Proteon Therapeutics Announces Third Quarter 2017 Financial Results
“I am pleased that we remain on-track to complete enrollment in the first quarter of 2018 in PATENCY-2, our second Phase 3 clinical trial of vonapanitase,” said
Recent Highlights for 2017
Strengthened Board of Directors with leadership and industry expertise. Proteon strengthened its Board of Directors with the appointment of
PATENCY-2 enrollment on track for completion in Q1 2018. PATENCY-2 is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial expected to enroll 600 patients with chronic kidney disease (CKD) in
Phase 3 PATENCY-1 clinical results were presented in Q3 at the (i)
In Q2, vonapanitase received Breakthrough Therapy Designation from the
The Company continues enrollment in a Phase 1 clinical study of vonapanitase in patients with peripheral artery disease (PAD). The multicenter, randomized, double-blind, placebo-controlled Phase 1 dose escalation study is expected to enroll 24 symptomatic PAD patients being treated with balloon angioplasty of an artery below the knee and to follow each patient for up to seven months. Immediately following successful angioplasty, vonapanitase or placebo is delivered to the arterial wall using the Mercator MedSystems Bullfrog® Micro-Infusion Catheter. The primary outcome measure of the study is safety and the secondary outcome measure is technical feasibility of study drug delivery via the catheter.
Upcoming Key Milestones
- Complete enrollment of 600 patients in PATENCY-2 in the first quarter of 2018.
- Enroll 24 patients in the PAD Phase 1 trial.
- Presentation at BIO-EUROPE 2017 on
November 7th in Berlin.
- Presentation by
Barry Browne, M.D., at the Controversies in Dialysis Access (CiDA) on November 9th in San Diego.
- Presentation at the Stifel 2017 Healthcare Conference
November 15th in New York City, NY.
- Presentation by
Keith Ozaki, M.D., at the 44th Annual VEITH Symposium on November 18th in New York City.
Third quarter 2017 Financial Results
Cash, cash equivalents and available-for-sale investments totaled
R&D expenses: Research and development expenses for the third quarter of 2017 were
G&A expenses: General and administrative expenses for the third quarter of 2017 were
Net loss: Net loss for the third quarter of 2017 was
Financial guidance: The Company expects that its cash, cash equivalents and available-for-sale investments will be sufficient to fund its operations into the fourth quarter of 2019, based on the Company’s current operating plan.
Vonapanitase is an investigational drug intended to improve hemodialysis vascular access outcomes. Vonapanitase is applied in a single administration and is currently being studied in a Phase 3 clinical trial in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis. Vonapanitase has received breakthrough therapy, fast track and orphan drug designations from the
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that are, or may be deemed to be, "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the terms “estimates,” “anticipates,” "expects,” “plans,” "intends,” “may,” or “will,” in each case, their negatives or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements, including the number of patients to be enrolled in and the timing of enrollment in the Company’s ongoing clinical trials of vonapanitase, when the Company expects to report top-line data from the PATENCY-2 trial, the effect or benefit of vonapanitase in patients with CKD, whether vonapanitase improves fistula patency or use for hemodialysis, the potential surgical and endovascular applications for vonapanitase, including PAD, the sufficiency of the Company’s cash, cash-equivalents and available-for-sale investments to fund the Company’s operations into the fourth quarter of 2019, and those relating to future events or our future financial performance or condition, involve substantial known and unknown risks, uncertainties and other important factors that may cause our actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties and other factors, including whether our cash resources will be sufficient to fund the Company’s operating expenses and capital expenditure requirements for the period anticipated; whether data from early nonclinical or clinical studies will be indicative of the data that will be obtained from future clinical trials; whether vonapanitase will advance through the clinical trial process on the anticipated timeline and warrant submission for regulatory approval; whether such a submission would receive approval from the
|Proteon Therapeutics, Inc.
|Consolidated Balance Sheet Data
|September 30,||December 31,|
|Cash, cash equivalents and available-for-sale investments||$||47,430||$||41,317|
|Prepaid expenses and other current assets||554||1,438|
|Property and equipment, net and other non-current assets||580||765|
|Accounts payable and accrued expenses||$||9,094||$||5,079|
|Preferred Stock, common stock and additional paid-in-capital||223,667||198,218|
|Accumulated deficit and accumulated other comprehensive income||(184,197||)||(159,777||)|
|Total liabilities and stockholders’ deficit||$||48,564||$||43,520|
|Proteon Therapeutics, Inc.|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended
|Nine Months Ended
|Research and development||$||10,336||$||4,842||$||18,473||$||14,432|
|General and administrative||1,970||2,324||6,299||7,407|
|Total operating expenses||12,306||7,166||24,772||21,839|
|Loss from operations||(12,306||)||(7,166||)||(24,772||)||(21,839||)|
|Other income (expense):|
|Other (expense) income, net||(84||)||13||198||120|
|Total other (expense) income||(1||)||59||359||275|
|Accretion of convertible preferred stock||(6,747||)||-||(6,747||)||-|
|Net loss attributable to common stockholders||$||(19,054||)||$||(7,107||)||$||(31,160||)||$||(21,564||)|
|Net loss per share attributable to common stockholders - basic and diluted||$||(1.08||)||$||(0.43||)||$||(1.82||)||$||(1.30||)|
|Weighted-average common shares outstanding used in net loss per share attributable to common stockholders - basic and diluted||17,574,371||16,582,276||17,158,032||16,550,483|
|Supplemental disclosure of stock-based compensation expense and loss from currency forward contracts:|
|Included in operating expenses, above, are the following amounts for non-cash stock based compensation expense:|
|Research and development||$||235||$||168||$||841||$||797|
|General and administrative||513||519||1,618||1,702|
|Included in other expense, above, are the following amounts from forward foreign currency contracts:|
|Realized (losses) gains from forward foreign currency contracts||$||-||$||(4||)||$||-||$||(8||)|
|Unrealized (losses) gains from forward foreign currency contracts||-||2||-||127|
Source: Proteon Therapeutics, Inc.