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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 10-Q

 

x            QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 2012

 

or

 

¨       TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from ___________ to ___________.

 

Commission file number:  000 -35005

 

 

 

VENTRUS BIOSCIENCES, INC.

(Exact name of Registrant as specified in its charter)

 

Delaware 20-8729264
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)  

 

99 Hudson Street, 5th Floor, New York, New York 10013

(Address of principal executive offices, including zip code)

 

(646) 706-5208

(Registrant’s telephone number, including area code)

 

 

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  YES x   NO ¨

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  YES  x   NO ¨

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company.  See definition of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large Accelerated Filer ¨   Accelerated Filer   x  
Non-accelerated Filer ¨   (Do not check if smaller reporting company)  Smaller Reporting Company   ¨

 

Indicate by check mark whether registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  YES ¨  NO x

 

As of November 9, 2012 there were 12,934,350 shares of registrant’s common stock outstanding.

 

 
 

 

Index

 

  Page
   
PART I – FINANCIAL INFORMATION  
Item 1. Condensed   Financial Statements  
Condensed Balance Sheets as of September 30, 2012 (Unaudited) and December 31, 2011 1
Condensed Statements of Operations for Three and Nine Months ended September 30, 2012 and 2011 and for the period October 7, 2005 (Inception) to September 30, 2012 (Unaudited) 2
Condensed Statement of Changes in Stockholders’ Equity for the Nine Months ended September 30, 2012 (Unaudited) 3
Condensed Statements of Cash Flows for Nine Months ended September 30, 2012, and 2011 and for the period October 7, 2005 (Inception) to September 30, 2012 (Unaudited) 4-5
Notes to Unaudited Condensed Financial Statements 6
Item 2.   Management’s Discussion and Analysis of Financial Condition and Results of Operations 12-17
Item 4.   Controls and Procedures 17-18
PART II – OTHER INFORMATION  
Item 6.   Exhibits 19

 

i
 

 

PART I – FINANCIAL INFORMATION

 

Item 1.     Financial Statements

 

VENTRUS BIOSCIENCES, INC.

A Development Stage Company

 

CONDENSED BALANCE SHEETS

 

   September 30,
2012
   December 31,
2011
 
   (Unaudited)     
ASSETS          
Current assets:          
Cash and cash equivalents  $23,560,079   $36,975,434 
Other current assets   111,184    62,129 
Total current assets   23,671,263    37,037,563 
           
Computer equipment, net   8,107    8,218 
           
Total assets  $23,679,370   $37,045,781 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable  $1,843,095   $2,342,074 
Accrued expenses   838,101    171,000 
           
Total current liabilities   2,681,196    2,513,074 
           
Commitments          
Stockholders’ equity:          
Preferred stock, $.001 par value; 5,000,000 shares authorized, none issued   -    - 
Common stock, $.001 par value; 50,000,000 shares authorized; 12,934,350 and 12,406,406 issued and outstanding at September 30, 2012 and December 31, 2011, respectively   12,934    12,406 
Additional paid-in capital   109,513,645    102,049,385 
Deficit accumulated during the development stage   (88,528,405)   (67,529,084)
           
Total stockholders’ equity   20,998,174    34,532,707 
           
Total liabilities and stockholders’ equity  $23,679,370   $37,045,781 

 

See Notes to Condensed Financial Statements

 

1
 

 

VENTRUS BIOSCIENCES, INC.

 

A Development Stage Company

 

CONDENSED STATEMENTS OF OPERATIONS (UNAUDITED)

 

   Three Months
Ended
September 30,
2012
   Three Months
Ended
September 30,
2011
   Nine Months
Ended
September 30,
2012
   Nine Months
Ended
September 30,
2011
   Period from
October 7, 2005
(Inception) to
September 30, 2012
 
Operating expenses:                         
Research and development  $4,188,127   $3,667,179   $16,772,777   $7,737,523   $56,302,020 
General and administrative   1,182,176    1,878,718    4,265,889    7,376,738    18,510,957 
                          
Loss from operations   (5,370,303)   (5,545,897)   (21,038,666)   (15,114,261)   (74,812,977)
Other income (expense)                         
Interest income   14,906    28,423    39,345    47,880    135,398 
Interest expense:                         
Beneficial conversion feature   -    -    -    -    (6,001,496)
Amortization of debt  discount and warrants   -    (253,302)   -    (302,327)   (2,865,758)
Interest expense   -    (30,605)   -    (116,664)   (4,983,572)
    -    (283,907)   -    (418,991)   (13,850,826)
Net loss  $(5,355,397)  $(5,801,381)   (20,999,321)   (15,485,372)  $(88,528,405)
                          
Basic and diluted net loss per common share  $(0.41)  $(0.50)  $(1.66)  $(1.79)     
                          
Weighted average common shares outstanding – basic and diluted   12,933,340    11,616,786    12,657,538    8,672,858      

 

See Notes to Condensed Financial Statements

 

2
 

 

VENTRUS BIOSCIENCES, INC.

A Development Stage Company

 

CONDENSED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY (UNAUDITED)

For the Nine Months Ended September 30, 2012

           Deficit     
           Accumulated     
           Additional   During the     
   Common Stock   Paid-in   Development     
   Shares   Amount   Capital   Stage   Total 
Balance at January 1, 2012   12,406,406   $12,406   $102,049,385   $(67,529,084)  $34,532,707 
Options exercised between January 1, 2012 and September 30, 2012   68,240    68    427,749    -    427,817 
Shares issued in a cashless exercise of options   47,550    48    (48)   -    - 
Shares issued in a cashless exercise of warrants   11,620    11    (11)   -    - 
Warrants exercised from January 1, 2012 and September 30, 2012   45,834    46    302,459    -    302,505 
                          
Proceeds from common stock sold (at an average $12.45 per share), net of costs   354,700    355    4,166,139    -    4,166,494 
                          
Stock-based compensation for the period from January 1, 2012 to September 30, 2012 to employees and directors   -    -    2,241,659    -    2,241,659 
Stock-based payments for the period from January 1, 2012 to September 30, 2012 to consultants   -    -    326,313         326,313 
Net loss for the period                  (20,999,321)   (20,999,321)
                          
Balance at September 30, 2012   12,934,350   $12,934   $109,513,645   $(88,528,405)  $20,998,174 

 

See Notes to Condensed Financial Statements

 

3
 

 

VENTRUS BIOSCIENCES, INC.

A Development Stage Company

 

CONDENSED STATEMENTS OF CASH FLOWS (UNAUDITED)

 

   Nine Months
Ended
September 30,
2012
   Nine Months
Ended
September 30,
2011
   Period from
October 7, 2005
(Inception) to
September 30, 2012
 
             
Cash flows from operating activities:               
Net loss  $(20,999,321)  $(15,485,372)  $(88,528,405)
                
Adjustments to reconcile net loss to net cash used in operating activities:               
Stock-based compensation   2,241,659    2,168,071    8,181,930 
Stock-based payments to consultants   326,313    3,632,397    4,317,130 
Depreciation   3,351    2,749    34,356 
Stock issued in connection with license agreement   -    -    414,825 
Charge resulting from beneficial note conversion   -    -    6,001,496 
Stock issued to vendor        -    5,000 
Warrants issued in connection with related party note conversion   -    -    1,255,978 
Amortization of deferred financing costs and debt discount        328,958    3,466,010 
Non-cash research and development   -    -    1,087,876 
Interest payable – notes   -    -    2,139,909 
                
Expenses paid on behalf of the Company satisfied through the issuance of notes   -    -    227,910 
Interest payable – related parties        -    266,279 
    -           
Changes in operating assets and liabilities:               
Other current assets   (49,055)   (66,068)   (111,184)
Accounts payable and accrued expenses   168,122    683,010    2,493,659 
                
Net cash used in operating activities   (18,308,931)   (8,736,255)   (58,747,231)
                
Cash flows from investing activities:               
Purchase of office and computer equipment   (3,240)   (11,964)   (42,464)
Net cash used in investing activities   (3,240)   (11,964)   (42,464)
Cash flows from financing activities:               
Net proceeds from sale of common stock   4,166,494    49,988,823    69,339,661 
Proceeds from notes payable   -    -    11,522,380 
Proceeds from notes payable to related parties   -    -    5,041,953 
Payment for deferred financing costs   -    -    (1,431,603)

 

4
 

 

VENTRUS BIOSCIENCES, INC.

A Development Stage Company

 

CONDENSED STATEMENTS OF CASH FLOWS (continued)

 

   Nine Months
Ended
September 30,
2012
   Nine Months
Ended
September
30, 2011
   Period from
October 7, 2005
(Inception) to
September 30, 2012
 
             
Repayment of notes   -    (2,792,380)   (2,719,380)
                
Repayment of notes payable - related party   -    -    (1,573,000)
                
Proceeds from the exercise of warrants and options   730,322    274,983    2,169,762 
                
Net cash provided by financing activities   4,896,816    47,471,426    82,349,774 
                
Net increase (decrease) in cash and cash equivalents   (13,415,355)   38,723,207    23,560,079 
                
Beginning of period   36,975,434    14,571,055    - 
                
End of period   23,560,079    53,294,262    23,560,079 
                
Supplemental schedule of non-cash financing activities:               
Warrants issued to placement agent  $-   $-   $341,334 
Warrants issued to investors in connection with convertible notes  $-   $-   $1,166,989 
Debt discount on Paramount Credit Partners, LLC notes  $-   $302,327   $782,376 
Related party notes and accrued interest converted to 2010 Senior convertible notes  $-   $-   $3,995,667 
Debt discount on 2010 senior convertible notes  $-   $-   $1,468,254 
Notes and accrued interest converted to common stock  $-   $-   $14,003,158 
                
Supplemental disclosure – cash paid for interest  $-   $277,324   $685,397 

 

See Notes to Condensed Financial Statements

 

5
 

 

 

VENTRUS BIOSCIENCES, INC.

(A Development Stage Company)

 

Notes to Condensed Financial Statements

(September 30, 2012)

 

Note 1 — Organization, Business and Basis of Presentation:

 

Organization and business:

 

Ventrus BioSciences Inc. (“Ventrus” or the “Company”) is a specialty pharmaceutical company currently focused on the development and commercialization of late-stage prescription drugs addressing gastrointestinal problems, specifically anal disorders. Ventrus was incorporated in the State of Delaware on October 7, 2005 and commenced operations in April 2007.

 

Basis of presentation:

 

The accompanying condensed balance sheet as of December 31, 2011, which has been derived from the Company’s audited financial statements, and the unaudited interim condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles and the rules and regulations of the Securities and Exchange Commission (“SEC”) related to a quarterly report on Form 10-Q. Certain information and note disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States have been condensed or omitted pursuant to those rules and regulations, although the Company believes that the disclosures made are adequate to make the information presented not misleading. The unaudited interim condensed financial statements reflect all adjustments which, in the opinion of management, are necessary for a fair presentation of the results for the periods presented. All such adjustments are of a normal and recurring nature. These unaudited condensed financial statements should be read in conjunction with the financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K and Form 10-K/A for the year ended December 31, 2011 filed on March 14 and June 13, 2012, respectively. The operating results presented in these unaudited condensed financial statements are not necessarily indicative of the results that may be expected for any future periods.

 

Capital Resources:

 

The Company has not derived any revenue from product sales to date as its products have not been approved for sale by the U.S. Food and Drug Administration (“FDA”) or any foreign regulatory agency. Since inception, the Company’s operations have been financed primarily through the sale of equity securities, the proceeds from the exercise of warrants and stock options and issuance of debt. The Company has incurred losses from operations and negative cash flows since inception and expects to continue to incur substantial losses for the foreseeable future as it continues product development. As a result, the Company may need to obtain additional funds to finance its operations in the future. In July 2011, the Company raised net proceeds of approximately $47,600,000 in a secondary offering of its equity securities. In May and June 2012, the Company raised approximately $4,166,000 in an at-the-market common equity sales program. Until the Company can generate significant cash from its operations, it intends to obtain any additional funding it requires through strategic relationships, public or private equity or debt financings, or other arrangements and it cannot assure such funding will be available on reasonable terms, or at all. The Company currently has sufficient funds to meet its operating requirements and scheduled regulatory and development activities through the second quarter of 2014.

 

Note 2 — Summary of Significant Accounting Policies:

 

Cash and Cash Equivalents:

 

All highly liquid investments with maturities of three months or less at the time of purchase are considered to be cash equivalents. All of the Company’s cash equivalents have liquid markets and high credit ratings. The Company maintains its cash in bank deposit and other accounts, the balances of which, at times and at September 30, 2012, exceed federally insured limits.

 

6
 

 

VENTRUS BIOSCIENCES, INC.

(A Development Stage Company)

 

Notes to Condensed Financial Statements (continued)

(September 30, 2012)

 

Use of estimates:

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates.

 

Significant estimates inherent in the preparation of the accompanying financial statements include the fair value of stock options and warrants granted to employees, consultants, directors, investors, licensors, placement agents and underwriters.

 

Additionally, the Company provides a valuation allowance for deferred income tax assets when it is considered more likely than not that all or a portion of such deferred income tax assets will not be realized.

 

Stock-based compensation:

 

The Company’s share-based compensation cost is measured at grant date, using the Black-Scholes option pricing model to estimate the fair value of the award, and is recognized as expense over the employee’s or director’s requisite service period on a straight-line basis. The Company accounts for stock options and warrants granted to non-employees on a fair value basis which is estimated using the Black-Scholes option pricing model. The initial non-cash charge to operations for non-employee options and warrants with vesting are revalued at the end of each reporting period until vested and recognized as consulting expense over the related vesting period.

 

Research and development:

 

Research and development expenses include personnel and facility-related expenses, third party contracted services including clinical trial costs, manufacturing and process development costs, research costs and other consulting services. Research and development costs are expensed as incurred. In instances where the Company enters into agreements with third parties for clinical trials, manufacturing and process development, research and other consulting activities, costs are expensed as services are performed. Amounts due under such arrangements may be either fixed fee or fee for service, and may include upfront payments, monthly payments, and payments upon the completion of milestones or receipt of deliverables.

 

The Company’s accruals for clinical trials are based on estimates of the services received and pursuant to contracts with the respective clinical trial centers and clinical research organizations. In the normal course of business, the Company contracts with third parties to perform various clinical trial activities in the ongoing development of potential products. The financial terms of these agreements are subject to negotiation and variation from contract to contract and may result in uneven payment flows. Payments under the contracts depend on factors such as the achievement of certain events, the successful enrollment of patients, and the completion of portions of the clinical trial or similar conditions. The objective of the Company’s accrual policy is to match the recording of expenses in its financial statements to the actual services received. As such, expense accruals related to clinical trials are recognized based on the estimate of the degree of completion of the event or events specified in the specific clinical study or trial contract.

 

Income taxes:

 

The Company’s income tax expense consists of current and deferred income tax expense or benefit. Current income tax expense or benefit is the amount of income taxes expected to be payable or refundable for the current year. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when it is more likely than not that some or all of the deferred tax assets will not be realized.

 

7
 

 

VENTRUS BIOSCIENCES, INC.

(A Development Stage Company)

 

Notes to Condensed Financial Statements (continued)

(September 30, 2012)

 

Loss per common share:

 

Basic net loss per common share excludes dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per common share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the entity unless inclusion of such shares would be anti-dilutive. Since the Company has only incurred losses, basic and diluted net loss per share is the same. The number of potentially dilutive securities (options and warrants) excluded from the diluted loss per share calculation for the nine-month periods ended September 30, 2012 and 2011 was 3,133,606 and 2,916,981 respectively.

 

Note 3 — Commitments:

 

Employment agreements:

 

The Company has employment agreements with the Chief Executive Officer (“CEO”) and the Chief Financial Officer (“CFO”) and, until September 30, 2012, the Chief Business Officer (“CBO”), who resigned effective that day, which provide for aggregate base salaries of $875,000 per year, a guaranteed bonus of $75,000 per year for the CEO and annual performance-based bonuses of up to 50%, 25% and 20%, respectively, of their base salaries. The agreements for the CEO and CFO also provide incentive bonuses of $250,000 and $500,000 for each in the event that the Company’s market capitalization exceeds specified levels. The first threshold was met and each of the $250,000 bonuses were paid in the third quarter of 2011. 

 

In 2011, the agreements with the CEO and CFO were amended to provide that if the second market capitalization threshold is attained, the bonus of $500,000 will be paid in a combination of shares of the Company’s common stock worth $300,000 and $200,000 in cash. The number of the shares of common stock each was determined by the closing price of the Company’s common stock as reported on NASDAQ on August 24, 2011 ($9.85), which results in 30,457 shares to be issued to each of our CEO and our CFO if the second market capitalization threshold is attained. As of September 30, 2012, the second market capitalization threshold had not been attained.

 

Note 4 — Stockholders’ Transactions:

 

Common Stock Transactions:

 

On January 31, 2012, the Company filed a shelf registration statement with the SEC under which it may offer shares of its common stock and preferred stock, various series of debt securities and/or warrants to purchase any of such securities, either individually or in units, in one or more offerings, up to a total dollar amount of $100,000,000. The registration statement became effective as of February 10, 2012. As part of the shelf registration statement, the Company included a prospectus for a possible at-the-market common equity sales program for the sale of up to $20,000,000 of common stock. In May and June 2012, the Company sold an aggregate of 354,700 shares under this program, resulting in net proceeds of approximately $4,166,000, or $11.7452 per share. As of September 30, 2012, an aggregate of approximately $95,500,000 worth of securities is available under the shelf registration statement out of which approximately $15,500,000 of common stock is available for the at-the-market common equity sales program.

 

Common Stock Options and Warrants:

 

In connection with the Company’s financings in 2007, 2008, 2009 and 2010, the Company issued warrants to investors and/or placement agents to purchase shares of common stock as well as certain consulting warrants.

 

8
 

 

VENTRUS BIOSCIENCES, INC.

(A Development Stage Company)

 

Notes to Condensed Financial Statements (continued)

(September 30, 2012)

 

A summary of the Company’s warrant activity and related information is as follows:

 

   Nine Months  Ended
September 30, 2012
 
         
       Weighted Average 
   Shares   Exercise Price 
Outstanding at beginning of period   956,443   $7.61 
Granted   -   $- 
Exercised   81,792   $7.00 
Outstanding at end of period   874,651   $7.67 
Warrants exercisable at end of period   874,651   $7.67 

 

Included in the exercise of 81,792 warrants are 35,958 warrants that were exercised utilizing a cashless exercise feature. All outstanding warrants have vested and no additional expense is expected to be recorded in the future years.

 

In August 2010, the Company’s stockholders approved the 2010 Equity Incentive Plan (the “2010 Plan”). In May 2011, the Company’s stockholders approved an amendment to the 2010 Plan to increase the shares reserved for issuance from 2,467,200 to 3,967,200 shares of the Company’s common stock. The 2010 Plan authorizes the Company to issue equity incentive awards in the form of shares, options or other awards based on Ventrus common stock as part of an overall compensation package to provide performance-based compensation to attract and retain qualified personnel.

 

In November 2010, the Company granted options to non-employee directors to purchase an aggregate of 160,000 shares under the 2010 Plan. In addition, under our CEO’s and CFO’s respective employment agreements, the Company granted to our CEO and CFO options under the 2010 plan to purchase 573,599 shares and 305,920 shares, respectively, at a price of $6.00 per share.

 

In January 2012, the Company granted options to purchase 35,000 shares to a new director and 168,000 options to purchase shares to seven employees. Additionally, the company granted options to purchase an aggregate of 162,740 shares to seven consultants all pursuant to the 2010 Plan. The exercise prices of the options granted were at the then market value of the Company’s common stock ($8.10 - $10.62 per share).

 

In August 2012 the Company granted options to purchase 15,000 shares to a new employee under the 2010 Plan at the exercise price of $3.75 per share.

 

9
 

 

VENTRUS BIOSCIENCES, INC.

(A Development Stage Company)

 

Notes to Condensed Financial Statements (continued)

(September 30, 2012)

 

A summary of the Company’s option activity and related information is as follows:

 

   Nine Months Ended
September 30, 2012
     
   Shares   Weighted
Average
Exercise
Price
   Aggregate
Intrinsic Value
 
Outstanding at beginning of period   2,046,455   $6.40   $- 
Granted   380,740   $8.46   $- 
Exercised   168,240   $6.11   $- 
                
Outstanding at end of period   2,258,955   $6.80   $- 
Options exercisable at end of period   1,850,996           

 

Included in the exercise of 168,240 options are 100,000 options that were exercised utilizing a cashless exercise feature. The Company expects that all but 95,940 outstanding unvested options will vest.

 

The fair value of the options granted for the nine-month period ended September 30, 2012, was based on the following assumptions:

 

   2012 
Risk-free interest rate   1.03% - 1.44%
Expected volatility   76.31% -77.18%
-Expected life of options   5.50 years 
Expected dividend yield   0%

 

Estimated future stock-based compensation expense relating to unvested stock options is as follows:

 

Calendar Years Ending December 31,  Future Stock
Option
Compensation
Expense
 
2012 (October through December)  $693,373 
2013   1,382,334 
2014   566,351 
2015   9,914 
Total estimated future stock-based compensation expense – stock options  $2,651,972 

 

The weighted average remaining contractual life of options outstanding at September 30, 2012 is approximately 7.5 years and the cost is expected to be recognized over a weighted-average period of 1.36 years.

 

10
 

 

VENTRUS BIOSCIENCES, INC.

(A Development Stage Company)

 

Notes to Condensed Financial Statements (continued)

(September 30, 2012)

 

Stock-based compensation expensed to research and development expense for the nine months ended September 30, 2012 and 2011 was $704,097 and $819,954 respectively. Stock-based compensation expensed to general and administrative expense for the nine months ended September 30, 2012 and 2011 was $1,863,876 and $4,246,914, respectively.

 

Note 5 — License Agreements:

 

Diltiazem (VEN 307) And Phenylepherine (VEN 308)

 

In March 2007, pursuant to an Exclusive License Agreement, S.L.A. Pharma, AG (“S.L.A. Pharma”) granted Paramount BioSciences, LLC, or PBS, a royalty-bearing license to sell, make and use diltiazem (VEN 307) for treatment, through topical administration, of anal fissures and phenylepherine (VEN 308) for treatment, through topical administration, of fecal incontinence in the United States, Canada and Mexico. In August 2007, pursuant to an Assignment and Assumption Agreement, PBS sold all of its rights in and arising out of the Exclusive License Agreement with S.L.A. Pharma to Ventrus for $1,087,876. The corresponding U.S. and foreign patents and applications for the two compounds have been licensed to Ventrus under the Assignment and Assumption Agreement (the technology referred to collectively as the “Compound Technology”). In the event that the Compound Technology is commercialized, the Company is obligated to pay to S.L.A. Pharma annual royalties, based upon net sales of the product. In addition, the Company is required to make payments to S.L.A. Pharma up to an aggregate amount of $20 million upon the achievement of various milestones related to regulatory events. Should the Company make any improvements regarding the Compound Technology, the Company is required to grant S.L.A. Pharma licenses to use such improvements.

 

As compensation for S.L.A. Pharma’s participation in the management and the development of the technologies, Ventrus is required to make separate payments to S.L.A. Pharma equal to $41,500 per month (“Monthly Payments”) for each of diltiazem and phenylephrine. Per the agreement, Ventrus’ obligation to make these Monthly Payments was to terminate upon a new drug application (“NDA”) filing. Pursuant to amendments to the Exclusive License Agreement, the Company, as of September 30, 2010, was no longer required to make additional monthly payments for phenylephrine. At September 30, 2012, the Company had no amounts due to S.L.A. Pharma.

 

Ventrus is also required to reimburse S.L.A. Pharma for clinical development costs associated with the technology development of both diltiazem and phenylephrine. Ventrus’ total payment obligation for the diltiazem project was limited to $4,200,000, and these payments were made from August 2007 through December 31, 2011. Both Ventrus and S.L.A. Pharma have agreed to add additional services outside the scope of the agreement for $400,000. The services have not yet been provided by S.L.A. Pharma. S.L.A. Pharma has been paid $600,000 for services for the phenylephrine project through September 30, 2012. S.L.A. Pharma did not provide Ventrus with any services for the phenylephrine project in 2011 or the nine months ended September 30, 2012, and management does not expect any services from S.L.A. Pharma for the phenylephrine project in the foreseeable future.

 

On June 6, 2011, Ventrus further amended the Exclusive License Agreement with S.L.A. Pharma. The amendment eliminates its potential $800,000 milestone payment to S.L.A. Pharma for the development of diltiazem, previously payable upon the completion of enrollment into the Phase III clinical trial that S.L.A. Pharma conducted in Europe. It also eliminates S.L.A. Pharma’s ability to terminate the license agreement at any time, with one month’s notice, in the event that Ventrus had failed to make a required payment and a third party wished to enter into a license agreement for diltiazem and phenylephrine, provided the termination would not have been effective if within that one-month period Ventrus paid all the then required payments under the agreement. Pursuant to the amendment, Ventrus must pay S.L.A. Pharma up to $1,000,000 in milestone payments, payable in four equal installments of $250,000 once specified thresholds of randomized patients are achieved in the Phase III trial for diltiazem that S.L.A. Pharma was conducting in Europe. The first two milestones were met and paid in the third quarter of 2011 and the third and fourth milestones were met and paid in the fourth quarter of 2011. On October 9, 2012, Ventrus made a milestone payment of $125,000 to S.L.A. which was due upon Investigational Review Board approval of a Phase III study of a licensed product incorporating Anoheal. Additionally, upon Ventrus’ receipt of a quality controlled final study report of the Phase III trial for diltiazem in Europe, Ventrus must pay S.L.A. Pharma $400,000 in development costs for diltiazem.

 

As of September 30, 2012, Ventrus’ total remaining payment obligation for the phenylephrine project shall not exceed $400,000, consisting of to-be-agreed-upon services.

 

Iferanserin (VEN 309)

 

In March 2008, Ventrus entered into an exclusive worldwide license agreement with Sam Amer & Co., Inc. (“Amer”) whereby Ventrus acquired certain patent rights to iferanserin (VEN 309) for the topical treatment of any anorectal disorders. On June 5, 2011, the Company entered into an agreement with Amer to acquire all rights, title and interest to iferanserin, which acquisition closed on November 14, 2011. On June 25, 2012, based on the results of the Phase III clinical trial, the Company ceased all research and development activity related to iferanserin. 

 

11
 

 

Item 2.   Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

The interim financial statements and this Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2011, and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K and Form 10-K/A for the year ended December 31, 2011 filed on March 14 and June 13, 2012, respectively.  In addition to historical information, this discussion and analysis contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.  These forward-looking statements are subject to risks and uncertainties, including those set forth under “Part I. Item 1. Business - Risk Factors” in our Annual Report on Form 10-K/A for the year ended December 31, 2011, “Part II. Item 1A. Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2012, and elsewhere in this report, that could cause actual results to differ materially from historical results or anticipated results.

 

Overview

 

We are a specialty pharmaceutical company currently focused on the development and commercialization of late-stage prescription drugs addressing gastrointestinal problems, specifically anal disorders.

 

On May 14, 2012, we reported that a Phase III, randomized, double-blind, placebo-controlled clinical trial of VEN 307 for the treatment of anal fissures met its endpoints. We had a pre-NDA meeting with the U.S. Food and Drug Administration, or FDA, on August 30, 2012 at which time it was determined that we would need to conduct a second Phase III Clinical Trial comparing VEN 307 against placebo to support our planned new drug application, or NDA. We initiated this Phase III Trial in the fourth quarter of 2012, which we expect to complete in the fourth quarter of 2013. This trial will randomize in a 1:1 ratio, 400 subjects to either 2% diltiazem cream applied peri-anally 3 times daily or a placebo cream, at approximately 120 sites primarily in the US with supplemental sites in Canada and Israel. The treatment’s duration will be approximately 4 weeks. The primary endpoint is similar to that in the prior Phase II Trial conducted by SLA: pain on defecation at 4 weeks. The key secondary endpoints are average daily Pain and Patients’ Global Impression, also at 4 weeks. Assuming positive results, we expect to be able to file the NDA in the fourth quarter of 2013. Additional studies to be included in the NDA are 2 cutaneous safety trials; a cumulative irritation study in 30 patients and a sensitization study in 200 patients, following standardized protocols commonly used for the safety evaluation of dermatology products in the US for FDA review.

  

On June 25, 2012, we reported that a Phase III, randomized, double-blind, placebo-controlled clinical trial of VEN 309 for the treatment of symptomatic hemorrhoids did not meet its endpoints.

 

Based on the results of both completed Phase III trials, we have determined that our current resources would be better allocated toward the planned completion of VEN 307 development program in anal fissures. Consequently, we have no immediate plans to continue development of VEN 309 and have ceased all activity related to VEN 309 other than the winding down of the program.

 

VEN 307, which we have in-licensed from S.L.A. Pharma, is a pre-mixed and pre-packaged proprietary topical formulation of the drug diltiazem that we are developing for the treatment of anal fissures. We estimate that over four million people in the U.S. currently suffer from anal fissures and that there are approximately 1.1 million office visits per year and yet, to our knowledge, there is only one drug that has been approved by the FDA for this condition.

 

In addition to our lead product VEN 307, we also have in-licensed VEN 308 (phenylephrine) from S.L.A. Pharma. VEN 308 is intended to treat fecal incontinence associated with ileal pouch anal anastomosis, or IPAA. To our knowledge, there are no FDA-approved drugs for the treatment of fecal incontinence. We intend to explore further development of VEN 308 subject to available resources.

  

12
 

 

Since our inception, we have had no revenue from product sales, and have funded our operations principally through debt financings, our initial public offering in 2010, a public offering of our common stock in July 2011 and an at-the-market equity offering sales program conducted in May and June 2012. Our operations to date have been primarily limited to organizing and staffing our company, licensing our product candidates, developing clinical trials for our product candidates, establishing manufacturing for our product candidates, maintaining and improving our patent portfolio and raising capital. We have generated significant losses to date, and we expect to continue to generate losses as we progress towards the commercialization of VEN 307. As of September 30, 2012, we had a deficit accumulated during the development stage of $88,528,405. Because we do not generate revenue from any of our product candidates, our losses will continue as we advance our product candidates towards regulatory approval and eventual commercialization. As a result, our operating losses are likely to be substantial over the next several years. We are unable to predict the extent of any future losses or when we will become profitable, if at all.

 

We believe that our existing cash will be sufficient to fund our projected operating requirements through the second quarter of 2014. Until we can generate a sufficient amount of product revenue, if ever, we expect to finance future cash needs through public or private equity offerings, debt financings or corporate collaborations and licensing arrangements.

 

Critical Accounting Policies

 

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP. Our significant accounting policies are more fully described in Note 2 to the December 31, 2011 audited financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2011. The following accounting policies are critical to fully understanding and evaluating our financial results.

 

Use of Estimates

 

The preparation of financial statements in conformity with U.S. GAAP requires our management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent liabilities at the date of the financial statements as well as the reported revenue, if any, and expenses during the reporting periods. On an ongoing basis, management evaluates their estimates and judgments. Management bases estimates on historical experience and on various other factors that they believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results might differ from these estimates under different assumptions or conditions.

 

Stock-Based Compensation

 

We account for stock options granted to employees and directors, measured at grant date, based on the estimated fair value of the award, which is recognized as expense over the employee’s or director’s requisite service period on a straight-line basis. We account for stock options and warrants granted to non-employees on a fair value basis. The initial non-cash charge to operations for nonemployee options and warrants with vesting are revalued at the end of each reporting period based upon the change in the fair value of the options and recognized as consulting expense over the related service period. For the purpose of valuing options and warrants granted to employees and directors and to non-employees, we use the Black-Scholes option pricing model. To determine the risk-free interest rate, we utilize the U.S. Treasury yield curve in effect at the time of grant with a term consistent with the expected term of the awards. We estimate the expected life of the options granted based on anticipated exercises in the future periods assuming the success of our business model as currently forecasted. For warrants and non-employee options, we use the contractual term of the warrant, the length of the note or option as the expected term. The expected dividend yield reflects our current and expected future policy for dividends on our common stock. The expected stock price volatility for our stock options will be calculated by examining historical volatilities for publicly traded industry peers as we do not now and for the near future will not have any significant trading history for our common stock. Forfeiture rates will be calculated based on the expected service period for our employees.

 

Research and Development Expense

 

Research and development expenses consist primarily of costs associated with: (i) internal costs associated with our development activities; (ii) payments we make to third party contract research organizations, contract manufacturers, and consultants; (iii) technology and intellectual property license costs; and (iv) patent reimbursements. All research and development is expensed as incurred. License fees and pre-approved milestone payments due under each research and development arrangement that are paid prior to regulatory approval are expensed when the license is entered into or the milestone is achieved.

 

13
 

 

Conducting a significant amount of research and development is central to our business model. Since our inception on October 7, 2005 to September 30, 2012, we incurred $56,302,020 in research and development expenses. Product candidates in later-stage clinical development generally have higher development costs than those in earlier stages of development, primarily due to the significantly increased size and duration of the clinical trials. Included in research and development expense is the purchase price we paid in 2011 for VEN 309, discussed below.

 

In June 2011, we entered into an asset purchase agreement with Sam Amer & Company (the “Purchase Agreement”) to acquire all rights, title and interest to VEN 309 (including patents, know how, other research materials and other indications), iferanserin inventory for use in clinical trials and a non-compete agreement. We paid $500,000 on execution of the Purchase Agreement and $12 million at closing, which took place on November 14, 2011. Additionally, we paid Amer $50,000 on execution and $5,000 per month through the closing for the consulting service. Upon the closing of the acquisition, the Exclusive License Agreement that we had previously entered into with Amer terminated.

 

Under the Purchase Agreement, we were obligated to make regulatory and commercialization milestone payments and pay royalties to Amer upon commercialization of VEN 309. The Purchase Agreement also contained a non-compete for Amer, Dr. Amer and his wife, but we determined that the non-compete had minimal value due to the age of Dr. and Mrs. Amer. Accordingly, we allocated the entire purchase price to in-process research and development and concluded that there is no alternative future use for these assets. Therefore, the entire $12.5 million has been recorded as a research and development expense in the statement of operations. In June 2012, after receipt of data from our Phase III clinical trial for VEN 309, we announced that we have no immediate plans to continue development of VEN 309, which has resulted and will continue to result in a reduction in expenses.

 

We plan to increase our research and development expenses for the foreseeable future in order to complete development of our active product candidate, VEN 307. The following table summarizes the research and development expenses related to our product candidates and other projects. The table reflects expenses directly attributable to each development candidate, which are tracked on a project basis.

 

   3 Months
ended
9/30/2012
   3 Months
ended
9/30/2011
   9 Months
ended
9/30/2012
   9 Months
ended
9/30/2011
   Period from
October 7, 2005
(inception) to
September 30, 2012
 
VEN 307  $1,948,690    633,535   $2,933,993   $1,003,057   $8,657,917 
VEN 309  $2,094,085   $2,763,084   $13,134,687   $5,914,512   $43,805,526 
Other  $145,352   $270,560   $704,097   $819,954   $3,838,577 

 

The process of conducting pre-clinical studies and clinical trials necessary to obtain FDA approval is costly and time consuming. The probability of success for each product candidate and clinical trial may be affected by a variety of factors, including, among others, the quality of the product candidate’s early clinical data, investment in the program, competition, manufacturing capabilities and commercial viability. As a result of the uncertainties discussed above, the uncertainty associated with clinical trial enrollments and the risks inherent in the development process, we are unable to determine with certainty the duration and completion costs of current or future clinical stages of our product candidate or when, or to what extent, we will generate revenues from the commercialization and sale of our product candidate. Development timelines, probability of success and development costs vary widely. Based on its current status, we anticipate that to complete the clinical trial process and commercialize our lead product candidate VEN 307 will cost approximately $20 million. This estimate could change significantly depending on the progress, timing and results of non-clinical and clinical trials associated with VEN 307. We believe our cash resources at September 30, 2012 will allow us to take VEN 307 through a second Phase III trial and through the second quarter 2014.

 

Off-Balance Sheet Arrangements

 

Since our inception, we have not engaged in any off-balance sheet arrangements, including the use of structured finance, special purpose entities or variable interest entities.

 

14
 

 

Results of Operations

 

Comparison of the Three Months Ended September 30, 2012 and September 30, 2011

 

Research and Development Expense

 

Research and development expense was $4,188,127 for the three months ended September 30, 2012, an increase of $520,948 or 14.205%, from $3,667,179 for same period in 2011. The primary reason for the increase was the costs associated with the new Phase III clinical trial for VEN 307, which commenced in the third quarter of 2012 and the closing out of the VEN 309 Phase III trial. Additionally, we incurred higher development costs due to initiation of nonclinical and pharmacology trials for VEN 309 which subsequently ended, and manufacturing costs to support future clinical studies for VEN 307. We expect that our research and development expenses will decrease due to the termination of the development of VEN 309.

 

General and Administrative Expense

 

General and administrative expense consists primarily of salaries, consulting fees and other related costs, professional fees for legal services and accounting services, insurance and travel expenses, as well as the option expense associated with the grants of options to our employees, consultants and directors. The termination of the development of VEN 309 did not have a significant effect on our general and administrative expenses.

 

General and administrative, or G&A, expense was $1,182,176 for the three months ended September 30, 2012, a decrease of $696,542 or 37.075% from $1,878,718 for the three months ended September 30, 2011. The decrease was primarily due to a decrease in stock option and warrant expense, investor relations expense and a reclassification of a few salaries from G&A to R&D.

 

Interest Income and Expense

 

We had no interest expense for the three months ended September 30, 2012, which was a decrease of $30,605 from the three months ended September 30, 2011. We did not have any outstanding loans during the three months ended September30, 2012, and therefore did not incur interest expense. Interest income was $14,906 for the three months ended September 30, 2012 compared to $28,423 for the same period in 2011. 

 

Comparison of the Nine Months Ended September 30, 2012 and September 30, 2011

 

Research and Development Expense

 

Research and development expense was $16,772,777 for the nine months ended September 30, 2012, an increase of $9,035,254 or 116.772% from $7,737,523 for same period in 2011. The primary reason for the increase was the costs associated with the Phase III clinical trials for VEN 309, which commenced in the third quarter of 2011 and was terminated in June 2012. Additionally, we have incurred higher development costs due to initiation of nonclinical and pharmacology trials for VEN 309 and manufacturing costs to support future clinical studies for VEN 307 and VEN 309. Our research and development expenses incurred on the development of VEN 309, decreased due to the termination of this development in June 2012. We expect the R&D expenses for VEN 307 to increase in the future.

 

General and Administrative Expense

 

General and administrative expense consists primarily of salaries, consulting fees and other related costs, professional fees for legal services and accounting services, insurance and travel expenses, as well as the option expense associated with the grants of options to our employees and directors. The termination of the development of VEN 309 did not have a significant effect on our general and administrative expenses.

 

G&A expense was $4,265,889 for the nine months ended September 30, 2012, a decrease of $3,110,849 or 43.91%, from $7,376,738 for the nine months ended September 30, 2011. The decrease was primarily due to a decrease in stock option and warrant expense, investor relations expense and a reclassification of a few salaries from G&A to R&D.

 

15
 

 

Interest Income and Expense

 

We had no interest expense for the nine months ended September 30, 2012, which is a decrease of $116,664 from the nine months ended September 30, 2011. We did not have any outstanding loans during the first three quarters of 2012 and therefore did not incur interest expense. Interest income decreased slightly, from $47,880 to $39,345.

 

Liquidity and Capital Resources

 

Sources of Liquidity

 

As a result of our significant research and development expenditures and the lack of any FDA-approved products to generate product sales revenue, we have not been profitable and have generated operating losses since we were incorporated in October 2005. We have funded our operations through September 30, 2012 principally with debt (which in connection with our initial public offering, all of the convertible notes, and accrued interest thereon, were converted into common stock or repaid) and equity financing, including raising approximately $15.2 million in net proceeds in our initial public offering, which closed on December 22, 2010, and approximately $2.4 million in net proceeds upon the exercise on January 7, 2011 of the over-allotment option granted to the underwriter of our initial public offering. In July 2011, we raised $47.6 million in net proceeds in a registered public offering of our common stock. In May and June 2012, we raised approximately $4,166,000 in net proceeds under an at-the-market program.

 

On January 31, 2012, we filed a shelf registration statement with the Securities and Exchange Commission, or SEC, under which we may offer shares of our common stock and preferred stock, various series of debt securities and/or warrants to purchase any of such securities, either individually or in units, in one or more offerings, up to a total dollar amount of $100,000,000. The registration statement became effective as of February 10, 2012. As part of the shelf registration statement, we included a prospectus for a possible at-the-market common equity sales program for the sale of up to $20,000,000 of our common stock. In May and June 2012, we raised $4,166,000 in net proceeds under the at-the-market program. At September 30, 2012, an aggregate of approximately $95,500,000 worth of securities is available under the shelf registration statement, out of which approximately $15,500,000 of common stock is available for the at-the-market common equity sales program.

 

Net Cash Used in Operating Activities

 

Net cash used in operating activities was $18,308,931 for the nine months ended September 30, 2012 to fund our research and development program build out and general and administrative expenses. The net loss of $20,999,321 for the nine months ended September 30, 2012 was greater than cash used in operating activities by $2,690,390. The primary reasons for the difference are attributed to a stock-based compensation charge of $2,567,972 and an increase of accounts payable of $168,122.

 

Net Cash Used in Investing Activities

 

Net cash used in investing activities was $3,240 for the nine months ended September 30, 2012.

 

Net Cash Provided by Financing Activities

 

Net cash provided by financing activities was $4,896,816 for the nine months ended September 30, 2012, and consisted of $427,817 from the exercise of options, $302,505 from exercise of warrants, and $4,166,494 (net of expenses of $250,988) from the sale of common stock.

 

Funding Requirements

 

We expect to incur losses for the foreseeable future. We expect to incur ongoing general and administrative expenses and research and development expenses as we pursue the development of VEN 307. Our future capital requirements will depend on a number of factors, including primarily the costs, timing and outcome of clinical trials and regulatory approvals, and, to a lesser extent, the costs involved in preparing, filing, prosecuting, maintaining, defending, and enforcing patent claims and other intellectual property rights, the acquisition of licenses to new products or compounds, the status of competitive products, the availability of financing, and our success in developing markets for our product candidates.

 

16
 

 

Based on our analysis of our future development costs, we estimate our expected future expenditures related to product development, through our recently begun second Phase III trial for VEN 307, as follows:

 

·costs of the second Phase III clinical trial of VEN 307 in the treatment of anal fissures: $12,000;000;

 

·payment of fees for applications or supplements subject to the Prescription Drug User Fee Act (PDUFA) and regulatory consultants: $2,100,000; and

 

·payment to S.L.A. Pharma of our licensing obligations for VEN 307 of $41,500 per month until the filing of an NDA with the FDA, $400,000 in development costs upon receipt of a quality controlled final study report for the Phase III clinical trial, and up to $3,000,000 in approval milestones.

 

We believe that our existing cash and cash equivalents will be sufficient to enable us to fund our operating expenses and capital expenditure requirements through the second quarter of 2014. We have based these estimates on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect, which would cause us to require additional capital earlier. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical trials.

 

We do not anticipate that we will generate product revenue for at least the next several years. In the absence of additional funding, we expect our continuing operating losses to result in increases in our cash used in operations over the next several quarters and years.

 

To the extent our capital resources are insufficient to meet our future capital requirements, we will need to finance our future cash needs through public or private equity offerings, collaboration agreements, debt financings or licensing arrangements. However, the credit markets and the financial services industry have recently been experiencing a period of turmoil and uncertainty that have made equity and debt financing more difficult to obtain. Additional funding may not be available to us on acceptable terms or at all. In addition, the terms of any financing may adversely affect the holdings or the rights of our stockholders. For example, if we raise additional funds by issuing equity securities or by selling convertible debt securities, further dilution to our existing stockholders may result. If we raise funds through collaboration agreements or licensing arrangements, we may be required to relinquish rights to our technologies or drug candidates, or grant licenses on terms that are not favorable to us. If adequate funds are not available, we may be required to terminate, significantly modify or delay our research and development programs, reduce our planned commercialization efforts, or obtain funds through collaborators that may require us to relinquish rights to our technologies or drug candidates that we might otherwise seek to develop or commercialize independently. Conversely, we may elect to raise additional funds even before we need them if the conditions for raising capital are favorable, including through offerings of securities pursuant to our shelf registration statement on Form S-3, under which we currently have up to approximately $95 million in securities available for issuance, including up to approximately $15.5 million in shares of common stock that we may offer and sell under the at-the-market equity sales program.

 

Item 3.   Quantitative and Qualitative Disclosures about Market Risk

 

Not applicable .

 

Item 4.   Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

We maintain a system of disclosure controls and procedures, as defined in Exchange Act Rule 13a-15(e),which is designed to provide reasonable assurance that information, which is required to be disclosed in our reports filed pursuant to the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), is accumulated and communicated to management in a timely manner. At the end of the period covered by this report, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Exchange Act Rule 13a-15(b). Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this report were effective.

 

17
 

 

Changes in Internal Control over Financial Reporting

 

There were no changes in our internal control over financial reporting in the third quarter of 2012 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

18
 

 

PART II - OTHER INFORMATION

 

Item 6.    Exhibits

 

Exhibit

Number

  Description of Document  

Registrant’s

Form

  Dated  

Exhibit

Number

 

Filed

Herewith

31.1   Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.               X
31.2   Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.               X
32.1   Certification of Chief Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.               X
32.2   Certification of Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.               X
101   Financials in XBRL format.               X

  

19
 

 

SIGNATURES

 

In accordance with the requirements of the Exchange Act of 1934, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  Ventrus Biosciences, Inc.
Date: November 13, 2012    
     
  By:   /s/ David J. Barrett
    David J. Barrett
    Chief Financial Officer