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 June 30, 2017, and recent
business highlights.
“Our productive dialogue with the FDA has
created a clear path forward for vonapanitase, and we believe the
decision by the FDA to grant vonapanitase a Breakthrough Therapy
designation speaks to the clinical importance of fistula survival
and use for hemodialysis to patients with chronic kidney disease,”
said Timothy Noyes, President and Chief Executive Officer of
Proteon. “In addition, we are pleased to have closed earlier this
month on our previously announced $22.0 million financing. We
expect this transaction will allow the Company to operate for more
than six months beyond the expected release of topline data from
the PATENCY-2 Phase 3 clinical trial.”
Recent Highlights for 2017
In May, vonapanitase received
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.
Closed on $22.0 million financing
transaction. This month, Proteon raised gross proceeds of
$22.0 million. The transaction was led by an affiliate of Deerfield
Management and other participants in the financing included
Abingworth, Fairmount Funds, Perceptive Advisors, Pharmstandard, RA
Capital, Skyline Ventures, TVM Capital and certain other
stockholders who invested prior to the Company’s initial public
offering. The Company intends to use the proceeds from the
transaction to complete the ongoing PATENCY-2 trial and fund
continued market access activities. The financing also extends the
Company’s cash runway from the third quarter of 2018 into the
fourth quarter of 2019, which allows the Company to operate for
more than six months beyond the expected release of topline data
from the PATENCY-2 trial based on the Company’s current operating
plan.
Board of Directors strengthened with
leadership and industry expertise. Proteon strengthened
its Board of Directors with the appointment of Jonathan Leff, a
Partner at Deerfield Management, to the Board of Directors. Mr.
Leff brings extensive industry experience to the board room having
been a director at multiple publicly-traded biotechnology and
pharmaceutical companies. He is also active in public policy
discussions related to healthcare and medical innovations.
PATENCY-2 enrollment on track for
completion in Q1 2018. PATENCY-2 is a multicenter,
randomized, double-blind, placebo-controlled Phase 3 clinical trial
expected to enroll 600 patients with CKD in the United States and
Canada undergoing surgical creation of a radiocephalic
arteriovenous fistula for hemodialysis. PATENCY-2’s co-primary
endpoints are secondary patency and fistula use for hemodialysis,
each of which demonstrated improvements in the Company’s first
Phase 3 clinical trial, 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 in Q2 at the (i) 10th Congress of the Vascular
Access Society in Ljubljana, Slovenia, (ii) National Kidney
Foundation 2017 Spring Clinical Meetings in Orlando, FL, and (iii)
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
is safety and the secondary outcome measure is 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 Baird 2017 Global Healthcare Conference
September 6-7 in New York City, NY.
- Presentation of PATENCY-1 results at the Vascular Access
Society of Britain and Ireland Conference September 28-29 in
Belfast, Northern Ireland.
- Presentation by Barry Browne, M.D. at the CIDA on Controversies
in Dialysis Access on November 9th in San Diego.
- Presentation by Keith Ozaki, M.D. at the 44th Annual VEITH
Symposium on November 18th in New York City.
Second Quarter 2017 Financial
Results
Cash, cash equivalents and available-for-sale
investments totaled $31.7 million as of June 30, 2017, compared to
$41.3 million as of December 31, 2016. The decrease was driven by
operational costs for the first six-month period of 2017. On August
2, 2017, we closed on the $22.0 million preferred stock financing
announced on June 22, 2017.
R&D expenses: Research and
development expenses for the second quarter of 2017 were $3.9
million as compared to $5.2 million for the second 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
second quarter of 2017 as compared to the second quarter of
2016.
G&A expenses: General and
administrative expenses for the second quarter of 2017 were $2.1
million as compared to $2.6 million for the second quarter of 2016.
The decrease in G&A expenses was due primarily to decreased
overhead and personnel expenses in the second quarter of 2017 than
in the second quarter of 2016.
Net loss: Net loss for the
second quarter of 2017 was $5.6 million as compared to $7.9 million
for the second quarter of 2016. Net loss included stock-based
compensation expense of $0.9 million for the second quarter of 2017
and $0.9 million for the second quarter of 2016.
Financial guidance: When
including the $22.0 million preferred stock financing that closed
on August 2, 2017, 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
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" 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 clinical trials of vonapanitase, when the Company
expects to report top-line data from the PATENCY-2 trial, 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 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, 2016, as filed
with the Securities and Exchange Commission (“SEC”) on March 16,
2017, 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, |
|
|
|
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
|
Cash,
cash equivalents and available-for-sale investments |
|
$ |
31,742 |
|
|
$ |
41,317 |
|
|
|
|
|
|
|
|
|
|
Prepaid
expenses and other current assets |
|
|
1,280 |
|
|
|
1,438 |
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net and other non-current assets |
|
|
609 |
|
|
|
765 |
|
|
|
|
|
|
|
|
|
|
Total
assets |
|
$ |
33,631 |
|
|
$ |
43,520 |
|
|
|
|
|
|
|
|
|
|
Accounts payable and
accrued expenses |
|
$ |
4,137 |
|
|
$ |
5,079 |
|
|
|
|
|
|
|
|
|
|
Other liabilities |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Preferred Stock, common stock and additional paid-in-capital |
|
|
201,384 |
|
|
|
198,218 |
|
|
|
|
|
|
|
|
|
|
Accumulated deficit and accumulated other comprehensive income
|
|
|
(171,890 |
) |
|
|
(159,777 |
) |
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ deficit |
|
$ |
33,631 |
|
|
$ |
43,520 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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, |
|
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
3,891 |
|
|
$ |
5,241 |
|
|
$ |
8,137 |
|
|
$ |
9,590 |
|
|
|
General
and administrative |
|
|
2,095 |
|
|
|
2,613 |
|
|
|
4,329 |
|
|
|
5,083 |
|
|
|
Total
operating expenses |
|
|
5,986 |
|
|
|
7,854 |
|
|
|
12,466 |
|
|
|
14,673 |
|
|
|
Loss
from operations |
|
|
(5,986 |
) |
|
|
(7,854 |
) |
|
|
(12,466 |
) |
|
|
(14,673 |
) |
|
|
Other
income (expense): |
|
|
|
|
|
|
|
|
|
|
Investment income |
|
|
46 |
|
|
|
53 |
|
|
|
78 |
|
|
|
109 |
|
|
|
Other
(expense) income, net |
|
|
332 |
|
|
|
(104 |
) |
|
|
282 |
|
|
|
107 |
|
|
|
Total other (expense) income |
|
|
378 |
|
|
|
(51 |
) |
|
|
360 |
|
|
|
216 |
|
|
|
Net
loss |
|
$ |
(5,608 |
) |
|
$ |
(7,905 |
) |
|
$ |
(12,106 |
) |
|
$ |
(14,457 |
) |
|
|
Net loss
per share attributable to common stockholders - basic and
diluted |
|
$ |
(0.33 |
) |
|
$ |
(0.48 |
) |
|
$ |
(0.72 |
) |
|
$ |
(0.87 |
) |
|
|
Weighted-average common shares outstanding used in net loss per
shareattributable to common stockholders - basic and diluted |
|
|
17,207,672 |
|
|
|
16,561,239 |
|
|
|
16,923,515 |
|
|
|
16,534,413 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
$ |
308 |
|
|
$ |
321 |
|
|
$ |
606 |
|
|
$ |
629 |
|
|
|
General
and administrative |
|
|
559 |
|
|
|
625 |
|
|
|
1,106 |
|
|
|
1,183 |
|
|
|
Total |
|
$ |
867 |
|
|
$ |
946 |
|
|
$ |
1,712 |
|
|
$ |
1,812 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Included in other expense, above, are the following amounts
from forward foreign currency contracts: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Realized
(losses) gains from forward foreign currency contracts |
|
$ |
- |
|
|
$ |
(10 |
) |
|
$ |
- |
|
|
$ |
(4 |
) |
|
|
Unrealized (losses) gains from forward foreign currency
contracts |
|
|
- |
|
|
|
(53 |
) |
|
|
- |
|
|
|
125 |
|
|
|
Total |
|
$ |
- |
|
|
$ |
(63 |
) |
|
$ |
- |
|
|
$ |
121 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Investor ContactGeorge Eldridge, Proteon
Therapeutics, Senior Vice President and Chief Financial
Officer781-890-0102geldridge@proteontherapeutics.comMedia
ContactAnn Stanesa, Ten Bridge
Communications617-230-0347proteon@tenbridgecommunications.com
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