What changed in this filing

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Item 1A. Risk Factors

2024-11-19 compared with 2024-08-15 · 11 added, 48 removed, 0 unchanged (100% of the section changed)

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.

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.

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

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.

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

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

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.

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.

In addition to the other information set forth in this Quarterly Report

on Form 10-Q, carefully consider the risk factors described under the heading “Part I – Item 1A.

Risk Factors” in our

most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and “Part II – Item 1A.

Risk Factors”

in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024.

Such risks described are not the only risks facing us.

risks and uncertainties not currently known to us, or that our management currently deems to be immaterial, also may adversely affect

our business, financial condition, and/or operating results.

There have been no material changes to those risk factors since their disclosure

in our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1A. Risk Factors