Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2020 | May 08, 2020 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2020 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | CURIS INC | |
Entity Central Index Key | 0001108205 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Emerging Growth Company | false | |
Small Business | true | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 36,582,309 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Current Assets: | ||
Cash and cash equivalents | $ 12,532 | $ 15,430 |
Restricted cash | 153 | 153 |
Investments | 6 | 5,113 |
Accounts receivable | 2,507 | 3,244 |
Prepaid expenses and other current assets | 1,311 | 1,063 |
Total current assets | 16,509 | 25,003 |
Property and equipment, net | 396 | 154 |
Restricted cash | 816 | 816 |
Operating lease right-of-use asset | 0 | 149 |
Goodwill | 8,982 | 8,982 |
Other assets | 3 | 3 |
Total assets | 26,706 | 35,107 |
Current Liabilities: | ||
Accounts payable | 4,267 | 4,465 |
Accrued liabilities | 1,719 | 1,910 |
Operating lease liability | 0 | 166 |
Total current liabilities | 5,986 | 6,541 |
Liability related to the sale of future royalties, net | 60,989 | 62,477 |
Total liabilities | 66,975 | 69,018 |
Stockholders’ Deficit: | ||
Common stock, $0.01 par value—101,250,000 shares authorized; 36,582,309 shares issued and outstanding at March 31, 2020; 33,241,793 shares issued and outstanding at December 31, 2019 | 366 | 332 |
Additional paid-in capital | 986,055 | 982,738 |
Accumulated deficit | (1,026,690) | (1,016,981) |
Total stockholders’ deficit | (40,269) | (33,911) |
Total liabilities and stockholders’ deficit | $ 26,706 | $ 35,107 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (USD per share) | $ 0.01 | $ 0.01 |
Common stock authorized (shares) | 101,250,000 | 101,250,000 |
Common stock issued (shares) | 36,582,309 | 33,241,793 |
Common stock outstanding (shares) | 36,582,309 | 33,241,793 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Revenues, net: | ||
Total revenues, net | $ 2,709 | $ 1,767 |
Costs and expenses: | ||
Cost of royalties | 125 | 108 |
Research and development | 7,473 | 4,074 |
General and administrative | 3,593 | 3,143 |
Total costs and expenses | 11,191 | 7,325 |
Loss from operations | (8,482) | (5,558) |
Other expense: | ||
Loss on debt extinguishment | 0 | (3,495) |
Interest income | 50 | 108 |
Imputed interest expense related to the sale of future royalties | (1,298) | (131) |
Interest expense, debt | 0 | (791) |
Other income (expense), net | 21 | (17) |
Total other expense | (1,227) | (4,326) |
Net loss | $ (9,709) | $ (9,884) |
Net loss per common share (basic and diluted) (USD per share) | $ (0.28) | $ (0.30) |
Weighted average common shares (basic and diluted) (shares) | 34,453,189 | 33,150,869 |
Unrealized gain on marketable securities | $ 0 | $ 0 |
Comprehensive loss | (9,709) | (9,884) |
Royalties | ||
Revenues, net: | ||
Total revenues, net | 2,515 | 2,137 |
Other revenue | ||
Revenues, net: | ||
Total revenues, net | 211 | 0 |
Contra revenue, net | ||
Revenues, net: | ||
Total revenues, net | $ (17) | $ (370) |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' DEFICIT - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Aspire Capital Fund, LLC | Aspire Capital Fund, LLCCommon Stock | Aspire Capital Fund, LLCAdditional Paid-in Capital |
Beginning balance (shares) at Dec. 31, 2018 | 33,159,253.2 | ||||||
Beginning balance at Dec. 31, 2018 | $ (4,496) | $ 332 | $ 980,012 | $ (984,840) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Cancellation of restricted stock awards | 651 | 651 | |||||
Cancellation of restricted stock awards (shares) | (8,473) | ||||||
Cancellation of restricted stock awards | 0 | ||||||
Net loss | (9,884) | (9,884) | |||||
Ending balance (shares) at Mar. 31, 2019 | 33,150,780.2 | ||||||
Ending balance at Mar. 31, 2019 | $ (13,729) | $ 332 | 980,663 | (994,724) | |||
Beginning balance (shares) at Dec. 31, 2019 | 33,241,793 | 33,241,793 | |||||
Beginning balance at Dec. 31, 2019 | $ (33,911) | $ 332 | 982,738 | (1,016,981) | |||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Cancellation of restricted stock awards | 625 | 625 | |||||
Issuance of shares in connection with Aspire Capital agreement (shares) | 3,340,516 | ||||||
Issuance of shares in connection with Aspire Capital agreement | $ 2,726 | $ 34 | $ 2,692 | ||||
Net loss | $ (9,709) | (9,709) | |||||
Ending balance (shares) at Mar. 31, 2020 | 36,582,309 | 36,582,309 | |||||
Ending balance at Mar. 31, 2020 | $ (40,269) | $ 366 | $ 986,055 | $ (1,026,690) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (9,709) | $ (9,884) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 25 | 35 |
Non-cash lease expense | 149 | 240 |
Stock-based compensation expense | 625 | 651 |
Amortization of debt issuance costs | 0 | 8 |
Non-cash imputed interest expense related to the sale of future royalties | 235 | 131 |
Non-cash interest expense on investments | 25 | 4 |
Loss on extinguishment of debt | 0 | 3,495 |
Loss on disposal of fixed assets | 0 | 5 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 737 | 1,078 |
Prepaid expenses, and other assets | (248) | 146 |
Accounts payable and accrued and other liabilities | (689) | (2,895) |
Operating lease liability | (166) | (247) |
Total adjustments | 693 | 2,651 |
Net cash used in operating activities | (9,016) | (7,233) |
Cash flows from investing activities: | ||
Sales and maturities of investments | 5,082 | 600 |
Purchase of property and equipment | (241) | 0 |
Net cash provided by investing activities | 4,841 | 600 |
Cash flows from financing activities: | ||
Sale of common stock | 3,000 | 0 |
Proceeds from royalty interest purchase agreement with Oberland Capital Management, LLC | 0 | 65,000 |
Payment of issuance costs on royalty interest purchase agreement | 0 | (250) |
Payment of liability of future royalties, net of imputed interest | (1,723) | 0 |
Payment on termination of credit agreement with HealthCare Royalty Partners, III, L.P. | 0 | (37,162) |
Payments on Curis Royalty’s debt | 0 | (1,825) |
Net cash provided by financing activities | 1,277 | 25,763 |
Net decrease in cash and cash equivalents and restricted cash | (2,898) | 19,130 |
Cash and cash equivalents and restricted cash, beginning of period | 16,399 | 23,789 |
Cash and cash equivalents and restricted cash, end of period | 13,501 | 42,919 |
Accrued issuance costs | 274 | 334 |
Property and equipment purchases in accounts payable | 26 | 0 |
Cash paid for interest | 1,062 | 948 |
Non-cash commitment shares issued to Aspire Capital | $ 900 | $ 0 |
Nature of Business
Nature of Business | 3 Months Ended |
Mar. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business | Nature of Business Curis, Inc. is a biotechnology company focused on the development of first-in-class and innovative therapeutics for the treatment of cancer. Throughout these Condensed Consolidated Financial Statements, Curis, Inc. and its wholly owned subsidiaries are collectively referred to as “the Company,” or “Curis.” The Company conducts its research and development programs both internally and through strategic collaborations. The Company’s clinical stage drug candidates are CA-4948, CI-8993, and fimepinostat: • CA-4948 which is being tested in a Phase 1 dose escalating clinical trial in patients with non-Hodgkin lymphomas, including those with Myeloid Differentiation Primary Response 88 (“MYD88”), alterations. The Company reported preliminary clinical data from the study in December 2019. The Company is starting a separate Phase 1 trial for acute myeloid leukemia and myelodysplastic syndromes and anticipates the first patient enrolling in the second quarter of 2020. • CI-8993, a monoclonal antibody designed to antagonize the V-domain Ig suppressor of T cell activation (“VISTA”) signaling pathway, which the Company plans to begin clinical testing in a Phase 1a/1b trial in the second half of 2020. • Fimepinostat, which is currently being explored in clinical studies in patients with MYC-altered diffuse large B-cell lymphoma (“DLBCL”) and solid tumors and has been granted Orphan Drug Designation and Fast Track Designation for the treatment of DLBCL by the U.S. Food and Drug Administration, (”FDA”) in April 2015 and May 2018, respectively. The Company began enrollment in a Phase 1 combination study with venetoclax in DLBCL patients, including patients with translocations in both MYC and the BCL2 gene, also referred to as double-hit lymphoma, or high-grade B-cell lymphoma (“HGBL”). The Company reported preliminary clinical data from this combination study in December 2019. In March 2020, the Company announced that although it observed no significant drug-drug interaction in its Phase 1 study of fimepinostat in combination with venetoclax, the Company did not see an efficacy signal that would warrant continuation of the study. Accordingly, no further patients will be enrolled in this study. The Company is currently evaluating future studies for fimepinostat. The Company's pipeline includes CA-170, for which the Company announced initial data from a clinical study in patients with mesothelioma, in conjunction with the Society of lmmunotherapy of Cancer conference in November 2019. Based on this data, no further patients will be enrolled in the study. The Company is currently evaluating future studies for CA-170. The Company’s pipeline also includes CA-327, which is a pre-Investigational New Drug (“IND”) stage oncology drug candidate. The Company is party to a collaboration with Genentech Inc. (“Genentech”), a member of the Roche Group, under which F. Hoffmann-La Roche Ltd (“Roche”) and Genentech are commercializing Erivedge® (vismodegib), a first-in-class orally administered small molecule Hedgehog signaling pathway inhibitor. Erivedge is approved for the treatment of advanced basal cell carcinoma (“BCC”). In January 2015, and as amended in September 2016 and February 2020, the Company entered into a collaboration, option and license agreement focused on immuno-oncology and selected precision oncology targets with Aurigene Discovery Technologies Limited (Aurigene). The collaboration with Aurigene is comprised of multiple programs, and the Company had the option to exclusively license each program, including data, intellectual property and compounds associated therewith, once a development candidate is nominated within such program. In October 2015, the Company exercised options to license two programs under this collaboration. The first licensed program is in the immuno-oncology field and the Company has named CA-170, an orally available small molecule antagonist of two immune checkpoints, VISTA and programmed death ligand-1 (PDL1), as the development candidate from this program. The second licensed program is in the precision oncology field and the Company has named CA-4948, an orally available small molecule inhibitor of Interleukin-1 receptor-associated kinase 4 (IRAK4) as the development candidate. In October 2016, the Company exercised its option to license a third program in the collaboration, and designated CA-327, a distinct orally available small molecule antagonist of two immune checkpoints PDL1 and T-cell immunoglobulin and mucin domain containing protein-3 (TIM3) as the development candidate from this program. In March 2018, the Company exercised its option to license a fourth program, which is an immuno-oncology program. In January 2020, Curis entered into an option and license agreement with ImmuNext, Inc. Pursuant to the terms of the option and license agreement, the Company has the option, exercisable for a specified period as set forth in the option and license agreement, to obtain an exclusive license to develop and commercialize certain VISTA antagonizing compounds, including ImmuNext's lead compound, CI-8993, and products containing these compounds in the field of oncology. The Company is subject to risks common to companies in the biotechnology industry as well as risks that are specific to the Company’s business, including, but not limited to: the Company’s ability to continue as a going concern; the Company’s ability to obtain adequate financing to fund its operations; the Company’s ability to advance and expand its research and development programs; the impacts of the COVID-19 pandemic and responsive actions related thereto; the Company’s reliance on Aurigene to successfully preclinically develop drug candidates under the parties’ collaboration agreement; the Company’s reliance on Roche and Genentech to successfully commercialize Erivedge in the approved indication of advanced BCC and to progress its clinical development in indications other than BCC; the ability of the Company and its wholly owned subsidiary, Curis Royalty, LLC (Curis Royalty) to satisfy the terms of the royalty interest purchase agreement (the Oberland Purchase Agreement) with TPC Investments I LP and TPC Investments II LP, referred to as the Purchasers, each of which is a Delaware limited partnership managed by Oberland Capital Management, LLC, and Lind SA LLC, referred to as the Agent, a Delaware limited liability company managed by Oberland Capital Management, LLC, as collateral agent for the Purchasers; the Company’s ability to obtain and maintain necessary intellectual property protection; development by the Company’s competitors of new or better technological innovations; the Company's dependence on key personnel; the Company’s ability to comply with regulatory requirements; the Company's ability to obtain and maintain applicable regulatory approvals and commercialize any approved product candidates: the Company’s ability to execute on its overall business strategies; and the Company’s ability to maintain its listing on the Nasdaq Global Stock Market. The Company’s future operating results will largely depend on the progress of drug candidates currently in its development pipeline and the magnitude of payments that it may receive and make under its current and potential future collaborations. The results of the Company’s operations have varied and will likely continue to vary significantly from year to year and quarter to quarter and depend on a number of factors, including, but not limited to: the timing, outcome and cost of the Company’s preclinical studies and clinical trials for its drug candidates; Aurigene’s ability to successfully develop preclinical programs under the Company’s collaboration with Aurigene, as well as the Company’s ability to further develop programs under this collaboration; Roche and Genentech’s ability to successfully commercialize Erivedge; and positive results in Roche and Genentech’s ongoing clinical trials. The Company has incurred net losses and negative cash flows from operations since its inception. As of March 31, 2020 , the Company had an accumulated deficit of approximately $1.0 billion, and for the three months ended March 31, 2020 , the Company incurred a net loss of $9.7 million and used $9.0 million of cash in operations. The Company expects to continue to generate operating losses in the foreseeable future. The Company anticipates that its $12.5 million of existing cash, cash equivalents and investments at March 31, 2020 should enable the Company to maintain its planned operations into the third quarter of 2020. Based on the Company's available cash resources, recurring losses and cash outflows from operations since inception, an expectation of continuing operating losses and cash outflows from operations for the foreseeable future and the need to raise additional capital to finance its future operations, the Company concluded it does not have sufficient cash on hand to support current operations within the next 12 months from the date of filing this Quarterly Report on Form 10-Q. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern. The Company expects to finance its operations through its common stock purchase agreement with Aspire Capital Fund LLC, or Aspire Capital, and its at-the-market sales agreement with JonesTrading Institutional Services LLC, or JonesTrading or other potential equity financings, debt financings or other capital sources. However, the Company may not be successful in securing additional financing on acceptable terms, or at all. Furthermore, high volatility in the capital markets resulting from the COVID-19 pandemic has had, and could continue to have, a negative impact on the price of the Company’s common stock, and could adversely impact the Company’s ability to raise additional funds. The Company’s ability to raise additional funds will depend, among other factors, on financial, economic and market conditions, many of which are outside of its control and it may be unable to raise financing when needed, or on terms favorable to the Company. If necessary funds are not available, the Company will have to delay, reduce the scope of, or eliminate some of its development programs, potentially delaying the time to market for or preventing the marketing of any of its product candidates. In addition, in light of the Company’s limited cash resources, it may seek to engage in one or more strategic alternatives, such as a strategic partnership with one or more parties, the licensing, sale or divestiture of some of its assets or proprietary technologies or the sale of the Company, but there can be no assurance that the Company would be able to enter into such a transaction or transactions on a timely basis or on terms favorable to it, or at all. COVID-19 Pandemic In December 2019, an outbreak of respiratory illness caused by a strain of novel coronavirus, COVID-19, began in China. That outbreak has led to millions of confirmed cases worldwide, including in the Unites States and other countries where the Company is conducting clinical trials or activities in support thereof. The World Health Organization declared the outbreak a global public health emergency on January 30, 2020 and declared it a pandemic on March 11, 2020. In addition to those who have been directly affected, billions more have been affected by governmental efforts around the world to slow the spread of the outbreak. The outbreak and government measures taken in response have also had a significant impact, both direct and indirect, on businesses and commerce. The Company has enrolled, and will seek to enroll, cancer patients in its clinical trials at sites located both in the United States and internationally, including in Germany. Many of the Company’s clinical trial sites have imposed restrictions on entry as a result of the COVID-19 pandemic, which may have a negative impact on the Company’s ability to conduct its clinical trials. We may face difficulties recruiting or retaining patients in our ongoing and planned clinical trials if patients are affected by the virus or are fearful of visiting or traveling to our clinical trial sites because of the outbreak. For example, all of the Company’s clinical trial sites for its ongoing Phase 1 clinical trial for CA-4948 in patients with non-Hodgkin lymphomas, including those with MYD88 alterations, are at large academic research hospitals that have imposed restrictions on entry which could potentially prohibit clinical trial monitors and patients from entering the trial sites. The Company is actively working with its CRO partners to follow FDA guidelines on performing remote monitoring to the extent possible and to arrange for the shipment of medicine directly from the clinical trial site to patients who are enrolled in its trials, if required; however, there is no assurance such arrangements will be successful. As a result, further enrollment in the Company’s ongoing clinical trial for CA-4948 in patients with non-Hodgkin lymphomas may be delayed and patients currently enrolled in the trial may cease treatment due to the restrictions described above or fear of visiting or inability to visit the Company’s trial sites. In addition, the Company does not currently know the duration or to what degree medical facilities, including the Company’s clinical trial sites, will continue to be impacted by the pandemic. As a result, enrollment in this trial has been slower than expected and the timeline of the Company’s ongoing clinical trial in CA-4948 may be delayed. In addition, the Company has not initiated enrollment for its planned Phase 1 clinical trial in CA-4948 in patients with acute myeloid leukemia and myelodysplastic syndromes. Clinical trial sites for this study may also impose restrictions similar to those described above. As a result, initiation of enrollment in this trial has been slower than expected and the Company may not be able to enroll this trial on its planned timeline, which would cause a delay in the overall timeline for this trial. Similarly, the Company has not initiated its planned Phase 1 clinical trial for CI-8993, and initiation and enrollment of this study may be delayed due to the factors discussed above. The Company and its collaborators, third-party contract manufacturers, contract research organizations and clinical sites could experience delays or disruptions in supply of product candidates and/or procuring items that are essential for its research and development activities, including, for example, raw materials used in the manufacturing of its product candidates, basic medical and laboratory supplies used in its clinical trials or preclinical studies, or animals that are used for preclinical testing, in each case, for which there may be shortages because of ongoing efforts to address the outbreak. Some of the Company’s product candidates, or materials contained therein, may come from facilities located in areas impacted by COVID-19, including India, China, and Europe. In addition, any disruptions could impact the supply, manufacturing or distribution of Erivedge, and sales of Erivedge may be negatively impacted by a decrease in new prescriptions as a result of a decline in patient medical visits due to the COVID-19 pandemic, which could negatively impact the amount and timing of any royalty revenue the Company may receive from Genentech related to Erivedge ® . The Company is also experiencing delays in closing down its clinical trial sites related to its fimepinostat and CA-170 trials due to restrictions on non-essential workers imposed at those sites in response to COVID-19, which has delayed the winding down of these trials and may result in additional costs and expenses. In addition, the Company has been unable to relocate to its new headquarters. The Company expects to relocate to its new location in the second quarter of 2020, however, this timeline may change to the extent restrictions as a result of the pandemic continue. Additionally, the pandemic has already caused significant disruptions in the financial markets, and may continue to cause such disruptions, which could impact the Company’s ability to raise additional funds. The Company cannot be certain what the overall impact of the COVID-19 pandemic will be on its business and the pandemic has the potential to adversely affect the Company’s business, financial condition, results of operations, and prospects. CARES Act PPP Loan On April 21, 2020, the Company entered into a promissory note evidencing an unsecured $0.9 million loan (the “PPP Loan”) under the Payroll Protection Program (“PPP”), of the Coronavirus Aid, Relief, and Economic Security Act, (“CARES Act”). The PPP loan is being made through Silicon Valley Bank. The term of the PPP loan is 24 -months. The interest rate on the PPP loan is 1% , which shall be deferred for the first six months of the term of the loan. The promissory note evidencing the PPP loan contains customary events of default relating to, among other things, payment defaults, breach of representations and warranties, or provisions of the promissory note. The occurrence of an event of default may result in the repayment of all amounts outstanding, collection of all amounts we owe, and/or filing suit and obtaining judgment against us. Under the terms of the CARES Act, PPP loan recipients can apply for and be granted forgiveness for all or a portion of loans granted under the PPP. Such forgiveness will be determined, subject to limitations, based on the use of loan proceeds for payroll costs and mortgage interest, rent or utility costs and the maintenance of employee and compensation levels. No assurance is provided that we will obtain forgiveness of the PPP loan in whole or in part. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies (a) Basis of Presentation and Principles of Consolidation The accompanying Condensed Consolidated Financial Statements have been prepared in accordance with the instructions to Form 10-Q and Article 8 of Regulation S-X. These statements, however, are condensed and do not include all disclosures required by accounting principles generally accepted in the U.S. (“GAAP”), for complete financial statements and should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 as filed with the Securities and Exchange Commission (“SEC”), on March 19, 2020 . In the opinion of the Company, the unaudited financial statements contain all adjustments (all of which were considered normal and recurring) necessary for a fair statement of the Company’s financial position at March 31, 2020 ; the results of operations for the three -month periods ended March 31, 2020 and 2019 ; stockholders' deficit for the three -month periods ended March 31, 2020 and 2019 ; and the cash flows for the three -month periods ended March 31, 2020 and 2019 . The Condensed Consolidated Balance Sheet at December 31, 2019 was derived from audited annual financial statements but does not contain all of the footnote disclosures from the annual financial statements. In accordance with Accounting Standards Update (“ASU”) 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40) , the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the Consolidated Financial Statements are issued. (b) Use of Estimates and Assumptions The preparation of the Company’s Condensed Consolidated Financial Statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts and disclosure of certain assets and liabilities at the balance sheet date. Such estimates include the performance obligations under the Company’s collaboration agreements; the estimated repayment term of the Company’s debt and related short- and long-term classification; the fair value of the Company’s debt; the collectability of receivables; the carrying value of property and equipment and intangible assets; and the assumptions used in the Company’s valuation of stock-based compensation and the value of certain investments and liabilities. Actual results may differ from such estimates. These interim results are not necessarily indicative of results to be expected for a full year or subsequent interim periods. The extent to which COVID-19 impacts the Company’s business and financial results will depend on numerous evolving factors including, but not limited to: the magnitude and duration of the COVID-19 pandemic, the extent to which it will impact worldwide macroeconomic conditions including interest rates, employment rates and health insurance coverage, the speed of the anticipated recovery, and governmental and business responses to the pandemic. The Company assessed certain accounting matters that generally require consideration of forecasted financial information in context with the information reasonably available to the Company and the unknown future impacts of COVID-19 as of March 31, 2020 and through the date of this report. The accounting matters assessed included, but were not limited to, the carrying value of goodwill. The Company’s future assessment of the magnitude and duration of the COVID-19 pandemic, as well as other factors, could result in additional material impacts to the Company’s consolidated financial statements in future reporting periods. (c) Cash Equivalents, Restricted Cash, and Investments The Company had cash and cash equivalents of $12.5 million and $15.4 million as of March 31, 2020 and December 31, 2019 respectively. Cash equivalents consist of short-term, highly liquid investments purchased with original maturities of three months or less. All other liquid investments are classified as marketable securities. The Company classified $1.0 million of its cash as restricted cash, as of March 31, 2020 and December 31, 2019. This amount represents the security deposit delivered to the respective landlords of the Company's current and future Lexington, Massachusetts headquarters. The Company's combined cash and restricted cash balances were $13.5 million and $42.9 million as of March 31, 2020, and 2019 respectively, as presented on the Company's Consolidated Statements of Cash Flows. The Company’s short-term investments are marketable debt securities with original maturities of greater than three months from the date of purchase, but less than twelve months from the balance sheet date, and long-term investments are marketable debt securities with original maturities of greater than twelve months from the balance sheet. Marketable securities consist of commercial paper, corporate bonds and notes, and government obligations. All of the Company’s investments have been designated available-for-sale and are stated at fair value. Unrealized gains and temporary losses on investments are included in accumulated other comprehensive income (loss) as a separate component of stockholders’ equity. Realized gains and losses, dividends and interest income are included in other income (expense) in the period during which the securities are sold. Any premium or discount arising at purchase is amortized and/or accreted to interest income. (d) Revenue Recognition The Company’s business strategy includes entering into collaborative license and development agreements with biotechnology and pharmaceutical companies for the development and commercialization of the Company’s drug candidates. The terms of the agreements typically include non-refundable license fees, funding of research and development, payments based upon achievement of clinical development and regulatory objectives, and royalties on product sales. License Fees and Multiple Element Arrangements If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, upfront fees allocated to the license at such time as 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 promises, the Company utilizes judgment to assess the nature of the combined performance obligations to determine whether the combined performance obligations are 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, upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. If the Company is involved in a steering committee as part of a multiple element arrangement, the Company assesses whether its involvement constitutes a performance obligation or a right to participate. Steering committee services that are not determined to be distinct performance obligations are combined with other research services or performance obligations required under an arrangement, if any, in determining the level of effort required in an arrangement and the period over which the Company expects to complete its aggregate performance obligations. Appropriate methods of measuring progress include output methods and input methods. In determining the appropriate method for measuring progress, the Company considers the nature of service that the Company promises to transfer to the customer. When the Company decides on a method of measurement, the Company will apply that single method of measuring progress for each performance obligation satisfied over time and will apply that method consistently to similar performance obligations and in similar circumstances. If the Company cannot reasonably measure its progress toward complete satisfaction of a performance obligation because it lacks reliable information that would be required to apply an appropriate method of measuring progress, but the Company can reasonably estimate when the performance obligation ceases or the remaining obligations become inconsequential and perfunctory, then revenue is not recognized until the Company can reasonably estimate when the performance obligation ceases or becomes inconsequential. Revenue is then recognized over the remaining estimated period of performance. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations under an arrangement. Contingent Research Milestone Payments ASC 606 constrains the amount of variable consideration included in the transaction price in that either all, or a portion, of an amount of variable consideration should be included in the transaction price. The variable consideration amount should be included only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The assessment of whether variable consideration should be constrained is largely a qualitative one that has two elements: the likelihood of a change in estimate, and the magnitude thereof. Variable consideration is not constrained if the potential reversal of cumulative revenue recognized is not significant, for example. If the consideration in a contract includes a variable amount, a company will estimate the amount of consideration in exchange for transfer of promised goods or services. The consideration also can vary if a company’s entitlement to the consideration is contingent on the occurrence or nonoccurrence of a future event. The Company considers contingent research milestone payments to fall under the scope of variable consideration, which should be estimated for revenue recognition purposes at the inception of the contract and reassessed ongoing at the end of each reporting period. The Company assesses whether contingent research milestones should be considered variable consideration that should be constrained and thus not part of the transaction price. This includes an assessment of the probability that all or some of the milestones revenue could be reversed when the uncertainty around whether or not the achievement of each milestone is resolved, and the amount of reversal could be significant. GAAP provides factors to consider when assessing whether variable consideration should be constrained. All of the factors should be considered, and no factor is determinative. The Company considers all relevant factors. Reimbursement of Costs Reimbursement of research and development costs by third party collaborators is recognized as revenue over time provided the Company has determined that it transfers control (i.e. performs the services) of a service over time and, therefore, satisfies a performance obligation according to the provisions outlined in ASC 606-10-25-27, Revenue Recognition . Royalty Revenue Since the first quarter of 2012, the Company has recognized royalty revenues related to Genentech’s and Roche’s sales of Erivedge. For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the 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 or all of the royalty has been allocated has been satisfied (or partially satisfied). The Company expects to continue recognizing royalty revenue from Genentech’s sales of Erivedge in the U.S. and in other markets where Genentech and Roche successfully obtain marketing approval, if any (see Note 8, Research and Development Collaborations ). However, a portion of Erivedge royalties will be paid to the Purchasers under the Oberland Purchase Agreement (see Note 7, Liability Related to the Sale of Future Royalties ). Contra Revenue, Net Contra revenue, net represents shared costs, primarily related to intellectual property, with the Company's collaboration partners, and reserves for potential royalty reductions. With respect to each of the foregoing areas of revenue recognition, the Company exercises significant judgment in determining whether an arrangement contains multiple elements, and, if so, how much revenue is allocable to each element. In addition, the Company exercises its judgment in determining when its significant obligations have been met under such agreements and the specific time periods over which it recognized revenue, such as non-refundable, up-front license fees. To the extent that actual facts and circumstances differ from its initial judgment, its revenue recognition with respect to such transactions would change accordingly and any such change could affect its reported financial results. Summary During the three months ended March 31, 2020 and 2019 , total gross revenues were 92% and 100% respectively, from the Company’s collaboration with Genentech. In addition to the revenues received from Genentech, the Company received a milestone payment from a previously out-licensed technology in the first quarter of 2020. (e) Reclassifications and Revisions Certain prior period amounts have been reclassified to conform with the current period presentation. Reclassifications had no material impact on previously reported results of operations, financial position or cash flows. A revision was made to the Condensed Consolidated Statement of Cash Flows for the three months ended March 31, 2019 to correctly reflect the prepayment fees associated with the termination of the credit agreement with HealthCare Royalty Partners, III, L.P. (“HealthCare Royalty”). This correction reduced the net cash used in operating activities and reduced the net cash provided by financing activities for the three months ended March 31, 2019 by $3.4 million , from the amounts previously reported. The revision to the Condensed Consolidated Statement of Cash Flows noted above represents an error that is not deemed to be material to the prior period Condensed Consolidated Financial Statements. (f) Segment Reporting The Company operates in a single reportable segment, which is the research and development of innovative cancer therapeutics. The Company expects that any products that are successfully developed and commercialized would be used in the healthcare industry and would be regulated in the United States by the FDA and in overseas markets by similar regulatory authorities. (g) New Accounting Pronouncements Issued, Not Yet Adopted In August 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2018-13, Fair Value Measurement, which modified the disclosure requirements for fair value measurement under ASC 820. The standard was originally effective for annual reporting periods and interim periods within those annual periods, beginning after December 15, 2019, with early adoption permitted, however, in November 2019 the effective date for smaller reporting companies was extended to January 1, 2023 with the issuance of ASU 2019-10 Financial Instruments-Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) Effective Dates. The Company is currently evaluating the effects of this standard and does not expect that adoption of this standard will have a material impact on its consolidated financial statements. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. This standard requires that for most financial assets, losses be based on an expected loss approach which includes estimates of losses over the life of exposure that considers historical, current and forecasted information. Expanded disclosures related to the methods used to estimate the losses as well as a specific disaggregation of balances for financial assets are also required. The targeted transition relief standard allows filers an option to irrevocably elect the fair value option of ASC 825-10, Financial Instruments-Overall, applied on an instrument-by-instrument basis for eligible instruments. In November 2019 the effective date for smaller reporting companies was extended to January 1, 2023 with the issuance of ASU 2019-10 Financial Instruments-Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) Effective Dates. The Company is currently evaluating the effects of this standard and does not expect that adoption of this standard will have a material impact on its consolidated financial statements. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company has adopted the provisions of the FASB Codification Topic 820, Fair Value Measurements and Disclosures (“Topic 820”) for its financial assets and liabilities that are re-measured and reported at fair value each reporting period and the non-financial assets and liabilities that are re-measured and reported at fair value on a non-recurring basis. Fair value is the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining fair value, the Company considers the principal or most advantageous market in which it would transact and consider assumptions that market participants would use when pricing the asset or liability. Topic 820 establishes a three-level valuation hierarchy for disclosure of fair value measurements. Financial assets and liabilities are categorized within the valuation hierarchy based upon the lowest level of input that is significant to the measurement of fair value. The three levels of the hierarchy are defined as follows: Level 1 Quoted prices in active markets for identical assets or liabilities. Level 2 Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. In accordance with the fair value hierarchy, the following table shows the fair value as of March 31, 2020 and December 31, 2019 of those financial assets and liabilities that are measured at fair value on a recurring basis, according to the valuation techniques the Company used to determine their fair value. No financial assets or liabilities are measured at fair value on a nonrecurring basis at March 31, 2020 and 2019 . Quoted Prices in Active Markets (Level 1) Other Observable Inputs (Level 2) Unobservable Inputs (Level 3) Fair Value As of March 31, 2020: Cash equivalents: Money market funds $ 10,268 $ — $ — $ 10,268 Short-term investments: Corporate commercial paper, bonds and notes — 6 — 6 Total assets at fair value $ 10,268 $ 6 $ — $ 10,274 Quoted Prices in Active Markets (Level 1) Other Observable Inputs (Level 2) Unobservable Inputs (Level 3) Fair Value As of December 31, 2019: Cash equivalents: Money market funds $ 10,684 $ — $ — $ 10,684 US government obligations — 550 — 550 Commercial paper — 300 — 300 Municipal bonds — 90 — 90 Short-term investments: Corporate commercial paper, bonds and notes — 5,113 — 5,113 Total assets at fair value $ 10,684 $ 6,053 $ — $ 16,737 |
Investments
Investments | 3 Months Ended |
Mar. 31, 2020 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | Investments The amortized cost, unrealized gains and losses and fair value of investments available-for-sale as of March 31, 2020 were as follows: Amortized Cost Unrealized Gain Unrealized Loss Fair Value Corporate bonds and notes – short-term $ 6 $ — $ — $ 6 Total investments $ 6 $ — $ — $ 6 Short-term investments have maturities ranging from one to twelve months with a weighted-average maturity of 0.3 years at March 31, 2020 . The amortized cost, unrealized gains and losses and fair value of investments available-for-sale as of December 31, 2019 were as follows: Amortized Cost Unrealized Gain Unrealized Loss Fair Value Corporate bonds and notes – short-term $ 5,113 $ — $ — $ 5,113 Total investments $ 5,113 $ — $ — $ 5,113 Short-term investments have maturities ranging from one to twelve months with a weighted-average maturity of 0.1 years at December 31, 2019 . As of March 31, 2020 , the Company did not have any debt securities in an unrealized loss position. |
Accrued Liabilities
Accrued Liabilities | 3 Months Ended |
Mar. 31, 2020 | |
Other Liabilities Disclosure [Abstract] | |
Accrued Liabilities | Accrued Liabilities Accrued liabilities consisted of the following: March 31, December 31, Accrued compensation $ 670 $ 1,413 Professional fees 245 289 Other 804 208 Total $ 1,719 $ 1,910 |
Leases and Commitments
Leases and Commitments | 3 Months Ended |
Mar. 31, 2020 | |
Leases [Abstract] | |
Leases and Commitments | Leases and Commitments The Company leases real estate, including laboratory and office space, and certain equipment. The lease for the current real estate property used for office, research and laboratory space located at 4 Maguire Road in Lexington, Massachusetts expired on February 29, 2020. The Company is exercising its contractual right to holdover on a month-to-month basis until its new facility is available for occupancy. On December 5, 2019, Curis, Inc. entered into a new lease for its administrative, research and development requirements located at 128 Spring Street in Lexington, Massachusetts. In accordance with the accounting requirements under ASC 842, the lease obligation will not be recorded until its commencement date which is expected in the second quarter of 2020. The Company did record the security deposit provided to the landlord which was classified as restricted cash. The total cash obligation for the base rent over the seven year term of the lease agreement is approximately $8.3 million and the Company will begin paying rent on the commencement date. Under the current guidance, as of March 31, 2020 , the Company does not have any reportable leases, as the new office located at 128 Spring Street in Lexington, Massachusetts is being finalized and is pending a certificate of occupancy. The Company remains at its 4 Maguire Road location on a month-to-month basis until occupancy at the new location is permitted. The Company’s remaining lease commitments for all leased facilities with an initial or remaining term of at least one year were as follows as of December 31, 2019 . Year Ending December 31, 2020 $ 168 Total minimum payments $ 168 |
Liability Related to the Sale o
Liability Related to the Sale of Future Royalties | 3 Months Ended |
Mar. 31, 2020 | |
Nonmonetary Transactions [Abstract] | |
Liability Related to the Sale of Future Royalties | Liability Related to the Sale of Future Royalties On March 22, 2019 , the Company and Curis Royalty entered into the Oberland Purchase Agreement pursuant to which the Company sold to the Purchasers a portion of its rights to receive royalties from Genentech on potential net sales of Erivedge. As upfront consideration for the purchase of the royalty rights, at closing the Purchasers paid to Curis Royalty $65.0 million less certain transaction expenses. Curis Royalty will also be entitled to receive up to approximately $70.7 million in milestone payments based on sales of Erivedge as follows: (i) $17.2 million if the Purchasers and Curis Royalty receive aggregate royalty payments pursuant to the Oberland Purchase Agreement in excess of $18.0 million during the calendar year 2021, subject to certain exceptions and (ii) $53.5 million if the Purchasers receive payments pursuant to the Oberland Purchase Agreement in excess of $117.0 million on or prior to December 31, 2026. Concurrently with the closing of the Oberland Purchase Agreement, Curis Royalty used a portion of the proceeds to terminate and repay its prior loan with HealthCare Royalty. In connection with such termination, Curis Royalty paid approximately $37.2 million to satisfy its remaining loan obligations to HealthCare Royalty, including approximately $33.8 million in principal balance on the loan and $3.4 million in accrued and unpaid interest and prepayment fees. Curis Royalty also used a portion of the proceeds to pay transaction costs of approximately $0.3 million, resulting in net proceeds of approximately $27.5 million. The Oberland Purchase Agreement provides that after the occurrence of an event of default as defined under the security agreement by Curis Royalty, the Purchasers shall have the option, for a period of 180 days , to require Curis Royalty to repurchase a portion of certain royalty and royalty related payments, excluding a portion of non U.S. royalties retained by Curis Royalty, referred to as the Purchased Receivables, at a price, referred to as the Put/Call Price, equal to a percentage, beginning at a low triple digit percentage and increasing over time up to a low mid triple digit percentage of the sum of the upfront purchase price and any portion of the milestone payments paid in a lump sum by the Purchasers, if any, minus certain payments previously received by the Purchasers with respect to the Purchased Receivables. Additionally, Curis Royalty shall have the option at any time to repurchase the Purchased Receivables at the Put/Call Price as of the date of such repurchase. As a result of its obligation to pay future royalties to Oberland, the Company recorded the proceeds from this transaction as a liability on its Condensed Consolidated Balance Sheet that will be accounted for using the interest method over the estimated life of the Oberland Purchase Agreement. As a result, the Company imputes interest on the transaction and recorded imputed interest expense at the estimated interest rate. Its estimate of the interest rate under the agreement is based on the amount of royalty payments expected to be received by Oberland over the life of the arrangement. The Company periodically assesses the expected royalty payments to Curis Royalty from Genentech using a combination of historical results and forecasts from market data sources. To the extent such payments are greater or less than its initial estimates or the timing of such payments is materially different than its original estimates, the Company will adjust the amortization of the liability. The Company determined the fair value of the liability related to the sale of future royalties at the time of the Oberland Purchase Agreement to be $65.0 million, with a current effective annual imputed interest rate of 8.2% . The Company incurred $0.6 million of transaction costs in connection with the agreement. These transaction costs will be amortized to imputed interest expense over the estimated term of the Oberland Purchase Agreement. The following table shows the activity with respect to the liability related to the sale of future royalties during the three months ended March 31, 2020 . Carrying value of liability related to the sale of future royalties at January 1, 2020 $ 62,477 Amortization of capitalized issuance costs 15 Imputed interest expense recognized for the three months ended March 31, 2020 1,283 Less: payments to Oberland Capital, LLC (2,786 ) Carrying value of liability related to the sale of future royalties at March 31, 2020 $ 60,989 The following table shows the activity with respect to the liability related to the sale of future royalties from the inception of the Oberland Purchase Agreement through December 31, 2019 Liability related to the sale of future royalties at March 22, 2019 $ 65,000 Capitalized issuance costs (584 ) Imputed interest expense recognized for the three months ended December 31, 2019 4,055 Less: payments to Oberland Capital, LLC (5,994 ) Carrying value of liability related to the sale of future royalties at December 31, 2019 $ 62,477 |
Research and Development Collab
Research and Development Collaborations | 3 Months Ended |
Mar. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Research and Development Collaborations | Research and Development Collaborations (a) Genentech In June 2003, the Company licensed its proprietary Hedgehog pathway technologies to Genentech for human therapeutic use. The primary focus of the collaborative research plan has been to develop molecules that inhibit the Hedgehog pathway for the treatment of various cancers. The collaboration is currently focused on the development of Erivedge, which is being commercialized by Genentech in the U.S. and by Genentech’s parent company, Roche, in several other countries for the treatment of advanced BCC. Pursuant to the agreement, the Company is eligible to receive up to an aggregate of $115.0 million in contingent cash milestone payments, exclusive of royalty payments, in connection with the development of Erivedge or another small molecule Hedgehog pathway inhibitor, assuming the successful achievement by Genentech and Roche of specified clinical development and regulatory objectives. Of this amount, the Company has received $59.0 million in cash milestone payments as of March 31, 2020 . In addition to these payments and pursuant to the collaboration agreement, the Company is entitled to a royalty on net sales of Erivedge that ranges from 5% to 7.5% . The royalty rate applicable to Erivedge may be decreased by 2% on a country-by-country basis in certain specified circumstances, including when a competing product that binds to the same molecular target as Erivedge is approved by the applicable regulatory authority in another country, and is being sold in such country, by a third party for use in the same indication as Erivedge, or, when there is no issued intellectual property covering Erivedge in a territory in which sales are recorded. In 2015, the FDA and the European Medicine Agency’s Committee for Medicinal Products for Human Use, approved another Hedgehog signaling pathway inhibitor, Odomzo® (“sonidegib”), which is marketed by Sun Pharmaceutical Industries Ltd., for use in locally advanced BCC. Beginning in the fourth quarter of 2015, Genentech applied the 2% royalty reduction on U.S. sales of Erivedge as a result of the first commercial sale of Odomzo® in the U.S. and the Company anticipates that Genentech will reduce by 2% royalties on net sales of Erivedge outside of the United States on a country-by-country basis to the extent that sonidegib is approved by the applicable country's regulatory authority and is being sold in such country. However, pursuant to the Oberland Purchase Agreement, Curis has retained its rights with respect to the 2% of royalties that are subject to such reduction in countries where such reduction has not occurred, subject to the terms and conditions of the Oberland Purchase Agreement. The Company has identified the that only contingent royalty revenue remains to be recognized in the future. The Company recognized $2.5 million and $2.1 million in royalty revenue under the Genentech collaboration during the three months ended March 31, 2020 and 2019 , respectively. The Company also recorded costs of royalty revenues within the costs and expenses section of its Condensed Consolidated Statements of Operations and Comprehensive Loss of $0.1 million, during both of the three months ended March 31, 2020 and 2019 , respectively. Cost of royalty revenues comprises 5% of the royalty payments that Curis Royalty receives from Genentech, through February 2022, which the Company is obligated to pay to university licensors. Genentech incurred immaterial expense during the three months ended March 31, 2020 , and 2019 , respectively. Under this collaboration, the Company is obligated to reimburse Genentech, and the Company records contra-revenues in its Condensed Consolidated Statements of Operations and Comprehensive Loss. The Company will continue to recognize revenue for expense reimbursement as such reimbursable expenses are incurred, provided that the provisions of ASC 606 are met. The Company recorded a receivable from Genentech under this collaboration, comprised primarily of Erivedge royalties earned in the first half of 2020 and 2019 , respectively. The receivable recorded in the Company's current assets section of its Condensed Consolidated Balance Sheets amounted to $2.5 million and $3.2 million as of March 31, 2020 and 2019 , respectively. As previously discussed in Note 7, Liability Related to the Sale of Future Royalties a portion of royalty revenues received from Genentech on net sales of Erivedge will be paid to the Purchasers pursuant to the Oberland Purchase Agreement. (b) Aurigene In January 2015, the Company entered into an exclusive collaboration agreement with Aurigene for the discovery, development and commercialization of small molecule compounds in the areas of immuno-oncology and selected precision oncology targets. Under the collaboration agreement, Aurigene granted the Company an option to obtain exclusive, royalty-bearing licenses to relevant Aurigene technology to develop, manufacture and commercialize products containing certain of such compounds anywhere in the world, except for India and Russia, which are territories retained by Aurigene. In connection with the collaboration agreement, the Company issued to Aurigene 3,424,026 shares of its common stock valued at $24.3 million in partial consideration for the rights granted to the Company under the collaboration agreement, which the Company recognized as expense during the year ended December 31, 2015. The shares were issued pursuant to a stock purchase agreement with Aurigene dated January 18, 2015 . In September 2016 the Company and Aurigene entered into an amendment to the collaboration agreement. Under the terms of the amendment, in exchange for the issuance by the Company to Aurigene of 2,041,666 shares of its common stock, Aurigene waived payment of up to a total of $24.5 million in potential milestones and other payments associated with the first four programs in the collaboration that may have become due from the Company under the collaboration agreement. To the extent any of these waived milestones or other payments are not payable by the Company, for example in the event one or more of the milestone events do not occur, the Company will have the right to deduct the unused waived amount from any one or more of the milestone payment obligations tied to achievement of commercial milestone events. The amendment also provides that, in the event supplemental program activities are performed by Aurigene, the Company will provide up to $2.0 million of additional funding for each of the third and fourth licensed program. The shares were issued pursuant to a stock purchase agreement with Aurigene dated September 7, 2016. In February 2020 the Company and Aurigene further amended their collaboration agreement. Under the terms of the amended agreement, Aurigene will fund and conduct a Phase 2b/3 randomized study evaluating CA-170, in combination with chemoradiation, in approximately 240 patients with non-squamous non-small cell lung cancer. In turn, Aurigene receives rights to develop and commercialize CA-170 in Asia, in addition to its existing rights in India and Russia, based on the terms of the original agreement. The Company retains U.S., European Union, and rest of world rights to CA-170, and is entitled to receive royalty payments on potential future sales of CA-170 in Asia at percentage rates ranging from the high single digits up to 10% subject to specified reductions. As of March 31, 2020 , the Company has exercised its option to license the following four programs under the collaboration: 1. IRAK4 Program - a precision oncology program of small molecule inhibitors of IRAK4. The development candidate is CA-4948, an orally available small molecule inhibitor of IRAK4. 2. PD1/VISTA Program - an immuno-oncology program of small molecule antagonists of PD1 and VISTA immune checkpoint pathways. The development candidate is CA-170, an orally available small molecule antagonist of VISTA and PDL1. 3. PD1/TIM3 Program - an immuno-oncology program of small molecule antagonists of PD1 and TIM3 immune checkpoint pathways. The development candidate is CA-327, an orally available small molecule antagonist of PDL1 and TIM3. 4. In March 2018, the Company exercised its option to license a fourth program, which is an immuno-oncology program. For each of the Company's licensed programs (as described above) the Company is obligated to use commercially reasonable efforts to develop, obtain regulatory approval for, and commercialize at least one product in each of the U.S., specified countries in the European Union and Japan, and Aurigene is obligated to use commercially reasonable efforts to perform its obligations under the development plan for such licensed program in an expeditious manner. Subject to specified exceptions, Aurigene and the Company agreed to collaborate exclusively with each other on the discovery, research, development and commercialization of programs and compounds within immuno-oncology for an initial period of approximately two years from the effective date of the collaboration agreement. At the Company's option, and subject to specified conditions, it may extend such exclusivity for up to three additional one year periods by paying to Aurigene additional exclusivity option fees on an annual basis. The Company exercised the first one-year exclusivity option in the first quarter of 2017. The fee for this exclusivity option exercise was $7.5 million, which the Company paid in two equal installments in the first and third quarters of 2017. The Company elected not to further exercise its exclusivity option and thus did not make the $10.0 million payment required for this additional exclusivity in 2018. As a result of the Company’s election to not further exercise its exclusivity option, Curis is no longer operating under broad immuno-oncology exclusivity with Aurigene. In 2019, the Company elected not to further exercise its exclusivity option related to the IRAK4 and PD1/VISTA programs and did not make the $2.0 million payment required for this continued exclusivity. Since January 2015, the Company has paid $14.5 million in research payments and has waived $19.5 million in milestone payments under the terms of the 2016 amendment. For each of the IRAK4, PD1/VISTA,PD1/TIM3 programs, and the fourth immuno-oncology program: the Company has remaining unpaid or unwaived payment obligations of $42.5 million per program, related to regulatory approval and commercial sales milestones, plus specified additional payments for approvals for additional indications, if any. In addition to the collaboration agreement, in June 2017, the Company entered into a master development and manufacturing agreement with Aurigene for the supply of drug substance and drug product. The Company incurred immaterial expenses related to Aurigene for the three month periods ended March 31, 2020 and 2019 , respectively. (c) ImmuNext On January 6, 2020, the Company entered into an option and license agreement with ImmuNext (the “ImmuNext Agreement”). Under the terms of the ImmuNext Agreement, the Company agreed to engage in a collaborative effort with ImmuNext, and to conduct a Phase 1a/1b clinical trial of CI-8993. In exchange, ImmuNext granted the Company an exclusive option, exercisable until the earlier of (a) four years after January 6, 2020 and (b) 90 days after database lock for the first Phase 1a/1b trial in which the endpoints are satisfied (the “Option Period”), to obtain an exclusive, worldwide license to develop and commercialize certain VISTA antagonizing compounds and products containing these compounds in the field of oncology. A joint steering committee composed of representatives from each of the parties will manage the non-clinical and clinical development of the VISTA Compounds and Products during the Option Period, including, but not limited to, the approval of the plan for the Phase 1a/1b trial. During the Option Period, the Company will conduct the Phase 1a/1b trial and ImmuNext will conduct certain agreed upon non-clinical research activities to support the Phase 1a/1b trial. Additionally, the Company will assign to ImmuNext all right, title and interest in and to, inventions made by the Company alone or jointly with ImmuNext in conducting clinical and non-clinical activities under the ImmuNext Agreement and any patent rights covering those inventions. If the option is exercised, ImmuNext will assign to the Company (i) all such inventions that were made solely by the Company and any patent rights covering those inventions that were assigned by the Company to ImmuNext during the Option Period and (ii) a joint ownership interest in all such inventions that were made jointly by the Company and ImmuNext and patent rights covering those inventions that were assigned by the Company to ImmuNext during the Option Period, except for any of those inventions that relates to certain compounds to which ImmuNext has retained exclusive rights. In consideration of the grant of the option, the Company made an upfront payment to ImmuNext of $1.3 million which is included in research and development expense as the acquired intellectual property is not yet completed. If the Company elects to exercise the option, the Company has agreed to pay to ImmuNext an option exercise fee of $20.0 million . If the Company elects to exercise the option, ImmuNext will be eligible to receive up to $4.6 million in potential development milestones, up to $84.3 million in potential regulatory approval milestones, and up to $125.0 million in potential sales milestone payments from the Company. In addition, ImmuNext is eligible to receive tiered royalties on annual net sales on a product-by-product and country-by-country basis, at percentage rates ranging from high single digits to low double digits, subject to specified adjustments. The royalty payment obligations under the ImmuNext Agreement with respect to a product in a country will expire on the later of (i) expiration of the last-to-expire valid claim of the ImmuNext patents or jointly owned patents covering the manufacture, use or sale of such product in such country, (ii) the expiration of all regulatory exclusivity for such product in such country, and (iii) 10 years from the first commercial sale of such product in such country. In partial consideration for drug substance, technical advice, and maintenance of ImmuNext’s existing IND and access to ImmuNext’s technology, the Company has agreed to make semi-annual maintenance fee payments of $0.4 million to ImmuNext during the Option Period. In addition, the Company has agreed to reimburse ImmuNext for certain documented external costs and expenses incurred by ImmuNext in carrying out non-clinical research activities approved by the joint steering committee, up to $0.3 million per calendar year, unless otherwise agreed to by both parties in writing. In addition, the Company has agreed to pay ImmuNext a low double-digit percentage of sublicense revenue received by the Company or its Affiliates. Unless earlier terminated, the ImmuNext Agreement will expire upon either: (a) expiration of the Option Period if the Company has not exercised the option; or (b) expiration of all royalty payment obligations for any and all products. Upon expiration (but not on earlier termination) of the ImmuNext Agreement after exercise of the option, the license granted by ImmuNext to the Company shall automatically become fully paid-up, royalty-free, irrevocable and perpetual. |
Common Stock
Common Stock | 3 Months Ended |
Mar. 31, 2020 | |
Equity [Abstract] | |
Common Stock | Common Stock (a) 2015 Sales Agreement with Cowen and Company, LLC On July 2, 2015, the Company entered into a sales agreement with Cowen and Company, LLC (“Cowen”), pursuant to which the Company could sell from time to time up to $30.0 million of the Company’s common stock through an “at-the-market” equity offering program under which Cowen will act as sales agent. Subject to the terms and conditions of the sales agreement, Cowen could sell the common stock by methods deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on the Nasdaq Global Market, on any other existing trading market for the common stock or to or through a market maker other than on an exchange. In addition, with the Company’s prior written approval, Cowen could also sell the common stock by any other method permitted by law, including in negotiated transactions. Pursuant to the terms of the agreement, the aggregate compensation payable to Cowen was 3% of the gross sales price of the common stock sold by Cowen pursuant to the sales agreement. Each party agreed in the sales agreement to provide indemnification and contribution against certain liabilities, including liabilities under the Securities Act, subject to the terms of the sales agreement. The Company did no t sell shares of common stock under this sales agreement during 2020. As of December 31, 2019, the Company sold an aggregate of 420,796 shares of common stock pursuant to this sales agreement, for net proceeds of $6.2 million . In connection with entering in a new sales agreement with JonesTrading Institutional Services LLC, or JonesTrading, the Company terminated its sales agreement with Cowen and the “at-the-market” equity offering program in March 2020, and the program with Cowen is no longer available for use by the Company. (b) 2019 Charter Amendment On May 23, 2019, the Company's stockholders approved an increase to the number of authorized shares of its common stock from 67,500,000 shares to 101,250,000 shares. (c) Aspire Capital Fund LLC On February 26, 2020, the Company entered into a common stock purchase agreement (the “Agreement”) for the sale of up to $30.0 million of the Company's common stock with Aspire Capital Fund, LLC (“Aspire Capital”). Under the terms of the Agreement, Aspire Capital has made an initial investment of $3.0 million via purchase of 2,693,965 common shares of the Company. As consideration for Aspire Capital’s obligation under the Agreement, the Company issued 646,551 shares of common stock to Aspire Capital as a commitment fee. In addition, Aspire Capital has committed to purchasing up to an additional $27.0 million in shares of the Company's common stock at the Company’s request, from time to time during a 30 -month period at prices based on the market price at the time of each sale, subject to specified terms and limitations. There are no warrants, derivatives, or other share classes associated with this Agreement. The Company will control the timing and amount of the further sale of its common stock to Aspire Capital. There are no restrictions on future financings and there are no financial covenants, participation rights, rights of first refusal, or penalties in the Agreement. The Company has the right to terminate the Agreement at any time without any additional cost or penalty. The Company also entered into a Registration Rights Agreement with Aspire Capital in connection with its entry into the Agreement. (d) 2020 Sales Agreement with JonesTrading Institutional Services LLC On March 4, 2020, the Company entered into a Capital on Demand™ Sales Agreement (the “Sales Agreement”) with JonesTrading to sell from time to time up to $30.0 million of the Company’s common stock through an “at-the-market” equity offering program under which JonesTrading will act as sales agent. Subject to the terms and conditions of the Sales Agreement, JonesTrading could sell the common stock by any method deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), including sales made directly on the Nasdaq Global Market, on any other existing trading market for the common stock or to or through a market maker other than on an exchange. In addition, with the Company’s prior written approval, JonesTrading may also sell the common stock by any other method permitted by law, including in privately negotiated transactions. Pursuant to the terms of the Sales Agreement, the aggregate compensation payable to JonesTrading was 3% of the gross proceeds from sales of the common stock sold by JonesTrading pursuant to the Sales Agreement. Each party agreed in the Sales Agreement to provide indemnification and contribution against certain liabilities, including liabilities under the Securities Act, subject to the terms of the Sales Agreement. The Company did no t sell any shares of common stock under this Sales Agreement during the quarter ended March 31, 2020 . |
Stock Plans and Stock Based Com
Stock Plans and Stock Based Compensation | 3 Months Ended |
Mar. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Stock Plans and Stock Based Compensation | Stock Plans and Stock Based Compensation As of March 31, 2020 , the Company had two shareholder-approved, share-based compensation plans: (i) the Amended and Restated 2010 Employee Stock Purchase Plan (“ESPP”), adopted by the Company's board of directors in April 2017 and approved by shareholders in June 2017, and (ii) the Third Amended and Restated 2010 Stock Incentive Plan, (“2010 Plan”), adopted by the Board of Directors in March 2018 and approved by shareholders in May 2018. New employees are typically issued options as an inducement equity award under Nasdaq Listing Rule 5635(c)(4) outside of the 2010 Plan. The Third Amended and Restated 2010 Stock Incentive Plan The 2010 Plan permits the granting of incentive and non-qualified stock options and stock awards to employees, officers, directors, and consultants of the Company and its subsidiaries at prices determined by the Company’s Board of Directors. On May 23, 2019 the Company's shareholders approved an amendment to the Company's Third Amended and Restated 2010 Stock Incentive Plan to reserve an additional 4,700,000 shares of common stock for issuance under the 2010 Plan. The Company can issue up to 10,890,000 shares of its common stock pursuant to awards granted under the 2010 Plan. Options become exercisable as determined by the Board of Directors and expire up to ten years from the date of grant. The 2010 Plan uses a “fungible share” concept under which each share of stock subject to awards granted as options and stock appreciation rights, will cause one share per share under the award to be removed from the available share pool, while each share of stock subject to awards granted as restricted stock, restricted stock units, other stock based awards or performance awards where the price charged for the award is less than 100% of the fair market value of the Company’s common stock will cause 1.3 shares per share under the award to be removed from the available share pool. As of March 31, 2020 the Company had only granted options to purchase shares of the Company’s common stock with an exercise price equal to the closing market price of the Company’s common stock on the Nasdaq Global Market on the grant date. As of March 31, 2020 , 1,395,833 shares remained available for grant under the 2010 Plan. During the three months ended March 31, 2020 , the Company’s board of directors granted options to purchase a total of 2,538,150 shares of the Company’s common stock to the officers and employees of the Company, under the 2010 Plan or in the form of inducement awards pursuant to Nasdaq Marketplace Rules. Of these options, options to purchase 878,150 shares were granted to non-officer employees and vest as to 25% of the shares underlying the award after the first year and as to an additional 6.25% of the shares underlying the award in each subsequent quarter, based upon continued employment over a four year period, and are exercisable at a price equal to the closing price of the Company’s common stock on the Nasdaq Global Market on the grant dates. Additionally, the Company’s board of directors authorized a grant of options to purchase 1,520,000 shares of the Company’s common stock to its officers in March 2020. Such stock options have an exercise price equal to $1.26 per share, the closing price of the Company’s common stock on the Nasdaq Global Market on the date of grant, and will vest and become exercisable as to 25% of the shares underlying the award after the first year and as to an additional 6.25% of the shares underlying the award in each subsequent quarter, based upon continued employment over a four year period. During the first quarter of 2020, the Company’s board of directors granted options to its non-employee directors to purchase 720,000 shares of common stock under the 2010 Plan, which will vest and become exercisable one year from the date of grant. These options were granted at an exercise price of $1.26 per share, which equals the closing market price of the Company’s common stock on the Nasdaq Global Market on the grant date. There were no additional non-employee grants made in the current quarter. Nonstatutory Inducement Grants For certain new employees the Company issues options as an inducement equity award under Nasdaq Listing Rule 5635(c)(4) outside of the 2010 Plan. Each option will vest as to 25% of the shares underlying the option on the first anniversary of the grant date, and as to an additional 6.25% of the shares underlying the option in each subsequent quarter, based upon continued employment over a four year period. During the three months ended March 31, 2020 , the Company’s board of directors granted options to purchase 140,000 shares of common stock as inducement equity awards. These options were granted at a weighted average exercise price of $1.85 which is based on the closing market price of the Company’s common stock on the Nasdaq Global Market on the grant date. Employee and Director Grants Vesting Tied to Service Conditions In determining the fair value of stock options, the Company generally uses the Black-Scholes option pricing model. The Black-Scholes option pricing model employs the following key assumptions for employee and director options awarded during the three months ended March 31, 2020 and 2019 based on the assumptions noted in the following table: Three Months Ended 2020 2019 Expected term (years) – employees and officers 5.5 5.5 Expected term (years) – directors 5.5 5.5 Risk free interest rate 0.9-1.7% 2.5-2.6% Expected Volatility 80 % 76 % Expected Dividends None None The expected volatility is based on the annualized daily historical volatility of the Company’s stock price for a time period consistent with the expected term of each grant. Management believes that the historical volatility of the Company’s stock price best represents the future volatility of the stock price. The risk free interest rate is based on the U.S. Treasury yield in effect at the time of grant for the expected term of the respective grant. The Company has not historically paid cash dividends, and does not expect to pay cash dividends in the foreseeable future. The expected terms and stock price volatility utilized in the calculation involve management’s best estimates at that time, both of which impact the fair value of the option calculated under the Black-Scholes methodology and, ultimately, the expense that will be recognized over the life of the option. GAAP also requires that the Company recognize compensation expense for only the portion of options that are expected to vest. Therefore, management calculated an estimated annual pre-vesting forfeiture rate that is derived from historical employee termination behavior since the inception of the Company, as adjusted. If the actual number of forfeitures differs from those estimated by management, additional adjustments to compensation expense may be required in future periods. A summary of stock option activity under the 2010 Plan, the 2000 Stock Incentive Plan, the 2000 Director Stock Option Plan and nonstatutory inducement awards are summarized as follows: Number of Shares Weighted Average Exercise Price per Share Weighted Average Remaining Contractual Life Aggregate Intrinsic Value Unvested, December 31, 2019 6,158,026 $ 3.43 8.33 Granted 3,258,150 1.29 Exercised — — Canceled (55,749 ) 7.52 Outstanding, March 31, 2020 9,360,427 $ 2.66 8.64 $ — Exercisable at March 31, 2020 2,966,332 $ 5.04 7.40 $ — Vested and unvested expected to vest at March 31, 2020 8,030,728 $ 2.86 8.53 $ — The weighted average grant date fair values of the stock options granted during the three months ended March 31, 2020 and 2019 were $0.76 for each period. As of March 31, 2020 , there was approximately $4.5 million of unrecognized compensation cost related to unvested employee stock option awards outstanding, net of the impact of estimated forfeitures that is expected to be recognized as expense over a weighted average period of 2.85 years. There were no options exercised during the three months ended March 31, 2020 and 2019 . The following table presents a summary of unvested restricted stock awards (“RSAs”) under the 2010 Plan as of March 31, 2020 : Number of Shares Weighted Average Grant Date Fair Value Unvested, December 31, 2019 30,937 $ 3.45 Awarded — — Vested (10,313 ) 3.45 Forfeited — — Unvested, March 31, 2020 20,624 $ 3.45 As of March 31, 2020 , there were 20,624 shares outstanding covered by RSAs that are expected to vest. The weighted average fair value of these shares of restricted stock was $3.45 per share and the aggregate fair value of these shares of restricted stock was approximately $0.1 million. As of March 31, 2020 , there were approximately $0.1 million of unrecognized compensation costs, net of estimated forfeitures, related to RSAs granted to officers, which are expected to be recognized as expense over a remaining weighted average period of 1.81 years. Second Amended and Restated 2010 Employee Stock Purchase Plan The Company has reserved 2,000,000 of its shares of common stock for issuance under the ESPP. Eligible employees may purchase shares of the Company’s common stock at 85% of the lower closing market price of the common stock at the beginning of the enrollment period or ending date of the any purchase period within a two year enrollment period, as defined. The Company has four six month purchase periods per each two year enrollment period. If, within any one of the four purchase periods in an enrollment period, the purchase period ending stock price is lower than the stock price at the beginning of the enrollment period, the two year enrollment resets at the new lower stock price. This aspect of the plan was amended in 2017. Prior to 2017, the plan included two six month purchase periods per year with no defined enrollment period. As of March 31, 2020 , no shares were issued under the ESPP. As of March 31, 2020 , there were 1,677,934 shares available for future purchase under the ESPP. ESPP compensation expense for the three months ended March 31, 2020 and 2019 was no t material. Total Stock Based Compensation Expense For the three months ended March 31, 2020 and 2019 , the Company recorded stock based compensation expense to the following line items in its costs and expenses section of the Condensed Consolidated Statements of Operations and Comprehensive Loss, including expense related to its ESPP: Three Months Ended 2020 2019 Research and development expenses $ 170 $ 176 General and administrative expenses 455 475 Total stock based compensation expense $ 625 $ 651 |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Income (Loss) | 3 Months Ended |
Mar. 31, 2020 | |
Equity [Abstract] | |
Accumulated Other Comprehensive Income (Loss) | Accumulated Other Comprehensive Income (Loss) The Company had an immaterial balance of accumulated other comprehensive income as of March 31, 2020 and December 31, 2019 . The Company had an immaterial balance of accumulated other comprehensive income as of March 31, 2019 and December 31, 2018 . |
Loss Per Common Share
Loss Per Common Share | 3 Months Ended |
Mar. 31, 2020 | |
Earnings Per Share [Abstract] | |
Loss Per Common Share | Loss Per Common Share Basic and diluted loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted net loss per common share is the same as basic net loss per common share for the three months ended March 31, 2020 and 2019 , because the effect of the potential common stock equivalents would be antidilutive due to the Company’s net loss position for these periods. Antidilutive securities consist of stock options outstanding of 9,360,427 and 5,270,080 as of March 31, 2020 and 2019 , respectively. |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2020 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions (a) Agreement with Head of Research and Development - Robert E. Martell, M.D., Ph.D. On October, 17, 2018 , the Company entered into an exclusive option and license agreement with Epi-Cure Pharmaceuticals, Inc., (“Epi-Cure”) a privately held early stage biotechnology company. Robert E. Martell, M.D., Ph.D., the Company’s Head of Research and Development and a former director of the Company, is a founder of Epi-Cure, was formerly an officer and director of Epi-Cure, and is currently a holder of a convertible promissory note to Epi-Cure. Under the terms of the option and license agreement, Epi-Cure has granted Curis an exclusive option to certain program compounds that may arise during the initial research and development period, and any extension thereof. Upon execution of the option and license agreement, the Company paid Epi-Cure an upfront payment of $0.1 million for legal and consulting costs incurred by Epi-Cure in connection with the transaction. In July 2019, the Company extended the research and development period of the program until April 2020, as permitted under the terms of the agreement. Under the terms of the agreement, Epi-Cure will have primary responsibility for conducting research and development activities and Curis will be responsible for funding up to $0.5 million of the research and development program costs and expenses during the initial research and development period. After the end of the research and development period, Curis has sixty days to elect to exercise its option to license the program compounds. If the Company makes this election it will make a $2.0 million license fee payment and will be responsible for the development and commercialization of products that may result from the collaboration. Curis will also make cash payments to Epi-Cure subject to successful achievement of certain patent, development, regulatory, and commercial milestones, up to $63.0 million and will also pay Epi-Cure mid-single digit royalties on net product sales if product candidates derived from this collaboration are successfully developed. Epi-Cure has retained the right to opt in to co-develop and share in profits upon initiation of a Phase 2 clinical study, in which event Curis will share in any development costs and profits on a 50/50 basis. Epi-Cure also has the right to opt out of co-development/co-profit in which case they will receive royalty payments in lieu of profit sharing. Each party has the right to terminate the agreement for uncured material breach by the other party. Curis has the right to terminate the agreement for its convenience upon 60 days prior written notice. The agreement also sets forth customary terms regarding each party’s intellectual property ownership rights, representations and warranties, indemnification obligations, confidentiality rights and obligations, patent prosecution, and maintenance and defense rights and obligations. For the three months ended March 31, 2020 , Curis paid and expensed $0.2 million of fees related to this agreement. (b) Agreement with David Tuck, M.D. On May 24, 2018, the Company announced that David Tuck, M.D., Chief Medical Officer, provided notice of his intention to retire from the Company, effective as of August 31, 2018. Dr. Tuck subsequently determined to retire on August 3, 2018. The Company and Dr. Tuck entered into a letter agreement on August 1, 2018 pursuant to which Dr. Tuck agreed to provide the Company with specified advisory services commencing on August 4, 2018 and extending until May 3, 2019. The Company paid him a monthly retainer of $35.0 thousand during the Advisory Period and (ii) reimbursed him for any pre-approved reasonable, documented out-of-pocket expenses relating to his advisory services. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | The accompanying Condensed Consolidated Financial Statements have been prepared in accordance with the instructions to Form 10-Q and Article 8 of Regulation S-X. These statements, however, are condensed and do not include all disclosures required by accounting principles generally accepted in the U.S. (“GAAP”), for complete financial statements and should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 as filed with the Securities and Exchange Commission (“SEC”), on March 19, 2020 . |
Use of Estimates | The preparation of the Company’s Condensed Consolidated Financial Statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts and disclosure of certain assets and liabilities at the balance sheet date. Such estimates include the performance obligations under the Company’s collaboration agreements; the estimated repayment term of the Company’s debt and related short- and long-term classification; the fair value of the Company’s debt; the collectability of receivables; the carrying value of property and equipment and intangible assets; and the assumptions used in the Company’s valuation of stock-based compensation and the value of certain investments and liabilities. Actual results may differ from such estimates. |
Cash Equivalents, Restricted Cash, and Investments | The Company’s short-term investments are marketable debt securities with original maturities of greater than three months from the date of purchase, but less than twelve months from the balance sheet date, and long-term investments are marketable debt securities with original maturities of greater than twelve months from the balance sheet. Marketable securities consist of commercial paper, corporate bonds and notes, and government obligations. All of the Company’s investments have been designated available-for-sale and are stated at fair value. Unrealized gains and temporary losses on investments are included in accumulated other comprehensive income (loss) as a separate component of stockholders’ equity. Realized gains and losses, dividends and interest income are included in other income (expense) in the period during which the securities are sold. Any premium or discount arising at purchase is amortized and/or accreted to interest income. Cash equivalents consist of short-term, highly liquid investments purchased with original maturities of three months or less. All other liquid investments are classified as marketable securities. |
Revenue Recognition | Revenue Recognition The Company’s business strategy includes entering into collaborative license and development agreements with biotechnology and pharmaceutical companies for the development and commercialization of the Company’s drug candidates. The terms of the agreements typically include non-refundable license fees, funding of research and development, payments based upon achievement of clinical development and regulatory objectives, and royalties on product sales. License Fees and Multiple Element Arrangements If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, upfront fees allocated to the license at such time as 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 promises, the Company utilizes judgment to assess the nature of the combined performance obligations to determine whether the combined performance obligations are 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, upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. If the Company is involved in a steering committee as part of a multiple element arrangement, the Company assesses whether its involvement constitutes a performance obligation or a right to participate. Steering committee services that are not determined to be distinct performance obligations are combined with other research services or performance obligations required under an arrangement, if any, in determining the level of effort required in an arrangement and the period over which the Company expects to complete its aggregate performance obligations. Appropriate methods of measuring progress include output methods and input methods. In determining the appropriate method for measuring progress, the Company considers the nature of service that the Company promises to transfer to the customer. When the Company decides on a method of measurement, the Company will apply that single method of measuring progress for each performance obligation satisfied over time and will apply that method consistently to similar performance obligations and in similar circumstances. If the Company cannot reasonably measure its progress toward complete satisfaction of a performance obligation because it lacks reliable information that would be required to apply an appropriate method of measuring progress, but the Company can reasonably estimate when the performance obligation ceases or the remaining obligations become inconsequential and perfunctory, then revenue is not recognized until the Company can reasonably estimate when the performance obligation ceases or becomes inconsequential. Revenue is then recognized over the remaining estimated period of performance. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations under an arrangement. Contingent Research Milestone Payments ASC 606 constrains the amount of variable consideration included in the transaction price in that either all, or a portion, of an amount of variable consideration should be included in the transaction price. The variable consideration amount should be included only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The assessment of whether variable consideration should be constrained is largely a qualitative one that has two elements: the likelihood of a change in estimate, and the magnitude thereof. Variable consideration is not constrained if the potential reversal of cumulative revenue recognized is not significant, for example. If the consideration in a contract includes a variable amount, a company will estimate the amount of consideration in exchange for transfer of promised goods or services. The consideration also can vary if a company’s entitlement to the consideration is contingent on the occurrence or nonoccurrence of a future event. The Company considers contingent research milestone payments to fall under the scope of variable consideration, which should be estimated for revenue recognition purposes at the inception of the contract and reassessed ongoing at the end of each reporting period. The Company assesses whether contingent research milestones should be considered variable consideration that should be constrained and thus not part of the transaction price. This includes an assessment of the probability that all or some of the milestones revenue could be reversed when the uncertainty around whether or not the achievement of each milestone is resolved, and the amount of reversal could be significant. GAAP provides factors to consider when assessing whether variable consideration should be constrained. All of the factors should be considered, and no factor is determinative. The Company considers all relevant factors. Reimbursement of Costs Reimbursement of research and development costs by third party collaborators is recognized as revenue over time provided the Company has determined that it transfers control (i.e. performs the services) of a service over time and, therefore, satisfies a performance obligation according to the provisions outlined in ASC 606-10-25-27, Revenue Recognition . Royalty Revenue Since the first quarter of 2012, the Company has recognized royalty revenues related to Genentech’s and Roche’s sales of Erivedge. For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the 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 or all of the royalty has been allocated has been satisfied (or partially satisfied). The Company expects to continue recognizing royalty revenue from Genentech’s sales of Erivedge in the U.S. and in other markets where Genentech and Roche successfully obtain marketing approval, if any (see Note 8, Research and Development Collaborations ). However, a portion of Erivedge royalties will be paid to the Purchasers under the Oberland Purchase Agreement (see Note 7, Liability Related to the Sale of Future Royalties ). Contra Revenue, Net Contra revenue, net represents shared costs, primarily related to intellectual property, with the Company's collaboration partners, and reserves for potential royalty reductions. With respect to each of the foregoing areas of revenue recognition, the Company exercises significant judgment in determining whether an arrangement contains multiple elements, and, if so, how much revenue is allocable to each element. In addition, the Company exercises its judgment in determining when its significant obligations have been met under such agreements and the specific time periods over which it recognized revenue, such as non-refundable, up-front license fees. To the extent that actual facts and circumstances differ from its initial judgment, its revenue recognition with respect to such transactions would change accordingly and any such change could affect its reported financial results. |
Reclassifications | Certain prior period amounts have been reclassified to conform with the current period presentation. |
Fair Value Measurements | Fair Value of Financial Instruments The Company has adopted the provisions of the FASB Codification Topic 820, Fair Value Measurements and Disclosures (“Topic 820”) for its financial assets and liabilities that are re-measured and reported at fair value each reporting period and the non-financial assets and liabilities that are re-measured and reported at fair value on a non-recurring basis. Fair value is the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining fair value, the Company considers the principal or most advantageous market in which it would transact and consider assumptions that market participants would use when pricing the asset or liability. Topic 820 establishes a three-level valuation hierarchy for disclosure of fair value measurements. Financial assets and liabilities are categorized within the valuation hierarchy based upon the lowest level of input that is significant to the measurement of fair value. The three levels of the hierarchy are defined as follows: Level 1 Quoted prices in active markets for identical assets or liabilities. Level 2 Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
Loss Per Common Share | Loss Per Common Share Basic and diluted loss per common share is computed by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding during the period. Diluted net loss per common share is the same as basic net loss per common share for the three months ended March 31, 2020 and 2019 , because the effect of the potential common stock equivalents would be antidilutive due to the Company’s net loss position for these periods. |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets or Liabilities Measured at Fair Value on Recurring Basis | In accordance with the fair value hierarchy, the following table shows the fair value as of March 31, 2020 and December 31, 2019 of those financial assets and liabilities that are measured at fair value on a recurring basis, according to the valuation techniques the Company used to determine their fair value. No financial assets or liabilities are measured at fair value on a nonrecurring basis at March 31, 2020 and 2019 . Quoted Prices in Active Markets (Level 1) Other Observable Inputs (Level 2) Unobservable Inputs (Level 3) Fair Value As of March 31, 2020: Cash equivalents: Money market funds $ 10,268 $ — $ — $ 10,268 Short-term investments: Corporate commercial paper, bonds and notes — 6 — 6 Total assets at fair value $ 10,268 $ 6 $ — $ 10,274 Quoted Prices in Active Markets (Level 1) Other Observable Inputs (Level 2) Unobservable Inputs (Level 3) Fair Value As of December 31, 2019: Cash equivalents: Money market funds $ 10,684 $ — $ — $ 10,684 US government obligations — 550 — 550 Commercial paper — 300 — 300 Municipal bonds — 90 — 90 Short-term investments: Corporate commercial paper, bonds and notes — 5,113 — 5,113 Total assets at fair value $ 10,684 $ 6,053 $ — $ 16,737 |
Investments (Tables)
Investments (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Amortized Cost of Unrealized Gains and Losses and Fair Value of Investments | The amortized cost, unrealized gains and losses and fair value of investments available-for-sale as of December 31, 2019 were as follows: Amortized Cost Unrealized Gain Unrealized Loss Fair Value Corporate bonds and notes – short-term $ 5,113 $ — $ — $ 5,113 Total investments $ 5,113 $ — $ — $ 5,113 The amortized cost, unrealized gains and losses and fair value of investments available-for-sale as of March 31, 2020 were as follows: Amortized Cost Unrealized Gain Unrealized Loss Fair Value Corporate bonds and notes – short-term $ 6 $ — $ — $ 6 Total investments $ 6 $ — $ — $ 6 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Other Liabilities Disclosure [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following: March 31, December 31, Accrued compensation $ 670 $ 1,413 Professional fees 245 289 Other 804 208 Total $ 1,719 $ 1,910 |
Leases and Commitments (Tables)
Leases and Commitments (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Leases [Abstract] | |
Remaining Lease Commitments | The Company’s remaining lease commitments for all leased facilities with an initial or remaining term of at least one year were as follows as of December 31, 2019 . Year Ending December 31, 2020 $ 168 Total minimum payments $ 168 |
Liability Related to the Sale_2
Liability Related to the Sale of Future Royalties (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Nonmonetary Transactions [Abstract] | |
Schedule of Liability Due to Non-Cash Transaction | The following table shows the activity with respect to the liability related to the sale of future royalties during the three months ended March 31, 2020 . Carrying value of liability related to the sale of future royalties at January 1, 2020 $ 62,477 Amortization of capitalized issuance costs 15 Imputed interest expense recognized for the three months ended March 31, 2020 1,283 Less: payments to Oberland Capital, LLC (2,786 ) Carrying value of liability related to the sale of future royalties at March 31, 2020 $ 60,989 The following table shows the activity with respect to the liability related to the sale of future royalties from the inception of the Oberland Purchase Agreement through December 31, 2019 Liability related to the sale of future royalties at March 22, 2019 $ 65,000 Capitalized issuance costs (584 ) Imputed interest expense recognized for the three months ended December 31, 2019 4,055 Less: payments to Oberland Capital, LLC (5,994 ) Carrying value of liability related to the sale of future royalties at December 31, 2019 $ 62,477 |
Stock Plans and Stock Based C_2
Stock Plans and Stock Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Key Assumptions for Options Awarded | The Black-Scholes option pricing model employs the following key assumptions for employee and director options awarded during the three months ended March 31, 2020 and 2019 based on the assumptions noted in the following table: Three Months Ended 2020 2019 Expected term (years) – employees and officers 5.5 5.5 Expected term (years) – directors 5.5 5.5 Risk free interest rate 0.9-1.7% 2.5-2.6% Expected Volatility 80 % 76 % Expected Dividends None None |
Schedule of Stock Option Activity | A summary of stock option activity under the 2010 Plan, the 2000 Stock Incentive Plan, the 2000 Director Stock Option Plan and nonstatutory inducement awards are summarized as follows: Number of Shares Weighted Average Exercise Price per Share Weighted Average Remaining Contractual Life Aggregate Intrinsic Value Unvested, December 31, 2019 6,158,026 $ 3.43 8.33 Granted 3,258,150 1.29 Exercised — — Canceled (55,749 ) 7.52 Outstanding, March 31, 2020 9,360,427 $ 2.66 8.64 $ — Exercisable at March 31, 2020 2,966,332 $ 5.04 7.40 $ — Vested and unvested expected to vest at March 31, 2020 8,030,728 $ 2.86 8.53 $ — |
Schedule of Restricted Stock Award Activity | The following table presents a summary of unvested restricted stock awards (“RSAs”) under the 2010 Plan as of March 31, 2020 : Number of Shares Weighted Average Grant Date Fair Value Unvested, December 31, 2019 30,937 $ 3.45 Awarded — — Vested (10,313 ) 3.45 Forfeited — — Unvested, March 31, 2020 20,624 $ 3.45 |
Schedule of Stock-Based Compensation Expense | For the three months ended March 31, 2020 and 2019 , the Company recorded stock based compensation expense to the following line items in its costs and expenses section of the Condensed Consolidated Statements of Operations and Comprehensive Loss, including expense related to its ESPP: Three Months Ended 2020 2019 Research and development expenses $ 170 $ 176 General and administrative expenses 455 475 Total stock based compensation expense $ 625 $ 651 |
Nature of Business (Details)
Nature of Business (Details) $ in Thousands | 3 Months Ended | |||||
Mar. 31, 2020USD ($)segment | Mar. 31, 2019USD ($) | Apr. 21, 2020USD ($) | Dec. 31, 2019USD ($) | Mar. 31, 2018program | Oct. 31, 2016program | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Number of reportable segments | segment | 1 | |||||
Retained earnings (accumulated deficit) | $ (1,026,690) | $ (1,016,981) | ||||
Net loss | 9,709 | $ 9,884 | ||||
Cash used in operations | 9,016 | $ 7,233 | ||||
Cash, cash equivalents, and investments | $ 12,500 | |||||
Aurigene | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Number of programs licensed in collaboration agreement | program | 4 | 3 | ||||
Cares Act PPP Loan | Subsequent Event | Commercial Paper | Silicon Valley Bank | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Unsecured loan | $ 900 | |||||
Unsecured loan term (months) | 24 months | |||||
Unsecured loan interest rate (percent) | 1.00% |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands | 3 Months Ended | |||
Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||
Cash and cash equivalents | $ 12,532 | $ 15,430 | ||
Restricted cash | 1,000 | 1,000 | ||
Cash and restricted balances | 13,501 | $ 42,919 | 16,399 | $ 23,789 |
Operating lease right-of-use asset | 0 | $ 149 | ||
Reduction of net cash used in operating activities | (9,016) | (7,233) | ||
Reduction of net cash provided by financing activities | $ (1,277) | (25,763) | ||
Overstatement of Prepayment Fees | Restatement Adjustment | ||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||
Reduction of net cash used in operating activities | 3,400 | |||
Reduction of net cash provided by financing activities | $ 3,400 | |||
Customer Concentration Risk | Genentech, Inc. | ||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||||
Concentration risk (as a percent) | 92.22511% | 100.00% |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Summary (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Short-term investments: | ||
Corporate commercial paper, bonds and notes | $ 6 | $ 5,113 |
Corporate commercial paper, bonds and notes | ||
Short-term investments: | ||
Corporate commercial paper, bonds and notes | 6 | 5,113 |
Fair Value, Measurements, Recurring | ||
Short-term investments: | ||
Total assets at fair value | 10,274 | 16,737 |
Fair Value, Measurements, Recurring | Corporate commercial paper, bonds and notes | ||
Short-term investments: | ||
Corporate commercial paper, bonds and notes | 6 | 5,113 |
Fair Value, Measurements, Recurring | Money market funds | ||
Cash equivalents: | ||
Cash equivalents | 10,268 | 10,684 |
Fair Value, Measurements, Recurring | US government obligations | ||
Cash equivalents: | ||
Cash equivalents | 550 | |
Fair Value, Measurements, Recurring | Commercial paper | ||
Cash equivalents: | ||
Cash equivalents | 300 | |
Fair Value, Measurements, Recurring | Municipal bonds | ||
Cash equivalents: | ||
Cash equivalents | 90 | |
Fair Value, Measurements, Recurring | Quoted Prices in Active Markets (Level 1) | ||
Short-term investments: | ||
Total assets at fair value | 10,268 | 10,684 |
Fair Value, Measurements, Recurring | Quoted Prices in Active Markets (Level 1) | Corporate commercial paper, bonds and notes | ||
Short-term investments: | ||
Corporate commercial paper, bonds and notes | 0 | 0 |
Fair Value, Measurements, Recurring | Quoted Prices in Active Markets (Level 1) | Money market funds | ||
Cash equivalents: | ||
Cash equivalents | 10,268 | 10,684 |
Fair Value, Measurements, Recurring | Quoted Prices in Active Markets (Level 1) | US government obligations | ||
Cash equivalents: | ||
Cash equivalents | 0 | |
Fair Value, Measurements, Recurring | Quoted Prices in Active Markets (Level 1) | Commercial paper | ||
Cash equivalents: | ||
Cash equivalents | 0 | |
Fair Value, Measurements, Recurring | Quoted Prices in Active Markets (Level 1) | Municipal bonds | ||
Cash equivalents: | ||
Cash equivalents | 0 | |
Fair Value, Measurements, Recurring | Other Observable Inputs (Level 2) | ||
Short-term investments: | ||
Total assets at fair value | 6 | 6,053 |
Fair Value, Measurements, Recurring | Other Observable Inputs (Level 2) | Corporate commercial paper, bonds and notes | ||
Short-term investments: | ||
Corporate commercial paper, bonds and notes | 6 | 5,113 |
Fair Value, Measurements, Recurring | Other Observable Inputs (Level 2) | Money market funds | ||
Cash equivalents: | ||
Cash equivalents | 0 | 0 |
Fair Value, Measurements, Recurring | Other Observable Inputs (Level 2) | US government obligations | ||
Cash equivalents: | ||
Cash equivalents | 550 | |
Fair Value, Measurements, Recurring | Other Observable Inputs (Level 2) | Commercial paper | ||
Cash equivalents: | ||
Cash equivalents | 300 | |
Fair Value, Measurements, Recurring | Other Observable Inputs (Level 2) | Municipal bonds | ||
Cash equivalents: | ||
Cash equivalents | 90 | |
Fair Value, Measurements, Recurring | Unobservable Inputs (Level 3) | ||
Short-term investments: | ||
Total assets at fair value | 0 | 0 |
Fair Value, Measurements, Recurring | Unobservable Inputs (Level 3) | Corporate commercial paper, bonds and notes | ||
Short-term investments: | ||
Corporate commercial paper, bonds and notes | 0 | 0 |
Fair Value, Measurements, Recurring | Unobservable Inputs (Level 3) | Money market funds | ||
Cash equivalents: | ||
Cash equivalents | $ 0 | 0 |
Fair Value, Measurements, Recurring | Unobservable Inputs (Level 3) | US government obligations | ||
Cash equivalents: | ||
Cash equivalents | 0 | |
Fair Value, Measurements, Recurring | Unobservable Inputs (Level 3) | Commercial paper | ||
Cash equivalents: | ||
Cash equivalents | 0 | |
Fair Value, Measurements, Recurring | Unobservable Inputs (Level 3) | Municipal bonds | ||
Cash equivalents: | ||
Cash equivalents | $ 0 |
Investments - Narrative (Detail
Investments - Narrative (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2020 | Dec. 31, 2018 | |
Debt Securities, Available-for-sale [Line Items] | ||
Weighted-average maturity of short-term investments | 3 months 13 days | 1 month 6 days |
Debt securities in an unrealized loss position | $ 0 | |
Short-term Investments | Minimum | ||
Debt Securities, Available-for-sale [Line Items] | ||
Maturity range for short-term investments | 1 month | 1 month |
Short-term Investments | Maximum | ||
Debt Securities, Available-for-sale [Line Items] | ||
Maturity range for short-term investments | 12 months | 12 months |
Investments - Amortized Cost of
Investments - Amortized Cost of Unrealized Gains and Losses and Fair Value of Investments (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 6 | $ 5,113 |
Unrealized Gain | 0 | 0 |
Unrealized Loss | 0 | 0 |
Fair Value | 6 | 5,113 |
Corporate bonds and notes – short-term | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 6 | 5,113 |
Unrealized Gain | 0 | 0 |
Unrealized Loss | 0 | 0 |
Fair Value | $ 6 | $ 5,113 |
Accrued Liabilities - Summary (
Accrued Liabilities - Summary (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Other Liabilities Disclosure [Abstract] | ||
Accrued compensation | $ 670 | $ 1,413 |
Professional fees | 245 | 289 |
Other | 804 | 208 |
Total | $ 1,719 | $ 1,910 |
Leases and Commitments (Details
Leases and Commitments (Details) - Building - MASSACHUSETTS $ in Millions | Dec. 05, 2019USD ($) |
Lessee, Lease, Description [Line Items] | |
Lease not yet commenced, term (years) | 7 years |
Lease not yet commenced, liability | $ 8.3 |
Leases and Commitments - Curren
Leases and Commitments - Current Lease Maturities (Details) $ in Thousands | Mar. 31, 2020USD ($) |
Leases [Abstract] | |
2020 | $ 168 |
Total minimum payments | $ 168 |
Liability Related to the Sale_3
Liability Related to the Sale of Future Royalties (Details) - USD ($) $ in Thousands | Mar. 22, 2019 | Mar. 31, 2020 | Dec. 31, 2019 | Mar. 31, 2019 |
Nonmonetary Transaction [Line Items] | ||||
Proceeds from royalty interest purchase agreement with Oberland Capital Management, LLC | $ 0 | $ 65,000 | ||
Payment towards debt obligations | 0 | $ 1,825 | ||
Transaction fees | $ 600 | |||
Non-cash interest rate (percent) | 8.20% | |||
Carrying value of liability related to the sale of future royalties at January 1, 2020 | $ 65,000 | $ 62,477 | ||
Amortization of capitalized issuance costs | 15 | |||
Capitalized issuance costs | (584) | |||
Imputed interest expense recognized for the three months ended March 31, 2020 | 1,283 | 4,055 | ||
Less: payments to Oberland Capital, LLC | (2,786) | (5,994) | ||
Carrying value of liability related to the sale of future royalties at March 31, 2020 | $ 60,989 | $ 62,477 | ||
Oberland Capital | ||||
Nonmonetary Transaction [Line Items] | ||||
Proceeds from royalty interest purchase agreement with Oberland Capital Management, LLC | 65,000 | |||
Cash proceeds from royalty purchase agreement | 70,700 | |||
Purchaser default option period (days) | 180 days | |||
HealthCare Royalty Partners III, L.P. | ||||
Nonmonetary Transaction [Line Items] | ||||
Proceeds from royalty interest purchase agreement with Oberland Capital Management, LLC | 27,500 | |||
Payment towards debt obligations | 37,200 | |||
Repayment of debt, principal | 33,800 | |||
Accrued and unpaid interest and prepayment fees | 3,400 | |||
Transaction fees | 300 | |||
Royalty Amounts in 2021 | Oberland Capital | ||||
Nonmonetary Transaction [Line Items] | ||||
Cash proceeds from royalty purchase agreement | 17,200 | |||
Royalty amount threshold | 18,000 | |||
Aggregate Net Royalties Prior to 2027 | Oberland Capital | ||||
Nonmonetary Transaction [Line Items] | ||||
Cash proceeds from royalty purchase agreement | 53,500 | |||
Royalty amount threshold | $ 117,000 |
Research and Development Coll_2
Research and Development Collaborations - Narrative (Details) | Jan. 06, 2020USD ($) | Sep. 30, 2016USD ($)programshares | Jun. 30, 2003USD ($) | Mar. 31, 2020USD ($)producttermprogram | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2015USD ($)shares | Feb. 29, 2020patient | Dec. 31, 2019USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2017payment |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Total revenues, net | $ 2,709,000 | $ 1,767,000 | |||||||||
Cost of royalties | 125,000 | 108,000 | |||||||||
Accounts receivable | 2,507,000 | $ 3,244,000 | |||||||||
Value of common stock issued | $ 366,000 | $ 332,000 | |||||||||
Number of program licensed | program | 4 | 4 | |||||||||
Collaboration agreement, number of optional additional terms | term | 3 | ||||||||||
Collaboration agreement, optional additional term | 1 year | ||||||||||
Option fees | $ 7,500,000 | ||||||||||
Number of payments | payment | 2 | ||||||||||
Exclusivity payment | 2,000,000 | $ 10,000,000 | |||||||||
Research and Development, Net | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Revenues | 0 | 0 | |||||||||
Royalties | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Total revenues, net | 2,515,000 | 2,137,000 | |||||||||
Genentech, Inc. | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Research and development collaboration expense | 0 | ||||||||||
Genentech, Inc. | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Amount received for specified clinical development and regulatory objectives | 59,000,000 | ||||||||||
Percentage of royalty rate decrease | 2.00% | ||||||||||
Cost of royalties | 100,000 | 100,000 | |||||||||
Accounts receivable | $ 2,500,000 | $ 3,200,000 | |||||||||
Royalty rate, percentage of sales (percent) | 5.00% | ||||||||||
Genentech, Inc. | Royalties | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Total revenues, net | $ 2,500,000 | 2,100,000 | |||||||||
Genentech, Inc. | Maximum | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Eligible to receive contingent cash payment for specified clinical development and regulatory objectives (up to) | $ 115,000,000 | ||||||||||
Percentage of royalty on net sales | 7.50% | ||||||||||
Genentech, Inc. | Minimum | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Percentage of royalty on net sales | 5.00% | ||||||||||
Aurigene | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Research and development collaboration expense | $ 0 | $ 0 | |||||||||
Issued shares of common stock (in shares) | shares | 3,424,026.2 | ||||||||||
Value of common stock issued | $ 24,300,000 | ||||||||||
Shares issued of common stock in exchange for waived payment (in shares) | shares | 2,041,666 | ||||||||||
Waived payment of milestone and other payments (up to) | $ 24,500,000 | ||||||||||
Number of patients in trial | patient | 240 | ||||||||||
Collaboration agreement, number of products required to commercialize (at least) | product | 1 | ||||||||||
Collaboration agreement period | 2 years | ||||||||||
Milestone payments waived to date | $ 19,500,000 | ||||||||||
Aurigene | Programs three and four | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Agreement to provide additional funding, if options are exercised (up to) | $ 2,000,000 | ||||||||||
Payments made under collaboration arrangements | 14,500,000 | ||||||||||
Aurigene | IRAK4, PD1/VISTA,PD1/TIM3 Program | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Waived payment of milestone and other payments (up to) | $ 42,500,000 | ||||||||||
ImmuNext | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Upfront payment due | $ 1,300,000 | ||||||||||
Option exercise fee | $ 20,000,000 | ||||||||||
Expiration period (years) | 10 years | ||||||||||
Semi-annual maintenance fee payments | $ 400,000 | ||||||||||
Maximum reimbursable expenses | 300,000 | ||||||||||
ImmuNext | Maximum | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Development milestone payments | 4,600,000 | ||||||||||
Regulatory approval milestone payments | 84,300,000 | ||||||||||
Sales milestone payments | $ 125,000,000 | ||||||||||
Asia | Aurigene | Maximum | |||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||
Royalty rate, percentage of sales (percent) | 10.00% |
Common Stock - Narrative (Detai
Common Stock - Narrative (Details) - USD ($) | Feb. 26, 2020 | Jul. 02, 2015 | Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | Mar. 04, 2020 | May 23, 2019 | May 22, 2019 |
Class of Stock [Line Items] | ||||||||
Sale of common stock | $ 3,000,000 | $ 0 | ||||||
Common stock authorized (shares) | 101,250,000 | 101,250,000 | 101,250,000 | 67,500,000 | ||||
Cowen | At-the-market sale facility | ||||||||
Class of Stock [Line Items] | ||||||||
Compensation payable, percentage of gross sales price | 3.00% | |||||||
Shares of common stock sold (shares) | 0 | 420,796 | ||||||
Sale of common stock | $ 6,200,000 | |||||||
Aspire Capital Fund, LLC | ||||||||
Class of Stock [Line Items] | ||||||||
Sale of common stock | $ 3,000,000 | |||||||
Common stock issued (shares) | 2,693,965 | |||||||
JonesTrading Institutional Services LLC | ||||||||
Class of Stock [Line Items] | ||||||||
Compensation fee (percent of gross proceeds) | 3.00% | |||||||
Maximum | Cowen | At-the-market sale facility | ||||||||
Class of Stock [Line Items] | ||||||||
Planned proceeds from sale of stock (up to) | $ 30,000,000 | |||||||
Common Stock | Aspire Capital Fund, LLC | ||||||||
Class of Stock [Line Items] | ||||||||
Authorized amount of stock repurchase | $ 30,000,000 | |||||||
Remaining authorized stock purchase amount | $ 27,000,000 | |||||||
Purchase period (months) | 30 months | |||||||
Commitment fee (shares) | 646,551 | |||||||
Common Stock | JonesTrading Institutional Services LLC | ||||||||
Class of Stock [Line Items] | ||||||||
Shares of common stock sold (shares) | 0 | |||||||
Authorized amount | $ 30,000,000 |
Stock Plans and Stock Based C_3
Stock Plans and Stock Based Compensation - Narrative (Details) | May 23, 2019shares | Jan. 31, 2019$ / sharesshares | Mar. 31, 2020USD ($)purchase_periodplan$ / sharesshares | Mar. 31, 2019USD ($)$ / sharesshares | Dec. 31, 2016purchase_period | Dec. 31, 2019$ / sharesshares |
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Number of shareholder-approved, share-based compensation plans | plan | 2 | |||||
Number of options granted (shares) | 3,258,150 | |||||
Exercise price (USD per share) | $ / shares | $ 1.85 | |||||
Awarded (shares) | 140,000 | |||||
Weighted average grant-date fair values of stock options (USD per share) | $ / shares | $ 0.76 | $ 0.76 | ||||
Unrecognized compensation cost, net of estimated forfeitures | $ | $ 4,500,000 | |||||
Unrecognized compensation cost, weighted average period for recognition | 2 years 10 months 5 days | |||||
Intrinsic values of employee stock options exercised | $ | $ 0 | $ 0 | ||||
Compensation expense related to employee and director stock option grants | $ | $ 625,000 | $ 651,000 | ||||
Restricted Stock | ||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Exercise price (USD per share) | $ / shares | $ 0 | |||||
Awarded (shares) | 0 | |||||
Outstanding shares (shares) | 20,624 | 30,937 | ||||
Weighted average fair value (USD per share) | $ / shares | $ 3.45 | $ 3.45 | ||||
Fair value | $ | $ 100,000 | |||||
Stock options outstanding | ||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Vesting period of options (years) | 4 years | |||||
Officers | Restricted Stock | ||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Vesting period of options (years) | 4 years | |||||
Officers and Non-Employee Directors | Restricted Stock | ||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Unrecognized compensation cost, net of estimated forfeitures | $ | $ 100,000 | |||||
Unrecognized compensation cost, weighted average period for recognition | 1 year 9 months 22 days | |||||
Tranche one | ||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Percentage of vested shares which are exercisable under stock option | 25.00% | |||||
Tranche two | ||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Percentage of vested shares which are exercisable under stock option | 6.25% | |||||
Amended and Restated 2010 Stock Incentive Plan | ||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Shares authorized (shares) | 10,890,000 | |||||
Shares awarded under plan (shares) | 1,395,833 | |||||
Amended and Restated 2010 Stock Incentive Plan | Stock Options, or Stock Appreciation Rights | ||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Expiration period (years) | 10 years | |||||
Shares removed from pool (shares per share) | 1 | |||||
Amended and Restated 2010 Stock Incentive Plan | Restricted Stock, RSUs, Other Stock-Based Awards, or Performance Awards | ||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Shares removed from pool (shares per share) | 1.3 | |||||
Purchase price of common stock (percentage of fair market value) | 100.00% | |||||
Amended and Restated 2010 Stock Incentive Plan | Employee Stock | ||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Additional shares authorized (shares) | 4,700,000 | |||||
2010 Plan | ||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Number of options granted (shares) | 2,538,150 | |||||
2010 Plan | Officers | ||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Number of options granted (shares) | 1,520,000 | |||||
Vesting period of options (years) | 4 years | |||||
Exercise price (USD per share) | $ / shares | $ 1.26 | |||||
2010 Plan | Non-Employee Directors | ||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Number of options granted (shares) | 0 | 720,000 | ||||
Exercise price (USD per share) | $ / shares | $ 1.26 | |||||
2010 Plan | Tranche one | ||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Options granted to employees (shares) | 878,150 | |||||
Percentage of vested shares which are exercisable under stock option | 25.00% | |||||
2010 Plan | Tranche one | Officers | ||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Percentage of vested shares which are exercisable under stock option | 25.00% | |||||
2010 Plan | Tranche two | ||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Percentage of vested shares which are exercisable under stock option | 6.25% | |||||
2010 Plan | Tranche two | Officers | ||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Percentage of vested shares which are exercisable under stock option | 6.25% | |||||
Employee Stock Purchase Plan | Employee Stock | ||||||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||||||
Shares authorized (shares) | 2,000,000 | |||||
Purchase price of common stock (percentage of fair market value) | 85.00% | |||||
Enrollment period (years) | 2 years | |||||
Number of purchase periods per year | purchase_period | 4 | 2 | ||||
Stock plan offering period (months) | 6 months | |||||
Stock issued under employee stock purchase plans (shares) | 0 | |||||
Stock available under ESPPs (shares) | 1,677,934 | |||||
Compensation expense related to employee and director stock option grants | $ | $ 0 |
Stock Plans and Stock Based C_4
Stock Plans and Stock Based Compensation - Key Assumptions (Details) | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||
Risk-free interest rate (minimum) (as a percent) | 0.90% | 2.50% |
Risk-free interest rate (maximum) (as a percent) | 1.70% | 2.60% |
Expected volatility (as a percent) | 80.00% | 76.00% |
Employees and Officers | ||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||
Expected term (years) | 5 years 6 months | 5 years 6 months |
Directors | ||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||
Expected term (years) | 5 years 6 months | 5 years 6 months |
Stock Plans and Stock Based C_5
Stock Plans and Stock Based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2020 | Dec. 31, 2019 | |
Number of Shares | ||
Beginning balance (shares) | 6,158,026 | |
Granted (shares) | 3,258,150 | |
Exercised (shares) | 0 | |
Canceled (shares) | (55,749) | |
Ending balance (shares) | 9,360,427 | 6,158,026 |
Exercisable at end of period (shares) | 2,966,332 | |
Vested and unvested expected to vest at end of period (shares) | 8,030,728 | |
Weighted Average Exercise Price per Share | ||
Beginning balance (USD per share) | $ 3.43 | |
Granted (USD per share) | 1.29 | |
Exercised (USD per share) | 0 | |
Canceled (USD per share) | 7.52 | |
Ending balance (USD per share) | 2.66 | $ 3.43 |
Exercisable at end of period (USD per share) | 5.04 | |
Vested and unvested expected to vest at end of period (USD per share) | $ 2.86 | |
Weighted Average Remaining Contractual Life | ||
Outstanding at end of period | 8 years 7 months 20 days | 8 years 3 months 29 days |
Exercisable at end of period | 7 years 4 months 24 days | |
Vested and unvested expected to vest at end of period | 8 years 6 months 10 days | |
Aggregate Intrinsic Value | ||
Outstanding at end of period | $ 0 | |
Exercisable at end of period | 0 | |
Vested and unvested expected to vest at end of period | $ 0 |
Stock Plans and Stock Based C_6
Stock Plans and Stock Based Compensation - Restricted Stock Award Activity (Details) | 3 Months Ended |
Mar. 31, 2020$ / sharesshares | |
Number of Shares | |
Awarded (shares) | shares | 140,000 |
Weighted Average Grant Date Fair Value | |
Awarded (USD per share) | $ / shares | $ 1.85 |
Restricted Stock | |
Number of Shares | |
Beginning balance (shares) | shares | 30,937 |
Awarded (shares) | shares | 0 |
Vested (shares) | shares | (10,313) |
Forfeited (shares) | shares | 0 |
Ending balance (shares) | shares | 20,624 |
Weighted Average Grant Date Fair Value | |
Beginning balance (USD per share) | $ / shares | $ 3.45 |
Vested (USD per share) | $ / shares | 3.45 |
Awarded (USD per share) | $ / shares | 0 |
Forfeited (USD per share) | $ / shares | 0 |
Ending balance (USD per share) | $ / shares | $ 3.45 |
Stock Plans and Stock Based C_7
Stock Plans and Stock Based Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||
Total stock based compensation expense | $ 625 | $ 651 |
Research and development expenses | ||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||
Total stock based compensation expense | 170 | 176 |
General and administrative expenses | ||
Deferred Compensation Arrangement with Individual, Share-based Payments [Line Items] | ||
Total stock based compensation expense | $ 455 | $ 475 |
Loss Per Common Share - Narrati
Loss Per Common Share - Narrative (Details) - shares | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Stock options outstanding | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (shares) | 9,360,427 | 5,270,080 |
Related Party Transactions - Na
Related Party Transactions - Narrative (Details) | Oct. 17, 2018USD ($) | Aug. 01, 2018USD ($) | Mar. 31, 2020USD ($)day |
Related Party Transaction [Line Items] | |||
Monthly retainer for advisory services | $ 35,000 | ||
Epi-Cure Pharmaceuticals, Inc. | Affiliated Entity | |||
Related Party Transaction [Line Items] | |||
Amount paid for transaction | $ 200,000 | ||
Expenses from transactions with related party | 200,000 | ||
Epi-Cure Pharmaceuticals, Inc. | Affiliated Entity | Agreement With Head of Research and Development | |||
Related Party Transaction [Line Items] | |||
Purchases from related party | $ 100,000 | ||
Maximum funding amount | $ 500,000 | ||
Minimum days notice to terminate prior to written notice (days) | day | 60 | ||
License payment if option is exercised | $ 2,000,000 | ||
Milestone payments | $ 63,000,000 | ||
Epi-Cure Pharmaceuticals, Inc. | Affiliated Entity | Development Costs and Profits | |||
Related Party Transaction [Line Items] | |||
Cost and revenue split (percent) | 50.00% |