Proteon Therapeutics Announces Second Quarter 2015 Financial Results
"I am pleased that the first Phase 3 clinical study of vonapanitase is on track to complete enrollment by the end of the year and that we recently enrolled our first patient in our second Phase 3 clinical study of vonapanitase," said
Recent Highlights for 2015
Enrollment in the first Phase 3 clinical study of investigational vonapanitase (formerly known as PRT-201) is on track for completion by year-end. In
First patient enrolled in second Phase 3 clinical study of vonapanitase. The Company recently announced enrollment of the first patient in its second Phase 3 study of vonapanitase. The second Phase 3 study, like the first Phase 3 study, is a randomized, double-blind, placebo-controlled study expected to enroll 300 patients with CKD undergoing surgical creation of a radiocephalic AVF for hemodialysis. The primary and secondary efficacy endpoints are the same as the first Phase 3 clinical study. The Company has not provided guidance as to when data from the second Phase 3 study will be available.
Top-line results from Phase 1 clinical study of vonapanitase. The Company recently announced top-line results in 14 patients from its Phase 1 study of vonapanitase with symptomatic peripheral artery disease (PAD). The open-label, single center Phase 1 dose escalation study enrolled patients being treated with balloon angioplasty due to symptomatic PAD of the superficial femoral or popliteal artery. Immediately following successful angioplasty, vonapanitase was delivered to the arterial wall using the Mercator MedSystems Bullfrog® Micro-Infusion Catheter. The primary endpoint of the study was safety and the secondary endpoint was technical feasibility of drug delivery via the catheter. The data suggested that catheter-based treatment with vonapanitase was generally well tolerated and technically feasible.
Key Milestones for 2015
- Plans to present at an upcoming medical meeting results from the Company's PAD Phase 1 clinical study of vonapanitase.
- Expects to complete enrollment by year-end in Proteon's first AVF Phase 3 clinical study of vonapanitase.
Second Quarter 2015 Financial Results
Cash position: Cash, cash equivalents and available-for-sale investments totaled
Revenues: No revenues were recorded in the second quarter of 2015 or in the second quarter of 2014.
R&D expenses: Research and development expenses for the second quarter of 2015 were
G&A expenses: General and administrative expenses for the second quarter of 2015 were
Other expenses: Other expenses for the second quarter of 2015 were
Net loss: Net loss for the second quarter of 2015 was
Financial guidance: The Company expects that its cash, cash equivalents and available-for-sale investments will be sufficient to fund its operations into 2018.
Foreign currency hedging: In the second quarter of 2015, Proteon entered into forward foreign currency contracts to reduce its foreign currency exposure through 2016 under a contract with the manufacturer of Proteon's active pharmaceutical ingredient (API). Proteon's contract with such manufacturer requires Proteon to make payments in Swiss Francs. In the future, Proteon may purchase additional forward foreign currency contracts for forecasted expenses denominated in other foreign currencies.
Vonapanitase (formerly PRT-201) is an investigational drug designed to improve arteriovenous fistula (AVF) patency, the period of time during which an AVF remains open with adequate blood flow to enable hemodialysis. Vonapanitase is applied in a single administration and is currently being studied in two Phase 3 clinical trials in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis. Vonapanitase has received 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." In some cases these forward-looking statements can be identified by the use of forward-looking terminology, including the terms "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately," "potential," or, in each case, their negatives or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements, including those regarding the overall patient enrollment in the second Phase 3 clinical study of vonapanitase, the timing of completion of patient enrollment in the first Phase 3 clinical study of vonapanitase, timing for availability of data from the first and second Phase 3 studies of vonapanitase, timing to present results for our ongoing PAD Phase 1 clinical study of vonapanitase, the sufficiency of the Company's cash, cash-equivalents and available-for-sale investments to fund the Company's operations, the amount of expenses to be incurred in connection with the
|Proteon Therapeutics, Inc.|
|Consolidated Balance Sheet Data|
|June 30,||December 31,|
|Cash, cash equivalents and available-for-sale investments||$ 74,736||$ 83,595|
|Prepaid expenses and other current assets||1,052||1,006|
|Property and equipment, net and other non-current assets||787||197|
|Total assets||$ 76,575||$ 84,798|
|Accounts payable, accrued expenses and other liabilities||$ 2,816||$ 2,338|
|Preferred Stock, common stock and additional paid-in-capital||193,282||192,340|
|Accumulated deficit and accumulated other comprehensive loss||(119,523)||(109,880)|
|Total liabilities and stockholders' deficit||$ 76,575||$ 84,798|
|Proteon Therapeutics, Inc.|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Research and development||$ 3,090||$ 1,596||$ 5,704||$ 2,785|
|General and administrative||1,891||912||3,900||1,656|
|Total operating expenses||4,981||2,508||9,603||4,441|
|Loss from operations||(4,981)||(2,508)||(9,603)||(4,441)|
|Other income (expense):|
|Interest income (expense), net||37||(26)||77||(854)|
|Total other income (expense)||(91)||(55)||(51)||(953)|
|Net loss||$ (5,072)||$ (2,563)||$ (9,654)||$ (5,394)|
|Net loss per share attributable to common stockholders - basic and diluted||$ (0.31)||$ (18.55)||$ (0.59)||$ (36.64)|
|Weighted-average common shares outstanding used in net loss per share attributable to common stockholders - basic and diluted||16,449,937||240,374||16,449,316||240,254|
|Supplemental disclosure of stock-based compensation expense:|
|Included in operating expenses, above, are the following amounts for non-cash stock based compensation expense:|
|Research and development||$ 138||$ 11||$ 247||$ 21|
|General and administrative||338||21||636||28|
|Total||$ 476||$ 32||$ 883||$ 49|
|Included in other expense, above, are the following amounts from forward foreign currency contracts:|
|Realized losses from forward foreign currency contracts||$ (14)||$ --||$ (14)||$ --|
|Unrealized losses from forward foreign currency contracts||(112)||--||(112)||--|
|Total||$ (126)||$ --||$ (126)||$ --|