Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2020 | May 06, 2020 | |
Cover [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 | |
Trading Symbol | SNDX | |
Entity Registrant Name | SYNDAX PHARMACEUTICALS INC | |
Entity Central Index Key | 0001395937 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Common Stock, Shares Outstanding | 36,094,929 | |
Entity Shell Company | false | |
Title of 12(b) Security | Common Stock | |
Security Exchange Name | NASDAQ | |
Entity File Number | 001-37708 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 32-0162505 | |
Entity Address, Address Line One | 35 Gatehouse Drive | |
Entity Address, Address Line Two | Building D | |
Entity Address, Address Line Three | Floor 3 | |
Entity Address, City or Town | Waltham | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02451 | |
City Area Code | 781 | |
Local Phone Number | 419-1400 | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 44,629 | $ 24,609 |
Restricted cash | 115 | |
Short-term investments | 54,376 | 35,166 |
Prepaid expenses and other current assets | 5,086 | 2,556 |
Total current assets | 104,206 | 62,331 |
Property and equipment, net | 259 | 281 |
Right-of-use asset, net | 608 | 716 |
Other assets | 82 | 197 |
Total assets | 105,155 | 63,525 |
Current liabilities: | ||
Accounts payable | 8,998 | 6,178 |
Accrued expenses and other current liabilities | 7,795 | 10,195 |
Current portion of deferred revenue | 1,517 | 1,517 |
Current portion of right-of-use liability | 480 | 478 |
Total current liabilities | 18,790 | 18,368 |
Long-term liabilities: | ||
Deferred revenue, less current portion | 12,754 | 13,133 |
Right-of-use liability, less current portion | 306 | 419 |
Loan payable | 19,792 | |
Other long-term liabilities | 4 | 5 |
Total long-term liabilities | 32,856 | 13,557 |
Total liabilities | 51,646 | 31,925 |
Commitments | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value, 10,000,000 shares authorized; 0 shares outstanding at March 31, 2020 and December 31, 2019 | ||
Common stock, $0.0001 par value, 100,000,000 shares authorized; 30,240,838 and 27,140,484 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively | 3 | 3 |
Additional paid-in capital | 564,164 | 527,067 |
Accumulated other comprehensive income | 48 | |
Accumulated deficit | (510,706) | (495,470) |
Total stockholders’ equity | 53,509 | 31,600 |
Total liabilities and stockholders’ equity | $ 105,155 | $ 63,525 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2020 | Dec. 31, 2019 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 30,240,838 | 27,140,484 |
Common stock, shares outstanding | 30,240,838 | 27,140,484 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Revenue: | ||
Total revenues | $ 379 | $ 379 |
Type of revenue [extensible list] | us-gaap:LicenseMember | |
Operating expenses: | ||
Research and development | 9,562 | $ 11,279 |
General and administrative | 5,917 | 3,911 |
Total operating expenses | 15,479 | 15,190 |
Loss from operations | (15,100) | (14,811) |
Other (expense) income: | ||
Interest expense | (449) | |
Interest income | 333 | 452 |
Other (expense) income | (20) | 57 |
Total other (expense) income | (136) | 509 |
Net loss | (15,236) | (14,302) |
Other comprehensive income (loss): | ||
Unrealized gain on marketable securities | 48 | 33 |
Comprehensive loss | (15,188) | (14,269) |
Net loss attributable to common stockholders | $ (19,142) | $ (14,302) |
Net loss per share attributable to common stockholders—basic and diluted | $ (0.56) | $ (0.53) |
Weighted-average number of common shares used to compute net loss per share attributable to common stockholders—basic and diluted | 34,328,640 | 27,023,466 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (15,236,000) | $ (14,302,000) |
Adjustments to reconcile net loss to net cash from operating activities: | ||
Depreciation | 23,000 | (180,000) |
Amortization and accretion of investments | (110,000) | |
Non-cash operating lease expense | 108,000 | |
Non-cash interest expense | 62,000 | |
Stock-based compensation | 1,829,000 | 1,592,000 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (2,530,000) | (2,453,000) |
Accounts payable | 2,820,000 | 2,908,000 |
Deferred revenue | (379,000) | (379,000) |
Accrued expenses and other liabilities | (2,512,000) | (4,017,000) |
Net cash used in operating activities | (15,925,000) | (16,831,000) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of short-term investments | (34,938,000) | (20,628,000) |
Proceeds from sales and maturities of short-term investments | 15,885,000 | 33,380,000 |
Net cash (used in) provided by investing activities | (19,053,000) | 12,752,000 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from debt agreement, net | 19,730,000 | |
Proceeds from Employee Stock Purchase Plan | 64,000 | 27,000 |
Proceeds from stock option exercises | 338,000 | |
Other | (2,000) | |
Net cash provided by financing activities | 54,998,000 | 28,426,000 |
NET INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | 20,020,000 | 24,347,000 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH—beginning of period | 24,724,000 | 33,985,000 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH —end of period | 44,744,000 | 58,332,000 |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: | ||
Cash paid for interest | 126,000 | |
SUPPLEMENTAL DISCLOSURES OF NONCASH INVESTING AND FINANCING ACTIVITIES: | ||
Issuance costs debt included in accounts payable and accrued expenses | 82,000 | 171,000 |
At-the-Market Offering [Member] | ||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of common stock, net | 830,000 | |
Private Placement [Member] | ||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of common stock, net | $ 34,866,000 | $ 27,571,000 |
Nature of Business
Nature of Business | 3 Months Ended |
Mar. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Nature of Business | 1. Nature of Business Syndax Pharmaceuticals, Inc. (“we,” “us,” “our” or the “Company”) is a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. We were incorporated in Delaware in 2005. We base our operations in Waltham, Massachusetts and we operate in one segment. |
Basis of Presentation
Basis of Presentation | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation | 2. Basis of Presentation The Company has prepared the accompanying condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Certain information and footnote disclosures normally included in the Company’s annual financial statements have been condensed or omitted. The interim unaudited condensed financial statements have been prepared on the same basis as the annual audited financial statements and in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of March 31, 2020, and the results of operations and comprehensive loss for the three months ended March 31, 2020 and 2019, and cash flows for the three months ended March 31, 2020 and 2019. The results for the three months ended March 31, 2020 are not necessarily indicative of the results to be expected for the year ending December 31, 2020, any other interim periods, or any future year or period. These interim financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2019, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K that was filed with the Securities and Exchange Commission (“SEC”) on March 5, 2020. In 2011, the Company established a wholly owned subsidiary in the United Kingdom. There have been no activities for this entity to date. In 2014, the Company established a wholly owned U.S. subsidiary, Syndax Securities Corporation. The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Significant Accounting Policies The Company’s significant accounting policies, which are disclosed in the audited consolidated financial statements for the year ended December 31, 2019 and the notes thereto are included in the Company’s Annual Report on Form 10-K that was filed with the SEC on March 5, 2020. Since the date of that filing, there have been no material changes to the Company’s significant accounting policies except as noted below. Significant Risks and Uncertainties With the global spread of the ongoing COVID-19 pandemic in the first and second quarters of 2020, we have implemented business continuity plans designed to address and mitigate the impact of the COVID-19 pandemic on our business. We anticipate that the COVID-19 pandemic could have an impact on the clinical development timelines for one or more of our clinical programs. The extent to which the COVID-19 pandemic impacts our business, our clinical development, manufacturing of clinical and commercial drug substance and drug product, and regulatory efforts, our corporate development objectives and the value of and market for our common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S., Europe and other countries, and the effectiveness of actions taken globally to contain and treat the disease. The global economic slowdown, the overall disruption of global healthcare systems and the other risks and uncertainties associated with the pandemic could have a material adverse effect on our business, financial condition, results of operations and growth prospects. In addition, we are subject to other challenges and risks specific to our business and our ability to execute on our strategy, as well as risks and uncertainties common to companies in the pharmaceutical industry with development and commercial operations, including, without limitation, risks and uncertainties associated with: obtaining regulatory approval of our late-stage product candidate; delays or problems in the supply of our products, loss of single source suppliers or failure to comply with manufacturing regulations; identifying, acquiring or in-licensing additional products or product candidates; pharmaceutical product development and the inherent uncertainty of clinical success; and the challenges of protecting and enhancing our intellectual property rights; complying with applicable regulatory requirements. In addition, to the extent the ongoing COVID-19 pandemic adversely affects our business and results of operations, it may also have the effect of heightening many of the other risks and uncertainties discussed above. Debt Issuance Cost Debt issuance costs consist of payments made to secure commitments under certain debt financing arrangements. These amounts are recognized as interest expense over the period of the financing arrangement using the effective interest method. If the financing arrangement is canceled or forfeited, or if the utility of the arrangement to the Company is otherwise compromised, these costs are recognized as interest expense immediately. The Company’s consolidated financial statements present debt issuance costs related to a recognized debt liability as a direct reduction from the carrying amount of that debt liability. Derivative Financial Instruments The Company accounts for derivative financial instruments as either equity or liabilities in accordance with Accounting Standards Codification Topic 815, Derivatives and Hedging, based on the characteristics and provisions of each instrument. Embedded derivatives are required to be bifurcated from the host instruments and recorded at fair value if the derivatives are not clearly and closely related to the host instruments on issuance date. The Company did not have any material embedded derivatives that required bifurcation upon issuance or as of March 31, 2020. Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of costs and expenses during the reporting period. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The Company’s actual results may differ from these estimates under different assumptions or conditions. We anticipate that the COVID-19 pandemic will have an impact on the clinical and pre-clinical development timelines for our clinical and pre-clinical programs. Estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require the exercise of judgment. As of the date of issuance of these financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities. These estimates may change as new events occur and additional information is obtained and are recognized in the consolidated financial statements as soon as they become known. Actual results could differ from those estimates and any such differences may be material to the Company’s financial statements. |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 3 Months Ended |
Mar. 31, 2020 | |
Revenue From Contract With Customer [Abstract] | |
Revenue from Contracts with Customers | 4. Revenue from Contracts with Customers On December 19, 2014 (the “Effective Date”), the Company entered into a license agreement with Kyowa Kirin, Co., Ltd. (the KKC License Agreement), under which the Company granted KKC an exclusive license to develop and commercialize entinostat in Japan and Korea. Under the terms of the KKC License Agreement, the Company will be responsible for the manufacture and supply of the products during the development activities. In addition to the license and manufacturing obligations, the Company is obligated to provide KKC access to know-how and regulatory information the Company may develop over the life of the entinostat patent. Lastly, to the extent additional intellectual property is developed during the term of the agreement, KKC will receive the right to the intellectual property when and if available. KKC will conduct the development, regulatory approval filings, and commercialization activities of entinostat in Japan and Korea. KKC paid the Company $25.0 million upfront, which included a $7.5 million equity investment and a $17.5 million non-refundable cash payment. In addition, to the extent certain development and commercial milestones are achieved, KKC will be required to pay the Company up to $75.0 million in milestone payments over the term of the license agreement. The term of the agreement commenced on the Effective Date and, unless earlier terminated in accordance with the terms of the agreement, will continue on a country-by-country and product-by-product basis, until the later of: (i) the date all valid claims of the last effective patent among the Company’s patents expires or is abandoned, withheld, or is otherwise invalidated in such country; and (ii) 15 years from the date of the first commercial sale of a product in the Japan or Korea. The equity purchase and the up-front payment of the license fee were accounted for separately. The Company allocated the amount of consideration equal to the fair value of the shares on the Effective Date, which resulted in $7.7 million of proceeds allocated to the equity purchase and the remaining consideration of $17.3 million allocated to the up-front license fee. In October 2017, the Company announced that KKC enrolled the first Japanese patient into a local pivotal study of entinostat for the treatment of hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer. In accordance with the terms of the license agreement, KKC paid the Company a $5.0 million milestone payment which the Company received in December 2017. The Company determined that the performance obligations associated with the KKC License Agreement include (i) the combined license, rights to access and use materials and data, and rights to additional intellectual property, and (ii) the clinical supply obligation. All other goods or services promised to KHK are immaterial in the context of the agreement. Under ASC 606, the identification of the clinical supply obligation as a distinct performance obligation separate and apart from the license performance obligation resulted in a change in the performance period. The start of the performance period under ASC 606 was determined to be the contract inception date, December 19, 2014. The clinical supply was identified as a separate performance obligation under ASC 606 as (i) the Company is not providing a significant service of integration whereby the clinical supply and other promises are inputs into a combined output, (ii) the clinical supply does not significantly modify or customize the other promises nor is it significantly modified or customized by them, and (iii) the clinical supply is not highly interdependent or highly interrelated with the other promises in the agreement as KKC could choose not to purchase the clinical supply from the Company without significantly affecting the other promised goods or services. The Company further concluded that the clinical supply represented an immaterial performance obligation and therefore the entire $17.3 million allocated to the upfront payment was allocated to the combined license and will be recognized ratably over the performance period, representing contract inception though 2029. In 2017, KKC achieved a development milestone, and was required to pay the Company $5.0 million. The Company is recognizing the development milestone consideration over the performance period coinciding with the license to intellectual property. As the Company determined that its performance obligations associated with the KKC Agreement at contract inception were not distinct and represented a single performance obligation, and that the obligations for goods and services provided would be completed over the performance period of the agreement, any payments received by the Company from KKC, including the upfront payment and progress-dependent development and regulatory milestone payments, are recognized as revenue using a time-based proportional performance model over the contract term (December 2014 through 2029) of the collaboration, within license fees. Contract liabilities consisted of deferred revenue, as presented on the consolidated balance sheet, as of March 31, 2020. Deferred revenue related to the KHK License Agreement was $14.3 million as of March 31, 2020 and will be recognized over the remainder of the contract term. |
Net Loss per Share Attributable
Net Loss per Share Attributable to Common Stockholders | 3 Months Ended |
Mar. 31, 2020 | |
Earnings Per Share [Abstract] | |
Net Loss per Share Attributable to Common Stockholders | 5. Net Loss per Share Attributable to Common Stockholders Basic net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period. Because the Company has reported a net loss for all periods presented, diluted net loss per common share is the same as basic net loss per common share for those periods. The following table summarizes the computation of basic and diluted net loss per share attributable to common stockholders of the Company: Three Months Ended March 31, 2020 2019 (In thousands, except share and per share data) Numerator—basic and diluted: Net loss $ (15,236 ) $ (14,302 ) Deemed dividend due to warrant reset (3,906 ) — Net loss attributable to common stockholders—basic and diluted $ (19,142 ) $ (14,302 ) Net loss per share attributable to common stockholders—basic and diluted $ (0.56 ) $ (0.53 ) Denominator—basic and diluted: Weighted-average number of common shares used to compute net loss per share attributable to common stockholders—basic and diluted 34,328,640 27,023,466 The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding because such securities have an antidilutive impact due to losses reported (in common stock equivalent shares): March 31, 2020 2019 Options to purchase common stock 6,897,802 5,629,120 Warrants to purchase common stock 4,595,039 4,595,039 Employee Stock Purchase Plan 24,214 27,471 Non-vested restricted stock units (RSUs) 15,000 — In June 2018, the Company signed an exchange agreement with an investor under which the investor exchanged 2,000,000 shares of common stock for 2,000,000 warrants. Further, as discussed in Note 13, in March 2019, the Company sold 2,095,039 shares of common stock as well as 2,500,000 pre-funded warrants and 4,595,039 Series 1 and Series 2 warrants. The pre-funded warrants are exercisable into shares of common stock for $0.0001 per share. |
Significant Agreements
Significant Agreements | 3 Months Ended |
Mar. 31, 2020 | |
Equity [Abstract] | |
Significant Agreements | 6. Significant Agreements Vitae Pharmaceuticals, Inc. In October 2017, the Company entered into a license agreement (the “Allergan License Agreement”) with Vitae Pharmaceuticals, Inc., a subsidiary of Allergan plc (“Allergan”), under which Allergan granted the Company an exclusive, sublicensable, worldwide license to a portfolio of preclinical, orally available, small molecule inhibitors of the interaction of Menin with the Mixed Lineage Leukemia (“MLL”) protein (the “Menin Assets”). The Company made a nonrefundable upfront payment of $5.0 million to Allergan in the fourth quarter of 2017. Additionally, subject to the achievement of certain milestone events, the Company may be required to pay Allergan up to $99.0 million in one-time development and regulatory milestone payments over the term of the Allergan License Agreement. In the event that the Company or any of its affiliates or sublicensees commercializes the Menin Assets, the Company will also be obligated to pay Allergan low single to low double-digit royalties on sales, subject to reduction in certain circumstances, as well as up to an aggregate of $70.0 million in potential one-time, sales-based milestone payments based on achievement of certain annual sales thresholds. Under certain circumstances, the Company may be required to share a percentage of non-royalty income from sublicensees, subject to certain deductions, with Allergan. The Company is solely responsible for the development and commercialization of the Menin Assets. Each party may terminate the Allergan License Agreement for the other party’s uncured material breach or insolvency; and the Company may terminate the Allergan License Agreement at will at any time upon advance written notice to Allergan. Allergan may terminate the Allergan License Agreement if the Company or any of its affiliates or sublicensees institutes a legal challenge to the validity, enforceability, or patentability of the licensed patent rights. Unless terminated earlier in accordance with its terms, the Allergan License Agreement will continue on a country-by-country and product-by-product basis until the later of: (i) the expiration of all of the licensed patent rights in such country; (ii) the expiration of all regulatory exclusivity applicable to the product in such country; and (iii) 10 years from the date of the first commercial sale of the product in such country. As of the date of the Allergan License Agreement, the asset acquired had no alternative future use nor had it reached a stage of technological feasibility. As the processes or activities that were acquired along with the license do not constitute a “business,” the transaction has been accounted for as an asset acquisition. In June 2019, the Company achieved certain development and regulatory milestones. As a result, in June 2019, the Company recorded $4.0 million as research and development expense. The $4.0 million payable has been recorded in accounts payable as of March 31, 2020. UCB Biopharma Sprl In 2016, the Company entered into a license agreement (the “UCB License Agreement”) with UCB Biopharma Sprl (“UCB”), under which UCB granted to the Company a worldwide, sublicenseable, exclusive license to UCB6352, which the Company refers to as axatilimab, an investigational new drug (“IND”) ready anti-CSF-1R monoclonal antibody. The Company made a nonrefundable upfront payment of $5.0 million to UCB in 2016. Additionally, subject to the achievement of certain milestone events, the Company may be required to pay UCB up to $119.5 million in one-time development and regulatory milestone payments over the term of the UCB License Agreement. In the event that the Company or any of its affiliates or sublicensees commercializes axatilimab, the Company will also be obligated to pay UCB low double-digit royalties on sales, subject to reduction in certain circumstances, as well as up to an aggregate of $250.0 million in potential one-time, sales-based milestone payments based on achievement of certain annual sales thresholds. Under certain circumstances, the Company may be required to share a percentage of non-royalty income from sublicensees, subject to certain deductions, with UCB. The Company is solely responsible for the development and commercialization of axatilimab, except that UCB is performing a limited set of transitional chemistry, manufacturing and control tasks related to axatilimab. Each party may terminate the UCB License Agreement for the other party’s uncured material breach or insolvency; and the Company may terminate the UCB License Agreement at will at any time upon advance written notice to UCB. UCB may terminate the UCB License Agreement if the Company or any of its affiliates or sublicensees institutes a legal challenge to the validity, enforceability, or patentability of the licensed patent rights. Unless terminated earlier in accordance with its terms, the UCB License Agreement will continue on a country-by-country and product-by-product basis until the later of: (i) the expiration of all of the licensed patent rights in such country; (ii) the expiration of all regulatory exclusivity applicable to the product in such country; and (iii) 10 years from the date of the first commercial sale of the product in such country. As of the date of the UCB License Agreement, the asset acquired had no alternative future use nor had it reached a stage of technological feasibility. As the processes or activities that were acquired along with the license do not constitute a “business,” the transaction has been accounted for as an asset acquisition. Eastern Cooperative Oncology Group In March 2014, the Company entered into the ECOG Agreement with Eastern Cooperative Oncology Group, a contracting entity for the Eastern Cooperative Oncology Group—American College of Radiology Imaging Network Cancer Research Group (“ECOG-ACRIN”), that describes the parties’ obligations with respect to the NCI-sponsored pivotal Phase 3 clinical trial of entinostat. Under the terms of the ECOG Agreement, ECOG-ACRIN will perform this clinical trial in accordance with the clinical trial protocol and a mutually agreed scope of work. The Company is providing a fixed level of financial support for the clinical trial through an upfront payment of $0.7 million and a series of payments of up to $1.0 million each that are comprised of milestone payments through the completion of enrollment and time-based payments through the completion of patient monitoring post-enrollment. In addition, the Company is obligated to supply entinostat and placebo to ECOG-ACRIN for use in the clinical trial. From the second quarter of 2016 through the fourth quarter of 2018, we have entered into a number of amendments to the agreement to provide for additional study activities resulting in an increase of the contractual obligation of $5.1 million. We have agreed to provide this additional financial support to fund the additional activities required to ensure that the E2112 clinical trial will satisfy FDA registration requirements. As of March 31, 2020, the Company’s aggregate payment obligations under this agreement are approximately $24.6 million; and its remaining payment obligations are approximately $5.8 million, which are estimated to be paid over a period of approximately two years. Data and inventions from the Phase 3 clinical trial are owned by ECOG-ACRIN. The Company has access to the data generated in the clinical trial, both directly from ECOG-ACRIN under the ECOG Agreement as well as from the NCI. Additionally, ECOG-ACRIN has granted the Company a non-exclusive royalty-free license to any inventions or discoveries that are derived from entinostat as a result of its use during the clinical trial, along with a first right to negotiate an exclusive license to any of these inventions or discoveries. Either party may terminate the ECOG Agreement in the event of an uncured material breach by the other party or if the U.S. Food and Drug Administration (“FDA”) or National Cancer Institute (“NCI”) withdraws the authorization to perform the clinical trial in the United States. The parties may jointly terminate the ECOG Agreement if the parties agree that safety-related issues support termination of the clinical trial. The Company records the appropriate clinical trial expenses in its financial statements by matching those expenses with the period in which the services and efforts are expended. The Company accounts for these expenses according to the progress of the clinical trial as measured by patient enrollment and the timing of various aspects of the clinical trial. The Company determines accrual estimates through financial models, taking into account discussion with applicable personnel and ECOG-ACRIN as to the progress or state of consummation of the clinical trial or the services completed. Bayer Pharma AG (formerly known as Bayer Schering Pharma AG) In March 2007, the Company entered into a license agreement (the “Bayer Agreement”) with Bayer Schering Pharma AG (“Bayer”) for a worldwide, exclusive license to develop and commercialize entinostat and any other products containing the same active ingredient. Under the terms of the Bayer Agreement, the Company paid a nonrefundable upfront license fee of $2.0 million and is responsible for the development and marketing of entinostat. The Company recorded the $2.0 million license fee as research and development expense during the year ended December 31, 2007, as it had no alternative future use. The Company will pay Bayer royalties on a sliding scale based on net sales, if any, and make future milestone payments to Bayer of up to $150.0 million in the event that certain specified development and regulatory goals and sales levels are achieved. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 7. Fair Value Measurements The carrying amounts of cash and cash equivalents, restricted cash, accounts payable, and accrued expenses approximated their estimated fair values due to the short-term nature of these financial instruments. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value are performed in a manner to maximize the use of observable inputs and minimize the use of unobservable inputs. The accounting standard describes a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value, which are the following: Level 1— Quoted prices (unadjusted) in active markets that are accessible at the market date for identical unrestricted assets or liabilities. Level 2— Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs for which all significant inputs 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. During the periods presented, the Company has not changed the manner in which it values assets and liabilities that are measured at fair value using Level 3 inputs. The Company recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period. There were no transfers within the hierarchy for any of periods presented. A summary of the assets and liabilities carried at fair value in accordance with the hierarchy defined above is as follows: Fair Value Measurements Using Quoted Prices Significant (unadjusted) Other Significant Total in Active Observable Unobservable Carrying Markets Inputs Inputs Value (Level 1) (Level 2) (Level 3) (In thousands) March 31, 2020 Assets: Cash and cash equivalents $ 44,629 $ 44,629 $ — $ — Short-term investments 54,376 — 54,376 — Total assets $ 99,005 $ 44,629 $ 54,376 $ — December 31, 2019 Assets: Cash and cash equivalents $ 24,609 $ 23,439 $ 1,170 $ — Short-term investments 35,166 — 35,166 — Total assets $ 59,775 $ 23,439 $ 36,336 $ — Cash and cash equivalents of $44.6 million and $23.4 million as of March 31, 2020 and December 31, 2019, respectively, consisted of overnight investments and money market funds and are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices in active markets. Cash equivalents of $1.2 million as of December 31, 2019, consisted of highly rated corporate bonds and commercial paper and are classified within Level 2 of the fair value hierarchy because pricing inputs are other than quoted prices in active markets, which are either directly or indirectly observable as of the reporting date, and fair value is determined through the use of models or other valuation methodologies. Short-term investments of $54.4 million and $35.2 million as of March 31, 2020 and December 31, 2019, respectively, consisted of commercial paper, highly rated corporate bonds and asset backed securities and are classified within Level 2 of the fair value hierarchy because pricing inputs are other than quoted prices in active markets, which are either directly or indirectly observable as of the reporting date, and fair value is determined through the use of models or other valuation methodologies. The short-term investments are classified as available-for-sale securities. As of March 31, 2020, the remaining contractual maturities of the available-for-sale securities were less than one year, and the balance in the Company’s accumulated other comprehensive income was comprised solely of activity related to the Company’s available-for-sale securities. There were no realized gains or losses recognized on the sale or maturity of available-for-sale securities during the three months ended March 31, 2020 and 2019. As a result, the Company did not reclassify any amounts out of accumulated other comprehensive income for the same periods. The Company has a limited number of available-for-sale securities in insignificant loss positions as of March 31, 2020, which the Company does not intend to sell and has concluded it will not be required to sell before recovery of the amortized cost for the investment at maturity. The following table summarizes the available-for-sale securities: Amortized Unrealized Unrealized Cost Gains Losses Fair Value (In thousands) March 31, 2020 Commercial paper $ 36,987 $ 85 $ — $ 37,072 Corporate bonds 15,041 1 (38 ) 15,004 Asset-backed securities 2,300 — — 2,300 $ 54,328 $ 86 $ (38 ) $ 54,376 December 31, 2019 Commercial paper $ 15,675 $ 5 $ — $ 15,680 Corporate bonds 18,361 — (5 ) 18,356 Asset-backed securities 2,300 — — 2,300 $ 36,336 $ 5 $ (5 ) $ 36,336 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 3 Months Ended |
Mar. 31, 2020 | |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | |
Prepaid Expenses and Other Current Assets | 8. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following: March 31, 2020 December 31, 2019 (In thousands) Short-term deposits $ 2,343 $ 1,297 Prepaid clinical supplies 152 166 Interest receivable on investments 167 116 Reimbursable costs 324 416 Prepaid insurance 1,693 214 Other 407 347 Total prepaid expenses and other current assets $ 5,086 $ 2,556 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 3 Months Ended |
Mar. 31, 2020 | |
Payables And Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 9. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following: March 31, 2020 December 31, 2019 (In thousands) Accrued professional fees $ 373 $ 403 Accrued compensation and related costs 1,223 2,800 Accrued clinical costs 5,664 6,726 Other 535 266 Total accrued expenses and other current liabilities $ 7,795 $ 10,195 |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 10. Stock-Based Compensation In January 2020, the number of shares of common stock available for issuance under the 2015 Omnibus Incentive Plan (“2015 Plan”), was increased by 1,085,619 shares due to the automatic annual provision to increase shares available under the 2015 Plan. As of March 31, 2020, the total number of shares of common stock available for issuance under the 2015 Plan was 765,348. The Company recognized stock-based compensation expense related to the issuance of stock option awards to employees and non-employees and related to the 2015 Employee Stock Purchase Plan (“ESPP”) in the condensed consolidated statements of comprehensive loss as follows: Three Months Ended March 31, 2020 2019 (In thousands) Research and development $ 532 $ 534 General and administrative 1,297 1,058 Total $ 1,829 $ 1,592 Compensation expense by type of award in the three months ended March 31, 2020 and 2019 was as follows: Three Months Ended March 31, 2020 2019 (In thousands) Stock options $ 1,793 $ 1,559 Employee Stock Purchase Plan 36 33 Total $ 1,829 $ 1,592 During the three months ended March 31, 2020, the Company granted 1,121,825 stock options to certain executives and employees having service-based vesting conditions. The grant date fair value of the options granted in the three months ended March 31, 2020, was $7.3 million, or $6.52 per share on a weighted-average basis and will be recognized as compensation expense over the requisite service period of three to four years. In 2019, the Company granted 583,000 stock options to certain employees to purchase shares of common stock that contain certain performance-based vesting criteria, primarily related to the achievement of certain clinical and regulatory development milestones related to product candidates. Recognition of stock-based compensation expense associated with these performance-based stock options commences when the performance condition is considered probable of achievement, using management’s best estimates, which consider the inherent risk and uncertainty regarding the future outcomes of the milestones. The achievement of one of the performance milestones was considered to be probable and the Company recorded approximately $50,000 of stock compensation expense associated with these awards for the three months ended March 31, 2020. One performance milestone was not achieved by December 31, 2019, and therefore 194,338 stock options were cancelled on January 1, 2020. For the remaining award containing performance-based vesting criteria, the achievement of the milestone was considered not probable, nor met, and therefore no expense has been recognized related to this award for the three months ended March 31, 2020. During the three months ended March 31, 2020, 51,034 options were exercised for cash proceeds of $338,000. No options were exercised in the three months ended March 31, 2019. As of March 31, 2020, there was $15.6 million of unrecognized compensation cost related to employee and non-employee unvested stock options granted under the 2015 and 2007 Plans, which is expected to be recognized over a weighted-average remaining service period of 2.7 years. Stock compensation costs have not been capitalized by the Company. Restricted stock units During the three months ended March 31, 2020, the Company granted 15,000 shares of the Company’s restricted stock units. The shares are scheduled to vest in equal annual tranches over a four-year period on the anniversary date of the related grant. The fair value of these shares totaled $142,000 at the grant date, representing a weighted-average grant date fair value per share of $9.47. |
Employee Stock Purchase Plan
Employee Stock Purchase Plan | 3 Months Ended |
Mar. 31, 2020 | |
Postemployment Benefits [Abstract] | |
Employee Stock Purchase Plan | 11. Employee Stock Purchase Plan In January 2020, the number of shares of common stock available for issuance under the ESPP, was increased by 271,404 shares as a result of the automatic increase provision of the ESPP. As of March 31, 2020, the total number of shares of common stock available for issuance under the ESPP was 1,115,797. The issued 12,601 shares during the first three months of 2020. The ESPP is considered a compensatory plan with the related compensation cost expensed over the six-month offering period starting on February 1 and on August 1. The compensation expense related to the ESPP for the three months ended March 31, 2020, was approximately $36,000. The compensation expense related to the ESPP recorded in the three months ended March 31, 2019, was approximately $33,000. |
Loan Payable
Loan Payable | 3 Months Ended |
Mar. 31, 2020 | |
Debt Disclosure [Abstract] | |
Loan Payable | 12. Loan Payable In February 2020, the Company entered into a loan and security agreement (the “Loan Agreement”) with Hercules Capital, Inc. (“Hercules”), which provided for aggregate maximum borrowings of up to $30.0 million, consisting of (i) a term loan of up to $20.0 million, which was funded on February 7, 2020 (the “Initial Advance”), and (ii) subject to Hercules’ investment committee approval, an additional term loan of up to $10.0 million, available for borrowing from February 7, 2020 to December 15, 2020 (the “Tranche 2 Advance”). Borrowings under the Loan Agreement bear interest at an annual rate equal to the greater of (i) 9.85% or (ii) 5.10% plus the Wall Street Journal prime rate. As of March 31, 2020, the Company’s interest rate under the Loan Agreement was 9.85%. Borrowings under the Loan Agreement are repayable in monthly interest-only payments through October 1, 2021, or April 1, 2022 if the Phase 3 clinical trial of entinostat (E2112) in patients with advanced hormone receptor positive, human epidermal growth factor receptor 2 negative, breast cancer has achieved the primary efficacy endpoint sufficient to file an NDA as the next step in clinical development (“Performance Milestone”). After the interest-only payment period, borrowings under the Loan Agreement are repayable in equal monthly payments of principal and accrued interest until the maturity date of the loan, which is either (i) September 1, 2023, or (ii) March 1, 2024 upon achievement of the Performance Milestone (the “Maturity Date”). At the Company’s option, the Company may prepay all, but not less than all, of the outstanding borrowings, subject to a prepayment premium equal to (i) 2.0% of the principal amount outstanding if the prepayment occurs during the first year following the applicable loan being funded, (ii) 1.5% of the principal amount outstanding if the prepayment occurs during the second year following the applicable loan being funded, and (iii) 1.0% of the principal amount outstanding at any time thereafter but prior to the Maturity Date. In addition, the Company paid a $100,000 facility charge upon closing, which is being expensed over the term of the debt, and will pay a $50,000 facility charge in connection with the Tranche 2 Advance. The Loan Agreement also provides for a final payment, payable upon maturity or the repayment in full of all obligations under the agreement, of up to 4.99% of the aggregate principal amount of the Term Loan Advances (as defined in the Loan Agreement). The final payment will be accrued over the term of the debt. Borrowings under the Loan Agreement are collateralized by substantially all of the Company’s and its subsidiaries personal property and other assets, other than its intellectual property. The Loan Agreement includes a minimum cash covenant of $12.5 million that applies commencing on October 1, 2020, subject to reduction upon satisfaction of certain conditions as set forth in the Loan Agreement. In addition, the Loan Agreement includes customary affirmative and restrictive covenants and representations and warranties, including a covenant against the occurrence of a “change in control,” financial reporting obligations, and certain limitations on indebtedness, liens (including a negative pledge on intellectual property and other assets), investments, distributions (including dividends), collateral, investments, distributions, transfers, mergers or acquisitions, taxes, corporate changes, and deposit accounts. The Loan Agreement also includes customary events of default, including payment defaults, breaches of covenants following any applicable cure period, the occurrence of certain events that could reasonably be expected to have a “material adverse effect” as set forth in the Loan Agreement, cross acceleration to third-party indebtedness and certain events relating to bankruptcy or insolvency. Upon the occurrence of an event of default, a default interest rate of an additional 5.0% may be applied to the outstanding principal balance, and Hercules may declare all outstanding obligations immediately due and payable and take such other actions as set forth in the Loan Agreement. In connection with the Loan Agreement, the Company was required to enter into separate deposit account control agreements with the lender in order to perfect the lender’s security interest in the cash collateral in the Company’s operating accounts. In the event of a default under the Loan Agreement, the lender would have the right to take control of the operating accounts and restrict the Company’s access to the operating accounts and the funds therein. During the quarter ended March 31, 2020, the Company recognized $0.4 million of interest expense related to the Initial Advance pursuant to the Loan Agreement. As of March 31, 2020, the Company’s maturities of principal obligations under its long-term debt are as follows: Amount Remainder of 2020 $ — 2021 3,057 2022 9,809 2023 7,134 Total principal outstanding 20,000 Unamortized final fee 49 Unamortized debt issuance costs (257 ) Total $ 19,792 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2020 | |
Equity [Abstract] | |
Stockholders' Equity | 13. Stockholders’ Equity The following table presents the changes in stockholders’ equity for the three months ended March 31, 2020: (In thousands, except share data) Common Stock $0.0001 Par Value Additional Paid-In Capital Accumulated Other Comprehensive Income / (Loss) Accumulated Deficit Total Stockholders’ Equity Shares Amount Balance as of December 31, 2019 27,140,484 $ 3 $ 527,067 $ — $ (495,470 ) $ 31,600 Stock purchase under ESPP 12,601 — — — — — Stock-based compensation expense — — 1,829 — — 1,829 Proceeds from direct offering, net of $93 offering expenses 3,036,719 — 24,201 — — 24,201 Proceeds from pre-funded common stock warrant from direct offering, net of $41 offering expenses — — 10,665 — — 10,665 Deemed dividend from repricing Series 1 and 2 warrants — — 3,906 — — 3,906 Repricing Series 1 and 2 warrants — — (3,906 ) — — (3,906 ) Proceeds from exercise of stock options 51,034 — 338 — — 338 Unrealized gains on short-term investments — — 48 — 48 Employee withholdings ESPP — — 64 — — 64 Net loss — — — — (15,236 ) (15,236 ) Balance as of March 31, 2020 30,240,838 $ 3 $ 564,164 $ 48 $ (510,706 ) $ 53,509 The following table presents the changes in stockholders’ equity for the three months ended March 31, 2019: (In thousands, except share data) Common Stock $0.0001 Par Value Additional Paid-In Capital Accumulated Other Comprehensive Income / (Loss) Accumulated Deficit Total Stockholders’ Equity Shares Amount Balance as of December 31, 2018 24,835,951 $ 2 $ 492,493 $ (25 ) $ (439,423 ) $ 53,047 Stock purchase under ESPP 23,970 — — — — — Proceeds from 'at-the-market' offering, net of $34 offering expenses 140,819 — 830 — — 830 Stock-based compensation expense — — 1,592 — — 1,592 Proceeds from direct offering, net of $1,571 in common stock warrants, $78 offering expenses 2,095,039 1 10,921 — — 10,922 Proceeds from pre-funded common stock warrant from direct offering, net of $1,875 in common stock warrants, $93 offering expenses — — 13,032 — — 13,032 Issuance of common stock warrant with direct offering — — 3,446 — — 3,446 Unrealized gains on short-term investments — — — 33 — 33 Employee withholdings ESPP — — 26 — — 26 Net loss — — — — (14,302 ) (14,302 ) Balance as of March 31, 2019 27,095,779 $ 3 $ 522,340 $ 8 $ (453,725 ) $ 68,626 In April 2017, the Company entered into a sales agreement with Cowen and Company, LLC (“Cowen”) under which the Company may issue and sell shares of our common stock having aggregate sales proceeds of up to $50.0 million from time to time through Cowen, acting as agent, in a series of one or more at-the-market (the “2017 ATM Program”) equity offerings. Cowen is not required to sell any specific amount, but acts as our sales agent using commercially reasonable efforts consistent with its normal trading and sales practices. The Company pays Cowen up to 3% of the gross proceeds from any common stock sold through this sales agreement. In the first quarter of 2019, the Company sold 140,819 shares of common stock under the 2017 ATM Program for net proceeds of $0.8 million. In August 2019, the Company entered into a new sales agreement with Cowen under which the Company may issue and sell shares of its common stock having aggregate sales proceeds of up to $50.0 million from time to time through Cowen, acting as agent, in a series of one or more ATM equity offerings (the “2019 ATM Program”). Cowen is not required to sell any specific amount, but acts as the Company’s sales agent using commercially reasonable efforts consistent with its normal trading and sales practices. Shares sold pursuant to the sales agreement will be sold pursuant to a shelf registration statement on Form S-3 (Registration No. 333-233564), which was declared effective on September 10, 2019. The Company’s common stock will be sold at prevailing market prices at the time of the sale; and as a result, prices may vary. In the first quarter of 2020, and through May 6, 2020, the Company sold no additional shares of common stock under the ATM program. In March 2019, the Company issued 2,095,039 shares of its common stock and pre-funded warrants to purchase 2,500,000 shares of common stock to certain investors in a registered direct offering. The pre-funded warrants are exercisable immediately upon issuance at an exercise price of $0.0001 per share and have a term of 20 years. The Company sold the shares of common stock and pre-funded warrants together with two series of warrants, Series 1 Warrants and Series 2 Warrants, to purchase an aggregate of 4,595,039 shares of the Company’s common stock (collectively, the “Series Warrants”). The offering price for the securities was $6.00 per share (or $5.9999 for each Pre-Funded Warrant). The aggregate gross proceeds to the Company from this offering were $27.6 million, excluding any proceeds the Company may receive upon exercise of the pre-funded warrants and Series Warrants and offering costs of $0.2 million. No underwriter or placement agent participated in the offering. The Series Warrants are immediately exercisable. Each Series 1 Warrant has an initial exercise price of $12.00 per share of common stock and each Series 2 Warrant has an initial exercise price of $18.00 per share of common stock, in each case subject to certain adjustments. The Series Warrants expire on the earlier of (i) 90 days following the Company’s confirmation to holders of the Company’s release of positive data confirming the achievement of the specified primary endpoint of overall survival benefit in the E2112 clinical trial in breast cancer patients, or (ii) December 31, 2020. If, prior to the expiration date of the Series Warrant, the Company sells additional capital stock or derivative securities convertible into or exercisable for capital stock, as defined, in one or more related transactions primarily for the purpose of raising capital at a Weighted-Average Price (as described below) below $12.00 per share, then the initial exercise price of the Series Warrants will be automatically reset upon exercise to an exercise price (the “Adjusted Exercise Price”) that is the midpoint between the initial exercise price and the lowest Weighted-Average Price per share at which the Company sells capital stock or derivative securities convertible into or exercisable for capital stock in a subsequent offering prior to the exercise date; provided, however, that the Adjusted Exercise Price will not be reduced below $6.00 per share. The Weighted-Average Price shall be calculated as the weighted-average common stock equivalent price of the equity securities sold in such transaction(s) (excluding any derivative securities with an exercise or conversion price that is above the closing sale price as of the time of pricing such offering(s)). In no event will the exercise price for the Series Warrants be adjusted more than once pursuant to this adjustment mechanism. The Pre-Funded Warrants and the Series Warrants may not be exercised by the holder to the extent that the holder, together with its affiliates, would beneficially own, after such exercise more than 9.99% of the shares of the Company’s common stock then outstanding (subject to the right of the holder to increase or decrease such beneficial ownership limitation upon notice to the Company, provided that such limitation cannot exceed 19.99%) and provided that any increase in the beneficial ownership limitation shall not be effective until 61 days after such notice is delivered. The Series Warrants were classified as a component of permanent equity and were recorded at the issuance date using a relative fair value allocation method. The Series Warrants are equity classified because they are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. In addition, such warrants do not provide any guarantee of value or return . In January 2020, the Company sold 3,036,719 shares of common stock, and pre-funded warrants to purchase 1,338,287 shares of common stock. The offering price for the securities was $8.00 per share of common stock or $7.9999 for each pre-funded warrant. As a result of this offering, the exercise price of Series 1 Warrants and Series 2 Warrants outstanding reset from $12.00 per share to $10.00 per share and from $18.00 per share to $13.00, respectively. The Company recorded $3.9 million as a deemed dividend which represents the value transferred to the warrant holders due to the Series Warrant adjustment mechanism being triggered. The deemed dividend was recorded as both an increase and a decrease in Additional Paid-in-Capital and reduced net income available to common stockholders by the same amount. The key inputs to the valuation model included the weighted average volatility of 96.74% and the weighted average expected term of 0.4 years. The Company has reserved for future issuance the following shares of common stock related to the potential warrant exercise, exercise of stock options, and the employee stock purchase plan: March 31, 2020 Common stock issuable under pre-funded warrants 5,838,287 Series 1 and 2 warrants 4,595,039 Options to purchase common stock 765,348 Employee Stock Purchase Plan 1,115,797 |
Related-Party Transactions
Related-Party Transactions | 3 Months Ended |
Mar. 31, 2020 | |
Related Party Transactions [Abstract] | |
Related-Party Transactions | 14. Related-Party Transactions The Company’s chief executive officer and member of the board of directors is also an Executive Partner at MPM Asset Management, LLC, which holds an investment in the Company’s common stock. |
Subsequent Event
Subsequent Event | 3 Months Ended |
Mar. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Event | 15. Subsequent Event In May 2020, the Company closed an underwritten public offering whereby the Company sold 5,555,556 shares of common stock at a price of $18.00 per share. The aggregate net proceeds received by the Company were $93.7 million, net of underwriting discounts and commissions and estimated offering expenses payable by the Company. The offering allows for an additional 833,333 shares to be issued pursuant to the underwriters’ exercise of their option to purchase additional shares of common stock. |
Basis of Presentation (Policies
Basis of Presentation (Policies) | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | In 2011, the Company established a wholly owned subsidiary in the United Kingdom. There have been no activities for this entity to date. In 2014, the Company established a wholly owned U.S. subsidiary, Syndax Securities Corporation. The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. |
Significant Accounting Policies | Significant Accounting Policies The Company’s significant accounting policies, which are disclosed in the audited consolidated financial statements for the year ended December 31, 2019 and the notes thereto are included in the Company’s Annual Report on Form 10-K that was filed with the SEC on March 5, 2020. Since the date of that filing, there have been no material changes to the Company’s significant accounting policies except as noted below. |
Significant Risks and Uncertainties | Significant Risks and Uncertainties With the global spread of the ongoing COVID-19 pandemic in the first and second quarters of 2020, we have implemented business continuity plans designed to address and mitigate the impact of the COVID-19 pandemic on our business. We anticipate that the COVID-19 pandemic could have an impact on the clinical development timelines for one or more of our clinical programs. The extent to which the COVID-19 pandemic impacts our business, our clinical development, manufacturing of clinical and commercial drug substance and drug product, and regulatory efforts, our corporate development objectives and the value of and market for our common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S., Europe and other countries, and the effectiveness of actions taken globally to contain and treat the disease. The global economic slowdown, the overall disruption of global healthcare systems and the other risks and uncertainties associated with the pandemic could have a material adverse effect on our business, financial condition, results of operations and growth prospects. In addition, we are subject to other challenges and risks specific to our business and our ability to execute on our strategy, as well as risks and uncertainties common to companies in the pharmaceutical industry with development and commercial operations, including, without limitation, risks and uncertainties associated with: obtaining regulatory approval of our late-stage product candidate; delays or problems in the supply of our products, loss of single source suppliers or failure to comply with manufacturing regulations; identifying, acquiring or in-licensing additional products or product candidates; pharmaceutical product development and the inherent uncertainty of clinical success; and the challenges of protecting and enhancing our intellectual property rights; complying with applicable regulatory requirements. In addition, to the extent the ongoing COVID-19 pandemic adversely affects our business and results of operations, it may also have the effect of heightening many of the other risks and uncertainties discussed above. |
Debt Issuance Cost | Debt Issuance Cost Debt issuance costs consist of payments made to secure commitments under certain debt financing arrangements. These amounts are recognized as interest expense over the period of the financing arrangement using the effective interest method. If the financing arrangement is canceled or forfeited, or if the utility of the arrangement to the Company is otherwise compromised, these costs are recognized as interest expense immediately. The Company’s consolidated financial statements present debt issuance costs related to a recognized debt liability as a direct reduction from the carrying amount of that debt liability. |
Derivative Financial Instruments | Derivative Financial Instruments The Company accounts for derivative financial instruments as either equity or liabilities in accordance with Accounting Standards Codification Topic 815, Derivatives and Hedging, based on the characteristics and provisions of each instrument. Embedded derivatives are required to be bifurcated from the host instruments and recorded at fair value if the derivatives are not clearly and closely related to the host instruments on issuance date. The Company did not have any material embedded derivatives that required bifurcation upon issuance or as of March 31, 2020. |
Use of Estimates | Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of costs and expenses during the reporting period. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The Company’s actual results may differ from these estimates under different assumptions or conditions. We anticipate that the COVID-19 pandemic will have an impact on the clinical and pre-clinical development timelines for our clinical and pre-clinical programs. Estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require the exercise of judgment. As of the date of issuance of these financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities. These estimates may change as new events occur and additional information is obtained and are recognized in the consolidated financial statements as soon as they become known. Actual results could differ from those estimates and any such differences may be material to the Company’s financial statements. |
Net Loss per Share Attributab_2
Net Loss per Share Attributable to Common Stockholders (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Net Loss per Share Attributable to Common Stockholders | The following table summarizes the computation of basic and diluted net loss per share attributable to common stockholders of the Company: Three Months Ended March 31, 2020 2019 (In thousands, except share and per share data) Numerator—basic and diluted: Net loss $ (15,236 ) $ (14,302 ) Deemed dividend due to warrant reset (3,906 ) — Net loss attributable to common stockholders—basic and diluted $ (19,142 ) $ (14,302 ) Net loss per share attributable to common stockholders—basic and diluted $ (0.56 ) $ (0.53 ) Denominator—basic and diluted: Weighted-average number of common shares used to compute net loss per share attributable to common stockholders—basic and diluted 34,328,640 27,023,466 |
Potential Dilutive Securities Excluded from Computation of Diluted Net Loss per Common Share | The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares outstanding because such securities have an antidilutive impact due to losses reported (in common stock equivalent shares): March 31, 2020 2019 Options to purchase common stock 6,897,802 5,629,120 Warrants to purchase common stock 4,595,039 4,595,039 Employee Stock Purchase Plan 24,214 27,471 Non-vested restricted stock units (RSUs) 15,000 — |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Schedule of Fair Values of Financial Assets and Liabilities Measured at Fair Value | A summary of the assets and liabilities carried at fair value in accordance with the hierarchy defined above is as follows: Fair Value Measurements Using Quoted Prices Significant (unadjusted) Other Significant Total in Active Observable Unobservable Carrying Markets Inputs Inputs Value (Level 1) (Level 2) (Level 3) (In thousands) March 31, 2020 Assets: Cash and cash equivalents $ 44,629 $ 44,629 $ — $ — Short-term investments 54,376 — 54,376 — Total assets $ 99,005 $ 44,629 $ 54,376 $ — December 31, 2019 Assets: Cash and cash equivalents $ 24,609 $ 23,439 $ 1,170 $ — Short-term investments 35,166 — 35,166 — Total assets $ 59,775 $ 23,439 $ 36,336 $ — |
Summary of Available-for-Sale Securities | The following table summarizes the available-for-sale securities: Amortized Unrealized Unrealized Cost Gains Losses Fair Value (In thousands) March 31, 2020 Commercial paper $ 36,987 $ 85 $ — $ 37,072 Corporate bonds 15,041 1 (38 ) 15,004 Asset-backed securities 2,300 — — 2,300 $ 54,328 $ 86 $ (38 ) $ 54,376 December 31, 2019 Commercial paper $ 15,675 $ 5 $ — $ 15,680 Corporate bonds 18,361 — (5 ) 18,356 Asset-backed securities 2,300 — — 2,300 $ 36,336 $ 5 $ (5 ) $ 36,336 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following: March 31, 2020 December 31, 2019 (In thousands) Short-term deposits $ 2,343 $ 1,297 Prepaid clinical supplies 152 166 Interest receivable on investments 167 116 Reimbursable costs 324 416 Prepaid insurance 1,693 214 Other 407 347 Total prepaid expenses and other current assets $ 5,086 $ 2,556 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following: March 31, 2020 December 31, 2019 (In thousands) Accrued professional fees $ 373 $ 403 Accrued compensation and related costs 1,223 2,800 Accrued clinical costs 5,664 6,726 Other 535 266 Total accrued expenses and other current liabilities $ 7,795 $ 10,195 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share Based Compensation Expense Related to Issuance of Stock Option Awards to Employees and Non Employees Related to Employee Stock Purchase Plan | The Company recognized stock-based compensation expense related to the issuance of stock option awards to employees and non-employees and related to the 2015 Employee Stock Purchase Plan (“ESPP”) in the condensed consolidated statements of comprehensive loss as follows: Three Months Ended March 31, 2020 2019 (In thousands) Research and development $ 532 $ 534 General and administrative 1,297 1,058 Total $ 1,829 $ 1,592 |
Compensation Expense by Type of Award | Compensation expense by type of award in the three months ended March 31, 2020 and 2019 was as follows: Three Months Ended March 31, 2020 2019 (In thousands) Stock options $ 1,793 $ 1,559 Employee Stock Purchase Plan 36 33 Total $ 1,829 $ 1,592 |
Loan Payable (Tables)
Loan Payable (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Debt Disclosure [Abstract] | |
Summary of Maturities of Principal Obligations Under Long-term Debt | As of March 31, 2020, the Company’s maturities of principal obligations under its long-term debt are as follows: Amount Remainder of 2020 $ — 2021 3,057 2022 9,809 2023 7,134 Total principal outstanding 20,000 Unamortized final fee 49 Unamortized debt issuance costs (257 ) Total $ 19,792 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Equity [Abstract] | |
Summary of Changes in Stockholders' Equity | The following table presents the changes in stockholders’ equity for the three months ended March 31, 2020: (In thousands, except share data) Common Stock $0.0001 Par Value Additional Paid-In Capital Accumulated Other Comprehensive Income / (Loss) Accumulated Deficit Total Stockholders’ Equity Shares Amount Balance as of December 31, 2019 27,140,484 $ 3 $ 527,067 $ — $ (495,470 ) $ 31,600 Stock purchase under ESPP 12,601 — — — — — Stock-based compensation expense — — 1,829 — — 1,829 Proceeds from direct offering, net of $93 offering expenses 3,036,719 — 24,201 — — 24,201 Proceeds from pre-funded common stock warrant from direct offering, net of $41 offering expenses — — 10,665 — — 10,665 Deemed dividend from repricing Series 1 and 2 warrants — — 3,906 — — 3,906 Repricing Series 1 and 2 warrants — — (3,906 ) — — (3,906 ) Proceeds from exercise of stock options 51,034 — 338 — — 338 Unrealized gains on short-term investments — — 48 — 48 Employee withholdings ESPP — — 64 — — 64 Net loss — — — — (15,236 ) (15,236 ) Balance as of March 31, 2020 30,240,838 $ 3 $ 564,164 $ 48 $ (510,706 ) $ 53,509 The following table presents the changes in stockholders’ equity for the three months ended March 31, 2019: (In thousands, except share data) Common Stock $0.0001 Par Value Additional Paid-In Capital Accumulated Other Comprehensive Income / (Loss) Accumulated Deficit Total Stockholders’ Equity Shares Amount Balance as of December 31, 2018 24,835,951 $ 2 $ 492,493 $ (25 ) $ (439,423 ) $ 53,047 Stock purchase under ESPP 23,970 — — — — — Proceeds from 'at-the-market' offering, net of $34 offering expenses 140,819 — 830 — — 830 Stock-based compensation expense — — 1,592 — — 1,592 Proceeds from direct offering, net of $1,571 in common stock warrants, $78 offering expenses 2,095,039 1 10,921 — — 10,922 Proceeds from pre-funded common stock warrant from direct offering, net of $1,875 in common stock warrants, $93 offering expenses — — 13,032 — — 13,032 Issuance of common stock warrant with direct offering — — 3,446 — — 3,446 Unrealized gains on short-term investments — — — 33 — 33 Employee withholdings ESPP — — 26 — — 26 Net loss — — — — (14,302 ) (14,302 ) Balance as of March 31, 2019 27,095,779 $ 3 $ 522,340 $ 8 $ (453,725 ) $ 68,626 |
Schedule of Common Stock Reserved for Future Issuance | The Company has reserved for future issuance the following shares of common stock related to the potential warrant exercise, exercise of stock options, and the employee stock purchase plan: March 31, 2020 Common stock issuable under pre-funded warrants 5,838,287 Series 1 and 2 warrants 4,595,039 Options to purchase common stock 765,348 Employee Stock Purchase Plan 1,115,797 |
Nature of Business - Additional
Nature of Business - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2020Segment | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Number of operating segments | 1 |
Date of incorporation | Oct. 11, 2005 |
State of incorporation | DE |
Revenue from Contract with Cust
Revenue from Contract with Customers - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
Oct. 31, 2017 | Dec. 19, 2014 | Mar. 31, 2020 | Dec. 31, 2017 | Dec. 31, 2019 | |
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | |||||
Up-front payment allocated to preferred stock value | |||||
Kyowa Kirin Co., Ltd. [Member] | |||||
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | |||||
Milestone payment agreement terms | In accordance with the terms of the license agreement | ||||
License Agreement [Member] | Kyowa Kirin Co., Ltd. [Member] | |||||
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | |||||
License agreement upfront payment received | $ 25,000,000 | ||||
Up-front payment allocated to equity purchase | 7,500,000 | ||||
Up-front license fee received | $ 17,500,000 | ||||
Period of termination after first commercial sale of first licensed product | 15 years | ||||
Up-front payment allocated to preferred stock value | $ 7,700,000 | ||||
Up-front payment allocated to license fee | 17,300,000 | ||||
Milestone payment received | $ 5,000,000 | $ 5,000,000 | |||
Upfront payment allocation to performance obligation | $ 17,300,000 | ||||
Performance obligation period | 2029 | ||||
Deferred revenue | $ 14,300,000 | ||||
License Agreement [Member] | Kyowa Kirin Co., Ltd. [Member] | Maximum [Member] | |||||
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | |||||
Milestone payment receivable upon achievement of development and commercial milestone | $ 75,000,000 |
Net Loss per Share Attributab_3
Net Loss per Share Attributable to Common Stockholders - Computation of Basic and Diluted Net Loss per Share Attributable to Common Stockholders (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Numerator—basic and diluted: | ||
Net loss | $ (15,236) | $ (14,302) |
Net loss attributable to common stockholders—basic and diluted | $ (19,142) | $ (14,302) |
Net loss per share attributable to common stockholders—basic and diluted | $ (0.56) | $ (0.53) |
Denominator—basic and diluted: | ||
Weighted-average number of common shares used to compute net loss per share attributable to common stockholders—basic and diluted | 34,328,640 | 27,023,466 |
Warrant [Member] | ||
Numerator—basic and diluted: | ||
Deemed dividend due to warrant reset | $ (3,906) |
Net Loss per Share Attributab_4
Net Loss per Share Attributable to Common Stockholders - Potential Dilutive Securities Excluded from Computation of Diluted Net Loss per Common Share (Detail) - shares | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Options to Purchase Common Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of diluted net loss per common share | 6,897,802 | 5,629,120 |
Warrants to Purchase Common Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of diluted net loss per common share | 4,595,039 | 4,595,039 |
Employee Stock Purchase Plan [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of diluted net loss per common share | 24,214 | 27,471 |
RSUs [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of diluted net loss per common share | 15,000 |
Net Loss per Share Attributab_5
Net Loss per Share Attributable to Common Stockholders - Additional Information (Detail) - $ / shares | Jun. 18, 2018 | Mar. 31, 2020 | Jan. 31, 2020 | Mar. 31, 2019 |
Earnings Per Share Basic [Line Items] | ||||
Common stock, new shares issued | 2,095,039 | 3,036,719 | ||
Biotechnology Value Fund, L.P. [Member] | ||||
Earnings Per Share Basic [Line Items] | ||||
Number of common stock converted to warrants | 2,000,000 | |||
Number of common stock warrants issued | 2,000,000 | |||
Pre-Funded Warrants [Member] | ||||
Earnings Per Share Basic [Line Items] | ||||
Warrant exercise price per share | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Warrant issued | 2,500,000 | 1,338,287 | ||
Series 1 and Series 2 Warrants [Member] | ||||
Earnings Per Share Basic [Line Items] | ||||
Warrant issued | 4,595,039 |
Significant Agreements - Additi
Significant Agreements - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | 30 Months Ended | |||||||
Jun. 30, 2019 | Oct. 31, 2017 | Mar. 31, 2014 | Dec. 31, 2007 | Mar. 31, 2007 | Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2018 | Dec. 31, 2019 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Research and development expense | $ 9,562,000 | $ 11,279,000 | |||||||||
Accounts payable | 8,998,000 | $ 6,178,000 | |||||||||
Allergan License Agreement [Member] | Vitae Pharmaceuticals Inc [Member] | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Upfront milestone payable | $ 5,000,000 | ||||||||||
Potential milestone payments to be made | $ 99,000,000 | ||||||||||
Aggregate potential milestone payable | $ 70,000,000 | ||||||||||
License expiration year | 10 years | ||||||||||
Allergan License Agreement [Member] | Vitae Pharmaceuticals Inc [Member] | Milestone Liability [Member] | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Accounts payable | 4,000,000 | ||||||||||
Allergan License Agreement [Member] | Vitae Pharmaceuticals Inc [Member] | Accrued Milestone Expenses [Member] | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Research and development expense | $ 4,000,000 | ||||||||||
UCB License Agreement [Member] | UCB Biopharma [Member] | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Upfront milestone payable | $ 5,000,000 | ||||||||||
Potential milestone payments to be made | 119,500,000 | ||||||||||
Aggregate potential milestone payable | $ 250,000,000 | ||||||||||
License expiration year | 10 years | ||||||||||
Clinical Trial [Member] | Eastern Cooperative Oncology Group [Member] | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Upfront milestone payable | $ 700,000 | ||||||||||
Milestone payment payable | $ 1,000,000 | ||||||||||
Increase in contractual obligation | $ 5,100,000 | ||||||||||
Aggregate payment obligation | 24,600,000 | ||||||||||
Remaining contractual obligation | $ 5,800,000 | ||||||||||
Period of contractual obligation | 2 years | ||||||||||
License Agreement [Member] | Bayer Pharma AG [Member] | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Research and development expense | $ 2,000,000 | ||||||||||
Up-front license fee paid | $ 2,000,000 | ||||||||||
License Agreement [Member] | Bayer Pharma AG [Member] | Maximum [Member] | |||||||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||||||||
Aggregate payment obligation | $ 150,000,000 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Fair Values of Financial Assets and Liabilities Measured at Fair Value (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments | $ 54,376 | $ 35,166 |
Carrying Value [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 44,629 | 24,609 |
Short-term investments | 54,376 | 35,166 |
Total assets | 99,005 | 59,775 |
Quoted Prices (Unadjusted) in Active Markets Level 1 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 44,629 | 23,439 |
Total assets | 44,629 | 23,439 |
Significant Other Observable Inputs Level 2 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents | 1,170 | |
Short-term investments | 54,376 | 35,166 |
Total assets | $ 54,376 | $ 36,336 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 3 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | |
Fair Value Measurements [Line Items] | |||
Available for sale debt securities fair value | $ 54,376,000 | $ 36,336,000 | |
Realized gains or losses recognized on the sale or maturity of available-for-sale securities | 0 | $ 0 | |
Quoted Prices (Unadjusted) in Active Markets Level 1 [Member] | |||
Fair Value Measurements [Line Items] | |||
Cash and cash equivalents fair value | 44,629,000 | 23,439,000 | |
Quoted Prices (Unadjusted) in Active Markets Level 1 [Member] | Overnight Investments, Money Market Funds and Highly Rated Corporate Bonds Member] | |||
Fair Value Measurements [Line Items] | |||
Cash and cash equivalents fair value | 44,600,000 | 23,400,000 | |
Significant Other Observable Inputs Level 2 [Member] | |||
Fair Value Measurements [Line Items] | |||
Cash and cash equivalents fair value | 1,170,000 | ||
Significant Other Observable Inputs Level 2 [Member] | Corporate Bonds and Commercial Paper [Member] | |||
Fair Value Measurements [Line Items] | |||
Cash and cash equivalents fair value | 1,200,000 | ||
Significant Other Observable Inputs Level 2 [Member] | Commercial Paper, Corporate Bonds and Asset Backed Securities [Member] | Short-term Investments [Member] | |||
Fair Value Measurements [Line Items] | |||
Available for sale debt securities fair value | $ 54,400,000 | $ 35,200,000 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Available-for-Sale Securities (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | $ 54,328 | $ 36,336 |
Unrealized Gains | 86 | 5 |
Unrealized Losses | (38) | (5) |
Fair Value | 54,376 | 36,336 |
Commercial Paper [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 36,987 | 15,675 |
Unrealized Gains | 85 | 5 |
Fair Value | 37,072 | 15,680 |
Corporate Bonds [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 15,041 | 18,361 |
Unrealized Gains | 1 | |
Unrealized Losses | (38) | (5) |
Fair Value | 15,004 | 18,356 |
Asset Back Securities [Member] | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Cost | 2,300 | 2,300 |
Fair Value | $ 2,300 | $ 2,300 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | ||
Short-term deposits | $ 2,343 | $ 1,297 |
Prepaid clinical supplies | 152 | 166 |
Interest receivable on investments | 167 | 116 |
Reimbursable costs | 324 | 416 |
Prepaid insurance | 1,693 | 214 |
Other | 407 | 347 |
Total prepaid expenses and other current assets | $ 5,086 | $ 2,556 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Payables And Accruals [Abstract] | ||
Accrued professional fees | $ 373 | $ 403 |
Accrued compensation and related costs | 1,223 | 2,800 |
Accrued clinical costs | 5,664 | 6,726 |
Other | 535 | 266 |
Total accrued expenses and other current liabilities | $ 7,795 | $ 10,195 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) | Jan. 01, 2020 | Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | Jan. 31, 2020 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock options exercised, shares | 51,034 | 0 | |||
Proceeds from stock option exercises | $ 338,000 | ||||
Restricted Stock Units [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock option granted to certain executives and employees | 15,000 | ||||
Shares, vesting period | 4 years | ||||
Fair value of shares at grant date | 142,000 | ||||
Weighted average grant date fair value per share | $ 9.47 | ||||
2015 Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares available for issuance | 1,085,619 | ||||
2015 Plan [Member] | Maximum [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares available for issuance | 765,348 | ||||
2007 Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock option granted to certain executives and employees | 1,121,825 | ||||
Options grant date fair value amount | $ 7,300,000 | ||||
Weighted average grant date fair value of options | $ 6.52 | ||||
Stock compensation expense | $ 50,000 | ||||
Recognized compensation expense related to stock option not met | 0 | ||||
Sock option not met, options cancelled | 194,338 | ||||
2007 Plan [Member] | Employees [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock option granted to certain executives and employees | 583,000 | ||||
2015 and 2007 [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized compensation expense related to stock option | $ 15,600,000 | ||||
Weighted average period to recognize compensation expense | 2 years 8 months 12 days |
Stock-Based Compensation - Shar
Stock-Based Compensation - Share Based Compensation Expense Related to Issuance of Stock Option Awards to Employees and Non Employees Related to Employee Stock Purchase Plan (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share based compensation expense, total | $ 1,829 | $ 1,592 |
Research and Development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share based compensation expense, total | 532 | 534 |
General and Administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share based compensation expense, total | $ 1,297 | $ 1,058 |
Stock-Based Compensation - Comp
Stock-Based Compensation - Compensation Expense by Type of Award (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share based compensation expense, total | $ 1,829 | $ 1,592 |
Options to Purchase Common Stock [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share based compensation expense, total | 1,793 | 1,559 |
Employee Stock Purchase Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share based compensation expense, total | $ 36 | $ 33 |
Employee Stock Purchase Plan -
Employee Stock Purchase Plan - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | |
Jan. 31, 2020 | Mar. 31, 2020 | Mar. 31, 2019 | |
Employee Benefit Plans [Line Items] | |||
Compensation expense | $ 1,829 | $ 1,592 | |
Employee Stock Purchase Plan [Member] | |||
Employee Benefit Plans [Line Items] | |||
Common stock available for issuance | 271,404 | ||
Number of shares issued under plan | 12,601 | ||
Compensation expense | $ 36 | $ 33 | |
Employee Stock Purchase Plan [Member] | Maximum [Member] | |||
Employee Benefit Plans [Line Items] | |||
Common stock available for issuance | 1,115,797 |
Loan Payable - Additional Infor
Loan Payable - Additional Information (Detail) - USD ($) | Oct. 01, 2020 | Feb. 29, 2020 | Mar. 31, 2020 |
Debt Instrument [Line Items] | |||
Interest expense related to the loan agreement | $ 449,000 | ||
Hercules [Member] | Loan Agreement [Member] | |||
Debt Instrument [Line Items] | |||
Aggregate maximum borrowings | $ 30,000,000 | ||
Interest rate description | Borrowings under the Loan Agreement bear interest at an annual rate equal to the greater of (i) 9.85% or (ii) 5.10% plus the Wall Street Journal prime rate. | ||
Interest rate | 9.85% | ||
Maturity date | Sep. 1, 2023 | ||
Percentage of prepayment premium of principal amount outstanding in first year | 2.00% | ||
Percentage of prepayment premium of principal amount outstanding in second year | 1.50% | ||
Percentage of prepayment premium of principal amount outstanding thereafter prior to maturity date | 1.00% | ||
Facility charge paid | $ 100,000 | ||
Interest expense related to the loan agreement | $ 400,000 | ||
Hercules [Member] | Loan Agreement [Member] | Scenario Forecast [Member] | |||
Debt Instrument [Line Items] | |||
Minimum cash covenant | $ 12,500,000 | ||
Default interest rate | 5.00% | ||
Hercules [Member] | Loan Agreement [Member] | Performance Milestone [Member] | |||
Debt Instrument [Line Items] | |||
Maturity date | Mar. 1, 2024 | ||
Hercules [Member] | Loan Agreement [Member] | Wall Street Journal Prime Rate [Member] | |||
Debt Instrument [Line Items] | |||
Basis spread on variable rate | 5.10% | ||
Hercules [Member] | Loan Agreement [Member] | Minimum [Member] | |||
Debt Instrument [Line Items] | |||
Interest rate | 9.85% | ||
Hercules [Member] | Loan Agreement [Member] | Maximum [Member] | |||
Debt Instrument [Line Items] | |||
Percentage of repayment on aggregate principal amount of term loan advances | 4.99% | ||
Hercules [Member] | Loan Agreement [Member] | Term Loan [Member] | |||
Debt Instrument [Line Items] | |||
Term loan | $ 20,000,000 | ||
Hercules [Member] | Loan Agreement [Member] | Additional Term Loan [Member] | |||
Debt Instrument [Line Items] | |||
Term loan | 10,000,000 | ||
Hercules [Member] | Loan Agreement [Member] | Tranche 2 [Member] | |||
Debt Instrument [Line Items] | |||
Facility charge paid | $ 50,000 |
Loan Payable - Summary of Matur
Loan Payable - Summary of Maturities of Principal Obligations Under Long-term Debt (Detail) $ in Thousands | Mar. 31, 2020USD ($) |
Debt Disclosure [Abstract] | |
2021 | $ 3,057 |
2022 | 9,809 |
2023 | 7,134 |
Total principal outstanding | 20,000 |
Unamortized final fee | 49 |
Unamortized debt issuance costs | (257) |
Total | $ 19,792 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Changes in Stockholders' Equity (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | |
Jan. 31, 2020 | Mar. 31, 2020 | Mar. 31, 2019 | |
Class of Stock [Line Items] | |||
Beginning balance | $ 31,600 | $ 31,600 | $ 53,047 |
Proceeds from 'at-the-market' offering, net, value | 830 | ||
Stock-based compensation expense | 1,829 | 1,592 | |
Proceeds from direct offering, net, value | 24,201 | 10,922 | |
Proceeds from pre-funded common stock warrant from direct offering, net, value | 10,665 | 13,032 | |
Issuance of common stock warrant with direct offering, value | $ 3,446 | ||
Repricing Series 1 and 2 warrants | 3,900 | ||
Proceeds from exercise of stock options, value | $ 338 | ||
Proceeds from exercise of stock options, shares | 51,034 | 0 | |
Unrealized gains on short-term investments | $ 48 | $ 33 | |
Employee withholdings ESPP | 64 | 26 | |
Net loss | (15,236) | (14,302) | |
Ending balance | 53,509 | 68,626 | |
Series 1 and 2 [Member] | |||
Class of Stock [Line Items] | |||
Deemed dividend from repricing Series 1 and 2 warrants | 3,906 | ||
Repricing Series 1 and 2 warrants | (3,906) | ||
Common Stock [Member] | |||
Class of Stock [Line Items] | |||
Beginning balance | $ 3 | $ 3 | $ 2 |
Beginning balance, Shares | 27,140,484 | 27,140,484 | 24,835,951 |
Stock purchase under ESPP, Shares | 12,601 | 23,970 | |
Proceeds from "at-the-market" offering, net, shares | 140,819 | ||
Proceeds from direct offering, net, value | $ 1 | ||
Proceeds from direct offering,net, Shares | 3,036,719 | 2,095,039 | |
Proceeds from exercise of stock options, shares | 51,034 | ||
Ending balance | $ 3 | $ 3 | |
Ending balance, Shares | 30,240,838 | 27,095,779 | |
Additional Paid-In Capital [Member] | |||
Class of Stock [Line Items] | |||
Beginning balance | $ 527,067 | $ 527,067 | $ 492,493 |
Proceeds from 'at-the-market' offering, net, value | 830 | ||
Stock-based compensation expense | 1,829 | 1,592 | |
Proceeds from direct offering, net, value | 24,201 | 10,921 | |
Proceeds from pre-funded common stock warrant from direct offering, net, value | 10,665 | 13,032 | |
Issuance of common stock warrant with direct offering, value | 3,446 | ||
Proceeds from exercise of stock options, value | 338 | ||
Employee withholdings ESPP | 64 | 26 | |
Ending balance | 564,164 | 522,340 | |
Additional Paid-In Capital [Member] | Series 1 and 2 [Member] | |||
Class of Stock [Line Items] | |||
Deemed dividend from repricing Series 1 and 2 warrants | 3,906 | ||
Repricing Series 1 and 2 warrants | (3,906) | ||
Accumulated Other Comprehensive Income / (Loss) [Member] | |||
Class of Stock [Line Items] | |||
Beginning balance | (25) | ||
Unrealized gains on short-term investments | 48 | 33 | |
Ending balance | 48 | 8 | |
Accumulated Deficit [Member] | |||
Class of Stock [Line Items] | |||
Beginning balance | $ (495,470) | (495,470) | (439,423) |
Net loss | (15,236) | (14,302) | |
Ending balance | $ (510,706) | $ (453,725) |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Changes in Stockholders' Equity (Parenthetical) (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Equity [Abstract] | ||
At-the-market, offering expenses | $ 34 | |
Direct offering, common stock warrants | 1,571 | |
Direct offering, offering expenses | $ 93 | 78 |
Pre-funded common stock warrants | 1,875 | |
Pre-funded common stock warrants offering expenses | $ 41 | $ 93 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | ||||||
May 06, 2020shares | Mar. 31, 2020$ / sharesshares | Jan. 31, 2020USD ($)$ / sharesshares | Aug. 31, 2019USD ($) | Mar. 31, 2019USD ($)Seriesofwarrant$ / sharesshares | Apr. 30, 2017USD ($) | Mar. 31, 2020$ / sharesshares | Mar. 31, 2019USD ($)$ / sharesshares | |
Class Of Stock [Line Items] | ||||||||
Common stock, new shares issued | shares | 2,095,039 | 3,036,719 | ||||||
Number of series of warrants | Seriesofwarrant | 2 | |||||||
Gross proceeds from offering | $ | $ 27.6 | |||||||
Offering costs | $ | $ 0.2 | |||||||
Weighted average expected term | 4 months 24 days | 1 year 4 months 24 days | 1 year 4 months 24 days | |||||
Deemed dividend transferred to the warrant holders | $ | $ 3.9 | |||||||
Weighted Average Volatility Rate [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Warrants and rights outstanding, measurement input | 0.9674 | 0.891 | 0.891 | |||||
Common Stock [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Common stock, new shares issued | shares | 2,095,039 | |||||||
Pre-Funded Warrants [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Warrants issued (in shares) | shares | 1,338,287 | 2,500,000 | 2,500,000 | |||||
Warrant exercise price per share | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||
Warrant term | 20 years | |||||||
Offering price | 7.9999 | $ 5.9999 | ||||||
Maximum period allowed to increase beneficial ownership limitation after notice | 61 days | |||||||
Minimum percentage of common stock can be held upon exercise of warrant | 9.99% | |||||||
Maximum beneficial ownership limitation percentage | 19.99% | |||||||
Series Warrants [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Warrants issued (in shares) | shares | 4,595,039 | 4,595,039 | ||||||
Warrant term | 90 days | |||||||
Offering price | 8 | $ 6 | ||||||
Weighted average price | $ 12 | |||||||
Total fair value of warrant | $ | $ 3.4 | |||||||
Series One Warrants [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Warrant exercise price per share | 12 | 12 | ||||||
Series Two Warrants [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Warrant exercise price per share | $ 18 | 18 | ||||||
Maximum [Member] | Series One Warrants [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Warrant exercise price per share | 12 | |||||||
Maximum [Member] | Series Two Warrants [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Warrant exercise price per share | 18 | |||||||
Minimum [Member] | Series Warrants [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Adjusted exercise price | $ 6 | |||||||
Minimum [Member] | Series One Warrants [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Warrant exercise price per share | 10 | |||||||
Minimum [Member] | Series Two Warrants [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Warrant exercise price per share | $ 13 | |||||||
At The Market Equity Offering Sales Agreement [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Proceeds from issuance of common stock in follow-on public stock offering, net | $ | $ 0.8 | |||||||
Common stock, new shares issued | shares | 0 | 140,819 | ||||||
At The Market Equity Offering Sales Agreement [Member] | Subsequent Event [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Common stock, new shares issued | shares | 0 | |||||||
Cowen and Company LLC [Member] | At The Market Equity Offering Sales Agreement [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Proceeds from issuance of common stock in follow-on public stock offering, net | $ | $ 50 | $ 50 | ||||||
Cowen and Company LLC [Member] | At The Market Equity Offering Sales Agreement [Member] | Maximum [Member] | ||||||||
Class Of Stock [Line Items] | ||||||||
Payment percentage of gross proceeds from sales agreement | 3.00% |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Common Stock Reserved for Future Issuance (Detail) | Mar. 31, 2020shares |
Pre-Funded Warrants [Member] | |
Class Of Stock [Line Items] | |
Common stock reserved for future issuance | 5,838,287 |
Series 1 and 2 Warrants [Member] | |
Class Of Stock [Line Items] | |
Common stock reserved for future issuance | 4,595,039 |
Options to Purchase Common Stock [Member] | |
Class Of Stock [Line Items] | |
Common stock reserved for future issuance | 765,348 |
Employee Stock Purchase Plan [Member] | |
Class Of Stock [Line Items] | |
Common stock reserved for future issuance | 1,115,797 |
Subsequent Event - Additional I
Subsequent Event - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | |||
May 31, 2020 | Mar. 31, 2020 | Jan. 31, 2020 | Dec. 31, 2019 | |
Subsequent Event [Line Items] | ||||
Common stock, new shares issued | 2,095,039 | 3,036,719 | ||
Additional purchase of common stock | 30,240,838 | 27,140,484 | ||
Underwritten Public Offering [Member] | Scenario Forecast [Member] | ||||
Subsequent Event [Line Items] | ||||
Common stock, new shares issued | 5,555,556 | |||
Offering price | $ 18 | |||
Proceeds from issuance of common stock, net | $ 93.7 | |||
Underwriters [Member] | Scenario Forecast [Member] | ||||
Subsequent Event [Line Items] | ||||
Additional purchase of common stock | 833,333 |