Proteon Therapeutics Announces First Quarter 2018 Financial Results
“I am pleased by our team’s many accomplishments in the first quarter of 2018, which keep Proteon on track for a potential BLA filing in 2019,” said
Recent Highlights for 2018
Enrollment completed in PATENCY-2, the second Phase 3 clinical trial of investigational vonapanitase, in
Successful completion of the three drug substance validation runs. The Company manufactured three batches of vonapanitase’s active pharmaceutical ingredient (API) in the second half of 2017, each of which met the intended release specifications in the first quarter of 2018. The Company expects to include documentation of the manufacturing process and results from these validation runs in a potential BLA filing in the second half of 2019 if positive topline data from the PATENCY-2 trial is released earlier in 2019. The API manufacturing campaign was validated at commercial scale at Lonza Ltd.’s facility in Visp, Switzerland.
Important amendment to the supply agreement with
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.
- 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
JMP Securities Life Science Conference June 20-21in New York City, NY.
- Presentation by
Keith Ozaki, M.D., at the Vascular Access Society of Americas (VASA) on May 12th in New Orleans.
First Quarter 2018 Financial Results
Cash, cash equivalents and available-for-sale investments totaled
R&D expenses: Research and development expenses for the first quarter of 2018 were
MG&A expenses: Marketing, general and administrative expenses for the first quarter of 2018 were
Net loss: Net loss for the first quarter of 2018 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|
|March 31,||December 31,|
|Cash, cash equivalents and available-for-sale investments||$||36,818||$||42,141|
|Prepaid expenses and other current assets||1,215||1,339|
|Property and equipment, net and other non-current assets||476||499|
|Accounts payable and accrued expenses||$||9,020||$||9,240|
|Preferred Stock, common stock and additional paid-in-capital||225,315||224,494|
|Accumulated deficit and accumulated other comprehensive income||(195,826||)||(189,755||)|
|Total liabilities and stockholders’ deficit||$||38,509||$||43,979|
|Proteon Therapeutics, Inc.|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended March 31,|
|Research and development||$||4,071||$||4,246|
|General and administrative||2,294||2,234|
|Total operating expenses||6,365||6,480|
|Loss from operations||(6,365||)||(6,480||)|
|Other income (expense):|
|Other income (expense), net||192||(50||)|
|Total other (expense) income||284||(18||)|
|Net loss per share attributable to common stockholders - basic and diluted||$||(0.34||)||$||(0.39||)|
|Weighted-average common shares outstanding used in net loss per share attributable to common stockholders - basic and diluted||17,674,729||16,636,201|
Source: Proteon Therapeutics, Inc.