CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains “forward-looking statements” that involve risks and uncertainties, as well as assumptions that, if they never materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. The statements contained in this Annual Report on Form 10-K that are not purely historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or Exchange Act. Such forward-looking statements include our need to raise additional money to fund our operations for the next twelve months as a going concern; our estimates regarding expenses, future revenue, capital requirements and our need for additional financing and other financial items; the outcome of the process to explore strategic alternatives to maximize shareholder value; any statements of the plans, strategies and objectives of management for future operations; any statements about the advantages of our products and platform technology; estimates regarding the potential market opportunity for our products and platform technology; factors that may affect our operating results; statements about our ability to establish and maintain intellectual property rights; statements about our ability to retain key personnel; statements related to future capital expenditures; statements related to future economic conditions or performance; and other matters that do not relate strictly to historical facts or statements of assumptions underlying any of the foregoing. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “will,” “plan,” “project,” “seek,” “should,” “target,” “would,” and similar expressions or variations intended to identify forward-looking statements. These statements are based on the beliefs and assumptions of our management based on information currently available to management. Such forward-looking statements are subject to risks, uncertainties and other important factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section titled “Summary Risk Factors” described below and “Risk Factors” included in Item 1A of Part I of this Annual Report on Form 10-K, and the risks discussed in our other U.S. Securities and Exchange Commission, or SEC, filings. Furthermore, such forward-looking statements speak only as of the date of this report. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.
As used in this report, the terms “Eyenovia, Inc.,” “Eyenovia,” “Company,” “company,” “we,” “us,” and “our” mean Eyenovia, Inc. and its subsidiaries unless the context indicates otherwise.
Summary Risk Factors
Some of the factors that could materially and adversely affect our financial condition, results of operations, cash flow, the market price of shares of our common stock or our prospects include, but are not limited to, the following. You should read this summary together with the more detailed description of each risk factor contained in Item 1A “Risk Factors” in this Annual Report on Form 10-K.
Risks Related to Our Financial Position and Need for Additional Capital
| ● | We will need to raise additional capital to remain a going concern, which may not be available on acceptable terms, or at all. |
| ● | Our ongoing exploration of alternative strategic paths may not result in entering into or completing transactions when necessary, and the process of reviewing alternative strategic paths or their conclusion could adversely affect our stock price. |
| ● | Delisting of our common stock from Nasdaq could prevent us from maintaining an active, liquid and orderly trading market for our common stock and may materially and adversely impact our ability to consummate certain strategic transactions. |
| ● | We have entered into a loan modification agreement with Avenue and, based on our lack of financial liquidity, we cannot guarantee that we will be able to comply with the terms of this agreement, or continue obtaining forbearance if needed. |
| ● | We have incurred operating losses since our inception. We expect to continue to incur losses for the foreseeable future and might never achieve or maintain profitability. |
Risks Related to the Proposed Combination between Eyenovia and Betaliq
| ● | The proposed business combination may not be consummated on the terms described in the non-binding Letter of Intent (as defined herein) or at all. |
| ● | Failure to enter into a definitive business combination agreement or consummate the proposed business combination could negatively affect Eyenovia’s business, future business and financial results. |
| ● | Eyenovia and Betaliq, Inc. (“Betaliq”) will be subject to various uncertainties while the proposed business combination is pending that could adversely affect the anticipated benefits of the business combination. |
| ● | Eyenovia expects to incur substantial transaction costs in connection with the proposed business combination. |
Risks Related to Regulatory Approval of Our Products and Other Legal Compliance Matters
| ● | We are subject to ongoing regulatory obligations and continued regulatory review of our products, which may result in significant additional expense. Additionally, our products could be subject to post-market study requirements, marketing and labeling restrictions, and even recall or market withdrawal if unanticipated safety issues are discovered. In addition, we may be subject to penalties or other enforcement action if we fail to comply with regulatory requirements. |
Risks Related to Our Business Operations and Managing Growth
| ● | We are highly dependent on the services of our senior management team, including our Chief Executive Officer, and if we are not able to retain these members of our management team or recruit and retain additional management, clinical, scientific and sales personnel, our business will be harmed. |
| ● | We have limited corporate infrastructure. |
Risks Related to Our Dependence on Third Parties
| ● | We may encounter delays in the manufacturing of the second generation Optejet device, including as a result of our reliance on third parties for manufacturing activities, and this may cause delays in the commercialization of our products. Any such |
delays would increase the risk that we will not have sufficient quantities of our products or such quantities at an acceptable cost, which could delay, prevent or impair our commercialization efforts.
| ● | If we, our service providers or our third-party manufacturers fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business. |
Risks Related to Our Intellectual Property and Potential Litigation
| ● | Our success depends on our ability to protect our intellectual property and proprietary technology. |
| ● | Our patents covering our proprietary technology may be subject to challenge, narrowing, circumvention and invalidation by third parties. |
| ● | We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful. |
| ● | If we fail to comply with our obligations under our existing and any future intellectual property licenses with third parties, we could lose license rights that are important to our business. |
Risks Related to Ownership of Our Common Stock
| ● | A significant portion of our total outstanding shares may be sold into the market in the near future, which could cause the market price of our common stock to drop significantly, even if our business is performing well. |
| ● | The price of our common stock has been, and may continue to be, volatile and may fluctuate substantially, which could result in substantial losses for purchasers of our common stock. |
| ● | We have broad discretion in the use of our cash, including the net proceeds from our financings, and might not use them effectively. |
