These factors could
cause the delay of clinical trials, regulatory submissions, required approvals or commercialization of vonapanitase or any additional
product candidates, cause us to incur higher costs and prevent us from commercializing our products successfully. Furthermore,
if our suppliers fail to meet contractual requirements, and we are unable to secure one or more replacement suppliers capable of
production at a substantially equivalent cost, our clinical trials may be delayed or we could lose potential revenue.
Our business and operations would
suffer in the event of system failures or security breaches.
Despite the implementation
of security measures, our internal computer systems, and those of our CROs and other third parties on which we rely, are vulnerable
to damage from computer viruses, unauthorized access, cyber attacks, natural disasters, terrorism, war and telecommunication and
electrical failures. If issues were to arise and cause interruptions in our operations, it could result in a material disruption
of our drug and biologic development programs. For example, the loss of clinical trial data from completed or ongoing or planned
clinical trials could result in delays in our regulatory approval efforts and significantly increase our 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 our data or applications,
or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development of
vonapanitase or any additional product candidates could be delayed. We may also be vulnerable to cyber attacks by hackers, or other
malfeasance. This type of breach of our cybersecurity may compromise our confidential information and/or our financial information
and detrimentally impact our business or result in legal proceedings.
Our employees may engage in misconduct
or other improper activities, including noncompliance with regulatory standards and requirements and insider trading, which could
significantly harm our business.
We are exposed to
the risk of employee fraud or other misconduct. Misconduct by employees could include intentional failures to comply with the regulations
of the FDA and foreign regulators, provide accurate information to the FDA and foreign regulators, comply with healthcare fraud
and abuse laws and regulations in the United States and abroad, and report financial information or data accurately or disclose
unauthorized activities to us. In particular, sales, marketing and business arrangements in the healthcare industry are subject
to extensive laws and regulations intended to prevent fraud, misconduct, 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 commission,
customer incentive programs and other business arrangements. Employee misconduct could also involve the improper use of information
obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. We have
a Code of Business Conduct and Ethics, but it is not always possible to identify and deter employee misconduct, and the precautions
we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting
us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations.
If any actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions
could have a significant impact on our business, including the imposition of significant fines or other sanctions.
We have broad discretion in our use
of our cash and cash equivalents and may not use them effectively.
Our management has
broad discretion to use our cash and cash equivalents to fund our operations and could spend these funds in ways that do not improve
our results of operations or enhance the value of our Common Stock. The failure of our management to apply these funds effectively
could result in financial losses that could have a material adverse effect on our business, cause the price of our Common Stock
to decline and delay the development of our product candidates. Pending their use to fund our operations, we may invest our cash
and cash equivalents in a manner that does not produce income or that loses value.
Recent federal legislation may increase
the difficulty and cost for us to commercialize vonapanitase and may affect the prices we may obtain, and impair our ability to
profitably sell vonapanitase, if approved.
In the United States
and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the
healthcare system that could prevent or delay marketing approval for vonapanitase, restrict or regulate post-approval activities
and affect our ability to profitably sell vonapanitase, if approved. Legislative and regulatory proposals have been made to expand
post-approval requirements and restrict sales and promotional activities for pharmaceutical products. We do not know whether additional
legislative changes will be enacted, or whether the FDA regulations, targets or interpretations will be changed, or what the impact
of such changes on the marketing approvals of vonapanitase, if any, may be. In addition, increased scrutiny by the United States
Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject us to more
stringent product labeling and post-marketing testing and other requirements.