Document_and_Entity_Informatio
Document and Entity Information (USD $) | 12 Months Ended | ||
In Millions, except Share data, unless otherwise specified | Dec. 31, 2014 | Mar. 18, 2015 | Jun. 30, 2014 |
Document and Entity Information | |||
Entity Registrant Name | Onconova Therapeutics, Inc. | ||
Entity Central Index Key | 1130598 | ||
Document Type | 10-K | ||
Document Period End Date | 31-Dec-14 | ||
Amendment Flag | FALSE | ||
Current Fiscal Year End Date | -19 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Public Float | $68.70 | ||
Entity Common Stock, Shares Outstanding | 21,703,173 | ||
Document Fiscal Year Focus | 2014 | ||
Document Fiscal Period Focus | FY |
Consolidated_Balance_Sheets
Consolidated Balance Sheets (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Current assets: | ||
Cash and cash equivalents | $43,582,000 | $60,009,000 |
Marketable securities | 39,994,000 | |
Prepaid expenses and other current assets | 3,198,000 | 4,387,000 |
Restricted cash | 125,000 | |
Total current assets | 46,905,000 | 104,390,000 |
Property and equipment, net | 420,000 | 626,000 |
Restricted cash | 125,000 | |
Other non-current assets | 12,000 | 12,000 |
Total assets | 47,337,000 | 105,153,000 |
Current liabilities : | ||
Accounts payable | 4,027,000 | 3,710,000 |
Accrued expenses and other current liabilities | 5,777,000 | 5,820,000 |
Warrant liability | 20,000 | |
Deferred revenue | 455,000 | 788,000 |
Total current liabilities | 10,259,000 | 10,338,000 |
Deferred revenue, non-current | 13,455,000 | 13,909,000 |
Other | 1,000 | 6,000 |
Total liabilities | 23,715,000 | 24,253,000 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.01 par value, 5,000,000 authorized at December 31, 2014 and 2013, none issued and outstanding at December 31, 2014 and 2013 | ||
Common stock, $0.01 par value, 75,000,000 authorized at December 31, 2014 and 2013, 21,703,173 and 21,467,482 shares issued and outstanding at December 31, 2014 and 2013 | 217,000 | 215,000 |
Additional paid in capital | 317,122,000 | 311,093,000 |
Accumulated other comprehensive income | -13,000 | 1,000 |
Accumulated deficit | -294,578,000 | -230,896,000 |
Total Onconova Therapeutics, Inc. stockholders' equity | 22,748,000 | 80,413,000 |
Non-controlling interest | 874,000 | 487,000 |
Total stockholders' equity | 23,622,000 | 80,900,000 |
Total liabilities and stockholders' equity | $47,337,000 | $105,153,000 |
Consolidated_Balance_Sheets_Pa
Consolidated Balance Sheets (Parenthetical) (USD $) | Dec. 31, 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 | 21,703,173 | 21,467,482 |
Common stock, shares outstanding | 21,703,173 | 21,467,482 |
Consolidated_Statements_of_Ope
Consolidated Statements of Operations (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Consolidated Statements of Operations | |||||||||||
Revenue | $114,000 | $114,000 | $125,000 | $447,000 | $1,930,000 | $1,116,000 | $591,000 | $1,116,000 | $800,000 | $4,753,000 | $46,190,000 |
Operating expenses: | |||||||||||
General and administrative | 3,086,000 | 3,116,000 | 3,985,000 | 4,932,000 | 4,403,000 | 5,927,000 | 3,117,000 | 3,346,000 | 15,119,000 | 16,793,000 | 15,707,000 |
Research and development | 10,387,000 | 11,886,000 | 12,904,000 | 14,248,000 | 12,086,000 | 15,293,000 | 10,047,000 | 12,756,000 | 49,425,000 | 50,182,000 | 52,762,000 |
Total operating expenses | 13,473,000 | 15,002,000 | 16,889,000 | 19,180,000 | 16,489,000 | 21,220,000 | 13,164,000 | 16,102,000 | 64,544,000 | 66,975,000 | 68,469,000 |
Loss from operations | -13,359,000 | -14,888,000 | -16,764,000 | -18,733,000 | -14,559,000 | -20,104,000 | -12,573,000 | -14,986,000 | -63,744,000 | -62,222,000 | -22,279,000 |
Change in fair value of warrant liability | 1,000 | 3,000 | 16,000 | 61,000 | -31,000 | -2,000 | 14,000 | 20,000 | 42,000 | 367,000 | |
Interest expense | -1,000 | -1,000 | -2,000 | -2,000 | -4,000 | -8,608,000 | |||||
Other income, net | -14,000 | -20,000 | -19,000 | 1,000 | -126,000 | 47,000 | 15,000 | 127,000 | -50,000 | 63,000 | 608,000 |
Net loss before income taxes | -13,373,000 | -14,907,000 | -16,780,000 | -18,716,000 | -14,625,000 | -20,089,000 | -12,562,000 | -14,845,000 | -63,776,000 | -62,121,000 | -29,912,000 |
Income taxes | 19,000 | 3,000 | 432,000 | 19,000 | 435,000 | ||||||
Net loss | -13,392,000 | -14,907,000 | -16,780,000 | -18,716,000 | -14,628,000 | -20,521,000 | -12,562,000 | -14,845,000 | -63,795,000 | -62,556,000 | -29,912,000 |
Net loss attributable to non-controlling interest | 20,000 | 29,000 | 27,000 | 37,000 | 13,000 | 113,000 | 13,000 | ||||
Net loss attributable to Onconova Therapeutics, Inc | -14,615,000 | -20,521,000 | -12,562,000 | -14,845,000 | -63,682,000 | -62,543,000 | -29,912,000 | ||||
Accretion of redeemable convertible preferred stock | -269,000 | -1,032,000 | -1,019,000 | -2,320,000 | -3,953,000 | ||||||
Net loss applicable to common stockholders | ($13,372,000) | ($14,878,000) | ($16,753,000) | ($18,679,000) | ($14,615,000) | ($20,790,000) | ($13,594,000) | ($15,864,000) | ($63,682,000) | ($64,863,000) | ($33,865,000) |
Net loss per share of common stock, basic and diluted (in dollars per share) | ($0.62) | ($0.69) | ($0.77) | ($0.87) | ($0.68) | ($1.34) | ($5.21) | ($6.08) | ($2.94) | ($6.12) | ($15.35) |
Basic and diluted weighted average shares outstanding (in shares) | 21,694,403 | 21,691,017 | 21,658,625 | 21,568,302 | 21,419,208 | 15,480,416 | 2,609,495 | 2,607,406 | 21,653,536 | 10,594,227 | 2,206,888 |
Consolidated_Statements_of_Com
Consolidated Statements of Comprehensive Loss (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Consolidated Statements of Comprehensive Loss | |||
Net loss | ($63,795,000) | ($62,556,000) | ($29,912,000) |
Other comprehensive income, before tax: | |||
Foreign currency translation adjustments, net | -14,000 | 1,000 | |
Other comprehensive (loss) income, net of tax | -14,000 | 1,000 | |
Comprehensive loss | -63,809,000 | -62,555,000 | -29,912,000 |
Comprehensive loss attributable to non-controlling interest | 113,000 | 13,000 | |
Comprehensive loss attributable to Onconova Therapeutics, Inc | ($63,696,000) | ($62,542,000) | ($29,912,000) |
Consolidated_Statements_of_Red
Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (USD $) | Preferred Stock | Common Stock | Additional Paid in Capital | Accumulated deficit | Accumulated other comprehensive income | Non-controlling interest | Total |
Balance at Dec. 31, 2011 | $22,000 | ($138,441,000) | ($138,419,000) | ||||
Balance at Dec. 31, 2011 | 119,997,000 | ||||||
Balance (in shares) at Dec. 31, 2011 | 2,167,928 | ||||||
Balance (in shares) at Dec. 31, 2011 | 11,227,169 | ||||||
Increase (Decrease) in Stockholders' Equity | |||||||
Net loss | -29,912,000 | -29,912,000 | |||||
Issuance of preferred stock, net of issuance costs | 47,796,000 | ||||||
Issuance of preferred stock, net of issuance costs (in shares) | 3,030,303 | ||||||
Exercise of stock options | 4,000 | 4,690,000 | 4,694,000 | ||||
Exercise of stock options (in shares) | 438,556 | ||||||
Proceeds from stockholder in connection with settlement of stock option exercises | 3,943,000 | 3,943,000 | |||||
Settlement of stock option liabilities | -2,835,000 | -2,835,000 | |||||
Issuance of preferred stock upon exercise of warrants | 2,802,000 | ||||||
Issuance of preferred stock upon exercise of warrants (in shares) | 221,399 | ||||||
Exchange of convertible debt and preferred stock | 26,767,000 | ||||||
Exchange of convertible debt and preferred stock (in shares) | 2,433,328 | ||||||
Beneficial conversion feature on convertible debt | 8,176,000 | 8,176,000 | |||||
Accretion of preferred stock to redemption value | 3,953,000 | -3,953,000 | -3,953,000 | ||||
Balance at Dec. 31, 2012 | 26,000 | 10,021,000 | -168,353,000 | -158,306,000 | |||
Balance at Dec. 31, 2012 | 201,315,000 | ||||||
Balance (in shares) at Dec. 31, 2012 | 2,606,484 | ||||||
Balance (in shares) at Dec. 31, 2012 | 16,912,199 | ||||||
Increase (Decrease) in Stockholders' Equity | |||||||
Net loss | -62,543,000 | -13,000 | -62,556,000 | ||||
Other comprehensive income (loss) | 1,000 | 1,000 | |||||
Issuance of preferred stock, net of issuance costs | 500,000 | 500,000 | |||||
Exercise of stock options | 1,000 | 194,000 | 195,000 | ||||
Exercise of stock options (in shares) | 81,204 | ||||||
Proceeds from stockholder in connection with settlement of stock option exercises | 5,462,000 | 5,462,000 | |||||
Settlement of stock option liabilities | 14,482,000 | 14,482,000 | |||||
Conversion convertible preferred stock into common stock | -203,635,000 | 129,000 | 203,502,000 | 203,631,000 | |||
Conversion convertible preferred stock into common stock (in shares) | -16,912,199 | 12,838,127 | |||||
Issuance of common stock, net of issuance costs | 59,000 | 79,752,000 | 79,811,000 | ||||
Issuance of common stock, net of issuance costs (in shares) | 5,941,667 | ||||||
Accretion of preferred stock to redemption value | 2,320,000 | -2,320,000 | -2,320,000 | ||||
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 | -63,682,000 | -113,000 | -63,795,000 | ||||
Contribution from non-controlling interest | 500,000 | 500,000 | |||||
Other comprehensive income (loss) | -14,000 | -14,000 | |||||
Exercise of stock options | 2,000 | 961,000 | 963,000 | ||||
Exercise of stock options (in shares) | 235,691 | ||||||
Stock-based compensation | 5,068,000 | 5,068,000 | |||||
Balance at Dec. 31, 2014 | $217,000 | $317,122,000 | ($294,578,000) | ($13,000) | $874,000 | $23,622,000 | |
Balance (in shares) at Dec. 31, 2014 | 21,703,173 |
Condensed_Consolidated_Stateme
Condensed Consolidated Statements of Cash Flows (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Operating activities: | |||
Net loss | ($63,795,000) | ($62,556,000) | ($29,912,000) |
Adjustment to reconcile net loss to net cash (used in) provided by operating activities: | |||
Depreciation and amortization | 434,000 | 446,000 | 319,000 |
Loss on asset disposal | 3,000 | ||
Amortization of deferred financing fees | 15,000 | ||
Amortization of debt discount | 8,176,000 | ||
Change in fair value of warrant liabilities | -20,000 | -42,000 | -367,000 |
Treasury note discount amortization | -6,000 | -4,000 | |
Stock compensation expense | 5,068,000 | 8,015,000 | 13,844,000 |
Changes in assets and liabilities : | |||
Grants receivable | 78,000 | ||
Prepaid expenses and other current assets | 1,189,000 | -2,662,000 | -1,098,000 |
Other assets | -15,000 | ||
Accounts payable | 317,000 | -1,807,000 | -97,000 |
Accrued expenses and other current liabilities | -43,000 | 1,894,000 | 2,573,000 |
Other liabilities | -5,000 | -37,000 | -41,000 |
Deferred revenue | -787,000 | -4,631,000 | 8,155,000 |
Net cash (used in) provided by operating activities | -57,648,000 | -61,384,000 | 1,633,000 |
Investing activities: | |||
Payments for purchase of property and equipment | -228,000 | -609,000 | -279,000 |
Purchases of marketable securities | -39,990,000 | ||
Maturities of marketable securities | 40,000,000 | ||
Net cash provided by (used in) investing activities | 39,772,000 | -40,599,000 | -279,000 |
Financing activities: | |||
Proceeds from initial public offering of common stock, net of issuance costs | 79,811,000 | ||
Proceeds from the exercise of stock options | 963,000 | 157,000 | 165,000 |
Contribution from non-controlling interest | 500,000 | 500,000 | |
Reverse stock split cash paid in lieu of fractional shares | -4,000 | ||
Proceeds from stockholder in connection with settlement of stock option exercises | 3,943,000 | ||
Settlement of stock options | -2,835,000 | ||
Proceeds from the exercise of warrants | 2,167,000 | ||
Proceeds from stockholder loan and convertible debt | 25,824,000 | ||
Net cash provided by financing activities | 1,463,000 | 80,464,000 | 77,460,000 |
Effect of foreign currency translation on cash | -14,000 | 1,000 | |
Net decrease in cash and cash equivalents | -16,427,000 | -21,518,000 | 78,814,000 |
Cash and cash equivalents at beginning of period | 60,009,000 | 81,527,000 | 2,713,000 |
Cash and cash equivalents at end of period | 43,582,000 | 60,009,000 | 81,527,000 |
Supplemental disclosure of cash flow information: | |||
Income taxes paid | 435,000 | ||
Series H Preferred Stock | |||
Financing activities: | |||
Proceeds from the sale of preferred stock | 400,000 | ||
Series J Preferred Stock | |||
Financing activities: | |||
Proceeds from the sale of preferred stock | $47,796,000 |
Nature_of_Business
Nature of Business | 12 Months Ended |
Dec. 31, 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 variety of cancers. 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 development 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 license agreement, as subsequently amended, 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 year ended December 31, 2014, the Company incurred a net loss of $63,795,000 and as of December 31, 2014, the Company had generated an accumulated deficit of $294,578,000. The Company anticipates operating losses to continue for the foreseeable future due to, among other things, costs related to research, development of its product candidates and its preclinical programs, strategic alliances and its administrative organization. The Company will require substantial additional financing to fund its operations and to continue to execute its strategy. | |
From its inception through July 2013, 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. See Note 9. | |
During 2015, the Company implemented cost-reduction programs to reduce its operating losses. These programs may delay, scale-back, or eliminate certain of the Company's research and development activities and other aspects of its operations until such time as the Company is successful in securing adequate additional funding. As a result of the cost reduction programs, the Company estimates that its cash and cash equivalents at December 31, 2014 of $43.6 million will be sufficient to fund operations through 2015 and for the first quarter of 2016. The Company is also exploring various dilutive and non-dilutive sources of funding, including equity and debt financings, strategic alliances, business development and other sources. Such financings would be used to fund future research and development programs, including clinical trials for which the Company does not currently have the resources to fund. There can be no assurance, however, that the Company will be successful in obtaining such financing at the level needed to complete its research and development programs, 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 | 12 Months Ended | ||
Dec. 31, 2014 | |||
Summary of Significant Accounting Policies | |||
Summary of Significant Accounting Policies | |||
2. Summary of Significant Accounting Policies | |||
Basis of Presentation | |||
The consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States ("GAAP"). 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. | |||
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. | |||
Use of Estimates | |||
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses, other comprehensive income and related disclosures. On an ongoing basis, management evaluates its estimates, including estimates related to clinical trial accruals, warrant liability, and allocation of consideration to multiple element collaborative arrangements. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. | |||
Prior to completion of its IPO on July 30, 2013, the Company utilized estimates and assumptions in determining the fair value of its Common Stock. The Company granted stock options at exercise prices not less than the fair value of its Common Stock as determined by the board of directors, with input from management. Management used the assistance of a third-party valuation firm in estimating the fair value of the Common Stock. The board of directors determined the estimated fair value of the Common Stock based on a number of objective and subjective factors, including external market conditions affecting the biotechnology industry sector and the historic prices at which the Company sold shares of Preferred Stock. | |||
Concentrations of Credit Risk and Off-Balance Sheet Risk | |||
Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash, cash equivalents, restricted cash and marketable securities. The Company maintains a portion of its cash and cash equivalent balances in the form of money market accounts with financial institutions that management believes are creditworthy. Marketable securities are invested in U.S. Treasury obligations. The Company has no financial instruments with off-balance sheet risk of loss. | |||
Cash and Cash Equivalents | |||
The Company considers all highly liquid investments with original or remaining maturity from the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents include bank demand deposits, marketable securities with maturities of three months or less at purchase, and money market funds that invest primarily in certificates of deposit, commercial paper and U.S. government and U.S. government agency obligations. Cash equivalents are reported at fair value. | |||
Marketable Securities | |||
Marketable securities with original maturities longer than three months but which mature in less than one year from the balance sheet date are classified as current assets. Marketable securities that mature more than one year from the balance sheet date are classified as noncurrent assets. Marketable securities that the Company has the intent and ability to hold to maturity are classified as investments held-to-maturity and are reported at amortized cost. The difference between the acquisition cost and face values of held-to-maturity investments is amortized over the remaining term of the investments and added to or subtracted from the acquisition cost and interest income. As of December 31, 2014 and 2013, all of the Company's investments were classified as held-to-maturity. | |||
Fair Value of Financial Instruments | |||
The carrying amounts reported in the accompanying consolidated financial statements for cash and cash equivalents, marketable securities, accounts payable and accrued liabilities approximate their respective fair values because of the short-term nature of these accounts. The fair value of the warrant liability is discussed in Note 4, "Fair Value Measurements." | |||
Property and Equipment | |||
Property and equipment are stated at cost, less accumulated depreciation. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets. Leasehold improvements are amortized over the useful life of the asset or the lease term, whichever is shorter. Maintenance and repairs are expensed as incurred. The following estimated useful lives were used to depreciate the Company's assets: | |||
Estimated Useful Life | |||
Lab equipment | 5 - 6 years | ||
Software | 3 years | ||
Computer and office equipment | 5 - 6 years | ||
Leasehold improvements | Shorter of the lease term or estimated useful life | ||
Upon retirement or sale, the cost of the disposed asset and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is recognized. | |||
The Company reviews long-lived assets for impairment when events or changes in circumstances indicate that the carrying value of the assets may not be recoverable. Recoverability is measured by comparison of the assets' book value to future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the book value of the assets exceeds their fair value, which is measured based on the projected discounted future net cash flows generated from the assets. No impairment losses have been recorded through December 31, 2014. | |||
Restricted Cash | |||
Under one of the Company's office leases, the Company is required to provide the landlord a $125,000 letter of credit, which is secured by cash collateral recorded as restricted cash on the consolidated balance sheets as of December 31, 2014 and 2013. The letter of credit expired in March 2015 and the restriction on cash was discontinued. | |||
Foreign Currency Translation | |||
The reporting currency of the Company and its U.S. subsidiaries 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. | |||
Revenue Recognition | |||
The Company's revenue is generated primarily through collaborative research and license agreements. The terms of these agreements contain multiple deliverables which may include (i) licenses, (ii) research and development activities, (iii) participation in joint steering committees and (iv) product supply. The terms of these agreements may include nonrefundable upfront license fees, payments for research and development activities, payments based upon the achievement of certain milestones, royalty payments based on product sales derived from the collaboration, and payments for supplying product. In all instances, revenue is recognized only when the price is fixed or determinable, persuasive evidence of an arrangement exists, delivery has occurred or the services have been rendered, collectability of the resulting receivable is reasonably assured, and the Company has fulfilled its performance obligations under the contract. | |||
For arrangements with multiple elements, the Company recognizes revenue in accordance with the Financial Accounting Standards Board ("FASB") Accounting Standards Update ("ASU") No. 2009-13, Multiple-Deliverable Revenue Arrangements ("ASU 2009-13"), which provides guidance for separating and allocating consideration in a multiple element arrangement. The selling prices of deliverables under an arrangement may be derived using third-party evidence ("TPE"), or a best estimate of selling price ("BESP"), if vendor-specific objective evidence of selling price ("VSOE") is not available. The objective of BESP is to determine the price at which the Company would transact a sale if the element within the license agreement was sold on a standalone basis. Establishing BESP involves management's judgment and considers multiple factors, including market conditions and company-specific factors, including those factors contemplated in negotiating the agreements, as well as internally developed models that include assumptions related to market opportunity, discounted cash flows, estimated development costs, probability of success and the time needed to commercialize a product candidate pursuant to the license. In validating the BESP, management considers whether changes in key assumptions used to determine the BESP will have a significant effect on the allocation of the arrangement consideration between the multiple deliverables. The Company may use third-party valuation specialists to assist it in determining BESP. Deliverables under the arrangement are separate units of accounting if (i) the delivered item has value to the customer on a standalone basis and (ii) if the arrangement includes a general right of return relative to the delivered item, delivery or performance of the undelivered item is considered probable and substantially within the Company's control. The arrangement consideration that is fixed or determinable at the inception of the arrangement is allocated to the separate units of accounting based on their relative selling prices. The appropriate revenue recognition model is applied to each element and revenue is accordingly recognized as each element is delivered. Management exercises significant judgment in determining whether a deliverable is a separate unit of accounting. | |||
In determining the separate units of accounting, the Company evaluates whether the license has standalone value to the collaborator based on consideration of the relevant facts and circumstances for each arrangement. Factors considered in this determination include the research and development capabilities of the collaborator and the availability of relevant research expertise in the marketplace. In addition, the Company considers whether or not (i) the collaborator could use the license for its intended purpose without the receipt of the remaining deliverables, (ii) the value of the license was dependent on the undelivered items and (iii) the collaborator or other vendors could provide the undelivered items. | |||
Under a collaborative research and license agreement, a steering committee is typically responsible for overseeing the general working relationships, determining the protocols to be followed in the research and development performed and evaluating the results from the continued development of the product. The Company evaluates whether its participation in joint steering committees is a substantive obligation or whether the services are considered inconsequential or perfunctory. The factors the Company considers in determining if its participation in a joint steering committee is a substantive obligation include: (i) which party negotiated or requested the steering committee, (ii) how frequently the steering committee meets, (iii) whether or not there are any penalties or other recourse if the Company does not attend the steering committee meetings, (iv) which party has decision making authority on the steering committee and (v) whether or not the collaborator has the requisite experience and expertise associated with the research and development of the licensed intellectual property. | |||
Whenever the Company determines that an element is delivered over a period of time, revenue is recognized using either a proportional performance model, if a pattern of performance can be determined or a straight-line model over the period of performance, which is typically the research and development term. Progress achieved under the Company's various clinical research organization contracts are typically used as the measure of performance when applying the proportional performance method. At the end of each reporting period, the Company reassesses its cumulative measure of performance and makes appropriate adjustments, if necessary. The Company recognizes revenue using the proportional performance model whenever the Company is able to make reasonably reliable estimates of the level of effort required to complete its performance obligations under an arrangement. Revenue recognized under the proportional performance model at each reporting period is determined by multiplying the total expected payments under the contract (excluding royalties and payments contingent upon achievement of milestones) by the ratio of the level of effort incurred to date to the estimated total level of effort required to complete the performance obligations under the arrangement. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the proportional performance model as of each reporting period. Alternatively, if the Company is not able to make reasonably reliable estimates of the level of effort required to complete its performance obligations under an arrangement, then revenue under the arrangement is recognized on a straight-line basis over the period expected to be required to complete the Company's performance obligations. | |||
Incentive milestone payments may be triggered either by the results of the Company's research efforts or by events external to it, such as regulatory approval to market a product or attaining agreed-upon sales levels. Consideration that is contingent upon achievement of a milestone is recognized in its entirety as revenue in the period in which the milestone is achieved, but only if the consideration earned from the achievement of a milestone meets all the criteria for the milestone to be considered substantive at the inception of the arrangement. For a milestone to be considered substantive, the consideration earned by achieving the milestone must (i) be commensurate with either the Company's performance to achieve the milestone or the enhancement of the value of the item delivered as a result of a specific outcome resulting from the Company's performance to achieve the milestone, (ii) relate solely to past performance and (iii) be reasonable relative to all deliverables and payment terms in the collaboration agreement. | |||
For events for which the occurrences are contingent solely upon the passage of time or are the result of performance by a third party, the contingent payments will be recognized as revenue when payments are earned, the amounts are fixed and determinable and collectability is reasonably assured. | |||
Royalties are recorded as earned in accordance with the contract terms when third party sales can be reliably measured and collectability is reasonably assured. | |||
The Company recognized revenue of $334,000, $4,176,000 and $45,490,000 during the years ended December 31, 2014, 2013 and 2012, respectively, as a result of its license and collaboration agreement with Baxter. The Company recognized revenue of $466,000, $577,000 and $503,000 during the years ended December 31, 2014, 2013 and 2012, respectively, as a result of its license and collaboration agreement with SymBio. The remaining revenue recognized during the year ended December 31, 2012 of $197,000 pertained to research and development services provided by the Company under certain research grants. The Baxter and SymBio agreements are the only agreements that are being accounted for under ASU 2009-13. See Note 14, "License and Collaboration Agreements," for a further discussion of the agreements with Baxter and SymBio. | |||
Research and Development Expenses | |||
Research and development costs are charged to expense as incurred. These costs include, but are not limited to, license fees related to the acquisition of in-licensed products; employee-related expenses, including salaries, benefits and travel; expenses incurred under agreements with contract research organizations and investigative sites that conduct clinical trials and preclinical studies; the cost of acquiring, developing and manufacturing clinical trial materials; facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and other supplies; and costs associated with preclinical activities and regulatory operations. | |||
Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided to the Company by its vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as prepaid or accrued research and development expense, as the case may be. | |||
Comprehensive Loss | |||
Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. | |||
Income Taxes | |||
The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. The deferred tax asset primarily includes net operating loss and tax credit carry forwards, accrued expenses not currently deductible and the cumulative temporary differences related to certain research and patent costs, which have been charged to expense in the accompanying statements of operations but have been recorded as assets for income tax purposes. The portion of any deferred tax asset for which it is more likely than not that a tax benefit will not be realized must then be offset by recording a valuation allowance. A full valuation allowance has been established against all of the deferred tax assets (see Note 7, "Income Taxes"), as it is more likely than not that these assets will not be realized given the Company's history of operating losses. The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not to be sustained upon examination based on the technical merits of the position. The amount for which an exposure exists is measured as the largest amount of benefit determined on a cumulative probability basis that the Company believes is more likely than not to be realized upon ultimate settlement of the position. | |||
Preferred Stock | |||
The Company accounted for the redemption premium and issuance costs on its Preferred Stock using the effective interest method, accreting such amounts to its Preferred Stock from the date of issuance to the earliest date of redemption. 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. See Note 9. | |||
Stock Warrants | |||
Freestanding warrants that are related to the purchase of Stock are classified as liabilities and recorded at fair value. The warrants are subject to re-measurement at each balance sheet date and any change in fair value is recognized as a component of change in fair value of warrant liability in the consolidated statements of operations. See Note 9. The warrants are classified as Level 3 liabilities (see Note 4 for a discussion of the fair value hierarchy). | |||
Stock-Based Compensation Expense | |||
The Company applies the provisions of FASB Accounting Standards Codification ("ASC") Topic 718, Compensation—Stock Compensation ("ASC 718"), which requires the measurement and recognition of compensation expense for all stock-based awards made to employees and non-employees, including employee stock options. | |||
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"), 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") (See Note 11). Because the Company had established a pattern of providing cash settlement alternatives for option holders, the Company accounted for its stock-based compensation awards as liability awards. The Company measured liability awards based on the award's intrinsic value on the grant date and then re-measured them at each reporting date until the date of settlement. Compensation expense was recognized on a straight-line basis over the requisite service period for each separately vesting portion of the award. Compensation expense for each period until settlement was based on the change in intrinsic value (or a portion of the change in intrinsic value, depending on the percentage of the requisite service that has been rendered at the reporting date). Changes in the intrinsic value of a liability that occur after the end of the requisite service period were considered compensation expense in the period in which the changes occur. On April 23, 2013, the Company distributed a notification letter to all equity award holders under 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. The remaining expense for these options is being recognized on a straight-line basis over the remaining requisite service period. | |||
Share-based payment transactions with employees, including grants of employee stock options, are recognized as compensation expense over the requisite service period based on their estimated fair values. ASC 718 also requires significant judgment and the use of estimates, particularly surrounding Black-Scholes assumptions such as stock price volatility over the option term and expected option lives, as well as expected option forfeiture rates, to estimate the grant date fair value of equity-based compensation and requires the recognition of the fair value of stock compensation in the statement of operations. | |||
Clinical Trial Expense Accruals | |||
As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company's objective is to reflect the appropriate trial expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. The Company determines accrual estimates through financial models taking into account discussion with applicable personnel and outside service providers as to the progress or state of consummation of trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company's clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period. For the years ended December 31, 2014, 2013 and 2012, there were no material adjustments to the Company's prior period estimates of accrued expenses for clinical trials. | |||
Collaboration Arrangements | |||
A collaboration arrangement is defined as a contractual arrangement that has or may have significant financial milestones associated with success-based development, which include certain arrangements the Company has entered into regarding the research and development, manufacture and/or commercialization of products and product candidates. These collaborations generally provide for non-refundable, upfront license fees, research and development and commercial performance milestone payments, cost sharing and royalty payments. The collaboration agreements with third-parties are performed on a "best efforts" basis with no guarantee of either technological or commercial success. The Company evaluates whether an arrangement is a collaboration arrangement at its inception based on the facts and circumstances specific to the arrangement. The Company reevaluates whether an arrangement qualifies or continues to qualify as a collaboration arrangement whenever there is a change in the anticipated or actual ultimate commercial success of the endeavor. See Note 14, "License and Collaboration Agreements," for a discussion of the Company's current collaborations with Baxter and SymBio. | |||
Basic and Diluted Net Loss Per Share of Common Stock | |||
Basic net loss per share of common stock is computed by dividing net loss applicable to common stockholders by the weighted-average number of shares of Common Stock outstanding during the period, excluding the dilutive effects of Preferred Stock, warrants to purchase Preferred Stock and stock options. Diluted net loss per share of common stock is computed by dividing the net loss applicable to common stockholders by the sum of the weighted-average number of shares of Common Stock outstanding during the period plus the potential dilutive effects of Preferred Stock and warrants to purchase Preferred Stock, and stock options outstanding during the period calculated in accordance with the treasury stock method, but are excluded if their effect is anti-dilutive. Because the impact of these items is anti-dilutive during periods of net loss, there was no difference between basic and diluted net loss per share of Common Stock for the years ended December 31, 2014, 2013 and 2012. | |||
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 financial reporting process and its consolidated financial position, results of operations and related disclosures. | |||
Property_and_Equipment
Property and Equipment | 12 Months Ended | |||||||
Dec. 31, 2014 | ||||||||
Property and Equipment | ||||||||
Property and Equipment | ||||||||
3. Property and Equipment | ||||||||
Property and equipment and related accumulated depreciation are as follows: | ||||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Laboratory equipment | $ | 1,037,000 | $ | 866,000 | ||||
Software | 92,000 | 92,000 | ||||||
Computer and office equipment | 433,000 | 433,000 | ||||||
Leasehold improvements | 1,063,000 | 1,011,000 | ||||||
| | | | | | | | |
2,625,000 | 2,402,000 | |||||||
Less accumulated depreciation | (2,205,000 | ) | (1,776,000 | ) | ||||
| | | | | | | | |
$ | 420,000 | $ | 626,000 | |||||
| | | | | | | | |
| | | | | | | | |
Depreciation and amortization expense was $434,000, $446,000 and $319,000 for the years ended December 31, 2014, 2013 and 2012, respectively. | ||||||||
Fair_Value_Measurements
Fair Value Measurements | 12 Months Ended | |||||||||||||||||||||||||
Dec. 31, 2014 | ||||||||||||||||||||||||||
Fair Value Measurements | ||||||||||||||||||||||||||
Fair Value Measurements | ||||||||||||||||||||||||||
4. Fair Value Measurements | ||||||||||||||||||||||||||
The Company applies various valuation approaches in determining the fair value of its financial assets and liabilities within a hierarchy that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company's assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available under the circumstances. The fair value hierarchy is broken down into three levels based on the source of inputs as follows: | ||||||||||||||||||||||||||
Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access. | ||||||||||||||||||||||||||
Level 2—Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly. | ||||||||||||||||||||||||||
Level 3—Valuations based on inputs that are unobservable and significant to the overall fair value measurement. | ||||||||||||||||||||||||||
The availability of observable inputs can vary among the various types of financial assets and liabilities. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, for financial statement disclosure purposes, the level in the fair value hierarchy within which the fair value measurement is classified is based on the lowest level input that is significant to the overall fair value measurement. | ||||||||||||||||||||||||||
The Company had no assets or liabilities classified as Level 1 or Level 2. The Series G Preferred Stock warrants (see Note 9) are classified as Level 3. The fair values of these instruments are determined using models based on market observable inputs and management judgment. There were no material re-measurements of fair value during the years ended December 31, 2014 and 2013 with respect to financial assets and liabilities, other than those assets and liabilities that are measured at fair value on a recurring basis. | ||||||||||||||||||||||||||
The Company has classified the Series G Preferred Stock warrants as a liability and has re-measured the liability to estimated fair value at December 31, 2014 and 2013, using the Black-Scholes option pricing model using the following assumptions: contractual life according to the remaining terms of the warrants, no dividend yield, weighted average risk-free interest rate of 0.03% and 0.34% at December 31, 2014 and 2013, respectively, and weighted average volatility of 102.26% and 74.40% at December 31, 2014 and 2013, respectively. | ||||||||||||||||||||||||||
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 December 31, 2014 and 2013. | ||||||||||||||||||||||||||
Fair Value Measurement as of | Fair Value Measurement as of | |||||||||||||||||||||||||
December 31, 2014 | 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 years ended December 31, 2014 and 2013: | ||||||||||||||||||||||||||
Warrant | ||||||||||||||||||||||||||
Liability | ||||||||||||||||||||||||||
Balance at December 31, 2012 | $ | 62,000 | ||||||||||||||||||||||||
Change in fair value upon re-measurement | (42,000 | ) | ||||||||||||||||||||||||
| | | | | ||||||||||||||||||||||
Balance at December 31, 2013 | 20,000 | |||||||||||||||||||||||||
Change in fair value upon re-measurement | (20,000 | ) | ||||||||||||||||||||||||
| | | | | ||||||||||||||||||||||
Balance at December 31, 2014 | $ | — | ||||||||||||||||||||||||
| | | | | ||||||||||||||||||||||
| | | | | ||||||||||||||||||||||
The fair values of cash equivalents, marketable securities, accounts payable and accrued liabilities approximate their respective carrying values due to the short-term nature of these accounts. | ||||||||||||||||||||||||||
There were no transfers between Level 1 and Level 2 in any of the periods reported. | ||||||||||||||||||||||||||
Net_Loss_Per_Share_of_Common_S
Net Loss Per Share of Common Stock | 12 Months Ended | ||||||||||
Dec. 31, 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 table sets forth the computation of basic and diluted earnings per share for the years ended December 31, 2014, 2013 and 2012: | |||||||||||
Year ended December 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
Basic and diluted net loss per share of common stock: | |||||||||||
Net loss attributable to Onconova Therapeutics, Inc | $ | (63,682,000 | ) | $ | (62,543,000 | ) | $ | (29,912,000 | ) | ||
Accretion to redemption value of preferred stock | — | (2,320,000 | ) | (3,953,000 | ) | ||||||
| | | | | | | | | | | |
Net loss applicable to common stockholders | $ | (63,682,000 | ) | $ | (64,863,000 | ) | $ | (33,865,000 | ) | ||
| | | | | | | | | | | |
| | | | | | | | | | | |
Weighted average shares of common stock outstanding | 21,653,536 | 10,594,227 | 2,206,888 | ||||||||
| | | | | | | | | | | |
| | | | | | | | | | | |
Net loss per share of common stock—basic and diluted | $ | (2.94 | ) | $ | (6.12 | ) | $ | (15.35 | ) | ||
| | | | | | | | | | | |
| | | | | | | | | | | |
The following potentially dilutive securities outstanding at December 31, 2014, 2013 and 2012 have been excluded from the computation of diluted weighted average shares outstanding, as they would be antidilutive: | |||||||||||
December 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
Preferred Stock | — | — | 12,838,127 | ||||||||
Warrants | 4,597 | 4,597 | 4,597 | ||||||||
Stock options | 4,631,299 | 4,344,365 | 2,564,147 | ||||||||
| | | | | | | | | | | |
4,635,896 | 4,348,962 | 15,406,871 | |||||||||
| | | | | | | | | | | |
| | | | | | | | | | | |
Balance_Sheet_Detail
Balance Sheet Detail | 12 Months Ended | |||||||
Dec. 31, 2014 | ||||||||
Balance Sheet Detail | ||||||||
Balance Sheet Detail | ||||||||
6. Balance Sheet Detail | ||||||||
Prepaid expenses and other current assets are as follows: | ||||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Research and development | $ | 1,782,000 | $ | 2,242,000 | ||||
Manufacturing | 451,000 | 1,051,000 | ||||||
Insurance | 578,000 | 645,000 | ||||||
Other | 387,000 | 449,000 | ||||||
| | | | | | | | |
$ | 3,198,000 | $ | 4,387,000 | |||||
| | | | | | | | |
| | | | | | | | |
Accrued expenses and other current liabilities are as follows: | ||||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Research and development | $ | 4,482,000 | $ | 4,625,000 | ||||
Employee compensation | 854,000 | 509,000 | ||||||
Professional fees | 418,000 | 310,000 | ||||||
Taxes | 18,000 | 302,000 | ||||||
Other | 5,000 | 74,000 | ||||||
| | | | | | | | |
$ | 5,777,000 | $ | 5,820,000 | |||||
| | | | | | | | |
| | | | | | | | |
Income_Taxes
Income Taxes | 12 Months Ended | ||||||||||
Dec. 31, 2014 | |||||||||||
Income Taxes | |||||||||||
Income Taxes | |||||||||||
7. Income Taxes | |||||||||||
The Company accounts for income taxes under FASB ASC 740 ("ASC 740"). Deferred income tax assets and liabilities are determined based upon differences between financial reporting and tax bases of assets and liabilities, which are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. | |||||||||||
Income taxes have been based on the following income (loss) before income tax expense: | |||||||||||
December 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
Domestic | (63,910,000 | ) | (62,154,000 | ) | $ | (29,912,000 | ) | ||||
Foreign | 134,000 | 33,000 | — | ||||||||
| | | | | | | | | | | |
$ | (63,776,000 | ) | $ | (62,121,000 | ) | $ | (29,912,000 | ) | |||
| | | | | | | | | | | |
| | | | | | | | | | | |
The provision for income taxes consists of the following: | |||||||||||
December 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
Current | |||||||||||
US Federal | $ | — | $ | 140,000 | $ | — | |||||
State and Local | — | 285,000 | — | ||||||||
Foreign | 19,000 | 10,000 | — | ||||||||
| | | | | | | | | | | |
Total Current | $ | 19,000 | $ | 435,000 | $ | — | |||||
| | | | | | | | | | | |
Deferred | |||||||||||
US Federal | $ | — | $ | — | $ | — | |||||
State and Local | — | — | — | ||||||||
Foreign | — | — | — | ||||||||
| | | | | | | | | | | |
Total Deferred | $ | — | $ | — | $ | — | |||||
| | | | | | | | | | | |
Total Expense (Benefit) | $ | 19,000 | $ | 435,000 | $ | — | |||||
| | | | | | | | | | | |
| | | | | | | | | | | |
As of December 31, 2014, the Company had federal net operating loss ("NOL") carry forwards of $160,266,000, state NOL carry forwards of $141,053,000 and research and development tax credit carry forwards of $56,612,000, which are available to reduce future taxable income. The federal NOL and tax credit carry forwards will begin to expire at various dates starting in 2022. The state NOL carry forwards will begin to expire at various dates starting in 2016. The NOL carry forwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. NOL and tax credit carry forwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, as well as similar state tax provisions. This could limit the amount of NOLs that the Company can utilize annually to offset future taxable income or tax liabilities. The amount of the annual limitation, if any, will be determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. | |||||||||||
The Company's reserves related to taxes are based on a determination of whether and how much of a tax benefit taken by the Company in its tax filings or positions is more likely than not to be realized. The Company recognized no material adjustment for unrecognized income tax benefits. Through December 31, 2014, the Company had no unrecognized tax benefits or related interest and penalties accrued. | |||||||||||
The principal components of the Company's deferred tax assets are as follows: | |||||||||||
December 31, | |||||||||||
2014 | 2013 | ||||||||||
Deferred tax assets: | |||||||||||
Net operating loss carryovers | $ | 63,776,000 | $ | 47,364,000 | |||||||
R&D tax credits | 56,750,000 | 35,223,000 | |||||||||
Non-qualified stock options | 4,916,000 | 3,988,000 | |||||||||
Deferred revenue | 5,648,000 | 5,938,000 | |||||||||
Charitable contributions | 6,000 | 6,000 | |||||||||
Accrued expenses | 691,000 | 586,000 | |||||||||
Fixed assets | 164,000 | 199,000 | |||||||||
| | | | | | | | ||||
Deferred tax assets | 131,951,000 | 93,304,000 | |||||||||
Less valuation allowance | (131,951,000 | ) | (93,304,000 | ) | |||||||
| | | | | | | | ||||
Net deferred tax assets | $ | — | $ | — | |||||||
| | | | | | | | ||||
| | | | | | | | ||||
ASC 740 requires a valuation allowance to reduce the deferred tax assets reported if, based on the weight of available evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. After consideration of all the evidence, both positive and negative, the Company has recorded a full valuation allowance against its deferred tax assets at December 31, 2014 and 2013, respectively, because the Company's management has determined that is it more likely than not that these assets will not be fully realized. The Company experienced a net change in valuation allowance of $38,647,000 and $38,007,000 for the years ended December 31, 2014 and 2013, respectively. | |||||||||||
A reconciliation of income tax (expense) benefit at the statutory federal income tax rate and income taxes as reflected in the financial statements is as follows: | |||||||||||
December 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
Federal income tax expense at statutory rate | 34 | % | 34 | % | 34 | % | |||||
Permanent items | (8.9 | ) | (8.3 | ) | (25.1 | ) | |||||
State income tax, net of federal benefit | 4.2 | 4.5 | 1.8 | ||||||||
Tax credits | 33.8 | 34.4 | 18.5 | ||||||||
Provision to return | (2.4 | ) | (3.8 | ) | — | ||||||
Change in valuation allowance | (60.7 | ) | (61.2 | ) | (29.1 | ) | |||||
Other | — | (0.2 | ) | (0.1 | ) | ||||||
| | | | | | | | | | | |
Effective income tax rate | (0.0 | )% | (0.6 | )% | 0 | % | |||||
| | | | | | | | | | | |
| | | | | | | | | | | |
Convertible_Promissory_Notes
Convertible Promissory Notes | 12 Months Ended |
Dec. 31, 2014 | |
Convertible Promissory Notes | |
Convertible Promissory Notes | |
8. Convertible Promissory Notes | |
In March 2012, the Company offered to its stockholders the opportunity to participate in a $30,000,000 private placement of convertible promissory notes (the "Convertible Debt Offering"). From April through July 2012, the Company had aggregate closings of the Convertible Debt Offering of $26,444,000, including $620,000 from the principal that remained outstanding on a stockholder loan at December 31, 2011. | |
In July 2012, the Company amended and restated its certificate of incorporation and designated Series I Preferred Stock. The Company and the holders of the convertible promissory notes amended the Equity Scenario provision of the notes to permit the holders to convert the convertible promissory notes into shares of Series I Preferred Stock at a conversion price of $11.00 per share. | |
In connection with the amendment of the convertible promissory notes, the notes were also analyzed to determine the existence of a beneficial conversion feature. The Company concluded that an $8,176,000 contingent beneficial conversion feature existed related to the Equity Scenario as of July 2012. The fair value of the Series I Preferred Stock used to calculate the value of the beneficial conversion feature was determined by management with the assistance of a third-party valuation firm. | |
On July 27, 2012, the holders of the convertible promissory notes exercised their right to convert the outstanding principal and interest into Series I Preferred Stock. Upon conversion, the holders received 2,443,328 shares of Series I Preferred Stock, and the Company recorded interest expense of $8,176,000, which was equal to the amount of the unamortized contingent beneficial conversion feature. | |
Preferred_Stock_and_Stockholde
Preferred Stock and Stockholders' Equity (Deficit) | 12 Months Ended |
Dec. 31, 2014 | |
Preferred Stock and Stockholders' Equity (Deficit) | |
Preferred Stock and Stockholders' Equity (Deficit) | |
9. Preferred Stock and Stockholders' Equity (Deficit) | |
From its inception to July 2013, 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. At January 1, 2012 there were 11,227,169 shares of Preferred Stock issued and outstanding. | |
In July 2012, the Company issued 2,433,328 shares of Series I Preferred Stock in exchange for the conversion of the convertible promissory notes and accrued interest in the amount of $26,444,000 and $323,000, respectively. The effective conversion price was $11.00 per share. Additionally, in July 2012, the Company issued 3,030,303 shares of Series J Preferred Stock at $16.50 per share for gross proceeds of $50,000,000. Issuance costs associated with this offering were $2,204,000. | |
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. See Note 17. | |
Warrant Transactions | |
The Company issued 6,128 Series G Preferred Stock warrants in connection with a loan and security agreement. Additionally, the Company issued one Series G Preferred Stock warrant for every two shares of Series G Preferred Stock purchased in 2009 and 2010. The warrants were initially recorded at their fair value calculated using the Black-Scholes model, with the following weighted average assumptions: exercise price of $9.79, share price of $9.79, expected term of three years, risk-free rate of 1.52% and volatility of 85.46%. The warrants are classified as liabilities because they are exercisable for Preferred Stock, and the value of the warrants is adjusted to current fair value at each reporting period end. For the years ended December 31, 2014, 2013 and 2012, the Company recorded $20,000, $42,000 and $367,000, 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 4,597 Common Stock warrants (after giving effect to the one-for-1.333 reverse stock split). | |
StockBased_Compensation
Stock-Based Compensation | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Stock-Based Compensation | |||||||||||||||||
Stock-Based Compensation | |||||||||||||||||
10. Stock-Based Compensation | |||||||||||||||||
In January 2008, the board of directors approved the 2007 Equity Compensation Plan (the "2007 Plan"), which amended, restated and renamed the Company's 1999 Stock Based Compensation Plan (the "1999 Plan"), which provided for the granting of incentive and nonqualified stock options and restricted stock to its employees, directors and consultants at the discretion of the board of directors. | |||||||||||||||||
Further, in July 2013, the Company's board of directors and stockholders approved, effective immediately prior to the listing of the Common Stock on the NASDAQ Global Select Market, the 2013 Equity Compensation Plan (the "2013 Plan"), which amended, restated and renamed the 2007 Plan . Under the 2013 Plan, the Company may grant incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock, restricted stock units, deferred share awards, performance awards and other equity-based awards to employees, directors and consultants. The Company initially reserved 6,107,831 shares of Common Stock for issuance, subject to adjustment as set forth in the 2013 Plan. At December 31, 2014, there were 1,012,310 shares available for future issuance. | |||||||||||||||||
Stock-based compensation expense includes stock options granted to employees and non-employees and has been reported in the Company's statements of operations and comprehensive loss in either research and development expenses or general and administrative expenses depending on the function performed by the optionee. No net tax benefits related to the stock-based compensation costs have been recognized since the Company's inception. The Company recognized stock-based compensation expense as follows for the years ended December 31, 2014, 2013 and 2012: | |||||||||||||||||
Year ended December 31, | |||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||
General and administrative | $ | 2,082,000 | $ | 4,845,000 | $ | 7,199,000 | |||||||||||
Research and development | $ | 2,986,000 | $ | 3,170,000 | $ | 6,645,000 | |||||||||||
| | | | | | | | | | | |||||||
$ | 5,068,000 | $ | 8,015,000 | $ | 13,844,000 | ||||||||||||
| | | | | | | | | | | |||||||
| | | | | | | | | | | |||||||
A summary of stock option activity for the year ended December 31, 2014 is as follows: | |||||||||||||||||
Options Outstanding | |||||||||||||||||
Shares | Number of | Weighted- | Weighted | Aggregate | |||||||||||||
Available | Shares | Average | Average | Intrinsic | |||||||||||||
for Grant | Exercise | Remaining | Value | ||||||||||||||
Price | Contractual | ||||||||||||||||
Term (in years) | |||||||||||||||||
Balance, December 31, 2013 | 676,236 | 4,344,365 | $ | 11.05 | 7.91 | ||||||||||||
Authorized | 858,699 | — | |||||||||||||||
Granted | (1,015,300 | ) | 1,015,300 | 4.51 | |||||||||||||
Exercised | — | (235,691 | ) | 4.07 | |||||||||||||
Forfeitures | 492,675 | (492,675 | ) | 10.4 | |||||||||||||
| | | | | | | | | | | | | | | | | |
Balance, December 31, 2014 | 1,012,310 | 4,631,299 | $ | 10.04 | 7.89 | $ | 42,923 | ||||||||||
| | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | |
Vested or expected to vest at December 31, 2014 | 4,548,832 | $ | 10.04 | 7.89 | $ | 42,923 | |||||||||||
| | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | |
Exercisable at December 31, 2014 | 2,639,334 | $ | 10.44 | 6.94 | $ | 42,923 | |||||||||||
| | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | |
The intrinsic value of options exercised during the years ended December 31, 2014, 2013, and 2012 was $1,842,000, $1,076,000, and $4,510,000, respectively. The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the quoted price of the Company's common stock for those awards that have an exercise price currently below the closing price. | |||||||||||||||||
Information with respect to stock options outstanding and exercisable at December 31, 2014 is as follows: | |||||||||||||||||
Exercise Price | Shares | Exercisable | |||||||||||||||
$1.33 - $5.58 | 928,933 | 115,381 | |||||||||||||||
$5.76 - $6.00 | 577,891 | 577,891 | |||||||||||||||
$6.13 - $7.53 | 626,066 | 517,255 | |||||||||||||||
$13.28 - $13.48 | 1,673,334 | 807,473 | |||||||||||||||
$14.68 - $15.12 | 759,888 | 580,172 | |||||||||||||||
$21.79 - $28.81 | 65,187 | 41,162 | |||||||||||||||
| | | | | | | | ||||||||||
4,631,299 | 2,639,334 | ||||||||||||||||
| | | | | | | | ||||||||||
| | | | | | | | ||||||||||
Options granted after April 23, 2013 | |||||||||||||||||
The Company accounts for all stock-based payments made after April 23, 2013 to employees and directors using an option pricing model for estimating fair value. Accordingly, stock-based compensation expense is measured based on the estimated fair value of the awards on the date of grant, net of forfeitures. Compensation expense is recognized for the portion that is ultimately expected to vest over the period during which the recipient renders the required services to the Company using the straight-line single option method. In accordance with authoritative guidance, the fair value of non-employee stock based awards is re-measured as the awards vest, and the resulting increase in fair value, if any, is recognized as expense in the period the related services are rendered. | |||||||||||||||||
The Company uses the Black-Scholes option-pricing model to estimate the fair value of stock options at the grant date. The Black-Scholes model requires the Company to make certain estimates and assumptions, including estimating the fair value of the Company's common stock, assumptions related to the expected price volatility of the Company's stock, the period during which the options will be outstanding, the rate of return on risk-free investments and the expected dividend yield for the Company's stock. | |||||||||||||||||
As of December 31, 2014, there was $10,450,000 of unrecognized compensation expense related to the unvested stock options issued from April 24, 2013 through December 31, 2014, which is expected to be recognized over a weighted-average period of approximately 3.31 years. | |||||||||||||||||
The weighted-average assumptions underlying the Black-Scholes calculation of grant date fair value include the following: | |||||||||||||||||
Year Ended | Period from | ||||||||||||||||
December 31, 2014 | April 24, 2013 to | ||||||||||||||||
December 31, 2013 | |||||||||||||||||
Risk-free interest rate | 1.84% | 1.73% | |||||||||||||||
Expected volatility | 78.60% | 77.00% | |||||||||||||||
Expected term | 6.15 years | 5.87 years | |||||||||||||||
Expected dividend yield | 0% | 0% | |||||||||||||||
Weighted-average grant date fair value | $3.10 | $9.72 | |||||||||||||||
The weighted-average valuation assumptions were determined as follows: | |||||||||||||||||
• | Risk-free interest rate: The Company based the risk-free interest rate on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected option term. | ||||||||||||||||
• | Expected term of options: Due to its lack of sufficient historical data, the Company estimates the expected life of its employee stock options using the "simplified" method, as prescribed in Staff Accounting Bulletin (SAB) No. 107, whereby the expected life equals the arithmetic average of the vesting term and the original contractual term of the option. | ||||||||||||||||
• | Expected stock price volatility: Due to the Company's limited operating history 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. | ||||||||||||||||
• | Expected annual dividend yield: The Company has never paid, and does not expect to pay dividends in the foreseeable future. Accordingly, the Company assumed an expected dividend yield of 0.0%. | ||||||||||||||||
• | Estimated forfeiture rate: The Company's estimated annual forfeiture rate on stock option grants was 4.14% in 2014 and 1.69% in 2013, based on the historical forfeiture experience. | ||||||||||||||||
Options granted through April 23, 2013 | |||||||||||||||||
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 December 31, 2014, there was $729,000 of unrecognized compensation expense related to these unvested awards, which is expected to be recognized over a weighted-average period of approximately 1.78 years. | |||||||||||||||||
Employee_Benefit_Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2014 | |
Employee Benefit Plan | |
Employee Benefit Plan | |
11. Employee Benefit Plan | |
In October 2007, the Company established a 401(k) Retirement Savings Plan. Employees are eligible to participate in the plan as soon as they join the Company if they are at least 21 years of age and work a minimum of 1,000 hours per year. The Company matches $0.60 for every dollar of the first 6% of payroll that employees invest, up to the legal limit. Employer contributions vest over four years at the rate of 25% per year. For the years ended December 31, 2014, 2013 and 2012, the Company contributed $276,000, $289,000 and $159,000, respectively. | |
Commitments_and_Contingencies
Commitments and Contingencies | 12 Months Ended | ||||
Dec. 31, 2014 | |||||
Commitments and Contingencies | |||||
Commitments and Contingencies | |||||
12. Commitments and Contingencies | |||||
Operating leases | |||||
In January 2007, the Company entered into a lease for 8,100 square feet of office and lab space in Newtown, Pennsylvania, and in October 2009, the Company and the landlord amended the lease to add three additional one-year options to extend the lease term. In November 2013 the Company renewed the lease for the period April 1, 2014 to March 31, 2015, for rent of $11,000 per month. In December 2014 the Company renewed the lease for the period April 1, 2015 to March 31, 2016, for rent of $11,500 per month. In September 2012, the Company sub-leased an additional 1,356 square feet of office space. The lease has been renewed through August 31, 2015 for rent of $1,600 per month. | |||||
The Company rents 4,807 square feet of office space in Pennington, New Jersey under two leases for $8,100 per month. Both leases are cancellable with three months' written notice and have been cancelled effective May 2015. The lease required the Company to provide the landlord a $125,000 letter of credit, the collateral for which is recorded as restricted cash on the consolidated balance sheets. The letter of credit expired in March 2015 and the restriction on cash was discontinued. | |||||
The Company rents office space in Munich, Germany under one year leases that run from January 1 to December 31. For the period January 1, 2014 to December 31, 2014 the rent was €4,300 per month. For the period January 1, 2015 to December 31, 2015 the rent is €4,500 per month. | |||||
Future minimum lease payments under these non-cancellable leases having terms in excess of one year as of December 31, 2014 are as follows: | |||||
December 31, | |||||
2014 | |||||
2015 | $ | 136,000 | |||
2016 | 35,000 | ||||
| | | | | |
Total minimum lease payments | $ | 171,000 | |||
| | | | | |
| | | | | |
Rent expense was $389,000, $309,000 and $233,000 for the years ended December 31, 2014, 2013 and 2012, respectively. | |||||
Employment agreements | |||||
The Company has entered into employment agreements with certain of its executives. The agreements provide for, among other things, salary, bonus and severance payments. | |||||
Research_Agreements
Research Agreements | 12 Months Ended |
Dec. 31, 2014 | |
Research Agreements | |
Research Agreements | |
13. 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 December 31, 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, 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 December 31, 2014 and 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 December 31, 2014 and 2013. | |
License_and_Collaboration_Agre
License and Collaboration Agreements | 12 Months Ended |
Dec. 31, 2014 | |
License and Collaboration Agreements | |
License and Collaboration Agreements | |
14. 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 2.3 months was not sufficient to establish the required level of statistical significance and, therefore did not achieve the primary endpoint of the trial. 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 fifty percent of the costs of the next phase 3 trial of rigosertib IV in higher-risk MDS, up to $15.0 million. If the Company chooses to do so then the approval milestone for higher-risk MDS will be reduced by $15.0 million. | |
On January 27, 2015, Onconova was notified that Baxter has elected not to pursue additional clinical trials, or the submission of a drug approval application, for rigosertib oral in lower-risk MDS patients. Onconova would have received a milestone payment under its agreement with Baxter if the parties had mutually agreed to progress the development of oral rigosertib in lower-risk MDS patients. The decision by Baxter does not alter the collaboration agreement between the parties. Onconova has the right to continue the development of oral rigosertib in this indication on its own, and Baxter has the right to commercialize oral rigosertib for lower-risk MDS in its territory, subject to its ongoing compliance with the agreement, including payment of applicable milestones. | |
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 development and license agreement contemplates that the Company and Baxter may 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. | |
The Company is eligible to receive pre-commercial milestone payments if specified development and regulatory milestones are achieved. The potential pre-commercial development milestone payments to the Company include $25,000,000 for each drug approval application filed for indications specified in the agreement, and up to $100,000,000 for marketing approval for each of the specified MDS indications. | |
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 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 $333,000, $4,176,000 and $3,100,000, for the years ended December 31, 2014, 2013 and 2012, 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 Series J 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 of $455,000, $455,000 and $455,000, for the years ended December 31, 2014, 2013 and 2012, respectively. In addition, the Company recognized revenues related to the supply agreement with Symbio in the amounts of $11,000, $122,000 and $48,000 for the years ended December 31, 2014, 2013 and 2012, respectively. | |
Preclinical_Collaboration
Preclinical Collaboration | 12 Months Ended |
Dec. 31, 2014 | |
Preclinical Collaboration | |
Preclinical Collaboration | |
15. Preclinical Collaboration | |
In December 2012, the Company agreed to form GBO, an entity owned by 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. During November 2014, GVK BIO made an additional capital contribution of $500,000 which increased its interest in GBO to 17.5%. 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. In addition, upon the occurrence of certain events, namely termination of our participation in the programs either with or without a change in control, GVK BIO will be entitled to purchase or obtain our interest in GBO. GVK BIO will have operational control of GBO and the Company will have strategic and scientific control. | |
RelatedParty_Transactions
Related-Party Transactions | 12 Months Ended |
Dec. 31, 2014 | |
Related-Party Transactions | |
Related-Party Transactions | |
16. 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 years ended December 31, 2014, 2013 and 2012 were $1,215,000, $1,235,000 and $1,230,000, respectively. At December 31, 2014 and 2013, the Company had no outstanding amounts payable to Mount Sinai. | |
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 years ended December 31, 2014, 2013 and 2012 were $0, $107,000 and $157,000, respectively. At December 31, 2014 and 2013, the Company had no outstanding amounts payable to this supplier. | |
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 years ended December 31, 2014, 2013 and 2012 were $446,000, $1,354,000 and $316,000, respectively. At December 31, 2014 and 2013, the Company owed this supplier $8,000 and $157,000, 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 its 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 years ended December 31, 2014, 2013 and 2012 were $194,000, $182,000 and $165,000, respectively. At December 31, 2014 and December 31, 2013, the Company had no outstanding amounts payable under this agreement. | |
Initial_Public_Offering
Initial Public Offering | 12 Months Ended |
Dec. 31, 2014 | |
Initial Public Offering | |
Initial Public Offering | |
17. Initial Public Offering | |
On July 24, 2013, the Company's Registration Statement on Form S-1 was declared effective by the SEC, and on July 25, 2013, the Company's Common Stock began trading on the NASDAQ Global Select 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 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 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. | |
Securities_Registration_and_Sa
Securities Registration and Sales Agreement | 12 Months Ended |
Dec. 31, 2014 | |
Securities registration and sales agreement | |
Securities Registration and Sales Agreement | |
18. Securities Registration and Sales Agreement | |
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 Select 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 (Form S-3 No. 333-199219), relating to the shares, which was filed with the SEC became effective on November 20, 2014. As of December 31, 2014, no shares had been sold under this agreement. 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. | |
Subsequent_Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2014 | |
Subsequent Events | |
Subsequent Events | |
19. Subsequent Event | |
During February 2015, the Company reduced its workforce by approximately 35% and terminated the lease for one of its two U.S. office facilities. The Company expects the costs of these actions to be approximately $1 million, comprised primarily of severance and continuation of benefits coverage for the terminated employees, which extend into the third quarter of 2015. | |
Quarterly_Data
Quarterly Data | 12 Months Ended | |||||||||||||
Dec. 31, 2014 | ||||||||||||||
Quarterly Data (unaudited) | ||||||||||||||
Quarterly Data (unaudited)` | ||||||||||||||
20. Quarterly Data (unaudited) | ||||||||||||||
2014 | ||||||||||||||
First | Second | Third | Fourth | |||||||||||
Quarter | Quarter | Quarter | Quarter | |||||||||||
Revenue | $ | 447,000 | $ | 125,000 | $ | 114,000 | $ | 114,000 | ||||||
Operating expenses: | ||||||||||||||
General and administrative | 4,932,000 | 3,985,000 | 3,116,000 | 3,086,000 | ||||||||||
Research and development | 14,248,000 | 12,904,000 | 11,886,000 | 10,387,000 | ||||||||||
| | | | | | | | | | | | | | |
Total operating expenses | 19,180,000 | 16,889,000 | 15,002,000 | 13,473,000 | ||||||||||
| | | | | | | | | | | | | | |
Loss from operations | (18,733,000 | ) | (16,764,000 | ) | (14,888,000 | ) | (13,359,000 | ) | ||||||
Change in fair value of warrant liability | 16,000 | 3,000 | 1,000 | |||||||||||
— | ||||||||||||||
Other income, net | 1,000 | (19,000 | ) | (20,000 | ) | (14,000 | ) | |||||||
| | | | | | | | | | | | | | |
Net loss before income taxes | (18,716,000 | ) | (16,780,000 | ) | (14,907,000 | ) | (13,373,000 | ) | ||||||
Income taxes | — | — | — | 19,000 | ||||||||||
| | | | | | | | | | | | | | |
Net loss | (18,716,000 | ) | (16,780,000 | ) | (14,907,000 | ) | (13,392,000 | ) | ||||||
Net loss attributable to non-controlling interest | 37,000 | 27,000 | 29,000 | 20,000 | ||||||||||
| | | | | | | | | | | | | | |
Net loss applicable to common stockholders | $ | (18,679,000 | ) | $ | (16,753,000 | ) | $ | (14,878,000 | ) | $ | (13,372,000 | ) | ||
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
Net loss per share of common stock, basic and diluted* | $ | (0.87 | ) | $ | (0.77 | ) | $ | (0.69 | ) | $ | (0.62 | ) | ||
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
Basic and diluted weighted average shares outstanding | 21,568,302 | 21,658,625 | 21,691,017 | 21,694,403 | ||||||||||
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
2013 | ||||||||||||||
First | Second | Third | Fourth | |||||||||||
Quarter | Quarter | Quarter | Quarter | |||||||||||
Revenue | $ | 1,116,000 | $ | 591,000 | $ | 1,116,000 | $ | 1,930,000 | ||||||
Operating expenses: | ||||||||||||||
General and administrative | 3,346,000 | 3,117,000 | 5,927,000 | 4,403,000 | ||||||||||
Research and development | 12,756,000 | 10,047,000 | 15,293,000 | 12,086,000 | ||||||||||
| | | | | | | | | | | | | | |
Total operating expenses | 16,102,000 | 13,164,000 | 21,220,000 | 16,489,000 | ||||||||||
| | | | | | | | | | | | | | |
Loss from operations | (14,986,000 | ) | (12,573,000 | ) | (20,104,000 | ) | (14,559,000 | ) | ||||||
Change in fair value of warrant liability | 14,000 | (2,000 | (31,000 | 61,000 | ||||||||||
) | ) | |||||||||||||
Interest expense | — | (2,000 | ) | (1,000 | ) | (1,000 | ) | |||||||
Other income, net | 127,000 | 15,000 | 47,000 | (126,000 | ) | |||||||||
| | | | | | | | | | | | | | |
Net loss before income taxes | (14,845,000 | ) | (12,562,000 | ) | (20,089,000 | ) | (14,625,000 | ) | ||||||
Income taxes | — | — | 432,000 | 3,000 | ||||||||||
| | | | | | | | | | | | | | |
Net loss | (14,845,000 | ) | (12,562,000 | ) | (20,521,000 | ) | (14,628,000 | ) | ||||||
Net loss attributable to non-controlling interest | — | — | — | 13,000 | ||||||||||
| | | | | | | | | | | | | | |
Net loss attributable to Onconova Therapeutics, Inc | (14,845,000 | ) | (12,562,000 | ) | (20,521,000 | ) | (14,615,000 | ) | ||||||
Accretion of redeemable convertible preferred stock | (1,019,000 | ) | (1,032,000 | ) | (269,000 | ) | — | |||||||
| | | | | | | | | | | | | | |
Net loss applicable to common stockholders | $ | (15,864,000 | ) | $ | (13,594,000 | ) | $ | (20,790,000 | ) | $ | (14,615,000 | ) | ||
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
Net loss per share of common stock, basic and diluted* | $ | (6.08 | ) | $ | (5.21 | ) | $ | (1.34 | ) | $ | (0.68 | ) | ||
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
Basic and diluted weighted average shares outstanding | 2,607,406 | 2,609,495 | 15,480,416 | 21,419,208 | ||||||||||
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
* | Earnings Per Share (EPS) in each quarter is computed using the weighted-average number of shares outstanding during that quarter while EPS for the full year is computed using the weighted-average number of shares outstanding during the year. Thus, the sum of the four quarters' EPS does not equal the full-year EPS. | |||||||||||||
Summary_of_Significant_Account1
Summary of Significant Accounting Policies (Policies) | 12 Months Ended | ||
Dec. 31, 2014 | |||
Summary of Significant Accounting Policies | |||
Basis of Presentation | |||
Basis of Presentation | |||
The consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States ("GAAP"). 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. | |||
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. | |||
Use of Estimates | |||
Use of Estimates | |||
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses, other comprehensive income and related disclosures. On an ongoing basis, management evaluates its estimates, including estimates related to clinical trial accruals, warrant liability, and allocation of consideration to multiple element collaborative arrangements. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. | |||
Prior to completion of its IPO on July 30, 2013, the Company utilized estimates and assumptions in determining the fair value of its Common Stock. The Company granted stock options at exercise prices not less than the fair value of its Common Stock as determined by the board of directors, with input from management. Management used the assistance of a third-party valuation firm in estimating the fair value of the Common Stock. The board of directors determined the estimated fair value of the Common Stock based on a number of objective and subjective factors, including external market conditions affecting the biotechnology industry sector and the historic prices at which the Company sold shares of Preferred Stock. | |||
Concentrations of Credit Risk and Off-Balance Sheet Risk | |||
Concentrations of Credit Risk and Off-Balance Sheet Risk | |||
Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash, cash equivalents, restricted cash and marketable securities. The Company maintains a portion of its cash and cash equivalent balances in the form of money market accounts with financial institutions that management believes are creditworthy. Marketable securities are invested in U.S. Treasury obligations. The Company has no financial instruments with off-balance sheet risk of loss. | |||
Cash and Cash Equivalents | |||
Cash and Cash Equivalents | |||
The Company considers all highly liquid investments with original or remaining maturity from the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents include bank demand deposits, marketable securities with maturities of three months or less at purchase, and money market funds that invest primarily in certificates of deposit, commercial paper and U.S. government and U.S. government agency obligations. Cash equivalents are reported at fair value. | |||
Marketable Securities | |||
Marketable Securities | |||
Marketable securities with original maturities longer than three months but which mature in less than one year from the balance sheet date are classified as current assets. Marketable securities that mature more than one year from the balance sheet date are classified as noncurrent assets. Marketable securities that the Company has the intent and ability to hold to maturity are classified as investments held-to-maturity and are reported at amortized cost. The difference between the acquisition cost and face values of held-to-maturity investments is amortized over the remaining term of the investments and added to or subtracted from the acquisition cost and interest income. As of December 31, 2014 and 2013, all of the Company's investments were classified as held-to-maturity. | |||
Fair Value of Financial Instruments | |||
Fair Value of Financial Instruments | |||
The carrying amounts reported in the accompanying consolidated financial statements for cash and cash equivalents, marketable securities, accounts payable and accrued liabilities approximate their respective fair values because of the short-term nature of these accounts. The fair value of the warrant liability is discussed in Note 4, "Fair Value Measurements." | |||
Property and Equipment | |||
Property and Equipment | |||
Property and equipment are stated at cost, less accumulated depreciation. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets. Leasehold improvements are amortized over the useful life of the asset or the lease term, whichever is shorter. Maintenance and repairs are expensed as incurred. The following estimated useful lives were used to depreciate the Company's assets: | |||
Estimated Useful Life | |||
Lab equipment | 5 - 6 years | ||
Software | 3 years | ||
Computer and office equipment | 5 - 6 years | ||
Leasehold improvements | Shorter of the lease term or estimated useful life | ||
Upon retirement or sale, the cost of the disposed asset and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is recognized. | |||
The Company reviews long-lived assets for impairment when events or changes in circumstances indicate that the carrying value of the assets may not be recoverable. Recoverability is measured by comparison of the assets' book value to future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the book value of the assets exceeds their fair value, which is measured based on the projected discounted future net cash flows generated from the assets. No impairment losses have been recorded through December 31, 2014. | |||
Restricted Cash | |||
Restricted Cash | |||
Under one of the Company's office leases, the Company is required to provide the landlord a $125,000 letter of credit, which is secured by cash collateral recorded as restricted cash on the consolidated balance sheets as of December 31, 2014 and 2013. The letter of credit expired in March 2015 and the restriction on cash was discontinued. | |||
Foreign Currency Translation | |||
Foreign Currency Translation | |||
The reporting currency of the Company and its U.S. subsidiaries 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. | |||
Revenue Recognition | |||
Revenue Recognition | |||
The Company's revenue is generated primarily through collaborative research and license agreements. The terms of these agreements contain multiple deliverables which may include (i) licenses, (ii) research and development activities, (iii) participation in joint steering committees and (iv) product supply. The terms of these agreements may include nonrefundable upfront license fees, payments for research and development activities, payments based upon the achievement of certain milestones, royalty payments based on product sales derived from the collaboration, and payments for supplying product. In all instances, revenue is recognized only when the price is fixed or determinable, persuasive evidence of an arrangement exists, delivery has occurred or the services have been rendered, collectability of the resulting receivable is reasonably assured, and the Company has fulfilled its performance obligations under the contract. | |||
For arrangements with multiple elements, the Company recognizes revenue in accordance with the Financial Accounting Standards Board ("FASB") Accounting Standards Update ("ASU") No. 2009-13, Multiple-Deliverable Revenue Arrangements ("ASU 2009-13"), which provides guidance for separating and allocating consideration in a multiple element arrangement. The selling prices of deliverables under an arrangement may be derived using third-party evidence ("TPE"), or a best estimate of selling price ("BESP"), if vendor-specific objective evidence of selling price ("VSOE") is not available. The objective of BESP is to determine the price at which the Company would transact a sale if the element within the license agreement was sold on a standalone basis. Establishing BESP involves management's judgment and considers multiple factors, including market conditions and company-specific factors, including those factors contemplated in negotiating the agreements, as well as internally developed models that include assumptions related to market opportunity, discounted cash flows, estimated development costs, probability of success and the time needed to commercialize a product candidate pursuant to the license. In validating the BESP, management considers whether changes in key assumptions used to determine the BESP will have a significant effect on the allocation of the arrangement consideration between the multiple deliverables. The Company may use third-party valuation specialists to assist it in determining BESP. Deliverables under the arrangement are separate units of accounting if (i) the delivered item has value to the customer on a standalone basis and (ii) if the arrangement includes a general right of return relative to the delivered item, delivery or performance of the undelivered item is considered probable and substantially within the Company's control. The arrangement consideration that is fixed or determinable at the inception of the arrangement is allocated to the separate units of accounting based on their relative selling prices. The appropriate revenue recognition model is applied to each element and revenue is accordingly recognized as each element is delivered. Management exercises significant judgment in determining whether a deliverable is a separate unit of accounting. | |||
In determining the separate units of accounting, the Company evaluates whether the license has standalone value to the collaborator based on consideration of the relevant facts and circumstances for each arrangement. Factors considered in this determination include the research and development capabilities of the collaborator and the availability of relevant research expertise in the marketplace. In addition, the Company considers whether or not (i) the collaborator could use the license for its intended purpose without the receipt of the remaining deliverables, (ii) the value of the license was dependent on the undelivered items and (iii) the collaborator or other vendors could provide the undelivered items. | |||
Under a collaborative research and license agreement, a steering committee is typically responsible for overseeing the general working relationships, determining the protocols to be followed in the research and development performed and evaluating the results from the continued development of the product. The Company evaluates whether its participation in joint steering committees is a substantive obligation or whether the services are considered inconsequential or perfunctory. The factors the Company considers in determining if its participation in a joint steering committee is a substantive obligation include: (i) which party negotiated or requested the steering committee, (ii) how frequently the steering committee meets, (iii) whether or not there are any penalties or other recourse if the Company does not attend the steering committee meetings, (iv) which party has decision making authority on the steering committee and (v) whether or not the collaborator has the requisite experience and expertise associated with the research and development of the licensed intellectual property. | |||
Whenever the Company determines that an element is delivered over a period of time, revenue is recognized using either a proportional performance model, if a pattern of performance can be determined or a straight-line model over the period of performance, which is typically the research and development term. Progress achieved under the Company's various clinical research organization contracts are typically used as the measure of performance when applying the proportional performance method. At the end of each reporting period, the Company reassesses its cumulative measure of performance and makes appropriate adjustments, if necessary. The Company recognizes revenue using the proportional performance model whenever the Company is able to make reasonably reliable estimates of the level of effort required to complete its performance obligations under an arrangement. Revenue recognized under the proportional performance model at each reporting period is determined by multiplying the total expected payments under the contract (excluding royalties and payments contingent upon achievement of milestones) by the ratio of the level of effort incurred to date to the estimated total level of effort required to complete the performance obligations under the arrangement. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the proportional performance model as of each reporting period. Alternatively, if the Company is not able to make reasonably reliable estimates of the level of effort required to complete its performance obligations under an arrangement, then revenue under the arrangement is recognized on a straight-line basis over the period expected to be required to complete the Company's performance obligations. | |||
Incentive milestone payments may be triggered either by the results of the Company's research efforts or by events external to it, such as regulatory approval to market a product or attaining agreed-upon sales levels. Consideration that is contingent upon achievement of a milestone is recognized in its entirety as revenue in the period in which the milestone is achieved, but only if the consideration earned from the achievement of a milestone meets all the criteria for the milestone to be considered substantive at the inception of the arrangement. For a milestone to be considered substantive, the consideration earned by achieving the milestone must (i) be commensurate with either the Company's performance to achieve the milestone or the enhancement of the value of the item delivered as a result of a specific outcome resulting from the Company's performance to achieve the milestone, (ii) relate solely to past performance and (iii) be reasonable relative to all deliverables and payment terms in the collaboration agreement. | |||
For events for which the occurrences are contingent solely upon the passage of time or are the result of performance by a third party, the contingent payments will be recognized as revenue when payments are earned, the amounts are fixed and determinable and collectability is reasonably assured. | |||
Royalties are recorded as earned in accordance with the contract terms when third party sales can be reliably measured and collectability is reasonably assured. | |||
The Company recognized revenue of $334,000, $4,176,000 and $45,490,000 during the years ended December 31, 2014, 2013 and 2012, respectively, as a result of its license and collaboration agreement with Baxter. The Company recognized revenue of $466,000, $577,000 and $503,000 during the years ended December 31, 2014, 2013 and 2012, respectively, as a result of its license and collaboration agreement with SymBio. The remaining revenue recognized during the year ended December 31, 2012 of $197,000 pertained to research and development services provided by the Company under certain research grants. The Baxter and SymBio agreements are the only agreements that are being accounted for under ASU 2009-13. See Note 14, "License and Collaboration Agreements," for a further discussion of the agreements with Baxter and SymBio. | |||
Research and Development Expenses | |||
Research and Development Expenses | |||
Research and development costs are charged to expense as incurred. These costs include, but are not limited to, license fees related to the acquisition of in-licensed products; employee-related expenses, including salaries, benefits and travel; expenses incurred under agreements with contract research organizations and investigative sites that conduct clinical trials and preclinical studies; the cost of acquiring, developing and manufacturing clinical trial materials; facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and other supplies; and costs associated with preclinical activities and regulatory operations. | |||
Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided to the Company by its vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as prepaid or accrued research and development expense, as the case may be. | |||
Comprehensive Loss | |||
Comprehensive Loss | |||
Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. | |||
Income Taxes | |||
Income Taxes | |||
The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. The deferred tax asset primarily includes net operating loss and tax credit carry forwards, accrued expenses not currently deductible and the cumulative temporary differences related to certain research and patent costs, which have been charged to expense in the accompanying statements of operations but have been recorded as assets for income tax purposes. The portion of any deferred tax asset for which it is more likely than not that a tax benefit will not be realized must then be offset by recording a valuation allowance. A full valuation allowance has been established against all of the deferred tax assets (see Note 7, "Income Taxes"), as it is more likely than not that these assets will not be realized given the Company's history of operating losses. The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not to be sustained upon examination based on the technical merits of the position. The amount for which an exposure exists is measured as the largest amount of benefit determined on a cumulative probability basis that the Company believes is more likely than not to be realized upon ultimate settlement of the position. | |||
Preferred Stock | |||
Preferred Stock | |||
The Company accounted for the redemption premium and issuance costs on its Preferred Stock using the effective interest method, accreting such amounts to its Preferred Stock from the date of issuance to the earliest date of redemption. 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. See Note 9. | |||
Stock Warrants | |||
Stock Warrants | |||
Freestanding warrants that are related to the purchase of Stock are classified as liabilities and recorded at fair value. The warrants are subject to re-measurement at each balance sheet date and any change in fair value is recognized as a component of change in fair value of warrant liability in the consolidated statements of operations. See Note 9. The warrants are classified as Level 3 liabilities (see Note 4 for a discussion of the fair value hierarchy). | |||
Stock-Based Compensation Expense | |||
Stock-Based Compensation Expense | |||
The Company applies the provisions of FASB Accounting Standards Codification ("ASC") Topic 718, Compensation—Stock Compensation ("ASC 718"), which requires the measurement and recognition of compensation expense for all stock-based awards made to employees and non-employees, including employee stock options. | |||
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"), 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") (See Note 11). Because the Company had established a pattern of providing cash settlement alternatives for option holders, the Company accounted for its stock-based compensation awards as liability awards. The Company measured liability awards based on the award's intrinsic value on the grant date and then re-measured them at each reporting date until the date of settlement. Compensation expense was recognized on a straight-line basis over the requisite service period for each separately vesting portion of the award. Compensation expense for each period until settlement was based on the change in intrinsic value (or a portion of the change in intrinsic value, depending on the percentage of the requisite service that has been rendered at the reporting date). Changes in the intrinsic value of a liability that occur after the end of the requisite service period were considered compensation expense in the period in which the changes occur. On April 23, 2013, the Company distributed a notification letter to all equity award holders under 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. The remaining expense for these options is being recognized on a straight-line basis over the remaining requisite service period. | |||
Share-based payment transactions with employees, including grants of employee stock options, are recognized as compensation expense over the requisite service period based on their estimated fair values. ASC 718 also requires significant judgment and the use of estimates, particularly surrounding Black-Scholes assumptions such as stock price volatility over the option term and expected option lives, as well as expected option forfeiture rates, to estimate the grant date fair value of equity-based compensation and requires the recognition of the fair value of stock compensation in the statement of operations. | |||
Clinical Trial Expense Accruals | |||
Clinical Trial Expense Accruals | |||
As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company's objective is to reflect the appropriate trial expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. The Company determines accrual estimates through financial models taking into account discussion with applicable personnel and outside service providers as to the progress or state of consummation of trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company's clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period. For the years ended December 31, 2014, 2013 and 2012, there were no material adjustments to the Company's prior period estimates of accrued expenses for clinical trials. | |||
Collaboration Arrangements | |||
Collaboration Arrangements | |||
A collaboration arrangement is defined as a contractual arrangement that has or may have significant financial milestones associated with success-based development, which include certain arrangements the Company has entered into regarding the research and development, manufacture and/or commercialization of products and product candidates. These collaborations generally provide for non-refundable, upfront license fees, research and development and commercial performance milestone payments, cost sharing and royalty payments. The collaboration agreements with third-parties are performed on a "best efforts" basis with no guarantee of either technological or commercial success. The Company evaluates whether an arrangement is a collaboration arrangement at its inception based on the facts and circumstances specific to the arrangement. The Company reevaluates whether an arrangement qualifies or continues to qualify as a collaboration arrangement whenever there is a change in the anticipated or actual ultimate commercial success of the endeavor. See Note 14, "License and Collaboration Agreements," for a discussion of the Company's current collaborations with Baxter and SymBio. | |||
Basic and Diluted Net Loss Per Share of Common Stock | |||
Basic and Diluted Net Loss Per Share of Common Stock | |||
Basic net loss per share of common stock is computed by dividing net loss applicable to common stockholders by the weighted-average number of shares of Common Stock outstanding during the period, excluding the dilutive effects of Preferred Stock, warrants to purchase Preferred Stock and stock options. Diluted net loss per share of common stock is computed by dividing the net loss applicable to common stockholders by the sum of the weighted-average number of shares of Common Stock outstanding during the period plus the potential dilutive effects of Preferred Stock and warrants to purchase Preferred Stock, and stock options outstanding during the period calculated in accordance with the treasury stock method, but are excluded if their effect is anti-dilutive. Because the impact of these items is anti-dilutive during periods of net loss, there was no difference between basic and diluted net loss per share of Common Stock for the years ended December 31, 2014, 2013 and 2012. | |||
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 financial reporting process and its consolidated financial position, results of operations and related disclosures. | |||
Summary_of_Significant_Account2
Summary of Significant Accounting Policies (Tables) | 12 Months Ended | ||
Dec. 31, 2014 | |||
Summary of Significant Accounting Policies | |||
Schedule of estimated useful lives used to depreciate the Company's assets | |||
Estimated Useful Life | |||
Lab equipment | 5 - 6 years | ||
Software | 3 years | ||
Computer and office equipment | 5 - 6 years | ||
Leasehold improvements | Shorter of the lease term or estimated useful life | ||
Property_and_Equipment_Tables
Property and Equipment (Tables) | 12 Months Ended | |||||||
Dec. 31, 2014 | ||||||||
Property and Equipment | ||||||||
Schedule of property and equipment and related accumulated depreciation | ||||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Laboratory equipment | $ | 1,037,000 | $ | 866,000 | ||||
Software | 92,000 | 92,000 | ||||||
Computer and office equipment | 433,000 | 433,000 | ||||||
Leasehold improvements | 1,063,000 | 1,011,000 | ||||||
| | | | | | | | |
2,625,000 | 2,402,000 | |||||||
Less accumulated depreciation | (2,205,000 | ) | (1,776,000 | ) | ||||
| | | | | | | | |
$ | 420,000 | $ | 626,000 | |||||
| | | | | | | | |
| | | | | | | | |
Fair_Value_Measurements_Tables
Fair Value Measurements (Tables) | 12 Months Ended | |||||||||||||||||||||||||
Dec. 31, 2014 | ||||||||||||||||||||||||||
Fair Value Measurements | ||||||||||||||||||||||||||
Schedule of financial assets and liabilities measured at fair value on a recurring basis | ||||||||||||||||||||||||||
Fair Value Measurement as of | Fair Value Measurement as of | |||||||||||||||||||||||||
December 31, 2014 | 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, 2012 | $ | 62,000 | ||||||||||||||||||||||||
Change in fair value upon re-measurement | (42,000 | ) | ||||||||||||||||||||||||
| | | | | ||||||||||||||||||||||
Balance at December 31, 2013 | 20,000 | |||||||||||||||||||||||||
Change in fair value upon re-measurement | (20,000 | ) | ||||||||||||||||||||||||
| | | | | ||||||||||||||||||||||
Balance at December 31, 2014 | $ | — | ||||||||||||||||||||||||
| | | | | ||||||||||||||||||||||
| | | | | ||||||||||||||||||||||
Net_Loss_Per_Share_of_Common_S1
Net Loss Per Share of Common Stock (Tables) | 12 Months Ended | ||||||||||
Dec. 31, 2014 | |||||||||||
Net Loss Per Share of Common Stock | |||||||||||
Schedule of computation of basic and diluted earnings per share | |||||||||||
Year ended December 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
Basic and diluted net loss per share of common stock: | |||||||||||
Net loss attributable to Onconova Therapeutics, Inc | $ | (63,682,000 | ) | $ | (62,543,000 | ) | $ | (29,912,000 | ) | ||
Accretion to redemption value of preferred stock | — | (2,320,000 | ) | (3,953,000 | ) | ||||||
| | | | | | | | | | | |
Net loss applicable to common stockholders | $ | (63,682,000 | ) | $ | (64,863,000 | ) | $ | (33,865,000 | ) | ||
| | | | | | | | | | | |
| | | | | | | | | | | |
Weighted average shares of common stock outstanding | 21,653,536 | 10,594,227 | 2,206,888 | ||||||||
| | | | | | | | | | | |
| | | | | | | | | | | |
Net loss per share of common stock—basic and diluted | $ | (2.94 | ) | $ | (6.12 | ) | $ | (15.35 | ) | ||
| | | | | | | | | | | |
| | | | | | | | | | | |
Schedule of antidilutive securities which have been excluded from the computation of diluted weighted average shares outstanding | |||||||||||
December 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
Preferred Stock | — | — | 12,838,127 | ||||||||
Warrants | 4,597 | 4,597 | 4,597 | ||||||||
Stock options | 4,631,299 | 4,344,365 | 2,564,147 | ||||||||
| | | | | | | | | | | |
4,635,896 | 4,348,962 | 15,406,871 | |||||||||
| | | | | | | | | | | |
| | | | | | | | | | | |
Balance_Sheet_Detail_Tables
Balance Sheet Detail (Tables) | 12 Months Ended | |||||||
Dec. 31, 2014 | ||||||||
Balance Sheet Detail | ||||||||
Schedule of prepaid expenses and other current assets | ||||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Research and development | $ | 1,782,000 | $ | 2,242,000 | ||||
Manufacturing | 451,000 | 1,051,000 | ||||||
Insurance | 578,000 | 645,000 | ||||||
Other | 387,000 | 449,000 | ||||||
| | | | | | | | |
$ | 3,198,000 | $ | 4,387,000 | |||||
| | | | | | | | |
| | | | | | | | |
Schedule of accrued expenses and other current liabilities | ||||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Research and development | $ | 4,482,000 | $ | 4,625,000 | ||||
Employee compensation | 854,000 | 509,000 | ||||||
Professional fees | 418,000 | 310,000 | ||||||
Taxes | 18,000 | 302,000 | ||||||
Other | 5,000 | 74,000 | ||||||
| | | | | | | | |
$ | 5,777,000 | $ | 5,820,000 | |||||
| | | | | | | | |
| | | | | | | | |
Income_Taxes_Tables
Income Taxes (Tables) | 12 Months Ended | ||||||||||
Dec. 31, 2014 | |||||||||||
Income Taxes | |||||||||||
Schedule of income taxes based on income (loss) before income tax expense | |||||||||||
December 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
Domestic | (63,910,000 | ) | (62,154,000 | ) | $ | (29,912,000 | ) | ||||
Foreign | 134,000 | 33,000 | — | ||||||||
| | | | | | | | | | | |
$ | (63,776,000 | ) | $ | (62,121,000 | ) | $ | (29,912,000 | ) | |||
| | | | | | | | | | | |
| | | | | | | | | | | |
Schedule of provision for income taxes | |||||||||||
December 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
Current | |||||||||||
US Federal | $ | — | $ | 140,000 | $ | — | |||||
State and Local | — | 285,000 | — | ||||||||
Foreign | 19,000 | 10,000 | — | ||||||||
| | | | | | | | | | | |
Total Current | $ | 19,000 | $ | 435,000 | $ | — | |||||
| | | | | | | | | | | |
Deferred | |||||||||||
US Federal | $ | — | $ | — | $ | — | |||||
State and Local | — | — | — | ||||||||
Foreign | — | — | — | ||||||||
| | | | | | | | | | | |
Total Deferred | $ | — | $ | — | $ | — | |||||
| | | | | | | | | | | |
Total Expense (Benefit) | $ | 19,000 | $ | 435,000 | $ | — | |||||
| | | | | | | | | | | |
| | | | | | | | | | | |
Schedule of principal components of the Company's deferred tax assets | |||||||||||
December 31, | |||||||||||
2014 | 2013 | ||||||||||
Deferred tax assets: | |||||||||||
Net operating loss carryovers | $ | 63,776,000 | $ | 47,364,000 | |||||||
R&D tax credits | 56,750,000 | 35,223,000 | |||||||||
Non-qualified stock options | 4,916,000 | 3,988,000 | |||||||||
Deferred revenue | 5,648,000 | 5,938,000 | |||||||||
Charitable contributions | 6,000 | 6,000 | |||||||||
Accrued expenses | 691,000 | 586,000 | |||||||||
Fixed assets | 164,000 | 199,000 | |||||||||
| | | | | | | | ||||
Deferred tax assets | 131,951,000 | 93,304,000 | |||||||||
Less valuation allowance | (131,951,000 | ) | (93,304,000 | ) | |||||||
| | | | | | | | ||||
Net deferred tax assets | $ | — | $ | — | |||||||
| | | | | | | | ||||
| | | | | | | | ||||
Schedule of reconciliation of income tax (expense) benefit at the statutory federal income tax rate and income taxes as reflected in the financial statements | |||||||||||
December 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
Federal income tax expense at statutory rate | 34 | % | 34 | % | 34 | % | |||||
Permanent items | (8.9 | ) | (8.3 | ) | (25.1 | ) | |||||
State income tax, net of federal benefit | 4.2 | 4.5 | 1.8 | ||||||||
Tax credits | 33.8 | 34.4 | 18.5 | ||||||||
Provision to return | (2.4 | ) | (3.8 | ) | — | ||||||
Change in valuation allowance | (60.7 | ) | (61.2 | ) | (29.1 | ) | |||||
Other | — | (0.2 | ) | (0.1 | ) | ||||||
| | | | | | | | | | | |
Effective income tax rate | (0.0 | )% | (0.6 | )% | 0 | % | |||||
| | | | | | | | | | | |
| | | | | | | | | | | |
StockBased_Compensation_Tables
Stock-Based Compensation (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Stock-Based Compensation | |||||||||||||||||
Schedule of stock-based compensation expense | |||||||||||||||||
Year ended December 31, | |||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||
General and administrative | $ | 2,082,000 | $ | 4,845,000 | $ | 7,199,000 | |||||||||||
Research and development | $ | 2,986,000 | $ | 3,170,000 | $ | 6,645,000 | |||||||||||
| | | | | | | | | | | |||||||
$ | 5,068,000 | $ | 8,015,000 | $ | 13,844,000 | ||||||||||||
| | | | | | | | | | | |||||||
| | | | | | | | | | | |||||||
Schedule of stock option activity | |||||||||||||||||
Options Outstanding | |||||||||||||||||
Shares | Number of | Weighted- | Weighted | Aggregate | |||||||||||||
Available | Shares | Average | Average | Intrinsic | |||||||||||||
for Grant | Exercise | Remaining | Value | ||||||||||||||
Price | Contractual | ||||||||||||||||
Term (in years) | |||||||||||||||||
Balance, December 31, 2013 | 676,236 | 4,344,365 | $ | 11.05 | 7.91 | ||||||||||||
Authorized | 858,699 | — | |||||||||||||||
Granted | (1,015,300 | ) | 1,015,300 | 4.51 | |||||||||||||
Exercised | — | (235,691 | ) | 4.07 | |||||||||||||
Forfeitures | 492,675 | (492,675 | ) | 10.4 | |||||||||||||
| | | | | | | | | | | | | | | | | |
Balance, December 31, 2014 | 1,012,310 | 4,631,299 | $ | 10.04 | 7.89 | $ | 42,923 | ||||||||||
| | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | |
Vested or expected to vest at December 31, 2014 | 4,548,832 | $ | 10.04 | 7.89 | $ | 42,923 | |||||||||||
| | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | |
Exercisable at December 31, 2014 | 2,639,334 | $ | 10.44 | 6.94 | $ | 42,923 | |||||||||||
| | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | |
Schedule of information with respect to stock options outstanding and exercisable | |||||||||||||||||
Exercise Price | Shares | Exercisable | |||||||||||||||
$1.33 - $5.58 | 928,933 | 115,381 | |||||||||||||||
$5.76 - $6.00 | 577,891 | 577,891 | |||||||||||||||
$6.13 - $7.53 | 626,066 | 517,255 | |||||||||||||||
$13.28 - $13.48 | 1,673,334 | 807,473 | |||||||||||||||
$14.68 - $15.12 | 759,888 | 580,172 | |||||||||||||||
$21.79 - $28.81 | 65,187 | 41,162 | |||||||||||||||
| | | | | | | | ||||||||||
4,631,299 | 2,639,334 | ||||||||||||||||
| | | | | | | | ||||||||||
| | | | | | | | ||||||||||
Schedule of weighted-average assumptions used for estimating the fair value of the stock compensation granted | |||||||||||||||||
Year Ended | Period from | ||||||||||||||||
December 31, 2014 | April 24, 2013 to | ||||||||||||||||
December 31, 2013 | |||||||||||||||||
Risk-free interest rate | 1.84% | 1.73% | |||||||||||||||
Expected volatility | 78.60% | 77.00% | |||||||||||||||
Expected term | 6.15 years | 5.87 years | |||||||||||||||
Expected dividend yield | 0% | 0% | |||||||||||||||
Weighted-average grant date fair value | $3.10 | $9.72 | |||||||||||||||
Commitments_and_Contingencies_
Commitments and Contingencies (Tables) | 12 Months Ended | ||||
Dec. 31, 2014 | |||||
Commitments and Contingencies | |||||
Schedule of future minimum lease payments under non-cancellable leases | |||||
December 31, | |||||
2014 | |||||
2015 | $ | 136,000 | |||
2016 | 35,000 | ||||
| | | | | |
Total minimum lease payments | $ | 171,000 | |||
| | | | | |
| | | | | |
Quarterly_Data_Tables
Quarterly Data (Tables) | 12 Months Ended | |||||||||||||
Dec. 31, 2014 | ||||||||||||||
Quarterly Data (unaudited) | ||||||||||||||
Schedule of quarterly data | ||||||||||||||
2014 | ||||||||||||||
First | Second | Third | Fourth | |||||||||||
Quarter | Quarter | Quarter | Quarter | |||||||||||
Revenue | $ | 447,000 | $ | 125,000 | $ | 114,000 | $ | 114,000 | ||||||
Operating expenses: | ||||||||||||||
General and administrative | 4,932,000 | 3,985,000 | 3,116,000 | 3,086,000 | ||||||||||
Research and development | 14,248,000 | 12,904,000 | 11,886,000 | 10,387,000 | ||||||||||
| | | | | | | | | | | | | | |
Total operating expenses | 19,180,000 | 16,889,000 | 15,002,000 | 13,473,000 | ||||||||||
| | | | | | | | | | | | | | |
Loss from operations | (18,733,000 | ) | (16,764,000 | ) | (14,888,000 | ) | (13,359,000 | ) | ||||||
Change in fair value of warrant liability | 16,000 | 3,000 | 1,000 | |||||||||||
— | ||||||||||||||
Other income, net | 1,000 | (19,000 | ) | (20,000 | ) | (14,000 | ) | |||||||
| | | | | | | | | | | | | | |
Net loss before income taxes | (18,716,000 | ) | (16,780,000 | ) | (14,907,000 | ) | (13,373,000 | ) | ||||||
Income taxes | — | — | — | 19,000 | ||||||||||
| | | | | | | | | | | | | | |
Net loss | (18,716,000 | ) | (16,780,000 | ) | (14,907,000 | ) | (13,392,000 | ) | ||||||
Net loss attributable to non-controlling interest | 37,000 | 27,000 | 29,000 | 20,000 | ||||||||||
| | | | | | | | | | | | | | |
Net loss applicable to common stockholders | $ | (18,679,000 | ) | $ | (16,753,000 | ) | $ | (14,878,000 | ) | $ | (13,372,000 | ) | ||
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
Net loss per share of common stock, basic and diluted* | $ | (0.87 | ) | $ | (0.77 | ) | $ | (0.69 | ) | $ | (0.62 | ) | ||
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
Basic and diluted weighted average shares outstanding | 21,568,302 | 21,658,625 | 21,691,017 | 21,694,403 | ||||||||||
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
2013 | ||||||||||||||
First | Second | Third | Fourth | |||||||||||
Quarter | Quarter | Quarter | Quarter | |||||||||||
Revenue | $ | 1,116,000 | $ | 591,000 | $ | 1,116,000 | $ | 1,930,000 | ||||||
Operating expenses: | ||||||||||||||
General and administrative | 3,346,000 | 3,117,000 | 5,927,000 | 4,403,000 | ||||||||||
Research and development | 12,756,000 | 10,047,000 | 15,293,000 | 12,086,000 | ||||||||||
| | | | | | | | | | | | | | |
Total operating expenses | 16,102,000 | 13,164,000 | 21,220,000 | 16,489,000 | ||||||||||
| | | | | | | | | | | | | | |
Loss from operations | (14,986,000 | ) | (12,573,000 | ) | (20,104,000 | ) | (14,559,000 | ) | ||||||
Change in fair value of warrant liability | 14,000 | (2,000 | (31,000 | 61,000 | ||||||||||
) | ) | |||||||||||||
Interest expense | — | (2,000 | ) | (1,000 | ) | (1,000 | ) | |||||||
Other income, net | 127,000 | 15,000 | 47,000 | (126,000 | ) | |||||||||
| | | | | | | | | | | | | | |
Net loss before income taxes | (14,845,000 | ) | (12,562,000 | ) | (20,089,000 | ) | (14,625,000 | ) | ||||||
Income taxes | — | — | 432,000 | 3,000 | ||||||||||
| | | | | | | | | | | | | | |
Net loss | (14,845,000 | ) | (12,562,000 | ) | (20,521,000 | ) | (14,628,000 | ) | ||||||
Net loss attributable to non-controlling interest | — | — | — | 13,000 | ||||||||||
| | | | | | | | | | | | | | |
Net loss attributable to Onconova Therapeutics, Inc | (14,845,000 | ) | (12,562,000 | ) | (20,521,000 | ) | (14,615,000 | ) | ||||||
Accretion of redeemable convertible preferred stock | (1,019,000 | ) | (1,032,000 | ) | (269,000 | ) | — | |||||||
| | | | | | | | | | | | | | |
Net loss applicable to common stockholders | $ | (15,864,000 | ) | $ | (13,594,000 | ) | $ | (20,790,000 | ) | $ | (14,615,000 | ) | ||
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
Net loss per share of common stock, basic and diluted* | $ | (6.08 | ) | $ | (5.21 | ) | $ | (1.34 | ) | $ | (0.68 | ) | ||
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
Basic and diluted weighted average shares outstanding | 2,607,406 | 2,609,495 | 15,480,416 | 21,419,208 | ||||||||||
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
* | Earnings Per Share (EPS) in each quarter is computed using the weighted-average number of shares outstanding during that quarter while EPS for the full year is computed using the weighted-average number of shares outstanding during the year. Thus, the sum of the four quarters' EPS does not equal the full-year EPS. | |||||||||||||
Nature_of_Business_Details
Nature of Business (Details) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
item | item | ||||||||||
Nature of Business | |||||||||||
Number of clinical-stage product candidates | 3 | 3 | |||||||||
Net loss | ($13,392,000) | ($14,907,000) | ($16,780,000) | ($18,716,000) | ($14,628,000) | ($20,521,000) | ($12,562,000) | ($14,845,000) | ($63,795,000) | ($62,556,000) | ($29,912,000) |
Accumulated deficit | ($294,578,000) | ($230,896,000) | ($294,578,000) | ($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 $) | 12 Months Ended | 0 Months Ended | |
Dec. 31, 2013 | Jul. 30, 2013 | Dec. 31, 2014 | |
Initial Public Offering | |||
Common stock, par value (in dollars per share) | $0.01 | $0.01 | |
Proceeds from initial public offering of common stock, net of issuance costs | $79,811,000 | ||
Preferred stock outstanding (in shares) | 0 | ||
IPO | |||
Initial Public Offering | |||
Number of shares issued in initial public offering | 5,941,667 | ||
Common stock, par value (in dollars per share) | $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 | ||
Over-allotment option | |||
Initial Public Offering | |||
Number of shares issued in initial public offering | 775,000 |
Summary_of_Significant_Account3
Summary of Significant Accounting Policies (Details) (USD $) | 12 Months Ended |
Dec. 31, 2014 | |
item | |
Segment Information | |
Number of operating segments | 1 |
Concentrations of Credit Risk and Off-Balance Sheet Risk | |
Off-balance sheet risk, asset | $0 |
Off-balance sheet risk, liability | $0 |
Summary_of_Significant_Account4
Summary of Significant Accounting Policies (Details 2) (USD $) | 12 Months Ended |
Dec. 31, 2014 | |
Property and Equipment | |
Impairment losses | $0 |
Laboratory equipment | Minimum | |
Property and Equipment | |
Estimated useful lives | P5Y |
Laboratory equipment | Maximum | |
Property and Equipment | |
Estimated useful lives | P6Y |
Software | |
Property and Equipment | |
Estimated useful lives | P3Y |
Computer and office equipment | Minimum | |
Property and Equipment | |
Estimated useful lives | P5Y |
Computer and office equipment | Maximum | |
Property and Equipment | |
Estimated useful lives | P6Y |
Summary_of_Significant_Account5
Summary of Significant Accounting Policies (Details 3) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Restricted Cash | ||
Restricted cash | $125,000 | |
Restricted cash | $125,000 |
Summary_of_Significant_Account6
Summary of Significant Accounting Policies (Details 4) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Revenue Recognition | |||||||||||
Recognized revenues | $114,000 | $114,000 | $125,000 | $447,000 | $1,930,000 | $1,116,000 | $591,000 | $1,116,000 | $800,000 | $4,753,000 | $46,190,000 |
Research and development revenue | 197,000 | ||||||||||
Collaboration arrangement | Baxter | |||||||||||
Revenue Recognition | |||||||||||
Recognized revenues | 334,000 | 4,176,000 | 45,490,000 | ||||||||
Research and development revenue | 333,000 | 4,176,000 | 3,100,000 | ||||||||
Collaboration arrangement | SymBio | |||||||||||
Revenue Recognition | |||||||||||
Recognized revenues | $466,000 | $577,000 | $503,000 |
Summary_of_Significant_Account7
Summary of Significant Accounting Policies (Details 5) (USD $) | 0 Months Ended | |
Apr. 23, 2013 | Jul. 30, 2013 | |
Preferred Stock | ||
Preferred stock outstanding (in shares) | 0 | |
Stock-Based Compensation Expense | ||
Reclassification of options from liabilities to stockholders' deficit | $14,482,000 |
Property_and_Equipment_Details
Property and Equipment (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Property and Equipment | |||
Property, Plant and Equipment, Gross | $2,625,000 | $2,402,000 | |
Less accumulated depreciation | -2,205,000 | -1,776,000 | |
Property and equipment, net | 420,000 | 626,000 | |
Depreciation and amortization expense | 434,000 | 446,000 | 319,000 |
Laboratory equipment | |||
Property and Equipment | |||
Property, Plant and Equipment, Gross | 1,037,000 | 866,000 | |
Software | |||
Property and Equipment | |||
Property, Plant and Equipment, Gross | 92,000 | 92,000 | |
Computer and office equipment | |||
Property and Equipment | |||
Property, Plant and Equipment, Gross | 433,000 | 433,000 | |
Leasehold improvements | |||
Property and Equipment | |||
Property, Plant and Equipment, Gross | $1,063,000 | $1,011,000 |
Fair_Value_Measurements_Detail
Fair Value Measurements (Details) (USD $) | 1 Months Ended | 12 Months Ended | |
Jun. 30, 2009 | Dec. 31, 2014 | Dec. 31, 2013 | |
Series G Preferred Stock Warrant | |||
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) | 1.52% | ||
Warrants | Series G Preferred Stock Warrant | |||
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) | 102.26% | 74.40% | |
Warrants | Series G Preferred Stock Warrant | 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) | 0.03% | 0.34% | |
Recurring basis | |||
Financial assets and liabilities measured at fair value | |||
Warrant liability | 20,000 | ||
Total | 20,000 | ||
Recurring basis | Level 3 | |||
Financial assets and liabilities measured at fair value | |||
Warrant liability | 20,000 | ||
Total | 20,000 |
Fair_Value_Measurements_Detail1
Fair Value Measurements (Details 2) (Warrants, USD $) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
Warrants | ||
Reconciliation of the warrant liability measured at fair value | ||
Balance at the beginning of the period | $20,000 | $62,000 |
Change in fair value upon re-measurement | -20,000 | -42,000 |
Balance at the end of the period | $20,000 |
Fair_Value_Measurements_Detail2
Fair Value Measurements (Details 3) (USD $) | Dec. 31, 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 |
Net_Loss_Per_Share_of_Common_S2
Net Loss Per Share of Common Stock (Details) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Basic and diluted net loss per share of common stock: | |||||||||||
Net loss attributable to Onconova Therapeutics, Inc | ($14,615,000) | ($20,521,000) | ($12,562,000) | ($14,845,000) | ($63,682,000) | ($62,543,000) | ($29,912,000) | ||||
Accretion to redemption value of preferred stock | -269,000 | -1,032,000 | -1,019,000 | -2,320,000 | -3,953,000 | ||||||
Net loss applicable to common stockholders | ($13,372,000) | ($14,878,000) | ($16,753,000) | ($18,679,000) | ($14,615,000) | ($20,790,000) | ($13,594,000) | ($15,864,000) | ($63,682,000) | ($64,863,000) | ($33,865,000) |
Weighted average shares of common stock outstanding (in shares) | 21,694,403 | 21,691,017 | 21,658,625 | 21,568,302 | 21,419,208 | 15,480,416 | 2,609,495 | 2,607,406 | 21,653,536 | 10,594,227 | 2,206,888 |
Net loss per share of common stock, basic and diluted (in dollars per share) | ($0.62) | ($0.69) | ($0.77) | ($0.87) | ($0.68) | ($1.34) | ($5.21) | ($6.08) | ($2.94) | ($6.12) | ($15.35) |
Net_Loss_Per_Share_of_Common_S3
Net Loss Per Share of Common Stock (Details 2) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
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 | 4,635,896 | 4,348,962 | 15,406,871 |
Preferred Stock | |||
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 | 12,838,127 | ||
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 | 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 | 4,631,299 | 4,344,365 | 2,564,147 |
Balance_Sheet_Detail_Details
Balance Sheet Detail (Details) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Prepaid expenses and other current assets: | ||
Research and development | $1,782,000 | $2,242,000 |
Manufacturing | 451,000 | 1,051,000 |
Insurance | 578,000 | 645,000 |
Other | 387,000 | 449,000 |
Total | 3,198,000 | 4,387,000 |
Property and equipment: | ||
Property and equipment | 2,625,000 | 2,402,000 |
Accumulated depreciation | -2,205,000 | -1,776,000 |
Property and equipment, net | 420,000 | 626,000 |
Accrued expenses | ||
Research and development | 4,482,000 | 4,625,000 |
Employee compensation | 854,000 | 509,000 |
Professional fees | 418,000 | 310,000 |
Taxes | 18,000 | 302,000 |
Other | 5,000 | 74,000 |
Total | $5,777,000 | $5,820,000 |
Income_Taxes_Details
Income Taxes (Details) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Income taxes based on income (loss) before income tax expense | |||||||||||
Domestic | ($63,910,000) | ($62,154,000) | ($29,912,000) | ||||||||
Foreign | 134,000 | 33,000 | |||||||||
Net loss before income taxes | -13,373,000 | -14,907,000 | -16,780,000 | -18,716,000 | -14,625,000 | -20,089,000 | -12,562,000 | -14,845,000 | -63,776,000 | -62,121,000 | -29,912,000 |
Current | |||||||||||
US Federal | 140,000 | ||||||||||
State and Local | 285,000 | ||||||||||
Foreign | 19,000 | 10,000 | |||||||||
Total Current | 19,000 | 435,000 | |||||||||
Total Expense (Benefit) | $19,000 | $3,000 | $432,000 | $19,000 | $435,000 |
Income_Taxes_Details_2
Income Taxes (Details 2) (USD $) | Dec. 31, 2014 |
Federal | |
Income Taxes | |
Net operating loss (NOL) carry forwards | $160,266,000 |
State | |
Income Taxes | |
Net operating loss (NOL) carry forwards | $141,053,000 |
Income_Taxes_Details_3
Income Taxes (Details 3) (USD $) | Dec. 31, 2014 |
Income Taxes | |
Research and development tax credit carry forwards | $56,612,000 |
Income_Taxes_Details_4
Income Taxes (Details 4) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Unrecognized tax benefits | |||
Unrecognized tax benefits | $0 | ||
Interest and penalties accrued | 0 | ||
Deferred tax assets: | |||
Net operating loss carryovers | 63,776,000 | 47,364,000 | |
R&D tax credits | 56,750,000 | 35,223,000 | |
Non-qualified stock options | 4,916,000 | 3,988,000 | |
Deferred revenue | 5,648,000 | 5,938,000 | |
Charitable contributions | 6,000 | 6,000 | |
Accrued expenses | 691,000 | 586,000 | |
Fixed assets | 164,000 | 199,000 | |
Deferred tax assets | 131,951,000 | 93,304,000 | |
Less valuation allowance | -131,951,000 | -93,304,000 | |
Net change in valuation allowance | $38,647,000 | $38,007,000 | |
Reconciliation of income tax (expense) benefit at the statutory federal income tax rate and income taxes | |||
Federal income tax expense at statutory rate (as a percent) | 34.00% | 34.00% | 34.00% |
Permanent items (as a percent) | -8.90% | -8.30% | -25.10% |
State income tax, net of federal benefit (as a percent) | 4.20% | 4.50% | 1.80% |
Tax credits (as a percent) | 33.80% | 34.40% | 18.50% |
Provision to return (as a percent) | -2.40% | -3.80% | |
Change in valuation allowance (as a percent) | -60.70% | -61.20% | -29.10% |
Other (as a percent) | -0.20% | -0.10% | |
Effective income tax rate (as a percent) | 0.00% | -0.60% | 0.00% |
Convertible_Promissory_Notes_D
Convertible Promissory Notes (Details) (USD $) | 1 Months Ended | 4 Months Ended | 0 Months Ended | ||
Jul. 31, 2012 | Jul. 31, 2012 | Jul. 27, 2012 | Dec. 31, 2012 | Mar. 31, 2012 | |
Stockholder loan | |||||
Convertible promissory notes | |||||
Principal outstanding | $620,000 | ||||
Convertible Debt Offering | |||||
Convertible promissory notes | |||||
Amount of notes offered in private placement | 30,000,000 | ||||
Aggregate closings | 26,444,000 | ||||
Contingent beneficial conversion feature | 8,176,000 | ||||
Convertible Debt Offering | Series I Preferred Stock | |||||
Convertible promissory notes | |||||
Conversion price (in dollars per share) | $11 | $11 | |||
Number of shares of preferred stock issued upon conversion | 2,433,328 | 2,443,328 | |||
Interest expense | $8,176,000 |
Preferred_Stock_and_Stockholde1
Preferred Stock and Stockholders' Equity (Deficit) (Details) (USD $) | 3 Months Ended | 12 Months Ended | 1 Months Ended | 4 Months Ended | 0 Months Ended | 1 Months Ended | |||||||||||
Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Jun. 30, 2009 | Jul. 31, 2012 | Jul. 27, 2012 | Jul. 31, 2012 | Jul. 30, 2013 | Jan. 01, 2012 | Dec. 31, 2011 | |
Composition of share capital | |||||||||||||||||
Preferred stock, par value per share (in dollars per share) | $0.01 | $0.01 | $0.01 | ||||||||||||||
Common stock outstanding (in shares) | 21,467,482 | 21,703,173 | 21,467,482 | ||||||||||||||
Activity of the preferred stock | |||||||||||||||||
Balance (in shares) | 0 | ||||||||||||||||
Balance (in shares) | 0 | ||||||||||||||||
Weighted average assumptions | |||||||||||||||||
Change in fair value of warrant liabilities | ($1,000) | ($3,000) | ($16,000) | ($61,000) | $31,000 | $2,000 | ($14,000) | ($20,000) | ($42,000) | ($367,000) | |||||||
Series G Preferred Stock Warrant | |||||||||||||||||
Activity of the preferred stock | |||||||||||||||||
Number of warrants issued (in shares) | 6,128 | ||||||||||||||||
Ratio of the number of warrants issued for each share of preferred stock purchased | 0.5 | ||||||||||||||||
Weighted average assumptions | |||||||||||||||||
Exercise price (in dollars per share) | $9.79 | ||||||||||||||||
Share price (in dollars per share) | $9.79 | ||||||||||||||||
Expected term | 3 years | ||||||||||||||||
Risk-free rate (as a percent) | 1.52% | ||||||||||||||||
Volatility (as a percent) | 85.46% | ||||||||||||||||
Change in fair value of warrant liabilities | 20,000 | 42,000 | 367,000 | ||||||||||||||
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 | 1.333 | ||||||||||||||||
Convertible Debt Offering | |||||||||||||||||
Preferred stock and stockholders' deficit | |||||||||||||||||
Principal amount of the notes converted | 26,444,000 | ||||||||||||||||
Accrued interest | 323,000 | 323,000 | |||||||||||||||
Preferred Stock | |||||||||||||||||
Composition of share capital | |||||||||||||||||
Preferred stock, par value per share (in dollars per share) | $0.01 | ||||||||||||||||
Activity of the preferred stock | |||||||||||||||||
Balance (in shares) | 11,227,169 | 11,227,169 | 11,227,169 | ||||||||||||||
Balance (in shares) | 16,912,199 | 11,227,169 | 11,227,169 | ||||||||||||||
Series I Preferred Stock | Convertible Debt Offering | |||||||||||||||||
Preferred stock and stockholders' deficit | |||||||||||||||||
Number of shares of preferred stock issued upon conversion of note | 2,443,328 | 2,433,328 | |||||||||||||||
Issue price (in dollars per share) | $11 | $11 | |||||||||||||||
Series J Preferred Stock | |||||||||||||||||
Preferred stock and stockholders' deficit | |||||||||||||||||
Gross proceeds from issuance of shares of preferred stock | 50,000,000 | ||||||||||||||||
Issue price (in dollars per share) | $16.50 | $16.50 | |||||||||||||||
Number of shares of preferred stock issued | 3,030,303 | ||||||||||||||||
Issuance costs associated with offering | $2,204,000 | ||||||||||||||||
Activity of the preferred stock | |||||||||||||||||
Issuance of Preferred Stock (in shares) | 3,030,303 |
StockBased_Compensation_Detail
Stock-Based Compensation (Details) (USD $) | 12 Months Ended | 204 Months Ended | |||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2014 | Jul. 31, 2013 | |
Stock-based compensation | |||||
Total stock-based compensation | $5,068,000 | $8,015,000 | $13,844,000 | ||
Additional disclosures | |||||
Net tax benefits related to the stock-based compensation costs | 0 | ||||
Stock options | |||||
Shares available for grant | |||||
Balance at the beginning of period (in shares) | 676,236 | ||||
Authorized (in shares) | 858,699 | 858,699 | |||
Granted (in shares) | -1,015,300 | ||||
Forfeited (in shares) | 492,675 | ||||
Balance at the end of the period (in shares) | 1,012,310 | 676,236 | 1,012,310 | ||
Number of Shares | |||||
Balance at the beginning of the period (in shares) | 4,344,365 | ||||
Granted (in shares) | 1,015,300 | ||||
Exercised (in shares) | -235,691 | ||||
Forfeited (in shares) | -492,675 | ||||
Balance at the end of the period (in shares) | 4,631,299 | 4,344,365 | 4,631,299 | ||
Vested or expected to vest at the end of the period (in shares) | 4,548,832 | 4,548,832 | |||
Exercisable at the end of the period (in shares) | 2,639,334 | 2,639,334 | |||
Weighted-Average Exercise Price | |||||
Balance at the beginning of the period (in dollars per share) | $11.05 | ||||
Granted (in dollars per share) | $4.51 | ||||
Exercised (in dollars per share) | $4.07 | ||||
Forfeited (in dollars per share) | $10.40 | ||||
Balance at the end of the period (in dollars per share) | $10.04 | $11.05 | $10.04 | ||
Vested or expected to vest at the end of the period (in dollars per share) | $10.04 | $10.04 | |||
Exercisable at the end of the period (in dollars per share) | $10.44 | $10.44 | |||
Weighted-Average Remaining Contractual Term | |||||
Outstanding at the beginning of the period | 7 years 10 months 21 days | 7 years 10 months 28 days | |||
Outstanding at the end of the period | 7 years 10 months 21 days | 7 years 10 months 28 days | |||
Vested or expected to vest at the end of the period | 7 years 10 months 21 days | ||||
Exercisable at the end of the period | 6 years 11 months 9 days | ||||
Additional disclosures | |||||
Aggregate intrinsic value of options outstanding | 42,923 | 42,923 | |||
Aggregate intrinsic value of vested options | 42,923 | 42,923 | |||
Aggregate intrinsic value of options Exercisable | 42,923 | 42,923 | |||
Intrinsic value of options exercised | 1,842,000 | 1,076,000 | 4,510,000 | ||
Stock options | 2013 Plan | |||||
Shares available for grant | |||||
Balance at the beginning of period (in shares) | 1,012,310 | ||||
Authorized (in shares) | 6,107,831 | ||||
Balance at the end of the period (in shares) | 1,012,310 | ||||
General and administrative | |||||
Stock-based compensation | |||||
Total stock-based compensation | 2,082,000 | 4,845,000 | 7,199,000 | ||
Research and development | |||||
Stock-based compensation | |||||
Total stock-based compensation | $2,986,000 | $3,170,000 | $6,645,000 |
StockBased_Compensation_Detail1
Stock-Based Compensation (Details 2) (USD $) | 12 Months Ended |
Dec. 31, 2014 | |
Options Outstanding | |
Shares | 4,631,299 |
Exercisable | |
Number (in shares) | 2,639,334 |
Exercise Price Range $1.33 - $2.67 | |
Options Outstanding | |
Shares | 928,933 |
Exercisable | |
Number (in shares) | 115,381 |
Exercise Price Range $1.33 - $2.67 | Minimum | |
Stock-based compensation | |
Exercise Price (in dollars per share) | $1.33 |
Exercise Price Range $1.33 - $2.67 | Maximum | |
Stock-based compensation | |
Exercise Price (in dollars per share) | $5.58 |
Exercise Price Range $5.76 - 6.00 | |
Options Outstanding | |
Shares | 577,891 |
Exercisable | |
Number (in shares) | 577,891 |
Exercise Price Range $5.76 - 6.00 | Minimum | |
Stock-based compensation | |
Exercise Price (in dollars per share) | $5.76 |
Exercise Price Range $5.76 - 6.00 | Maximum | |
Stock-based compensation | |
Exercise Price (in dollars per share) | $6 |
Exercise Price Range $6.13 - $7.53 | |
Options Outstanding | |
Shares | 626,066 |
Exercisable | |
Number (in shares) | 517,255 |
Exercise Price Range $6.13 - $7.53 | Minimum | |
Stock-based compensation | |
Exercise Price (in dollars per share) | $6.13 |
Exercise Price Range $6.13 - $7.53 | Maximum | |
Stock-based compensation | |
Exercise Price (in dollars per share) | $7.53 |
Exercise Price Range $13.28 - $13.48 | |
Options Outstanding | |
Shares | 1,673,334 |
Exercisable | |
Number (in shares) | 807,473 |
Exercise Price Range $13.28 - $13.48 | Minimum | |
Stock-based compensation | |
Exercise Price (in dollars per share) | $13.28 |
Exercise Price Range $13.28 - $13.48 | Maximum | |
Stock-based compensation | |
Exercise Price (in dollars per share) | $13.48 |
Exercise Price Range $14.67 - $15.00 | |
Options Outstanding | |
Shares | 759,888 |
Exercisable | |
Number (in shares) | 580,172 |
Exercise Price Range $14.67 - $15.00 | Minimum | |
Stock-based compensation | |
Exercise Price (in dollars per share) | $14.68 |
Exercise Price Range $14.67 - $15.00 | Maximum | |
Stock-based compensation | |
Exercise Price (in dollars per share) | $15.12 |
Exercise Price Range $21.79 - $28.81 | |
Options Outstanding | |
Shares | 65,187 |
Exercisable | |
Number (in shares) | 41,162 |
Exercise Price Range $21.79 - $28.81 | Minimum | |
Stock-based compensation | |
Exercise Price (in dollars per share) | $21.79 |
Exercise Price Range $21.79 - $28.81 | Maximum | |
Stock-based compensation | |
Exercise Price (in dollars per share) | $28.81 |
StockBased_Compensation_Detail2
Stock-Based Compensation (Details 3) (USD $) | 9 Months Ended | 12 Months Ended | |
Dec. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | |
Additional disclosures | |||
Share Based Compensation Arrangement by Share Based Payment Award Reclassification to Stockholders Deficit | $14,482,000 | ||
Unrecognized compensation expense of unvested liability awards | 729,000 | ||
Unrecognized compensation cost of options granted but not yet vested | $10,450,000 | ||
Weighted-average period for recognizing unrecognized compensation expense of unvested liability awards | 1 year 9 months 11 days | ||
Weighted-average period for recognizing unrecognized compensation expense related to unvested stock options | 3 years 3 months 22 days | ||
Stock options | |||
Assumptions used to determine fair values for nonemployee options | |||
Risk-free interest rates (as a percent) | 1.73% | 1.84% | |
Expected volatility (as a percent) | 77.00% | 78.60% | |
Expected life | 5 years 10 months 13 days | 6 years 1 month 24 days | |
Expected dividend yield (as a percent) | 0.00% | 0.00% | |
Weighted-average grant fair value (in dollars per share) | $9.72 | $3.10 | |
Additional disclosures | |||
Annualized forfeiture rate (as a percent) | 4.14% | 1.69% |
Employee_Benefits_Plan_Details
Employee Benefits Plan (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Employee Benefit Plan | |||
Minimum age of employees required to be eligible for participation | 21 years | ||
Minimum working hours per year required to be eligible for participation | 1000 hours | ||
Employer's match for every dollar of the first specified percentage of payroll that employees invest | $0.60 | ||
First specified percentage of payroll that employees invest | 6.00% | ||
Employer's contribution, vesting period | 4 years | ||
Employer contribution annual vesting percentage | 25.00% | ||
Contributions | $276,000 | $289,000 | $159,000 |
Commitments_and_Contingencies_1
Commitments and Contingencies (Details) | 12 Months Ended | 1 Months Ended | 1 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Oct. 31, 2009 | Jan. 31, 2007 | Nov. 30, 2013 | Dec. 31, 2014 | Sep. 30, 2012 | Dec. 31, 2014 | Dec. 31, 2014 | Dec. 31, 2014 | Dec. 31, 2014 | |
USD ($) | USD ($) | USD ($) | Office and lab space of 8,100 square feet area in Newtown, Pennsylvania | Office and lab space of 8,100 square feet area in Newtown, Pennsylvania | Office and lab space of 8,100 square feet area in Newtown, Pennsylvania | Office and lab space of 8,100 square feet area in Newtown, Pennsylvania | Additional office space of 1,356 square feet area in Newtown, Pennsylvania | Office Space of 5247 Square Feet Area in Pennington, New Jersey | Office Space in Munich, Germany | Office Space in Munich, Germany | Office Space in Munich, Germany | |
item | sqft | April 2014 To March 2015 | April 2015 To March 2016 | USD ($) | USD ($) | January 2014 To December 2014 | January 2015 To December 2015 | |||||
USD ($) | USD ($) | sqft | lease | EUR (€) | EUR (€) | |||||||
sqft | ||||||||||||
Operating leases | ||||||||||||
Area of space leased (in square feet) | 8,100 | 1,356 | 4,807 | |||||||||
Number of leases | 2 | |||||||||||
Lease cancellation period | 3 months | |||||||||||
Lease term | 1 year | |||||||||||
Additional lease term under option | 1 year | |||||||||||
Lease rent per month | $11,000 | $11,500 | $8,100 | € 4,300 | € 4,500 | |||||||
Letter of credit provided to landlord | 125,000 | |||||||||||
Number of options available for lease extensions | 3 | |||||||||||
Sub-lease rent per month | 1,600 | |||||||||||
Future minimum lease payments under these non-cancellable leases | ||||||||||||
2014 | 136,000 | |||||||||||
2015 | 35,000 | |||||||||||
Total minimum lease payments | 171,000 | |||||||||||
Rent expense | $389,000 | $309,000 | $233,000 |
Research_Agreements_Details
Research Agreements (Details) (USD $) | 12 Months Ended | |||||
Dec. 31, 2014 | Dec. 31, 2012 | Dec. 31, 2011 | Dec. 31, 2013 | Jan. 31, 2013 | 31-May-10 | |
Temple | ||||||
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 | |||||
Expense in connection with the collaboration agreement | 12,500,000 | |||||
LLS | Rigosertib | ||||||
Research Agreements | ||||||
Payments made in connection with the collaboration agreement | 1,000,000 | |||||
Milestone payments received recorded as deferred revenue | 8,000,000 | 8,000,000 | ||||
LLS | Rigosertib | Maximum | ||||||
Research Agreements | ||||||
Potential milestone payments | 8,000,000 | 10,000,000 | ||||
Potential milestone and royalty payment obligation | $23,000,000 | $23,000,000 |
License_and_Collaboration_Agre1
License and Collaboration Agreements (Details) (USD $) | 3 Months Ended | 12 Months Ended | 1 Months Ended | |||||||||||||
Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Jul. 31, 2013 | Sep. 30, 2012 | Feb. 28, 2014 | Jul. 31, 2011 | Jul. 31, 2012 | |
License and collaboration agreements | ||||||||||||||||
Research and development revenue | $197,000 | |||||||||||||||
Recognized revenues | 114,000 | 114,000 | 125,000 | 447,000 | 1,930,000 | 1,116,000 | 591,000 | 1,116,000 | 800,000 | 4,753,000 | 46,190,000 | |||||
Collaboration arrangement | Baxter | ||||||||||||||||
License and collaboration agreements | ||||||||||||||||
Consideration received for the Preferred Stock | 4,950,000 | 50,000,000 | ||||||||||||||
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 | 333,000 | 4,176,000 | 3,100,000 | |||||||||||||
Recognized revenues | 334,000 | 4,176,000 | 45,490,000 | |||||||||||||
Collaboration arrangement | SymBio | ||||||||||||||||
License and collaboration agreements | ||||||||||||||||
Recognized revenues | 466,000 | 577,000 | 503,000 | |||||||||||||
Collaboration arrangement | SymBio | Rigosertib IV in higher risk MDS patients | Supply agreement | ||||||||||||||||
License and collaboration agreements | ||||||||||||||||
Recognized revenues | 122,000 | |||||||||||||||
Collaboration arrangement | Rigosertib | Baxter | ||||||||||||||||
License and collaboration agreements | ||||||||||||||||
Number of initial rigosertib indications | 3 | |||||||||||||||
Upfront payment | 50,000,000 | |||||||||||||||
Notice period to terminate the agreement | 180 days | |||||||||||||||
Aggregate potential milestone payments based on annual net sales of rigosertib | 250,000,000 | |||||||||||||||
Collaboration arrangement | Rigosertib | Baxter | Rigosertib IV in higher risk MDS patients | ||||||||||||||||
License and collaboration agreements | ||||||||||||||||
Term of improvement observed | 2 years 3 months 18 days | |||||||||||||||
Funding percentage to the entity | 50.00% | |||||||||||||||
Cost funded to the entity | 15,000,000 | |||||||||||||||
Reduction in milestone payment | 15,000,000 | |||||||||||||||
Collaboration arrangement | Rigosertib | Baxter | Rigosertib IV in pancreatic cancer patients | ||||||||||||||||
License and collaboration agreements | ||||||||||||||||
Potential pre-commercial milestone payments for joint decision to proceed with the development of rigosertib for certain indications | 25,000,000 | |||||||||||||||
Collaboration arrangement | Rigosertib | Baxter | Rigosertib IV in pancreatic cancer patients | Maximum | ||||||||||||||||
License and collaboration agreements | ||||||||||||||||
Potential milestone payments for regulatory approvals of specified indications | 100,000,000 | |||||||||||||||
Collaboration arrangement | Rigosertib | SymBio | ||||||||||||||||
License and collaboration agreements | ||||||||||||||||
Upfront payment | 7,500,000 | |||||||||||||||
Aggregate potential milestone payments based on annual net sales of rigosertib | 30,000,000 | |||||||||||||||
Percentage of royalty payments based on net sales of rigosertib | 20.00% | |||||||||||||||
Recognized revenues | 455,000 | 455,000 | 455,000 | |||||||||||||
Collaboration arrangement | Rigosertib | SymBio | Supply agreement | ||||||||||||||||
License and collaboration agreements | ||||||||||||||||
Binding commitments | 0 | |||||||||||||||
Recognized revenues | 11,000 | 48,000 | ||||||||||||||
Collaboration arrangement | Rigosertib | SymBio | United States and Japan | ||||||||||||||||
License and collaboration agreements | ||||||||||||||||
Aggregate milestone payments due upon receipt of marketing approval for an additional indication | 4,000,000 | |||||||||||||||
Collaboration arrangement | Rigosertib | SymBio | Maximum | ||||||||||||||||
License and collaboration agreements | ||||||||||||||||
Aggregate milestone payments | 22,000,000 | |||||||||||||||
Collaboration arrangement | Rigosertib | SymBio | MDS IV indication | United States | ||||||||||||||||
License and collaboration agreements | ||||||||||||||||
Regulatory milestones payments due upon receipt of marketing approval for indication | 5,000,000 | |||||||||||||||
Collaboration arrangement | Rigosertib | SymBio | MDS IV indication | Japan | ||||||||||||||||
License and collaboration agreements | ||||||||||||||||
Regulatory milestones payments due upon receipt of marketing approval for indication | 3,000,000 | |||||||||||||||
Collaboration arrangement | Rigosertib | SymBio | Rigosertib oral in lower risk MDS patients | United States | ||||||||||||||||
License and collaboration agreements | ||||||||||||||||
Regulatory milestones payments due upon receipt of marketing approval for indication | 5,000,000 | |||||||||||||||
Collaboration arrangement | Rigosertib | SymBio | Rigosertib oral in lower risk MDS patients | Japan | ||||||||||||||||
License and collaboration agreements | ||||||||||||||||
Regulatory milestones payments due upon receipt of marketing approval for indication | 5,000,000 | |||||||||||||||
Collaboration arrangement | Rigosertib | SymBio | Rigosertib IV in combination with gemcitabine for pancreatic cancer patients | United States | ||||||||||||||||
License and collaboration agreements | ||||||||||||||||
Potential development milestones payments due after enrollment of the first patient in event of decision made to start phase 3 clinical trial of indication | 3,000,000 | |||||||||||||||
Regulatory milestones payments due upon receipt of marketing approval for indication | 5,000,000 | |||||||||||||||
Collaboration arrangement | Rigosertib | SymBio | Rigosertib IV in combination with gemcitabine for pancreatic cancer patients | Japan | ||||||||||||||||
License and collaboration agreements | ||||||||||||||||
Regulatory milestones payments due upon receipt of marketing approval for indication | 3,000,000 | |||||||||||||||
Series J Preferred Stock | ||||||||||||||||
License and collaboration agreements | ||||||||||||||||
Consideration received for the Preferred Stock | 50,000,000 | |||||||||||||||
Series J Preferred Stock | Collaboration arrangement | Baxter | ||||||||||||||||
License and collaboration agreements | ||||||||||||||||
Consideration received for the Preferred Stock | $50,000,000 |
Preclinical_Collaboration_Deta
Preclinical Collaboration (Details) (GBO, USD $) | 12 Months Ended | 1 Months Ended | 12 Months Ended |
Dec. 31, 2014 | Nov. 30, 2014 | Dec. 31, 2013 | |
item | |||
Preclinical Collaboration | |||
Number of new programs to be collaborated and developed | 2 | ||
Ownership interest in the joint venture (as a percent) | 90.00% | ||
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 | ||
GVK BIO | |||
Preclinical Collaboration | |||
Initial capital contribution | $500,000 | ||
Ownership interest in the joint venture (as a percent) | 17.50% | 10.00% | |
Additional capital contributions | $500,000 | ||
GVK BIO | Minimum | |||
Preclinical Collaboration | |||
Ownership interest in the joint venture (as a percent) | 10.00% | ||
GVK BIO | Maximum | |||
Preclinical Collaboration | |||
Ownership interest in the joint venture (as a percent) | 50.00% |
RelatedParty_Transactions_Deta
Related-Party Transactions (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Mount Sinai | |||
Related-party transactions | |||
Payments to related party | $1,215,000 | $1,235,000 | $1,230,000 |
Amounts due to related party | 0 | 0 | |
Supplier business owned by board members | |||
Related-party transactions | |||
Payments to related party | 0 | 107,000 | 157,000 |
Amounts due to related party | 0 | 0 | |
Corporations owned by former board members | |||
Related-party transactions | |||
Payments to related party | 446,000 | 1,354,000 | 316,000 |
Amounts due to related party | 8,000 | 157,000 | |
Member of board of directors | |||
Related-party transactions | |||
Payments to related party | 194,000 | 182,000 | 165,000 |
Amounts due to related party | $0 | $0 |
Initial_Public_Offering_Detail
Initial Public Offering (Details) (USD $) | 0 Months Ended | 12 Months Ended | 0 Months Ended | |
Jul. 17, 2013 | Dec. 31, 2013 | Jul. 30, 2013 | Jul. 31, 2013 | |
Initial Public Offering | ||||
Preferred stock outstanding (in shares) | 0 | |||
Net proceeds received from the sale, net of underwriting discounts and commissions and other estimated offering expenses | $79,811,000 | |||
Reverse stock split of common stock | 0.75 | |||
Designated public offering amended threshold gross proceeds, minimum | 25,000,000 | |||
IPO | ||||
Initial Public Offering | ||||
Net proceeds received from the sale, net of underwriting discounts and commissions and other estimated offering expenses | $79,811,000 |
Securities_Registration_and_Sa1
Securities Registration and Sales Agreement (Details) (USD $) | 1 Months Ended | ||
Oct. 31, 2014 | Dec. 31, 2014 | Dec. 31, 2013 | |
Securities Registration and Sales Agreement | |||
Common stock issued (in shares) | 21,703,173 | 21,467,482 | |
Securities registration October 2014 | |||
Securities Registration and Sales Agreement | |||
At-the-market equity program, aggregate offering price | $20,000,000 | ||
At-the-market equity program, commission percentage | 3.00% | ||
Common stock issued (in shares) | 0 |
Subsequent_Event_Details
Subsequent Event (Details) (Subsequent event, USD $) | 1 Months Ended |
In Millions, unless otherwise specified | Feb. 28, 2015 |
lease | |
Subsequent event | |
Subsequent Event | |
Percentage of reduction in workforce | 35.00% |
Number of leases terminated | 1 |
Number of Leases | 2 |
Severance and lease termination cost | $1 |
Quarterly_Data_Details
Quarterly Data (Details) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Quarterly Data (unaudited) | |||||||||||
Revenues | $114,000 | $114,000 | $125,000 | $447,000 | $1,930,000 | $1,116,000 | $591,000 | $1,116,000 | $800,000 | $4,753,000 | $46,190,000 |
Operating expenses: | |||||||||||
General and administrative | 3,086,000 | 3,116,000 | 3,985,000 | 4,932,000 | 4,403,000 | 5,927,000 | 3,117,000 | 3,346,000 | 15,119,000 | 16,793,000 | 15,707,000 |
Research and development | 10,387,000 | 11,886,000 | 12,904,000 | 14,248,000 | 12,086,000 | 15,293,000 | 10,047,000 | 12,756,000 | 49,425,000 | 50,182,000 | 52,762,000 |
Total operating expenses | 13,473,000 | 15,002,000 | 16,889,000 | 19,180,000 | 16,489,000 | 21,220,000 | 13,164,000 | 16,102,000 | 64,544,000 | 66,975,000 | 68,469,000 |
Loss from operations | -13,359,000 | -14,888,000 | -16,764,000 | -18,733,000 | -14,559,000 | -20,104,000 | -12,573,000 | -14,986,000 | -63,744,000 | -62,222,000 | -22,279,000 |
Change in fair value of warrant liability | 1,000 | 3,000 | 16,000 | 61,000 | -31,000 | -2,000 | 14,000 | 20,000 | 42,000 | 367,000 | |
Interest expense | -1,000 | -1,000 | -2,000 | -2,000 | -4,000 | -8,608,000 | |||||
Other income, net | -14,000 | -20,000 | -19,000 | 1,000 | -126,000 | 47,000 | 15,000 | 127,000 | -50,000 | 63,000 | 608,000 |
Net loss before income taxes | -13,373,000 | -14,907,000 | -16,780,000 | -18,716,000 | -14,625,000 | -20,089,000 | -12,562,000 | -14,845,000 | -63,776,000 | -62,121,000 | -29,912,000 |
Income taxes | 19,000 | 3,000 | 432,000 | 19,000 | 435,000 | ||||||
Net loss | -13,392,000 | -14,907,000 | -16,780,000 | -18,716,000 | -14,628,000 | -20,521,000 | -12,562,000 | -14,845,000 | -63,795,000 | -62,556,000 | -29,912,000 |
Net loss attributable to non-controlling interest | 20,000 | 29,000 | 27,000 | 37,000 | 13,000 | 113,000 | 13,000 | ||||
Net loss attributable to Onconova Therapeutics, Inc | -14,615,000 | -20,521,000 | -12,562,000 | -14,845,000 | -63,682,000 | -62,543,000 | -29,912,000 | ||||
Accretion of redeemable convertible preferred stock | -269,000 | -1,032,000 | -1,019,000 | -2,320,000 | -3,953,000 | ||||||
Net loss applicable to common stockholders | ($13,372,000) | ($14,878,000) | ($16,753,000) | ($18,679,000) | ($14,615,000) | ($20,790,000) | ($13,594,000) | ($15,864,000) | ($63,682,000) | ($64,863,000) | ($33,865,000) |
Net loss per share of common stock, basic and diluted (in dollars per share) | ($0.62) | ($0.69) | ($0.77) | ($0.87) | ($0.68) | ($1.34) | ($5.21) | ($6.08) | ($2.94) | ($6.12) | ($15.35) |
Basic and diluted weighted average shares outstanding (in shares) | 21,694,403 | 21,691,017 | 21,658,625 | 21,568,302 | 21,419,208 | 15,480,416 | 2,609,495 | 2,607,406 | 21,653,536 | 10,594,227 | 2,206,888 |