During the nine months
ended September 30, 2017, our total research and development expenses increased by $4.0 million primarily due to an increase of
$4.6 million in our manufacturing pre-validation and validation efforts in the nine months ended September 30, 2017 as compared
to the nine months ended September 30, 2016 and offset by $0.3 million in lower clinical expenses related to our ongoing radiocephalic
AVF Phase 3 and our PAD clinical trials and a decrease of $0.3 million in our internal research and development expenses in the
nine months ended September 30, 2017 as compared to the nine months ended September 30, 2017.
General and Administrative
Expenses. During the nine months ended September 30, 2017, our total general and administrative expenses were $1.1 million
lower as compared to the nine months ended September 30, 2016 primarily due to decreased overhead and personnel expenses.
During the nine months ended September 30, 2017, investment income decreased by an immaterial amount.
Other Income, Net.
During the nine months ended September 30, 2017, other income, net changed by $0.1 million primarily due to foreign currency
remeasurement gain of $0.2 million for cash denominated in Swiss Francs and the change in the nine months ended September 30, 2016
in the fair value associated with the forward foreign currency contracts we entered into in the second quarter of 2015. As of December
31, 2016, all forward foreign currency contracts had been settled and are no longer outstanding.
Liquidity and Capital Resources
Since our inception and through the nine months ended September 30, 2017, we had received $197.2 million in
net proceeds comprised of $115.5 million from the issuance of private equity securities, $7.7 million from the issuance of convertible
notes, $10.0 million from business development activities, $0.2 million from government grants, $62.5 million from our IPO and
$1.3 million from the sale of common stock under our ATM program. As of September 30, 2017, our cash and cash equivalents and available-for-sale
investments totaled $47.4 million.
Operating Capital Requirements
We expect to incur
increasing operating losses for at least the next several years as we (i) conduct our Phase 3 clinical trials for vonapanitase
in radiocephalic fistulas, thereafter seeking marketing approval for vonapanitase in radiocephalic fistulas assuming successful
trial outcomes, and (ii) pursue development of vonapanitase for additional indications, including brachiocephalic arteriovenous
fistulas and grafts. We may not be able to complete the development and initiate commercialization of vonapanitase if, among other
things, our clinical trials are not successful, the FDA does not approve vonapanitase, or the FDA does not approve vonapanitase
when we expect.
We believe that our
cash and cash equivalents and available-for-sale investments as of September 30, 2017 will be sufficient to fund our operating
expenses and capital expenditure requirements into the fourth quarter of 2019. We believe that these funds will be sufficient to
enable us to report top line data from our second Phase 3 trial of vonapanitase in radiocephalic fistulas, named PATENCY-2 and
to fund our ongoing development and CMC activities.
Our forecast of the
period of time through which our financial resources will be adequate to support our operations is a forward-looking statement
and involves risks and uncertainties, and actual results could vary as a result of a number of factors. We have based this estimate
on assumptions that may prove to be wrong and we could exhaust our available capital resources sooner than we currently expect.
Our future funding requirements, both near and long-term, will depend on many factors, including:
||the timing and costs of our Phase 3 clinical trial of vonapanitase in radiocephalic fistulas;|
||the timing and costs of developing vonapanitase for additional indications, including PAD;|
||the outcome, timing and costs of seeking regulatory approvals;|