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.
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 the United States, the effect or benefit of vonapanitase
in patients with chronic kidney disease (CKD), whether vonapanitase
improves fistula use for hemodialysis or secondary patency, the
potential long-term commercial supply of active pharmaceutical
ingredient (API) for vonapanitase, 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 fourth quarter of 2019, 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 the Company’s 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 the Company can successfully commercialize and market
its product candidates, are described more fully in our Annual
Report on Form 10-K for the year ended December 31, 2017, as filed
with the Securities and Exchange Commission (“SEC”) on March 14,
2018, and the Company’s 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 the Company’s forward-looking statements, no person should place
undue reliance on these statements or regard these statements as a
representation or warranty by the Company or any other person that
the Company will achieve its objectives and plans in any specified
time frame, or at all. The forward-looking statements contained in
this press release represent the Company’s estimates and
assumptions only as of the date of this press release and, except
as required by law, the Company undertakes 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) |
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
Cash, cash equivalents
and available-for-sale investments |
|
$ |
26,454 |
|
|
$ |
42,141 |
|
|
|
|
|
|
Prepaid expenses and
other current assets |
|
|
1,057 |
|
|
|
1,339 |
|
|
|
|
|
|
Property and equipment,
net and other non-current assets |
|
|
341 |
|
|
|
499 |
|
|
|
|
|
|
Total
assets |
|
$ |
27,852 |
|
|
$ |
43,979 |
|
|
|
|
|
|
Accounts payable and
accrued expenses |
|
$ |
2,231 |
|
|
$ |
9,240 |
|
|
|
|
|
|
Preferred Stock, common
stock and additional paid-in-capital |
|
|
226,321 |
|
|
|
224,494 |
|
|
|
|
|
|
Accumulated deficit and
accumulated other comprehensive income |
|
|
(200,700 |
) |
|
|
(189,755 |
) |
|
|
|
|
|
Total
liabilities and stockholders’ deficit |
|
$ |
27,852 |
|
|
$ |
43,979 |
|
|
|
|
|
|
Proteon Therapeutics, Inc. |
Condensed Consolidated Statements of
Operations |
(in thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
2,760 |
|
|
$ |
3,891 |
|
|
$ |
6,831 |
|
|
$ |
8,137 |
|
General
and administrative |
|
|
2,240 |
|
|
|
2,095 |
|
|
|
4,534 |
|
|
|
4,329 |
|
Total
operating expenses |
|
|
5,000 |
|
|
|
5,986 |
|
|
|
11,365 |
|
|
|
12,466 |
|
Loss from
operations |
|
|
(5,000 |
) |
|
|
(5,986 |
) |
|
|
(11,365 |
) |
|
|
(12,466 |
) |
Other
income (expense): |
|
|
|
|
|
|
|
|
Investment income |
|
|
106 |
|
|
|
46 |
|
|
|
198 |
|
|
|
78 |
|
Other
income (expense), net |
|
|
15 |
|
|
|
332 |
|
|
|
207 |
|
|
|
282 |
|
Total
other (expense) income |
|
|
121 |
|
|
|
378 |
|
|
|
405 |
|
|
|
360 |
|
Net loss |
|
$ |
(4,879 |
) |
|
$ |
(5,608 |
) |
|
$ |
(10,960 |
) |
|
$ |
(12,106 |
) |
Net loss per share
attributable to common stockholders - basic and diluted |
|
$ |
(0.28 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.62 |
) |
|
$ |
(0.72 |
) |
Weighted-average common
shares outstanding used in net loss per share attributable to
common stockholders - basic and diluted |
|
|
17,674,729 |
|
|
|
17,207,672 |
|
|
|
17,674,729 |
|
|
|
16,923,515 |
|
|
|
|
|
|
|
|
|
|
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 |
|
$ |
312 |
|
|
$ |
308 |
|
|
$ |
579 |
|
|
$ |
606 |
|
General
and administrative |
|
|
610 |
|
|
|
559 |
|
|
|
1,164 |
|
|
|
1,106 |
|
Total |
|
$ |
922 |
|
|
$ |
867 |
|
|
$ |
1,743 |
|
|
$ |
1,712 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investor ContactGeorge Eldridge, Proteon
Therapeutics, Senior Vice President and Chief Financial
Officer781-890-0102geldridge@proteontherapeutics.com
Media ContactAnn Stanesa, Ten
Bridge
Communications617-230-0347proteon@tenbridgecommunications.com
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