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Table of Contents

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-Q

(Mark One)    

ý

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2013

OR

o

 

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: 001-35403

Verastem, Inc.
(Exact name of registrant as specified in its charter)

Delaware
(State or other jurisdiction of
incorporation or organization)
  27-3269467
(I.R.S. Employer
Identification Number)

215 First Street, Suite 440
Cambridge, MA

(Address of principal executive offices)

 

02142
(Zip Code)

(617) 252-9300
(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 ý    No o

        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 ý    No o

        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 the definitions of "large accelerated filer," "accelerated filer" and "smaller reporting company" in Rule 12b-2 of the Exchange Act.

Large accelerated filer o   Accelerated filer o   Non-accelerated filer ý
(Do not check if a
smaller reporting company)
  Smaller reporting company o

        Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o    No ý

        As of July 31, 2013 there were 25,593,992 shares of Common Stock, $0.0001 par value per share, outstanding.

   


Table of Contents


TABLE OF CONTENTS

PART I—FINANCIAL INFORMATION

   


Item 1.


 


Condensed Consolidated Financial Statements (Unaudited)


 


2


Item 2.


 


Management's Discussion and Analysis of Financial Condition and Results of Operations


 


12


Item 3.


 


Quantitative and Qualitative Disclosures About Market Risk


 


15


Item 4.


 


Controls and Procedures


 


16


PART II—OTHER INFORMATION


 

 


Item 1.


 


Legal Proceedings


 


17


Item 1A.


 


Risk Factors


 


17


Item 2.


 


Unregistered Sales of Equity Securities and Use of Proceeds


 


17


Item 3.


 


Defaults Upon Senior Securities


 


17


Item 4.


 


Mine Safety Disclosures


 


17


Item 5.


 


Other Information


 


18


Item 6.


 


Exhibits


 


18

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FORWARD-LOOKING STATEMENTS

        This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements related to present facts or current conditions or of historical facts, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including the development of our compounds, the timeline for clinical development and regulatory approval of our compounds, the structure of our planned clinical trials and our ability to fund operations, are forward looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

        Forward-looking statements are not guarantees of future performance and our actual results could differ materially from the results discussed in the forward-looking statements. Factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, our ability to raise additional capital to support our clinical development program and other operations, our ability to develop products of commercial value and to identify, discover and obtain rights to additional potential product candidates, our ability to protect and maintain our intellectual property and the ability of our licensors to obtain and maintain patent protection for the technology or products that we license from them, the outcome of research and development activities and the fact that the preclinical and clinical testing of our compounds may not be predictive of the success of later clinical trials, our reliance on third-parties, competitive developments, the effect of current and future legislation and regulation and regulatory actions, as well as other risks described in our Annual Report on Form 10-K and other filings with the Securities and Exchange Commission, or SEC.

        As a result of these and other factors, we may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.


Table of Contents


PART I—FINANCIAL INFORMATION

Item 1.    Condensed Consolidated Financial Statements (Unaudited).


Verastem, Inc.

(A development stage company)

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited)

(in thousands, except per share amounts)

 
  June 30,
2013
  December 31,
2012
 

Assets

             

Current assets:

             

Cash and cash equivalents

  $ 13,880   $ 10,096  

Short-term investments

    43,571     46,480  

Prepaid expenses and other current assets

    841     506  
           

Total current assets

    58,292     57,082  

Property and equipment, net

    730     811  

Long-term investments

    20,558     34,944  

Restricted cash

    86     86  

Other long-term assets

    295      
           

Total assets

  $ 79,961   $ 92,923  
           

Liabilities, redeemable convertible preferred stock and stockholders' equity

             

Current liabilities:

             

Accounts payable

  $ 2,034   $ 1,848  

Accrued expenses

    2,354     551  

Other current liabilities

    850      
           

Total current liabilities

    5,238     2,399  

Deferred rent

    16     38  

Liability for shares subject to repurchase

    16     20  

Stockholders' equity

             

Preferred stock, $0.0001 par value; 5,000 shares authorized; none issued

         

Common stock, $0.0001 par value; 100,000, shares authorized 20,794 and 20,364 shares issued and outstanding at June 30, 2013 and December 31, 2012, respectively

    2     2  

Additional paid-in capital

    140,430     136,893  

Accumulated other comprehensive (loss) income

    (3 )   22  

Deficit accumulated during the development stage

    (65,738 )   (46,451 )
           

Total stockholders' equity

    74,691     90,466  
           

Total liabilities, redeemable convertible preferred stock and stockholders' equity

  $ 79,961   $ 92,923  
           

   

See accompanying notes.

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Verastem, Inc.

(A development stage company)

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(unaudited)

(in thousands, except per share amounts)

 
  Three months ended,
June 30,
  Six Months ended
June 30,
  Period from
August 4, 2010
(inception) to
June 30,
2013
 
 
  2013   2012   2013   2012  

Operating expenses:

                               

Research and development

  $ 6,045   $ 4,683   $ 11,341   $ 9,486   $ 43,336  

General and administrative

    4,239     2,213     8,024     4,338     22,741  
                       

Total operating expenses

    10,284     6,896     19,365     13,824     66,077  
                       

Loss from operations

    (10,284 )   (6,896 )   (19,365 )   (13,824 )   (66,077 )

Interest income

    34     71     78     128     339  
                       

Net loss

    (10,250 )   (6,825 )   (19,287 )   (13,696 )   (65,738 )
                       

Accretion of preferred stock

                (6 )   (40 )
                       

Net loss applicable to common stockholders

  $ (10,250 ) $ (6,825 ) $ (19,287 ) $ (13,702 ) $ (65,778 )
                       

Net loss per share applicable to common stockholders—basic and diluted

  $ (0.49 ) $ (0.34 ) $ (0.94 ) $ (0.79 ) $ (6.20 )
                       

Weighted-average number of common shares used in net loss per share applicable to common stockholders—basic and diluted

    20,729     19,863     20,607     17,278     10,608  
                       

Comprehensive loss

  $ (10,271 ) $ (6,791 ) $ (19,312 ) $ (13,705 ) $ (65,741 )
                       

   

See accompanying notes.

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Verastem, Inc.

(A development stage company)

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

(in thousands)

 
  Six months ended
June 30,
  Period from
August 4, 2010
(Inception) to
June 30,
2013
 
 
  2013   2012  

Operating activities

                   

Net loss

  $ (19,287 ) $ (13,696 ) $ (65,738 )

Adjustments to reconcile net loss to net cash used in operating activities:

                   

Depreciation and amortization

    112     94     402  

Stock-based compensation expense

    5,182     3,012     14,269  

Common stock issued in exchange for license

            2,003  

Obligation to issue a warrant in exchange for license

            439  

Change in fair value of obligation to issue warrant

        431     398  

Changes in operating assets and liabilities:

                   

Prepaid expenses and other current assets

    (630 )   (379 )   (1,136 )

Accounts payable

    186     177     2,034  

Accrued expenses and deferred rent

    1,781     420     2,370  
               

Net cash used in operating activities

    (12,656 )   (9,941 )   (44,959 )

Investing activities

                   

Purchases of property and equipment

    (31 )   (167 )   (1,134 )

Purchases of investments

    (44,209 )   (116,923 )   (234,088 )

Maturities of investments

    61,479     64,229     169,958  

Increase in restricted cash

            (86 )
               

Net cash provided by (used in) investing activities

    17,239     (52,861 )   (65,350 )

Financing activities

                   

Proceeds from issuance of redeemable convertible preferred stock

            68,107  

Proceeds from the exercise of stock options

    30         33  

Net proceeds from the issuance of common stock and restricted common stock

        57,599     56,878  

Cash used to settle restricted stock liability awards

    (829 )       (829 )
               

Net cash (used in) provided by financing activities

    (799 )   57,599     124,189  
               

Increase (decrease) in cash and cash equivalents

    3,784     (5,203 )   13,880  

Cash and cash equivalents at beginning of period

    10,096     20,954      
               

Cash and cash equivalents at end of period

  $ 13,880   $ 15,751   $ 13,880  
               

Supplemental disclosure of non-cash financing activity

                   

Accretion of redeemable convertible preferred stock to redemption value

  $   $ 6   $ 40  
               

Conversion of redeemable convertible preferred stock upon initial public offering

  $   $ 68,148   $ 68,148  
               

Reclassification of obligation to issue warrant from liabilities to equity

  $   $ 837   $ 837  
               

   

See accompanying notes.

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Verastem, Inc.

(A development stage company)

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

1. Summary of significant accounting policies

Basis of presentation

        The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States ("GAAP") for interim financial reporting and as required by Regulation S-X, Rule 10-01. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim financial information have been included. When preparing financial statements in conformity with GAAP, the Company must make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures at the date of the financial statements. Actual results could differ from those estimates. Additionally, operating results for the three months ended June 30, 2013 are not necessarily indicative of the results that may be expected for any other interim period or for the fiscal year ending December 31, 2013. For further information, refer to the financial statements and footnotes included in the Company's Annual Report on Form 10-K for the year ended December 31, 2012 as filed with the Securities and Exchange Commission ("SEC") on March 26, 2013.

Subsequent Events

        In preparing the financial statements included in this Form 10-Q, the Company has evaluated all subsequent events that occurred after June 30, 2013 through the date of the filing of this Form 10-Q. In July 2013, the Company closed a public offering in which it sold 4,255,000 shares of its common stock at a price of $15 per share (Note 7).

2. Fair value of financial instruments

        The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. The fair value hierarchy is now established that prioritizes valuation inputs based on the observable nature of those inputs. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. The hierarchy defines three levels of valuation inputs:

Level 1 inputs   Quoted prices in active markets for identical assets or liabilities

Level 2 inputs

 

Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly

Level 3 inputs

 

Unobservable inputs that reflect the Company's own assumptions about the assumptions market participants would use in pricing the asset or liability

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Verastem, Inc.

(A development stage company)

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

2. Fair value of financial instruments (Continued)

        The following table presents information about the Company's financial assets and liabilities that have been measured at fair value at June 30, 2013 and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value (in thousands).

Description
  Total   Quoted prices
in active
markets
(Level 1)
  Significant
other
observable
inputs
(Level 2)
  Significant
unobservable
inputs
(Level 3)
 

Financial assets

                         

Cash equivalents

  $ 12,208   $ 6,208   $ 6,000   $  

Short-term investments

    43,571         43,571      

Long-term investments

    20,558         20,558      
                   

Total financial assets

  $ 76,337   $ 6,208   $ 70,129   $  
                   

Financial liabilities

                         

Liability classified stock-based compensation awards

  $ 850   $   $ 850   $  
                   

Total financial liabilities

  $ 850   $   $ 850   $  
                   

        The following table presents information about the Company's financial assets that have been measured at fair value at December 31, 2012 and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value (in thousands).

Description
  Total   Quoted prices
in active
markets
(Level 1)
  Significant
other
observable
inputs
(Level 2)
  Significant
unobservable
inputs
(Level 3)
 

Financial assets

                         

Cash equivalents

  $ 8,171   $ 8,171   $   $  

Short-term investments

    46,480         46,480      

Long-term investments

    34,944         34,944      
                   

Total financial assets

  $ 89,595   $ 8,171   $ 81,424   $  
                   

        The Company's cash equivalents and investments are comprised of money market accounts, government-sponsored enterprise securities and commercial paper of publicly traded companies secured by the U.S. government. These investments have been initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing third party pricing services or other market observable data. The pricing services utilize industry standard valuation models, including both income and market based approaches and observable market inputs to determine value. These observable market inputs include reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates and other industry and economic events. The Company validates the prices provided by third party pricing services by reviewing their pricing methods and matrices, obtaining market values from other pricing sources, analyzing pricing data in certain instances and confirming that the relevant markets are active. After completing its validation procedures, the

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Verastem, Inc.

(A development stage company)

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

2. Fair value of financial instruments (Continued)

Company did not adjust or override any fair value measurements provided by the pricing services as of June 30, 2013.

        The Company's liability classified stock-based compensation awards are comprised of restricted stock units that allow for greater than minimum statutory tax withholdings. These awards are valued based on the fair value of the Company's common stock underlying the awards, which is traded on an active market.

3. Investments

        The Company's investments are classified as available-for-sale pursuant to Accounting Standards Codification (ASC) 320, Investments—Debt and Equity Securities. The Company classifies investments available to fund current operations as current assets on its balance sheets. Investments are classified as long-term assets on the balance sheets if (i) the Company has the intent and ability to hold the investments for a period of at least one year and (ii) the contractual maturity date of the investments is greater than one year.

        Investments are carried at fair value with unrealized gains and losses included as a component of accumulated other comprehensive (loss) income, until such gains and losses are realized. If a decline in the fair value is considered other-than-temporary, based on available evidence, the unrealized loss is transferred from other comprehensive loss to the statement of operations. There were no charges taken for other-than-temporary declines in fair value of short-term or long-term investments during the three and six months ended June 30, 2013 and 2012 or for the period from August 4, 2010 (inception) to June 30, 2013. The Company recorded ($25,000), ($9,000), ($21,000), $34,000 and ($3,000) of unrealized gains/(losses) during the six months ended June 30, 2013 and 2012, three months ended June 30, 2013 and 2012, and the period from August 4, 2010 (inception) to June 30, 2013, respectively. Realized gains and losses are included in interest income in the statement of operations. There were no realized gains or losses recognized during the three and six months ended June 30, 2013 or 2012 or for the period from August 4, 2010 (inception) to June 30, 2013. The Company utilizes the specific identification method as a basis to determine the cost of securities sold.

        The Company reviews investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment's carrying amount is not recoverable within a reasonable period of time. To determine whether an impairment is other-than-temporary, the Company considers the intent to sell, or whether it is more likely than not that the Company will be required to sell, the investment before recovery of the investment's amortized cost basis. Evidence considered in this assessment includes reasons for the impairment, compliance with the Company's investment policy, the severity and the duration of the impairment and changes in value subsequent to year end. As of June 30, 2013, there were no investments with a fair value that was significantly lower than the amortized cost basis or any investments that had been in an unrealized loss position for a significant period.

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Verastem, Inc.

(A development stage company)

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

3. Investments (Continued)

        Cash, cash equivalents and investments at June 30, 2013 and December 31, 2012 consist of the following (in thousands):

 
  Amortized
Cost
  Gross
Unrealized
Gains
  Gross
Unrealized
Losses
  Fair
Value
 

June 30, 2013

                         

Cash and cash equivalents:

                         

Cash and money market accounts

  $ 7,880   $   $   $ 7,880  

Government-sponsored enterprise securities

   
6,000
   
   
   
6,000
 
                   

Total cash and cash equivalents

  $ 13,880   $   $   $ 13,880  

Investments:

                         

Government-sponsored enterprise securities (due within 1 year)

  $ 43,562   $ 10   $ (1 ) $ 43,571  

Government-sponsored enterprise securities (due within 1 - 2 years)

    20,570         (12 )   20,558  
                   

Total investments

  $ 64,132   $ 10   $ (13 ) $ 64,129  
                   

Total cash, cash equivalents, and investments

  $ 78,012   $ 10   $ (13 ) $ 78,009  
                   

 

 
  Amortized
Cost
  Gross
Unrealized
Gains
  Gross
Unrealized
Losses
  Fair
Value
 

December 31, 2012

                         

Cash and cash equivalents:

                         

Cash and money market accounts

  $ 10,096   $   $   $ 10,096  
                   

Total cash and cash equivalents

  $ 10,096   $   $   $ 10,096  

Investments:

                         

Government-sponsored enterprise securities (due within 1 year)

  $ 46,469   $ 14   $ (3 ) $ 46,480  

Government-sponsored enterprise securities (due within 1 - 2 years)

    34,931     14     (1 )   34,944  
                   

Total investments

  $ 81,400   $ 28   $ (4 ) $ 81,424  
                   

Total cash, cash equivalents, and investments

  $ 91,496   $ 28   $ (4 ) $ 91,520  
                   

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Verastem, Inc.

(A development stage company)

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

4. Accrued expenses

        Accrued expenses consist of the following (in thousands):

 
  June 30,
2013
  December 31,
2012
 

Contract research organizations

  $ 942   $ 69  

Compensation and related benefits

    670     173  

Other

    385     54  

Professional fees

    316     183  

Deferred rent

    41     36  

Consulting

        36  
           

  $ 2,354   $ 551  
           

5. Net loss per share

        Basic and diluted net loss per common share is calculated by dividing net loss applicable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for common stock equivalents. The Company's potentially dilutive shares, which include outstanding stock options, unvested restricted stock and unvested restricted stock units are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share when their effect is dilutive.

        The following potentially dilutive securities were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:

 
  Three Months ended   Six Months ended    
 
 
  Period from
August 4, 2010
(inception) to
June 30, 2013
 
 
  June 30,
2013
  June 30,
2012
  June 30,
2013
  June 30,
2012
 

Outstanding stock options

    2,263     495     2,263     495     2,263  

Unvested restricted stock

    538     1,143     538     1,143     538  

Unvested restricted stock units

    623     598     623     598     623  

6. Stock-based compensation

        In December 2011, the Company adopted the 2012 Incentive Plan (the 2012 Plan). The 2012 Plan became effective upon the closing of the Company's IPO in February 2012. The 2012 Plan provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock awards, restricted stock units and other stock-based and cash awards. Upon effectiveness, the number of shares of common stock reserved under the 2012 Plan was the sum of 3,428,571 shares plus the number of shares available under the 2010 Equity Incentive Plan (the 2010 Plan). The number of shares reserved under the 2012 Plan is increased by the number of shares of common stock (up to a maximum of 571,242 shares) subject to outstanding awards under the 2010 Plan that expire, terminate or are otherwise surrendered, cancelled, forfeited or repurchased. The 2012 Plan includes an "evergreen provision" that allows for an annual increase in the number of shares of common stock available for issuance under the 2012 Plan. The annual increase will be added on the first day of each year beginning in 2013 and each subsequent anniversary until the expiration of the 2012 Plan, equal to

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Verastem, Inc.

(A development stage company)

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

6. Stock-based compensation (Continued)

the lowest of 1,285,714 shares of common stock, 4.0% of the number of shares of common stock outstanding and an amount determined by the board of directors. On January 1, 2013, the shares available under the 2012 Plan increased by 844,448 shares of common stock.

Restricted stock

        A summary of the Company's nonvested restricted stock as of June 30, 2013 and changes during the six months ended June 30, 2013 is as follows:

 
  Shares   Weighted-
average
purchase price
per share
 

Nonvested at December 31, 2012

    747,000   $ 0.027  

Vested

    (208,860 )   0.022  
           

Nonvested at June 30, 2013

    538,140   $ 0.029  
           

        As of June 30, 2013, there was $4.4 million of total unrecognized stock-based compensation expense related to non-vested restricted stock. The expense is expected to be recognized over a weighted average period of 1.3 years.

        A summary of the Company's nonvested restricted stock units (RSUs) as of June 30, 2013 and changes during the six months ended June 30, 2013 is as follows:

 
  Shares   Weighted-
average
grant date
fair value
 

Outstanding at December 31, 2012

    899,204   $ 10.70  

Settled

    (237,718 )   10.50  

Canceled

    (38,570 )   11.00  
           

Outstanding at June 30, 2013

    622,916   $ 10.76  
           

        As of June 30, 2013, there was $6.5 million of total unrecognized stock-based compensation expense related to non-vested RSUs granted under the 2012 Plan. The expense is expected to be recognized over a weighted-average period of 2.5 years.

        During the first quarter of 2013, the Company amended the terms of certain RSUs related to a total of 657,058 shares of common stock to allow for tax withholdings greater than the minimum required statutory withholding amount. As a result of this change in the terms of the awards, the outstanding RSUs are considered to be liability instruments. As a result of this modification, the Company records a liability for the fair value of the awards as of each reporting date with the change in fair value recorded through the statement of operations. The Company will record stock-based compensation expense equal to the greater of the original grant date fair value of the awards or the settlement date fair value. During the three and six months ended June 30, 2013, the Company deposited with tax authorities $55,000 and $829,000, respectively, to settle the tax liability for awards

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Verastem, Inc.

(A development stage company)

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)

6. Stock-based compensation (Continued)

that settled during the respective periods. The liability related to these awards is recorded within other current liabilities on the consolidated balance sheet as of June 30, 2013.

Stock options

        A summary of the Company's stock option activity and related information follows:

 
  Shares   Weighted-
average
price
per share
  Weighted-
average
remaining
contractual
term
(years)
  Aggregate
intrinsic
value
 

Outstanding at December 31, 2012

    1,424,241   $ 6.90              

Granted

    985,500     9.71              

Exercised

    (71,527 )   0.42              

Canceled

    (74,884 )   5.88              
                       

Outstanding at June 30, 2013

    2,263,330   $ 8.36     9.2   $ 12,486,058  
                   

Exercisable at June 30, 2013

    508,195   $ 7.17     8.8   $ 3,408,595  
                   

Vested and expected to vest at June 30, 2013(1)

    1,956,947   $ 8.71     9.3   $ 10,113,988  
                   

(1)
This represents the number of vested options as of June 30, 2013, plus the number of unvested options expected to vest as of June 30, 2013, based on the unvested options at June 30, 2013, adjusted for the estimated forfeiture rate

        The fair value of each stock option is estimated on the grant date using the Black-Scholes option-pricing model using the following assumptions:

 
  Six Months ended
June 31,
 
  2013   2012

Risk-free interest rate

  1.0 - 1.3%   0.8 - 2.7%

Dividend yield

   

Volatility

  75%   69 - 72%

Expected term (years)

  6.0   5.3 - 6.1

7. Subsequent Events

        In July 2013, the Company closed a public offering in which it sold 4,255,000 shares of its common stock to the public at a price of $15 per share, including 555,000 shares issued pursuant to the exercise of the underwriters' option to purchase additional shares. This offering was completed under the shelf registration statement that was filed on Form S-3 and declared effective by the Securities Exchange Commission on February 14, 2013. The net proceeds from this offering were approximately $59.8 million, after deducting underwriting discounts and commissions and other offering expenses payable by the Company.

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

        You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and related notes appearing elsewhere in this quarterly report. The following discussion contains forward-looking statements that involve risks and uncertainties. Our actual results and the timing of certain events could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including those discussed below and elsewhere in this quarterly report or in our annual report on Form 10-K.

OVERVIEW

        We are a clinical biopharmaceutical company focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells. We also develop proprietary companion diagnostics. A cancer stem cell is a particularly aggressive type of tumor cell, resistant to conventional cancer therapy, that we believe is an underlying cause of tumors, their recurrence and metastasis. We have proprietary technology to create a stable population of cancer stem cells that we use to screen for and identify small molecule compounds that target cancer stem cells. Our most advanced programs target the Focal Adhesion Kinase, or FAK, and the PI3K/mTOR signaling pathways. Our lead FAK inhibitor, VS-6063, is currently in Phase 1/1b testing in combination with weekly paclitaxel in ovarian cancer and we expect to initiate a registration directed trial of VS-6063 in mesothelioma in the third quarter of 2013. VS-6063 has been assigned defactinib as the United States Adopted Name (USAN). We have received orphan drug designation for the use of VS-6063 in mesothelioma in the European Union and in the United States. We plan to initiate a Phase 1 study of VS-6063 in Japan in the third quarter of 2013 with the goal of including Japanese sites into the registration driven mesothelioma trial. In addition we expect to start a Phase 2 study of VS-6063 in non-small cell lung cancer in the third quarter of 2013. In addition to VS-6063, our FAK inhibitor VS-4718 is in a Phase 1 clinical trial in patients with advanced cancers and we expect our dual mTORC1/2 and PI3K inhibitor VS-5584 to enter a Phase 1 clinical trial in patients with advanced cancers in the fourth quarter of 2013.

        We commenced active operations in the second half of 2010. Our operations to date have been limited to organizing and staffing our company, business planning, raising capital, acquiring and developing our technology, identifying potential product candidates, undertaking preclinical studies of our most advanced product candidates and, conducting clinical trials for VS-6063 and VS-4718. As of June 30, 2013, we have not generated any revenues and have financed our operations with net proceeds from the private placement of our preferred stock and our initial public offering. We have raised additional proceeds in July 2013 from a follow-on offering of our common stock.

        As of June 30, 2013, we had a deficit accumulated during the development stage of $65.7 million. We had net losses of $19.3 million, $13.7 million and $65.7 million for the six months ended June, 2013 and 2012 and for the period from August 4, 2010 (inception) to June 30, 2013. We expect to incur significant expenses and increasing operating losses for the foreseeable future. We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development and initiate clinical trials of, and seek marketing approval for, our product candidates. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations. Adequate additional financing may not be available to us on acceptable terms, or at all. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts. We will need to generate significant revenues to achieve profitability, and we may never do so.

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CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS AND ESTIMATES

        We believe that several accounting policies are important to understanding our historical and future performance. We refer to these policies as "critical" because these specific areas generally require us to make judgments and estimates about matters that are uncertain at the time we make the estimate, and different estimates—which also would have been reasonable—could have been used, which would have resulted in different financial results.

        The critical accounting policies we identified in our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2012 related to accrued research and development expenses and stock-based compensation. There were no changes to these critical accounting policies in the three and six months ended June 30, 2013. It is important that the discussion of our operating results that follows be read in conjunction with the critical accounting policies disclosed in our Annual Report on Form 10-K, as filed with the SEC on March 26, 2013.

        The Company has elected to follow the extended transition period guidance provided for in Securities Act Section 7(a)(2)(B) for complying with new or revised accounting standards. The Company will disclose the date on which adoption of such standards is required for non-emerging growth companies and the date on which the Company will adopt the recently issued accounting standards.

RESULTS OF OPERATIONS

Comparison of the Three Months ended June 30, 2013 and June 30, 2012

        Research and development expense.    Research and development expense for the three months ended June 30, 2013 (2013 Quarter) was $6.0 million compared to $4.7 million for the three months ended June 30, 2012 (2012 Quarter). The $1.3 million increase from the 2012 Quarter to the 2013 Quarter was primarily related to an increase of $1.1 million in contract research organization expense for outsourced biology, chemistry and development services, a $407,000 increase in personnel costs primarily due to increased headcount and a $235,000 increase in stock-based compensation expense. These increases were partially offset by a decrease of $365,000 in license fee expense primarily related to the upfront payment made to S*Bio Pte Ltd. (S*Bio) in the 2012 Quarter.

        General and administrative expense.    General and administrative expense for the 2013 Quarter was $4.2 million compared to $2.2 million for the 2012 Quarter. The $2.0 million increase from the 2012 Quarter to the 2013 Quarter primarily resulted from an increase of $971,000 in stock-based compensation expense associated with restricted stock units and restricted stock units with performance-based vesting provisions, an increase in professional fees and other costs of $624,000, a $266,000 increase in corporate franchise taxes and an increase in consulting fees of $166,000.

        Interest income.    Interest income decreased to $34,000 for the 2013 Quarter from $71,000 for the 2012 Quarter. This decrease was due to an average lower cash balance for the 2013 Quarter compared to the 2012 Quarter.

Comparison of the Six Months ended June 30, 2013 and June 30, 2012

        Research and development expense.    Research and development expense for the six months ended June 30, 2013 (2013 Period) was $11.3 million compared to $9.5 million for the six months ended June 30, 2012 (2012 Period). The $1.8 million increase from the 2012 Period to the 2013 Period was primarily related to an increase of $1.7 million in contract research organization expense for outsourced biology, chemistry and development services, a $791,000 increase in personnel costs primarily due to increased headcount and a $160,000 increase in stock-based compensation expense. These increases were partially offset by a decrease of $732,000 in license fee expense primarily related to the

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revaluation of the obligation to issue the warrant to Poniard Pharmaceuticals in the 2012 Period associated with the license and the upfront payment to S*Bio.

        General and administrative expense.    General and administrative expense for the 2013 Period was $8.0 million compared to $4.3 million for the 2012 Period. The $3.7 million increase from the 2012 Period to the 2013 Period primarily resulted from an increase of $2.0 million in stock-based compensation expense associated with restricted stock units and restricted stock units with performance-based vesting provisions, an increase in professional fees and other costs of $1.1 million, an increase in consulting fees of $277,000 and a $226,000 increase in corporate franchise taxes.

        Interest income.    Interest income decreased to $78,000 for the 2013 Period from $128,000 for the 2012 Period. This decrease was due to a lower cash balance for the 2013 Period compared to the 2012 Period.

LIQUIDITY AND CAPITAL RESOURCES

Sources of liquidity

        As of June 30, 2013, we have not generated any revenues. Since our inception in August 2010, we have financed our operations principally through private placements and our initial public offering. We have raised additional proceeds in July 2013 from a follow-on offering of our common stock. As of June 30, 2013, we had $78 million in cash, cash equivalents, and investments. We primarily invest our cash, cash equivalents and investments in a U.S. Treasury money market fund, government-sponsored enterprise securities and commercial paper.

        In July 2013, we closed a public offering in which we sold 4,255,000 shares of common stock at a price of $15 per share, including 555,000 shares issued pursuant to the exercise of the underwriters' option to purchase additional shares. This offering was completed under the shelf registration statement that was filed on Form S-3 and declared effective by the Securities Exchange Commission on February 14, 2013. The net proceeds to the Company from this offering were approximately $59.8 million, after deducting underwriting discounts and commissions and other offering expenses payable by the Company.

Cash flows

        Operating activities.    The use of cash in all periods resulted primarily from our net losses adjusted for non-cash charges and changes in the components of working capital. The significant increase in cash used in operating activities for the 2013 Period compared to the 2012 Period is due to an increase in research and development expenses as we increased our research and development headcount and increased spending on external research and development costs.

        Investing activities.    The cash provided by investing activities for the 2013 Period reflects the net maturities of investments of $17.3 million. The cash used in investing activities for the 2012 Period reflects the net purchases of investments of $52.9 million and the purchase of $167,000 of property and equipment.

        Financing activities.    The cash used in financing activities for the 2013 Period reflects cash used to pay tax withholdings for certain restricted stock units that were net settled by employees. The cash provided by financing activities in the 2012 Period reflects the net proceeds from our initial public offering less issuance costs paid in prior periods.

Funding requirements

        We expect our existing cash, cash equivalents and investments, including proceeds from our July 2013 public offering, will enable us to fund our current operating plan and capital expenditure

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requirements through the first half of 2016. We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, and the extent to which we may enter into collaborations with third parties for development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenses associated with completing the development of our current product candidates. Our future capital requirements will depend on many factors, including:

        Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. We do not have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

OFF-BALANCE SHEET ARRANGEMENTS

        We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined under Securities and Exchange Commission rules.

Item 3.    Quantitative and Qualitative Disclosures About Market Risk.

        We are exposed to market risk related to changes in interest rates. We had cash, cash equivalents and investments of $78 million as of June 30, 2013, consisting of cash, U.S. Treasury money market fund, government-sponsored enterprise securities and commercial paper. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates, particularly because most of our investments are in short-term securities. Our available-for-sale

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securities are subject to interest rate risk and will fall in value if market interest rates increase. Due to the short-term duration most of our investment portfolio and the low risk profile of our investments, an immediate 100 basis point change in interest rates would not have a material effect on the fair market value of our portfolio.

        We contract with CROs and contract manufacturers globally. We may be subject to fluctuations in foreign currency rates in connection with these agreements. Transactions denominated in currencies other than the functional currency are recorded based on exchange rates at the time such transactions arise. As of June 30, 2013, approximately $573,000 of our total liabilities were denominated in currencies other than the functional currency.

Item 4.    Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

        Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2013. The term "disclosure controls and procedures," as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company's management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of June 30, 2013, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control Over Financial Reporting

        No change in our internal control over financial reporting occurred during the fiscal quarter ended June 30, 2013 that has materially affected, or is reasonably likely to materially affect, the Company's internal control over financial reporting.

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PART II—OTHER INFORMATION

Item 1.    Legal Proceedings.

        None.

Item 1A.    Risk Factors.

        You should carefully review and consider the information regarding certain factors that could materially affect our business, financial condition or future results set forth under Item 1A. (Risk Factors) in our Annual Report on Form 10-K for the fiscal year ended December 31, 2012. There have been no material changes from the factors disclosed in our 2012 Annual Report on Form 10-K, although we may disclose changes to such factors or disclose additional factors from time to time in our future filings with the Securities and Exchange Commission.

Item 2.    Unregistered Sales of Equity Securities and Use of Proceeds.

RECENT SALES OF UNREGISTERED SECURITIES

        None.

PURCHASE OF EQUITY SECURITIES

        We did not purchase any of our registered equity securities during the period covered by this Quarterly Report on Form 10-Q.

USE OF PROCEEDS FROM REGISTERED SECURITIES

        In February 2012, we completed an initial public offering of 6,325,000 shares of our common stock at a price of $10.00 per share for an aggregate offering price of $63.3 million. The offer and sale of all of the shares in the offering were registered under the Securities Act pursuant to a registration statement on Form S-1 (File No. 333-177677), which was declared effective by the SEC on January 26, 2012, and a registration statement on Form S-1 (File No. 333-179910) filed pursuant to Rule 462(b) of the Securities Act.

        As of June 30, 2013, we have used approximately $36 million of the net proceeds primarily to fund the preclinical and clinical development of our lead product candidates, to advance and expand the research,preclinical and clinical development of additional product candidates and companion diagnostics and for working capital, capital expenditures and other general corporate purposes. We have invested the balance of the net proceeds from the offering in a variety of capital preservation investments, including investment grade, interest bearing instruments and U.S. government securities. There has been no material change in our planned use of the balance of the net proceeds from the offering as described in our final prospectus filed with the SEC pursuant to Rule 424(b) under the Securities Act.

Item 3.    Defaults Upon Senior Securities.

        None.

Item 4.    Mine Safety Disclosures.

        None.

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Item 5.    Other Information.

        The following disclosure is provided in accordance with and in satisfaction of the requirements of Item 2.02 "Results of Operations and Financial Condition" of Form 8-K:

        On August 13, 2013, Verastem, Inc. announced its financial results for the quarter ended June 30, 2013 and commented on certain corporate accomplishments and plans. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 hereto.

        The information furnished in Item 5 (including Exhibit 99.1) shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (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, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 6.    Exhibits.

        The exhibits filed as part of this Quarterly Report on Form 10-Q are set forth on the Exhibit Index, which Exhibit Index is incorporated herein by reference.

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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 thereunto duly authorized.

    VERASTEM, INC.

Date: August 13, 2013

 

By:

 

/s/ ROBERT FORRESTER

Robert Forrester
President and Chief Executive Officer
(Principal executive officer)

Date: August 13, 2013

 

By:

 

/s/ JOHN B. GREEN

John B. Green
Chief Financial Officer
(Principal financial and accounting officer)

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EXHIBIT INDEX

  10.1 # Employment agreement, dated May 10, 2013, by and between Verastem, Inc. and John B. Green (incorporated by reference to Exhibit 99.2 to current report on Form 8-K (File No: 001-35463) filed by the Registrant on May 14, 2013

 

10.2

#

Letter Agreement, dated June 6, 2013, by and between Verastem, Inc. and Robert Forrester (filed herewith)

 

31.1

 

Certification of Chief Executive Officer pursuant to Rules 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).

 

31.2

 

Certification of Chief Financial Officer pursuant to Rules 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).

 

32.1

 

Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).

 

32.2

 

Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).

 

99.1

 

Press Release issued by Verastem, Inc. on August 13, 2013 (furnished herewith).

 

101.INS


XBRL Instance Document

 

101.SCH


XBRL Taxonomy Extension Schema Document

 

101.CAL


XBRL Taxonomy Extension Calculation Linkbase Document

 

101.DEF


XBRL Taxonomy Extension Definition Linkbase Document

 

101.LAB


XBRL Taxonomy Extension Label Linkbase Document

Submitted electronically herewith.

#
Management contract or compensation plan, contract or agreement.

        In accordance with Rule 406T of Regulation S-T, the XBRL related information in Exhibit 101 to this Quarterly Report on Form 10-Q is deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act, is deemed not filed for purposes of Section 18 of the Exchange Act, and otherwise is not subject to liability under these sections.

20




Exhibit 10.2

 

 

June 6, 2013

 

Robert Forrester

c/o Verastem, Inc.

215 First Street, Suite 440

Cambridge, Massachusetts 02142

 

Dear Robert:

 

It is my pleasure to confirm certain terms of your appointment as a member of the Board of Directors (the “Board”) of Verastem, Inc. (the “Company”).

 

If you are no longer serving as the Company’s Chief Executive Officer, you hereby agree to resign as a member of the Board upon the Board’s request for your resignation.

 

This letter may not be modified or amended, and no breach shall be deemed to be waived, unless agreed to in writing by you and an expressly authorized representative of the Board.  This letter may be executed in two or more counterparts, each of which shall be an original and all of which together shall constitute one and the same instrument.  This is a Massachusetts contract and shall be governed and construed in accordance with the laws of the Commonwealth of Massachusetts, without regard to the conflict-of-laws principles thereof.

 

If this letter correctly sets forth the terms under which you will serve as a member of the Board, please sign the enclosed duplicate of this letter in the space provided below and return it to me.

 

 

Sincerely,

 

 

 

 

 

By:

/s/ Henri A. Termeer

 

 

Henri A. Termeer

 

 

Lead Director, Board of Directors

 

 

Agreed and Accepted:

 

 

 

 

 

/s/Robert Forrester

 

June 6, 2013

Robert Forrester

 

Date

 




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Exhibit 31.1

CERTIFICATIONS

I, Robert Forrester, certify that:

        1.     I have reviewed this Quarterly Report on Form 10-Q of Verastem, Inc.;

        2.     Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

        3.     Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

        4.     The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

        5.     The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

    /s/ ROBERT FORRESTER

Robert Forrester
President and Chief Executive Officer

Date: August 13, 2013




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CERTIFICATIONS

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Exhibit 31.2

CERTIFICATIONS

I, John B. Green, certify that:

        1.     I have reviewed this Quarterly Report on Form 10-Q of Verastem, Inc.;

        2.     Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

        3.     Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

        4.     The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

        5.     The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

    /s/ JOHN B. GREEN

John B. Green
Chief Financial Officer

Date: August 13, 2013




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CERTIFICATIONS

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Exhibit 32.1

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

        In connection with the Quarterly Report on Form 10-Q of Verastem, Inc. (the "Company") for the period ended June 30, 2013, as filed with the Securities and Exchange Commission on the date hereof (the "Report"), the undersigned, President and Chief Executive Officer of the Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:

    /s/ ROBERT FORRESTER

Robert Forrester
President and Chief Executive Officer

Date: August 13, 2013




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CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

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Exhibit 32.2

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

        In connection with the Quarterly Report on Form 10-Q of Verastem, Inc. (the "Company") for the period ended June 30, 2013 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), the undersigned, John B. Green, Chief Financial Officer of the Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:

    /s/ JOHN B. GREEN

John B. Green
Chief Financial Officer

Date: August 13, 2013




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CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

Exhibit 99.1

 

 

Verastem Reports Second Quarter 2013 Financial and Corporate Results

 

CAMBRIDGE, MA — August 13, 2013 — Verastem, Inc. (NASDAQ: VSTM), focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, today reported financial results for the second quarter ended June 30, 2013, and also commented on certain corporate accomplishments and plans.

 

“We have made significant progress in our mission to create drugs targeting cancer stem cells and to enable a more durable response for patients battling cancer,” said Robert Forrester, President and Chief Executive Officer of Verastem. “We recently received orphan drug designation in both the U.S. and Europe for defactinib (VS-6063), and the registration-directed study in mesothelioma is on track for initiation this quarter. We are also encouraged by the early signs of clinical activity in ovarian cancer and have now opened the expansion phase of the ongoing Phase 1b trial of defactinib in combination with weekly paclitaxel in ovarian cancer.”

 

“We have seen rapid and substantial progress this year toward our goal of delivering new medicines with meaningful therapeutic potential for patients with cancer,” said Christoph Westphal, M.D., Ph.D., Verastem Executive Chairman. “We look forward to carrying this momentum through the second half of the year.”

 

Q2 2013 and Recent Accomplishments

 

Our significant accomplishments include the following:

 

Advanced FAK inhibition program

 

·                  Completed the Phase 1 portion of a Phase 1/1b trial of defactinib in combination with paclitaxel in patients with ovarian cancer and opened the Phase 1b portion of trial

 

                 Achieved a Complete Response in one of the three patients on the first cohort

 

                 The combination was well tolerated at all dose levels with no worsening of the well-known side effects of paclitaxel

 

·                  Received orphan drug designation in the U.S. and Europe for the use of defactinib in mesothelioma

 

·                  Initiated a Phase 1 dose-escalation trial of VS-4718 in patients with advanced cancer at three U.S. locations

 

·                  Presented 3 posters on the role of FAK in cancer stem cell-driven disease progression at the annual American Association of Cancer Research (AACR) and American Society of Clinical Oncology (ASCO) conferences

 



 

Progressed the dual PI3K/mTOR inhibition program

 

·                  Presented data at the 2013 AACR Annual Meeting demonstrating the ability of VS-5584 treatment to induce tumor regression in taxane-resistant patient-derived xenograft models

 

·                  Completed IND-enabling toxicity studies for VS-5584 with the goal of initiating a Phase 1 study in Q4

 

Strengthened balance sheet and executive leadership team, and hosted our second annual Research and Development Day

 

·                  Closed on a $63.8 million public offering with net proceeds to Verastem totaling approximately $59.8 million in July 2013

 

·                  Jack Green appointed Chief Financial Officer

 

·                  Robert Forrester named President, Chief Executive Officer

 

·                  Members of the Verastem leadership team provided an overview of the Company’s development programs at the Company’s annual Research and Development Day.  Guest speakers included:

 

                 Robert Weinberg, Ph.D., Whitehead Institute and Verastem scientific cofounder and chair of the Scientific Advisory Board

 

                 Jose Baselga, M.D., Ph.D., Physician in Chief, Memorial Sloan-Kettering Cancer Center and Verastem Scientific Advisory Board member

 

                 Richard Gralla, M.D., Albert Einstein College of Medicine and Verastem Mesothelioma Steering Committee member

 

                 A replay of the event is available here

 

Increased the understanding of cancer stem cells and the biomarker merlin in mesothelioma

 

·                  Hosted a mesothelioma briefing session at ASCO 2013

 

                 Guest speaker Dean Fennell, Ph.D., FRCP, Chair of Thoracic Medical Oncology at the University of Leicester, President of the International Mesothelioma Interest Group and member of the Verastem Mesothelioma Steering Committee presented the upcoming registration-directed study of defactinib in mesothelioma

 

2013 Milestones

 

Our planned upcoming clinical milestones include the following:

 

·                  Initiate a registration-directed randomized, double blind, placebo controlled study for defactinib  in malignant pleural mesothelioma in Q3 2013

 

·                  Initiate a Phase 1 bridging study for defactinib in advanced solid tumors in Japan in Q3 2013, with goal of facilitating inclusion of Japanese sites into global mesothelioma trial by year end

 



 

2014

 

·                  Initiate a Phase 2 clinical trial for defactinib in KRas-mutated NSCLC in Q3 2013

 

·                  Initiate Phase 1 dose escalation study of VS-5584 in patients with advanced solid tumors and lymphomas in Q4 2013

 

·                  Report data from the Phase 1 portion of the ongoing defactinib + weekly paclitaxel combination trial in ovarian cancer in Q4 2013

 

Upcoming Events

 

·                  Wedbush Life Sciences Management Access Conference on Wednesday, August 14th at 3:40pm ET in NY, NY

 

·                  Forbes Global CEO Conference 2013; September 3rd-5th, in Bali, Indonesia

 

·                  Baird Healthcare Conference on Wednesday, September 11th at 9:05am ET in NY, NY

 

·                  Stifel Healthcare Conference 2013 on Wednesday, September 11th at 1:30pm ET in Boston, MA

 

Second Quarter 2013 Financial Results

 

As of June 30, 2013, Verastem had cash, cash equivalents and investments of $78.0 million compared to $84.4 million on March 31, 2013 and $91.5 million on December 31, 2012, a difference of $6.4 million for the second quarter and $13.5 million year to date. Including the $59.8 million of net proceeds from the equity offering in July 2013 and the cash, cash equivalents and investments on hand of $78.0 million as of June 30, 2013, the company has $137.8 million of available capital to fund future operations.

 

Net loss for the second quarter ended June 30, 2013 (the “2013 Quarter”) was $10.3 million, or $0.49 per share applicable to common shareholders, as compared to net loss of $6.8 million, or $0.34 per share, for the same period in 2012 (the “2012 Quarter”). Net loss includes stock-based compensation expense of $2.7 million and $1.5 million for the 2013 Quarter and 2012 Quarter, respectively.

 

Research and development expense for the 2013 Quarter was $6.0 million compared to $4.7 million for the 2012 Quarter. The $1.3 million increase from the 2012 Quarter to the 2013 Quarter was primarily related to an increase of $1.1 million in contract research organization expense, a $407,000 increase in personnel costs primarily due to increased head count and a $235,000 increase in stock-based compensation. These increases were partially offset by a decrease in license fee expense from the 2012 Quarter.

 

General and administrative expense for the 2013 Quarter was $4.2 million compared to $2.2 million for the 2012 Quarter. The $2.0 million increase from the 2012 Quarter to the 2013 Quarter primarily resulted from an increase of $971,000 in stock-based compensation expense, an increase in professional

 



 

fees and other costs of $624,000, an increase in corporate franchise taxes of $266,000 and an increase in consulting fees of $166,000.

 

The number of outstanding common shares as of July 31, 2013, was 25,593,992.

 

About Verastem, Inc.

 

Verastem, Inc. (NASDAQ: VSTM) is discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells. Cancer stem cells are an underlying cause of tumor recurrence and metastasis. Verastem is developing small molecule inhibitors of signaling pathways that are critical to cancer stem cell survival and proliferation: FAK, PI3K/mTOR and Wnt. For more information, please visit www.verastem.com.

 

Forward-looking statements:

 

This press release includes forward-looking statements about the Company’s strategy, future plans and prospects, including statements regarding the development of the Company’s compounds, including defactinib, VS-4718 and VS-5584 and the Company’s FAK and diagnostic programs generally, the timeline for clinical development and regulatory approval of the Company’s compounds, the expected timing for the reporting of data from ongoing studies, the structure of the Company’s planned clinical trials and the Company’s ability to fund operations. The words “anticipate,” “appear,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include the risks that the preclinical testing of the Company’s compounds and preliminary data from clinical trials may not be predictive of the results or success of later clinical trials, that data may not be available when we expect it to be, that the Company will be unable to successfully complete the clinical development of its compounds, including defactinib, VS-4718 and VS-5584, that the development of the Company’s compounds will take longer or cost more than planned, and that the Company’s compounds will not receive regulatory approval or become commercially successful products. Other risks and uncertainties include those identified under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012 and in any subsequent SEC filings. The forward-looking statements contained in this presentation reflect the Company’s current views with respect to future events, and the Company does not undertake and specifically disclaims any obligation to update any forward-looking statements.

 

Contact Verastem, Inc.

Brian Sullivan, 617-252-9314

bsullivan@verastem.com

 


 

(A development-stage company)

Unaudited Selected Consolidated Balance Sheet Information

(in thousands)

 

 

 

June 30,

 

December 31,

 

 

 

2013

 

2012

 

Cash, cash equivalents and investments

 

$

78,009

 

$

91,520

 

Prepaid expenses and other current assets

 

841

 

506

 

Property and equipment, net

 

730

 

811

 

Other assets

 

381

 

86

 

Total assets

 

$

79,961

 

$

92,923

 

 

 

 

 

 

 

Accounts payable and accrued expenses

 

$

4,388

 

$

2,399

 

Other liabilities

 

882

 

58

 

Stockholders’ equity

 

74,691

 

90,466

 

Total liabilities and stockholders’ equity

 

$

79,961

 

$

92,923

 

 



 

Verastem, Inc.

(A development-stage company)

Unaudited Condensed Consolidated Statements of Operations

(in thousands, except per share amounts)

 

 

 

Three months ended, June 30,

 

Six months ended, June 30,

 

 

 

2013

 

2012

 

2013

 

2012

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

$

6,045

 

$

4,683

 

$

11,341

 

$

9,486

 

General and administrative

 

4,239

 

2,213

 

8,024

 

4,338

 

Total operating expenses

 

10,284

 

6,896

 

19,365

 

13,824

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(10,284

)

(6,896

)

(19,365

)

(13,824

)

Interest income

 

34

 

71

 

78

 

128

 

Net loss

 

$

(10,250

)

$

(6,825

)

$

(19,287

)

$

(13,696

)

 

 

 

 

 

 

 

 

 

 

Accretion of preferred stock

 

 

 

 

(6

)

 

 

 

 

 

 

 

 

 

 

Net loss applicable to common stockholders

 

$

(10,250

)

$

(6,825

)

$

(19,287

)

$

(13,702

)

 

 

 

 

 

 

 

 

 

 

Net loss per share applicable to common stockholders—basic and diluted

 

$

(0.49

)

$

(0.34

)

$

(0.94

)

$

(0.79

)

Weighted-average number of common shares used in net loss per share applicable to common stockholders-basic and diluted

 

20,729

 

19,863

 

20,607

 

17,278