Item 1A. Risk Factors
Item 1A.
Risk Factors
Our business faces many risks, a number of which are described in the section
captioned “Risk Factors” in our Annual Report for the year ended December 31, 2024, filed with the SEC on April 16, 2024.
The risks described in our Annual Report and below may not be the only risks we face. Other risks of which we are not yet aware, or that
we currently believe are not material, may also materially and adversely impact our business operations or financial results. If any of
the events or circumstances described in the risk factors contained in our Annual Report or described below occur, our business, financial
condition or results of operations could be adversely impacted and the value of an investment in our securities could decline. Investors
and prospective investors should consider the risks described in our Annual Report and below, and the information contained in the section
captioned “Warning Concerning Forward-Looking Statements” and elsewhere in this Quarterly Report before deciding whether to
invest in our securities.
Our failure to protect our intellectual property rights may undermine
our competitive position, and external infringements of our intellectual property rights may adversely affect our business.
Our success and ability to compete depends in part on our intellectual
property. We primarily rely on a combination of patent, trademark, trade secret, and copyright laws, as well as confidentiality procedures
and contractual restrictions with our employees, contractors and others to establish and protect our intellectual property rights. However,
confidentiality and license arrangements may be breached by counterparties, and there may not be adequate remedies available to us for
any such breach. Accordingly, we may not be able to effectively protect our intellectual property rights or to enforce our contractual
rights. In addition, our trade secrets may be leaked or otherwise become available to, or be independently discovered by, our competitors.
The steps we take to protect our intellectual property rights may be inadequate or we may be unable to secure intellectual property protection
for some of our properties. Infringement of intellectual property rights continues to pose a serious risk of doing business.
We have filed, and may in the future file, patent applications, such as
the two patent applications we have included in this Quarterly Report. It is possible, however, that these innovations may not be patentable.
In addition, given the cost, effort and risks associated with patent application, we may choose not to seek patent protection for some
innovations. Furthermore, our patent applications may not lead to granted patents, the scope of the protection gained may be insufficient
or an issued patent may be deemed invalid or unenforceable. In addition, we have filed, and may continue to file, applications on certain
of our trademarks, which may not always be approved on a timely basis, or at all. We also cannot guarantee that any of our present or
future patents, trademarks or other intellectual property rights will not lapse or be invalidated, circumvented, challenged, or abandoned.
If we are unable to protect our intellectual property, our competitors
could use our intellectual property to market offerings similar to ours and our ability to compete effectively would be impaired. Moreover,
others may independently develop drug delivery treatments that are competitive to ours or infringe on our intellectual property. The enforcement
of our intellectual property rights depends on our legal actions against these infringers being successful, but we cannot be sure these
actions will be successful, even when our rights have been infringed. In addition, defending our intellectual property rights might entail
significant expense and diversion of management resources. Any of our intellectual property rights may be challenged by others or invalidated
through administrative processes or litigations. We can provide no assurance that we will prevail in such litigations, and, even if we
do prevail, we may not obtain a meaningful relief. Accordingly, despite our efforts, we may be unable to prevent external parties from
infringing or misappropriating our intellectual property. Any intellectual property that we own may not provide us with competitive advantages
or may be successfully challenged by external parties.
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