ATRX Adhera Therapeutics Inc

Risks

• We have terminated our business operations and are currently pursuing other opportunities to restructure our company. If we are not successful in these efforts, it is likely that we will discontinue all operations and seek bankruptcy protection.
• Our current cash is not sufficient to fund our business operations beyond April of 2020. If additional capital is not available, we may have to cease operations, or take other actions that could adversely impact our shareholders.
• If we are unable to raise sufficient additional capital, we may seek to merge with or be acquired by another entity, or to sell our assets to another entity, and that transaction may adversely affect our business and the value of our securities.
• We may be unable to repay the indebtedness to the holders of outstanding promissory notes.
• We are dependent on our key personnel, and if we are unable to retain such personnel, or to attract and retain other highly qualified personnel, then we may be unable to successfully develop our business.
• If we raise capital and make strategic acquisitions of products, technologies or other businesses, we will incur a variety of costs and potential liabilities and might never realize the anticipated benefits.
• Failure of our internal control over financial reporting could harm our business and financial results.
• We depend on our information technology and infrastructure.
• Our business and operations could suffer in the event of system failures.
• We may be unable to adequately protect our information technology systems from cyber-attacks, which could result in the disclosure of confidential information, damage our reputation, and subject us to significant financial and legal exposure.
• The development of pharmaceutical products is uncertain and may never lead to marketable products.
• If we or our partners are unable to acquire or develop, and commercialize products, our business will be adversely affected.
• To the extent that we undertake any R&D activities regarding our current or future development assets, clinical trials of such assets would be expensive and time-consuming, and the results of any of these trials would be uncertain.
• Any product candidates that we may develop may cause undesirable side effects or have other properties that could halt their development, prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.
• Even if regulatory approvals are obtained for any of the products that we may develop or acquire, such products will be subject to ongoing regulatory obligations and continued regulatory review. If we or a partner fail to comply with continuing U.S. and foreign regulations, the approvals to market drugs could be lost and our business would be materially adversely affected.
• We and our partners are subject to extensive U.S. and foreign government regulation regarding the development and commercialization of pharmaceutical products.
• We may use hazardous chemicals and biological materials in our business. Any disputes relating to improper use, handling, storage or disposal of these materials could be time-consuming and costly.
• We were dependent upon Prestalia for our ability to generate revenue from the sale of products, and we are dependent upon Les Laboratoires Servier for our rights to Prestalia.
• We may become dependent on our collaborative arrangements with third parties for a substantial portion of our revenue, and our development and commercialization activities may be delayed or reduced if we fail to initiate, negotiate or maintain successful collaborative arrangements.
• An interruption in the supply of raw and bulk materials needed for the development and manufacture of our products could cause product development and/or sales to be slowed or stopped.
• We will rely on third parties to conduct clinical trials, and those third parties may not perform satisfactorily, including failing to meet established timelines for the completion of such clinical trials.
• We have limited manufacturing experience or resources, and, to the extent that we engage in a business that involve the manufacturing of pharmaceutical products, we will have to either incur significant costs to develop this expertise or rely on third parties to manufacture our products.
• If we are unable to adequately protect our proprietary technology from legal challenges, infringement or alternative technologies, our competitive position may be hurt, and our operating results may be negatively impacted.
• Because intellectual property rights are of limited duration, expiration of intellectual property rights and licenses will negatively impact our operating results.
• Our patent applications may be inadequate in terms of priority, scope or commercial value.
• We have depended in the past with respect to our prior business operations, and we may depend in the future, on technologies we license, and if we lose the right to license such technologies or we fail to license new technologies in the future, our ability to develop or commercialize new or existing products would be harmed.
• We may be required to defend lawsuits or pay damages for product liability claims.
• As a result of a paragraph IV challenge to our Prestalia product, our Prestalia product may face generic competition beginning in January 2021. To the extent that we continue to sell Prestalia, our ability to generate revenues from the sale of that product will be adversely impacted if a generic version of Prestalia is launched on or after that date.
• To the extent that we continue to operate in the biopharmaceutical industry, if we or any of our partners, consultants, collaborators, manufacturers, vendors or service providers fail to comply with healthcare laws and regulations, or legal obligations related to privacy, data protection and information security, we or they could be subject to enforcement actions, which could result in penalties and negatively affect our ability to develop, market and sell our products.
• Any drugs that we may commercialize in the future may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, which, once such drugs are commercialized, could have a material adverse effect on our business and financial results.
• The biopharmaceutical market is intensely competitive. If we are unable to compete effectively with existing drugs and commercialization platforms, and existing and new treatment methods and technologies, we may be unable to commercialize successfully any drugs that we develop or acquire.
• The trading price of our common stock has been volatile, and investors in our common stock may experience substantial losses.
• A former director and executive officer controls a large percentage of the outstanding shares of our common stock (without giving effect to the conversion of voting preferred stock), and thus can influence our corporate actions.
• We may not be able to achieve secondary trading of our stock in certain states because our common stock is not nationally traded.
• Our common stock is quoted on the OTCQB, which may limit the ability of our stockholders to sell their securities and may cause volatility in the price of our common stock.
• Our common stock is considered a “penny stock,” and thereby is subject to additional sale and trading regulations that may make it more difficult to sell.
• Various restrictions in our charter documents and Delaware law could prevent or delay a change in control of our company that is not supported by our board of directors.
• We have never paid dividends on our common stock and do not anticipate paying cash dividends on our common stock in the foreseeable future.
• A significant number of shares of our common stock are subject to options, warrants and conversion rights. The issuance of these shares, which in some cases may occur on a cashless basis, will dilute the interests of other security holders and may depress the price of our common stock.