Throughout this Annual Report on Form 10-K (the“Annual Report”), the“Company,”* and references to*“we,”* “us,” or similar such references should be understood to be references to Clene Inc. and its consolidated subsidiaries.*
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Certain statements in this Annual Report may constitute “forward-looking statements” for purposes of the federal securities laws. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding our future operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements in this Annual Report may include, for example, statements about:
| ● | our future financial performance, including our ability to continue as a going concern; |
| ● | our plans and strategies to raise additional funding; |
| ● | the clinical results of our drug candidates; |
| ● | the likelihood of commercial success for our drug candidates; |
| ● | our plans and strategies to obtain and maintain regulatory approvals of our drug candidates; |
| ● | the size and growth potential of the markets for our drug candidates, and our ability to serve those markets, either alone or in combination with others; |
| ● | changes in the market for our drug candidates; |
| ● | expansion plans and opportunities; and |
| ● | any other statements that address events or developments that we intend or believe will or may occur in the future. |
These forward-looking statements represent our views as of the date of this Annual Report and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date.
As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include:
| ● | our substantial dependence on the successful commercialization of our drug candidates, if approved, in the future; |
| ● | our significant net losses and net operating cash outflows; |
| ● | our ability to demonstrate the efficacy and safety of our drug candidates; |
| ● | the clinical results for our drug candidates, which may not support further development or marketing approval; |
| ● | actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; |
| ● | our ability to achieve commercial success for our drug candidates, if approved; |
| ● | our ability to obtain and maintain protection of intellectual property for our technology and drug candidates; |
| ● | our reliance on third parties to conduct research, drug development, and other services; |
| ● | our limited operating history and our ability to obtain additional funding for operations and to complete the licensing or development and commercialization of our drug candidates; |
| ● | the impact of any future epidemics, pandemics, or conflicts; |
| ● | changes in applicable laws or regulations; |
| ● | the effects of inflation; |
| ● | the effects of staffing and materials shortages; |
| ● | the possibility that we may be adversely affected by other economic, business, and/or competitive factors; and |
| ● | other risks and uncertainties set forth in the section entitled “Risk Factors.” |
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Annual Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to rely unduly upon these statements.
SUMMARY OF MATERIAL RISKS ASSOCIATED WITH OUR BUSINESS
Our business is subject to numerous material and other risks that you should be aware of before making an investment decision. These risks are discussed more fully in the section entitled “Risk Factors.” These risks include, among others, the following:
| ● | We depend substantially on the successful commercialization of our drug candidates in the future, which may fail to materialize or may experience significant delays. |
| ● | We currently do not generate any revenue from the commercial sales of drug candidates and we may not become profitable when expected, or at all. |
| ● | We have incurred significant net losses and net operating cash outflows since our inception and expect to continue to incur significant net losses for the foreseeable future. |
| ● | Our ability to continue as a going concern requires that we obtain sufficient funding to finance our operations, which may not be available on acceptable terms, or at all. A failure to obtain this necessary capital when needed could force us to delay, limit, reduce, or terminate our drug development or commercialization efforts. |
| ● | Unstable market and economic conditions may have serious adverse consequences on our business, financial condition, results of operations, and prospects. |
| ● | We have a limited operating history, which may make it difficult to evaluate our current business and predict our future performance. |
| ● | We may encounter difficulties in managing our growth and expanding our operations successfully. |
| ● | Changes in government regulation or in practices relating to the pharmaceutical and biotechnology industries, including potential healthcare reform, could decrease the need for our drug candidates, or make it more difficult to obtain regulatory approvals for our drug candidates and commercialize them. |
| ● | Our internal computer systems, or those used by any CROs or other third-party contractors or consultants we may engage, may fail or suffer security breaches. |
| ● | We manufacture all of our drug candidates ourselves, and intend to manufacture most, if not all, of any approved drugs ourselves as well. |
| ● | Delays in completing and receiving regulatory approvals for our manufacturing facilities could delay our development plans or commercialization efforts. |
| ● | Damage to, destruction of, or interruption of production at our manufacturing facilities would negatively affect our business and prospects. |
| ● | Significant or sustained inflation could adversely affect our business, financial condition, and results of operations. |
| ● | Our future success depends on our ability to retain key executives and to attract, train, retain, develop, and motivate qualified and highly skilled personnel. |
| ● | Our business and operations have been affected by and could be materially and adversely affected in the future by the effects of health epidemics and pandemics, which could also cause material adverse effects on the business and operations of third parties on which we rely. |
| ● | We have identified material weaknesses in our internal control over financial reporting. If we fail to remediate these material weaknesses, or if we experience additional material weaknesses in the future or otherwise fail to maintain an effective system of internal controls, we may not be able to accurately or timely report our financial condition or results of operations. |
| ● | There is significant uncertainty associated with our drug candidates and their viability as a commercial product. |
| ● | We have not previously obtained any regulatory approval for a drug candidate and we may be unable to obtain or may be delayed in obtaining regulatory approval for any of our drug candidates. |
| ● | Preclinical and clinical development of drug candidates involves a lengthy and expensive process with an uncertain outcome, and we are unable to predict if or when we will successfully develop or commercialize any of our drug candidates. |
| ● | Clinical trials of our drug candidates may fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities, or may not otherwise produce positive results, which may cause us to incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our drug candidates. |
| ● | If we are not able to obtain, or experience delays in obtaining, required regulatory approvals, we will not be able to commercialize our drug candidates, and our ability to generate revenue will be materially impaired. |
| ● | Any of our drug candidates, if approved, would continue to be subject to ongoing or additional regulatory obligations and regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our drug candidates. |
| ● | Even if we are able to commercialize any approved drug candidates, the drugs may become subject to national or other third-party reimbursement practices or unfavorable pricing regulations. |
| ● | Our drug candidates, if approved in the future, may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success and the market opportunity for the drug candidate may be smaller than we estimate. |
| ● | As a company, we have no experience in launching and marketing drugs. If we are unable to develop sales, marketing and distribution capabilities or enter into sales, marketing and distribution agreements or arrangements with third parties, we may not be successful in commercializing any drugs, if approved, or generating drug candidate sales revenue. |
| ● | We face substantial competition from other pharmaceutical and biotechnology companies, and our operating results may suffer if we fail to compete effectively. |
| ● | If we are unable to obtain and maintain sufficient patent protection for our drug candidates through intellectual property rights, or if the scope of such intellectual property rights obtained is not sufficiently broad, third parties could develop and commercialize products similar or identical to our products, and our ability to commercialize our approved drugs successfully may be adversely affected. |
| ● | There can be no assurance that we will be able to comply with the continued listing requirements of the Nasdaq Capital Market (“Nasdaq”). |
| ● | The price of our common stock, $0.0001 par value (“Common Stock”), may be volatile. |
