Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2020 | Oct. 31, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2020 | |
Document Transition Report | false | |
Entity File Number | 001-35867 | |
Entity Registrant Name | CHIMERIX, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 33-0903395 | |
Entity Address, Address Line One | 2505 Meridian Parkway | |
Entity Address, Address Line Two | Suite 100 | |
Entity Address, City or Town | Durham | |
Entity Address, State or Province | NC | |
Entity Address, Postal Zip Code | 27713 | |
City Area Code | 919 | |
Local Phone Number | 806-1074 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | CMRX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 62,633,889 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001117480 | |
Current Fiscal Year End Date | --12-31 |
Consolidated Balance Sheets (Un
Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 38,130 | $ 16,901 |
Short-term investments, available-for-sale | 49,635 | 96,574 |
Accounts receivable | 378 | 1,233 |
Prepaid expenses and other current assets | 2,100 | 3,385 |
Total current assets | 90,243 | 118,093 |
Property and equipment, net of accumulated depreciation | 291 | 540 |
Operating lease right-of-use assets | 2,943 | 709 |
Other long-term assets | 27 | 34 |
Total assets | 93,504 | 119,376 |
Current liabilities: | ||
Accounts payable | 880 | 2,398 |
Accrued liabilities | 6,532 | 6,830 |
Total current liabilities | 7,412 | 9,228 |
Lease-related obligations | 2,923 | 196 |
Total liabilities | 10,335 | 9,424 |
Stockholders’ equity: | ||
Preferred stock, $0.001 par value, 10,000,000 shares authorized at September 30, 2020 and December 31, 2019; no shares issued and outstanding as of September 30, 2020 and December 31, 2019 | 0 | 0 |
Common stock, $0.001 par value, 200,000,000 shares authorized at September 30, 2020 and December 31, 2019; 62,629,722 and 61,590,013 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively | 63 | 62 |
Additional paid-in capital | 783,758 | 778,693 |
Accumulated other comprehensive gain, net | 33 | 35 |
Accumulated deficit | (700,685) | (668,838) |
Total stockholders’ equity | 83,169 | 109,952 |
Total liabilities and stockholders’ equity | $ 93,504 | $ 119,376 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
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) | 200,000,000 | 200,000,000 |
Common stock, shares issued (in shares) | 62,629,722 | 61,590,013 |
Common stock, shares outstanding (in shares) | 62,629,722 | 61,590,013 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Total revenues | $ 1,609 | $ 1,958 | $ 4,252 | $ 5,752 |
Operating expenses: | ||||
Research and development | 10,018 | 7,453 | 27,545 | 34,795 |
General and administrative | 3,151 | 4,024 | 9,466 | 18,022 |
Acquired in-process research and development | 0 | 65,045 | 0 | 65,045 |
Total operating expenses | 13,169 | 76,522 | 37,011 | 117,862 |
Loss from operations | (11,560) | (74,564) | (32,759) | (112,110) |
Other income: | ||||
Interest income and other, net | 149 | 834 | 912 | 3,037 |
Net loss | (11,411) | (73,730) | (31,847) | (109,073) |
Other comprehensive loss: | ||||
Unrealized (loss)/gain on debt investments, net | (97) | (36) | (2) | 182 |
Comprehensive loss | $ (11,508) | $ (73,766) | $ (31,849) | $ (108,891) |
Per share information: | ||||
Net loss, basic and diluted (in dollars per share) | $ (0.18) | $ (1.26) | $ (0.51) | $ (2.04) |
Weighted-average shares outstanding, basic and diluted (in shares) | 62,242,456 | 58,457,110 | 62,009,941 | 53,519,207 |
Contract revenue | ||||
Total revenues | $ 1,591 | $ 1,958 | $ 4,158 | $ 5,752 |
Licensing revenue | ||||
Total revenues | $ 18 | $ 0 | $ 94 | $ 0 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Gain (Loss) | Accumulated Deficit |
Beginning Balance at Dec. 31, 2018 | $ 177,604 | $ 51 | $ 733,907 | $ (92) | $ (556,262) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Share-based compensation | 4,073 | 4,073 | |||
Exercise of stock options | 13 | 13 | |||
Employee stock purchase plan purchases | 170 | 170 | |||
Comprehensive loss: | |||||
Unrealized gain (loss) on investments, net | 140 | 140 | |||
Net loss | (17,693) | (17,693) | |||
Comprehensive loss | (17,553) | ||||
Ending Balance at Mar. 31, 2019 | 164,307 | 51 | 738,163 | 48 | (573,955) |
Beginning Balance at Dec. 31, 2018 | 177,604 | 51 | 733,907 | (92) | (556,262) |
Comprehensive loss: | |||||
Unrealized gain (loss) on investments, net | 182 | ||||
Comprehensive loss | (108,891) | ||||
Ending Balance at Sep. 30, 2019 | 111,948 | 61 | 777,133 | 89 | (665,335) |
Beginning Balance at Mar. 31, 2019 | 164,307 | 51 | 738,163 | 48 | (573,955) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Share-based compensation | 2,367 | 2,367 | |||
Exercise of stock options | 17 | 17 | |||
Comprehensive loss: | |||||
Unrealized gain (loss) on investments, net | 77 | 77 | |||
Net loss | (17,650) | (17,650) | |||
Comprehensive loss | (17,573) | ||||
Ending Balance at Jun. 30, 2019 | 149,118 | 51 | 740,547 | 125 | (591,605) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Share-based compensation | 1,529 | 1,529 | |||
Exercise of stock options | 13 | 13 | |||
Employee stock purchase plan purchases | 154 | 154 | |||
Issuance of common stock, net of issuance costs | 34,900 | 10 | 34,890 | ||
Comprehensive loss: | |||||
Unrealized gain (loss) on investments, net | (36) | (36) | |||
Net loss | (73,730) | (73,730) | |||
Comprehensive loss | (73,766) | ||||
Ending Balance at Sep. 30, 2019 | 111,948 | 61 | 777,133 | 89 | (665,335) |
Beginning Balance at Dec. 31, 2019 | 109,952 | 62 | 778,693 | 35 | (668,838) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Share-based compensation | 1,326 | 1,326 | |||
Employee stock purchase plan purchases | 229 | 229 | |||
Comprehensive loss: | |||||
Unrealized gain (loss) on investments, net | (46) | (46) | |||
Net loss | (10,420) | (10,420) | |||
Comprehensive loss | (10,466) | ||||
Ending Balance at Mar. 31, 2020 | 101,041 | 62 | 780,248 | (11) | (679,258) |
Beginning Balance at Dec. 31, 2019 | 109,952 | 62 | 778,693 | 35 | (668,838) |
Comprehensive loss: | |||||
Unrealized gain (loss) on investments, net | (2) | ||||
Comprehensive loss | (31,849) | ||||
Ending Balance at Sep. 30, 2020 | 83,169 | 63 | 783,758 | 33 | (700,685) |
Beginning Balance at Mar. 31, 2020 | 101,041 | 62 | 780,248 | (11) | (679,258) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Share-based compensation | 1,391 | 1,391 | |||
Exercise of stock options | 578 | 578 | |||
Comprehensive loss: | |||||
Unrealized gain (loss) on investments, net | 141 | 141 | |||
Net loss | (10,016) | (10,016) | |||
Comprehensive loss | (9,875) | ||||
Ending Balance at Jun. 30, 2020 | 93,135 | 62 | 782,217 | 130 | (689,274) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Share-based compensation | 1,282 | 1,282 | |||
Exercise of stock options | 63 | 1 | 62 | ||
Employee stock purchase plan purchases | 197 | 197 | |||
Comprehensive loss: | |||||
Unrealized gain (loss) on investments, net | (97) | (97) | |||
Net loss | (11,411) | (11,411) | |||
Comprehensive loss | (11,508) | ||||
Ending Balance at Sep. 30, 2020 | $ 83,169 | $ 63 | $ 783,758 | $ 33 | $ (700,685) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (31,847) | $ (109,073) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation of property and equipment | 309 | 451 |
Amortization of discount/premium on investments | (268) | (1,557) |
Share-based compensation | 4,000 | 7,969 |
Fair value of common stock issued for license agreement | 0 | 34,900 |
(Gain)/loss on sale of investments | (1) | 31 |
Gain on sale of equipment | (10) | 0 |
Lease-related amortization | (47) | (57) |
Changes in operating assets and liabilities: | ||
Accounts receivable | 855 | (1,492) |
Prepaid expenses and other assets | 1,284 | 178 |
Accounts payable and accrued liabilities | (1,268) | (3,062) |
Net cash used in operating activities | (26,993) | (71,712) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (60) | (150) |
Proceeds from sale of property and equipment | 10 | 0 |
Purchases of short-term investments | (58,895) | (130,351) |
Proceeds from sales of short-term investments | 1,498 | 13,112 |
Proceeds from maturities of short-term investments | 104,602 | 127,000 |
Net cash provided by investing activities | 47,155 | 9,611 |
Cash flows from financing activities: | ||
Proceeds from exercise of stock options | 641 | 43 |
Proceeds from employee stock purchase plan | 426 | 324 |
Payments of deferred offering costs | 0 | (23) |
Net cash provided by financing activities | 1,067 | 344 |
Net increase (decrease) in cash and cash equivalents | 21,229 | (61,757) |
Cash and cash equivalents: | ||
Beginning of period | 16,901 | 81,106 |
End of period | $ 38,130 | $ 19,349 |
The Business and Summary of Sig
The Business and Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
The Business and Summary of Significant Accounting Policies | The Business and Summary of Significant Accounting Policies Description of Business Chimerix, Inc. (the Company) is a development-stage biopharmaceutical company dedicated to accelerating the advancement of innovative medicines that make a meaningful impact in the lives of patients living with cancer and other serious diseases. The Company has two clinical-stage product candidates, dociparstat sodium (DSTAT) and brincidofovir (BCV). DSTAT is a heparin derivative with significantly decreased anticoagulant activity; this enables dosing at higher concentrations to achieve anti-inflammatory and other potentially beneficial effects that cannot be safely achieved with commercially available forms of heparin. DSTAT is in development as a potential first-line therapy in acute myeloid leukemia (AML) and as a potential treatment for acute lung injury (ALI) in COVID-19 patients. BCV is an investigational lipid conjugate that is in development as a medical countermeasure for smallpox. The Company expects to continue its evaluation of external innovation in order to license, acquire or otherwise gain access to molecules that further broaden its pipeline of investigational agents in cancer or other serious diseases. Basis of Presentation The accompanying unaudited consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) for interim financial information, 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 GAAP for complete financial statements and should be read in conjunction with the Company’s audited financial statements and notes thereto included in its Annual Report on Form 10-K for the year ended December 31, 2019. In the opinion of the Company’s management, all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of its financial position, operating results and cash flows for the periods presented have been included. Operating results for the three and nine months ended September 30, 2020 are not necessarily indicative of the results that may be expected for the full year, for any other interim period or for any future year. Reclassifications Certain prior period amounts in the accompanying consolidated financial statements have been reclassified to conform to the current year presentation. These reclassifications had no effect on previously reported net income or stockholders' equity (deficit). Fair Value of Financial Instruments The carrying amounts of certain financial instruments, including accounts receivable, accounts payable and accrued expenses approximate their fair values due to the short-term nature of such instruments. For assets and liabilities recorded at fair value, it is the Company’s policy to maximize the use of observable inputs and minimize the use of unobservable inputs when developing fair value measurements, in accordance with the fair value hierarchy. Fair value measurements for assets and liabilities where there exists limited or no observable market data are based primarily upon estimates and are often calculated based on the economic and competitive environment, the characteristics of the asset or liability and other factors. Therefore, fair value measurements cannot be determined with precision and may not be realized in an actual sale or immediate settlement of the asset or liability. Additionally, there may be inherent weaknesses in any calculation technique and changes in the underlying assumptions used, including discount rates and estimates of future cash flows, could significantly affect the calculated current or future fair values. The Company utilizes fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures. The Company groups assets and liabilities at fair value in three levels, based on the markets in which the assets and liabilities are traded and the reliability of the assumptions used to determine fair value. The determination of where an asset or liability falls in the hierarchy requires significant judgment. These levels are: • Level 1 — Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access. • Level 2 — Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, and models for which all significant inputs are observable, either directly or indirectly. • Level 3 — Valuations based on inputs that are unobservable and significant to the overall fair value measurement. At September 30, 2020 and December 31, 2019, the Company had cash equivalents including money market funds, whose value is based on quoted market prices. At September 30, 2020 and December 31, 2019, the Company had short term investments, including U.S. Treasury securities, whose value is based on quoted market prices. Accordingly, these securities are classified as Level 1. At September 30, 2020 and December 31, 2019, the Company had short-term investments, including commercial paper and corporate bonds. As quoted prices are not available for these securities, they are valued using independent pricing models or other model-based valuation techniques such as the present value of future cash flows, adjusted for the security’s credit rating, prepayment assumptions and other factors such as credit loss assumptions. Accordingly, these securities are classified as Level 2. There was no material re-measurement to fair value of financial assets and liabilities that are not measured at fair value on a recurring basis. For additional information regarding the Company's investments, please refer to Note 2, "Investments." Below are tables that present information about certain assets measured at fair value on a recurring basis (in thousands): Fair Value Measurements September 30, 2020 Total Quoted Prices in Significant Other Significant Cash equivalents Money market funds $ 34,816 $ 34,816 $ — $ — Total cash equivalents 34,816 34,816 — — Short-term investments U.S. treasury securities 34,227 34,227 — — Commercial paper 3,999 — 3,999 — Corporate bonds 11,409 — 11,409 — Total short-term investments 49,635 34,227 15,408 — Total assets $ 84,451 $ 69,043 $ 15,408 $ — Fair Value Measurements December 31, 2019 Total Quoted Prices in Significant Other Significant Cash equivalents Money market funds $ 11,854 $ 11,854 $ — $ — Total cash equivalents 11,854 11,854 — — Short-term investments U.S. treasury securities 22,493 22,493 — — Commercial paper 43,119 — 43,119 — Corporate bonds 30,962 — 30,962 — Total short-term investments 96,574 22,493 74,081 — Total assets $ 108,428 $ 34,347 $ 74,081 $ — Accrued Liabilities Accrued liabilities consisted of the following (in thousands): September 30, 2020 December 31, 2019 Accrued research and development expenses $ 3,034 $ 1,868 Accrued compensation 2,752 3,626 Other accrued liabilities 746 1,336 Total accrued liabilities $ 6,532 $ 6,830 Revenue Recognition Policy The Company’s revenues generally consist of (i) contract revenue - revenue generated under federal contracts, and (ii) collaboration and licensing revenue - revenue related to non-refundable upfront fees, royalties and milestone payments earned under license agreements. Revenue is recognized in accordance with the criteria outlined in Accounting Standards Codification (ASC) 606 issued by the Financial Accounting Standards Board (FASB). Following this accounting pronouncement, a five-step approach is applied for recognizing revenue, including (1) identify the contract with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when, or as, the entity satisfies a performance obligation. Biomedical Advanced Research and Development Authority (BARDA) In February 2011, the Company entered into a contract with BARDA for the advanced development of BCV as a medical countermeasure in the event of a smallpox release. Under the contract, the Company may receive up to $75.8 million in expense reimbursement and $5.3 million in fees over the performance of 1 base segment and 4 option segments. Exercise of each option segment is solely at the discretion of BARDA. The Company assessed the services in accordance with the authoritative guidance and concluded that there is a potential of 5 separate contracts (1 base segment and 4 option segments) within this agreement, each of which has a single performance obligation. At present, all option segments (1 through 4) have been exercised, as well as the base segment. The transaction price for each segment, based on the transaction price as defined in each segment contract, is allocated to the single performance obligation for each contract. The transaction price is recognized over time by measuring the progress toward complete satisfaction of the performance obligation. For reimbursable expenses, this occurs as qualifying research activities are conducted based on invoices from company vendors. For the fixed fee, the progress toward complete satisfaction is estimated based on the costs incurred to date relative to the total estimated costs per the terms of each contract. The Company typically invoices BARDA monthly as costs are incurred. Any amounts received in advance of performance are recorded as deferred revenue until earned. The base segment and first option segment were completed prior to adoption of ASC 606. The Company is currently performing under the fourth option segment of the contract during which the Company may receive up to a total of $4.6 million in expense reimbursement and fees. The second and third option segments were completed on August 20, 2020. The fourth option segment is scheduled to end on February 15, 2021. SymBio Pharmaceuticals On September 30, 2019, the Company entered into a license agreement with SymBio Pharmaceuticals Limited (SymBio) under which the Company granted SymBio exclusive worldwide rights to develop, manufacture and commercialize BCV for all human indications, excluding the prevention and treatment of orthopoxviruses, including smallpox. The Company assessed the agreement in accordance with the authoritative guidance and concluded that the SymBio contract includes multiple performance obligations. The SymBio contract has one fixed transaction amount of a $5.0 million upfront payment received in October 2019 and several variable transaction amounts, up to $180 million, due to the Company at certain regulatory and commercial milestones, along with low double-digit percent royalties based on net sales of BCV. All variable transaction amounts are fully constrained, therefore the allocated transaction price is $5.0 million. The majority of the transaction price of the contract has been allocated to the combined performance obligation of the granting of the license to BCV and associated technology transfer which was recognized when the technology transfer was completed in the fourth quarter of 2019. The revenue from regulatory and commercial milestones and royalties from net sales will be recognized upon the occurrence of the triggering events or when those transaction amounts are no longer fully constrained. Research and Development Prepaids and Accruals As part of the process of preparing financial statements, the Company is required to estimate its expenses resulting from its obligation under contracts with vendors and consultants and clinical site agreements in connection with its research and development efforts. The financial terms of these contracts are subject to negotiations which vary contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to the Company under such contracts. The Company’s objective is to reflect the appropriate research and development expenses in its financial statements by matching those expenses with the period in which services and efforts are expended. The Company accounts for these expenses according to the progress of its research and development efforts. The Company determines prepaid and accrual estimates through discussion with applicable personnel and outside service providers as to the progress or state of communication of clinical trials, or other services completed. The Company adjusts its rate of research and development expense recognition if actual results differ from its estimates. The Company makes estimates of its prepaid and accrued expenses as of each balance sheet date in its financial statements based on facts and circumstances known at that time. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of status and timing of services performed relative to the actual status and timing of services performed may vary and may result in the Company reporting amounts that are too high or too low for any particular period. Through September 30, 2020, there had been no material adjustments to the Company’s prior period estimates of prepaid and accruals for research and development expenses. The Company’s research and development prepaids and accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Basic and Diluted Net Loss Per Share of Common Stock Basic net loss per share of common stock is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during the period, excluding the dilutive effects of non-vested restricted stock, stock options, and employee stock purchase plan purchase rights. Diluted net loss per share of common stock is computed by dividing net loss by the sum of the weighted-average number of shares of common stock outstanding during the period plus the potential dilutive effects of non-vested restricted stock, stock options, and employee stock purchase plan purchase rights outstanding during the period calculated in accordance with the treasury stock method, but are excluded if their effect is anti-dilutive. Because the impact of these items is anti-dilutive during the periods of net loss, there was no difference between basic and diluted loss per share of common stock for the three and nine months ended September 30, 2020 and 2019. Impact of Recently Issued Accounting Standards In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments |
Investments
Investments | 9 Months Ended |
Sep. 30, 2020 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | Investments The following tables summarize the Company's debt investments (in thousands): September 30, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Corporate bonds $ 11,381 $ 28 $ — $ 11,409 U.S. treasury securities 34,230 2 (5) 34,227 Commercial paper 3,990 9 — 3,999 Total investments $ 49,601 $ 39 $ (5) $ 49,635 December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Corporate bonds $ 30,952 $ 19 $ (9) $ 30,962 Commercial paper 43,109 14 (4) 43,119 U.S. treasury securities 22,478 17 (2) 22,493 Total investments $ 96,539 $ 50 $ (15) $ 96,574 The following tables summarize the Company's debt investments with unrealized losses, aggregated by investment type and the length of time that individual investments have been in a continuous unrealized loss position (in thousands, except number of securities): September 30, 2020 Less than 12 Months Greater than 12 Months Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss U.S. treasury securities $ 25,128 $ (5) $ — $ — $ 25,128 $ (5) Total $ 25,128 $ (5) $ — $ — $ 25,128 $ (5) Number of securities with unrealized losses 8 — 8 December 31, 2019 Less than 12 Months Greater than 12 Months Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate bonds $ 9,657 $ (9) $ — $ — $ 9,657 $ (9) Commercial paper 10,147 (4) — — 10,147 (4) U.S. treasury securities 2,994 (2) — — 2,994 (2) Total $ 22,798 $ (15) $ — $ — $ 22,798 $ (15) Number of securities with unrealized losses 9 — 9 The Company periodically reviews available-for-sale debt investments for other-than-temporary declines in fair value below the cost basis and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company evaluates, among other things, the duration and extent to which the fair value of a security is less than its cost; the financial condition of the issuer and any changes thereto; and the Company’s intent to sell, or whether it will more likely than not be required to sell, the security before recovery of its cost basis. At September 30, 2020, the Company did not intend to sell, and was not more likely than not to be required to sell, the available-for-sale debt investments in an unrealized loss position before recovery of the cost basis of the securities, which may be at maturity. There were no such declines in value for the three and nine months ended September 30, 2020 and 2019. Unrealized gains and losses on debt investments are recorded to unrealized (loss) gain on debt investments, net in the Consolidated Statements of Operations and Comprehensive Loss. The Company recognizes interest income on an accrual basis in interest income in the Consolidated Statements of Operations and Comprehensive Loss. The following table summarizes the scheduled maturity for the Company's debt investments at September 30, 2020 (in thousands): Maturing in one year or less $ 49,635 Maturing after one year through two years — Total debt investments $ 49,635 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Leases The Company leases its facilities under long-term operating leases that expire at various dates through 2026. The Company generally has options to renew lease terms on its facilities, which may be exercised at the Company's sole discretion. In addition, certain lease arrangements may be terminated prior to their original expiration date at the Company's discretion. The Company evaluates renewal and termination options at the lease commencement date to determine if it is reasonably certain to exercise the option and has concluded on all operating leases that it is not reasonably certain that any options will be exercised. The weighted-average remaining lease term for the Company's operating leases as of September 30, 2020 was 6.03 years. Expense related to leases is recorded on a straight-line basis over the lease term. Lease expense under operating leases, including common area maintenance fees, totaled approximately $184,000 and $187,000, respectively, for the three months ended September 30, 2020 and 2019, and $550,000 and $563,000 for the nine months ended September 30, 2020 and 2019, respectively. The discount rate implicit within the Company's leases is generally not determinable and therefore the Company determines the discount rate based on its incremental borrowing rate based on the information available at commencement date. As of September 30, 2020, the operating lease liabilities reflect a weighted-average discount rate of 7.93%. The following table sets forth the operating lease right-of-use assets and liabilities as of September 30, 2020 (in thousands): Assets Operating lease right-of-use assets $ 2,943 Liabilities Operating lease short-term liabilities (recorded within Accrued liabilities) $ 91 Operating lease long-term liabilities (recorded within Lease-related obligations) 2,923 Total operating lease liabilities $ 3,014 Operating lease payments over the remainder of the lease terms are as follows (in thousands): Years Ending December 31, As of September 30, 2020 2020 $ 147 2021 (1) 260 2022 715 2023 736 2024 759 All remaining years 1,248 Total future minimum rental payments $ 3,865 Less amount of lease payments representing interest 851 Total present value of lease payments $ 3,014 (1) The Company entered into the Ninth Amendment of its lease for the Company's headquarters in Durham, North Carolina, which extended the term of the lease 65 months to July 31, 2026. As part of the amendment, the Company will receive a rent abatement of the first 5 months of the new lease term which begins on March 1, 2021. Additionally, the Ninth Amendment grants the Company a refurbishment allowance, which the Company expects to receive in 2021 after the refurbishment has been completed. As of December 31, 2019, operating lease payments over the remainder of the lease terms were as follows (in thousands): Years Ending December 31, As of December 31, 2019 2020 $ 719 2021 182 Total future minimum rental payments $ 901 Less amount of lease payments representing interest 66 Total present value of lease payments $ 835 For the three months ended September 30, 2020 and 2019, the Company made lease payments of approximately $181,000 and $188,000, respectively, and for the nine months ended September 30, 2020 and 2019, the Company made lease payments of approximately $538,000 and $574,000, respectively, which are included in operating cash flows. Sublease The Company subleases 3,537 square feet of its office space under a non-cancelable operating lease that expires in February 2021. For the three and nine months ended September 30, 2020 and 2019, the Company recognized approximately $18,000 and $53,000 of income in Interest income and other, net on the Consolidated Statement of Operations and Comprehensive Loss. Total future minimum rentals under the non-cancelable operating sublease are presented below (in thousands): Years Ending December 31, As of September 30, 2020 2020 $ 21 2021 14 Total future minimum sublease rentals $ 35 Significance of Revenue Source The Company is the recipient of federal research contract funds from BARDA, the sole source of the Company's contract revenue. Periodic audits are required under the Company’s BARDA agreement and certain costs may be questioned as appropriate under the BARDA agreement. Management believes that such amounts in the current year, if any, are not significant. Accordingly, no provision for refundable amounts under the BARDA agreement had been made as of September 30, 2020 and December 31, 2019. |
Equity Transactions and Share-b
Equity Transactions and Share-based Compensation | 9 Months Ended |
Sep. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Equity Transactions and Share-based Compensation | Equity Transactions and Share-based Compensation Stock Options The Company maintains a 2013 Equity Incentive Plan (the 2013 Plan), which provides for the grant of incentive stock options (ISOs), non-statutory stock options (NSOs), stock appreciation rights, restricted stock awards, restricted stock unit (RSU) awards, performance-based stock awards, and other forms of equity compensation (collectively, stock awards), all of which may be granted to employees, including officers, non-employee directors and consultants of the Company and its affiliates. Additionally, the 2013 Plan provides for the grant of performance cash awards. The number of shares of common stock reserved for future issuance automatically increases on January 1 of each calendar year by 4% of the total number of shares of capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the Company’s board of directors. On January 1, 2020, the common stock reserved for issuance under the 2013 Plan was automatically increased by 2.5 million shares. As of September 30, 2020, there was a total of 3.4 million shares reserved for future issuance under the 2013 Plan. The Company issued approximately 21,000 and 263,000 shares of common stock pursuant to the exercise of stock options during the three and nine months ended September 30, 2020. The Company issued approximately 5,000 and 19,000 shares of common stock pursuant to the exercise of stock options during the three and nine months ended September 30, 2019, respectively. Employee Stock Purchase Plan The Company maintains a 2013 Employee Stock Purchase Plan (ESPP), which provides for the issuance of shares of common stock pursuant to purchase rights granted to the Company’s employees or to employees of any of its designated affiliates. The Company has reserved a total of 3.5 million shares of common stock to be purchased under the ESPP, of which 2.4 million shares remained available for purchase as of September 30, 2020. The number of shares of common stock reserved for issuance automatically increases on January 1 of each calendar year, by the lesser of (a) 1% of the total number of shares of common stock outstanding on December 31 of the preceding calendar year, (b) 422,535 shares, or (c) a number determined by the Company’s board of directors that is less than (a) and (b). On January 1, 2020, the common stock reserved for issuance under the ESPP was automatically increased by an additional 422,535 shares. The ESPP provides for an automatic reset feature to start participants on a new twenty-four month participation period in the event that the common stock market value on a purchase date is less than the common stock value on the first day of the twenty-four month offering period. Eligible employees may authorize an amount up to 15% of their salary to purchase common stock at the lower of a 15% discount to the beginning price of their offering period or a 15% discount to the ending price of each six-month purchase interval. The Company issued approximately 160,000 and 96,000 shares of common stock pursuant to the ESPP during the three months ended September 30, 2020 and 2019, respectively. The Company issued approximately 337,000 and 209,000 shares of common stock pursuant to the ESPP during the nine months ended September 30, 2020 and 2019, respectively. Compensation expense for shares purchased under the ESPP related to the purchase discount and the “look-back” option and were determined using a Black-Scholes option pricing model. Restricted Stock Units The Company has issued RSUs to certain employees which vest based on service criteria. When vested, the RSU represents the right to be issued the number of shares of the Company's common stock that is equal to the number of RSUs granted. The grant date fair value for RSUs is based upon the market price of the Company's common stock on the date of the grant. The fair value is then amortized to compensation expense over the requisite service period or vesting term. The Company issued approximately 277,000 and 440,000 shares of common stock pursuant to the vesting of RSUs during the three and nine months ended September 30, 2020, respectively. The Company issued approximately 50,000 and 419,000 shares of common stock pursuant to the vesting of RSUs during the three and nine months ended September 30, 2019, respectively. Stock-based Compensation For awards with only service conditions and graded-vesting features, the Company recognizes compensation expense on a straight-line basis over the requisite service period. Total share-based compensation expense recognized related to stock options, the ESPP and RSUs was as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Research and development expense $ 625 $ 901 $ 2,090 $ 3,170 General and administrative expense 657 628 1,910 4,799 Total share-based compensation expense $ 1,282 $ 1,529 $ 4,000 $ 7,969 Compensation expense for the nine months ended September 30, 2019 includes $1.8 million of share-based compensation expense related to the accelerated vesting and modification of stock options and RSUs of the Company's then President and CEO in connection with her severance agreement. Related to the Company's reduction in workforce that occurred in May 2019, compensation expense for the nine months ended September 30, 2019 includes $0.7 million of share-based compensation expense related to the accelerated vesting and modifications of stock options and RSUs. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company estimates an annual effective tax rate of 0% for the year ending December 31, 2020 as the Company incurred losses for the nine month period ended September 30, 2020, and is forecasting an estimated net loss for both financial statement and tax purposes for the year ending December 31, 2020. Therefore, no federal or state income taxes are expected and none have been recorded at this time. Income taxes have been accounted for using the liability method in accordance with FASB ASC 740. Due to the Company's history of losses since inception, there is not enough evidence at this time to support that the Company will generate future income of a sufficient amount and nature to utilize the benefits of its net deferred tax assets. Accordingly, the deferred tax assets have been reduced by a full valuation allowance, since the Company cannot currently support that realization of its deferred tax assets is more likely than not. However, the Company feels its deferred tax assets may be used upon the Company becoming profitable. At September 30, 2020, the Company had no unrecognized tax benefits that would reduce the Company’s effective tax rate if recognized. |
Significant Agreements
Significant Agreements | 9 Months Ended |
Sep. 30, 2020 | |
Revenue Recognition [Abstract] | |
Significant Agreements | Significant Agreements Biomedical Advanced Research and Development Authority (BARDA) In February 2011, the Company entered into a contract with BARDA for the advanced development of BCV as a medical countermeasure in the event of a smallpox release. Under the contract, BARDA will reimburse the Company, plus pay a fixed fee, for the research and development of BCV as a broad-spectrum therapeutic antiviral for the treatment of smallpox infections. The contract consists of an initial performance period, referred to as the base performance segment, plus up to four extension periods, referred to as option segments, of which all have been exercised. Under the contract as currently in effect, the Company may receive up to $75.8 million in expense reimbursement and $5.3 million in fees. The Company is currently performing under the fourth option segment of the contract during which the Company may receive up to a total of $4.6 million in expense reimbursement and fees. The second and third option segments were completed on August 20, 2020. The fourth option segment is scheduled to end on February 15, 2021. Of the $75.8 million in expense reimbursement and $5.3 million in fees that the Company may receive, approximately $78.9 million in expense reimbursement and fees has been awarded. As of September 30, 2020, of the total funding the Company had invoiced an aggregate of $74.4 million with respect to the base performance segment and the four option segments. For the three months ended September 30, 2020 and 2019, the Company recognized revenue under this contract of $1.6 million and $2.0 million, respectively, and for the nine months ended September 30, 2020 and 2019, the Company recognized revenue under this contract of $4.2 million and $5.8 million, respectively. Cantex Pharmaceuticals, Inc. On July 26, 2019, the Company entered into a License and Development Agreement with Cantex Pharmaceuticals, Inc. (Cantex) pursuant to which the Company acquired exclusive worldwide rights to develop and commercialize, for any and all uses, a glycosaminoglycan compound known as DSTAT, which is currently being studied for the treatment of acute myeloid leukemia and acute lung injury in patients with COVID-19. Under the terms of the license agreement, the Company will be responsible for, and bear the future costs of, worldwide development and commercialization of DSTAT. In connection with the transaction, Cantex assigned to the Company all of its rights under its DSTAT supply agreements, including its bulk API agreement with Scientific Protein Laboratories LLC (SPL), pursuant to which SPL will exclusively produce DSTAT for the Company through October 2030. In consideration for the license rights, the Company made an upfront cash payment of $30.0 million to Cantex and issued to Cantex 10.0 million shares of its common stock. During 2019, the Company recognized $65.0 million of acquired in-process research and development expenses for the $30.0 million upfront cash payment, the fair value of the 10.0 million shares of common stock issued to Cantex and $0.1 million of transaction costs. The license agreement obligates the Company to pay Cantex regulatory milestone payments of up to $202.5 million upon receipt of product approvals in the United States, the European Union and Japan, and sales milestone payments of up to $385.0 million upon achievement of specified net sales levels. The Company also agreed to pay Cantex tiered royalties based on percentages of net sales beginning at 10% and not to exceed the high-teens. SymBio Pharmaceuticals On September 30, 2019, the Company entered into a license agreement with SymBio under which the Company granted SymBio exclusive worldwide rights to develop, manufacture and commercialize BCV for all human indications, excluding the prevention and treatment of orthopoxviruses, including smallpox. Under the terms of the license agreement, SymBio will be responsible for, and bear the future costs of, worldwide development and commercialization of BCV in the licensed indications. Either party may terminate the license agreement upon the occurrence of a material breach by the other party (subject to standard cure periods). SymBio may also terminate the license agreement without cause on a country-by-country basis upon ninety days' prior notice. In exchange for the license to SymBio under the Company's BCV rights, the Company received an upfront payment of $5.0 million in October 2019. In addition, the Company is eligible to receive up to $180.0 million in clinical, regulatory and commercial milestones worldwide, as well as low double-digit percent royalties based on net sales of BCV. Since entering into the license agreement in September 2019, the Company has recognized all of the $5.0 million upfront payment. |
Restructuring Costs
Restructuring Costs | 9 Months Ended |
Sep. 30, 2020 | |
Restructuring and Related Activities [Abstract] | |
Restructuring Costs | Restructuring CostsIn May 2019, the Company made the decision to discontinue the development of oral and IV BCV development programs for the treatment of Adenovirus (AdV) in stem-cell transplant (HCT) patients. The Company's development efforts with respect to BCV are now focused on the treatment of smallpox. As a result, the Company restructured its operations, which included a reduction in workforce of 43 full-time employees and the accrual of expenses to close-out the clinical trials for the oral and IV development programs of BCV in AdV (study 210, study 211, AdAPT) and other supportive BCV development programs. In 2019, the Company recorded charges for one-time employee termination benefits of $3.3 million, contract close-out costs of $2.0 million, other BCV development costs of $0.3 million, and losses on disposals of fixed assets of $0.3 million during 2019. The $2.0 million of contract close-out costs were recorded through an increase in liabilities of $1.5 million with the remainder recognized through the expensing of prepaid balances. As of December 31, 2019, the Company had a clinical trial accrual balance related to the AdAPT, 210 and 211 trial terminations of $27,000, other development costs accrual balance of $0.1 million, and severance accrual balance of $0.2 million. Additionally, as of December 31, 2019 prepaid balances of $1.3 million for unused deposits have been reclassed to other receivables, which was recorded in prepaid expenses and other current assets on the Consolidated Balance Sheet. The following table summarizes the restructuring charges (in thousands) recorded in 2019 during the period subsequent to the restructuring in May 2019: Employee Termination Benefits Clinical Trial Close-out Costs Other Development Costs Fixed Asset Disposals Total Research and development $ 1,437 $ 2,021 $ 339 $ — $ 3,797 General and administrative 1,909 — — — 1.909 Interest income and other, net — — — 250 250 Total restructuring expenses $ 3,346 $ 2,021 $ 339 $ 250 $ 5,956 For the three months ended September 30, 2019, the Company recorded a $156,000 reduction of research and development restructuring charges. For the nine months ended September 30, 2019, $4.4 million of research and development and $1.9 million of general and administrative restructuring charges were recorded. The following table sets forth the accrual activity for employee termination benefits and contract close-out costs (in thousands) for 2019. Employee Termination Benefits Clinical Trial Close-out Costs Other Development Costs Fixed Asset Disposals Total Balance at January 1, 2019 $ — $ — $ — $ — $ — Accruals 3,335 2,131 315 — 5,781 Revised estimates 11 (621) 24 250 (336) Payments (3,163) (1,483) (229) (250) (5,125) Balance at December 31, 2019 $ 183 $ 27 $ 110 $ — $ 320 The following table sets forth the accrual activity for employee termination benefits and contract close-out costs (in thousands) for the nine months ended September 30, 2020. Employee Termination Benefits Clinical Trial Close-out Costs Other Development Costs Total Balance at December 31, 2019 $ 183 $ 27 $ 110 $ 320 Revised estimates — (14) — (14) Payments (114) (4) (100) (218) Balance at March 31, 2020 $ 69 $ 9 $ 10 $ 88 Revised estimates — (5) — (5) Payments (69) — — (69) Balance at June 30, 2020 $ — $ 4 $ 10 $ 14 Revised estimates — (4) (10) (14) Payments — — — — Balance at September 30, 2020 $ — $ — $ — $ — For the three and nine months ended September 30, 2020, the revised accrual estimates resulted in a decrease to research and development expenses of $14,000 and $33,000, respectively. Additionally, during the nine months ended September 30, 2020 refunds of unused deposits of $1.3 million were received, which were previously recorded in prepaid expenses and other current assets on the Consolidated Balance Sheet. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent EventsThe Company has evaluated subsequent events through the issuance date of these financial statements to ensure that this filing includes appropriate disclosure of events both recognized in the financial statements as of September 30, 2020, and events which occurred subsequently but were not recognized in the financial statements. |
The Business and Summary of S_2
The Business and Summary of Significant Accounting Policies (Policy) | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of PresentationThe accompanying unaudited consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) for interim financial information, 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 GAAP for complete financial statements and should be read in conjunction with the Company’s audited financial statements and notes thereto included in its Annual Report on Form 10-K for the year ended December 31, 2019. In the opinion of the Company’s management, all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of its financial position, operating results and cash flows for the periods presented have been included. Operating results for the three and nine months ended September 30, 2020 are not necessarily indicative of the results that may be expected for the full year, for any other interim period or for any future year. |
Reclassifications | Reclassifications Certain prior period amounts in the accompanying consolidated financial statements have been reclassified to conform to the current year presentation. These reclassifications had no effect on previously reported net income or stockholders' equity (deficit). |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amounts of certain financial instruments, including accounts receivable, accounts payable and accrued expenses approximate their fair values due to the short-term nature of such instruments. For assets and liabilities recorded at fair value, it is the Company’s policy to maximize the use of observable inputs and minimize the use of unobservable inputs when developing fair value measurements, in accordance with the fair value hierarchy. Fair value measurements for assets and liabilities where there exists limited or no observable market data are based primarily upon estimates and are often calculated based on the economic and competitive environment, the characteristics of the asset or liability and other factors. Therefore, fair value measurements cannot be determined with precision and may not be realized in an actual sale or immediate settlement of the asset or liability. Additionally, there may be inherent weaknesses in any calculation technique and changes in the underlying assumptions used, including discount rates and estimates of future cash flows, could significantly affect the calculated current or future fair values. The Company utilizes fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures. The Company groups assets and liabilities at fair value in three levels, based on the markets in which the assets and liabilities are traded and the reliability of the assumptions used to determine fair value. The determination of where an asset or liability falls in the hierarchy requires significant judgment. These levels are: • Level 1 — Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access. • Level 2 — Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, and models for which all significant inputs are observable, either directly or indirectly. • Level 3 — Valuations based on inputs that are unobservable and significant to the overall fair value measurement. At September 30, 2020 and December 31, 2019, the Company had cash equivalents including money market funds, whose value is based on quoted market prices. At September 30, 2020 and December 31, 2019, the Company had short term investments, including U.S. Treasury securities, whose value is based on quoted market prices. Accordingly, these securities are classified as Level 1. At September 30, 2020 and December 31, 2019, the Company had short-term investments, including commercial paper and corporate bonds. As quoted prices are not available for these securities, they are valued using independent pricing models or other model-based valuation techniques such as the present value of future cash flows, adjusted for the security’s credit rating, prepayment assumptions and other factors such as credit loss assumptions. Accordingly, these securities are classified as Level 2. There was no material re-measurement to fair value of financial assets and liabilities that are not measured at fair value on a recurring basis. For additional information regarding the Company's investments, please refer to Note 2, "Investments." |
Revenue Recognition | Revenue Recognition Policy The Company’s revenues generally consist of (i) contract revenue - revenue generated under federal contracts, and (ii) collaboration and licensing revenue - revenue related to non-refundable upfront fees, royalties and milestone payments earned under license agreements. Revenue is recognized in accordance with the criteria outlined in Accounting Standards Codification (ASC) 606 issued by the Financial Accounting Standards Board (FASB). Following this accounting pronouncement, a five-step approach is applied for recognizing revenue, including (1) identify the contract with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when, or as, the entity satisfies a performance obligation. Biomedical Advanced Research and Development Authority (BARDA) In February 2011, the Company entered into a contract with BARDA for the advanced development of BCV as a medical countermeasure in the event of a smallpox release. Under the contract, the Company may receive up to $75.8 million in expense reimbursement and $5.3 million in fees over the performance of 1 base segment and 4 option segments. Exercise of each option segment is solely at the discretion of BARDA. The Company assessed the services in accordance with the authoritative guidance and concluded that there is a potential of 5 separate contracts (1 base segment and 4 option segments) within this agreement, each of which has a single performance obligation. At present, all option segments (1 through 4) have been exercised, as well as the base segment. The transaction price for each segment, based on the transaction price as defined in each segment contract, is allocated to the single performance obligation for each contract. The transaction price is recognized over time by measuring the progress toward complete satisfaction of the performance obligation. For reimbursable expenses, this occurs as qualifying research activities are conducted based on invoices from company vendors. For the fixed fee, the progress toward complete satisfaction is estimated based on the costs incurred to date relative to the total estimated costs per the terms of each contract. The Company typically invoices BARDA monthly as costs are incurred. Any amounts received in advance of performance are recorded as deferred revenue until earned. The base segment and first option segment were completed prior to adoption of ASC 606. The Company is currently performing under the fourth option segment of the contract during which the Company may receive up to a total of $4.6 million in expense reimbursement and fees. The second and third option segments were completed on August 20, 2020. The fourth option segment is scheduled to end on February 15, 2021. SymBio Pharmaceuticals |
Research and Development Prepaids and Accruals | Research and Development Prepaids and Accruals As part of the process of preparing financial statements, the Company is required to estimate its expenses resulting from its obligation under contracts with vendors and consultants and clinical site agreements in connection with its research and development efforts. The financial terms of these contracts are subject to negotiations which vary contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to the Company under such contracts. The Company’s objective is to reflect the appropriate research and development expenses in its financial statements by matching those expenses with the period in which services and efforts are expended. The Company accounts for these expenses according to the progress of its research and development efforts. The Company determines prepaid and accrual estimates through discussion with applicable personnel and outside service providers as to the progress or state of communication of clinical trials, or other services completed. The Company adjusts its rate of research and development expense recognition if actual results differ from its estimates. The Company makes estimates of its prepaid and accrued expenses as of each balance sheet date in its financial statements based on facts and circumstances known at that time. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of status and timing of services performed relative to the actual status and timing of services performed may vary and may result in the Company reporting amounts that are too high or too low for any particular period. Through September 30, 2020, there had been no material adjustments to the Company’s prior period estimates of prepaid and accruals for research and development expenses. The Company’s research and development prepaids and accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. |
Basic and Diluted Net Loss Per Share of Common Stock | Basic and Diluted Net Loss Per Share of Common Stock Basic net loss per share of common stock is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during the period, excluding the dilutive effects of non-vested restricted stock, stock options, and employee stock purchase plan purchase rights. Diluted net loss per share of common stock is computed by dividing net loss by the sum of the weighted-average number of shares of common stock outstanding during the period plus the potential dilutive effects of non-vested restricted stock, stock options, and employee stock purchase plan purchase rights outstanding during the period calculated in accordance with the treasury stock method, but are excluded if their effect is anti-dilutive. Because the impact of these items is anti-dilutive during the periods of net loss, there was no difference between basic and diluted loss per share of common stock for the three and nine months ended September 30, 2020 and 2019. |
Impact of Recently Issued Accounting Standards and Impact of Recently Adopted Accounting Standards | Impact of Recently Issued Accounting Standards In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments |
The Business and Summary of S_3
The Business and Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Schedule of certain assets measured at fair value on a recurring basis | Below are tables that present information about certain assets measured at fair value on a recurring basis (in thousands): Fair Value Measurements September 30, 2020 Total Quoted Prices in Significant Other Significant Cash equivalents Money market funds $ 34,816 $ 34,816 $ — $ — Total cash equivalents 34,816 34,816 — — Short-term investments U.S. treasury securities 34,227 34,227 — — Commercial paper 3,999 — 3,999 — Corporate bonds 11,409 — 11,409 — Total short-term investments 49,635 34,227 15,408 — Total assets $ 84,451 $ 69,043 $ 15,408 $ — Fair Value Measurements December 31, 2019 Total Quoted Prices in Significant Other Significant Cash equivalents Money market funds $ 11,854 $ 11,854 $ — $ — Total cash equivalents 11,854 11,854 — — Short-term investments U.S. treasury securities 22,493 22,493 — — Commercial paper 43,119 — 43,119 — Corporate bonds 30,962 — 30,962 — Total short-term investments 96,574 22,493 74,081 — Total assets $ 108,428 $ 34,347 $ 74,081 $ — |
Schedule of accrued liabilities | Accrued liabilities consisted of the following (in thousands): September 30, 2020 December 31, 2019 Accrued research and development expenses $ 3,034 $ 1,868 Accrued compensation 2,752 3,626 Other accrued liabilities 746 1,336 Total accrued liabilities $ 6,532 $ 6,830 |
Investments (Tables)
Investments (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of short-term and long-term investments | The following tables summarize the Company's debt investments (in thousands): September 30, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Corporate bonds $ 11,381 $ 28 $ — $ 11,409 U.S. treasury securities 34,230 2 (5) 34,227 Commercial paper 3,990 9 — 3,999 Total investments $ 49,601 $ 39 $ (5) $ 49,635 December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Corporate bonds $ 30,952 $ 19 $ (9) $ 30,962 Commercial paper 43,109 14 (4) 43,119 U.S. treasury securities 22,478 17 (2) 22,493 Total investments $ 96,539 $ 50 $ (15) $ 96,574 |
Summary of investments with unrealized losses, aggregated by investment type and the length of time | The following tables summarize the Company's debt investments with unrealized losses, aggregated by investment type and the length of time that individual investments have been in a continuous unrealized loss position (in thousands, except number of securities): September 30, 2020 Less than 12 Months Greater than 12 Months Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss U.S. treasury securities $ 25,128 $ (5) $ — $ — $ 25,128 $ (5) Total $ 25,128 $ (5) $ — $ — $ 25,128 $ (5) Number of securities with unrealized losses 8 — 8 December 31, 2019 Less than 12 Months Greater than 12 Months Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate bonds $ 9,657 $ (9) $ — $ — $ 9,657 $ (9) Commercial paper 10,147 (4) — — 10,147 (4) U.S. treasury securities 2,994 (2) — — 2,994 (2) Total $ 22,798 $ (15) $ — $ — $ 22,798 $ (15) Number of securities with unrealized losses 9 — 9 |
Summary of the scheduled maturity of company investments | The following table summarizes the scheduled maturity for the Company's debt investments at September 30, 2020 (in thousands): Maturing in one year or less $ 49,635 Maturing after one year through two years — Total debt investments $ 49,635 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Operating Lease Right-of-Use Assets and Liabilities | The following table sets forth the operating lease right-of-use assets and liabilities as of September 30, 2020 (in thousands): Assets Operating lease right-of-use assets $ 2,943 Liabilities Operating lease short-term liabilities (recorded within Accrued liabilities) $ 91 Operating lease long-term liabilities (recorded within Lease-related obligations) 2,923 Total operating lease liabilities $ 3,014 |
Operating Lease Maturity | Operating lease payments over the remainder of the lease terms are as follows (in thousands): Years Ending December 31, As of September 30, 2020 2020 $ 147 2021 (1) 260 2022 715 2023 736 2024 759 All remaining years 1,248 Total future minimum rental payments $ 3,865 Less amount of lease payments representing interest 851 Total present value of lease payments $ 3,014 (1) The Company entered into the Ninth Amendment of its lease for the Company's headquarters in Durham, North Carolina, which extended the term of the lease 65 months to July 31, 2026. As part of the amendment, the Company will receive a rent abatement of the first 5 months of the new lease term which begins on March 1, 2021. Additionally, the Ninth Amendment grants the Company a refurbishment allowance, which the Company expects to receive in 2021 after the refurbishment has been completed. As of December 31, 2019, operating lease payments over the remainder of the lease terms were as follows (in thousands): Years Ending December 31, As of December 31, 2019 2020 $ 719 2021 182 Total future minimum rental payments $ 901 Less amount of lease payments representing interest 66 Total present value of lease payments $ 835 |
Sublease Income | Total future minimum rentals under the non-cancelable operating sublease are presented below (in thousands): Years Ending December 31, As of September 30, 2020 2020 $ 21 2021 14 Total future minimum sublease rentals $ 35 |
Equity Transactions and Share_2
Equity Transactions and Share-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of employee and non-employee share-based compensation expense recognized related to stock options, the ESPP and RSUs | Total share-based compensation expense recognized related to stock options, the ESPP and RSUs was as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Research and development expense $ 625 $ 901 $ 2,090 $ 3,170 General and administrative expense 657 628 1,910 4,799 Total share-based compensation expense $ 1,282 $ 1,529 $ 4,000 $ 7,969 |
Restructuring Costs (Tables)
Restructuring Costs (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Restructuring and Related Activities [Abstract] | |
Restructuring and Related Costs | The following table summarizes the restructuring charges (in thousands) recorded in 2019 during the period subsequent to the restructuring in May 2019: Employee Termination Benefits Clinical Trial Close-out Costs Other Development Costs Fixed Asset Disposals Total Research and development $ 1,437 $ 2,021 $ 339 $ — $ 3,797 General and administrative 1,909 — — — 1.909 Interest income and other, net — — — 250 250 Total restructuring expenses $ 3,346 $ 2,021 $ 339 $ 250 $ 5,956 |
Schedule of Restructuring Reserve by Type of Cost | The following table sets forth the accrual activity for employee termination benefits and contract close-out costs (in thousands) for 2019. Employee Termination Benefits Clinical Trial Close-out Costs Other Development Costs Fixed Asset Disposals Total Balance at January 1, 2019 $ — $ — $ — $ — $ — Accruals 3,335 2,131 315 — 5,781 Revised estimates 11 (621) 24 250 (336) Payments (3,163) (1,483) (229) (250) (5,125) Balance at December 31, 2019 $ 183 $ 27 $ 110 $ — $ 320 The following table sets forth the accrual activity for employee termination benefits and contract close-out costs (in thousands) for the nine months ended September 30, 2020. Employee Termination Benefits Clinical Trial Close-out Costs Other Development Costs Total Balance at December 31, 2019 $ 183 $ 27 $ 110 $ 320 Revised estimates — (14) — (14) Payments (114) (4) (100) (218) Balance at March 31, 2020 $ 69 $ 9 $ 10 $ 88 Revised estimates — (5) — (5) Payments (69) — — (69) Balance at June 30, 2020 $ — $ 4 $ 10 $ 14 Revised estimates — (4) (10) (14) Payments — — — — Balance at September 30, 2020 $ — $ — $ — $ — |
The Business and Summary of S_4
The Business and Summary of Significant Accounting Policies - Description of Business (Details) | 9 Months Ended |
Sep. 30, 2020product_candidate | |
Accounting Policies [Abstract] | |
Number of product candidates | 2 |
The Business and Summary of S_5
The Business and Summary of Significant Accounting Policies - Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Fair Value, Separate Account Investment [Line Items] | ||
Short-term investments | $ 49,635 | $ 96,574 |
Fair value, measurements, recurring | ||
Fair Value, Separate Account Investment [Line Items] | ||
Cash equivalents | 34,816 | 11,854 |
Short-term investments | 49,635 | 96,574 |
Total assets | 84,451 | 108,428 |
Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Separate Account Investment [Line Items] | ||
Cash equivalents | 34,816 | 11,854 |
Short-term investments | 34,227 | 22,493 |
Total assets | 69,043 | 34,347 |
Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Separate Account Investment [Line Items] | ||
Cash equivalents | 0 | 0 |
Short-term investments | 15,408 | 74,081 |
Total assets | 15,408 | 74,081 |
Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Separate Account Investment [Line Items] | ||
Cash equivalents | 0 | 0 |
Short-term investments | 0 | 0 |
Total assets | 0 | 0 |
Money market funds | Fair value, measurements, recurring | ||
Fair Value, Separate Account Investment [Line Items] | ||
Cash equivalents | 34,816 | 11,854 |
Money market funds | Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Separate Account Investment [Line Items] | ||
Cash equivalents | 34,816 | 11,854 |
Money market funds | Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Separate Account Investment [Line Items] | ||
Cash equivalents | 0 | 0 |
Money market funds | Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Separate Account Investment [Line Items] | ||
Cash equivalents | 0 | 0 |
U.S. treasury securities | Fair value, measurements, recurring | ||
Fair Value, Separate Account Investment [Line Items] | ||
Short-term investments | 34,227 | 22,493 |
U.S. treasury securities | Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Separate Account Investment [Line Items] | ||
Short-term investments | 34,227 | 22,493 |
U.S. treasury securities | Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Separate Account Investment [Line Items] | ||
Short-term investments | 0 | 0 |
U.S. treasury securities | Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Separate Account Investment [Line Items] | ||
Short-term investments | 0 | 0 |
Commercial paper | Fair value, measurements, recurring | ||
Fair Value, Separate Account Investment [Line Items] | ||
Short-term investments | 3,999 | 43,119 |
Commercial paper | Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Separate Account Investment [Line Items] | ||
Short-term investments | 0 | 0 |
Commercial paper | Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Separate Account Investment [Line Items] | ||
Short-term investments | 3,999 | 43,119 |
Commercial paper | Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Separate Account Investment [Line Items] | ||
Short-term investments | 0 | 0 |
Corporate bonds | Fair value, measurements, recurring | ||
Fair Value, Separate Account Investment [Line Items] | ||
Short-term investments | 11,409 | 30,962 |
Corporate bonds | Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Separate Account Investment [Line Items] | ||
Short-term investments | 0 | 0 |
Corporate bonds | Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Separate Account Investment [Line Items] | ||
Short-term investments | 11,409 | 30,962 |
Corporate bonds | Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Separate Account Investment [Line Items] | ||
Short-term investments | $ 0 | $ 0 |
The Business and Summary of S_6
The Business and Summary of Significant Accounting Policies - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Accounting Policies [Abstract] | ||
Accrued research and development expenses | $ 3,034 | $ 1,868 |
Accrued compensation | 2,752 | 3,626 |
Other accrued liabilities | 746 | 1,336 |
Total accrued liabilities | $ 6,532 | $ 6,830 |
The Business and Summary of S_7
The Business and Summary of Significant Accounting Policies - Revenue Recognition (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | 116 Months Ended | 121 Months Ended | |||
Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2020USD ($) | Feb. 15, 2021USD ($)revenue_contractbase_segmentoption_segment | Oct. 31, 2019USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Total revenues | $ 1,609,000 | $ 1,958,000 | $ 4,252,000 | $ 5,752,000 | ||||
BARDA | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Total revenues | 1,600,000 | 2,000,000 | 4,200,000 | 5,800,000 | $ 74,400,000 | |||
BARDA | Scenario, Forecast | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Total revenues | $ 78,900,000 | |||||||
Total number of base segments | base_segment | 1 | |||||||
Total number of option segments | option_segment | 4 | |||||||
Total number of separate contracts | revenue_contract | 5 | |||||||
BARDA | Expense reimbursement | Scenario, Forecast | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Total revenues | $ 75,800,000 | |||||||
BARDA | Fees | Scenario, Forecast | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Total revenues | 5,300,000 | |||||||
BARDA Fourth Option Segment | Scenario, Forecast | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Total revenues | $ 4,600,000 | |||||||
SymBio Pharmaceuticals | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Total revenues | $ 5,000,000 | |||||||
Initial upfront payment to be received | 5,000,000 | 5,000,000 | $ 5,000,000 | |||||
Payment to be received upon achievement of milestones | $ 180,000,000 | $ 180,000,000 | $ 180,000,000 | $ 180,000,000 | $ 180,000,000 | $ 180,000,000 |
Investments - Summary of Availa
Investments - Summary of Available-for-Sale securities (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Schedule of Investments [Line Items] | ||
Amortized Cost | $ 49,601 | $ 96,539 |
Gross Unrealized Gains | 39 | 50 |
Gross Unrealized Losses | (5) | (15) |
Estimated Fair Value | 49,635 | 96,574 |
Corporate bonds | ||
Schedule of Investments [Line Items] | ||
Amortized Cost | 11,381 | 30,952 |
Gross Unrealized Gains | 28 | 19 |
Gross Unrealized Losses | 0 | (9) |
Estimated Fair Value | 11,409 | 30,962 |
U.S. treasury securities | ||
Schedule of Investments [Line Items] | ||
Amortized Cost | 34,230 | 22,478 |
Gross Unrealized Gains | 2 | 17 |
Gross Unrealized Losses | (5) | (2) |
Estimated Fair Value | 34,227 | 22,493 |
Commercial paper | ||
Schedule of Investments [Line Items] | ||
Amortized Cost | 3,990 | 43,109 |
Gross Unrealized Gains | 9 | 14 |
Gross Unrealized Losses | 0 | (4) |
Estimated Fair Value | $ 3,999 | $ 43,119 |
Investments - Summary of Invest
Investments - Summary of Investments with Unrealized Losses, Aggregated by Investment Type and the Length of Time (Details) $ in Thousands | Sep. 30, 2020USD ($)security | Dec. 31, 2019USD ($)security |
Debt Securities, Available-for-sale [Line Items] | ||
Fair value, less than 12 months | $ 25,128 | $ 22,798 |
Unrealized loss, less than 12 months | (5) | (15) |
Fair value, greater than 12 months | 0 | 0 |
Unrealized loss, greater than 12 months | 0 | 0 |
Fair value, total | 25,128 | 22,798 |
Unrealized loss, total | $ (5) | $ (15) |
Number of securities with unrealized losses, less than 12 months | security | 8 | 9 |
Number of securities with unrealized losses, greater than 12 months | security | 0 | 0 |
Number of securities with unrealized losses, total | security | 8 | 9 |
Corporate bonds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair value, less than 12 months | $ 9,657 | |
Unrealized loss, less than 12 months | (9) | |
Fair value, greater than 12 months | 0 | |
Unrealized loss, greater than 12 months | 0 | |
Fair value, total | 9,657 | |
Unrealized loss, total | (9) | |
Commercial paper | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair value, less than 12 months | 10,147 | |
Unrealized loss, less than 12 months | (4) | |
Fair value, greater than 12 months | 0 | |
Unrealized loss, greater than 12 months | 0 | |
Fair value, total | 10,147 | |
Unrealized loss, total | (4) | |
U.S. treasury securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Fair value, less than 12 months | $ 25,128 | 2,994 |
Unrealized loss, less than 12 months | (5) | (2) |
Fair value, greater than 12 months | 0 | 0 |
Unrealized loss, greater than 12 months | 0 | 0 |
Fair value, total | 25,128 | 2,994 |
Unrealized loss, total | $ (5) | $ (2) |
Investments - Schedule of Inves
Investments - Schedule of Investment Maturity (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Investments, Debt and Equity Securities [Abstract] | ||
Maturing in one year or less | $ 49,635 | |
Maturing after one year through two years | 0 | |
Total debt investments | $ 49,635 | $ 96,574 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020USD ($)ft² | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($)ft² | Sep. 30, 2019USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Weighted average remaining lease term | 6 years 10 days | 6 years 10 days | ||
Rent expense under non-cancelable operating leases | $ 184 | $ 187 | $ 550 | $ 563 |
Weighted average discount rate | 7.93% | 7.93% | ||
Lease payments | $ 181 | 188 | $ 538 | 574 |
Area of sublease space (in sq ft) | ft² | 3,537 | 3,537 | ||
Sublease income | $ 18 | $ 18 | $ 53 | $ 53 |
Commitments and Contingencies_2
Commitments and Contingencies - Operating Lease Right-of-Use Assets and Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Assets | ||
Operating lease right-of-use assets | $ 2,943 | $ 709 |
Liabilities | ||
Operating lease short-term liabilities (recorded within Accrued liabilities) | 91 | |
Operating lease long-term liabilities (recorded within Lease-related obligations) | 2,923 | 196 |
Total present value of lease payments | $ 3,014 | $ 835 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:AccruedLiabilitiesCurrent | us-gaap:AccruedLiabilitiesCurrent |
Commitments and Contingencies_3
Commitments and Contingencies - Maturity Analysis of Operating Lease Liabilities (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Dec. 31, 2019 | |
Lessee, Operating Lease, Liability, Payment, Due [Abstract] | ||
2020 | $ 147 | $ 719 |
2021 | 260 | 182 |
2022 | 715 | |
2023 | 736 | |
2024 | 759 | |
All remaining years | 1,248 | |
Total future minimum rental payments | 3,865 | 901 |
Less amount of lease payments representing interest | 851 | 66 |
Total present value of lease payments | $ 3,014 | $ 835 |
Lease extension term | 65 months | |
Rent abatement term | 5 months |
Commitments and Contingencies_4
Commitments and Contingencies - Minimum Sublease Rentals (Details) $ in Thousands | Sep. 30, 2020USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2020 | $ 21 |
2021 | 14 |
Total future minimum sublease rentals | $ 35 |
Equity Transactions and Share_3
Equity Transactions and Share-based Compensation (Details) - USD ($) $ in Millions | Jan. 01, 2020 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares issued for restricted stock units (in shares) | 277,000 | 50,000 | 440,000 | 419,000 | |
Chief Executive Officer | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Acceleration compensation | $ 1.8 | ||||
Employees | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Acceleration compensation | $ 0.7 | ||||
The 2013 Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Evergreen option provision, equity increase | 4.00% | ||||
Additional shares authorized (in shares) | 2,500,000 | ||||
Number of shares reserved for future issuance (in shares) | 3,400,000 | 3,400,000 | |||
Shares issued pursuant to the exercise of stock options (in shares) | 21,000 | 5,000 | 263,000 | 19,000 | |
The 2013 Employee Stock Purchase Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Evergreen option provision, equity increase | 1.00% | ||||
Additional shares authorized (in shares) | 422,535 | ||||
Number of shares reserved for future issuance (in shares) | 2,400,000 | 2,400,000 | |||
Number of shares authorized to be granted (in shares) | 3,500,000 | 3,500,000 | |||
Number of shares reserved for issuance, annual increase (in shares) | 422,535 | ||||
Participation term | 24 months | ||||
Percentage of pay that employee can contribute, maximum | 15.00% | 15.00% | |||
Discounted purchase price from market price, offering date | 15.00% | ||||
Discounted purchase price from market price, purchase date | 15.00% | ||||
Purchase interval | 6 months | ||||
Shares issued pursuant to employee stock purchase plan (in shares) | 160,000 | 96,000 | 337,000 | 209,000 |
Equity Transactions and Share_4
Equity Transactions and Share-based Compensation - Schedule of Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total share-based compensation expense | $ 1,282 | $ 1,529 | $ 4,000 | $ 7,969 |
Research and development expense | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total share-based compensation expense | 625 | 901 | 2,090 | 3,170 |
General and administrative expense | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total share-based compensation expense | $ 657 | $ 628 | $ 1,910 | $ 4,799 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2021 | |
Income Tax Contingency [Line Items] | ||
Federal or state income taxes | $ 0 | |
Unrecognized tax benefits | $ 0 | |
Scenario, Forecast | ||
Income Tax Contingency [Line Items] | ||
Estimated annual effective tax rate | 0.00% |
Significant Agreements (Details
Significant Agreements (Details) shares in Millions | Oct. 01, 2019 | Jul. 26, 2019USD ($)shares | Feb. 28, 2011extension | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2020USD ($) | Feb. 15, 2021USD ($) | Oct. 31, 2019USD ($) |
Long-term Purchase Commitment [Line Items] | |||||||||||
Total revenues | $ 1,609,000 | $ 1,958,000 | $ 4,252,000 | $ 5,752,000 | |||||||
BARDA | |||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||
Number of extension periods | extension | 4 | ||||||||||
Total revenues | 1,600,000 | 2,000,000 | 4,200,000 | 5,800,000 | $ 74,400,000 | ||||||
Cantex Pharmaceuticals Inc. | |||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||
Upfront cash payment for license and development agreement | $ 30,000,000 | ||||||||||
Shares issued for license and development agreement (in shares) | shares | 10 | ||||||||||
Acquired in-process research and development | $ 65,000,000 | ||||||||||
Transaction costs | 100,000 | ||||||||||
Payments to be made for regulatory milestones (up to) | 202,500,000 | ||||||||||
Payments to be made upon achievement of specified net sales levels (up to) | $ 385,000,000 | ||||||||||
Royalty percentage to be paid (at least) | 10.00% | ||||||||||
SymBio Pharmaceuticals | |||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||
Total revenues | $ 5,000,000 | ||||||||||
Termination notice period | 90 days | ||||||||||
Initial upfront payment to be received | 5,000,000 | 5,000,000 | $ 5,000,000 | ||||||||
Payment to be received upon achievement of milestones | $ 180,000,000 | $ 180,000,000 | $ 180,000,000 | $ 180,000,000 | $ 180,000,000 | $ 180,000,000 | |||||
Scenario, Forecast | BARDA | |||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||
Total revenues | $ 78,900,000 | ||||||||||
Scenario, Forecast | BARDA | Expense reimbursement | |||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||
Total revenues | 75,800,000 | ||||||||||
Scenario, Forecast | BARDA | Fees | |||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||
Total revenues | 5,300,000 | ||||||||||
Scenario, Forecast | BARDA Fourth Option Segment | |||||||||||
Long-term Purchase Commitment [Line Items] | |||||||||||
Total revenues | $ 4,600,000 |
Restructuring Costs (Details)
Restructuring Costs (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 7 Months Ended | 9 Months Ended | 12 Months Ended | ||||
May 31, 2019employee | Sep. 30, 2020USD ($) | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Sep. 30, 2019USD ($) | Dec. 31, 2019USD ($) | Sep. 30, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Restructuring Cost and Reserve [Line Items] | |||||||||
Reduction in workforce | employee | 43 | ||||||||
One-time employee termination benefits | $ 3,346 | $ 3,300 | |||||||
Accrued contract close-out costs | 2,021 | 2,000 | |||||||
Other BCV development costs | 339 | 300 | |||||||
Fixed Asset Disposals | 250 | 300 | |||||||
Accrual balance | $ 0 | $ 14 | $ 88 | 320 | $ 0 | 320 | $ 0 | ||
Restructuring charges | $ (156) | 5,956 | |||||||
Revised estimates | (14) | (5) | (14) | (33) | (336) | ||||
Proceeds from refund of deposits | 1,300 | ||||||||
Revision of Prior Period, Adjustment | |||||||||
Restructuring Cost and Reserve [Line Items] | |||||||||
Unused deposits | (1,300) | (1,300) | |||||||
Other assets | 1,300 | 1,300 | |||||||
Trial Terminations | |||||||||
Restructuring Cost and Reserve [Line Items] | |||||||||
Change in accrual balance | 1,500 | ||||||||
Accrual balance | 0 | 4 | 9 | 27 | 0 | 27 | 0 | ||
Revised estimates | (4) | (5) | (14) | (621) | |||||
Other Development Costs | |||||||||
Restructuring Cost and Reserve [Line Items] | |||||||||
Accrual balance | 0 | 10 | 10 | 110 | 0 | 110 | 0 | ||
Revised estimates | (10) | 0 | 0 | 24 | |||||
Severance Accrual Balance | |||||||||
Restructuring Cost and Reserve [Line Items] | |||||||||
Accrual balance | 0 | 0 | 69 | $ 183 | $ 0 | 183 | $ 0 | ||
Revised estimates | $ 0 | $ 0 | $ 0 | $ 11 |
Restructuring Costs - Summary o
Restructuring Costs - Summary of Restructuring Charges (Details) - USD ($) $ in Thousands | 3 Months Ended | 7 Months Ended | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2019 | Sep. 30, 2019 | Dec. 31, 2019 | |
Restructuring Cost and Reserve [Line Items] | ||||
Employee Termination Benefits | $ 3,346 | $ 3,300 | ||
Clinical Trial Close-out Costs | 2,021 | 2,000 | ||
Other Development Costs | 339 | 300 | ||
Fixed Asset Disposals | 250 | $ 300 | ||
Total | $ (156) | 5,956 | ||
Research and development expense | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Employee Termination Benefits | 1,437 | |||
Clinical Trial Close-out Costs | 2,021 | |||
Other Development Costs | 339 | |||
Fixed Asset Disposals | 0 | |||
Total | 4,400 | 3,797 | $ 4,400 | |
General and administrative expense | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Employee Termination Benefits | 1,909 | |||
Clinical Trial Close-out Costs | 0 | |||
Other Development Costs | 0 | |||
Fixed Asset Disposals | 0 | |||
Total | $ 1,900 | 1,909 | $ 1,900 | |
Interest income and other, net | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Employee Termination Benefits | 0 | |||
Clinical Trial Close-out Costs | 0 | |||
Other Development Costs | 0 | |||
Fixed Asset Disposals | 250 | |||
Total | $ 250 |
Restructuring Costs - Accrual A
Restructuring Costs - Accrual Activity for Restructuring Accrual (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2020 | Dec. 31, 2019 | |
Restructuring Reserve [Roll Forward] | |||||
Beginning balance | $ 14 | $ 88 | $ 320 | $ 320 | $ 0 |
Accruals | 5,781 | ||||
Revised estimates | (14) | (5) | (14) | (33) | (336) |
Payments | 0 | (69) | (218) | (5,125) | |
Ending balance | 0 | 14 | 88 | 0 | 320 |
Employee Termination Benefits | |||||
Restructuring Reserve [Roll Forward] | |||||
Beginning balance | 0 | 69 | 183 | 183 | 0 |
Accruals | 3,335 | ||||
Revised estimates | 0 | 0 | 0 | 11 | |
Payments | 0 | (69) | (114) | (3,163) | |
Ending balance | 0 | 0 | 69 | 0 | 183 |
Clinical Trial Close-out Costs | |||||
Restructuring Reserve [Roll Forward] | |||||
Beginning balance | 4 | 9 | 27 | 27 | 0 |
Accruals | 2,131 | ||||
Revised estimates | (4) | (5) | (14) | (621) | |
Payments | 0 | 0 | (4) | (1,483) | |
Ending balance | 0 | 4 | 9 | 0 | 27 |
Other Development Costs | |||||
Restructuring Reserve [Roll Forward] | |||||
Beginning balance | 10 | 10 | 110 | 110 | 0 |
Accruals | 315 | ||||
Revised estimates | (10) | 0 | 0 | 24 | |
Payments | 0 | 0 | (100) | (229) | |
Ending balance | $ 0 | $ 10 | 10 | 0 | 110 |
Fixed Asset Disposals | |||||
Restructuring Reserve [Roll Forward] | |||||
Beginning balance | $ 0 | $ 0 | 0 | ||
Accruals | 0 | ||||
Revised estimates | 250 | ||||
Payments | (250) | ||||
Ending balance | $ 0 |