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SEC Filings

SEELOS THERAPEUTICS, INC. filed this Form S-3 on 02/01/2019
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exposure to blood-borne pathogens and the handling of biohazardous materials. Additional federal, state and local laws and regulations affecting Seelos' operations may be adopted in the future. Seelos may incur substantial costs to comply with, and substantial fines or penalties if Seelos violates any of these laws or regulations.

Seelos relies significantly on information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cybersecurity incidents, could harm Seelos' ability to operate Seelos' business effectively.

Despite the implementation of security measures, Seelos' internal computer systems and those of third parties with which Seelos contracts are vulnerable to damage from cyber-attacks, computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. System failures, accidents or security breaches could cause interruptions in Seelos' operations, and could result in a material disruption of Seelos' drug development and clinical activities and business operations, in addition to possibly requiring substantial expenditures of resources to remedy. The loss of drug development or clinical trial data could result in delays in Seelos' regulatory approval efforts and significantly increase Seelos' costs to recover or reproduce the data. To the extent that any disruption or security breach were to result in a loss of, or damage to, Seelos' data or applications, or inappropriate disclosure of confidential or proprietary information, Seelos could incur liability and its development programs and the development of its product candidates could be delayed.

Seelos' employees and consultants may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

Seelos is exposed to the risk of employee or consultant fraud or other misconduct. Misconduct by Seelos' employees or consultants could include intentional failures to comply with FDA regulations, provide accurate information to the FDA, comply with manufacturing standards, comply with federal and state healthcare fraud and abuse laws and regulations, report financial information or data accurately or disclose unauthorized activities to Seelos. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commissions, customer incentive programs and other business arrangements. Employee and consultant misconduct also could involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to Seelos' reputation. It is not always possible to identify and deter such misconduct, and the precautions Seelos takes to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting Seelos from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against Seelos, and Seelos is not successful in defending itself or asserting Seelos' rights, those actions could have a material adverse effect on Seelos' business, financial condition and results of operations, and result in the imposition of significant fines or other sanctions against Seelos.

Business disruptions such as natural disasters could seriously harm Seelos' future revenues and financial condition and increase its costs and expenses.

Seelos and its suppliers may experience a disruption in their business as a result of natural disasters. A significant natural disaster, such as an earthquake, hurricane, flood or fire, could severely damage or destroy Seelos' headquarters or facilities or the facilities of Seelos' manufacturers or suppliers, which could have a material and adverse effect on Seelos' business, financial condition and results of operations. In addition, terrorist acts or acts of war targeted at the U.S., and specifically the greater New York, New York region, could cause damage or disruption to Seelos, its employees, facilities, partners and suppliers, which could have a material adverse effect on Seelos' business, financial condition and results of operations.

Seelos may engage in strategic transactions that could impact its liquidity, increase its expenses and present significant distractions to its management.

From time to time, Seelos may consider strategic transactions, such as acquisitions of companies, asset purchases and out-licensing or in-licensing of products, product candidates or technologies. Additional potential transactions that Seelos may consider include a variety of different business arrangements, including spin-offs, strategic partnerships, joint ventures, restructurings, divestitures, business combinations and investments. Any such transaction may require Seelos to incur non-recurring or other charges, may increase Seelos' near- and long-term expenditures and may pose significant integration challenges or disrupt Seelos' management or business, which could adversely affect Seelos' business, financial condition and results of operations. For example, these transactions may entail numerous operational and financial risks, including:

  • exposure to unknown liabilities;
  • disruption of Seelos' business and diversion of Seelos' management's time and attention in order to develop acquired products, product candidates or technologies;
  • incurrence of substantial debt or dilutive issuances of equity securities to pay for any of these transactions;
  • higher-than-expected transaction and integration costs;
  • write-downs of assets or goodwill or impairment charges;


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