849				9,800
COMMITMENTS AND CONTINGENCIES (NOTE 13)
STOCKHOLDERS' EQUITY
Class A Common stock, $.0001 par value; 600,000,000 shares authorized; 57,131,702 and 56,840,949 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively			5				5
Class B Common stock, $.0001 par value; 27,000,000 shares authorized; 15,055,288 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively			2				2
Additional paid-in capital			340,480				338,114
Accumulated deficit			(273,726	)			(253,722	)
Total stockholders' equity			66,761				84,399
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY		$	76,610			$	94,199

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

 

 

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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,
		2024				2023				2024				2023
Sales
Device		$	2,970			$	2,810			$	5,674			$	4,942
Service			661				571				1,252				1,074
Total sales			3,631				3,381				6,926				6,016
Cost of sales
Device			1,422				1,549				2,921				2,620
Service			406				388				848				797
Total cost of sales			1,828				1,937				3,769				3,417
Gross margin			1,803				1,444				3,157				2,599
Operating Expenses:
Research and development			5,959				5,331				11,529				10,792
General and administrative			4,421				5,306				8,851				11,488
Sales and marketing			2,269				2,499				4,273				5,046
Total operating expenses			12,649				13,136				24,653				27,326
Loss from operations			(10,846	)			(11,692	)			(21,496	)			(24,727	)
Interest income			675				1,030				1,471				1,899
Other income, net			15				25				21				31
Loss before provision for income taxes			(10,156	)			(10,637	)			(20,004	)			(22,797	)
Provision for income taxes			—				—				—				—
Net loss and comprehensive loss		$	(10,156	)		$	(10,637	)		$	(20,004	)		$	(22,797	)
Net loss per common share attributable to common stockholders, basic and diluted		$	(0.14	)		$	(0.15	)		$	(0.28	)		$	(0.32	)
Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted			72,041,332				71,201,170				71,987,688				71,033,629

 

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

 

 

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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, 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			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			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
		Class A Common Stock								Class B Common Stock								Additional				Accumulated				Total Stockholders'
		Shares				Amount				Shares				Amount				Paid-in Capital				Deficit				Equity
Balance, December 31, 2022			55,622,488			$	5				15,055,288			$	2			$	333,199			$	(209,484	)		$	123,722
Net loss			—				—				—				—				—				(12,160	)			(12,160	)
Issuance of restricted stock			324,296				—				—				—				—				—				—
Exercise of stock options			54,211				—				—				—				49				—				49
Stock-based compensation expense			—				—				—				—				1,126				—				1,126
Balance, March 31, 2023			56,000,995				5				15,055,288				2				334,374				(221,644	)			112,737
Net loss			—				—				—				—				—				(10,637	)			(10,637	)
Issuance of restricted stock			219,887				—				—				—				—				—				—
Exercise of stock options			63,656				—				—				—				58				—				58
Stock-based compensation expense			—				—				—				—				1,133				—				1,133
Balance, June 30, 2023			56,284,538			$	5				15,055,288			$	2			$	335,565			$	(232,281	)		$	103,291

 

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

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HYPERFINE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(in thousands)

		Six Months Ended June 30,
		2024				2023
Cash flows from operating activities:
Net loss		$	(20,004	)		$	(22,797	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation			516				513
Stock-based compensation expense			2,206				2,259
Loss on disposal of property and equipment, net			100				100
Payments received on net investment in lease			18				4
Changes in assets and liabilities:
Accounts receivable, net			(2,179	)			(1,845	)
Unbilled receivables			(1,179	)			(209	)
Inventory			(1,000	)			(1,537	)
Prepaid expenses and other current assets			(518	)			946
Due from related parties			—				48
Prepaid inventory			693				281
Other long term assets			46				129
Accounts payable			867				666
Deferred grant funding			(621	)			198
Deferred revenue			68				(134	)
Due to related parties			5				45
Accrued expenses and other current liabilities			(912	)			(1,817	)
Operating lease liabilities, net			1				—
Net cash used in operating activities			(21,893	)			(23,150	)
Cash flows from investing activities:
Purchases of property and equipment			(216	)			(283	)
Net cash used in investing activities			(216	)			(283	)
Cash flows from financing activities:
Proceeds from exercise of stock options			114				107
Net cash provided by financing activities			114				107
Net decrease in cash and cash equivalents and restricted cash			(21,995	)			(23,326	)
Cash, cash equivalents and restricted cash, beginning of period			75,804				118,243
Cash, cash equivalents and restricted cash, end of period			53,809				94,917
Reconciliation of cash, cash equivalents, and restricted cash reported in the balance sheets
Cash and cash equivalents			53,809				93,948
Restricted cash			—				969
Total cash, cash equivalents and restricted cash		$	53,809			$	94,917
Supplemental disclosure of noncash information:
Unpaid purchase of property and equipment		$	735			$	28

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

 

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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, 2023 contained in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 22, 2024. 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 Annual Report on Form 10-K for the year ended December 31, 2023, and of this Quarterly Report on Form 10-Q. 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, 2024 and 2023, 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 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, and to provide a highly differentiated experience for patients, timely imaging to 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. The easy-to-use interface and portable design of our Swoop® system make it easily and readily accessible anywhere in a hospital, clinic, 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 (“CT”) or positron emission tomography (“PET”).

 

The demand for MR imaging has been increasing due to the aging population and the rising prevalence of neurological, neurodegenerative, and cardiovascular conditions, 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. The Swoop® system is the next generation brain imaging device designed to increase access to MRI in a cost-effective manner and expand the current $35 billion imaging market.

 

Despite their advantages, many healthcare institutions worldwide lack the facilities, specialized operators, and capital necessary to acquire and maintain expensive conventional MRI devices. The Swoop® system is the first U.S. Food and Drug Administration (“FDA”)-cleared, portable, ULF, MR brain imaging system and 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 conditions inside and outside the hospital. We designed the Swoop® system to address the limitations of conventional imaging technologies and make MR brain imaging accessible nearly anytime and anywhere across professional healthcare settings. We believe the adoption of the Swoop® system by healthcare professionals has 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, for the reconstruction and denoising of T1, T2, and fluid-attenuated inversion recovery (“FLAIR”) sequences. The Swoop® system also incorporates deep learning denoising in the diffusion-weighted imaging (“DWI”) sequences for image post-processing. The integration of deep learning does not require any additional steps from the user. As a result, deep learning can enhance the image quality and, consequently, the diagnostic value of images generated at ULF. The algorithms are designed to improve ULF image quality, while reducing the impact of scan artifacts. The images created with these algorithms were validated by expert radiologists. The Swoop® system is used clinically every day as the first mover

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in the field of portable ULF MRI, and with an install base that continues to expand. The learnings from this field experience have served to improve our software, AI, and denoising algorithms resulting in the image quality and performance improvements of our product over the nine software releases 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 FDA in 2020 and has now received nine subsequent clearances from the FDA after the initial clearance. In February and October 2023, we received 510(k) clearances from the FDA to our Swoop® system AI-powered software. The combination of these two software updates significantly improved DWI, incorporated deep-learning based denoising in the post-processing of DWI images for crisper images, and improved image quality for all Swoop® system sequences. In July 2024, we received 510(k) clearance from the FDA for the latest update to our Swoop® system AI-powered software. This software update significantly reduces scan times across multiple MR sequences without sacrificing image quality. The Swoop® system has also received marketing authorization for brain imaging in several countries, including the European Union (CE certification), the United Kingdom (UK Conformity Assessment (“UKCA”)), Canada, Australia and New Zealand.

 

Key Performance Measures

 

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

 

Total revenues were $3.6 million and $6.9 million for the three and six months ended June 30, 2024, respectively, an increase of $0.3 million, or 7.4% and $0.9 million, or 15.1% from the three and six months ended June 30, 2023. See "Results of Operations". Total Swoop® system units sold were 13 units and 26 units, for the three and six months ended June 30, 2024, respectively, a decrease of 1 unit and an increase of 2 units from the three and six months ended June 30, 2023.

 

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 and applications. We believe that, from our commercial and clinical experience, we are gaining invaluable insights into the Swoop® system’s utility. We believe these learnings will enable us to further improve our product and develop new services and tools in the future. We are continuously improving our image quality and imaging capabilities. Building upon this foundation and our expertise in ULF brain imaging, we plan to develop new imaging applications, broadening the range of clinical uses for our proprietary technology. Additionally, we are leveraging our strengths in AI and cloud technology to explore the Swoop® system’s role as a brain imaging clinical decision support platform. While these technical innovations may increase our research and development expenses, we expect them to have a positive impact on our results of operations and profitability in the future.

 

Commercialization efforts of the Swoop® system

 

Our results have included revenue from the United States and outside the United States. Our Swoop® system received initial 510(k) clearance from the FDA in 2020. Initially, we are 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. As of 2024, we have targeted a select number of international markets to add to our commercial efforts operating through distributors.

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Expand sales in international markets

 

In 2024, we are executing on our international expansion plans by entering into agreements with experienced and accomplished distributors. We have distribution partners covering several countries across Europe and Asia Pacific, as well as Canada. With the Swoop® system’s transformative, affordable, and accessible platform, we aim to serve more clinicians and patients needing brain imaging across the globe. The Swoop® system has received marketing authorization for brain imaging in several countries, including the European Union (CE certification), the United Kingdom (UKCA), Canada, Australia and New Zealand. Additionally, we have begun preparing for the regulatory approval process in India through Central Drugs Standard Control Organization.

Our commitment to the vision of providing affordable and accessible imaging that enables earlier detection and timely management of health conditions worldwide is furthermore advanced by grant funding from the BMGF. 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. As of June 30, 2024 and December 31, 2023, 25 and 22 Swoop® system units, respectively, have been delivered to the BMGF. 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 3-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. During the three and six months ended June 30, 2024, we completed and delivered the remaining Swoop system® devices and delivered a grant milestone of a software update, we received cash of $0.6 million which settled an outstanding grant receivable of $0.5 million as of March 31, 2024, and partially paid $0.1 million of grant fulfilled during the three months ended June 30, 2024. As of June 30, 2024, we recorded grant receivable of $0.2 million excluding interest earned, as part of prepaid expenses and other current assets in our unaudited condensed consolidated balance sheet.

 

Results of Operations

 

The following is a discussion of our results of operations for the three and six months ended June 30, 2024 and 2023. 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)		2024				2023				%				2024				2023				%
Sales
Device		$	2,970			$	2,810				5.7	%		$	5,674			$	4,942				14.8	%
Service			661				571				15.8	%			1,252				1,074				16.6	%
Total sales			3,631				3,381				7.4	%		$	6,926			$	6,016				15.1	%
Cost of Sales
Device			1,422				1,549				(8.2	)%		$	2,921			$	2,620				11.5	%
Service			406				388				4.6	%			848				797				6.4	%
Cost of sales			1,828				1,937				(5.6	)%		$	3,769			$	3,417				10.3	%
Gross margin			1,803				1,444				24.9	%			3,157				2,599				21.5	%
Operating expenses:
Research and development			5,959				5,331				11.8	%		$	11,529			$	10,792				6.8	%
General and administrative			4,421				5,306				(16.7	)%			8,851				11,488				(23.0	)%
Sales and marketing			2,269				2,499				(9.2	)%			4,273				5,046				(15.3	)%
Total operating expenses			12,649				13,136				(3.7	)%			24,653				27,326				(9.8	)%
Loss from operations			(10,846	)			(11,692	)			(7.2	)%		$	(21,496	)		$	(24,727	)			(13.1	)%
Interest income			675				1,030				(34.5	)%		$	1,471			$	1,899				(22.5	)%
Other income, net			15				25				(40.0	)%			21				31				(32.3	)%
Loss before provision for income taxes			(10,156	)			(10,637	)			(4.5	)%		$	(20,004	)		$	(22,797	)			(12.3	)%
Provision for income taxes			—				—								—				—
Net loss and comprehensive loss		$	(10,156	)		$	(10,637	)			(4.5	)%		$	(20,004	)		$	(22,797	)			(12.3	)%

 

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Comparison of the Three Months Ended June 30, 2024 and 2023 ($ Amounts shown in tables in thousands)

 

Sales

 

		Three Months Ended June 30,								Change								Six Months Ended June 30,								Change
		2024				2023				Amount				%				2024				2023				Amount				%
Device		$	2,970			$	2,810			$	160				5.7	%		$	5,674			$	4,942			$	732				14.8	%
Service			661				571				90				15.8	%			1,252				1,074				178				16.6	%
Total sales		$	3,631			$	3,381			$	250				7.4	%		$	6,926			$	6,016			$	910				15.1	%

 

 

Device sales increased by $0.2 million, or 5.7%, for the three months ended June 30, 2024 compared to the three months ended June 30, 2023. The increase in device revenue is mainly due to an increase in unit average selling price offset by a decreased sales volume by one unit in the three months ended June 30, 2024 as compared to the three months ended June 30, 2023.

 

Service sales increased by $0.1 million, or 15.8%, for the three months ended June 30, 2024 compared to the three months ended June 30, 2023. This increase was driven by an increase in the volume of commercial system units installed as generally all commercial systems installations generate recurring service revenue. Service sales revenue is generally recognized over time as we are providing the customer with ongoing access to our resources and software upgrades throughout the subscription period. This type of revenue is recurring in nature and we expect will continue to grow as more devices are sold.

 

Device sales increased by $0.7 million, or 14.8%, for the six months ended June 30, 2024 compared to the six months ended June 30, 2023. The increase in device revenue is mainly due to an increase by two units sold in the six months ended June 30, 2024.

 

Service sales increased by $0.2 million, or 16.6%, for the six months ended June 30, 2024 compared to the six months ended June 30, 2023. This increase was driven by an increase in the volume of commercial system units installed as generally all commercial systems installations generate recurring service revenue.

 

Cost of sales

 

		Three Months Ended June 30,								Change								Six Months Ended June 30,								Change
		2024				2023				Amount				%				2024				2023				Amount				%
Device		$	1,422			$	1,549			$	(127	)			(8.2	)%		$	2,921			$	2,620			$	301				11.5	%
Service			406				388				18				4.6	%			848				797				51				6.4	%
Total cost of sales		$	1,828			$	1,937			$	(109	)			(5.6	)%		$	3,769			$	3,417			$	352				10.3	%
Percentage of revenue			50.3	%			57.3	%											54.4	%			56.8	%

 

 

Cost of device sales decreased by $0.1 million, or 8.2%, for the three months ended June 30, 2024 compared to the three months ended June 30, 2023. This decrease was driven primarily by a decreased sales volume by one unit in the three months ended June 30, 2024, as compared to the three months ended June 30, 2023 and inventory related charges in the three months ended June 30, 2023.

 

Cost of service sales increased by $18 thousand, or 4.6%, for the three months ended June 30, 2024 compared to the three months ended June 30, 2023. This increase is due to the increased install base.

 

Cost of device sales increased by $0.3 million, or 11.5%, for the six months ended June 30, 2024 compared to the six months ended June 30, 2023. This increase was driven primarily by an increase by two units sold in the six months ended June 30, 2024.

 

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Cost of service sales increased by $0.1 million, or 6.4%, for the six months ended June 30, 2024 compared to the six months ended June 30, 2023. This increase is due to the increased install base.

 

Research and development

 

		Three Months Ended June 30,								Change								Six Months Ended June 30,								Change
		2024				2023				Amount				%				2024				2023				Amount				%
Research and development		$	5,959			$	5,331			$	628				11.8	%		$	11,529			$	10,792			$	737				6.8	%

 

 

Research and development expenses increased by $0.6 million, or 11.8%, for the three months ended June 30, 2024 compared to the three months ended June 30, 2023. This increase was driven primarily by an increase in personnel-related costs and stock-based compensation expenses of $0.7 million and other research and development expenses.

 

Research and development expenses increased by $0.7 million, or 6.8%, for the six months ended June 30, 2024 compared to the six months ended June 30, 2023. This increase was driven primarily by an increase in personnel-related costs and stock-based compensation expenses of $1.4 million and an increase in consulting costs of $0.5 million, partially offset by $0.9 million of a higher grant fulfillment credits.

 

General and administrative

 

		Three Months Ended June 30,								Change								Six Months Ended June 30,								Change
		2024				2023				Amount				%				2024				2023				Amount				%
General and administrative		$	4,421			$	5,306			$	(885	)			(16.7	)%		$	8,851			$	11,488			$	(2,637	)			(23.0	)%

 

 

General and administrative expenses decreased by $0.9 million, or 16.7%, for the three months ended June 30, 2024 compared to the three months ended June 30, 2023. This decrease was driven primarily by a decrease in personnel-related costs and stock-based compensation expenses of $0.4 million, a decrease in legal and patent expenses of $0.2 million, and a decrease in accounting, auditing, SEC, and insurance expenses of $0.2 million.

 

General and administrative expenses decreased by $2.6 million, or 23.0%, for the six months ended June 30, 2024 compared to the six months ended June 30, 2023. This decrease was driven primarily by a decrease in personnel-related costs and stock-based compensation expenses of $1.4 million, a decrease in legal and patent expenses of $0.4 million, and a decrease in accounting, auditing, SEC, and insurance expenses of $0.4 million.

 

Sales and marketing

 

		Three Months Ended June 30,								Change								Six Months Ended June 30,								Change
		2024				2023				Amount				%				2024				2023				Amount				%
Sales and marketing		$	2,269			$	2,499			$	(230	)			(9.2	)%		$	4,273			$	5,046			$	(773	)			(15.3	)%

 

 

Sales and marketing expenses decreased by $0.2 million, or 9.2%, for the three months ended June 30, 2024 compared to the three months ended June 30, 2023. This decrease was driven primarily by a decrease in marketing research and advertising of $0.2 million, while we continue to focus on sales and sales support activities.

 

Sales and marketing expenses decreased by $0.8 million, or 15.3%, for the six months ended June 30, 2024 compared to the six months ended June 30, 2023. This decrease was driven primarily by a decrease in marketing research and advertising of $0.3 million, and a decrease in sales and marketing infrastructure of $0.2 million, while we continue to focus on sales and sales support activities.

 

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Interest income

 

		Three Months Ended June 30,								Change								Six Months Ended June 30,								Change
		2024				2023				Amount				%				2024				2023				Amount				%
Interest income		$	675			$	1,030			$	(355	)			(34.5	)%		$	1,471			$	1,899			$	(428	)			(22.5	)%

 

Interest income decreased by $0.4 million for the three months ended June 30, 2024 compared to the three months ended June 30, 2023. The decrease was driven primarily by lower cash balances in money market funds and demand deposit accounts during the three months ended June 30, 2024 compared to the three months ended June 30, 2023.

 

Interest income decreased by $0.4 million for the six months ended June 30, 2024 compared to the six months ended June 30, 2023. The decrease was driven primarily by lower cash balances in money market funds and demand deposit accounts during the six months ended June 30, 2024 compared to the six months ended June 30, 2023.

 

Other income, net

 

		Three Months Ended June 30,								Change								Six Months Ended June 30,								Change
		2024				2023				Amount				%				2024				2023				Amount				%
Other income, net		$	15			$	25			$	(10	)			(40.0	)%		$	21			$	31			$	(10	)			(32.3	)%

 

Other income, net decreased by $10 thousand for the three months ended June 30, 2024 compared to the three months ended June 30, 2023. Other income, net during the three months ended June 30, 2024 was $15 thousand consisting primarily of interest income from customer financing of approximately $24 thousand, offset by a net realized loss on foreign currencies of approximately $5 thousand and other expenses of $4 thousand.

 

Other income, net decreased by $10 thousand the six months ended June 30, 2024 compared to the six months ended June 30, 2023. Other income, net during the six months ended June 30, 2024 was $21 thousand consisting primarily of interest income from customer financing of approximately $48 thousand, offset by a net realized loss on foreign currencies of approximately $18 thousand and other expenses of $9 thousand.

 

Liquidity and Capital Resources

 

We have funded our operations primarily with proceeds from the issuance of common and preferred stock. We have incurred significant cash burn and recurring net losses, which includes a net loss of $20.0 million for the six months ended June 30, 2024, and an accumulated deficit of $273.7 million as of June 30, 2024. As of June 30, 2024, we had cash and cash equivalents of $53.8 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 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. Our shelf registration statement on Form S-3 also includes a prospectus (the “Sales Agreement 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 in November 2023 (the “Sales Agreement”), for our “at-the-market” equity program. We are not obligated to make any sales of Class A common stock under the Sales Agreement. As of June 30, 2024, we had not sold any Class A common stock pursuant to the Sales Agreement. As of the filing of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, we are subject to the SEC general instructions of Form S-3 known as the “baby shelf rules.” Under these instructions, the amount of funds we can raise through primary public offerings of securities in any 12-month period using our registration statement on Form S-3 is limited to one-third of

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the aggregate market value of the shares of our common stock held by non-affiliates. Therefore, we are limited in the amount of proceeds we are able to raise by selling shares of our common stock using our Form S-3, including under the Sales Agreement, until such time as our public float exceeds $75 million. On March 22, 2024, we filed an amendment to the Sales Agreement Prospectus, pursuant to which, as of such date, we may offer and sell shares of our Class A common stock having an aggregate offering price of up to $22.8 million from time to time through or to B. Riley.

 

Our ability to access capital when needed is not assured and, if capital is not available when, and in the amounts needed, we could be required to delay, scale back or abandon some or all of our development programs, commercialization of our products, and other operations which could materially harm our operations, financial condition and operating results. We expect that our existing cash and cash equivalents, together with proceeds from the sales of our products and services, will enable us to conduct our planned operations for at least the next 12 months. Factors that could accelerate cash needs include: (i) delays in achieving scientific and technical milestones; (ii) unforeseen capital expenditures and fabrication costs related to manufacturing; (iii) changes we may make in our business or commercialization and hiring strategy; (iv) costs of running a public company; (v) higher inflation and increases in product transportation and labor costs; and (vi) 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, 2024, we had cash and cash equivalents of $53.8 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)		2024				2023
Net cash used in operating activities		$	(21,893	)		$	(23,150	)
Net cash used in investing activities			(216	)			(283	)
Net cash provided by financing activities			114				107
Net decrease in cash, cash equivalents, and restricted cash		$	(21,995	)		$	(23,326	)

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Net cash used in operating activities

 

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, 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 the 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.

 

For the six months ended June 30, 2023, net cash used in operating activities of $23.2 million was due primarily to a net loss of $22.8 million and changes in operating assets and liabilities of $3.2 million, partially offset by non-cash items of $2.8 million. Non-cash items were primarily stock-based compensation expense of $2.3 million and depreciation expense of $0.5 million. Changes in operating assets and liabilities were driven primarily by an increase in accounts receivable and unbilled receivables of $1.8 million driven primarily by increased revenue, a decrease in accrued expense and other current liabilities of $1.8 million driven primarily by lower bonus and salary and benefit accrual due to a decreased headcount, and an increase in inventory of $1.5 million, partially offset by a decrease in prepaid expenses and other current assets of $0.9 million, an increase in accounts payable of $0.7 million, a decrease in prepaid inventory of $0.3 million and an increase in deferred grant funding of $0.2 million.

 

Net cash used in investing activities

 

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

 

For the six months ended June 30, 2023, net cash used in investing activities of $0.3 million was from fixed assets purchased.

 

Net cash provided by financing activities

 

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

 

For the six months ended June 30, 2023, 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 and six months ended June 30, 2024 and 2023.

 

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. As of June 30, 2024 and December 31, 2023, 25 and 22 Swoop® system units, respectively, were delivered to the BMGF. 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 3-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.

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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, 2024.

 

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, 2024 and 2023 included elsewhere in this Quarterly Report on Form 10-Q.

 

Critical Accounting Policies and Significant Judgments and Estimates

 

Our management's discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). 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”, 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 Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 22, 2024.

 

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, 2024 and 2023 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, 2024 consisted of $53.8 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, 2024, the annualized effect of a 0.5 percentage point decrease in interest rates would be to decrease earnings before income taxes by $0.3 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, 2024. Based upon that evaluation, our principal executive officer and principal financial officer have concluded that, as of June 30, 2024, 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, 2024, 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 most recent Annual Report on Form 10-K, filed with the SEC on March 22, 2024. There have been no material changes in our risk factors from those described in our Annual Report on Form 10-K, other than the updates to the risk factors 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.

We could fail to maintain the listing of our Class A common stock on Nasdaq, which could seriously harm the liquidity of our shares and our ability to raise capital or complete a strategic transaction.

 

The Nasdaq Stock Market has established continued listing requirements, including a requirement to maintain a minimum closing bid price of at least $1.00 per share. In December 2022 and May 2024, we received written notices from Nasdaq notifying us that, because the closing bid price for our Class A common stock had fallen below $1.00 per share for 30 consecutive business days, we no longer met the minimum bid price requirement for continued inclusion on The Nasdaq Global Market. Although we have since regained compliance with the bid price requirement and our Class A common stock continues to trade on The Nasdaq Global Market, there can be no assurance that we will be able to maintain compliance with the bid price requirement or other Nasdaq requirements in the future. If we are not able to maintain compliance with Nasdaq requirements, our Class A common stock may be delisted from Nasdaq, which could have a material adverse effect on us and our stockholders, including by reducing the liquidity of our shares and having a material adverse effect on our ability to raise capital or complete a strategic transaction.

 

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, 2024, 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
3.1		Certificate of Incorporation of Hyperfine, Inc., as amended.		X
10.1+		Nonemployee Director Compensation Policy, As amended.				Form 10-Q (Exhibit 10.1)		5/14/2024		001-39949
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

 

+ Management contract or compensatory plan or arrangement.

* 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 9, 2024		By: /s/ Maria Sainz
		Maria Sainz
		President and Chief Executive Officer
Date: August 9, 2024		By: /s/ Brett Hale
		Brett Hale
		Chief Administrative Officer, Chief Financial Officer, Treasurer and Corporate Secretary

 

 

 

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