Ventrus Biosciences Reports Third Quarter 2012 Financial Results
NEW YORK, Nov. 13, 2012 (GLOBE NEWSWIRE) -- Ventrus Biosciences, Inc.
(Nasdaq:VTUS) today reported financial results for the third quarter ended
September 30, 2012.
"Following a successful discussion with the FDA and receipt of written
feedback from our meeting, we now have a clear path forward toward the
submission of a new drug application for VEN 307 as a treatment for anal
fissures," said Russell H. Ellison, M.D., M.Sc., Chairman and Chief Executive
Officer of Ventrus Biosciences, Inc. "This includes completion of a second
Phase 3 trial, which began enrolling patients in November, is expected to be
complete by the fourth quarter of 2013 and should serve as confirmation of the
positive results we saw in our first Phase 3 study.Anal fissures represent a
significant market opportunity, one with no treatment standard and a
concentrated prescriber base among gastroenterologist and colorectal
For the three months ended September 30, Ventrus's operating loss was $5.4
million which included approximately $735,000 in non-cash stock based
compensation expense.Operating loss for the nine months ended September 30,
2012 was approximately $21.0 million which included approximately $2.5 million
in non-cash stock based compensation expense.General and administrative
expense was $1.1 million for the third quarter of 2012, compared to $1.9
million for the same period in 2011.The decrease was primarily due to a
decrease in stock option and warrant expense.Research and development expense
was $4.2 million for the third quarter of 2012, compared to $3.7 million for
the same period in 2011.The increase was primarily due to the costs
associated with closing out the Phase III clinical trial for VEN 309 and
manufacturing costs to support future clinical studies for VEN 307.
At September 30, 2012, cash and cash equivalents were approximately $23.6
million, compared to approximately $37.0 million at December 31, 2011. Gross
cash spend in the third quarter 2012 was approximately $5.3 million, as
compared to approximately $5.6 million in the same period in the prior
year.Average monthly gross spend was approximately $1.8 million in the third
quarter, as compared to approximately $2.3 million in the second quarter of
2012.Ventrus expects average monthly cash spend to decrease by approximately
$1 million per month for the remainder of the year.
Ventrus is a development stage pharmaceutical company focused on the
development of late-stage prescription drugs for gastrointestinal problems,
specifically anal disorders. Our lead product is topical diltiazem (VEN 307)
for the treatment of anal fissures for which the first Phase 3 trial was
initiated in November 2010, and reported positive top line results in May
2012. The second Phase 3 trial began enrollment in the fourth quarter of 2012
and is ongoing. Our product candidate portfolio also includes topical
phenylephrine (VEN 308) intended to treat fecal incontinence. VEN 307 and VEN
308 are two molecules that were previously approved and marketed for other
indications and that have been formulated into our in-licensed proprietary
topical treatments for these new gastrointestinal indications.
Please Note: The information provided herein contains estimates and other
forward-looking statements regarding future events. Such statements are just
predictions and are subject to risks and uncertainties that could cause the
actual events or results to differ materially. These risks and uncertainties
include, among others: the components, timing, cost and results of clinical
trials and other development activities involving our product candidates; the
unpredictability of the clinical development of our product candidates and of
the duration and results of regulatory review of those candidates by the FDA
and foreign regulatory authorities; the unpredictability of the size of the
markets for, and market acceptance of, any of our products; our anticipated
capital expenditures, our estimates regarding our capital requirements, and
our need for future capital; our reliance on our lead product candidate, VEN
307; our ability to retain and hire necessary employees and to staff our
operations appropriately; and the possible impairment of, or inability to
obtain, intellectual property rights and the costs of obtaining such rights
from third parties. The reader is referred to the documents that we file from
time to time with the Securities and Exchange Commission.
CONTACT: Ventrus BioSciences, Inc.
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