Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2014 | Oct. 31, 2014 | |
Document and Entity Information | ' | ' |
Entity Registrant Name | 'Onconova Therapeutics, Inc. | ' |
Entity Central Index Key | '0001130598 | ' |
Document Type | '10-Q | ' |
Document Period End Date | 30-Sep-14 | ' |
Amendment Flag | 'false | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Well-known Seasoned Issuer | 'No | ' |
Entity Voluntary Filers | 'No | ' |
Entity Current Reporting Status | 'Yes | ' |
Entity Filer Category | 'Non-accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 21,692,240 |
Document Fiscal Year Focus | '2014 | ' |
Document Fiscal Period Focus | 'Q3 | ' |
Condensed_Consolidated_Balance
Condensed Consolidated Balance Sheets (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Current assets: | ' | ' |
Cash and cash equivalents | $42,348,000 | $60,009,000 |
Marketable securities | 14,999,000 | 39,994,000 |
Prepaid expenses and other current assets | 4,278,000 | 4,387,000 |
Total current assets | 61,625,000 | 104,390,000 |
Property and equipment, net | 512,000 | 626,000 |
Restricted cash | 125,000 | 125,000 |
Other non-current assets | 12,000 | 12,000 |
Total assets | 62,274,000 | 105,153,000 |
Current liabilities : | ' | ' |
Accounts payable | 5,385,000 | 3,710,000 |
Accrued expenses and other current liabilities | 7,202,000 | 5,820,000 |
Warrant liability | ' | 20,000 |
Deferred revenue | 455,000 | 788,000 |
Total current liabilities | 13,042,000 | 10,338,000 |
Deferred revenue, non-current | 13,568,000 | 13,909,000 |
Other | 1,000 | 6,000 |
Total liabilities | 26,611,000 | 24,253,000 |
Commitments and contingencies | ' | ' |
Stockholders' equity (deficit): | ' | ' |
Preferred stock, $0.01 par value, 5,000,000 authorized at September 30, 2014 and December 31, 2013 none issued and outstanding at September 30, 2014 and December 31, 2013 | ' | ' |
Common stock, $0.01 par value, 75,000,000 authorized at September 30, 2014 and December 31, 2013, 21,692,240 and 21,467,482 shares issued and outstanding at September 30, 2014 and December 31, 2013 | 217,000 | 215,000 |
Additional paid in capital | 316,266,000 | 311,093,000 |
Accumulated other comprehensive income | -8,000 | 1,000 |
Accumulated deficit | -281,206,000 | -230,896,000 |
Total Onconova Therapeutics, Inc. stockholders' equity | 35,269,000 | 80,413,000 |
Non-controlling interest | 394,000 | 487,000 |
Total stockholders' equity | 35,663,000 | 80,900,000 |
Total liabilities and stockholders' equity | $62,274,000 | $105,153,000 |
Condensed_Consolidated_Balance1
Condensed Consolidated Balance Sheets (Parenthetical) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Consolidated Balance Sheets | ' | ' |
Preferred stock, par value (in dollars per share) | $0.01 | $0.01 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $0.01 | $0.01 |
Common stock, shares authorized | 75,000,000 | 75,000,000 |
Common stock, shares issued | 21,692,240 | 21,467,482 |
Common stock, shares outstanding | 21,692,240 | 21,467,482 |
Condensed_Consolidated_Stateme
Condensed Consolidated Statements of Operations (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Consolidated Statements of Operations | ' | ' | ' | ' |
Revenue | $114,000 | $1,116,000 | $686,000 | $2,823,000 |
Operating expenses: | ' | ' | ' | ' |
General and administrative | 3,116,000 | 5,927,000 | 12,033,000 | 12,390,000 |
Research and development | 11,886,000 | 15,293,000 | 39,038,000 | 38,096,000 |
Total operating expenses | 15,002,000 | 21,220,000 | 51,071,000 | 50,486,000 |
Loss from operations | -14,888,000 | -20,104,000 | -50,385,000 | -47,663,000 |
Change in fair value of warrant liability | 1,000 | -31,000 | 20,000 | -19,000 |
Other income, net | -20,000 | 46,000 | -38,000 | 186,000 |
Net loss before income taxes | -14,907,000 | -20,089,000 | -50,403,000 | -47,496,000 |
Income taxes | ' | 432,000 | ' | 432,000 |
Net loss | -14,907,000 | -20,521,000 | -50,403,000 | -47,928,000 |
Net loss attributable to non-controlling interest | 29,000 | ' | 93,000 | ' |
Net loss attributable to Onconova Therapeutics, Inc | -14,878,000 | -20,521,000 | -50,310,000 | -47,928,000 |
Accretion of redeemable convertible preferred stock | ' | -269,000 | ' | -2,320,000 |
Net loss applicable to common stockholders | ($14,878,000) | ($20,790,000) | ($50,310,000) | ($50,248,000) |
Net loss per share of common stock, basic and diluted (in dollars per share) | ($0.69) | ($1.34) | ($2.32) | ($7.23) |
Basic and diluted weighted average shares outstanding (in shares) | 21,691,017 | 15,480,416 | 21,639,764 | 6,946,248 |
Consolidated_Statements_of_Com
Consolidated Statements of Comprehensive Loss (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Consolidated Statements of Comprehensive Loss | ' | ' | ' | ' |
Net loss | ($14,907,000) | ($20,521,000) | ($50,403,000) | ($47,928,000) |
Other comprehensive income, before tax: | ' | ' | ' | ' |
Foreign currency translation adjustments, net | -8,000 | -23,000 | -9,000 | -18,000 |
Other comprehensive (loss) income, net of tax | -8,000 | -23,000 | -9,000 | -18,000 |
Comprehensive loss | -14,915,000 | -20,544,000 | -50,412,000 | -47,946,000 |
Comprehensive loss attributable to non-controlling interest | 29,000 | ' | 93,000 | ' |
Comprehensive loss attributable to Onconova Therapeutics, Inc | ($14,886,000) | ($20,544,000) | ($50,319,000) | ($47,946,000) |
Consolidated_Statement_of_Stoc
Consolidated Statement of Stockholders' Equity (USD $) | Common Stock | Additional Paid in Capital | Accumulated deficit | Accumulated other comprehensive income | Non-controlling interest | Total |
Balance at Dec. 31, 2013 | $215,000 | $311,093,000 | ($230,896,000) | $1,000 | $487,000 | $80,900,000 |
Balance (in shares) at Dec. 31, 2013 | 21,467,482 | ' | ' | ' | ' | ' |
Increase (Decrease) in Stockholders' Equity | ' | ' | ' | ' | ' | ' |
Net loss | ' | ' | -50,310,000 | ' | -93,000 | -50,403,000 |
Other comprehensive income | ' | ' | ' | -9,000 | ' | -9,000 |
Exercise of stock options | 2,000 | 946,000 | ' | ' | ' | 948,000 |
Exercise of stock options (in shares) | 224,758 | ' | ' | ' | ' | ' |
Stock-based compensation | ' | 4,227,000 | ' | ' | ' | 4,227,000 |
Balance at Sep. 30, 2014 | $217,000 | $316,266,000 | ($281,206,000) | ($8,000) | $394,000 | $35,663,000 |
Balance (in shares) at Sep. 30, 2014 | 21,692,240 | ' | ' | ' | ' | ' |
Condensed_Consolidated_Stateme1
Condensed Consolidated Statements of Cash Flows (USD $) | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 2013 | |
Operating activities: | ' | ' |
Net loss | ($50,403,000) | ($47,928,000) |
Adjustment to reconcile net loss to net cash used in operating activities : | ' | ' |
Depreciation and amortization | 336,000 | 326,000 |
Change in fair value of warrant liabilities | -20,000 | 19,000 |
Treasury note discount amortization | -5,000 | ' |
Stock compensation expense | 4,227,000 | 6,939,000 |
Changes in assets and liabilities : | ' | ' |
Prepaid expenses and other current assets | 109,000 | -3,601,000 |
Accounts payable | 1,675,000 | -1,112,000 |
Accrued expenses | 1,382,000 | 3,892,000 |
Other liabilities | -5,000 | -14,000 |
Deferred revenue | -674,000 | -2,775,000 |
Net cash used in operating activities | -43,378,000 | -44,254,000 |
Investing activities: | ' | ' |
Payments for purchase of property and equipment | -222,000 | -515,000 |
Maturities of marketable securities | 25,000,000 | -39,990,000 |
Net cash provided by (used in) investing activities | 24,778,000 | -40,505,000 |
Financing activities: | ' | ' |
Proceeds from initial public offering of common stock, net of issuance costs | ' | 79,811,000 |
Proceeds from the exercise of stock options | 948,000 | 51,000 |
Net cash provided by financing activities | 948,000 | 79,862,000 |
Effect of foreign currency translation on cash | -9,000 | -18,000 |
Net decrease in cash and cash equivalents | -17,661,000 | -4,915,000 |
Cash and cash equivalents at beginning of period | 60,009,000 | 81,527,000 |
Cash and cash equivalents at end of period | $42,348,000 | $76,612,000 |
Nature_of_Business
Nature of Business | 9 Months Ended |
Sep. 30, 2014 | |
Nature of Business | ' |
Nature of Business | ' |
1. Nature of Business | |
The Company | |
Onconova Therapeutics, Inc. (the “Company”) was incorporated in the State of Delaware on December 22, 1998 and commenced operations on January 1, 1999. The Company’s headquarters are located in Newtown, Pennsylvania. The Company is a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer. Using its proprietary chemistry platform, the Company has created an extensive library of targeted anti-cancer agents designed to work against specific cellular pathways that are important to cancer cells. The Company believes that the drug candidates in its pipeline have the potential to be efficacious in a wide variety of cancers without causing harm to normal cells. The Company has three clinical-stage product candidates and several preclinical programs. To accelerate and broaden the development of rigosertib, the Company’s most advanced product candidate, the Company entered into a collaboration and license agreement in 2012 with Baxter Healthcare SA (“Baxter”), a subsidiary of Baxter International Inc., which grants Baxter certain rights to commercialize rigosertib in Europe. In 2011, the Company entered into a collaboration and license agreement with SymBio Pharmaceuticals Limited (“SymBio”), which grants SymBio certain rights to commercialize rigosertib in Japan and Korea. The Company has retained development and commercialization rights to rigosertib in the rest of the world, including the United States. During 2012, Onconova Europe GmbH was established as a wholly owned subsidiary of the Company for the purpose of further developing business in Europe. In April 2013, GBO, LLC, a Delaware limited liability company, (“GBO”) was formed pursuant to a collaboration agreement with GVK Biosciences Private Limited, a private limited company located in India, (“GVK BIO”) to collaborate and develop new programs using the Company’s technology platform through filing of an investigational new drug application (“IND”) and /or conducting proof of concept studies using the Company’s technology platform. | |
Liquidity | |
The Company has incurred recurring operating losses since inception. For the nine months ended September 30, 2014, the Company incurred a net loss of $50,403,000 and as of September 30, 2014, the Company had generated an accumulated deficit of $281,206,000. The Company anticipates operating losses to continue for the foreseeable future due to, among other things, costs related to research funding, development of its product candidates and its preclinical programs, strategic alliances and the development of its administrative organization. The Company will require substantial additional financing to continue to fund its operations and execute its strategy. | |
Since its inception, the Company raised significant capital through the issuance of redeemable convertible preferred stock, par value $0.01 per share, in ten series denominated as Series A through Series J (“Series A Preferred Stock” through “Series J Preferred Stock,” respectively, and collectively the “Preferred Stock”). On July 30, 2013, the Company completed its initial public offering (the “IPO”) of 5,941,667 shares of the Company’s common stock, par value $0.01 per share (“Common Stock”), at a price of $15.00 per share, including 775,000 shares of Common Stock issued upon the exercise in full by the underwriters of their option to purchase additional shares at the same price to cover over-allotments. The Company received net proceeds of $79,811,000 from the sale, net of underwriting discounts and commissions and other estimated offering expenses. Immediately prior to the consummation of the IPO, all outstanding shares of Preferred Stock automatically converted into shares of Common Stock at the applicable conversion ratio then in effect. As a result of the conversion, as of July 30, 2013, the Company had no shares of Preferred Stock outstanding. | |
The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company’s ability to continue as a going concern is dependent on its ability to raise additional capital to fund its research and development and commercial programs and meet its obligations. Management intends to fund future operations through additional securities offerings, licensing revenue, grants, government contracts, debt and, if any of the Company’s product candidates receive marketing approval, future sales of its products. There can be no assurance, however, that the Company will be successful in obtaining financing at the level needed to sustain operations, on terms acceptable to the Company, or at all, or that the Company will obtain approvals necessary to market its products or achieve profitability or sustainable, positive cash flow. | |
Summary_of_Significant_Account
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2014 | |
Summary of Significant Accounting Policies | ' |
Summary of Significant Accounting Policies | ' |
2. Summary of Significant Accounting Policies | |
Basis of Presentation | |
The condensed consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States (“GAAP”) for interim financial information. Certain information and footnotes normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). The financial statements include the consolidated accounts of the Company, its wholly-owned subsidiary, Onconova Europe GmbH, and GBO. All significant intercompany transactions have been eliminated. | |
Unaudited Interim Financial Information | |
The accompanying condensed consolidated balance sheet as of September 30, 2014, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2014 and 2013, the consolidated statement of stockholders’ equity for the nine months ended September 30, 2014 and the condensed consolidated statements of cash flows for the nine months ended September 30, 2014 and 2013 are unaudited. The interim unaudited condensed consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2014 and the results of its operations, and its cash flows for the three and nine months ended September 30, 2014 and 2013. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2014 and 2013 are unaudited. The results for the nine months ended September 30, 2014 are not necessarily indicative of results to be expected for the year ending December 31, 2014, any other interim periods, or any future year or period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2013 included in the Company’s annual report on Form 10-K filed with the SEC on March 20, 2014. | |
Segment Information | |
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one segment, which is the identification and development of oncology therapeutics. | |
Significant Accounting Policies | |
The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2013 included in the Company’s annual report on Form 10-K filed with the SEC on March 20, 2014. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies. | |
Foreign Currency Translation | |
The reporting currency of the Company and its U.S. subsidiary is the U.S. dollar. The functional currency of the Company’s non-U.S. subsidiary is the local currency. Assets and liabilities of the foreign subsidiary are translated into U.S. dollars based on exchange rates at the end of the period. Revenues and expenses are translated at average exchange rates during the reporting period. Gains and losses arising from the translation of assets and liabilities are included as a component of accumulated other comprehensive income. Gains and losses resulting from foreign currency transactions are reflected within the Company’s results of operations. The Company has not utilized any foreign currency hedging strategies to mitigate the effect of its foreign currency exposure. | |
Recent Accounting Pronouncements | |
In July 2013, the Financial Accounting Standards Board (the “FASB”) issued guidance clarifying that an unrecognized tax benefit, or a portion of an unrecognized tax benefit, should be presented in the financial statements as a reduction to a deferred tax asset for a net operating loss carryforward, a similar tax loss, or a tax credit carryforward if such settlement is required or expected in the event the uncertain tax benefit is disallowed. In situations where a net operating loss carryforward, a similar tax loss, or a tax credit carryforward is not available at the reporting date under the tax law of the applicable jurisdiction or the tax law of the jurisdiction does not require, and the entity does not intend to use, the deferred tax asset for such purpose, the unrecognized tax benefit should be presented in the financial statements as a liability and should not be netted with the deferred tax asset. The guidance was effective for fiscal years, and interim periods within those years, beginning after December 15, 2013. The Company adopted these new provisions during the quarter beginning January 1, 2014. The guidance did not have an impact on the Company’s consolidated financial position, results of operations or cash flows. | |
In May 2014, the FASB issued guidance on revenue from contracts with customers that will supersede most current revenue recognition guidance. The underlying principle is that an entity will recognize revenue to depict the transfer of goods or services to customers at an amount that the entity expects to be entitled to in exchange for those goods or services. The guidance is effective for the interim and annual periods beginning on or after December 15, 2016, and early adoption is not permitted. The guidance permits the use of either a retrospective or cumulative effect transition method. The Company has not yet selected a transition method and is currently evaluating the impact of the amended guidance on the Company’s consolidated financial position, results of operations and related disclosures. | |
In August 2014, the FASB issued guidance on determining when and how to disclose going-concern uncertainties in the financial statements. The new standard requires management to perform interim and annual assessments of an entity’s ability to continue as a going concern within one year of the date the financial statements are issued. An entity must provide certain disclosures if conditions or events raise substantial doubt about the entity’s ability to continue as a going concern. The guidance applies to all entities and is effective for annual periods ending after December 15, 2016, and interim periods thereafter, with early adoption permitted. The Company is evaluating the potential impact of the new guidance on its quarterly reporting process and its consolidated financial position, results of operations and related disclosures. | |
Fair_Value_Measurements
Fair Value Measurements | 9 Months Ended | |||||||||||||||||||||||||
Sep. 30, 2014 | ||||||||||||||||||||||||||
Fair Value Measurements | ' | |||||||||||||||||||||||||
Fair Value Measurements | ' | |||||||||||||||||||||||||
3. Fair Value Measurements | ||||||||||||||||||||||||||
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. | ||||||||||||||||||||||||||
The Company utilizes a valuation hierarchy for disclosure of the inputs to the valuations used to measure fair value. This hierarchy prioritizes the inputs into three broad levels as follows. Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument. Level 3 inputs are unobservable inputs based on the Company’s own assumptions used to measure assets and liabilities at fair value. A financial asset or liability’s classification within the hierarchy is determined based on the lowest level input that is significant to the fair value measurement. | ||||||||||||||||||||||||||
The Company had no assets or liabilities classified as Level 1 or Level 2. The warrant liability (see Note 7) is classified as Level 3. | ||||||||||||||||||||||||||
The Company has classified the warrants as a liability and has re-measured the liability to estimated fair value at September 30, 2014 and December 31, 2013, using the Black-Scholes option pricing model with the following assumptions: contractual life according to the remaining terms of the warrants, no dividend yield, weighted average risk-free interest rates of 0.04% and 0.34% at September 30, 2014 and December 31, 2013, respectively, and weighted average volatility of 58.98% and 74.40% at September 30, 2014 and December 31, 2013, respectively. The volatility was based on average historical share price trading data for a group of 11 comparable companies. | ||||||||||||||||||||||||||
The following fair value hierarchy table presents information about the Company’s financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2014 and December 31, 2013: | ||||||||||||||||||||||||||
Fair Value Measurement as of September 30, 2014 | Fair Value Measurement as of December 31, 2013 | |||||||||||||||||||||||||
Level 1 | Level 2 | Level 3 | Balance | Level 1 | Level 2 | Level 3 | Balance | |||||||||||||||||||
Warrant liability | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | 20,000 | $ | 20,000 | ||||||||||
Total | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | 20,000 | $ | 20,000 | ||||||||||
The following table presents a reconciliation of the Company’s liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) for the nine months ended September 30, 2014: | ||||||||||||||||||||||||||
Warrant Liability | ||||||||||||||||||||||||||
Balance at December 31, 2013 | $ | 20,000 | ||||||||||||||||||||||||
Change in fair value upon re-measurement | (20,000 | ) | ||||||||||||||||||||||||
Balance at September 30, 2014 | $ | — | ||||||||||||||||||||||||
There were no transfers between Level 1 and Level 2 in any of the periods reported. | ||||||||||||||||||||||||||
Marketable_Securities
Marketable Securities | 9 Months Ended | |||||||
Sep. 30, 2014 | ||||||||
Marketable Securities | ' | |||||||
Marketable Securities | ' | |||||||
4. Marketable Securities | ||||||||
Marketable securities with initial maturities longer than three months but that mature within one year from the balance sheet date are classified as current assets and are summarized as follows: | ||||||||
September | December 31, | |||||||
30, 2014 | 2013 | |||||||
U.S. Treasury obligations | $ | 14,999,000 | $ | 39,994,000 | ||||
As of September 30, 2014 and December 31, 2013, all of the Company’s investments were classified as held-to-maturity. | ||||||||
Net_Loss_Per_Share_of_Common_S
Net Loss Per Share of Common Stock | 9 Months Ended | |||||
Sep. 30, 2014 | ||||||
Net Loss Per Share of Common Stock | ' | |||||
Net Loss Per Share of Common Stock | ' | |||||
5. Net Loss Per Share of Common Stock | ||||||
The following potentially dilutive securities outstanding at September 30, 2014 and 2013 have been excluded from the computation of diluted weighted average shares outstanding, as they would be antidilutive: | ||||||
September 30, | ||||||
2014 | 2013 | |||||
Warrants | 4,597 | 4,597 | ||||
Stock options | 4,112,326 | 3,549,842 | ||||
4,116,923 | 3,554,439 | |||||
Balance_Sheet_Detail
Balance Sheet Detail | 9 Months Ended | |||||||
Sep. 30, 2014 | ||||||||
Balance Sheet Detail | ' | |||||||
Balance Sheet Detail | ' | |||||||
6. Balance Sheet Detail | ||||||||
Prepaid expenses and other current assets: | ||||||||
September 30, | December 31, | |||||||
2014 | 2013 | |||||||
Research and development | $ | 2,571,000 | $ | 2,242,000 | ||||
Manufacturing | 444,000 | 1,051,000 | ||||||
Insurance | 851,000 | 645,000 | ||||||
Other | 412,000 | 449,000 | ||||||
$ | 4,278,000 | $ | 4,387,000 | |||||
Property and equipment: | ||||||||
September 30, | December 31, | |||||||
2014 | 2013 | |||||||
Property and equipment | $ | 2,621,000 | $ | 2,402,000 | ||||
Accumulated depreciation | (2,109,000 | ) | (1,776,000 | ) | ||||
$ | 512,000 | $ | 626,000 | |||||
Accrued expenses and other current liabilities: | ||||||||
September 30, | December 31, | |||||||
2014 | 2013 | |||||||
Research and development | $ | 4,571,000 | $ | 4,625,000 | ||||
Employee compensation | 2,122,000 | 509,000 | ||||||
Professional fees | 450,000 | 310,000 | ||||||
Taxes | — | 302,000 | ||||||
Other | 59,000 | 74,000 | ||||||
$ | 7,202,000 | $ | 5,820,000 | |||||
Warrants
Warrants | 9 Months Ended |
Sep. 30, 2014 | |
Warrants | ' |
Warrants | ' |
7. Warrants | |
In June 2009, the Company issued 6,128 Series G Preferred Stock warrants in connection with a Loan and Security Agreement. The warrants were initially recorded at their fair value calculated using the Black-Scholes model. The warrants are classified as liabilities due to certain anti-dilution provisions, and the value of the warrants is adjusted to current fair value at each reporting period end. For the nine months ended September 30, 2014 and 2013, the Company recorded $20,000 and $(19,000), respectively, in the consolidated statements of operations related to the change in the fair value of the outstanding warrants. | |
Immediately prior to the consummation of the IPO, the 6,128 Series G Preferred Stock warrants outstanding were automatically converted into warrants to purchase 4,597 shares of Common Stock (after giving effect to the one-for-1.333 reverse stock split that became effective on July 17, 2013 in connection with the IPO). The outstanding warrants, unless sooner exercised, will expire on July 30, 2016. | |
StockBased_Compensation
Stock-Based Compensation | 9 Months Ended | |||||||||||||
Sep. 30, 2014 | ||||||||||||||
Stock-Based Compensation | ' | |||||||||||||
Stock-Based Compensation | ' | |||||||||||||
8. Stock-Based Compensation | ||||||||||||||
The Company recognized stock-based compensation expense as follows for the three and nine months ended September 30, 2014 and 2013: | ||||||||||||||
Three Months ended September 30, | Nine Months ended September 30, | |||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||
General and administrative | $ | 430,000 | $ | 2,821,000 | $ | 1,754,000 | $ | 4,347,000 | ||||||
Research and development | 1,156,000 | 1,275,000 | 2,473,000 | 2,592,000 | ||||||||||
$ | 1,586,000 | $ | 4,096,000 | $ | 4,227,000 | $ | 6,939,000 | |||||||
Stock options may be granted with exercise prices of not less than the estimated fair value of the Common Stock on the date of grant and generally vest over a period of up to four years. Stock options granted under the Company’s 2013 Equity Compensation Plan generally expire no later than ten years from the date of grant. A summary of stock option activity for the nine months ended September 30, 2014 is as follows: | ||||||||||||||
Weighted- | ||||||||||||||
Average | ||||||||||||||
Weighted- | Remaining | |||||||||||||
Average | Contractual | |||||||||||||
Number of | Exercise | Term | ||||||||||||
Options | Price | (in years) | ||||||||||||
Outstanding at December 31, 2013 | 4,344,365 | $ | 11.05 | 7.91 | ||||||||||
Granted | 201,500 | 6.6 | ||||||||||||
Exercised | (224,758 | ) | 4.2 | |||||||||||
Forfeited | (208,781 | ) | 12.44 | |||||||||||
Outstanding at September 30, 2014 | 4,112,326 | $ | 11.14 | 7.52 | ||||||||||
Vested or expected to vest at September 30, 2014 | 4,042,828 | $ | 11.14 | 7.52 | ||||||||||
Exercisable at September 30, 2014 | 2,739,222 | $ | 10.21 | 6.85 | ||||||||||
The Company utilized the Black-Scholes valuation model for estimating the fair value of the stock compensation granted, with the following weighted-average assumptions: | ||||||||||||||
Employee Stock | ||||||||||||||
Options For the | ||||||||||||||
Nine Months | ||||||||||||||
Ended | ||||||||||||||
September 30, 2014 | ||||||||||||||
Average risk-free interest rates | 1.86 | % | ||||||||||||
Average expected life (in years) | 6.02 | |||||||||||||
Expected volatility | 76.99 | % | ||||||||||||
Weighted-average fair value (in dollars) | $ | 4.47 | ||||||||||||
Due to the Company’s limited operating history as a public company and a lack of company specific historical and implied volatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. When selecting these public companies on which it has based its expected stock price volatility, the Company selected companies with comparable characteristics to it, including enterprise value, risk profiles, position within the industry, and with historical share price information sufficient to meet the expected life of the stock-based awards. The historical volatility data was computed using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of the stock-based awards. Due to its lack of sufficient historical data, the Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. The Company has estimated the expected life of its employee stock options using the “simplified” method, whereby, the expected life equals the arithmetic average of the vesting term and the original contractual term of the option. The risk-free interest rates for periods within the expected life of the option are based on the U.S. Treasury yield curve in effect during the period the options were granted. The Company has never paid, and does not expect to pay dividends in the foreseeable future. | ||||||||||||||
Based on the Company’s historical experience, the Company has assumed an annualized forfeiture rate of 1.69% for its options. Under the true-up provisions of the stock based compensation guidance, the Company will record additional expense if the actual forfeiture rate is lower than estimated, and will record a recovery of prior expense if the actual forfeiture is higher than estimated. | ||||||||||||||
As of September 30, 2014, there was $8,018,000 of unrecognized compensation expense related to the unvested stock options issued from April 23, 2013 through September 30, 2014, which is expected to be recognized over a weighted-average period of approximately 3.00 years. | ||||||||||||||
At certain times throughout the Company’s history, the chairman of the Company’s board of directors, who is also a significant stockholder of the Company (the “Significant Holder”), has afforded option holders the opportunity for liquidity in transactions in which options were exercised and the shares of Common Stock issued in connection therewith were simultaneously purchased by the Significant Holder (each, a “Purchase Transaction”). Because the Company had established a pattern of providing cash settlement alternatives for option holders, the Company has accounted for its stock-based compensation awards as liability awards, the fair value of which is then re-measured at each balance sheet date. | ||||||||||||||
On April 23, 2013, the Company distributed a notification letter to all equity award holders under the Company’s 2007 Equity Compensation Plan (the “2007 Plan”) advising them that Purchase Transactions would no longer occur, unless, at the time of a Purchase Transaction, the option holder has held the Common Stock issued upon exercise of options for a period of greater than six months prior to selling such Common Stock to the Significant Holder and that any such sale to the Significant Holder would be at the fair value of the Common Stock on the date of such sale. Based on these new criteria for Purchase Transactions, the Company remeasured options outstanding under the 2007 Plan as of April 23, 2013 to their intrinsic value and reclassified such options from liabilities to stockholders’ deficit within the Company’s consolidated balance sheets, which amounted to $14,482,000. As of September 30, 2014, there was $892,000 of unrecognized compensation expense related to these unvested awards, which is expected to be recognized over a weighted-average period of approximately 1.95 years. | ||||||||||||||
Research_Agreements
Research Agreements | 9 Months Ended |
Sep. 30, 2014 | |
Research Agreements | ' |
Research Agreements | ' |
9. Research Agreements | |
The Company has entered into various licensing and right-to-sublicense agreements with educational institutions for the exclusive use of patents and patent applications, as well as any patents that may develop from research being conducted by such educational institutions in the field of anticancer therapy, genes and proteins. Results from this research have been licensed to the Company pursuant to these agreements. Under one of these agreements with Temple University (“Temple”), the Company is required to make annual maintenance payments to Temple and royalty payments based upon a percentage of sales generated from any products covered by the licensed patents, with minimum specified royalty payments. As no sales had been generated through September 30, 2014 under the licensed patents, the Company has not incurred any royalty expenses related to this agreement. In addition, the Company is required to pay Temple 25% of any sublicensing fees received by the Company. In 2011, the Company recorded $1,875,000 of expense related to the Temple agreement in connection with the collaboration agreement the Company executed with SymBio. In 2012, the company recorded $12,500,000 of expense related to the Temple agreement in connection with the collaboration agreement the Company executed with Baxter. These expenses were recorded in the consolidated statement of operations as research and development expenses. | |
In May 2010, the Company signed a funding agreement with the Leukemia and Lymphoma Society (“LLS”) to fund the development of rigosertib. Under this agreement, the Company was entitled to receive milestone payments of up to $10,000,000 through 2013 in connection with clinical trials to be conducted. The aggregate milestone payment amount was subsequently reduced to $8,000,000 pursuant to an amendment signed in January 2013, after which LLS was not obligated to fund any further amounts. During the year ended December 31, 2012, in connection with the execution of the Baxter agreement (Note 10), the Company paid $1,000,000 to LLS and recorded this amount in research and development expenses. This payment reduced the maximum milestone and royalty payment obligation under this agreement to $23,000,000 at September 30, 2014 and December 31, 2013. No further payments are due to LLS if rigosertib does not obtain regulatory approval. If rigosertib is approved by the regulatory authorities, the Company must proceed with commercialization of the licensed product or repay the amount funded. LLS is entitled to receive regulatory and commercial milestone payments and royalties from the Company based on the Company’s net sales of the licensed product. As a result of the potential obligation to repay the funds under this arrangement, the $8,000,000 of milestone payments received, have been recorded as deferred revenue at September 30, 2014 and December 31, 2013. | |
License_and_Collaboration_Agre
License and Collaboration Agreements | 9 Months Ended |
Sep. 30, 2014 | |
License and Collaboration Agreements | ' |
License and Collaboration Agreements | ' |
10. License and Collaboration Agreements | |
Baxter Agreement | |
In September 2012, the Company entered into a development and license agreement with Baxter granting Baxter an exclusive, royalty-bearing license for the research, development, commercialization and manufacture (in specified instances) of rigosertib in all therapeutic indications in Europe (the “Baxter Territory”) In accordance with this agreement, Baxter made a $50,000,000 upfront payment to the Company. In July 2012, Baxter purchased $50,000,000 of the Company’s Series J Preferred Stock, which automatically converted to shares of Common Stock immediately prior to the consummation of the IPO. Baxter also invested $4,950,000 in the Company’s IPO. | |
Under the terms of the agreement, the Company was initially required to perform research and development to advance three initial rigosertib indications, rigosertib intravenous (“IV”) in higher risk myelodysplastic syndrome (“MDS”) patients, rigosertib IV in pancreatic cancer patients and rigosertib oral in lower risk MDS patients, through Phase 3, Phase 3 and Phase 2 clinical trials, respectively. | |
In December 2013, a pre-planned interim futility and safety analysis of the pancreatic cancer trial was performed and the trial was discontinued. As a result, at this time the Company is not pursuing a pancreatic cancer indication. | |
In February 2014, the Company announced top-line analysis of a Phase 3 trial of rigosertib IV in higher risk MDS patients. Although the results of this study showed numerical improvement in median overall survival in the rigosertib treated patients, the observed improvement in survival of 2.4 months was not sufficient to establish the required level of statistical significance and, therefore did not achieve the primary endpoint of the trial. If an additional Phase 3 clinical trial for rigosertib IV in higher-risk MDS patients is required to obtain marketing approval in the Baxter Territory, the Company could elect to have Baxter fund a percentage of the costs of such additional trial up to a specified maximum; however, any such election would reduce potential future milestone payments. | |
At the completion of the current Phase 2 trial for rigosertib oral in lower risk MDS patients and the review of the resulting data and findings, the Company and Baxter may decide whether or not to pursue further development of rigosertib for this indication. If the Company and Baxter mutually agree to progress the development of rigosertib oral in lower risk MDS patients, then certain milestone payments will be payable to the Company, and the Company will be required to use its commercially reasonable efforts to progress the development of rigosertib for this indication to a drug approval application in the Baxter Territory. | |
The Company and Baxter may work together for potential future rigosertib indications, beyond the initial indications noted above. Generally, if Baxter chooses to participate in the development of additional indications, Baxter will be responsible for a percentage of all research and development costs and expenses and the Company could earn additional milestone payments. Baxter has full responsibility for all commercialization activities for the product in the Baxter Territory, at Baxter’s sole cost and expense. | |
The Company and Baxter have agreed to negotiate a supply agreement under terms satisfactory to both parties whereby the Company will supply Baxter with Baxter’s required levels of product to support commercialization efforts in the Baxter Territory. Baxter also has the right to engage third parties for the manufacture and supply of its requirements for the licensed product. | |
Under the terms of the agreement, Baxter made an upfront payment of $50,000,000. The Company is eligible to receive pre-commercial milestone payments of up to an aggregate of $337,500,000 if specified development and regulatory milestones are achieved. The potential pre-commercial development milestone payments to the Company include the following: | |
$50,000,000 for mutual agreement to file for any marketing approval of rigosertib for higher-risk MDS in either the European Union or in all of Germany, United Kingdom, France, Italy and Spain; | |
$25,000,000 for the joint decision to proceed with the development of rigosertib for lower-risk MDS; | |
$25,000,000 for each drug approval application filed for indications specified in the agreement; and | |
up to $212,500,000 for the marketing approvals of the rigosertib MDS indications specified in the agreement based, in part, on whether an additional Phase 3 trial is required to obtain marketing approval for rigosertib IV in higher-risk MDS patients. | |
The Company is also potentially eligible to receive an additional $20,000,000 pre-commercial milestone payment related to the timing of regulatory approval of the MDS IV indication in Europe. In addition to these pre-commercial milestones, the Company is eligible to receive up to an aggregate of $250,000,000 in milestone payments based on Baxter’s achievement of pre-specified threshold levels of annual net sales of rigosertib. The Company will also be entitled to receive royalties at percentage rates ranging from the low-teens to the low-twenties on net sales of rigosertib by Baxter in the Baxter Territory. | |
The agreement with Baxter will remain in effect until the expiration of all applicable royalty terms and satisfaction of all payment obligations in each licensed country, unless terminated earlier in accordance with the terms of the agreement. Either party may terminate due to the uncured material breach or bankruptcy of the other party, force majeure, or in the event of a specified commercial failure. The Company may terminate the agreement in the event that Baxter brings a challenge against it in relation to the licensed patents. Baxter may terminate the agreement without cause upon 180 days’ prior written notice. | |
The Company determined that the deliverables under the Baxter agreement include the exclusive, royalty-bearing, sublicensable license to rigosertib and the research and development services to be performed by the Company. The Company concluded that the license had standalone value to Baxter and was separable from the research and development services because the license is sublicensable, there are no restrictions as to Baxter’s use of the license and Baxter has significant research capabilities in this field. | |
In determining the separate units of accounting, the Company considered applicable accounting guidance and noted that in an arrangement with multiple deliverables, the delivered item or items shall be considered a separate unit of accounting if the delivered item or items have value to the customer on a stand-alone basis. The item or items have value on a stand-alone basis if they are sold separately by any vendor or the customer could resell the delivered item(s) on a stand-alone basis. In the context of a customer’s ability to resell the delivered item(s), this criterion does not require the existence of an observable market for the deliverable(s). | |
The Baxter agreement allows Baxter to sublicense rigosertib and its ability to sublicense is not contingent on the approval or right of first refusal by the Company. The Company determined that Baxter’s ability to sublicense the intellectual property to others demonstrates that the license has stand-alone value. In addition, at the time of entering into the Baxter agreement in September 2012, the rigosertib program was in a Phase 3 clinical trial for higher risk MDS, a Phase 3 clinical trial for pancreatic cancer and a Phase 2 trial for lower risk MDS. The protocols for the clinical trials had been written and provided to Baxter and a Special Protocol Assessment had already been granted to the Company by the U.S. Food and Drug Administration (the “FDA”) for higher risk MDS. These later stage clinical trials, where protocols have been prepared and trials are in process, can be completed more easily by entities other than the Company, as compared to earlier stage clinical trials. The remaining services to be performed by the Company are not proprietary and could be performed by other qualified parties. For example, the Company relies on clinical research organizations (“CROs”) to complete the clinical trials, and Baxter could engage the same or similar CROs to complete the trials on its behalf. Although Baxter is not performing development activities related to rigosertib, Baxter possesses the internal expertise (or a vendor could be hired) to complete the efforts under the rigosertib programs without further assistance from the Company. | |
Baxter develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide. Baxter employs over 50,000 people, with significant revenues and expenditures for research and development. Baxter has expertise in completing clinical trials, assessing clinical trial results and preparing regulatory filings and has also developed and obtained regulatory and marketing approval in Europe for numerous products used to treat hematologic conditions. Baxter has expertise in rare hematologic conditions, and the Company believes that rigosertib is a natural complement to Baxter’s existing treatments for patients with these conditions. | |
Baxter has the rights and full access to past and future intellectual information in order to obtain regulatory approval of rigosertib in Europe. In connection with the Baxter agreement, the Company licensed to Baxter all information and all patents controlled by the Company necessary for the development, manufacture, use and sale of rigosertib and all present and future formulations and dosages in all present and future therapeutic indications in the licensed territory. | |
Accordingly, given Baxter’s ability to sublicense under the agreement and its ability internally or with outside help to conduct the ongoing development efforts, the Company concluded that the license has stand-alone value. In order to determine if the license can be treated as a separate unit of accounting, the Company also considered whether there is a general right of return associated with the license. The $50,000,000 upfront payment received by the Company is non-refundable; therefore, there is no right of return for the license. As a result, the Company concluded that the license is a separate unit of accounting. | |
The Company was not able to establish vendor-specific objective evidence of selling price or third-party evidence for either the license or the research and development services and instead allocated the arrangement consideration between the license and research and development services based on their relative selling prices using best estimate of selling price (“BESP”). Management developed the BESP of the license using a discounted cash flow model, taking into consideration assumptions including the development and commercialization timeline, discount rate and probability of success. Management utilized a third party valuation specialist to assist with the determination of BESP of the license. Management estimated the selling price of the research and development services using third party costs and a discounted cash flow model. The estimated selling prices utilized assumptions including internal estimates of research and development personnel needed to perform the research and development services; and estimates of expected cash outflows to third parties for services and supplies over the expected period that the services will be performed. | |
The key assumptions in these models included the following market conditions and entity-specific factors: (a) the specific rights provided under the license, (b) the stage of development of rigosertib and estimated remaining development and commercialization timelines, (c) the probability of successfully developing and commercializing rigosertib, (d) the market size including the associated sales figures which generate royalty revenue, (e) cost of goods sold, which was assumed to be a specified percentage of revenues based on estimated cost of goods sold of a typical oncology product, (f) sales and marketing costs, which were based on the costs required to field an oncology sales force and marketing group, including external costs required to promote an oncology product, (g) the expected product life of rigosertib assuming commercialization and (h) the competitive environment. The Company utilized a discount rate of 16%, representing the cost of capital derived from returns on equity for comparable companies. | |
Based on management’s analyses, it was determined that the BESP of the license was $120,000,000 and the BESP of the research and development services was $20,600,000. As noted above, the Company received an up-front payment of $50,000,000 under the Baxter agreement, which represents the allocable agreement consideration. Based on the respective BESPs, this payment was allocated $42,400,000 to the license and $7,600,000 to the research and development services. Since the delivery of the license occurred upon the execution of the Baxter agreement and there was no general right of return, $42,400,000 of the $50,000,000 upfront payment was recognized upon the execution of the Baxter agreement. The portion allocated to research and development services was recognized over the period of performance on a proportional performance basis through March 31, 2014. Management estimated the period of performance to be the period necessary for completion of the non-contingent obligations to perform research and development services required to advance the three formulations of rigosertib described above. As of March 31, 2014, all of the deferred revenue related to such research and development services was recognized. The Company recognized research and development revenue under the Baxter agreement of $0 and $979,000, for the three months ended September 30, 2014 and 2013, respectively, and $333,000 and $2,435,000, for the nine months ended September 30, 2014 and 2013, respectively. | |
The Company and Baxter have agreed to establish a joint committee to facilitate the governance and oversight of the parties’ activities under the agreements. Management considered whether participation on the joint committee may be a deliverable and determined that it was not a deliverable. Had management considered participation on the joint committee as a deliverable, it would not have had a material impact on the accounting for the arrangement based on the analysis of the estimated selling price of such participation. | |
As noted above, in July 2012, Baxter purchased Series J Preferred Stock. Because the Series J Preferred Stock was acquired within several months of the Baxter development and license agreement, management considered whether the Preferred Stock was issued at fair value and if not, whether the consideration received for the Series J Preferred Stock ($50,000,000) or for the collaboration and license agreement ($50,000,000) should be allocated in the financial statements in a manner differently than the prices stated in the agreements. Management, with the assistance of an outside valuation specialist, determined that the price paid by Baxter for the Series J Preferred Stock approximated its fair value, and therefore the consideration received under the agreements was allocated in accordance with terms of the individual agreements. | |
SymBio Agreement | |
In July 2011, the Company entered into a license agreement with SymBio, as subsequently amended, granting SymBio an exclusive, royalty-bearing license for the development and commercialization of rigosertib in Japan and Korea. Under the SymBio license agreement, SymBio is obligated to use commercially reasonable efforts to develop and obtain market approval for rigosertib inside the licensed territory and the Company has similar obligations outside of the licensed territory. The Company has also entered into an agreement with SymBio providing for it to supply SymBio with development-stage product. Under the SymBio license agreement, the Company also agreed to supply commercial product to SymBio under specified terms that will be included in a commercial supply agreement to be negotiated prior to the first commercial sale of rigosertib. The supply of development-stage product and the supply of commercial product will be at the Company’s cost plus a defined profit margin. Sales of development-stage product have been de minimis. The Company has additionally granted SymBio a right of first negotiation to license or obtain the rights to develop and commercialize compounds having a chemical structure similar to rigosertib in the licensed territory. | |
Under the terms of the SymBio license agreement, the Company received an upfront payment of $7,500,000. The Company is eligible to receive milestone payments of up to an aggregate of $22,000,000 from SymBio upon the achievement of specified development and regulatory milestones for specified indications. Of the regulatory milestones, $5,000,000 is due upon receipt of marketing approval in the United States for rigosertib IV in higher risk MDS patients, $3,000,000 is due upon receipt of marketing approval in Japan for rigosertib IV in higher risk MDS patients, $5,000,000 is due upon receipt of marketing approval in the United States for rigosertib oral in lower risk MDS patients, and $5,000,000 is due upon receipt of marketing approval in Japan for rigosertib oral in lower risk MDS patients. Furthermore, upon receipt of marketing approval in the United States and Japan for an additional specified indication of rigosertib, which the Company is currently not pursuing, an aggregate of $4,000,000 would be due. In addition to these pre-commercial milestones, the Company is eligible to receive tiered milestone payments based upon annual net sales of rigosertib by SymBio of up to an aggregate of $30,000,000. | |
Further, under the terms of the SymBio license agreement, SymBio will make royalty payments to the Company at percentage rates ranging from the mid-teens to 20% based on net sales of rigosertib by SymBio. | |
Royalties will be payable under the SymBio agreement on a country-by-country basis in the licensed territory, until the later of the expiration of marketing exclusivity in those countries, a specified period of time after first commercial sale of rigosertib in such country, or the expiration of all valid claims of the licensed patents covering rigosertib or the manufacture or use of rigosertib in such country. If no valid claim exists covering the composition of matter of rigosertib or the use of or treatment with rigosertib in a particular country before the expiration of the royalty term, and specified competing products achieve a specified market share percentage in such country, SymBio’s obligation to pay the Company royalties will continue at a reduced royalty rate until the end of the royalty term. In addition, the applicable royalties payable to the Company may be reduced if SymBio is required to pay royalties to third-parties for licenses to intellectual property rights necessary to develop, use, manufacture or commercialize rigosertib in the licensed territory. The license agreement with SymBio will remain in effect until the expiration of the royalty term. However, the SymBio license agreement may be terminated earlier due to the uncured material breach or bankruptcy of a party, or force majeure. If SymBio terminates the license agreement in these circumstances, its licenses to rigosertib will survive, subject to SymBio’s milestone and royalty obligations, which SymBio may elect to defer and offset against any damages that may be determined to be due from the Company. In addition, the Company may terminate the license agreement in the event that SymBio brings a challenge against it in relation to the licensed patents, and SymBio may terminate the license agreement without cause by providing the Company with written notice within a specified period of time in advance of termination. | |
The Company determined that the deliverables under the SymBio agreement include the exclusive, royalty-bearing, sublicensable license to rigosertib, the research and development services to be provided by the Company and its obligation to serve on a joint committee. The Company concluded that the license did not have standalone value to SymBio and was not separable from the research and development services, because of the uncertainty of SymBio’s ability to develop rigosertib in the SymBio territory on its own and the uncertainty of SymBio’s ability to sublicense rigosertib and recover a substantial portion of the original upfront payment of $7,500,000 paid by SymBio to the Company. | |
The supply of rigosertib for SymBio’s commercial requirements is contingent upon the receipt of regulatory approvals to commercialize rigosertib in Japan and Korea. Because the Company’s commercial supply obligation was contingent upon the receipt of future regulatory approvals, and there were no binding commitments or firm purchase orders pending for commercial supply at or near the execution of the agreement, the commercial supply obligation is deemed to be contingent and is not valued as a deliverable under the SymBio agreement. If SymBio orders the supplies from the Company, the Company expects the pricing for this supply to equal its third-party manufacturing cost plus a pre-negotiated percentage, which will not result in a significant incremental discount to market rates. | |
Due to the lack of standalone value for the license, research and development services, and joint committee obligation, the upfront payment is being recognized ratably using the straight line method through December 2027, the expected term of the agreement. The Company recognized revenues under this agreement in the amounts of $114,000 and $113,000 for the three months ended September 30, 2014 and 2013, respectively, and $341,000 and $341,000 for the nine months ended September 30, 2014 and 2013, respectively. In addition, the Company recognized revenues related to the supply agreement with SymBio in the amounts of $0 and $23,000 for the three months ended September 30, 2014 and 2013, respectively, and $12,000 and $47,000 for the nine months ended September 30, 2014 and 2013, respectively. | |
Preclinical_Collaboration
Preclinical Collaboration | 9 Months Ended |
Sep. 30, 2014 | |
Preclinical Collaboration | ' |
Preclinical Collaboration | ' |
11. Preclinical Collaboration | |
In December 2012, the Company agreed to form GBO, an entity jointly-owned by both the Company and GVK BIO. The purpose of GBO is to collaborate on and develop two programs through filing of an investigational new drug application (“IND”) and/or conducting proof of concept studies using the Company’s technology platform. | |
During 2013, GVK BIO made an initial capital contribution of $500,000 in exchange for a 10% interest in GBO, and the Company made an initial capital contribution of a sub-license to all the intellectual property controlled by the Company related to the two specified programs in exchange for a 90% interest. Under the terms of the agreement, GVK BIO may make additional capital contributions. The GVK BIO percentage interest in GBO may change from the initial 10% to up to 50%, depending on the amount of its total capital contributions. The Company evaluates its variable interests in GBO on a quarterly basis and has determined that it is the primary beneficiary. | |
For thirty days following the 15-month anniversary of the commencement of either of the two programs, the Company will have an option to (i) cancel the license and (ii) purchase all rights in and to that program. There are three of these buy-back scenarios depending on the stage of development of the underlying assets. GVK BIO will have operational control of GBO and the Company will have strategic and scientific control. | |
Initial_Public_Offering
Initial Public Offering | 9 Months Ended |
Sep. 30, 2014 | |
Initial Public Offering | ' |
Initial Public Offering | ' |
12. Initial Public Offering | |
On July 24, 2013, the Company’s Registration Statement was declared effective by the SEC, and on July 25, 2013, the Company’s Common Stock began trading on the NASDAQ Global Market under the symbol “ONTX.” | |
On July 30, 2013, immediately prior to the consummation of the IPO, all outstanding shares of Preferred Stock automatically converted into shares of Common Stock at the applicable conversion ratio then in effect. Commencing with the conversion, the Company has had no shares of Preferred Stock outstanding. | |
On July 30, 2013, the Company completed the IPO. The Company received net proceeds of $79,811,000 from the IPO, net of underwriting discounts and commissions and other offering expenses. | |
In preparation for the IPO, the Company’s board of directors and stockholders approved a one-for-1.333 reverse stock split of the Company’s Common Stock. The reverse stock split became effective on July 17, 2013. All Common Stock share and per share amounts in the condensed consolidated financial statements and notes thereto have been retroactively adjusted for all periods presented to give effect to this reverse stock split, including reclassifying an amount equal to the reduction in par value of common stock to additional paid-in capital. The reverse stock split did not result in a retroactive adjustment of share amounts for the Preferred Stock. In addition, in July 2013, the Company’s board of directors and stockholders approved an amendment of the Company’s certificate of incorporation to, among other things, change the definition of a designated public offering to remove the per share price requirement and to set the threshold at gross proceeds to the Company of at least $25.0 million. | |
RelatedParty_Transactions
Related-Party Transactions | 9 Months Ended |
Sep. 30, 2014 | |
Related-Party Transactions | ' |
Related-Party Transactions | ' |
13. Related-Party Transactions | |
The Company has entered into a research agreement, as subsequently amended, with the Mount Sinai School of Medicine (“Mount Sinai”), with which a member of its board of directors and a significant stockholder is affiliated. Mount Sinai is undertaking research on behalf of the Company on the terms set forth in the agreements. Mount Sinai, in connection with the Company, will prepare applications for patents generated from the research. Results from all projects will belong exclusively to Mount Sinai, but the Company will have an exclusive option to license any inventions. Payments to Mount Sinai under this research agreement for the three months ended September 30, 2014 and 2013 were $715,000 and $420,000, respectively and for the nine months ended September 30, 2014 and 2013 were $1,010,000 and $645,000, respectively. At September 30, 2014 and December 31, 2013, the Company owed Mount Sinai $191,000 and $0, respectively, which is included in accounts payable on the consolidated balance sheets. | |
The Company outsources the synthesis of some of its chemical compounds to vendors in the United States and in foreign countries. During 2013, a supplier, of which a member of the Company’s board of directors and a significant stockholder was an owner, produced one of these compounds under contract. The Company’s aggregate payments for these services for the three months ended September 30, 2014 and 2013 were $0 and $0, respectively and for the nine months ended September 30, 2014 and 2013 were $0 and $107,000, respectively. At September 30, 2014 and December 31, 2013, the Company had no outstanding amounts payable to this supplier. The board member is no longer affiliated with this company. | |
The Company purchases chemical compounds and sources development services from corporations owned by a former member of its board of directors. The Company’s aggregate payments to these suppliers for the three months ended September 30, 2014 and 2013 were $61,000 and $634,000, respectively and for the nine months ended September 30, 2014 and 2013 were $446,000 and $939,000, respectively. At September 30, 2014 and December 31, 2013, the Company owed these suppliers $0 and $156,000 respectively, which is included in accounts payable on the consolidated balance sheets. The Company also rents office space in Pennington, New Jersey from a corporation related to these suppliers and affiliated with the former member of our board of directors. | |
The Company has entered into a consulting agreement with a member of its board of directors, who is also a significant stockholder. The board member provides consulting services to the Company on the terms set forth in the agreement. Payments to this board member for the three months ended September 30, 2014, and 2013 were $47,000 and $45,000, respectively and for the nine months ended September 30, 2014 and 2013 were $146,000 and $136,000, respectively. At September 30, 2014 and December 31, 2013, the Company had no outstanding amounts payable under this agreement. | |
Subsequent_Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2014 | |
Subsequent Events | ' |
Subsequent Events | ' |
14. Subsequent Event | |
In October 2014, the Company entered into a sales agreement with Cantor Fitzgerald & Co. (“Cantor”) to create an at-the-market equity program under which the Company from time to time may offer and sell shares of its Common Stock, having an aggregate offering price of up to $20,000,000 through Cantor. Upon delivery of a placement notice and subject to the terms and conditions of the sales agreement, Cantor will use its commercially reasonable efforts to sell the shares from time to time, based upon the Company’s instructions. The Company has provided Cantor with customary indemnification rights, and Cantor will be entitled to a commission of up to 3.0% of the gross proceeds per share sold. Sales of shares, if any, under the sales agreement may be made in transactions that are deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act of 1933, as amended, including sales made by means of ordinary brokers’ transactions, including on The NASDAQ Global Market, at market prices or as otherwise agreed with Cantor. The Company has no obligation to sell any shares under the sales agreement, and may at any time suspend offers under the sales agreement or terminate the sales agreement. A registration statement relating to the shares has been filed with the SEC but has not yet become effective. The shares may not be sold nor may offers to buy be accepted prior to the time that the registration statement becomes effective. This report shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state. | |
Summary_of_Significant_Account1
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2014 | |
Summary of Significant Accounting Policies | ' |
Basis of Presentation | ' |
Basis of Presentation | |
The condensed consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States (“GAAP”) for interim financial information. Certain information and footnotes normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). The financial statements include the consolidated accounts of the Company, its wholly-owned subsidiary, Onconova Europe GmbH, and GBO. All significant intercompany transactions have been eliminated. | |
Unaudited Interim Financial Information | ' |
Unaudited Interim Financial Information | |
The accompanying condensed consolidated balance sheet as of September 30, 2014, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2014 and 2013, the consolidated statement of stockholders’ equity for the nine months ended September 30, 2014 and the condensed consolidated statements of cash flows for the nine months ended September 30, 2014 and 2013 are unaudited. The interim unaudited condensed consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2014 and the results of its operations, and its cash flows for the three and nine months ended September 30, 2014 and 2013. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2014 and 2013 are unaudited. The results for the nine months ended September 30, 2014 are not necessarily indicative of results to be expected for the year ending December 31, 2014, any other interim periods, or any future year or period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2013 included in the Company’s annual report on Form 10-K filed with the SEC on March 20, 2014. | |
Segment Information | ' |
Segment Information | |
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one segment, which is the identification and development of oncology therapeutics. | |
Significant Accounting Policies | ' |
Significant Accounting Policies | |
The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2013 included in the Company’s annual report on Form 10-K filed with the SEC on March 20, 2014. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies. | |
Foreign Currency Translation | ' |
Foreign Currency Translation | |
The reporting currency of the Company and its U.S. subsidiary is the U.S. dollar. The functional currency of the Company’s non-U.S. subsidiary is the local currency. Assets and liabilities of the foreign subsidiary are translated into U.S. dollars based on exchange rates at the end of the period. Revenues and expenses are translated at average exchange rates during the reporting period. Gains and losses arising from the translation of assets and liabilities are included as a component of accumulated other comprehensive income. Gains and losses resulting from foreign currency transactions are reflected within the Company’s results of operations. The Company has not utilized any foreign currency hedging strategies to mitigate the effect of its foreign currency exposure. | |
Recent Accounting Pronouncements | ' |
Recent Accounting Pronouncements | |
In July 2013, the Financial Accounting Standards Board (the “FASB”) issued guidance clarifying that an unrecognized tax benefit, or a portion of an unrecognized tax benefit, should be presented in the financial statements as a reduction to a deferred tax asset for a net operating loss carryforward, a similar tax loss, or a tax credit carryforward if such settlement is required or expected in the event the uncertain tax benefit is disallowed. In situations where a net operating loss carryforward, a similar tax loss, or a tax credit carryforward is not available at the reporting date under the tax law of the applicable jurisdiction or the tax law of the jurisdiction does not require, and the entity does not intend to use, the deferred tax asset for such purpose, the unrecognized tax benefit should be presented in the financial statements as a liability and should not be netted with the deferred tax asset. The guidance was effective for fiscal years, and interim periods within those years, beginning after December 15, 2013. The Company adopted these new provisions during the quarter beginning January 1, 2014. The guidance did not have an impact on the Company’s consolidated financial position, results of operations or cash flows. | |
In May 2014, the FASB issued guidance on revenue from contracts with customers that will supersede most current revenue recognition guidance. The underlying principle is that an entity will recognize revenue to depict the transfer of goods or services to customers at an amount that the entity expects to be entitled to in exchange for those goods or services. The guidance is effective for the interim and annual periods beginning on or after December 15, 2016, and early adoption is not permitted. The guidance permits the use of either a retrospective or cumulative effect transition method. The Company has not yet selected a transition method and is currently evaluating the impact of the amended guidance on the Company’s consolidated financial position, results of operations and related disclosures. | |
In August 2014, the FASB issued guidance on determining when and how to disclose going-concern uncertainties in the financial statements. The new standard requires management to perform interim and annual assessments of an entity’s ability to continue as a going concern within one year of the date the financial statements are issued. An entity must provide certain disclosures if conditions or events raise substantial doubt about the entity’s ability to continue as a going concern. The guidance applies to all entities and is effective for annual periods ending after December 15, 2016, and interim periods thereafter, with early adoption permitted. The Company is evaluating the potential impact of the new guidance on its quarterly reporting process and its consolidated financial position, results of operations and related disclosures. | |
Fair_Value_Measurements_Tables
Fair Value Measurements (Tables) | 9 Months Ended | |||||||||||||||||||||||||
Sep. 30, 2014 | ||||||||||||||||||||||||||
Fair Value Measurements | ' | |||||||||||||||||||||||||
Schedule of financial assets and liabilities measured at fair value on a recurring basis | ' | |||||||||||||||||||||||||
Fair Value Measurement as of September 30, 2014 | Fair Value Measurement as of December 31, 2013 | |||||||||||||||||||||||||
Level 1 | Level 2 | Level 3 | Balance | Level 1 | Level 2 | Level 3 | Balance | |||||||||||||||||||
Warrant liability | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | 20,000 | $ | 20,000 | ||||||||||
Total | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | 20,000 | $ | 20,000 | ||||||||||
Schedule of reconciliation of liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) | ' | |||||||||||||||||||||||||
Warrant Liability | ||||||||||||||||||||||||||
Balance at December 31, 2013 | $ | 20,000 | ||||||||||||||||||||||||
Change in fair value upon re-measurement | (20,000 | ) | ||||||||||||||||||||||||
Balance at September 30, 2014 | $ | — | ||||||||||||||||||||||||
Marketable_Securities_Tables
Marketable Securities (Tables) | 9 Months Ended | |||||||
Sep. 30, 2014 | ||||||||
Marketable Securities | ' | |||||||
Summary of marketable securities | ' | |||||||
September | December 31, | |||||||
30, 2014 | 2013 | |||||||
U.S. Treasury obligations | $ | 14,999,000 | $ | 39,994,000 | ||||
Net_Loss_Per_Share_of_Common_S1
Net Loss Per Share of Common Stock (Tables) | 9 Months Ended | |||||
Sep. 30, 2014 | ||||||
Net Loss Per Share of Common Stock | ' | |||||
Schedule of antidilutive securities which have been excluded from the computation of diluted weighted average shares outstanding | ' | |||||
September 30, | ||||||
2014 | 2013 | |||||
Warrants | 4,597 | 4,597 | ||||
Stock options | 4,112,326 | 3,549,842 | ||||
4,116,923 | 3,554,439 | |||||
Balance_Sheet_Detail_Tables
Balance Sheet Detail (Tables) | 9 Months Ended | |||||||
Sep. 30, 2014 | ||||||||
Balance Sheet Detail | ' | |||||||
Schedule of prepaid expenses and other current assets | ' | |||||||
September 30, | December 31, | |||||||
2014 | 2013 | |||||||
Research and development | $ | 2,571,000 | $ | 2,242,000 | ||||
Manufacturing | 444,000 | 1,051,000 | ||||||
Insurance | 851,000 | 645,000 | ||||||
Other | 412,000 | 449,000 | ||||||
$ | 4,278,000 | $ | 4,387,000 | |||||
Schedule of property and equipment | ' | |||||||
September 30, | December 31, | |||||||
2014 | 2013 | |||||||
Property and equipment | $ | 2,621,000 | $ | 2,402,000 | ||||
Accumulated depreciation | (2,109,000 | ) | (1,776,000 | ) | ||||
$ | 512,000 | $ | 626,000 | |||||
Schedule of accrued expenses and other current liabilities | ' | |||||||
September 30, | December 31, | |||||||
2014 | 2013 | |||||||
Research and development | $ | 4,571,000 | $ | 4,625,000 | ||||
Employee compensation | 2,122,000 | 509,000 | ||||||
Professional fees | 450,000 | 310,000 | ||||||
Taxes | — | 302,000 | ||||||
Other | 59,000 | 74,000 | ||||||
$ | 7,202,000 | $ | 5,820,000 | |||||
StockBased_Compensation_Tables
Stock-Based Compensation (Tables) | 9 Months Ended | |||||||||||||
Sep. 30, 2014 | ||||||||||||||
Stock-Based Compensation | ' | |||||||||||||
Schedule of stock-based compensation expense | ' | |||||||||||||
Three Months ended September 30, | Nine Months ended September 30, | |||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||
General and administrative | $ | 430,000 | $ | 2,821,000 | $ | 1,754,000 | $ | 4,347,000 | ||||||
Research and development | 1,156,000 | 1,275,000 | 2,473,000 | 2,592,000 | ||||||||||
$ | 1,586,000 | $ | 4,096,000 | $ | 4,227,000 | $ | 6,939,000 | |||||||
Schedule of stock option activity | ' | |||||||||||||
Weighted- | ||||||||||||||
Average | ||||||||||||||
Weighted- | Remaining | |||||||||||||
Average | Contractual | |||||||||||||
Number of | Exercise | Term | ||||||||||||
Options | Price | (in years) | ||||||||||||
Outstanding at December 31, 2013 | 4,344,365 | $ | 11.05 | 7.91 | ||||||||||
Granted | 201,500 | 6.6 | ||||||||||||
Exercised | (224,758 | ) | 4.2 | |||||||||||
Forfeited | (208,781 | ) | 12.44 | |||||||||||
Outstanding at September 30, 2014 | 4,112,326 | $ | 11.14 | 7.52 | ||||||||||
Vested or expected to vest at September 30, 2014 | 4,042,828 | $ | 11.14 | 7.52 | ||||||||||
Exercisable at September 30, 2014 | 2,739,222 | $ | 10.21 | 6.85 | ||||||||||
Schedule of weighted-average assumptions used for estimating the fair value of the stock compensation granted | ' | |||||||||||||
Employee Stock | ||||||||||||||
Options For the | ||||||||||||||
Nine Months | ||||||||||||||
Ended | ||||||||||||||
September 30, 2014 | ||||||||||||||
Average risk-free interest rates | 1.86 | % | ||||||||||||
Average expected life (in years) | 6.02 | |||||||||||||
Expected volatility | 76.99 | % | ||||||||||||
Weighted-average fair value (in dollars) | $ | 4.47 | ||||||||||||
Nature_of_Business_Details
Nature of Business (Details) (USD $) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Dec. 31, 2013 | |
item | item | ||||
Nature of Business | ' | ' | ' | ' | ' |
Number of clinical-stage product candidates | 3 | ' | 3 | ' | ' |
Net loss | ($14,907,000) | ($20,521,000) | ($50,403,000) | ($47,928,000) | ' |
Accumulated deficit | ($281,206,000) | ' | ($281,206,000) | ' | ($230,896,000) |
Preferred stock, par value per share (in dollars per share) | $0.01 | ' | $0.01 | ' | ' |
Number of series denominated as Series A through Series J preferred stock | ' | ' | 10 | ' | ' |
Nature_of_Business_Details_2
Nature of Business (Details 2) (USD $) | 9 Months Ended | 0 Months Ended | 0 Months Ended | ||||
Sep. 30, 2013 | Sep. 30, 2014 | Dec. 31, 2013 | Jul. 30, 2013 | Jul. 30, 2013 | Jul. 30, 2013 | Jul. 30, 2013 | |
IPO | IPO | Over-allotment option | |||||
Initial Public Offering | ' | ' | ' | ' | ' | ' | ' |
Number of shares issued in initial public offering | ' | ' | ' | ' | 5,941,667 | ' | 775,000 |
Common stock, par value (in dollars per share) | ' | $0.01 | $0.01 | ' | ' | $0.01 | ' |
Price per share (in dollars per share) | ' | ' | ' | ' | ' | $15 | ' |
Proceeds from initial public offering of common stock, net of issuance costs | $79,811,000 | ' | ' | ' | $79,811,000 | ' | ' |
Preferred stock outstanding (in shares) | ' | ' | ' | 0 | ' | ' | ' |
Summary_of_Significant_Account2
Summary of Significant Accounting Policies (Details) | 9 Months Ended |
Sep. 30, 2014 | |
item | |
Segment Information | ' |
Number of operating segments | 1 |
Fair_Value_Measurements_Detail
Fair Value Measurements (Details) (USD $) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2014 | Dec. 31, 2013 | |
Assumption used to estimate the fair value of warrant liability by utilizing the Black-Scholes option pricing model | ' | ' |
Number of group companies of which average historical share price trading data used for estimation of volatility | 11 | ' |
Warrants | ' | ' |
Assumption used to estimate the fair value of warrant liability by utilizing the Black-Scholes option pricing model | ' | ' |
Dividend yield (as a percent) | 0.00% | 0.00% |
Weighted average volatility (as a percent) | 58.98% | 74.40% |
Warrants | Weighted average | ' | ' |
Assumption used to estimate the fair value of warrant liability by utilizing the Black-Scholes option pricing model | ' | ' |
Risk-free interest rate (as a percent) | 0.04% | 0.34% |
Recurring basis | Balance | ' | ' |
Financial assets and liabilities measured at fair value | ' | ' |
Total | ' | 20,000 |
Recurring basis | Balance | Warrants | Series G Preferred Stock Warrant | ' | ' |
Financial assets and liabilities measured at fair value | ' | ' |
Warrant liability | ' | 20,000 |
Recurring basis | Level 3 | ' | ' |
Financial assets and liabilities measured at fair value | ' | ' |
Total | ' | 20,000 |
Recurring basis | Level 3 | Warrants | Series G Preferred Stock Warrant | ' | ' |
Financial assets and liabilities measured at fair value | ' | ' |
Warrant liability | ' | 20,000 |
Fair_Value_Measurements_Detail1
Fair Value Measurements (Details 2) (Warrants, USD $) | 9 Months Ended |
Sep. 30, 2014 | |
Warrants | ' |
Reconciliation of the warrant liability measured at fair value | ' |
Balance at the beginning of the period | $20,000 |
Change in fair value upon re-measurement | ($20,000) |
Fair_Value_Measurements_Detail2
Fair Value Measurements (Details 3) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Transfers | ' | ' |
Amount of transfers of assets out of Level 1 into Level 2 | $0 | $0 |
Amount of transfers of assets out of Level 2 into Level 1 | 0 | 0 |
Amount of transfers of liabilities out of Level 1 into Level 2 | 0 | 0 |
Amount of transfers of liabilities out of Level 2 into Level 1 | $0 | $0 |
Marketable_Securities_Details
Marketable Securities (Details) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Marketable securities, current | ' | ' |
Marketable securities | $14,999,000 | $39,994,000 |
U.S. Treasury obligations | ' | ' |
Marketable securities, current | ' | ' |
Marketable securities | $14,999,000 | $39,994,000 |
Net_Loss_Per_Share_of_Common_S2
Net Loss Per Share of Common Stock (Details) | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 2013 | |
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares as they would be antidilutive | ' | ' |
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares | 4,116,923 | 3,554,439 |
Warrants | ' | ' |
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares as they would be antidilutive | ' | ' |
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares | 4,597 | 4,597 |
Stock options | ' | ' |
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares as they would be antidilutive | ' | ' |
Potentially dilutive securities outstanding excluded from the computation of diluted weighted average shares | 4,112,326 | 3,549,842 |
Balance_Sheet_Detail_Details
Balance Sheet Detail (Details) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Prepaid expenses and other current assets: | ' | ' |
Research and development | $2,571,000 | $2,242,000 |
Manufacturing | 444,000 | 1,051,000 |
Insurance | 851,000 | 645,000 |
Other | 412,000 | 449,000 |
Total | 4,278,000 | 4,387,000 |
Property and equipment: | ' | ' |
Property and equipment | 2,621,000 | 2,402,000 |
Accumulated depreciation | -2,109,000 | -1,776,000 |
Property and equipment, net | 512,000 | 626,000 |
Accrued expenses | ' | ' |
Research and development | 4,571,000 | 4,625,000 |
Employee compensation | 2,122,000 | 509,000 |
Professional fees | 450,000 | 310,000 |
Taxes | ' | 302,000 |
Other | 59,000 | 74,000 |
Total | $7,202,000 | $5,820,000 |
Warrants_Details
Warrants (Details) (USD $) | 3 Months Ended | 9 Months Ended | |||||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Jun. 30, 2009 | |
Series G Preferred Stock Warrant | Series G Preferred Stock Warrant | Series G Preferred Stock Warrant | |||||
Warrants | ' | ' | ' | ' | ' | ' | ' |
Number of warrants issued (in shares) | ' | ' | ' | ' | ' | ' | 6,128 |
Change in fair value of warrant liability | ($1,000) | $31,000 | ($20,000) | $19,000 | $20,000 | ($19,000) | ' |
Warrants outstanding immediately prior to IPO | ' | ' | ' | ' | 6,128 | ' | ' |
Preferred Stock warrants converted into common stock warrants (in shares) | ' | ' | ' | ' | 4,597 | ' | ' |
Common stock warrants, reverse stock split | ' | ' | ' | ' | 0.75 | ' | ' |
StockBased_Compensation_Detail
Stock-Based Compensation (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Stock-based compensation | ' | ' | ' | ' |
Total stock-based compensation | $1,586,000 | $4,096,000 | $4,227,000 | $6,939,000 |
General and administrative | ' | ' | ' | ' |
Stock-based compensation | ' | ' | ' | ' |
Total stock-based compensation | 430,000 | 2,821,000 | 1,754,000 | 4,347,000 |
Research and development | ' | ' | ' | ' |
Stock-based compensation | ' | ' | ' | ' |
Total stock-based compensation | $1,156,000 | $1,275,000 | $2,473,000 | $2,592,000 |
StockBased_Compensation_Detail1
Stock-Based Compensation (Details 2) (USD $) | 9 Months Ended | 12 Months Ended | 0 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2014 | Dec. 31, 2013 | Apr. 23, 2013 | Sep. 30, 2014 | Sep. 30, 2014 | |
Stock options | Stock options | Stock options | Stock options | Stock options | ||
2007 Plan | 2007 Plan | Maximum | ||||
Stock-based compensation | ' | ' | ' | ' | ' | ' |
Vesting period | ' | ' | ' | ' | ' | '4 years |
Expiration period | ' | ' | ' | ' | ' | '10 years |
Number of Options | ' | ' | ' | ' | ' | ' |
Balance at the beginning of the period (in shares) | ' | 4,344,365 | ' | ' | ' | ' |
Granted (in shares) | ' | 201,500 | ' | ' | ' | ' |
Exercised (in shares) | ' | -224,758 | ' | ' | ' | ' |
Forfeited (in shares) | ' | -208,781 | ' | ' | ' | ' |
Balance at the end of the period (in shares) | ' | 4,112,326 | 4,344,365 | ' | ' | ' |
Vested or expected to vest at the end of the period (in shares) | ' | 4,042,828 | ' | ' | ' | ' |
Exercisable at the end of the period (in shares) | ' | 2,739,222 | ' | ' | ' | ' |
Weighted-Average Exercise Price | ' | ' | ' | ' | ' | ' |
Balance at the beginning of the period (in dollars per share) | ' | $11.05 | ' | ' | ' | ' |
Granted (in dollars per share) | ' | $6.60 | ' | ' | ' | ' |
Exercised (in dollars per share) | ' | $4.20 | ' | ' | ' | ' |
Forfeited (in dollars per share) | ' | $12.44 | ' | ' | ' | ' |
Balance at the end of the period (in dollars per share) | ' | $11.14 | $11.05 | ' | ' | ' |
Vested or expected to vest at the end of the period (in dollars per share) | ' | $11.14 | ' | ' | ' | ' |
Exercisable at the end of the period (in dollars per share) | ' | $10.21 | ' | ' | ' | ' |
Weighted-Average Remaining Contractual Term | ' | ' | ' | ' | ' | ' |
Outstanding | ' | '7 years 6 months 7 days | '7 years 10 months 28 days | ' | ' | ' |
Vested or expected to vest at the end of the period | ' | '7 years 6 months 7 days | ' | ' | ' | ' |
Exercisable at the end of the period | ' | '6 years 10 months 6 days | ' | ' | ' | ' |
Weighted-average assumptions | ' | ' | ' | ' | ' | ' |
Average risk-free interest rates (as a percent) | ' | 1.86% | ' | ' | ' | ' |
Average expected life (in years) | ' | '6 years 7 days | ' | ' | ' | ' |
Expected volatility (as a percent) | ' | 76.99% | ' | ' | ' | ' |
Weighted-average fair value (in dollars per share) | ' | $4.47 | ' | ' | ' | ' |
Additional disclosures | ' | ' | ' | ' | ' | ' |
Annualized forfeiture rate (as a percent) | ' | 1.69% | ' | ' | ' | ' |
Unrecognized compensation expense of unvested liability awards | ' | ' | ' | ' | $892,000 | ' |
Weighted-average period for recognizing unrecognized compensation expense of unvested liability awards | '3 years | ' | ' | ' | ' | ' |
Unrecognized compensation cost of options granted but not yet vested | 8,018,000 | ' | ' | ' | ' | ' |
Period for recognizing unrecognized compensation cost of options granted but not yet vested | ' | ' | ' | ' | '1 year 11 months 12 days | ' |
Stock option liability | ' | ' | ' | ' | ' | ' |
Reclassification to stockholders' deficit | ' | ' | ' | ($14,482,000) | ' | ' |
Research_Agreements_Details
Research Agreements (Details) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 | Sep. 30, 2014 | Dec. 31, 2012 | Dec. 31, 2011 | Dec. 31, 2012 | Sep. 30, 2014 | Dec. 31, 2013 | Sep. 30, 2014 | Dec. 31, 2013 | Jan. 31, 2013 | 31-May-10 |
Temple | Temple | Temple | LLS | LLS | LLS | LLS | LLS | LLS | LLS | |||
Rigosertib | Rigosertib | Rigosertib | Rigosertib | Rigosertib | Rigosertib | Rigosertib | ||||||
Maximum | Maximum | Maximum | Maximum | |||||||||
Research Agreements | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Sales generated from products covered by the licensed patents | ' | ' | $0 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Percentage of sublicensing fees received to be paid by the entity | ' | ' | 25.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Payments made in connection with the collaboration agreement | ' | ' | ' | ' | 1,875,000 | 1,000,000 | ' | ' | ' | ' | ' | ' |
Expense in connection with the collaboration agreement | ' | ' | ' | 12,500,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Potential milestone payments | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 8,000,000 | 10,000,000 |
Potential milestone and royalty payment obligation | ' | ' | ' | ' | ' | ' | ' | ' | 23,000,000 | 23,000,000 | ' | ' |
Deferred revenue, non-current | $13,568,000 | $13,909,000 | ' | ' | ' | ' | $8,000,000 | $8,000,000 | ' | ' | ' | ' |
License_and_Collaboration_Agre1
License and Collaboration Agreements (Details) (USD $) | 3 Months Ended | 9 Months Ended | 1 Months Ended | 3 Months Ended | 9 Months Ended | 1 Months Ended | 3 Months Ended | 9 Months Ended | 3 Months Ended | 9 Months Ended | 1 Months Ended | 1 Months Ended | ||||||||||||||||||||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 | Jul. 31, 2013 | Sep. 30, 2012 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2012 | Feb. 28, 2014 | Sep. 30, 2012 | Jul. 31, 2011 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Jul. 31, 2011 | Jul. 31, 2011 | Jul. 31, 2011 | Jul. 31, 2011 | Jul. 31, 2011 | Jul. 31, 2011 | Jul. 31, 2011 | Jul. 31, 2012 | |
Baxter | Collaboration arrangement | Collaboration arrangement | Collaboration arrangement | Collaboration arrangement | Collaboration arrangement | Collaboration arrangement | Collaboration arrangement | Collaboration arrangement | Collaboration arrangement | Collaboration arrangement | Collaboration arrangement | Collaboration arrangement | Collaboration arrangement | Collaboration arrangement | Collaboration arrangement | Collaboration arrangement | Collaboration arrangement | Collaboration arrangement | Collaboration arrangement | Collaboration arrangement | Collaboration arrangement | Collaboration arrangement | Collaboration arrangement | Collaboration arrangement | Collaboration arrangement | Collaboration arrangement | Series J Preferred Stock | |||||
Minimum | Baxter | Baxter | Baxter | Baxter | Baxter | Baxter | Rigosertib | Rigosertib | Rigosertib | Rigosertib | Rigosertib | Rigosertib | Rigosertib | Rigosertib | Rigosertib | Rigosertib | Rigosertib | Rigosertib | Rigosertib | Rigosertib | Rigosertib | Rigosertib | Rigosertib | Rigosertib | Rigosertib | Rigosertib | Collaboration arrangement | |||||
item | Baxter | Baxter | Baxter | Baxter | SymBio | SymBio | SymBio | SymBio | SymBio | SymBio | SymBio | SymBio | SymBio | SymBio | SymBio | SymBio | SymBio | SymBio | SymBio | SymBio | Baxter | |||||||||||
item | Maximum | Rigosertib IV in higher risk MDS patients | MDS IV indication | Supply agreement | Supply agreement | Supply agreement | Supply agreement | Supply agreement | United States and Japan | Maximum | MDS IV indication | MDS IV indication | Rigosertib oral in lower risk MDS patients | Rigosertib oral in lower risk MDS patients | ||||||||||||||||||
United States | Japan | United States | Japan | |||||||||||||||||||||||||||||
License and collaboration agreements | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Consideration received for the Preferred Stock | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $50,000,000 |
Proceeds from IPO | ' | ' | ' | 79,811,000 | ' | 4,950,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of initial rigosertib indications | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 3 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Term of improvement observed | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '2 years 4 months 24 days | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Upfront payment | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 50,000,000 | ' | ' | ' | 7,500,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Aggregate milestone payments | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 337,500,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 22,000,000 | ' | ' | ' | ' | ' |
Potential pre-commercial milestone payments for achievement of the primary endpoint of a Phase 3 clinical trial for indication | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 50,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Potential pre-commercial milestone payments for joint decision to proceed with the development of rigosertib for certain indications | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 25,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Potential pre-commercial milestone payments for drug approval application filed for specified indications | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 25,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Potential milestone payments for regulatory approvals of specified indications | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 212,500,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Additional potential pre-commercial milestone payments related to the timing of regulatory approval of indication | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 20,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Aggregate potential milestone payments based on annual net sales of rigosertib | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 250,000,000 | ' | ' | ' | 30,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Written notice period to terminate the agreement | ' | ' | ' | ' | ' | ' | '180 days | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Percentage of royalty payments based on net sales of rigosertib | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 20.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of employees | ' | ' | ' | ' | 50,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Discount rate (as a percent) | ' | ' | ' | ' | ' | ' | 16.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
BESP of the license | ' | ' | ' | ' | ' | ' | 120,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
BESP of the research and development services | ' | ' | ' | ' | ' | ' | 20,600,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Up-front payment allocated to license | ' | ' | ' | ' | ' | ' | 42,400,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Up-front payment allocated to research and development services | ' | ' | ' | ' | ' | ' | 7,600,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Allocated up-front payment of license recognized upon execution of agreement | ' | ' | ' | ' | ' | ' | 42,400,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Research and development revenue | ' | ' | ' | ' | ' | ' | ' | 0 | 979,000 | 333,000 | 2,435,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Regulatory milestones payments due upon receipt of marketing approval for indication | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 5,000,000 | 3,000,000 | 5,000,000 | 5,000,000 | ' |
Aggregate milestone payments due upon receipt of marketing approval for an additional indication | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 4,000,000 | ' | ' | ' | ' | ' | ' |
Binding commitments | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0 | ' | ' | ' | ' | ' | ' | ' |
Recognized revenues | $114,000 | $1,116,000 | $686,000 | $2,823,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $114,000 | $113,000 | $341,000 | $341,000 | $0 | $23,000 | $12,000 | $47,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Preclinical_Collaboration_Deta
Preclinical Collaboration (Details) (GBO, USD $) | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2013 | |
item | item | GVK BIO | GVK BIO | GVK BIO | ||
item | Minimum | Maximum | ||||
Preclinical Collaboration | ' | ' | ' | ' | ' | ' |
Number of new programs to be collaborated and developed | ' | ' | 2 | ' | ' | ' |
Initial capital contribution | ' | ' | ' | $500,000 | ' | ' |
Ownership interest in the joint venture (as a percent) | ' | 90.00% | ' | 10.00% | 10.00% | 50.00% |
Number of products for which additional capital contributions necessary for IND approval | ' | ' | ' | 1 | ' | ' |
Period for which option available to cancel the license and purchase all rights following 15-month anniversary of commencement of program | '30 days | ' | ' | ' | ' | ' |
Period of anniversary following which option available to cancel the license and purchase all rights for thirty days | '15 months | ' | ' | ' | ' | ' |
Number of buy-back scenarios | 3 | ' | ' | ' | ' | ' |
Initial_Public_Offering_Detail
Initial Public Offering (Details) (USD $) | 0 Months Ended | 9 Months Ended | 0 Months Ended | ||
Jul. 17, 2013 | Sep. 30, 2013 | Jul. 31, 2013 | Jul. 30, 2013 | Jul. 30, 2013 | |
IPO | |||||
Initial Public Offering | ' | ' | ' | ' | ' |
Preferred stock outstanding (in shares) | ' | ' | ' | 0 | ' |
Proceeds from initial public offering of common stock, net of issuance costs | ' | $79,811,000 | ' | ' | $79,811,000 |
Reverse stock split of common stock | 0.75 | ' | ' | ' | ' |
Designated public offering amended threshold gross proceeds, minimum | ' | ' | $25,000,000 | ' | ' |
RelatedParty_Transactions_Deta
Related-Party Transactions (Details) (USD $) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Dec. 31, 2013 | |
Mount Sinai | ' | ' | ' | ' | ' |
Related-party transactions | ' | ' | ' | ' | ' |
Payments to related party | $715,000 | $420,000 | $1,010,000 | $645,000 | ' |
Amounts due to related party | 191,000 | ' | 191,000 | ' | 0 |
Supplier business owned by board members | ' | ' | ' | ' | ' |
Related-party transactions | ' | ' | ' | ' | ' |
Payments to related party | 0 | 0 | 0 | 107,000 | ' |
Amounts due to related party | 0 | ' | 0 | ' | 0 |
Corporations owned by former board members | ' | ' | ' | ' | ' |
Related-party transactions | ' | ' | ' | ' | ' |
Payments to related party | 61,000 | 634,000 | 446,000 | 939,000 | ' |
Amounts due to related party | 0 | ' | 0 | ' | 156,000 |
Member of board of directors | ' | ' | ' | ' | ' |
Related-party transactions | ' | ' | ' | ' | ' |
Payments to related party | 47,000 | 45,000 | 146,000 | 136,000 | ' |
Amounts due to related party | $0 | ' | $0 | ' | $0 |
Subsequent_Event_Details
Subsequent Event (Details) (Subsequent event, USD $) | 1 Months Ended |
Oct. 31, 2014 | |
Subsequent event | ' |
Subsequent Event | ' |
At-the-market equity program, aggregate offering price | $20,000,000 |
At-the-market equity program, commission percentage | 3.00% |