We may not be able to obtain orphan drug
designation for any of our product candidates, and even if we do, we may not be the first to obtain marketing approval for any
particular orphan indication due to the uncertainties associated with developing pharmaceutical products. Further, even if we obtain
orphan drug designation for a product, that exclusivity may not effectively protect the product from competition because different
drugs with different active moieties can be approved for the same condition. Orphan drug designation neither shortens the development
time or regulatory review time of a drug nor gives the drug any advantage in the regulatory review or approval process.
Due to our limited resources and access to
capital, we must prioritize development of certain product candidates.
Because we have limited resources and access
to capital to fund our operations, we must decide which product candidates to pursue and the amount of resources to allocate to
each. Our decisions concerning the allocation of research, collaboration, management and financial resources toward particular
compounds, product candidates or therapeutic areas may not lead to the development of viable commercial products and may divert
resources away from better opportunities. Similarly, our potential decisions to delay, terminate or collaborate with third parties
in respect of certain product development programs may also prove not to be optimal and could cause us to miss valuable opportunities.
If we make incorrect determinations regarding the market potential of our product candidates or misread trends in the biopharmaceutical
industry, in particular for neurological disorders, our business, financial condition and results of operations could be materially
Our research and development activities could
be affected or delayed as a result of possible restrictions on animal testing.
Certain laws and regulations require us
to test our product candidates on animals before initiating clinical studies in humans. Animal testing activities have been the
subject of controversy and adverse publicity. Animal rights groups and other organizations and individuals have attempted to stop
animal testing activities by pressing for legislation and regulation in these areas and by disrupting these activities through
protests and other means. To the extent the activities of these groups are successful, our research and development activities
may be interrupted, delayed or become more expensive.
internal computer systems, or those used by our third-party research institution collaborators, CROs or other contractors or consultants,
may fail or suffer security breaches.
Despite the implementation of security
measures, our internal computer systems and those of our future CROs and other contractors and consultants may be vulnerable to
damage from computer viruses and unauthorized access. Although to our knowledge we have not experienced any such material system
failure or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in
a material disruption of our development programs and our business operations. For example, the loss of clinical trial data from
completed, ongoing or future clinical trials could result in delays in our regulatory approval efforts and significantly increase
our costs to recover or reproduce the data. Likewise, we rely on our third-party research institution collaborators for research
and development of our product candidates and other third parties for the manufacture of our product candidates and to conduct
clinical trials, and similar events relating to their computer systems could also have a material adverse effect on our business.
To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or systems, or inappropriate
disclosure of confidential or proprietary information or personal data of our employees, partners and study subjects, we could
incur liability and the further development and commercialization of our product candidates could be delayed.
A breakdown or breach of our information
technology systems and cyber security efforts could subject us to liability, reputational damage or interrupt the operation of
We are increasingly dependent upon technology
systems and data. Our computer systems continue to increase in multitude and complexity due to the growth in our business, making
them potentially vulnerable to breakdown, malicious intrusion and random attack. Likewise, data privacy or security breaches
by individuals authorized to access our technology systems or others may pose a risk that sensitive data, including intellectual
property, trade secrets or personal information belonging to us, our patients or other business partners, may be exposed to unauthorized
persons or to the public. Cyber-attacks are increasing in their frequency, sophistication and intensity, and are becoming increasingly
difficult to detect. They are often carried out by motivated, well-resourced, skilled and persistent actors including nation states,
organized crime groups, “hacktivists” and