A Revolution in Mind November 2017 1 www.heliusmedical.com | TSE:HSM |OTCQB:HSDT
Legal Disclaimers This presentation includes certain statements that may constitute “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements contained in this presentation, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. These statements are based on management’s expectations at the time the statements are made and are subject to risks, uncertainty, and changes in circumstances, which may cause actual results, performance, financial condition or achievements to differ materially from anticipated results, performance, financial condition or achievements. All statements contained herein that are not clearly historical in nature are forward-looking and the words “anticipate,” “believe,” “calls for,” “could” “depends,” “estimate,” “expect,” “extrapolate,” “foresee,” “goal,” “intend,” “likely,” “might,” “plan,” “project,” “propose,” “potential,” “target,” “think,” and similar expressions, or that events or conditions “may,” “should occur” “will,” “would,” or any similar expressions are generally intended to identify forward-looking statements. The forward-looking statements in this presentation include but are not limited to statements relating to: progress, reports and interpretation of results from clinical studies, clinical development plans, product development activities, future product candidate success, plans for U.S. Food and Drug Administration (“FDA”) filings and their subsequent approvals, the safety and effectiveness of the PoNS TM device and the Company’s ability to commercialize the PoNS TM device. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions at the time they were made, they are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Factors that could cause the actual results to differ materially from those in the forward-looking statements include: uncertainties regarding the FDA regulatory approval process, including whether the results of our clinical trials will be sufficient to support an FDA approval of the PoNS TM device for marketing or whether the FDA may require that the Company conduct future clinical trials; future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; the intellectual property landscape; financial market conditions; continued availability of capital and financing; and future business decisions made by the Company and its competitors. These and additional risks and uncertainties are more fully described in the Company’s Transition Report on Form 10-K/T for the period ended December 31, 2016 filed with the Securities and Exchange Commission (“SEC”) on April 3, 2017 and the Company’s other public filings with the SEC and the Canadian securities regulators, which can be obtained from either www.sec.gov or www.sedar.com. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by applicable securities laws, the Company undertakes no obligation to update or alter these forward-looking statements (and expressly disclaims any such intention or obligation to do so) in the event that management's beliefs, estimates, opinions, or other factors should change. 2 www.heliusmedical.com | TSE:HSM |OTCQB:HSDT
Helius Medical TechnologiesManagement Philippe Deschamps Joyce LaViscount President and CEO CFO and COO Chairman and Director • 29 years in the health sciencesindustry • Over 30 years in the health sciences industry • Accomplished pharmaceutical/healthcare • Former CEO at MediMedia Health Marketing public companyCAO • Former President and CEO at GSW Worldwide • Former Executive Director/group controller at Aptalis Pharmaceuticals (Division of inVentivHealth) • Former Director of Neuroscience Marketing at • Former Chief Operating Officer and CFO Bristol-MyersSquibb MM Pharmaceutical Solutions Jonathan Sackier Chief Medical Officer • 31 years in the health sciencesindustry • Trained surgeon and pioneer of new medicaltechnologies • Has helped build severalcompanies including medical technology, research and product-design and medical contract salesorganizations Experienced management team with expertise in health sciences and commercialization 3
Equity Overview: Helius MedicalTechnologies Tickers: HSM:TSX, HSDT:OTCQB Market Cap 10/18/17: US$306.8M Shares Outstanding as of 10/18/17: 95.3M Price: HSM.T - CAD$3.97 | HDST - US$3.20 Shares Incl. Warrants& Options - 10/18/17: 115.4 M Mgmt Ownership as of 10/18/17: 32.5 M (39.9 M Incl. 52 Week High: US $4.14 | 52 Week Low: $1.20 Options) CAD $5.09 | 52 Week Low: CAD$1.61 6/30/17 Cash & Equivalents: US$6.9 M, $0 Debt Average Daily Volume CAD/US: 207K/36K Gross Proceeds from 6/17 PP: $5.3M HSDT 4
Funding toDate TCNL Lab Funding: • $7.1M ($3.0M NIH grants, $4.1M in cash donations from treated subjects) – 2008-2013 Cash from Securities Offerings: • $7.0M initial investment in connection with reverse merger – Q2 2014 • $1.0M convertible debenture – Q2 2014 • $2.8M non-brokered private placement – Q2 & Q3 2015 • $7.0M A&B Company (China) strategic investment – Q4 2015 • $8.0M US private placement/prospectus offering in Canada – Q2 2016 • $1.4M from exercise of warrants – Q2 2016 • $9.5M from underwritten registered public offering – Q12017 • $5.3M non-brokered private placement – Q2 2017 • $42M total funding through September 30, 2017 • Additional Non-Dilutive Funding: US Army • $2.6M expense reimbursement received through September 8, 2017, from sole source contract; ($3M totalcommitment – final milestone on FDA Clearance) 5
Funding From U.S.Army Medical Research and MaterialCommand CRADA with the U.S. Army Medical Research and Material Command effective February 2013 • U.S. Army commits non-dilutive funding and resources for PoNS ™ research • U.S. Army provides regulatory support, facilities and personnel asneeded • December 2015 modification extends CRADA through December 2017 and expands PoNS™ research into fully-funded tinnitus, PTSD, sleep disturbances and pain studies if the initial TBI trial results are positive • Army extended development CRADA to12/31/18 and commercialization through 12/31/2021 • Sole Source Cost-Share Contract executed July 2015 for TBI Trial • $2.6M in expense reimbursement received on the project to date • Significant financial support for TBI clinical and registrationaltrial • Helius sponsor of regulatory and clinical development • Army has agreed to extend contract to 12/31/18 6
The Inventors of PoNS ™ Technology TACTILE COMMUNICATION AND NEUROREHABILITATION LABORATORY (“TCNL”) UNIVERSITY OF WISCONSIN–MADISON Department of BiomedicalEngineering Founded in 1992 by a pioneer of neuroplasticity, Dr. Paul Bach-Y-Rita • Research center using various areas of science to study the theory and application of applied neuro- plasticity, the brain’s ability to reorganize in response to new information, needs, and pathways • Research objective to develop solutions for sensory and motor disorders TCNL Project Directors: Mitchell E. Tyler, Kurt Kaczmarek, Yuri P .Danilov • Over 20 years of individual experience in their respective fields of neuroscience, biomedical science and engineering • Co-discoverers of the retention effect and neurorehabilitation potential of tongue electrotactile stimulation • Recognized experts in electrotactile stimulation • Invented core tongue display technology Key Publications 1. Danilov YP et al. “New Approaches to neurorehabilitation: cranial nerve non-invasive neuromodulation (CN-NINM) technology. SPIE Proceedings. 2014. 2. Tyler ME et al. “Non-invasive neuromodulation to improve gait and chronic multiple sclerosis: a randomized double-blind controlled pilot trial. J. NeuroEngineering and Rehabilitation. 2014. 7
PoNS TM Designed to Stimulate the Trigeminal and Facial Nerves Through the Tongue 8 www.heliusmedical.com | TSE:HSM |OTCQB:HSDT
Developing a platform technology for the treatment of symptoms of neurologic disease or trauma Portable Neuromodulation Stimulator (“PoNS™”) • Delivers specially-patterned nerve impulses to the lower brainstem through disposable appliance placed on the tongue • Combined with specialized physiotherapy may help treat patients with chronicneurological symptoms caused by disease or trauma • Used investigationally with over 250 patients at the University of Wisconsin-Madison. Testsin pilot studies (MS, TBI and CP) and case series in other neurologic diseases have generated encouraging results. • Pivotal study for the treatment of symptoms of TBI (120 subjects, multiple sites) completed 9
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