CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS
This prospectus supplement, the accompanying base prospectus and the documents we have filed with the SEC that are incorporated by reference
herein and therein contain forward-looking statements. These statements are based on managements 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 Annual Report include but are not limited to statements relating to: clinical development plans,
product development activities, other products not yet developed or acquired, our product candidate success, plans for U.S. Food and Drug Administration, or FDA, filings and their subsequent approvals, other foreign or domestic regulatory filings by
us or our collaboration partners, including filings with CE Mark and the Therapeutic Goods Administration, our ability to commercialize the product(s), either independently or with collaboration partners, the safety and effectiveness of our product
candidate, the timeline for our improvement plans, our market awareness, our ability to compete effectively, the ability and limitation of our manufacturing source(s), our distribution network, the adequacy of our intellectual property protection,
our future patent approvals, potential infringement of our intellectual property, future litigation waged against us and its outcome, any product liability we may incur, the sufficiency of our operating insurance, including sufficient product
liability insurance, our limited operating history, our dependence on a small number of employees, employee conflicts of interest, our dependence on outside scientists and third party research institutions, our future expenses and cash flow, our
ability to become profitable, our future financing arrangements, our ability to accurately report our financial position, our accountants future perspective including any going concerns, our ability to maintain effective internal controls, any
future stock price, the potential dilution of the stock from future sales of the Companys equity securities, future disclosure requirements, future regulatory risks, our relationship with the U.S. Army, our ability to build the necessary
commercial infrastructure and to use existing reimbursement codes or receive reimbursement codes from the American Medical Association and the U.S. Department of Health and Human Services, and our ability to receive reimbursement coverage under
Medicare, Medicaid or under other insurance plans. These and additional risks and uncertainties are more fully described in this Annual Report and our other public filings with the Securities and Exchange Commission or the SEC.
Such forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by Helius,
are inherently subject to significant business, economic, competitive political and social uncertainties and contingencies. The factors and assumptions used by management of the Company to develop such forward-looking statements include, but are not
limited to, obtaining positive results of clinical trials, obtaining regulatory clearances, general business and economic conditions, the availability of financing on reasonable terms, the Companys ability to attract and retain skilled staff,
market competition, the assumption that our relationships with our manufacturer and other third parties will be maintained, the products and technology offered by the Companys competitors and the Companys ability to protect patents and
proprietary rights.
Although we believe 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. Forward-looking statements are not
guarantees of future performance and actual results may differ significantly from such forward-looking statements. Factors that could cause the actual results to differ materially from those in the forward-looking statements include future economic,
competitive, reimbursement and regulatory conditions; new product introductions, demographic trends, the intellectual property landscape, litigation, financial market conditions, continued availability of capital, and, future business decisions made
by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and
actual results or developments may differ materially from those projected in the forward-looking statements. 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, we undertake no obligation to update or alter these forward-looking statements (and expressly disclaim any such intention or obligation to do so) in the event that managements beliefs, estimates, opinions, or other
factors should change.
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