MYMX Mymetics Dashboard

Risks

• We have incurred significant losses since our inception and anticipate that we will continue to incur losses in the future.
• We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we will be unable to complete the development and potential commercialization of our product candidates.
• Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to product candidates.
• We have not generated any revenues to date from vaccine product sales. We may never achieve or sustain profitability, which could depress the market price of our securities, and could cause you to lose all or a part of your investment.
• The Coronavirus (Covid-19) pandemic could delay or eliminate current and future projects to commercialize our vaccine candidates that could reduce our anticipated cash flow and compel us to seek additional dilutive financing to maintain our current number of employees.
• Our existing and any future indebtedness could adversely affect our ability to operate our business.
• We might not be able to utilize a significant portion of our net operating loss carryforwards and foreign tax credit carryforwards.
• We might not be able to continue as a going concern.
• Our future success is dependent on the successful clinical development, regulatory approval and commercialization of our vaccine product candidates, which will require significant capital resources and years of additional clinical development effort.
• Because the results of pre-clinical studies or earlier clinical trials are not necessarily predictive of future results, our product candidates may not have favorable results in later clinical trials or receive regulatory approval.
• The therapeutic efficacy of our HIV and our other product candidates is unproven and we may not be able to successfully develop and commercialize our product candidates.
• Clinical development of product candidates involves a lengthy and expensive process with an uncertain outcome.
• Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following any marketing approval.
• Even if one or more of our product candidates receive regulatory approval, we may still face future development and regulatory difficulties.
• Changes in regulatory requirements and guidance may also occur and we may need to amend clinical trial protocols submitted to applicable regulatory authorities to reflect these changes. Amendments may require us to resubmit clinical trial protocols to IRBs for re-examination, which may impact the costs, timing or successful completion of a clinical trial.
• Even if we obtain regulatory approval for a product candidate, our products will remain subject to ongoing regulatory oversight.
• Failure to obtain regulatory approval in international jurisdictions would prevent our product candidates from being marketed abroad.
• Our commercial success depends upon attaining significant market acceptance of our product candidates, if approved, among physicians, patients, government and private payers and others in the medical community.
• If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates, we may be unable to generate any revenue.
• A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business.
• Our vaccine product candidates may not receive coverage and adequate reimbursement from third party payers, which could harm our financial performance.
• We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
• Product liability lawsuits against us could cause us to incur substantial liabilities and materially adversely impact our operations.
• Our product liability insurance coverage may not be adequate to cover any and all liabilities that we may incur.
• We rely, and will rely in the future, on third parties to conduct our pre-clinical studies and clinical trials. If these third parties do not appropriately carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our product candidates.
• If we lose our relationships with the third parties conducting our pre-clinical studies and clinical trials or providing other services to us, our vaccine development efforts could be delayed.
• We have no experience manufacturing our product candidates and have no manufacturing facility. We are dependent on third party manufacturers for the manufacture of our product candidates as well as on third parties for our supply chain, and if we experience problems with any such third parties, the manufacturing of our product candidates could be delayed.
• Disruptions or delays in the supply of our vaccine product candidates would delay development of our product candidates and impair our ability to generate revenues from the sale of our products, if approved.
• We may elect to enter into licensing or collaboration agreements with respect to some or all of our vaccine product candidates in certain territories. Our dependence on such relationships may adversely affect our business.
• If our third party manufacturers use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages.
• Recently enacted and future legislation, including potentially unfavorable pricing regulations or other healthcare reform initiatives, may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may obtain.
• Laws and regulations governing conduct of international operations may preclude us from developing, manufacturing and selling products outside of the United States and require us to develop and implement costly compliance programs.
• Our relationships with customers and third party payers will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
• If we are unable to protect our intellectual property rights or if our intellectual property rights are inadequate for our technology and vaccine product candidates, our competitive position could be harmed.
• Our intellectual property portfolio has certain pending patent applications. If our pending patent applications fail to issue or fail to issue with a scope that is meaningful to our product candidates, or if issued, if our patents are found to be invalid, not enforceable or not infringed by competitor products, our business will be adversely affected.
• Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could harm our business.
• We may not be able to protect our intellectual property rights throughout the world.
• Our competitors may be able to circumvent our patents by developing similar or alternative technologies or products in a non-infringing manner.
• Changes in patent laws, including recent patent reform legislation, could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.
• Obtaining and maintaining our patent protection depends on compliance with various procedural, document submissions, 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.
• We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and unsuccessful and have a material adverse effect on the success of our business.
• We may be subject to claims by third parties asserting that we have misappropriated their intellectual property through our employees and advisory board members.
• Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
• Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation.
• We will need to grow the size of our organization, and we may experience difficulties in managing this growth.
• Our future success depends on our ability to retain our executive officers and to attract, retain and motivate qualified personnel.
• If we are unable to attract and retain highly qualified employees, and other personnel, advisors and consultants with scientific, technical and managerial expertise, we may not be able to grow effectively.
• We may acquire other assets or businesses, or form collaborations or make investments in other companies or technologies that could harm our operating results, dilute our stockholders' ownership, increase our debt or cause us to incur significant expense.
• Our business and operations would suffer in the event of computer system failures.
• Business disruptions could seriously harm our future revenues and financial condition and increase our costs and expenses.
• We do not know whether an active, liquid and orderly trading market will develop for our securities or what the market price of our securities will be and as a result it may be difficult for you to sell your shares of common stock.
• Insiders have substantial influence over us and could delay or prevent a change in corporate control.
• If we do not meet the listing standards of a national securities exchange our investors’ ability to make transactions in our securities will be limited and we will be subject us to additional trading restrictions.
• If we fail to maintain an effective system of internal control over financial reporting in the future, we may not be able to accurately report our financial condition, results of operations or cash flows, which may adversely affect investor confidence in us and, as a result, the value of our securities.
• Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
• Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
• Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, will result in additional dilution of the percentage ownership of our stockholders and could cause our trading price to fall.
• Some provisions of our charter documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders and may prevent attempts by our stockholders to replace or remove our current management.