Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2019 | Nov. 01, 2019 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2019 | |
Amendment Flag | false | |
Entity Registrant Name | Onconova Therapeutics, Inc. | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 8,197,462 | |
Entity Central Index Key | 0001130598 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q3 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 4,821,000 | $ 16,970,000 |
Receivables | 23,000 | 35,000 |
Prepaid expenses and other current assets | 957,000 | 760,000 |
Total current assets | 5,801,000 | 17,765,000 |
Property and equipment, net | 54,000 | 9,000 |
Other non-current assets | 150,000 | 149,000 |
Total assets | 6,005,000 | 17,923,000 |
Current liabilities: | ||
Accounts payable | 4,524,000 | 4,039,000 |
Accrued expenses and other current liabilities | 3,448,000 | 4,173,000 |
Deferred revenue | 226,000 | 226,000 |
Total current liabilities | 8,198,000 | 8,438,000 |
Warrant liability | 96,000 | 176,000 |
Deferred revenue, non-current | 3,752,000 | 3,922,000 |
Total liabilities | 12,046,000 | 12,536,000 |
Commitments and contingencies | ||
Stockholders' (deficit) equity: | ||
Preferred stock, $0.01 par value, 5,000,000 authorized at September 30, 2019 and December 31, 2018, none issued and outstanding at September 30, 2019 and December 31, 2018 | ||
Common stock, $0.01 par value, 250,000,000 authorized at September 30, 2019 and December 31, 2018, 8,197,462 and 5,674,220 shares issued and outstanding at September 30, 2019 and December 31, 2018 | 82,000 | 57,000 |
Additional paid in capital | 391,556,000 | 387,238,000 |
Accumulated other comprehensive loss | (27,000) | (12,000) |
Accumulated deficit | (397,652,000) | (381,896,000) |
Total Onconova Therapeutics, Inc. stockholders' (deficit) equity | (6,041,000) | 5,387,000 |
Total stockholders' (deficit) equity | (6,041,000) | 5,387,000 |
Total liabilities and stockholders' (deficit) equity | $ 6,005,000 | $ 17,923,000 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 |
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 | 250,000,000 | 250,000,000 |
Common stock, shares issued | 8,197,462 | 5,674,220 |
Common stock, shares outstanding | 8,197,462 | 5,674,220 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Condensed Consolidated Statements of Operations | ||||
Revenue | $ 63,000 | $ 120,000 | $ 2,153,000 | $ 1,169,000 |
Operating expenses: | ||||
General and administrative | 1,640,000 | 1,729,000 | 6,634,000 | 5,672,000 |
Research and development | 3,521,000 | 3,985,000 | 11,490,000 | 12,632,000 |
Total operating expenses | 5,161,000 | 5,714,000 | 18,124,000 | 18,304,000 |
Loss from operations | (5,098,000) | (5,594,000) | (15,971,000) | (17,135,000) |
Gain on dissolution of GBO | 693,000 | |||
Change in fair value of warrant liability | 476,000 | 129,000 | 80,000 | 1,454,000 |
Other income, net | 27,000 | 117,000 | 135,000 | 229,000 |
Net loss | (4,595,000) | (5,348,000) | (15,756,000) | (14,759,000) |
Net loss attributable to non-controlling interest | 163,000 | |||
Net loss attributable to Onconova Therapeutics, Inc. | $ (4,595,000) | $ (5,348,000) | $ (15,756,000) | $ (14,922,000) |
Net loss per share, basic and diluted | $ (0.75) | $ (0.94) | $ (2.63) | $ (4.14) |
Basic and diluted weighted average shares outstanding (in shares) | 6,141,933 | 5,674,125 | 5,994,423 | 3,601,679 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Condensed Consolidated Statements of Comprehensive Loss | ||||
Net loss | $ (4,595,000) | $ (5,348,000) | $ (15,756,000) | $ (14,759,000) |
Other comprehensive loss, before tax: | ||||
Foreign currency translation adjustments, net | (13,000) | (2,000) | (15,000) | (10,000) |
Other comprehensive loss, net of tax | (13,000) | (2,000) | (15,000) | (10,000) |
Comprehensive loss | (4,608,000) | (5,350,000) | (15,771,000) | (14,769,000) |
Comprehensive loss attributable to non-controlling interest | (163,000) | |||
Comprehensive loss attributable to Onconova Therapeutics, Inc. | $ (4,608,000) | $ (5,350,000) | $ (15,771,000) | $ (14,932,000) |
Consolidated Statement of Stock
Consolidated Statement of Stockholders' (Deficit) Equity - USD ($) | Common Stock | Additional Paid in Capital | Accumulated deficit | Accumulated other comprehensive income (loss) | Non-controlling interest | Total |
Balance at Dec. 31, 2017 | $ 8,000 | $ 350,614,000 | $ (362,316,000) | $ 3,000 | $ 830,000 | $ (10,861,000) |
Balance (in shares) at Dec. 31, 2017 | 718,078 | |||||
Increase (Decrease) in Stockholders' Equity (Deficit) | ||||||
Net loss | (14,922,000) | 163,000 | (14,759,000) | |||
Other comprehensive income (loss) | (10,000) | (10,000) | ||||
Stock-based compensation | 833,000 | 833,000 | ||||
Dissolution of GBO | 993,000 | $ (993,000) | ||||
Shares issued in connection with reverse stock split (in shares) | 101 | |||||
Issuance of common stock and pre-funded warrants, net | $ 42,000 | 35,026,000 | 35,068,000 | |||
Issuance of common stock and pre-funded warrants, net (in shares) | 4,215,581 | |||||
Issuance of common stock upon exercise of warrants | $ 7,000 | 582,000 | 589,000 | |||
Issuance of common stock upon exercise of warrants (in shares) | 740,460 | |||||
Balance at Sep. 30, 2018 | $ 57,000 | 387,055,000 | (376,245,000) | (7,000) | 10,860,000 | |
Balance (in shares) at Sep. 30, 2018 | 5,674,220 | |||||
Balance at Jun. 30, 2018 | $ 57,000 | 386,760,000 | (370,897,000) | (5,000) | 15,915,000 | |
Balance (in shares) at Jun. 30, 2018 | 5,674,119 | |||||
Increase (Decrease) in Stockholders' Equity (Deficit) | ||||||
Net loss | (5,348,000) | (5,348,000) | ||||
Other comprehensive income (loss) | (2,000) | (2,000) | ||||
Stock-based compensation | 295,000 | 295,000 | ||||
Shares issued in connection with reverse stock split (in shares) | 101 | |||||
Balance at Sep. 30, 2018 | $ 57,000 | 387,055,000 | (376,245,000) | (7,000) | 10,860,000 | |
Balance (in shares) at Sep. 30, 2018 | 5,674,220 | |||||
Balance at Dec. 31, 2018 | $ 57,000 | 387,238,000 | (381,896,000) | (12,000) | $ 5,387,000 | |
Balance (in shares) at Dec. 31, 2018 | 5,674,220 | 5,674,220 | ||||
Increase (Decrease) in Stockholders' Equity (Deficit) | ||||||
Net loss | (15,756,000) | $ (15,756,000) | ||||
Other comprehensive income (loss) | (15,000) | (15,000) | ||||
Stock-based compensation | 950,000 | 950,000 | ||||
Issuance of common stock | $ 23,000 | 3,337,000 | 3,360,000 | |||
Issuance of common stock (in shares) | 2,302,458 | |||||
Issuance of common stock upon exercise of warrants | $ 2,000 | 31,000 | 33,000 | |||
Issuance of common stock upon exercise of warrants (in shares) | 220,784 | |||||
Balance at Sep. 30, 2019 | $ 82,000 | 391,556,000 | (397,652,000) | (27,000) | $ (6,041,000) | |
Balance (in shares) at Sep. 30, 2019 | 8,197,462 | 8,197,462 | ||||
Balance at Jun. 30, 2019 | $ 60,000 | 388,465,000 | (393,057,000) | (14,000) | $ (4,546,000) | |
Balance (in shares) at Jun. 30, 2019 | 5,998,524 | |||||
Increase (Decrease) in Stockholders' Equity (Deficit) | ||||||
Net loss | (4,595,000) | (4,595,000) | ||||
Other comprehensive income (loss) | (13,000) | (13,000) | ||||
Stock-based compensation | 145,000 | 145,000 | ||||
Issuance of common stock | $ 22,000 | 2,946,000 | 2,968,000 | |||
Issuance of common stock (in shares) | 2,198,938 | |||||
Balance at Sep. 30, 2019 | $ 82,000 | $ 391,556,000 | $ (397,652,000) | $ (27,000) | $ (6,041,000) | |
Balance (in shares) at Sep. 30, 2019 | 8,197,462 | 8,197,462 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Operating activities: | ||
Net loss | $ (15,756,000) | $ (14,759,000) |
Adjustment to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 11,000 | 44,000 |
Change in fair value of warrant liabilities | (80,000) | (1,454,000) |
Stock compensation expense | 950,000 | 833,000 |
Gain on dissolution of GBO | (693,000) | |
Changes in assets and liabilities: | ||
Receivables | 12,000 | 35,000 |
Prepaid expenses and other current assets | (198,000) | 124,000 |
Accounts payable | 485,000 | (1,229,000) |
Accrued expenses and other current liabilities | (725,000) | 153,000 |
Deferred revenue | (170,000) | (341,000) |
Net cash used in operating activities | (15,471,000) | (17,287,000) |
Investing activities: | ||
Payments for purchase of property and equipment | (56,000) | |
Net cash used in investing activities | (56,000) | |
Financing activities: | ||
Proceeds from the sale of common stock and warrants, net of costs | 3,360,000 | 35,068,000 |
Proceeds from the exercise of warrants | 33,000 | 589,000 |
Net cash provided by financing activities | 3,393,000 | 35,657,000 |
Effect of foreign currency translation on cash | (15,000) | (10,000) |
Net (decrease) increase in cash and cash equivalents | (12,149,000) | 18,360,000 |
Cash and cash equivalents at beginning of period | 16,970,000 | 4,024,000 |
Cash and cash equivalents at end of period | $ 4,821,000 | $ 22,384,000 |
Nature of Business
Nature of Business | 9 Months Ended |
Sep. 30, 2019 | |
Nature of Business | |
Nature of Business | 1. Nature of Business Reverse Stock Split All common stock, equity, share and per share amounts in the financial statements and notes have been retroactively adjusted to reflect a one-for-fifteen reverse stock split which was effective September 25, 2018. 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 an extensive library of targeted anti-cancer agents designed to work against specific cellular pathways that are important to cancer cells. The Company believes that the 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. On March 2, 2018, the Company entered into a License, Development and Commercialization Agreement with Pint International SA (which, together with its affiliate Pint Pharma GmbH, are collectively referred to as “Pint”). Under the terms of the agreement, the Company granted Pint an exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how to develop and commercialize any pharmaceutical product containing rigosertib in all uses of rigosertib in certain Latin America countries. 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 December 2017, the Company entered into a license and collaboration agreement with HanX for the further development, registration and commercialization of ON 123300 in Greater China. ON 123300 is a preclinical compound which the Company believes has the potential to overcome the limitations of current generation CDK 4/6 inhibitors. The key feature of the collaboration is that HanX will provide all funding required for future Chinese IND enabling studies necessary for filing an IND with the Chinese Food and Drug Administration. The studies would be conducted to meet the Good Laboratory Practice (“GLP”) requirements of the FDA such that the Company could simultaneously file an IND with the US FDA. The Company and HanX will oversee the IND enabling studies. The Company will maintain global rights to ON 123300 outside of China. In May 2019, we entered into a License and Collaboration Agreement (the “HanX License Agreement”) with HanX Biopharmaceuticals, Inc. (“HanX”), a company focused on development of novel oncology products, and two Securities Purchase Agreements (the “HanX Securities Purchase Agreements”) one with HanX and the other with an affiliate of HanX. Under the terms of the agreements, the Company granted to HanX an exclusive, royalty bearing license to study and commercialize rigosertib in greater China. The Company has retained development and commercialization rights to rigosertib in the rest of the world, including the United States. 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 were not developed to clinical stage as initially hoped, and GBO was dissolved in June 2018. On March 21, 2018, the Company amended its certificate of incorporation to increase the number of authorized shares of common stock par value $0.01 per share from 25,000,000 to 100,000,000. On June 7, 2018, the Company amended its certificate of incorporation again to increase the number of authorized shares of common stock, par value $0.01 per share, from 100,000,000 to 250,000,000. On September 25, 2018, the Company amended its certificate of incorporation to effect a one-for-fifteen reverse stock split of its common stock. Liquidity The Company has incurred recurring operating losses since inception. For the nine months ended September 30, 2019, the Company incurred a net loss of $15,756,000 and as of September 30, 2019 the Company had generated an accumulated deficit of $397,652,000. 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, 2019, the Company had cash and cash equivalents of $4,821,000. The Company will require substantial additional financing to fund its ongoing clinical trials and operations, and to continue to execute its strategy. These conditions raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. 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 39,611 shares of Common Stock, at a price of $2,250.00 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. From the IPO through December 31, 2016, the Company closed on several offerings which included Common Stock and warrants. Total net proceeds from these offerings was approximately $24.9 million. On April 26, 2017 the Company closed on an underwritten public offering of 165,079 shares of Common Stock. On May 17, 2017, the Company sold an additional 24,239 shares as a result of the underwriter’s exercise of its over-allotment option. Net proceeds from these transactions were approximately $5.3 million. On November 14, 2017 the Company closed on a registered direct offering to select accredited investors of 61,333 shares of common stock. Net proceeds were approximately $1.1 million. On February 12, 2018 the Company closed on an offering of units of common stock and warrants. The Company issued 467,000 shares of common stock, pre-funded warrants to purchase 196,167 share of common stock, and preferred stock warrants to purchase shares of Series A convertible preferred stock convertible into 696,325 shares of common stock. Net proceeds were approximately $8.7 million. (See Note 13) On May 1, 2018 the Company closed on an offering of units of common stock and warrants. The Company issued 3,694,118 shares of common stock, pre-funded warrants to purchase 815,686 shares of common stock, and preferred stock warrants to purchase shares of Series B convertible preferred stock convertible into 4,509,804 shares of common stock. Net proceeds were approximately $25.6 million. (See Note 13) In February and March 2019 the Company implemented a workforce reduction. Six employees were terminated, which represented approximately 24% of the Company’s workforce. A severance related charge of approximately $1,843,000, which includes a non-cash charge of approximately $415,000 related to the accelerated vesting of outstanding stock options, was recorded in the three months ended March 31, 2019. The severance expense will be paid in periodic amounts through February 2020. The accrued severance balance remaining at September 30, 2019 was $359,000. On May 10, 2019, the Company entered into a License and Collaboration Agreement (the “HanX License Agreement”) with HanX and two Securities Purchase Agreements (the “HanX Securities Purchase Agreements”), one with HanX and the other with an affiliate of HanX. Under the terms of the agreements, the Company granted to HanX an exclusive, royalty bearing license to study and commercialize rigosertib in greater China. In exchange for these rights, HanX agreed to make upfront payments to the Company totaling $4 million, including a $2 million fee and an investment totaling $2 million to purchase shares of the Company at a premium to market. In addition, HanX agreed to dedicate $2 million in local currency, to be placed in escrow, for clinical development expenses in greater China. In addition, the Company could receive regulatory, development and sales-based milestone payments to Onconova of up to $45.5 million and receive tiered royalties up to double digits on net sales in greater China. The Company will supply the finished product for sale in the licensed territories. HanX will also support the Company’s clinical trial initiatives in the territory. On July 9, 2019, the Company extended the deadline for payments under the HanX License Agreement and the HanX Securities Purchase Agreements. On August 8, 2019 Onconova received the non-refundable license fee from HanX. On August 14, 2019, the Company further extended the deadline of HanX’ remaining upfront payments relating to the its equity investment in the Company while HanX continues to seek Chinese regulatory approval for such equity investment. See Note 10 for additional information. On September 25, 2019 the Company closed on an offering of units of common stock and warrants. The Company issued 2,198,938 shares of common stock and warrants to purchase 2,198,938 shares of common stock.Net proceeds were approximately $3.0 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 continues to explore 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 until late in the fourth quarter of 2019. Accordingly, management has concluded that substantial doubt exists with respect to the Company’s ability to continue as a going concern within one year after the date that these financial statements are issued. Subsequent to September 30, 2019, on October 29, 2019, the Company filed a registration statement on Form S-1 (Registration No. 333-234360) to register $13.8 million of common stock and warrants. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2019 | |
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 (through the date of its dissolution in June 2018). All significant intercompany transactions have been eliminated. Unaudited Interim Financial Information The accompanying condensed consolidated balance sheet as of September 30, 2019, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2019 and 2018, the consolidated statements of stockholders’ (deficit) equity for the three and nine months ended September 30, 2019 and 2018 and the condensed consolidated statements of cash flows for the nine months ended September 30, 2019 and 2018 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, 2019, the results of its operations for the three and nine months ended September 30, 2019 and 2018, and its cash flows for the nine months ended September 30, 2019 and 2018. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2019 and 2018 are unaudited. The results for the three and nine months ended September 30, 2019 are not necessarily indicative of results to be expected for the year ending December 31, 2019, 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, 2018 included in the Company’s annual report on Form 10-K filed with the SEC on April 1, 2019. Certain prior year amounts have been reclassified to conform to current period presentation. All common stock, equity, share and per share amounts in the financial statements and notes have been retroactively adjusted to reflect a one-for-fifteen reverse stock split which was effective September 25, 2018. 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, 2018 included in the Company’s annual report on Form 10-K filed with the SEC on April 1, 2019. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies, with the exception of the adoption of new FASB guidance related to leases. Fair Value Measurements The carrying amounts reported in the accompanying consolidated financial statements for cash and cash equivalents, 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.” Revenue Recognition The Company recognizes revenue in accordance with Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (ASC 606), which the Company adopted effective January 1, 2018 using the modified retrospective method. There was no material impact to our financial position and results of operations as a result of the adoption. The Company applies ASC 606 to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. In accordance with ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that it will collect the consideration it is entitled to in exchange for the goods and services it transfers to the customer. At contract inception, the Company assesses the goods or services promised within each contract that falls under the scope of ASC 606, determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The Company derives revenue from collaboration and licensing agreements and from the sale of products associated with material transfer, collaboration and supply agreements. License, Collaboration and Other Revenues The Company enters into licensing and collaboration agreements, under which it licenses certain of its product candidates’ rights to third parties. The Company recognizes revenue related to these agreements in accordance with ASC 606. The terms of these arrangements typically include payment from third parties of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; and royalties on net sales of the licensed product. In determining the appropriate amount of revenue to be recognized as it fulfills its obligation under each of its agreements, the Company performs the five steps described above. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement of personnel costs, discount rates and probabilities of technical and regulatory success. Licensing of Intellectual Property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other performance obligations, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front-fees. The Company evaluates the measure of progress each reporting period, and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments : At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal will not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensees, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in their period of adjustment. Manufacturing supply services. Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply at the customer’s discretion are generally considered as options. The Company assesses if these options provide material rights to the licensee and if so, they are accounted for as separate performance obligations. If the Company is entitled to additional payments when the customer exercises these options, any additional payments are recorded when the customer obtains control of the goods, which is upon shipment. Royalties : For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some of all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue from its license agreements. Leases The Company accounts for leases in accordance with Accounting Standards Codification Topic 842, Leases (ASC 842), which the Company adopted effective January 1, 2019. The Company determines whether an arrangement is a lease at contract inception by establishing if the contract conveys the right to control the use of identified property, plant, or equipment for a period of time in exchange for consideration. Right of Use (ROU) Assets and Lease Liabilities are recognized at the lease commencement date based on the present value of all minimum lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments, when the implicit rate is not readily determinable. Lease terms may include options to extend or terminate the lease. These options are included in the lease term when it is reasonably certain that the Company will exercise that option. Operating lease expense is recognized on a straight-line basis over the lease term. The Company has elected the following policy elections on adoption: use of portfolio approach on leases of assets under master service agreements, exclusion of short term leases (term of 12 months or less) on the balance sheet, and not separating lease and non-lease components. At January 1, 2019 and September 30, 2019 the Company had one lease, which was for office space. The lease qualifies for the short term lease exception. Consequently, no ROU Asset or Lease Liability was recorded. The lease payments are being recognized as an expense on a straight-line basis over the lease term. Lease payments for the nine months ended September 30, 2019 were $144,000. Remaining payments due under the lease at September 30, 2019 are $80,000. Recent Accounting Pronouncements In February 2016 and through subsequent amendments, the FASB issued guidance which supersedes much of the previous guidance for leases. The new guidance 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 are 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 was effective for fiscal years beginning after December 15, 2018, and interim periods within those years, with early adoption permitted. In transition, lessees and lessors were permitted to recognize and measure leases at the date of adoption 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 adopted the guidance in ASC 842 effective January 1, 2019 using the modified retrospective method, which does not require the restatement of prior period amounts. There was no impact to the Company’s financial position and results of operations as a result of the adoption. In August 2018, the FASB issued guidance which changes the disclosure requirements for fair value measurement. The guidance amends the disclosure requirements in ASC Topic 820 by adding, changing, or removing certain disclosures. The guidance is effective for fiscal years beginning after December 15, 2019. The Company believes that the adoption of this guidance will not have a material impact on the Company’s consolidated financial statements. The Company is evaluating the impact of the adoption of the standard on its financial statement disclosures. In November 2018, the FASB issued guidance, which clarifies the interaction between ASC Topic 808, Collaborative Arrangements , and ASC Topic 606, Revenue from Contracts with Customers . The guidance, among other items, clarifies that certain transactions between collaborative participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account. The guidance is effective for fiscal years beginning after December 15, 2019. The Company is evaluating the impact that the adoption of this guidance will have on the Company’s consolidated financial statements. |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2019 | |
Revenue | |
Revenue | 3. Revenue The Company’s revenue during the three and nine months ended September 30, 2019 and 2018 was from its license and collaboration agreements with SymBio, HanX and Pint (See Note 10). Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Symbio Upfront license fee recognition over time $ 57,000 $ 114,000 $ 170,000 $ 341,000 Supplies 6,000 6,000 18,000 59,000 HanX - rigosertib Upfront license payment — — 1,965,000 — HanX - ON123300 Upfront license payment — — — 450,000 Pint Upfront license payment — — — 319,000 $ 63,000 $ 120,000 $ 2,153,000 $ 1,169,000 Deferred revenue is as follows: Symbio Upfront Payment Deferred balance at December 31, 2018 $ 4,148,000 Recognition to revenue 170,000 Deferred balance at September 30, 2019 $ 3,978,000 See Note 10, “License and Collaboration Agreements,” for a further discussion of the agreements with SymBio and HanX. |
Net Loss Per Share of Common St
Net Loss Per Share of Common Stock | 9 Months Ended |
Sep. 30, 2019 | |
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, 2019 and 2018 have been excluded from the computation of diluted weighted average shares outstanding, as they would be antidilutive (reflects the number of common shares as if the dilutive securities had been converted to common stock): September 30, 2019 2018 Warrants 5,614,307 5,725,506 Stock options 409,788 332,918 6,024,095 6,058,424 |
Warrants
Warrants | 9 Months Ended |
Sep. 30, 2019 | |
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 (reflects the number of common shares as if the warrants were converted to common stock) for the nine months ended September 30, 2019 is as follows: Balance Balance Exercise Expiration December 31, Warrants Warrants Warrants September 30, Description Classification Price Date 2018 Issued Exercised Expired 2019 Non-tradable warrants Liability $ 172.50 July 2021 6,456 — — — 6,456 Tradable warrants Liability $ 73.80 July 2021 212,801 — — — 212,801 Non-tradable pre-funded warrants Equity $ 0.15 July 2023 394 — — — 394 Non-tradable warrants Equity $ 6.69375 (1) 663,167 — — (392,834) (3) 270,333 Non-tradable warrants Equity $ 1.60 December 2022 — 392,834 (3) — — 392,834 Non-tradable warrants Equity $ 7.96875 (1) 33,158 — — — 33,158 Non-tradable warrants Equity $ 14.10 March 2021 5,000 — — — 5,000 Non-tradable warrants Equity $ 21.15 March 2021 8,333 — — — 8,333 Non-tradable warrants Equity $ 7.7895 June 2021 15,000 — — — 15,000 Non-tradable pre-funded warrants Equity $ 0.15 none 86,167 — (33,333) — 52,834 Non-tradable warrants Equity $ 6.375 (2) 4,432,962 — — (1,806,104) (3) 2,626,858 Non-tradable warrants Equity $ 1.600 December 2022 — 1,806,104 (3) — — 1,806,104 Non-tradable pre-funded warrants Equity $ 0.15 none 262,068 — (187,451) — 74,617 Non-tradable warrants Equity $ 2.00 September 2023 — 109,585 — — 109,585 5,725,506 2,308,523 (220,784) (2,198,938) 5,614,307 (1) These preferred stock warrants expire on the earlier of (A) the one-month anniversary of the date on which the Company publicly releases topline results of the INSPIRE Pivotal phase 3 that compare the overall survival (OS) of patients in the rigosertib group vs the Physician’s Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk and (B) December 31, 2019. These preferred stock warrants may be exercised on a cashless basis in certain circumstances specified therein. (2) These preferred stock warrants expire on the 18-month anniversary of June 8, 2018, the date on which the Company publicly announced through the filing of a Current Report on Form 8-K that a Certificate of Amendment to the Company’s Tenth Amended and Restated Certificate of Incorporation, as amended, to increase the number of authorized shares of common stock from 100,000,000 to 250,000,000, was filed with the Secretary of State of the State of Delaware. These preferred stock warrants may be exercised on a cashless basis in certain circumstances specified therein. (3) In September 2019, the Company entered into securities purchase agreements with certain investors pursuant to which it agreed to sell an aggregate of 2,198,938 shares of its common stock in a registered direct offering. The investors in this offering were holders of the Company’s warrants to purchase shares of its convertible preferred stock. The Company also entered into a warrant amendment with each investor pursuant to which, for each share of common stock purchased by the investor in the offering, the Company would amend one outstanding warrant with an exercise price of $6.69375 per common share held by the investor and/or one outstanding warrant with an exercise price of $6.375 per common share held by the investor, as applicable, to reduce the exercise price to $1.60 per common share and to extend the term of the warrants to December 31, 2022. The price for amending one outstanding warrant was $0.125 per share (on an as-converted basis per share of common stock). |
Balance Sheet Detail
Balance Sheet Detail | 9 Months Ended |
Sep. 30, 2019 | |
Balance Sheet Detail | |
Balance Sheet Detail | 6. Balance Sheet Detail Prepaid expenses and other current assets: September 30, December 31, 2019 2018 Research and development $ 436,000 $ 415,000 Premium on future equity purchase from HanX 214,000 $ — Manufacturing 29,000 111,000 Insurance 189,000 166,000 Other 89,000 68,000 $ 957,000 $ 760,000 Property and equipment: September 30, December 31, 2019 2018 Property and equipment $ 2,284,000 $ 2,228,000 Accumulated depreciation (2,230,000) (2,219,000) $ 54,000 $ 9,000 Accrued expenses and other current liabilities: September 30, December 31, 2019 2018 Research and development $ 2,098,000 $ 2,285,000 Employee compensation 1,137,000 1,650,000 Professional fees 213,000 225,000 Other — 13,000 $ 3,448,000 $ 4,173,000 |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2019 | |
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 12,912 shares of Common Stock, at a purchase price of $142.50 per share and warrants to purchase up to 6,456 shares of Common Stock (the “Warrants”) for aggregate gross proceeds of $1,840,000. The Company has classified the warrants as a liability (see Note 5). The estimated fair value using the Black-Scholes pricing model was approximately $0 at September 30, 2019 and December 31, 2018. On July 29, 2016 the Company closed on a Rights Offering, issuing 239,986 shares of Common Stock, 212,801 Tradable Warrants and 43,760 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 $73.80 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 $184.50 for each of 10 consecutive trading days. 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. The Company has determined that an active and orderly market for the Tradable Warrants has developed and that the Nasdaq Capital Market price is the best indicator of fair value of the warrant liability. The quoted market price was used to determine the fair value at December 31, 2018 and September 30, 2019. The Company estimated the fair value of the non-tradable warrant liability at September 30, 2019, using the Black-Scholes option pricing model with the following weighted-average assumptions: Risk-free interest rate 1.63 % Expected volatility 94.04 % Expected term 1.78 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, 2019 and December 31, 2018: Fair Value Measurement as of: September 30, 2019 December 31, 2018 Level 1 Level 2 Level 3 Balance Level 1 Level 2 Level 3 Balance Tradable warrants liability $ 96,000 $ — $ — $ 96,000 $ 176,000 $ — $ — $ 176,000 Non-tradable warrants liability — — — — — — — — Total $ 96,000 $ — $ — $ 96,000 $ 176,000 $ — $ — $ 176,000 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, 2019 | |
Stock-Based Compensation | |
Stock-Based Compensation | 8. Stock-Based Compensation The 2007 Equity Compensation Plan as amended (the “2007 Plan”), 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. The 2013 Equity Compensation Plan (the “2013 Plan”), 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 included 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. The 2018 Omnibus Incentive Compensation Plan (the “2018 Plan”) was unanimously approved by the Company’s Board of Directors on May 24, 2018 and was approved by the Company’s stockholders on June 27, 2018. The 2018 Plan replaces the 2013 Plan. Upon stockholders’ approval of the 2018 Plan, no further awards will be made under the 2013 Plan. Awards granted under the 2013 Plan will continue in effect in accordance with the terms of the applicable award agreement and the terms of the 2013 Plan in effect when the awards were granted. Under the 2018 Plan, the Company may grant incentive stock options, non-qualified stock options, stock awards, stock units, stock appreciation rights and other stock-based awards to employees, non-employee directors and consultants, and advisors. The maximum aggregate number of shares of the Company’s common stock that may be issued under the 2018 Plan is 6,035,316, which is equal to the sum of (i) 6,000,000 shares of the Company’s common stock, plus (ii) 35,316 shares, which is the number of shares of the Company common stock reserved for issuance under the 2013 Plan that remained available as of the effective date of the 2018 Plan. In addition, the number of shares of common stock subject to outstanding awards under the 2013 Plan that terminate, expire, or are cancelled, forfeited, exchanged, or surrendered without having been exercised, vested, or paid in shares under the 2013 Plan after the effective date of the 2018 Plan will be available for issuance under the 2018 Plan. The 2018 Plan was amended following unanimous approval of the Company’s Board of Directors on April 24, 2019 and was approved by the Company’s shareholders on June 17, 2019. The amended 2018 Plan (the “Amended Plan”) allowed for an additional 589,500 shares of the Company’s common stock that may be issued under the Amended Plan with respect to awards made on and after June 17, 2019. At September 30, 2019, there were 644,396 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, 2019 and 2018: Three Months ended September 30, Nine Months ended September 30, 2019 2018 2019 2018 General and administrative $ 64,000 $ 159,000 $ 670,000 $ 421,000 Research and development 81,000 136,000 280,000 363,000 $ 145,000 $ 295,000 $ 950,000 $ 784,000 A summary of stock option activity for the nine months ended September 30, 2019 is as follows: Options Outstanding Weighted Weighted- Average Shares Average Remaining Aggregate Available Number of Exercise Contractual Intrinsic for Grant Shares Price Term (in years) Value Balance, December 31, 2018 95,264 379,328 $ 76.33 9.19 $ 0 Authorized 589,500 — Granted (64,998) 64,998 $ 3.16 9.77 Exercised — — $ — Forfeitures 24,630 (34,538) $ 60.09 8.68 Balance, September 30, 2019 644,396 409,788 $ 66.09 8.63 $ 0 Vested or expected to vest, September 30, 2019 401,793 $ 119.90 8.12 $ 0 Exercisable at September 30, 2019 216,681 $ 119.90 8.12 $ 0 Information with respect to stock options outstanding and exercisable at September 30, 2019 is as follows: Exercise Price Shares Exercisable $2.49 – $3.72 71,998 — $4.34 – $7.05 270,246 154,316 $16.35 – $97.50 48,133 42,968 $222.00 – $225.00 1,871 1,871 $348.00 – $597.00 4,867 4,866 $651.00 – $1,129.50 5,428 5,415 $1,992.00 – $2,268.00 6,910 6,910 $4,156.50 – $4,371.00 335 335 409,788 216,681 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, 2019, there was $741,000 of unrecognized compensation expense related to the unvested stock options issued from April 24, 2013 through September 30, 2019, which is expected to be recognized over a weighted-average period of approximately 1.92 years. The weighted-average assumptions underlying the Black-Scholes calculation of grant date fair value include the following: Nine Months ended September 30, 2019 2018 Risk-free interest rate 1.92 % 2.60 % Expected volatility 82.58 % 74.13 % Expected term 5.85 years 5.78 years Expected dividend yield 0 % 0 % Weighted average grant date fair value $ 1.81 $ 12.60 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 2019 and 2018, based on the historical forfeiture experience. |
Research Agreements
Research Agreements | 9 Months Ended |
Sep. 30, 2019 | |
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, 2019 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, 2019 | |
License and Collaboration Agreements | |
License and Collaboration Agreements | 10. License and Collaboration Agreements 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 in 2011. 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 assessed the SymBio arrangement in accordance with ASC 606 and determined that its performance obligations 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 was not distinct since it was of no benefit to SymBio without the ongoing research and development services and that, as such, the license and the research and development services should be bundled as a single performance obligation. Since the provision of the license and research and development services are considered a single performance obligation, the $7,500,000 upfront payment is being recognized as revenue ratably through December 2037, the expected period over which the Company expects the research and development services to be performed as the services are performed. SymBio’s purchases of rigosertib as development-stage product or for commercial requirements represent options under the agreement and revenues are therefore recognized when control of the product is transferred, which is typically when shipped. 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. In January 2018, the agreement was amended to provide SymBio a discount of 35% on future purchases, limited to a cumulative total amount of $300,000. HanX ON 123300 Agreement In December 2017, the Company entered into a license and collaboration agreement with HanX, a company focused on development of novel oncology products, for the further development, registration and commercialization of ON 123300 in Greater China. ON 123300 is a preclinical compound which the Company believes has the potential to overcome the limitations of current generation CDK 4/6 inhibitors. The key feature of the collaboration is that HanX will provide all funding required for future Chinese IND enabling studies necessary for filing an IND with the Chinese Food and Drug Administration. The studies would be conducted to meet the Good Laboratory Practice (“GLP”) requirements of the FDA such that the Company could simultaneously file an IND with the US FDA. The Company and HanX will oversee the IND enabling studies. The Company will maintain global rights to ON 12330 outside of China. Pursuant to the agreement, the Company received a $450,000 upfront payment on April 11, 2018. If the compound receives regulatory approval and is commercialized, the Company would receive regulatory and commercial milestone payments, as well as royalties on sales in the Greater China territory. The Company assessed the HanX arrangement for revenue recognition in accordance with ASC 606 and determined that the license was distinct and that control of the license had been transferred during the first quarter of 2018. As such, the Company recognized the $450,000 allocated to the license in the quarter ended March 31, 2018. Pint Agreement On March 2, 2018, the Company entered into a License, Development and Commercialization Agreement (the “License Agreement”) and a Securities Purchase Agreement (the “Securities Purchase Agreement”) with Pint. Under the terms of the License Agreement, the Company granted Pint an exclusive, royalty-bearing license, with the right to sublicense, under certain Company patent rights and know-how to develop and commercialize any pharmaceutical product (the “Product”) containing rigosertib in all uses of rigosertib in humans in Latin American countries (the “Territory,” including Argentina, Belize, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, El Salvador, French Guiana, British Guiana, Suriname, Guatemala, Haiti, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Uruguay and Venezuela). Pint agreed to make an upfront equity investment in the Company’s common stock. In addition, the Company could receive up to $41.5 million in additional regulatory, development and sales-based milestone payments, an additional equity investment, as well as tiered, double digit royalties based on net aggregate net sales in the Territory. Pint and the Company have also agreed to enter into a supply agreement providing for Pint purchasing rigosertib and the Product from the Company within 90 days of the FDA approval of an a New Drug Application (“NDA”) for the Product. Pint may terminate the License Agreement in whole (but not in part) at any time upon 45 days’ prior written notice. The License Agreement also contains certain provisions for termination by either party in the event of breach of the License Agreement by the other party, subject to a cure period, or bankruptcy of the other party. Under the terms of the Securities Purchase Agreement, Pint agreed to make an upfront equity investment in the Company at a specified premium to the Company’s share price. Pursuant to the Securities Purchase Agreement, closing of the upfront equity investment occurred on April 4, 2018 and Pint purchased 54,463 shares of common stock for $1,250,000. The total amount of the premium was $319,000 and this amount was allocated to the license. In addition, under the Securities Purchase Agreement, if the FDA approves the NDA for the Product, Pint will reimburse the Company for certain research and development expenses. Half of the reimbursement amount will be paid in cash, the other half of the amount will be by an equity investment at a premium to the average of the volume weighted average price of common stock for the ten consecutive trading days ended on the day the FDA approves the NDA. Pursuant to the Securities Purchase Agreement, the common stock purchased by Pint is subject to certain lock-up restrictions and Pint is entitled to certain registration and participation rights. The Company assessed the Pint arrangement for revenue recognition in accordance with ASC 606 and determined that the license was distinct and that control of the license had been transferred during the second quarter of 2018. As such, the Company recognized the $319,000 allocated to the license in the quarter ended June 30, 2018. HanX Rigosertib Agreement On May 10, 2019, the Company entered into a License and Collaboration Agreement (the “HanX License Agreement”) with HanX and two Securities Purchase Agreements (the “HanX Securities Purchase Agreements”), one with HanX and the other with an affiliate of HanX. Under the terms of the HanX License Agreement, the Company granted HanX an exclusive, royalty-bearing license, with the right to sublicense, to study and commercialize rigosertib in greater China (the “HanX Territory,” including the People’s Republic of China, Hong Kong, Macau and Taiwan). In exchange for these rights, the agreement required HanX to make upfront payments to the Company totaling $4 million, including a $2.0 million upfront fee and an investment totaling $2.0 million to purchase shares of the Company at a premium to market. HanX was also required to dedicate $2.0 million in local currency, to be placed in escrow, for clinical development expenses in the HanX Territory. If HanX spends more than $2.0 million in the research and development of rigosertib during the first two years after the effective date of the HanX License Agreement, the Company shall reimburse HanX such excess amount up to a maximum aggregate amount of $0.5 million. In addition, the Company could receive regulatory, development and sales-based milestone payments up to $45.5 million and receive tiered royalties up to double digits on net sales in in the HanX Territory. The Company will also supply rigosertib for sale in the HanX Territory. Unless terminated earlier, the HanX License Agreement will expire upon the expiration of all royalty payment obligations. HanX may terminate the HanX License Agreement in whole (but not in part) at any time upon 45 days’ prior written notice. The HanX License Agreement also contains certain provisions for termination by either party in the event of breach of the HanX License Agreement by the other party, subject to a cure period, or bankruptcy of the other party. Under the terms of the HanX Securities Purchase Agreement, HanX and its affiliate agreed to make upfront equity investments in the Company at a specified premium to the Company’s share price. The common stock purchased by HanX and its affiliates is subject to certain lock-up restrictions and HanX and its affiliates are entitled to certain registration and participation rights. The Company assessed the HanX License Agreement for revenue recognition in accordance with ASC 606 and determined that there are two distinct performance obligations: the license and the supply of rigosertib for sale in the HanX Territory. The Company concluded that control of the license had been transferred to HanX during the three months ended June 30, 2019 and recognized license revenue of $1.7 million, which is net of applicable taxes withheld by the Chinese government, related to the $2.0 million upfront fee. The Company believes a portion of the tax being withheld by the Chinese government may be recoverable at a later date and could be recognized as license revenue if and when recovered by the Company. The $1.7 million was recorded as a receivable at June 30, 2019 and the payment was received in August 2019. Pursuant to the HanX Securities Purchase Agreements, closing of one of the upfront equity investments occurred on May 15, 2019 when an affiliate of HanX purchased 103,520 shares of common stock for $0.5 million. The total amount of the premium was $0.1 million and this amount was recognized as license revenue during the three months ended June 30, 2019. On July 9, 2019, the Company extended the deadline for payments under the HanX License Agreement and the HanX Securities Purchase Agreements. On August 8, 2019 Onconova received the non-refundable license fee from HanX. On August 14, 2019, the Company further extended the deadline of HanX’s remaining upfront payments relating to its equity investment in the Company while HanX continues to seek Chinese regulatory approval for such equity investment. At inception of the HanX License Agreement, it is uncertain as to whether the Company will need to reimburse HanX for all, or a portion, of the $0.5 million excess research and development spending. Therefore, the Company has determined that no liability should be recorded at September 30, 2019, and will reassess this conclusion at each reporting period. In addition, as the development milestones are not within the control of the Company they are not considered probable and revenue will be recognized only upon the achievement of the milestone. The sales milestones and sales-based royalties related to the license will be recognized as revenue as sales occur. For the supply of rigosertib for sale in the HanX Territory, the Company will recognize revenue at a point in time when HanX obtains control of the product, which is typically upon shipment. |
Preclinical Collaboration _ Non
Preclinical Collaboration / Non-controlling Interest | 9 Months Ended |
Sep. 30, 2019 | |
Preclinical Collaboration / Non-controlling Interest | |
Preclinical Collaboration / Non-controlling Interest | 11. Preclinical Collaboration / Non-controlling Interest In December 2012, the Company agreed to form GBO, an entity owned by the Company and GVK. The purpose of GBO was 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. 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 made additional capital contributions. The GVK percentage interest in GBO could have changed 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 evaluated its variable interests in GBO on a quarterly basis and determined that it was the primary beneficiary. GBO was reflected in the Company’s financial statements as a non-controlling interest. The two preclinical programs sublicensed to GBO were not developed to clinical stage as initially hoped, and GBO was dissolved in June 2018. The dissolution resulted in a gain of $693,000 to the Company, primarily as a result of forgiveness of GBO payables to GVK. Upon consolidation of GBO, the $693,000 gain and $(163,000) non-controlling interest portion were recorded by the Company in the quarter ended June 30, 2018. |
Related-Party Transactions
Related-Party Transactions | 9 Months Ended |
Sep. 30, 2019 | |
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 stockholder is affiliated. Mount Sinai is undertaking research on behalf of the Company on the terms set forth in the agreements. Mount Sinai, in collaboration 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, resulting therefrom. Payments to Mount Sinai under this research agreement for the three months ended September 30, 2019 and 2018 were $88,000 and $88,000, respectively, and for the nine months ended September 30, 2019 and 2018 were $263,000 and $263,000, respectively. At September 30, 2019 and December 31, 2018, the Company had $88,000 and $88,000, respectively, payable to Mount Sinai under this agreement. The Company has entered into a consulting agreement with a member of its board of directors. The board member provides consulting services to the Company on the terms set forth in the agreement. Payments to this board member for both the three months ended September 30, 2019 and 2018 were $33,000, and for both the nine months ended September 30, 2019 and 2018 were $99,000. At both September 30, 2019 and December 31, 2018, the Company had $33,000 payable under this agreement. |
Securities Registrations and Sa
Securities Registrations and Sales Agreements | 9 Months Ended |
Sep. 30, 2019 | |
Securities Registrations and Sales Agreements | |
Securities Registrations and Sales Agreements | 13. Securities Registrations and Sales Agreements 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 5,645 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 666 shares of Common Stock on any business day, increasing to up to 1,666 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 $233.40. 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 1,333 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 February 8, 2018, the Company entered into an underwriting agreement (the “February 2018 Underwriting Agreement”) with H.C. Wainwright & Co., LLC (“HCW”), relating to the public offering (the “February 2018 Offering”) of 380,500 shares of the Company’s common stock and pre-funded warrants (the “February 2018 Pre-Funded Warrants”) to purchase an aggregate of 196,167 shares of common stock. Each share of common stock or February 2018 Pre-Funded Warrant, as applicable, was sold as a unit with a warrant to purchase Series A Preferred Stock which is convertible to common stock (the “February 2018 Preferred Stock Warrants”). Each February 2018 Preferred Stock Warrant is for one-fifteenth of a share of common stock, on an as converted basis. The combined public offering price was $15.15 per common stock unit or $15.00 per February 2018 Pre-Funded Warrant unit. The Company also granted HCW a 30-day option to purchase up to 86,500 additional shares of common stock at a purchase price of $15.00 per share and February 2018 Preferred Stock Warrants to purchase shares of Series A Preferred Stock convertible into 86,500 shares of common stock at a purchase price of $0.15 per February 2018 Preferred Stock Warrant, less the underwriting discounts and commissions. Prior to closing, HCW exercised this option in full. The offering closed on February 12, 2018. Net proceeds from the offering were approximately $8.7 million after deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering to fund the development of its clinical and preclinical programs, for other research and development activities and for general corporate purposes, which may include capital expenditures and funding its working capital needs. The shares of common stock or February 2018 Pre-Funded Warrants, as applicable, and the accompanying February 2018 Preferred Stock Warrants could only be purchased together as a unit in the offering but were issued as separate securities. The February 2018 Pre-Funded Warrants are exercisable immediately at an exercise price of $0.15 per share, may be exercised until they are exercised in full, and may be exercised on a cashless basis in certain circumstances specified therein. The February 2018 Preferred Stock Warrants are exercisable immediately for Series A Preferred Stock at an exercise price of $15.15 per common share, on an as converted basis and will expire on the earlier of (A) the one-month anniversary of the date on which the Company publically releases topline results of the INSPIRE Pivotal phase 3 that compare the overall survival (OS) of patients in the rigosertib group vs the Physician’s Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk and (B) December 31, 2019. The February 2018 Preferred Stock Warrants may be exercised on a cashless basis in certain circumstances specified therein. HCW acted as sole book-running manager for the offering, which was a firm commitment underwritten public offering pursuant to a registration statement on Form S-1 (Registration No. 333-222374) that was declared effective by the SEC on February 7, 2018. The offering was made only by means of a prospectus forming a part of the effective registration statement. The Company paid HCW a commission equal to 7.0% of the gross proceeds of the offering, a management fee equal to 1.0% of the gross proceeds of the offering and other expenses. As additional compensation, the Company issued warrants to HCW exercisable for shares of Series A Preferred Stock, which are convertible into 33,158 shares of common stock subject to the terms of the Series A Preferred Stock. These warrants have substantially the same terms as the February 2018 Preferred Stock Warrants except that the exercise price per share is equal to $18.9375 per share of common stock, on an as converted basis. On September 24, 2018, in exchange for HCW agreement to provide shareholder advisory services to the Company for a period of three months starting on September 24, 2018, the Company repriced these warrants to an exercise price per share equal to $7.96875 per share of common stock, on an as converted basis. On April 27, 2018, the Company entered into an underwriting agreement with HCW relating to the public offering (the “April 2018 Offering”) of 3,105,882 shares of the Company’s common stock and pre-funded warrants (the “May 2018 Pre-Funded Warrants”) to purchase an aggregate of 815,686 shares of common stock. Each share of common stock or May 2018 Pre-Funded Warrant, as applicable, was sold as a unit with a warrant to purchase Series B Preferred Stock which is convertible to common stock (the “May 2018 Preferred Stock Warrants”). Each May 2018 Preferred Stock Warrant is for one-fifteenth of a share of common stock, on an as converted basis. The combined public offering price was $6.375 per common stock unit or $6.225 per May 2018 Pre-Funded Warrant unit. The Company also granted HCW a 30-day option to purchase up to 588,235 additional shares of common stock at a purchase price of $6.225 per share and May 2018 Preferred Stock Warrants to purchase shares of Series B Preferred Stock convertible into 588,235 shares of common stock at a purchase price of $0.15 per May 2018 Preferred Stock Warrant, less the underwriting discounts and commissions. Prior to closing, HCW exercised this option in full. The offering closed on May 1, 2018. Net proceeds from the offering were approximately $25.6 million after deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering to fund the development of its clinical and preclinical programs, for other research and development activities and for general corporate purposes, which may include capital expenditures and funding its working capital needs. The shares of common stock or May 2018 Pre-Funded Warrants, as applicable, and the accompanying May 2018 Preferred Stock Warrants could only be purchased together as a unit in the offering but were issued as separate securities. The May 2018 Pre-Funded Warrants are exercisable immediately at an exercise price of $0.15 per share, may be exercised until they are exercised in full, and may be exercised on a cashless basis in certain circumstances. The May 2018 Preferred Stock Warrants are exercisable immediately for Series B Preferred Stock at an exercise price of $6.375 per common share, on an as converted basis and will expire on the 18-month anniversary of June 8, 2018, the date on which the Company publicly announced through the filing of a Current Report on Form 8-K that a Certificate of Amendment to the Company’s Tenth Amended and Restated Certificate of Incorporation, as amended, to increase the number of authorized shares of common stock from 100,000,000 to 250,000,000, was filed with the Secretary of State of the State of Delaware. The May 2018 Preferred Stock Warrants may be exercised on a cashless basis in certain circumstances. HCW acted as sole book-running manager for the offering, which was a firm commitment underwritten public offering pursuant to a registration statement on Form S-1 (Registration No. 333-224315) that was declared effective by the SEC on April 26, 2018. The offering was made only by means of a prospectus forming a part of the effective registration statement. The Company paid HCW a commission equal to 8.0% of the gross proceeds of the offering, a management fee equal to 1.0% of the gross proceeds of the offering and other expenses. In connection with the February 2018 Offering, the Company agreed to certain restrictions (the “Company Lock-Up”) set forth in Section 5(j) of the February 2018 Underwriting Agreement. The Company Lock-Up, among other items, prohibited the Company, during a period of one hundred and thirty-five (135) days from February 8, 2018, without the prior written consent of HCW, from offering or selling any Common Stock or any securities convertible into or exercisable or exchangeable for Common Stock. In order to received HCW’s waiver of the Company Lock-Up, in connection with the April 2018 Offering, on April 16, 2018, the Company entered into a Lock-Up Waiver Agreement (the “Lock-Up Waiver Agreement”) with HCW and certain holders of the February 2018 Preferred Stock Warrants, pursuant to which (i) HCW waived the Company Lock-Up solely with respect to the April 2018 Offering, and (ii) the Company agreed to reduce the exercise price of the February 2018 Preferred Stock Warrants such that the exercise price of the February 2018 Preferred Stock Warrants shall be equal to 105% of the public offering price of common stock sold in the April 2018 Offering (but only to the extent that such public offering price is lower than the current exercise price of the February 2018 Preferred Stock Warrants) and that such repricing shall be effective concurrently with the closing of the April 2018 Offering. This modification of the February 2018 Preferred Stock Warrants was accounted for as an equity issuance cost. In accordance with the Lock-Up Waiver Agreements, the exercise price of the February 2018 Preferred Stock Warrants was repriced from $15.15 per share of common stock, on as converted basis to $6.69375 per share of common stock, on as converted basis, when the April 2018 Offering closed on May 1, 2018. On September 23, 2019, the Company entered into securities purchase agreements with certain institutional and accredited investors pursuant to which it agreed to sell an aggregate of 2,198,938 shares of its common stock, par value $0.01 per share (“common stock”) in a registered direct offering to the investors for gross proceeds of approximately $3.5 million. The purchase price per share of common stock was $1.60 per share. The investors in this offering are holders of the Company’s warrants to purchase shares of its convertible preferred stock issued in February 2018 (referred to as the February 2018 warrants) and May 2018 (referred to as the May 2018 warrants). The Company also entered into a warrant amendment with each investor pursuant to which, for each share of common stock purchased by the investor in the offering, the Company will amend one outstanding February 2018 warrant held by the investor and/or one outstanding May 2018 warrant held by the investor, as applicable, to reduce the exercise price of the February 2018 warrants and/or May 2018 warrants to $1.60 per share (on an as-converted basis per share of common stock) and to extend the term of the February 2018 warrants and/or May 2018 warrants to December 31, 2022. The price for amending one outstanding February 2018 warrant and/or one outstanding May 2018 warrant was $0.125 per share (on an as-converted basis per share of common stock). On an as-converted basis per share of common stock, 392,834 Series A preferred stock warrants and 1,806,104 Series B preferred stock warrants were modified in connection with this offering. The modification of these warrants resulted in an increase in their fair value of approximately $2.1 million, calculated using a Black-Scholes valuation model. This amount was recorded as a cost of the financing in additional paid-in capital because this modification was required to complete the offering. The offering closed on September 25, 2019. Net proceeds from the offering were approximately $3.0 million after deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering to fund the development of its clinical and preclinical programs, for other research and development activities and for general corporate purposes, which may include capital expenditures and funding its working capital needs. The Company also entered into an engagement letter with H.C. Wainwright & Co., LLC (“Wainwright”), pursuant to which Wainwright agreed to serve as exclusive placement agent for the offering. The Company agreed to pay Wainwright $56,000 for non-accountable expenses, and $10,000 for clearing expenses. The Company also agreed to issue to Wainwright placement agent warrants to purchase up to 109,585 shares of common stock. The placement agent warrants have an exercise price of $2.00 per share of common stock, which equals 125% of the offering price for the shares sold in the registered direct offering. The placement agent warrants will be immediately exercisable and will expire on September 23, 2023. Additionally, the Company granted to Wainwright, subject to certain conditions, a six-month right of first refusal with respect to additional raises of funds. In addition, if any investor introduced to the Company by Wainwright participates in a capital raising transaction during the eight months following termination or expiration of the engagement of Wainwright, the Company agreed to pay to Wainwright compensation of 8% of the capital provided by such investor. The shares the Company’s common stock subject to the securities purchase agreement were sold pursuant to a prospectus supplement filed with the Securities and Exchange Commission (“SEC”), in connection with a takedown from the Company’s effective shelf registration statement on Form S-3 (File No. 333-221684) (the “Registration Statement”) and the base prospectus dated as of December 28, 2017 contained in such Registration Statement. The Company also filed with the SEC amended prospectus supplements relating to the amendments to the February 2018 warrants (pursuant to a registration statement on Form S-1 (Registration No. 333-222374)) and May 2018 warrants (pursuant to a registration statement on Form S-1 (Registration No. 333-224315)). |
Subsequent Event
Subsequent Event | 9 Months Ended |
Sep. 30, 2019 | |
Subsequent Event | |
Subsequent Event | 14. Subsequent Event On October 29, 2019, the Company filed a registration statement on Form S-1 (Registration No. 333-234360) to register $13.8 million of common stock and warrants. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2019 | |
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 (through the date of its dissolution in June 2018). 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, 2019, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2019 and 2018, the consolidated statements of stockholders’ (deficit) equity for the three and nine months ended September 30, 2019 and 2018 and the condensed consolidated statements of cash flows for the nine months ended September 30, 2019 and 2018 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, 2019, the results of its operations for the three and nine months ended September 30, 2019 and 2018, and its cash flows for the nine months ended September 30, 2019 and 2018. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2019 and 2018 are unaudited. The results for the three and nine months ended September 30, 2019 are not necessarily indicative of results to be expected for the year ending December 31, 2019, 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, 2018 included in the Company’s annual report on Form 10-K filed with the SEC on April 1, 2019. Certain prior year amounts have been reclassified to conform to current period presentation. All common stock, equity, share and per share amounts in the financial statements and notes have been retroactively adjusted to reflect a one-for-fifteen reverse stock split which was effective September 25, 2018. |
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, 2018 included in the Company’s annual report on Form 10-K filed with the SEC on April 1, 2019. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies, with the exception of the adoption of new FASB guidance related to leases. |
Fair Value Measurements | Fair Value Measurements The carrying amounts reported in the accompanying consolidated financial statements for cash and cash equivalents, 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.” |
Revenue Recognition | Revenue Recognition The Company recognizes revenue in accordance with Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (ASC 606), which the Company adopted effective January 1, 2018 using the modified retrospective method. There was no material impact to our financial position and results of operations as a result of the adoption. The Company applies ASC 606 to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. In accordance with ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that it will collect the consideration it is entitled to in exchange for the goods and services it transfers to the customer. At contract inception, the Company assesses the goods or services promised within each contract that falls under the scope of ASC 606, determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The Company derives revenue from collaboration and licensing agreements and from the sale of products associated with material transfer, collaboration and supply agreements. License, Collaboration and Other Revenues The Company enters into licensing and collaboration agreements, under which it licenses certain of its product candidates’ rights to third parties. The Company recognizes revenue related to these agreements in accordance with ASC 606. The terms of these arrangements typically include payment from third parties of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; and royalties on net sales of the licensed product. In determining the appropriate amount of revenue to be recognized as it fulfills its obligation under each of its agreements, the Company performs the five steps described above. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement of personnel costs, discount rates and probabilities of technical and regulatory success. Licensing of Intellectual Property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other performance obligations, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front-fees. The Company evaluates the measure of progress each reporting period, and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone Payments : At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal will not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensees, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in their period of adjustment. Manufacturing supply services. Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply at the customer’s discretion are generally considered as options. The Company assesses if these options provide material rights to the licensee and if so, they are accounted for as separate performance obligations. If the Company is entitled to additional payments when the customer exercises these options, any additional payments are recorded when the customer obtains control of the goods, which is upon shipment. Royalties : For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some of all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue from its license agreements. |
Leases | Leases The Company accounts for leases in accordance with Accounting Standards Codification Topic 842, Leases (ASC 842), which the Company adopted effective January 1, 2019. The Company determines whether an arrangement is a lease at contract inception by establishing if the contract conveys the right to control the use of identified property, plant, or equipment for a period of time in exchange for consideration. Right of Use (ROU) Assets and Lease Liabilities are recognized at the lease commencement date based on the present value of all minimum lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments, when the implicit rate is not readily determinable. Lease terms may include options to extend or terminate the lease. These options are included in the lease term when it is reasonably certain that the Company will exercise that option. Operating lease expense is recognized on a straight-line basis over the lease term. The Company has elected the following policy elections on adoption: use of portfolio approach on leases of assets under master service agreements, exclusion of short term leases (term of 12 months or less) on the balance sheet, and not separating lease and non-lease components. At January 1, 2019 and September 30, 2019 the Company had one lease, which was for office space. The lease qualifies for the short term lease exception. Consequently, no ROU Asset or Lease Liability was recorded. The lease payments are being recognized as an expense on a straight-line basis over the lease term. Lease payments for the nine months ended September 30, 2019 were $144,000. Remaining payments due under the lease at September 30, 2019 are $80,000. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In February 2016 and through subsequent amendments, the FASB issued guidance which supersedes much of the previous guidance for leases. The new guidance 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 are 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 was effective for fiscal years beginning after December 15, 2018, and interim periods within those years, with early adoption permitted. In transition, lessees and lessors were permitted to recognize and measure leases at the date of adoption 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 adopted the guidance in ASC 842 effective January 1, 2019 using the modified retrospective method, which does not require the restatement of prior period amounts. There was no impact to the Company’s financial position and results of operations as a result of the adoption. In August 2018, the FASB issued guidance which changes the disclosure requirements for fair value measurement. The guidance amends the disclosure requirements in ASC Topic 820 by adding, changing, or removing certain disclosures. The guidance is effective for fiscal years beginning after December 15, 2019. The Company believes that the adoption of this guidance will not have a material impact on the Company’s consolidated financial statements. The Company is evaluating the impact of the adoption of the standard on its financial statement disclosures. In November 2018, the FASB issued guidance, which clarifies the interaction between ASC Topic 808, Collaborative Arrangements , and ASC Topic 606, Revenue from Contracts with Customers . The guidance, among other items, clarifies that certain transactions between collaborative participants should be accounted for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account. The guidance is effective for fiscal years beginning after December 15, 2019. The Company is evaluating the impact that the adoption of this guidance will have on the Company’s consolidated financial statements. |
Revenue (Tables)
Revenue (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Revenue | |
Schedule of recognized revenue under funding, license and collaboration agreements | Three Months Ended September 30, Nine Months Ended September 30, 2019 2018 2019 2018 Symbio Upfront license fee recognition over time $ 57,000 $ 114,000 $ 170,000 $ 341,000 Supplies 6,000 6,000 18,000 59,000 HanX - rigosertib Upfront license payment — — 1,965,000 — HanX - ON123300 Upfront license payment — — — 450,000 Pint Upfront license payment — — — 319,000 $ 63,000 $ 120,000 $ 2,153,000 $ 1,169,000 |
Schedule of deferred revenue | Symbio Upfront Payment Deferred balance at December 31, 2018 $ 4,148,000 Recognition to revenue 170,000 Deferred balance at September 30, 2019 $ 3,978,000 |
Net Loss Per Share of Common _2
Net Loss Per Share of Common Stock (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
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, 2019 2018 Warrants 5,614,307 5,725,506 Stock options 409,788 332,918 6,024,095 6,058,424 |
Warrants (Tables)
Warrants (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Warrants | |
Schedule of warrants outstanding and warrant activity | Balance Balance Exercise Expiration December 31, Warrants Warrants Warrants September 30, Description Classification Price Date 2018 Issued Exercised Expired 2019 Non-tradable warrants Liability $ 172.50 July 2021 6,456 — — — 6,456 Tradable warrants Liability $ 73.80 July 2021 212,801 — — — 212,801 Non-tradable pre-funded warrants Equity $ 0.15 July 2023 394 — — — 394 Non-tradable warrants Equity $ 6.69375 (1) 663,167 — — (392,834) (3) 270,333 Non-tradable warrants Equity $ 1.60 December 2022 — 392,834 (3) — — 392,834 Non-tradable warrants Equity $ 7.96875 (1) 33,158 — — — 33,158 Non-tradable warrants Equity $ 14.10 March 2021 5,000 — — — 5,000 Non-tradable warrants Equity $ 21.15 March 2021 8,333 — — — 8,333 Non-tradable warrants Equity $ 7.7895 June 2021 15,000 — — — 15,000 Non-tradable pre-funded warrants Equity $ 0.15 none 86,167 — (33,333) — 52,834 Non-tradable warrants Equity $ 6.375 (2) 4,432,962 — — (1,806,104) (3) 2,626,858 Non-tradable warrants Equity $ 1.600 December 2022 — 1,806,104 (3) — — 1,806,104 Non-tradable pre-funded warrants Equity $ 0.15 none 262,068 — (187,451) — 74,617 Non-tradable warrants Equity $ 2.00 September 2023 — 109,585 — — 109,585 5,725,506 2,308,523 (220,784) (2,198,938) 5,614,307 (1) These preferred stock warrants expire on the earlier of (A) the one-month anniversary of the date on which the Company publicly releases topline results of the INSPIRE Pivotal phase 3 that compare the overall survival (OS) of patients in the rigosertib group vs the Physician’s Choice group, in all patients and in a subgroup of patients with IPSS-R very high risk and (B) December 31, 2019. These preferred stock warrants may be exercised on a cashless basis in certain circumstances specified therein. (2) These preferred stock warrants expire on the 18-month anniversary of June 8, 2018, the date on which the Company publicly announced through the filing of a Current Report on Form 8-K that a Certificate of Amendment to the Company’s Tenth Amended and Restated Certificate of Incorporation, as amended, to increase the number of authorized shares of common stock from 100,000,000 to 250,000,000, was filed with the Secretary of State of the State of Delaware. These preferred stock warrants may be exercised on a cashless basis in certain circumstances specified therein. (3) In September 2019, the Company entered into securities purchase agreements with certain investors pursuant to which it agreed to sell an aggregate of 2,198,938 shares of its common stock in a registered direct offering. The investors in this offering were holders of the Company’s warrants to purchase shares of its convertible preferred stock. The Company also entered into a warrant amendment with each investor pursuant to which, for each share of common stock purchased by the investor in the offering, the Company would amend one outstanding warrant with an exercise price of $6.69375 per common share held by the investor and/or one outstanding warrant with an exercise price of $6.375 per common share held by the investor, as applicable, to reduce the exercise price to $1.60 per common share and to extend the term of the warrants to December 31, 2022. The price for amending one outstanding warrant was $0.125 per share (on an as-converted basis per share of common stock). |
Balance Sheet Detail (Tables)
Balance Sheet Detail (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Balance Sheet Detail | |
Schedule of prepaid expenses and other current assets | September 30, December 31, 2019 2018 Research and development $ 436,000 $ 415,000 Premium on future equity purchase from HanX 214,000 $ — Manufacturing 29,000 111,000 Insurance 189,000 166,000 Other 89,000 68,000 $ 957,000 $ 760,000 |
Schedule of property and equipment and related accumulated depreciation | September 30, December 31, 2019 2018 Property and equipment $ 2,284,000 $ 2,228,000 Accumulated depreciation (2,230,000) (2,219,000) $ 54,000 $ 9,000 |
Schedule of accrued expenses and other current liabilities | September 30, December 31, 2019 2018 Research and development $ 2,098,000 $ 2,285,000 Employee compensation 1,137,000 1,650,000 Professional fees 213,000 225,000 Other — 13,000 $ 3,448,000 $ 4,173,000 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Fair Value Measurements | |
Schedule of Black-Scholes option pricing model assumptions | Risk-free interest rate 1.63 % Expected volatility 94.04 % Expected term 1.78 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, 2019 December 31, 2018 Level 1 Level 2 Level 3 Balance Level 1 Level 2 Level 3 Balance Tradable warrants liability $ 96,000 $ — $ — $ 96,000 $ 176,000 $ — $ — $ 176,000 Non-tradable warrants liability — — — — — — — — Total $ 96,000 $ — $ — $ 96,000 $ 176,000 $ — $ — $ 176,000 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Stock-Based Compensation | |
Schedule of stock-based compensation expense | Three Months ended September 30, Nine Months ended September 30, 2019 2018 2019 2018 General and administrative $ 64,000 $ 159,000 $ 670,000 $ 421,000 Research and development 81,000 136,000 280,000 363,000 $ 145,000 $ 295,000 $ 950,000 $ 784,000 |
Schedule of stock option activity | Options Outstanding Weighted Weighted- Average Shares Average Remaining Aggregate Available Number of Exercise Contractual Intrinsic for Grant Shares Price Term (in years) Value Balance, December 31, 2018 95,264 379,328 $ 76.33 9.19 $ 0 Authorized 589,500 — Granted (64,998) 64,998 $ 3.16 9.77 Exercised — — $ — Forfeitures 24,630 (34,538) $ 60.09 8.68 Balance, September 30, 2019 644,396 409,788 $ 66.09 8.63 $ 0 Vested or expected to vest, September 30, 2019 401,793 $ 119.90 8.12 $ 0 Exercisable at September 30, 2019 216,681 $ 119.90 8.12 $ 0 |
Schedule of information with respect to stock options outstanding and exercisable | Information with respect to stock options outstanding and exercisable at September 30, 2019 is as follows: Exercise Price Shares Exercisable $2.49 – $3.72 71,998 — $4.34 – $7.05 270,246 154,316 $16.35 – $97.50 48,133 42,968 $222.00 – $225.00 1,871 1,871 $348.00 – $597.00 4,867 4,866 $651.00 – $1,129.50 5,428 5,415 $1,992.00 – $2,268.00 6,910 6,910 $4,156.50 – $4,371.00 335 335 409,788 216,681 |
Schedule of weighted-average assumptions used for estimating the fair value of the stock compensation granted | Nine Months ended September 30, 2019 2018 Risk-free interest rate 1.92 % 2.60 % Expected volatility 82.58 % 74.13 % Expected term 5.85 years 5.78 years Expected dividend yield 0 % 0 % Weighted average grant date fair value $ 1.81 $ 12.60 |
Nature of Business - Reverse St
Nature of Business - Reverse Stock Split (Details) | Sep. 25, 2018 |
Nature of Business | |
Reverse stock split ratio | 0.067 |
Nature of Business - The Compan
Nature of Business - The Company (Details) | Sep. 25, 2018 | Sep. 30, 2019product$ / sharesshares | Dec. 31, 2018$ / sharesshares | Jun. 07, 2018shares | Mar. 21, 2018shares | Dec. 31, 2017$ / sharesshares | Dec. 31, 2012Program |
Number of clinical-stage product candidates | product | 3 | ||||||
Common Stock authorized (in shares) | shares | 250,000,000 | 250,000,000 | 250,000,000 | 100,000,000 | 25,000,000 | ||
Common stock, par value (in dollars per share) | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | ||||
Reverse stock split ratio | 0.067 | ||||||
GBO | |||||||
Number of clinical programs (in programs) | Program | 2 |
Nature of Business - Liquidity
Nature of Business - Liquidity (Details) | Sep. 25, 2019USD ($)shares | Aug. 09, 2019USD ($) | May 15, 2019shares | May 10, 2019USD ($)agreement | May 01, 2018USD ($)shares | Feb. 12, 2018USD ($)shares | Nov. 14, 2017USD ($)shares | May 17, 2017USD ($)shares | Apr. 26, 2017shares | Jul. 29, 2016shares | Jan. 05, 2016USD ($)$ / sharesshares | Jul. 30, 2013USD ($)$ / sharesshares | Mar. 31, 2019employee | Sep. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Dec. 31, 2016USD ($) | Oct. 29, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) |
Liquidity | ||||||||||||||||||||||
Net loss | $ (4,595,000) | $ (5,348,000) | $ (15,756,000) | $ (14,759,000) | ||||||||||||||||||
Accumulated deficit | 397,652,000 | 397,652,000 | $ 381,896,000 | |||||||||||||||||||
Cash and cash equivalents | 4,821,000 | $ 22,384,000 | 4,821,000 | $ 22,384,000 | $ 16,970,000 | $ 4,024,000 | ||||||||||||||||
Issuance of common stock (in shares) | shares | 2,198,938 | 3,694,118 | 467,000 | 61,333 | 24,239 | 165,079 | 239,986 | 12,912 | ||||||||||||||
Securities warrants may be converted to (in shares) | shares | 2,198,938 | 815,686 | 196,167 | 6,456 | ||||||||||||||||||
Price per share (in dollars per share) | $ / shares | $ 142.50 | |||||||||||||||||||||
Proceeds from stock and warrant offerings, net | $ 3,000,000 | $ 25,600,000 | $ 8,700,000 | $ 1,840,000 | $ 24,900,000 | |||||||||||||||||
Proceeds from issuance of stock, net | $ 1,100,000 | $ 5,300,000 | ||||||||||||||||||||
FTE positions eliminated | employee | 6 | |||||||||||||||||||||
FTE eliminated positions (as percent of workforce) | 24.00% | |||||||||||||||||||||
Severance charge | $ 1,843,000 | |||||||||||||||||||||
Non-cash charge, accelerated options | $ 415,000 | |||||||||||||||||||||
Restructuring reserve | $ 359,000 | $ 359,000 | ||||||||||||||||||||
Subsequent Event | ||||||||||||||||||||||
Liquidity | ||||||||||||||||||||||
Registered common stock and warrants | $ 13,800,000 | |||||||||||||||||||||
Hanx | ||||||||||||||||||||||
Liquidity | ||||||||||||||||||||||
Issuance of common stock (in shares) | shares | 103,520 | |||||||||||||||||||||
License and collaboration agreements | Hanx | ||||||||||||||||||||||
Liquidity | ||||||||||||||||||||||
Security purchase agreements | agreement | 2 | |||||||||||||||||||||
License and collaboration agreements | Rigosertib | Hanx | ||||||||||||||||||||||
Liquidity | ||||||||||||||||||||||
Committed amount | $ 4,000,000 | |||||||||||||||||||||
Collaboration revenue | $ 2,000,000 | |||||||||||||||||||||
Committed investment revenue | 2,000,000 | |||||||||||||||||||||
Escrow Deposit | 2,000,000 | |||||||||||||||||||||
Potential milestone revenue | $ 45,500,000 | |||||||||||||||||||||
Convertible preferred stock | ||||||||||||||||||||||
Liquidity | ||||||||||||||||||||||
Securities warrants may be converted to (in shares) | shares | 4,509,804 | 696,325 | ||||||||||||||||||||
IPO | ||||||||||||||||||||||
Liquidity | ||||||||||||||||||||||
Issuance of common stock (in shares) | shares | 39,611 | |||||||||||||||||||||
Price per share (in dollars per share) | $ / shares | $ 2,250 | |||||||||||||||||||||
Proceeds from initial public offering, net of issuance costs | $ 79,811,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Unaudited Interim Financial Information (Details) | Sep. 25, 2018 |
Summary of Significant Accounting Policies | |
Reverse stock split ratio | 0.067 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Segment Information (Details) | 9 Months Ended |
Sep. 30, 2019segment | |
Segment Information | |
Number of operating segments | 1 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Leases (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2019 | Jan. 01, 2019 | |
Segment Information | ||
Amount of right of use asset | $ 0 | $ 0 |
Amount of lease liabilities | 0 | $ 0 |
Amount of lease payments | 144,000 | |
Remaining lease payments | $ 80,000 |
Revenue (Details)
Revenue (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Revenue | ||||
Revenue | $ 63,000 | $ 120,000 | $ 2,153,000 | $ 1,169,000 |
SymBio | ||||
Revenue | ||||
Revenue | 57,000 | 114,000 | 170,000 | 341,000 |
SymBio | Supplies | ||||
Revenue | ||||
Revenue | $ 6,000 | $ 6,000 | 18,000 | 59,000 |
Hanx | Rigosertib | ||||
Revenue | ||||
Revenue | $ 1,965,000 | |||
Hanx | ON123300 | ||||
Revenue | ||||
Revenue | 450,000 | |||
Pint | ||||
Revenue | ||||
Revenue | $ 319,000 |
Revenue - Deferred (Details)
Revenue - Deferred (Details) | 9 Months Ended |
Sep. 30, 2019USD ($) | |
Deferred revenue | |
Balance at the beginning of the period | $ 226,000 |
Balance at the end of the period | 226,000 |
SymBio | |
Deferred revenue | |
Balance at the beginning of the period | 4,148,000 |
Recognition to revenue | 170,000 |
Balance at the end of the period | $ 3,978,000 |
Net Loss Per Share of Common _3
Net Loss Per Share of Common Stock (Details) - shares | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
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 | 6,024,095 | 6,058,424 |
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 | 5,614,307 | 5,725,506 |
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 | 409,788 | 332,918 |
Warrants (Details)
Warrants (Details) - $ / shares | Oct. 23, 2019 | Sep. 25, 2019 | May 01, 2018 | Feb. 12, 2018 | Nov. 14, 2017 | May 17, 2017 | Apr. 26, 2017 | Jul. 29, 2016 | Jan. 05, 2016 | Sep. 30, 2019 | Dec. 31, 2018 | Jun. 07, 2018 | Mar. 21, 2018 | Feb. 08, 2018 | Dec. 31, 2017 |
Warrants outstanding and warrant activity | |||||||||||||||
Balance at beginning of the period (in shares) | 5,725,506 | ||||||||||||||
Warrants Issued (in shares) | 2,308,523 | ||||||||||||||
Warrants Exercised (in shares) | (220,784) | ||||||||||||||
Warrants Expired (in shares) | (2,198,938) | ||||||||||||||
Balance at end of the period (in shares) | 5,614,307 | ||||||||||||||
Common Stock authorized (in shares) | 250,000,000 | 250,000,000 | 250,000,000 | 100,000,000 | 25,000,000 | ||||||||||
Issuance of stock (in shares) | 2,198,938 | 3,694,118 | 467,000 | 61,333 | 24,239 | 165,079 | 239,986 | 12,912 | |||||||
Certain institutional and accredited investors | |||||||||||||||
Warrants outstanding and warrant activity | |||||||||||||||
Sale of Common Stock, Agreed Number | 2,198,938 | ||||||||||||||
Securities purchase agreements | |||||||||||||||
Warrants outstanding and warrant activity | |||||||||||||||
Warrant exercise price (in dollars per share) | $ 0.125 | ||||||||||||||
Non-tradable warrants expiring July 2021, Liability | |||||||||||||||
Warrants outstanding and warrant activity | |||||||||||||||
Warrant exercise price (in dollars per share) | $ 172.50 | ||||||||||||||
Balance at beginning of the period (in shares) | 6,456 | ||||||||||||||
Balance at end of the period (in shares) | 6,456 | ||||||||||||||
Tradable warrants expiring July 2021 | |||||||||||||||
Warrants outstanding and warrant activity | |||||||||||||||
Warrant exercise price (in dollars per share) | $ 73.80 | $ 73.80 | |||||||||||||
Balance at beginning of the period (in shares) | 212,801 | ||||||||||||||
Balance at end of the period (in shares) | 212,801 | ||||||||||||||
Term (in years) | 5 years | ||||||||||||||
Non-tradable pre-funded warrants expiring July 2023 | |||||||||||||||
Warrants outstanding and warrant activity | |||||||||||||||
Warrant exercise price (in dollars per share) | $ 0.15 | ||||||||||||||
Balance at beginning of the period (in shares) | 394 | ||||||||||||||
Balance at end of the period (in shares) | 394 | ||||||||||||||
Non-tradable warrants with exercise price | |||||||||||||||
Warrants outstanding and warrant activity | |||||||||||||||
Warrant exercise price (in dollars per share) | $ 6.69375 | ||||||||||||||
Balance at beginning of the period (in shares) | 663,167 | ||||||||||||||
Warrants Expired (in shares) | (392,834) | ||||||||||||||
Balance at end of the period (in shares) | 270,333 | ||||||||||||||
Non-tradable warrant - security purchase agreement | |||||||||||||||
Warrants outstanding and warrant activity | |||||||||||||||
Warrant exercise price (in dollars per share) | $ 1.60 | ||||||||||||||
Warrants Issued (in shares) | 392,834 | ||||||||||||||
Balance at end of the period (in shares) | 392,834 | ||||||||||||||
Non-tradable warrants with exercise price 7.96875 Equity | |||||||||||||||
Warrants outstanding and warrant activity | |||||||||||||||
Warrant exercise price (in dollars per share) | $ 7.96875 | ||||||||||||||
Balance at beginning of the period (in shares) | 33,158 | ||||||||||||||
Balance at end of the period (in shares) | 33,158 | ||||||||||||||
Non-tradable warrants with exercise price 14.10 Equity | |||||||||||||||
Warrants outstanding and warrant activity | |||||||||||||||
Warrant exercise price (in dollars per share) | $ 14.10 | ||||||||||||||
Balance at beginning of the period (in shares) | 5,000 | ||||||||||||||
Balance at end of the period (in shares) | 5,000 | ||||||||||||||
Non-tradable warrants with exercise price 21.15 Equity | |||||||||||||||
Warrants outstanding and warrant activity | |||||||||||||||
Warrant exercise price (in dollars per share) | $ 21.15 | ||||||||||||||
Balance at beginning of the period (in shares) | 8,333 | ||||||||||||||
Balance at end of the period (in shares) | 8,333 | ||||||||||||||
Non-tradable warrants with exercise price 7.7895 Equity | |||||||||||||||
Warrants outstanding and warrant activity | |||||||||||||||
Warrant exercise price (in dollars per share) | $ 7.7895 | ||||||||||||||
Balance at beginning of the period (in shares) | 15,000 | ||||||||||||||
Balance at end of the period (in shares) | 15,000 | ||||||||||||||
Non-tradable pre-funded warrants with exercise Price 0.15 Equity | |||||||||||||||
Warrants outstanding and warrant activity | |||||||||||||||
Warrant exercise price (in dollars per share) | $ 0.15 | ||||||||||||||
Balance at beginning of the period (in shares) | 86,167 | ||||||||||||||
Warrants Exercised (in shares) | (33,333) | ||||||||||||||
Balance at end of the period (in shares) | 52,834 | ||||||||||||||
Non-tradable warrants with exercise price 6.375 Equity | |||||||||||||||
Warrants outstanding and warrant activity | |||||||||||||||
Warrant exercise price (in dollars per share) | $ 6.69375 | $ 6.375 | $ 15.15 | ||||||||||||
Balance at beginning of the period (in shares) | 4,432,962 | ||||||||||||||
Warrants Expired (in shares) | (1,806,104) | ||||||||||||||
Balance at end of the period (in shares) | 2,626,858 | ||||||||||||||
Term (in years) | 18 months | ||||||||||||||
Non-tradable warrant - security purchase agreement II | |||||||||||||||
Warrants outstanding and warrant activity | |||||||||||||||
Warrant exercise price (in dollars per share) | $ 1.600 | ||||||||||||||
Warrants Issued (in shares) | 1,806,104 | ||||||||||||||
Balance at end of the period (in shares) | 1,806,104 | ||||||||||||||
Non-tradable warrants with exercise price 0.15 Equity1 | |||||||||||||||
Warrants outstanding and warrant activity | |||||||||||||||
Warrant exercise price (in dollars per share) | $ 0.15 | ||||||||||||||
Balance at beginning of the period (in shares) | 262,068 | ||||||||||||||
Warrants Exercised (in shares) | (187,451) | ||||||||||||||
Balance at end of the period (in shares) | 74,617 | ||||||||||||||
Non-tradable warrants with exercise price 2.00 Equity | |||||||||||||||
Warrants outstanding and warrant activity | |||||||||||||||
Warrant exercise price (in dollars per share) | $ 2 | ||||||||||||||
Warrants Issued (in shares) | 109,585 | ||||||||||||||
Balance at end of the period (in shares) | 109,585 |
Balance Sheet Detail - Prepaid
Balance Sheet Detail - Prepaid Expenses and Other Current Assets (Details) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Prepaid expenses and other current assets: | ||
Research and development | $ 436,000 | $ 415,000 |
Premium on future equity purchase from HanX | 214,000 | |
Manufacturing | 29,000 | 111,000 |
Insurance | 189,000 | 166,000 |
Other | 89,000 | 68,000 |
Total | $ 957,000 | $ 760,000 |
Balance Sheet Detail - Property
Balance Sheet Detail - Property and Equipment (Details) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Property and equipment: | ||
Property and equipment, gross | $ 2,284,000 | $ 2,228,000 |
Accumulated depreciation | (2,230,000) | (2,219,000) |
Property and equipment, net | $ 54,000 | $ 9,000 |
Balance Sheet Detail - Accrued
Balance Sheet Detail - Accrued Expenses and Other Current Liabilities (Details) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Accrued expenses and other current liabilities: | ||
Research and development | $ 2,098,000 | $ 2,285,000 |
Employee compensation | 1,137,000 | 1,650,000 |
Professional fees | 213,000 | 225,000 |
Other | 13,000 | |
Total | $ 3,448,000 | $ 4,173,000 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) | Sep. 25, 2019 | May 01, 2018 | Feb. 12, 2018 | Nov. 14, 2017 | May 17, 2017 | Apr. 26, 2017 | Jul. 29, 2016 | Jan. 05, 2016 | Dec. 31, 2016 | Sep. 30, 2019 |
Sale of Securities | ||||||||||
Issuance of common stock (in shares) | 2,198,938 | 3,694,118 | 467,000 | 61,333 | 24,239 | 165,079 | 239,986 | 12,912 | ||
Price per share (in dollars per share) | $ 142.50 | |||||||||
Securities warrants may be converted to (in shares) | 2,198,938 | 815,686 | 196,167 | 6,456 | ||||||
Proceeds from stock and warrant offerings, net | $ 3,000,000 | $ 25,600,000 | $ 8,700,000 | $ 1,840,000 | $ 24,900,000 | |||||
Tradable warrants liability | ||||||||||
Sale of Securities | ||||||||||
Redemption price (in dollars per share) | $ 0.001 | |||||||||
Volume weighted average price per share of common stock (in dollars per share) | $ 184.50 | |||||||||
Threshold consecutive trading days (in days) | 10 days | |||||||||
Tradable warrants expiring July 2021 | ||||||||||
Sale of Securities | ||||||||||
Warrants issued (in shares) | 212,801 | |||||||||
Term (in years) | 5 years | |||||||||
Exercise price (in dollars per share) | $ 73.80 | $ 73.80 | ||||||||
Pre-funded warrants | ||||||||||
Sale of Securities | ||||||||||
Warrants issued (in shares) | 43,760 |
Fair Value Measurements - Weigh
Fair Value Measurements - Weighted-average assumptions (Details) | Sep. 30, 2019Y |
Expected term | |
Assumption used to estimate the fair value of warrant liability by utilizing the Black-Scholes option pricing model | |
Measurement input | 1.78 |
Pre-funded warrants | Risk-free interest rate | |
Assumption used to estimate the fair value of warrant liability by utilizing the Black-Scholes option pricing model | |
Measurement input | 1.63 |
Pre-funded warrants | Expected volatility | |
Assumption used to estimate the fair value of warrant liability by utilizing the Black-Scholes option pricing model | |
Measurement input | 94.04 |
Pre-funded warrants | Expected dividend yield | |
Assumption used to estimate the fair value of warrant liability by utilizing the Black-Scholes option pricing model | |
Measurement input | 0 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value Hierarchy Table (Details) - USD ($) | Sep. 30, 2019 | Dec. 31, 2018 |
Liabilities measured at fair value | ||
Warrant liability | $ 96,000 | $ 176,000 |
Recurring basis | ||
Liabilities measured at fair value | ||
Total | 96,000 | 176,000 |
Recurring basis | Tradable warrants liability | ||
Liabilities measured at fair value | ||
Warrant liability | 96,000 | 176,000 |
Recurring basis | Level 1 | ||
Liabilities measured at fair value | ||
Total | 96,000 | 176,000 |
Recurring basis | Level 1 | Tradable warrants liability | ||
Liabilities measured at fair value | ||
Warrant liability | $ 96,000 | $ 176,000 |
Fair Value Measurements - Trans
Fair Value Measurements - Transfers (Details) | Sep. 30, 2019USD ($) |
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 (Detai
Stock-Based Compensation (Details) - shares | 9 Months Ended | |||
Sep. 30, 2019 | Dec. 31, 2018 | Jun. 27, 2018 | Jul. 31, 2013 | |
2013 Plan | ||||
Stock-Based Compensation | ||||
Shares authorized (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 | |||
2013 Plan | Common Stock | ||||
Stock-Based Compensation | ||||
Shares authorized (in shares) | 35,316 | |||
2018 Plan | ||||
Stock-Based Compensation | ||||
Shares authorized (in shares) | 6,035,316 | |||
Additional shares authorized (in shares) | 589,500 | |||
2018 Plan | Common Stock | ||||
Stock-Based Compensation | ||||
Shares authorized (in shares) | 6,000,000 | |||
Stock options | ||||
Stock-Based Compensation | ||||
Additional shares authorized (in shares) | 589,500 | |||
Common Stock available for future issuance (in shares) | 644,396 | 95,264 |
Stock-Based Compensation - Expe
Stock-Based Compensation - Expense (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Stock-Based Compensation | ||||
Net tax benefits related to the stock-based compensation costs | $ 0 | |||
Total stock-based compensation | $ 145,000 | $ 295,000 | 950,000 | $ 784,000 |
General and administrative | ||||
Stock-Based Compensation | ||||
Total stock-based compensation | 64,000 | 159,000 | 670,000 | 421,000 |
Research and development | ||||
Stock-Based Compensation | ||||
Total stock-based compensation | $ 81,000 | $ 136,000 | $ 280,000 | $ 363,000 |
Stock-Based Compensation - Acti
Stock-Based Compensation - Activity (Details) - Stock options - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Shares Available for Grant | ||
Balance at the beginning of the period (in shares) | 95,264 | |
Additional shares authorized (in shares) | 589,500 | |
Granted | (64,998) | |
Granted (in shares) | 64,998 | |
Forfeitures (in shares) | 24,630 | |
Balance at the end of the period (in shares) | 644,396 | 95,264 |
Number of Shares | ||
Balance at the beginning of the period (in shares) | 379,328 | |
Granted (in shares) | 64,998 | |
Forfeitures (in shares) | (34,538) | |
Balance at the end of the period (in shares) | 409,788 | 379,328 |
Vested or expected to vest at the end of the period (in shares) | 401,793 | |
Exercisable at the end of the period (in shares) | 216,681 | |
Weighted-Average Exercise Price | ||
Balance at the beginning of the period (in dollars per share) | $ 76.33 | |
Granted (in dollars per share) | 3.16 | |
Forfeitures (in dollars per share) | 60.09 | |
Balance at the end of the period (in dollars per share) | 66.09 | $ 76.33 |
Vested or expected to vest at the end of the period (in dollars per share) | 119.90 | |
Exercisable at the end of the period (in dollars per share) | $ 119.90 | |
Additional Disclosures | ||
Weighted average remaining contractual term | 8 years 7 months 17 days | 9 years 2 months 9 days |
Weighted average remaining contractual term of options forfeitures | 8 years 8 months 5 days | |
Weighted average remaining contractual term of options granted | 9 years 9 months 7 days | |
Weighted average remaining contractual term of options vested or expected to vest | 8 years 1 month 13 days | |
Weighted average remaining contractual term of options exercisable | 8 years 1 month 13 days | |
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 - Outs
Stock-Based Compensation - Outstanding and Exercisable (Details) - Stock options | 9 Months Ended |
Sep. 30, 2019$ / sharesshares | |
Share-Based Compensation | |
Shares (in shares) | 409,788 |
Exercisable (in shares) | 216,681 |
Exercise Price Range $2.49 - $3.72 | |
Share-Based Compensation | |
Exercise price, lower range limit (in dollars per share) | $ / shares | $ 2.49 |
Exercise price, upper range limit (in dollars per share) | $ / shares | $ 3.72 |
Shares (in shares) | 71,998 |
Exercise Price Range $4.34 - $7.05 | |
Share-Based Compensation | |
Exercise price, lower range limit (in dollars per share) | $ / shares | $ 4.34 |
Exercise price, upper range limit (in dollars per share) | $ / shares | $ 7.05 |
Shares (in shares) | 270,246 |
Exercisable (in shares) | 154,316 |
Exercise Price Range $16.35 - $97.50 | |
Share-Based Compensation | |
Exercise price, lower range limit (in dollars per share) | $ / shares | $ 16.35 |
Exercise price, upper range limit (in dollars per share) | $ / shares | $ 97.50 |
Shares (in shares) | 48,133 |
Exercisable (in shares) | 42,968 |
Exercise Price Range $222.00 - $225.00 | |
Share-Based Compensation | |
Exercise price, lower range limit (in dollars per share) | $ / shares | $ 222 |
Exercise price, upper range limit (in dollars per share) | $ / shares | $ 225 |
Shares (in shares) | 1,871 |
Exercisable (in shares) | 1,871 |
Exercise Price Range $348.00 - $597.00 | |
Share-Based Compensation | |
Exercise price, lower range limit (in dollars per share) | $ / shares | $ 348 |
Exercise price, upper range limit (in dollars per share) | $ / shares | $ 597 |
Shares (in shares) | 4,867 |
Exercisable (in shares) | 4,866 |
Exercise Price Range $651.00 - $1,129.50 | |
Share-Based Compensation | |
Exercise price, lower range limit (in dollars per share) | $ / shares | $ 651 |
Exercise price, upper range limit (in dollars per share) | $ / shares | $ 1,129.50 |
Shares (in shares) | 5,428 |
Exercisable (in shares) | 5,415 |
Exercise Price Range $1,992.00 - $2,268.00 | |
Share-Based Compensation | |
Exercise price, lower range limit (in dollars per share) | $ / shares | $ 1,992 |
Exercise price, upper range limit (in dollars per share) | $ / shares | $ 2,268 |
Shares (in shares) | 6,910 |
Exercisable (in shares) | 6,910 |
Exercise Price Range $4,156.50 - $4,371.00 | |
Share-Based Compensation | |
Exercise price, lower range limit (in dollars per share) | $ / shares | $ 4,156.50 |
Exercise price, upper range limit (in dollars per share) | $ / shares | $ 4,371 |
Shares (in shares) | 335 |
Exercisable (in shares) | 335 |
Stock-Based Compensation - Unre
Stock-Based Compensation - Unrecognized Compensation Expense (Details) - Stock options | 9 Months Ended |
Sep. 30, 2019USD ($) | |
Stock-Based Compensation | |
Unrecognized compensation expense related to unvested stock options | $ 741,000 |
Weighted-average period for recognizing unrecognized compensation expense related to unvested stock options (in years) | 1 year 11 months 1 day |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value Assumptions (Details) - Stock options - $ / shares | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Assumptions used | ||
Risk-free interest rate (as a percent) | 1.92% | 2.60% |
Expected volatility (as a percent) | 82.58% | 74.13% |
Expected term (in years) | 5 years 10 months 6 days | 5 years 9 months 11 days |
Expected dividend yield (as a percent) | 0.00% | 0.00% |
Weighted average grant date fair value (in dollars per share) | $ 1.81 | $ 12.60 |
Annualized forfeiture rate (as a percent) | 4.14% | 4.14% |
Research Agreements (Details)
Research Agreements (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Research Agreements | ||||
Revenue | $ 63,000 | $ 120,000 | $ 2,153,000 | $ 1,169,000 |
Research agreements | ||||
Research Agreements | ||||
Revenue | $ 0 |
License and Collaboration Agr_2
License and Collaboration Agreements (Details) - USD ($) | Sep. 25, 2019 | Aug. 09, 2019 | May 15, 2019 | May 10, 2019 | May 01, 2018 | Mar. 02, 2018 | Feb. 12, 2018 | Nov. 14, 2017 | May 17, 2017 | Apr. 26, 2017 | Jul. 29, 2016 | Jan. 05, 2016 | Jan. 31, 2018 | Jul. 31, 2011 | Sep. 30, 2019 | Jun. 30, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Apr. 11, 2018 |
License and collaboration agreements | ||||||||||||||||||||||
Revenue | $ 63,000 | $ 120,000 | $ 2,153,000 | $ 1,169,000 | ||||||||||||||||||
Issuance of common stock (in shares) | 2,198,938 | 3,694,118 | 467,000 | 61,333 | 24,239 | 165,079 | 239,986 | 12,912 | ||||||||||||||
Value of common stock | 2,968,000 | 3,360,000 | ||||||||||||||||||||
Research and development | $ 3,521,000 | 3,985,000 | $ 11,490,000 | 12,632,000 | ||||||||||||||||||
License revenue receivable | $ 1,700,000 | |||||||||||||||||||||
Common Stock | ||||||||||||||||||||||
License and collaboration agreements | ||||||||||||||||||||||
Issuance of common stock (in shares) | 2,198,938 | 2,302,458 | ||||||||||||||||||||
Value of common stock | $ 22,000 | $ 23,000 | ||||||||||||||||||||
SymBio | ||||||||||||||||||||||
License and collaboration agreements | ||||||||||||||||||||||
Revenue | $ 57,000 | $ 114,000 | 170,000 | 341,000 | ||||||||||||||||||
Recognition to revenue | 170,000 | |||||||||||||||||||||
Hanx | ||||||||||||||||||||||
License and collaboration agreements | ||||||||||||||||||||||
Issuance of common stock (in shares) | 103,520 | |||||||||||||||||||||
Value of common stock | $ 500,000 | |||||||||||||||||||||
Redemption premium | 100,000 | |||||||||||||||||||||
Research and development | $ 500,000 | |||||||||||||||||||||
Hanx | ON123300 | ||||||||||||||||||||||
License and collaboration agreements | ||||||||||||||||||||||
Revenue | 450,000 | |||||||||||||||||||||
Hanx | Rigosertib | ||||||||||||||||||||||
License and collaboration agreements | ||||||||||||||||||||||
Revenue | $ 1,965,000 | |||||||||||||||||||||
Pint | ||||||||||||||||||||||
License and collaboration agreements | ||||||||||||||||||||||
Revenue | $ 319,000 | |||||||||||||||||||||
Issuance of common stock (in shares) | 54,463 | |||||||||||||||||||||
Value of common stock | $ 1,250,000 | |||||||||||||||||||||
Redemption premium | 319,000 | |||||||||||||||||||||
License and collaboration agreements | SymBio | ||||||||||||||||||||||
License and collaboration agreements | ||||||||||||||||||||||
Contract with customer, liability | $ 7,500,000 | |||||||||||||||||||||
Potential milestone revenue | 22,000,000 | |||||||||||||||||||||
Percentage of discount on future purchases | 35.00% | |||||||||||||||||||||
Cumulative amount of discount on purchases | $ 300,000 | |||||||||||||||||||||
License and collaboration agreements | SymBio | Rigosertib | ||||||||||||||||||||||
License and collaboration agreements | ||||||||||||||||||||||
Contract with customer, liability | 7,500,000 | |||||||||||||||||||||
Aggregate potential milestone payments based on annual net sales | $ 30,000,000 | |||||||||||||||||||||
Percentage of royalty payments based on net sales of rigosertib (as a percent) | 20.00% | |||||||||||||||||||||
License and collaboration agreements | SymBio | Rigosertib | United States and Japan | ||||||||||||||||||||||
License and collaboration agreements | ||||||||||||||||||||||
Regulatory milestones payments due upon receipt of marketing approval for indication | $ 4,000,000 | |||||||||||||||||||||
License and collaboration agreements | SymBio | Rigosertib | United States | Higher risk patients | ||||||||||||||||||||||
License and collaboration agreements | ||||||||||||||||||||||
Regulatory milestones payments due upon receipt of marketing approval for indication | 5,000,000 | |||||||||||||||||||||
License and collaboration agreements | SymBio | Rigosertib | United States | Lower risk patients | ||||||||||||||||||||||
License and collaboration agreements | ||||||||||||||||||||||
Regulatory milestones payments due upon receipt of marketing approval for indication | 5,000,000 | |||||||||||||||||||||
License and collaboration agreements | SymBio | Rigosertib | Japan | Higher risk patients | ||||||||||||||||||||||
License and collaboration agreements | ||||||||||||||||||||||
Regulatory milestones payments due upon receipt of marketing approval for indication | 3,000,000 | |||||||||||||||||||||
License and collaboration agreements | SymBio | Rigosertib | Japan | Lower risk patients | ||||||||||||||||||||||
License and collaboration agreements | ||||||||||||||||||||||
Regulatory milestones payments due upon receipt of marketing approval for indication | $ 5,000,000 | |||||||||||||||||||||
License and collaboration agreements | Hanx | ||||||||||||||||||||||
License and collaboration agreements | ||||||||||||||||||||||
Collaborative Arrangement upfront Payment | 2,000,000 | |||||||||||||||||||||
Revenue | $ 1,700,000 | |||||||||||||||||||||
License and collaboration agreements | Hanx | ON123300 | ||||||||||||||||||||||
License and collaboration agreements | ||||||||||||||||||||||
Contract with customer, liability | $ 450,000 | |||||||||||||||||||||
License and collaboration agreements | Hanx | Rigosertib | ||||||||||||||||||||||
License and collaboration agreements | ||||||||||||||||||||||
Potential milestone revenue | 45,500,000 | |||||||||||||||||||||
Committed amount | 4,000,000 | |||||||||||||||||||||
Committed investment revenue | 2,000,000 | |||||||||||||||||||||
Research and development | 2,000,000 | |||||||||||||||||||||
Maximum aggregate amount | 500,000 | |||||||||||||||||||||
Collaboration revenue | $ 2,000,000 | |||||||||||||||||||||
Escrow Deposit | $ 2,000,000 | |||||||||||||||||||||
License and collaboration agreements | Hanx | HanX license payment | ||||||||||||||||||||||
License and collaboration agreements | ||||||||||||||||||||||
Revenue | $ 450,000 | |||||||||||||||||||||
License and collaboration agreements | Pint | ||||||||||||||||||||||
License and collaboration agreements | ||||||||||||||||||||||
Potential milestone revenue | $ 41,500,000 | |||||||||||||||||||||
Revenue | $ 319,000 | |||||||||||||||||||||
Prior written notice period for termination (in days) | 45 days |
Preclinical Collaboration _ N_2
Preclinical Collaboration / Non-controlling Interest (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |
Nov. 30, 2014USD ($) | Jun. 30, 2018USD ($) | Sep. 30, 2018USD ($) | Dec. 31, 2013USD ($) | Dec. 31, 2012Program | |
Preclinical Collaboration | |||||
Gain on dissolution of GBO | $ 693,000 | ||||
Non-controlling interest portion upon consolidation | $ (163,000) | ||||
GBO | |||||
Preclinical Collaboration | |||||
Number of clinical programs (in programs) | Program | 2 | ||||
Ownership percentage (as percent) | 90.00% | ||||
Gain on dissolution of GBO | $ 693,000 | ||||
Non-controlling interest portion upon consolidation | $ (163,000) | ||||
GBO | GVK BIO | |||||
Preclinical Collaboration | |||||
Capital contribution | $ 500,000 | $ 500,000 | |||
Ownership percentage (as percent) | 17.50% | 10.00% | |||
GBO | GVK BIO | Potential ownership based on capital contribution | Minimum | |||||
Preclinical Collaboration | |||||
Ownership percentage (as percent) | 10.00% | ||||
GBO | GVK BIO | Potential ownership based on capital contribution | Maximum | |||||
Preclinical Collaboration | |||||
Ownership percentage (as percent) | 50.00% |
Related-Party Transactions (Det
Related-Party Transactions (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | |
Member of board of directors | |||||
Related-Party Transactions | |||||
Payments to related party | $ 88 | $ 88 | $ 263 | $ 263 | |
Amounts due to related party | 88 | 88 | $ 88 | ||
Significant shareholder | |||||
Related-Party Transactions | |||||
Payments to related party | 33 | $ 33 | 99 | $ 99 | |
Amounts due to related party | $ 33 | $ 33 | $ 33 |
Securities Registrations and _2
Securities Registrations and Sales Agreements - Sales and Purchase Agreements (Details) - USD ($) | Sep. 25, 2019 | May 01, 2018 | Feb. 12, 2018 | Nov. 14, 2017 | May 17, 2017 | Apr. 26, 2017 | Jul. 29, 2016 | Jan. 05, 2016 | Oct. 08, 2015 |
Securities Registrations and Sales Agreement | |||||||||
Issuance of common stock (in shares) | 2,198,938 | 3,694,118 | 467,000 | 61,333 | 24,239 | 165,079 | 239,986 | 12,912 | |
Proceeds from issuance of stock, net | $ 1,100,000 | $ 5,300,000 | |||||||
Lincoln Park | Purchase Agreements | |||||||||
Securities Registrations and Sales Agreement | |||||||||
Maximum potential consideration | $ 15,000,000 | ||||||||
Issuance of common stock (in shares) | 5,645 | ||||||||
Proceeds from issuance of stock, net | $ 1,500,000 | ||||||||
Business day limit (in shares) | 666 | ||||||||
Business day limit contingent upon the closing price of the stock (in shares) | 1,666 | ||||||||
Regular purchase, one day limit | $ 1,000,000 | ||||||||
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) | $ 233.40 | ||||||||
Stock issued as consideration (in shares) | 1,333 |
Securities Registrations and _3
Securities Registrations and Sales Agreements - Underwriting agreement with HCW (Details) - USD ($) | Sep. 25, 2019 | May 01, 2018 | Apr. 27, 2018 | Apr. 16, 2018 | Feb. 12, 2018 | Feb. 08, 2018 | Nov. 14, 2017 | May 17, 2017 | Apr. 26, 2017 | Jul. 29, 2016 | Jan. 05, 2016 | Sep. 30, 2019 | Sep. 30, 2019 | Dec. 31, 2016 | Dec. 31, 2018 | Sep. 24, 2018 | Jun. 07, 2018 | Apr. 26, 2018 | Mar. 21, 2018 | Dec. 31, 2017 | May 31, 2017 |
Subsidiary, Sale of Stock [Line Items] | |||||||||||||||||||||
Issuance of stock (in shares) | 2,198,938 | 3,694,118 | 467,000 | 61,333 | 24,239 | 165,079 | 239,986 | 12,912 | |||||||||||||
Warrants Issued (in shares) | 2,308,523 | ||||||||||||||||||||
Number of securities to each class of warrant (in shares) | 2,198,938 | 815,686 | 196,167 | 6,456 | |||||||||||||||||
Share price (in dollars per share) | $ 142.50 | ||||||||||||||||||||
Proceeds from stock and warrant offerings, net | $ 3,000,000 | $ 25,600,000 | $ 8,700,000 | $ 1,840,000 | $ 24,900,000 | ||||||||||||||||
Common Stock authorized (in shares) | 250,000,000 | 250,000,000 | 250,000,000 | 250,000,000 | 100,000,000 | 25,000,000 | |||||||||||||||
Percentage of exercise price of warrants | 105.00% | ||||||||||||||||||||
Securities purchase agreements | |||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||||||||||
Warrant exercise price (in dollars per share) | $ 0.125 | $ 0.125 | |||||||||||||||||||
Common Stock | |||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||||||||||
Issuance of stock (in shares) | 2,198,938 | 2,302,458 | |||||||||||||||||||
Non-tradable pre-funded warrants expiring July 2023 | |||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||||||||||
Number of securities to each class of warrant (in shares) | 86,500 | ||||||||||||||||||||
Warrant exercise price (in dollars per share) | $ 0.15 | $ 0.15 | |||||||||||||||||||
Non-tradable warrants with exercise price 7.96875 Equity | |||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||||||||||
Warrant exercise price (in dollars per share) | 7.96875 | 7.96875 | |||||||||||||||||||
Number of common stock shares for conversion preferred stock received as compensation | 33,158 | ||||||||||||||||||||
Warrants exercise price received as compensation (in dollars per share) | $ 18.9375 | $ 7.96875 | |||||||||||||||||||
Non-tradable warrants with exercise price 6.375 Equity | |||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||||||||||
Warrant exercise price (in dollars per share) | $ 6.69375 | $ 15.15 | 6.375 | 6.375 | |||||||||||||||||
Number of securities converted from warrants as compensation | 0.6667 | 0.0667 | |||||||||||||||||||
Non-tradable warrants with exercise price 6.375 Equity | Series B Convertible Preferred Stock | |||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||||||||||
Warrant exercise price (in dollars per share) | $ 6.375 | ||||||||||||||||||||
May 2018 warrants | |||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||||||||||
Warrant exercise price (in dollars per share) | 0.125 | $ 0.125 | |||||||||||||||||||
Non-tradable warrants with exercise price 2.00 Equity | |||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||||||||||
Warrants Issued (in shares) | 109,585 | ||||||||||||||||||||
Warrant exercise price (in dollars per share) | 2 | $ 2 | |||||||||||||||||||
HCW | |||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||||||||||
Underwriters commission (in percentage) | 7.00% | 8.00% | |||||||||||||||||||
Management fee (in percentage) | 1.00% | 1.00% | |||||||||||||||||||
HCW | Non-tradable warrants with exercise price 2.00 Equity | |||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||||||||||
Warrant exercise price (in dollars per share) | $ 2 | $ 2 | |||||||||||||||||||
The Offering | |||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||||||||||
Issuance of stock (in shares) | 3,105,882 | 380,500 | |||||||||||||||||||
Share price (in dollars per share) | $ 6.375 | $ 15.15 | |||||||||||||||||||
The Offering | Pre-funded warrants | |||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||||||||||
Number of securities to each class of warrant (in shares) | 196,167 | ||||||||||||||||||||
Warrant purchase price (in dollars per share) | $ 15 | ||||||||||||||||||||
Over-allotment | HCW | |||||||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||||||||||||||
Issuance of stock (in shares) | 86,500 | ||||||||||||||||||||
Share price (in dollars per share) | $ 6.225 | $ 15 | |||||||||||||||||||
Period available to underwriters to purchase additional shares under the offering | 30 days | ||||||||||||||||||||
Lock-up period for purchased shares by counterparty (in days) | 135 days |
Securities Registrations and _4
Securities Registrations and Sales Agreements - Securities Purchase Agreement (Details) - USD ($) | Oct. 23, 2019 | Sep. 25, 2019 | Nov. 14, 2017 | May 17, 2017 | Sep. 30, 2019 |
Securities Registration and Sales Agreement | |||||
Proceeds from issuance of stock, net | $ 1,100,000 | $ 5,300,000 | |||
Agreed percentage of compensation on investor capital | 8.00% | ||||
Non-tradable warrant - security purchase agreement | |||||
Securities Registration and Sales Agreement | |||||
Exercise price (in dollars per share) | $ 1.60 | ||||
Non-tradable warrant - security purchase agreement II | |||||
Securities Registration and Sales Agreement | |||||
Exercise price (in dollars per share) | 1.600 | ||||
May 2018 warrants | |||||
Securities Registration and Sales Agreement | |||||
Exercise price (in dollars per share) | 0.125 | ||||
Non-tradable warrants with exercise price 2.00 Equity | |||||
Securities Registration and Sales Agreement | |||||
Exercise price (in dollars per share) | 2 | ||||
HCW | Non-tradable warrants with exercise price 2.00 Equity | |||||
Securities Registration and Sales Agreement | |||||
Exercise price (in dollars per share) | $ 2 | ||||
Liable to pay non-accountable expenses | $ 56,000 | ||||
Liable to pay clearing expenses | $ 10,000 | ||||
Percentage of exercise price on offering price of direct offering | 125.00% | ||||
HCW | Non-tradable warrants with exercise price 2.00 Equity | Maximum | |||||
Securities Registration and Sales Agreement | |||||
Common stock purchased by issuing warrants | 109,585 | ||||
Certain institutional and accredited investors | |||||
Securities Registration and Sales Agreement | |||||
Number of common shares agreed to sell | 2,198,938 | ||||
Par value per share | $ 0.01 | ||||
Proceeds from offering | $ 3,500,000 | ||||
Purchase price (per share) | $ 1.60 | ||||
Proceeds from issuance of stock, net | $ 3,000,000 | ||||
Securities purchase agreements | |||||
Securities Registration and Sales Agreement | |||||
Exercise price (in dollars per share) | $ 0.125 |
Subsequent Event - (Details)
Subsequent Event - (Details) $ in Millions | Oct. 29, 2019USD ($) |
Subsequent Event | |
Subsequent Event | |
Registered common stock and warrants | $ 13.8 |