Item 1A. Risk Factors
Item 1A. Risk Factors.
In addition to the other information set
forth in this Report, you should carefully consider the factors discussed in Part I, Item 1A. “Risk Factors” in our
Form 10-K filed with the Commission on August 13, 2020. The information set forth therein and in this Report could materially affect
our business, financial position and results of operations. There are no material changes from the risk factors set forth the 10-K,
except as follows:
As a result of the clinical hold
that has been placed on our IND by the FDA, it may take considerable time and expense to respond to the FDA and no assurance can
be given that the FDA will remove the clinical hold in which case our business and prospects will likely suffer material adverse
consequences.
On October 1, 2020, we received notice
that the FDA had placed our IND for a planned Phase 2b clinical trial in LAPC on clinical hold. As part of the clinical hold process,
the FDA has asked for additional information, tasks to be performed by us and new preclinical studies. It may take a considerable
period of time, the length of which is unknown at this time, for us to conduct such tasks and preclinical studies and to generate
and prepare the requested information. In addition, the significant expense of such work is likely to require us to raise additional
capital. It is possible that the service providers that we will utilize for such work may have considerable backlogs and/or are
suffering from slowdowns as a result of COVID-19 and may not be able to perform such work for an extended period of time. Even
if we are able to fully respond to the FDA’s requests, they may subsequently make additional requests that we would need
to fulfill prior to the lifting of the clinical hold and we may never be able to begin our clinical trial in LAPC, obtain regulatory
approval or obtain commercialization for our product candidates. An inability to conduct clinical trial in LAPC as a result of
the clinical hold or otherwise, would likely force us to terminate our clinical development plans. It is possible that we will
be unable to fully respond to the FDA in a satisfactory manner, and as a result the clinical hold may never be lifted. If the clinical
hold is not lifted or if the lifting takes an extended period of time, our business and prospects will likely suffer material adverse
consequences.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.