Cover
Cover - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Feb. 25, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
Current Fiscal Year End Date | --12-31 | ||
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 Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 578,617,872 | ||
Entity Common Stock, Shares Outstanding | 87,027,677 | ||
Documents Incorporated by Reference | Document Description Portions of the registrant’s notice of annual meeting of stockholders and proxy statement to be filed pursuant to Regulation 14A within 120 days after registrant’s fiscal year end of December 31, 2021 are incorporated by reference into Part III of this report……………………………………………………… | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001117480 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2021 | |
Auditor Information [Abstract] | |
Auditor Name | Ernst & Young LLP |
Auditor Firm ID | 42 |
Auditor Location | Raleigh, NC |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 15,397 | $ 46,989 |
Short-term investments, available-for-sale | 72,970 | 31,973 |
Accounts receivable | 0 | 340 |
Inventories | 2,760 | 0 |
Prepaid expenses and other current assets | 4,678 | 2,356 |
Total current assets | 95,805 | 81,658 |
Long-term investments | 2,022 | 0 |
Property and equipment, net of accumulated depreciation | 253 | 214 |
Operating lease right-of-use assets | 2,404 | 2,825 |
Other long-term assets | 56 | 26 |
Total assets | 100,540 | 84,723 |
Current liabilities: | ||
Accounts payable | 2,788 | 1,283 |
Accrued liabilities | 13,108 | 7,250 |
Note payable | 14,000 | 0 |
Total current liabilities | 29,896 | 8,533 |
Operating Lease Long-term Liabilities (recorded within Lease-related obligations) | 2,392 | 2,814 |
Total liabilities | 32,288 | 11,347 |
Stockholders’ equity: | ||
Preferred stock, $0.001 par value, 10,000,000 shares authorized at December 31, 2021 and 2020; no shares issued and outstanding as of December 31, 2021 and 2020 | 0 | 0 |
Common stock, $0.001 par value; 200,000,000 shares authorized at December 31, 2021 and 2020; 86,884,266 and 62,816,039 shares issued and outstanding at December 31, 2021 and 2020, respectively | 87 | 63 |
Additional paid-in capital | 953,782 | 785,673 |
Accumulated other comprehensive loss, net | (21) | 0 |
Accumulated deficit | (885,596) | (712,360) |
Total stockholders’ equity | 68,252 | 73,376 |
Total liabilities and stockholders’ equity | $ 100,540 | $ 84,723 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in USD 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 USD per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, shares issued (in shares) | 86,884,266 | 62,816,039 |
Common stock, shares outstanding (in shares) | 86,884,266 | 62,816,039 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenues: | |||
Revenues | $ 1,979 | $ 5,372 | $ 12,519 |
Operating expenses: | |||
Research and development | 73,817 | 36,232 | 42,288 |
General and administrative | 18,672 | 13,656 | 21,169 |
Acquired in-process research and development | 82,890 | 0 | 65,045 |
Total operating expenses | 175,379 | 49,888 | 128,502 |
Loss from operations | (173,400) | (44,516) | (115,983) |
Other income: | |||
Interest income and other, net | 164 | 994 | 3,407 |
Net loss | (173,236) | (43,522) | (112,576) |
Other comprehensive loss: | |||
Unrealized (loss) gain on investments, net | (21) | (35) | 127 |
Comprehensive loss | $ (173,257) | $ (43,557) | $ (112,449) |
Per share information: | |||
Net loss, basic (in dollars per share) | $ (2.04) | $ (0.70) | $ (2.03) |
Net loss, diluted (in dollars per share) | $ (2.04) | $ (0.70) | $ (2.03) |
Weighted-average shares outstanding, basic (in shares) | 84,930,255 | 62,183,947 | 55,501,973 |
Weighted-average shares outstanding, diluted (in shares) | 84,930,255 | 62,183,947 | 55,501,973 |
Contract and grant revenue | |||
Revenues: | |||
Revenues | $ 1,928 | $ 5,274 | $ 7,604 |
Licensing revenue | |||
Revenues: | |||
Revenues | $ 51 | $ 98 | $ 4,915 |
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) |
Beginning balance (in shares) at Dec. 31, 2018 | 50,735,279 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Share-based compensation | 9,528 | 9,528 | |||
Exercise of stock options | 43 | 43 | |||
Exercise of stock options (in shares) | 19,284 | ||||
Employee stock purchase plan purchases | 326 | 326 | |||
Employee stock purchase plan purchases (in shares) | 209,075 | ||||
RSU stock issuance | 0 | $ 1 | (1) | ||
RSU stock issuance (in shares) | 626,375 | ||||
Issuance of common stock, net of issuance costs | 34,900 | $ 10 | 34,890 | ||
Issuance of common stock, net of issuance costs (in shares) | 10,000,000 | ||||
Comprehensive loss: | |||||
Unrealized (loss) gain on investments, net | 127 | 127 | |||
Net loss | (112,576) | (112,576) | |||
Comprehensive loss | (112,449) | ||||
Ending balance (in shares) at Dec. 31, 2019 | 61,590,013 | ||||
Ending Balance at Dec. 31, 2019 | 109,952 | $ 62 | 778,693 | 35 | (668,838) |
Increase (Decrease) in Stockholders' Equity | |||||
Share-based compensation | 5,568 | 5,568 | |||
Exercise of stock options | $ 987 | $ 1 | 986 | ||
Exercise of stock options (in shares) | 409,988 | 409,988 | |||
Employee stock purchase plan purchases | $ 426 | 426 | |||
Employee stock purchase plan purchases (in shares) | 337,072 | ||||
RSU stock issuance (in shares) | 478,966 | ||||
Comprehensive loss: | |||||
Unrealized (loss) gain on investments, net | (35) | (35) | |||
Net loss | (43,522) | (43,522) | |||
Comprehensive loss | (43,557) | ||||
Ending balance (in shares) at Dec. 31, 2020 | 62,816,039 | ||||
Ending Balance at Dec. 31, 2020 | 73,376 | $ 63 | 785,673 | 0 | (712,360) |
Increase (Decrease) in Stockholders' Equity | |||||
Share-based compensation | 12,260 | 12,260 | |||
Exercise of stock options | $ 3,831 | $ 1 | 3,830 | ||
Exercise of stock options (in shares) | 909,997 | 841,775 | |||
Employee stock purchase plan purchases | $ 755 | $ 1 | 754 | ||
Employee stock purchase plan purchases (in shares) | 542,931 | ||||
RSU stock issuance (in shares) | 430,002 | ||||
Issuance of common stock related to asset acquisition | 43,445 | $ 9 | 43,436 | ||
Issuance of common stock related to asset acquisition (in shares) | 8,723,769 | ||||
Issuance of common stock, net of issuance costs | 107,842 | $ 13 | 107,829 | ||
Issuance of common stock, net of issuance costs (in shares) | 13,529,750 | ||||
Comprehensive loss: | |||||
Unrealized (loss) gain on investments, net | (21) | (21) | |||
Net loss | (173,236) | (173,236) | |||
Comprehensive loss | (173,257) | ||||
Ending balance (in shares) at Dec. 31, 2021 | 86,884,266 | ||||
Ending Balance at Dec. 31, 2021 | $ 68,252 | $ 87 | $ 953,782 | $ (21) | $ (885,596) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flows from operating activities: | |||
Net loss | $ (173,236) | $ (43,522) | $ (112,576) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation of property and equipment | 167 | 402 | 564 |
Amortization of discount/premium on investments | 846 | (190) | (1,842) |
Share-based compensation | 12,260 | 5,568 | 9,528 |
Fair value of common stock issued related to asset acquisition | 43,445 | 0 | 0 |
Note payable related to asset acquisition | 14,000 | 0 | 0 |
Fair value of common stock issued for license agreement | 0 | 0 | 34,900 |
(Gain)/Loss on disposition of assets | 0 | (10) | 264 |
(Gain)/Loss on sale of investments | (2) | (4) | 31 |
Lease-related amortization | 301 | (14) | (76) |
Changes in operating assets and liabilities: | |||
Accounts receivable | 340 | 893 | (903) |
Inventories | (2,760) | 0 | 0 |
Prepaid expenses and other assets | (2,352) | 1,025 | (777) |
Accounts payable and accrued liabilities | 7,061 | (186) | (4,294) |
Net cash used in operating activities | (99,930) | (36,038) | (75,181) |
Cash flows from investing activities: | |||
Purchases of property and equipment | (207) | (58) | (158) |
Purchases of short-term investments | (105,355) | (73,978) | (167,528) |
Purchases of long-term investments | (9,594) | 0 | 0 |
Proceeds from sales of short-term investments | 4,207 | 17,287 | 13,117 |
Proceeds from maturities of short-term investments | 66,858 | 121,452 | 165,200 |
Proceeds from sale of property and equipment | 0 | 10 | 0 |
Net cash (used in) provided by investing activities | (44,091) | 64,713 | 10,631 |
Cash flows from financing activities: | |||
Proceeds from exercise of stock options | 3,831 | 987 | 43 |
Proceeds from employee stock purchase plan | 755 | 426 | 325 |
Proceeds from issuance of common stock, net of commissions | 107,843 | 0 | 0 |
Payments of deferred offering costs | 0 | 0 | (23) |
Net cash provided by financing activities | 112,429 | 1,413 | 345 |
Net (decrease) increase in cash and cash equivalents | (31,592) | 30,088 | (64,205) |
Beginning of period | 46,989 | 16,901 | 81,106 |
End of period | 15,397 | 46,989 | 16,901 |
Supplemental disclosure of cash flow information | |||
Non-cash purchases of property and equipment | $ 0 | $ 18 | $ 0 |
The Business and Summary of Sig
The Business and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
The Business and Summary of Significant Accounting Policies | The Business and Summary of Significant Accounting Policies Description of Business Chimerix is a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. In June 2021, the U.S. Food and Drug Administration (FDA) approved TEMBEXA (brincidofovir) for the treatment of smallpox as a medical countermeasure. Our two most advanced clinical-stage development programs are ONC201 and dociparstat sodium (DSTAT). ONC201 is in development for recurrent H3 K27M-mutant glioma. DSTAT is in Phase 3 development as a potential first-line therapy in acute myeloid leukemia (AML). Basis of Presentation The consolidated financial statements include the accounts of the Company, and its wholly owned subsidiaries. The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP). The preparation of the Company’s consolidated financial statements requires estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities in the consolidated financial statements and accompanying notes. Although these estimates are based on knowledge of current events and actions the Company may undertake in the future, actual results may ultimately differ from these estimates and assumptions. 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). Cash and Cash Equivalents The Company considers any highly liquid instrument with an original maturity of three months or less at acquisition to be a cash equivalent. Cash equivalents consist of money market funds. Investments Investments consist primarily of commercial paper, corporate bonds, and U.S. Treasury securities. The Company invests in high-credit quality investments in accordance with its investment policy which minimizes the probability of loss. Available-for-sale debt securities are carried at fair value as determined by quoted market prices, with the unrealized gains and losses, net of tax, reported as a separate component of stockholders’ equity. Realized gains and losses are determined using the specific identification method and transactions are recorded on a settlement date basis in interest income and other, net. For the year ended December 31, 2021, approximately $2,000 of realized gains were reclassified from accumulated other comprehensive loss, net in the Consolidated Balance Sheets to interest income and other, net in the Consolidated Statements of Operations and Comprehensive Loss. Investments with original maturities beyond three months at the date of purchase and which mature on, or less than twelve months from, the balance sheet date are classified as short-term. Investments with a maturity beyond twelve months from the balance sheet date are classified as long-term. The Company periodically reviews available-for-sale debt securities 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 amortized cost basis. The Company does not intend to sell, and is not likely to be required to sell, the available-for-sale debt securities in an unrealized loss position before recovery of the amortized cost bases of the debt securities, which may be maturity. Any such declines in value judged to be other-than-temporary on available-for-sale debt securities are reported in other-than-temporary impairment of investment. Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist of cash, cash equivalents, short-term investments, long-term investments and accounts receivable. The Company is exposed to credit risk, subject to federal deposit insurance, in the event of default by the financial institutions holding its cash and cash equivalents to the extent of amounts recorded on the balance sheets. Accounts receivable represent amounts due from an agency of the federal government. Accounts Receivable Accounts receivable at December 31, 2020 consisted of amounts billed under the Company’s contract with the Biomedical Advanced Research and Development Authority (BARDA). Receivables under the BARDA contract are recorded as qualifying research activities are conducted and invoices from the Company’s vendors are received. The Company carries its accounts receivable at cost less an allowance for doubtful accounts. On a periodic basis, the Company evaluates its accounts receivable and establishes an allowance based on its history of collections and write-offs and the current status of all receivables. The Company does not accrue interest on trade receivables. If accounts become uncollectible, they will be written off through a charge to the allowance for doubtful accounts. The Company has not recorded a charge to allowance for doubtful accounts as management believes all receivables are fully collectible. 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 December 31, 2021 and December 31, 2020, the Company had cash equivalents, including money market funds, and short-term investments, including U.S. Treasury securities, whose value is based on using quoted market prices. At December 31, 2021, the Company had long-term investments, including U.S. Treasury securities, whose value is based on using quoted market prices. Accordingly, these securities are classified as Level 1. At December 31, 2021, the Company had short-term investments, including commercial paper, corporate bonds and U.S. Treasury securities. At December 31, 2020, the Company had short-term investments including 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 is a table that presents information about certain assets measured at fair value on a recurring basis (in thousands): Fair Value Measurements December 31, 2021 Total Quoted Prices in Significant Other Significant Cash equivalents Money market funds $ 11,841 $ 11,841 $ — $ — Total cash equivalents 11,841 11,841 — — Short-term investments U.S. Treasury securities 7,517 2,523 4,994 — Commercial paper 34,887 — 34,887 — Corporate bonds 30,566 — 30,566 — Total short-term investments 72,970 2,523 70,447 — Long-term investments U.S. Treasury securities 2,022 2,022 — — Total long-term investments 2,022 2,022 — — Total assets $ 86,833 $ 16,386 $ 70,447 $ — Fair Value Measurements December 31, 2020 Total Quoted Prices in Significant Other Significant Cash equivalents Money market funds $ 1,503 $ 1,503 $ — $ — Total cash equivalents 1,503 1,503 — — Short-term investments U.S. Treasury securities 28,715 28,715 — — Corporate bonds 3,258 — 3,258 — Total short-term investments 31,973 28,715 3,258 — Total assets $ 33,476 $ 30,218 $ 3,258 $ — Inventories We consider regulatory approval of product candidates to be uncertain and product manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained. As such, the manufacturing costs for product candidates incurred prior to regulatory approval are not capitalized as inventory but are expensed as research and development costs. We begin capitalization of these inventory related costs once regulatory approval is obtained. We primarily use actual costs to determine our cost basis for inventories. At December 31, 2021, our inventory is related to TEMBEXA, which is being manufactured for the treatment of smallpox and potential delivery to the Strategic National Stockpile (SNS) for the U.S. government and other government agencies. TEMBEXA was approved by the FDA on June 4, 2021, at which time we began to capitalize inventory costs associated with TEMBEXA. Prior to FDA approval of TEMBEXA, all costs related to the manufacturing of TEMBEXA were charged to research and development expense in the period incurred as there was no alternative future use. We value our inventories at the lower of cost or estimated net realizable value. We determine the cost of its inventories, which includes amounts related to materials, manufacturing costs, shipping and handling costs on a first-in, first-out (FIFO) basis. Work-in-process includes all inventory costs prior to packaging and labelling, including raw material, active product ingredient, and drug product. Finished goods include packaged and labelled products. Our inventories at December 31, 2021, consisted of $2.8 million of work-in-process and no finished goods. Our assessment of market value requires the use of estimates regarding the net realizable value of its inventory balances, including an assessment of excess or obsolete inventory. Our determination that a valuation reserve might be required, in addition to the quantification of such reserve, requires it to utilize judgment. We determine excess or obsolete inventory based on multiple factors, including an estimate of the future demand for its products, product expiration dates and current sales levels. Our assumptions of future demand for its products are inherently uncertain and if we were to change any of these judgments or estimates, it could cause a material increase or decrease in the amount of inventory reserves that we report in a particular period. In addition, our inventory may experience expiration of its shelf-life stability. During the twelve months ended December 31, 2021, we did not record a reserve for inventory as we assume TEMBEXA will be sold to the US government under a procurement contract with Biomedical Advanced Research and Development Authority (BARDA) or could be sold to other governmental agencies. Should no procurement contract be secured in the future, we may reserve part or all of our inventory balance, which would be included in cost of sales. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): December 31, 2021 2020 Prepaid research and development expenses $ 1,726 $ 1,167 Interest receivable 348 104 Prepaid insurance 450 354 Other prepaid expenses and current assets 2,154 731 Total prepaid expenses and other current assets $ 4,678 $ 2,356 Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which generally range from three Impairment of Property and Equipment The Company evaluates property and equipment for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. If the estimated future cash flows (undiscounted and without interest charges) from the use of an asset are less than the carrying value, a write-down would be recorded to reduce the related asset to its estimated fair value. For the twelve months ended December 31, 2021 and 2020, no such write-downs have occurred. Leases At the inception of an arrangement, we determine if an arrangement is, or contains, a lease based on the unique facts and circumstances present in that arrangement. Lease classification, recognition, and measurement are then determined at the lease commencement date. For arrangements that contain a lease we (i) identify lease and non-lease components, (ii) determine the consideration in the contract, (iii) determine whether the lease is an operating or financing lease; and (iv) recognize lease right-of-use (ROU) assets and liabilities. Lease liabilities and their corresponding ROU assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable and as such, we use our incremental borrowing rate based on the information available at the lease commencement date, which represents an internally developed rate that would be incurred to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment. Most leases include options to renew and, or, terminate the lease, which can impact the lease term. The exercise of these options is at our discretion and we do not include any of these options within the expected lease term as we are not reasonably certain we will exercise these options. The current portion of our operating lease liabilities is included in accrued liabilities and the long-term portion is included in lease-related obligations. Accrued Liabilities Accrued liabilities consisted of the following (in thousands): December 31, 2021 2020 Accrued compensation $ 5,491 $ 4,473 Accrued research and development expenses 4,642 1,375 Accrued legal expenses 359 651 Other accrued liabilities 2,616 751 Total accrued liabilities $ 13,108 $ 7,250 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 brincidofovir as a medical countermeasure in the event of a smallpox release. Under the contract, the Company received $72.5 million in expense reimbursement and $4.6 million in fees over the performance of 1 base segment and 4 option segments. Exercise of each option segment was solely at the discretion of BARDA. The Company assessed the services in accordance with the authoritative guidance and concluded that there was a potential of 5 separate contracts (1 base segment and four option segments) within this agreement, each of which had a single performance obligation. All option segments (one through four) were exercised, as well as the base segment. The transaction price for each segment, based on the transaction price as defined in each segment contract, was allocated to the single performance obligation for each contract. The transaction price was recognized over time by measuring the progress toward complete satisfaction of the performance obligation. For reimbursable expenses, this occurred as qualifying research activities were conducted based on invoices from company vendors. For the fixed fee, the progress toward complete satisfaction was estimated based on the costs incurred to date relative to the total estimated costs per the terms of each contract. The Company typically invoiced BARDA monthly as costs were incurred. Any amounts received in advance of performance were recorded as deferred revenue until earned. The base segment and first option segment were completed prior to adoption of ASC 606. The second and third option segments were completed on August 20, 2020. The fourth option segment was completed on September 1, 2021 and the contract has expired in accordance with its terms. Grant Revenue Grant revenue under cost-plus-fixed-fee grants from the federal government and private foundations is recognized as allowable costs are incurred and fees are earned. As a result of its acquisition of Oncoceutics, Inc. (Oncoceutics), the Company became the beneficiary of two federal grant programs and two grant programs with private foundations, of which the federal grant programs ended in the third quarter of 2021. At December 31, 2021, the Company has a deferred revenue balance of $0.2 million related to these grants. Additionally, for the twelve months ended months ended December 31, 2021, the Company recognized $0.4 million of grant revenue related to these grants. 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 $180.0 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 December 31, 2021, 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. Research and Development Expenses Major components of research and development costs include cash compensation, stock-based compensation, preclinical studies, clinical trial and related clinical manufacturing, drug development, materials and supplies, legal, regulatory compliance, and fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf. Research and development costs, including upfront fees and milestones paid to contract research organizations, are expensed as goods are received or services rendered. Costs incurred in connection with clinical trial activities for which the underlying nature of the activities themselves do not directly relate to active research and development, such as costs incurred for market research and focus groups linked to clinical strategy as well as costs to build the Company’s brand, are not included in research and development costs but are reflected as general and administrative costs. Interest Income and Other, Net Interest income and other, net consists primarily of interest earned on our cash, cash equivalents and short-term and long-term investments. Income Taxes Deferred tax assets and liabilities are determined based on differences between the financial and tax reporting bases of assets and liabilities and are measured using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Valuation allowances are established when the Company determines that it is more likely than not that some portion of a deferred tax asset will not be realized. The Company has incurred operating losses from April 7, 2000 (inception) through December 31, 2021, and therefore has not recorded any current provision for income taxes. Additionally, the Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities based on the technical merits of the position. The tax benefit recognized in the financial statements for a particular tax position is based on the largest benefit that is more likely than not to be realized upon settlement. Accordingly, the Company establishes reserves for uncertain tax positions. The FASB Staff Q&A, Topic 740, No. 5, Accounting for Global Intangible Low-Taxed Income (GILTI), states that an entity can make an accounting policy election to either recognized deferred taxes for temporary basis differences expected to reverse as GILTI in future years or to provide for the tax expense related to GILTI in the year the tax is incurred as a period expense only. The Company has elected to account for GILTI as a period expense in the year the tax is incurred. Share-Based Compensation The Company measures and recognizes compensation expense for all share-based payment awards made to employees and directors, including employee stock options, restricted stock units and the employee stock purchase plan purchase rights, based on estimated fair values. The fair value of employee stock options and employee stock purchase plan purchase rights is estimated on the grant date using the Black-Scholes valuation model. The grant-date fair value for restricted stock units is based upon the market price of the Company’s common stock on the date of the grant. The value of the portion of the award that is ultimately expected to vest is recorded as expense over the requisite service periods. For performance-based awards compensation cost is recognized when it is probable that the performance criteria will be met. The Company estimates forfeitures at the time of grant and revises those estimates in subsequent periods if actual forfeitures differ from its estimates. The Company uses historical data to estimate forfeitures and records share-based compensation expense only for those awards that are expected to vest. To the extent that actual forfeitures differ from the Company’s estimates, the difference is recorded as a cumulative adjustment in the period the estimates were revised. For the years ended December 31, 2021, 2020 and 2019, the Company applied a forfeiture rate based on the Company’s historical forfeitures. 401(k) Plan The Company maintains a defined contribution employee retirement plan (401(k) plan). For the years ended December 31, 2021, 2020 and 2019, the Company recognized expenses for matching contributions of $0.4 million, $0.3 million and $0.3 million, respectively. Basic and Dilutive 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 warrants to purchase common stock, 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 warrants to purchase common stock, 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 at December 31, 2021, 2020 and 2019. The calculation of weighted-average diluted shares outstanding excludes the dilutive effect of non-vested restricted stock, stock options to purchase common stock, and employee stock purchase plan purchase rights as the impact of such items are anti-dilutive during periods of net loss. Potential common shares excluded from the calculations were 4,672,859, 1,162,161, and 1,571,356, for the years ended December 31, 2021, 2020 and 2019, respectively. Segments The Company operates in only one segment, pharmaceuticals. In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments |
Investments
Investments | 12 Months Ended |
Dec. 31, 2021 | |
Investments [Abstract] | |
Investments | Investments The following tables summarize the Company’s short-term and long-term debt investments (in thousands): December 31, 2021 Amortized Cost Gross Unrealized Gross Unrealized Estimated Corporate bonds $ 30,571 $ 2 $ (7) $ 30,566 Commercial paper 34,890 2 (5) 34,887 U.S. Treasury securities 9,552 — (13) 9,539 Total investments $ 75,013 $ 4 $ (25) $ 74,992 December 31, 2020 Amortized Cost Gross Unrealized Gross Unrealized Estimated Corporate bonds $ 3,256 $ 2 $ — $ 3,258 U.S. Treasury securities 28,717 1 (3) 28,715 Total investments $ 31,973 $ 3 $ (3) $ 31,973 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): December 31, 2021 Less than 12 Months Greater than 12 Months Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate bonds $ 28,362 $ (7) $ — $ — $ 28,362 $ (7) Commercial paper 8,991 (5) — — 8,991 (5) U.S. Treasury securities 9,539 (13) — — 9,539 (13) Total $ 46,892 $ (25) $ — $ — $ 46,892 $ (25) Number of securities with unrealized losses 18 — 18 December 31, 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 $ 16,598 $ (3) $ — $ — $ 16,598 $ (3) Total $ 16,598 $ (3) $ — $ — $ 16,598 $ (3) Number of securities with unrealized losses 6 — 6 The following table summarizes the scheduled maturity for the Company’s debt investments at December 31, 2021 (in thousands): December 31, 2021 Maturing in one year or less $ 72,970 Maturing after one year through two years 2,022 Total debt investments $ 74,992 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and Equipment Property and equipment, net of accumulated depreciation consisted of the following (in thousands): December 31, 2021 2020 Lab equipment $ 2,341 $ 2,323 Leasehold improvements 1,713 1,584 Computer equipment 817 1,207 Office furniture and equipment 520 520 Property and equipment 5,391 5,634 Less accumulated depreciation (5,138) (5,420) Property and equipment, net of accumulated depreciation $ 253 $ 214 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
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 December 31, 2021 was 4.58 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 $0.7 million and $0.7 million for the twelve months ended December 31, 2021 and 2020, 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 December 31, 2021, the operating lease liabilities reflect a weighted-average discount rate of 7.89%. The following table sets forth the operating lease right-of-use assets and liabilities as of December 31, 2021 (in thousands): Assets Operating Lease Right-of-Use Assets $ 2,404 Liabilities Operating Lease Short-term Liabilities (recorded within Accrued liabilities) $ 432 Operating Lease Long-term Liabilities (recorded within Lease-related obligations) 2,392 Total Operating Lease Liabilities $ 2,824 Operating lease payments over the remainder of the lease terms are as follows (in thousands): Years Ending December 31, As of December 31, 2021 2022 637 2023 736 2024 759 2025 781 2026 467 Total future minimum rental payments $ 3,380 Less amount of lease payments representing interest 556 Total present value of lease payments $ 2,824 For the twelve months ended December 31, 2021 and 2020, the Company made lease payments of approximately $0.5 million and $0.7 million, respectively, which are included in operating cash flows. Sublease The Company subleased 3,537 square feet of its office space under a non-cancelable operating lease that expired February 2021. For the twelve months ended December 31, 2021 and 2020, the Company recognized approximately $12,000 and $71,000 of income in Interest income and other, net on the Consolidated Statement of Operations and Comprehensive Loss, respectively. As this lease has terminated, there are no future minimum rentals payments to be received. Significance of Revenue Source |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity (Deficit) | Stockholders’ Equity (Deficit) Common Stock The Company’s common stock consists of 200 million authorized shares at December 31, 2021 and 2020, and 86.9 million and 62.8 million shares issued and outstanding at December 31, 2021 and December 31, 2020, respectively. Shares Reserved for Future Issuance The Company has reserved shares of common stock for future issuances as follows: December 31, 2021 2020 For exercise of outstanding common stock options 11,649,594 8,906,271 For delivery upon vesting of outstanding restricted stock units 896,222 1,133,049 For future equity awards under the 2013 Equity Incentive Plan 2,076,923 3,342,555 For future purchases under the 2013 Employee Stock Purchase Plan 2,298,817 2,419,213 Total shares of common stock reserved for future issuances 16,921,556 15,801,088 Stock Options The Company maintains a 2013 Equity Incentive Plan (the 2013 Plan). The 2013 Plan provides for the grant of incentive stock options (ISOs), nonstatutory 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. ISOs may be granted only to employees. All other awards may be granted to employees, including officers, and to non-employee directors and consultants. The number of shares of common stock reserved for issuance under the 2013 Plan will automatically increase on January 1 of each year, continuing through and including January 1, 2023, by 4.0% 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. The Company estimates the fair value of its share-based awards to employees, directors and consultants using the Black-Scholes option-pricing model. The Black-Scholes model requires the input of assumptions, including (a) the expected stock price volatility, (b) the calculation of expected term of the award, (c) the risk-free interest rate and (d) expected dividends. For stock options, the Company uses historical volatility data to estimate the volatility of our common stock price and historical exercise data to estimate the expected life. The risk-free interest rates for the periods within the expected life of the option are based on the U.S. Treasury instrument with a life that is similar to the expected life of the option grant. The Company has never paid, and does not expect to pay, dividends in the foreseeable future. The following table illustrates the assumptions for the Black-Scholes model used in determining the fair value of the stock options granted: Years Ended December 31, 2021 2020 2019 Expected volatility 95.84 % 93.24 % 88.77 % Expected term (in years) 6.0 6.0 6.0 Weighted-average risk-free interest rate 0.71 % 1.24 % 2.42 % Expected dividend yield — % — % — % Weighted-average fair value per option $ 6.67 $ 1.78 $ 1.71 A summary of activity related to the Company’s stock options is as follows: Number of Options Weighted-Average Weighted-Average Total Intrinsic Value Balance, December 31, 2019 8,390,304 $ 8.36 7.47 Granted 3,508,080 2.37 — Exercised (409,988) 2.41 — Forfeited (2,575,125) 11.80 — Balance, December 31, 2020 8,913,271 $ 5.28 7.52 Granted 3,903,750 8.74 — Exercised (909,997) 4.69 — Forfeited (257,432) 15.12 — Balance, December 31, 2021 11,649,592 $ 6.27 7.65 $ 25,754 Exercisable at December 31, 2021 6,133,945 $ 6.62 6.83 $ 15,293 Vested or expected to vest at December 31, 2021 10,855,470 $ 6.28 7.58 $ 24,368 As of December 31, 2021, there was approximately $19.6 million of total unrecognized compensation cost related to non-vested stock options granted under the 2013 Plan. That compensation cost is expected to be recognized over a weighted-average period of approximately 2.78 years. Other information regarding the Company’s stock options is as follows (in thousands, except per share data): Years Ended December 31, 2021 2020 2019 Weighted-average grant-date fair value per share of options granted $ 6.67 $ 1.78 $ 1.71 Total intrinsic value of options exercised $ 3,496 $ 355 $ 10 Total fair value of shares vested $ 8,642 $ 4,188 $ 6,798 The following table summarizes, at December 31, 2021, by price range: (1) for stock option awards outstanding under the 2013 Plan, the number of stock option awards outstanding, their weighted-average remaining life and their weighted-average exercise price; and (2) for stock option awards exercisable under the 2013 Plan, the number of stock option awards exercisable and their weighted-average exercise price: Outstanding Exercisable Exercise Price Range ($) Number Weighted-Average Remaining Contractual Life (in years) Weighted-Average Exercise Price Number Weighted-Average Exercise Price 1.37 to 7.57 7,273,390 7.55 $ 2.89 4,424,385 $ 2.97 7.58 to 8.06 814,900 6.13 7.98 617,400 8.02 8.07 to 18.75 3,162,602 8.86 9.61 693,460 10.69 18.76 to 53.74 398,700 3.06 37.86 398,700 37.86 1.37 to 53.74 11,649,592 7.65 $ 6.27 6,133,945 $ 6.62 In April 2019, the Company granted stock options covering a total of 1,750,000 shares in connection with the hiring of its Chief Executive Officer and Chief Business Officer. These grants were non-qualified stock options, have a 10-year term and will vest over four years, with one-fourth vesting on the one-year anniversary of the grant date and remaining three-fourths vesting over the following three years in equal monthly installments. These stock options are subject to the terms of the 2013 Plan, but were granted outside of the 2013 Plan, as they constituted inducement grants in accordance with Nasdaq Stock Market rules. Employee Stock Purchase Plan In February 2013, the Company’s board of directors adopted the 2013 Employee Stock Purchase Plan (ESPP), which was subsequently ratified by stockholders and became effective in April 2013. The purpose of the ESPP is to retain the services of new employees and secure the services of new and existing employees while providing incentives for such individuals to exert maximum efforts toward the Company’s success and that of its affiliates. The ESPP initially authorized the issuance of 704,225 shares of common stock pursuant to purchase rights granted to the Company’s employees or to employees of any of its designated affiliates. The number of shares of common stock reserved for issuance will automatically increase on January 1 of each calendar year, from January 1, 2014 through January 1, 2023 by the least 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). The ESPP is intended to qualify as an “employee stock purchase plan” within the meaning of Section 423 of the Internal Revenue Code of 1986. The common stock reserved for future issuance under the ESPP was automatically increased by an additional 422,535 shares on January 1, 2020 and 2021, bringing the total number of shares of common stock that may be purchased under the ESPP to 3,493,866 and 3,916,401, respectively. The Company has reserved a total of 3,916,401 shares of common stock to be purchased under the ESPP, of which 2,298,817 and 2,419,213 shares remained available for purchase at December 31, 2021 and 2020, respectively. 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 ESPP also 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. The Company issued 542,931 and 337,072 shares of common stock pursuant to the ESPP for the year ended December 31, 2021 and 2020, respectively. Compensation expense for purchase rights under the ESPP related to the purchase discount and the “look-back” option were determined using a Black-Scholes option pricing model. The following table illustrates the assumptions for the Black-Scholes model used in determining the fair value of the ESPP purchase rights: Years Ended December 31, 2021 2020 2019 Expected volatility 97.54 % 75.39 % 57.22 % Expected term (in years) 0.71 1.28 1.23 Weighted-average risk-free interest rate 0.25 % 0.37 % 2.36 % Expected dividend yield — % — % — % Weighted-average option value per share $ 6.55 $ 0.93 $ 1.00 As of December 31, 2021, the Company had a liability of $0.4 million representing employees' contributions to the ESPP. Restricted Stock Units For the years ended December 31, 2021 and 2020, the Company issued RSUs to certain employees and consultants 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. For the years ended December 31, 2021 and 2020, the Company issued 430,002 and 478,966 shares of common stock pursuant to the vesting of RSUs, respectively. A summary of activity related to the Company’s RSUs is as follows: Number of Restricted Weighted-Average Grant-Date Fair Value Balance, December 31, 2020 1,133,049 $ 2.61 Granted 216,875 9.28 Share issuance (430,002) 2.88 Forfeited (23,700) 6.80 Balance, December 31, 2021 896,222 $ 3.98 The total unrecognized compensation cost related to the non-vested RSUs as of December 31, 2021 wa s $2.3 million an d will be recognized over a weighted average period of approxima tely 2.39 years. 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 stock-based compensation expense was as follows (in thousands): Years Ended December 31, 2021 2020 2019 Income Statement Classification: Research and development expense $ 6,611 $ 2,969 $ 4,089 General and administrative expense 5,649 2,599 5,439 Total stock-based compensation expense $ 12,260 $ 5,568 $ 9,528 Cash received from exercises under all share-based payment arrangements for 2021, 2020 and 2019 was $4.6 million, $1.4 million and $0.4 million, respectively. There was no actual tax benefit realized for the tax deductions from exercises of the share-based payment arrangements during 2021, 2020 or 2019. On February 5, 2019, Dr. M. Michelle Berrey, the Company’s then President and Chief Executive Officer, resigned. The Company entered into a severance agreement with Dr. Berrey that provides for severance benefits to her in connection with her resignation. Among other benefits, Dr. Berrey received accelerated vesting of her outstanding stock options and RSUs as if she had continued service for an additional 15-month period. In addition, Dr. Berrey's vested options were modified to extend her exercise period to May 5, 2020. The Company recorded a charge of $1.8 million to compensation expense on the date of her resignation related to the acceleration of vesting and the modifications of her outstanding stock options and RSUs. In May 2019, related to the Company’s reduction in workforce further discussed in Note 8, certain outstanding stock option and RSU grants received accelerated vesting as if the service period of the terminated employee continued for an additional 12-month period. In addition, certain vested options were modified to extend their exercise period for 12 months. The Company recorded a charge of $0.7 million to compensation expense on the date of the reduction in workforce related to the acceleration of vesting and the modifications of the outstanding stock options and RSUs. At-The-Market Equity Offering On August 10, 2020, we entered into an Open Market Sale Agreement SM (the Jefferies Sales Agreement) with Jefferies LLC, as agent, pursuant to which we may offer and sell, from time to time through Jefferies, up to $75 million of shares of our common stock. Sales of our common stock made pursuant to the Jefferies Sales Agreement, if any, will be made under our shelf registration statement on Form S-3 (File No. 333-244146), which was declared effective by the SEC on August 17, 2020. We have not sold any shares of our common stock under the Jefferies Sales Agreement. On May 6, 2021, we filed an automatic shelf registration statement on Form S-3 with the SEC, which became effective upon filing, pursuant to which we registered for sale an unlimited amount of any combination of our common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that we may determine, so long as we continue to satisfy the requirements of a “well-known seasoned issuer” under SEC rules, This registration statement will remain in effect for up to three years from the date it became effective. As of December 31, 2021, no sales have been made under the automatic shelf registration statement. Public Offering of Common Stock On January 20, 2021, the Company entered into an underwriting agreement (the Underwriting Agreement) with Jefferies LLC and Cowen and Company, LLC, as representatives of the several underwriters named therein (collectively, the Underwriters), relating to the issuance and sale of 11,765,000 shares (the Shares) of the Company's common stock. The price to the public in this offering was $8.50 per share, and the Underwriters agreed to purchase the Shares from the Company pursuant to the Underwriting Agreement at a price of $7.99 per share. Under the terms of the Underwriting Agreement, the Company granted the Underwriters a 30-day option to purchase up to 1,764,750 additional shares of the Company's common stock at the public offering price. The net proceeds to the Company from this offering were approximately $107.8 million, as the Underwriters’ option to purchase additional shares was exercised in full, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The offering closed on January 25, 2021. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes No income tax expense or benefit has been recorded for the years ended December 31, 2021, 2020 or 2019. This is due to the establishment of a valuation allowance against the deferred tax assets generated during those periods. At December 31, 2021, the Company has concluded that it is more likely than not that the Company may not realize the benefit of its deferred tax assets due to its history of losses. Accordingly, the net deferred tax assets have been fully reserved. A reconciliation of the difference between the benefit for income taxes and income taxes at the statutory U.S. federal income tax rate is as follows for the years ended December 31, 2021, 2020, and 2019 (in thousands, except percentages): 2021 2020 2019 Amount % of Pretax Amount % of Pretax Amount % of Pretax Income tax benefit at statutory rate $ (36,379) 21.0 % $ (9,140) 21.0 % $ (23,641) 21.0 % State income taxes (8,060) 4.7 % (138) 0.3 % (1,596) 1.4 % Research and development credits (1,565) 0.9 % (1,088) 2.5 % (1,190) 1.1 % In process R&D 26,395 (15.2) % — — % — — % Permanent items 711 (0.4) % 505 (1.2) % 696 (0.6) % Provision to return adjustments 126 (0.1) % 81 (0.2) % 937 (0.8) % Effect of change in federal tax rate — — % — — % — — % Effect of change in state tax rate 3,478 (2.0) % 1,139 (2.6) % (117) 0.1 % Removal of excess tax benefit — — % — — % — — % Increase in unrecognized tax benefits 439 (0.3) % 272 (0.6) % 298 (0.3) % Current year forfeitures 435 (0.3) % 4,026 (9.2) % — — % Change in valuation allowance 14,420 (8.3) % 4,343 (10.0) % 24,613 (21.9) % Net benefit $ — — % $ — — % $ — — % The components of deferred tax assets and liabilities at December 31, 2021 and 2020 were as follows (in thousands): December 31, 2021 2020 Deferred tax assets: Domestic net operating loss carryforwards $ 138,548 $ 123,381 Research and development expenses 1,191 293 Capitalized Section 174 expenses — — License fees 14,131 12,556 Research and development credits 17,738 15,498 Capital loss carryforwards 484 403 Accrued bonuses 888 943 Share-based compensation 4,885 3,541 Other 1,457 961 Total gross deferred tax assets 179,322 157,576 Valuation allowance (178,705) (156,973) Total deferred tax assets 617 603 Deferred tax liabilities: Right-of-use asset (617) (603) Total deferred tax liabilities (617) (603) Total deferred tax assets and liabilities, net $ — $ — At December 31, 2021, the Company had net operating loss carryforwards for federal and state tax purposes of approximately $637.9 million and $455.4 million, respectively. At December 31, 2020, the Company had net operating loss carryforwards for federal and state tax purposes of approximately $551.0 million and $388.5 million, respectively. Federal losses of $414.7 million begin to expire in 2023 and $223.2 million of the federal losses carry forward indefinitely. State losses of $409.2 million begin to expire in 2022 and $46.2 million of the state losses carry forward indefinitely. In addition, the Company has tax credit carryforwards for federal tax purposes of approximately $23.3 million as of December 31, 2021, which begin to expire in 2022. The Company also has capital loss carryforwards for federal tax purposes of $1.9 million, which begin to expire in 2022. The future utilization of net operating loss and tax credit carryforwards may be limited due to changes in ownership. Management has recorded a valuation allowance for all of the deferred tax assets due to the uncertainty of future taxable income. The Company incorporated a subsidiary in the United Kingdom in 2014. However, the subsidiary had zero activity in 2021 and as such, has no undistributed earnings. The Company dissolved the United Kingdom subsidiary in 2021. The Company incorporated a subsidiary in Ireland during 2018. However, the subsidiary had no activity during 2019, 2020 and 2021, and as such, has no undistributed earnings. The Company acquired Oncoceutics in 2021 and is including the activity for 2021 in its consolidated financial statements. In general, if the Company experiences a greater than 50% aggregate change in ownership of certain significant stockholders over a three-year period (a Section 382 ownership change), utilization of its pre-change net operating loss carryforwards is subject to an annual limitation under Section 382 of the Internal Revenue Code of 1986, as amended (and similar state laws). The annual limitation generally is determined by multiplying the value of the Company’s stock at the time of such ownership change (subject to certain adjustments) by the applicable long-term tax-exempt rate. Such limitations may result in expiration of a portion of the net operating loss carryforwards before utilization and may be substantial. The ability of the Company to use its net operating loss carryforwards may be limited or lost if the Company experiences a Section 382 ownership change in connection with offerings or as a result of future changes in its stock ownership. Losses from a specific period may be subject to multiple limitations and would generally be limited by the lowest of those limitations. The Company has determined that a Section 382 ownership change occurred in 2007, and as such, losses incurred prior to that date are subject to an annual limitation of at least $762,000. The Company evaluated Section 382 ownership changes subsequent to 2007 through September 30, 2020 and concluded that a Section 382 ownership change occurred in 2013 as a result of the initial public offering. As such, losses incurred prior to that date are subject to an annual limitation of at least $6.7 million. The acquired Oncoceutics net operating losses may be subject to limitations under Section 382, however no study has been completed as of the year ended December 31, 2021. The Company has determined that there may be a future limitation on the Company’s ability to utilize its entire federal R&D credit carryover. Therefore, the Company recognized an uncertain tax benefit associated with the federal R&D credit carryover during the years ended December 31, 2021 and 2020, as follows (in thousands): Balance at December 31, 2019 $ 4,023 Increases related to 2020 272 Increases related to prior periods — Balance at December 31, 2020 4,295 Increases related to 2021 391 Increases related to prior periods 48 Balance at December 31, 2021 $ 4,734 On November 18, 2021, Governor Roy Cooper signed into law the 2021 Appropriations Act which phases out the corporate income tax for North Carolina. The Bill phases out the current 2.5% North Carolina corporate income tax rate over five years starting in 2025, reaching zero by 2030. For tax years beginning on or after January 1, 2025 the rate is 2.25%. The rate decreases to 2% in 2026 and 2027; and to 1% in 2028 and 2029. After 2029, the rate decreases to 0%. As a result of the revised tax rate, the Company adjusted its North Carolina net operating loss deferred tax asset as of December 31, 2021 by applying the revised tax rate, which resulted in a decrease to the deferred tax assets and a corresponding decrease to the valuation allowance of approximately $7.1 million. The Company has determined that it had no other material uncertain tax benefits for the year ended December 31, 2021. As of December 31, 2021, due to the carry forward of unutilized net operating losses and research and development credits, the Company is subject to U.S. federal and state income tax examinations for the tax years 2002 through 2021. The Company recognizes accrued interest related to unrecognized tax benefits in interest expense and penalties in operating expense. No amounts were accrued for the payment of interest and penalties at December 31, 2021. The Tax Act subjects a US shareholder to tax on global intangible low-taxed income (GILTI) earned by certain foreign subsidiaries. The FASB Staff Q&A, Topic 740, No. 5, Accounting for Global Intangible Low-Taxed Income, states that an entity can make an accounting policy election to either recognized deferred taxes for temporary basis differences expected to |
Significant Agreements
Significant Agreements | 12 Months Ended |
Dec. 31, 2021 | |
Contractors [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 TEMBEXA as a medical countermeasure in the event of a smallpox release. Under the contract, BARDA agreed to reimburse the Company, plus pay a fixed fee, for the research and development of TEMBEXA 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, the Company received $72.5 million in expense reimbursement and $4.6 million in fees. The fourth option segment ended on September 1, 2021 and the contract has expired in accordance with its terms. For the years ended December 31, 2021, 2020, and 2019, the Company recognized revenue under this contract of $1.6 million, $5.3 million and $7.6 million, respectively. License and Development Agreement with 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. Under the terms of the license agreement, the Company is responsible for, and bears 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 2040. 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. For the twelve months ended December 31, 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 for the 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), or upon certain events involving the bankruptcy or insolvency of the other party. 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 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 of revenue related to the upfront payment. Ohara Agreement In 2019, Oncoceutics, Inc., a Delaware corporation (Oncoceutics) entered into a license, development and commercialization agreement with Ohara Pharmaceutical Co., Ltd. for ONC201 in Japan. The Company is entitled to receive up to $2.5 million in nonrefundable regulatory milestone payments. The Company is entitled to tiered royalties based on the aggregate annual net sales of all products, as defined in the agreement, in Japan. CR Sanjiu Agreement |
Oncoceutics Acquisition
Oncoceutics Acquisition | 12 Months Ended |
Dec. 31, 2021 | |
Business Combination and Asset Acquisition [Abstract] | |
Oncoceutics Acquisition | Oncoceutics Acquisition On January 7, 2021, the Company, Ocean Merger Sub, Inc., a Delaware corporation and wholly-owned subsidiary of the Company (Merger Sub), Oncoceutics and Fortis Advisors, LLC solely in its capacity as representative of the securityholders of Oncoceutics (the Securityholders’ Representative), entered into an Agreement and Plan of Merger (the Merger Agreement). Concurrently with the execution of the Merger Agreement, Merger Sub merged with and into Oncoceutics (the Merger) whereupon the separate corporate existence of Merger Sub ceased, with Oncoceutics continuing as the surviving corporation of the Merger as a wholly-owned subsidiary of the Company. As consideration for the Merger, the Company (a) paid an upfront cash payment of approximately $25.0 million, subject to certain customary adjustments, (b) issued an aggregate of 8,723,769 shares of the Company's common stock, (c) issued a promissory note to the Securityholders' Representative in the principal amount of $14.0 million (the Seller Note), to be paid in cash, subject to the terms and conditions of the Merger Agreement and the Seller Note, upon the one year anniversary of the closing of the Merger, and (d) agreed to make contingent payments up to an aggregate of $360.0 million based on the achievement of certain development, regulatory and commercialization events as set forth in the Merger Agreement, as well as additional tiered royalty payments based upon future net sales of ONC 201 and ONC 206 products, subject to certain reductions as set forth in the Merger Agreement, and a contingent payment in the event the Company receives any proceeds from the sale of a rare pediatric disease priority review voucher based on Oncoceutics' products. The closing payment may be adjusted after the closing, pursuant to procedures set forth in the Merger Agreement, in connection with the finalization of the cash, transaction expenses, debt and working capital amounts at closing. As of December 31, 2021, the Company has recorded an estimated liability of $0.2 million related to closing payment adjustments. Additionally, as of December 31, 2021, the Company has recorded an estimated receivable of $0.6 million related to the repayment of certain severance amounts due from the Oncoceutics' shareholders. The promissory note totaling $14.0 million and the net of the previously mentioned receivable and liability, less $0.4 million held back as a reserve against estimated post-closing transaction expenses, was paid to the Oncoceutics' shareholders in January 2022. A $20.0 million milestone payment was paid and expensed to research and development expenses in the fourth quarter of 2021 related to the achievement of the 20% ORR, evaluated by BICR, of ONC201 in recurrent H3 K27M-mutant glioma patients success milestone. The Company accounted for the Oncoceutics acquisition as an asset acquisition as the majority of the value of the assets acquired related to the ONC201 acquired in-process research and development (IPR&D) asset. In accordance with Accounting Standards Codification (ASC) Subtopic 730-10-25, Accounting for Research and Development Costs, the up-front payments to acquire a new drug compound, are immediately expensed as acquired IPR&D and future milestone payments are expensed to research and development expenses when paid or payable in transactions other than a business combination provided that the drug has not achieved regulatory approval for marketing and, absent obtaining such approval, has no alternative future use. Therefore, the portion of the purchase price that was allocated to the IPR&D assets acquired was immediately expensed. Other assets acquired and liabilities assumed, were recorded at fair value. The following represents the consideration paid and purchase price allocation for the acquisition of Oncoceutics (in thousands, except for per share data): Cash $ 23,836 One-year closing anniversary payment 14,000 Shares common stock issued as consideration 8,723,769 Stock price per share on effective date 4.98 Value of estimated common stock consideration 43,445 Total consideration $ 81,281 Net assets acquired $ (1,310) IPR&D assets expensed 82,591 Total purchase price allocated $ 81,281 Transaction costs expensed to IPR&D (1) $ 299 Total IPR&D expensed $ 82,890 |
Restructuring Costs
Restructuring Costs | 12 Months Ended |
Dec. 31, 2021 | |
Restructuring and Related Activities [Abstract] | |
Restructuring Costs | Restructuring Costs In 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. 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 the twelve months ended December 31, 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 and other development costs accrual balance of $0.1 million. As of December 31, 2019, the Company had a severance accrual balance of $0.2 million. The following table summarizes the restructuring charges (in thousands) recorded for the twelve months ended December 31, 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 The following table sets forth the accrual activity for employee termination benefits and contract close-out costs (in thousands) for the twelve months ended December 31, 2019. No additional charges are expected to be incurred. 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 twelve months ended December 31, 2020. Employee Termination Benefits Clinical Trial Close-out Costs Other Development Costs Total Balance at December 31, 2019 $ 183 $ 27 $ 110 $ 320 Revised estimates — (23) (10) (33) Payments (183) (4) (100) (287) Balance at December 31, 2020 $ — $ — $ — $ — For the twelve months ended December 31, 2020, the revised accrual estimates resulted in a decrease to research and development expenses of $33,000. Additionally, during the twelve ended December 31, 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. |
Selected Quarterly Financial Da
Selected Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2021 | |
Selected Quarterly Financial Information [Abstract] | |
Selected Quarterly Financial Data (Unaudited) | Selected Quarterly Financial Data (Unaudited) The following financial information reflects all normal recurring adjustments, which are, in the opinion of management, necessary for a fair statement of the results of the interim periods. Summarized quarterly data for 2021 and 2020 are as follows (in thousands, except share and per share data): 2021 Quarters Fourth Third Second First Revenue $ 46 $ 107 $ 391 $ 1,435 Operating loss (39,532) (18,600) (17,815) (97,453) Net loss (39,498) (18,560) (17,763) (97,415) Net loss per share, basic and diluted $ (0.45) $ (0.21) $ (0.21) $ (1.21) Weighted-average shares outstanding, basic and diluted 86,867,070 86,335,357 86,225,836 80,204,094 2020 Quarters Fourth Third Second First Revenue $ 1,120 $ 1,609 $ 1,402 $ 1,241 Operating loss (11,757) (11,560) (10,286) (10,913) Net loss (11,675) (11,411) (10,016) (10,420) Net loss per share, basic and diluted $ (0.19) $ (0.18) $ (0.16) $ (0.17) Weighted-average shares outstanding, basic and diluted 62,702,181 62,242,456 62,042,778 61,742,035 Net loss per share is computed independently for each of the quarters presented. Therefore, the sum of the quarterly per share calculations will not necessarily equal the annual per share calculation. Diluted weighted-average shares outstanding are |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events The 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 December 31, 2021, and events which occurred subsequently but were not recognized in the financial statements. On January 31, 2022 (the Effective Date), the Company entered into a Loan and Security Agreement (the Loan Agreement), by and between the Company, as borrower, and Silicon Valley Bank, as the lender (the Lender). The Loan Agreement provides for a four-year secured revolving loan facility (the Credit Facility) in an aggregate principal amount of up to $50.0 million. Proceeds from the Credit Facility may be used for working capital and general corporate purposes. The Company has no obligation to draw down any amount under the Credit Facility, and has not drawn down any amount as of the date of this filing. The Company may borrow, repay and re-borrow funds under the Credit Facility without a prepayment penalty until January 31, 2026 (the Maturity Date), at which time the Credit Facility expires, and all outstanding revolving loans under the Credit Facility, together with all accrued and unpaid interest, must be repaid. No exit fee exists upon expiration of the Credit Facility on the Maturity Date. Subject to the satisfaction of certain liquidity ratios, the full $50.0 million of the Credit Facility will be available for the Company to borrow on a non-formula basis. If the Company is unable to meet these liquidity ratios, then availability under the Credit Facility is determined based on a borrowing base equal to percentages of certain accounts receivable and certain purchase orders (which include prospective options for BARDA to procure TEMBEXA treatment courses) for the Company’s goods in accordance with a formula set forth in the Loan Agreement. Borrowings under the Credit Facility accrue interest at a floating per annum rate of the greater of (i) 1.50% above the Prime Rate (as defined below) and (ii) 4.75%. Prime Rate is defined as the rate of interest per annum published in The Wall Street Journal or any successor publication thereto as the “prime rate”. If such rate of interest from The Wall Street Journal becomes unavailable, the “Prime Rate” shall mean the rate of interest per annum announced by the Lender as its prime rate in effect. In each case, in the event such prime rate is less than zero, such rate shall be deemed to be zero for purposes of the Loan Agreement. The Company must also pay an unused line fee equal to 0.25% per annum on the unused portion of the Credit Facility, payable quarterly in arrears. Upon the termination of the Loan Agreement for any reason prior to the Maturity Date, the Company will be required to pay to the Lender an early termination fee of $0.5 million. The Loan Agreement also requires the Company to pay the Lender a non-refundable commitment fee of $0.5 million, payable in four equal installments beginning on the Effective Date and each anniversary of the Effective Date thereafter until January 31, 2025. The Company’s obligations under the Loan Agreement are secured by a first lien on substantially all assets of the Company other than the Company’s intellectual property, with a negative pledge on the Company’s intellectual property. The Loan Agreement contains customary affirmative and negative covenants and customary events of default that permit the Lender to accelerate the Company’s outstanding obligations under the Loan Agreement, all as set forth in the Loan Agreement. The Loan Agreement also contains financial covenants requiring the Company to maintain specified liquidity and cash levels at certain times as set forth in the Loan Agreement. |
The Business and Summary of S_2
The Business and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The consolidated financial statements include the accounts of the Company, and its wholly owned subsidiaries. The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP). The preparation of the Company’s consolidated financial statements requires estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities in the consolidated financial statements and accompanying notes. Although these estimates are based on knowledge of current events and actions the Company may undertake in the future, actual results may ultimately differ from these estimates and assumptions. |
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). |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers any highly liquid instrument with an original maturity of three months or less at acquisition to be a cash equivalent. Cash equivalents consist of money market funds. |
Investments | Investments Investments consist primarily of commercial paper, corporate bonds, and U.S. Treasury securities. The Company invests in high-credit quality investments in accordance with its investment policy which minimizes the probability of loss. Available-for-sale debt securities are carried at fair value as determined by quoted market prices, with the unrealized gains and losses, net of tax, reported as a separate component of stockholders’ equity. Realized gains and losses are determined using the specific identification method and transactions are recorded on a settlement date basis in interest income and other, net. For the year ended December 31, 2021, approximately $2,000 of realized gains were reclassified from accumulated other comprehensive loss, net in the Consolidated Balance Sheets to interest income and other, net in the Consolidated Statements of Operations and Comprehensive Loss. Investments with original maturities beyond three months at the date of purchase and which mature on, or less than twelve months from, the balance sheet date are classified as short-term. Investments with a maturity beyond twelve months from the balance sheet date are classified as long-term. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist of cash, cash equivalents, short-term investments, long-term investments and accounts receivable. The Company is exposed to credit risk, subject to federal deposit insurance, in the event of default by the financial institutions holding its cash and cash equivalents to the extent of amounts recorded on the balance sheets. Accounts receivable represent amounts due from an agency of the federal government. |
Accounts Receivable | Accounts Receivable Accounts receivable at December 31, 2020 consisted of amounts billed under the Company’s contract with the Biomedical Advanced Research and Development Authority (BARDA). Receivables under the BARDA contract are recorded as qualifying research activities are conducted and invoices from the Company’s vendors are received. The Company carries its accounts receivable at cost less an allowance for doubtful accounts. On a periodic basis, the Company evaluates its accounts receivable and establishes an allowance based on its history of collections and write-offs and the current status of all receivables. The Company does not accrue interest on trade receivables. If accounts become uncollectible, they will be written off through a charge to the allowance for doubtful accounts. The Company has not recorded a charge to allowance for doubtful accounts as management believes all receivables are fully collectible. |
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 December 31, 2021 and December 31, 2020, the Company had cash equivalents, including money market funds, and short-term investments, including U.S. Treasury securities, whose value is based on using quoted market prices. At December 31, 2021, the Company had long-term investments, including U.S. Treasury securities, whose value is based on using quoted market prices. Accordingly, these securities are classified as Level 1. At December 31, 2021, the Company had short-term investments, including commercial paper, corporate bonds and U.S. Treasury securities. At December 31, 2020, the Company had short-term investments including 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." |
Inventories | Inventories We consider regulatory approval of product candidates to be uncertain and product manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained. As such, the manufacturing costs for product candidates incurred prior to regulatory approval are not capitalized as inventory but are expensed as research and development costs. We begin capitalization of these inventory related costs once regulatory approval is obtained. We primarily use actual costs to determine our cost basis for inventories. At December 31, 2021, our inventory is related to TEMBEXA, which is being manufactured for the treatment of smallpox and potential delivery to the Strategic National Stockpile (SNS) for the U.S. government and other government agencies. TEMBEXA was approved by the FDA on June 4, 2021, at which time we began to capitalize inventory costs associated with TEMBEXA. Prior to FDA approval of TEMBEXA, all costs related to the manufacturing of TEMBEXA were charged to research and development expense in the period incurred as there was no alternative future use. We value our inventories at the lower of cost or estimated net realizable value. We determine the cost of its inventories, which includes amounts related to materials, manufacturing costs, shipping and handling costs on a first-in, first-out (FIFO) basis. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which generally range from three |
Impairment of Property and Equipment | Impairment of Property and EquipmentThe Company evaluates property and equipment for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. If the estimated future cash flows (undiscounted and without interest charges) from the use of an asset are less than the carrying value, a write-down would be recorded to reduce the related asset to its estimated fair value. |
Leases | Leases At the inception of an arrangement, we determine if an arrangement is, or contains, a lease based on the unique facts and circumstances present in that arrangement. Lease classification, recognition, and measurement are then determined at the lease commencement date. For arrangements that contain a lease we (i) identify lease and non-lease components, (ii) determine the consideration in the contract, (iii) determine whether the lease is an operating or financing lease; and (iv) recognize lease right-of-use (ROU) assets and liabilities. Lease liabilities and their corresponding ROU assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable and as such, we use our incremental borrowing rate based on the information available at the lease commencement date, which represents an internally developed rate that would be incurred to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment. Most leases include options to renew and, or, terminate the lease, which can impact the lease term. The exercise of these options is at our discretion and we do not include any of these options within the expected lease term as we are not reasonably certain we will exercise these options. |
Revenue Recognition | Revenue Recognition Policy |
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 December 31, 2021, 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. |
Research and Development Expenses | Research and Development Expenses Major components of research and development costs include cash compensation, stock-based compensation, preclinical studies, clinical trial and related clinical manufacturing, drug development, materials and supplies, legal, regulatory compliance, and fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf. Research and development costs, including upfront fees and milestones paid to contract research organizations, are expensed as goods are received or services rendered. Costs incurred in connection with clinical trial activities for which the underlying nature of the activities themselves do not directly relate to active research and development, such as costs incurred for market research and focus groups linked to clinical strategy as well as costs to build the Company’s brand, are not included in research and development costs but are reflected as general and administrative costs. |
Interest Income and Other, Net | Interest Income and Other, Net Interest income and other, net consists primarily of interest earned on our cash, cash equivalents and short-term and long-term investments. |
Income Taxes | Income Taxes Deferred tax assets and liabilities are determined based on differences between the financial and tax reporting bases of assets and liabilities and are measured using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Valuation allowances are established when the Company determines that it is more likely than not that some portion of a deferred tax asset will not be realized. The Company has incurred operating losses from April 7, 2000 (inception) through December 31, 2021, and therefore has not recorded any current provision for income taxes. Additionally, the Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities based on the technical merits of the position. The tax benefit recognized in the financial statements for a particular tax position is based on the largest benefit that is more likely than not to be realized upon settlement. Accordingly, the Company establishes reserves for uncertain tax positions. The FASB Staff Q&A, Topic 740, No. 5, Accounting for Global Intangible Low-Taxed Income (GILTI), states that an entity can make an accounting policy election to either recognized deferred taxes for temporary basis differences expected to reverse as GILTI in future years or to provide for the tax expense related to GILTI in the year the tax is incurred as a period expense only. The Company has elected to account for GILTI as a period expense in the year the tax is incurred. |
Share-Based Compensation | Share-Based Compensation The Company measures and recognizes compensation expense for all share-based payment awards made to employees and directors, including employee stock options, restricted stock units and the employee stock purchase plan purchase rights, based on estimated fair values. The fair value of employee stock options and employee stock purchase plan purchase rights is estimated on the grant date using the Black-Scholes valuation model. The grant-date fair value for restricted stock units is based upon the market price of the Company’s common stock on the date of the grant. The value of the portion of the award that is ultimately expected to vest is recorded as expense over the requisite service periods. For performance-based awards compensation cost is recognized when it is probable that the performance criteria will be met. The Company estimates forfeitures at the time of grant and revises those estimates in subsequent periods if actual forfeitures differ from its estimates. The Company uses historical data to estimate forfeitures and records share-based compensation expense only for those awards that are expected to vest. To the extent that actual forfeitures differ from the Company’s estimates, the difference is recorded as a cumulative adjustment in the period the estimates were revised. For the years ended December 31, 2021, 2020 and 2019, the Company applied a forfeiture rate based on the Company’s historical forfeitures. |
401(k) Plan | 401(k) PlanThe Company maintains a defined contribution employee retirement plan (401(k) plan). |
Basic and Dilutive Net Loss Per Share of Common Stock | Basic and Dilutive 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 warrants to purchase common stock, 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 warrants to purchase common stock, 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 at December 31, 2021, 2020 and 2019. |
Segments | SegmentsThe Company operates in only one segment, pharmaceuticals. |
Impact of Recently Issued 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) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Assets and Liabilities Measured at Fair Value on a Recurring Basis | Below is a table that presents information about certain assets measured at fair value on a recurring basis (in thousands): Fair Value Measurements December 31, 2021 Total Quoted Prices in Significant Other Significant Cash equivalents Money market funds $ 11,841 $ 11,841 $ — $ — Total cash equivalents 11,841 11,841 — — Short-term investments U.S. Treasury securities 7,517 2,523 4,994 — Commercial paper 34,887 — 34,887 — Corporate bonds 30,566 — 30,566 — Total short-term investments 72,970 2,523 70,447 — Long-term investments U.S. Treasury securities 2,022 2,022 — — Total long-term investments 2,022 2,022 — — Total assets $ 86,833 $ 16,386 $ 70,447 $ — Fair Value Measurements December 31, 2020 Total Quoted Prices in Significant Other Significant Cash equivalents Money market funds $ 1,503 $ 1,503 $ — $ — Total cash equivalents 1,503 1,503 — — Short-term investments U.S. Treasury securities 28,715 28,715 — — Corporate bonds 3,258 — 3,258 — Total short-term investments 31,973 28,715 3,258 — Total assets $ 33,476 $ 30,218 $ 3,258 $ — |
Schedule of Prepaid and Other Current Assets | Prepaid expenses and other current assets consisted of the following (in thousands): December 31, 2021 2020 Prepaid research and development expenses $ 1,726 $ 1,167 Interest receivable 348 104 Prepaid insurance 450 354 Other prepaid expenses and current assets 2,154 731 Total prepaid expenses and other current assets $ 4,678 $ 2,356 |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): December 31, 2021 2020 Accrued compensation $ 5,491 $ 4,473 Accrued research and development expenses 4,642 1,375 Accrued legal expenses 359 651 Other accrued liabilities 2,616 751 Total accrued liabilities $ 13,108 $ 7,250 |
Investments (Tables)
Investments (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Investments [Abstract] | |
Summary of Short-term and Long-term Investments | The following tables summarize the Company’s short-term and long-term debt investments (in thousands): December 31, 2021 Amortized Cost Gross Unrealized Gross Unrealized Estimated Corporate bonds $ 30,571 $ 2 $ (7) $ 30,566 Commercial paper 34,890 2 (5) 34,887 U.S. Treasury securities 9,552 — (13) 9,539 Total investments $ 75,013 $ 4 $ (25) $ 74,992 December 31, 2020 Amortized Cost Gross Unrealized Gross Unrealized Estimated Corporate bonds $ 3,256 $ 2 $ — $ 3,258 U.S. Treasury securities 28,717 1 (3) 28,715 Total investments $ 31,973 $ 3 $ (3) $ 31,973 |
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): December 31, 2021 Less than 12 Months Greater than 12 Months Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate bonds $ 28,362 $ (7) $ — $ — $ 28,362 $ (7) Commercial paper 8,991 (5) — — 8,991 (5) U.S. Treasury securities 9,539 (13) — — 9,539 (13) Total $ 46,892 $ (25) $ — $ — $ 46,892 $ (25) Number of securities with unrealized losses 18 — 18 December 31, 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 $ 16,598 $ (3) $ — $ — $ 16,598 $ (3) Total $ 16,598 $ (3) $ — $ — $ 16,598 $ (3) Number of securities with unrealized losses 6 — 6 |
Summary of the Scheduled Maturity of Company Investments | The following table summarizes the scheduled maturity for the Company’s debt investments at December 31, 2021 (in thousands): December 31, 2021 Maturing in one year or less $ 72,970 Maturing after one year through two years 2,022 Total debt investments $ 74,992 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Summary of Property and Equipment, net | Property and equipment, net of accumulated depreciation consisted of the following (in thousands): December 31, 2021 2020 Lab equipment $ 2,341 $ 2,323 Leasehold improvements 1,713 1,584 Computer equipment 817 1,207 Office furniture and equipment 520 520 Property and equipment 5,391 5,634 Less accumulated depreciation (5,138) (5,420) Property and equipment, net of accumulated depreciation $ 253 $ 214 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
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 December 31, 2021 (in thousands): Assets Operating Lease Right-of-Use Assets $ 2,404 Liabilities Operating Lease Short-term Liabilities (recorded within Accrued liabilities) $ 432 Operating Lease Long-term Liabilities (recorded within Lease-related obligations) 2,392 Total Operating Lease Liabilities $ 2,824 |
Operating Lease Maturity | Operating lease payments over the remainder of the lease terms are as follows (in thousands): Years Ending December 31, As of December 31, 2021 2022 637 2023 736 2024 759 2025 781 2026 467 Total future minimum rental payments $ 3,380 Less amount of lease payments representing interest 556 Total present value of lease payments $ 2,824 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Shares Reserved for Future Issuance | The Company has reserved shares of common stock for future issuances as follows: December 31, 2021 2020 For exercise of outstanding common stock options 11,649,594 8,906,271 For delivery upon vesting of outstanding restricted stock units 896,222 1,133,049 For future equity awards under the 2013 Equity Incentive Plan 2,076,923 3,342,555 For future purchases under the 2013 Employee Stock Purchase Plan 2,298,817 2,419,213 Total shares of common stock reserved for future issuances 16,921,556 15,801,088 |
Schedule of Fair Value Assumptions, Stock Options | The following table illustrates the assumptions for the Black-Scholes model used in determining the fair value of the stock options granted: Years Ended December 31, 2021 2020 2019 Expected volatility 95.84 % 93.24 % 88.77 % Expected term (in years) 6.0 6.0 6.0 Weighted-average risk-free interest rate 0.71 % 1.24 % 2.42 % Expected dividend yield — % — % — % Weighted-average fair value per option $ 6.67 $ 1.78 $ 1.71 |
Summary of Activity Related to Stock Options | A summary of activity related to the Company’s stock options is as follows: Number of Options Weighted-Average Weighted-Average Total Intrinsic Value Balance, December 31, 2019 8,390,304 $ 8.36 7.47 Granted 3,508,080 2.37 — Exercised (409,988) 2.41 — Forfeited (2,575,125) 11.80 — Balance, December 31, 2020 8,913,271 $ 5.28 7.52 Granted 3,903,750 8.74 — Exercised (909,997) 4.69 — Forfeited (257,432) 15.12 — Balance, December 31, 2021 11,649,592 $ 6.27 7.65 $ 25,754 Exercisable at December 31, 2021 6,133,945 $ 6.62 6.83 $ 15,293 Vested or expected to vest at December 31, 2021 10,855,470 $ 6.28 7.58 $ 24,368 |
Schedule of Other Information Regarding Stock Options | Other information regarding the Company’s stock options is as follows (in thousands, except per share data): Years Ended December 31, 2021 2020 2019 Weighted-average grant-date fair value per share of options granted $ 6.67 $ 1.78 $ 1.71 Total intrinsic value of options exercised $ 3,496 $ 355 $ 10 Total fair value of shares vested $ 8,642 $ 4,188 $ 6,798 |
Schedule of Share-based Compensation, Shares Authorized | The following table summarizes, at December 31, 2021, by price range: (1) for stock option awards outstanding under the 2013 Plan, the number of stock option awards outstanding, their weighted-average remaining life and their weighted-average exercise price; and (2) for stock option awards exercisable under the 2013 Plan, the number of stock option awards exercisable and their weighted-average exercise price: Outstanding Exercisable Exercise Price Range ($) Number Weighted-Average Remaining Contractual Life (in years) Weighted-Average Exercise Price Number Weighted-Average Exercise Price 1.37 to 7.57 7,273,390 7.55 $ 2.89 4,424,385 $ 2.97 7.58 to 8.06 814,900 6.13 7.98 617,400 8.02 8.07 to 18.75 3,162,602 8.86 9.61 693,460 10.69 18.76 to 53.74 398,700 3.06 37.86 398,700 37.86 1.37 to 53.74 11,649,592 7.65 $ 6.27 6,133,945 $ 6.62 |
Schedule of Fair Value Assumptions, Employee Stock Purchase Plan | The following table illustrates the assumptions for the Black-Scholes model used in determining the fair value of the ESPP purchase rights: Years Ended December 31, 2021 2020 2019 Expected volatility 97.54 % 75.39 % 57.22 % Expected term (in years) 0.71 1.28 1.23 Weighted-average risk-free interest rate 0.25 % 0.37 % 2.36 % Expected dividend yield — % — % — % Weighted-average option value per share $ 6.55 $ 0.93 $ 1.00 |
Summary of Activity Related to Restricted Stock Units | A summary of activity related to the Company’s RSUs is as follows: Number of Restricted Weighted-Average Grant-Date Fair Value Balance, December 31, 2020 1,133,049 $ 2.61 Granted 216,875 9.28 Share issuance (430,002) 2.88 Forfeited (23,700) 6.80 Balance, December 31, 2021 896,222 $ 3.98 |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs | 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 stock-based compensation expense was as follows (in thousands): Years Ended December 31, 2021 2020 2019 Income Statement Classification: Research and development expense $ 6,611 $ 2,969 $ 4,089 General and administrative expense 5,649 2,599 5,439 Total stock-based compensation expense $ 12,260 $ 5,568 $ 9,528 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Reconciliation of the Difference between the Benefit for Income Taxes and Income Taxes at the Statutory U.S. Federal Income Tax Rate | A reconciliation of the difference between the benefit for income taxes and income taxes at the statutory U.S. federal income tax rate is as follows for the years ended December 31, 2021, 2020, and 2019 (in thousands, except percentages): 2021 2020 2019 Amount % of Pretax Amount % of Pretax Amount % of Pretax Income tax benefit at statutory rate $ (36,379) 21.0 % $ (9,140) 21.0 % $ (23,641) 21.0 % State income taxes (8,060) 4.7 % (138) 0.3 % (1,596) 1.4 % Research and development credits (1,565) 0.9 % (1,088) 2.5 % (1,190) 1.1 % In process R&D 26,395 (15.2) % — — % — — % Permanent items 711 (0.4) % 505 (1.2) % 696 (0.6) % Provision to return adjustments 126 (0.1) % 81 (0.2) % 937 (0.8) % Effect of change in federal tax rate — — % — — % — — % Effect of change in state tax rate 3,478 (2.0) % 1,139 (2.6) % (117) 0.1 % Removal of excess tax benefit — — % — — % — — % Increase in unrecognized tax benefits 439 (0.3) % 272 (0.6) % 298 (0.3) % Current year forfeitures 435 (0.3) % 4,026 (9.2) % — — % Change in valuation allowance 14,420 (8.3) % 4,343 (10.0) % 24,613 (21.9) % Net benefit $ — — % $ — — % $ — — % |
Components of Deferred Tax Assets and Liabilities | The components of deferred tax assets and liabilities at December 31, 2021 and 2020 were as follows (in thousands): December 31, 2021 2020 Deferred tax assets: Domestic net operating loss carryforwards $ 138,548 $ 123,381 Research and development expenses 1,191 293 Capitalized Section 174 expenses — — License fees 14,131 12,556 Research and development credits 17,738 15,498 Capital loss carryforwards 484 403 Accrued bonuses 888 943 Share-based compensation 4,885 3,541 Other 1,457 961 Total gross deferred tax assets 179,322 157,576 Valuation allowance (178,705) (156,973) Total deferred tax assets 617 603 Deferred tax liabilities: Right-of-use asset (617) (603) Total deferred tax liabilities (617) (603) Total deferred tax assets and liabilities, net $ — $ — |
Summary of Uncertain Tax Benefit | Therefore, the Company recognized an uncertain tax benefit associated with the federal R&D credit carryover during the years ended December 31, 2021 and 2020, as follows (in thousands): Balance at December 31, 2019 $ 4,023 Increases related to 2020 272 Increases related to prior periods — Balance at December 31, 2020 4,295 Increases related to 2021 391 Increases related to prior periods 48 Balance at December 31, 2021 $ 4,734 |
Oncoceutics Acquisition (Tables
Oncoceutics Acquisition (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Business Combination and Asset Acquisition [Abstract] | |
Asset Acquisition | The following represents the consideration paid and purchase price allocation for the acquisition of Oncoceutics (in thousands, except for per share data): Cash $ 23,836 One-year closing anniversary payment 14,000 Shares common stock issued as consideration 8,723,769 Stock price per share on effective date 4.98 Value of estimated common stock consideration 43,445 Total consideration $ 81,281 Net assets acquired $ (1,310) IPR&D assets expensed 82,591 Total purchase price allocated $ 81,281 Transaction costs expensed to IPR&D (1) $ 299 Total IPR&D expensed $ 82,890 |
Restructuring Costs (Tables)
Restructuring Costs (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Restructuring and Related Activities [Abstract] | |
Restructuring and Related Costs | The following table summarizes the restructuring charges (in thousands) recorded for the twelve months ended December 31, 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 the twelve months ended December 31, 2019. No additional charges are expected to be incurred. 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 twelve months ended December 31, 2020. Employee Termination Benefits Clinical Trial Close-out Costs Other Development Costs Total Balance at December 31, 2019 $ 183 $ 27 $ 110 $ 320 Revised estimates — (23) (10) (33) Payments (183) (4) (100) (287) Balance at December 31, 2020 $ — $ — $ — $ — |
Selected Quarterly Financial _2
Selected Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Selected Quarterly Financial Information [Abstract] | |
Schedule of Quarterly Financial Information | The following financial information reflects all normal recurring adjustments, which are, in the opinion of management, necessary for a fair statement of the results of the interim periods. Summarized quarterly data for 2021 and 2020 are as follows (in thousands, except share and per share data): 2021 Quarters Fourth Third Second First Revenue $ 46 $ 107 $ 391 $ 1,435 Operating loss (39,532) (18,600) (17,815) (97,453) Net loss (39,498) (18,560) (17,763) (97,415) Net loss per share, basic and diluted $ (0.45) $ (0.21) $ (0.21) $ (1.21) Weighted-average shares outstanding, basic and diluted 86,867,070 86,335,357 86,225,836 80,204,094 2020 Quarters Fourth Third Second First Revenue $ 1,120 $ 1,609 $ 1,402 $ 1,241 Operating loss (11,757) (11,560) (10,286) (10,913) Net loss (11,675) (11,411) (10,016) (10,420) Net loss per share, basic and diluted $ (0.19) $ (0.18) $ (0.16) $ (0.17) Weighted-average shares outstanding, basic and diluted 62,702,181 62,242,456 62,042,778 61,742,035 |
The Business and Summary of S_4
The Business and Summary of Significant Accounting Policies (Narrative) (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||||||
Oct. 31, 2019USD ($) | Feb. 28, 2011USD ($) | Feb. 28, 2011segment | Feb. 28, 2011contract | Feb. 28, 2011extension | Dec. 31, 2021USD ($)grant | Sep. 30, 2021USD ($) | Jun. 30, 2021USD ($) | Mar. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Sep. 30, 2020USD ($) | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Dec. 31, 2021USD ($)productgrantsegmentshares | Dec. 31, 2020USD ($)shares | Dec. 31, 2019USD ($)shares | |
Class of Stock | ||||||||||||||||
Number of product candidates | product | 2 | |||||||||||||||
Investments | ||||||||||||||||
Accumulated other comprehensive loss, net | $ (21,000) | $ 0 | $ (21,000) | $ 0 | ||||||||||||
Interest income and other, net | 164,000 | 994,000 | $ 3,407,000 | |||||||||||||
Inventory | ||||||||||||||||
Inventory, work in process, gross | 2,800,000 | 2,800,000 | ||||||||||||||
Inventory, finished goods, gross | 0 | 0 | ||||||||||||||
Property and Equipment | ||||||||||||||||
Impairment of long-lived assets | 0 | 0 | ||||||||||||||
Revenue Recognition | ||||||||||||||||
Contract revenue | 46,000 | $ 107,000 | $ 391,000 | $ 1,435,000 | $ 1,120,000 | $ 1,609,000 | $ 1,402,000 | $ 1,241,000 | 1,979,000 | 5,372,000 | 12,519,000 | |||||
Defined Contribution Plan | ||||||||||||||||
Defined contribution plan, cost recognized | $ 400,000 | $ 300,000 | $ 300,000 | |||||||||||||
Basic and Diluted Net Loss Per Share of Common Stock | ||||||||||||||||
Antidilutive shares excluded from earnings per share calculation (in shares) | shares | 4,672,859 | 1,162,161 | 1,571,356 | |||||||||||||
Segments | ||||||||||||||||
Number of operating segments | segment | 1 | |||||||||||||||
SymBio Pharmaceuticals | ||||||||||||||||
Revenue Recognition | ||||||||||||||||
Contract revenue | $ 5,000,000 | |||||||||||||||
Scenario, Adjustment | ||||||||||||||||
Investments | ||||||||||||||||
Accumulated other comprehensive loss, net | (2,000) | $ (2,000) | ||||||||||||||
Interest income and other, net | $ 2,000 | |||||||||||||||
Minimum | ||||||||||||||||
Property and Equipment | ||||||||||||||||
Property and equipment, useful life | 3 years | |||||||||||||||
Maximum | ||||||||||||||||
Property and Equipment | ||||||||||||||||
Property and equipment, useful life | 5 years | |||||||||||||||
Grant | Oncoceutics, Inc. | ||||||||||||||||
Revenue Recognition | ||||||||||||||||
Contract revenue | $ 400,000 | |||||||||||||||
Contract with customer, asset, after allowance for credit loss | $ 200,000 | 200,000 | ||||||||||||||
BARDA | ||||||||||||||||
Revenue Recognition | ||||||||||||||||
Contract revenue | $ 1,600,000 | $ 5,300,000 | $ 7,600,000 | |||||||||||||
Number of base segments | segment | 1 | |||||||||||||||
Number of option segments | 4 | 4 | ||||||||||||||
Number of contracts | contract | 5 | |||||||||||||||
BARDA | Expense Reimbursement | ||||||||||||||||
Revenue Recognition | ||||||||||||||||
Contract revenue | $ 72,500,000 | |||||||||||||||
BARDA | Fees | ||||||||||||||||
Revenue Recognition | ||||||||||||||||
Contract revenue | $ 4,600,000 | |||||||||||||||
SymBio Pharmaceuticals | ||||||||||||||||
Revenue Recognition | ||||||||||||||||
Contract revenue | 5,000,000 | |||||||||||||||
Payment to be received upon achievement of milestones | $ 180,000,000 | |||||||||||||||
License agreement cost | $ 5,000,000 | |||||||||||||||
Federal Goverment | Oncoceutics, Inc. | ||||||||||||||||
Revenue Recognition | ||||||||||||||||
Number of grants acquired | grant | 2 | 2 | ||||||||||||||
Private Foundations | Oncoceutics, Inc. | ||||||||||||||||
Revenue Recognition | ||||||||||||||||
Number of grants acquired | grant | 2 | 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 | Dec. 31, 2021 | Dec. 31, 2020 |
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | $ 72,970 | $ 31,973 |
Fair value, measurements, recurring | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 11,841 | 1,503 |
Short-term investments, available-for-sale | 72,970 | 31,973 |
Long-term investments | 2,022 | |
Total assets | 86,833 | 33,476 |
Fair value, measurements, recurring | U.S. Treasury securities | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 7,517 | 28,715 |
Long-term investments | 2,022 | |
Fair value, measurements, recurring | Commercial paper | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 34,887 | |
Fair value, measurements, recurring | Corporate bonds | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 30,566 | 3,258 |
Fair value, measurements, recurring | Money market funds | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 11,841 | 1,503 |
Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 11,841 | 1,503 |
Short-term investments, available-for-sale | 2,523 | 28,715 |
Long-term investments | 2,022 | |
Total assets | 16,386 | 30,218 |
Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | U.S. Treasury securities | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 2,523 | 28,715 |
Long-term investments | 2,022 | |
Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | Commercial paper | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 0 | |
Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | Corporate bonds | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 0 | 0 |
Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | Money market funds | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 11,841 | 1,503 |
Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 0 | 0 |
Short-term investments, available-for-sale | 70,447 | 3,258 |
Long-term investments | 0 | |
Total assets | 70,447 | 3,258 |
Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | U.S. Treasury securities | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 4,994 | 0 |
Long-term investments | 0 | |
Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | Commercial paper | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 34,887 | |
Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | Corporate bonds | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 30,566 | 3,258 |
Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | Money market funds | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 0 | 0 |
Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 0 | 0 |
Short-term investments, available-for-sale | 0 | 0 |
Long-term investments | 0 | |
Total assets | 0 | 0 |
Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | U.S. Treasury securities | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 0 | 0 |
Long-term investments | 0 | |
Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | Commercial paper | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 0 | |
Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | Corporate bonds | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 0 | 0 |
Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | Money market funds | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | $ 0 | $ 0 |
The Business and Summary of S_6
The Business and Summary of Significant Accounting Policies (Schedule of Prepaid and Other Current Assets) (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Prepaid Expense and Other Assets, Current | ||
Prepaid research and development expenses | $ 1,726 | $ 1,167 |
Interest receivable | 348 | 104 |
Prepaid insurance | 450 | 354 |
Other prepaid expenses and current assets | 2,154 | 731 |
Total prepaid expenses and other current assets | $ 4,678 | $ 2,356 |
The Business and Summary of S_7
The Business and Summary of Significant Accounting Policies (Schedule of Accrued Liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Accrued Liabilities, Current | ||
Accrued compensation | $ 5,491 | $ 4,473 |
Accrued research and development expenses | 4,642 | 1,375 |
Accrued legal expenses | 359 | 651 |
Other accrued liabilities | 2,616 | 751 |
Total accrued liabilities | $ 13,108 | $ 7,250 |
Investments - Summary of Availa
Investments - Summary of Available-for-Sale Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Schedule of Investments | ||
Amortized Cost | $ 75,013 | $ 31,973 |
Gross Unrealized Gains | 4 | 3 |
Gross Unrealized Losses | (25) | (3) |
Estimated Fair Value | 74,992 | 31,973 |
Corporate bonds | ||
Schedule of Investments | ||
Amortized Cost | 30,571 | 3,256 |
Gross Unrealized Gains | 2 | 2 |
Gross Unrealized Losses | (7) | 0 |
Estimated Fair Value | 30,566 | 3,258 |
Commercial paper | ||
Schedule of Investments | ||
Amortized Cost | 34,890 | |
Gross Unrealized Gains | 2 | |
Gross Unrealized Losses | (5) | |
Estimated Fair Value | 34,887 | |
U.S. Treasury securities | ||
Schedule of Investments | ||
Amortized Cost | 9,552 | 28,717 |
Gross Unrealized Gains | 0 | 1 |
Gross Unrealized Losses | (13) | (3) |
Estimated Fair Value | $ 9,539 | $ 28,715 |
Investments - Summary of Invest
Investments - Summary of Investments with Unrealized Losses, Aggregated by Investment Type and the Length of Time (Details) $ in Thousands | Dec. 31, 2021USD ($)security | Dec. 31, 2020USD ($)security |
Schedule of Investments | ||
Fair value, less than 12 months | $ 46,892 | $ 16,598 |
Unrealized loss, less than 12 months | (25) | (3) |
Fair value, greater than 12 months | 0 | 0 |
Unrealized loss, greater than 12 months | 0 | 0 |
Fair value, total | 46,892 | 16,598 |
Unrealized loss, total | $ (25) | $ (3) |
Number of securities with unrealized losses, less than 12 months | security | 18 | 6 |
Number of securities with unrealized losses, greater than 12 months | security | 0 | 0 |
Number of securities with unrealized losses, total | security | 18 | 6 |
Corporate bonds | ||
Schedule of Investments | ||
Fair value, less than 12 months | $ 28,362 | |
Unrealized loss, less than 12 months | (7) | |
Fair value, greater than 12 months | 0 | |
Unrealized loss, greater than 12 months | 0 | |
Fair value, total | 28,362 | |
Unrealized loss, total | (7) | |
Commercial paper | ||
Schedule of Investments | ||
Fair value, less than 12 months | 8,991 | |
Unrealized loss, less than 12 months | (5) | |
Fair value, greater than 12 months | 0 | |
Unrealized loss, greater than 12 months | 0 | |
Fair value, total | 8,991 | |
Unrealized loss, total | (5) | |
U.S. Treasury securities | ||
Schedule of Investments | ||
Fair value, less than 12 months | 9,539 | $ 16,598 |
Unrealized loss, less than 12 months | (13) | (3) |
Fair value, greater than 12 months | 0 | 0 |
Unrealized loss, greater than 12 months | 0 | 0 |
Fair value, total | 9,539 | 16,598 |
Unrealized loss, total | $ (13) | $ (3) |
Investments - Available for Sal
Investments - Available for Sale Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Investments [Abstract] | ||
Maturing in one year or less | $ 72,970 | |
Maturing after one year through two years | 2,022 | |
Total debt investments | $ 74,992 | $ 31,973 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment, Net | ||
Property and equipment | $ 5,391 | $ 5,634 |
Less accumulated depreciation | (5,138) | (5,420) |
Property and equipment, net of accumulated depreciation | 253 | 214 |
Lab equipment | ||
Property, Plant and Equipment, Net | ||
Property and equipment | 2,341 | 2,323 |
Leasehold improvements | ||
Property, Plant and Equipment, Net | ||
Property and equipment | 1,713 | 1,584 |
Computer equipment | ||
Property, Plant and Equipment, Net | ||
Property and equipment | 817 | 1,207 |
Office furniture and equipment | ||
Property, Plant and Equipment, Net | ||
Property and equipment | $ 520 | $ 520 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021USD ($)ft² | Dec. 31, 2020USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | ||
Weighted average remaining lease term | 4 years 6 months 29 days | |
Lease expense under operating leases | $ 700 | $ 700 |
Weighted average discount rate | 7.89% | |
Lease payments | $ 500 | 700 |
Area of sublease space (in sq ft) | ft² | 3,537 | |
Sublease income | $ 12 | 71 |
BARDA | Refundable Agreements | ||
Disaggregation of Revenue | ||
Provision for refundable amounts | $ 52 | $ 38 |
Commitments and Contingencies_2
Commitments and Contingencies - Operating Lease Right-of-Use Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
ASSETS | ||
Operating Lease Right-of-Use Assets | $ 2,404 | $ 2,825 |
Liabilities | ||
Operating Lease Short-term Liabilities (recorded within Accrued liabilities) | 432 | |
Operating Lease Long-term Liabilities (recorded within Lease-related obligations) | 2,392 | $ 2,814 |
Total Operating Lease Liabilities | $ 2,824 | |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Liability | Liability |
Commitments and Contingencies_3
Commitments and Contingencies - Maturity Analysis of Operating Lease Liabilities (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Years Ending December 31, | |
2022 | $ 637 |
2023 | 736 |
2024 | 759 |
2025 | 781 |
2026 | 467 |
Total future minimum rental payments | 3,380 |
Less amount of lease payments representing interest | 556 |
Total Operating Lease Liabilities | $ 2,824 |
Stockholders' Equity (Deficit_2
Stockholders' Equity (Deficit) (Narrative) (Details) - USD ($) | Jan. 20, 2021 | Jan. 01, 2021 | Jan. 01, 2020 | Feb. 05, 2019 | May 31, 2019 | Apr. 30, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Aug. 10, 2020 | Feb. 28, 2013 |
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 | |||||||||
Common stock, shares issued (in shares) | 86,884,266 | 62,816,039 | |||||||||
Common stock, shares outstanding (in shares) | 86,884,266 | 62,816,039 | |||||||||
Shares reserved for future issuance (in shares) | 16,921,556 | 15,801,088 | |||||||||
Liability | $ 13,108,000 | $ 7,250,000 | |||||||||
Proceeds from exercise of all share-based payment arrangements | 4,600,000 | 1,400,000 | $ 400,000 | ||||||||
Tax benefit from share-based payment arrangements | $ 0 | $ 0 | $ 0 | ||||||||
Accelerated compensation period | 15 months | 12 months | |||||||||
Accelerated compensation | $ 1,800,000 | $ 700,000 | |||||||||
Employee stock option | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||
Shares reserved for future issuance (in shares) | 11,649,594 | 8,906,271 | |||||||||
Restricted stock units (RSUs) | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||
Unrecognized compensation costs, period of recognition | 2 years 4 months 20 days | ||||||||||
Shares reserved for future issuance (in shares) | 896,222 | 1,133,049 | |||||||||
Shares issued pursuant to vesting of RSUs (in shares) | 430,002 | 478,966 | |||||||||
Unrecognized compensation costs | $ 2,300,000 | ||||||||||
Public Offering | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||
Sale of common stock, amount authorized | $ 75,000,000 | ||||||||||
Public Stock Offering | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||
Common stock sold (in shares) | 11,765,000 | ||||||||||
Common stock sold (in USD per share) | $ 8.50 | ||||||||||
Sale of common stock, net offering proceeds | $ 107,800,000 | ||||||||||
Underwriter's Option | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||
Common stock sold (in shares) | 1,764,750 | ||||||||||
Common stock sold (in USD per share) | $ 7.99 | ||||||||||
Purchase option term | 30 days | ||||||||||
Chief Executive Officer | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||
Options granted (in shares) | 1,750,000 | ||||||||||
Chief Executive Officer | Employee stock option | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||
Expiration period | 10 years | ||||||||||
Vesting period | 4 years | ||||||||||
Year One | Chief Executive Officer | Employee stock option | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||
Vesting percentage | 25.00% | ||||||||||
Year Two | Chief Executive Officer | Employee stock option | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||
Vesting percentage | 25.00% | ||||||||||
Year Three | Chief Executive Officer | Employee stock option | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||
Vesting percentage | 25.00% | ||||||||||
Year Four | Chief Executive Officer | Employee stock option | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||
Vesting percentage | 25.00% | ||||||||||
The 2013 Plan | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||
Share-based compensation, equity increase percentage | 4.00% | ||||||||||
Unrecognized compensation costs | $ 19,600,000 | ||||||||||
Unrecognized compensation costs, period of recognition | 2 years 9 months 10 days | ||||||||||
Shares reserved for future issuance (in shares) | 2,076,923 | 3,342,555 | |||||||||
The 2013 Employee Stock Purchase Plan | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award | |||||||||||
Share-based compensation, equity increase percentage | 1.00% | ||||||||||
Number of shares authorized to be granted (in shares) | 704,225 | ||||||||||
Number of shares authorized, increase amount (in shares) | 422,535 | ||||||||||
Number of additional shares authorized (in shares) | 422,535 | 422,535 | |||||||||
Number of shares available for grant (in shares) | 3,916,401 | 3,493,866 | 3,916,401 | ||||||||
Shares reserved for future issuance (in shares) | 2,298,817 | 2,419,213 | |||||||||
Percentage of pay that employee can contribute, maximum | 15.00% | ||||||||||
Discount from market price, entry date | 15.00% | ||||||||||
Discount from market price, purchase date | 15.00% | ||||||||||
Employee stock purchase plan, purchase period | 6 months | ||||||||||
Employee stock purchase plan, automatic reset participation period | 24 months | ||||||||||
Employee stock purchase plan purchases (in shares) | 542,931 | 337,072 | |||||||||
Liability | $ 400,000 |
Stockholders' Equity (Deficit_3
Stockholders' Equity (Deficit) (Schedule of Shares Reserved for Future Issuance) (Details) - shares | Dec. 31, 2021 | Dec. 31, 2020 |
Share-based Compensation Arrangement by Share-based Payment Award | ||
Shares reserved for future issuance (in shares) | 16,921,556 | 15,801,088 |
The 2013 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Shares reserved for future issuance (in shares) | 2,076,923 | 3,342,555 |
The 2013 Employee Stock Purchase Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Shares reserved for future issuance (in shares) | 2,298,817 | 2,419,213 |
Employee stock option | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Shares reserved for future issuance (in shares) | 11,649,594 | 8,906,271 |
Restricted stock units (RSUs) | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Shares reserved for future issuance (in shares) | 896,222 | 1,133,049 |
Stockholders' Equity (Deficit_4
Stockholders' Equity (Deficit) (Assumption Used to Determine the Fair Value of Options Granted) (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award | |||
Weighted-average fair value per option (in usd per share) | $ 6.67 | $ 1.78 | $ 1.71 |
Employee stock option | |||
Share-based Compensation Arrangement by Share-based Payment Award | |||
Expected volatility | 95.84% | 93.24% | 88.77% |
Expected term (in years) | 6 years | 6 years | 6 years |
Weighted-average risk-free interest rate | 0.71% | 1.24% | 2.42% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Weighted-average fair value per option (in usd per share) | $ 6.67 | $ 1.78 | $ 1.71 |
Stockholders' Equity (Deficit_5
Stockholders' Equity (Deficit) (Summary of Activity Related to Stock Options) (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Number of Options Outstanding | |||
Beginning balance (in shares) | 8,913,271 | 8,390,304 | |
Granted (in shares) | 3,903,750 | 3,508,080 | |
Exercised (in shares) | (909,997) | (409,988) | |
Forfeited (in shares) | (257,432) | (2,575,125) | |
Ending balance (in shares) | 11,649,592 | 8,913,271 | 8,390,304 |
Exercisable (in shares) | 6,133,945 | ||
Vested and expected to vest (in shares) | 10,855,470 | ||
Weighted-Average Exercise Price | |||
Beginning balance (in usd per share) | $ 5.28 | $ 8.36 | |
Granted (in usd per share) | 8.74 | 2.37 | |
Exercised (in usd per share) | 4.69 | 2.41 | |
Forfeited (in usd per share) | 15.12 | 11.80 | |
Ending balance (in usd per share) | 6.27 | $ 5.28 | $ 8.36 |
Exercisable (in usd per share) | 6.62 | ||
Vested or expected to vest (in usd per share) | $ 6.28 | ||
Additional Disclosure | |||
Weighted-average remaining contractual life (in years) | 7 years 7 months 24 days | 7 years 6 months 7 days | 7 years 5 months 19 days |
Weighted-average remaining contractual life (in years), Exercisable | 6 years 9 months 29 days | ||
Weighted-average remaining contractual life (in years), Vested or expected to vest | 7 years 6 months 29 days | ||
Total intrinsic value of options outstanding | $ 25,754 | ||
Total intrinsic value of options exercisable | 15,293 | ||
Total intrinsic value of options vested or expected to vest | $ 24,368 |
Stockholders' Equity (Deficit_6
Stockholders' Equity (Deficit) (Schedule of other information regarding stock options) (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Stockholders' Equity Note [Abstract] | |||
Weighted-average fair value per option (in usd per share) | $ 6.67 | $ 1.78 | $ 1.71 |
Total intrinsic value of options exercised | $ 3,496 | $ 355 | $ 10 |
Total fair value of shares vested | $ 8,642 | $ 4,188 | $ 6,798 |
Stockholders' Equity (Deficit_7
Stockholders' Equity (Deficit) (Schedule of Share-based Compensation, Shares Authorized) (Details) | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
1.37 to 7.57 | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Share-based compensation, lower range limit (in usd per share) | $ 1.37 |
Share-based compensation, upper range limit (in usd per share) | $ 7.57 |
Share-based compensation, number of outstanding options (in shares) | shares | 7,273,390 |
Share-based compensation, outstanding options, weighted average remaining contractual term | 7 years 6 months 18 days |
Share-based compensation, outstanding options, weighted average exercise price (in usd per share) | $ 2.89 |
Share-based compensation, number of exercisable options (in shares) | shares | 4,424,385 |
Share-based compensation, exercisable options, weighted average exercise price (in usd per share) | $ 2.97 |
7.58 to 8.06 | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Share-based compensation, lower range limit (in usd per share) | 7.58 |
Share-based compensation, upper range limit (in usd per share) | $ 8.06 |
Share-based compensation, number of outstanding options (in shares) | shares | 814,900 |
Share-based compensation, outstanding options, weighted average remaining contractual term | 6 years 1 month 17 days |
Share-based compensation, outstanding options, weighted average exercise price (in usd per share) | $ 7.98 |
Share-based compensation, number of exercisable options (in shares) | shares | 617,400 |
Share-based compensation, exercisable options, weighted average exercise price (in usd per share) | $ 8.02 |
8.07 to 18.75 | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Share-based compensation, lower range limit (in usd per share) | 8.07 |
Share-based compensation, upper range limit (in usd per share) | $ 18.75 |
Share-based compensation, number of outstanding options (in shares) | shares | 3,162,602 |
Share-based compensation, outstanding options, weighted average remaining contractual term | 8 years 10 months 9 days |
Share-based compensation, outstanding options, weighted average exercise price (in usd per share) | $ 9.61 |
Share-based compensation, number of exercisable options (in shares) | shares | 693,460 |
Share-based compensation, exercisable options, weighted average exercise price (in usd per share) | $ 10.69 |
18.76 to 53.74 | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Share-based compensation, lower range limit (in usd per share) | 18.76 |
Share-based compensation, upper range limit (in usd per share) | $ 53.74 |
Share-based compensation, number of outstanding options (in shares) | shares | 398,700 |
Share-based compensation, outstanding options, weighted average remaining contractual term | 3 years 21 days |
Share-based compensation, outstanding options, weighted average exercise price (in usd per share) | $ 37.86 |
Share-based compensation, number of exercisable options (in shares) | shares | 398,700 |
Share-based compensation, exercisable options, weighted average exercise price (in usd per share) | $ 37.86 |
1.37 to 53.74 | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Share-based compensation, lower range limit (in usd per share) | 1.37 |
Share-based compensation, upper range limit (in usd per share) | $ 53.74 |
Share-based compensation, number of outstanding options (in shares) | shares | 11,649,592 |
Share-based compensation, outstanding options, weighted average remaining contractual term | 7 years 7 months 24 days |
Share-based compensation, outstanding options, weighted average exercise price (in usd per share) | $ 6.27 |
Share-based compensation, number of exercisable options (in shares) | shares | 6,133,945 |
Share-based compensation, exercisable options, weighted average exercise price (in usd per share) | $ 6.62 |
Stockholders' Equity (Deficit_8
Stockholders' Equity (Deficit) (Schedule of Share-Based Compensation) (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award | |||
Weighted-average fair value per option (in usd per share) | $ 6.67 | $ 1.78 | $ 1.71 |
The 2013 Employee Stock Purchase Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award | |||
Expected volatility | 97.54% | 75.39% | 57.22% |
Expected term (in years) | 8 months 15 days | 1 year 3 months 10 days | 1 year 2 months 23 days |
Weighted-average risk-free interest rate | 0.25% | 0.37% | 2.36% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Weighted-average fair value per option (in usd per share) | $ 6.55 | $ 0.93 | $ 1 |
Stockholders' Equity (Deficit_9
Stockholders' Equity (Deficit) (Summary of Activity Related to Restricted Stock Units) (Details) - Restricted stock units (RSUs) | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Number of Restricted Stock Units Outstanding | |
Beginning balance (in shares) | shares | 1,133,049 |
Granted (in shares) | shares | 216,875 |
Shares issuance (in shares) | shares | (430,002) |
Forfeited (in shares) | shares | (23,700) |
Ending balance (in shares) | shares | 896,222 |
Weighted-Average Grant-Date Fair Value | |
Beginning balance (in usd per share) | $ / shares | $ 2.61 |
Granted (in usd per share) | $ / shares | 9.28 |
Shares issuance (in usd per share) | $ / shares | 2.88 |
Forfeited (in usd per share) | $ / shares | 6.80 |
Ending balance (in usd per share) | $ / shares | $ 3.98 |
Stockholders' Equity (Defici_10
Stockholders' Equity (Deficit) (Schedule of Allocation of Recognized Period Costs) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award | |||
Allocated share-based compensation expense | $ 12,260 | $ 5,568 | $ 9,528 |
Research and development expense | |||
Share-based Compensation Arrangement by Share-based Payment Award | |||
Allocated share-based compensation expense | 6,611 | 2,969 | 4,089 |
General and administrative expense | |||
Share-based Compensation Arrangement by Share-based Payment Award | |||
Allocated share-based compensation expense | $ 5,649 | $ 2,599 | $ 5,439 |
Income Taxes (Reconciliation of
Income Taxes (Reconciliation of the Difference between the Benefit for Income Taxes and Income Taxes at the Statutory U.S. Federal Income Tax Rate) (Alternate) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Amount | |||
Income tax benefit at statutory rate | $ (36,379,000) | $ (9,140,000) | $ (23,641,000) |
State income taxes | (8,060,000) | (138,000) | (1,596,000) |
Research and development credits | (1,565,000) | (1,088,000) | (1,190,000) |
In process R&D | 26,395,000 | 0 | 0 |
Permanent items | 711,000 | 505,000 | 696,000 |
Provision to return adjustments | 126,000 | 81,000 | 937,000 |
Effect of change in federal tax rate | 0 | 0 | 0 |
Effect of change in state tax rate | 3,478,000 | 1,139,000 | (117,000) |
Removal of excess tax benefit | 0 | 0 | 0 |
Increase in unrecognized tax benefits | 439,000 | 272,000 | 298,000 |
Current year forfeitures | 435,000 | 4,026,000 | 0 |
Change in valuation allowance | 14,420,000 | 4,343,000 | 24,613,000 |
Net benefit | $ 0 | $ 0 | $ 0 |
% of Pretax Earnings | |||
Income tax benefit at statutory rate | 21.00% | 21.00% | 21.00% |
State income taxes | 4.70% | 0.30% | 1.40% |
Research and development credits | 0.90% | 2.50% | 1.10% |
In process R&D | (15.20%) | 0.00% | 0.00% |
Permanent items | (0.40%) | (1.20%) | (0.60%) |
Provision to return adjustments | (0.10%) | (0.20%) | (0.80%) |
Effect of change in federal tax rate | 0.00% | 0.00% | 0.00% |
Effect of change in state tax rate | (2.00%) | (2.60%) | 0.10% |
Removal of excess tax benefit | 0.00% | 0.00% | 0.00% |
Increase in unrecognized tax benefits | (0.30%) | (0.60%) | (0.30%) |
Current year forfeitures | (0.30%) | (9.20%) | 0.00% |
Change in valuation allowance | (8.30%) | (10.00%) | (21.90%) |
Net benefit | 0.00% | 0.00% | 0.00% |
Income Taxes (Components of Def
Income Taxes (Components of Deferred Tax Assets and Liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Domestic net operating loss carryforwards | $ 138,548 | $ 123,381 |
Research and development expenses | 1,191 | 293 |
Capitalized Section 174 expenses | 0 | 0 |
License fees | 14,131 | 12,556 |
Research and development credits | 17,738 | 15,498 |
Capital loss carryforwards | 484 | 403 |
Accrued bonuses | 888 | 943 |
Share-based compensation | 4,885 | 3,541 |
Other | 1,457 | 961 |
Total gross deferred tax assets | 179,322 | 157,576 |
Valuation allowance | (178,705) | (156,973) |
Total deferred tax assets | 617 | 603 |
Deferred tax liabilities: | ||
Right-of-use asset | (617) | (603) |
Total deferred tax liabilities | (617) | (603) |
Total deferred tax assets and liabilities, net | $ 0 | $ 0 |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) - USD ($) | Nov. 18, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2014 | Dec. 31, 2007 |
Operating Loss Carryforwards | ||||||
Income tax expense (benefit) | $ 0 | $ 0 | $ 0 | |||
Loss limitation ownership change benchmark amount | $ 762,000 | |||||
Annual limitation of operating loss carryforwards | $ 6,700,000 | |||||
Decrease in deferred tax asset | 7,100,000 | |||||
Decrease in deferred tax asset valuation allowance | $ 7,100,000 | |||||
Penalties and interest accrued | 0 | |||||
United Kingdom | ||||||
Operating Loss Carryforwards | ||||||
Undisturbed foreign earnings | 0 | |||||
Federal | ||||||
Operating Loss Carryforwards | ||||||
Operating loss carryforwards | 637,900,000 | 551,000,000 | ||||
Operating loss carryforwards, subject to expiration | 414,700,000 | |||||
Operating loss carryforwards, not subject to expiration | 223,200,000 | |||||
State | ||||||
Operating Loss Carryforwards | ||||||
Operating loss carryforwards | 455,400,000 | $ 388,500,000 | ||||
Operating loss carryforwards, subject to expiration | 409,200,000 | |||||
Operating loss carryforwards, not subject to expiration | 46,200,000 | |||||
Tax Credit Carryforward | Federal | ||||||
Operating Loss Carryforwards | ||||||
Tax credit carryforward | 23,300,000 | |||||
Capital Loss Carryforward | Federal | ||||||
Operating Loss Carryforwards | ||||||
Tax credit carryforward | $ 1,900,000 |
Income Taxes (Summary of Uncert
Income Taxes (Summary of Uncertain Tax Benefit) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns | ||
Beginning balance | $ 4,295 | $ 4,023 |
Increase related to current year tax positions | 391 | 272 |
Increases related to prior periods | 48 | 0 |
Ending balance | $ 4,734 | $ 4,295 |
Significant Agreements (Details
Significant Agreements (Details) shares in Millions | Sep. 30, 2019 | Jul. 26, 2019USD ($)shares | Oct. 31, 2019USD ($) | Feb. 28, 2011USD ($) | Feb. 28, 2011segment | Feb. 28, 2011extension | Dec. 31, 2021USD ($) | Sep. 30, 2021USD ($) | Jun. 30, 2021USD ($) | Mar. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Sep. 30, 2020USD ($) | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2020USD ($) |
Long-term Purchase Commitment | ||||||||||||||||||
Contract revenue | $ 46,000 | $ 107,000 | $ 391,000 | $ 1,435,000 | $ 1,120,000 | $ 1,609,000 | $ 1,402,000 | $ 1,241,000 | $ 1,979,000 | $ 5,372,000 | $ 12,519,000 | |||||||
License | ||||||||||||||||||
Long-term Purchase Commitment | ||||||||||||||||||
Contract revenue | 51,000 | 98,000 | 4,915,000 | |||||||||||||||
BARDA | ||||||||||||||||||
Long-term Purchase Commitment | ||||||||||||||||||
Number of option segments | 4 | 4 | ||||||||||||||||
Contract revenue | $ 1,600,000 | 5,300,000 | 7,600,000 | |||||||||||||||
BARDA | Expense Reimbursement | ||||||||||||||||||
Long-term Purchase Commitment | ||||||||||||||||||
Contract revenue | $ 72,500,000 | |||||||||||||||||
BARDA | Fees | ||||||||||||||||||
Long-term Purchase Commitment | ||||||||||||||||||
Contract revenue | $ 4,600,000 | |||||||||||||||||
Cantex Pharmaceuticals | ||||||||||||||||||
Long-term Purchase Commitment | ||||||||||||||||||
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 | ||||||||||||||||||
Contract revenue | $ 5,000,000 | |||||||||||||||||
Termination notice period | 90 days | |||||||||||||||||
Payment to be received upon achievement of milestones | $ 180,000,000 | |||||||||||||||||
SymBio Pharmaceuticals | License | ||||||||||||||||||
Long-term Purchase Commitment | ||||||||||||||||||
Contract revenue | $ 5,000,000 | |||||||||||||||||
Ohara Pharmaceutical Co., Ltd. | ||||||||||||||||||
Long-term Purchase Commitment | ||||||||||||||||||
License agreement, nonrefundable regulatory milestone payment to be received | $ 2,500,000 | |||||||||||||||||
Sanjiu Medical & Pharmaceutical Co., Ltd. | Oncoceutics, Inc. | ||||||||||||||||||
Long-term Purchase Commitment | ||||||||||||||||||
Payment to be received upon achievement of milestones | $ 5,000,000 | $ 5,000,000 | $ 5,000,000 |
Oncoceutics Acquisition - Narra
Oncoceutics Acquisition - Narrative (Details) - USD ($) $ in Thousands | Jan. 07, 2021 | Dec. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 31, 2022 |
Asset Acquisition | ||||||
Acquired in-process research and development | $ 82,890 | $ 0 | $ 65,045 | |||
Oncoceutics, Inc. | ||||||
Asset Acquisition | ||||||
Cash payment for acquisition | $ 25,000 | |||||
Number of shares issued for acquisition | 8,723,769 | |||||
One-year closing anniversary payment | $ 14,000 | |||||
Contingent consideration for acquisition | 360,000 | |||||
Liability for closing payment adjustments | $ 200 | 200 | ||||
Accounts and notes receivable net | 600 | $ 600 | ||||
Acquired in-process research and development | $ 82,591 | $ 20,000 | ||||
Oncoceutics, Inc. | Subsequent Event | ||||||
Asset Acquisition | ||||||
Estimated post-closing, transaction expenses | $ 400 |
Oncoceutics Acquisition - Consi
Oncoceutics Acquisition - Consideration Paid and Purchase Price Allocation (Details) - USD ($) $ / shares in Units, $ in Thousands | Jan. 07, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Asset Acquisition | ||||||
IPR&D assets expensed | $ 82,890 | $ 0 | $ 65,045 | |||
Oncoceutics, Inc. | ||||||
Asset Acquisition | ||||||
Cash | $ 23,836 | |||||
One-year closing anniversary payment | $ 14,000 | |||||
Shares common stock issued as consideration (in shares) | 8,723,769 | |||||
Stock price per share on effective date (in USD per share) | $ 4.98 | |||||
Value of estimated common stock consideration | $ 43,445 | |||||
Total consideration | 81,281 | |||||
Net assets acquired | (1,310) | |||||
IPR&D assets expensed | 82,591 | $ 20,000 | ||||
Total purchase price allocated | 81,281 | |||||
Transaction costs expensed to IPR&D | 299 | |||||
Transaction costs expensed to IPR&D | $ 82,890 | |||||
Transaction expenses | $ 600 |
Restructuring Costs (Details)
Restructuring Costs (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
May 31, 2019employee | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Restructuring Cost and Reserve | ||||
Reduction in workforce | employee | 43 | |||
One-time employee termination benefits | $ 3,346 | |||
Accrued contract close-out costs | 2,021 | |||
Other BCV development costs | 339 | |||
Fixed asset disposals | 250 | |||
Accrual balance | $ 0 | 320 | $ 0 | |
Revised estimates | (33) | (336) | ||
Refunds of unused deposits | 1,300 | |||
Trial Terminations | ||||
Restructuring Cost and Reserve | ||||
Change in accrual balance | 1,500 | |||
Accrual balance | 0 | 27 | 0 | |
Revised estimates | (23) | (621) | ||
Other Development Costs | ||||
Restructuring Cost and Reserve | ||||
Accrual balance | 0 | 110 | 0 | |
Revised estimates | (10) | 24 | ||
Severance Accrual Balance | ||||
Restructuring Cost and Reserve | ||||
Accrual balance | 0 | 183 | $ 0 | |
Revised estimates | $ 0 | $ 11 |
Restructuring Costs - Summary o
Restructuring Costs - Summary of Restructuring Charges (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Restructuring Cost and Reserve | |
Employee Termination Benefits | $ 3,346 |
Clinical Trial Close-out Costs | 2,021 |
Other Development Costs | 339 |
Fixed Asset Disposals | 250 |
Total | 5,956 |
Research and development expense | |
Restructuring Cost and Reserve | |
Employee Termination Benefits | 1,437 |
Clinical Trial Close-out Costs | 2,021 |
Other Development Costs | 339 |
Fixed Asset Disposals | 0 |
Total | 3,797 |
General and administrative expense | |
Restructuring Cost and Reserve | |
Employee Termination Benefits | 1,909 |
Clinical Trial Close-out Costs | 0 |
Other Development Costs | 0 |
Fixed Asset Disposals | 0 |
Total | 1,909 |
Interest income and other, net | |
Restructuring Cost and Reserve | |
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 | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Restructuring Reserve | ||
Beginning balance | $ 320 | $ 0 |
Accruals | 5,781 | |
Revised estimates | (33) | (336) |
Payments | (287) | (5,125) |
Ending balance | 0 | 320 |
Employee Termination Benefits | ||
Restructuring Reserve | ||
Beginning balance | 183 | 0 |
Accruals | 3,335 | |
Revised estimates | 0 | 11 |
Payments | (183) | (3,163) |
Ending balance | 0 | 183 |
Clinical Trial Close-out Costs | ||
Restructuring Reserve | ||
Beginning balance | 27 | 0 |
Accruals | 2,131 | |
Revised estimates | (23) | (621) |
Payments | (4) | (1,483) |
Ending balance | 0 | 27 |
Other Development Costs | ||
Restructuring Reserve | ||
Beginning balance | 110 | 0 |
Accruals | 315 | |
Revised estimates | (10) | 24 |
Payments | (100) | (229) |
Ending balance | 0 | 110 |
Fixed Asset Disposals | ||
Restructuring Reserve | ||
Beginning balance | $ 0 | 0 |
Accruals | 0 | |
Revised estimates | 250 | |
Payments | (250) | |
Ending balance | $ 0 |
Selected Quarterly Financial _3
Selected Quarterly Financial Data (Unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Selected Quarterly Financial Information [Abstract] | |||||||||||
Revenues | $ 46 | $ 107 | $ 391 | $ 1,435 | $ 1,120 | $ 1,609 | $ 1,402 | $ 1,241 | $ 1,979 | $ 5,372 | $ 12,519 |
Operating loss | (39,532) | (18,600) | (17,815) | (97,453) | (11,757) | (11,560) | (10,286) | (10,913) | (173,400) | (44,516) | (115,983) |
Net loss | $ (39,498) | $ (18,560) | $ (17,763) | $ (97,415) | $ (11,675) | $ (11,411) | $ (10,016) | $ (10,420) | $ (173,236) | $ (43,522) | $ (112,576) |
Net loss, basic (in dollars per share) | $ (0.45) | $ (0.21) | $ (0.21) | $ (1.21) | $ (0.19) | $ (0.18) | $ (0.16) | $ (0.17) | $ (2.04) | $ (0.70) | $ (2.03) |
Net loss, diluted (in dollars per share) | $ (0.45) | $ (0.21) | $ (0.21) | $ (1.21) | $ (0.19) | $ (0.18) | $ (0.16) | $ (0.17) | $ (2.04) | $ (0.70) | $ (2.03) |
Weighted-average shares outstanding, basic (in shares) | 86,867,070 | 86,335,357 | 86,225,836 | 80,204,094 | 62,702,181 | 62,242,456 | 62,042,778 | 61,742,035 | 84,930,255 | 62,183,947 | 55,501,973 |
Weighted-average shares outstanding, diluted (in shares) | 86,867,070 | 86,335,357 | 86,225,836 | 80,204,094 | 62,702,181 | 62,242,456 | 62,042,778 | 61,742,035 | 84,930,255 | 62,183,947 | 55,501,973 |
Subsequent Events (Details)
Subsequent Events (Details) - Revolving Credit Facility - Subsequent Event | Jan. 31, 2022USD ($)installment |
Subsequent Event | |
Line of credit facility, maximum borrowing capacity | $ 50,000,000 |
Debt instrument, term | 4 years |
Debt instrument, interest rate, stated percentage | 4.75% |
Line of credit facility, unused capacity, commitment fee percentage | 0.25% |
Debt instrument, early termination fee | $ 500,000 |
Debt instrument, unused borrowing capacity, fee | $ 500,000 |
Number of installment payments (installment) | installment | 4 |
Prime Rate | |
Subsequent Event | |
Debt instrument, basis spread on variable rate | 1.50% |