Proteon Therapeutics Announces Fourth Quarter and Full-Year 2017 Financial Results
“With enrollment completed on schedule in PATENCY-2, our second Phase 3 clinical trial of investigational vonapanitase, we are now focused on study follow-up and preparing for a potential BLA filing in the fourth quarter of 2019,” said
2017 Highlights and Recent Events
Enrollment completed in PATENCY-2, the second Phase 3 clinical trial of investigational vonapanitase. PATENCY-2 is a multicenter, randomized, double-blind, placebo-controlled trial that treated 603 patients in
In the second quarter of 2017, vonapanitase received Breakthrough Therapy designation from the
In the third quarter of 2017, completed
Board of Directors Strengthened with leadership and industry expertise. Proteon strengthened its Board of Directors with the appointment of
Enrollment continues in a Phase 1 clinical trial of vonapanitase in patients with peripheral artery disease (PAD). The multicenter, randomized, double-blind, placebo-controlled Phase 1 dose escalation trial 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 trial is safety and the secondary outcome measure is technical feasibility of study drug delivery via the catheter.
- Completed enrollment of 603 treated patients in PATENCY-2 in
- Complete enrollment of 24 patients in the PAD Phase 1 trial by the fourth quarter of 2018.
- Release top-line data from PATENCY-2 in
- Presentation at the Cowen 38th Annual
Health Care Conference March 12th in Boston, MA.
- Presentation at the Oppenheimer’s 28th Annual Healthcare Conference
March 21st in New York, NY.
2017 Financial Results
Cash, cash equivalents and available-for-sale investments totaled
R&D expenses: Research and development expenses for 2017 were
MG&A expenses: Marketing, general and administrative expenses for 2017 were
Net loss: Net loss for 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
Proteon Therapeutics is committed to improving the health of patients with kidney and vascular diseases through the development of novel, first-in-class therapeutics. Proteon's lead product candidate, vonapanitase, is an investigational drug intended to improve hemodialysis vascular access outcomes. Proteon is evaluating vonapanitase in patients with CKD undergoing surgical creation of a radiocephalic arteriovenous fistula. Proteon is also evaluating vonapanitase in a Phase 1 clinical trial in patients with PAD. For more information, please visit www.proteontx.com.
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 Phase 1 clinical trial of vonapanitase in patients with peripheral artery disease (PAD), when the Company expects to release top-line data from the PATENCY-2 trial, whether and when the Company may submit a Biologics License Application (BLA) in
|Proteon Therapeutics, Inc.|
|Consolidated Balance Sheet Data|
|Cash, cash equivalents and available-for-sale investments||$||42,141||$||41,317|
|Prepaid expenses and other current assets||1,339||1,438|
|Property and equipment, net and other non-current assets||499||765|
|Accounts payable and accrued expenses||$||9,240||$||5,079|
|Preferred Stock, common stock and additional paid-in-capital||224,494||198,218|
|Accumulated deficit and accumulated other comprehensive loss||(189,755||)||(159,777||)|
|Total liabilities and stockholders’ deficit||$||43,979||$||43,520|
|Proteon Therapeutics, Inc.|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Year Ended December 31,|
|Research and development||$||21,686||$||18,869||$||12,381|
|General and administrative||8,676||9,836||8,489|
|Total operating expenses||30,362||28,705||20,870|
|Loss from operations||(30,362||)||(28,705||)||(20,870||)|
|Other income (expense):|
|Other (expense) income||139||(14||)||(651||)|
|Total other (expense) income||398||179||(507||)|
|Accretion of redeemable convertible preferred stock to redemption value||(6,747||)||-||-|
|Net loss attributable to common stockholders||$||(36,711||)||$||(28,526||)||$||(21,377||)|
|Net loss per share attributable to common stockholders - basic and diluted||$||(2.13||)||$||(1.72||)||$||(1.30||)|
|Weighted-average common shares outstanding used in net loss per share attributable to common stockholders - basic and diluted||17,274,326||16,561,799||16,464,123|
|Supplemental disclosure of stock-based compensation expense and loss from currency forward contracts:|
|Included in operating expenses, above, are the following amounts for non-cash stock based compensation expense:|
|Research and development||$||1,109||$||1,114||$||650|
|General and administrative||2,118||2,229||1,514|
|Included in other expense, above, are the following amounts from forward foreign currency contracts:|
|Realized losses from forward foreign currency contracts||$||-||$||(61||)||$||(52||)|
|Unrealized losses from forward foreign currency contracts||-||127||(537||)|
Source: Proteon Therapeutics, Inc.