Helius Medical Technologies(US:HSDT)2025-03-25 20:05Financial Performance - Total revenue decreased by $124,000, from $644,000 in 2023 to $520,000 in 2024, representing a decline of approximately 19.3%[374] - Net product sales in the U.S. dropped by $143,000, from $324,000 in 2023 to $181,000 in 2024, a decrease of about 44.1%[374] - Gross loss for 2024 was $62,000 compared to a gross profit of $61,000 in 2023, indicating a year-over-year variance of $123,000[378] - Total operating expenses increased by $1,352,000, from $12,489,000 in 2023 to $13,841,000 in 2024, an increase of approximately 10.8%[374] - Net loss for 2024 was $11,742,000, compared to a net loss of $8,850,000 in 2023, reflecting an increase in loss of $2,892,000[374] - Cash and cash equivalents decreased from $5,182,000 in 2023 to $1,088,000 in 2024, a decline of approximately 79.0%[388] - Net cash used in operating activities increased by $625,000, from $10,416,000 in 2023 to $11,041,000 in 2024[390] - The company expects to continue incurring significant expenses and operating losses for the foreseeable future, indicating substantial doubt about its ability to continue as a going concern[395] - The company does not currently have sufficient resources to achieve profitability and anticipates needing additional financing[408] - There is uncertainty regarding the availability of funding to meet required expenditures[408] Capital Raising and Financial Resources - The company generated gross proceeds of $3.7 million from warrant exercise inducement offer letters on January 21, 2025[351] - The company received net proceeds of approximately $5.5 million from a registered public offering of its Common Stock and warrants in May 2024[359] - The company raised $5.5 million in net proceeds from a public offering completed in May 2024[388] - The company plans to use available capital resources primarily to expand U.S. commercialization efforts and fund clinical trials[396] Product Development and Commercialization - The final payment rate for the PoNS Mouthpiece was set at $2,963.30 effective January 1, 2025, while the PoNS Controller was preliminarily priced at $532.27[357] - The company established Revelation Neuro on March 11, 2025, to develop a new AI-powered brain-computer interface for personalized neurorehabilitation[350] - The company completed enrollment of 128 participants for its stroke registrational program by December 31, 2024, exceeding the initial target of 90[366] - The company began commercial sales of the PoNS device in the U.S. in April 2022, following the acceptance of prescriptions in March 2022[346] - The company partnered with Lovell Government Services to make the PoNS device available to federal healthcare systems, with pricing set at $23,843.72 for the PoNS device[358] - The company anticipates it will take at least 24 months to obtain broad coverage and reimbursement among government and private payers from the effective date of HCPCS codes[368] - The company is pursuing commercial insurance coverage for PoNS within the Durable Medical Equipment benefit category, with CMS assigning HCPCS Level II codes effective April 1, 2024[353] Compliance and Regulatory Matters - The company received a Notification Letter from Nasdaq on August 9, 2024, indicating non-compliance with the minimum bid price requirement of $1.00 per share for 30 consecutive business days[348]