Proteon Therapeutics, Inc. Announces Third Quarter 2014 Financial Results

WALTHAM, Mass., Nov. 25, 2014 (GLOBE NEWSWIRE) -- Proteon Therapeutics Inc. (Nasdaq:PRTO), a company developing novel, first-in-class pharmaceuticals to address the medical needs of patients with kidney and vascular diseases, today reported financial results for the quarter ended September 30, 2014, and recent business highlights.

"It has been an exciting quarter for Proteon as we initiated a Phase 3 clinical study of PRT-201 in chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula (AVF)," said Timothy Noyes, President and Chief Executive Officer of Proteon. "We also raised additional capital in our initial public offering, enabling us to accelerate the initiation of our second Phase 3 clinical study of PRT-201 and fund additional research and development activities."

Third Quarter and Recent Highlights:

In July 2014, the Company treated its first patient in a Phase 3 clinical study of its lead product, PRT-201. Patient enrollment is progressing as expected and the study is on track for data to be available in the first quarter of 2017.

In October 2014, the Company closed its initial public offering raising gross proceeds of $61.1 million. In November 2014, the underwriters exercised their 30-day option and purchased 916,500 additional shares of common stock increasing the total gross proceeds from the initial public offering to $70.3 million. After deducting underwriting discounts and commissions and offering-related expenses, total net proceeds generated, when including the underwriters' overallotment purchase, were approximately $62.5 million.

Cash, cash equivalents and marketable securities totaled $21.7 million as of September 30, 2014, compared to $5.2 million as of December 31, 2013. With such capital and with the net proceeds of $62.5 million from our initial public offering, we believe we can fund our operations into 2018.

Revenue was $2.9 million for the third quarter of 2014 and related to deferred revenue recognized as revenue upon the expiration in August 2014 of residual rights under an option agreement with a major pharmaceutical company originally entered into in 2009.

Research and development expenses were $1.8 million for the third quarter of 2014 compared to $1.0 million for the same period in 2013. The increase was due primarily to the initiation of our Phase 3 trial in the third quarter of 2014.

General and administrative expenses were $1.0 million for the third quarter of 2014 compared to $0.9 million for the same period in 2013. The increase was due primarily to higher headcount in 2014 than in 2013.

Other expense, net was ($5.3) million for the third quarter of 2014 compared to ($189,000) for the same period in 2013. In connection with our Series D financing in May 2014, the investors received rights to purchase additional shares of Series D preferred stock. These investor rights represented financial instruments, which were accounted for as a liability. The non-cash increase in the fair value of such liability was $5.3 million in the third quarter of 2014 as the likelihood of the Company's initial public offering had increased during the quarter. The Series D investor rights obligation was settled during the fourth quarter as part of our initial public offering and the liability decreased to zero.

Net loss for the three months ended September 30, 2014 was $5.2 million, or $31.03 per share, as compared to a net loss of $2.1 million, or $15.60 per share, for the same period in 2013. Net loss includes stock-based compensation expense of $0.2 million for the third quarter of 2014 and $21,000 for the third quarter of 2013.

Proteon Therapeutics will not be conducting a conference call in conjunction with this earnings release.

About PRT-201

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. PRT-201 has received fast track and orphan drug designations from the Food and Drug Administration and orphan medicinal product designation from the European Commission for hemodialysis vascular access indications.

About Proteon Therapeutics

Proteon Therapeutics Inc. is developing novel, first-in-class pharmaceuticals to address the medical needs of patients with kidney and vascular diseases. The company is headquartered in Waltham, Mass. For additional information, please visit www.proteontherapeutics.com.

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