Form 8-K - Current report

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

August 12, 2024

Date of Report (Date of earliest event reported)

HELIUS MEDICAL TECHNOLOGIES, INC.

(Exact name of Registrant as Specified in Its Charter)

-
DELAWARE	001-38445	36-4787690
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

642 Newtown Yardley Road, Suite 100 Newtown, PA		18940
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: (215) 944-6100

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:


☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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

Title of each class

Trading

Symbol(s)

Name of each exchange on which registered

Common Stock

HSDT

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

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. ☐

Item 2.02Results of Operations and Financial Condition.

On August 12, 2024, Helius Medical Technologies, Inc. (the “Registrant”) issued a press release announcing its financial results for the quarter ended June 30, 2024, as well as information regarding a conference call to discuss these financial results and the Registrant’s recent corporate highlights. A copy of this press release is furnished herewith as Exhibit 99.1 to this Current Report and is incorporated herein by reference.

In accordance with General Instruction B.2. of Form 8-K, the information in this Item 2.02, and Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any of the Registrant’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description

99.1		Press Release dated August 12, 2024.
104		Cover Page Interactive Data File (embedded within Inline XBRL document)

SIGNATURE

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 hereunto duly authorized.


	HELIUS MEDICAL TECHNOLOGIES, INC.

Dated: August 12, 2024	By:	/s/ Jeffrey S. Mathiesen
		Jeffrey S. Mathiesen
		Chief Financial Officer and Treasurer

Exhibit 99.1

Helius Medical Technologies, Inc. Reports Second Quarter 2024 Financial Results

-- Company to host call at 4:30pm today --

NEWTOWN, Pa., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced results for the quarter ended June 30, 2024.

Second Quarter and Recent Business Updates

●	Secured the first third-party reimbursement for the Portable Neuromodulation Stimulator (“PoNS®”) device from a major insurance carrier at $23,900, representing a significant milestone toward increasing PoNS accessibility.

●	Received preliminary Centers for Medicare & Medicaid Services (“CMS”) payment determination for reimbursement of PoNS, paving the way to final price determination on October 1, 2024.

●	Completed site participation enrollment for the U.S. registrational program in stroke; on track for a submission in the first half of 2025 to the U.S. Food and Drug Administration (“FDA”).

●	Secured Federal Supply Schedule contract pricing with the U.S. Department of Veterans Affairs (“VA”) at $23,843.72 and $7,344.97 for the PoNS device and mouthpiece, respectively, through its partnership with Lovell® Government Services.

●	Secured DAPA contract pricing with the U.S. Department of Department of Defense (“DoD”) at $23,724.50 and $7,308.25 for the PoNS device and mouthpiece, respectively, through its partnership with Lovell Government Services.

●	Commenced building out nationwide sales representation at VA sites in June 2024, establishing coverage in thirteen states plus Puerto Rico to date.

●	Q2 2024 revenue up $47 thousand or 35% compared to Q1 2024, reflecting increased product sales in both the U.S. and Canada.

●	Q2 2024 revenue of $182 thousand, compared to $256 thousand in Q2 2023, reflecting the expiration of the Patient Therapy Access Program (“PTAP”) on June 30, 2023.

●	Closed on $6.4 million public offering, raising net proceeds of approximately $5.5 million.

“Our team has been working tirelessly to get PoNS into the hands of MS patients who suffer from gait and balance impairment. These efforts are starting to pay off and during the quarter we made several important advancements toward removing barriers to our innovative technology. We were pleased to announce the first third-party reimbursement for PoNS from a major

insurance carrier at $23,900 and are now just a few weeks away from CMS publishing its final reimbursement rates to be effective on October 1, which we believe will be a significant catalyst for growing revenue as well as negotiating reimbursement with other third-party payers,” stated Helius’ President and Chief Executive Officer, Dane Andreeff.

He continued, “In June, we completed site participation enrollment for our registrational program in stroke. This groundbreaking program is being conducted at several of the top neurorehabilitation centers in the U.S., and the results will be crucial to seeking regulatory approval in 2025. To bolster our FDA submission and support national reimbursement efforts in Canada, we’ve begun a Canadian study with the goal of enrolling at least 40 subjects at three centers of excellence for stroke rehabilitation.”

“The third quarter of 2024 will be pivotal for Helius and will help frame our future. We expect to have a first read of the primary endpoint’s results of our PoNSTEP study, further expand our VA sales rep organization and penetrate VA sites, and receive final reimbursement determination by CMS. I’m proud of what we’ve accomplished to get to this point and excited about the outlook for Helius as these key milestones play out,” concluded Andreeff.

Second Quarter 2024 Financial Results

Total revenue for the second quarter of 2024 was $182 thousand, a decrease of $74 thousand compared to $256 thousand in the second quarter of 2023, resulting from the termination of PTAP on June 30, 2023, and the termination of temporary cash pay pricing in May 2024. Revenue for the quarter increased by $47 thousand or 35% compared to the first quarter of 2024, as a result of increased sales in both the U.S. and Canada.

Cost of revenue decreased to $118 thousand for the three months ended June 30, 2024, compared to $184 thousand for the comparable period in 2023, primarily attributable to lower sales compared to the same period in the prior year.

Selling, general and administrative expenses for the second quarter of 2024 were $2.5 million, comparable to the $2.6 million reported in the second quarter of 2023.

Research and development expenses for the second quarter of 2024 increased slightly to $0.9 million, compared to $0.7 million in the second quarter of 2023, driven primarily by an increase in clinical trial activities for stroke and risk of fall programs.

Total operating expenses for the second quarter of 2024 were $3.3 million, flat compared to the $3.3 million reported in the second quarter of 2023.

Operating loss for the second quarter of 2024 was $3.3 million, compared to an operating loss of $3.2 million for the prior year period.

Net loss was $1.6 million for the second quarter of 2024, flat compared to a net loss of $1.6 million in the corresponding prior year period. The basic and diluted net loss per share for the second

quarter was $0.64 per share, compared to a net loss of $2.92 per share for the second quarter of 2023.

Cash and Liquidity

Cash used in operating activities was flat at $5.9 million for the six months ended June 30, 2024 and June 30, 2023.

As of June 30, 2024, the Company had cash of $6.4 million and no debt outstanding with a projected cash runway into 2025.

Conference Call

Date:Monday, August 12, 2024

Time:4:30 p.m. Eastern Time

Webcast:Click Here

The webcast will be archived under the Newsroom section of the Company’s investor relations website.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using an orally applied technology platform that amplifies the brain’s ability to engage physiologic compensatory mechanisms and promote neuroplasticity, improving the lives of people dealing with neurologic diseases. The Company’s first commercial product is the Portable Neuromodulation Stimulator. For more information about the PoNS® or Helius Medical Technologies, visit www.heliusmedical.com.

About the PoNS Device and PoNS Therapy

The Portable Neuromodulation Stimulator (PoNS) is an innovative, non-implantable, orally applied therapy that delivers neurostimulation through a mouthpiece connected to a controller and it’s used, primarily at home, with physical rehabilitation exercise, to improve balance and gait. The PoNS device, which delivers mild electrical impulses to the tongue, is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only.

PoNS has shown effectiveness in treating gait or balance and a significant reduction in the risk of falling in stroke patients in Canada, where it received authorization for sale in three indications:

(i) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from stroke and is to be used in conjunction with physical therapy; (ii) for use as a short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy; and (iii) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy. PoNS is also authorized for sale in Australia for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait. For more information visit www.ponstherapy.com.

Cautionary Disclaimer Statement

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “expect,” “continue,” “will,” “goal,” “aim” and similar expressions. Such forward-looking statements include, among others, statements regarding the sufficiency of the Company’s future cash position, the development, commercialization and success of the Company’s PoNS and PoNS Treatment, the progress of the Company’s clinical programs, future decisions and approvals from applicable regulatory entities in the U.S. and Canada, reimbursement status with third party payers, the Company’s strategic operating plans, and the uses and effectiveness of PoNS and PoNS Therapy.

There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include uncertainties associated with the Company’s capital requirements to achieve its business objectives, availability of funds, the Company’s ability to find additional sources of funding, manufacturing, labor shortage and supply chain risks, including risks related to manufacturing delays, the Company’s ability to obtain national Medicare insurance coverage and to obtain a reimbursement code, the Company’s ability to continue to build internal commercial infrastructure, secure state distribution licenses, market awareness of the PoNS device, future clinical trials and the clinical development process, the product development process and the FDA regulatory submission review and approval process, other development activities, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.

The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to

update the reasons why actual results could differ from such statements except to the extent required by law.

Investor Relations Contact

Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com

Helius Medical Technologies, Inc.

Unaudited Condensed Consolidated Statements of Operations

(in thousands, except share and per share data)


	Three Months Ended				Six Months Ended
	June 30,				June 30,
	2024		2023		2024		2023
Revenue
Product sales, net	$	171	$	244	$	295	$	350
Other revenue		11		12		22		17
Total revenue		182		256		317		367
Cost of revenue		118		184		241		306
Gross profit		64		72		76		61
Operating expenses
Selling, general and administrative expenses		2,457		2,569		5,090		5,443
Research and development expenses		870		684		1,658		1,570
Amortization expense		7		38		14		77
Total operating expenses		3,334		3,291		6,762		7,090
Loss from operations		(3,270)		(3,219)		(6,686)		(7,029)
Nonoperating income (expense)
Interest income (expense), net		(5)		89		(13)		189
Change in fair value of derivative liability		1,733		1,223		2,875		2,444
Foreign exchange gain (loss)		(141)		259		(429)		254
Other income, net		71		—		125		—
Nonoperating income, net		1,658		1,571		2,558		2,887
Loss before provision for income taxes		(1,612)		(1,648)		(4,128)		(4,142)
Provision for income taxes		—		—		—		—
Net loss	$	(1,612)	$	(1,648)	$	(4,128)	$	(4,142)
Loss per share
Basic	$	(0.64)	$	(2.92)	$	(2.48)	$	(7.34)
Diluted	$	(0.64)	$	(2.92)	$	(2.48)	$	(7.34)
Weighted average number of common shares outstanding
Basic		2,518,071		564,423		1,667,699		564,279
Diluted		2,518,071		564,423		1,667,699		564,279

Helius Medical Technologies, Inc.

Unaudited Condensed Consolidated Balance Sheets

(in thousands, except share data)


	June 30, 2024		December 31, 2023
ASSETS
Current assets
Cash and cash equivalents	$	6,387	$	5,182
Accounts receivable, net		121		117
Other receivables		538		520
Inventory, net		821		457
Prepaid expenses and other current assets		774		1,162
Total current assets		8,641		7,438
Property and equipment, net		165		178
Intangible assets, net		9		24
Operating lease right-of-use asset, net		31		52
Total assets	$	8,846	$	7,692
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable	$	1,287	$	531
Accrued and other current liabilities		694		1,260
Current portion of operating lease liabilities		35		45
Current portion of deferred revenue		41		43
Total current liabilities		2,057		1,879
Operating lease liabilities, net of current portion		—		12
Deferred revenue, net of current portion		103		128
Derivative liability		347		3,323
Total liabilities		2,507		5,342
STOCKHOLDERS’ EQUITY
Class A common stock, $0.001 par value; 150,000,000 shares authorized; 3,198,196 and 714,590 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively		3		1
Additional paid-in capital		170,666		162,979
Accumulated deficit		(164,085)		(159,957)
Accumulated other comprehensive loss		(245)		(673)
Total stockholders' equity		6,339		2,350
Total liabilities and stockholders' equity	$	8,846	$	7,692

Document and Entity Information	Aug. 12, 2024
Document and Entity Information [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 12, 2024
Entity Registrant Name	HELIUS MEDICAL TECHNOLOGIES, INC.
Entity Central Index Key	0001610853
Entity Emerging Growth Company	false
Entity File Number	001-38445
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	36-4787690
Entity Address, Address Line One	642 Newtown Yardley Road
Entity Address, Adress Line Two	Suite 100
Entity Address, City or Town	Newtown
Entity Address State Or Province	PA
Entity Address, Postal Zip Code	18940
City Area Code	(215)
Local Phone Number	944-6100
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock
Trading Symbol	HSDT
Security Exchange Name	NASDAQ