the FDA may determine that our clinical trials did not comply with GCPs. In addition, our future clinical trials will require a
sufficient number of test subjects to evaluate the safety and efficacy of vonapanitase or any additional product candidates. Accordingly,
if our CROs fail to comply with these regulations or fail to recruit a sufficient number of patients, we may be required to repeat
such clinical trials, which would delay the regulatory approval process.
Our CROs are not our
employees, and we are therefore unable to monitor on a day-to-day basis whether or not they devote sufficient time and resources
to our clinical and preclinical programs. These CROs may also have relationships with other commercial entities, including our
competitors, for whom they may also be conducting clinical trials or other product development activities that could harm our competitive
position. If our CROs do not successfully carry out their contractual duties or obligations, fail to meet expected deadlines, or
if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols
or regulatory requirements, or for any other reasons, our clinical trials may be extended, delayed or terminated, and we may not
be able to obtain regulatory approval for, or successfully commercialize, vonapanitase or any additional product candidates. If
any such event were to occur, we may be subject to regulatory enforcement actions, our financial results and the commercial prospects
for vonapanitase or any additional product candidates would be harmed, our costs could increase, and our ability to generate revenues
could be delayed.
If any of our relationships
with these third-party CROs terminates, we may not be able to enter into arrangements with alternate CROs or to do so on commercially
reasonable terms. Further, switching or adding additional CROs involves additional costs and requires management time and focus.
In addition, a transition period may be required when a new CRO commences work. As a result, delays may occur, which could materially
impact our ability to meet our desired clinical development timelines. Though we carefully manage our relationships with our CROs,
there can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will
not have a material adverse impact on our business, financial condition and prospects.
We also rely on other
third parties to store and distribute our products for the clinical trials that we conduct. Any performance failure on the part
of our distributors could delay clinical development or marketing approval of vonapanitase or any additional product candidates
or commercialization of our product, if approved, producing additional losses and depriving us of potential product revenue.
We may seek to form partnerships
in the future with respect to vonapanitase or any additional product candidates, and we may not realize the benefits of such partnerships.
We may form partnerships,
create joint ventures or collaborations or enter into licensing arrangements with third parties for the development and commercialization
of vonapanitase or any additional product candidates. We face significant competition in seeking appropriate strategic partners
and the negotiation process is time-consuming and complex. Any delays in entering into new strategic partnership agreements related
to our product candidates could delay the development and commercialization of our product candidates and reduce their competitiveness
even if they reach the market. Moreover, we may not be successful in our efforts to establish a strategic partnership or other
collaborative arrangement for any additional product candidates. For example, potential partners may consider that our research
and development pipeline is insufficiently developed to justify a collaborative effort, or that vonapanitase or any additional
product candidates and programs do not have the requisite commercial or clinical potential in the target population. Even if we
are successful in establishing such a strategic partnership or collaboration, we cannot be certain that, following such a strategic
transaction or license, we will be able to progress the development and commercialization of the applicable product candidates
as envisioned, or that we will achieve the revenues that would justify such transaction.