Company Overview

Helius Medical Technologies, Inc. is a neurotechnology company focused on neurological wellness. The company’s main product is the Portable Neuromodulation Stimulator (PoNS), an innovative non-implantable medical device that delivers mild electrical stimulation to the surface of the tongue to provide treatment of gait deficit and chronic balance deficit. PoNS has marketing clearance in the U.S. for use as a short-term treatment of gait deficit due to mild-to-moderate symptoms for multiple sclerosis, and is authorized for sale in Canada for three indications related to balance and gait deficits.

Recent Developments

• Financing: The company raised $1.2 million in net proceeds from the sale of promissory notes and common stock in April 2025. It also raised $3.4 million in net proceeds from the exercise of warrants and $0.1 million from its at-the-market (ATM) offering program in January 2025.

• Nasdaq Compliance: The company received notices from Nasdaq regarding non-compliance with the minimum bid price and stockholders’ equity requirements for continued listing. The company is working to regain compliance within the extension periods granted by Nasdaq.

• Reimbursement: The company announced its first reimbursement payment from Anthem Blue Cross Blue Shield for the PoNS device. It is also pursuing broader commercial insurance coverage and working to obtain favorable reimbursement rates from CMS.

• Partnerships and Expansion: The company established Revelation Neuro to pursue development of a new brain-computer interface technology. It also partnered with Lovell Government Services to make PoNS available to federal healthcare systems.

• Clinical Trials: The company is conducting a registrational program for the use of PoNS in stroke patients, including three studies that have exceeded the initial enrollment targets.

Material Trends and Uncertainties

• Global economic conditions remain uncertain, with factors like supply chain disruptions, inflation, and interest rate hikes potentially impacting the company’s operations and access to capital.

• The company’s ability to achieve profitability will depend heavily on the successful commercialization of PoNS Therapy in the U.S.

• The company faces substantial doubt about its ability to continue as a going concern and will need to seek additional funding to continue operations beyond the second quarter of 2025.

Results of Operations

• Revenue decreased 36% year-over-year in Q1 2025 due to lower unit volumes in the U.S.

• Gross profit turned to a loss of $72,000 in Q1 2025 from a profit of $12,000 in Q1 2024, primarily due to the revenue decline.

• Operating expenses increased 15% year-over-year, driven by higher selling, general and administrative as well as R&D costs.

• Net loss increased from $2.5 million in Q1 2024 to $3.8 million in Q1 2025.

Liquidity and Capital Resources

• The company had $1.1 million in cash and cash equivalents as of March 31, 2025, with $1.4 million in working capital.

• The company’s primary sources of cash have been proceeds from public and private stock offerings, warrant exercises, and its ATM program.

• The company believes its existing capital resources, along with the recent financing activities, will be sufficient to fund operations into the second quarter of 2025, but it will need to seek additional funding thereafter to continue operations.

• There is substantial doubt about the company’s ability to continue as a going concern if it is unable to raise sufficient additional capital.