Upon inspection, 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.