Table of Contents 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, 2022 OR ☐ 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) Indicate by check mark wh ...

Financial Data and Key Metrics Changes - Total revenue for Q2 2022 was $119,000, an increase of 68% compared to $71,000 in Q2 2021 [21] - Gross profit for Q2 2022 was $31,000, up from $4,000 in the prior year [21] - Operating expenses decreased to $3.5 million in Q2 2022 from $6.2 million in Q2 2021, primarily due to lower stock-based compensation and clinical trial costs [22] - Net loss for Q2 2022 was $3.8 million, or $0.97 per share, compared to a net loss of $6 million, or $2.58 per share, in the same period last year [22] - Cash burn from operations was $3.7 million in Q2 2022, slightly down from $3.8 million in Q2 2021 [23] Business Line Data and Key Metrics Changes - The first commercial sales of the Portable Neuromodulation Stimulator (PoNS) device were reported, contributing $63,000 to total revenue [21][7] - The company has received over 300 inquiries regarding PoNS therapy, indicating strong market interest [9] Market Data and Key Metrics Changes - In Canada, the number of authorized PoNS clinics increased to 41 from 37 at the end of 2021 [18] - Sales in the U.S. are currently on a cash pay basis, with a list price of $25,700 for the PoNS device [13] Company Strategy and Development Direction - The company is focusing on expanding its commercial presence through telehealth and e-commerce initiatives, expected to launch later this year [12] - A self-paced online training module for physical therapists has been implemented to expedite the training process [11] - The company aims to establish a registry program for MS patients treated with PoNS therapy to collect health and economic data [13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the reception of PoNS therapy and expects revenue to increase sequentially throughout the year and into 2023 [25] - The company is currently evaluating additional measures to achieve greater market adoption in Canada [19] - Management acknowledged challenges in training physical therapists and obtaining prescriptions but believes new initiatives will help overcome these hurdles [32] Other Important Information - The company closed an $18 million public offering after Q2 2022, increasing its cash balance to approximately $19.7 million [23] - A pilot trial for stroke patients is expected to commence soon, with full enrollment anticipated by mid-2023 [17] Q&A Session Summary Question: What is the impact of foreign exchange loss for the quarter? - Management indicated that the foreign exchange loss relates to intercompany activity and does not forecast FX impacts [29] Question: Can you discuss the size of the commercial organization and audience uptake? - The commercial uptake is in the early stages, with a focus on training physical therapists and engaging with neurologists and PT clinics [31] Question: What is the status of discussions with payers in the U.S.? - Management noted that they are in early stages of payer discussions and are looking to replicate successful pilot studies from Canada in the U.S. [34] Question: What is the enrollment size for the pilot trial in South Carolina for stroke? - The enrollment size for the pilot trial is 12 patients [35]

Table of Contents For the quarterly period ended June 30, 2022 OR 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 ☐ 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 | | -- ...

Financial Data and Key Metrics Changes - Total revenue for Q1 2022 was $190,000, a 126% increase from $84,000 in Q1 2021 [32] - Gross profit for Q1 2022 was $66,000, slightly down from $69,000 in the prior year [32] - Operating expenses increased to $4.6 million in Q1 2022 from $3.6 million in Q1 2021, primarily due to increased compensation expenses [33] - Operating loss for Q1 2022 was $4.6 million compared to a loss of $3.5 million in the prior year [34] - Net loss for Q1 2022 was $4.3 million, or a loss of $1.15 per share, compared to a net loss of $3.4 million, or a loss of $1.65 per share in the same period last year [34] - Cash burn from operations was $4.7 million in Q1 2022, up from $2.9 million in Q1 2021 [35] - As of March 31, 2022, the company had $6.3 million in cash and no debt [36] Business Line Data and Key Metrics Changes - PoNS Therapy was commercially available in the U.S. for the first time in Q1 2022, targeting gait deficits due to mild-to-moderate MS symptoms [8][9] - The established U.S. list price for the PoNS device is $25,700, with a one-time cost of $17,800 for the controller and $7,900 for the mouthpiece [17] - The company has received 23 prescriptions, with two patients purchasing devices on a cash-pay basis [20] Market Data and Key Metrics Changes - Approximately 1 million people in the U.S. suffer from MS, with over 70% reporting difficulties walking [21] - The company has 41 authorized PoNS clinics in Canada, up from 37 at the end of 2021, representing a more than 10% increase [29] Company Strategy and Development Direction - The company aims to expand accessibility of PoNS Therapy through patient assistance programs and is pursuing third-party coverage [18] - The company is optimistic about the new Transitional Coverage for Emerging Technologies (TCET) proposed by CMS, which may include PoNS due to its FDA breakthrough designations [19] - The company plans to enhance its marketing initiatives and hire experienced sales representatives to support the U.S. launch [23] Management's Comments on Operating Environment and Future Outlook - Management expects second quarter revenue to be modestly above first quarter levels, with future quarterly revenue anticipated to increase sequentially throughout the year and into 2023 [37] - The company believes it can achieve positive quarterly cash flow from operations by Q4 2023 [37] - The analysis indicates that approximately 128,000 patients treated for MS annually in the U.S. would qualify for PoNS treatment, representing a multi-billion dollar market opportunity [38] Other Important Information - The Therapeutic Experience Program (TEP) aims to treat 40 to 50 patients across 10 to 12 Centers of Excellence during 2022 [15] - The company is actively working to publish results from its clinical experience program in Canada by late 2022 [30] Q&A Session Summary Question: Can you talk about the progress on the payer front and discussions regarding TCET? - Management is assisting patients with reimbursement claims and is optimistic about the TCET program, which is similar to the previous MCIT program [45] Question: Can you discuss the audience engagement and commercial efforts? - Engagement has been meaningful with key stakeholders including neurologists and physical therapists, who are becoming familiar with the therapy [46][48] Question: How are the clinics in Canada performing? - Clinics are now operating at full capacity, and there is a consistent flow of patients for treatments, especially in MS [49] Question: What is the status of manufacturing and inventory? - The company has sufficient inventory to meet demand in both the U.S. and Canada, despite labor issues affecting production timelines [50] Question: Any activity outside North America? - The company has received TGA clearance in Australia, which presents a larger market opportunity due to broader treatment indications [51]

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, 2022 OR ☐ 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 jurisdictio ...

Helius Medical Technologies, Inc. (NASDAQ:HSDT) Q4 2021 Earnings Conference Call March 14, 2022 5:00 PM ET Company Participants Michelle Bilski - In-Site Communications, IR Dane Andreeff - President and CEO Jeff Mathiesen - CFO Conference Call Participants Destiny Hance - Ladenburg Thalmann Operator Ladies and gentlemen, thank you for standing by, and welcome to the Helius Medical Technologies Earnings Results Call. [Operator Instructions] Please be advised that today's conference call is being recorded. I ...

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, 2021 or ☐ 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 ju ...

Helius Medical Technologies, Inc. (NASDAQ:HSDT) Q3 2021 Earnings Conference Call November 10, 2021 5:00 PM ET Company Participants Judy DiClemente - Insight Communications, IR Dane Andreeff - President and CEO Jeff Mathiesen - CFO Conference Call Participants Joe Gomes - Noble Capital Markets Disclaimer*: This transcript is designed to be used alongside the freely available audio recording on this page. Timestamps within the transcript are designed to help you navigate the audio should the corresponding tex ...

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, 2021 OR ☐ 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 jurisdi ...

Helius Medical Technologies, Inc. (NASDAQ:HSDT) Q2 2021 Earnings Conference Call August 12, 2021 5:00 PM ET Company Participants Dane Andreeff – President and Chief Executive Officer Jeff Mathiesen – Chief Financial Officer Conference Call Participants Jeffrey Cohen – Ladenburg Thalmann Gregory Aurand – Noble Capital Markets Operator Please standby. Good evening, ladies and gentlemen and welcome to the Second Quarter of Fiscal Year 2021 Earnings Conference Call for Helius Medical Technologies. At this time, ...