Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2021 | Apr. 26, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-36310 | |
Entity Registrant Name | CONCERT PHARMACEUTICALS, INC. | |
Entity Incorporation, State | DE | |
Entity Tax Identification Number | 20-4839882 | |
Entity Address, Street | 65 Hayden Avenue | |
Entity Address, Suite | Suite 3000N | |
Entity Address, City | Lexington | |
Entity Address, State | MA | |
Entity Address, Postal Zip Code | 02421 | |
City Area Code | 781 | |
Local Phone Number | 860-0045 | |
Title of each class | Common Stock, par value $0.001 per share | |
Trading Symbol(s) | CNCE | |
Name of each exchange on which registered | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 32,173,778 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001367920 | |
Current Fiscal Year End Date | --12-31 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 89,772 | $ 77,202 |
Investments, available for sale | 22,009 | 52,766 |
Marketable equity securities | 3,255 | 1,969 |
Interest receivable | 27 | 145 |
Accounts receivable | 79 | 686 |
Income taxes receivable, current | 2,346 | 2,346 |
Prepaid expenses and other current assets | 6,367 | 7,610 |
Total current assets | 123,855 | 142,724 |
Property and equipment, net | 6,063 | 6,363 |
Restricted cash | 1,157 | 1,157 |
Other assets | 32 | 51 |
Operating lease right-of-use asset, long-term | 8,884 | 8,968 |
Total assets | 139,991 | 159,263 |
Current liabilities: | ||
Accounts payable | 508 | 230 |
Accrued expenses and other liabilities | 6,811 | 9,017 |
Lease liability, current portion | 984 | 931 |
Total current liabilities | 8,303 | 10,178 |
Accrued expenses, net of current portion | 108 | 108 |
Deferred revenue, long-term | 2,750 | 2,750 |
Lease liability, net of current portion | 14,791 | 15,065 |
Total liabilities | 25,952 | 28,101 |
Commitments (Note 11) | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value per share; 5,000,000 shares authorized; no shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively | 0 | 0 |
Common stock, $0.001 par value per share; 100,000,000 shares authorized; 32,374,379 and 32,062,799 shares issued and 32,173,778 and 31,862,198 shares outstanding as of March 31, 2021 and December 31, 2020, respectively | 31 | 31 |
Additional paid-in capital | 406,198 | 400,636 |
Accumulated other comprehensive loss | (74) | (58) |
Accumulated deficit | (292,116) | (269,447) |
Total stockholders’ equity | 114,039 | 131,162 |
Total liabilities and stockholders’ equity | $ 139,991 | $ 159,263 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) (Parenthetical) - $ / shares | Mar. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 32,374,379 | 32,062,799 |
Common stock, shares outstanding (in shares) | 32,173,778 | 31,862,198 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Revenue: | ||
License and research and development revenue | $ 5 | $ 7 |
Operating expenses: | ||
Research and development | 18,500 | 13,986 |
General and administrative | 5,485 | 4,672 |
Total operating expenses | 23,985 | 18,658 |
Loss from operations | (23,980) | (18,651) |
Investment income | 25 | 563 |
Unrealized gain (loss) on marketable equity securities | 1,286 | (2,389) |
Net loss | (22,669) | (20,477) |
Other comprehensive (loss) income: | ||
Unrealized (loss) gain on investments, available for sale | (16) | 523 |
Comprehensive loss | $ (22,685) | $ (19,954) |
Net loss per share applicable to common stockholders - basic and diluted (in dollars per share) | $ (0.67) | $ (0.70) |
Weighted-average number of common shares used in net loss per share applicable to common stockholders - basic and diluted (in shares) | 33,894 | 29,110 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (UNAUDITED) - USD ($) $ in Thousands | Total | IPO | Common Stock | Common StockIPO | In Treasury | Additional paid-in capital | Additional paid-in capitalIPO | Accumulated other comprehensive (loss) income | Accumulated deficit |
Beginning balance at Dec. 31, 2019 | $ 101,457 | $ 24 | $ 296,145 | $ (31) | $ (194,681) | ||||
Beginning balance (in shares) at Dec. 31, 2019 | 24,066,000 | (200,000) | |||||||
Increase (Decrease) in Stockholders' Equity | |||||||||
Exercise of stock options | 435 | 435 | |||||||
Exercise of stock options (in shares) | 51,000 | ||||||||
Unrealized loss on short-term investments | 523 | 523 | |||||||
Stock-based compensation expense | 2,477 | 2,477 | |||||||
Net loss | (20,477) | (20,477) | |||||||
Ending balance at Mar. 31, 2020 | 154,479 | $ 29 | 369,116 | 492 | (215,158) | ||||
Ending balance (in shares) at Mar. 31, 2020 | 29,852,000 | (200,000) | |||||||
Beginning balance at Dec. 31, 2020 | 131,162 | $ 31 | 400,636 | (58) | (269,447) | ||||
Beginning balance (in shares) at Dec. 31, 2020 | 32,063,000 | (200,000) | |||||||
Increase (Decrease) in Stockholders' Equity | |||||||||
Exercise of stock options | $ 89 | 89 | |||||||
Exercise of stock options (in shares) | 10,130 | 10,000 | |||||||
Release of restricted stock units | $ 0 | ||||||||
Release of restricted stock units (in shares) | 136,000 | ||||||||
Unrealized loss on short-term investments | (16) | (16) | |||||||
Stock-based compensation expense | 3,431 | 3,431 | |||||||
New shares issued | 2,042 | $ 70,064 | $ 5 | 2,042 | $ 70,059 | ||||
New shares issued (in shares) | 165,000 | 5,735,000 | |||||||
Net loss | (22,669) | (22,669) | |||||||
Ending balance at Mar. 31, 2021 | $ 114,039 | $ 31 | $ 406,198 | $ (74) | $ (292,116) | ||||
Ending balance (in shares) at Mar. 31, 2021 | 32,374,000 | (200,000) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Operating activities | ||
Net loss | $ (22,669) | $ (20,477) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 392 | 408 |
Stock-based compensation expense | 3,431 | 2,477 |
Accretion of premiums and discounts on investments | 29 | (80) |
Unrealized (gain) loss on marketable equity securities | (1,286) | 2,389 |
Non-cash lease expense | 84 | 68 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 74 | 71 |
Interest receivable | 118 | (168) |
Prepaid expenses and other current assets | 1,243 | 539 |
Other assets | 19 | 14 |
Accounts payable | 278 | 563 |
Accrued expenses and other liabilities | (2,206) | (3,932) |
Operating lease liability | (221) | 294 |
Net cash used in operating activities | (20,714) | (17,834) |
Investing activities | ||
Purchases of property and equipment | (92) | (112) |
Purchases of investments | 0 | (93,417) |
Maturities of investments | 30,712 | 33,900 |
Net cash provided by (used in) investing activities | 30,620 | (59,629) |
Financing activities | ||
Proceeds from exercise of stock options | 89 | 435 |
Proceeds from common stock and pre-funded warrants sold, net of underwriters’ discount and costs | 0 | 70,064 |
Proceeds from at-the-market offering, net of issuance costs | 2,575 | 0 |
Net cash provided by financing activities | 2,664 | 70,499 |
Net increase (decrease) in cash and cash equivalents and restricted cash | 12,570 | (6,964) |
Cash, cash equivalents and restricted cash at beginning of period | 78,359 | 54,200 |
Cash, cash equivalents and restricted cash at end of period | 90,929 | 47,236 |
Supplemental cash flow information: | ||
Purchases of property and equipment unpaid at period end | 3 | 0 |
Cash paid included in measurement of lease liabilities | 742 | 244 |
Pre-funded stock warrants issued | $ 0 | $ 16,736 |
Nature of Business
Nature of Business | 3 Months Ended |
Mar. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business | Nature of Business Concert Pharmaceuticals, Inc., or the Company, was incorporated on April 12, 2006 as a Delaware corporation and has its operations based in Lexington, Massachusetts. The Company is a clinical stage biopharmaceutical company that is developing small molecule drugs that it discovered through the application of its deuterated chemical entity platform, or DCE Platform ® . Selective incorporation of deuterium into known molecules has the potential, on a case-by-case basis, to provide better pharmacokinetic or metabolic properties, thereby enhancing their clinical safety, tolerability or efficacy. As discussed in detail in the “Overview” section in Part I, Item 2. of this Quarterly Report on Form 10-Q, the Company’s most advanced product candidate is CTP-543, which it is evaluating in a Phase 3 clinical program for the treatment of alopecia areata, a serious autoimmune dermatological condition. The Company is also assessing a number of earlier-stage pipeline candidates. Liquidity and Going Concern As of March 31, 2021, the Company had cash, cash equivalents and investments of $111.8 million and net working capital of $115.6 million. The Company has incurred cumulative net losses of $292.1 million since inception and requires capital to continue future development activities. The Company does not have any products approved for sale and has not generated any revenue from product sales. The Company has financed its operations primarily through the public offering and private placement of its equity, debt financing, funding from collaborations and patent assignments, an asset sale and other arrangements. The Company expects its expenses to increase in connection with its ongoing activities, particularly as it conducts its Phase 3 clinical trials of CTP-543 in alopecia areata. For information regarding the Company’s recently completed equity financings, see Note 12. The Company is subject to risks common to companies in the biotechnology industry, including, but not limited to, risks of failure or unsatisfactory results of nonclinical studies and clinical trials, the need to obtain additional financing to fund the future development of its pipeline, the need to obtain marketing approval for its product candidates, the need to successfully commercialize and gain market acceptance of its product candidates, dependence on key personnel, protection of proprietary technology, compliance with government regulations, development by competitors of technological innovations and ability to transition from pilot-scale manufacturing to large-scale production of products. Under Accounting Standards Codification, or ASC, Topic 205-40, Presentation of Financial Statements - Going Concern , management is required at each reporting period to evaluate whether there are conditions and events, considered in the aggregate, that raise substantial doubt about an entity's ability to continue as a going concern within one year after the date that the financial statements are issued. This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the financial statements are issued. When substantial doubt exists, management evaluates whether the mitigating effect of its plans sufficiently alleviates the substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management's plans, however, is only considered if both (i) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued and (ii) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued. Generally, to be considered probable of being effectively implemented, the plans must have been approved by the Company’s board of directors before the date that the financial statements are issued. Successful completion of the Company’s development program and, ultimately, the attainment of profitable operations are dependent upon future events, including obtaining adequate financing to support the Company’s cost structure and operating plan. Management’s plans to alleviate its financing requirements include, among other things, pursuing one or more of the following steps to raise additional capital, none of which can be guaranteed or are entirely within the Company’s control: • raise funding through the sale of the Company’s common stock; • raise funding through debt financing; and • establish collaborations with potential partners to advance the Company’s product pipeline. Based on the Company’s current operating plan, management believes that its current cash, cash equivalents and available-for-sale investments will allow the Company to meet its liquidity requirements through 2021. The Company’s history of significant losses, its negative cash flows from operations, its limited liquidity resources currently on hand and its dependence on its ability to obtain additional financing to fund its operations after the current resources are exhausted, about which there can be no certainty, have resulted in management’s assessment that there is substantial doubt about the Company’s ability to continue as a going concern for a period of at least twelve months from the issuance date of this Quarterly Report on Form 10-Q. The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business, and do not include any adjustments that may result from the outcome of this uncertainty. If the Company is unable to raise capital when needed or on acceptable terms, or if it is unable to procure collaboration arrangements to advance its programs, the Company would be forced to discontinue some of its operations or develop and implement a plan to further extend payables, reduce overhead or scale back its current operating plan until sufficient additional capital is raised to support further operations. There can be no assurance that such a plan would be successful. |
Basis of Presentation and Signi
Basis of Presentation and Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Significant Accounting Policies | Basis of Presentation and Significant Accounting Policies Basis of Presentation The condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments, consisting of normal recurring accruals and revisions of estimates, considered necessary for a fair presentation of the condensed consolidated financial statements have been included. Interim results for the three months ended March 31, 2021 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2021 or any other future period. The accompanying condensed consolidated financial statements reflect the accounts of the Company and its subsidiaries. All intercompany transactions between the Company and its subsidiaries have been eliminated. Management has determined that the Company operates in one segment: the development of pharmaceutical products on its own behalf or in collaboration with others. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the Company’s consolidated financial statements and the accompanying notes included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 filed with the Securities and Exchange Commission, or SEC, on February 25, 2021. Unless otherwise indicated, all amounts in the following tables are in thousands except share and per share amounts. Use of Estimates and Summary of Significant Accounting Policies The preparation of the consolidated financial statements in conformity with U.S. generally accepted accounting principles, or GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, equity, revenue, expenses and the disclosure of contingent assets and liabilities and the Company’s ability to continue as a going concern. In preparing the consolidated financial statements, management used estimates in the following areas, among others: revenue recognition; prepaid and accrued research and development expenses; stock-based compensation expense; and the evaluation of the existence of conditions and events that raise substantial doubt regarding the Company’s ability to continue as a going concern. Actual results could differ from those estimates. During the three months ended March 31, 2021, there have been no material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020. Pending Accounting Pronouncements In June 2016, the Financial Accounting Standards Board issued Accounting Standards Update, or ASU, 2016-13, Financial Instruments-Credit Losses . This standard requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. As a smaller reporting company, ASU 2016-13 will become effective for the Company for fiscal years beginning after December 15, 2022, and early adoption is permitted. The Company is currently evaluating the impact that ASU 2016-13 will have on its financial statements and related disclosures. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The Company has certain financial assets and liabilities that are recorded at fair value which have been classified as Level 1, 2 or 3 within the fair value hierarchy as described in the accounting standards for fair value measurements: • Level 1—quoted prices for identical instruments in active markets; • Level 2—quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-derived valuations in which all significant inputs and significant value drivers are observable in active markets; and • Level 3—valuations derived from valuation techniques in which one or more significant value drivers are unobservable. The tables below present information about the Company’s financial assets and liabilities that are measured and carried at fair value as of March 31, 2021 and December 31, 2020 and indicate the level within the fair value hierarchy where each measurement is classified. The carrying amounts reflected in the condensed consolidated balance sheets for cash, prepaid expenses and other current assets, restricted cash, accounts payable and accrued expenses approximate their fair value due to their short-term nature. Level 1 Level 2 Level 3 Total March 31, 2021 Cash equivalents: Money market funds $ 81,808 $ — $ — $ 81,808 Investments, available for sale: U.S. Treasury obligations 9,007 — — 9,007 Government agency securities 1,001 12,001 — 13,002 Marketable equity securities: Corporate equity securities (Note 8) 3,255 — — 3,255 Total $ 95,071 $ 12,001 $ — $ 107,072 Level 1 Level 2 Level 3 Total December 31, 2020 Cash equivalents: Money market funds $ 69,928 $ — $ — $ 69,928 Investments, available for sale: U.S. Treasury obligations 25,528 — — 25,528 Government agency securities 8,737 18,501 — 27,238 Marketable equity securities: Corporate equity securities (Note 8) 1,969 — — 1,969 Total $ 106,162 $ 18,501 $ — $ 124,663 |
Cash, Cash Equivalents, Investm
Cash, Cash Equivalents, Investments and Marketable Equity Securities | 3 Months Ended |
Mar. 31, 2021 | |
Cash and Cash Equivalents [Abstract] | |
Cash, Cash Equivalents, Investments and Marketable Equity Securities | Cash, Cash Equivalents, Investments and Marketable Equity Securities Cash equivalents include all highly liquid investments maturing within 90 days from the date of purchase. Investments consist of securities with original maturities greater than 90 days when purchased. The Company classifies these investments as available for sale and records them at fair value in the accompanying consolidated balance sheets. Unrealized gains or losses from equity securities are included in net income. Unrealized gains or losses from other investments, including debt securities, are included in accumulated other comprehensive (loss) income. Premiums or discounts from par value are amortized to investment income over the life of the underlying investment. Cash, cash equivalents, available for sale investments and marketable equity securities included the following as of March 31, 2021 and December 31, 2020: Average Maturity Amortized Cost Unrealized Gains Unrealized Losses Fair Value March 31, 2021 Cash $ 7,964 $ — $ — $ 7,964 Money market funds 81,808 — — 81,808 Cash and cash equivalents $ 89,772 $ — $ — $ 89,772 U.S. Treasury obligations 57 days $ 9,006 $ 1 $ — $ 9,007 Government agency securities 47 days 13,000 2 — 13,002 Investments, available for sale $ 22,006 $ 3 $ — $ 22,009 March 31, 2021 Acquisition Value Unrealized Gains Unrealized Losses Fair Value Marketable equity securities (Note 8) $ 10,451 $ — $ (7,196) $ 3,255 Average Maturity Amortized Cost Unrealized Gains Unrealized Losses Fair Value December 31, 2020 Cash $ 7,274 $ — $ — $ 7,274 Money market funds 69,928 — — 69,928 Cash and cash equivalents $ 77,202 $ — $ — $ 77,202 U.S. Treasury obligations 70 days $ 25,523 $ 5 $ — $ 25,528 Government agency securities 82 days 27,225 13 — 27,238 Investments, available for sale $ 52,748 $ 18 $ — $ 52,766 December 31, 2020 Acquisition Value Unrealized Gains Unrealized Losses Fair Value Marketable equity securities (Note 8) $ 10,451 $ — $ (8,482) $ 1,969 |
Restricted Cash
Restricted Cash | 3 Months Ended |
Mar. 31, 2021 | |
Cash and Cash Equivalents [Abstract] | |
Restricted Cash | Restricted Cash Restricted cash as of March 31, 2021 and 2020 was held as collateral for stand-by letters of credit issued by the Company to its landlord in connection with the current lease for its principal facilities located at 65 Hayden Avenue, Lexington, Massachusetts. For additional information regarding the Company’s lease, refer to Note 11. Cash, cash equivalents and restricted cash consisted of the following as of March 31, 2021 and 2020: March 31, March 31, Cash and cash equivalents $ 89,772 $ 46,079 Restricted cash 1,157 1,157 Total cash, cash equivalents and restricted cash shown in the statements of cash flows $ 90,929 $ 47,236 |
Accrued Expenses and Other Liab
Accrued Expenses and Other Liabilities | 3 Months Ended |
Mar. 31, 2021 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Liabilities | Accrued Expenses and Other Liabilities Accrued expenses and other liabilities consisted of the following as of March 31, 2021 and December 31, 2020: March 31, December 31, Accrued professional fees and other $ 566 $ 709 Employee compensation and benefits 978 3,690 Research and development expenses 5,267 4,618 Accrued expenses and other liabilities $ 6,811 $ 9,017 Employee compensation and benefits, net of current portion $ 108 $ 108 Accrued expenses and other liabilities, net of current portion $ 108 $ 108 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes Deferred tax assets and deferred tax liabilities are recognized based on temporary differences between the financial reporting and tax basis of assets and liabilities using statutory rates. A valuation allowance is recorded against deferred tax assets if it is more likely than not that some or all of the deferred tax assets will not be realized. The Company’s ability to use its operating loss carryforwards and tax credits to offset future taxable income is subject to restrictions under Sections 382 and 383 of the U.S. Internal Revenue Code. Net operating loss and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code. Such changes would limit the Company’s use of its operating loss carryforwards and tax credits. In such a situation, the Company may be required to pay income taxes, even though significant operating loss carryforwards and tax credits exist. The Company records a provision or benefit for income taxes on ordinary pre-tax income or loss based on its estimated effective tax rate for the year. As of March 31, 2021, the Company forecasts an ordinary pre-tax loss for the year ended December 31, 2021 and, since it maintains a full valuation allowance on its deferred tax assets, the Company did not record an income tax be nefit relating to this period. The Company adopted ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes , effective January 1, 2020. Under ASU 2019-12, the Company, having a full valuation and a loss in continuing operations, will no longer include the impacts of items in other comprehensive income in determining intra-period allocation of tax expense for continuing operations. Under ASU 2019-12, the Company can apply this change to intra-period tax allocation on a prospective basis. For the three months ended March 31, 2021 , the Company applied the tax allocation rules of ASU 2019-12 to th e $16 thousand of unrealized losses on available for sale investments recognized in other comprehensive income, which did not have a material impact on the consolidated financial statements or related disclosures. |
Revenue
Revenue | 3 Months Ended |
Mar. 31, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Revenue | Revenue The Company’s revenue is generated through collaborative licensing agreements, patent assignments and sales of intellectual property. The Company generates its revenue through one segment. The revenue recognized under each of the Company’s arrangements during the current and prior periods is described below. Contract Assets The Company did not have a contract asset as of March 31, 2021 or December 31, 2020. Contract Liabilities As of March 31, 2021 and December 31, 2020, the Company had $2.8 million in contract liabilities related to variable consideration paid in advance but currently constrained from recognition. The $2.8 million of contract liabilities consisted of deferred revenue related to a payment received from GlaxoSmithKline that the Company will not recognize as revenue until all repayment obligations lapse. Revenue Arrangements Processa On October 4, 2017, the Company entered into an Option and License Agreement, or the Option, with Promet Therapeutics, LLC, or Promet, pursuant to which the Company granted Promet an option to obtain an exclusive license to CTP-499, a deuterated analog of 1-(S)-5-hydroxyhexyl-3,7-dimethylxanthine, or HDX, an active metabolite of pentoxifylline, provided certain conditions were met. On October 5, 2017, Promet closed an asset purchase agreement with Heatwurx, Inc., a public company, creating Processa Pharmaceuticals, Inc., or Processa. On March 19, 2018, the Company entered into an Amendment to the Option, or the Amendment, and a Securities Purchase Agreement with both Promet and Processa. Pursuant to the Amendment, the Company granted Promet, who then assigned to Processa, an exclusive, worldwide, royalty-bearing license to develop, manufacture and commercialize CTP-499, now known as PCS-499. Upon transfer of the license and as consideration for the license, the Company received 2,090,301 shares of common stock of Processa. In December 2019, Processa implemented a reverse stock split, and the Company now owns 298,615 shares of common stock of Processa. The Company is also eligible to receive royalties on worldwide net sales. The Amendment contained one performance obligation: an exclusive, worldwide, royalty-bearing license to develop, manufacture and commercialize CTP-499. The Company determined that the transaction price was $10.5 million, which was based on the fair value of the non-cash consideration received on March 19, 2018, which consisted of 2,090,301 shares of publicly traded common stock of Processa. The transaction price of $10.5 million was allocated to the single performance obligation. The performance obligation was considered satisfied at contract inception, as the exclusive license transferred control to the customer at this point in time. Accordingly, revenue of $10.5 million was recognized during the first quarter of 2018. Subsequent changes to the fair value of the underlying securities are recognized as unrealized gains or losses on marketable equity securities in the condensed consolidated statements of operations and comprehensive loss. The Amendment contains consideration that is variable based on royalties upon the customer’s commercial success with the licensed product. The consideration related to royalty payments is considered variable consideration that is fully constrained in accordance with the royalty recognition constraint. The variable consideration related to royalties will be recognized in the period the products are sold by Processa and the Company has a present right to payment. For the three months ended March 31, 2020, the Company recognized $1 thousand in revenue related to intellectual property cost reimbursements. For the three months ended March 31, 2021, the Company did not recognize revenue related to intellectual property cost reimbursements. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation The Company’s equity incentive plans provide for the issuance of a variety of stock-based awards, including incentive stock options, nonstatutory stock options and awards of stock, to directors, officers and employees of the Company, as well as consultants and advisors to the Company. As of March 31, 2021, the Company has granted awards in the form of stock options and restricted stock units, or RSUs. The stock options generally have been granted with an exercise price equal to the closing market price of the Company’s common stock on the date of grant, a vesting period of one three Effective January 1, 2021, an additional 1,274,487 shares were added to the Company’s 2014 Stock Incentive Plan, or the 2014 Plan, for future issuance pursuant to the terms of the 2014 Plan. As of March 31, 2021, there were 1,413,116 shares of common stock available for future awards under the 2014 Plan. Total stock-based compensation expense related to all stock-based options and awards recognized in the condensed consolidated statements of operations and comprehensive loss consisted of: Three Months Ended March 31, 2021 2020 Research and development $ 1,851 $ 1,255 General and administrative 1,580 1,222 Total stock-based compensation expense $ 3,431 $ 2,477 Stock Options Stock options are valued using the Black-Scholes-Merton option valuation model, and compensation cost is recognized based on such fair value over the period of vesting. The weighted-average fair value of options granted in the three months ended March 31, 2021 and 2020 reflect the following weighted-average assumptions: Three Months Ended March 31, 2021 2020 Expected volatility 69.71 % 68.19 % Expected term 6.0 years 6.0 years Risk-free interest rate 0.54 % 1.47 % Expected dividend yield — % — % The following table provides certain information related to the Company’s outstanding stock options: Three Months Ended March 31, 2021 2020 (Amounts in thousands, except per share data) Weighted-average fair value of options granted, per option $ 7.87 $ 6.67 Aggregate grant date fair value of options vested during the period $ 2,066 $ 2,184 Total cash received from exercises of stock options $ 89 $ 435 Total intrinsic value of stock options exercised $ 42 $ 93 The following is a summary of stock option activity for the three months ended March 31, 2021: Number of Weighted Weighted Aggregate (in years) (in thousands) Outstanding at December 31, 2020 4,652,870 $ 14.48 Granted 734,011 $ 12.85 Exercised (10,130) $ 8.80 Forfeited or expired (10,541) $ 13.33 Outstanding at March 31, 2021 5,366,210 $ 14.27 6.77 $ 123 Exercisable at March 31, 2021 3,470,478 $ 14.56 5.67 $ 123 Vested and expected to vest at March 31, 2021 (1) 5,213,393 $ 14.31 6.70 $ 123 (1) Represents the number of vested stock option shares as of March 31, 2021, plus the number of unvested stock option shares that the Company estimated as of March 31, 2021 would vest, based on the unvested stock option shares as of March 31, 2021 and an estimated forfeiture rate of 6% . As of March 31, 2021, there w as $15.0 million of unre cognized compensation cost related to stock options that are expected to vest. The stock option costs are expected to be recognized over a weighted-average remaining vesting period of 2.6 years . Restricted Stock Units On August 15, 2019, or the 2019 RSU grant date, the Company granted 0.4 million RSUs, or the 2019 RSUs, to certain executives and employees. All of the 2019 RSUs are service-based and vest ratably over two years. 35% of the 2019 RSUs vested on the first anniversary of the 2019 RSU grant date, and the remainder will vest on the second anniversary of the 2019 RSU grant date. On February 14, 2020, or the 2020 RSU grant date, the Company granted 0.4 million RSUs, or the 2020 RSUs, to executives and employees. All of the 2020 RSUs are service-based and vest ratably over three years, with one third of the 2020 RSUs vesting on each anniversary of the 2020 RSU grant date through February 14, 2023. On January 5, 2021, or the 2021 RSU grant date, the Company granted 0.3 million RSUs, or the 2021 RSUs, to executives and employees. All of the 2021 RSUs are service-based and vest ratably over three years, with one third of the 2021 RSUs vesting on each anniversary of the 2021 RSU grant date through January 5, 2024. RSUs are not included in issued and outstanding common stock until the shares have vested and settled. As of March 31, 2021, 0.1 million of the 2019 RSUs and 0.1 million of the 2020 RSUs had vested. The fair value of an RSU is measured based on the market price of the underlying common stock on the date of grant. The following is a summary of RSU activity for the three months ended March 31, 2021: Number of Weighted- Outstanding at December 31, 2020 661,033 $ 10.64 Granted 302,525 $ 13.07 Released (136,127) $ 10.87 Forfeited (5,555) $ 11.30 Outstanding at March 31, 2021 821,876 $ 11.49 As of March 31, 2021, there was $7.4 million of u nrecognized compensation cost related to RSUs that are expected to vest. The RSU costs are expected to be recognized over a weighted-average remaining vesting pe riod of 1.7 years. |
Loss Per Share
Loss Per Share | 3 Months Ended |
Mar. 31, 2021 | |
Earnings Per Share [Abstract] | |
Loss Per Share | Loss Per Share Basic net loss per common share is calculated by dividing net loss allocable to common stockholders by the weighted-average common shares outstanding during the period, without consideration of stock options and RSUs as common stock equivalents. The weighted-average common shares outstanding as of March 31, 2021 includes pre-funded warrants to purchase up to an aggregate of 1.8 million shares of common stock that were issued in connection with a public offering that closed in January 2020. For purposes of the diluted net loss per share calculation, common stock equivalents are excluded from the calculation if their effect would be anti-dilutive. As such, basic and diluted net loss per share applicable to common stockholders are the same for periods with a net loss. The following table illustrates the determination of loss per share for each period presented. Three Months Ended March 31, 2021 2020 (Amounts in thousands, except per share amounts) Numerator: Net loss applicable to common stockholders - basic and diluted $ (22,669) $ (20,477) Denominator: Weighted-average shares outstanding - basic and diluted 33,894 29,110 Net loss per share applicable to common stockholders - basic and diluted $ (0.67) $ (0.70) Anti-dilutive potential common stock equivalents excluded from the calculation of net loss per share*: Stock options 5,366 4,633 Restricted stock units 822 799 Warrants 61 61 *For the three months ended March 31, 2021, the Company has presented "Anti-dilutive potential common stock equivalents excluded from the calculation of net loss per share" to include all stock equivalents that could potentially dilute basic earnings per share. The Company has corrected the presentation for the three months ended March 31, 2020 and has concluded that this change is not material to the current or any prior period financial statements. |
Commitments
Commitments | 3 Months Ended |
Mar. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | Commitments Lease The Company currently has a lease, or the Lease, for approximately 56,000 square feet of office and laboratory space located at 65 Hayden Avenue, Lexington, Massachusetts, or the Premises. The Lease is classified as an operating lease. The lease term extends ten years following January 1, 2019. The Company is entitled to two five-year options to extend the Lease. The Lease provides for annual base rent of approximately $2.8 million in the first year following January 1, 2019, which increases on a yearly basis by 3.0% (subject to an abatement of base rent of approximately $0.5 million at the beginning of the second year of the lease term). There are no variable payments, exercise purchase options, penalties, fees or residual value guarantees under the Lease. The Company is also obligated to pay the landlord for certain costs, taxes and operating expenses related to the Premises, subject to certain exclusions. The Company recorded a liability for the Lease of $16.9 million on January 1, 2019. This lease liability is amortized over the remaining lease term in an amount equal to the difference between the cash rent paid and the monthly interest calculated on the remaining lease liability. As of March 31, 2021, the Company had a current lease liability of $1.0 million and a non-current lease liability of $14.8 million recorded in its condensed consolidated balance sheets. On January 1, 2019, the Company recorded a right-of-use asset in the amount of $9.5 million, which represents the lease liability of $16.9 million, adjusted for previously accrued rent of $2.9 million and previously recorded unamortized lease incentives in the amount of $4.5 million. The right-of-use asset is amortized over the remaining lease term in an amount equal to the difference between the calculated straight-line expense of the total lease payments less the monthly interest calculated on the remaining lease liability. As of March 31, 2021, the Company had a long-term lease asset of $8.9 million recorded in its condensed consolidated balance sheets. The Company recognizes lease expense, calculated as the remaining cost of the Lease allocated over the remaining lease term, on a straight-line basis. Lease expense is presented as part of continuing operations in the condensed consolidated statements of operations and comprehensive loss. For the three months ended March 31, 2021, the Company recogniz ed $0.6 million in lease expense. For the three months ended March 31, 2021, the Company paid $0.7 million in rent. As a payment arising from an operating lease, the $0.7 million is classified within operating activities in the condensed consolidated statements of cash flows. For the three months ended March 31, 2021 and 2020, the weighted-average remaining lease term was 7.75 years and 8.75 years, respectively, and the weighted-average discount rate was 13.08%. |
Open Market Sale Agreement
Open Market Sale Agreement | 3 Months Ended |
Mar. 31, 2021 | |
Equity [Abstract] | |
Open Market Sale Agreement | Open Market Sale Agreement On March 1, 2019, the Company entered into an Open Market Sale Agreement, or the ATM Agreement, with Jefferies LLC, or Jefferies, with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $50.0 million, referred to as Placement Shares, through Jefferies as its sales agent. The Company will pay Jefferies a commission equal to 3.0% of the gross sales proceeds of any Placement Shares sold through Jefferies under the ATM Agreement, and also has provided Jefferies with customary indemnification and contribution rights. On November 5, 2020, the Company entered into an amendment to the ATM Agreement with Jefferies to increase the aggregate offering price of Placement Shares that may be offered and sold pursuant to the ATM Agreement from up to $50.0 million to up to $100.0 million. However, on March 7, 2021, the Company’s ability to further use the first $50.0 million expired. As a result, from March 7, 2021 onward, the Company may only offer and sell up to an additional $50.0 million pursuant to the ATM Agreement. During the year ended December 31, 2019, the Company sold 36,167 shares of its common stock pursuant to the ATM Agreement for net proceeds of $0.4 million, after payment of cash commissions of 3.0% of the gross proceeds to Jefferies. Additionally, the Company incurred approximately $0.3 million during the year ended December 31, 2019 related to legal, accounting and other fees in connection with the ATM Agreement. During the year ended December 31, 2020, the Company sold 2,008,197 shares of its common stock pursuant to the ATM Agreement for net proceeds of $22.8 million, after payment of cash commissions of 3.0% of the gross proceeds to Jefferies. Additionally, the Company incurred approximately $0.3 million during the year ended December 31, 2020 related to legal, accounting and other fees in connection with the ATM Agreement. During the three months ended March 31, 2021, the Company sold 165,323 shares of its common stock pursuant to the ATM Agreement for net proceeds of $2.0 million, after payment of cash commissions of 3.0% of the gross proceeds to Jefferies. Cash provided by financing activities for the three months ended March 31, 2021 includes $0.5 million in net proceeds from sales pursuant to the ATM Agreement that had been classified as a receivable as of December 31, 2020. |
Basis of Presentation, Signific
Basis of Presentation, Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments, consisting of normal recurring accruals and revisions of estimates, considered necessary for a fair presentation of the condensed consolidated financial statements have been included. Interim results for the three months ended March 31, 2021 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2021 or any other future period. The accompanying condensed consolidated financial statements reflect the accounts of the Company and its subsidiaries. All intercompany transactions between the Company and its subsidiaries have been eliminated. Management has determined that the Company operates in one segment: the development of pharmaceutical products on its own behalf or in collaboration with others. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the Company’s consolidated financial statements and the accompanying notes included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 filed with the Securities and Exchange Commission, or SEC, on February 25, 2021. Unless otherwise indicated, all amounts in the following tables are in thousands except share and per share amounts. |
Use of Estimates and Summary of Significant Accounting Policies | Use of Estimates and Summary of Significant Accounting Policies The preparation of the consolidated financial statements in conformity with U.S. generally accepted accounting principles, or GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, equity, revenue, expenses and the disclosure of contingent assets and liabilities and the Company’s ability to continue as a going concern. In preparing the consolidated financial statements, management used estimates in the following areas, among others: revenue recognition; prepaid and accrued research and development expenses; stock-based compensation expense; and the evaluation of the existence of conditions and events that raise substantial doubt regarding the Company’s ability to continue as a going concern. Actual results could differ from those estimates. During the three months ended March 31, 2021, there have been no material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020. |
Recently Adopted Accounting Pronouncements and Pending Accounting Pronouncements | Pending Accounting Pronouncements In June 2016, the Financial Accounting Standards Board issued Accounting Standards Update, or ASU, 2016-13, Financial Instruments-Credit Losses . This standard requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. As a smaller reporting company, ASU 2016-13 will become effective for the Company for fiscal years beginning after December 15, 2022, and early adoption is permitted. The Company is currently evaluating the impact that ASU 2016-13 will have on its financial statements and related disclosures. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of financial assets and liabilities recognized at fair value | The tables below present information about the Company’s financial assets and liabilities that are measured and carried at fair value as of March 31, 2021 and December 31, 2020 and indicate the level within the fair value hierarchy where each measurement is classified. The carrying amounts reflected in the condensed consolidated balance sheets for cash, prepaid expenses and other current assets, restricted cash, accounts payable and accrued expenses approximate their fair value due to their short-term nature. Level 1 Level 2 Level 3 Total March 31, 2021 Cash equivalents: Money market funds $ 81,808 $ — $ — $ 81,808 Investments, available for sale: U.S. Treasury obligations 9,007 — — 9,007 Government agency securities 1,001 12,001 — 13,002 Marketable equity securities: Corporate equity securities (Note 8) 3,255 — — 3,255 Total $ 95,071 $ 12,001 $ — $ 107,072 Level 1 Level 2 Level 3 Total December 31, 2020 Cash equivalents: Money market funds $ 69,928 $ — $ — $ 69,928 Investments, available for sale: U.S. Treasury obligations 25,528 — — 25,528 Government agency securities 8,737 18,501 — 27,238 Marketable equity securities: Corporate equity securities (Note 8) 1,969 — — 1,969 Total $ 106,162 $ 18,501 $ — $ 124,663 |
Cash, Cash Equivalents, Inves_2
Cash, Cash Equivalents, Investments and Marketable Equity Securities (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of cash equivalents and short-term and long-term investments | Cash, cash equivalents, available for sale investments and marketable equity securities included the following as of March 31, 2021 and December 31, 2020: Average Maturity Amortized Cost Unrealized Gains Unrealized Losses Fair Value March 31, 2021 Cash $ 7,964 $ — $ — $ 7,964 Money market funds 81,808 — — 81,808 Cash and cash equivalents $ 89,772 $ — $ — $ 89,772 U.S. Treasury obligations 57 days $ 9,006 $ 1 $ — $ 9,007 Government agency securities 47 days 13,000 2 — 13,002 Investments, available for sale $ 22,006 $ 3 $ — $ 22,009 March 31, 2021 Acquisition Value Unrealized Gains Unrealized Losses Fair Value Marketable equity securities (Note 8) $ 10,451 $ — $ (7,196) $ 3,255 Average Maturity Amortized Cost Unrealized Gains Unrealized Losses Fair Value December 31, 2020 Cash $ 7,274 $ — $ — $ 7,274 Money market funds 69,928 — — 69,928 Cash and cash equivalents $ 77,202 $ — $ — $ 77,202 U.S. Treasury obligations 70 days $ 25,523 $ 5 $ — $ 25,528 Government agency securities 82 days 27,225 13 — 27,238 Investments, available for sale $ 52,748 $ 18 $ — $ 52,766 December 31, 2020 Acquisition Value Unrealized Gains Unrealized Losses Fair Value Marketable equity securities (Note 8) $ 10,451 $ — $ (8,482) $ 1,969 |
Restricted Cash (Tables)
Restricted Cash (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of restrictions on cash and cash equivalents | Cash, cash equivalents and restricted cash consisted of the following as of March 31, 2021 and 2020: March 31, March 31, Cash and cash equivalents $ 89,772 $ 46,079 Restricted cash 1,157 1,157 Total cash, cash equivalents and restricted cash shown in the statements of cash flows $ 90,929 $ 47,236 |
Accrued Expenses and Other Li_2
Accrued Expenses and Other Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Payables and Accruals [Abstract] | |
Schedule of accrued expenses and other liabilities | Accrued expenses and other liabilities consisted of the following as of March 31, 2021 and December 31, 2020: March 31, December 31, Accrued professional fees and other $ 566 $ 709 Employee compensation and benefits 978 3,690 Research and development expenses 5,267 4,618 Accrued expenses and other liabilities $ 6,811 $ 9,017 Employee compensation and benefits, net of current portion $ 108 $ 108 Accrued expenses and other liabilities, net of current portion $ 108 $ 108 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of stock-based compensation expense related to all stock based awards recognized in statements of operations and comprehensive income (loss) | Total stock-based compensation expense related to all stock-based options and awards recognized in the condensed consolidated statements of operations and comprehensive loss consisted of: Three Months Ended March 31, 2021 2020 Research and development $ 1,851 $ 1,255 General and administrative 1,580 1,222 Total stock-based compensation expense $ 3,431 $ 2,477 |
Schedule of estimated weighted-average assumptions of options granted | The weighted-average fair value of options granted in the three months ended March 31, 2021 and 2020 reflect the following weighted-average assumptions: Three Months Ended March 31, 2021 2020 Expected volatility 69.71 % 68.19 % Expected term 6.0 years 6.0 years Risk-free interest rate 0.54 % 1.47 % Expected dividend yield — % — % |
Schedule of outstanding stock options | The following table provides certain information related to the Company’s outstanding stock options: Three Months Ended March 31, 2021 2020 (Amounts in thousands, except per share data) Weighted-average fair value of options granted, per option $ 7.87 $ 6.67 Aggregate grant date fair value of options vested during the period $ 2,066 $ 2,184 Total cash received from exercises of stock options $ 89 $ 435 Total intrinsic value of stock options exercised $ 42 $ 93 |
Summary of stock option activity | The following is a summary of stock option activity for the three months ended March 31, 2021: Number of Weighted Weighted Aggregate (in years) (in thousands) Outstanding at December 31, 2020 4,652,870 $ 14.48 Granted 734,011 $ 12.85 Exercised (10,130) $ 8.80 Forfeited or expired (10,541) $ 13.33 Outstanding at March 31, 2021 5,366,210 $ 14.27 6.77 $ 123 Exercisable at March 31, 2021 3,470,478 $ 14.56 5.67 $ 123 Vested and expected to vest at March 31, 2021 (1) 5,213,393 $ 14.31 6.70 $ 123 (1) Represents the number of vested stock option shares as of March 31, 2021, plus the number of unvested stock option shares that the Company estimated as of March 31, 2021 would vest, based on the unvested stock option shares as of March 31, 2021 and an estimated forfeiture rate of 6% . |
Summary of RSU activity | The following is a summary of RSU activity for the three months ended March 31, 2021: Number of Weighted- Outstanding at December 31, 2020 661,033 $ 10.64 Granted 302,525 $ 13.07 Released (136,127) $ 10.87 Forfeited (5,555) $ 11.30 Outstanding at March 31, 2021 821,876 $ 11.49 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Earnings Per Share [Abstract] | |
Computation of basic and diluted earnings (loss) per share | The following table illustrates the determination of loss per share for each period presented. Three Months Ended March 31, 2021 2020 (Amounts in thousands, except per share amounts) Numerator: Net loss applicable to common stockholders - basic and diluted $ (22,669) $ (20,477) Denominator: Weighted-average shares outstanding - basic and diluted 33,894 29,110 Net loss per share applicable to common stockholders - basic and diluted $ (0.67) $ (0.70) Anti-dilutive potential common stock equivalents excluded from the calculation of net loss per share*: Stock options 5,366 4,633 Restricted stock units 822 799 Warrants 61 61 |
Nature of Business - Additional
Nature of Business - Additional Information (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Cash and cash equivalents and investments | $ 111,800 | |
Net working capital | 115,600 | |
Accumulated deficit | $ (292,116) | $ (269,447) |
Basis of Presentation, Signif_2
Basis of Presentation, Significant Accounting Policies - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2021segment | |
Accounting Policies [Abstract] | |
Number of segments | 1 |
Fair Value Measurements - Finan
Fair Value Measurements - Financial Assets and Liabilities Recognized at Fair Value (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Fair value, cash equivalents | $ 89,772 | $ 77,202 |
Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Fair value, cash equivalents | 81,808 | 69,928 |
Fair value measurements | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Corporate equity securities (Note 8) | 3,255 | 1,969 |
Total financial assets at fair value | 107,072 | 124,663 |
Fair value measurements | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Corporate equity securities (Note 8) | 3,255 | 1,969 |
Total financial assets at fair value | 95,071 | 106,162 |
Fair value measurements | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Corporate equity securities (Note 8) | 0 | 0 |
Total financial assets at fair value | 12,001 | 18,501 |
Fair value measurements | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Corporate equity securities (Note 8) | 0 | 0 |
Total financial assets at fair value | 0 | 0 |
Fair value measurements | U.S. Treasury obligations | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Fair value, investments available-for-sale securities | 9,007 | 25,528 |
Fair value measurements | U.S. Treasury obligations | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Fair value, investments available-for-sale securities | 9,007 | 25,528 |
Fair value measurements | U.S. Treasury obligations | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Fair value, investments available-for-sale securities | 0 | 0 |
Fair value measurements | U.S. Treasury obligations | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Fair value, investments available-for-sale securities | 0 | 0 |
Fair value measurements | Government agency securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Fair value, investments available-for-sale securities | 13,002 | 27,238 |
Fair value measurements | Government agency securities | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Fair value, investments available-for-sale securities | 1,001 | 8,737 |
Fair value measurements | Government agency securities | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Fair value, investments available-for-sale securities | 12,001 | 18,501 |
Fair value measurements | Government agency securities | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Fair value, investments available-for-sale securities | 0 | 0 |
Fair value measurements | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Fair value, cash equivalents | 81,808 | 69,928 |
Fair value measurements | Money market funds | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Fair value, cash equivalents | 81,808 | 69,928 |
Fair value measurements | Money market funds | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Fair value, cash equivalents | 0 | 0 |
Fair value measurements | Money market funds | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Fair value, cash equivalents | $ 0 | $ 0 |
Cash, Cash Equivalents, Inves_3
Cash, Cash Equivalents, Investments and Marketable Equity Securities - Cash Equivalents and Short-term and Long-term Investments (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2020 |
Cash and Cash Equivalents | |||
Amortized cost, cash and cash equivalents | $ 89,772 | $ 77,202 | $ 46,079 |
Fair value, cash and cash equivalent | 89,772 | 77,202 | |
Investments, available for sale | |||
Debt Securities | |||
Amortized cost, investments available for sale | 22,006 | 52,748 | |
Unrealized Gains | 3 | 18 | |
Unrealized Losses | 0 | 0 | |
Fair value, available-for-sale securities | 22,009 | 52,766 | |
U.S. Treasury obligations | |||
Debt Securities | |||
Amortized cost, investments available for sale | 9,006 | 25,523 | |
Unrealized Gains | 1 | 5 | |
Unrealized Losses | 0 | 0 | |
Fair value, available-for-sale securities | 9,007 | 25,528 | |
Government agency securities | |||
Debt Securities | |||
Amortized cost, investments available for sale | 13,000 | 27,225 | |
Unrealized Gains | 2 | 13 | |
Unrealized Losses | 0 | 0 | |
Fair value, available-for-sale securities | 13,002 | 27,238 | |
Marketable equity securities | |||
Marketable Securities | |||
Acquisition Value | 10,451 | 10,451 | |
Unrealized Gains | 0 | 0 | |
Unrealized Losses | (7,196) | (8,482) | |
Fair Value | 3,255 | 1,969 | |
Cash | |||
Cash and Cash Equivalents | |||
Amortized cost, cash and cash equivalents | 7,964 | 7,274 | |
Fair value, cash and cash equivalent | 7,964 | 7,274 | |
Money market funds | |||
Cash and Cash Equivalents | |||
Amortized cost, cash and cash equivalents | 81,808 | 69,928 | |
Fair value, cash and cash equivalent | $ 81,808 | $ 69,928 | |
Measurement Input, Expected Term | U.S. Treasury obligations | |||
Debt Securities | |||
Average maturity (in days) | 57 days | 70 days | |
Measurement Input, Expected Term | Government agency securities | |||
Debt Securities | |||
Average maturity (in days) | 47 days | 82 days |
Restricted Cash (Details)
Restricted Cash (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2020 | Dec. 31, 2019 |
Cash and Cash Equivalents [Abstract] | ||||
Cash and cash equivalents | $ 89,772 | $ 77,202 | $ 46,079 | |
Restricted cash | 1,157 | 1,157 | 1,157 | |
Total cash, cash equivalents and restricted cash shown in the statements of cash flows | $ 90,929 | $ 78,359 | $ 47,236 | $ 54,200 |
Accrued Expenses and Other Li_3
Accrued Expenses and Other Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Accrued professional fees and other | $ 566 | $ 709 |
Employee compensation and benefits | 978 | 3,690 |
Research and development expenses | 5,267 | 4,618 |
Accrued expenses and other liabilities | 6,811 | 9,017 |
Employee compensation and benefits, net of current portion | 108 | 108 |
Accrued expenses, net of current portion | $ 108 | $ 108 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Unrealized loss on short-term investments | $ 16 | $ (523) |
Revenue - Additional Informatio
Revenue - Additional Information (Details) | 3 Months Ended | |
Mar. 31, 2021USD ($)segment | Dec. 31, 2020USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative | ||
Number of segments | segment | 1 | |
Contract asset | $ 0 | $ 0 |
Contract liability | 2,800,000 | $ 2,800,000 |
GlaxoSmithKline | ||
Collaborative Arrangement and Arrangement Other than Collaborative | ||
Contract liability | $ 2,800,000 |
Revenue - Processa (Details)
Revenue - Processa (Details) - USD ($) $ in Thousands | Mar. 19, 2018 | Mar. 31, 2021 | Mar. 31, 2020 | Mar. 31, 2018 | Dec. 31, 2020 | Dec. 31, 2019 |
Revenue Recognition, Milestone Method | ||||||
Shares owned (in shares) | 32,173,778 | 31,862,198 | ||||
Allocable arrangement consideration | $ 10,500 | $ 5 | $ 7 | $ 10,500 | ||
Processa | ||||||
Revenue Recognition, Milestone Method | ||||||
Equity received from sale (in shares) | 2,090,301 | |||||
Shares owned (in shares) | 298,615 | |||||
Allocable arrangement consideration | $ 1 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) $ in Millions | Jan. 05, 2021 | Feb. 14, 2020 | Jan. 01, 2020 | Aug. 15, 2019 | Mar. 31, 2021 |
2014 Stock Incentive Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||
Additional shares issued under the plan (in shares) | 1,274,487 | ||||
Common stock available for future award grant (in shares) | 1,413,116 | ||||
Stock options | |||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||
Total unrecognized compensation cost related to unvested options | $ 15 | ||||
Total unrecognized compensation cost, weighted-average recognition period (years) | 2 years 7 months 6 days | ||||
Restricted stock units | |||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||
Vesting period (in years) | 1 year 8 months 12 days | ||||
Number of RSUs, granted (in shares) | 302,525 | ||||
Total unrecognized compensation cost related to restricted stock units | $ 7.4 | ||||
Restricted stock units | 2019 RSU | |||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||
Vesting period (in years) | 2 years | ||||
Number of RSUs, granted (in shares) | 400,000 | ||||
Share-based payment award, vested | 100,000 | ||||
Restricted stock units | 2019 RSU | Tranche One | |||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||
Award vesting percentage | 35.00% | ||||
Restricted stock units | 2019 RSU | Tranche Two | |||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||
Award vesting percentage | 65.00% | ||||
Restricted stock units | 2020 RSU | |||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||
Vesting period (in years) | 3 years | ||||
Number of RSUs, granted (in shares) | 400,000 | ||||
Share-based payment award, vested | 100,000 | ||||
Restricted stock units | 2020 RSU | Tranche One | |||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||
Award vesting percentage | 33.00% | ||||
Restricted stock units | 2020 RSU | Tranche Two | |||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||
Award vesting percentage | 33.00% | ||||
Restricted stock units | 2020 RSU | Tranche Three | |||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||
Award vesting percentage | 33.00% | ||||
Restricted stock units | 2021 RSU | |||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||
Vesting period (in years) | 3 years | ||||
Number of RSUs, granted (in shares) | 300,000 | ||||
Minimum | Stock options | |||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||
Vesting period (in years) | 1 year | ||||
Median | Stock options | |||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||
Vesting period (in years) | 3 years | ||||
Maximum | Stock options | |||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||
Vesting period (in years) | 4 years | ||||
Awards expiration period (in years) | 10 years |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-Based Compensation Expense Related to All Stock Based Awards Recognized in Statements of Operations and Comprehensive Income (Loss) (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award | ||
Stock-based compensation expense | $ 3,431 | $ 2,477 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Stock-based compensation expense | 1,851 | 1,255 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Stock-based compensation expense | $ 1,580 | $ 1,222 |
Stock-Based Compensation - Esti
Stock-Based Compensation - Estimated Weighted-Average Assumptions of Options Granted (Details) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | ||
Expected volatility | 69.71% | 68.19% |
Expected term | 6 years | 6 years |
Risk-free interest rate | 0.54% | 1.47% |
Expected dividend yield | 0.00% | 0.00% |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value of Options (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | ||
Weighted average grant date fair value of options granted, per option (in dollars per share) | $ 7.87 | $ 6.67 |
Aggregate grant date fair value of options vested during the period | $ 2,066 | $ 2,184 |
Total cash received from exercises of stock options | 89 | 435 |
Total intrinsic value of stock options exercised | $ 42 | $ 93 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Details) $ / shares in Units, $ in Thousands | 3 Months Ended |
Mar. 31, 2021USD ($)$ / sharesshares | |
Number of Option Shares | |
Number of options, Outstanding beginning balance (in shares) | shares | 4,652,870 |
Number of options, Granted (in shares) | shares | 734,011 |
Number of options, Exercised (in shares) | shares | (10,130) |
Number of options, Forfeited or expired (in shares) | shares | (10,541) |
Number of options, Outstanding ending balance (in shares) | shares | 5,366,210 |
Number of options, Exercisable (in shares) | shares | 3,470,478 |
Number of options, Vested and expected to vest (in shares) | shares | 5,213,393 |
Weighted Average Exercise Price per Share | |
Weighted average exercise price per share, Outstanding at beginning of year (in dollars per share) | $ / shares | $ 14.48 |
Weighted average exercise price per share, Granted (in dollars per share) | $ / shares | 12.85 |
Weighted average exercise price per share, Exercised (in dollars per share) | $ / shares | 8.80 |
Weighted average exercise price per share, Forfeited or expired (in dollars per share) | $ / shares | 13.33 |
Weighted average exercise price per share, Outstanding ending balance (in dollars per share) | $ / shares | 14.27 |
Weighted average exercise price per share, Exercisable (in dollars per share) | $ / shares | 14.56 |
Weighted average exercise price per share, Vested and expected to vest (in dollars per share) | $ / shares | $ 14.31 |
Weighted Average Remaining Contractual Term (In years) | |
Weighted average remaining contractual term, Outstanding | 6 years 9 months 7 days |
Weighted average remaining contractual term, Exercisable | 5 years 8 months 1 day |
Weighted average remaining contractual term, Vested and expected to vest | 6 years 8 months 12 days |
Aggregate Intrinsic Value | |
Aggregate intrinsic value, Outstanding | $ | $ 123 |
Aggregate intrinsic value, Exercisable | $ | 123 |
Aggregate intrinsic value, Vested and expected to vest | $ | $ 123 |
Estimated forfeiture rate (percent) | 6.00% |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of RSU Activity (Details) - Restricted stock units | 3 Months Ended |
Mar. 31, 2021$ / sharesshares | |
Number of RSUs | |
Number of RSUs, Outstanding beginning balance (in shares) | shares | 661,033 |
Number of RSUs, Granted (in shares) | shares | 302,525 |
Number of RSUs, Released (in shares) | shares | (136,127) |
Number of RSUs, Forfeited (in shares) | shares | (5,555) |
Number of RSUs, Outstanding ending balance (in shares) | shares | 821,876 |
Weighted- Average Grant Date Fair Value | |
Weighted average grant date fair value, Outstanding at beginning of year (in dollars per share) | $ / shares | $ 10.64 |
Weighted average grant date fair value, Granted (in dollars per share) | $ / shares | 13.07 |
Weighted average grant date fair value, Released (in dollars per share) | $ / shares | 10.87 |
Weighted average grant date fair value, Forfeited (in dollars per share) | $ / shares | 11.30 |
Weighted average grant date fair value, Outstanding at ending of year (in dollars per share) | $ / shares | $ 11.49 |
Loss Per Share - Computation of
Loss Per Share - Computation of Basic and Diluted Earnings (Loss) Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Numerator: | ||
Net loss applicable to common stockholders - basic and diluted (in shares) | $ (22,669) | $ (20,477) |
Denominator: | ||
Weighted-average number of common shares used in net loss per share applicable to common stockholders - basic and diluted (in shares) | 33,894 | 29,110 |
Net loss per share applicable to common stockholders - basic and diluted (in dollars per share) | $ (0.67) | $ (0.70) |
Stock options | ||
Anti-dilutive potential common stock equivalents excluded from the calculation of net loss per share*: | ||
Anti-dilutive stock options, restricted stock units, and warrants (in shares) | 5,366 | 4,633 |
Restricted stock units | ||
Anti-dilutive potential common stock equivalents excluded from the calculation of net loss per share*: | ||
Anti-dilutive stock options, restricted stock units, and warrants (in shares) | 822 | 799 |
Warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share | ||
Warrants to purchase common shares (in shares) | 1,800 | |
Anti-dilutive potential common stock equivalents excluded from the calculation of net loss per share*: | ||
Anti-dilutive stock options, restricted stock units, and warrants (in shares) | 61 | 61 |
Commitments - Additional Inform
Commitments - Additional Information (Details) ft² in Thousands, $ in Thousands | 1 Months Ended | 3 Months Ended | |||
Jan. 31, 2019USD ($) | Mar. 31, 2021USD ($)ft²extension | Mar. 31, 2020USD ($) | Dec. 31, 2020USD ($) | Jan. 01, 2019USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | |||||
Area of leased office and laboratory space (in square feet) | ft² | 56 | ||||
Term of contract (in years) | 10 years | ||||
Number of extensions (in year) | extension | 2 | ||||
Length of extension (in year) | 5 years | ||||
Annual base rent amount | $ 2,800 | ||||
Annual rent increase, percent | 3.00% | ||||
Abatement of base rent amount | $ 500 | ||||
Operating lease liability | $ 16,900 | ||||
Lease liability, current portion | 984 | $ 931 | |||
Lease liability, net of current portion | 14,791 | 15,065 | |||
Operating lease right-of-use assets | 8,884 | $ 8,968 | 9,500 | ||
Reduction to accrued rent | 2,900 | ||||
Reduction to incentive to lessee | $ 4,500 | ||||
Operating lease, expense | 600 | ||||
Operating lease, payments | $ 742 | $ 244 | |||
Weighted average remaining lease term (in years) | 7 years 9 months | 8 years 9 months | |||
Weighted average discount rate (in percent) | 13.08% | 13.08% |
Open Market Sale Agreement (Det
Open Market Sale Agreement (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||
Mar. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Mar. 07, 2021 | Nov. 05, 2020 | Nov. 04, 2020 | Mar. 01, 2019 | |
Subsidiary, Sale of Stock | |||||||
Receivables from shares sold | $ 500,000 | ||||||
ATM | |||||||
Subsidiary, Sale of Stock | |||||||
Sale of stock, authorized amount | $ 50,000,000 | ||||||
Sale of stock, commission rate (in percent) | 3.00% | 3.00% | 3.00% | 3.00% | |||
Number of shares issued in transaction (in shares) | 165,323 | 2,008,197 | 36,167 | ||||
Proceeds from issuance of common stock | $ 2,000,000 | $ 22,800,000 | $ 400,000 | ||||
Professional fees | $ 300,000 | $ 300,000 | |||||
ATM | Maximum | |||||||
Subsidiary, Sale of Stock | |||||||
Sale of stock, authorized amount | $ 50,000,000 | $ 100,000,000 | $ 50,000,000 |