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NEWTOWN, Pa., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced the publication of an important, peer-reviewed study titled Translingual Neural Stimulation with the Portable Neuromodulation Stimulator (PoNS™) Induces Structural Changes Leading to Functional Recovery in Patients with Mild-to-Moderate Traumatic Brain Injury. The study was published in the peer reviewed journal EMJ Radiology. 2020;1[1]:64-71.

Traumatic brain injury (“TBI”) of varying severity can result in balance and movement disorders, for which the benefits of treatment with physical therapy has limits. In this study, a 9 patient subset of the original 43 patients published in “Translingual Neurostimulation for the Treatment of Chronic Symptoms Due to Mild-to-Moderate Traumatic Brain Injury” with balance issues received translingual neural stimulation (“TLNS”) with the PoNS device, in concert with physical therapy, and the effects on grey matter volume (“GMV”) in the brain were evaluated. TBI-related balance and movement impairments were also assessed with the Sensory Organization Test (“SOT”) and Dynamic Gait Index (“DGI”), which are validated and objective means of scoring such deficits.

When comparing pre- and post-intervention results, the most prominent GMV changes were increases within the cerebellum and temporal regions, which are involved in automatic processing of gait, balance, motor control and visual-motion relationships. Decreases of GMV in the frontal and occipital lobes (which are involved in conscious/effortful processing of gait, balance, motor control, and vision) positively correlated to increases in SOT/DGI scores.  These results suggest that TLNS with the PoNS device could induce brain plasticity changes leading to positive changes in functional assessments. Overall, these data indicate that TLNS delivered in conjunction with physical therapy may offer an integrative way to treat balance disorders after a mild-to-moderate TBI.

“The University of Wisconsin, Madison, participated in a multicenter clinical trial of the PoNS to address balance issues after traumatic brain injury and saw the regimen improve subjects’ outcomes,” said study investigator Dr. Vivek Prabhakaran. “The data published in this article shows that commensurate with clinical improvement experienced by these subjects after the PoNS regime, there were changes in the brain documented with MRI. This suggests that the PoNS regime induces brain plasticity changes, which may be relevant for clinical recovery. We should continue to document these changes in future studies and are keen to see this treatment deployed to help a massive unmet clinical need.” 

“I am thrilled that the body of scientific evidence showing the potential beneficial effects of our PoNS technology continues to grow,” added Dane Andreeff, Interim Chief Executive Officer of Helius. “It is particularly exciting when we can observe, as in this work, the brain changing positively following PoNS Treatment.”

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a neurotech company focused on neurological wellness.  The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself.  The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS™).  For more information, visit www.heliusmedical.com.

About the PoNS™ Device and PoNS Treatment™

The Portable Neuromodulation Stimulator (PoNS™) is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from multiple sclerosis (MS), and chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI) and is to be used in conjunction with physical therapy. The PoNS™ is an investigational medical device in the United States, the European Union (“EU”), and Australia (“AUS”). The device is currently under review for de novo classification and clearance by the FDA for use in gait deficits in MS. It is also under premarket review by the AUS Therapeutic Goods Administration. PoNS™ is currently not commercially available in the United States, the European Union or Australia.

Investor Relations Contact:

Westwicke Partners on behalf of Helius Medical Technologies, Inc.
Mike Piccinino, CFA
443-213-0500
investorrelations@heliusmedical.com

Cautionary Disclaimer Statement: 

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “continue,” “look forward,” “will” and similar expressions. Such forward-looking statements include, among others, statements regarding the Company’s future clinical and regulatory development plans for the PoNS device and the potential regulatory clearance of the PoNS device, the success of the Company’s PoNS device in treating balance disorders, the success of the Company’s future trials, its business and commercialization initiatives and objectives, and the potential receipt of regulatory clearance of the PoNS device in the United States, the European Union and Australia.

There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the impact of the COVID-19 pandemic, uncertainties associated with clinical trial enrollments and the results of clinical trials, uncertainties associated with the clinical development process and regulatory submission and approval process, uncertainties associated with the Company’s capital requirements to achieve its business objectives and other risks detailed from time to time in the filings made by the Company with securities regulators, including the risks and uncertainties about the Company’s business described in the “Risk Factors” sections of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.

The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.

The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.


NEWTOWN, Pa., Aug. 31, 2020 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that management will participate in the following upcoming investor conferences in September:

The LD 500 Virtual Investor Conference, which is being held from September 1st-4th.

  • Management will present on Tuesday, September 1st at 1:20 p.m. Eastern Time.

The Wall Street Investor Forum Virtual Conference, which is being held on September 10th.

  • Management will present on Thursday, September 10th at 9:20 a.m. Eastern Time. The presentation will be followed by a virtual breakout session.

The H.C. Wainwright 22nd Annual Global Investment Conference, which is being held virtually from September 14th-16th.

  • Management will present on Wednesday, September 16th at 12:00 p.m. Eastern Time.

Live audio webcasts of the presentations will be provided under the ‘Events’ section of the Helius Medical Technologies investor relations website at https://heliusmedical.com/index.php/investor-relations/events/upcoming-events. Archives of the webcasts will be available for replay following the conference.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS™). For more information, visit www.heliusmedical.com.

About the PoNS™ Device and PoNS Treatment™

The Portable Neuromodulation Stimulator (PoNS™) is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from multiple sclerosis (MS), and chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI) and is to be used in conjunction with physical therapy. The PoNS™ is an investigational medical device in the United States, the European Union (“EU”), and Australia (“AUS”). The device is currently under review for clearance by the FDA. It is also under premarket review by the AUS Therapeutic Goods Administration. PoNS™ is currently not commercially available in the United States, the European Union or Australia.

Investor Relations Contact:

Westwicke Partners on behalf of Helius Medical Technologies, Inc.
Mike Piccinino, CFA
investorrelations@heliusmedical.com


NEWTOWN, Pa., Aug. 25, 2020 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that Philippe Deschamps, has stepped down from his positions as President and Chief Executive Officer (“CEO”) and resigned his position as Chairman of the Board of Directors, effective August 23, 2020. Current members of the Board of Directors, Dane C. Andreeff and Blane Walter, have been appointed to the respective positions of Interim President and CEO, effective August 23, 2020, and Chairman of the Board of Directors, effective August 23, 2020. Mr. Andreeff will continue to serve as a director of the Company and is expected to serve as Interim President and CEO until the Board of Directors completes its search for a permanent successor.

“On behalf of my fellow directors, I would like to thank Phil for his leadership and dedication to Helius Medical Technologies over the last seven years,” said Blane Walter. “Phil has led the Company since its early days and his achievements have enabled Helius to transition to a publicly-traded, commercial-stage company that is currently awaiting regulatory clearance in the U.S. We wish him the very best in his future endeavors.”

Mr. Walter continued, “The Board and I believe Dane is an excellent candidate to build upon Helius’ recent regulatory and operational progress as we conduct the search for a permanent successor. Dane has been an important adviser to the Company as a member of the Helius Board of Directors for the last three years, is a large shareholder and is well-versed in all aspects of its strategy. For over 20 years, he has served as General Partner and Portfolio Manager at Maple Leaf Partners, LP, a hedge fund which he founded and subsequently grew to over $2 billion in assets under management. Dane also possesses significant experience advising other companies as a board member, including multiple companies in the healthcare sector. Importantly, Dane is dedicated to pursuing our objectives as an organization efficiently and effectively, and has elected to take no additional compensation in return for his service as Interim President and CEO. We look forward to leveraging his leadership skills, and experience in managing and advising businesses, as Helius pursues its next phase of growth.”

“During my tenure as a member of Helius’ Board, I have been consistently impressed with the potential of our PoNS technology and dedication our organization has shown to bringing it to the aid of patients suffering from the effects of chronic conditions like multiple sclerosis and traumatic brain injury,” said Dane C. Andreeff. “Helius has made exciting regulatory and operational progress this year, expanding our network of authorized PoNS clinics to 19 locations in Canada, obtaining FDA Breakthrough Designation for our target indication in MS – which represents a high unmet medical need – and ultimately submitting our request for U.S. FDA de novo classification and clearance earlier this month. In view of this progress, I believe we are well-positioned to begin the next phase of growth as an organization. As Interim President and CEO, I am committed to building on our recent achievements in Canada and the U.S., and driving continued operational progress for the benefit of our patients and shareholders.”

“It has been a privilege and a great pleasure to serve on the executive leadership team and Board of Directors at Helius and I’m proud of the many accomplishments that we have achieved during my tenure,” said Philippe Deschamps. “I remain a significant shareholder in Helius and a firm believer that the PoNS technology represents a truly revolutionary approach to the treatment of neurological disease and trauma. I look forward to the Company’s future progress under Dane and Blane’s leadership and expertise.”

About Dane C. Andreeff

Dane C. Andreeff has served as a member of Helius’ Board of Directors since August 2017. Mr. Andreeff is the General Partner and Portfolio Manager at Maple Leaf Partners, LP, which owns approximately 3% of Helius’ outstanding common stock. Maple Leaf Partners, LP is a hedge fund founded by Mr. Andreeff, where he has been employed since 1996. In 2003, the fund was seeded by Julian Robertson’s Tiger Management and later grew to over $2 billion in assets under management.

Mr. Andreeff has served as a member of the Board of Directors of HDL Therapeutics, Inc., a privately held medical technology and device company focused on infusing plasma with preβ-HDL for the treatment of multiple cardiovascular indications, since 2012, Myocardial Solutions, Ltd., a privately held medical technology company with an FDA-cleared cardiac MRI software known as MyoStrain® that provides a 10-minute test for detecting heart dysfunction in multiple cardiovascular indications – including cardiotoxicity in cancer treatment, since 2016, and TraceSecurity, LLC, a privately held, profitable cybersecurity services company, since 2005.

Mr. Andreeff received his Bachelor’s degree in Economics from the University of Texas at Arlington in 1989 and his Master’s degree in Economics from the University of Texas at Arlington in 1991.

About Blane Walter

Mr. Walter has served as a member of Helius’ Board of Directors since December 2015. Mr. Walter is a partner at Talisman Capital Partners, a position he has held since 2011. In 1999, Mr. Walter founded inChord Communications, Inc., a global private healthcare communications company, which was acquired by inVentiv Health in 2005. Mr. Walter joined inVentiv Health as president of the Communications division in 2005 and was named Chief Executive Officer in 2008. He served in that capacity until leading the sale of the company to Thomas H. Lee Partners in 2010. Following the buyout, Mr. Walter served as vice chairman of inVentiv Group, a holding company which survived the buyout, from 2011 to August 2017.

Mr. Walter received his Bachelor’s degree in Marketing and Finance from Boston College in 1993.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS™). For more information, visit www.heliusmedical.com.

About the PoNS™ Device and PoNS Treatment™

The Portable Neuromodulation Stimulator (PoNS™) is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from multiple sclerosis (MS), and chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI) and is to be used in conjunction with physical therapy. The PoNS™ is an investigational medical device in the United States, the European Union (“EU”), and Australia (“AUS”). The device is currently under review for de novo classification and clearance by the FDA. It is also under premarket review by the AUS Therapeutic Goods Administration. PoNS™ is currently not commercially available in the United States, the European Union or Australia.

Investor Relations Contact:

Westwicke Partners on behalf of Helius Medical Technologies, Inc.
Mike Piccinino, CFA
443-213-0500
investorrelations@heliusmedical.com

Cautionary Disclaimer Statement:

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “continue,” “look forward,” “will” and similar expressions. Such forward-looking statements include, among others, statements regarding the Company’s future growth and operational progress, including clinical and regulatory development plans for the PoNS device, potential regulatory clearance of the PoNS device, plans to conduct a search for a permanent President and Chief Executive Officer and potential of the PoNS technology.

There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the impact of the COVID-19 pandemic, uncertainties associated with clinical trial enrollments and the results of clinical trials, uncertainties associated with the clinical development process and FDA regulatory submission and approval process, including the Company’s capital requirements to achieve its business objectives, and other risks detailed from time to time in the filings made by the Company with securities regulators, and including the risks and uncertainties about the Company’s business described in the “Risk Factors” sections of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.

The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.

The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

 


NEWTOWN, Pa., Aug. 12, 2020 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today reported financial results for the quarter ended June 30, 2020.

Second Quarter and Recent Business Updates

  • On April 30, 2020, the Company announced that its registrational clinical trial, TBI-001, was published on April 29, 2020 in Neuromodulation: Technology at the Neural Interface. The TBI-001 trial found that PoNS Treatment™ provided significant improvement in balance in patients with a chronic balance deficit following a mild-to-moderate traumatic brain injury (“mmTBI”).
  • On May 12, 2020, the Company announced that it has received Breakthrough Designation for its PoNS™ device as a potential treatment for gait deficit due to symptoms of Multiple Sclerosis (“MS”), to be used as an adjunct to a supervised therapeutic exercise program.
  • On July 14, 2020, the Company announced the dismissal of a putative shareholder class action lawsuit in the Southern District of New York.
  • On August 6, 2020, the Company announced that it has submitted a request to the U.S. Food and Drug Administration (“FDA”) for de novo classification and clearance of the Portable Neuromodulation Stimulator (PoNS™) device and reported preliminary financial results for the second quarter and six months ended June 30, 2020.

Second Quarter 2020 Financial Summary

  • Revenue of $0.1 million, compared to revenue of $0.5 million in second quarter of 2019.
  • Operating loss of $3.7 million, compared to operating loss of $5.8 million in second quarter of 2019.
  • Net loss of $3.4 million, compared to net loss of $0.2 million in second quarter of 2019.
  • As of June 30, 2020, the Company had cash of $5.3 million, compared to $5.5 million at December 31, 2019. The Company had no debt outstanding at June 30, 2020.
  • Net cash provided by financing activities during the three months ended June 30, 2020 was $4.1 million.

“Helius is excited by the considerable progress we have made on our U.S. regulatory strategy, following our strategic decision in the first quarter to prioritize an Multiple Sclerosis (“MS”) indication as the regulatory pathway to pursue our first U.S. regulatory clearance,” said Philippe Deschamps, Chief Executive Officer of Helius. “After obtaining Breakthrough Device Designation in May, our clinical and regulatory team continued to work diligently during the second quarter, with the goal of submitting a request for de novo classification and clearance for an MS indication in the second half of 2020. The submission of our request for de novo classification and clearance – which we announced on August 6th – is the culmination of their collective effort and success, as well as an important step forward on the path to making our PoNS Treatment available to the estimated 1 million MS patients in the U.S.”

Mr. Deschamps continued: “From a commercial standpoint, during the second quarter we, like many companies in the medical device industry, continued to be impacted by the unprecedented level of disruption created by the COVID-19 pandemic. Most notably, PoNS authorized clinics in Canada continued to suspend in-clinic patient treatments and remained effectively closed in April to comply with government restrictions enacted to slow the spread of the virus. We have been pleased to see clinics reopen in late-May and June, albeit under federal and provincial requirements limiting their capacity to 50% of normal services. As a result of these COVID-related mandates, along with clinic policies designed to ensure appropriate social distancing, clinics in Canada continue to operate at significantly reduced productivity. As such, we believe we remain in the very early stages of recovery, and are unlikely to see material improvements in business trends until these federal and provincial requirements are lifted. Despite the challenging operating environment, our Canadian commercial team has remained focused on supporting our existing clinic customers, and has made important progress in expanding our network of authorized clinics in recent months.”

Mr. Deschamps concluded: “In spite of the ongoing challenges presented by COVID-19, I’m incredibly proud of the commitment and focus that our team has shown with regard to executing against our regulatory and commercial objectives. Most importantly, we remain convinced that our PoNS Treatment represents a truly novel technology, with the potential to improve the lives of patients suffering from the effects of MS, TBI, and other chronic conditions. Looking ahead, we remain committed to pursuing our regulatory and commercial strategies efficiently and effectively to bring our novel PoNS technology into the hands of as many patients as possible.”

Second Quarter 2020 Financial Results

Total revenue for the second quarter of 2020 was $0.1 million, compared to $0.5 million in the second quarter of 2019. Product sales represented approximately 95% of total revenue in the second quarter of 2020 compared to 91% of total revenue in the second quarter of 2019. Product sales both periods were generated through sales of the PoNS device pursuant to supply agreements with nineteen PoNS Authorized clinic locations in Canada. License and fee revenue represented 5% of sales in the second quarter of 2020, compared to 9% of sales in the second quarter of 2019.

Gross profit for the second quarter of 2020 was $0.1 million, compared to gross profit of $0.3 million in the second quarter of 2019. Operating expenses for the second quarter of 2020 decreased $2.3 million, or 38% year-over-year, to $3.8 million, compared to $6.1 million in the second quarter of 2019.

Operating loss for the second quarter of 2020 decreased $2.1 million, or 36% year-over-year, to $3.7 million, compared to $5.8 million in the second quarter of 2019.

Total other income for the second quarter of 2020 was $0.4 million, compared to $5.6 million in the second quarter of 2019.

Net loss for the second quarter of 2020 was $3.4 million, or $(0.08) per basic and diluted common share, compared to a net loss of $0.2 million, or $(0.01) per basic and diluted common share, in the second quarter of 2019. Weighted average shares used to compute basic and diluted net loss per common share were 40.6 million and 25.9 million for the second quarters of 2020 and 2019, respectively. 

Six Months Ended June 30, 2020 Financial Results

Total revenue for the six months ended June 30, 2020 was $0.3 million, compared to $1.2 million in the prior year period. Product sales represented 94% of total revenue for the six months ended June 30, 2020, compared to 96% of total revenue in the prior year period. Product sales in both periods were generated through sales of the PoNS device pursuant to supply agreements with nineteen PoNS Authorized clinic locations in Canada. License and fee revenue represented 6% of total revenue for the six months ended June 30, 2020, compared to 4% of total revenue in the prior year period.

Gross profit for the six months June 30, 2020 was $0.2 million, compared to gross profit of $0.7 million in the prior year period. Operating expenses for the six months ended June 30, 2020 decreased $5.5 million, or 41% year-over-year, to $7.9 million, compared to $13.4 million in the prior year period.

Operating loss the six months ended June 30, 2020 decreased $4.9 million, or 39% year-over-year, to $7.7 million, compared to operating loss of $12.6 million in the prior year period.

Total other expense for the six months ended June 30, 2020 was $0.4 million, compared to $13.8 million of other income in the prior year period.

Net loss for the six months ended June 30, 2020 was $8.1 million, or $(0.22) per basic and diluted common share, compared to net income of $1.1 million, or $0.04 per basic and diluted common share, in the prior year period. Weighted average shares used to compute basic net income (loss) per share were 36.2 million and 25.9 million for the six months ended June 30, 2020 and 2019, respectively. Weighted average shares used to compute diluted net income (loss) per share were 36.2 million and 26.0 million for the six months ended June 30, 2020 and 2019, respectively.

Net cash provided by financing activities during the six months ended June 30, 2020 was $6.7 million, of which $4.8 million consisted of net proceeds from the issuance of 8,138,808 shares of the Company’s common stock at an average price of $0.62 per share in connection with the Company’s At The Market Agreement (“ATM”).

As of June 30, 2020, the Company had cash of $5.3 million, compared to $5.5 million at December 31, 2019.

Full Year 2020 Outlook

On May 7, 2020, the Company withdrew its previously announced full year 2020 outlook. The Company is currently unable to estimate the duration and impact of the COVID-19 pandemic on its financial and operating results for the full year 2020.

Conference Call

Management will host a conference call at 5:00 p.m. Eastern Time on August 12, 2020 to discuss the results of the quarter and business outlook. Those who would like to participate may dial 877-407-2988 (201-389-0923 for international callers) and provide access code 13705949. A live webcast of the call will also be provided on the Events section of the Company's investor relations website at:

https://heliusmedical.com/index.php/investor-relations/events/upcoming-events.

For those unable to participate, a replay of the call will be available for two weeks at 877-660-6853 (201-612-7415 for international callers); access code 13705949. The webcast will be archived on the Events section of the Company’s investor relations website.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS™). For more information, visit www.heliusmedical.com.

About the PoNS Device and PoNS Treatment

The Portable Neuromodulation Stimulator (PoNS) is an authorized class II, non-implantable medical device authorized for sale in Canada. PoNS is intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy and is indicated as a short term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury and is to be used in conjunction with physical therapy. The PoNS is an investigational medical device in the United States, the European Union, and Australia, and is currently under review for clearance by the AUS Therapeutic Goods Administration. PoNS Treatment is currently not commercially available in the United States, the European Union or Australia.

Cautionary Disclaimer Statement: 

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “continue,” “look forward,” “will” and similar expressions. Such forward-looking statements include, among others, statements regarding the COVID-19 pandemic, including its impact on the Company, the Company’s future clinical and regulatory development plans for the PoNS, the success of the Company’s planned study, business and commercialization initiatives and objectives, the potential receipt of regulatory clearance of the PoNS device in the United States and the Company’s revenue guidance.

There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the uncertainties associated with clinical trial enrollments and the results of the planned study, uncertainties associated with the clinical development process and FDA regulatory submission and approval process, including the Company’s capital requirements to achieve its business objectives and other risks detailed from time to time in the filings made by the Company with securities regulators, and including the risks and uncertainties about the Company’s business described in the “Risk Factors” sections of the Company’s Annual Report on Form 10-K for the years ended December 31, 2019 and December 31, 2018, its Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.

The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.

The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Helius Medical Technologies, Inc.
Unaudited Consolidated Balance Sheets
(Except for share data, amounts in thousands)

  June 30, 2020  December 31, 2019 
ASSETS        
Current assets        
Cash $5,264  $5,459 
Accounts receivable, net  56   210 
Other receivables  138   364 
Inventory, net of reserve  570   598 
Prepaid expenses  715   610 
Total current assets  6,743   7,241 
Property and equipment, net  478   712 
Other assets        
Goodwill  710   1,242 
Intangible assets, net  638   582 
Operating lease right-of-use asset, net  117   552 
Other assets  18   18 
Total other assets  1,483   2,394 
TOTAL ASSETS $8,704  $10,347 
LIABILITIES AND STOCKHOLDERS' EQUITY        
Current liabilities        
Accounts payable $456  $1,676 
Accrued liabilities  1,084   1,519 
Operating lease liability  154   172 
Derivative financial instruments  1   5 
Deferred revenue  332   430 
Total current liabilities  2,027   3,802 
Non-current liabilities        
Operating lease liability  62   465 
Deferred revenue  219   245 
TOTAL LIABILITIES  2,308   4,512 
STOCKHOLDERS’ EQUITY        
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding as of June 30, 2020 and December 31, 2019      
Class A common stock, $0.001 par value; 150,000,000 shares authorized; 45,114,506 and 30,718,554 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively  45   31 
Additional paid-in capital  119,763   111,479 
Accumulated other comprehensive loss  (521)  (902)
Accumulated deficit  (112,891)  (104,773)
TOTAL STOCKHOLDERS’ EQUITY  6,396   5,835 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $8,704  $10,347 
         


Helius Medical Technologies, Inc.
Unaudited Consolidated Statements of Operations and Comprehensive (Loss) Income
(Amounts in thousands except share and per share data)

  Three Months Ended  Six Months Ended 
  June 30,  June 30, 
  2020  2019  2020  2019 
Revenue:                
Product sales, net $126  $469  $317  $1,146 
Fee revenue     49   9   49 
License revenue  7      13    
Total operating revenue  133   518   339   1,195 
Cost of sales:                
Cost of product sales  64   212   165   448 
Gross profit  69   306   174   747 
Operating expenses:                
Research and development  1,308   2,275   2,428   4,956 
Selling, general and administrative  2,394   3,845   5,255   8,426 
Amortization expense  89      215    
Total operating expenses  3,791   6,120   7,898   13,382 
Operating loss  (3,722)  (5,814)  (7,724)  (12,635)
Other income (expense):                
Other income  56   13   63   24 
Change in fair value of derivative financial instruments  (1)  5,548   3   13,837 
Foreign exchange gain (loss)  306   67   (460)  (88)
Total other income (expense)  361   5,628   (394)  13,773 
Net (loss) income  (3,361)  (186)  (8,118)  1,138 
Other comprehensive (loss) income:                
Foreign currency translation adjustments  (255)  (124)  381   (236)
Comprehensive (loss) income $(3,616) $(310) $(7,737) $902 
Net (loss) income per share                
Basic $(0.08) $(0.01) $(0.22) $0.04 
Diluted $(0.08) $(0.01) $(0.22) $0.04 
Weighted average shares outstanding                
Basic  40,623,343   25,870,600   36,179,362   25,851,501 
Diluted  40,623,343   25,870,600   36,179,362   25,953,654 


Helius Medical Technologies, Inc.
Unaudited Condensed Consolidated Statements of Cash Flows
(Amounts in thousands)

  Six Months Ended 
  June 30, 
  2020  2019 
Cash flows from operating activities:        
Net (loss) income $(8,118) $1,138 
Adjustments to reconcile net (loss) income to net cash used in operating activities:        
Change in fair value of derivative financial instruments  (3)  (13,837)
Stock-based compensation expense  1,571   1,776 
Unrealized foreign exchange loss  433   153 
Depreciation expense  67   47 
Amortization expense  215    
Provision for doubtful accounts  153    
Intangible asset impairment  181    
Loss from disposal of property and equipment  110    
Gain from lease modification  (56)   
Changes in operating assets and liabilities:        
Accounts receivable  1   (546)
Other receivables  226   (207)
Inventory  28   (510)
Prepaid expenses  (105)  145 
Other current assets     264 
Operating lease liability  70   (7)
Accounts payable  (1,288)  655 
Accrued liabilities  (381)  (285)
Deferred revenue  (83)   
Net cash used in operating activities  (6,979)  (11,214)
Cash flows from investing activities:        
Purchase of property and equipment  (3)  (204)
Proceeds from sale of property and equipment  61    
Internally developed software  (7)   
Net cash provided by (used in) investing activities  51   (204)
Cash flows from financing activities:        
Proceeds from the issuance of common stock and accompanying warrants  7,233    
Share issuance costs  (506)  (52)
Proceeds from the exercise of stock options and warrants     215 
Proceeds from Paycheck Protection Program Loan  323    
Repayment of Paycheck Protection Program Loan  (323)   
Net cash provided by financing activities  6,727   163 
Effect of foreign exchange rate changes on cash  6   (17)
Net decrease in cash  (195)  (11,272)
Cash at beginning of period  5,459   25,583 
Cash at end of period $5,264  $14,311 
         

 

CONTACT: Investor Relations Contact:

Westwicke Partners on behalf of Helius Medical Technologies, Inc.
Mike Piccinino, CFA
investorrelations@heliusmedical.com

NEWTOWN, Pa., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that second quarter of fiscal year 2020 financial results will be released after the market closes on Wednesday, August 12th.

Management will host a conference call at 5:00 p.m. Eastern Time on August 12th to discuss the results of the quarter. Those who would like to participate may dial 877-407-2988 (201-389-0923 for international callers) and provide access code 13705949. A live webcast of the call will also be provided on the Events section of the Company's investor relations website and can be accessed directly via the following link: https://78449.themediaframe.com/dataconf/productusers/hls/mediaframe/39028/indexl.html.

For those unable to participate, a replay of the call will be available for two weeks at 877-660-6853 (201-612-7415 for international callers); access code 13705949. The webcast will be archived on the Events section of the Company’s investor relations website.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS™). For more information, visit www.heliusmedical.com.

About the PoNS Device and PoNS Treatment

The Portable Neuromodulation Stimulator (PoNS) is an authorized class II, non-implantable medical device authorized for sale in Canada. PoNS is intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy and indicated as a short term treatment (14 weeks) chronic balance deficit due to mild-to-moderate traumatic brain injury and is to be used in conjunction with physical therapy. The PoNS is an investigational medical device in the United States, the European Union, and Australia, and is currently under review for clearance by the FDA and AUS Therapeutic Goods Administration. PoNS Treatment is currently not commercially available in the United States, the European Union or Australia.

Investor Relations Contact:

Westwicke Partners on behalf of Helius Medical Technologies, Inc.

Mike Piccinino, CFA

investorrelations@heliusmedical.com