Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 06, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-36183 | |
Entity Registrant Name | Eiger BioPharmaceuticals, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 33-0971591 | |
Entity Address, Address Line One | 2155 Park Boulevard | |
Entity Address, City or Town | Palo Alto | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94306 | |
City Area Code | 650 | |
Local Phone Number | 272-6138 | |
Title of 12(b) Security | Common Stock (par value $0.001 per share) | |
Trading Symbol | EIGR | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 44,384,684 | |
Amendment Flag | false | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001305253 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 27,501 | $ 25,798 |
Short-term debt securities | 11,920 | 73,150 |
Accounts receivable, net | 1,321 | 1,749 |
Inventories, net | 1,105 | 2,853 |
Prepaid expenses and other current assets | 12,777 | 13,985 |
Total current assets | 54,624 | 117,535 |
Property and equipment, net | 677 | 696 |
Operating lease right-of-use assets | 209 | 561 |
Other assets | 144 | 1,347 |
Total assets | 55,654 | 120,139 |
Current liabilities: | ||
Accounts payable | 4,858 | 8,975 |
Accrued liabilities | 11,461 | 15,655 |
Current portion of operating lease liabilities | 205 | 491 |
Total current liabilities | 16,524 | 25,121 |
Debt | 40,734 | 39,625 |
Operating lease liabilities | 0 | 83 |
Total liabilities | 57,258 | 64,829 |
Stockholders’ (deficit) equity: | ||
Common stock | 44 | 44 |
Additional paid-in capital | 497,140 | 492,759 |
Accumulated other comprehensive loss | (86) | (300) |
Accumulated deficit | (498,702) | (437,193) |
Total stockholders’ (deficit) equity | (1,604) | 55,310 |
Total liabilities and stockholders’ (deficit) equity | $ 55,654 | $ 120,139 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenues [Abstract] | ||||
Product revenue, net | $ 3,209,000 | $ 4,024,000 | $ 11,970,000 | $ 10,788,000 |
Costs and operating expenses: | ||||
Cost of sales | 115,000 | 1,231,000 | 1,492,000 | |
Cost of sales | (77,000) | |||
Research and development | 14,568,000 | 22,198,000 | 50,717,000 | 56,761,000 |
Selling, general and administrative | 5,454,000 | 6,964,000 | 20,502,000 | 20,804,000 |
Total costs and operating expenses | 20,137,000 | 30,393,000 | 71,142,000 | 79,057,000 |
Loss from operations | (16,928,000) | (26,369,000) | (59,172,000) | (68,269,000) |
Interest expense | (1,412,000) | (1,092,000) | (4,040,000) | (2,912,000) |
Interest income | 485,000 | 347,000 | 1,856,000 | 613,000 |
Other (expense) income, net | (175,000) | 3,000 | (149,000) | (1,044,000) |
Loss before provision for income taxes | (18,030,000) | (27,111,000) | (61,505,000) | (71,612,000) |
Provision for income taxes | 0 | 0 | 4,000 | 26,000 |
Net loss | $ (18,030,000) | $ (27,111,000) | $ (61,509,000) | $ (71,638,000) |
Net loss per common share: | ||||
Basic (in USD per share) | $ (0.41) | $ (0.62) | $ (1.39) | $ (1.76) |
Diluted (in USD per share) | $ (0.41) | $ (0.62) | $ (1.39) | $ (1.76) |
Weighted-average common shares outstanding: | ||||
Basic (in shares) | 44,320,164 | 44,010,553 | 44,254,711 | 40,806,581 |
Diluted (in shares) | 44,320,164 | 44,010,553 | 44,254,711 | 40,806,581 |
Product revenue, net | ||||
Revenues [Abstract] | ||||
Product revenue, net | $ 3,209,000 | $ 4,024,000 | $ 11,720,000 | $ 10,038,000 |
Other revenue | ||||
Revenues [Abstract] | ||||
Product revenue, net | $ 0 | $ 0 | $ 250,000 | $ 750,000 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (18,030,000) | $ (27,111,000) | $ (61,509,000) | $ (71,638,000) |
Other comprehensive loss: | ||||
Unrealized gain (loss) on available-for-sale debt securities, net | 26,000 | 141,000 | 186,000 | (471,000) |
Foreign currency translation adjustment | 52,000 | 0 | 27,000 | 0 |
Comprehensive loss | $ (17,952,000) | $ (26,970,000) | $ (61,296,000) | $ (72,109,000) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders’ (Deficit) Equity (Unaudited) - USD ($) | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive (Loss) | Accumulated Deficit |
Balance, beginning of period (in shares) at Dec. 31, 2021 | 34,568,821 | ||||
Balance, beginning of period at Dec. 31, 2021 | $ 72,399,000 | $ 35,000 | $ 412,930,000 | $ (149,000) | $ (340,417,000) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon offering at-the-market, net of commissions (in shares) | 5,841,786 | ||||
Issuance of common stock upon offering at-the-market, net of $1,288 of commissions | 45,610,000 | $ 6,000 | 45,604,000 | ||
Issuance of common stock upon exercise of stock options (in shares) | 15,995 | ||||
Issuance of common stock upon exercise of stock options | 144,000 | 144,000 | |||
Vesting of common stock issued under Product Development Agreement | 19,000 | 19,000 | |||
Issuance of common stock upon ESPP purchase (in shares) | 18,130 | ||||
Issuance of common stock upon ESPP purchase | 64,000 | 64,000 | |||
Issuance of common stock upon release of restricted stock units and performance stock units (in shares) | 85,106 | ||||
Stock-based compensation expense | 2,047,000 | 2,047,000 | |||
Unrealized gain (loss) on available-for-sale debt securities, net | (373,000) | (373,000) | |||
Net loss | (22,643,000) | (22,643,000) | |||
Balance, end of period (in shares) at Mar. 31, 2022 | 40,529,838 | ||||
Balance, end of period at Mar. 31, 2022 | 97,267,000 | $ 41,000 | 460,808,000 | (522,000) | (363,060,000) |
Balance, beginning of period (in shares) at Dec. 31, 2021 | 34,568,821 | ||||
Balance, beginning of period at Dec. 31, 2021 | 72,399,000 | $ 35,000 | 412,930,000 | (149,000) | (340,417,000) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Unrealized gain (loss) on available-for-sale debt securities, net | (471,000) | ||||
Cumulative translation adjustment | 0 | ||||
Net loss | (71,638,000) | ||||
Balance, end of period (in shares) at Sep. 30, 2022 | 44,048,028 | ||||
Balance, end of period at Sep. 30, 2022 | 78,308,000 | $ 44,000 | 490,939,000 | (620,000) | (412,055,000) |
Balance, beginning of period (in shares) at Mar. 31, 2022 | 40,529,838 | ||||
Balance, beginning of period at Mar. 31, 2022 | 97,267,000 | $ 41,000 | 460,808,000 | (522,000) | (363,060,000) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon offering at-the-market, net of commissions (in shares) | 2,686,288 | ||||
Issuance of common stock upon offering at-the-market, net of $1,288 of commissions | 20,564,000 | $ 2,000 | 20,562,000 | ||
Issuance of common stock upon exercise of stock options (in shares) | 1,604 | ||||
Issuance of common stock upon exercise of stock options | 9,000 | 9,000 | |||
Issuance of common stock to lender (in shares) | 749,053 | ||||
Issuance of common stock to lender | 5,000,000 | $ 1,000 | 4,999,000 | ||
Stock-based compensation expense | 2,208,000 | 2,208,000 | |||
Unrealized gain (loss) on available-for-sale debt securities, net | (239,000) | (239,000) | |||
Net loss | (21,884,000) | (21,884,000) | |||
Balance, end of period (in shares) at Jun. 30, 2022 | 43,966,783 | ||||
Balance, end of period at Jun. 30, 2022 | 102,925,000 | $ 44,000 | 488,586,000 | (761,000) | (384,944,000) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon exercise of stock options (in shares) | 3,512 | ||||
Issuance of common stock upon exercise of stock options | 27,000 | 27,000 | |||
Issuance of common stock upon ESPP purchase (in shares) | 29,985 | ||||
Issuance of common stock upon ESPP purchase | 104,000 | 104,000 | |||
Issuance of common stock upon release of restricted stock units and performance stock units (in shares) | 47,748 | ||||
Stock-based compensation expense | 2,222,000 | 2,222,000 | |||
Unrealized gain (loss) on available-for-sale debt securities, net | 141,000 | 141,000 | |||
Cumulative translation adjustment | 0 | ||||
Net loss | (27,111,000) | (27,111,000) | |||
Balance, end of period (in shares) at Sep. 30, 2022 | 44,048,028 | ||||
Balance, end of period at Sep. 30, 2022 | 78,308,000 | $ 44,000 | 490,939,000 | (620,000) | (412,055,000) |
Balance, beginning of period (in shares) at Dec. 31, 2022 | 44,074,284 | ||||
Balance, beginning of period at Dec. 31, 2022 | 55,310,000 | $ 44,000 | 492,759,000 | (300,000) | (437,193,000) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon ESPP purchase (in shares) | 29,986 | ||||
Issuance of common stock upon ESPP purchase | 41,000 | 41,000 | |||
Issuance of common stock upon release of restricted stock units and performance stock units (in shares) | 192,147 | ||||
Stock-based compensation expense | 2,542,000 | 2,542,000 | |||
Unrealized gain (loss) on available-for-sale debt securities, net | 167,000 | 167,000 | |||
Cumulative translation adjustment | (37,000) | (37,000) | |||
Net loss | (22,784,000) | (22,784,000) | |||
Balance, end of period (in shares) at Mar. 31, 2023 | 44,296,417 | ||||
Balance, end of period at Mar. 31, 2023 | 35,239,000 | $ 44,000 | 495,342,000 | (170,000) | (459,977,000) |
Balance, beginning of period (in shares) at Dec. 31, 2022 | 44,074,284 | ||||
Balance, beginning of period at Dec. 31, 2022 | 55,310,000 | $ 44,000 | 492,759,000 | (300,000) | (437,193,000) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Unrealized gain (loss) on available-for-sale debt securities, net | 186,000 | ||||
Cumulative translation adjustment | 27,000 | ||||
Net loss | (61,509,000) | ||||
Balance, end of period (in shares) at Sep. 30, 2023 | 44,384,684 | ||||
Balance, end of period at Sep. 30, 2023 | (1,604,000) | $ 44,000 | 497,140,000 | (86,000) | (498,702,000) |
Balance, beginning of period (in shares) at Mar. 31, 2023 | 44,296,417 | ||||
Balance, beginning of period at Mar. 31, 2023 | 35,239,000 | $ 44,000 | 495,342,000 | (170,000) | (459,977,000) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation expense | 745,000 | 745,000 | |||
Unrealized gain (loss) on available-for-sale debt securities, net | (7,000) | (7,000) | |||
Cumulative translation adjustment | 13,000 | 13,000 | |||
Net loss | (20,695,000) | (20,695,000) | |||
Balance, end of period (in shares) at Jun. 30, 2023 | 44,296,417 | ||||
Balance, end of period at Jun. 30, 2023 | 15,295,000 | $ 44,000 | 496,087,000 | (164,000) | (480,672,000) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock upon ESPP purchase (in shares) | 21,700 | ||||
Issuance of common stock upon ESPP purchase | 15,000 | 15,000 | |||
Issuance of common stock upon release of restricted stock units and performance stock units (in shares) | 66,567 | ||||
Stock-based compensation expense | 1,038,000 | 1,038,000 | |||
Unrealized gain (loss) on available-for-sale debt securities, net | 26,000 | 26,000 | |||
Cumulative translation adjustment | 52,000 | 52,000 | |||
Net loss | (18,030,000) | (18,030,000) | |||
Balance, end of period (in shares) at Sep. 30, 2023 | 44,384,684 | ||||
Balance, end of period at Sep. 30, 2023 | $ (1,604,000) | $ 44,000 | $ 497,140,000 | $ (86,000) | $ (498,702,000) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders’ (Deficit) Equity (Unaudited) (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Jun. 30, 2022 | Mar. 31, 2022 | |
Statement of Stockholders' Equity [Abstract] | ||
Stock issuance costs | $ 716 | $ 1,288 |
Condensed Consolidated Statem_5
Condensed Consolidated Statements of Cash Flow (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Operating activities | ||
Net loss | $ (61,509) | $ (71,638) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 218 | 219 |
Inventory write down | 11 | 1,043 |
Amortization of debt securities premiums and discounts | (1,046) | 698 |
Loss on extinguishment of debt | 0 | 1,144 |
Non-cash interest expense | 1,109 | 867 |
Reduction in the carrying amount of right-of-use assets | 352 | 407 |
Common stock issued under Product Development Agreement | 0 | 19 |
Stock-based compensation | 4,325 | 6,477 |
Change in operating assets and liabilities: | ||
Accounts receivable | 421 | 118 |
Inventories | 2,263 | (892) |
Prepaid expenses and other current assets | 424 | (2,181) |
Other assets | 1,987 | (616) |
Accounts payable | (4,157) | 2,722 |
Accrued liabilities | (4,623) | 1,315 |
Operating lease liabilities | (369) | (465) |
Net cash used in operating activities | (60,594) | (60,763) |
Investing activities | ||
Purchase of debt securities available-for-sale | (19,388) | (55,538) |
Proceeds from maturities of debt securities available-for-sale | 81,850 | 43,489 |
Purchase of property and equipment | (233) | (116) |
Net cash provided by (used in) investing activities | 62,229 | (12,165) |
Financing activities | ||
Issuance of common stock upon offering at-the-market, net of commissions | 0 | 66,402 |
Proceeds from issuance of common stock to lender | 0 | 5,000 |
Proceeds from issuance of common stock upon stock option exercises | 0 | 180 |
Proceeds from issuance of common stock upon ESPP purchase | 56 | 168 |
Proceeds from debt | 0 | 39,840 |
Repayment of debt | 0 | (33,277) |
Payment of debt issuance costs | 0 | (1,054) |
Common stock offering costs | (22) | (244) |
Net cash provided by financing activities | 34 | 77,015 |
Effect of foreign exchange on cash and cash equivalents | 34 | 0 |
Net increase in cash and cash equivalents | 1,703 | 4,087 |
Cash and cash equivalents at beginning of period | 25,798 | 22,221 |
Cash and cash equivalents at end of period | 27,501 | 26,308 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 2,931 | 2,038 |
Income taxes paid | $ 188 | $ 43 |
Description of Business
Description of Business | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | Description of Business Eiger BioPharmaceuticals, Inc. (the Company or Eiger) was incorporated in the State of Delaware on November 6, 2008. Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies for rare metabolic diseases. Eiger’s lead product candidate, avexitide, is a well-characterized, first-in-class glucagon-like peptide-1 ( GLP-1) antagonist and is in development for the treatment of post-bariatric hypoglycemia (PBH) and other forms of hyperinsulinemic hypoglycemia (HH) arising after gastrointestinal surgeries. These disorders are characterized by exaggerated secretion of GLP-1 after meals, dysregulated secretion of insulin, followed by a rapid drop in blood sugar. Avexitide is the only drug in development for PBH with Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA). Avexitide is also in development for congenital hyperinsulinism (HI), an ultra-rare, life-threatening, pediatric disorder of persistent hypoglycemia that results in irreversible brain damage in up to 50% of children with the condition. Avexitide has completed Phase 2 for both PBH and HI, and Phase 3 study start-up activities for PBH have been initiated. The FDA approved the Company’s first commercial product, Zokinvy ® (lonafarnib), to reduce risk of mortality of Hutchinson-Gilford progeria syndrome (HGPS) and for treatment of processing-deficient progeroid laminopathies (PL), with either heterozygous LMNA mutation with progerin-like protein accumulation, or homozygous or compound heterozygous ZMPSTE24 mutations, on November 20, 2020. Collectively known as progeria, HGPS and PL are ultra-rare, fatal, genetic premature aging diseases that accelerate mortality in young patients. In July 2022, the Company announced that the European Commission (EC) granted marketing authorization (MA) under exceptional circumstances for Zokinvy through the centralized procedure. The EC's MA is valid in all 27 European Union (EU) member states plus Iceland, Liechtenstein, and Norway. In May 2022, the Pharmaceutical Division at the Ministry of Health of Israel granted regulatory approval for Zokinvy in Israel. In August 2022, the Medicine and Healthcare products Regulatory Agency (MHRA) granted approval in the UK. The Company commercially launched Zokinvy in the U.S. in January 2021 and started to recognize product revenue in the first quarter of 2021. The first European sales were recognized in the fourth quarter of 2022. In June 2023, the Company announced that it is focusing its clinical development efforts on advancing avexitide in HH indications, including PBH. The Company will continue to commercialize Zokinvy (lonafarnib) for the treatment of HGPS and processing-deficient PL. In addition, Eiger is evaluating strategic partnering options for its virology assets, lonafarnib and peginterferon lambda. In June 2023, the Company also announced that it has appointed David Apelian, MD, PhD, MBA, who has served as interim Chief Executive Officer (CEO) since December 2022, as the Company's next CEO. The Company’s principal operations are based in Palo Alto, California, with subsidiaries in Delaware, Ireland, England and Wales. The Company operates in one segment. Liquidity As of September 30, 2023, the Company had $39.4 million of cash, cash equivalents and short-term securities, comprised of $27.5 million of cash and cash equivalents and $11.9 million of short-term debt securities available-for-sale. The Company had an accumulated deficit of $498.7 million as of September 30, 2023 and negative cash flows of $60.6 million from operating activities during the nine months ended September 30, 2023. As the Company continues to incur losses, its transition to profitability will depend on the successful development, approval, and commercialization of product candidates and on the achievement of sufficient revenues to support its cost structure. The Company may never achieve profitability, and until it does, the Company will need to continue to raise additional capital. Based on its recurring losses from operations incurred since inception, expectation of continuing operating losses and negative cash flows for the foreseeable future, need to raise additional capital to finance its future operations, and given the current cash, cash equivalents and short-term securities balance, the Company has concluded that there is substantial doubt regarding the Company’s ability to continue as a going concern beyond twelve months after the date that these condensed consolidated financial statements are issued. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The condensed consolidated financial statements include the accounts of Eiger BioPharmaceuticals, Inc. and its wholly owned subsidiaries, EBPI Merger Inc., EB Pharma LLC, Eiger BioPharmaceuticals Europe Limited, and EigerBio Europe Limited, have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) and follow the requirements of the Securities and Exchange Commission (SEC) regarding interim financial reporting. All intercompany balances and transactions have been eliminated in consolidation. Certain information and note disclosures normally included in the financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. As such, the information included in this Quarterly Report on Form 10-Q should be read in conjunction with the consolidated financial statements and accompanying notes included in the Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 17, 2023. Significant Accounting Policies Other than impacted accounting policies related to the Company's adoption of current expected credit loss (CECL) as disclosed below, there have been no new or material changes to the significant accounting policies discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates. The Company bases its estimates on historical experience and on various other market-specific and relevant assumptions that the Company believes to be reasonable under the circumstances. Actual results could differ from those estimates. Concentrations of Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash, cash equivalents and investments. The Company’s cash is held by financial institutions in the United States and Ireland. Amounts on deposit may at times exceed federally insured limits. The Company is exposed to credit risk in the event of default by the financial institutions holding its cash, cash equivalents and investments and issuers of investments. The Company manages its credit risk by holding its cash, cash equivalents and investments in large financial institutions within the U.S and Ireland. In addition, the Company’s investment policy limits investments to certain types of instruments such as money market funds, debt securities issued by the U.S. government and its agencies, corporate debt securities, commercial paper as well as asset-backed securities, and places restrictions on the credit ratings, maturities and concentration by type and issuer. The Company has not experienced any losses on its deposits of cash, cash equivalents and investments. The Company relies on one supply chain for each of its product candidates. If any of the single source suppliers in any of the supply chains fail to satisfy the Company’s requirements on a timely basis, the Company could suffer delays in its clinical development programs and activities which could adversely affect its operating results. Two customers accounted for approximately 58 percent and 39 percent of the Company’s accounts receivable as of September 30, 2023. Two customers accounted for approximately 58 percent and 42 percent of the Company’s accounts receivable as of December 31, 2022. Two customers accounted for approximately 74 percent and 26 percent of product revenue during the three months ended September 30, 2023. Two customers accounted for approximately 76 percent and 23 percent of product revenue during the nine months ended September 30, 2023. One customer accounted for approximately 99 percent of product revenue during the three months ended September 30, 2022. One customer accounted for approximately 100 percent of product revenue during the nine months ended September 30, 2022. Foreign Currency Exchange Foreign Currency Transaction Risk The foreign currency transaction risk relates to changes in exchange rates on monetary assets, liabilities, revenues and expenses held at Eiger BioPharmaceuticals Europe Limited . Gains and losses on foreign currency transactions result primarily from monetary assets, liabilities, revenues and expenses denominated in Euro. Aggregated transaction losses for the three and nine months ended September 30, 2023 were $0.2 million and $0.1 million, respectively . The Company expects the foreign currency gain/loss to continue to fluctuate as long as the Company continue to hold monetary assets and liabilities at its subsidiaries in Ireland and England and Wales. Market uncertainty could potentially lead to significant volatility with foreign currency exchange rates, which could result in additional foreign currency gain/loss. Foreign Currency Translation Risk The foreign currency translation risk relates to the translation of the foreign consolidated subsidiaries' assets, liabilities, revenues and expenses from the subsidiaries’ functional currency to the U.S. dollar at each reporting date. Fluctuations in exchange rates may impact the amount of assets, liabilities, revenues and expenses reported on the consolidated balance sheets and consolidated statements of operations. The financial statements of the Company’s foreign subsidiaries, which have a functional currency other than the U.S. dollar, are translated into U.S. dollars using a current exchange rate. Gains and losses resulting from this translation are recognized as a foreign currency translation adjustment within accumulated other comprehensive loss, which is a component of stockholders' (deficit) equity and comprehensive income (loss). Aggregate translation gain, net of tax, was $52,000 and $27,000 for the three months and nine months ended September 30, 2023 , respectively. There were no translation gains or losses for the three and nine months ended September 30, 2022. Debt Securities All securities are short-term in nature and consist of debt securities classified as available-for-sale and have maturities greater than 90 days, but less than 365 days from the date of acquisition. The Company’s debt securities consist of available-for-sale securities that are classified as Level 2 because their value is based on valuations using significant inputs derived from, or corroborated by, observable market data. The Company evaluates, on a quarterly basis, its available-for-sale debt securities for potential impairment. For available-for-sale debt securities in an unrealized loss position, the Company assesses whether such declines are due to credit related factors such as changes to the rating of the security by a ratings agency, market conditions and supportable forecasts of economic and market conditions, among others. If the fair value of available-for-sale debt securities is less than the amortized cost basis, the Company assesses whether it has plans to sell the security or it is more likely than not it will be required to sell any available-for-sale debt security before recovery of its amortized cost basis. If either condition is met, the security’s amortized cost basis is written down to fair value and is recognized through other (expense) income, net. If neither condition is met, declines as a result of credit losses, if any, are recognized as an allowance for credit loss, limited to the amount of unrealized loss, through other (expense) income, net. Any portion of the unrealized loss that is not a result of a credit loss, is recognized in other comprehensive loss. The cost of available-for-sale securities sold is based on the specific-identification method . Realized gains and losses on the sale of debt securities are determined using the specific-identification method and recorded in other (expense) income, net. Accounts Receivable Accounts receivable represent amounts billed to the Company’s customers, net of an allowance for credit losses. Trade accounts receivable are recorded at invoiced amounts and do not bear interest. The allowance for credit losses reflects the Company’s best estimate of probable losses inherent in the receivable portfolio determined based on various factors, including age of the outstanding invoice, credit quality of the customer, historical experience, current economic conditions, and management’s expectations of future economic conditions. The Company regularly reviews the adequacy of the allowance for credit losses by considering the age of each outstanding invoice and the collection history of each customer to determine the appropriate amount of allowance for credit losses. The Company had no allowance for credit losses as of September 30, 2023 and December 31, 2022. The Company had no credit losses for the periods presented. Recent Adopted Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Updates (ASU) No. 2016-13, Financial Instruments—Credit Losses (Topic 326) . ASU 2016-13 requires an entity to utilize a new impairment model that requires measurement and recognition of expected credit losses for most financial assets and certain other instruments, including but not limited to available-for-sale debt securities. Credit losses relating to available-for-sale debt securities will be recorded through an allowance for credit losses rather than as a direct write-down to the security. The new guidance requires the use of forward-looking expected credit loss models based on historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount, which may result in earlier recognition of credit losses under the new guidance. In April 2019, the FASB issued ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments – Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, which clarifies and corrects certain unintended applications of the guidance contained in each of the amended Topics. Additionally, in May 2019, the FASB issued ASU No. 2019-05, Financial Instruments – Credit Losses (Topic 326), which provides an option to irrevocably elect to measure certain individual financial assets at fair value instead of amortized cost. In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) , which |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements Fair value accounting is applied for all financial assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis (at least annually). As of September 30, 2023 and December 31, 2022, the carrying amount of cash equivalents, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued liabilities approximated their estimated fair value due to their relatively short maturities. Management believes the terms of its long-term debt reflect current market conditions for an instrument with similar terms and maturity, therefore the carrying value of the Company’s debt approximated its fair value. There were no transfers into or out of Level 3 of the fair value hierarchy during the periods presented. The following tables present the fair value hierarchy for assets and liabilities measured at fair value, and summarize the estimated value of the Company’s cash equivalents and debt securities and the gross unrealized holding gains and losses (in thousands): September 30, 2023 Level Amortized cost Unrealized gain Unrealized loss Estimated Fair Cash equivalents: Money market funds 1 $ 9,553 $ — $ — $ 9,553 Total cash equivalents $ 9,553 $ — $ — $ 9,553 Debt securities: U.S. government bonds 2 $ 11,934 $ — $ (14) $ 11,920 Total debt securities $ 11,934 $ — $ (14) $ 11,920 Classified as: Cash equivalents 1 $ 9,553 Short-term debt securities 2 11,920 $ 21,473 December 31, 2022 Level Amortized cost Unrealized gain Unrealized loss Estimated Fair Cash equivalents: Money market funds 1 $ 11,546 $ — $ — $ 11,546 Commercial paper 2 3,968 — — 3,968 Total cash equivalents $ 15,514 $ — $ — $ 15,514 Debt securities: U.S. government bonds 2 $ 39,646 $ 3 $ (86) $ 39,563 Corporate debt securities 2 28,759 — (117) 28,642 Commercial paper 2 4,945 — — 4,945 Total debt securities $ 73,350 $ 3 $ (203) $ 73,150 Classified as: Cash equivalents 1 & 2 $ 15,514 Short-term debt securities 2 73,150 $ 88,664 Other than the debt balance as discussed in Note 6, there were no financial liabilities as of September 30, 2023 and December 31, 2022. During the three and nine months ended September 30, 2023, the Company did not recognize any credit losses. The Company determined that the decline in fair value of debt securities was not due to credit-related factors, and no allowance for expected credit losses was recorded as of September 30, 2023 . |
Balance Sheet Components
Balance Sheet Components | 9 Months Ended |
Sep. 30, 2023 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Components | Balance Sheet Components Inventories Inventories consist of the following (in thousands): September 30, December 31, Raw materials $ 517 $ 1,703 Work-in-progress 494 884 Finished goods 94 266 Total inventories, net $ 1,105 $ 2,853 The write downs of inventory were immaterial for the three and nine months ended September 30, 2023. The Company wrote down $1.0 million of inventory for the three and nine months ended September 30, 2022. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following (in thousands): September 30, December 31, Short term deposits $ 5,006 $ 4,542 Prepaid research costs 3,751 2,822 Prepaid contract manufacturing costs 1,659 3,542 Prepaid insurance 604 586 Prepaid marketing 122 753 Other 1,635 1,740 Total prepaid expenses and other current assets $ 12,777 $ 13,985 Accrued Liabilities Accrued liabilities consist of the following (in thousands): September 30, December 31, Compensation and related benefits $ 3,600 $ 6,167 Contract research costs 3,688 4,188 Product revenue reserves 2,334 1,373 Contract manufacturing costs 922 2,101 Legal fees 187 562 Other 730 1,264 Total accrued liabilities $ 11,461 $ 15,655 |
Bristol-Meyers Squibb License A
Bristol-Meyers Squibb License Agreement | 9 Months Ended |
Sep. 30, 2023 | |
Product Development Agreement [Abstract] | |
Bristol-Meyers Squibb License Agreement | Bristol-Meyers Squibb License Agreement On April 20, 2016, the Company and Bristol-Myers Squibb Company (BMS) entered into a License Agreement (the BMS License Agreement) and a Common Stock Purchase Agreement (the BMS Purchase Agreement). Under the BMS License Agreement, BMS granted the Company an exclusive, worldwide, license to research, develop, manufacture, and sell products containing PEG-interferon Lambda-1a (peginterferon lambda or the Licensed Product) for all therapeutic and diagnostic uses in humans and animals. The Company is responsible for the development and commercialization of the Licensed Product at its sole cost and expense. The Company paid BMS $2.0 million and issued 157,587 shares of its common stock at an aggregate fair value of $3.2 million in April 2016. The BMS License Agreement |
Debt
Debt | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Debt | Debt Innovatus Term Loan On June 1, 2022 (Closing Date), the Company entered into a term loan and security agreement (Innovatus Loan) with Innovatus Life Sciences Lending Fund I, LP (Innovatus), providing for up to $75.0 million funded in three tranches with a maturity date of August 31, 2027. The floating per annum interest rate of the Innovatus Loan is equal to the sum of (a) the greater of (i) the Prime Rate published in the Money Rates section of the Wall Street Journal (or any successor thereto) and (ii) 3.5%, plus (b) 3.75%; provided that, at the election of the Borrower, up to 2.25% of such rate shall be payable in-kind until the third anniversary of the closing date. The Company is required to make monthly interest-only payments through July 1, 2027, after which the Company is required to make monthly amortizing payments, with the remaining balance of the principal plus accrued and unpaid interest due at maturity. 2.25% of the interest is payable in-kind for the first three years of the term by increasing the principal balance. Prepayments of the loan, in whole or in part, will be subject to an early prepayment fee which ranges between 3% and 0% and declines each year until the third anniversary date of the Closing Date, after which no prepayment fee is required. The Company is also required to pay an exit fee upon any payment or prepayment equal to 6.5% of the aggregate principal amount of the tranches funded under the Innovatus Loan. The Innovatus Loan contains customary representations, warranties, events of default, including failure to pay amounts due, breaches of covenants and warranties, material adverse change events, certain cross defaults and judgements, and insolvency, and covenants of the Company and its subsidiaries, including a requirement to maintain a cash balance of not less than 5% of the aggregate principal amount of funded and outstanding loan terms at all times. Should the Company be unable to comply with these covenants or if the Company defaults on any portion of its outstanding borrowings, the lender can also impose a 5% penalty, restrict access to additional borrowings under the loan and security agreement, and accelerate the maturity of the debt to be immediately due and payable. The Company believes it is in compliance with the terms included with the Innovatus Loan. The Innovatus Loan is secured by perfected first priority liens on the Company's assets, including a commitment by the Company to not allow any liens to be placed upon the Company's intellectual property. The Company was funded $40.0 million in June 2022 on the Closing Date under Tranche A. The remaining $35.0 million is divided into two tranches (Tranche B and Tranche C). The $17.5 million under each of Tranche B and Tranche C will be available for a period commencing on the later of (a) the first date that the Company achieves certain development and regulatory milestones applicable to each Tranche and (b) November 1, 2022. Both Tranche B and Tranche C draw periods end on the earlier of (a) June 30, 2024 or (b) an event of default. The Company is currently eligible to draw the $17.5 million under Tranche B, but has not done so as of September 30, 2023. The Company identified a number of embedded derivatives that require bifurcation from the Innovatus Loan. These embedded features include mandatory prepayment upon an event of default or change in control and contingent rate increases. However, the fair value of these embedded features was deemed to be immaterial on the date of issuance. At each subsequent reporting period, the Company will reassess the fair value of the embedded features and will record a liability if the fair value of the features becomes material. In connection with the issuance of the Innovatus Loan, the Company recorded a debt discount of $0.2 million and capitalized debt issuance costs of $1.1 million. The discount and issuance costs will be amortized over the life of the loan. Interest expense for the Innovatus Loan for the three and nine months ended September 30, 2023 was $1.4 million and $4.0 million, respectively, and is inclusive of non-cash amortization of the debt discount and debt issuance costs and accretion of final payment. The carrying amount of the Innovatus Loan approximates fair value. The effective interest rate for the Innovatus Loan was 13.84% as of September 30, 2023. Additionally, in connection with entering into the Innovatus Loan, the Company entered into a Stock Purchase Agreement with Innovatus for the sale of common stock with an aggregate value of $5.0 million. On June 1, 2022, the Company issued 749,053 shares of common stock to Innovatus at a per share purchase price of $6.6751, the preceding five-day volume weighted average price per share. A portion of the loan proceeds was used to repay in full the approximately $33.5 million of aggregate principal amount, unpaid interest, and exit fees in connection with loans outstanding owed to Oxford Finance LLC (the Oxford Loan) by the Company. Oxford Term Loan On June 1, 2022, upon entering into the Innovatus Loan, the Company repaid the Oxford Loan, including (i) the $30.0 million outstanding principal balances, (ii) $0.2 million in accrued and unpaid interest, and (iii) other final payments consisting of $3.3 million, for a total payment of $33.5 million. The Company recorded a loss of $1.1 million on early extinguishment of the debt related to the unamortized debt premium, discount, and cost of issuance, which was recognized as a component of other (expense) income, net in the condensed consolidated statement of operations. The Company accounts for the amortization of the debt discount utilizing the effective interest method. Debt and unamortized discount balances are as follows (in thousands): September 30, December 31, Face value of debt $ 41,218 $ 40,531 Exit fee 2,600 2,600 Unamortized debt discount associated with exit fee, debt issuance costs and loan origination fees (3,084) (3,506) Total debt, net $ 40,734 $ 39,625 |
Common Stock
Common Stock | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Common Stock | Common Stock The Company had reserved shares of common stock for issuance as follows: September 30, December 31, Options issued and outstanding 7,335,274 6,143,183 Options available for future grants 3,359,214 1,976,460 Restricted and performance stock units outstanding 219,562 641,407 Shares available for issuance under ESPP 736,371 788,057 Shares available for issuance under 2021 Inducement Plan 702,600 380,000 Total 12,353,021 9,929,107 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation In June 2016, the Company’s Board of Directors adopted and in August 2016 the Company’s stockholders approved the Amended and Restated 2013 Equity Incentive Plan (Restated 2013 Plan). As of September 30, 2023, there were 3,359,214 shares available for grant under the Restated 2013 Plan. During the second quarter of 2021, the Company approved the 2021 Inducement Plan to be used exclusively for grants of awards to individuals that were not previously employees or directors of the Company as a material inducement to such individuals’ entry into employment with the Company within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules. As of September 30, 2023, there were 702,600 shares remaining and available to be issued under the 2021 Inducement Plan. Awards Modification On February 6, 2023, the Company entered into a separation agreement and general release with David Cory, the Company's former President and CEO. Pursuant to the separation agreement, 50% of Mr. Cory's unvested equity awards were accelerated to vest on the date the separation agreement was executed. Additionally, the exercise period for Mr. Cory's vested awards was extended, including his accelerated awards. The stock compensation recognized related to these modifications was $0 and $0.9 million for the three and nine months ended September 30, 2023, which is reflected in selling, general and administrative expenses. Stock-Based Compensation Expense Total stock-based compensation expense recognized was as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Research and development $ 650 $ 856 $ 2,001 $ 2,301 Selling, general and administrative 388 1,366 2,324 4,176 Total $ 1,038 $ 2,222 $ 4,325 $ 6,477 As of September 30, 2023, the total unrecognized compensation expense related to unvested options was $6.2 million, which the Company expects to recognize over an estimated weighted average period of 2.7 years. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income TaxesThe Company’s provision for income taxes was approximately $0 and $4,000 for the three and nine months ended September 30, 2023, respectively, with an effective tax rate of (0.01)% for the nine months ended September 30, 2023. The Company’s provision for income taxes was approximately $0 and $26,000 for the three and nine months ended September 30, 2022, respectively, with an effective tax rate of (0.04)% for the nine months ended September 30, 2022. The effective tax rate in each period differs from the U.S. statutory tax rate primarily due to the valuation allowances on the Company’s deferred tax assets as it is more likely than not that some or all of the Company’s deferred tax assets will not be realized. The tax expense recorded for the three and nine months ended September 30, 2023 relates to state taxes. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Lease Agreements In October 2017, the Company entered into a non-cancelable operating facility lease agreement for 8,029 square feet of office space located at 2155 Park Boulevard in Palo Alto, California. The lease commenced on March 1, 2018 and was to expire in February 2023. The lease had a three-year renewal option prior to expiration. The lease included rent escalation clauses throughout the lease term. In October 2017, the Company provided a security deposit of $0.3 million. In February 2023, the Company amended the lease to extend the lease by one year with a one year renewal option. The extended lease commenced on March 1, 2023 and expires on February 28, 2024. The Company accounted for the amendment as a lease modification in accordance with ASC Topic 842. The Company also has additional operating leases that are included in its lease accounting but are not considered material for disclosure. The maturities of the Company’s operating lease liabilities as of September 30, 2023 were as follows (in thousands): Undiscounted lease payments September 30, 2023 Remaining in 2023 $ 124 2024 84 2025 1 Total undiscounted payments 209 Less: imputed interest 4 Present value of future lease payments 205 Less: current portion of operating lease liabilities 205 Operating lease liabilities $ — Rent expense recognized for the Company’s operating leases was $0.1 million for the three months ended September 30, 2023 and 2022, and $0.4 million for the nine months ended September 30, 2023 and 2022. Under the terms of the lease agreements, the Company is also responsible for certain variable lease payments that are not included in the measurement of the lease liability. Variable lease payments for the operating leases were $23,000 for the three months ended September 30, 2023 and 2022, and $0.1 million for the nine months ended September 30, 2023 and 2022. The operating cash outflows for the operating lease liabilities were $0.4 million and $0.5 million for the nine months ended September 30, 2023 and 2022, respectively. As of September 30, 2023 and December 31, 2022, the weighted-average remaining lease terms were 0.4 years and 1.2 years, and weighted-average discount rates were 12.81% and 12.82%, respectively. Legal Matters Schoen v. Eiger BioPharmaceuticals, Inc., et al. , Case No. 22-cv-06985 On November 8, 2022 a putative securities class action complaint was filed in the United States District Court for the Northern District of California alleging that the company and two former executives violated Sections 10(b) and 20(a) of the Securities Exchange Act and SEC Rule 10b-5. The complaint alleged generally that between March 2021 and October 2022, material misstatements and omissions were made to shareholders regarding the TOGETHER study of peginterferon lambda for the treatment of COVID-19 as well as the likelihood of FDA approval of an Emergency Use Authorization for peginterferon lambda. The Court appointed a lead plaintiff on March 2, 2023. On April 10, 2023, the lead plaintiff filed a notice of voluntary dismissal without prejudice. The Progeria Research Foundation, Inc. v. Eiger BioPharmaceuticals, Inc. Arbitration On November 15, 2022, the Company received a demand for arbitration (Demand) from claimant The Progeria Research Foundation, Inc. (PRF) asserting two claims under a May 15, 2018 Collaboration and Supply Agreement (the PRF Collaboration Agreement) between the parties. PRF has alleged that the Company breached an obligation to supply quantities of a drug as requested by PRF. PRF also has a claim for declaratory relief regarding the grant of licenses under the PRF Collaboration Agreement. On January 18, 2023, the Company filed a response to the Demand denying PRF’s claims, contesting the arbitrability of PRF’s claim for declaratory relief, and asserting a counterclaim for declaratory relief related to the contractual provision underlying PRF’s original drug supply claim. To give the parties an opportunity to discuss a potential negotiated resolution of their dispute, the arbitration has been suspended through the end of 2023. As a result, all arbitration activities are now on hold, and the final hearing, originally scheduled for May 9 – 12, 2023, in Boston, Massachusetts, was cancelled. |
Commitments and Contingencies | Commitments and Contingencies Lease Agreements In October 2017, the Company entered into a non-cancelable operating facility lease agreement for 8,029 square feet of office space located at 2155 Park Boulevard in Palo Alto, California. The lease commenced on March 1, 2018 and was to expire in February 2023. The lease had a three-year renewal option prior to expiration. The lease included rent escalation clauses throughout the lease term. In October 2017, the Company provided a security deposit of $0.3 million. In February 2023, the Company amended the lease to extend the lease by one year with a one year renewal option. The extended lease commenced on March 1, 2023 and expires on February 28, 2024. The Company accounted for the amendment as a lease modification in accordance with ASC Topic 842. The Company also has additional operating leases that are included in its lease accounting but are not considered material for disclosure. The maturities of the Company’s operating lease liabilities as of September 30, 2023 were as follows (in thousands): Undiscounted lease payments September 30, 2023 Remaining in 2023 $ 124 2024 84 2025 1 Total undiscounted payments 209 Less: imputed interest 4 Present value of future lease payments 205 Less: current portion of operating lease liabilities 205 Operating lease liabilities $ — Rent expense recognized for the Company’s operating leases was $0.1 million for the three months ended September 30, 2023 and 2022, and $0.4 million for the nine months ended September 30, 2023 and 2022. Under the terms of the lease agreements, the Company is also responsible for certain variable lease payments that are not included in the measurement of the lease liability. Variable lease payments for the operating leases were $23,000 for the three months ended September 30, 2023 and 2022, and $0.1 million for the nine months ended September 30, 2023 and 2022. The operating cash outflows for the operating lease liabilities were $0.4 million and $0.5 million for the nine months ended September 30, 2023 and 2022, respectively. As of September 30, 2023 and December 31, 2022, the weighted-average remaining lease terms were 0.4 years and 1.2 years, and weighted-average discount rates were 12.81% and 12.82%, respectively. Legal Matters Schoen v. Eiger BioPharmaceuticals, Inc., et al. , Case No. 22-cv-06985 On November 8, 2022 a putative securities class action complaint was filed in the United States District Court for the Northern District of California alleging that the company and two former executives violated Sections 10(b) and 20(a) of the Securities Exchange Act and SEC Rule 10b-5. The complaint alleged generally that between March 2021 and October 2022, material misstatements and omissions were made to shareholders regarding the TOGETHER study of peginterferon lambda for the treatment of COVID-19 as well as the likelihood of FDA approval of an Emergency Use Authorization for peginterferon lambda. The Court appointed a lead plaintiff on March 2, 2023. On April 10, 2023, the lead plaintiff filed a notice of voluntary dismissal without prejudice. The Progeria Research Foundation, Inc. v. Eiger BioPharmaceuticals, Inc. Arbitration On November 15, 2022, the Company received a demand for arbitration (Demand) from claimant The Progeria Research Foundation, Inc. (PRF) asserting two claims under a May 15, 2018 Collaboration and Supply Agreement (the PRF Collaboration Agreement) between the parties. PRF has alleged that the Company breached an obligation to supply quantities of a drug as requested by PRF. PRF also has a claim for declaratory relief regarding the grant of licenses under the PRF Collaboration Agreement. On January 18, 2023, the Company filed a response to the Demand denying PRF’s claims, contesting the arbitrability of PRF’s claim for declaratory relief, and asserting a counterclaim for declaratory relief related to the contractual provision underlying PRF’s original drug supply claim. To give the parties an opportunity to discuss a potential negotiated resolution of their dispute, the arbitration has been suspended through the end of 2023. As a result, all arbitration activities are now on hold, and the final hearing, originally scheduled for May 9 – 12, 2023, in Boston, Massachusetts, was cancelled. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Net Loss Per Share Basic net loss per share of common stock is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during the period, without consideration for potentially dilutive securities. Since the Company was in a loss position for the three and nine months ended September 30, 2023 and 2022, diluted net loss per share is the same as basic net loss per share as the inclusion of all potential common shares outstanding would have been anti-dilutive. Dilutive potential common stock equivalents include the assumed exercise, vesting and issuance of employee stock awards using the treasury stock method. The following table sets forth the outstanding potentially dilutive securities which have been excluded in the calculation of diluted net loss per share because including such securities would be anti-dilutive (in common stock equivalent shares): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Options to purchase common stock 7,335,274 6,876,679 7,335,274 6,876,679 Restricted and Performance stock units (unvested) 219,562 753,356 219,562 753,356 ESPP 252,922 85,110 252,922 85,110 Total 7,807,758 7,715,145 7,807,758 7,715,145 |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent EventsIn preparing the condensed consolidated financial statements as of September 30, 2023, the Company evaluated subsequent events for recognition and measurement purposes through the filing date of this Quarterly Report on Form 10-Q. The Company concluded that no events or transactions have occurred that require disclosure in the accompanying condensed consolidated financial statements. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Pay vs Performance Disclosure | ||||||||
Net loss | $ (18,030) | $ (20,695) | $ (22,784) | $ (27,111) | $ (21,884) | $ (22,643) | $ (61,509) | $ (71,638) |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The condensed consolidated financial statements include the accounts of Eiger BioPharmaceuticals, Inc. and its wholly owned subsidiaries, EBPI Merger Inc., EB Pharma LLC, Eiger BioPharmaceuticals Europe Limited, and EigerBio Europe Limited, have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP) and follow the requirements of the Securities and Exchange Commission (SEC) regarding interim financial reporting. All intercompany balances and transactions have been eliminated in consolidation. Certain information and note disclosures normally included in the financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. As such, the information included in this Quarterly Report on Form 10-Q should be read in conjunction with the consolidated financial statements and accompanying notes included in the Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 17, 2023. |
Use of Estimates | Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates. The Company bases its estimates on historical experience and on various other market-specific and relevant assumptions that the Company believes to be reasonable under the circumstances. Actual results could differ from those estimates. |
Concentrations of Risk | Concentrations of Risk Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash, cash equivalents and investments. The Company’s cash is held by financial institutions in the United States and Ireland. Amounts on deposit may at times exceed federally insured limits. The Company is exposed to credit risk in the event of default by the financial institutions holding its cash, cash equivalents and investments and issuers of investments. The Company manages its credit risk by holding its cash, cash equivalents and investments in large financial institutions within the U.S and Ireland. In addition, the Company’s investment policy limits investments to certain types of instruments such as money market funds, debt securities issued by the U.S. government and its agencies, corporate debt securities, commercial paper as well as asset-backed securities, and places restrictions on the credit ratings, maturities and concentration by type and issuer. The Company has not experienced any losses on its deposits of cash, cash equivalents and |
Foreign Currency Exchange | Foreign Currency Exchange Foreign Currency Transaction Risk The foreign currency transaction risk relates to changes in exchange rates on monetary assets, liabilities, revenues and expenses held at Eiger BioPharmaceuticals Europe Limited . Gains and losses on foreign currency transactions result primarily from monetary assets, liabilities, revenues and expenses denominated in Euro. Aggregated transaction losses for the three and nine months ended September 30, 2023 were $0.2 million and $0.1 million, respectively . The Company expects the foreign currency gain/loss to continue to fluctuate as long as the Company continue to hold monetary assets and liabilities at its subsidiaries in Ireland and England and Wales. Market uncertainty could potentially lead to significant volatility with foreign currency exchange rates, which could result in additional foreign currency gain/loss. Foreign Currency Translation Risk The foreign currency translation risk relates to the translation of the foreign consolidated subsidiaries' assets, liabilities, revenues and expenses from the subsidiaries’ functional currency to the U.S. dollar at each reporting date. Fluctuations in exchange rates may impact the amount of assets, liabilities, revenues and expenses reported on the consolidated balance sheets and consolidated statements of operations. The financial statements of the Company’s foreign subsidiaries, which have a functional currency other than the U.S. dollar, are translated into U.S. dollars using a current exchange rate. Gains and losses resulting from this translation are recognized as a foreign currency translation adjustment within accumulated other comprehensive loss, which is a component of stockholders' (deficit) equity and comprehensive income (loss). Aggregate translation gain, net of tax, was $52,000 and $27,000 for the three months and nine months ended September 30, 2023 , respectively. There were no translation gains or losses for the three and nine months ended September 30, 2022. |
Debt Securities | Debt Securities All securities are short-term in nature and consist of debt securities classified as available-for-sale and have maturities greater than 90 days, but less than 365 days from the date of acquisition. The Company’s debt securities consist of available-for-sale securities that are classified as Level 2 because their value is based on valuations using significant inputs derived from, or corroborated by, observable market data. The Company evaluates, on a quarterly basis, its available-for-sale debt securities for potential impairment. For available-for-sale debt securities in an unrealized loss position, the Company assesses whether such declines are due to credit related factors such as changes to the rating of the security by a ratings agency, market conditions and supportable forecasts of economic and market conditions, among others. If the fair value of available-for-sale debt securities is less than the amortized cost basis, the Company assesses whether it has plans to sell the security or it is more likely than not it will be required to sell any available-for-sale debt security before recovery of its amortized cost basis. If either condition is met, the security’s amortized cost basis is written down to fair value and is recognized through other (expense) income, net. If neither condition is met, declines as a result of credit losses, if any, are recognized as an allowance for credit loss, limited to the amount of unrealized loss, through other (expense) income, net. Any portion of the unrealized loss that is not a result of a credit loss, is recognized in other comprehensive loss. The cost of available-for-sale securities sold is based on the specific-identification method . Realized gains and losses on the sale of debt securities are determined using the specific-identification method and recorded in other (expense) income, net. |
Accounts Receivable | Accounts Receivable Accounts receivable represent amounts billed to the Company’s customers, net of an allowance for credit losses. Trade accounts receivable are recorded at invoiced amounts and do not bear interest. The allowance for credit losses reflects the Company’s best estimate of probable losses inherent in the receivable portfolio determined based on various factors, |
Recent Adopted Accounting Pronouncements | Recent Adopted Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Updates (ASU) No. 2016-13, Financial Instruments—Credit Losses (Topic 326) . ASU 2016-13 requires an entity to utilize a new impairment model that requires measurement and recognition of expected credit losses for most financial assets and certain other instruments, including but not limited to available-for-sale debt securities. Credit losses relating to available-for-sale debt securities will be recorded through an allowance for credit losses rather than as a direct write-down to the security. The new guidance requires the use of forward-looking expected credit loss models based on historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount, which may result in earlier recognition of credit losses under the new guidance. In April 2019, the FASB issued ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments – Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, which clarifies and corrects certain unintended applications of the guidance contained in each of the amended Topics. Additionally, in May 2019, the FASB issued ASU No. 2019-05, Financial Instruments – Credit Losses (Topic 326), which provides an option to irrevocably elect to measure certain individual financial assets at fair value instead of amortized cost. In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) , which deferred the effective date for ASU No. 2016-13 for smaller reporting companies to fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The Company adopted this guidance on a modified-retrospective basis effective January 1, 2023 and noted no material impact to the Company’s condensed consolidated financial statements. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Estimated Value of Cash Equivalents and Debt Securities and Gross Unrealized Holding Gains and Losses | The following tables present the fair value hierarchy for assets and liabilities measured at fair value, and summarize the estimated value of the Company’s cash equivalents and debt securities and the gross unrealized holding gains and losses (in thousands): September 30, 2023 Level Amortized cost Unrealized gain Unrealized loss Estimated Fair Cash equivalents: Money market funds 1 $ 9,553 $ — $ — $ 9,553 Total cash equivalents $ 9,553 $ — $ — $ 9,553 Debt securities: U.S. government bonds 2 $ 11,934 $ — $ (14) $ 11,920 Total debt securities $ 11,934 $ — $ (14) $ 11,920 Classified as: Cash equivalents 1 $ 9,553 Short-term debt securities 2 11,920 $ 21,473 December 31, 2022 Level Amortized cost Unrealized gain Unrealized loss Estimated Fair Cash equivalents: Money market funds 1 $ 11,546 $ — $ — $ 11,546 Commercial paper 2 3,968 — — 3,968 Total cash equivalents $ 15,514 $ — $ — $ 15,514 Debt securities: U.S. government bonds 2 $ 39,646 $ 3 $ (86) $ 39,563 Corporate debt securities 2 28,759 — (117) 28,642 Commercial paper 2 4,945 — — 4,945 Total debt securities $ 73,350 $ 3 $ (203) $ 73,150 Classified as: Cash equivalents 1 & 2 $ 15,514 Short-term debt securities 2 73,150 $ 88,664 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Inventory | Inventories consist of the following (in thousands): September 30, December 31, Raw materials $ 517 $ 1,703 Work-in-progress 494 884 Finished goods 94 266 Total inventories, net $ 1,105 $ 2,853 |
Schedule of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consist of the following (in thousands): September 30, December 31, Short term deposits $ 5,006 $ 4,542 Prepaid research costs 3,751 2,822 Prepaid contract manufacturing costs 1,659 3,542 Prepaid insurance 604 586 Prepaid marketing 122 753 Other 1,635 1,740 Total prepaid expenses and other current assets $ 12,777 $ 13,985 |
Schedule of Components of Accrued Liabilities | Accrued liabilities consist of the following (in thousands): September 30, December 31, Compensation and related benefits $ 3,600 $ 6,167 Contract research costs 3,688 4,188 Product revenue reserves 2,334 1,373 Contract manufacturing costs 922 2,101 Legal fees 187 562 Other 730 1,264 Total accrued liabilities $ 11,461 $ 15,655 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Long-Term Debt and Unamortized Discount Balances | Debt and unamortized discount balances are as follows (in thousands): September 30, December 31, Face value of debt $ 41,218 $ 40,531 Exit fee 2,600 2,600 Unamortized debt discount associated with exit fee, debt issuance costs and loan origination fees (3,084) (3,506) Total debt, net $ 40,734 $ 39,625 |
Common Stock (Tables)
Common Stock (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Common Stock Reserved For Future Issuances | The Company had reserved shares of common stock for issuance as follows: September 30, December 31, Options issued and outstanding 7,335,274 6,143,183 Options available for future grants 3,359,214 1,976,460 Restricted and performance stock units outstanding 219,562 641,407 Shares available for issuance under ESPP 736,371 788,057 Shares available for issuance under 2021 Inducement Plan 702,600 380,000 Total 12,353,021 9,929,107 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Non-cash Stock Based Compensation Expense | Total stock-based compensation expense recognized was as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Research and development $ 650 $ 856 $ 2,001 $ 2,301 Selling, general and administrative 388 1,366 2,324 4,176 Total $ 1,038 $ 2,222 $ 4,325 $ 6,477 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Schedule of Maturity of Operating Leases Liabilities and Future Minimum Lease Payments | The maturities of the Company’s operating lease liabilities as of September 30, 2023 were as follows (in thousands): Undiscounted lease payments September 30, 2023 Remaining in 2023 $ 124 2024 84 2025 1 Total undiscounted payments 209 Less: imputed interest 4 Present value of future lease payments 205 Less: current portion of operating lease liabilities 205 Operating lease liabilities $ — |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Potentially Dilutive Shares Excluded from Computation of Diluted Net Loss Per Share | The following table sets forth the outstanding potentially dilutive securities which have been excluded in the calculation of diluted net loss per share because including such securities would be anti-dilutive (in common stock equivalent shares): Three Months Ended Nine Months Ended 2023 2022 2023 2022 Options to purchase common stock 7,335,274 6,876,679 7,335,274 6,876,679 Restricted and Performance stock units (unvested) 219,562 753,356 219,562 753,356 ESPP 252,922 85,110 252,922 85,110 Total 7,807,758 7,715,145 7,807,758 7,715,145 |
Description of Business - Addit
Description of Business - Additional Information (Detail) $ in Thousands | 9 Months Ended | ||
Sep. 30, 2023 USD ($) segment | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Number of operating segments | segment | 1 | ||
Cash, cash equivalents and short-term investments | $ 39,400 | ||
Cash and cash equivalents | 27,501 | $ 25,798 | |
Debt securities, available-for-sale | 11,900 | ||
Accumulated deficit | 498,702 | $ 437,193 | |
Net cash used in operating activities | $ 60,594 | $ 60,763 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Product Information [Line Items] | |||||||
Aggregated transaction gains (losses) | $ (200,000) | $ (100,000) | |||||
Foreign currency translation adjustment | 52,000 | $ 13,000 | $ (37,000) | $ 0 | 27,000 | $ 0 | |
Accounts receivable, allowance for doubtful accounts | 0 | 0 | $ 0 | ||||
Bad debt expense | $ 0 | $ 0 | $ 0 | $ 0 | |||
Customer A | Financing Receivable | Customer Concentration Risk | |||||||
Product Information [Line Items] | |||||||
Concentration risk | 58% | 58% | |||||
Customer A | Revenue Benchmark | Customer Concentration Risk | |||||||
Product Information [Line Items] | |||||||
Concentration risk | 74% | 99% | 76% | 100% | |||
Customer B | Financing Receivable | Customer Concentration Risk | |||||||
Product Information [Line Items] | |||||||
Concentration risk | 39% | 42% | |||||
Customer B | Revenue Benchmark | Customer Concentration Risk | |||||||
Product Information [Line Items] | |||||||
Concentration risk | 26% | 23% |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Financial liabilities | $ 0 | $ 0 | $ 0 |
Allowance for credit loss, not previously recorded | 0 | 0 | |
Allowance for expected credit losses | 0 | 0 | |
Unrealized loss | 14,000 | 14,000 | |
Unrealized loss position for more than 12 months | $ 0 | 0 | |
Fair Value, Inputs, Level 3 | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Transfers in or out of level 3 | $ 0 | $ 0 |
Fair Value Measurements - Estim
Fair Value Measurements - Estimated Value of Cash Equivalents and Debt Securities and Gross Unrealized Holding Gains and Losses (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Cash Equivalents and Investment Securities [Line Items] | ||
Cash equivalents, amortized cost | $ 9,553 | $ 15,514 |
Cash equivalents, estimated fair value | 9,553 | 15,514 |
Debt securities, amortized cost | 11,934 | 73,350 |
Debt securities, unrealized gain | 0 | 3 |
Unrealized loss | (14) | (203) |
Debt securities, estimated fair value | 11,920 | 73,150 |
Assets, fair value | 21,473 | 88,664 |
Commercial paper | Level 2 | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Debt securities, amortized cost | 4,945 | |
Debt securities, unrealized gain | 0 | |
Unrealized loss | 0 | |
Debt securities, estimated fair value | 4,945 | |
U.S. government bonds | Level 2 | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Debt securities, amortized cost | 11,934 | 39,646 |
Debt securities, unrealized gain | 0 | 3 |
Unrealized loss | (14) | (86) |
Debt securities, estimated fair value | 11,920 | 39,563 |
Corporate debt securities | Level 2 | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Debt securities, amortized cost | 28,759 | |
Debt securities, unrealized gain | 0 | |
Unrealized loss | (117) | |
Debt securities, estimated fair value | 28,642 | |
Short-term debt securities | Level 2 | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Debt securities, estimated fair value | 11,920 | 73,150 |
Money market funds | Level 1 | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Cash equivalents, amortized cost | 9,553 | 11,546 |
Cash equivalents, estimated fair value | 9,553 | 11,546 |
Cash equivalents | Level 1 | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Cash equivalents, estimated fair value | $ 9,553 | |
Cash equivalents | Level 1 and 2 | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Cash equivalents, estimated fair value | 15,514 | |
Commercial paper | Level 2 | ||
Cash Equivalents and Investment Securities [Line Items] | ||
Cash equivalents, amortized cost | 3,968 | |
Cash equivalents, estimated fair value | $ 3,968 |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Balance Sheet Related Disclosures [Abstract] | ||
Raw materials | $ 517 | $ 1,703 |
Work-in-progress | 494 | 884 |
Finished goods | 94 | 266 |
Total inventories, net | $ 1,105 | $ 2,853 |
Balance Sheet Components - Narr
Balance Sheet Components - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | ||||
Inventory write down | $ 0 | $ 1,000 | $ 11 | $ 1,043 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Prepaid Expenses and Other Current Assets (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Balance Sheet Related Disclosures [Abstract] | ||
Short term deposits | $ 5,006 | $ 4,542 |
Prepaid research costs | 3,751 | 2,822 |
Prepaid contract manufacturing costs | 1,659 | 3,542 |
Prepaid insurance | 604 | 586 |
Prepaid marketing | 122 | 753 |
Other | 1,635 | 1,740 |
Total prepaid expenses and other current assets | $ 12,777 | $ 13,985 |
Balance Sheet Components - Sc_3
Balance Sheet Components - Schedule of Components of Accrued Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Balance Sheet Related Disclosures [Abstract] | ||
Compensation and related benefits | $ 3,600 | $ 6,167 |
Contract research costs | 3,688 | 4,188 |
Product revenue reserves | 2,334 | 1,373 |
Contract manufacturing costs | 922 | 2,101 |
Legal fees | 187 | 562 |
Other | 730 | 1,264 |
Total accrued liabilities | $ 11,461 | $ 15,655 |
Bristol-Meyers Squibb License_2
Bristol-Meyers Squibb License Agreement - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | ||
Mar. 31, 2022 | Apr. 30, 2016 | Jun. 30, 2022 | Mar. 31, 2022 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Value of common stock issued during period | $ 20,564 | $ 45,610 | ||
Common Stock | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Issuance of common stock (in shares) | 2,686,288 | 5,841,786 | ||
Value of common stock issued during period | $ 2 | $ 6 | ||
Licensing Agreements | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Up front cash payments | $ 2,000 | |||
BMS Transaction | Common Stock | Purchase Agreement | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Issuance of common stock (in shares) | 157,587 | |||
Value of common stock issued during period | $ 3,200 | |||
BMS Transaction | Licensing Agreements | Development And Regulatory Milestones | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Milestone obligations | 61,000 | |||
BMS Transaction | Licensing Agreements | Commercial Sales | Maximum | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Milestone obligations | 128,000 | |||
BMS Transaction | Licensing Agreements | Development Phase Two | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Milestone obligations | $ 3,000 | |||
BMS Transaction | Licensing Agreements | Development Phase Three | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Milestone obligations | $ 5,000 |
Debt - Additional Information (
Debt - Additional Information (Detail) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Jun. 01, 2022 USD ($) tranche $ / shares shares | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Jun. 30, 2022 USD ($) tranche | Mar. 31, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Debt Instrument [Line Items] | ||||||||
Face value of term loan | $ 41,218 | $ 41,218 | $ 40,531 | |||||
Interest expense | 1,412 | $ 1,092 | 4,040 | $ 2,912 | ||||
Issuance of common stock upon offering at-the-market, net of $1,288 of commissions | $ 20,564 | $ 45,610 | ||||||
Loss on extinguishment of debt | 0 | 1,144 | ||||||
Line of Credit | Secured Debt | Innovatus Stock Purchase Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Issuance of common stock upon offering at-the-market, net of $1,288 of commissions | $ 5,000 | |||||||
Sale of common stock, shares issued (in shares) | shares | 749,053 | |||||||
Sale of common stock (in USD per share) | $ / shares | $ 6.6751 | |||||||
Line of Credit | Innovatus Loan | Secured Debt | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan agreement, aggregate borrowing capacity | $ 75,000 | |||||||
Number of tranches | tranche | 3 | |||||||
Debt Instrument, percent of interest due (in percent) | 0.0225 | |||||||
Interest due timeframe | 3 years | |||||||
Percentage of exit fee on principal balance | 6.50% | |||||||
Minimum cash balance of face value of loan (in percent) | 0.05 | |||||||
Debt instrument, penalty percentage | 5% | |||||||
Debt discount | $ 200 | |||||||
Capitalized debt issuance costs | $ 1,100 | |||||||
Interest expense | 1,400 | $ 4,000 | ||||||
Effective interest rate | 13.84% | |||||||
Line of Credit | Innovatus Loan | Secured Debt | Minimum | ||||||||
Debt Instrument [Line Items] | ||||||||
Prepayment fee | 3% | |||||||
Line of Credit | Innovatus Loan | Secured Debt | Maximum | ||||||||
Debt Instrument [Line Items] | ||||||||
Prepayment fee | 0% | |||||||
Line of Credit | Innovatus Loan | Secured Debt | Variable Rate Component One | Minimum | ||||||||
Debt Instrument [Line Items] | ||||||||
Minimum prime rate | 3.50% | |||||||
Line of Credit | Innovatus Loan | Secured Debt | Variable Rate Component Two | ||||||||
Debt Instrument [Line Items] | ||||||||
Minimum prime rate | 3.75% | |||||||
Line of Credit | Innovatus Loan | Secured Debt, Tranche A | ||||||||
Debt Instrument [Line Items] | ||||||||
Face value of term loan | 40,000 | |||||||
Line of Credit | Innovatus Loan | Secured Debt, Tranche B | ||||||||
Debt Instrument [Line Items] | ||||||||
Face value of term loan | $ 17,500 | $ 17,500 | $ 17,500 | |||||
Line of Credit | Innovatus Loan | Secured Debt, Tranche B And C | ||||||||
Debt Instrument [Line Items] | ||||||||
Number of tranches | tranche | 2 | |||||||
Face value of term loan | $ 35,000 | |||||||
Line of Credit | Oxford Loan | Secured Debt | ||||||||
Debt Instrument [Line Items] | ||||||||
Face value of term loan | $ 33,500 | |||||||
Line of Credit | Amended Oxford Loan | Amended Tranche A | ||||||||
Debt Instrument [Line Items] | ||||||||
Loan agreement, aggregate borrowing capacity | 30,000 | |||||||
Accrued and unpaid interest | 200 | |||||||
Other final payments | 3,300 | |||||||
Repayments of loan agreement exit fee | $ 33,500 | |||||||
Loss on extinguishment of debt | $ 1,100 |
Debt - Schedule of Long-Term De
Debt - Schedule of Long-Term Debt and Unamortized Discount Balances (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Debt Disclosure [Abstract] | ||
Face value of debt | $ 41,218 | $ 40,531 |
Exit fee | 2,600 | 2,600 |
Unamortized debt discount associated with exit fee, debt issuance costs and loan origination fees | (3,084) | (3,506) |
Total debt, net | $ 40,734 | $ 39,625 |
Common Stock (Details)
Common Stock (Details) - shares | Sep. 30, 2023 | Dec. 31, 2022 |
Share-Based Payment Arrangement [Abstract] | ||
Options issued and outstanding (in shares) | 7,335,274 | 6,143,183 |
Options available for future grants (in shares) | 3,359,214 | 1,976,460 |
Restricted and performance stock units outstanding (in shares) | 219,562 | 641,407 |
Shares available for issuance under ESPP (in shares) | 736,371 | 788,057 |
Shares available for issuance under 2021 Inducement Plan (in shares) | 702,600 | 380,000 |
Total (in shares) | 12,353,021 | 9,929,107 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 USD ($) shares | Sep. 30, 2023 USD ($) shares | Sep. 30, 2022 USD ($) | Feb. 06, 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total unrecognized compensation expense | $ | $ 6.2 | $ 6.2 | ||
Weighted-average period for recognition (in years) | 2 years 8 months 12 days | |||
Former CEO | Unvested Stock Options, Performance-Based Restricted Stock Units, And Time-Based RSUs | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Accelerated vesting | 0.50 | |||
Stock compensation recognized (reversed) | $ | $ 0 | $ 0.9 | ||
Restated 2013 Plan | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Number of shares available to be issued (in shares) | shares | 3,359,214 | 3,359,214 | ||
Inducement Plan 2021 | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Number of shares available to be issued (in shares) | shares | 702,600 | 702,600 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Non-cash Stock Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total | $ 1,038 | $ 2,222 | $ 4,325 | $ 6,477 |
Research and development | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total | 650 | 856 | 2,001 | 2,301 |
Selling, general and administrative | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total | $ 388 | $ 1,366 | $ 2,324 | $ 4,176 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | ||||
Provision for income taxes | $ 0 | $ 0 | $ 4,000 | $ 26,000 |
Effective tax rate | (0.01%) | (0.04%) |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Feb. 28, 2023 | Dec. 31, 2022 | Nov. 15, 2022 claim | Oct. 31, 2017 USD ($) ft² | |
Other Commitments [Line Items] | ||||||||
Rent expense recognized for company's operating leases | $ 100 | $ 100 | $ 400 | $ 400 | ||||
Variable lease payments for operating leases | $ 23 | $ 23 | 100 | 100 | ||||
Operating cash outflows for operating lease liabilities | $ 400 | $ 500 | ||||||
Weighted-average remaining lease term (in years) | 4 months 24 days | 4 months 24 days | 1 year 2 months 12 days | |||||
Weighted-average discount rate (in percent) | 12.81% | 12.81% | 12.82% | |||||
Number of claims | claim | 2 | |||||||
Palo Alto, California | ||||||||
Other Commitments [Line Items] | ||||||||
Total leased space | ft² | 8,029 | |||||||
Lease renewal term | 1 year | 3 years | ||||||
Renewal extension term | 1 year | |||||||
Security deposit | $ 300 |
Commitments and Contingencies_2
Commitments and Contingencies - Maturity of Operating Leases Liabilities and Future Minimum Lease Payments (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
Remaining in 2023 | $ 124 | |
2024 | 84 | |
2025 | 1 | |
Total undiscounted payments | 209 | |
Less: imputed interest | 4 | |
Present value of future lease payments | 205 | |
Less: current portion of operating lease liabilities | 205 | $ 491 |
Operating lease liabilities | $ 0 | $ 83 |
Net Loss Per Share - Summary of
Net Loss Per Share - Summary of Potentially Dilutive Shares Excluded from Computation of Diluted Net (Loss) Income Per Share (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities | 7,807,758 | 7,715,145 | 7,807,758 | 7,715,145 |
Options to purchase common stock | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities | 7,335,274 | 6,876,679 | 7,335,274 | 6,876,679 |
Restricted and Performance stock units (unvested) | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities | 219,562 | 753,356 | 219,562 | 753,356 |
ESPP | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities | 252,922 | 85,110 | 252,922 | 85,110 |