[Part I. Financial Information](index=4&type=section&id=Part%20I.%20Financial%20Information) [Item 1. Condensed Consolidated Financial Statements](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) The unaudited condensed consolidated financial statements as of September 30, 2020, reflect a **$6.0 million** asset base, a **$11.6 million** net loss, and **$2.7 million** cash, raising substantial doubt about the company's ability to continue as a going concern [Unaudited Condensed Consolidated Balance Sheets](index=4&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2020, total assets decreased to **$6.0 million** from **$10.3 million** at year-end 2019, driven by a reduction in cash to **$2.7 million**, with total liabilities and stockholders' equity also declining Condensed Consolidated Balance Sheet Data (in thousands) | Account | Sep 30, 2020 | Dec 31, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $2,680 | $5,459 | | Total current assets | $4,136 | $7,241 | | TOTAL ASSETS | $6,026 | $10,347 | | **Liabilities & Equity** | | | | Total current liabilities | $2,565 | $3,802 | | TOTAL LIABILITIES | $2,829 | $4,512 | | TOTAL STOCKHOLDERS' EQUITY | $3,197 | $5,835 | [Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the nine months ended September 30, 2020, total operating revenue was **$0.47 million**, resulting in an **$11.4 million** operating loss and a **$11.6 million** net loss, compared to a **$4.5 million** net loss in 2019 Statement of Operations Highlights (in thousands) | Metric | Nine Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2019 | | :--- | :--- | :--- | | Total operating revenue | $470 | $1,344 | | Gross profit | $283 | $806 | | Total operating expenses | $11,667 | $19,177 | | Operating loss | $(11,384) | $(18,371) | | Net loss | $(11,595) | $(4,450) | | Net loss per share (Basic & Diluted) | $(0.30) | $(0.17) | [Unaudited Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2020, net cash used in operating activities was **$9.6 million**, with **$6.7 million** provided by financing activities, resulting in a **$2.8 million** net decrease in cash and an ending balance of **$2.7 million** Cash Flow Summary (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(9,567) | $(16,460) | | Net cash provided by (used in) investing activities | $40 | $(260) | | Net cash provided by financing activities | $6,727 | $163 | | Net decrease in cash | $(2,779) | $(16,564) | | Cash at end of period | $2,680 | $9,019 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's business, accounting policies, and financial items, highlighting a 'Going Concern' uncertainty, COVID-19 impact, Nasdaq delisting notice, and a subsequent **$3.2 million** private placement - The company is a neurotech firm focused on neurological wellness, with its first product being the **Portable Neuromodulation Stimulator (PoNS™)**. The device is authorized for sale in Canada for treating gait deficit in MS and balance deficit in mmTBI, but remains investigational in the U.S., EU, and Australia[15](index=15&type=chunk)[16](index=16&type=chunk) - There is substantial doubt about the company's ability to continue as a going concern. As of September 30, 2020, cash was **$2.7 million**, with an operating loss of **$11.4 million** for the nine-month period and an accumulated deficit of **$116.4 million**[18](index=18&type=chunk) - The **COVID-19 pandemic** has adversely impacted business by causing the closure and reduced capacity of PoNS clinics in Canada, impacting commercial activities and potentially delaying clinical programs and regulatory approvals[20](index=20&type=chunk) - The company received a **delisting notice from Nasdaq** for failing to meet the minimum **$1.00 bid price requirement**. The compliance period was extended to December 3, 2020, with a potential further 180-day extension[23](index=23&type=chunk)[24](index=24&type=chunk) - Subsequent to the quarter end, on October 26, 2020, the company closed a private placement raising gross proceeds of approximately **$3.4 million** (**$3.2 million net**), increasing pro forma stockholders' equity to **$6.5 million**[128](index=128&type=chunk)[130](index=130&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the PoNS™ device's regulatory status, expanded Canadian approval, U.S. de novo request for MS, and the impact of COVID-19 on commercialization, noting that existing capital will fund operations only through most of the first quarter of 2021 [Regulatory Status and Commercialization](index=24&type=section&id=Regulatory%20Status%20and%20Commercialization) The PoNS device received expanded Canadian marketing authorization for MS gait deficit, while a U.S. de novo request for MS was submitted after a prior mmTBI denial, with Canadian commercialization impacted by COVID-19 - Received expanded Canadian marketing authorization for PoNS to treat gait deficit in patients with mild and moderate **MS symptoms** in March 2020[138](index=138&type=chunk) - Submitted a request to the FDA for de novo classification and clearance of the PoNS device for treating gait deficit in MS patients on August 4, 2020. The device previously received **Breakthrough Designation** for this indication[141](index=141&type=chunk)[144](index=144&type=chunk) - The FDA denied the initial U.S. request for de novo classification for **mmTBI** in April 2019. A new clinical trial (TBI-002) intended to support a resubmission has been temporarily suspended[147](index=147&type=chunk)[152](index=152&type=chunk) - Canadian commercialization efforts were impacted by **COVID-19**, which led to clinic closures and operations at reduced capacity. As of September 30, 2020, the company had **22 authorized clinic locations**[159](index=159&type=chunk)[164](index=164&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) For the nine months ended September 30, 2020, revenue decreased to **$0.5 million** from **$1.3 million**, while operating expenses significantly fell to **$11.7 million** due to reduced R&D and SG&A costs following the 2019 U.S. regulatory denial Comparison of Operations for the Nine Months Ended September 30 (in thousands) | Metric | 2020 | 2019 | Change | | :--- | :--- | :--- | :--- | | Total operating revenue | $470 | $1,344 | $(874) | | Gross profit | $283 | $806 | $(523) | | Research and development | $3,755 | $6,462 | $(2,707) | | Selling, general and administrative | $7,625 | $12,715 | $(5,090) | | Operating loss | $(11,384) | $(18,371) | $6,987 | | Net loss | $(11,595) | $(4,450) | $(7,145) | - The year-over-year decrease in revenue was primarily due to pent-up demand positively impacting sales in the first half of 2019, the negative impact of the **COVID-19 pandemic** beginning in March 2020, and the impact of pricing changes[188](index=188&type=chunk) - The decrease in R&D expenses was mainly due to the completion of **PoNS device development** in 2019 and reduced medical affairs and professional services costs[190](index=190&type=chunk) - The decrease in SG&A expenses was primarily due to lower headcount, a reduction in commercial operations expense after the **2019 FDA denial**, and lower stock-based compensation[192](index=192&type=chunk)[193](index=193&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) The company's cash balance was **$2.7 million** as of September 30, 2020, with a subsequent **$3.2 million** private placement, but existing capital is only sufficient through most of the first quarter of 2021, reinforcing significant going concern risk - The company's cash balance was **$2.7 million** as of September 30, 2020[205](index=205&type=chunk) - In October 2020, the company raised approximately **$3.2 million** in net proceeds from a private placement of common stock and warrants[204](index=204&type=chunk)[205](index=205&type=chunk) - Management believes existing capital resources, including the October financing, will only be sufficient to fund operations throughout most of the **first quarter of 2021**[207](index=207&type=chunk) - The company will require additional funding to support ongoing activities. Failure to raise sufficient capital may compel the company to reduce operations, sell assets, or cease operations entirely[207](index=207&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not applicable - Not applicable[216](index=216&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2020, with no material changes to internal control over financial reporting during the quarter - The Interim Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of the end of the period[217](index=217&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[218](index=218&type=chunk) [Part II. Other Information](index=34&type=section&id=Part%20II.%20Other%20Information) [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company is not a party to any material legal proceedings, as a previously disclosed shareholder class action lawsuit was voluntarily dismissed by plaintiffs on July 1, 2020 - A putative shareholder class action lawsuit, Caramahai v. Helius Medical Technologies, Inc. et al., was voluntarily dismissed by the plaintiffs, and the final order dismissing the litigation was signed on July 1, 2020[123](index=123&type=chunk)[126](index=126&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) Updated risk factors highlight the adverse impact of the COVID-19 pandemic on commercial activities and clinical programs, alongside a Nasdaq delisting notice for failing to meet the minimum bid price requirement - The **COVID-19 pandemic** has adversely impacted business by causing clinic closures and reduced capacity, delaying clinical programs, and creating potential supply chain disruptions[221](index=221&type=chunk)[222](index=222&type=chunk)[223](index=223&type=chunk) - The company received a **delisting notice from Nasdaq** for its stock price falling below the **$1.00 minimum bid requirement**. The compliance period ends December 3, 2020, though an additional 180-day extension may be possible[226](index=226&type=chunk)[227](index=227&type=chunk)[228](index=228&type=chunk) - A potential delisting from Nasdaq could seriously harm the liquidity of the company's stock and its ability to raise capital[229](index=229&type=chunk) [Item 6. Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, material agreements, and certifications by the CEO and CFO

The Last Frontier in Healthcare Empowering the Natural Healing Process of the Brain September 2020 LegalDisclaimers This presentation contains forward-looking statements, including statements about: uncertainties regarding the FDA regulatory approval process, whether the results of our clinical trials will be sufficient to support an FDA, CE Mark or TGA approval of the PoNS™ device for marketing or whether the agencies may require that the Company conduct future clinical trials; future economic, competitive ...

Financial Data and Key Metrics Changes - The company reported total revenue of $133,000 for Q2 2020, a decrease from $518,000 in the prior year period, significantly impacted by COVID-19 disruptions [17][29] - Gross profit for Q2 2020 was $69,000 compared to $306,000 in the prior year [32] - Operating loss for Q2 2020 was $3.7 million, an improvement from $5.8 million in the prior year [34] - The net loss for Q2 2020 was $3.4 million or $0.08 per share, compared to a net loss of $186,000 or $0.01 per share in Q2 2019 [35] Business Line Data and Key Metrics Changes - Product sales represented approximately 95% of total revenue in Q2 2020, up from 91% in Q2 2019, driven by sales to neuroplasticity clinics in Canada [29] - The company authorized five additional clinics in Canada during the quarter, bringing the total to 19 authorized clinics [27] Market Data and Key Metrics Changes - The COVID-19 pandemic led to the closure of all PoNS authorized clinics in Canada by the end of March, with productivity significantly impacted due to capacity restrictions [21][22] - By the end of June, almost all clinics had reopened, but were operating at about 30% capacity due to ongoing restrictions [43] Company Strategy and Development Direction - The company is prioritizing the pursuit of an indication for multiple sclerosis (MS) as a pathway for obtaining U.S. clearance for the PoNS device, based on favorable clinical data [10][11] - The company aims to submit a request for de novo classification and clearance in the second half of 2020, having received Breakthrough Designation from the FDA [12][14] Management's Comments on Operating Environment and Future Outlook - Management expressed frustration over the uncertainty caused by COVID-19 but remains focused on regulatory and commercial strategies [42][45] - The company is optimistic about the potential of the PoNS technology to improve the lives of patients with neurological conditions [45][46] Other Important Information - The company had $5.3 million in cash as of June 30, 2020, a slight decrease from $5.5 million at the end of 2019, with no outstanding debt [36] - The company raised approximately $6.7 million in financing activities during the first half of 2020 [38] Q&A Session Summary Question: What is the size of the clinics currently open and their patient run rate? - The clinics are private neurological clinics with varying sizes, focused on developing a network in Southern Ontario. They are eager to return to full operations but face challenges due to COVID-19 [50][51] Question: When will the company hear back from the FDA regarding the submission? - The first review is an administrative one, and the company expects it to be a formality. They will report any material feedback from the FDA [54] Question: What is the expected cash burn for the second half of the year? - The expected cash burn has been reduced from $1.2 million to approximately $1 million per month [55] Question: How quickly will the newly added clinics start treating patients? - The clinics are eager to start treating patients, but their capacity is limited due to COVID-19 restrictions. They are working to increase patient flow as conditions improve [57][60] Question: What is the status of the PoNS cost to users? - The company has implemented a program allowing patients to pay over time, reducing upfront costs for the initial treatment [80]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period to Commission File No. 001-38445 HELIUS MEDICAL TECHNOLOGIES, INC. (Exact name of Registrant as specified in its charter) (215) 944-6100 (Registrant's telephone number, includ ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period to Commission File No. 001-38445 HELIUS MEDICAL TECHNOLOGIES, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or org ...

Helius Medical Technologies, Inc. (NASDAQ:HSDT) Q1 2020 Earnings Conference Call May 7, 2020 5:00 PM ET Company Participants Phil Deschamps - Chairman, President & Chief Executive Officer Joyce LaViscount - Chief Financial Officer & Chief Operations Officer Conference Call Participants Jeff Porter - Porter Capital Anthony Lamport - The Lambda Funds Operator Good evening, ladies and gentlemen, and welcome to the First Quarter of Fiscal Year 2020 Earnings Conference Call for Helius Medical Technologies. At th ...

Helius Medical Technologies, Inc. (NASDAQ:HSDT) Q4 2019 Earnings Conference Call March 12, 2020 5:00 PM ET Company Participants Phil Deschamps - Chairman, President and Chief Executive Officer Sukhvinder Kalsi-Ryan - Affiliate Scientist, Kite Research Institute; and Member of the University Health Network Joyce LaViscount - Chief Financial Officer and Chief Operations Officer Conference Call Participants Jeff Porter - Porter Capital Anthony Lamport - The Lambda Funds Operator Good evening, ladies and gentle ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. For the Fiscal Year Ended December 31, 2019 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. For the transition period from _____ to _____ Commission File No. 001-38445 HELIUS MEDICAL TECHNOLOGIES, INC. (Exact name of registrant as specified in its charter) Delaware 36-4787690 (State or other juris ...

Financial Data and Key Metrics Changes - The company reported total revenue of $150,000 for Q3 2019, compared to no revenue in the prior year period [44] - Gross profit for Q3 2019 was $61,000, with operating expenses increasing by $907,000 or 19% year-over-year to $5.8 million [45] - Operating loss for Q3 2019 was $5.7 million, compared to an operating loss of $4.9 million for the prior year period [49] - The net loss for Q3 2019 was $5.6 million or $0.21 per share, compared to a net loss of $4.5 million or $0.19 per share for Q3 2018 [50] Business Line Data and Key Metrics Changes - Revenue in Q3 was primarily driven by sales of PoNS devices to three new clinics in Toronto, Calgary, and Ottawa [44] - Patient treatment starts were 23 in Q1, 38 in Q2, and 32 in Q3, with a modest decline in Q3 attributed to scheduling issues during summer vacations [23][24] Market Data and Key Metrics Changes - The company reported 66 million impressions from marketing efforts, resulting in 4 million video views and 356 clinic consultations during the quarter [28] - The primary drivers of patient starts in Q3 were the founding clinics in Montreal and Surrey, along with three new clinics that became operational [24] Company Strategy and Development Direction - The company is focused on expanding access to PoNS treatment by increasing the number of authorized clinics and pursuing marketing initiatives to raise awareness [25][27] - A strategic decision was made to acquire Heuro Canada to improve commercial efficiency and accelerate the adoption of PoNS technology [33][34] - The company aims to secure reimbursement from insurers for treatments, having already obtained two fully reimbursed patient treatments [36] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early commercialization progress and the potential for continued growth in Q4 2019 [60] - The company is actively engaged with the FDA to refine its strategy for resubmitting an application for de novo classification of the PoNS device [39][41] Other Important Information - The company updated its revenue guidance for 2019 to a range of $1.5 million to $1.6 million, down from the previous range of $1.6 million to $2 million [57] - The company had approximately $9 million in cash as of September 30, 2019, down from $25.6 million at the end of 2018 [51] Q&A Session Summary Question: Can you talk about increased traffic at the open PoNS centers in Canada as a result of some of the online work that you've done? - Management noted 356 engagements in clinics, with a mix of early adopters and those waiting for reimbursement [67][68] Question: Can you talk about the reimbursement levels established in the two instances mentioned? - Reimbursement amounts were between $22,000 and $30,000 for the two treatments, with efforts to template successful reimbursement patterns for broader application [71][72] Question: Can you provide a range of what the burn is expected to go down to in Q4? - Management indicated that the burn rate would be reduced, excluding costs associated with the Heuro acquisition [79] Question: How will the company finance itself during 2020? - Management is exploring all possible ways to raise funds while focusing on protecting existing shareholders [85]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period to Commission File No. 001-38445 HELIUS MEDICAL TECHNOLOGIES, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of (I.R.S. Employer ...