Helius Medical Technologies (Nasdaq: HSDT) raised over $500M in a PIPE led by Pantera Capital and Summer Capital, with potential proceeds above $1.25B if warrants are exercised. Funds will launch a SOL treasury strategy, making SOL the main reserve and exploring DeFi opportunities.https://t.co/TOlX8h1FnR ...

Accessibility StatementSkip Navigation  Preeminent SOL-backed treasury vehicle - with potential to deliver over $1.25 billion - unlocks capital markets to accelerate Solana's growth NEWTOWN, Pa., Sept. 15, 2025 /PRNewswire/ -- Helius Medical Technologies, Inc. (Nasdaq: HSDT) ("Helius" or the "Company") today announced the pricing of an oversubscribed private investment in public equity offering (the "Offering") for the purchase and sale of common stock (and/or pre-funded warrants to purchase shares of comm ...

PART I. FINANCIAL INFORMATION [ITEM 1. Condensed Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) This section presents the company's unaudited condensed consolidated financial statements and accompanying notes [Unaudited Condensed Consolidated Balance Sheets](index=3&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows a significant increase in cash and total stockholders' equity as of June 30, 2025 ASSETS (in thousands) | ASSETS (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Cash and cash equivalents | $6,078 | $1,088 | | Total current assets | $7,803 | $3,424 | | Total assets | $7,893 | $3,542 | | LIABILITIES AND STOCKHOLDERS' EQUITY (in thousands) | June 30, 2025 | December 31, 2024 | | Total current liabilities | $1,805 | $2,163 | | Total liabilities | $1,867 | $2,483 | | Total stockholders' equity | $6,026 | $1,059 | - The company's cash and cash equivalents increased significantly from **$1,088 thousand** at December 31, 2024, to **$6,078 thousand** at June 30, 2025[7](index=7&type=chunk) - Total stockholders' equity saw a substantial increase from **$1,059 thousand** to **$6,026 thousand** over the six-month period[7](index=7&type=chunk) [Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company experienced a significant increase in net loss and a sharp decline in revenue for H1 2025 Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) | (in thousands, except share and per share data) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total revenue | $43 | $182 | $92 | $317 | | Gross (loss) profit | $(53) | $64 | $(125) | $76 | | Loss from operations | $(3,322) | $(3,270) | $(7,333) | $(6,686) | | Change in fair value of derivative liability | $(6,028) | $1,733 | $(5,919) | $2,875 | | Net loss | $(9,833) | $(1,612) | $(13,671) | $(4,128) | | Basic Loss per share | $(79.73) | $(485.30) | $(201.55) | $(1,886.90) | - **Net loss significantly increased** for both the three and six months ended June 30, 2025, primarily due to a substantial loss from the change in fair value of derivative liability[9](index=9&type=chunk) - Total revenue **decreased by 76%** for the three months and **71%** for the six months ended June 30, 2025, compared to the prior year periods[9](index=9&type=chunk) [Unaudited Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity increased substantially in H1 2025, driven by a rise in additional paid-in capital Condensed Consolidated Statements of Stockholders' Equity (in thousands, except share data) | (in thousands, except share data) | Balance as of January 1, 2025 | Balance as of June 30, 2025 | | :-------------------------------- | :---------------------------- | :-------------------------- | | Class A Common Stock (Amount) | $0 | $1 | | Additional Paid-In Capital | $172,425 | $191,690 | | Accumulated Deficit | $(171,699) | $(185,370) | | Accumulated Other Comprehensive Loss | $333 | $(295) | | Total Stockholders' Equity | $1,059 | $6,026 | - Total stockholders' equity increased from **$1,059 thousand** at January 1, 2025, to **$6,026 thousand** at June 30, 2025, driven by capital raises[11](index=11&type=chunk) - Additional paid-in capital increased by **$19,265 thousand** during the six months ended June 30, 2025[11](index=11&type=chunk) [Unaudited Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Financing activities drove a significant net increase in cash and cash equivalents during the first half of 2025 Condensed Consolidated Statements of Cash Flows (in thousands) | (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(6,293) | $(5,892) | | Net cash used in investing activities | $0 | $(5) | | Net cash provided by financing activities | $11,283 | $7,103 | | Net increase in cash and cash equivalents | $4,990 | $1,205 | | Cash and cash equivalents at end of period | $6,078 | $6,387 | - Net cash provided by financing activities significantly increased to **$11,283 thousand** in H1 2025, up from $7,103 thousand in H1 2024[13](index=13&type=chunk) - The company reported a net increase in cash and cash equivalents of **$4,990 thousand** for the six months ended June 30, 2025[13](index=13&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the basis of presentation, accounting policies, and supplemental financial information [1. BASIS OF PRESENTATION](index=8&type=section&id=1.%20BASIS%20OF%20PRESENTATION) The financial statements are prepared per SEC rules and GAAP, with substantial doubt about going concern - The unaudited condensed consolidated financial statements are prepared in accordance with SEC rules and GAAP, with certain information condensed or omitted[14](index=14&type=chunk) - Management's estimates and assumptions are used, and interim results are not necessarily indicative of full-year operations[15](index=15&type=chunk)[16](index=16&type=chunk) [Reverse Stock Splits](index=8&type=section&id=Reverse%20Stock%20Splits) The company executed two reverse stock splits in 2025, which have been retroactively applied - A **1-for-15 reverse stock split** became effective on May 2, 2025[17](index=17&type=chunk) - A **1-for-50 reverse stock split** became effective on July 1, 2025[18](index=18&type=chunk) - All common stock and per share amounts in the financial statements have been retroactively adjusted to reflect these splits[19](index=19&type=chunk) [Going Concern Uncertainty](index=8&type=section&id=Going%20Concern%20Uncertainty) Significant operating losses and a large accumulated deficit raise doubt about the company's ability to continue - As of June 30, 2025, the company had **$6.1 million in cash** and cash equivalents, an operating loss of **$7.3 million** for the six months, and an accumulated deficit of **$185.4 million**[20](index=20&type=chunk) - These factors indicate **substantial doubt** about the company's ability to continue as a going concern within one year[22](index=22&type=chunk) - The company plans to fund operations by utilizing current cash, PoNS device sales, and raising additional capital through equity or debt financings, though there is no assurance of success[23](index=23&type=chunk) [Global Economic Conditions](index=10&type=section&id=Global%20Economic%20Conditions) Uncertain global economic conditions pose risks to the company's capital access and financial results - Worldwide economic conditions remain uncertain due to geopolitical conflicts, banking system disruptions, increased inflation, and high interest rates[24](index=24&type=chunk) - These conditions have adversely affected the company's access to and cost of capital, potentially impacting its business, financial condition, results of operations, and liquidity[24](index=24&type=chunk)[25](index=25&type=chunk) [2. RECENT ACCOUNTING PRONOUNCEMENTS](index=10&type=section&id=2.%20RECENT%20ACCOUNTING%20PRONOUNCEMENTS) The company is evaluating the impact of new accounting standards for expense, income tax, and climate disclosures - The company is evaluating ASU 2024-03 (Expense Disaggregation Disclosures), effective FY2027 (annual) and FY2028 (interim), which requires tabular disclosure of certain income statement expense categories[26](index=26&type=chunk) - The company is evaluating ASU 2023-09 (Improvements to Income Tax Disclosures), effective FY2025, which requires expanded annual disclosures for income tax rate reconciliation and taxes paid by jurisdiction[27](index=27&type=chunk)[28](index=28&type=chunk)[29](index=29&type=chunk) - The company is evaluating SEC Release No 33-11275 (Climate-Related Disclosures), phasing in for non-accelerated filers starting FY2027, which requires disclosure of material Scope 1 and Scope 2 greenhouse gas emissions[30](index=30&type=chunk) [3. SUPPLEMENTAL BALANCE SHEET DISCLOSURES](index=12&type=section&id=3.%20SUPPLEMENTAL%20BALANCE%20SHEET%20DISCLOSURES) This section provides detailed breakdowns of accounts receivable, inventory, and accrued liabilities - Accounts receivable decreased from **$70 thousand** at December 31, 2024, to **$12 thousand** at June 30, 2025, with no allowance for credit losses[31](index=31&type=chunk) Inventory, net (in thousands) | Inventory, net (in thousands) | June 30, 2025 | December 31, 2024 | | :---------------------------- | :------------ | :---------------- | | Raw materials | $575 | $576 | | Work-in-process | $379 | $402 | | Finished goods | $279 | $145 | | Inventory, gross | $1,233 | $1,123 | | Inventory reserve | $(92) | $(87) | | Inventory, net | $1,141 | $1,036 | Accrued and other current liabilities (in thousands) | Accrued and other current liabilities (in thousands) | June 30, 2025 | December 31, 2024 | | :--------------------------------------------------- | :------------ | :---------------- | | Insurance payable | $91 | $356 | | Employees benefits | $328 | $759 | | Total accrued and other current liabilities | $472 | $1,239 | [Deferred revenue](index=13&type=section&id=Deferred%20revenue) Deferred revenue relates to an exclusive distribution agreement that was terminated in July 2025 - Deferred revenue is comprised of the unamortized amount under an Exclusive Distribution Agreement with Health Tech Connex Inc (HTC)[36](index=36&type=chunk) - The company terminated the Exclusivity Agreement with HTC on July 13, 2025, due to a material breach of obligations[36](index=36&type=chunk) [4. LEASES](index=13&type=section&id=4.%20LEASES) The company extended its headquarters operating lease through March 2026 with total future payments of $36 thousand - The operating lease for the company's headquarters was extended through March 31, 2026, at **$4 thousand per month**[37](index=37&type=chunk) Expected operating lease costs (in thousands) | Expected operating lease costs (in thousands) | Amount | | :------------------------------------ | :----- | | 2025 (remaining) | $24 | | 2026 | $12 | | Total lease payments | $36 | [5. FAIR VALUE MEASUREMENTS](index=13&type=section&id=5.%20FAIR%20VALUE%20MEASUREMENTS) The company's derivative liability, classified as Level 3, is measured at fair value on a quarterly basis - Fair value inputs are categorized into Level 1 (quoted prices), Level 2 (observable inputs), and Level 3 (unobservable inputs)[39](index=39&type=chunk)[40](index=40&type=chunk)[41](index=41&type=chunk) - The company's derivative liability, primarily warrants from the August 2022 and June 2025 offerings, is classified as **Level 3** and recorded at fair value quarterly[43](index=43&type=chunk) [6. COMMON STOCK, PREFERRED STOCK AND WARRANTS](index=15&type=section&id=6.%20COMMON%20STOCK%2C%20PREFERRED%20STOCK%20AND%20WARRANTS) The company engaged in multiple financing activities in H1 2025, including offerings and warrant exercises - The 2025 Offering on June 6, 2025, involved the issuance of common stock, pre-funded warrants, and common warrants, generating aggregate gross proceeds of **$9.1 million**[45](index=45&type=chunk)[50](index=50&type=chunk) - The 2025 Warrants were classified as a derivative liability due to a Zero Cash Provision, resulting in a **$6.2 million loss** from the change in fair value[47](index=47&type=chunk) - A private placement on April 24, 2025, generated **$1.3 million** in gross proceeds from unsecured promissory notes and common stock issuance[51](index=51&type=chunk)[52](index=52&type=chunk) - A warrant exercise inducement offer on January 21, 2025, generated approximately **$3.7 million** in gross proceeds from the exercise of existing warrants[56](index=56&type=chunk) - Under the At-The-Market (ATM) offering program, the company sold shares generating **$0.1 million** in net proceeds in H1 2025, and increased the program capacity to **$25.0 million** in July 2025, subsequently selling 379,040 shares for **$5.0 million** net proceeds[58](index=58&type=chunk)[140](index=140&type=chunk) - The 2022 Public Warrants are classified as a derivative liability, with a fair value of **$0** as of June 30, 2025, down from $0.2 million at December 31, 2024[59](index=59&type=chunk)[60](index=60&type=chunk) [7. STOCK-BASED COMPENSATION](index=20&type=section&id=7.%20STOCK-BASED%20COMPENSATION) Stock-based compensation expense increased in H1 2025, with more shares authorized under the equity plan - The number of shares authorized for issuance under the 2022 Equity Incentive Plan increased from 3,605 to **142,286 shares** in June 2025[64](index=64&type=chunk) - Total stock-based compensation expense for the six months ended June 30, 2025, was **$1,031 thousand**, compared to $767 thousand in the prior year[68](index=68&type=chunk) - As of June 30, 2025, the remaining unrecognized compensation expense related to nonvested stock options was **$0.8 million**, to be amortized over 0.8 years[68](index=68&type=chunk) [8. BASIC AND DILUTED LOSS PER SHARE](index=24&type=section&id=8.%20BASIC%20AND%20DILUTED%20LOSS%20PER%20SHARE) The company reported a net loss per share, with potential dilutive securities excluded from the calculation Loss per share | Loss per share | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Basic | $(79.73) | $(485.30) | $(201.55) | $(1,886.90) | | Diluted | $(79.73) | $(485.30) | $(201.55) | $(1,886.90) | - Outstanding stock options (3,635) and warrants (18,554) were not included in the computation of diluted net loss per share as they would have been **anti-dilutive** due to the net loss[72](index=72&type=chunk) [9. COMMITMENTS AND CONTINGENCIES](index=25&type=section&id=9.%20COMMITMENTS%20AND%20CONTINGENCIES) The company has royalty payment obligations on net revenue from PoNS device sales - The company is obligated to pay a **4% royalty** on net revenue from PoNS device sales under a license agreement with Advanced NeuroRehabilitation, LLC[73](index=73&type=chunk) - Royalty expense for the six months ended June 30, 2025, was approximately **$3 thousand**, a decrease from $12 thousand in the prior year[73](index=73&type=chunk) [10. SEGMENT AND GEOGRAPHIC INFORMATION](index=25&type=section&id=10.%20SEGMENT%20AND%20GEOGRAPHIC%20INFORMATION) The company operates as a single segment with revenue concentrated in the U.S. and Canada [Segment Information](index=25&type=section&id=Segment%20Information) The company operates as a single reporting segment focused on its PoNS® device - The company operates as a **single reporting segment** focused on the development and commercialization of PoNS® devices[74](index=74&type=chunk) [Geographic Information](index=25&type=section&id=Geographic%20Information) Revenue declined significantly in both the U.S. and Canada, with high customer concentration Revenue (in thousands) | Revenue (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | United States | $7 | $67 | $26 | $146 | | Canada | $26 | $104 | $45 | $149 | | Total product sales, net | $33 | $171 | $71 | $295 | | Total revenue | $43 | $182 | $92 | $317 | - Total revenue for the six months ended June 30, 2025, decreased to **$92 thousand** from $317 thousand in the prior year, with significant declines in both U.S. and Canadian product sales[75](index=75&type=chunk) - Customer concentration is high, with four customers accounting for **87% of net product sales** for the three months ended June 30, 2025[75](index=75&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition, operational results, recent developments, and liquidity [Company Overview](index=29&type=section&id=Company%20Overview) Helius Medical Technologies is a neurotechnology company focused on its primary product, the PoNS® device - Helius Medical Technologies is a neurotechnology company focused on non-implantable technologies for neurological wellness[80](index=80&type=chunk) - Its primary product, **PoNS®**, is a non-implantable medical device delivering mild electrical stimulation to the tongue for gait and chronic balance deficits[81](index=81&type=chunk) - PoNS has U.S. marketing clearance for gait deficit due to mild-to-moderate MS symptoms and is authorized for sale in Canada for TBI, MS, and stroke indications[81](index=81&type=chunk) [Recent Developments](index=29&type=section&id=Recent%20Developments) Recently enacted legislation is not expected to have a material impact on the company's financial statements - The One Big Beautiful Bill Act (OBBBA) was signed into law on July 4, 2025, but the company **does not expect a material impact** on its financial statements[82](index=82&type=chunk) [Corporate Updates](index=29&type=section&id=Corporate%20Updates) This section covers recent financing activities, Nasdaq compliance, commercialization efforts, and clinical studies [Financing and Stock](index=29&type=section&id=Financing%20and%20Stock) The company executed multiple financing transactions and two reverse stock splits in 2025 - On June 6, 2025, the company completed a public offering generating **$9.1 million** in gross proceeds from common stock and warrants[83](index=83&type=chunk) - A **1-for-50 reverse stock split** became effective on July 1, 2025, and a **1-for-15 reverse stock split** became effective on May 2, 2025[84](index=84&type=chunk)[85](index=85&type=chunk) - A private placement on April 24, 2025, generated **$1.3 million** in gross proceeds from promissory notes and common stock[84](index=84&type=chunk) - A warrant exercise inducement offer on January 21, 2025, generated **$3.7 million** in gross proceeds[85](index=85&type=chunk)[86](index=86&type=chunk) [Nasdaq Compliance](index=31&type=section&id=Nasdaq%20Compliance) The company regained compliance with all Nasdaq listing requirements but remains under a monitoring period - The company received delisting notices for non-compliance with Nasdaq's **Minimum Bid Price Requirement** (August 9, 2024) and **Stockholders' Equity Requirement** (March 31, 2025)[87](index=87&type=chunk)[89](index=89&type=chunk) - Compliance with the Minimum Bid Price Requirement was regained on June 3, 2025, following the May 2025 Reverse Stock Split[91](index=91&type=chunk) - Compliance with the Stockholders' Equity Requirement was regained on July 7, 2025, after the completion of the 2025 Offering[92](index=92&type=chunk) - The company is now in compliance with all applicable Nasdaq listing criteria but will be subject to a **Mandatory Panel Monitor** until July 7, 2026[92](index=92&type=chunk) [Commercialization](index=33&type=section&id=Commercialization) The company is advancing commercialization through reimbursement approvals and strategic partnerships [Reimbursement](index=33&type=section&id=Reimbursement) The company secured CMS codes and payment rates, along with approvals from major healthcare payers - CMS assigned HCPCS Level II codes for the PoNS controller (A4593) and mouthpiece (A4594), effective April 1, 2024[95](index=95&type=chunk) - Final CMS payment rates were set at **$532.27** for the PoNS Controller (effective April 1, 2025) and **$2,963.30** for the PoNS Mouthpiece (effective January 1, 2025)[97](index=97&type=chunk)[98](index=98&type=chunk)[99](index=99&type=chunk) - The company announced reimbursement approvals from major healthcare payers including **Anthem Blue Cross Blue Shield** (March 2025), **United Healthcare** (May 2025), and **Aetna Healthcare** (June 2025)[99](index=99&type=chunk)[100](index=100&type=chunk) [Partnership with Lovell Government Services](index=35&type=section&id=Partnership%20with%20Lovell%20Government%20Services) A partnership with Lovell Government Services expands PoNS availability to federal healthcare systems - The company partnered with Lovell Government Services in Q1 2024 to make the PoNS device available to federal healthcare systems[103](index=103&type=chunk) - PoNS became available on the **Veteran Affairs Federal Supply Schedule** and General Services Administration Advantage Contracts in May 2024, with pricing increasing in March 2025[103](index=103&type=chunk) [Canadian Commercialization](index=35&type=section&id=Canadian%20Commercialization) A new agreement with HealthPro aims to expand PoNS access in Canadian hospitals - On July 11, 2025, the company secured a product listing agreement with **HealthPro**, Canada's leading group purchasing organization, enabling promotion of PoNS to over 2,000 hospitals[105](index=105&type=chunk) [Revelation Neuro](index=35&type=section&id=Revelation%20Neuro) A new subsidiary was formed to develop an AI-powered brain-computer interface for neurorehabilitation - **Revelation Neuro, Inc.** was established on March 11, 2025, to develop a new AI-powered brain-computer interface for personalized neurorehabilitation[106](index=106&type=chunk) [Stroke Study](index=35&type=section&id=Stroke%20Study) The pivotal stroke study met its primary endpoint, with an FDA submission planned for Q3 2025 - The company completed enrollment for its stroke registrational program (SRP) studies by the end of January 2025, with **159 subjects**, exceeding the initial target[109](index=109&type=chunk) - Preliminary analysis showed the pivotal study **met the primary endpoint** of statistically significant improvements in gait and/or balance deficit due to stroke with active PoNS therapy[110](index=110&type=chunk)[111](index=111&type=chunk) - FDA authorization for stroke is targeted for submission in **Q3 2025**, with authorization expected by the end of 2025 or early 2026[111](index=111&type=chunk) [Strategic Alternatives](index=37&type=section&id=Strategic%20Alternatives) The company is exploring strategic alternatives to maximize stockholder value - On November 18, 2024, the company initiated a process to explore **strategic alternatives** to maximize stockholder value, engaging B Riley Securities as a financial advisor[112](index=112&type=chunk) [Material Trends and Uncertainties](index=37&type=section&id=Material%20Trends%20and%20Uncertainties) Global economic conditions continue to present risks to the company's operations and financial stability [Global Economic Conditions](index=37&type=section&id=Global%20Economic%20Conditions) Uncertain global economic conditions pose risks to the company's capital access and financial results - Worldwide economic conditions remain uncertain due to supply chain disruptions, labor shortages, global conflicts, increased inflation, and high interest rates[113](index=113&type=chunk) - These factors have adversely affected the company's access to and cost of capital, potentially impacting its business, financial condition, results of operations, and liquidity[113](index=113&type=chunk)[114](index=114&type=chunk) [Results of Operations](index=38&type=section&id=Results%20of%20Operations) This section compares the company's operational results for the three and six months ended June 30, 2025 and 2024 [Three Months Ended June 30, 2025 compared to the Three Months Ended June 30, 2024](index=38&type=section&id=Three%20Months%20Ended%20June%2030%2C%202025%20compared%20to%20the%20Three%20Months%20Ended%20June%2030%2C%202024) Net loss increased substantially in Q2 2025, driven by a change in derivative liability fair value Comparison of Operations (in thousands) | (in thousands) | 2025 | 2024 | Change | | :------------- | :--- | :--- | :----- | | Total revenue | $43 | $182 | $(139) | | Gross (loss) profit | $(53) | $64 | $(117) | | Loss from operations | $(3,322) | $(3,270) | $(52) | | Net loss | $(9,833) | $(1,612) | $(8,221) | - Net loss increased significantly by **$8,221 thousand**, primarily driven by a **$7,761 thousand** negative change in the fair value of derivative liability[116](index=116&type=chunk)[124](index=124&type=chunk) - Total product sales decreased due to lower unit volumes in the U.S. (termination of temporary cash pay pricing) and Canada (material breach of agreement)[117](index=117&type=chunk) [Six Months Ended June 30, 2025 compared to the Six Months Ended June 30, 2024](index=41&type=section&id=Six%20Months%20Ended%20June%2030%2C%202025%20compared%20to%20the%20Six%20Months%20Ended%20June%2030%2C%202024) Net loss widened in H1 2025 due to lower revenue and a significant change in derivative liability fair value Comparison of Operations (in thousands) | (in thousands) | 2025 | 2024 | Change | | :------------- | :--- | :--- | :----- | | Total revenue | $92 | $317 | $(225) | | Gross (loss) profit | $(125) | $76 | $(201) | | Loss from operations | $(7,333) | $(6,686) | $(647) | | Net loss | $(13,671) | $(4,128) | $(9,543) | - Net loss increased by **$9,543 thousand**, primarily due to an **$8,794 thousand** negative change in the fair value of derivative liability[127](index=127&type=chunk)[135](index=135&type=chunk) - Total product sales decreased due to lower unit volumes in the U.S. (termination of temporary cash pay pricing) and Canada (material breach of agreement)[128](index=128&type=chunk) - Selling, general and administrative expenses increased by **$351 thousand**, and research and development expenses increased by **$109 thousand**[127](index=127&type=chunk)[131](index=131&type=chunk)[132](index=132&type=chunk) [Liquidity and Capital Resources](index=43&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity improved due to financing activities, but substantial doubt about going concern remains Liquidity Summary (in thousands) | (in thousands) | June 30, 2025 | December 31, 2024 | | :------------- | :------------ | :---------------- | | Cash and cash equivalents | $6,078 | $1,088 | | Working capital | $5,998 | $1,261 | - Primary sources of cash and cash equivalents have been proceeds from public and private offerings of common stock and warrant exercises[138](index=138&type=chunk)[139](index=139&type=chunk)[140](index=140&type=chunk)[141](index=141&type=chunk)[142](index=142&type=chunk) [Statement of Cash Flows](index=43&type=section&id=Statement%20of%20Cash%20Flows) Net cash from financing activities more than offset cash used in operations during H1 2025 Cash Flow Summary (in thousands) | (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(6,293) | $(5,892) | | Net cash provided by financing activities | $11,283 | $7,103 | | Net increase in cash and cash equivalents | $4,990 | $1,205 | - Net cash provided by financing activities increased by **$4,180 thousand**, primarily from warrant inducement, ATM sales, private placement, and a common stock/warrant offering[143](index=143&type=chunk)[146](index=146&type=chunk) [Cash Requirements](index=45&type=section&id=Cash%20Requirements) Existing capital is expected to fund operations into Q2 2026, but additional funding will be required - The company reported a net loss of **$13.7 million** for H1 2025 and an accumulated deficit of **$185.4 million** as of June 30, 2025, indicating substantial doubt about its ability to continue as a going concern[147](index=147&type=chunk) - Existing capital resources, including **$5.0 million** net proceeds from July 2025 ATM sales, are expected to fund operations into **Q2 2026**[148](index=148&type=chunk) - Additional funding through equity or debt financing will be required thereafter to continue operations and fund planned clinical trials for stroke[148](index=148&type=chunk) - Failure to raise sufficient additional capital may compel the company to reduce operations, sell assets, or cease operations[149](index=149&type=chunk) [Critical Accounting Policies and Estimates](index=45&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) There have been no material changes to the company's critical accounting policies since the 2024 10-K - The company's financial statements are based on management's estimates and assumptions in accordance with U.S. GAAP[150](index=150&type=chunk) - There have been **no material changes** in critical accounting policies from those described in the 2024 10-K[151](index=151&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures About Market Risk](index=47&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states there are no applicable quantitative and qualitative disclosures about market risk [ITEM 4. Controls and Procedures](index=47&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes in internal control [Evaluation of Disclosure Controls and Procedures](index=47&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) The CEO and CFO found the company's disclosure controls and procedures to be effective as of June 30, 2025 - The CEO and CFO concluded that the company's disclosure controls and procedures were **effective** as of June 30, 2025[153](index=153&type=chunk) [Changes in Internal Control over Financial Reporting](index=47&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) No material changes to internal control over financial reporting occurred during the reporting period - There have been **no material changes** in the company's internal control over financial reporting during the period covered by this report[154](index=154&type=chunk) PART II. Other Information [ITEM 1. Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no material legal proceedings or significant pending litigation - The company is **not currently a party** to any material legal proceedings[155](index=155&type=chunk) [ITEM 1A. Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) The company regained Nasdaq compliance but remains subject to a monitoring period and ongoing delisting risks - Risk factors have not materially changed from the 2024 10-K, except for updates on **Nasdaq listing compliance**[156](index=156&type=chunk) - The company regained compliance with Nasdaq's **Minimum Bid Price Requirement** (June 3, 2025) and **Stockholders' Equity Requirement** (July 7, 2025)[162](index=162&type=chunk)[163](index=163&type=chunk) - The company is subject to a **Mandatory Panel Monitor** until July 7, 2026, and faces ongoing risks of delisting, which could negatively affect stock price, liquidity, and capital-raising ability[163](index=163&type=chunk)[164](index=164&type=chunk)[166](index=166&type=chunk) [ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=49&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section states there were no unregistered sales of equity securities or use of proceeds to report [ITEM 3. Defaults Upon Senior Securities](index=49&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section indicates there were no defaults upon senior securities to report [ITEM 4. Mine Safety Disclosures](index=49&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states there are no mine safety disclosures to report [ITEM 5. Other Information](index=51&type=section&id=Item%205.%20Other%20Information) This section provides information regarding Rule 10b5-1 trading plans for directors and officers [Rule 10b5-1 Trading Plans – Directors and Section 16 Officers](index=51&type=section&id=Rule%2010b5-1%20Trading%20Plans%20%E2%80%93%20Directors%20and%20Section%2016%20Officers) No directors or Section 16 officers adopted or terminated Rule 10b5-1 trading plans during the period - **None** of the company's directors or Section 16 officers adopted or terminated any Rule 10b5-1 trading plans during the six months ended June 30, 2025[172](index=172&type=chunk) [ITEM 6. Exhibits](index=52&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Form 10-Q [SIGNATURES](index=54&type=section&id=Signatures) The report is signed by the CEO and CFO on August 14, 2025

Core Viewpoint - Helius Medical Technologies, Inc. announced positive outcomes from the PoNS Stroke Registrational Program, supporting a planned FDA submission for treating gait and balance deficits in chronic stroke patients under the Breakthrough Device Designation [1][2]. Group 1: Clinical Trials and Results - The PoNS Stroke Registrational Program included two pivotal clinical studies: a double-blind, randomized controlled trial and a single-arm trial, initiated in April 2024, following positive FDA interaction [2][3]. - A total of 159 patients were enrolled across the three studies, with 130 completing both the treatment and follow-up phases, conducted at 10 clinical sites in the US and Canada [3]. - The primary endpoints focused on improving gait and balance deficits after 12 weeks, with secondary endpoints assessing fall risk and durability of effect, showing statistically significant improvements with active PoNS therapy [4][7]. Group 2: Market Potential and Future Plans - Over 7 million stroke patients experience symptoms, with approximately 80% suffering from balance and gait deficits, indicating a substantial market opportunity [5]. - Helius plans to submit an application to the FDA for stroke indication during Q3 2025, aiming to provide an impactful treatment for stroke survivors [5][10]. Group 3: Product Overview - The Portable Neuromodulation Stimulator (PoNS) is a non-implantable device that delivers neurostimulation through a mouthpiece, used in conjunction with physical rehabilitation to improve balance and gait [6][10]. - PoNS has received authorization in Canada for treating gait deficits due to stroke and is also approved in Australia for similar uses [9].

Core Points - Helius Medical Technologies, Inc. has demonstrated compliance with the equity requirement for continued listing on the Nasdaq Capital Market as of July 7, 2025 [1] - The company previously regained compliance with the minimum bid price requirement on June 3, 2025, and is currently in full compliance with Nasdaq's continued listing requirements [2] - Helius will be subject to a Mandatory Panel Monitor for one year following the compliance notice [3] Company Overview - Helius Medical Technologies is a neurotech company focused on addressing neurologic deficits through a novel therapeutic neuromodulation approach [4] - The company's primary product is the Portable Neuromodulation Stimulator, which aims to enhance the brain's ability to engage compensatory mechanisms and promote neuroplasticity [4]

Group 1 - U.S. stock futures showed mixed results, with Dow futures decreasing by approximately 0.1% [1] - Helius Medical Technologies, Inc. (HSDT) experienced a significant pre-market decline, with shares dropping 10.9% to $8.42 following a $25 million share offering prospectus filing [1] - Blue Gold Limited (BGL) shares fell 15.6% to $63.00 in pre-market trading after a 30% drop on Monday [3] Group 2 - Pelthos Therapeutics Inc. (PTHS) shares decreased by 8.3% to $23.79 after a substantial gain of 60% on Monday [3] - AirJoule Technologies Corp (AIRJ) shares fell 5.8% to $4.82 in pre-market trading [3] - Aebi Schmidt Holding (AEBI) shares dipped 5.2% to $11.50 after a decline of over 10% on Monday [3] Group 3 - SolarEdge Technologies, Inc. (SEDG) shares declined 5.1% to $25.08 after a 4% drop on Monday, despite an upgrade from Keybanc analyst Sophie Karp from Underweight to Sector Weight [3] - Sunrun Inc. (RUN) shares slipped 4.8% to $10.58 after gaining more than 5% on Monday, also receiving an upgrade from Keybanc analyst Sophie Karp from Underweight to Sector Weight [3] - Shoals Technologies Group Inc (SHLS) shares fell 4% to $6.05 after a 5% gain on Monday [3]

- CignaHealth becomes fifth major payer to authorize claim for PoNS Device at out-of-network adjusted negotiated list price of $19,161- About Helius Medical Technologies, Inc. Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using 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 ...

Core Insights - The PoNS Therapeutic Experience Program (PoNSTEP) study demonstrates long-term benefits of PoNS Therapy for gait deficits in individuals with Multiple Sclerosis (MS) [1][2] - The study results were presented at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, highlighting the importance of treatment adherence for achieving clinically meaningful improvements [2][3] Study Details - The PoNSTEP study is an open-label, observational, interventional multi-center research study assessing adherence to PoNS Therapy for gait deficits in MS patients [5] - The study involved 43 MS participants and was conducted at six Centers of Excellence across the United States [5] - The primary endpoint is the maintenance of gait improvement from the end of supervised therapy to the end of unsupervised therapy, with secondary endpoints including maintenance of improvement over six months [5] Treatment and Mechanism - PoNS Therapy combines the Portable Neuromodulation Stimulator (PoNS) device with physical therapy, applied for 100-120 minutes per day [5][7] - The PoNS device delivers mild electrical impulses to the tongue and is indicated for short-term treatment of gait deficits due to mild-to-moderate MS symptoms [7][8] Clinical Impact and Recognition - The study provides the first clinical trial evidence of PoNS Therapy's long-term benefits for functional rehabilitation in the MS population [3] - There is growing recognition of PoNS Therapy's direct effect on the central nervous system and its targeted mechanism of action compared to other interventions [3] Reimbursement and Access - Helius Medical Technologies has successfully obtained initial reimbursement from federal and private payers, which is expected to lower barriers to prescribing PoNS Therapy [4] - The company is actively engaging with health insurance providers to expand access to PoNS Therapy for all individuals with MS [3][4]

Core Insights - Aetna has authorized a claim for the PoNS Device at an out-of-network negotiated price of $18,350, joining Anthem and United in providing reimbursement for the device [1][2] - The company is actively pursuing broader in-network coverage for the PoNS Device at list price and aims to align commercial payments with the rates offered by the VA/DoD at $26,228 [2] - The PoNS Device is indicated for short-term treatment of gait deficits due to mild-to-moderate symptoms from multiple sclerosis (MS) and is used in conjunction with physical rehabilitation exercises [3][4] Company Overview - Helius Medical Technologies, Inc. is focused on delivering innovative neurotech solutions for neurologic deficits, with the Portable Neuromodulation Stimulator (PoNS) as its first commercial product [5] - The PoNS Device delivers neurostimulation through a mouthpiece and is primarily used at home to improve balance and gait in patients aged 22 and over [3][5] - The device has shown effectiveness in treating gait and balance issues, significantly reducing the risk of falls in stroke patients in Canada [4]

Core Viewpoint - Helius Medical Technologies, Inc. has announced a public offering of 2,768,600 shares of Class A common stock and accompanying warrants, priced at $3.27 per share, aiming to raise approximately $9.1 million in gross proceeds before expenses [1][3]. Group 1: Offering Details - The public offering includes 2,768,600 shares of Class A common stock and warrants to purchase an equal number of shares at a combined price of $3.27 per share [1]. - Each warrant will expire in 2.5 years from issuance, is immediately exercisable at an initial price of $7.3575 per share, and can be exchanged for 2.0 common shares under a zero cash exercise option [2]. - The offering is expected to close on June 6, 2025, subject to customary closing conditions [3]. Group 2: Regulatory and Contact Information - A registration statement on Form S-1 was filed with the SEC and declared effective on June 4, 2025, with a final prospectus to be available on the SEC's website [4]. - Electronic copies of the prospectus can be obtained from Maxim Group LLC, the sole placement agent for the offering [4][7].