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SEC Filings

10-Q
PROTEON THERAPEUTICS INC filed this Form 10-Q on 08/07/2017
Entire Document
 
 

 

Liquidity and Capital Resources

 

Since our inception and through the six months ended June 30, 2017, we had received $174.5 million in net proceeds comprised of $94.0 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 June 30, 2017, our cash and cash equivalents and available-for-sale investments totaled $31.7 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, when including the closing of our $22 million preferred equity financing on August 2, 2017 our cash and cash equivalents and available-for-sale investments as of June 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;

  · the costs of commercialization activities for vonapanitase in radiocephalic fistulas and other indications if we receive marketing approval, including the costs and timing of establishing product sales, marketing, distribution and manufacturing capabilities;

  · subject to receipt of marketing approval, revenue received from commercial sales of vonapanitase;

  · the terms and timing of any future collaborations, licensing, consulting or other arrangements that we may establish;

  · the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights, including royalty payments that we are obligated to pay to Johns Hopkins University pursuant to our assignment agreement related to vonapanitase;

  · the costs of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights and defending against intellectual property related claims; and

  · the extent to which we in-license or acquire other products and technologies.

 

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