UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2015
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 |
|
27-3269467 |
|
|
|
117 Kendrick Street, Suite 500 |
|
02494 |
(781) 292-4200
(Registrants 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 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 x 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 x |
|
Non-accelerated filer o |
|
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 x
As of August 5, 2015 there were 36,897,405 shares of Common Stock, $0.0001 par value per share, outstanding.
|
| |
4 | ||
Managements Discussion and Analysis of Financial Condition and Results of Operations |
13 | |
17 | ||
18 | ||
|
| |
19 | ||
19 | ||
19 | ||
19 | ||
19 | ||
19 | ||
19 |
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 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, are forward looking statements. Such statements relate to, among other things, the development of our product candidates, including VS-6063, VS-4718 and VS-5584, and our FAK, PI3K/mTOR, and diagnostics programs generally, the timeline for clinical development and regulatory approval of our product candidates, the expected timing for the reporting of data from on-going trials and for the COMMAND interim analysis, the structure of our planned or pending clinical trials, additional planned studies, our rights to develop or commercialize our product candidates and our ability to finance contemplated development activities and fund operations for a specified period. 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 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 fact that the preclinical and clinical testing of our product candidates and preliminary data from clinical trials may not be predictive of the success of ongoing or later clinical trials, that data may not be available when we expect it to be, that enrollment of clinical trials may take longer than expected, that our product candidates may cause unexpected safety events, that we will be unable to successfully initiate or complete the clinical development of our product candidates, including VS-6063, VS-4718 and VS-5584, that development of our product candidates will take longer or cost more than planned, 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 (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.
Item 1. Condensed Consolidated Financial Statements (Unaudited).
Verastem, Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
(in thousands, except per share amounts)
|
|
June 30, |
|
December 31, |
| ||
Assets |
|
|
|
|
| ||
Current assets: |
|
|
|
|
| ||
Cash and cash equivalents |
|
$ |
35,172 |
|
$ |
33,901 |
|
Short-term investments |
|
96,921 |
|
58,774 |
| ||
Prepaid expenses and other current assets |
|
651 |
|
2,641 |
| ||
Total current assets |
|
132,744 |
|
95,316 |
| ||
Property and equipment, net |
|
2,456 |
|
2,825 |
| ||
Restricted cash |
|
203 |
|
203 |
| ||
Other assets |
|
293 |
|
305 |
| ||
Total assets |
|
$ |
135,696 |
|
$ |
98,649 |
|
Liabilities and stockholders equity |
|
|
|
|
| ||
Current liabilities: |
|
|
|
|
| ||
Accounts payable |
|
$ |
2,999 |
|
$ |
3,216 |
|
Accrued expenses |
|
6,478 |
|
5,519 |
| ||
Liability classified stock-based compensation awards |
|
360 |
|
469 |
| ||
Total current liabilities |
|
9,837 |
|
9,204 |
| ||
Other liabilities |
|
598 |
|
677 |
| ||
Liability for shares subject to repurchase |
|
|
|
2 |
| ||
Stockholders equity: |
|
|
|
|
| ||
Convertible preferred stock, $0.0001 par value; 5,000 shares authorized; none issued and outstanding |
|
|
|
|
| ||
Common stock, $0.0001 par value; 100,000 shares authorized; 36,854 and 27,259 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively |
|
4 |
|
3 |
| ||
Additional paid-in capital |
|
296,800 |
|
229,770 |
| ||
Accumulated other comprehensive income |
|
32 |
|
11 |
| ||
Accumulated deficit |
|
(171,575 |
) |
(141,018 |
) | ||
Total stockholders equity |
|
125,261 |
|
88,766 |
| ||
Total liabilities and stockholders equity |
|
$ |
135,696 |
|
$ |
98,649 |
|
See accompanying notes.
Verastem, Inc.
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, |
| ||||||||
|
|
2015 |
|
2014 |
|
2015 |
|
2014 |
| ||||
Operating expenses: |
|
|
|
|
|
|
|
|
| ||||
Research and development |
|
$ |
11,045 |
|
$ |
8,305 |
|
$ |
21,573 |
|
$ |
16,716 |
|
General and administrative |
|
4,417 |
|
4,782 |
|
9,131 |
|
9,505 |
| ||||
Total operating expenses |
|
15,462 |
|
13,087 |
|
30,704 |
|
26,221 |
| ||||
Loss from operations |
|
(15,462 |
) |
(13,087 |
) |
(30,704 |
) |
(26,221 |
) | ||||
Interest income |
|
85 |
|
65 |
|
147 |
|
137 |
| ||||
Net loss |
|
$ |
(15,377 |
) |
$ |
(13,022 |
) |
$ |
(30,557 |
) |
$ |
(26,084 |
) |
Net loss per sharebasic and diluted |
|
$ |
(0.42 |
) |
$ |
(0.51 |
) |
$ |
(0.87 |
) |
$ |
(1.02 |
) |
Weighted-average number of common shares used in net loss per sharebasic and diluted |
|
36,522 |
|
25,669 |
|
34,931 |
|
25,574 |
| ||||
|
|
|
|
|
|
|
|
|
| ||||
Net loss |
|
$ |
(15,377 |
) |
$ |
(13,022 |
) |
$ |
(30,557 |
) |
$ |
(26,084 |
) |
Unrealized gains (losses) on available-for-sale securities |
|
(7 |
) |
7 |
|
21 |
|
1 |
| ||||
Comprehensive loss |
|
$ |
(15,384 |
) |
$ |
(13,015 |
) |
$ |
(30,536 |
) |
$ |
(26,083 |
) |
See accompanying notes.
Verastem, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
|
|
Six months ended |
| ||||
|
|
2015 |
|
2014 |
| ||
Operating activities |
|
|
|
|
| ||
Net loss |
|
$ |
(30,557 |
) |
$ |
(26,084 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
| ||
Depreciation and amortization |
|
377 |
|
141 |
| ||
Amortization of premiums and discounts on available for sale marketable securities |
|
135 |
|
152 |
| ||
Stock-based compensation expense |
|
5,671 |
|
6,910 |
| ||
Common stock issued to purchase technology rights |
|
|
|
1,197 |
| ||
Changes in operating assets and liabilities: |
|
|
|
|
| ||
Prepaid expenses, other current assets and other assets |
|
(83 |
) |
(324 |
) | ||
Accounts payable |
|
(58 |
) |
(187 |
) | ||
Accrued expenses and other liabilities |
|
880 |
|
373 |
| ||
Liability classified stock-based compensation awards |
|
(109 |
) |
(170 |
) | ||
Net cash used in operating activities |
|
(23,744 |
) |
(17,992 |
) | ||
Investing activities |
|
|
|
|
| ||
Purchases of property and equipment |
|
(196 |
) |
(412 |
) | ||
Purchases of investments |
|
(95,333 |
) |
(26,640 |
) | ||
Maturities of investments |
|
57,072 |
|
49,295 |
| ||
Increase in restricted cash |
|
|
|
(203 |
) | ||
Net cash (used in) provided by investing activities |
|
(38,457 |
) |
22,040 |
| ||
Financing activities |
|
|
|
|
| ||
Proceeds from the exercise of stock options |
|
9 |
|
11 |
| ||
Net proceeds from the sale of common stock |
|
63,716 |
|
|
| ||
Cash used to settle restricted stock liability awards |
|
(253 |
) |
(557 |
) | ||
Net cash provided by (used in) financing activities |
|
63,472 |
|
(546 |
) | ||
Increase in cash and cash equivalents |
|
1,271 |
|
3,502 |
| ||
Cash and cash equivalents at beginning of period |
|
33,901 |
|
18,889 |
| ||
Cash and cash equivalents at end of period |
|
$ |
35,172 |
|
$ |
22,391 |
|
See accompanying notes.
Verastem, Inc.
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 and related disclosures at the date of the financial statements. Actual results could differ from those estimates. Additionally, operating results for the three and six months ended June 30, 2015 are not necessarily indicative of the results that may be expected for any other interim period or for the fiscal year ending December 31, 2015. For further information, refer to the financial statements and footnotes included in the Companys Annual Report on Form 10-K for the year ended December 31, 2014 as filed with the SEC on March 10, 2015.
Recent Accounting Pronouncements
Revenue Recognition
In May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-09, which amends the guidance for accounting for revenue from contracts with customers. This ASU supersedes the revenue recognition requirements in Accounting Standards Codification Topic 605, Revenue Recognition, and creates a new Topic 606, Revenue from Contracts with Customers. This guidance was originally pronounced to become effective for fiscal years beginning after December 15, 2016, with early adoption not permitted. On July 9, 2015, the FASB decided to defer the effective date of the ASU by one year. As a result, the Company will be required to apply the new revenue standard to annual reporting periods beginning after December 15, 2017, and would be permitted to adopt the ASU early, but not before the original public organization effective date (annual periods beginning after December 15, 2016). Two adoption methods are permitted: retrospectively to all prior reporting periods presented, with certain practical expedients permitted; or retrospectively with the cumulative effect of initially adopting the ASU recognized at the date of initial application. The Company has not yet determined which adoption method it will utilize or the effect that the adoption of this guidance will have on its consolidated financial statements.
There have been no changes to the Companys significant accounting policies included in the Companys Annual Report on Form 10-K for the year ended December 31, 2014 as filed with the SEC on March 10, 2015.
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 that is now established 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 Companys own assumptions about the assumptions market participants would use in pricing the asset or liability |
The following table presents information about the Companys financial assets and liabilities that have been measured at fair value at June 30, 2015 and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value (in thousands).
Description |
|
Total |
|
Quoted prices |
|
Significant |
|
Significant |
| ||||
Financial assets |
|
|
|
|
|
|
|
|
| ||||
Cash equivalents |
|
$ |
33,896 |
|
$ |
33,896 |
|
$ |
|
|
$ |
|
|
Short-term investments |
|
96,921 |
|
|
|
96,921 |
|
|
| ||||
Total financial assets |
|
$ |
130,817 |
|
$ |
33,896 |
|
$ |
96,921 |
|
$ |
|
|
Financial liabilities |
|
|
|
|
|
|
|
|
| ||||
Liability classified stock-based compensation awards |
|
$ |
360 |
|
$ |
360 |
|
$ |
|
|
$ |
|
|
Total financial liabilities |
|
$ |
360 |
|
$ |
360 |
|
$ |
|
|
$ |
|
|
The following table presents information about the Companys financial assets and liabilities that have been measured at fair value at December 31, 2014 and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value (in thousands).
Description |
|
Total |
|
Quoted prices |
|
Significant |
|
Significant |
| |||||
Financial assets |
|
|
|
|
|
|
|
|
| |||||
Cash equivalents |
|
$ |
32,140 |
|
$ |
32,140 |
|
$ |
|
|
$ |
|
| |
Short-term investments |
|
58,774 |
|
|
|
58,774 |
|
|
| |||||
Total financial assets |
|
$ |
90,914 |
|
$ |
32,140 |
|
$ |
58,774 |
|
$ |
|
| |
Financial liabilities |
|
|
|
|
|
|
|
|
| |||||
Liability classified stock-based compensation awards |
|
$ |
469 |
|
$ |
469 |
|
$ |
|
|
$ |
|
| |
Total financial liabilities |
|
$ |
469 |
|
$ |
469 |
|
$ |
|
|
$ |
|
| |
The Companys cash equivalents and investments are comprised of money market accounts, government-sponsored enterprise securities, corporate bonds and commercial paper. 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 Company did not adjust or override any fair value measurements provided by the pricing services as of June 30, 2015.
The Companys liability classified stock-based compensation awards are comprised of restricted stock units (RSUs) that allow for greater than minimum statutory tax withholdings. These awards are valued based on the fair value of the Companys common stock underlying the awards, which is traded on an active market. During the first quarter of 2013, the Company amended the terms of certain RSUs to allow for cash 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 the six months ended June 30, 2015 and 2014, the Company made approximate payments of $30,000, $253,000, $58,000 and $557,000, respectively, to settle the tax liability for awards that settled during the periods.
3. Investments
The Companys investments are classified as available-for-sale pursuant to the accounting standards for investments in 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, 2015 and 2014. The Company recorded approximate unrealized gains and (losses) of $(7,000), $21,000, $7,000 and $1,000 during the three and six months ended June 30, 2015 and 2014, 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, 2015 or 2014. 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 investments 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 investments amortized cost basis. Evidence considered in this assessment includes reasons for the impairment, compliance with the Companys investment policy, the severity and the duration of the impairment and changes in value subsequent to year end. As of June 30, 2015, 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.
Cash, cash equivalents and investments at June 30, 2015 and December 31, 2014 consist of the following (in thousands):
|
|
Amortized |
|
Gross |
|
Gross |
|
Fair |
| ||||
June 30, 2015 |
|
|
|
|
|
|
|
|
| ||||
Cash and cash equivalents: |
|
|
|
|
|
|
|
|
| ||||
Cash and money market accounts |
|
$ |
35,172 |
|
$ |
|
|
$ |
|
|
$ |
35,172 |
|
Total cash and cash equivalents |
|
$ |
35,172 |
|
$ |
|
|
$ |
|
|
$ |
35,172 |
|
Investments: |
|
|
|
|
|
|
|
|
| ||||
Corporate bonds and commercial paper (due within 1 year) |
|
$ |
96,889 |
|
$ |
49 |
|
$ |
(17 |
) |
$ |
96,921 |
|
Total investments |
|
$ |
96,889 |
|
$ |
49 |
|
$ |
(17 |
) |
$ |
96,921 |
|
Total cash, cash equivalents and investments |
|
$ |
132,061 |
|
$ |
49 |
|
$ |
(17 |
) |
$ |
132,093 |
|
|
|
Amortized |
|
Gross |
|
Gross |
|
Fair |
| ||||
December 31, 2014 |
|
|
|
|
|
|
|
|
| ||||
Cash and cash equivalents: |
|
|
|
|
|
|
|
|
| ||||
Cash and money market accounts |
|
$ |
33,901 |
|
$ |
|
|
$ |
|
|
$ |
33,901 |
|
Total cash and cash equivalents |
|
$ |
33,901 |
|
$ |
|
|
$ |
|
|
$ |
33,901 |
|
Investments: |
|
|
|
|
|
|
|
|
| ||||
Government-sponsored enterprise securities (due within 1 year) |
|
$ |
3,700 |
|
$ |
|
|
$ |
|
|
$ |
3,700 |
|
Corporate bonds and commercial paper (due within 1 year) |
|
55,063 |
|
18 |
|
(7 |
) |
55,074 |
| ||||
Total investments |
|
$ |
58,763 |
|
$ |
18 |
|
$ |
(7 |
) |
$ |
58,774 |
|
Total cash, cash equivalents and investments |
|
$ |
92,664 |
|
$ |
18 |
|
$ |
(7 |
) |
$ |
92,675 |
|
4. Accrued expenses
Accrued expenses consist of the following (in thousands):
|
|
June 30, |
|
December 31, |
| ||
Contract research organization costs |
|
$ |
4,390 |
|
$ |
3,049 |
|
Compensation and related benefits |
|
1,588 |
|
1,990 |
| ||
Professional fees |
|
290 |
|
233 |
| ||
Deferred rent |
|
152 |
|
144 |
| ||
Other |
|
58 |
|
103 |
| ||
|
|
$ |
6,478 |
|
$ |
5,519 |
|
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 Companys potentially dilutive shares, which include outstanding stock options, restricted stock units, unvested restricted stock and the warrant issued in 2014 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 for the periods indicated because including them would have had an anti-dilutive effect:
|
|
Three months ended |
|
Six months ended |
| ||||
|
|
2015 |
|
2014 |
|
2015 |
|
2014 |
|
Outstanding stock options |
|
5,434,711 |
|
4,151,058 |
|
5,434,711 |
|
4,151,058 |
|
Outstanding warrants |
|
142,857 |
|
142,857 |
|
142,857 |
|
142,857 |
|
Unvested restricted stock units |
|
178,614 |
|
393,768 |
|
178,614 |
|
393,768 |
|
Unvested restricted stock |
|
|
|
120,422 |
|
|
|
120,422 |
|
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 Companys 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 that are reserved under the 2012 Plan is the sum of 3,428,571 shares plus the number of shares available under the Companys prior 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 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, 2015 and 2014, the shares available under the 2012 Plan increased by 1,081,045 and 1,026,309 shares of common stock, respectively.
In December 2014, the Company established an inducement award program (in accordance with NASDAQ Listing Rule 5635(c)(4)) under which it may grant non-statutory stock options to purchase up to an aggregate of 750,000 shares of common stock to new employees as inducement for prospective employees to enter into employment with the Company. The program is governed by the terms of the 2012 Plan but the shares are not issued pursuant to the 2012 Plan. The Company has granted 210,000 options to purchase shares under this program as of June 30, 2015.
Restricted common stock
A summary of the Companys restricted common stock activity and related information is as follows:
|
|
Shares |
|
Weighted- |
| |
Unvested at December 31, 2014 |
|
7,995 |
|
$ |
0.28 |
|
Vested |
|
(7,995 |
) |
0.28 |
| |
Unvested at June 30, 2015 |
|
|
|
$ |
0.00 |
|
No restricted common stock was granted during the three and six months ended June 30, 2015 and 2014. The total fair value of shares vested during the three and six months ended June 30, 2015 and 2014 was approximately $0, $59,000, $556,000 and $706,000, respectively. As of June 30, 2015, there was no unrecognized stock-based compensation expense related to unvested restricted common stock.
A summary of the Companys restricted stock units (RSUs) activity and related information is as follows:
|
|
Shares |
|
Weighted- |
| |
Outstanding at December 31, 2014 |
|
293,747 |
|
$ |
10.54 |
|
Settled |
|
(88,017 |
) |
10.63 |
| |
Forfeited |
|
(27,116 |
) |
9.68 |
| |
Outstanding at June 30, 2015 |
|
178,614 |
|
$ |
10.63 |
|
No RSUs were granted during the three and six months ended June 30, 2015 and 2014. The total fair value of RSUs vested during the three and six months ended June 30, 2015 and 2014 was an approximate $63,000, $936,000, $125,000 and $122,000, respectively. As of June 30, 2015, there was $968,000 of total unrecognized stock-based compensation expense related to unvested RSUs granted under the 2012 Plan. The Company expects to recognize this expense over a weighted average period of 0.6 years.
During the first quarter of 2013, the Company amended the terms of certain RSUs related to a total of 697,060 shares of common stock to allow for tax withholdings greater than the minimum required statutory withholding amount, of which 141,298 remain outstanding as of June 30, 2015. 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, 2015 and 2014, the Company made approximate deposits with the taxing authorities of $30,000, $253,000, $58,000 and $557,000, respectively, in respect of the tax liability for awards that settled during such periods.
Stock options
A summary of the Companys stock option activity and related information follows:
|
|
Shares |
|
Weighted- |
|
Weighted- |
|
Aggregate |
| ||
Outstanding at December 31, 2014 |
|
4,206,440 |
|
$ |
10.38 |
|
|
|
|
| |
Granted |
|
1,375,444 |
|
8.76 |
|
|
|
|
| ||
Exercised |
|
(31,496 |
) |
0.28 |
|
|
|
|
| ||
Forfeited |
|
(115,677 |
) |
9.33 |
|
|
|
|
| ||
Outstanding at June 30, 2015 |
|
5,434,711 |
|
$ |
10.05 |
|
8.3 |
|
$ |
1,472,296 |
|
Exercisable at June 30, 2015 |
|
2,494,309 |
|
$ |
9.80 |
|
7.7 |
|
$ |
1,378,858 |
|
Vested and expected to vest at June 30, 2015 |
|
5,137,830 |
|
$ |
10.05 |
|
8.3 |
|
$ |
1,467,276 |
|
The fair value of each stock option is estimated on the grant date using the Black-Scholes option-pricing model using the following weighted average assumptions:
|
|
Six months ended |
| ||
|
|
2015 |
|
2014 |
|
Risk-free interest rate |
|
1.6% |
|
2.0% |
|
Dividend yield |
|
|
|
|
|
Volatility |
|
72% |
|
81% |
|
Expected term (years) |
|
6.0 |
|
6.2 |
|
7. Equity Offerings
In January 2015, the Company closed a public offering in which it sold 8,337,500 shares of its common stock to the public at a price of $6.50 per share, including 1,087,500 shares issued pursuant to the exercise of the underwriters option to purchase additional shares. The offering was completed under the shelf registration statement that was filed on Form S-3 and declared effective by the SEC on January 8, 2014. The net proceeds from this offering were approximately $50.9 million, after deducting underwriting discounts and commissions.
In December 2013, the Company established an at-the-market equity offering program pursuant to which it is able to offer and sell up to $35.0 million of its common stock at then current market prices from time to time through Cantor Fitzgerald & Co., as sales agent. In November 2014, the Company commenced sales under this program. Through December 31, 2014, the Company sold 1,346,676 shares under this program for net proceeds of approximately $11.6 million (after deducting commissions and other offering expenses) and the Company sold an additional 690,370 and 1,160,679 shares in the three and six months ended June 30, 2015, respectively, for net proceeds of approximately $6.2 million and $10.7 million (after deducting commissions and other offering expenses). Of the cumulative net proceeds through June 30, 2015, $9.5 million was received in 2014 and $12.7 million was received in 2015.
8. Subsequent Events
The Company reviews all activity subsequent to quarter end but prior to issuance of the condensed consolidated financial statements for events that could require disclosure or that could impact the carrying value of assets or liabilities as of the balance sheet date. During the period the Company did not have any material subsequent events.
Item 2. Managements 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. Please also refer to the section under the heading Forward-Looking Statements.
OVERVIEW
We are a biopharmaceutical company focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells. 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. Our most advanced programs target the Focal Adhesion Kinase (FAK) and the PI3K/mTOR signaling pathways. Our lead FAK inhibitor, 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. VS-6063 is currently in a registration-directed trial (COMMAND) in patients with malignant pleural mesothelioma, a Phase 1b trial in combination with weekly paclitaxel for patients with ovarian cancer, a Phase 2 study in patients with non-small cell lung cancer, a Phase 2 trial preceding surgery in mesothelioma and a combination trial of VS-6063 and VS-5584 in patients with relapsed mesothelioma. We anticipate conducting an interim analysis of COMMAND during the third quarter of 2015 and following this and assuming the trial is not futile, we intend to communicate the specific patient population for the primary analysis. We also expect to update or announce results from the combination trial of VS-6063 and paclitaxel in patients with ovarian cancer and results from the Phase 2 study of VS-6063 in patients with non-small cell lung cancer in the second half of 2015 and to report preliminary data on the extended treatment cohort for the Phase 2 trial preceding surgery in mesothelioma in the first half of 2016. In addition to VS-6063, both our FAK inhibitor VS-4718 and our dual mTORC1/2 and PI3K inhibitor VS-5584 are in Phase 1 clinical trials in patients with advanced cancers. We have received orphan drug designation for the use of VS-5584 in mesothelioma in the European Union and in the United States. We also expect to report results from the Phase 1 trials of VS-4718 and VS-5584 in the second half of 2015.
Our operations to date have been organizing and staffing our company, business planning, raising capital, acquiring and developing our technology, identifying potential product candidates and undertaking preclinical studies and clinical trials for our product candidates. To date, we have not generated any revenues and have financed our operations with net proceeds from the private placement of our preferred stock, our initial public offering in February 2012, our follow-on offerings in July 2013 and January 2015 and sales of our common stock under our at-the-market equity offering program.
As of June 30, 2015, we had an accumulated deficit of $171.6 million. We had net losses of $30.6 million and $26.1 million for the six months ended June 30, 2015 and 2014, respectively. We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development and clinical trials of, and potentially 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.
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 estimateswhich also would have been reasonablecould 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, 2014 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, 2015. 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 10, 2015.
The Company has elected to follow the extended transition period guidance provided for in Section 7(a)(2)(B) of the Securities Act of 1933, as amended, 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, 2015 and June 30, 2014
Research and development expense. Research and development expense for the three months ended June 30, 2015 (2015 Quarter) was $11.0 million compared to $8.3 million for the three months ended June 30, 2014 (2014 Quarter). The $2.7 million increase from the 2014 Quarter to the 2015 Quarter was primarily related to an increase of $2.1 million in contract research organization (CRO) expense for outsourced biology, development and clinical services, which includes our clinical trial costs, and an approximate $732,000 increase in personnel costs primarily due to an increase in headcount. These increases were partially offset by a decrease in stock-based compensation of approximately $162,000 primarily due to restricted common stock that fully vested prior to the 2015 Quarter.
The table below summarizes our allocation of research and development expenses to our clinical programs for VS-6063, VS-4718 and VS-5584, for the 2015 Quarter and 2014 Quarter. Our project costing methodology does not allocate personnel and other indirect costs to specific clinical programs. These unallocated research and development expenses are summarized in the table below and include $2.1 million of personnel costs.
|
|
Three Months Ended June 30, |
| ||||
|
|
2015 |
|
2014 |
| ||
|
|
(in thousands) |
|
(in thousands) |
| ||
VS-6063 |
|
$ |
5,830 |
|
$ |
4,154 |
|
VS-4718 |
|
459 |
|
325 |
| ||
VS-5584 |
|
657 |
|
686 |
| ||
Unallocated research and development expense |
|
3,297 |
|
2,176 |
| ||
Unallocated stock-based compensation expense |
|
802 |
|
964 |
| ||
Total research and development expense |
|
$ |
11,045 |
|
$ |
8,305 |
|
Due to the uncertainty in drug development and the stage of development of our clinical programs, we are unable to predict the requirements, specific timing and estimated costs to complete the development of our product candidates or the timing of when material cash inflows may commence, if ever.
General and administrative expense. General and administrative expense for the 2015 Quarter was $4.4 million compared to $4.8 million for the 2014 Quarter. The $400,000 decrease from the 2014 Quarter to the 2015 Quarter was primarily due to decreased stock-based compensation of approximately $376,000, primarily due to restricted common stock that fully vested prior to the 2015 Quarter, decreased consulting and professional fees of approximately $175,000 and decreased travel and other G&A expenses of approximately $96,000. These decreases were partially offset by an increase in personnel costs of approximately $278,000 due to increased headcount.
Interest income. Interest income increased to approximately $85,000 for the 2015 Quarter from approximately $65,000 for the 2014 Quarter. This increase was primarily due to a higher average investment balance for the 2015 Quarter compared to the 2014 Quarter.
Comparison of the Six Months ended June 30, 2015 and June 30, 2014
Research and development expense. Research and development expense for the six months ended June 30, 2015 (2015 Period) was $21.6 million compared to $16.7 million for the six months ended June 30, 2014 (2014 Period). The $4.9 million increase from the 2014 Period to the 2015 Period was primarily related to an increase of approximately $5.0 million in CRO expense for outsourced biology, chemistry, development and clinical services, which includes our clinical trial costs, and an approximate $1.5 million increase in personnel costs due to increased headcount. These increases were partially offset by a decrease of $1.2 million in license fees, primarily due to the Encarta asset purchase in the 2014 Period, and a decrease of stock-based compensation of approximately $541,000 primarily due to restricted common stock that fully vested prior to the 2015 Period.
The table below summarizes our allocation of research and development expenses to our clinical programs for VS-6063, VS-4718 and VS-5584, for the six months ended June 30, 2015 and June 30, 2014 respectively. Our project costing methodology does not allocate personnel and other indirect costs to specific clinical programs. These unallocated research and development expenses are summarized in the table below and include $4.1 million of personnel costs.
|
|
Six months ended June 30, |
| ||||
|
|
2015 |
|
2014 |
| ||
|
|
(in thousands) |
|
(in thousands) |
| ||
VS-6063 |
|
$ |
10,992 |
|
$ |
7,039 |
|
VS-4718 |
|
995 |
|
1,778 |
| ||
VS-5584 |
|
1,508 |
|
1,190 |
| ||
Unallocated research and development expense |
|
6,440 |
|
4,529 |
| ||
Unallocated stock-based compensation expense |
|
1,638 |
|
2,180 |
| ||
Total research and development expense |
|
$ |
21,573 |
|
$ |
16,716 |
|
Due to the uncertainty in drug development and the stage of development of our clinical programs, we are unable to predict the requirements, specific timing and estimated costs to complete the development of our product candidates or the timing of when material cash inflows may commence, if ever.
General and administrative expense. General and administrative expense for the 2015 Period was $9.1 million compared to $9.5 million for the 2014 Period. The $400,000 decrease from the 2014 Period to the 2015 Period was primarily due to decreased stock-based compensation of approximately $634,000, primarily due to restricted common stock that fully vested prior to the 2015 Period, and decreased consulting and professional fees of approximately $459,000. These decreases were partially offset by an increase of approximately $744,000 in personnel costs due to increased headcount.
Interest income. Interest income increased to approximately $147,000 for the 2015 Period from approximately $137,000 for the 2014 Period. This increase was primarily due to a higher average investment balance for the 2015 Period compared to the 2014 Period.
LIQUIDITY AND CAPITAL RESOURCES
Sources of liquidity
To date, we have not generated any revenues. We have financed our operations to date through private placements of preferred stock, our initial public offering in February 2012, our follow-on offerings in July 2013 and January 2015 and sales of common stock under our at-the market equity offering program. As of June 30, 2015, we had received $68.1 million in net proceeds from the issuance of preferred stock and $189.9 million in net proceeds from our public offerings of common stock. As of June 30, 2015, we had $132.1 million in cash, cash equivalents and investments. We primarily invest our cash, cash equivalents and investments in a U.S. Treasury money market fund, corporate bonds and commercial paper.
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 $5.8 million increase in cash used in operating activities for the 2015 Period compared to the 2014 Period is primarily due to an increase in research and development expenses related to our ongoing clinical trials and development of our lead product candidates. We expect cash used in operating activities to continue to increase for the foreseeable future as we fund our increased research and development activities.
Investing activities. The cash used for investing activities for the 2015 Period primarily reflects the net purchases of investments of $38.3 million. The cash provided by investing activities for the 2014 Period primarily reflects the net maturities of investments of $22.7 million.
Financing activities. The cash provided by financing activities for the 2015 Period primarily represent net proceeds of $63.7 million from the sale of shares of our common stock in our January 2015 follow-on offering and our at-the-market equity offering program, offset in part by approximately $253,000 used to satisfy the tax withholding obligations on certain restricted stock units that were net settled by employees. The cash used in financing activities for the 2014 Period primarily reflects approximately $557,000 used to satisfy the tax withholding obligations on certain restricted stock units that were net settled by employees.
In December 2013, we established an at-the-market equity offering program pursuant to which we are able to offer and sell up to $35.0 million of our common stock at then current market prices from time to time through Cantor Fitzgerald & Co., as sales agent. In November 2014, we commenced sales under this program. Through December 31, 2014, we sold 1,346,676 shares under this program for net proceeds of approximately $11.6 million (after deducting commissions and other offering expenses) and we sold an additional 690,370 and 1,160,679 shares in the three and six months ended June 30, 2015, respectively, for net proceeds of approximately $6.2 million and $10.7 million (after deducting commissions and other offering expenses). Of the cumulative net proceeds through June 30, 2015, $9.5 million was received in 2014 and $12.7 million was received in 2015.
In January 2015, we completed a follow-on offering in which we sold 8,337,500 shares of our common stock to the public at a price of $6.50 per share, including 1,087,500 shares issued pursuant to the exercise of the underwriters option to purchase additional shares. The net proceeds from this offering were $50.9 million, after deducting underwriting discounts and commissions.
Funding requirements
We have three product candidates currently in clinical trials. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. We anticipate that our expenses will increase substantially if and as we:
· continue our registration-directed trial of VS-6063 in mesothelioma, including the initiation of associated studies in preparation for a possible NDA filing to the FDA and similar filings to other regulatory authorities;
· continue our other ongoing clinical trials with VS-6063, VS-5584 and VS-4718;
· initiate additional clinical trials for our product candidates;
· ultimately establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain marketing approval;
· maintain, expand and protect our intellectual property portfolio;
· acquire or in-license other products and technologies;
· hire additional clinical, development and scientific personnel; and
· add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts.
We expect our existing cash, cash equivalents and investments will enable us to fund our current operating plan and capital expenditure requirements into the first half of 2017. 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:
· the rate and size of enrollment, results and cost of completing our registration-directed trial of VS-6063 in mesothelioma;
· assuming favorable clinical results, the cost, timing and outcome of our efforts to seek approval of VS-6063 in mesothelioma in the United States and elsewhere in the world, including to fund the preparation and filing of regulatory submissions with the FDA and other regulatory agencies worldwide;
· assuming regulatory approval, the costs of future commercialization activities, including product sales, marketing, manufacturing and distribution, of VS-6063 in mesothelioma in the United States and elsewhere in the world, whether alone or through a third party;
· the scope, progress and results of our other ongoing and potential future clinical trials;
· the extent to which we acquire or in-license other products and technologies;
· the costs, timing and outcome of regulatory review of our product candidates and the costs of future commercialization activities for such product candidates, for which we receive marketing approval;
· revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval;
· the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; and
· our ability to establish collaborations on favorable terms, if at all.
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.
CONTRACTUAL OBLIGATIONS
There have been no material changes to the contractual obligations set forth in our Annual Report on Form 10-K for the year ended December 31, 2014.
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 had cash, cash equivalents and investments of $132.1 million as of June 30, 2015, consisting of cash, U.S. Treasury money market fund, corporate bonds 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 interest-bearing. Our available-for-sale securities are subject to interest rate risk and will fall in value if market interest rates increase. Due to the short-term duration of 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 our functional currency are recorded based on exchange rates at the time such transactions arise. As of June 30, 2015, $2.1 million of our total liabilities
were denominated in currencies other than our functional currency. At this time, an immediate 10% change in currency exchange rates would not have a material effect on our financial position, results of operations or cash flows.
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, 2015. The term disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act of 1934 (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 SECs rules and forms. 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, 2015, 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, 2015 that has materially affected, or is reasonably likely to materially affect, the Companys internal control over financial reporting.
None.
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, 2014. There have been no material changes from the factors disclosed in our 2014 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.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
None.
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 10, 2015, Verastem, Inc. announced its financial results for the quarter ended June 30, 2015 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.
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.
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 10, 2015 |
By: |
/s/ ROBERT FORRESTER |
|
|
|
|
|
Robert Forrester |
|
|
|
Date: August 10, 2015 |
By: |
/s/ JOHN B. GREEN |
|
|
|
|
|
John B. Green |
EXHIBIT INDEX
10.1 |
|
Consulting Agreement between Verastem, Inc. and Joanna Horobin, dated June 10, 2015 and effective July 10, 2015(incorporated by reference to Exhibit 10.1 to Current Report Form 8-K (file No. 001-35403) filed by the Registrant on June 10, 2015). |
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 10, 2015 (furnished herewith). |
101.INS |
|
XBRL Instance Document |
101.SCH |
|
XBRL Taxonomy Extension Schema Document |
101.CAL |
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XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF |
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XBRL Taxonomy Extension Definition Linkbase Document |
101.LAB |
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XBRL Taxonomy Extension Label Linkbase Document |
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 registrants 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:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting.
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/s/ ROBERT FORRESTER |
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Robert Forrester |
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Chief Executive Officer |
Date: August 10, 2015
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 registrants 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:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting.
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/s/ JOHN B. GREEN |
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John B. Green |
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Chief Financial Officer |
Date: August 10, 2015
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, 2015 as filed with the Securities and Exchange Commission on the date hereof (the Report), the undersigned, Robert Forrester, 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:
(1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ ROBERT FORRESTER |
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Robert Forrester |
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Chief Executive Officer |
Date: August 10, 2015
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, 2015 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:
(1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ JOHN B. GREEN |
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John B. Green |
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Chief Financial Officer |
Date: August 10, 2015
Exhibit 99.1
Verastem Reports Second Quarter 2015 Financial and Corporate Results
COMMAND Interim Analysis Anticipated in Third Quarter 2015
BOSTON, MA August 10, 2015 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, 2015, and also provided an overview of certain corporate accomplishments and plans.
Execution of the ongoing COMMAND trial continues to progress well and we remain on track to report the outcome of the interim analysis during the third quarter of 2015, said Robert Forrester, President and Chief Executive Officer of Verastem. The independent Data and Safety Monitoring Board (DSMB) will examine pre-specified efficacy and safety data sets to decide whether to recommend continuation in all patients as planned, or to enrich the study population based upon merlin status, or to stop the study early for futility. This will be an important milestone for Verastem.
Q2 2015 and Recent Highlights
VS-6063 (Focal Adhesion Kinase Inhibition)
· COMMAND (Control Of Mesothelioma with MAinteNance Defactinib) Study
· Registration-directed, randomized, double-blind, placebo-controlled study of VS-6063 as a switch maintenance treatment in patients with malignant pleural mesothelioma benefiting from frontline therapy with pemetrexed (Alimta®) and platinum
· Co-primary endpoints are Progression Free Survival (PFS) and Overall Survival (OS). The study is designed to provide 90% power to assess the superiority of PFS, with a 1 sided type I error rate of 0.025, assuming a hazard ratio of 0.67
· 308 patients enrolled at 72 centers in 15 countries as of August 6, 2015
· Interim analysis to define the primary patient population anticipated in Q3 2015
Presentations and Publications
· Reported encouraging scientific data in support of Verastems cancer stem cell inhibitors (VS-6063, VS-4718, and VS-5584) in multiple tumor types, including mesothelioma, small cell lung cancer, breast cancer, and hematologic malignancies, at the 2015 American Association of Cancer Research (AACR) Annual Meeting. Copies of the presentations can be accessed at: http://bit.ly/12otlcV
Corporate
· Appointed Lou Vaickus, MD, FACP as Interim Chief Medical Officer
· Hosted an analyst and investor event at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting. Guest speakers Professor Dean Fennell, Ph.D., FRCP, and Max Wicha, M.D., gave presentations on mesothelioma and the rationale and importance of targeting cancer stem cells through FAK inhibition
Upcoming Clinical Milestones
Verastems anticipated upcoming data milestones include:
VS-6063
· COMMAND interim analysis: Q3 2015
· Phase 2 results in KRAS-mutated NSCLC at the World Conference of Lung Cancer in Denver, CO on September 6-9th
· Updated results from the VS-6063/paclitaxel combination in patients with ovarian cancer: H2 2015
· Biomarker Window of Opportunity mesothelioma study with preliminary results from the extended treatment cohort: H1 2016
VS-4718
· Preliminary Phase 1 results in patients with advanced solid tumors: H2 2015
VS-5584
· Preliminary Phase 1 results in patients with advanced solid tumors: H2 2015
Second Quarter 2015 Financial Results
As of June 30, 2015, Verastem had cash, cash equivalents and investments of $132.1 million compared to $92.7 million as of December 31, 2014. Verastem used $12.0 million for operating activities in the second quarter ended June 30, 2015 (the 2015 Quarter).
Net loss for the 2015 Quarter was $15.4 million, or $0.42 per share, as compared to net loss of $13.0 million, or $0.51 per share, for the same period in 2014 (the 2014 Quarter). Net loss includes stock-based compensation expense of $2.6 million and $3.2 million for the 2015 Quarter and 2014 Quarter, respectively.
Research and development expense for the 2015 Quarter was $11.0 million compared to $8.3 million for the 2014 Quarter. The $2.7 million increase from the 2014 Quarter to the 2015 Quarter was primarily related to an increase of $2.1 million in contract research organization expense for outsourced biology, development and clinical services, which includes Verastems clinical trial costs, and an approximate $732,000 increase in personnel costs. These increases were partially offset by a decrease in stock-based compensation expense of approximately $162,000.
General and administrative expense for the 2015 Quarter was $4.4 million compared to $4.8 million for the 2014 Quarter. The $400,000 decrease was primarily due to a decrease in stock-based compensation expense.
There were 36,853,805 common shares outstanding as of June 30, 2015.
Financial Guidance
Based on current operating plans, the Company expects to have sufficient cash, cash equivalents and investments to fund its research and development programs and operations into the first half of 2017.
About VS-6063
VS-6063 (defactinib) is an orally available compound designed to target cancer stem cells through the potent inhibition of focal adhesion kinase (FAK). Cancer stem cells are an underlying cause of tumor resistance to chemotherapy, recurrence and ultimate disease progression. Research has demonstrated that FAK activity is critical for the growth and survival of cancer stem cells. VS-6063 is currently being studied in the registration-directed COMMAND trial in mesothelioma (www.COMMANDmeso.com), a Window of Opportunity study in patients with mesothelioma prior to surgery, a Phase 1/1b study in combination with paclitaxel in patients with ovarian cancer, a trial in patients with KRAS-mutated non-small cell lung cancer and a trial evaluating the combination of VS-6063 and VS-5584 in patients with relapsed mesothelioma. VS-6063 has been granted orphan drug designation for use in mesothelioma in the U.S. and EU.
About VS-4718
VS-4718 is an orally available compound designed to target cancer stem cells through the potent inhibition of focal adhesion kinase (FAK). VS-4718 is currently being studied in a Phase 1 dose escalation study in patients with advanced cancers.
About VS-5584
VS-5584 is an orally available compound that has demonstrated potent and highly selective activity against class 1 PI3K enzymes and dual inhibitory actions against mTORC1 and mTORC2. In preclinical studies, VS-5584 has been shown to reduce the percentage of cancer stem cells and induce tumor regression in chemotherapy-resistant models. Verastem is currently conducting a dose escalation trial of VS-5584 in patients with advanced solid tumors as a single agent and a combination trial of VS-5584 and VS-6063 in patients with relapsed mesothelioma. VS-5584 has been granted orphan drug designation for use in mesothelioma in the U.S. and EU.
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 and PI3K/mTOR. For more information, please visit www.verastem.com.
Forward-looking statements:
This press release includes forward-looking statements about the Companys strategy, future plans and prospects, including statements regarding the development and activity of the Companys product candidates, VS-6063, VS-4718 and VS-5584, and the Companys FAK, PI3K/mTOR and diagnostics programs generally, the timeline for clinical development and regulatory approval of our product candidates, the expected timing for the reporting of data from on-going trials and for the COMMAND interim analysis, the structure of our planned or pending clinical trials, our rights to develop or commercialize our product candidates and our ability to finance contemplated development activities and fund operations for a specified period.. 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 Companys product candidates and preliminary or interim data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials, that data may not be available when we expect it to be, that enrollment of clinical trials may take longer than expected, that our product candidates will cause unexpected safety events, that the Company will be unable to successfully initiate or complete the clinical development of its product candidates, that the development of the Companys product candidates will take longer or cost more than planned, and that the Companys product candidates will not receive regulatory approval or become commercially successful products. Other risks and uncertainties include those identified under the heading Risk Factors in the Companys Annual Report on Form 10-K for the year ended December 31, 2014 and in any subsequent SEC filings. The forward-looking statements contained in this press release reflect the Companys current views with respect to future events, and the Company does not undertake and specifically disclaims any obligation to update any forward-looking statements.
Verastem, Inc.
Brian Sullivan, 781-292-4214
bsullivan@verastem.com
Verastem, Inc.
Unaudited Selected Consolidated Balance Sheet Information
(in thousands)
|
|
June 30, |
|
December 31, |
| ||
|
|
2015 |
|
2014 |
| ||
Cash, cash equivalents and investments |
|
$ |
132,093 |
|
$ |
92,675 |
|
Prepaid expenses and other current assets |
|
651 |
|
2,641 |
| ||
Property and equipment, net |
|
2,456 |
|
2,825 |
| ||
Other assets |
|
496 |
|
508 |
| ||
Total assets |
|
$ |
135,696 |
|
$ |
98,649 |
|
|
|
|
|
|
| ||
Accounts payable and accrued expenses |
|
$ |
9,837 |
|
$ |
8,735 |
|
Other liabilities |
|
598 |
|
1,148 |
| ||
Stockholders equity |
|
125,261 |
|
88,766 |
| ||
Total liabilities and stockholders equity |
|
$ |
135,696 |
|
$ |
98,649 |
|
Verastem, Inc.
Unaudited Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
|
|
Three months ended June 30, |
|
Six months ended June 30, |
| ||||||||
|
|
2015 |
|
2014 |
|
2015 |
|
2014 |
| ||||
Operating expenses: |
|
|
|
|
|
|
|
|
| ||||
Research and development |
|
$ |
11,045 |
|
$ |
8,305 |
|
$ |
21,573 |
|
$ |
16,716 |
|
General and administrative |
|
4,417 |
|
4,782 |
|
9,131 |
|
9,505 |
| ||||
Total operating expenses |
|
15,462 |
|
13,087 |
|
30,704 |
|
26,221 |
| ||||
|
|
|
|
|
|
|
|
|
| ||||
Loss from operations |
|
(15,462 |
) |
(13,087 |
) |
(30,704 |
) |
(26,221 |
) | ||||
Interest income |
|
85 |
|
65 |
|
147 |
|
137 |
| ||||
Net loss |
|
$ |
(15,377 |
) |
$ |
(13,022 |
) |
$ |
(30,557 |
) |
$ |
(26,084 |
) |
|
|
|
|
|
|
|
|
|
| ||||
Net loss per sharebasic and diluted |
|
$ |
(0.42 |
) |
$ |
(0.51 |
) |
$ |
(0.87 |
) |
$ |
(1.02 |
) |
Weighted-average number of common shares used in net loss per share -basic and diluted |
|
36,522 |
|
25,669 |
|
34,931 |
|
25,574 |
|