Proteon Therapeutics, Inc. (NASDAQ:PRTO), a company developing novel, first-in-class therapeutics to address the medical needs of patients with kidney and vascular diseases, today announced its financial results for the quarter ended September 30, 2016, and recent business highlights.
“We are making strong progress in our Phase 3 program for investigational vonapanitase,” said Timothy Noyes, President and Chief Executive Officer of Proteon. “PATENCY-1 top-line results are expected in December, and our second Phase 3 trial, PATENCY-2, is on track to complete patient enrollment in the first quarter of 2017.”
Recent Highlights for 2016
Overview of Phase 1 clinical program of vonapanitase in peripheral artery disease (PAD) presented at the 28th Transcatheter Cardiovascular Therapeutics (TCT) Conference. Dr. Ehrin J. Armstrong, Associate Professor, Medicine-Cardiology at University of Colorado School of Medicine and Director, Interventional Cardiology VA Eastern Colorado Healthcare System, discussed Proteon’s two additional Phase 1 clinical studies evaluating vonapanitase in patients with PAD. These multicenter, dose-escalation studies will evaluate the safety and technical feasibility of a single administration of vonapanitase as a monotherapy and as an adjunct to angioplasty for patients with PAD.
Board of Directors strengthened with additional operating and leadership expertise. Proteon strengthened its Board of Directors with the appointment of Paul J. Hastings as Chairman. Paul brings substantial experience in the board room having been a lead director and/or chairman at multiple biotechnology companies. He also brings significant operational and commercial experience, having successfully led several biotechnology companies as their chief executive officer.
Key Milestones for 2016 and Early 2017
Report top-line data in December 2016 for PATENCY-1, the first Phase 3 clinical study of investigational vonapanitase in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula (AVF) for hemodialysis.
Complete enrollment in the first quarter of 2017 for PATENCY-2, the second Phase 3 clinical study of investigational vonapanitase.
Upcoming Events
Presentation at the Stifel 2016 Healthcare Conference on November 16th at 8:00 a.m. in New York City.
Participation in the Oppenheimer Life Sciences Summit on November 29th in New York City.
Third Quarter 2016 Financial Results
Cash position: Cash, cash equivalents and available-for-sale investments totaled $47.0 million as of September 30, 2016, compared to $65.3 million as of December 31, 2015. The decrease was driven by operational costs for the first nine-month period of 2016.
R&D expenses: Research and development expenses for the third quarter of 2016 were $4.8 million as compared to $3.1 million for the third quarter of 2015. The increase in R&D expenses was due primarily to increased expenses for our manufacturing pre-validation and validation efforts; increased external clinical expenses related to our ongoing radiocephalic AVF Phase 3 clinical trials and our PAD Phase 1 clinical trials; and increased personnel costs.
G&A expenses: General and administrative expenses for the third quarter of 2016 were $2.3 million as compared to $2.0 million for the third quarter of 2015. The increase in G&A expenses was due primarily to higher personnel costs in the third quarter of 2016 than in the third quarter of 2015.
Net loss: Net loss for the third quarter of 2016 was $7.1 million as compared to $5.4 million for the third quarter of 2015. Net loss included stock-based compensation expense of $0.7 million for the third quarter of 2016 and $0.6 million for the third quarter of 2015.
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 2017.
About Vonapanitase
Vonapanitase (formerly PRT-201) is an investigational drug designed to treat vessel injury response that leads to blockages in blood vessels and reduced blood flow. Vonapanitase is applied in a single administration and is currently being studied in two Phase 3 clinical trials, PATENCY-1 and PATENCY-2, in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula (AVF) for hemodialysis, and two Phase 1 clinical trials in patients with peripheral artery disease (PAD). Vonapanitase has received fast track and orphan drug designations from the U.S. Food and Drug Administration (FDA), and orphan medicinal product designation from the European Commission, for hemodialysis vascular access indications.
About Proteon Therapeutics
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 arteriovenous fistula (AVF) patency, the period of time during which an AVF remains open with adequate blood flow to enable hemodialysis. Proteon is currently evaluating vonapanitase in two Phase 3 clinical trials, PATENCY-1 and PATENCY-2, in patients with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic AVF for hemodialysis, and two Phase 1 clinical trials in patients with peripheral artery disease (PAD). For more information, please visit www.proteontherapeutics.com.
