Proteon Therapeutics Announces Fourth Quarter and Full-Year 2014 Financial Results
"In 2014, Proteon made significant clinical and operational progress in advancing the development of vonapanitase, formerly known as PRT-201," said
Initiated Phase 3 clinical study of vonapanitase. In
Commenced manufacturing validation effort. As part of the Company's effort to prepare (and assuming a successful outcome in its ongoing Phase 3 clinical study), Proteon accelerated its Chemistry, Manufacturing, and Controls, or CMC, activities and initiated the validation work.
Completed enrollment in peripheral artery disease (PAD) Phase 1 clinical study. The Company completed full enrollment of its Phase 1 clinical study in patients with symptomatic PAD of the superficial femoral or popliteal artery. Immediately following successful angioplasty, patients received vonapanitase delivered to the arterial wall via a drug delivery catheter. The Company expects data from this study to be released in the second half of 2015.
Obtained Generic name assignment from USAN and WHO.
Strengthened balance sheet. The Company raised approximately
Key Milestones for 2015
Plan to present in late March up to three years of data from the Company's AVF Phase 2 clinical study of vonapanitase.
Expect to treat the first patient by
June 30th in Proteon's second AVF Phase 3 clinical study of vonapanitase.
Plan to present in the second half of 2015 results from the Company's ongoing PAD Phase 1 clinical study of vonapanitase.
- Expect to complete enrollment by yearend in Proteon's first AVF Phase 3 clinical study of vonapanitase.
Fourth Quarter and Full-Year 2014 Financial Results
Cash position: Cash, cash equivalents and available-for-sale investments totaled
Revenues: Revenue in 2014 was
R&D expenses: Research and development expenses for 2014 were
G&A expenses: General and administrative expenses for 2014 were
Other income: Other income for 2014 was
Net loss: Net loss for 2014 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.
About Vonapanitase (PRT-201)
Vonapanitase (formerly PRT-201) is an investigational recombinant human elastase that is being studied for its ability to improve outcomes in patients suffering from vascular disease. Elastase has been shown in preclinical settings to reduce neointimal hyperplasia formation, which may result in improved blood flow and prolonged vessel patency. 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 initiation of the second phase 3 clinical study, patient enrollment in the phase 3 clinical study, timing for availability of data, timing for presentation of data from our AVF Phase 2 clinical study, timing to present results for our ongoing PAD Phase 1 clinical study, ability to fund operations, 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 our operating expenses and capital expenditure requirements for the period anticipated; whether data from early clinical trials 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 Food and Drug Administration or equivalent foreign regulatory agencies on a timely basis or at all; and whether we can successfully commercialize and market our product candidates, are described more fully in our Annual Report on Form 10-K for the year ended
|Proteon Therapeutics, Inc.|
|Consolidated Balance Sheet Data|
|Cash, cash equivalents and available-for-sale investments||$ 83,595||$ 5,152|
|Prepaid expenses and other current assets||1,006||178|
|Property and equipment, net and other non-current assets||197||329|
|Total assets||$ 84,798||$ 5,659|
|Accounts payable and accrued expenses||$ 2,338||$ 1,383|
|Preferred Stock, common stock and additional paid-in-capital||192,340||96,405|
|Accumulated deficit and accumulated other comprehensive loss||(109,880)||(100,514)|
|Total liabilities and stockholders' deficit||$ 84,798||$ 5,659|
|Proteon Therapeutics, Inc.|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Year Ended December 31,|
|Revenue||$ 2,948||$ --||$ --|
|Research and development||6,432||3,994||5,907|
|General and administrative||4,096||3,128||2,089|
|Total operating expenses||10,528||7,122||7,996|
|Loss from operations||(7,580)||(7,122)||(7,996)|
|Other income (expense):|
|Interest (expense) income, net||(833)||(857)||20|
|Total other income (expense)||4,238||(790)||26|
|Net loss||$ (3,342)||$ (7,912)||$ (7,970)|
|Net loss per share attributable to common stockholders - basic and diluted||$ (3.16)||$ (59.66)||$ (61.16)|
|Weighted-average common shares outstanding used in net loss per share attributable to common stockholders - basic and diluted||3,064,507||235,184||230,607|
|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||$ 114||$ 106||$ 46|
|General and administrative||345||49||64|
|Total||$ 459||$ 155||$ 110|