WALTHAM, Mass., Aug. 07, 2018 (GLOBE NEWSWIRE) -- 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 June 30, 2018, and recent business highlights.
“Our team made excellent progress in the second quarter of 2018,” said Timothy Noyes, President and Chief Executive Officer of Proteon. “We remain on track to release top-line data from PATENCY-2 in March 2019 and potentially file a BLA later that year. We also executed a long-term contract extension with Lonza for the commercial supply of investigational vonapanitase, an agreement that we believe reflects the strength of our relationship with Lonza and the robustness of our manufacturing process.”
Recent Highlights for 2018
Phase 3 PATENCY-2 clinical trial continues to follow patients, with top-line data expected in March 2019. PATENCY-2 is a multicenter, randomized, double-blind, placebo-controlled trial of investigational vonapanitase that treated 603 patients in the United States and Canada with chronic kidney disease (CKD) undergoing surgical creation of a radiocephalic arteriovenous fistula for hemodialysis. The study’s co-primary endpoints are fistula use for hemodialysis and secondary patency (i.e., time to fistula abandonment), each of which demonstrated improvements in PATENCY-1 using the same definitions as in PATENCY-2. If PATENCY-2 is successful in showing statistical significance (p?0.05) on each of the co-primary endpoints, Proteon expects to file a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) in the second half of 2019 and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in 2020.
Important amendment to the supply agreement with Lonza was signed, securing a potential long-term commercial supply of active pharmaceutical ingredient (API) for vonapanitase. Lonza has manufactured API for Proteon at its microbial manufacturing facility in Visp, Switzerland, since 2009. The amendment extends the term of the supply agreement until 2029.
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.
Key Milestones
- 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 March 2019.
Upcoming Events
- Presentation at two investor conferences in New York City, NY: the 2018 Baird Healthcare Conference September 5-6 and the Rodman & Renshaw 20th Annual Global Investment Conference September 4-6.
- Presentation by Timmy Lee, M.D., at Controversies in Dialysis Access (CiDA) on November 1st in Washington, DC.
- Presentation by Keith Ozaki, M.D., at the VEITH Symposium on November 17th in New York City, NY.
- Presentation by Steven Burke, M.D., at the Vascular Access Society of Britain and Ireland on September 28th in Portsmouth England.
Second Quarter 2018 Financial Results
Cash, cash equivalents and available-for-sale investments totaled $26.5 million as of June 30, 2018, compared to $42.1 million as of December 31, 2017. The decrease was primarily driven by operational costs for the first six-month period of 2018.
R&D expenses: Research and development expenses for the second quarter of 2018 were $2.8 million as compared to $3.9 million for the second quarter of 2017. The decrease in R&D expenses was due primarily to decreased expenses for our manufacturing validation efforts and for our ongoing clinical trials in the second quarter of 2018 as compared to the second quarter of 2017.
MG&A expenses: Marketing, general and administrative expenses for the second quarter of 2018 were $2.3 million as compared to $2.1 million for the second quarter of 2017. The increase in MG&A expenses was due primarily to higher overhead and personnel expenses in the second quarter of 2018 as compared to the second quarter of 2017.
Net loss: Net loss for the second quarter of 2018 was $4.9 million as compared to $5.6 million for the second quarter of 2017. Net loss included stock-based compensation expense of $0.9 million for the second quarter of 2018 and $0.9 million for the second quarter of 2017.
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.
About Vonapanitase
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 FDA, and Orphan Medicinal Product designation from the European Commission, for hemodialysis vascular access indications. In addition, vonapanitase may have other surgical and endovascular applications in diseases or conditions in which vessel injury leads to blockages in blood vessels and reduced blood flow. Proteon is currently conducting a Phase 1 clinical trial of vonapanitase in patients with peripheral artery disease (PAD).
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 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.
