Helius Medical Technologies(HSDT) - 2025 Q1 - Quarterly Report

Financial Performance - Total product sales decreased to $38 thousand in Q1 2025 from $124 thousand in Q1 2024, a decline of approximately 69%[96] - Gross loss for Q1 2025 was $72 thousand compared to a gross profit of $12 thousand in Q1 2024, reflecting a year-over-year variance of $84 thousand[99] - Selling, general and administrative expenses increased by $361 thousand to $2,994 thousand in Q1 2025 compared to Q1 2024[100] - Research and development expenses rose by $157 thousand to $945 thousand in Q1 2025, driven by increased product development costs[101] - The Company reported a net loss of $3.8 million for Q1 2025, compared to a net loss of $2.5 million in Q1 2024, indicating a year-over-year increase of 52%[96] - Cash and cash equivalents as of March 31, 2025, were $1,109 thousand, a slight increase from $1,088 thousand at the end of 2024[107] - The Company generated $3.4 million in net proceeds from warrant inducement offers during Q1 2025[116] Compliance and Regulatory Issues - The company received a notification from Nasdaq regarding non-compliance with the minimum bid price requirement, with a closing bid price below $1.00 per share for 30 consecutive business days[72] - The company received a letter from Nasdaq indicating continued non-compliance with the minimum stockholders' equity requirement, as reported equity fell below $2.5 million[75] Product Development and Partnerships - The company announced its first reimbursement payment from Anthem Blue Cross Blue Shield for the PoNS Device on March 11, 2025[78] - The final payment rate for the PoNS Mouthpiece was set at $2,963.30 effective January 1, 2025, while the PoNS Controller was capped at $532.27[84] - The company partnered with Lovell Government Services to make the PoNS device available to federal healthcare systems, with prices set at $23,843.72 for the PoNS device and $7,344.97 for the mouthpiece[87] - The company established Revelation Neuro, Inc. to develop a new AI-powered brain-computer interface for personalized neurorehabilitation[86] - The company anticipates it will take at least 24 months to obtain broad coverage and reimbursement among government and private payers following the effective date of HCPCS codes[85] - The company has established sales representative agreements to sell PoNS devices to Veterans Affairs facilities across various states[88] - The Company has been seeking a business partner to commercialize and distribute PoNS in Australia, where it is authorized for sale as a Class IIa medical device[69] - The Company enrolled 128 participants in its stroke registrational program by December 31, 2024, exceeding the initial target of 90[91] Strategic Initiatives - The Company plans to seek additional funding to support ongoing operations and clinical trials, indicating potential liquidity challenges[118] - The Company has initiated a process to explore strategic alternatives to maximize stockholder value, engaging B. Riley Securities as a financial advisor[92]