UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of
the
Securities Exchange Act of 1934
Date of
Report (Date of earliest event reported): February 14,
2011
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VENTRUS
BIOSCIENCES, INC.
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(Exact
name of registrant as specified in its charter)
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Delaware
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001-35005
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20-8729264
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(State
or other jurisdiction of incorporation)
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(Commission
File Number)
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(IRS
Employer ID Number)
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787
7th
Avenue, 48th
Floor, New York, New York
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10019
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant’s
telephone number, including area code
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(212)
554-4300
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Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
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o
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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o
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange
Act (17 CFR
240.14d-2(b))
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o
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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Item 7.01. Regulation
FD Disclosure.
On
February 14, 2011, at 9:00 a.m. (ET), Dr. Russell Ellison, President and Chief
Executive Officer of Ventrus Biosciences, Inc., will provide a presentation at
the 2011 BIO CEO & Investor Conference. A live audio webcast and replay
of the panel will be available on the “Investors” section of the Company’s
website at http://investor.ventrusbio.com/events.cfm. The
slides that Dr. Ellison will present are furnished herewith as Exhibit 99.1 and
are incorporated herein by reference.
The
information in this Form 8-K (including Exhibit 99.1) shall not be deemed
“filed” for purposes of Section 18 of the Securities Exchange Act of 1934
(the “Exchange Act”) or otherwise subject to the liabilities of that section,
nor shall it be deemed incorporated by reference in any filing under the
Securities Act of 1933 or the Exchange Act, except as expressly set forth by
specific reference in such a filing.
Item
9.01. Financial Statements and Exhibits.
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(d)
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Exhibits
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Exhibit No.
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Description
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99.1
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Slides
presented by Dr. Russell Ellison at the 2011 BIO CEO & Investor
Conference on February 14, 2011 (such Exhibit 99.1 is furnished and
not filed).
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SIGNATURES
Pursuant to the requirements of the
Securities Exchange Act of 1934, the registrant has duly caused this report to
be signed on its behalf by the undersigned hereunto duly
authorized.
| VENTRUS BIOSCIENCES, INC. | |||
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Date: February
14, 2011
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/s/ David J. Barrett
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David
J. Barrett, Chief Financial Officer
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EXHIBIT
99.1
This
material contains estimates and forward ‐ looking statements, as defined by the
Private Securities Litigation Reform Act of 1995. The words “believe,” “may,”
“might,” “will,” “aim,” “estimate,” “continue,” “would,” “anticipate,” “intend,”
“expect,” “plan” and similar words are intended to identify estimates and
forward ‐ looking statements . Our estimates and forward ‐ looking statements
are mainly based on our current expectations and estimates of future events and
trends, which affect or might affect our businesses and operations . Although we
believe that these estimates and forward ‐ looking statements are based upon
reasonable assumptions, they are subject to several risks and uncertainties and
are made in light of information currently available to us. Our estimates and
forward ‐ looking statements may be influenced by the following factors,
among others: our expectations regarding our revenues, expenses, effective tax
rates and other results of operations; our ability to obtain FDA approval of our
product candidates; our anticipated capital expenditures and our estimates
regarding our capital requirements; our liquidity and working capital
requirements; our need to obtain additional funding and our ability to obtain
future funding on acceptable terms; our product candidates and plans to
promote them; anticipated trends and challenges in our business and in the
markets in which we operate; our ability to retain and hire necessary employees
and to staff our operations appropriately; our ability to find future
acquisition opportunities on favorable terms or at all and to manage any
acquisitions; our ability to compete in our industry and innovation by our
competitors; our ability to stay abreast of new or modified laws and
regulations that currently apply or become applicable to our business; estimates
and estimate methodologies used in preparing our financial statements; and the
future trading prices of our common stock and the impact of securities analysts’
reports on these prices. Estimates and forward ‐ looking statements involve
risks and uncertainties and are not guarantees of future performance . As a
result of known and unknown risks and uncertainties, including those described
above, the estimates and forward ‐ looking statements discussed in this material
might not occur and our future results and our performance might differ
materially from those expressed in these forward ‐ looking statements due to,
including, but not limited to, the factors mentioned above. Estimates and
forward ‐ looking statements speak only as of the date they were made, and,
except to the extent required by law, we undertake no obligation to update or to
review any estimate and/or forward ‐looking statement because of new
information, future events or other factors.
Highlights A
Phase III company focused exclusively on gastroenterology (GI): ie: anal
disorders, a neglected area of drug development Our products address large
markets where there are no FDA approved drugs in the US 3 Late stage
products: Phase III – Hemorrhoids Phase III initiated – Anal fissures
Phase IIb – Fecal incontinence Near term milestones with 2 important data
read‐ outs expected in H1 2012 Multiple scenarios are possible for
development and commercialization after H1 data readouts
Experienced
Management Team Russell H. Ellison, MD, MSc: Chief Executive Officer and
Chairman of the Board 30 yrs experience in pharmaceutical industry, most
recently: EVP, Paramount Biosciences (2007-2010) VP Clinical
Development, Fibrogen Inc (2005-2007) VP Medical Affairs and CMO,
Sanofi-Synthelabo US (2002-2005) VP Medical Affairs and CMO, Roche US
(1997-2002) Prior Board Chairman, Cormedix Inc Prior board member of Cougar
Inc David J. Barrett, CPA: Chief Financial Officer CFO, NeuroHitech, a
public pharma company with development stage and marketed products (2006-2009)
CFO, Overture Asset Managers & Overture Financial services (hedge fund)
(2003-2006) Manager Deloitte & Touche (1999-2003)
Experienced
Development Team Monil Shah PharmD: VP Clinical Research Novartis,
Amgen, Fibrogen, Celgene Celine Scholl CPM Novartis
Merck,GSK Mohan Kabadi PhD: Head of Product Development &
Manufacturing > 20 years; BMS, Novartis, Faulding, Roche John
Dietrich PhD Preclinical Development (toxicology) > 30 years
experience
VEN 309:
Iferanserin Novel Treatment for Hemorrhoids
VEN 309:
Iferanserin Hemorrhoid Overview Symptoms Causes Bleeding, pain,
itch, swelling & Increased hydrostatic pressure = AV tenderness,
difficult defecation dilation, slower blood flow Market Serotonin
activation of 5HT2a receptors Efferent vasoconstriction,
platelet ~12.5 mm patients in US aggregation, further dilation and
Highest prevalence >50 years of age symptoms No FDA approved products in
U.S. and current products are not reimbursed 4 mm prescriptions written
annually in the U.S. for unapproved use in hemorrhoids 22 mm OTC units sold
annually in the U.S. No other known drugs in development in the
U.S.
VEN 309:
Iferanserin Product Overview Topical rectal ointment: applied
intra-anal BID (with applicator) Mechanism NCE – potent 5HT2a
antagonist : Does not cross the blood brain barrier except at doses much
higher than to be used therapeutically Selective for 5HT2a; 1/3 affinity for
5HT2c, very low affinity for 5HT2b (antagonist) and 1/1000 affinity for
other 5HT receptors Low systemic exposure: < 10% bioavailability
(rat) Indication Acute treatment of hemorrhoids Intellectual
Property: Licensed from the inventor Patents issued in all major
territories US COM patent expires 2015, Hatch-Waxman exclusivity 5 yrs (Rx
to OTC switch) New concentration range patent just filed; 20 yrs
exclusivity: prevents A/B rated generics Topical GI product with low
bioavailability : generic substitution potentially difficult
VEN 309:
Iferanserin Ready for Phase III Phase II completed -Excellent
safety profile 7 clinical trials, 220 patients exposed to VEN 309 Side
effects are local and minor; systemic side effects comparable to placebo No
SAE’s, no deaths Development plan: chronic use drug FDA confirmed PH
III status; agreement on primary endpoint 1500 patient safety database ; in
2 pivotal trials or 2 pivotals and 1 safety study (TBD) 104 wk 2 species
carcinogenicity (no prior findings of concern) is critical path to NDA filing
(2014) Clinical pharmacology program 2 pivotal trials (Phase III) to
be done in series, not on critical path SPA agreement expected March/April
2011
VEN 309:
Iferanserin 1st Pivotal Phase III Study: Proposed Design Start
mid-2011, double blind data available Q1 2012 400 patients Double
Blind; 0.5% iferanserin vs placebo ointment 60 sites (North America) 14 days
treatment with follow up at 28 days All patients roll to active treatment
after 28 days, with 12 month follow up to assess recurrence (open
label) Inclusion criteria Symptomatic grade I to III internal
hemorrhoids Bleeding from hemorrhoids 2 consecutive days prior to
randomization, with pain or itching accompanying the bleeding for the 2
days Primary endpoint: time to cessation of bleeding for a minimum of 3
days Secondary endpoints: cessation of pain and itching for 3
days
VEN 309:
Iferanserin Phase III Endpoints Confirmed in Phase IIb (German
Study) 6 sites in Germany, conducted 2003/2004 121 patients randomized
to iferanserin 0.5% (Phase III dose) BID vs placebo ointment Baseline and
weekly visits for 2 week treatment; follow up at 45
days Endpoints Primary: bleeding scale Secondary: itching and
pain scales Other: tenderness, fullness, throbbing, gas, difficulty in
defecation and physician’s assessment Safety
VEN 309:
Iferanserin German Phase IIb: Bleeding
VEN 309:
Iferanserin German Phase IIb: Pain
VEN 309:
Iferanserin German Phase IIb: Itching
VEN 309:
Iferanserin Analysis of German Phase IIb for Phase III
Endpoint* Success at FDA Agreed Primary Endpoint for the Pivotal
Trial German Study n = 121 Median Time to Bleeding Cessation for 3
Days * Post hoc
VEN 309:
Iferanserin Near Term Inflection Points Expect an SPA March/April
2011 1st patient in hemorrhoid trial in mid-2011 Potential
publications of existing preclinical and clinical data Expect PTO action in
mid-2011 on new IP Completion of enrollment of hemorrhoid trial in Q4
2011 Data from double blind phase of hemorrhoid trial in Q1
2012
VEN 307:
Diltiazem Cream Novel Treatment for Anal Fissures
VEN 307:
Diltiazem Cream Anal Fissures Overview Symptoms Causes Ischemic
tear in the anus Increased internal anal sphincter SEVERE pain pressure and
resultant decreased blood flow Market Usually with
constipation ~4 million patients in US Fiber followed by surgery is
standard of care No US approved products Compounded Diltiazem and some GTN are
already used by specialists 50% of patients referred to specialist – Most
common outcome is surgery because patients cannot stand the
pain
VEN 307:
Diltiazem Cream Product Overview Topical Diltiazem Cream: applied
peri-anally TID Originally approved as Cardizem® (Marion Labs) for angina
and high blood pressure Mechanism Calcium channel blocker -relaxes the
internal anal sphincter , reducing pain and increases tissue blood
flow Indication: pain associated with anal fissures Approval pathway:
505(b)(2) – only 2 pivotal trials required Intellectual
Property Method of use filed, expires 2017 (+ 3yrs Hatch-Waxman) – not yet
issued Multiple possibilities for BID formulations with 20 year IP: final
selection Q3 2011 – Can develop one of these (2 pivotals starting 2012) or
original (1 pivotal starting 2012)
VEN 307:
Diltiazem Cream Phase III Initiated Numerous investigator initiated
studies vs active comparator (GTN 0.2% to 0.5%) and fiber published with
favorable results for pain NDA program for GTN (Cellegesic) had multiple
failures: small trials, endpoint problem, and excess analgesic use in
treatment arm due to headaches FDA pre-IND meeting conducted in August
2007 Confirmed Phase III multi-dose plan Achieved clarity on primary
endpoint: reduction in pain Confirmed safety database Addressed weaknesses in
GTN studies in our protocol Phase III trial recently initiated (November)
with data in Q2 2012 Licensor (SLA) is conducting trial 465 patients in 30
sites in Europe Treated for 2 months: randomized double blind; fiber plus
2%, 4% VEN 307, and placebo Primary endpoint: reduction in pain on
defecation using a validated scale
VEN 307:
Diltiazem Cream Near Term Timelines Selection of new formulations with
extended IP (Q3 2011) PTO action on existing patent filing (Q3/4
2011) Completion of enrollment of European Phase III (Dec 2011 / Jan
2012) Data from Phase III trial (Q2 2012)
Corporate
Overview
Financial
Summary IPO in December 2010 3.335 million shares at $6.00 per share
Exchange: Nasdaq (“VTUS”) Capital Structure After IPO Cash and
Short-term Investments $17.6 million Debt $2.7 mm Common Shares Outstanding
7.2 million (9.3 million fully diluted) Market Cap ~$45
million
Upcoming
Milestones and News Flow Q1 2011 Q2 2011 Q3 2011 Q4 2011 Q1 2012 Q2 2012 VEN309
SPA Granted Phase III Initiated German Phase IIB Trial Published PTO Action on
New IP Phase III Enrollment Completed Phase III Data Announced Ongoing Open
Label Recurrence Data VEN307 New Formulations Selected with Long IP Complete
Phase III Enrollment PTO Action on Existing Patent Filing Phase III Data
Announced
Multiple
Future Scenarios Possible: Iferanaserin and Diltiazem Strategic options:
after data readouts in H1 2012 In 2015, 5-6 major pharma companies with
primary care and/or GI products and field forces Four with an OTC division 2-3
GI specialty companies Continued development of products by Ventrus:
cost/time to approval* After 1st data readout Q1 2012, approx. $20 mm to
develop iferanserin to approval; 2015 After 1st data readout Q2 2012,
approx $15 mm to develop diltiazem cream to approval
2014 Commercialization by Ventrus: Iferanserin: no effective Rx
competition: contracted primary care/GI field force (500-600) for 1-2 years
plus DTC year 2 Diltiazem: compounded version already in use; market is GI
surgeons = very low launch costs * excludes G&A
The
Opportunity Key Takeaways: The Products: VEN 309 will be the
first and ONLY FDA approved product for Hemorrhoids, with a market of >12.5
million patients VEN 307 will be the first and ONLY FDA approved product
for anal fissures, with a market of >4 million patients VEN 309 and 307:
validated Phase III endpoint that has already demonstrated efficacy in
multiple Phase II trials Great safety profile – limited side effects from
topical administration The Company: 2 high value data read-outs
expected over next year Significant news flow and multiple milestones
between now and data read-outs Multiple scenarios are possible for further
development and commercialization of the products after the data
readouts Experienced team with a history of success