Helius Medical Technologies, Inc. (NASDAQ:HSDT) Q1 2021 Earnings Conference Call May 17, 2021 5:00 PM ET Company Participants Dane Andreeff - Interim President & Chief Executive Officer Mark Leno - Vice President & General Manager, Canadian Operations Joyce LaViscount - Chief Financial Officer & Chief Operating Officer Conference Call Participants Joe Gomes - Noble Capital Operator Please standby. Good evening ladies and gentlemen and welcome to the First Quarter Fiscal Year 2021 Earnings Conference Call fo ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 For the transition period from to 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, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File No. 001-38445 HELIUS MEDICAL TECHNOLOGIES, INC. (Exact name of Registrant as specified in its charter) Delaware 36-4787690 (State or other jurisdictio ...

Helius Medical Technologies, Inc. (NASDAQ:HSDT) Q4 2020 Earnings Conference Call March 10, 2021 5:00 PM ET Company Participants Dane Andreeff - Interim President & Chief Executive Officer Mark Leno - Vice President & General Manager, Canadian Operations Joyce LaViscount - Chief Financial Officer & Chief Operating Officer Conference Call Participants Jeffrey Cohen - Ladenburg Thalmann Anthony Lamport - Lambda Fund Management Mark Palin - AALRR Operator Please standby. Good evening ladies and gentlemen, and w ...

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, 2020 ☐ 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 ...

Empowering the Healing Process of the Brain Disruptive Technology for Healthcare (NASDAQ:HSDT | TSX:HSM) Legal Disclaimers This presentation contains forward-looking statements, including statements about: uncertainties regarding the FDA regulatory approval process (including the FDA Breakthrough Designation), uncertainties regarding the regulatory approval process in China and Australia, whether the results of our clinical trials will be sufficient to support an FDA, CE Mark or TGA approval of the PoNS™ de ...

Financial Data and Key Metrics Changes - Total revenue for Q3 2020 was $131,000, a decrease from $150,000 in Q3 2019, primarily driven by sales to neurotherapy clinics in Canada impacted by COVID-19 [18][19] - Gross profits increased by $48,000 or 79% year-over-year to $109,000 due to a temporary reduction in manufacturing activity [26] - Operating expenses decreased by $2 million or 35% year-over-year to $3.8 million, reflecting cost reduction initiatives [26] - Operating loss for Q3 2020 was $3.7 million compared to $5.7 million for the prior year [27] - Net loss for Q3 2020 was $3.5 million or $0.08 per share, compared to a net loss of $5.6 million or $0.22 per share in the same period last year [27] Business Line Data and Key Metrics Changes - Sales performance in Canada continued to be impacted by COVID-19, with clinics operating at approximately 50% of normal capacity due to federal and provincial restrictions [19][20] - The number of authorized PoNS clinic locations increased from 7 to 27 in less than a year, nearly a fourfold increase [22] Market Data and Key Metrics Changes - The regulatory strategy focuses on obtaining clearance for the PoNS device for multiple sclerosis (MS), with a submission made on August 4, 2020 [12][13] - The FDA requested additional information on October 19, 2020, which the company is preparing to address [14][15] Company Strategy and Development Direction - The company aims to reposition itself for growth by focusing on regulatory approval in the U.S. and expanding its commercial activities in Canada [9][32] - Future plans include leveraging the PoNS device as a platform technology for new indications in stroke, cerebral palsy, and wellness applications [32] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges posed by COVID-19 but expressed confidence in the company's ability to progress on regulatory and commercial initiatives [31] - The company is committed to maintaining a disciplined approach to spending while exploring options to secure additional capital [29][30] Other Important Information - As of September 30, 2020, the company had $2.7 million in cash, down from $5.5 million at the end of 2019, with no outstanding debt [28] - A private placement closed on October 26, 2020, resulting in net proceeds of approximately $3.2 million [29] Q&A Session Summary Question: Why hasn't the company considered PoNS for Parkinson's? - Management indicated that while there is potential for the PoNS device in treating Parkinson's, the current focus is on indications with existing data. Future broader indications across multiple disease states are being considered [37]

[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 ...