Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 11, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Entity Interactive Data Current | Yes | |
Document Period End Date | Sep. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | CFRX | |
Entity Registrant Name | ContraFect Corporation | |
Entity Central Index Key | 0001478069 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Current Reporting Status | Yes | |
Entity Emerging Growth Company | false | |
Title of 12(b) Security | Common Stock, $0.0001 par value per share | |
Security Exchange Name | NASDAQ | |
Entity Shell Company | false | |
Entity File Number | 001-36577 | |
Entity Tax Identification Number | 39-2072586 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 28 Wells Avenue | |
Entity Address, Address Line Two | 3rd Floor | |
Entity Address, City or Town | Yonkers | |
Entity Address, State or Province | NY | |
Entity Address, Postal Zip Code | 10701 | |
City Area Code | 914 | |
Local Phone Number | 207-2300 | |
Entity Common Stock, Shares Outstanding | 39,332,721 | |
Document Quarterly Report | true | |
Document Transition Report | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 4,664 | $ 16,654 |
Marketable securities | 12,984 | 37,631 |
Prepaid expenses | 1,815 | 4,439 |
Other current assets | 586 | 4,140 |
Total current assets | 20,049 | 62,864 |
Property and equipment, net | 628 | 741 |
Operating lease right-of-use assets | 2,249 | 2,544 |
Other assets | 108 | 613 |
Total assets | 23,034 | 66,762 |
Current liabilities: | ||
Accounts payable | 15,348 | 2,389 |
Accrued and other current liabilities | 7,768 | 9,128 |
Current portion of lease liabilities | 667 | 657 |
Total current liabilities | 23,783 | 12,174 |
Warrant liabilities | 3 | 2,530 |
Long-term portion of lease liabilities | 2,313 | 2,609 |
Other liabilities | 38 | 73 |
Total liabilities | 26,137 | 17,386 |
Commitments and contingencies | ||
Stockholders' (deficit) equity: | ||
Preferred stock, $0.0001 par value, 25,000,000 shares authorized and none outstanding at September 30, 2022 and December 31, 2021 | ||
Common stock, $0.0001 par value, 125,000,000 shares authorized, 39,332,721 shares issued and outstanding at September 30, 2022 and December 31, 2021 | 4 | 4 |
Additional paid-in capital | 312,898 | 310,008 |
Accumulated other comprehensive loss | (140) | (84) |
Accumulated deficit | (315,865) | (260,552) |
Total stockholders' (deficit) equity | (3,103) | 49,376 |
Total liabilities and stockholders' (deficit) equity | $ 23,034 | $ 66,762 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 25,000,000 | 25,000,000 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 125,000,000 | 125,000,000 |
Common stock, shares issued | 39,332,721 | 39,332,721 |
Common stock, shares outstanding | 39,332,721 | 39,332,721 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Operating expenses | ||||
Research and development | $ 10,814 | $ 8,664 | $ 40,299 | $ 24,462 |
General and administrative | 3,366 | 3,022 | 9,886 | 8,722 |
Restructuring | 7,719 | 7,719 | ||
Total operating expenses | 21,899 | 11,686 | 57,904 | 33,184 |
Loss from operations | (21,899) | (11,686) | (57,904) | (33,184) |
Other income: | ||||
Interest income, net | 9 | 36 | 64 | 91 |
Change in fair value of warrant liabilities | 4,823 | 6,358 | 2,527 | 17,210 |
Total other income, net | 4,832 | 6,394 | 2,591 | 17,301 |
Net loss | $ (17,067) | $ (5,292) | $ (55,313) | $ (15,883) |
Per share information: | ||||
Basic net loss per share | $ (0.43) | $ (0.13) | $ (1.41) | $ (0.44) |
Shares used in computing net loss per share | 39,332,721 | 39,332,721 | 39,332,721 | 35,914,327 |
Diluted net loss per share | $ (0.43) | $ (0.13) | $ (1.41) | $ (0.44) |
Shares used in computing diluted net loss per share | 39,332,721 | 39,332,721 | 39,332,721 | 35,914,327 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (17,067) | $ (5,292) | $ (55,313) | $ (15,883) |
Other comprehensive loss: | ||||
Unrealized gain (loss) on available-for-sale securities | 73 | (1) | (56) | (22) |
Comprehensive loss | $ (16,994) | $ (5,293) | $ (55,369) | $ (15,905) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' (Deficit) Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Deficit [Member] |
Beginning Balance at Dec. 31, 2020 | $ 12,620 | $ 3 | $ 252,908 | $ (21) | $ (240,270) |
Beginning Balance, Shares at Dec. 31, 2020 | 27,810,161 | ||||
Issuance of securities in registered offering | 57,500 | $ 1 | 57,499 | ||
Issuance of securities in registered offering, Shares | 11,500,000 | ||||
Financing cost of sale of securities | (3,703) | (3,703) | |||
Issuance of common stock for exercise of warrants | 110 | 110 | |||
Issuance of common stock for exercise of warrants, Shares | 22,560 | ||||
Stock-based compensation | 581 | 581 | |||
Unrealized gain (loss) on marketable securities | (8) | (8) | |||
Net loss | (5,195) | (5,195) | |||
Ending balance at Mar. 31, 2021 | 61,905 | $ 4 | 307,395 | (29) | (245,465) |
Ending balance, Shares at Mar. 31, 2021 | 39,332,721 | ||||
Beginning Balance at Dec. 31, 2020 | $ 12,620 | $ 3 | 252,908 | (21) | (240,270) |
Beginning Balance, Shares at Dec. 31, 2020 | 27,810,161 | ||||
Issuance of common stock for exercise of warrants, Shares | 22,560 | ||||
Net loss | $ (15,883) | ||||
Ending balance at Sep. 30, 2021 | 53,005 | $ 4 | 309,197 | (43) | (256,153) |
Ending balance, Shares at Sep. 30, 2021 | 39,332,721 | ||||
Beginning Balance at Mar. 31, 2021 | 61,905 | $ 4 | 307,395 | (29) | (245,465) |
Beginning Balance, Shares at Mar. 31, 2021 | 39,332,721 | ||||
Stock-based compensation | 938 | 938 | |||
Unrealized gain (loss) on marketable securities | (13) | (13) | |||
Net loss | (5,396) | (5,396) | |||
Ending balance at Jun. 30, 2021 | 57,434 | $ 4 | 308,333 | (42) | (250,861) |
Ending balance, Shares at Jun. 30, 2021 | 39,332,721 | ||||
Stock-based compensation | 864 | 864 | |||
Unrealized gain (loss) on marketable securities | (1) | (1) | |||
Net loss | (5,292) | (5,292) | |||
Ending balance at Sep. 30, 2021 | 53,005 | $ 4 | 309,197 | (43) | (256,153) |
Ending balance, Shares at Sep. 30, 2021 | 39,332,721 | ||||
Beginning Balance at Dec. 31, 2021 | 49,376 | $ 4 | 310,008 | (84) | (260,552) |
Beginning Balance, Shares at Dec. 31, 2021 | 39,332,721 | ||||
Stock-based compensation | 919 | 919 | |||
Unrealized gain (loss) on marketable securities | (140) | (140) | |||
Net loss | (20,157) | (20,157) | |||
Ending balance at Mar. 31, 2022 | 29,998 | $ 4 | 310,927 | (224) | (280,709) |
Ending balance, Shares at Mar. 31, 2022 | 39,332,721 | ||||
Beginning Balance at Dec. 31, 2021 | 49,376 | $ 4 | 310,008 | (84) | (260,552) |
Beginning Balance, Shares at Dec. 31, 2021 | 39,332,721 | ||||
Net loss | (55,313) | ||||
Ending balance at Sep. 30, 2022 | (3,103) | $ 4 | 312,898 | (140) | (315,865) |
Ending balance, Shares at Sep. 30, 2022 | 39,332,721 | ||||
Beginning Balance at Mar. 31, 2022 | 29,998 | $ 4 | 310,927 | (224) | (280,709) |
Beginning Balance, Shares at Mar. 31, 2022 | 39,332,721 | ||||
Stock-based compensation | 965 | 965 | |||
Unrealized gain (loss) on marketable securities | 11 | 11 | |||
Net loss | (18,089) | (18,089) | |||
Ending balance at Jun. 30, 2022 | 12,885 | $ 4 | 311,892 | (213) | (298,798) |
Ending balance, Shares at Jun. 30, 2022 | 39,332,721 | ||||
Stock-based compensation | 1,006 | 1,006 | |||
Unrealized gain (loss) on marketable securities | 73 | 73 | |||
Net loss | (17,067) | (17,067) | |||
Ending balance at Sep. 30, 2022 | $ (3,103) | $ 4 | $ 312,898 | $ (140) | $ (315,865) |
Ending balance, Shares at Sep. 30, 2022 | 39,332,721 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities | ||
Net loss | $ (55,313) | $ (15,883) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 115 | 110 |
Stock-based compensation expense | 2,890 | 2,383 |
Change in fair value of warrant liabilities | (2,527) | (17,210) |
Net amortization of premium on marketable securities | 556 | 503 |
Changes in operating assets and liabilities: | ||
Decrease (increase) in prepaid expenses and other current and non-current assets | 6,709 | (6,260) |
Increase in accounts payable, accrued and other current liabilities | 11,564 | 3,800 |
Net cash used in operating activities | (36,006) | (32,557) |
Cash flows from investing activities | ||
Purchases of marketable securities | 0 | (47,644) |
Sales of marketable securities | 2,504 | |
Proceeds from maturities of marketable securities | 21,531 | 31,034 |
Purchases of property and equipment | (19) | |
Net cash provided by (used in) investing activities | 24,016 | (16,610) |
Cash flows from financing activities | ||
Proceeds from issuance of securities | 57,500 | |
Payment of financing costs of securities sold | (3,703) | |
Proceeds from the exercise of warrants | 110 | |
Net cash provided by financing activities | 53,907 | |
Net (decrease) increase in cash and cash equivalents | (11,990) | 4,740 |
Cash and cash equivalents at beginning of period | 16,654 | 15,485 |
Cash and cash equivalents at end of period | $ 4,664 | $ 20,225 |
Organization and Description of
Organization and Description of Business | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Organization and Description of Business | 1. Organization and Description of Business Organization and Business ContraFect Corporation (the “Company”) is a clinical-stage biotechnology company focused on the discovery and development of direct lytic agents (“DLAs”), including lysins and amurin peptides, as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections. The Company intends to address antibiotic-resistant infections using product candidates from our lysin and amurin peptide platforms. DLAs are fundamentally different than antibiotics and offer a potential paradigm shift in the treatment of antibiotic-resistant infections. The Company’s most advanced product candidate is exebacase, a lysin which targets S. aureus S. aureus S. aureus pre-specified follow-up The Company has incurred recurring losses since inception as a research and development organization and has an accumulated deficit of $315.9 million of cash in operations. The Company has relied on its ability to fund its operations through public and private debt and equity financings, and, to a lesser extent, grant funding and government contracts. The Company expects operating losses and negative cash flows to continue at significant levels in the future as it continues to advance its programs. As of September 30, 2022, the Company had approximately $ million in cash, cash equivalents and marketable securities, which, without additional funding, the Company believes will not be sufficient to meet its obligations within the next twelve months from the date of issuance of these consolidated financial statements. The Company plans to continue to fund its operations through public or private debt and equity financings, but there can be no assurances that such financing will continue to be available to the Company on satisfactory terms, or at all, particularly in light of the Trial Closure. As such, under the requirements of Accounting Standard Codification (“ASC”) 205-40, The consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates continuity of operations, the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. On August 14, 2020, the Company filed a shelf registration statement on Form S-3 S-3”) S-3 S-3 time-to-time On March 22, 2021, the Company completed an underwritten public offering under the Form S-3 On March 10, 2021, the Company entered into a cost-share contract (the “BARDA Contract”) with BARDA, a division of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. The base period for the BARDA Contract included government funding of up to reimburse expenses to support the conduct of the Phase 3 DISRUPT study and futility analysis. Following the interim futility analysis and the stopping of patient enrollment, on August 24, 2022, the BARDA Contract was modified to provide for and exercise an option by BARDA to provide up in funding to support a futility outcome root-cause analysis and the close-out of the Phase 3 DISRUPT study of exebacase. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying financial information as of September 30, 2022 and for the three and nine months ended September 30, 2022 and 2021 has been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Certain information and footnote disclosures normally included in consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) have been condensed or omitted pursuant to such rules and regulations. The consolidated balance sheet as of December 31, 2021 was derived from the Company’s audited consolidated financial statements. The Company’s audited consolidated financial statements as of and for the year ended December 31, 2021, including all related disclosures and the complete listing of significant accounting policies as described in Note 2 thereof, are included in the Company’s Annual Report on Form 10-K In the opinion of management, the unaudited financial information as of September 30, 2022 and for three and nine months ended September 30, 2022 and 2021 reflects all adjustments, which are normal recurring adjustments, necessary to present a fair statement of financial position, results of operations and cash flows. The results of operations for three and nine months ended September 30, 2022 are not necessarily indicative of the operating results for the full fiscal year or any future periods. Principles of Consolidation The Company has a wholly-owned subsidiary, ContraFect International Limited, in Scotland that establishes legal status for interactions with the European Economic Area. This subsidiary is dormant or is otherwise non-operative. Significant Risks and Uncertainties The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to, the results of clinical testing and trial activities of the Company’s products, the Company’s ability to obtain regulatory approval to market its products, competition from products manufactured and sold or being developed by other companies, the price of, and demand for, the Company’s products, the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, the Company’s ability to raise capital and the effects of the novel coronavirus, or COVID-19, The Company currently relies on a single manufacturer of drug substance for each of its product candidates and two manufacturers of drug product, one located in the United States and one in Western Europe, and there are no long-term supply agreements in place. A sustained disruption in the operations of any of these manufacturers, or in the event the Company would need to change to a new supplier, could result in a significant delay in the ability of the Company to complete any associated activities. Use of Estimates The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. On an ongoing basis, the Company evaluates its estimates and assumptions, including those related to research and development prepaid expenses and accruals, restructuring costs, stock-based compensation, warrant valuation and realization of net deferred income taxes. The Company’s actual results may differ from these estimates under different assumptions or conditions, including the effects of significant risks and uncertainties. Concentrations of Credit Risk Financial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash, cash equivalents and marketable securities. The Company holds these investments in highly rated financial institutions, and, by policy, limits the amounts of credit exposure to any one financial institution. These amounts at times may exceed federally insured limits. The Company has not experienced any credit losses in such accounts and does not believe it is exposed to any significant credit risk on these funds. The Company has no off-balance Cash and Cash Equivalents The Company considers all highly liquid investments with maturities at the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents include bank demand deposits, marketable securities with maturities of three months or less at purchase, and money market funds that invest primarily in certificates of deposit, commercial paper and U.S. government and U.S. government agency obligations. Cash equivalents are reported at fair value. Marketable Securities Marketable securities consist of investments in corporate debt securities. Management determines the appropriate classification of the securities at the time they are acquired and evaluates the appropriateness of such classifications at each balance sheet date. The Company classifies its marketable securities as available-for-sale pursuant to ASC 320, Investments – Debt and Equity Securities $ of losses and no realized gains losses on sales of marketable securities for the three and nine months ended September 30, The Company reviews marketable securities for other-than-temporary impairment whenever the fair value of a marketable security is less than the amortized cost and evidence indicates that a marketable security’s carrying amount is not recoverable within a reasonable period of time. Other-than-temporary impairments of investments are recognized in the consolidated statements of operations if the Company has experienced a credit loss, has the intent to sell the marketable security, or if it is more likely than not that the Company will be required to sell the marketable security before recovery of the amortized cost basis. Evidence considered in this assessment includes reasons for the impairment, compliance with the Company’s investment policy, the severity and the duration of the impairment and changes in value subsequent to the end of the period. Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents, marketable securities, accounts payable, accrued liabilities and warrant liabilities. Fair value estimates of these instruments are made at a specific point in time, based on relevant market information. These estimates may be subjective in nature and involve uncertainties and matters of judgment and therefore cannot be determined with precision. The fair value of the Company’s warrant liabilities is based upon unobservable inputs, as described further below. The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. Financial Accounting Standards Board (“FASB”) Accounting Standard Codification (“ASC”) Topic 820, Fair Value Measurements and Disclosures Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2—Valuations based on quoted prices for similar assets or liabilities in markets that are not active or for which all significant inputs are observable, either directly or indirectly. Level 3—Valuations that require inputs that reflect the Company’s own assumptions that are both significant to the fair value measurement and unobservable. To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The Company had no liabilities classified as Level 1 or Level 2. The carrying amounts reported in the accompanying financial statements for accounts payable and accrued liabilities approximate their respective fair values due to their short-term maturities. The fair value of the warrant liabilities is discussed in Note 4, “Fair Value Measurements.” Stock-based Compensation The Company accounts for stock-based compensation in accordance with ASC 718, Compensation—Stock Compensation, non-employees, The fair value of options is calculated using the Black-Scholes option pricing model on the date of grant based on key assumptions such as stock price, risk free interest rates, expected volatility, expected term, and expected dividend yield. The Company’s estimates of these assumptions are based on historical data and judgment regarding future trends and factors. Government Contracts and Grant Agreements The Company recognizes a receivable, which is included in other current assets on its consolidated balance sheet, and the related reduction in its research and development expenses when the actual reimbursable costs have been incurred and there is reasonable assurance that the Company has complied with the conditions of the applicable government contract or grant agreement and the amounts will be received. The Company recognized a reduction to its research and development expense in the amount of approximately $0.9 million and $3.7 million for the three months ended September 30, 2022 and 2021, and $5.2 million and $7.7 million for the nine months ended September 30, 2022 and 2021, respectively. The receivable for government contracts and grant agreements as of September 30, 2022 and December 31, 2021 was approximately $0.6 million and $4.1 million, respectively, and is included in other current assets on the consolidated balance sheet. The Company has approximately $8.5 million of committed government contract and grant agreement funding remaining as of September 30, 2022. Leases The Company accounts for leases in accordance with Accounting Standards Update No. 2016-02- Leases right-of-use Under the Company’s policy, it does not record an ROU asset or corresponding liability for arrangements where the initial lease term is one year or less. Those leases are expensed on a straight-line basis over the term of the lease. Restructuring The Company has made estimates and judgments regarding the amount and timing of its restructuring expense and liability, including current and future period termination Exit or Disposal Cost Obligations Net Loss Per Share Basic net loss per share applicable to common stockholders is calculated by dividing net loss applicable to common stockholders by the weighted average shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share applicable to common stockholders is calculated by adjusting weighted average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock method. For purposes of the dilutive net loss per share applicable to common stockholders’ calculation, stock options and warrants are considered to be common stock equivalents but are excluded from the calculation of diluted net loss per share applicable to common stockholders, as their effect would be anti-dilutive; therefore, basic and diluted net loss per share applicable to common stockholders were the same for all periods presented. Recently Adopted Accounting Pronouncements Government Assistance On January 1, 2022, the Company adopted Accounting Standards Update No. 2021-10, Disclosure by Business Entities about Government Assistance (ASU 2021-10) 2021-10 Recently Issued Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued a new Accounting Standards Update, Financial Instruments-Credit Losses (ASU 2016-13). 2016-13 available-for-sale |
Marketable Securities
Marketable Securities | 9 Months Ended |
Sep. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | 3. Marketable Securities Marketable securities at September 30, 2022 consisted of the following (in thousands): Marketable Securities Amortized Cost Unrealized Unrealized Fair Value Current: Corporate debt $ 13,124 $ — $ (140 ) $ 12,984 Marketable securities at December 31, 2021 consisted of the following (in thousands): Marketable Securities Amortized Cost Unrealized Unrealized Fair Value Current: Corporate debt $ 37,715 $ — $ (84 ) $ 37,631 Corporate debt includes obligations issued by investment-grade corporations and may include issues that have been guaranteed by governments and government agencies. Investments classified as short-term have maturities of less than one year, and investments classified as long-term are those that have maturities of greater than one year and management does not intend to liquidate within the next twelve months. All of the Company’s marketable securities have an effective maturity of less than two years. At September 30, 2022, the Company held 8 debt securities that individually and in total were in an immaterial unrealized loss position for less than one year. The aggregate fair value of debt securities in an unrealized loss position at September 30, 2022 was approximately $13.0 million. The Company evaluated its securities for other than temporary impairment and considered the decline in market value for the securities to be primarily attributable to current economic and market conditions. The Company intends to hold the securities to maturity but may be the There were no impairments for credit losses, and as such, the unrealized losses will continue to be recognized in the consolidated statements of comprehensive loss. Realized losses, if any, will be recognized in the Company’s statements of operations on a specific identification basis. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements The following fair value hierarchy table presents information about the Company’s financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2022 and December 31, 2021 (in thousands): Fair Value Measurement as of September 30, 2022 Quoted Prices Significant Significant Cash equivalents $ 3,017 $ — $ — Marketable securities 12,984 — — Warrant liabilities — — 3 Total $ 16,001 $ — $ 3 Fair Value Measurement as of December 31, 2021 Quoted Prices Significant Significant Cash equivalents $ 7,734 $ — $ — Marketable securities 37,631 — — Warrant liabilities — — 2,530 Total $ 45,365 $ — $ 2,530 The Company issued warrants to the purchasers of its May 27, 2020 offering (the “2020 Warrants”). The Company determined that these warrants should be classified as a liability and considered as a Level 3 financial instrument (see also Note 9, “Capital Structure”). The 2020 Warrants are re-measured As of As of Expected volatility 136.5 % 61.9 % Remaining contractual term (in years) 0.67 1.42 Risk-free interest rate 3.99 % 0.56 % Expected dividend yield — % — % Warrant liabilities The following tables present a reconciliation of the Company’s financial liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) for the three and nine months ended September 30, 2022 and 2021 (in thousands): Three Months Ended Nine Months Ended 2022 2021 2022 2021 Balance at beginning of period $ 4,826 $ 18,552 $ 2,530 $ 29,404 (Decrease) increase in fair value (1) (4,823 ) (6,358 ) (2,527 ) (17,210 ) Balance at end of period $ 3 $ 12,194 $ 3 $ 12,194 (1) The change in fair values of the warrant liabilities is recorded in other income in the consolidated statement of operations. The key inputs into the Black-Scholes option pricing model are the current per-share |
Accrued and Other Current Liabi
Accrued and Other Current Liabilities | 9 Months Ended |
Sep. 30, 2022 | |
Payables and Accruals [Abstract] | |
Accrued and Other Current Liabilities | 5. Accrued and Other Current Accrued and other current September 30, December 31, Accrued research and development service fees $ 3,638 $ 5,641 Accrued compensation costs 2,778 2,215 Accrued professional fees 1,046 819 Accrued facilities operation expenses 129 307 Other accrued expenses 177 146 Total accrued liabilities $ 7,768 $ 9,128 |
Net Loss Per Share of Common St
Net Loss Per Share of Common Stock | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share of Common Stock | 6. Net Loss Per Share of Common Stock Diluted net loss per share is the same as basic net loss per share for all periods presented because the effects of potentially dilutive items were anti-dilutive. Basic net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding. The following table sets forth the computation of basic and diluted net loss per share for common stockholders (in thousands, except share and per share data): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Net loss $ (17,067 ) $ (5,292 ) $ (55,313 ) $ (15,883 ) Weighted average shares of common stock outstanding 39,332,721 39,332,721 39,332,721 35,914,327 Net loss per share of common stock – basic and diluted $ (0.43 ) $ (0.13 ) $ (1.41 ) $ (0.44 ) The following potentially dilutive securities outstanding at September 30, 2022 and 2021 have been excluded from the computation of diluted weighted average shares outstanding, as they would have been anti-dilutive: September 30, 2022 2021 Options to purchase common stock 4,515,422 2,950,551 Warrants to purchase common stock 9,325,521 10,926,733 Total 13,840,943 13,877,284 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 7. Commitments and Contingencies Operating Leases In December 2010, the Company entered into a non-cancellable In January 2012, the Company entered into a non-cancellable The Company performed an evaluation of its other contracts in accordance with Topic 842 and has determined that, except for the leases described above, none of its contracts contain a lease. The balance sheet classification of the Company’s lease liabilities was as follows (in thousands): Description September 30, December 31, Operating lease liabilities: Current portion of lease liabilities $ 667 $ 657 Long-term portion of lease liabilities $ 2,313 $ 2,609 Operating lease liabilities are based on the net present value of the remaining lease payments over the remaining lease term. The leases are renewable at the end of the lease term at our option. For the purposes of determining the remaining lease term in contemplation of available extensions, the Company did not consider either renewal to be probable at this time. In determining the present value of lease payments, the Company estimated its incremental borrowing rate, or discount rate, based on the information available at the adoption date of Topic 842. The discount rate used to determine the operating lease liability was 9.93%. As of September 30, 2022, the maturities of our operating lease liabilities were as follows (in thousands): Amount October 1, 2022 - December 31, 2022 $ 173 Year ending December 31: 2023 707 2024 721 2025 736 2026 750 Thereafter 702 Total lease payments 3,789 Less: Present value adjustment (809 ) Operating lease liabilities $ 2,980 Lease costs under the terms of the Company’s leases for the three and nine months ended September 30, 2022 and 2021 were as follows (in thousands): Three Months Ended Nine Months Ended 2022 2021 2022 2021 Operating lease cost (1) $ 154 $ 154 $ 460 $ 461 Variable lease costs (2) 66 46 147 111 Total lease cost $ 220 $ 200 $ 607 $ 572 (1) Operating lease payments included in the measurement of the Company’s lease liabilities are comprised of fixed payments according to the terms of the Company’s leases. (2) Variable lease payments consist of the Company’s utility costs billed by and paid to its landlord. Variable lease payments are presented as operating expenses in the Company’s Consolidated Statement of Operations in the same line item as expense arising from fixed lease payments and in net cash used in operating activities in the Company’s Statement of Cash Flows. Rockefeller University License Agreements The Company has entered into the following license agreements with The Rockefeller University: • On July 12, 2011, the Company entered into a license agreement for the worldwide, exclusive right to a patent covering the composition of matter for the lysin PlySS2 for the treatment and prevention of diseases caused by gram-positive bacteria (the “CF-301 CF-301 • On June 1, 2011, the Company entered into a license agreement for the exclusive rights to The Rockefeller University’s interest in a joint patent application covering the method of delivering antibodies through the cell wall of gram-positive bacteria to the periplasmic space. This intellectual property was developed as a result of the sponsored research agreement between the Company and The Rockefeller University and was jointly discovered and filed by the two parties. • On September 23, 2010, the Company entered into a license agreement for the worldwide, exclusive right to develop, make, have made, use, import, lease, sell, and offer for sale products that would otherwise infringe a claim of the suite of patents and patent applications covering the composition of matter for eight individual lysin molecules for the treatment and prevention of diseases caused by gram-positive bacteria. The lysins in this suite have activity against Group B Streptococci Staphylococcus aureus, Streptococcus pneumonia, Bacillus anthracis, Enterococcus faecalis and Enterococcus faecium In consideration for the licenses, the Company paid Rockefeller license initiation fees in cash and stock. The Company has is The Company is CF-301 Each license agreement terminates upon the later of (i) the expiration or abandonment of the last licensed patent under the license agreement to expire or become abandoned, or (ii) 10 years after the first commercial sale of the first licensed product. The Rockefeller University may terminate any license agreement in the event of a breach of such agreement by the Company or if the Company challenges the validity or enforceability of the underlying patent rights. The Company may terminate any license agreement at any time on 60 days’ notice. Legal Contingencies From time to time, the Company may be involved in disputes and legal proceedings in the ordinary course of its business. These proceedings may include allegations of infringement of intellectual property, employment or other matters. The Company records a liability in its financial statements for these matters when a loss is known or considered probable and the amount can be reasonably estimated. The Company reviews these estimates each accounting period as additional information is known and adjusts the loss provision when appropriate. If a matter is both probable to result in a liability and the amounts of loss can be reasonably estimated, the Company estimates and discloses the possible loss or range of loss to the extent necessary to make the financial statements not misleading. If the loss is not probable or cannot be reasonably estimated, a liability is not recorded in the Company’s financial statements. The Company currently has no legal proceedings ongoing that management estimates could have a material effect on the Company’s financial statements. |
Restructuring
Restructuring | 9 Months Ended |
Sep. 30, 2022 | |
Restructuring and Related Activities [Abstract] | |
Restructuring | 8. Restructuring On July 29, 2022, the Company initiated a restructuring plan resulting in a reduction in workforce. The restructuring plan was designed to reduce costs and align resources with the Company’s anticipated product development milestones for exebacase and CF370 and to help preserve the value of the Company’s drug discovery operations. The restructuring reduced the Company’s workforce from 43 full-time employees as of June 30, 2022 to 27 full-time employees as of August 15, 2022, when the reduction was completed. The Company recognized a restructuring charge of approximately $7.7 million, including $1.6 million related to employee termination costs, including severance, health benefits and other related expenses from the workforce reduction, and $6.1 million from the write-off of prepaid manufacturing costs following the suspension of IV exebacase manufacturing activities. The following table summarizes the restructuring related charges within the Company’s consolidated statements of operations where they were recorded during the three and nine months ended September 30, 2022 (in thousands): Amount Employee termination costs and other related expenses $ 1,583 Write-off of prepaid manufacturing costs $ 6,136 Total $ 7,719 The restructuring costs were included in accounts payable and accrued and other current liabilities in the Company’s consolidated balance sheets. Activity for the nine months ended September 30, 2022 is summarized as follows (in thousands): As of September 30, 2022 Balance at beginning of period $ — Charge to expense 7,719 Payments made (361 ) Balance at end of period $ 7,358 As of September 30, 2022, the Company had $7.4 million remaining in accounts payable and accrued and other current liabilities on its consolidated balance sheet, which will be paid by the end of the first quarter of 2024. |
Capital Structure
Capital Structure | 9 Months Ended |
Sep. 30, 2022 | |
Capital Structure [Abstract] | |
Capital Structure | 9. Capital Structure Common Stock As of September 30, 2022, the Company was authorized to issue 125,000,000 shares of common stock. Follow-on On March 22, 2021, the Company completed an underwritten public offering of 11,500,000 shares of its common stock, including shares sold pursuant to the fully exercised overallotment option granted to the underwriters in connection with the offering, at a public offering price of $5.00 per share, resulting in net proceeds to the Company of approximately $53.8 million after underwriting discounts and commissions and offering expenses payable by the Company. On May 27, 2020, the Company completed an underwritten public offering of 11,797,752 shares of its common stock and warrants to purchase an additional 8,848,314 shares of its common stock at an exercise price of $4.90 per share. The public offering price was $4.45 for one share of common stock and an accompanying warrant to purchase 0.75 shares of common stock, resulting in net proceeds to the Company of approximately $48.9 million after underwriting discounts and commissions and offering expenses payable by the Company. The Company completed a concurrent private placement to Pfizer Inc. (“Pfizer”) of 674,156 shares of common stock and an accompanying warrant to purchase an additional 505,617 shares of its common stock at an exercise price of $4.90 per share (the “Pfizer Warrant”) at a price of $4.45 for one share of common stock and an accompanying warrant to purchase 0.75 shares of common stock, resulting in net proceeds to the Company of approximately $3.0 million. No warrants were exercised during the nine months ended September 30, 2022. Warrants to purchase 22,560 shares of common stock were exercised during the nine months ended September 30, 2021. The Company issued warrants in its 2020 and 2017 offerings (the “2020 Warrants”, and the “2017 Warrants”, respectively). re-measured The Pfizer Warrant does not contain the same fundamental transaction provision that obligates the Company to cash settle the warrants under a limited set of conditions not entirely within the Company’s control. Therefore, the Company determined that the Pfizer Warrant should be classified as equity in the Company’s consolidated balance sheet. Voting The holders of shares of common stock are entitled to one vote for each share of common stock held at all meetings of stockholders and written actions in lieu of meetings. Dividends The holders of shares of common stock are entitled to receive dividends, if and when declared by the board of directors. As of September 30, 2022, no dividends have been declared or paid on the Company’s common stock since inception. Reserved for Future Issuance The Company has reserved for future issuance the following number of shares of common stock as of September 30, 2022 and December 31, 2021: September 30, December 31, Outstanding options to purchase common stock 4,515,422 2,899,694 Outstanding warrants to purchase common stock 9,325,521 10,926,594 For future issuance under the 2014 Omnibus Incentive Plan 45,212 77,631 For future issuance under the 2021 Employment Inducement Plan 990,000 1,000,000 14,876,155 14,903,919 |
Stock Warrants
Stock Warrants | 9 Months Ended |
Sep. 30, 2022 | |
Text Block [Abstract] | |
Stock Warrants | 10. Stock Warrants As of September 30, 2022 and December 31, 2021, the Company had warrants to purchase the underlying common stock outstanding as shown in the table below. September 30, December 31, 2020 Warrants 8,819,904 8,819,904 2017 Warrants — 1,599,645 Pfizer Warrant 505,617 505,617 Other warrants (1) — 1,428 Warrants to purchase common stock 9,325,521 10,926,594 Weighted-average exercise price per share $ 4.90 $ 6.47 (1) Other warrants are comprised of warrants issued prior to the Company’s initial public offering (“IPO”), generally in exchange for services rendered to the Company. The following table summarizes information regarding the Company’s warrants outstanding at September 30, 2022: Exercise Prices Shares Expiration Date $4.90 9,325,521 May 27, 2023 |
Stock Option and Incentive Plan
Stock Option and Incentive Plans | 9 Months Ended |
Sep. 30, 2022 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock Option and Incentive Plans | 11. Stock Option and Incentive Plans Amended and Restated 2008 Equity Incentive Plan In July 2008, the Company adopted the 2008 Equity Incentive Plan (the “Plan”). On February 26, 2013, the board of directors approved an amended and restated plan (the “Amended Plan”) under which the number of shares of common stock available for issuance was 157,143. For new awards, the period that vested awards would remain exercisable upon termination of service was reduced from ten years to two years. The board of directors also increased the number of shares of common stock available under the Company’s Amended Plan on February 24, 2014 and April 29, 2014 to 185,714 and 235,714, respectively. As of the closing of the Company’s IPO, there were no further grants made under the Amended Plan. 2014 Omnibus Incentive Plan In April 2014, the Company’s board of directors adopted the 2014 Omnibus Incentive Plan (the “2014 Plan”). The 2014 Plan was approved by the Company’s stockholders on July 3, 2014. The 2014 Plan allows for the granting of incentive and non-qualified 2021 Omnibus Incentive Plan In September 2021, the Company’s board of directors adopted the 2021 Employment Incentive Omnibus Incentive Plan (the “2021 Plan”). The 2021 Plan allows for the granting of non-qualified The Company recognized compensation expense for stock-based compensation based on the fair value of the underlying instrument. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. A summary of stock option activity for the nine months ended September 30, 2022, is summarized as follows: Number of Weighted Weighted Aggregate Options outstanding at December 31, 2021 2,899,694 $ 9.12 Granted 1,834,000 3.06 Exercised — — Expired (49,335 ) 11.86 Forfeited (168,937 ) 4.13 Options outstanding at September 30, 2022 4,515,422 6.82 8.24 $ — Vested and exercisable at September 30, 2022 2,245,477 9.78 6.93 $ — The fair value of each option grant is estimated on the date of the grant using the Black-Scholes option-pricing model. The weighted average grant date fair value of options granted during the three months ended September 30, 2022 and 2021 was $0.30 and $3.93, respectively, and during the nine months ended September 30, 2022 and 2021 was $3.06 and $4.31, respectively. Total compensation expense recognized amounted to $1.0 million and $0.9 million for the three months ended September 30, 2022 and 2021, respectively, and $2.9 million and $2.4 million for the nine months ended September 30, 2022 and 2021, respectively. As of September 30, 2022, the total remaining unrecognized compensation cost related to unvested stock options was approximately $5.7 million which will be recognized over a weighted average period of approximately 2.16 years. The following assumptions were used to compute the fair value of stock options granted during the period: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Risk free interest rate 3.00 % 0.81 % 2.23 % 0.83 % Expected dividend yield — — — — Expected term (in years) 5.44 6.12 5.91 5.99 Expected volatility 99.5 % 95.1 % 91.9 % 94.5 % Risk-free interest rate Expected dividend yield— Expected term— Expected volatility— |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying financial information as of September 30, 2022 and for the three and nine months ended September 30, 2022 and 2021 has been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Certain information and footnote disclosures normally included in consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) have been condensed or omitted pursuant to such rules and regulations. The consolidated balance sheet as of December 31, 2021 was derived from the Company’s audited consolidated financial statements. The Company’s audited consolidated financial statements as of and for the year ended December 31, 2021, including all related disclosures and the complete listing of significant accounting policies as described in Note 2 thereof, are included in the Company’s Annual Report on Form 10-K In the opinion of management, the unaudited financial information as of September 30, 2022 and for three and nine months ended September 30, 2022 and 2021 reflects all adjustments, which are normal recurring adjustments, necessary to present a fair statement of financial position, results of operations and cash flows. The results of operations for three and nine months ended September 30, 2022 are not necessarily indicative of the operating results for the full fiscal year or any future periods. |
Principles of Consolidation | Principles of Consolidation The Company has a wholly-owned subsidiary, ContraFect International Limited, in Scotland that establishes legal status for interactions with the European Economic Area. This subsidiary is dormant or is otherwise non-operative. |
Significant Risks and Uncertainties | Significant Risks and Uncertainties The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to, the results of clinical testing and trial activities of the Company’s products, the Company’s ability to obtain regulatory approval to market its products, competition from products manufactured and sold or being developed by other companies, the price of, and demand for, the Company’s products, the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, the Company’s ability to raise capital and the effects of the novel coronavirus, or COVID-19, The Company currently relies on a single manufacturer of drug substance for each of its product candidates and two manufacturers of drug product, one located in the United States and one in Western Europe, and there are no long-term supply agreements in place. A sustained disruption in the operations of any of these manufacturers, or in the event the Company would need to change to a new supplier, could result in a significant delay in the ability of the Company to complete any associated activities. |
Use of Estimates | Use of Estimates The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. On an ongoing basis, the Company evaluates its estimates and assumptions, including those related to research and development prepaid expenses and accruals, restructuring costs, stock-based compensation, warrant valuation and realization of net deferred income taxes. The Company’s actual results may differ from these estimates under different assumptions or conditions, including the effects of significant risks and uncertainties. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash, cash equivalents and marketable securities. The Company holds these investments in highly rated financial institutions, and, by policy, limits the amounts of credit exposure to any one financial institution. These amounts at times may exceed federally insured limits. The Company has not experienced any credit losses in such accounts and does not believe it is exposed to any significant credit risk on these funds. The Company has no off-balance |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with maturities at the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents include bank demand deposits, marketable securities with maturities of three months or less at purchase, and money market funds that invest primarily in certificates of deposit, commercial paper and U.S. government and U.S. government agency obligations. Cash equivalents are reported at fair value. |
Marketable Securities | Marketable Securities Marketable securities consist of investments in corporate debt securities. Management determines the appropriate classification of the securities at the time they are acquired and evaluates the appropriateness of such classifications at each balance sheet date. The Company classifies its marketable securities as available-for-sale pursuant to ASC 320, Investments – Debt and Equity Securities $ of losses and no realized gains losses on sales of marketable securities for the three and nine months ended September 30, The Company reviews marketable securities for other-than-temporary impairment whenever the fair value of a marketable security is less than the amortized cost and evidence indicates that a marketable security’s carrying amount is not recoverable within a reasonable period of time. Other-than-temporary impairments of investments are recognized in the consolidated statements of operations if the Company has experienced a credit loss, has the intent to sell the marketable security, or if it is more likely than not that the Company will be required to sell the marketable security before recovery of the amortized cost basis. Evidence considered in this assessment includes reasons for the impairment, compliance with the Company’s investment policy, the severity and the duration of the impairment and changes in value subsequent to the end of the period. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents, marketable securities, accounts payable, accrued liabilities and warrant liabilities. Fair value estimates of these instruments are made at a specific point in time, based on relevant market information. These estimates may be subjective in nature and involve uncertainties and matters of judgment and therefore cannot be determined with precision. The fair value of the Company’s warrant liabilities is based upon unobservable inputs, as described further below. The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. Financial Accounting Standards Board (“FASB”) Accounting Standard Codification (“ASC”) Topic 820, Fair Value Measurements and Disclosures Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2—Valuations based on quoted prices for similar assets or liabilities in markets that are not active or for which all significant inputs are observable, either directly or indirectly. Level 3—Valuations that require inputs that reflect the Company’s own assumptions that are both significant to the fair value measurement and unobservable. To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The Company had no liabilities classified as Level 1 or Level 2. The carrying amounts reported in the accompanying financial statements for accounts payable and accrued liabilities approximate their respective fair values due to their short-term maturities. The fair value of the warrant liabilities is discussed in Note 4, “Fair Value Measurements.” |
Stock-based Compensation | Stock-based Compensation The Company accounts for stock-based compensation in accordance with ASC 718, Compensation—Stock Compensation, non-employees, The fair value of options is calculated using the Black-Scholes option pricing model on the date of grant based on key assumptions such as stock price, risk free interest rates, expected volatility, expected term, and expected dividend yield. The Company’s estimates of these assumptions are based on historical data and judgment regarding future trends and factors. |
Government Contracts and Grant Agreements | Government Contracts and Grant Agreements The Company recognizes a receivable, which is included in other current assets on its consolidated balance sheet, and the related reduction in its research and development expenses when the actual reimbursable costs have been incurred and there is reasonable assurance that the Company has complied with the conditions of the applicable government contract or grant agreement and the amounts will be received. The Company recognized a reduction to its research and development expense in the amount of approximately $0.9 million and $3.7 million for the three months ended September 30, 2022 and 2021, and $5.2 million and $7.7 million for the nine months ended September 30, 2022 and 2021, respectively. The receivable for government contracts and grant agreements as of September 30, 2022 and December 31, 2021 was approximately $0.6 million and $4.1 million, respectively, and is included in other current assets on the consolidated balance sheet. The Company has approximately $8.5 million of committed government contract and grant agreement funding remaining as of September 30, 2022. |
Leases | Leases The Company accounts for leases in accordance with Accounting Standards Update No. 2016-02- Leases right-of-use Under the Company’s policy, it does not record an ROU asset or corresponding liability for arrangements where the initial lease term is one year or less. Those leases are expensed on a straight-line basis over the term of the lease. |
Restructuring | Restructuring The Company has made estimates and judgments regarding the amount and timing of its restructuring expense and liability, including current and future period termination Exit or Disposal Cost Obligations |
Net Loss per Share | Net Loss Per Share Basic net loss per share applicable to common stockholders is calculated by dividing net loss applicable to common stockholders by the weighted average shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share applicable to common stockholders is calculated by adjusting weighted average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock method. For purposes of the dilutive net loss per share applicable to common stockholders’ calculation, stock options and warrants are considered to be common stock equivalents but are excluded from the calculation of diluted net loss per share applicable to common stockholders, as their effect would be anti-dilutive; therefore, basic and diluted net loss per share applicable to common stockholders were the same for all periods presented. |
Recently Adopted Accounting Pronouncements and Recent Issued Accounting Pronouncements Not Yet Adopted | Recently Adopted Accounting Pronouncements Government Assistance On January 1, 2022, the Company adopted Accounting Standards Update No. 2021-10, Disclosure by Business Entities about Government Assistance (ASU 2021-10) 2021-10 Recently Issued Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued a new Accounting Standards Update, Financial Instruments-Credit Losses (ASU 2016-13). 2016-13 available-for-sale |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Marketable Securities | Marketable securities at September 30, 2022 consisted of the following (in thousands): Marketable Securities Amortized Cost Unrealized Unrealized Fair Value Current: Corporate debt $ 13,124 $ — $ (140 ) $ 12,984 Marketable securities at December 31, 2021 consisted of the following (in thousands): Marketable Securities Amortized Cost Unrealized Unrealized Fair Value Current: Corporate debt $ 37,715 $ — $ (84 ) $ 37,631 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Information about Company's Financial Assets and Liabilities Measured at Fair Value on Recurring Basis | The following fair value hierarchy table presents information about the Company’s financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2022 and December 31, 2021 (in thousands): Fair Value Measurement as of September 30, 2022 Quoted Prices Significant Significant Cash equivalents $ 3,017 $ — $ — Marketable securities 12,984 — — Warrant liabilities — — 3 Total $ 16,001 $ — $ 3 Fair Value Measurement as of December 31, 2021 Quoted Prices Significant Significant Cash equivalents $ 7,734 $ — $ — Marketable securities 37,631 — — Warrant liabilities — — 2,530 Total $ 45,365 $ — $ 2,530 |
Reconciliation of Company's Financial Liabilities Measured at Fair Value on Recurring Basis Using Significant Unobservable Inputs (Level 3) | The following tables present a reconciliation of the Company’s financial liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) for the three and nine months ended September 30, 2022 and 2021 (in thousands): Three Months Ended Nine Months Ended 2022 2021 2022 2021 Balance at beginning of period $ 4,826 $ 18,552 $ 2,530 $ 29,404 (Decrease) increase in fair value (1) (4,823 ) (6,358 ) (2,527 ) (17,210 ) Balance at end of period $ 3 $ 12,194 $ 3 $ 12,194 |
2020 Warrants [Member] | |
Assumption Used to Determine Fair Value of Warrant Liability | The following assumptions were used in a Black-Scholes option-pricing model to determine the fair value of the warrant liability: As of As of Expected volatility 136.5 % 61.9 % Remaining contractual term (in years) 0.67 1.42 Risk-free interest rate 3.99 % 0.56 % Expected dividend yield — % — % |
Accrued and Other Current Lia_2
Accrued and Other Current Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Payables and Accruals [Abstract] | |
Summary of Accrued and Other Current Liabilities | Accrued and other current September 30, December 31, Accrued research and development service fees $ 3,638 $ 5,641 Accrued compensation costs 2,778 2,215 Accrued professional fees 1,046 819 Accrued facilities operation expenses 129 307 Other accrued expenses 177 146 Total accrued liabilities $ 7,768 $ 9,128 |
Net Loss Per Share of Common _2
Net Loss Per Share of Common Stock (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Computation of Basic and Diluted Loss Per Share for Common Stockholders | The following table sets forth the computation of basic and diluted net loss per share for common stockholders (in thousands, except share and per share data): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Net loss $ (17,067 ) $ (5,292 ) $ (55,313 ) $ (15,883 ) Weighted average shares of common stock outstanding 39,332,721 39,332,721 39,332,721 35,914,327 Net loss per share of common stock – basic and diluted $ (0.43 ) $ (0.13 ) $ (1.41 ) $ (0.44 ) |
Schedule of Antidilutive Securities Excluded from Computation of Diluted Weighted Average Shares Outstanding | The following potentially dilutive securities outstanding at September 30, 2022 and 2021 have been excluded from the computation of diluted weighted average shares outstanding, as they would have been anti-dilutive: September 30, 2022 2021 Options to purchase common stock 4,515,422 2,950,551 Warrants to purchase common stock 9,325,521 10,926,733 Total 13,840,943 13,877,284 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Classification of Lease Liabilities | The balance sheet classification of the Company’s lease liabilities was as follows (in thousands): Description September 30, December 31, Operating lease liabilities: Current portion of lease liabilities $ 667 $ 657 Long-term portion of lease liabilities $ 2,313 $ 2,609 |
Summary of Future Minimum Lease Payments | As of September 30, 2022, the maturities of our operating lease liabilities were as follows (in thousands): Amount October 1, 2022 - December 31, 2022 $ 173 Year ending December 31: 2023 707 2024 721 2025 736 2026 750 Thereafter 702 Total lease payments 3,789 Less: Present value adjustment (809 ) Operating lease liabilities $ 2,980 |
Lease, Cost | Lease costs under the terms of the Company’s leases for the three and nine months ended September 30, 2022 and 2021 were as follows (in thousands): Three Months Ended Nine Months Ended 2022 2021 2022 2021 Operating lease cost (1) $ 154 $ 154 $ 460 $ 461 Variable lease costs (2) 66 46 147 111 Total lease cost $ 220 $ 200 $ 607 $ 572 (1) Operating lease payments included in the measurement of the Company’s lease liabilities are comprised of fixed payments according to the terms of the Company’s leases. (2) Variable lease payments consist of the Company’s utility costs billed by and paid to its landlord. Variable lease payments are presented as operating expenses in the Company’s Consolidated Statement of Operations in the same line item as expense arising from fixed lease payments and in net cash used in operating activities in the Company’s Statement of Cash Flows. |
Restructuring (Tables)
Restructuring (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Restructuring and Related Activities [Abstract] | |
Schedule Of Restructuring And Related Costs | The following table summarizes the restructuring related charges within the Company’s consolidated statements of operations where they were recorded during the three and nine months ended September 30, 2022 (in thousands): Amount Employee termination costs and other related expenses $ 1,583 Write-off of prepaid manufacturing costs $ 6,136 Total $ 7,719 |
Schedule of Restructuring Reserve by Type of Cost | The restructuring costs were included in accounts payable and accrued and other current liabilities in the Company’s consolidated balance sheets. Activity for the nine months ended September 30, 2022 is summarized as follows (in thousands): As of September 30, 2022 Balance at beginning of period $ — Charge to expense 7,719 Payments made (361 ) Balance at end of period $ 7,358 |
Capital Structure (Tables)
Capital Structure (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Capital Structure [Abstract] | |
Summary of Common Stock Reserved for Future Issuance | The Company has reserved for future issuance the following number of shares of common stock as of September 30, 2022 and December 31, 2021: September 30, December 31, Outstanding options to purchase common stock 4,515,422 2,899,694 Outstanding warrants to purchase common stock 9,325,521 10,926,594 For future issuance under the 2014 Omnibus Incentive Plan 45,212 77,631 For future issuance under the 2021 Employment Inducement Plan 990,000 1,000,000 14,876,155 14,903,919 |
Stock Warrants (Tables)
Stock Warrants (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Text Block [Abstract] | |
Schedule of Warrants Outstanding | As of September 30, 2022 and December 31, 2021, the Company had warrants to purchase the underlying common stock outstanding as shown in the table below. September 30, December 31, 2020 Warrants 8,819,904 8,819,904 2017 Warrants — 1,599,645 Pfizer Warrant 505,617 505,617 Other warrants (1) — 1,428 Warrants to purchase common stock 9,325,521 10,926,594 Weighted-average exercise price per share $ 4.90 $ 6.47 (1) Other warrants are comprised of warrants issued prior to the Company’s initial public offering (“IPO”), generally in exchange for services rendered to the Company. The following table summarizes information regarding the Company’s warrants outstanding at September 30, 2022: Exercise Prices Shares Expiration Date $4.90 9,325,521 May 27, 2023 |
Stock Option and Incentive Pl_2
Stock Option and Incentive Plans (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of Stock Option Activity | A summary of stock option activity for the nine months ended September 30, 2022, is summarized as follows: Number of Weighted Weighted Aggregate Options outstanding at December 31, 2021 2,899,694 $ 9.12 Granted 1,834,000 3.06 Exercised — — Expired (49,335 ) 11.86 Forfeited (168,937 ) 4.13 Options outstanding at September 30, 2022 4,515,422 6.82 8.24 $ — Vested and exercisable at September 30, 2022 2,245,477 9.78 6.93 $ — |
Assumptions to Compute Fair Value of Stock Option Grants | The following assumptions were used to compute the fair value of stock options granted during the period: Three Months Ended Nine Months Ended 2022 2021 2022 2021 Risk free interest rate 3.00 % 0.81 % 2.23 % 0.83 % Expected dividend yield — — — — Expected term (in years) 5.44 6.12 5.91 5.99 Expected volatility 99.5 % 95.1 % 91.9 % 94.5 % |
Organization and Description _2
Organization and Description of Business - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||||
Aug. 15, 2022 | Jul. 29, 2022 | Mar. 22, 2021 | Mar. 10, 2021 | Aug. 14, 2020 | May 27, 2020 | Sep. 30, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Organization And Description Of Business [Line Items] | ||||||||||
Accumulated deficit | $ (315,865) | $ (315,865) | $ (260,552) | |||||||
Net cash used in operating activities | (36,006) | $ (32,557) | ||||||||
Number of shares issued | 11,797,752 | |||||||||
Cash Cash Equivalents And Marketable Securities | 17,600 | 17,600 | ||||||||
Restructuring charge | $ 7,700 | $ 7,700 | 7,719 | 7,719 | ||||||
Labor and Related Expense | 1,600 | 1,600 | 1,583 | 1,583 | ||||||
write-off of prepaid manufacturing costs | $ 6,100 | $ 6,100 | $ 6,136 | 6,136 | ||||||
BARDA Contract [Member] | Base Period BARDA Funding [Member] | ||||||||||
Organization And Description Of Business [Line Items] | ||||||||||
Total funding receives in future | $ 9,800 | |||||||||
Barda Extended Contract [Member] | Base Period BARDA Funding [Member] | ||||||||||
Organization And Description Of Business [Line Items] | ||||||||||
Total funding receives in future | $ 6,600 | |||||||||
Follow-on Offering [Member] | ||||||||||
Organization And Description Of Business [Line Items] | ||||||||||
Public offering price, per unit | $ 4.45 | |||||||||
Stock issued during period, value | $ 150,000 | |||||||||
Over-Allotment Option [Member] | ||||||||||
Organization And Description Of Business [Line Items] | ||||||||||
Number of shares issued | 11,500,000 | |||||||||
Public offering price, per unit | $ 5 | |||||||||
Proceeds from initial public offer | $ 53,800 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |||||
Maturity period of highly liquid investments | three months or less | ||||
Realized gains or losses on marketable securities | $ 18 | $ 0 | $ 18 | $ 0 | |
Number of securities in unrealized loss position for more than 12 months | 0 | 0 | 0 | 0 | |
Grants receivable recognized | $ 900,000 | $ 3,700,000 | $ 5,200,000 | $ 7,700,000 | |
Grants receivable | 600,000 | 600,000 | $ 4,100,000 | ||
Grants remaining to be awarded | 8,500,000 | 8,500,000 | |||
Level 1 [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Liabilities | 0 | 0 | |||
Level 2 [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Liabilities | $ 0 | $ 0 |
Marketable Securities - Schedul
Marketable Securities - Schedule of Marketable Securities (Detail) - Corporate debt [Member] - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Schedule of Available-for-sale Securities [Line Items] | ||
Marketable Securities, Amortized Cost | $ 13,124 | $ 37,715 |
Marketable Securities, Unrealized Gains | 0 | 0 |
Marketable Securities, Unrealized Losses | (140) | (84) |
Marketable Securities, Fair Value | $ 12,984 | $ 37,631 |
Marketable Securities - Additio
Marketable Securities - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2022 USD ($) Security | |
Marketable Securities [Abstract] | |
Maturity period classified current investments | less than one year |
Number of securities in unrealized loss position for less than one year | Security | 8 |
Aggregate fair value of debt securities | $ 13,000,000 |
Debt Securities, Held-to-Maturity, Allowance for Credit Loss | $ 0 |
Fair Value Measurements - Infor
Fair Value Measurements - Information about Company's Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 12,984 | $ 37,631 |
Warrant liabilities | (3) | (2,530) |
Fair Value, Measurements, Recurring [Member] | Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 3,017 | 7,734 |
Marketable securities | 12,984 | 37,631 |
Total | 16,001 | 45,365 |
Fair Value, Measurements, Recurring [Member] | Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant liabilities | 3 | 2,530 |
Total | $ 3 | $ 2,530 |
Fair Value Measurements - Assum
Fair Value Measurements - Assumption Used to Determine Fair Value of Warrant Liability (Detail) - 2020 Warrants [Member] | Sep. 30, 2022 yr | Dec. 31, 2021 yr |
Expected Volatility [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Fair value of warrant liability | 1.365 | 0.619 |
Remaining Contractual term (in years) [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Fair value of warrant liability | 0.67 | 1.42 |
Risk-free Interest Rate [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Fair value of warrant liability | 0.0399 | 0.0056 |
Fair Value Measurements - Recon
Fair Value Measurements - Reconciliation of Company's Financial Liabilities Measured at Fair Value on Recurring Basis Using Significant Unobservable Inputs (Level 3) (Detail) - Warrant Liabilities [Member] - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||||
Balance at beginning of period | $ 4,826 | $ 18,552 | $ 2,530 | $ 29,404 | |
(Decrease) increase in fair value | [1] | (4,823) | (6,358) | (2,527) | (17,210) |
Balance at end of period | $ 3 | $ 12,194 | $ 3 | $ 12,194 | |
[1]The change in fair values of the warrant liabilities is recorded in other income in the consolidated statement of operations. |
Accrued and Other Current Lia_3
Accrued and Other Current Liabilities - Summary of Accrued and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Accrued research and development service fees | $ 3,638 | $ 5,641 |
Accrued compensation costs | 2,778 | 2,215 |
Accrued professional fees | 1,046 | 819 |
Accrued facilities operation expenses | 129 | 307 |
Other accrued expenses | 177 | 146 |
Total accrued liabilities | $ 7,768 | $ 9,128 |
Net Loss Per Share of Common _3
Net Loss Per Share of Common Stock - Schedule of Computation of Basic and Diluted Loss Per Share for Common Stockholders (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Earnings Per Share [Abstract] | ||||||||
Net loss | $ (17,067) | $ (18,089) | $ (20,157) | $ (5,292) | $ (5,396) | $ (5,195) | $ (55,313) | $ (15,883) |
Shares used in computing net loss per share | 39,332,721 | 39,332,721 | 39,332,721 | 35,914,327 | ||||
Net (loss) income per share of common stock, basic | $ (0.43) | $ (0.13) | $ (1.41) | $ (0.44) | ||||
Shares used in computing diluted net loss per share | 39,332,721 | 39,332,721 | 39,332,721 | 35,914,327 | ||||
Diluted net loss per share | $ (0.43) | $ (0.13) | $ (1.41) | $ (0.44) |
Net Loss Per Share of Common _4
Net Loss Per Share of Common Stock - Schedule of Antidilutive Securities Excluded from Computation of Diluted Weighted Average Shares Outstanding (Detail) - shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially antidilutive securities outstanding excluded from the computation of diluted weighted average shares | 13,840,943 | 13,877,284 |
Employee Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially antidilutive securities outstanding excluded from the computation of diluted weighted average shares | 4,515,422 | 2,950,551 |
Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially antidilutive securities outstanding excluded from the computation of diluted weighted average shares | 9,325,521 | 10,926,733 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | 1 Months Ended | 9 Months Ended | ||||||
Jan. 31, 2012 ft² ExtensionOptions | Dec. 31, 2011 ExtensionOptions | Dec. 31, 2010 | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2020 USD ($) | Sep. 30, 2019 USD ($) | Jan. 01, 2019 | |
Loss Contingencies [Line Items] | ||||||||
Non-cancellable operating lease, expiration date | 2027-12 | 2025-12 | ||||||
Extended lease agreement, date | 2027-12 | |||||||
Number of lease extension options | ExtensionOptions | 2 | 2 | ||||||
Lease renewal termination period | 5 years | 5 years | ||||||
Area of space relinquished from lease agreement | ft² | 10,912 | |||||||
Milestone payment | $ 810,000 | |||||||
Operating lease, discount rate, percent | 9.93% | |||||||
Rockefeller University [Member] | ||||||||
Loss Contingencies [Line Items] | ||||||||
Annual maintenance fees payable in 2018 | $ 200,000 | $ 200,000 | $ 200,000 | |||||
Annual maintenance fees payable after 2018 | $ 200,000 | |||||||
Percentage of royalty on net sales | 5% | |||||||
Regulatory milestone payment | $ 5,000,000 | |||||||
Royalty or sublicense payment | $ 0 | $ 0 | ||||||
License agreement termination notice period | 60 days | |||||||
Period of termination after first commercial sale of first licensed product | 10 years | |||||||
License agreement termination description | Each license agreement terminates upon the later of (i) the expiration or abandonment of the last licensed patent under the license agreement to expire or become abandoned, or (ii) 10 years after the first commercial sale of the first licensed product. The Rockefeller University may terminate any license agreement in the event of a breach of such agreement by the Company or if the Company challenges the validity or enforceability of the underlying patent rights. The Company may terminate any license agreement at any time on 60 days’ notice. |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Classification of Lease Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Operating lease liabilities: | ||
Current portion of lease liabilities | $ 667 | $ 657 |
Long-term portion of lease liabilities | $ 2,313 | $ 2,609 |
Commitments and Contingencies_3
Commitments and Contingencies - Maturities of Operating Lease Liabilities (Detail) $ in Thousands | Sep. 30, 2022 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
October 1,2022 - December 31, 2022 | $ 173 |
2023 | 707 |
2024 | 721 |
2025 | 736 |
2026 | 750 |
Thereafter | 702 |
Total lease payments | 3,789 |
Less: Present value adjustment | (809) |
Operating lease liabilities | $ 2,980 |
Commitments and Contingencies_4
Commitments and Contingencies - Lease Cost (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | ||
Disclosure of Lease of Cost [Abstract] | |||||
Operating lease cost | [1] | $ 154 | $ 154 | $ 460 | $ 461 |
Variable lease costs | [2] | 66 | 46 | 147 | 111 |
Total lease cost | $ 220 | $ 200 | $ 607 | $ 572 | |
[1]Operating lease payments included in the measurement of the Company’s lease liabilities are comprised of fixed payments according to the terms of the Company’s leases.[2]Variable lease payments consist of the Company’s utility costs billed by and paid to its landlord. Variable lease payments are presented as operating expenses in the Company’s Consolidated Statement of Operations in the same line item as expense arising from fixed lease payments and in net cash used in operating activities in the Company’s Statement of Cash Flows. |
Restructuring - Schedule of Res
Restructuring - Schedule of Restructuring and Related Costs (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Aug. 15, 2022 | Jul. 29, 2022 | Sep. 30, 2022 | Sep. 30, 2022 | |
Restructuring Cost and Reserve [Line Items] | ||||
Employee termination costs and other related expenses | $ 1,600 | $ 1,600 | $ 1,583 | $ 1,583 |
Write-off of prepaid manufacturing costs | 6,100 | 6,100 | 6,136 | 6,136 |
Total | $ 7,700 | $ 7,700 | $ 7,719 | $ 7,719 |
Restructuring - Schedule of Re
Restructuring - Schedule of Restructuring Reserve by Type of Cost (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Aug. 15, 2022 | Jul. 29, 2022 | Sep. 30, 2022 | Sep. 30, 2022 | |
Restructuring Cost and Reserve [Line Items] | ||||
Balance at beginning of period | $ 0 | |||
Charge to expense | $ 7,700 | $ 7,700 | $ 7,719 | 7,719 |
Payments made | (361) | |||
Balance at end of period | $ 7,358 | $ 7,358 |
Restructuring - Additional Info
Restructuring - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Aug. 15, 2022 | Jul. 29, 2022 | Sep. 30, 2022 | Sep. 30, 2022 | |
Restructuring and Related Activities [Abstract] | ||||
Restructuring Charges | $ 7,700 | $ 7,700 | $ 7,719 | $ 7,719 |
Labor and Related Expense | 1,600 | 1,600 | 1,583 | 1,583 |
writeoff of prepaid manufacturing costs | $ 6,100 | $ 6,100 | 6,136 | 6,136 |
Accounts Payable and Accrued Liabilities, Current | $ 7,400 | $ 7,400 |
Capital Structure - Additional
Capital Structure - Additional Information (Detail) | 9 Months Ended | 12 Months Ended | |||||
Mar. 22, 2021 USD ($) $ / shares shares | May 27, 2020 USD ($) $ / shares shares | Jul. 27, 2016 USD ($) | Sep. 30, 2022 USD ($) shares | Sep. 30, 2021 shares | Dec. 31, 2020 | Jul. 25, 2017 USD ($) | |
Class of Stock [Line Items] | |||||||
Common stock, shares authorized | shares | 125,000,000 | ||||||
Number of shares issued | shares | 11,797,752 | ||||||
Net proceeds received | $ 48,900,000 | ||||||
Gross Proceed | $ 3,000,000 | ||||||
Dividends declared or paid | $ 0 | ||||||
Common stock, voting rights | The holders of shares of common stock are entitled to one vote for each share of common stock held at all meetings of stockholders and written actions in lieu of meetings. | ||||||
Issuance of common stock for exercise of warrants, Shares | shares | 22,560 | ||||||
Private Placement [Member] | |||||||
Class of Stock [Line Items] | |||||||
Public offering price, per unit | $ / shares | $ 4.45 | ||||||
Issuance of securities in private placement, Shares | shares | 674,156 | ||||||
Follow-on Offering [Member] | |||||||
Class of Stock [Line Items] | |||||||
Public offering price, per unit | $ / shares | $ 4.45 | ||||||
Warrants to purchase shares of common stock | shares | 8,848,314 | ||||||
Warrant exercise price per share | $ / shares | $ 4.9 | ||||||
Conversion ratio of common stock | 0.75 | 0.75 | |||||
Follow-on Offering [Member] | 2017 Warrants [Member] | |||||||
Class of Stock [Line Items] | |||||||
Fair value of warrants | $ 12,400,000 | ||||||
Issuance costs allocated to warrants | $ 900,000 | ||||||
Follow-on Offering [Member] | 2020 Warrants [Member] | |||||||
Class of Stock [Line Items] | |||||||
Fair value of warrants | $ 31,400,000 | ||||||
Issuance costs allocated to warrants | $ 2,200,000 | ||||||
Over-Allotment Option [Member] | |||||||
Class of Stock [Line Items] | |||||||
Number of shares issued | shares | 11,500,000 | ||||||
Public offering price, per unit | $ / shares | $ 5 | ||||||
Exercise price per common share | $ / shares | $ 5 | ||||||
Proceeds from Issuance Initial Public Offering | $ 53,800,000 | ||||||
Pfizer Warrants [Member] | |||||||
Class of Stock [Line Items] | |||||||
Warrants to purchase shares of common stock | shares | 505,617 | ||||||
Warrant exercise price per share | $ / shares | $ 4.9 |
Capital Structure - Summary of
Capital Structure - Summary of Common Stock Reserved for Future Issuance (Detail) - shares | Sep. 30, 2022 | Dec. 31, 2021 |
Class of Stock [Line Items] | ||
Common Stock reserved for future issuance | 14,876,155 | 14,903,919 |
Two Thousand Fourteen Omnibus Incentive Plan [Member] | ||
Class of Stock [Line Items] | ||
Common Stock reserved for future issuance | 45,212 | 77,631 |
Two Thousand Twenty One Employment Inducement Plan [Member] | ||
Class of Stock [Line Items] | ||
Common Stock reserved for future issuance | 990,000 | 1,000,000 |
Stock Options [Member] | ||
Class of Stock [Line Items] | ||
Common Stock reserved for future issuance | 4,515,422 | 2,899,694 |
Warrants [Member] | ||
Class of Stock [Line Items] | ||
Common Stock reserved for future issuance | 9,325,521 | 10,926,594 |
Stock Warrants - Schedule of Wa
Stock Warrants - Schedule of Warrants Outstanding (Detail) - $ / shares | 9 Months Ended | |||
Sep. 30, 2022 | Dec. 31, 2021 | May 27, 2020 | ||
Class of Warrant or Right [Line Items] | ||||
Shares Underlying Outstanding Warrants | 9,325,521 | 10,926,594 | ||
Weighted-average exercise price per share | $ 4.9 | $ 6.47 | ||
Pfizer Warrants [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Shares Underlying Outstanding Warrants | 505,617 | 505,617 | ||
Exercise Prices | $ 4.9 | |||
Other Warrants [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Shares Underlying Outstanding Warrants | [1] | 0 | 1,428 | |
Exercise Price Four Point Nine Zero [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Shares Underlying Outstanding Warrants | 9,325,521 | |||
Exercise Prices | $ 4.9 | |||
Expiration Start Date | May 27, 2023 | |||
2017 Warrants [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Shares Underlying Outstanding Warrants | 0 | 1,599,645 | ||
2020 Warrants [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Shares Underlying Outstanding Warrants | 8,819,904 | 8,819,904 | ||
[1]Other warrants are comprised of warrants issued prior to the Company’s initial public offering (“IPO”), generally in exchange for services rendered to the Company. |
Stock Option and Incentive Pl_3
Stock Option and Incentive Plans - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 9 Months Ended | |||||||||
Dec. 31, 2021 | Dec. 31, 2015 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 13, 2021 | Jul. 28, 2014 | Apr. 29, 2014 | Feb. 24, 2014 | Feb. 26, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Number of shares of common stock reserved pursuant to the plan | 14,903,919 | 14,876,155 | 14,876,155 | ||||||||
Weighted average grant date fair value of options | $ 0.3 | $ 3.93 | $ 3.06 | $ 4.31 | |||||||
Unrecognized compensation cost related to unvested stock options | $ 5.7 | $ 5.7 | |||||||||
Weighted average period of unvested stock options | 2 years 1 month 28 days | ||||||||||
Employee Stock Options [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Compensation expense recognized | $ 1 | $ 0.9 | $ 2.9 | $ 2.4 | |||||||
Amended and Restated 2008 Equity Incentive Plan [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Number of shares of common stock reserved pursuant to the plan | 157,143 | ||||||||||
Termination of service, Period | 2 years | ||||||||||
2008 Equity Incentive Plan [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Number of shares of common stock reserved pursuant to the plan | 235,714 | 185,714 | |||||||||
Termination of service, Period | 10 years | ||||||||||
2014 Omnibus Incentive Plan [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Number of shares of common stock reserved pursuant to the plan | 57,143 | ||||||||||
Number of additional shares increases of common stock reserved pursuant to the plan | 4,268,682 | ||||||||||
2014 Omnibus Incentive Plan [Member] | Maximum [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Annual increase of plan, percentage of common stock shares outstanding | 4% | ||||||||||
2021 Employment Inducement Omnibus Incentive Plan [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Number of shares of common stock reserved pursuant to the plan | 1,000,000 |
Stock Option and Incentive Pl_4
Stock Option and Incentive Plans - Summary of Stock Option Activity (Detail) | 9 Months Ended |
Sep. 30, 2022 USD ($) $ / shares shares | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Number of Options, Options outstanding, Beginning balance | shares | 2,899,694 |
Number of Options, Granted | shares | 1,834,000 |
Number of Options, Exercised | shares | 0 |
Number of Options, Expired | shares | (49,335) |
Number of Options, Forfeited | shares | (168,937) |
Number of Options, Options outstanding, Ending balance | shares | 4,515,422 |
Number of Options, Vested and exercisable, Ending Balance | shares | 2,245,477 |
Weighted Average Exercise Price, Options outstanding, Beginning balance | $ / shares | $ 9.12 |
Weighted Average Exercise Price, Granted | $ / shares | 3.06 |
Weighted Average Exercise Price, Exercised | $ / shares | 0 |
Weighted Average Exercise Price, Expired | $ / shares | 11.86 |
Weighted Average Exercise Price, Forfeited | $ / shares | 4.13 |
Weighted Average Exercise Price, Options outstanding, Ending balance | $ / shares | 6.82 |
Weighted Average Exercise Price, Vested and exercisable, Ending balance | $ / shares | $ 9.78 |
Weighted Average Remaining Contractual Life (in years), Options outstanding | 8 years 2 months 26 days |
Weighted Average Remaining Contractual Life (in years), Vested and exercisable | 6 years 11 months 4 days |
Aggregate Intrinsic value, Options outstanding | $ | $ 0 |
Aggregate Intrinsic value, Vested and exercisable | $ | $ 0 |
Stock Option and Incentive Pl_5
Stock Option and Incentive Plans - Assumptions to Compute Fair Value of Stock Option Grants (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||||
Risk free interest rate | 3% | 0.81% | 2.23% | 0.83% |
Expected dividend yield | $ 0 | $ 0 | $ 0 | $ 0 |
Expected term (in years) | 5 years 5 months 8 days | 6 years 1 month 13 days | 5 years 10 months 28 days | 5 years 11 months 26 days |
Expected volatility | 99.50% | 95.10% | 91.90% | 94.50% |