Hyperion Defi (HYPD) risk factors, FY2024 10-K

RISKS RELATED TO OUR FINANCIAL POSITION AND NEED FOR ADDITIONAL CAPITAL

1. 01We will need to raise additional capital to remain a going concern, which may not be available on acceptable terms, or at all
2. 02Significant Accounting Policies - Liquidity and Going Concern of our financial statements included within this Annual Report on Form 10-K
3. 03Our 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
4. 04Delisting 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
5. 05Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies
6. 06The terms of the Loan and Security Agreement require us to meet certain operating covenants and place restrictions on our operating and financial flexibility. If we raise additional capital through debt financing, the terms of any new debt could further restrict our ability to operate our business
7. 07We 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
8. 08On February 21, 2025, the Company entered into the Second Amendment, pursuant to which Avenue agreed to defer principal and interest payments on amounts outstanding until the end of September 2025. Deferred interest will accrue on the outstanding principal amount at the interest rate as defined in the Second Amendment
9. 09We 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
10. 10If we are unable to use carryforward tax losses or benefit from favorable tax legislation to reduce our taxes, our business, results of operations and financial condition may be adversely affected
11. 11Revenue Code of 1986, as amended, as well as similar state provisions. This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities

RISKS RELATED TO THE PROPOSED BUSINESS COMBINATION BETWEEN EYENOVIA AND BETALIQ

1. 12The proposed business combination may not be consummated on the terms described in the non-binding Letter of Intent or at all
2. 13Failure 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
3. 14Eyenovia and 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
4. 15Eyenovia expects to incur substantial transaction costs in connection with the proposed business combination

RISKS RELATED TO COMMERCIALIZATION OF OUR PRODUCTS

1. 16Our products may cause undesirable side effects, which could result in significant negative consequences
2. 17If the market opportunities for Mydcombi and clobetasol propionate are smaller than we believe they are, our product revenues may be adversely affected and our business may suffer
3. 18There can be no assurance that Mydcombi and clobetasol propionate will achieve commercial success or market acceptance, which could prevent us from becoming profitable
4. 19The specialty pharma market is highly competitive. If we or our licensees are unable to compete effectively with any existing products, new treatment methods and new technologies, we may be unable to commercialize our products
5. 20If we fail to establish and maintain effective manufacturing and distribution processes our business may be adversely affected
6. 21We are exposed to the risk of claims seeking monetary damages by individuals and the risk of investigations by regulatory authorities, which could cause us to incur substantial liabilities and to limit commercialization of any products that we develop
7. 22Product liability lawsuits against us could divert our resources and could cause us to incur substantial liabilities and to limit commercialization of any products that we develop
8. 23We may not be able to successfully commercialize Mydcombi or clobetasol propionate due to unfavorable pricing regulations or third-party coverage and reimbursement policies, which could make it difficult for us to sell Mydcombi or clobetasol propionate profitably

RISKS RELATED TO REGULATORY APPROVAL OF OUR PRODUCTS AND OTHER LEGAL COMPLIANCE MATTERS

1. 24Although we have obtained FDA approval for Mydcombi in the United States, we may never obtain approval for or commercialize Mydcombi or any of our current or future product candidates in any other jurisdiction, which would limit our ability to realize their full market potential
2. 25approvals, or if regulatory approvals in international markets are delayed, our target market will be reduced and our ability to realize the full market potential of any product we develop will be unrealized
3. 26to regulatory and enforcement actions our business, financial condition, results of operations, stock price and prospects will be materially harmed
4. 27Healthcare legislative reform measures may have a material adverse effect on our financial condition or results of operations
5. 28of the United States, it will require us to dedicate additional resources to comply with these laws, and these laws may preclude us from developing, manufacturing, or selling certain products and product candidates outside of the United States, which could limit our growth potential and increase our development costs

RISKS RELATED TO OUR BUSINESS OPERATIONS AND MANAGING GROWTH

1. 29We 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
2. 30In addition, we are dependent on our continued ability to retain and motivate highly qualified additional personnel. If we are not able to retain our management and to retain personnel necessary for the commercialization of our products, we might not be able to sustain our operations or grow
3. 31We have limited corporate infrastructure
4. 32We rely upon information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cyber security incidents, could harm our ability to operate our business effectively
5. 33Our employees, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading

RISKS RELATED TO OUR DEPENDENCE ON THIRD PARTIES

1. 34to do so on acceptable terms. If we are unable to reach acceptable agreements with a sufficient number of suppliers of materials, our commercialization activities will be delayed and our ability to implement our business plan will be compromised
2. 35If we, our service providers, or any third-party manufacturers fail to comply with laws regulating the protection of the environment and health and human safety, we could be subject to enforcement actions and our business prospects could be adversely affected

RISKS RELATED TO OUR INTELLECTUAL PROPERTY AND POTENTIAL LITIGATION

1. 36Our success depends on our ability to protect our intellectual property and proprietary technology
2. 37Our patents covering our proprietary technology may be subject to challenge, narrowing, circumvention and invalidation by third parties
3. 38We cannot be sure that we were the first to make the technologies claimed in our patents or patent applications or that we were the first to file for patent protection
4. 39The patent application process is subject to numerous risks and there can be no assurance that we will be successful in obtaining patents for which we have applied
5. 40It is difficult and costly to protect our intellectual property and our proprietary technologies, and we might not be able to ensure their protection
6. 41Obtaining and maintaining patent protection of our technologies depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
7. 42Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time and if we do not obtain protection under the Hatch-Waxman Amendments and similar non-U.S. legislation for extending the term of patents covering our products, our business may be materially harmed
8. 43Changes to the patent law in the United States or other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products
9. 44We might not be able to enforce our intellectual property rights throughout the world
10. 45If we are sued for infringing, misappropriating, or otherwise violating intellectual property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from commercializing our products
11. 46We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property and proprietary technology
12. 47We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful
13. 48If 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
14. 49If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be negatively impacted and our business would be harmed
15. 50If our trademarks and trade names are not adequately protected, then we might not be able to build name recognition in our marks of interest and our business may be adversely affected

RISKS RELATED TO OWNERSHIP OF OUR COMMON STOCK

1. 51A 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
2. 52The 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
3. 53We have broad discretion in the use of our cash, including the net proceeds from our financings, and might not use them effectively
4. 54We may be adversely affected by the effects of inflation
5. 55As a public company, we need to have effective internal controls and disclosure controls, which is costly and time consuming. Failure to develop and maintain adequate financial controls could cause us to have material weaknesses, which could adversely affect our operations and financial position
6. 56and we could be subject to sanctions or investigations by the stock exchange on which our common stock is listed, the SEC, or other regulatory authorities
7. 57We are an “smaller reporting company” and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors
8. 58Provisions in our corporate charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management
9. 59Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain
10. 60If securities analysts do not continue to publish research or reports about our business or if they publish negative evaluations of our stock, the price of our stock could decline