||create additional infrastructure to support our operations as a public company and our product development; and|
||experience any delays or encounter issues with any of the above.|
The net losses we incur may fluctuate significantly
from quarter to quarter and year to year, such that a period-to-period comparison of our results of operations may not be a good
indication of our future performance. In any particular quarter or quarters, our operating results could be below the expectations
of securities analysts or investors, which could cause our stock price to decline.
We will require substantial additional financing to achieve
our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay,
limit, reduce or terminate our product development, any commercialization efforts or other operations.
Our operations have consumed substantial
amounts of cash since inception. As of June 30, 2017, our cash, cash equivalents and available-for-sale investments were $31.7
million. Our research and development expenses were $8.1 million and $9.6 million for the six months ended June 30, 2017 and 2016,
respectively. We believe that we will continue to expend substantial resources for the foreseeable future developing vonapanitase
and any additional product candidates. These expenditures will include costs associated with research and development, potentially
acquiring new technologies, potentially obtaining regulatory approvals and manufacturing products, as well as marketing and selling
products approved for sale, if any. In addition, other unanticipated costs may arise. Because the outcome of our planned and anticipated
clinical trials is highly uncertain, we cannot reasonably estimate the actual amounts necessary to fund and successfully complete
the development and commercialization of vonapanitase or any additional product candidates.
We began enrolling
patients in our first Phase 3 clinical trial of vonapanitase during the third quarter of 2014 for patients undergoing creation
of radiocephalic fistulas, completed patient enrollment in October 2015 and released top-line data in December 2016. We enrolled
the first patient in our second Phase 3 trial in August 2015, expect to complete enrollment in the first quarter of 2018 and expect
to release top-line data in the first quarter of 2019. As of the closing of our $22 million preferred equity financing on August
2, 2017 and based on our current operating plan, and absent any future financings or strategic partnerships, we believe that our
existing cash, cash equivalents and available-for-sale investments will be sufficient to fund our projected operating expenses
and capital expenditure requirements into the fourth quarter of 2019, allowing us to report top-line data from our second Phase
3 trial of vonapanitase in radiocephalic fistulas, named PATENCY-2. Our cash runway could be shortened if there are any significant
and unexpected increases in spending on development programs or more rapid progress of development programs than anticipated. In
addition, we initiated two Phase 1 clinical trials of vonapanitase in patients with PAD in the fourth quarter of 2016. We may increase
the planned enrollment in the Phase 1 trial evaluating vonapanitase as an adjunct to angioplasty for PAD below the knee and begin
patient enrollment in the Phase 1 trial evaluating vonapanitase as a monotherapy for PAD above the knee. We may also initiate other
small Phase 1 or Phase 1/2 trials in additional indications, which would further reduce our capital resources. However, we do not
expect to initiate any other Phase 2 or Phase 3 trials prior to receiving and reviewing data from our second Phase 3 clinical trial.
Furthermore, our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional
funds sooner than planned, through public or private equity or debt financings, government or other third-party funding, marketing
and distribution arrangements and other collaborations, strategic alliances and licensing arrangements, or a combination of these
approaches. Even if we believe we have sufficient funds for our current or future operating plans, we may seek additional capital
if market conditions are favorable or if we have specific strategic considerations.
Additional fundraising efforts may
divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize vonapanitase
or any additional product candidates. In addition, we cannot guarantee that future financing will be available in sufficient amounts
or on terms acceptable to us, or at all. We could also be required to seek funds through arrangements with collaborative partners
or otherwise at an earlier stage than would otherwise be ideal and we may be required to relinquish rights to vonapanitase or any
additional product candidates, or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on
our business, operating results and prospects.