Helius Medical Technologies, Inc. Reports Second Quarter of Fiscal Year 2020 Financial Results

NEWTOWN, Pa., Aug. 12, 2020 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (a??Heliusa?? or the a??Companya??), a neurotech company focused on neurological wellness, today reported financial results for the quarter ended JuneA 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 inA Neuromodulation: Technology at the Neural Interface. The TBI-001 trial found that PoNS Treatmenta?? provided significant improvement in balance in patients with a chronic balance deficit following a mild-to-moderate traumatic brain injury (a??mmTBIa??).

On May 12, 2020, the Company announced that it has received Breakthrough Designation for its PoNSa?? device as a potential treatment for gait deficit due to symptoms of Multiple Sclerosis (a??MSa??), 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 (a??FDAa??) for de novo classification and clearance of the Portable Neuromodulation Stimulator (PoNSa??) 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 JuneA 30, 2020, the Company had cash of $5.3 million, compared to $5.5 million at DecemberA 31, 2019. The Company had no debt outstanding at JuneA 30, 2020.

Net cash provided by financing activities during the three months ended JuneA 30, 2020 was $4.1 million.

a??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 (a??MSa??) indication as the regulatory pathway to pursue our first U.S. regulatory clearance,a?? said Philippe Deschamps, Chief Executive Officer of Helius. a??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 a?? which we announced on August 6th a?? 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.a??Mr. Deschamps continued: a??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.a??
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