Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 01, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Interactive Data Current | Yes | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2022 | |
Document Period End Date | Jun. 30, 2022 | |
Document Fiscal Period Focus | Q2 | |
Entity Registrant Name | MADRIGAL PHARMACEUTICALS, INC. | |
Entity Central Index Key | 0001157601 | |
Entity File Number | 001-33277 | |
Current Fiscal Year End Date | --12-31 | |
Entity Tax Identification Number | 04-3508648 | |
Entity Incorporation, State or Country Code | DE | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Emerging Growth Company | false | |
Entity Small Business | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 17,103,395 | |
City Area Code | 267 | |
Local Phone Number | 824-2827 | |
Trading Symbol | MDGL | |
Security Exchange Name | NASDAQ | |
Title of 12(b) Security | Common Stock, $0.0001 Par Value Per Share | |
Entity Address, Address Line One | Four Tower Bridge | |
Entity Address, Address Line Two | 200 Barr Harbor Drive, Suite 200 | |
Entity Address, City or Town | West Conshohocken | |
Entity Address, Postal Zip Code | 19428 | |
Entity Address, State or Province | PA |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 53,272 | $ 36,269 |
Marketable securities | 158,494 | 234,077 |
Prepaid expenses and other current assets | 2,780 | 1,338 |
Total current assets | 214,546 | 271,684 |
Property and equipment, net | 789 | 851 |
Right-of-use asset | 1,057 | 797 |
Total assets | 216,392 | 273,332 |
Current liabilities: | ||
Accounts payable | 11,294 | 21,380 |
Accrued expenses | 71,836 | 55,048 |
Lease liability | 879 | 410 |
Total current liabilities | 84,009 | 76,838 |
Long term liabilities: | ||
Loan payable, net of discount | 48,670 | 0 |
Lease liability | 178 | 387 |
Total long term liabilities | 48,848 | 387 |
Total liabilities | 132,857 | 77,225 |
Stockholders' equity: | ||
Preferred stock, par value $0.0001 per share authorized: 5,000,000 shares at June 30, 2022 and December 31, 2021; 1,969,797 shares issued and outstanding at June 30, 2022 and December 31, 2021 | ||
Common stock, par value $0.0001 per share authorized: 200,000,000 at June 30, 2022 and December 31, 2021; 17,103,395 shares issued and outstanding at June 30, 2022 and December 31, 2021 | 2 | 2 |
Additional paid-in-capital | 879,538 | 863,495 |
Accumulated other comprehensive loss | (447) | (80) |
Accumulated deficit | (795,558) | (667,310) |
Total stockholders' equity | 83,535 | 196,107 |
Total liabilities and stockholders' equity | $ 216,392 | $ 273,332 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 1,969,797 | 1,969,797 |
Preferred stock, shares outstanding | 1,969,797 | 1,969,797 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 17,103,395 | 17,103,395 |
Common stock, shares outstanding | 17,103,395 | 17,103,395 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2022 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenues: | |||||
Total revenues | |||||
Operating expenses: | |||||
Research and development | 58,499 | 51,632 | 106,428 | 97,402 | |
General and administrative | 11,774 | 10,110 | 21,432 | 17,319 | |
Total operating expenses | 70,273 | 61,742 | 127,860 | 114,721 | |
Loss from operations | (70,273) | (61,742) | (127,860) | (114,721) | |
Interest income | 323 | 91 | 392 | 251 | |
Interest expense | (780) | 0 | (780) | 0 | |
Other income | 0 | 273 | |||
Net loss | $ (70,730) | $ (61,651) | $ (52,546) | $ (128,248) | $ (114,197) |
Net loss per common share: | |||||
Earnings Per Share, Basic | $ (4.14) | $ (3.72) | $ (7.5) | $ (7.05) | |
Earnings Per Share, Diluted | $ (4.14) | $ (3.72) | $ (7.5) | $ (7.05) | |
Weighted Average Number of Shares Outstanding, Basic | 17,103,395 | 16,571,322 | 17,103,395 | 16,207,880 | |
Weighted Average Number of Shares Outstanding, Diluted | 17,103,395 | 16,571,322 | 17,103,395 | 16,207,880 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (70,730) | $ (61,651) | $ (128,248) | $ (114,197) |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on available-for-sale securities | (45) | 29 | (367) | (32) |
Comprehensive loss | $ (70,775) | $ (61,622) | $ (128,615) | $ (114,229) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Preferred Stock | Common stock | Additional paid-in Capital | Accumulated other comprehensive income (loss) | Accumulated deficit |
Balance at Dec. 31, 2020 | $ 239,970 | $ 2 | $ 665,385 | $ 47 | $ (425,464) | |
Balance (in shares) at Dec. 31, 2020 | 1,969,797 | 15,508,146 | ||||
Increase (Decrease) in Stockholders' Equity | ||||||
Issuance of common shares in equity offering, excluding to related parties, net of transaction costs | 66,616 | $ 0 | 66,616 | |||
Issuance of common shares in equity offering, excluding to related parties, net of transaction costs (in shares) | 550,803 | |||||
Sale of common shares to related parties and exercise of common stock options, net of transaction costs | 478 | 478 | ||||
Sale of common shares to related parties and exercise of common stock options, net of transaction costs ( in shares) | 4,250 | |||||
Compensation expense related to stock options for services | 6,096 | 6,096 | ||||
Unrealized gain (loss) on marketable securities | (61) | (61) | ||||
Net loss | (52,546) | (52,546) | ||||
Balance at Mar. 31, 2021 | 260,553 | $ 2 | 738,575 | (14) | (478,010) | |
Balance (in shares) at Mar. 31, 2021 | 1,969,797 | 16,063,199 | ||||
Balance at Dec. 31, 2020 | 239,970 | $ 2 | 665,385 | 47 | (425,464) | |
Balance (in shares) at Dec. 31, 2020 | 1,969,797 | 15,508,146 | ||||
Increase (Decrease) in Stockholders' Equity | ||||||
Unrealized gain (loss) on marketable securities | (32) | |||||
Net loss | (114,197) | |||||
Balance at Jun. 30, 2021 | 270,651 | $ 2 | 810,295 | 15 | (539,661) | |
Balance (in shares) at Jun. 30, 2021 | 1,969,797 | 16,599,522 | ||||
Balance at Mar. 31, 2021 | 260,553 | $ 2 | 738,575 | (14) | (478,010) | |
Balance (in shares) at Mar. 31, 2021 | 1,969,797 | 16,063,199 | ||||
Increase (Decrease) in Stockholders' Equity | ||||||
Issuance of common shares in equity offering, excluding to related parties, net of transaction costs | 63,541 | $ 0 | 63,541 | |||
Issuance of common shares in equity offering, excluding to related parties, net of transaction costs (in shares) | 536,323 | |||||
Compensation expense related to stock options for services | 8,179 | 8,179 | ||||
Unrealized gain (loss) on marketable securities | 29 | 29 | ||||
Net loss | (61,651) | (61,651) | ||||
Balance at Jun. 30, 2021 | 270,651 | $ 2 | 810,295 | 15 | (539,661) | |
Balance (in shares) at Jun. 30, 2021 | 1,969,797 | 16,599,522 | ||||
Balance at Dec. 31, 2021 | $ 196,107 | $ 2 | 863,495 | (80) | (667,310) | |
Balance (in shares) at Dec. 31, 2021 | 17,103,395 | 1,969,797 | 17,103,395 | |||
Increase (Decrease) in Stockholders' Equity | ||||||
Compensation expense related to stock options for services | $ 7,477 | 7,477 | ||||
Unrealized gain (loss) on marketable securities | (322) | (322) | ||||
Net loss | (57,518) | (57,518) | ||||
Balance at Mar. 31, 2022 | 145,744 | $ 2 | 870,972 | (402) | (724,828) | |
Balance (in shares) at Mar. 31, 2022 | 1,969,797 | 17,103,395 | ||||
Balance at Dec. 31, 2021 | $ 196,107 | $ 2 | 863,495 | (80) | (667,310) | |
Balance (in shares) at Dec. 31, 2021 | 17,103,395 | 1,969,797 | 17,103,395 | |||
Increase (Decrease) in Stockholders' Equity | ||||||
Unrealized gain (loss) on marketable securities | $ (367) | |||||
Net loss | (128,248) | |||||
Balance at Jun. 30, 2022 | $ 83,535 | $ 2 | 879,538 | (447) | (795,558) | |
Balance (in shares) at Jun. 30, 2022 | 17,103,395 | 1,969,797 | 17,103,395 | |||
Balance at Mar. 31, 2022 | $ 145,744 | $ 2 | 870,972 | (402) | (724,828) | |
Balance (in shares) at Mar. 31, 2022 | 1,969,797 | 17,103,395 | ||||
Increase (Decrease) in Stockholders' Equity | ||||||
Compensation expense related to stock options for services | 7,944 | 7,944 | ||||
Unrealized gain (loss) on marketable securities | (45) | (45) | ||||
Issuance of warrants | 622 | 622 | ||||
Net loss | (70,730) | (70,730) | ||||
Balance at Jun. 30, 2022 | $ 83,535 | $ 2 | $ 879,538 | $ (447) | $ (795,558) | |
Balance (in shares) at Jun. 30, 2022 | 17,103,395 | 1,969,797 | 17,103,395 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (128,248) | $ (114,197) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 15,421 | 14,275 |
Depreciation and amortization expense | 217 | 202 |
Amortization of debt issuance costs and discount | 178 | 0 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (1,442) | (1,208) |
Accounts payable | (10,086) | 50 |
Accrued expense | 16,788 | 10,018 |
Accrued interest, net of interest received on maturity of investments | (101) | 550 |
Net cash used in operating activities | (107,273) | (90,310) |
Cash flows from investing activities: | ||
Purchases of marketable securities | (116,496) | (224,071) |
Sales and maturities of marketable securities | 191,813 | 163,328 |
Purchases of property and equipment, net of disposals | (155) | (46) |
Net cash provided by (used in) investing activities | 75,162 | (60,789) |
Cash flows from financing activities: | ||
Proceeds from issuances of stock, excluding related parties, net of transaction costs | 0 | 130,157 |
Proceeds from the exercise of common stock options | 0 | 478 |
Proceeds from issuance of loan payable | 50,000 | 0 |
Payment of debt issuance costs | (886) | 0 |
Net cash provided by financing activities | 49,114 | 130,635 |
Net increase (decrease) in cash and cash equivalents | 17,003 | (20,464) |
Cash and cash equivalents at beginning of period | 36,269 | 54,004 |
Cash and cash equivalents at end of period | 53,272 | 33,540 |
Supplemental disclosure of cash flow information: | ||
Obtaining a right-of-use asset in exchange for a lease liability | $ 583 | $ 376 |
Organization, Business and Basi
Organization, Business and Basis of Presentation | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization, Business and Basis of Presentation | 1. Organization, Business, and Basis of Presentation Organization and Business Madrigal Pharmaceuticals, Inc. (the “Company” or “Madrigal”) is a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), a liver disease with high unmet medical need. Madrigal’s lead candidate, resmetirom, is a once daily, oral, thyroid hormone receptor (THR)-ß selective agonist designed to target key underlying causes of NASH in the liver. Resmetirom is currently being evaluated in two Phase 3 clinical studies (MAESTRO-NASH and MAESTRO-NAFLD-1) MAESTRO-NAFLD-1 Basis of Presentation Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) have been condensed or omitted. Accordingly, the unaudited condensed consolidated financial statements do not include all information and footnotes required by GAAP for complete annual financial statements. However, we believe that the disclosures included in these financial statements are adequate to make the information presented not misleading. The unaudited condensed consolidated financial statements, in the opinion of management, reflect all adjustments, which include normal recurring adjustments, necessary for a fair statement of such interim results. The interim results are not necessarily indicative of the results that we will have for the full year ending December 31, 2022 or any subsequent period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes to those statements for the year ended December 31, 2021. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Principle of Consolidation The consolidated financial statements include the financial statements of the Company and its wholly owned subsidiaries. All significant intercompany balances have been eliminated in consolidation. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect certain reported amounts of assets and liabilities, and the reported amounts of revenues and expenses during the reporting periods. The Company bases its estimates on historical experience and various other assumptions that management believes to be reasonable under the circumstances. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates. Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. The Company maintains its cash in bank accounts, the balance of which, at times, exceeds Federal Deposit Insurance Corporation insured limits. The primary objective of the Company’s investment activities is to preserve its capital for the purpose of funding operations and the Company does not enter into investments for trading or speculative purposes. The Company’s cash is deposited in highly rated financial institutions in the United States. The Company invests in money market funds and high-grade, commercial paper and corporate bonds, which management believes are subject to minimal credit and market risk. Marketable Securities Marketable securities consist of investments in high-grade corporate obligations and government and government agency obligations that are classified as available-for-sale. The Company adjusts the cost of available-for-sale available-for-sale Marketable securities are stated at fair value, including accrued interest, with their unrealized gains and losses included as a component of accumulated other comprehensive income or loss, which is a separate component of stockholders’ equity. The fair value of these securities is based on quoted prices and observable inputs on a recurring basis. Realized gains and losses are determined on the specific identification method. During the six months ended June 30, 2022 and 2021, the Company did not have any realized gains or losses on marketable securities. Fair Value of Financial Instruments The carrying amounts of the Company’s financial instruments, which include cash equivalents and marketable securities, approximate their fair values. The fair value of the Company’s financial instruments reflects the amounts that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value hierarchy has the following three levels: Level 1—quoted prices in active markets for identical assets and liabilities. Level 2—observable inputs other than Level 1 inputs. Examples of Level 2 inputs include quoted prices in active markets for similar assets or liabilities and quoted prices for identical assets or liabilities in markets that are not active. Level 3—unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability. Financial assets and liabilities are classified in their entirety within the fair value hierarchy based on the lowest level of input that is significant to the fair value measurement. The Company measures the fair value of its marketable securities by taking into consideration valuations obtained from third- party pricing sources. The pricing services utilize industry standard valuation models, including both income and market based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker-dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities and other observable inputs. As of June 30, 2022, the Company’s financial assets valued based on Level 1 inputs consisted of cash and cash equivalents in a money market fund, its financial assets valued based on Level 2 inputs consisted of high-grade corporate and government agency bonds and commercial paper, and it had no financial assets valued based on Level 3 inputs. During the six months ended June 30, 2022 and 2021, the Company did not have any transfers of financial assets between Levels 1 and 2. As of June 30, 2022 and December 31, 2021, the Company did not have any financial liabilities that were recorded at fair value on a recurring basis on the balance sheet. Research and Development Costs Research and development costs are expensed as incurred. Research and development costs are comprised of costs incurred in performing research and development activities, including internal costs (including stock-based compensation), costs for consultants, milestone payments under licensing agreements, and other costs associated with the Company’s preclinical and clinical programs. In particular, the Company has conducted safety studies in animals, optimized and implemented the manufacturing of our drug, and conducted Phase 1-3 Patents Costs to secure and defend patents are expensed as incurred and are classified as general and administrative expense in the Company’s consolidated statements of operations. Stock-Based Compensation The Company recognizes stock-based compensation expense based on the grant date fair value of stock options granted to employees, officers, and directors. The Company uses the Black-Scholes option pricing model to determine the grant date fair value as management believes it is the most appropriate valuation method for its option grants. The Black-Scholes model requires inputs for risk-free interest rate, dividend yield, volatility and expected lives of the options. The expected lives for options granted represent the period of time that options granted are expected to be outstanding. The Company uses the simplified method for determining the expected lives of options. Expected volatility is based upon an industry estimate or blended rate including the Company’s historical trading activity. The risk-free rate for periods within the expected life of the option is based on the U.S. Treasury yield curve in effect at the time of the grant. The Company estimates the forfeiture rate based on historical data. This analysis is re-evaluated Certain of the employee stock options granted by the Company are structured to qualify as incentive stock options (“ISOs”). Under current tax regulations, the Company does not receive a tax deduction for the issuance, exercise or disposition of ISOs if the employee meets certain holding requirements. If the employee does not meet the holding requirements, a disqualifying disposition occurs, at which time the Company may receive a tax deduction. The Company does not record tax benefits related to ISOs unless and until a disqualifying disposition is reported. In the event of a disqualifying disposition, the entire tax benefit is recorded as a reduction of income tax expense. The Company has not recognized any income tax benefit for its share-based compensation arrangements due to the fact that the Company does not believe it is more likely than not it will realize the related deferred tax assets. Income Taxes The Company uses the asset and liability method to account for income taxes. Deferred tax assets and liabilities are determined based on the expected future tax consequences of temporary differences between the Company’s financial statement carrying amounts and the tax basis of assets and liabilities using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. The Company currently maintains a 100% valuation allowance on its deferred tax assets. Comprehensive Loss Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner Basic and Diluted Loss Per Common Share Basic net loss per share is computed using the weighted average number of common shares outstanding during the period, excluding any restricted stock that has been issued but is not yet vested. Diluted net loss per common share is computed using the weighted average number of common shares outstanding and the weighted average dilutive potential common shares outstanding using the treasury stock method. However, for the six months ended June 30, 2022 and 2021, diluted net loss per share is the same as basic net loss per share because the inclusion of weighted average shares of unvested restricted common stock, common stock issuable upon the exercise of stock options, and common stock issuable upon the conversion of preferred stock would be anti-dilutive. The following table summarizes outstanding securities not included in the computation of diluted net loss per common share, as their inclusion would be anti-dilutive: Six Months Ended June 30, 2022 2021 Common stock options 2,976,545 2,268,787 Preferred stock 1,969,797 1,969,797 Warrants 14,899 — Recent Accounting Pronouncements None |
Liquidity and Uncertainties
Liquidity and Uncertainties | 6 Months Ended |
Jun. 30, 2022 | |
Liquidity and Uncertainties | |
Liquidity and Uncertainties | 3. Liquidity and Uncertainties The Company is subject to risks common to development stage companies in the biopharmaceutical industry including, but not limited to, uncertainty of product development and commercialization, dependence on key personnel, uncertainty of market acceptance of products and product reimbursement, product liability, uncertain protection of proprietary technology, potential inability to raise additional financing necessary for development and commercialization, and compliance with the U.S. Food and Drug Administration (FDA) and other government regulations. The Company has incurred losses since inception, including approximately $128.2 million for the six months ended June 30, 2022, resulting in an accumulated deficit of approximately $795.6 million as of June 30, 2022. Management expects to incur losses for the foreseeable future. To date, the Company has funded its operations primarily through proceeds from sales of the Company’s capital stock. In addition, the Company entered into a Loan and Security Agreement (the “Loan ”) and the several banks and other financial institutions or entities party thereto which provides subject to the Company’s achievement of certain milestones. The million tranche was drawn at closing (see Note 6 – Long Term Debt). The Company believes that its cash, cash equivalents and marketable securities at June 30, 2022 will be sufficient to fund operations past one year from the issuance of these financial statements. To meet its future capital needs, the Company intends to raise additional capital through debt or equity financings, collaborations, partnerships or other strategic transactions. However, there can be no assurance that the Company will be able to complete any such transactions on acceptable terms or otherwise. The inability of the Company to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on the Company’s business, results of operations and financial condition. The Company has the ability to delay certain research activities and related clinical expenses if necessary due to liquidity concerns until a date when those concerns are relieved. |
Cash, Cash Equivalents and Mark
Cash, Cash Equivalents and Marketable Securities | 6 Months Ended |
Jun. 30, 2022 | |
Cash and Cash Equivalents [Abstract] | |
Cash, Cash Equivalents and Marketable Securities | 4. Cash, Cash Equivalents and Marketable Securities A summary of cash, cash equivalents and available-for-sale June 30, 2022 Unrealized Unrealized Fair Cost gains losses Value Cash and cash equivalents: Cash (Level 1) $ 1,728 $ — $ — $ 1,728 Money market funds (Level 1) 37,809 — — 37,809 Corporate debt securities due within 3 months of date of purchase (Level 2) 13,735 — — 13,735 Total cash and cash equivalents 53,272 — — 53,272 Marketable securities: Corporate debt securities due within 1 year of date of purchase (Level 2) 152,923 1 (431 ) 152,493 U.S. government and government sponsored entities due within 1 year of date of purchase (Level 2) 6,018 — (17 ) 6,001 Total cash, cash equivalents and marketable securities $ 212,213 $ 1 $ (448 ) $ 211,766 December 31, 2021 Unrealized Unrealized Fair Cost gains losses Value Cash and cash equivalents: Cash (Level 1) $ 18,877 $ — $ — $ 18,877 Money market funds (Level 1) 17,392 — — 17,392 Total cash and cash equivalents 36,269 — — 36,269 Marketable securities: Corporate debt securities due within 1 year of date of purchase (Level 2) 228,348 6 (66 ) 228,288 Corporate debt securities due within 1 to 2 years of date of purchase (Level 2) 5,809 — (20 ) 5,789 Total cash, cash equivalents and marketable securities $ 270,426 $ 6 $ (86 ) $ 270,346 |
Accrued Liabilities
Accrued Liabilities | 6 Months Ended |
Jun. 30, 2022 | |
Accrued Liabilities, Current [Abstract] | |
Accrued Liabilities | 5. Accrued Liabilities Accrued liabilities as of June 30, 2022 and December 31, 2021 consisted of the following (in thousands): June 30, December 31, 2022 2021 Contract research organization costs $ 57,288 $ 38,349 Other clinical study related costs 4,369 3,957 Compensation and benefits 3,577 6,769 Professional fees 3,959 2,455 Other 2,643 3,518 Total accrued liabilities $ 71,836 $ 55,048 |
Long Term Debt
Long Term Debt | 6 Months Ended |
Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
Long Term Debt | 6. Long Term Debt In May 2022 the Company and its wholly-owned subsidiary, Canticle Pharmaceuticals, Inc., entered into the million Loan Facility with the several banks and other financial institutions or entities party thereto (each, a “Lender” and collectively referred to as the “Lenders”), and Hercules Capital, Inc. (“Hercules”), in its capacity as administrative agent and collateral agent for itself and the Lenders. Under the terms of the Loan Facility, the first million tranche was drawn at closing. The Company may also draw up to an additional million in two separate tranches upon achievement of certain resmetirom clinical and regulatory milestones. A fourth tranche of million may be drawn by the Company, subject to the approval of Hercules. The Loan Facility has a minimum interest rate of 7.45% and adjusts with changes in the prime rate. and if the Company maintains compliance with applicable covenants. The Loan Facility matures in May 2026 and may be extended an additional year upon the achievement of certain clinical and regulatory milestones. The Loan Facility is secured by a security interest in substantially all of the Company’s assets, other than intellectual property. It includes an end of term charge of the aggregate principal amount, which is accounted for in the loan discount. In connection with the first tranche drawn at closing, the Company issued Hercules a warrant to purchase 14,899 shares, which had a Black-Scholes value of $0.6 million. Additional details of the Loan Facility were filed with the Securities and Exchange Commission (“SEC”) on a Current Report on Form 8-K 10-Q. The Loan Facility includes affirmative and restrictive financial covenants commencing on January 1, 2023, including maintenance of a minimum cash, cash equivalents and liquid funds covenant of $35.0 million, which may decrease in certain circumstances if the Company achieves certain clinical milestones and a revenue milestone, and a revenue-based covenant that could apply commencing at or after the time that financial reporting is due for the quarter ending September 30, 2024. The Loan Facility also includes customary covenants associated with a secured loan facility, including covenants concerning financial reporting obligations, and certain limitations on indebtedness, liens (including a negative pledge on intellectual property and other assets), investments, distributions (including dividends), collateral, investments, distributions, transfers, mergers or acquisitions, taxes, corporate changes, and deposit accounts. As of June 30, 2022, the outstanding principal under the Loan Facility was $50.0 million. The interest rate as of June 30, 2022 was 8.70%. As of June 30, 2022, the Company was in compliance with all loan covenants and provisions. Future minimum payments, including interest and principal, under the loans payable outstanding as of June 30, 2022 are as follows (in thousands): Period Ending June 30, 2022: Amount 2022 (remaining six months) $ 2,196 2023 4,410 2024 9,338 Thereafter 50,782 $ 66,726 Less amount representing interest (14,051 ) Less unamortized discount (4,005 ) Loans payable, net of discount $ 48,670 |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2022 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | 7. Stockholders’ Equity Common Stock Each common stockholder generally is entitled to one vote for each share of common stock held, subject to limitations as may be established for certain other classes and series of stock of the Company from time to time. Each share of common stock is entitled to receive dividends, as and when declared by the Company’s board of directors. The Company has never declared cash dividends on its common stock and does not expect to do so in the foreseeable future. Preferred Stock The Company’s Series A Convertible Preferred Stock (“Series A Preferred Stock”) has a par value of $0.0001 per share and is convertible into shares of the Common Stock at a one-to-one winding-up as-if-converted-to-Common-Stock as-converted At-The-Market In November 2020, the Company entered into an at-the-market “at-the-market” Under the 2020 Sales Agreement the Company sold 1,126,733 shares for an aggregate of approximately $137.4 million in gross proceeds, with net proceeds to the Company of approximately $134.8 million after deducting commissions and other transaction costs. Of those shares sold, 1,087,126 were sold in 2021. In June 2021, the Company filed with the SEC and had declared effective a new shelf registration statement on Form S-3 at-the-market at the Company’s option, through Cowen as its sales agent. The 2021 Sales Agreement supersedes the 2020 Sales Agreement. Subject to the terms and conditions of the 2021 Sales Agreement, Cowen will use commercially reasonable efforts consistent with its normal trading and sales practices to sell the common stock based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose). As of June 30, 2022, shares had been sold under the 2021 Sales Agreement for an aggregate of approximately $ million in gross proceeds, with net proceeds to the Company of approximately $ million after deducting commissions and other transaction costs. All of those shares were sold in 2021. As of June 30, 2022, $ million remained reserved and available for sale under the 2021 Sales Agreement and the Company’s related prospectus supplement. |
Stock-based Compensation
Stock-based Compensation | 6 Months Ended |
Jun. 30, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Stock-based Compensation | 8. Stock-based Compensation The Company’s 2015 Stock Plan, as amended, is our primary equity incentive compensation plan through which equity based grants are awarded. The 2015 Stock Plan provides for the grant of incentive stock options, non-statutory The following table summarizes stock option activity during the six months ended June 30, 2022: Shares Weighted Outstanding at January 1, 2022 2,301,574 $ 78.90 Options granted 736,395 83.35 Options cancelled (61,424 ) 100.82 Outstanding at June 30, 2022 2,976,545 $ 79.54 Exercisable at June 30, 2022 1,669,315 $ 69.41 The total cash received by the Company as a result of stock option exercises was $0 million and $0.5 million, respectively, for the six months ended June 30, 2022 and 2021. The total intrinsic value of options exercised was $0 million and $0.1 million, respectively, for the six months ended June 30, 2022 and 2021. The weighted-average grant date fair values, based on the Black-Scholes option model, of options granted during the six months ended June 30, 2022 and 2021 were $55.84 and $78.34, respectively. Stock-Based Compensation Expense Stock-based compensation expense during the six months ended June 30, 2022 and 2021 was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Stock-based compensation expense by type of award: Stock options $ 7,944 $ 8,179 $ 15,421 $ 14,275 Total stock-based compensation expense $ 7,944 $ 8,179 $ 15,421 $ 14,275 Effect of stock-based compensation expense by line item: Research and development $ 3,301 $ 2,860 $ 6,488 $ 5,497 General and administrative 4,643 5,319 8,933 8,778 Total stock-based compensation expense included in net loss $ 7,944 $ 8,179 $ 15,421 $ 14,275 Unrecognized |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. Commitments and Contingencies The Company has a Research, Development and Commercialization Agreement with Hoffmann-La The agreement requires future milestone payments to Roche. Remaining milestones under the agreement total $8 million and are payable upon Madrigal achieving specified objectives related to future regulatory approval in the United States and Europe of resmetirom or a product developed from resmetirom. Furthermore, a tiered single-digit royalty is payable on net sales of resmetirom or a product developed from resmetirom, subject to certain reductions. The Company has not achieved any additional product development or regulatory milestones and had no Licensed Product sales for the six months ended June 30, 2022 and 2021. The Company has entered into customary contractual arrangements and letters of intent in preparation for and in support of the Phase 3 clinical trials. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Principle of Consolidation | Principle of Consolidation The consolidated financial statements include the financial statements of the Company and its wholly owned subsidiaries. All significant intercompany balances have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect certain reported amounts of assets and liabilities, and the reported amounts of revenues and expenses during the reporting periods. The Company bases its estimates on historical experience and various other assumptions that management believes to be reasonable under the circumstances. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. The Company maintains its cash in bank accounts, the balance of which, at times, exceeds Federal Deposit Insurance Corporation insured limits. The primary objective of the Company’s investment activities is to preserve its capital for the purpose of funding operations and the Company does not enter into investments for trading or speculative purposes. The Company’s cash is deposited in highly rated financial institutions in the United States. The Company invests in money market funds and high-grade, commercial paper and corporate bonds, which management believes are subject to minimal credit and market risk. |
Marketable Securities | Marketable Securities Marketable securities consist of investments in high-grade corporate obligations and government and government agency obligations that are classified as available-for-sale. The Company adjusts the cost of available-for-sale available-for-sale Marketable securities are stated at fair value, including accrued interest, with their unrealized gains and losses included as a component of accumulated other comprehensive income or loss, which is a separate component of stockholders’ equity. The fair value of these securities is based on quoted prices and observable inputs on a recurring basis. Realized gains and losses are determined on the specific identification method. During the six months ended June 30, 2022 and 2021, the Company did not have any realized gains or losses on marketable securities. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amounts of the Company’s financial instruments, which include cash equivalents and marketable securities, approximate their fair values. The fair value of the Company’s financial instruments reflects the amounts that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value hierarchy has the following three levels: Level 1—quoted prices in active markets for identical assets and liabilities. Level 2—observable inputs other than Level 1 inputs. Examples of Level 2 inputs include quoted prices in active markets for similar assets or liabilities and quoted prices for identical assets or liabilities in markets that are not active. Level 3—unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability. Financial assets and liabilities are classified in their entirety within the fair value hierarchy based on the lowest level of input that is significant to the fair value measurement. The Company measures the fair value of its marketable securities by taking into consideration valuations obtained from third- party pricing sources. The pricing services utilize industry standard valuation models, including both income and market based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker-dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities and other observable inputs. As of June 30, 2022, the Company’s financial assets valued based on Level 1 inputs consisted of cash and cash equivalents in a money market fund, its financial assets valued based on Level 2 inputs consisted of high-grade corporate and government agency bonds and commercial paper, and it had no financial assets valued based on Level 3 inputs. During the six months ended June 30, 2022 and 2021, the Company did not have any transfers of financial assets between Levels 1 and 2. As of June 30, 2022 and December 31, 2021, the Company did not have any financial liabilities that were recorded at fair value on a recurring basis on the balance sheet. |
Research and Development Costs | Research and Development Costs Research and development costs are expensed as incurred. Research and development costs are comprised of costs incurred in performing research and development activities, including internal costs (including stock-based compensation), costs for consultants, milestone payments under licensing agreements, and other costs associated with the Company’s preclinical and clinical programs. In particular, the Company has conducted safety studies in animals, optimized and implemented the manufacturing of our drug, and conducted Phase 1-3 |
Patents | Patents Costs to secure and defend patents are expensed as incurred and are classified as general and administrative expense in the Company’s consolidated statements of operations. |
Stock-Based Compensation | Stock-Based Compensation The Company recognizes stock-based compensation expense based on the grant date fair value of stock options granted to employees, officers, and directors. The Company uses the Black-Scholes option pricing model to determine the grant date fair value as management believes it is the most appropriate valuation method for its option grants. The Black-Scholes model requires inputs for risk-free interest rate, dividend yield, volatility and expected lives of the options. The expected lives for options granted represent the period of time that options granted are expected to be outstanding. The Company uses the simplified method for determining the expected lives of options. Expected volatility is based upon an industry estimate or blended rate including the Company’s historical trading activity. The risk-free rate for periods within the expected life of the option is based on the U.S. Treasury yield curve in effect at the time of the grant. The Company estimates the forfeiture rate based on historical data. This analysis is re-evaluated Certain of the employee stock options granted by the Company are structured to qualify as incentive stock options (“ISOs”). Under current tax regulations, the Company does not receive a tax deduction for the issuance, exercise or disposition of ISOs if the employee meets certain holding requirements. If the employee does not meet the holding requirements, a disqualifying disposition occurs, at which time the Company may receive a tax deduction. The Company does not record tax benefits related to ISOs unless and until a disqualifying disposition is reported. In the event of a disqualifying disposition, the entire tax benefit is recorded as a reduction of income tax expense. The Company has not recognized any income tax benefit for its share-based compensation arrangements due to the fact that the Company does not believe it is more likely than not it will realize the related deferred tax assets. |
Income Taxes | Income Taxes The Company uses the asset and liability method to account for income taxes. Deferred tax assets and liabilities are determined based on the expected future tax consequences of temporary differences between the Company’s financial statement carrying amounts and the tax basis of assets and liabilities using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. The Company currently maintains a 100% valuation allowance on its deferred tax assets. |
Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner |
Basic and Diluted Loss Per Common Share | Basic and Diluted Loss Per Common Share Basic net loss per share is computed using the weighted average number of common shares outstanding during the period, excluding any restricted stock that has been issued but is not yet vested. Diluted net loss per common share is computed using the weighted average number of common shares outstanding and the weighted average dilutive potential common shares outstanding using the treasury stock method. However, for the six months ended June 30, 2022 and 2021, diluted net loss per share is the same as basic net loss per share because the inclusion of weighted average shares of unvested restricted common stock, common stock issuable upon the exercise of stock options, and common stock issuable upon the conversion of preferred stock would be anti-dilutive. The following table summarizes outstanding securities not included in the computation of diluted net loss per common share, as their inclusion would be anti-dilutive: Six Months Ended June 30, 2022 2021 Common stock options 2,976,545 2,268,787 Preferred stock 1,969,797 1,969,797 Warrants 14,899 — |
Recent Accounting Pronouncements | Recent Accounting Pronouncements None |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of the outstanding securities not included in the computation of diluted net loss per common share as their inclusion would be anti-dilutive | The following table summarizes outstanding securities not included in the computation of diluted net loss per common share, as their inclusion would be anti-dilutive: Six Months Ended June 30, 2022 2021 Common stock options 2,976,545 2,268,787 Preferred stock 1,969,797 1,969,797 Warrants 14,899 — |
Cash, Cash Equivalents and Ma_2
Cash, Cash Equivalents and Marketable Securities (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Cash and Cash Equivalents [Abstract] | |
Summary of cash, cash equivalents and available-for-sale marketable securities | A summary of cash, cash equivalents and available-for-sale June 30, 2022 Unrealized Unrealized Fair Cost gains losses Value Cash and cash equivalents: Cash (Level 1) $ 1,728 $ — $ — $ 1,728 Money market funds (Level 1) 37,809 — — 37,809 Corporate debt securities due within 3 months of date of purchase (Level 2) 13,735 — — 13,735 Total cash and cash equivalents 53,272 — — 53,272 Marketable securities: Corporate debt securities due within 1 year of date of purchase (Level 2) 152,923 1 (431 ) 152,493 U.S. government and government sponsored entities due within 1 year of date of purchase (Level 2) 6,018 — (17 ) 6,001 Total cash, cash equivalents and marketable securities $ 212,213 $ 1 $ (448 ) $ 211,766 December 31, 2021 Unrealized Unrealized Fair Cost gains losses Value Cash and cash equivalents: Cash (Level 1) $ 18,877 $ — $ — $ 18,877 Money market funds (Level 1) 17,392 — — 17,392 Total cash and cash equivalents 36,269 — — 36,269 Marketable securities: Corporate debt securities due within 1 year of date of purchase (Level 2) 228,348 6 (66 ) 228,288 Corporate debt securities due within 1 to 2 years of date of purchase (Level 2) 5,809 — (20 ) 5,789 Total cash, cash equivalents and marketable securities $ 270,426 $ 6 $ (86 ) $ 270,346 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Accrued Liabilities, Current [Abstract] | |
Schedule of Accrued Liabilities | Accrued liabilities as of June 30, 2022 and December 31, 2021 consisted of the following (in thousands): June 30, December 31, 2022 2021 Contract research organization costs $ 57,288 $ 38,349 Other clinical study related costs 4,369 3,957 Compensation and benefits 3,577 6,769 Professional fees 3,959 2,455 Other 2,643 3,518 Total accrued liabilities $ 71,836 $ 55,048 |
Long Term Debt - (Tables)
Long Term Debt - (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Maturities of Long-Term Debt [Table Text Block] | Future minimum payments, including interest and principal, under the loans payable outstanding as of June 30, 2022 are as follows (in thousands): Period Ending June 30, 2022: Amount 2022 (remaining six months) $ 2,196 2023 4,410 2024 9,338 Thereafter 50,782 $ 66,726 Less amount representing interest (14,051 ) Less unamortized discount (4,005 ) Loans payable, net of discount $ 48,670 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Summary of stock option activity | The following table summarizes stock option activity during the six months ended June 30, 2022: Shares Weighted Outstanding at January 1, 2022 2,301,574 $ 78.90 Options granted 736,395 83.35 Options cancelled (61,424 ) 100.82 Outstanding at June 30, 2022 2,976,545 $ 79.54 Exercisable at June 30, 2022 1,669,315 $ 69.41 |
Schedule of stock-based compensation expense | Stock-based compensation expense during the six months ended June 30, 2022 and 2021 was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Stock-based compensation expense by type of award: Stock options $ 7,944 $ 8,179 $ 15,421 $ 14,275 Total stock-based compensation expense $ 7,944 $ 8,179 $ 15,421 $ 14,275 Effect of stock-based compensation expense by line item: Research and development $ 3,301 $ 2,860 $ 6,488 $ 5,497 General and administrative 4,643 5,319 8,933 8,778 Total stock-based compensation expense included in net loss $ 7,944 $ 8,179 $ 15,421 $ 14,275 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Income Taxes (Details) | 6 Months Ended |
Jun. 30, 2022 | |
Income Taxes | |
Valuation allowance on deferred tax assets (as a percent) | 100% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Basic and Diluted Loss Per Common Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Stock options | ||
Anti-dilutive securities | ||
Outstanding securities not included in the computation of diluted net loss per common share as their inclusion would be anti-dilutive (in shares) | 2,976,545 | 2,268,787 |
Preferred Stock | ||
Anti-dilutive securities | ||
Outstanding securities not included in the computation of diluted net loss per common share as their inclusion would be anti-dilutive (in shares) | 1,969,797 | 1,969,797 |
Warrants | ||
Anti-dilutive securities | ||
Outstanding securities not included in the computation of diluted net loss per common share as their inclusion would be anti-dilutive (in shares) | 14,899 | 0 |
Liquidity and Uncertainties (De
Liquidity and Uncertainties (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
May 31, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Net loss | $ (70,730) | $ (57,518) | $ (61,651) | $ (52,546) | $ (128,248) | $ (114,197) | ||
Accumulated deficit | (795,558) | (795,558) | $ (667,310) | |||||
Debt instrument, Face amount | $ 50,000 | $ 50,000 | ||||||
Term Loan [Member] | ||||||||
Debt instrument, Face amount | $ 250,000 | |||||||
Proceeds from issuance of debt | $ 50,000 |
Cash, Cash Equivalents and Ma_3
Cash, Cash Equivalents and Marketable Securities (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2022 | Dec. 31, 2021 | |
Cash, Cash Equivalents and Marketable Securities | ||
Total cash, cash equivalents and marketable securities, Unrealized gains | $ 1 | $ 6 |
Total cash, cash equivalents and marketable securities, Unrealized losses | (448) | (86) |
Carrying value | ||
Cash, Cash Equivalents and Marketable Securities | ||
Cash and cash equivalents | 53,272 | 36,269 |
Total cash, cash equivalents and marketable securities, Cost | 212,213 | 270,426 |
Fair value | ||
Cash, Cash Equivalents and Marketable Securities | ||
Cash and cash equivalents | 53,272 | 36,269 |
Total cash, cash equivalents and marketable securities, Fair value | $ 211,766 | $ 270,346 |
Corporate debt securities due within 3 months of date of purchase | ||
Cash, Cash Equivalents and Marketable Securities | ||
Maturity period from date of purchase to classify an investment as marketable securities | 3 months | |
Corporate debt securities due within 3 months of date of purchase | Carrying value | Level 2 | ||
Cash, Cash Equivalents and Marketable Securities | ||
Cash and cash equivalents | $ 13,735 | |
Corporate debt securities due within 1 year of date of purchase | ||
Cash, Cash Equivalents and Marketable Securities | ||
Maturity period from date of purchase to classify an investment as marketable securities | 1 year | 1 year |
Corporate debt securities due within 1 year of date of purchase | Level 2 | ||
Cash, Cash Equivalents and Marketable Securities | ||
Marketable securities, unrealized gains | $ 1 | $ 6 |
Marketable securities, unrealized losses | (431) | (66) |
Corporate debt securities due within 1 year of date of purchase | Carrying value | Level 2 | ||
Cash, Cash Equivalents and Marketable Securities | ||
Marketable securities, cost | 152,923 | 228,348 |
Corporate debt securities due within 1 year of date of purchase | Fair value | Level 2 | ||
Cash, Cash Equivalents and Marketable Securities | ||
Marketable securities, fair value | $ 152,493 | $ 228,288 |
Corporate debt securities due within 1 to 2 years of date of purchase | Maximum [Member] | ||
Cash, Cash Equivalents and Marketable Securities | ||
Maturity period from date of purchase to classify an investment as marketable securities | 2 years | |
Corporate debt securities due within 1 to 2 years of date of purchase | Minimum [Member] | ||
Cash, Cash Equivalents and Marketable Securities | ||
Maturity period from date of purchase to classify an investment as marketable securities | 1 year | |
Corporate debt securities due within 1 to 2 years of date of purchase | Level 2 | ||
Cash, Cash Equivalents and Marketable Securities | ||
Marketable securities, unrealized gains | $ 0 | |
Marketable securities, unrealized losses | (20) | |
Corporate debt securities due within 1 to 2 years of date of purchase | Carrying value | Level 2 | ||
Cash, Cash Equivalents and Marketable Securities | ||
Marketable securities, cost | 5,809 | |
Corporate debt securities due within 1 to 2 years of date of purchase | Fair value | Level 2 | ||
Cash, Cash Equivalents and Marketable Securities | ||
Marketable securities, fair value | 5,789 | |
U.S. government and government sponsored entities due within 1 year of date of purchase | ||
Cash, Cash Equivalents and Marketable Securities | ||
Maturity period from date of purchase to classify an investment as marketable securities | 1 year | |
U.S. government and government sponsored entities due within 1 year of date of purchase | Carrying value | Level 2 | ||
Cash, Cash Equivalents and Marketable Securities | ||
Marketable securities, cost | $ 6,018 | |
Marketable securities, unrealized losses | (17) | |
Marketable securities, fair value | 6,001 | |
Cash | Carrying value | Level 1 | ||
Cash, Cash Equivalents and Marketable Securities | ||
Cash and cash equivalents | 1,728 | 18,877 |
Cash | Fair value | Level 1 | ||
Cash, Cash Equivalents and Marketable Securities | ||
Cash and cash equivalents | 1,728 | 18,877 |
Money market funds | Carrying value | Level 1 | ||
Cash, Cash Equivalents and Marketable Securities | ||
Cash and cash equivalents | 37,809 | 17,392 |
Money market funds | Fair value | Level 1 | ||
Cash, Cash Equivalents and Marketable Securities | ||
Cash and cash equivalents | $ 37,809 | $ 17,392 |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Accrued Liabilities, Current [Abstract] | ||
Contract research organization costs | $ 57,288 | $ 38,349 |
Other clinical study related costs | 4,369 | 3,957 |
Compensation and benefits | 3,577 | 6,769 |
Professional fees | 3,959 | 2,455 |
Other | 2,643 | 3,518 |
Total accrued liabilities | $ 71,836 | $ 55,048 |
Long Term Debt - Schedule of Ma
Long Term Debt - Schedule of Maturities of Long-Term Debt (Detail) $ in Thousands | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Long-Term Debt, Fiscal Year Maturity [Abstract] | |
2022 (remaining six months) | $ 2,196 |
2023 | 4,410 |
2024 | 9,338 |
Thereafter | 50,782 |
Long-Term Debt | 66,726 |
Less amount representing interest | (14,051) |
Less unamortized discount | (4,005) |
Loan payable, net of discount | $ 48,670 |
Long Term Debt - Additional Inf
Long Term Debt - Additional Information (Detail) - USD ($) $ in Millions | 1 Months Ended | ||||
Jan. 01, 2023 | May 09, 2022 | May 01, 2022 | May 31, 2022 | Jun. 30, 2022 | |
Debt instrument, Face amount | $ 50 | ||||
Interest rate | 8.70% | ||||
Percenatge of Term charges on aggregate principal amount | 5.35% | ||||
Debt conversion, converted instrument, warrants or options issued | 14,899 | ||||
Debt conversion, converted instrument, amount | $ 0.6 | ||||
Loan Facility [Member] | Subsequent Event [Member] | |||||
Line of credit facility, maximum borrowing capacity | $ 35 | ||||
Line of credit facility, expiration date | Sep. 30, 2024 | ||||
Drawn In Two Separate Tranches Upon AchievementOf Resmetirom Clinical And Regulatory Milestone s [Member] | |||||
Unused borrowing capacity that can be drawn | $ 125 | ||||
Term Loan | |||||
Debt instrument, Face amount | 250 | ||||
Proceeds from issuance of debt | $ 50 | ||||
Long term debt floor interest rate percentage | 7.45% | ||||
Debt Instrument Interest Payments Terms | The Company will pay interest-only monthly payments of accrued interest under the Loan Facility for a period of 30 months, which period may be extended to 36, 48, and 60 months upon the successive achievement of certain clinical and regulatory milestones | ||||
Term Loan | Drawn In Two Separate Tranches Upon AchievementOf Resmetirom Clinical And Regulatory Milestone s [Member] | |||||
Unused borrowing capacity that can be drawn | $ 75 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) - Common Stock (Details) | 6 Months Ended |
Jun. 30, 2022 Vote | |
Stockholders' Equity Note [Abstract] | |
Number of votes per share that common stockholders are entitled to receive | 1 |
Stockholders' Equity (Deficit_2
Stockholders' Equity (Deficit) - Preferred Stock (Details) - Series A Convertible Preferred Stock | 1 Months Ended |
Jun. 30, 2017 Vote shares | |
Stockholders' Equity (Deficit) | |
Preferred stock conversion ratio | shares | 1 |
Preferred shares number voting rights | Vote | 0 |
Stockholders' Equity (Deficit_3
Stockholders' Equity (Deficit) - At The Market Issuances (Details) - USD ($) $ in Millions | 1 Months Ended | 6 Months Ended | |
Nov. 30, 2020 | Jun. 30, 2022 | Jun. 30, 2021 | |
Stockholders' Equity (Deficit) | |||
Number of shares sold by the entity | 1,087,126 | ||
At-The-Market Issuance Sales Agreement | |||
Stockholders' Equity (Deficit) | |||
Number of shares sold by the entity | 1,126,733 | ||
Value of shares sold by the entity | $ 137.4 | ||
Net proceeds after deducting commissions and other transactions costs | $ 134.8 | ||
At-The-Market Issuance Sales Agreement | 2021 Sales Agreement [Member] | |||
Stockholders' Equity (Deficit) | |||
Number of shares sold by the entity | 497,043 | ||
Value of shares sold by the entity | $ 40.8 | ||
Net proceeds after deducting commissions and other transactions costs | 39.8 | ||
Remaining reserved amount under shelf registration | 159.2 | ||
Cowen & Co. LLC | Maximum | At-The-Market Issuance Sales Agreement | |||
Stockholders' Equity (Deficit) | |||
Maximum aggregate offering price | $ 200 | $ 200 |
Stock-based Compensation - Stoc
Stock-based Compensation - Stock Option (Details) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Additional disclosures | ||
Proceeds resulting from exercise of stock options | $ 0 | $ 478 |
Maximum | ||
Stock-based compensation expense | ||
Expiration period | 10 years | |
Stock options | ||
Stock-based compensation expense | ||
Options outstanding to purchase of common stock | 2,976,545 | |
Shares available for future issuance | 986,322 | |
Shares | ||
Outstanding at the beginning of the year (in shares) | 2,301,574 | |
Options granted (in shares) | 736,395 | |
Options cancelled (in shares) | (61,424) | |
Outstanding at the end of the year (in shares) | 2,976,545 | |
Exercisable at the end of the year (in shares) | 1,669,315 | |
Weighted average exercise price | ||
Outstanding at the beginning of the year (in dollars per share) | $ 78.9 | |
Options granted (in dollars per share) | 83.35 | |
Options cancelled (in dollars per share) | 100.82 | |
Outstanding at the end of the year (in dollars per share) | 79.54 | |
Exercisable at the end of the year (in dollars per share) | $ 69.41 | |
Additional disclosures | ||
Total intrinsic value of options exercised | $ 0 | 100 |
Proceeds resulting from exercise of stock options | $ 0 | $ 500 |
Weighted-average grant date fair value of options (in dollars per share) | $ 55.84 | $ 78.34 |
Stock-based Compensation - Expe
Stock-based Compensation - Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Stock-based compensation expense | ||||
Stock-based compensation expense | $ 7,944 | $ 8,179 | $ 15,421 | $ 14,275 |
Research and development | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | 3,301 | 2,860 | 6,488 | 5,497 |
General and administrative | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | 4,643 | 5,319 | 8,933 | 8,778 |
Stock options | ||||
Stock-based compensation expense | ||||
Stock-based compensation expense | $ 7,944 | $ 8,179 | $ 15,421 | $ 14,275 |
Stock-based Compensation - Unre
Stock-based Compensation - Unrecognized Expense (Details) - Stock options $ in Millions | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Unrecognized stock-based compensation expense | |
Unrecognized stock compensation expense | $ 70 |
Weighted average remaining period (in years) | 2 years 11 months 12 days |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) $ in Millions | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2019 | |
Commitments and Contingencies | |||
Licensed product sales | $ 0 | $ 0 | |
Research, Development and Commercialization Agreement | Hoffmann-La Roche ("Roche") | |||
Commitments and Contingencies | |||
Remainder of future milestone payments | $ 8 |