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
financial results for the quarter ended March 31, 2017, and recent
business highlights.
“Proteon continues to make significant clinical
progress evaluating vonapanitase for patients with chronic kidney
disease and peripheral artery disease,” said Timothy Noyes,
President and Chief Executive Officer of Proteon. “We are greatly
encouraged by the FDA’s recent decision to award vonapanitase
Breakthrough Therapy designation and we remain on track to complete
enrollment in our Phase 3 PATENCY-2 trial in the first quarter of
2018. Additionally, we are on track to enroll 24 patients in our
Phase 1 clinical trial in patients with peripheral artery disease
by the end of the year.”
Recent Highlights for 2017
Vonapanitase receives Breakthrough
Therapy designation from the U.S. Food and Drug
Administration (FDA) for increasing arteriovenous fistula secondary
patency (i.e., survival of the fistula without abandonment) and use
for hemodialysis in patients on or expected to initiate
hemodialysis. Secondary patency and use for hemodialysis are the
co-primary endpoints in PATENCY-2, Proteon’s ongoing pivotal Phase
3 clinical trial evaluating investigational vonapanitase in
patients with chronic kidney disease (CKD) undergoing surgical
creation of a radiocephalic arteriovenous fistula for hemodialysis.
The FDA awards Breakthrough Therapy designations to expedite the
development and review of investigational drugs that are intended
to treat serious or life-threatening conditions and have
demonstrated preliminary clinical evidence that the treatment may
offer a substantial improvement over currently available therapies
on one or more clinically significant endpoints.
Written confirmation from the FDA on
PATENCY-2 Protocol Amendment. Proteon received written
confirmation from the FDA that, if the Phase 3 PATENCY-2 trial is
successful in showing statistical significance (p≤0.05) on each of
the co-primary endpoints, the PATENCY-2 trial together with data
from previously completed studies would provide the basis for a
Biologics License Application (BLA) submission as a single pivotal
study. Proteon amended the protocol for the PATENCY-2 trial in the
first quarter of 2017 following Proteon’s review of the complete
data sets from the PATENCY-1 trial and interactions with the FDA.
The protocol amendment reordered the existing endpoints,
establishing secondary patency and fistula use for hemodialysis as
co-primary endpoints, and increased the planned enrollment from 300
to 500 patients. Proteon further increased the planned enrollment
to 600 patients in the second quarter of 2017.
PATENCY-2 enrollment on track for
completion in Q1 2018. PATENCY-2 is a multicenter,
randomized, double-blind, placebo-controlled Phase 3 study expected
to enroll 600 patients with CKD undergoing surgical creation of a
radiocephalic arteriovenous fistula for hemodialysis in the United
States and Canada. The study’s co-primary endpoints are secondary
patency and fistula use for hemodialysis, each of which
demonstrated improvements in PATENCY-1 using the same definitions
as in PATENCY-2. Enrollment of 600 patients is expected in the
first quarter of 2018 and Proteon expects to report top-line data
in the first quarter of 2019.
Phase 3 PATENCY-1 clinical results were
presented at the (i) American Society of Diagnostic and
Interventional Nephrology 13th Annual Scientific meeting in New
Orleans, LA, (ii) 10th Congress of the Vascular Access Society in
Ljubljana, Slovenia, (iii) National Kidney Foundation 2017 Spring
Clinical Meetings in Orlando, FL, and (iv) Charing Cross Symposium
(CX 2017) in London, England.
The Company continues enrollment in a
Phase 1 clinical study of vonapanitase in patients with peripheral
artery disease (PAD). The multicenter, randomized,
double-blind, placebo-controlled Phase 1 dose escalation study is
expected to enroll this year 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 study
will be safety and the secondary outcome measure will be technical
feasibility of study drug delivery via the catheter.
Upcoming Key Milestones
- Enroll 24 patients in the PAD Phase 1 trial before the end of
2017.
- Complete enrollment of 600 patients in PATENCY-2 in the first
quarter of 2018.
Upcoming Events
- Presentations at the JMP Securities Life Science Conference
June 20-21 in New York City, NY.
First Quarter 2017 Financial
Results
Cash, cash equivalents and available-for-sale
investments totaled $34.1 million as of March 31, 2017, compared to
$41.3 million as of December 31, 2016. The decrease was driven by
operational costs for the first three-month period of 2017.
R&D expenses: Research and
development expenses for the first quarter of 2017 were $4.2
million as compared to $4.3 million for the first quarter of 2016.
The decrease in R&D expenses was due primarily to a decrease in
our manufacturing pre-validation and validation expenses in the
first quarter of 2017 as compared to the first quarter of 2016.
G&A expenses: General and
administrative expenses for the first quarter of 2017 were $2.2
million as compared to $2.5 million for the first quarter of 2016.
The decrease in G&A expenses was due primarily to lower
corporate overhead expenses and lower expenses associated with
being a public reporting company in the first quarter of 2017 than
in the first quarter of 2016.
Net loss: Net loss for the
first quarter of 2017 was $6.5 million as compared to $6.6 million
for the first quarter of 2016. Net loss included stock-based
compensation expense of $0.8 million for the first quarter of 2017
and $0.9 million for the first quarter of 2016.
Financial guidance: The Company
expects that its cash, cash equivalents and available-for-sale
investments will be sufficient to fund its operations into the
third quarter of 2018.
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 program 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 currently enrolling patients in PATENCY-2, a Phase 3 clinical
trial evaluating vonapanitase in patients with CKD undergoing
surgical creation of a radiocephalic arteriovenous fistula for
hemodialysis. 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." 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 clinical trials of vonapanitase, when the
Company expects to report top-line data from the PATENCY-2 trial,
whether the PATENCY-2 trial will serve as a single pivotal trial or
additional studies will be necessary to support a BLA submission,
the effect or benefit of vonapanitase in patients with CKD, whether
vonapanitase improves fistula patency or use for hemodialysis, the
potential surgical and endovascular applications for vonapanitase,
including PAD, the sufficiency of the Company’s cash,
cash-equivalents and available-for-sale investments to fund the
Company’s operations into the third quarter of 2018, and those
relating to future events or our future financial performance or
condition, involve substantial known and unknown risks,
uncertainties and other important factors that may cause our actual
results, levels of activity, performance or achievements to differ
materially from those expressed or implied by these forward-looking
statements. These risks, uncertainties and other factors, including
whether our cash resources will be sufficient to fund our operating
expenses and capital expenditure requirements for the period
anticipated; whether data from early nonclinical or clinical
studies will be indicative of the data that will be obtained from
future clinical trials; whether vonapanitase will advance through
the clinical trial process on the anticipated timeline and warrant
submission for regulatory approval; whether such a submission would
receive approval from the U.S. Food and Drug Administration or
equivalent foreign regulatory agencies on a timely basis or at all;
and whether we can successfully commercialize and market our
product candidates, are described more fully in our Annual Report
on Form 10-K for the year ended December 31, 2016, as filed with
the Securities and Exchange Commission (“SEC”) on March 16, 2017,
and our subsequent Quarterly Reports on Form 10-Q and Current
Reports on Form 8-K, as filed with the SEC, particularly in the
sections titled “Risk Factors” and “Management's Discussion and
Analysis of Financial Condition and Results of Operations.” In
light of the significant uncertainties in our forward-looking
statements, you should not place undue reliance on these statements
or regard these statements as a representation or warranty by us or
any other person that we will achieve our objectives and plans in
any specified time frame, or at all. The forward-looking statements
contained in this press release represent our estimates and
assumptions only as of the date of this press release and, except
as required by law, we undertake no obligation to update or revise
publicly any forward-looking statements, whether as a result of new
information, future events or otherwise after the date of this
press release.
Proteon Therapeutics, Inc. |
|
Consolidated Balance Sheet Data |
|
(In thousands) |
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
Cash,
cash equivalents and available-for-sale investments |
|
$ |
34,132 |
|
|
$ |
41,317 |
|
|
|
|
|
|
|
|
Prepaid
expenses and other current assets |
|
|
1,255 |
|
|
|
1,438 |
|
|
|
|
|
|
|
|
Property
and equipment, net and other non-current assets |
|
|
637 |
|
|
|
765 |
|
|
|
|
|
|
|
|
Total
assets |
|
$ |
36,024 |
|
|
$ |
43,520 |
|
|
|
|
|
|
|
|
Accounts payable and
accrued expenses |
|
$ |
3,023 |
|
|
$ |
5,079 |
|
|
|
|
|
|
|
|
Other liabilities |
|
|
|
|
|
|
|
|
|
|
|
Preferred Stock, common stock and additional paid-in-capital |
|
|
199,276 |
|
|
|
198,218 |
|
|
|
|
|
|
|
|
Accumulated deficit and accumulated other comprehensive income |
|
|
(166,275 |
) |
|
|
(159,777 |
) |
|
|
|
|
|
|
|
Total liabilities and stockholders’ deficit |
|
$ |
36,024 |
|
|
$ |
43,520 |
|
|
|
|
|
|
|
|
Proteon Therapeutics, Inc. |
|
|
Condensed Consolidated Statements of
Operations |
|
|
(in thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research
and development |
|
$ |
4,246 |
|
|
$ |
4,349 |
|
|
|
General
and administrative |
|
|
2,234 |
|
|
|
2,470 |
|
|
|
Total
operating expenses |
|
|
6,480 |
|
|
|
6,819 |
|
|
|
Loss
from operations |
|
|
(6,480 |
) |
|
|
(6,819 |
) |
|
|
Other
income (expense): |
|
|
|
|
|
|
Investment income |
|
|
32 |
|
|
|
56 |
|
|
|
Other
(expense) income, net |
|
|
(50 |
) |
|
|
211 |
|
|
|
Total other (expense) income |
|
|
(18 |
) |
|
|
267 |
|
|
|
Net
loss |
|
$ |
(6,498 |
) |
|
$ |
(6,552 |
) |
|
|
Net loss
per share attributable to common stockholders - basic and
diluted |
|
$ |
(0.39 |
) |
|
$ |
(0.40 |
) |
|
|
Weighted-average common shares outstanding used in net loss per
share attributable to common stockholders - basic and diluted |
|
|
16,636,201 |
|
|
|
16,507,586 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
$ |
298 |
|
|
$ |
308 |
|
|
|
General
and administrative |
|
|
547 |
|
|
|
558 |
|
|
|
Total |
|
$ |
845 |
|
|
$ |
866 |
|
|
|
|
|
|
|
|
|
|
Included in other expense, above, are the following amounts
from forward foreign currency contracts: |
|
|
|
|
|
|
|
|
|
Realized
(losses) gains from forward foreign currency contracts |
|
$ |
- |
|
|
$ |
6 |
|
|
|
Unrealized (losses) gains from forward foreign currency
contracts |
|
|
- |
|
|
|
178 |
|
|
|
Total |
|
$ |
- |
|
|
$ |
184 |
|
|
|
Investor Contact George Eldridge, Proteon
Therapeutics, Senior Vice President and Chief Financial Officer
781-890-0102 geldridge@proteontherapeutics.com
Media ContactAnn Stanesa, Ten
Bridge
Communications617-230-0347proteon@tenbridgecommunications.com
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