Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2017 | Oct. 31, 2017 | |
Document and Entity Information [Abstract] | ||
Entity Registrant Name | Onconova Therapeutics, Inc. | |
Entity Central Index Key | 1,130,598 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2017 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 9,851,163 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q3 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 7,600 | $ 21,400 |
Receivables | 57 | 31 |
Prepaid expenses and other current assets | 1,000 | 1,588 |
Restricted cash | 50 | 50 |
Total current assets | 8,707 | 23,069 |
Property and equipment, net | 83 | 152 |
Other non-current assets | 12 | 12 |
Total assets | 8,802 | 23,233 |
Current liabilities: | ||
Accounts payable | 5,436 | 5,323 |
Accrued expenses and other current liabilities | 3,098 | 4,382 |
Deferred revenue | 455 | 455 |
Total current liabilities | 8,989 | 10,160 |
Warrant liability | 1,686 | 3,401 |
Deferred revenue, non-current | 4,205 | 4,545 |
Total liabilities | 14,880 | 18,106 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.01 par value, 5,000,000 authorized at September 30, 2017 and December 31, 2016, none issued and outstanding at September 30, 2017 and December 31, 2016 | ||
Common stock, $0.01 par value, 25,000,000 authorized at September 30, 2017 and December 31, 2016, 9,851,164 and 6,759,895 shares issued and outstanding at September 30, 2017 and December 31, 2016 | 99 | 68 |
Additional paid in capital | 349,103 | 342,484 |
Accumulated other comprehensive income | (1) | (31) |
Accumulated deficit | (356,109) | (338,224) |
Total Onconova Therapeutics, Inc. stockholders' (deficit) equity | (6,908) | 4,297 |
Non-controlling interest | 830 | 830 |
Total stockholders' (deficit) equity | (6,078) | 5,127 |
Total liabilities and stockholders' (deficit) equity | $ 8,802 | $ 23,233 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2017 | Dec. 31, 2016 |
Condensed 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 | 25,000,000 | 25,000,000 |
Common stock, shares issued | 9,851,164 | 6,759,895 |
Common stock, shares outstanding | 9,851,164 | 6,759,895 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Condensed Consolidated Statements of Operations | ||||
Revenue | $ 110 | $ 1,651 | $ 644 | $ 5,373 |
Operating expenses: | ||||
General and administrative | 1,728 | 1,975 | 5,623 | 7,229 |
Research and development | 5,141 | 3,991 | 14,641 | 15,377 |
Total operating expenses | 6,869 | 5,966 | 20,264 | 22,606 |
Loss from operations | (6,759) | (4,315) | (19,620) | (17,233) |
Change in fair value of warrant liability | (210) | 2,706 | 1,716 | 2,985 |
Other income, net | 8 | 10 | 19 | 28 |
Net loss | (6,961) | (1,599) | (17,885) | (14,220) |
Net loss attributable to Onconova Therapeutics, Inc. | $ (6,961) | $ (1,599) | $ (17,885) | $ (14,220) |
Net loss per share, basic and diluted (in dollars per share) | $ (0.71) | $ (0.29) | $ (2.09) | $ (3.90) |
Basic and diluted weighted average shares outstanding (in shares) | 9,851,164 | 5,438,105 | 8,551,839 | 3,643,210 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Comprehensive Loss - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Condensed Consolidated Statements of Comprehensive Loss | ||||
Net loss | $ (6,961,000) | $ (1,599,000) | $ (17,885,000) | $ (14,220,000) |
Other comprehensive income (loss), before tax: | ||||
Foreign currency translation adjustments, net | 9,000 | 2,000 | 30,000 | 5,000 |
Other comprehensive income (loss), net of tax | 9,000 | 2,000 | 30,000 | 5,000 |
Comprehensive loss | (6,952,000) | (1,597,000) | (17,855,000) | (14,215,000) |
Comprehensive loss attributable to Onconova Therapeutics, Inc | $ (6,952,000) | $ (1,597,000) | $ (17,855,000) | $ (14,215,000) |
Consolidated Statement of Stock
Consolidated Statement of Stockholders' Equity - 9 months ended Sep. 30, 2017 - USD ($) $ in Thousands | Common Stock | Additional Paid in Capital | Accumulated deficit | Accumulated other comprehensive income (loss) | Non-controlling interest | Total |
Balance at Dec. 31, 2016 | $ 68 | $ 342,484 | $ (338,224) | $ (31) | $ 830 | $ 5,127 |
Balance (in shares) at Dec. 31, 2016 | 6,759,895 | 6,759,895 | ||||
Increase (Decrease) in Stockholders' Equity (Deficit) | ||||||
Net loss | (17,885) | $ (17,885) | ||||
Other comprehensive income | 30 | 30 | ||||
Stock-based compensation | 1,333 | 1,333 | ||||
Issuance of common stock, net | $ 31 | 5,286 | 5,317 | |||
Issuance of common stock, net (in shares) | 3,091,269 | |||||
Balance at Sep. 30, 2017 | $ 99 | $ 349,103 | $ (356,109) | $ (1) | $ 830 | $ (6,078) |
Balance (in shares) at Sep. 30, 2017 | 9,851,164 | 9,851,164 |
Condensed Consolidated Stateme7
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Operating activities: | ||
Net loss | $ (17,885) | $ (14,220) |
Adjustment to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 69 | 72 |
Change in fair value of warrant liabilities | (1,716) | (2,985) |
Stock compensation expense | 1,333 | 3,357 |
Changes in assets and liabilities: | ||
Receivables | (26) | 600 |
Prepaid expenses and other current assets | 588 | 664 |
Accounts payable | 113 | 650 |
Accrued expenses and other current liabilities | (1,283) | 753 |
Deferred revenue | (340) | (341) |
Net cash used in operating activities | (19,147) | (11,450) |
Financing activities: | ||
Proceeds from the sale of common stock and warrants, net of costs | 5,317 | 17,421 |
Proceeds from the exercise of stock options | 3 | |
Net cash provided by financing activities | 5,317 | 17,424 |
Effect of foreign currency translation on cash | 30 | 5 |
Net (decrease) increase in cash and cash equivalents | (13,800) | 5,979 |
Cash and cash equivalents at beginning of period | 21,400 | 19,799 |
Cash and cash equivalents at end of period | $ 7,600 | $ 25,778 |
Nature of Business
Nature of Business | 9 Months Ended |
Sep. 30, 2017 | |
Nature of Business | |
Nature of Business | 1. Nature of Business Reverse Stock Split All Common Stock (as defined below), equity, share and per share amounts in the financial statements and notes have been retroactively adjusted to reflect a one-for-ten reverse stock split which was effective May 31, 2016. 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 product candidates primarily to treat cancer. Using its proprietary chemistry platform, the Company has created a library of targeted agents designed to work against cellular pathways important to cancer cells. The Company believes that the product 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. 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. In 2012, the Company entered into a development and license agreement with Baxter Healthcare SA, the predecessor in interest to Baxalta GmbH (together with its affiliates, “Baxalta”), pursuant to which the Company granted an exclusive, royalty-bearing license for the research, development, commercialization and manufacture (in specified instances) of rigosertib in all therapeutic indications in Europe. The Baxalta agreement terminated effective August 30, 2016, at which time the rights the Company licensed to Baxalta reverted to the Company at no cost. 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 an agreement with GVK Biosciences Private Limited, a private limited company located in India, (“GVK”) to collaborate and develop two programs using the Company’s technology platform. The two preclinical programs sublicensed to GBO have not been developed to clinical stage as initially hoped, and the Company is in discussions with GVK regarding the future of GBO. On May 31, 2016, the Company amended its certificate of incorporation to effect a 1 for 10 reverse stock split of its common stock par value $0.01 per share (“Common Stock”) and to decrease the number of authorized shares of Common Stock from 75,000,000 to 25,000,000. Liquidity The Company has incurred recurring operating losses since inception. For the nine months ended September 30, 2017, the Company incurred a net loss of $17,885,000 and as of September 30, 2017 the Company had generated an accumulated deficit of $356,109,000. 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. At September 30, 2017, the Company had cash and cash equivalents of $7,600,000. The Company will require substantial additional financing to fund its ongoing clinical trials and operations, and to continue to execute its strategy. From its inception through July 2013, the Company raised capital through the private issuance of preferred stock. On July 30, 2013, the Company completed its initial public offering (the “IPO”) of 594,167 shares of Common Stock, at a price of $150.00 per share. 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. 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 had the ability to offer and sell shares of its Common Stock having an aggregate offering price of up to $20,000,000 through Cantor (see Note 13). Net proceeds from sales of Common Stock under this program were $6,018,000 during the year ended December 31, 2015. The sales agreement with Cantor was terminated on January 5, 2016, and there were no sales of Common Stock under this program during the year ended December 31, 2016. In October 2015 the Company entered into a purchase agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”). Upon execution of this purchase agreement, Lincoln Park purchased 84,676 shares of the Company’s Common Stock for $1,500,000. Subject to the terms and conditions of the purchase agreement, including the effectiveness of a registration statement covering the resale of the shares, the Company may sell additional shares of its Common Stock, having an aggregate offering price of up to $15,000,000 to Lincoln Park from time to time until December 1, 2018. On January 5, 2016, the Company entered into a securities purchase agreement with an institutional investor providing for the issuance and sale by the Company of 193,684 shares of the Company’s Common Stock and warrants to purchase 96,842 shares of the Company’s Common Stock for aggregate net proceeds of $1.6 million. (See Note 13) On July 29, 2016 the Company closed on a rights offering of units of Common Stock and warrants. The Company issued 3,599,786 shares of Common Stock, 3,192,022 tradable warrants and 656,400 pre-funded warrants in connection with the rights offering. Net proceeds were approximately $15.8 million. (See Note 13) On April 26, 2017 the Company closed on an underwritten public offering of 2,476,190 shares of Common Stock. On May 17, 2017, the Company sold an additional 363,580 shares as a result of the underwriter’s exercise of its over-allotment option. Net proceeds from these transactions were approximately $5.3 million. (See Note 13) The Company has and may continue to delay, scale-back, or eliminate certain of its research and development activities and other aspects of its operations until such time as the Company is successful in securing additional funding. The Company is exploring various dilutive and non-dilutive sources of funding, including equity financings, strategic alliances, business development and other sources. The future success of the Company is dependent upon its ability to obtain additional funding. There can be no assurance, however, that the Company will be successful in obtaining such funding in sufficient amounts, on terms acceptable to the Company, or at all. The Company currently anticipates that current cash and cash equivalents will be sufficient to meet its anticipated cash requirements to the end of 2017. These factors raise substantial doubt about the Company’s ability to continue as a going concern. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2017 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The condensed consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States (“GAAP”) for interim financial information. Certain information and footnotes normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). The financial statements include the consolidated accounts of the Company, its wholly-owned subsidiary, Onconova Europe GmbH, and GBO. All significant intercompany transactions have been eliminated. Unaudited Interim Financial Information The accompanying condensed consolidated balance sheet as of September 30, 2017, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2017 and 2016, the consolidated statement of stockholders’ equity for the nine months ended September 30, 2017 and the condensed consolidated statements of cash flows for the nine months ended September 30, 2017 and 2016 are unaudited. The interim unaudited condensed consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2017, the results of its operations for the three and nine months ended September 30, 2017 and 2016, and its cash flows for the nine months ended September 30, 2017 and 2016. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2017 and 2016 are unaudited. The results for the three and nine months ended September 30, 2017 are not necessarily indicative of results to be expected for the year ending December 31, 2017, any other interim periods, or any future year or period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2016 included in the Company’s annual report on Form 10-K filed with the SEC on March 29, 2017. Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one segment, which is the identification and development of oncology therapeutics. Significant Accounting Policies The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2016 included in the Company’s annual report on Form 10-K filed with the SEC on March 29, 2017. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies. Fair Value Measurements 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 7, “Fair Value Measurements.” Recent Accounting Pronouncements 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. Currently, the only revenue the Company is recognizing is under its license and collaboration agreements with SymBio (See Note 10). The new guidance permits the use of either a retrospective or cumulative effect transition method and is effective for interim and annual periods beginning on or after December 15, 2017. Early adoption is permitted but not before December 15, 2016. The Company expects to adopt this guidance effective January 1, 2018 and is currently reviewing its contracts with SymBio, but it has not yet selected a transition method and is 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 adopted the new guidance as of December 31, 2016. Based on its current cash position and an evaluation of expected future net cash outflows the Company has determined there is substantial doubt about its ability to continue as a going concern (See Note 1). In February 2016, the FASB issued guidance which supersedes much of the current guidance for leases. The new standard requires lessees to recognize a right-of-use asset and a lease liability on their balance sheets for all the leases with terms greater than twelve months. Based on certain criteria, leases will be classified as either financing or operating, with classification affecting the pattern of expense recognition in the income statement. For leases with a term of twelve months or less, a lessee is permitted to make an accounting policy election by class of underlying asset not to recognize lease assets and lease liabilities. If a lessee makes this election, it should recognize lease expense for such leases generally on a straight-line basis over the lease term. The guidance is effective for fiscal years beginning after December 15, 2018, and interim periods within those years, with early adoption permitted. In transition, lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. The modified retrospective approach includes a number of optional practical expedients primarily focused on leases that commenced before the effective date of the new guidance, including continuing to account for leases that commence before the effective date in accordance with previous guidance, unless the lease is modified. The Company is evaluating the impact of the adoption of the standard on its consolidated financial statements. In March 2016, the FASB issued guidance which clarifies the implementation guidance on principal versus agent considerations in the revenue recognition standard issued in May 2014. The new standard clarifies how an entity should identify the unit of accounting (i.e. the specified good or service) for the principal versus agent evaluation and how it should apply the control principle to certain types of arrangements. The effective date and transition requirements are the same as the effective date and transition requirements in the May 2014 revenue standard (Accounting Standards Codification 606). The Company is currently assessing the adoption methodology and the impact the adoption of these ASUs will have on its consolidated financial position, results of operations and related disclosures. In March 2016, the FASB issued guidance that addresses the income tax effects of stock-based payments and eliminates the windfall pool concept, as all of the tax effects related to stock-based payments will now be recorded at settlement (or expiration) through the income statement. The new guidance also permits entities to make an accounting policy election for the impact of forfeitures on the recognition of expense for stock-based payment awards. Forfeitures can be estimated or recognized when they occur. The standard is effective for annual periods beginning after December 15, 2016 and interim periods within that reporting period. Early adoption is permitted in any interim or annual period, with any adjustment reflected as of the beginning of the fiscal year of adoption. The Company adopted the new guidance as of January 1, 2017. The adoption did not have a material impact on the Company’s condensed consolidated financial statements and related disclosures. In November 2016, the FASB issued guidance requiring that amounts generally described as restricted cash and restricted cash equivalents be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The guidance is effective for interim and annual periods beginning in 2018 and should be applied using a retrospective transition method to each period presented. Early adoption is permitted. The Company is currently evaluating the effect of the standard on its Consolidated Statement of Cash Flows. |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2017 | |
Revenue | |
Revenue | 3. Revenue The Company recognized revenue under its license and collaboration agreements with Baxalta and SymBio as follows: Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 Baxalta $ — $ $ — $ Symbio $ $ $ $ See Note 10, “License and Collaboration Agreements,” for a further discussion of the agreements with Baxalta and SymBio. |
Net Loss Per Share of Common St
Net Loss Per Share of Common Stock | 9 Months Ended |
Sep. 30, 2017 | |
Net Loss Per Share of Common Stock | |
Net Loss Per Share of Common Stock | 4. Net Loss Per Share of Common Stock The following potentially dilutive securities outstanding at September 30, 2017 and 2016 have been excluded from the computation of diluted weighted average shares outstanding, as they would be antidilutive: September 30, 2017 2016 Warrants Stock options |
Warrants
Warrants | 9 Months Ended |
Sep. 30, 2017 | |
Warrants | |
Warrants | 5. Warrants Common Stock warrants are accounted for in accordance with applicable accounting guidance provided in ASC Topic 815, Derivatives and Hedging — Contracts in Entity’s Own Equity (ASC Topic 815), as either derivative liabilities or as equity instruments depending on the specific terms of the warrant agreement. Some of the Company’s warrants are classified as liabilities because in certain circumstances they could require cash settlement. Warrants outstanding and warrant activity for the nine months ended September 30, 2017 is as follows: Balance Balance Exercise Expiration Decemeber 31, Warrants Warrants Warrants September 30, Description Classification Price Date 2016 Issued Exercised Expired 2017 Non-tradable warrants Liability $ July 2021 — — — Tradable warrants Liability $ July 2021 — — — Non-tradable pre-funded warrants Equity $ July 2023 — ) — — ) — |
Balance Sheet Detail
Balance Sheet Detail | 9 Months Ended |
Sep. 30, 2017 | |
Balance Sheet Detail | |
Balance Sheet Detail | 6. Balance Sheet Detail Prepaid expenses and other current assets: September 30, December 31, 2017 2016 Research and development $ $ Manufacturing Insurance Other $ $ Property and equipment: September 30, December 31, 2017 2016 Property and equipment $ $ Accumulated depreciation ) ) $ $ Accrued expenses and other current liabilities: September 30, December 31, 2017 2016 Research and development $ $ Employee compensation Professional fees Other — $ $ |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2017 | |
Fair Value Measurements | |
Fair Value Measurements | 7. Fair Value Measurements Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The Company utilizes a valuation hierarchy for disclosure of the inputs to the valuations used to measure fair value. This hierarchy prioritizes the inputs into three broad levels as follows. Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument. Level 3 inputs are unobservable inputs based on the Company’s own assumptions used to measure assets and liabilities at fair value. A financial asset or liability’s classification within the hierarchy is determined based on the lowest level input that is significant to the fair value measurement. On January 5, 2016, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with an institutional investor providing for the issuance and sale by the Company of 193,684 shares of Common Stock, at a purchase price of $9.50 per share and warrants to purchase up to 96,842 shares of Common Stock (the “Warrants”) for aggregate gross proceeds of $1,840,000 (see Note 13). The Company has classified the warrants as a liability (see Note 5). The fair value was estimated using the Black-Scholes pricing model. On July 29, 2016 the Company closed on a Rights Offering, issuing 3,599,786 shares of Common Stock, 3,192,022 Tradable Warrants and 656,400 Pre-Funded Warrants. The Tradable Warrants are exercisable for a period of five years for one share of Common Stock at an exercise price of $4.92 per share. After the one-year anniversary of issuance, the Company may redeem the Tradable Warrants for $0.001 per Tradable Warrant if the volume weighted average price of its Common Stock is above $12.30 for each of 10 consecutive trading days (see Note 13). The Company has classified the Tradable Warrants as a liability (see Note 5). The Tradable Warrants have been listed on the NASDAQ Capital Market since issuance and the Company regularly monitors the trading activity. During the period from issuance on July 29, 2016 through March 31, 2017 the Company determined that trading volume was insufficient to use the NASDAQ Capital Market value to determine the fair value of the warrant liability. The fair value was estimated using the Black-Scholes pricing model. During the quarter ended June 30, 2017, the Company determined that an active and orderly market for the Tradable Warrants had developed and that the NASDAQ Capital Market price was the best indicator of fair value of the warrant liability. Consequently, the Company changed its valuation technique from the Black-Scholes pricing model to the quoted market price, effective April 1, 2017. The change in valuation technique resulted in a reclassification of the liability within the valuation hierarchy form Level 3 to Level 1. The quoted market price was also used to determine the fair value at September 30, 2017. The Company estimated the fair value of the non-tradable warrant liability at September 30, 2017, using the Black-Scholes option pricing model with the following weighted-average assumptions: Risk-free interest rate 2.04% Expected volatility 76.06% Expected term 3.79 years Expected dividend yield 0% Expected volatility is based on the historical volatility of the Company’s Common Stock since its IPO in July 2013. The following fair value hierarchy table presents information about the Company’s financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2017 and December 31, 2016: Fair Value Measurement as of: September 30, 2017 December 31, 2016 Level 1 Level 2 Level 3 Balance Level 1 Level 2 Level 3 Balance Tradable warrants liability $ $ — $ — $ $ — $ — $ $ Non-tradable warrants liability — — — — Total $ $ — $ $ $ — $ — $ $ The following table presents a reconciliation of the Company’s liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) for the nine months ended September 30, 2017: Warrant Liability Balance at December 31, 2016 $ Change in fair value upon re-measurement Balance at March 31, 2017 Reclassification of tradable warrants to Level 1 ) Change in fair value upon re-measurement ) Balance at June 30, 2017 Change in fair value upon re-measurement ) Balance at September 30, 2017 $ There were no transfers between Level 1 and Level 2 in any of the periods reported. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2017 | |
Stock-Based Compensation | |
Stock-Based Compensation | 8. 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 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 610,783 shares of Common Stock for issuance, subject to adjustment as set forth in the 2013 Plan. The 2013 Plan includes an evergreen provision, pursuant to which the maximum aggregate number of shares that may be issued under the 2013 Plan is increased on the first day of each fiscal year by the lesser of (a) a number of shares equal to four percent (4%) of the issued and outstanding Common Stock of the Company, without duplication, (b) 200,000 shares and (c) such lesser number as determined by the Company’s board of directors, subject to specified limitations. At September 30, 2017, there were 45,255 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 three and nine months ended September 30, 2017 and 2016: Three Months ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 General and administrative $ $ $ $ Research and development $ $ $ $ A summary of stock option activity for the nine months ended September 30, 2017 is as follows: Options Outstanding Shares Number of Weighted- Weighted Aggregate Balance, December 31, 2016 $ $ 0 Authorized — Granted ) $ Exercised — — $ — Forfeitures ) $ Balance, September 30, 2017 $ $ Vested or expected to vest, September 30, 2017 $ $ Exercisable at September 30, 2017 $ $ Information with respect to stock options outstanding and exercisable at September 30, 2017 is as follows: Exercise Price Shares Exercisable $1.94 - $6.50 $14.80 - $15.00 $23.20 - $39.80 $43.40 - $75.30 $132.80 - $151.20 $277.10 - $291.40 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 Common 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 September 30, 2017, there was $1,414,000 of unrecognized compensation expense related to the unvested stock options issued from April 24, 2013 through September 30, 2017, which is expected to be recognized over a weighted-average period of approximately 1.83 years. The weighted-average assumptions underlying the Black-Scholes calculation of grant date fair value include the following: Nine Months ended September 30, 2017 2016 Risk-free interest rate 2.03% 1.35% Expected volatility 79.06% 75.71% Expected term 6.00 years 5.78 years Expected dividend yield 0% 0% Weighted average grant date fair value $1.77 $2.87 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: Expected volatility is based on the historical volatility of the Company’s Common Stock since its IPO in July 2013. · 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 2017 and 2016, 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 September 30, 2017, there was no unrecognized compensation expense related to these awards. |
Research Agreements
Research Agreements | 9 Months Ended |
Sep. 30, 2017 | |
Research Agreements | |
Research Agreements | 9. Research Agreements The Company has entered into various licensing and right-to-sublicense agreements with educational institutions for the exclusive use of patents and patent applications, as well as any patents that may develop from research being conducted by such educational institutions in the field of anticancer therapy, genes and proteins. Results from this research have been licensed to the Company pursuant to these agreements. Under one of these agreements with Temple University (“Temple”), the Company is required to make annual maintenance payments to Temple and royalty payments based upon a percentage of sales generated from any products covered by the licensed patents, with minimum specified royalty payments. As no sales had been generated through September 30, 2017 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 a percentage of any sublicensing fees received by the Company. |
License and Collaboration Agree
License and Collaboration Agreements | 9 Months Ended |
Sep. 30, 2017 | |
License and Collaboration Agreements | |
License and Collaboration Agreements | 10. License and Collaboration Agreements Baxalta Agreement In September 2012, the Company entered into a development and license agreement with Baxter Healthcare SA, the predecessor in interest to Baxalta, pursuant to which the Company granted an exclusive, royalty-bearing license for the research, development, commercialization and manufacture (in specified instances) of rigosertib in all therapeutic indications in Europe. In accordance with this agreement, the Company received an upfront cash payment of $50,000,000 in 2012. On March 3, 2016, the Company received a notification of Baxalta’s election to terminate the development and license agreement based on a strategic reprioritization review, effective August 30, 2016, at which time, the rights licensed to Baxalta reverted to the Company at no cost. Additionally, any rights the Company had to funding, pre-commercial milestone payments and royalties from Baxalta terminated in accordance with the agreement. Among other things, the Baxalta agreement contemplated development of rigosertib IV in higher-risk MDS patients, through the Company’s ONTIME trial and, potentially, additional Phase 3 clinical trials. The ONTIME trial did not achieve its primary endpoint and the Company is continuing the development of rigosertib IV in higher-risk MDS patients through its INSPIRE trial. In accordance with the agreement, the Company elected to have Baxalta fund fifty percent of the costs of the INSPIRE trial, up to $15.0 million. The funding from Baxalta terminated effective August 30, 2016. The Company recorded revenue related to Baxalta’s funding of the INSPIRE trial of $1,538,000 and $4,857,000 during the three and nine months ended September 30, 2016, respectively. The Company has overall responsibility for the trial, including determination of the trial specifications, selection of third party service providers and payment for all services and materials. SymBio Agreement In July 2011, the Company entered into a license agreement with SymBio, which has been 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. |
Preclinical Collaboration
Preclinical Collaboration | 9 Months Ended |
Sep. 30, 2017 | |
Preclinical Collaboration | |
Preclinical Collaboration | 11. Preclinical Collaboration In December 2012, the Company agreed to form GBO, an entity owned by the Company and GVK. The purpose of GBO is to collaborate on and develop two programs through filing of an investigational new drug application and/or conducting proof of concept studies using the Company’s technology platform. If a program failure occurs for one or both programs, the Company may contribute additional assets to GBO to establish a replacement program or programs. During 2013, GVK 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 sublicense 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 may make additional capital contributions. The GVK 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 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 the Company’s participation in the programs either with or without a change in control, GVK will be entitled to purchase or obtain the Company’s interest in GBO. GVK will have operational control of GBO and the Company will have strategic and scientific control. The two preclinical programs sublicensed to GBO have not been developed to clinical stage as initially hoped, and the Company is in discussions with GVK regarding the future of GBO. There was no activity in GBO during the nine months ended September 30, 2017 and 2016. |
Related-Party Transactions
Related-Party Transactions | 9 Months Ended |
Sep. 30, 2017 | |
Related-Party Transactions | |
Related-Party Transactions | 12. Related-Party Transactions The Company has entered into a research agreement, as subsequently amended, with the Mount Sinai School of Medicine (“Mount Sinai”), with which a member of its board of directors and a significant stockholder is affiliated. Mount Sinai is undertaking research on behalf of the Company on the terms set forth in the agreements. Mount Sinai, in connection with the Company, will prepare applications for patents generated from the research. Results from all projects will belong exclusively to Mount Sinai, but the Company will have an exclusive option to license any inventions. Payments to Mount Sinai under this research agreement for the three months ended September 30, 2017 and 2016 were $88,000 and $187,000, respectively, and for the nine months ended September 30, 2017 and 2016 were $263,000 and $374,000, respectively. At September 30, 2017 and December 31, 2016, the Company had $438,000 and $175,000, respectively, payable to Mount Sinai under this agreement. The Company has entered into a consulting agreement with a member of its board of directors, who is also a significant stockholder of the Company. The board member provides consulting services to the Company on the terms set forth in the agreement. Payments to this board member for the three months ended September 30, 2017 and 2016 were $33,000 and $33,000, respectively and for the nine months ended September 30, 2017 and 2016 were $99,000 and $99,000, respectively. At September 30, 2017 and December 31, 2016, the Company had $0 and $33,000, respectively, payable under this agreement. |
Securities Registrations and Sa
Securities Registrations and Sales Agreements | 9 Months Ended |
Sep. 30, 2017 | |
Securities Registrations and Sales Agreements | |
Securities Registrations and Sales Agreements | 13. Securities Registrations and Sales Agreements 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 was able to offer and sell shares of its Common Stock through Cantor. 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. During the year ended December 31, 2015, 2,715,165 shares were sold under the Cantor sales agreement for net proceeds of $6,018,000. The Cantor sales agreement was terminated on January 5, 2016, and there were no sales of Common Stock under this program during the year ended December 31, 2016. On October 8, 2015, the Company entered into a Purchase Agreement, and a registration rights agreement with Lincoln Park. A registration statement (Form S-1 No. 333-207533), relating to the shares, which was filed with the SEC became effective on November 3, 2015. Subject to the terms and conditions of the purchase agreement, including the effectiveness of a registration statement covering the resale of the shares, the Company may sell additional shares of its Common Stock, having an aggregate offering price of up to $15,000,000 to Lincoln Park from time to time until December 1, 2018. Upon execution of the Lincoln Park purchase agreement, Lincoln Park made an initial purchase of 84,676 shares of the Company’s Common Stock for $1,500,000. Subject to the terms and conditions of the purchase agreement, including the effectiveness of a registration statement covering the resale of the shares, the Company has the right to sell to and Lincoln Park is obligated to purchase up to an additional $15,000,000 of shares of Common Stock, subject to certain limitations, from time to time until December 1, 2018. The Company may direct Lincoln Park, at its sole discretion and subject to certain conditions, to purchase up to 10,000 shares of Common Stock on any business day, increasing to up to 25,000 shares depending upon the closing sale price of the Common Stock (such purchases, “Regular Purchases”). However, in no event shall a Regular Purchase be more than $1,000,000. The purchase price of shares of Common Stock related to the future funding will be based on the prevailing market prices of such shares at the time of sales. In addition, the Company may direct Lincoln Park to purchase additional amounts as accelerated purchases if on the date of a Regular Purchase the closing sale price of the Common Stock is not below the threshold price as set forth in the Purchase Agreement. The Company’s sales of shares of Common Stock to Lincoln Park under the Purchase Agreement were limited to no more than the number of shares that would result in the beneficial ownership by Lincoln Park and its affiliates, at any single point in time, of more than 4.99% of the then-outstanding shares of the Common Stock, which limit increased to 9.99% on May 1, 2016. Pursuant to the terms of the Lincoln Park purchase agreement and to comply with the listing rules of the NASDAQ Stock Market, the number of shares issued to Lincoln Park thereunder shall not exceed 19.99% of the Company’s shares outstanding on October 8, 2015 unless the approval of the Company’s stockholders is obtained. This limitation shall not apply if the average price paid for all shares issued and sold under the purchase agreement is equal to or greater than $15.56. The Company is not required or permitted to issue any shares of Common Stock under the Lincoln Park purchase agreement if such issuance would breach the Company’s obligations under the listing rules of the NASDAQ Stock Market. As consideration for entering into the purchase agreement, the Company issued to Lincoln Park 20,000 shares of Common Stock. Lincoln Park represented to the Company, among other things, that it was an “accredited investor” (as such term is defined in Rule 501(a) of Regulation D under the Securities Act of 1933, as amended (the “Securities Act”), and the Company sold the securities in reliance upon an exemption from registration contained in Section 4(2) under the Securities Act. The securities sold may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. The net proceeds to the Company under the Lincoln Park purchase agreement will depend on the frequency and prices at which the Company may sell shares of Common Stock to Lincoln Park. The Company expects that the proceeds received from the initial purchase and any additional proceeds from future sales to Lincoln Park will be used to fund the development of the Company’s clinical and preclinical programs, for other research and development activities and for general corporate purposes. On January 5, 2016, the Company entered into the Securities Purchase Agreement with an institutional investor providing for the issuance and sale by the Company of 193,684 shares of the Company’s Common Stock, at a purchase price of $9.50 per share and warrants to purchase up to 96,842 shares of the Company’s Common Stock for aggregate gross proceeds of $1,840,000. The Warrants will be exercisable from July 11, 2016 through July 11, 2021 at an exercise price of $11.50 per share of Common Stock, subject to customary adjustments. Net proceeds from the sale of the Common Stock and Warrants (not including any future proceeds from the exercise of the Warrants) were approximately $1,609,000 after deducting certain fees due to the placement agent and the Company’s estimated transaction expenses. The net proceeds received by the Company from the transactions will be used to fund the development of the Company’s clinical and preclinical programs, for other research and development activities and for general corporate purposes. The shares of Common Stock sold by the Company pursuant to the Securities Purchase Agreement were sold pursuant to an effective shelf registration statement on Form S-3, which was initially filed with the SEC on October 8, 2014 and subsequently declared effective on November 20, 2014 (File No. 333-199219). The Warrants were issued and sold without registration under the Securities Act in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder and in reliance on similar exemptions under applicable state laws. Accordingly, the Warrants and the shares of Common Stock underlying the Warrants may not be offered or sold except pursuant to an effective registration statement under the Securities Act or pursuant to an available exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in accordance with applicable state securities laws. These warrants are classified as liabilities because under certain specific circumstances the warrants could require cash settlement. On July 8, 2016, the Company distributed to holders of its Common Stock and to holders of certain of outstanding warrants, at no charge, non-transferable subscription rights to purchase units. Each unit consisted of one share of Common Stock and 0.75 of a tradable warrant representing the right to purchase one share of Common Stock (“Tradeable Warrants”). The offering of units pursuant to the subscription rights is referred to as the “Rights Offering.” On July 7, 2016, the Company entered into a dealer-manager agreement with Maxim Group LLC (“Maxim”), to engage Maxim as dealer-manager for the Rights Offering. In the Rights Offering, holders received 1.5 subscription rights for each share of Common Stock, or each share of Common Stock underlying participating warrants owned on the record date, July 7, 2016. Subscribers whose subscriptions otherwise would have resulted in their beneficial ownership of more than 4.99% of the Company’s Common Stock could elect to receive, in lieu of shares of Common Stock in excess of that threshold, pre-funded warrants to purchase the same number of shares of Common Stock for $0.01 (“Pre-Funded Warrants”), and the subscription price per unit consisting of a Pre-Funded Warrant in lieu of a share of Common Stock was reduced by the $0.01 exercise price. The Rights Offering closed on July 29, 2016. Gross proceeds from the offering were $17.4 million, which represents the sale of all 4,256,186, units at approximately $4.10 per unit. Net proceeds were approximately $15.8 million. The Company issued 3,599,786 shares of Common Stock, 3,192,022 Tradable Warrants and 656,400 Pre-Funded Warrants in the Rights Offering. The Tradable Warrants are exercisable for a period of five years for one share of Common Stock at an exercise price of $4.92 per share. After the one-year anniversary of issuance, the Company may redeem the Tradable Warrants for $0.001 per Tradable Warrant if the volume weighted average price of our Common Stock is above $12.30 for each of 10 consecutive trading days. On August 3, 2016, the Tradable Warrants were listed for trading on the NASDAQ Capital Market under the symbol “ONTXW.” The tradable warrants are classified as liabilities because under certain specific circumstances the warrants could require cash settlement. The Pre-Funded Warrants are exercisable for one share of Common Stock at an exercise price of $0.01. The exercise period for the Pre-Funded Warrants is seven years, which may be extended if an exercise would result in the holder’s beneficial ownership of our Common Stock exceeding 4.99%. In connection with the Rights Offering, the Company paid to Maxim a cash fee equal to (a) 4.5% of the dollar amount of the units sold to any holders of subscription rights who were beneficial owners of shares of the Company’s Common Stock prior to July 30, 2013, and (b) 8.0% of the dollar amount of the units sold to any other holders of subscription rights, plus a non-accountable expense allowance of $100,000 for expenses incurred in connection with the Rights Offering. A registration statement on Form S-1, as amended (File No. 333-211769), relating to the securities being offered and sold in connection with the Rights Offering was declared effective by the SEC on July 7, 2016. A prospectus and prospectus supplement relating to and describing the terms of the Rights Offering has been filed with the SEC as a part of the registration statement and is available on the SEC’s web site at http://www.sec.gov. In December 2016, the Company entered into a sales agreement (the “Sales Agreement”) with FBR Capital Markets & Co. (“FBR”) to create an at-the-market equity program (“ATM Program”) under which the Company from time to time may offer and sell shares of its Common Stock through FBR. The Shares to be sold under the Sales Agreement were issued and sold pursuant to the Company’s shelf registration statement on Form S-3 (File No 333-199219), previously filed with the SEC on October 8, 2014 and declared effective by the SEC on November 20, 2014. A prospectus supplement related to the Company’s ATM Program was filed with the SEC on December 5, 2016. Sales under the Sales Agreement were 20,499 shares for net proceeds of approximately $64,000. The Sales Agreement was terminated effective April 19, 2017. On April 20, 2017, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Laidlaw & Company (UK) Ltd. (“Laidlaw”), with respect to the issuance and sale in an underwritten public offering (the “Offering”) by the Company of 2,476,190 shares of Common Stock (the “Shares”), at a price to the public of $2.10 per Share. Pursuant to the Underwriting Agreement, the Company granted Laidlaw a 45-day option to purchase up to an additional 363,580 Shares. The Underwriting Agreement contained customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and Laidlaw, including for liabilities under the Securities Act of 1933, as amended (the “Securities Act”), other obligations of the parties and termination provisions. The Offering closed on April 26, 2017 and the proceeds to the Company, net of expenses, were approximately $4.6 million. On May 12, 2017, Laidlaw exercised their option to purchase 363,580 additional shares. Closing on the additional shares was May 17, 2017 and the proceeds to the Company, net of expenses, were approximately $0.7 million. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2017 | |
Subsequent Events | |
Subsequent Events | 14. Subsequent Events Subsequent to September 30, 2017 there was an increase in the fair value of the warrant liability calculated using the NASDAQ Capital Market quoted price. The fair value at September 30, 2017 was $1,686,000. The estimated fair value at November 8, 2017 is approximately $2,260,000. The estimated increase in the warrant liability would increase the Company’s net loss by approximately $574,000. |
Summary of Significant Accoun22
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2017 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The condensed consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States (“GAAP”) for interim financial information. Certain information and footnotes normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). The financial statements include the consolidated accounts of the Company, its wholly-owned subsidiary, Onconova Europe GmbH, and GBO. All significant intercompany transactions have been eliminated. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The accompanying condensed consolidated balance sheet as of September 30, 2017, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2017 and 2016, the consolidated statement of stockholders’ equity for the nine months ended September 30, 2017 and the condensed consolidated statements of cash flows for the nine months ended September 30, 2017 and 2016 are unaudited. The interim unaudited condensed consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2017, the results of its operations for the three and nine months ended September 30, 2017 and 2016, and its cash flows for the nine months ended September 30, 2017 and 2016. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2017 and 2016 are unaudited. The results for the three and nine months ended September 30, 2017 are not necessarily indicative of results to be expected for the year ending December 31, 2017, any other interim periods, or any future year or period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2016 included in the Company’s annual report on Form 10-K filed with the SEC on March 29, 2017. |
Segment Information | Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one segment, which is the identification and development of oncology therapeutics. |
Significant Accounting Policies | Significant Accounting Policies The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2016 included in the Company’s annual report on Form 10-K filed with the SEC on March 29, 2017. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies. |
Fair Value Measurements | Fair Value Measurements 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 7, “Fair Value Measurements.” |
Recent Accounting Pronouncements | Recent Accounting Pronouncements 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. Currently, the only revenue the Company is recognizing is under its license and collaboration agreements with SymBio (See Note 10). The new guidance permits the use of either a retrospective or cumulative effect transition method and is effective for interim and annual periods beginning on or after December 15, 2017. Early adoption is permitted but not before December 15, 2016. The Company expects to adopt this guidance effective January 1, 2018 and is currently reviewing its contracts with SymBio, but it has not yet selected a transition method and is 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 adopted the new guidance as of December 31, 2016. Based on its current cash position and an evaluation of expected future net cash outflows the Company has determined there is substantial doubt about its ability to continue as a going concern (See Note 1). In February 2016, the FASB issued guidance which supersedes much of the current guidance for leases. The new standard requires lessees to recognize a right-of-use asset and a lease liability on their balance sheets for all the leases with terms greater than twelve months. Based on certain criteria, leases will be classified as either financing or operating, with classification affecting the pattern of expense recognition in the income statement. For leases with a term of twelve months or less, a lessee is permitted to make an accounting policy election by class of underlying asset not to recognize lease assets and lease liabilities. If a lessee makes this election, it should recognize lease expense for such leases generally on a straight-line basis over the lease term. The guidance is effective for fiscal years beginning after December 15, 2018, and interim periods within those years, with early adoption permitted. In transition, lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. The modified retrospective approach includes a number of optional practical expedients primarily focused on leases that commenced before the effective date of the new guidance, including continuing to account for leases that commence before the effective date in accordance with previous guidance, unless the lease is modified. The Company is evaluating the impact of the adoption of the standard on its consolidated financial statements. In March 2016, the FASB issued guidance which clarifies the implementation guidance on principal versus agent considerations in the revenue recognition standard issued in May 2014. The new standard clarifies how an entity should identify the unit of accounting (i.e. the specified good or service) for the principal versus agent evaluation and how it should apply the control principle to certain types of arrangements. The effective date and transition requirements are the same as the effective date and transition requirements in the May 2014 revenue standard (Accounting Standards Codification 606). The Company is currently assessing the adoption methodology and the impact the adoption of these ASUs will have on its consolidated financial position, results of operations and related disclosures. In March 2016, the FASB issued guidance that addresses the income tax effects of stock-based payments and eliminates the windfall pool concept, as all of the tax effects related to stock-based payments will now be recorded at settlement (or expiration) through the income statement. The new guidance also permits entities to make an accounting policy election for the impact of forfeitures on the recognition of expense for stock-based payment awards. Forfeitures can be estimated or recognized when they occur. The standard is effective for annual periods beginning after December 15, 2016 and interim periods within that reporting period. Early adoption is permitted in any interim or annual period, with any adjustment reflected as of the beginning of the fiscal year of adoption. The Company adopted the new guidance as of January 1, 2017. The adoption did not have a material impact on the Company’s condensed consolidated financial statements and related disclosures. In November 2016, the FASB issued guidance requiring that amounts generally described as restricted cash and restricted cash equivalents be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The guidance is effective for interim and annual periods beginning in 2018 and should be applied using a retrospective transition method to each period presented. Early adoption is permitted. The Company is currently evaluating the effect of the standard on its Consolidated Statement of Cash Flows. |
Revenue (Tables)
Revenue (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Revenue | |
Schedule of recognized revenue under license and collaboration agreements | Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 Baxalta $ — $ $ — $ Symbio $ $ $ $ |
Net Loss Per Share of Common 24
Net Loss Per Share of Common Stock (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Net Loss Per Share of Common Stock | |
Schedule of antidilutive securities which have been excluded from the computation of diluted weighted average shares outstanding | September 30, 2017 2016 Warrants Stock options |
Warrants (Tables)
Warrants (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Warrants | |
Schedule of warrants outstanding and warrant activity | Balance Balance Exercise Expiration Decemeber 31, Warrants Warrants Warrants September 30, Description Classification Price Date 2016 Issued Exercised Expired 2017 Non-tradable warrants Liability $ July 2021 — — — Tradable warrants Liability $ July 2021 — — — Non-tradable pre-funded warrants Equity $ July 2023 — ) — — ) — |
Balance Sheet Detail (Tables)
Balance Sheet Detail (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Balance Sheet Detail | |
Schedule of prepaid expenses and other current assets | September 30, December 31, 2017 2016 Research and development $ $ Manufacturing Insurance Other $ $ |
Schedule of property and equipment | September 30, December 31, 2017 2016 Property and equipment $ $ Accumulated depreciation ) ) $ $ |
Schedule of accrued expenses and other current liabilities | September 30, December 31, 2017 2016 Research and development $ $ Employee compensation Professional fees Other — $ $ |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Fair Value Measurements | |
Schedule of Black-Scholes option pricing model assumptions | The Company estimated the fair value of the non-tradable warrant liability at September 30, 2017, using the Black-Scholes option pricing model with the following weighted-average assumptions: Risk-free interest rate 2.04% Expected volatility 76.06% Expected term 3.79 years Expected dividend yield 0% |
Schedule of financial assets and liabilities measured at fair value on a recurring basis | Fair Value Measurement as of: September 30, 2017 December 31, 2016 Level 1 Level 2 Level 3 Balance Level 1 Level 2 Level 3 Balance Tradable warrants liability $ $ — $ — $ $ — $ — $ $ Non-tradable warrants liability — — — — Total $ $ — $ $ $ — $ — $ $ |
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, 2016 $ Change in fair value upon re-measurement Balance at March 31, 2017 Reclassification of tradable warrants to Level 1 ) Change in fair value upon re-measurement ) Balance at June 30, 2017 Change in fair value upon re-measurement ) Balance at September 30, 2017 $ |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Stock-Based Compensation | |
Schedule of stock-based compensation expense | Three Months ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 General and administrative $ $ $ $ Research and development $ $ $ $ |
Schedule of stock option activity | Options Outstanding Shares Number of Weighted- Weighted Aggregate Balance, December 31, 2016 $ $ 0 Authorized — Granted ) $ Exercised — — $ — Forfeitures ) $ Balance, September 30, 2017 $ $ Vested or expected to vest, September 30, 2017 $ $ Exercisable at September 30, 2017 $ $ |
Schedule of information with respect to stock options outstanding and exercisable | Information with respect to stock options outstanding and exercisable at September 30, 2017 is as follows: Exercise Price Shares Exercisable $1.94 - $6.50 $14.80 - $15.00 $23.20 - $39.80 $43.40 - $75.30 $132.80 - $151.20 $277.10 - $291.40 |
Schedule of weighted-average assumptions used for estimating the fair value of the stock compensation granted | Nine Months ended September 30, 2017 2016 Risk-free interest rate 2.03% 1.35% Expected volatility 79.06% 75.71% Expected term 6.00 years 5.78 years Expected dividend yield 0% 0% Weighted average grant date fair value $1.77 $2.87 |
Nature of Business - Reverse St
Nature of Business - Reverse Stock Split (Details) | May 31, 2016 |
Nature of Business | |
Reverse stock split ratio | 0.1 |
Nature of Business - The Compan
Nature of Business - The Company - Clinical-stage Product Candidates (Details) | Sep. 30, 2017item |
Nature of Business | |
Number of clinical-stage product candidates | 3 |
Nature of Business - The Comp31
Nature of Business - The Company - Preclinical Collaboration (Details) - Program | Sep. 30, 2017 | Dec. 31, 2012 |
GBO | ||
Preclinical Collaboration | ||
Number of new programs to be collaborated and developed | 2 | 2 |
Nature of Business - The Comp32
Nature of Business - The Company - Reverse Stock Split (Details) | May 31, 2016$ / sharesshares | Sep. 30, 2017$ / sharesshares | Dec. 31, 2016$ / sharesshares | May 30, 2016shares |
Nature of Business | ||||
Reverse stock split ratio | 0.1 | |||
Common Stock, par value per share (in dollars per share) | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | |
Common Stock authorized (in shares) | shares | 25,000,000 | 25,000,000 | 25,000,000 | 75,000,000 |
Nature of Business - Liquidity
Nature of Business - Liquidity - Financial Statement Items (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | Dec. 31, 2015 | |
Nature of Business | ||||||
Net loss | $ (6,961) | $ (1,599) | $ (17,885) | $ (14,220) | ||
Accumulated deficit | 356,109 | 356,109 | $ 338,224 | |||
Cash and cash equivalents | $ 7,600 | $ 25,778 | $ 7,600 | $ 25,778 | $ 21,400 | $ 19,799 |
Nature of Business - Liquidit34
Nature of Business - Liquidity - Sale of Stock (Details) - IPO $ / shares in Units, $ in Thousands | Jul. 30, 2013USD ($)$ / sharesshares |
Sale of Securities | |
Issuance of stock (in shares) | shares | 594,167 |
Price per share (in dollars per share) | $ / shares | $ 150 |
Proceeds from initial public offering of common stock, net of issuance costs | $ | $ 79,811 |
Nature of Business - Liquidit35
Nature of Business - Liquidity - Sales and Purchase Agreements (Details) - USD ($) $ in Thousands | Oct. 08, 2015 | Oct. 31, 2015 | Oct. 31, 2014 | Dec. 31, 2016 | Dec. 31, 2015 |
At-the-market equity program | |||||
Sale of Securities | |||||
Aggregate offering price | $ 20,000 | ||||
Net proceeds from sales of common stock | $ 6,018 | ||||
Issuance of stock (in shares) | 0 | 2,715,165 | |||
Purchase agreement | Lincoln Park | |||||
Sale of Securities | |||||
Aggregate offering price | $ 15,000 | $ 15,000 | |||
Net proceeds from sales of common stock | $ 1,500 | $ 1,500 | |||
Issuance of stock (in shares) | 84,676 | 84,676 |
Nature of Business - Liquidit36
Nature of Business - Liquidity - Securities Purchase Agreement (Details) - Securities Purchase Agreement $ in Thousands | Jan. 05, 2016USD ($)shares |
Sale of Securities | |
Issuance of stock (in shares) | 193,684 |
Aggregate net proceeds | $ | $ 1,609 |
Common Stock Warrants | |
Sale of Securities | |
Shares of common stock warrants will purchase (in shares) | 96,842 |
Nature of Business - Liquidit37
Nature of Business - Liquidity - Rights Offering (Details) - Dealer-Manager Agreement, rights offering $ in Millions | Jul. 29, 2016USD ($)shares |
Sale of Securities | |
Issuance of stock (in shares) | 3,599,786 |
Aggregate net proceeds | $ | $ 15.8 |
Tradable warrants | |
Sale of Securities | |
Warrants issued (in shares) | 3,192,022 |
Pre-funded warrants | |
Sale of Securities | |
Warrants issued (in shares) | 656,400 |
Nature of Business - Liquidit38
Nature of Business - Liquidity - Underwritten Public Offering (Details) - USD ($) $ in Millions | May 17, 2017 | May 12, 2017 | Apr. 26, 2017 |
The Offering | |||
Subsidiary, Sale of Stock [Line Items] | |||
Issuance of stock (in shares) | 2,476,190 | ||
Net proceeds from sales of common stock | $ 5.3 | $ 4.6 | |
Underwriter's option | Laidlaw | |||
Subsidiary, Sale of Stock [Line Items] | |||
Issuance of stock (in shares) | 363,580 | ||
Net proceeds from sales of common stock | $ 0.7 | ||
Underwriter's option | Laidlaw | Maximum | |||
Subsidiary, Sale of Stock [Line Items] | |||
Issuance of stock (in shares) | 363,580 |
Summary of Significant Accoun39
Summary of Significant Accounting Policies (Details) | 9 Months Ended |
Sep. 30, 2017segment | |
Segment Information | |
Number of operating segments | 1 |
Revenue (Details)
Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Revenue | ||||
Revenues | $ 110 | $ 1,651 | $ 644 | $ 5,373 |
License and collaboration | ||||
Revenue | ||||
Revenues | 110 | 1,651 | 644 | 5,373 |
Baxalta | License and collaboration | ||||
Revenue | ||||
Revenues | 1,538 | 4,857 | ||
SymBio | License and collaboration | ||||
Revenue | ||||
Revenues | $ 110 | $ 113 | $ 644 | $ 516 |
Net Loss Per Share of Common 41
Net Loss Per Share of Common Stock (Details) - shares | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
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 | 4,202,144 | 4,234,998 |
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 | 3,294,771 | 3,525,771 |
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 | 907,373 | 709,227 |
Warrants (Details)
Warrants (Details) | 9 Months Ended |
Sep. 30, 2017$ / sharesshares | |
Warrants outstanding and warrant activity | |
Balance at beginning of the period (in shares) | 3,525,771 |
Warrants Exercised (in shares) | (231,000) |
Balance at end of the period (in shares) | 3,294,771 |
Non-tradable warrants expiring July 2021, liability | |
Warrants | |
Exercise Price (in dollars per share) | $ / shares | $ 11.50 |
Warrants outstanding and warrant activity | |
Balance at beginning of the period (in shares) | 96,842 |
Balance at end of the period (in shares) | 96,842 |
Tradable warrants expiring July 2021, liability | |
Warrants | |
Exercise Price (in dollars per share) | $ / shares | $ 4.92 |
Warrants outstanding and warrant activity | |
Balance at beginning of the period (in shares) | 3,192,022 |
Balance at end of the period (in shares) | 3,192,022 |
Non-tradable pre-funded warrants expiring July 2023, equity | |
Warrants | |
Exercise Price (in dollars per share) | $ / shares | $ 0.01 |
Warrants outstanding and warrant activity | |
Balance at beginning of the period (in shares) | 236,907 |
Warrants Exercised (in shares) | (231,000) |
Balance at end of the period (in shares) | 5,907 |
Balance Sheet Detail - Prepaid
Balance Sheet Detail - Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Prepaid expenses and other current assets: | ||
Research and development | $ 632 | $ 1,075 |
Manufacturing | 43 | 90 |
Insurance | 204 | 350 |
Other | 121 | 73 |
Total | $ 1,000 | $ 1,588 |
Balance Sheet Detail - Property
Balance Sheet Detail - Property and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Property and equipment: | ||
Property and equipment | $ 2,228 | $ 2,228 |
Accumulated depreciation | (2,145) | (2,076) |
Property and equipment, net | $ 83 | $ 152 |
Balance Sheet Detail - Accrued
Balance Sheet Detail - Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Accrued expenses and other current liabilities: | ||
Research and development | $ 1,982 | $ 2,376 |
Employee compensation | 945 | 1,573 |
Professional fees | 171 | 235 |
Other | 198 | |
Total | $ 3,098 | $ 4,382 |
Fair Value Measurements - Secur
Fair Value Measurements - Securities Purchase Agreement (Details) - Securities Purchase Agreement $ / shares in Units, $ in Thousands | Jan. 05, 2016USD ($)$ / sharesshares |
Sale of Securities | |
Issuance of stock (in shares) | 193,684 |
Share price (in dollars per share) | $ / shares | $ 9.50 |
Aggregate gross proceeds | $ | $ 1,840 |
Common Stock Warrants | |
Sale of Securities | |
Shares of common stock warrants will purchase (in shares) | 96,842 |
Fair Value Measurements - Right
Fair Value Measurements - Rights Offering (Details) - Dealer-Manager Agreement, rights offering | Jul. 29, 2016$ / sharesshares |
Sale of Securities | |
Issuance of stock (in shares) | 3,599,786 |
Tradable warrants | |
Sale of Securities | |
Rights or warrants issued (in shares) | 3,192,022 |
Exercisable, term (in years) | 5 years |
Shares into which each warrant can be converted (in shares) | 1 |
Exercise price (in dollars per share) | $ / shares | $ 4.92 |
Redemption period (in years) | 1 year |
Redemption price (in dollars per share) | $ / shares | $ 0.001 |
Volume weighted average price per share of common stock (in dollars per share) | $ / shares | $ 12.30 |
Threshold consecutive trading days (in days) | 10 days |
Pre-funded warrants | |
Sale of Securities | |
Rights or warrants issued (in shares) | 656,400 |
Shares into which each warrant can be converted (in shares) | 1 |
Exercise price (in dollars per share) | $ / shares | $ 0.01 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value Assumptions (Details) | 9 Months Ended |
Sep. 30, 2017 | |
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) | 2.04% |
Expected volatility (as a percent) | 76.06% |
Expected term | 3 years 9 months 15 days |
Expected dividend yield (as a percent) | 0.00% |
Fair Value Measurements - Fai49
Fair Value Measurements - Fair Value Hierarchy Table (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Liabilities measured at fair value | ||
Warrant liability | $ 1,686 | |
Tradable warrants | ||
Liabilities measured at fair value | ||
Warrant liability | 1,659 | $ 3,338 |
Level 1 | Tradable warrants | ||
Liabilities measured at fair value | ||
Warrant liability | 1,659 | |
Level 3 | Tradable warrants | ||
Liabilities measured at fair value | ||
Warrant liability | 3,338 | |
Recurring basis | ||
Liabilities measured at fair value | ||
Total | 1,686 | 3,401 |
Recurring basis | Non-tradable Warrants | ||
Liabilities measured at fair value | ||
Warrant liability | 27 | 63 |
Recurring basis | Level 1 | ||
Liabilities measured at fair value | ||
Total | 1,659 | |
Recurring basis | Level 3 | ||
Liabilities measured at fair value | ||
Total | 27 | 3,401 |
Recurring basis | Level 3 | Non-tradable Warrants | ||
Liabilities measured at fair value | ||
Warrant liability | $ 27 | $ 63 |
Fair Value Measurements - Recon
Fair Value Measurements - Reconciliation of Level 3 Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Jun. 30, 2017 | Mar. 31, 2017 | Sep. 30, 2017 | |
Reconciliation of the warrant liability measured at fair value | |||
Balance at the beginning of the period | $ 4,950 | $ 3,401 | $ 3,401 |
Reclassification of tradable warrants to Level 1 | (4,857) | ||
Change in fair value upon re-measurement | (53) | 1,549 | (13) |
Balance at the end of the period | $ 40 | $ 4,950 | $ 27 |
Fair Value Measurements - Trans
Fair Value Measurements - Transfers (Details) $ in Thousands | Sep. 30, 2017USD ($) |
Fair Value Measurements | |
Amount of transfers of assets out of Level 1 into Level 2 | $ 0 |
Amount of transfers of assets out of Level 2 into Level 1 | 0 |
Amount of transfers of liabilities out of Level 1 into Level 2 | 0 |
Amount of transfers of liabilities out of Level 2 into Level 1 | $ 0 |
Stock-Based Compensation - Comm
Stock-Based Compensation - Common Stock Reserved for Issuance and Shares Available for Future Issuance (Details) - Stock options - shares | Sep. 30, 2017 | Dec. 31, 2016 | Jul. 31, 2013 |
Stock-Based Compensation | |||
Common Stock reserved for issuance (in shares) | 610,783 | ||
Evergreen provision, percentage of issued and outstanding common stock (as a percent) | 4.00% | ||
Evergreen provision, shares (in shares) | 200,000 | ||
Common Stock available for future issuance (in shares) | 45,255 | 6,275 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Stock-Based Compensation | ||||
Net tax benefits related to the stock-based compensation costs | $ 0 | |||
Total stock-based compensation | $ 431 | $ 576 | 1,333 | $ 3,357 |
General and administrative | ||||
Stock-Based Compensation | ||||
Total stock-based compensation | 251 | 288 | 770 | 1,571 |
Research and development | ||||
Stock-Based Compensation | ||||
Total stock-based compensation | $ 180 | $ 288 | $ 563 | $ 1,786 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Details) - Stock options - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2017 | Dec. 31, 2016 | |
Shares Available for Grant | ||
Balance at the beginning of the period (in shares) | 6,275 | |
Authorized (in shares) | 200,000 | |
Granted (in shares) | (196,811) | |
Forfeitures (in shares) | (35,791) | |
Balance at the end of the period (in shares) | 45,255 | 6,275 |
Number of Shares | ||
Balance at the beginning of the period (in shares) | 746,353 | |
Granted (in shares) | (196,811) | |
Forfeitures (in shares) | (35,791) | |
Balance at the end of the period (in shares) | 907,373 | 746,353 |
Vested or expected to vest at the end of the period (in shares) | 893,634 | |
Exercisable at the end of the period (in shares) | 575,522 | |
Weighted-Average Exercise Price | ||
Balance at the beginning of the period (in dollars per share) | $ 53.50 | |
Granted (in dollars per share) | 2.58 | |
Forfeitures (in dollars per share) | 88.27 | |
Balance at the end of the period (in dollars per share) | 41.09 | $ 53.50 |
Vested or expected to vest at the end of the period (in dollars per share) | 60.82 | |
Exercisable at the end of the period (in dollars per share) | $ 60.82 | |
Additional Disclosures | ||
Weighted average remaining contractual term | 7 years 6 months 22 days | 7 years 8 months 12 days |
Weighted average remaining contractual term of options vested or expected to vest | 6 years 9 months | |
Weighted average remaining contractual term of options exercisable | 6 years 9 months | |
Aggregate intrinsic value of options outstanding | $ 0 | $ 0 |
Aggregate intrinsic value of options vested or expected to vest | 0 | |
Aggregate intrinsic value of options exercisable | $ 0 |
Stock-Based Compensation - St55
Stock-Based Compensation - Stock Options Outstanding and Exercisable (Details) - Stock options | 9 Months Ended |
Sep. 30, 2017$ / sharesshares | |
Share-Based Compensation | |
Shares (in shares) | 907,373 |
Exercisable (in shares) | 575,522 |
Exercise Price Range $1.94 - $6.50 | |
Share-Based Compensation | |
Exercise price, lower range limit (in dollars per share) | $ / shares | $ 1.94 |
Exercise price, upper range limit (in dollars per share) | $ / shares | $ 6.50 |
Shares (in shares) | 487,578 |
Exercisable (in shares) | 200,294 |
Exercise Price Range $14.80 - $15.00 | |
Share-Based Compensation | |
Exercise price, lower range limit (in dollars per share) | $ / shares | $ 14.80 |
Exercise price, upper range limit (in dollars per share) | $ / shares | $ 15 |
Shares (in shares) | 37,550 |
Exercisable (in shares) | 23,787 |
Exercise Price Range $23.20 - $39.80 | |
Share-Based Compensation | |
Exercise price, lower range limit (in dollars per share) | $ / shares | $ 23.20 |
Exercise price, upper range limit (in dollars per share) | $ / shares | $ 39.80 |
Shares (in shares) | 101,064 |
Exercisable (in shares) | 77,076 |
Exercise Price Range $43.40 - $75.30 | |
Share-Based Compensation | |
Exercise price, lower range limit (in dollars per share) | $ / shares | $ 43.40 |
Exercise price, upper range limit (in dollars per share) | $ / shares | $ 75.30 |
Shares (in shares) | 98,123 |
Exercisable (in shares) | 93,349 |
Exercise Price Range $132.80 - $151.20 | |
Share-Based Compensation | |
Exercise price, lower range limit (in dollars per share) | $ / shares | $ 132.80 |
Exercise price, upper range limit (in dollars per share) | $ / shares | $ 151.20 |
Shares (in shares) | 177,708 |
Exercisable (in shares) | 175,666 |
Exercise Price Range $277.10 - $291.40 | |
Share-Based Compensation | |
Exercise price, lower range limit (in dollars per share) | $ / shares | $ 277.10 |
Exercise price, upper range limit (in dollars per share) | $ / shares | $ 291.40 |
Shares (in shares) | 5,350 |
Exercisable (in shares) | 5,350 |
Stock-Based Compensation - Opti
Stock-Based Compensation - Options Granted after April 23, 2013 - Unrecognized Compensation Expense (Details) - Options granted after April 23, 2013 - Stock options $ in Thousands | 9 Months Ended |
Sep. 30, 2017USD ($) | |
Stock-Based Compensation | |
Unrecognized compensation expense related to unvested stock options | $ 1,414 |
Weighted-average period for recognizing unrecognized compensation expense related to unvested stock options (in years) | 1 year 9 months 29 days |
Stock-Based Compensation - Op57
Stock-Based Compensation - Options Granted after April 23, 2013 - Fair Value Assumptions (Details) - Options granted after April 23, 2013 - Stock options - $ / shares | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Assumptions used | ||
Risk-free interest rate (as a percent) | 2.03% | 1.35% |
Expected volatility (as a percent) | 79.06% | 75.71% |
Expected term (in years) | 6 years | 5 years 9 months 11 days |
Expected dividend yield (as a percent) | 0.00% | 0.00% |
Weighted average grant fair value (in dollars per share) | $ 1.77 | $ 2.87 |
Annualized forfeiture rate (as a percent) | 4.14% | 4.14% |
Stock-Based Compensation - Op58
Stock-Based Compensation - Options Granted through April 23, 2013 (Details) - Stock options - 2007 Plan - Options granted through April 23, 2013 - USD ($) | Apr. 23, 2013 | Sep. 30, 2017 |
Stock-Based Compensation | ||
Reclassification to stockholders' deficit | $ 14,482,000 | |
Unrecognized compensation expense of unvested liability awards | $ 0 |
Research Agreements (Details)
Research Agreements (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2017USD ($) | |
Temple | |
Research Agreements | |
Sales generated from products covered by the licensed patents | $ 0 |
License and Collaboration Agr60
License and Collaboration Agreements - Baxalta Agreement (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2012 | Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
License and collaboration agreements | |||||
Revenue | $ 110 | $ 1,651 | $ 644 | $ 5,373 | |
License agreement | Rigosertib | Baxalta | |||||
License and collaboration agreements | |||||
Upfront payment | $ 50,000 | ||||
Revenue | $ 1,538 | $ 4,857 | |||
License agreement | Rigosertib | Baxalta | Rigosertib IV in higher risk MDS patients | |||||
License and collaboration agreements | |||||
Funding percentage to the entity (as a percent) | 50.00% | ||||
Cost funded to the entity | $ 15,000 |
License and Collaboration Agr61
License and Collaboration Agreements - SymBio Agreement (Details) - Rigosertib - SymBio $ in Thousands | 1 Months Ended |
Jul. 31, 2011USD ($) | |
License agreement | |
License and collaboration agreements | |
Upfront payment | $ 7,500 |
Aggregate milestone payments | 22,000 |
Aggregate potential milestone payments based on annual net sales of rigosertib | $ 30,000 |
Percentage of royalty payments based on net sales of rigosertib (as a percent) | 20.00% |
Supply commitment agreement | |
License and collaboration agreements | |
Binding commitments | $ 0 |
United States and Japan | License agreement | |
License and collaboration agreements | |
Aggregate milestone payments due upon receipt of marketing approval for an additional indication | 4,000 |
United States | License agreement | MDS IV indication | |
License and collaboration agreements | |
Regulatory milestones payments due upon receipt of marketing approval for indication | 5,000 |
United States | License agreement | Rigosertib oral in lower risk MDS patients | |
License and collaboration agreements | |
Regulatory milestones payments due upon receipt of marketing approval for indication | 5,000 |
Japan | License agreement | MDS IV indication | |
License and collaboration agreements | |
Regulatory milestones payments due upon receipt of marketing approval for indication | 3,000 |
Japan | License agreement | Rigosertib oral in lower risk MDS patients | |
License and collaboration agreements | |
Regulatory milestones payments due upon receipt of marketing approval for indication | $ 5,000 |
Preclinical Collaboration (Deta
Preclinical Collaboration (Details) - GBO $ in Thousands | 1 Months Ended | 9 Months Ended | 12 Months Ended | |
Nov. 30, 2014USD ($) | Sep. 30, 2017Programitem | Dec. 31, 2013USD ($) | Dec. 31, 2012Program | |
Preclinical Collaboration | ||||
Number of new programs to be collaborated and developed | Program | 2 | 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 | item | 3 | |||
GVK BIO | ||||
Preclinical Collaboration | ||||
Initial capital contribution | $ 500 | |||
Ownership interest in the joint venture (as a percent) | 17.50% | 10.00% | ||
Additional capital contributions | $ 500 | |||
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% |
Related-Party Transactions (Det
Related-Party Transactions (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | |
Mount Sinai | |||||
Related-Party Transactions | |||||
Payments to related party | $ 88 | $ 187 | $ 263 | $ 374 | |
Amounts due to related party | 438 | 438 | $ 175 | ||
Member of board of directors | |||||
Related-Party Transactions | |||||
Payments to related party | 33 | $ 33 | 99 | $ 99 | |
Amounts due to related party | $ 0 | $ 0 | $ 33 |
Securities Registrations and 64
Securities Registrations and Sales Agreements - Sales and Purchase Agreements (Details) - USD ($) $ / shares in Units, $ in Thousands | Oct. 08, 2015 | Oct. 31, 2015 | Oct. 31, 2014 | Dec. 31, 2016 | Dec. 31, 2015 |
At-the-market equity program | |||||
Securities Registrations and Sales Agreement | |||||
Issuance of stock (in shares) | 0 | 2,715,165 | |||
Aggregate offering price | $ 20,000 | ||||
Net proceeds from sales of common stock | $ 6,018 | ||||
Lincoln Park | Purchase agreement | |||||
Securities Registrations and Sales Agreement | |||||
Issuance of stock (in shares) | 84,676 | 84,676 | |||
Aggregate offering price | $ 15,000 | $ 15,000 | |||
Net proceeds from sales of common stock | $ 1,500 | $ 1,500 | |||
Business day limit (in shares) | 10,000 | ||||
Business day limit contingent upon the closing price of the stock (in shares) | 25,000 | ||||
Regular purchase, one day limit | $ 1,000 | ||||
Beneficial ownership percentage (as a percent) | 4.99% | ||||
Beneficial ownership percentage after 180 days (as a percent) | 9.99% | ||||
Maximum shares issued as a percentage of shares outstanding (as a percent) | 19.99% | ||||
Minimum average price per share (in dollars per share) | $ 15.56 | ||||
Stock issued as consideration (in shares) | 20,000 |
Securities Registrations and 65
Securities Registrations and Sales Agreements - Securities Purchase Agreement (Details) - USD ($) $ / shares in Units, $ in Thousands | Jan. 05, 2016 | Sep. 30, 2017 |
Sale of Securities | ||
Value of stock issued | $ 5,317 | |
Securities Purchase Agreement | ||
Sale of Securities | ||
Issuance of stock (in shares) | 193,684 | |
Share price (in dollars per share) | $ 9.50 | |
Aggregate net proceeds | $ 1,609 | |
Securities Purchase Agreement | Common Stock Warrants | ||
Sale of Securities | ||
Shares of common stock warrants will purchase (in shares) | 96,842 | |
Value of stock issued | $ 1,840 | |
Exercise price (in dollars per share) | $ 11.50 |
Securities Registrations and 66
Securities Registrations and Sales Agreements - Warrants and Rights Offering (Details) - USD ($) | Jul. 29, 2016 | Dec. 31, 2016 | Sep. 30, 2017 | Sep. 30, 2016 |
Sale of Securities | ||||
Gross proceeds | $ 5,317,000 | $ 17,421,000 | ||
Dealer-Manager Agreement, rights offering | ||||
Sale of Securities | ||||
Beneficial ownership percentage threshold, elect to receive, in lieu of shares of common stock, certain pre-funded warrants to purchase the same amount of shares of common stock (as a percent) | 4.99% | |||
Gross proceeds | $ 17,400,000 | |||
Aggregate net proceeds | $ 15,800,000 | |||
Issuance of stock (in shares) | 3,599,786 | |||
Percentage of value of units sold to holders of subscription rights (as a percent) | 4.50% | |||
Percentage of value of units sold to other holders of subscription rights (as a percent) | 8.00% | |||
Non-accountable expense allowance paid | $ 100,000 | |||
FBR Capital Markets and Co. | ATM Program | ||||
Sale of Securities | ||||
Issuance of stock (in shares) | 20,499 | |||
Net proceeds from sales of common stock | $ 64,000 | |||
Non-transferrable Subscription Rights | Dealer-Manager Agreement, rights offering | ||||
Sale of Securities | ||||
Shares of common stock per unit (in shares) | 1 | |||
Tradable warrants per unit (in shares) | 0.75 | |||
Number of rights issued per share of common stock (in shares) | 1.5 | |||
Sale price per unit (in dollars per share) | $ 4.10 | |||
Rights or warrants issued (in shares) | 4,256,186 | |||
Tradable warrants | Dealer-Manager Agreement, rights offering | ||||
Sale of Securities | ||||
Shares into which each warrant can be converted (in shares) | 1 | |||
Exercise price (in dollars per share) | $ 4.92 | |||
Rights or warrants issued (in shares) | 3,192,022 | |||
Exercisable, term (in years) | 5 years | |||
Redemption period (in years) | 1 year | |||
Redemption price (in dollars per share) | $ 0.001 | |||
Volume weighted average price per share of common stock (in dollars per share) | $ 12.30 | |||
Threshold consecutive trading days (in days) | 10 days | |||
Pre-funded warrants | Dealer-Manager Agreement, rights offering | ||||
Sale of Securities | ||||
Shares into which each warrant can be converted (in shares) | 1 | |||
Beneficial ownership percentage threshold, extend exercise period (as a percent) | 4.99% | |||
Exercise price (in dollars per share) | $ 0.01 | |||
Rights or warrants issued (in shares) | 656,400 | |||
Exercise, term (in years) | 7 years |
Securities Registrations and 67
Securities Registrations and Sales Agreements - underwriting agreement (Details) - USD ($) $ / shares in Units, $ in Millions | May 17, 2017 | May 12, 2017 | Apr. 26, 2017 |
The Offering | |||
Issuance of stock (in shares) | 2,476,190 | ||
Share price (in dollars per share) | $ 2.10 | ||
Net proceeds from sales of common stock | $ 5.3 | $ 4.6 | |
Laidlaw | Underwriter's option | |||
Issuance of stock (in shares) | 363,580 | ||
Period available to underwriters to purchase additional shares under the offering | 45 days | ||
Net proceeds from sales of common stock | $ 0.7 | ||
Maximum | Laidlaw | Underwriter's option | |||
Issuance of stock (in shares) | 363,580 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ in Thousands | Nov. 08, 2017 | Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 |
Subsequent Events | |||||
Fair value of warrant liability | $ 1,686 | $ 1,686 | |||
Change in fair value of warrant liabilities | $ 210 | $ (2,706) | $ (1,716) | $ (2,985) | |
Subsequent Events | |||||
Subsequent Events | |||||
Fair value of warrant liability | $ 2,260 | ||||
Change in fair value of warrant liabilities | $ 574 |