Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Nov. 09, 2021 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2021 | |
Entity File Number | 001-38944 | |
Entity Registrant Name | Akero Therapeutics, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 81-5266573 | |
Entity Address, Address Line One | 601 Gateway Boulevard, Suite 350 | |
Entity Address, City or Town | South San Francisco | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94080 | |
City Area Code | 650 | |
Local Phone Number | 487-6488 | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | AKRO | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 34,888,302 | |
Entity Central Index Key | 0001744659 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 164,935 | $ 187,242 |
Short-term marketable securities | 50,146 | 81,145 |
Prepaid expenses and other current assets | 6,726 | 2,958 |
Total current assets | 221,807 | 271,345 |
Property and equipment, net | 101 | 131 |
Operating lease right-of-use asset | 1,511 | 1,662 |
Other assets, noncurrent | 114 | 201 |
Total assets | 223,533 | 273,339 |
Current liabilities: | ||
Accounts payable | 6,784 | 3,428 |
Accrued expenses and other current liabilities | 16,756 | 9,683 |
Total current liabilities | 23,540 | 13,111 |
Operating lease liability, noncurrent | 1,365 | 1,516 |
Total liabilities | 24,905 | 14,627 |
Commitments and contingencies (Note 11) | ||
Stockholders' equity: | ||
Common stock, $0.0001 par value, 150,000,000 shares authorized as of September 30, 2021 and December 31, 2020; 34,875,302 and 34,741,649 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively | 4 | 4 |
Additional paid-in capital | 476,521 | 468,238 |
Accumulated other comprehensive loss | (17) | (3) |
Accumulated deficit | (277,880) | (209,527) |
Total stockholders' equity | 198,628 | 258,712 |
Total liabilities and stockholders' equity | $ 223,533 | $ 273,339 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Condensed Consolidated Balance Sheets | ||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 34,875,302 | 34,741,649 |
Common stock, shares outstanding | 34,875,302 | 34,741,649 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Operating expenses: | ||||
Research and development | $ 19,470 | $ 17,379 | $ 54,048 | $ 39,207 |
General and administrative | 4,883 | 4,159 | 14,399 | 11,164 |
Total operating expenses | 24,353 | 21,538 | 68,447 | 50,371 |
Loss from operations | (24,353) | (21,538) | (68,447) | (50,371) |
Other income, net | 23 | 135 | 94 | 875 |
Net loss | (24,330) | (21,403) | (68,353) | (49,496) |
Net unrealized gain (loss) on short-term marketable securities | (8) | (74) | (14) | 22 |
Comprehensive loss | $ (24,338) | $ (21,477) | $ (68,367) | $ (49,474) |
Net loss per common share, basic and diluted | $ (0.70) | $ (0.63) | $ (1.96) | $ (1.63) |
Weighted-average number of shares used in computing net loss per common share, basic and diluted | 34,862,116 | 34,002,769 | 34,807,439 | 30,381,671 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Common Stock | Additional Paid-In-Capital | Accumulated Other Comprehensive Gain (Loss) | Accumulated Deficit | Total |
Balance at beginning at Dec. 31, 2019 | $ 3 | $ 259,049 | $ (6) | $ (130,320) | $ 128,726 |
Balance at beginning (in shares) at Dec. 31, 2019 | 28,567,837 | ||||
Exercise of stock options | 112 | 112 | |||
Exercise of stock options (in shares) | 103,385 | ||||
Vesting of restricted stock | 30 | 30 | |||
Stock-based compensation expense | 1,238 | 1,238 | |||
Disgorgement of stockholders' short-swing profits, net | 52 | 52 | |||
Net unrealized gain (loss) on short-term marketable securities | 51 | 51 | |||
Net loss | (11,886) | (11,886) | |||
Balance at ending at Mar. 31, 2020 | $ 3 | 260,481 | 45 | (142,206) | 118,323 |
Balance at ending (in shares) at Mar. 31, 2020 | 28,671,222 | ||||
Balance at beginning at Dec. 31, 2019 | $ 3 | 259,049 | (6) | (130,320) | 128,726 |
Balance at beginning (in shares) at Dec. 31, 2019 | 28,567,837 | ||||
Net unrealized gain (loss) on short-term marketable securities | 22 | ||||
Net loss | (49,496) | ||||
Balance at ending at Sep. 30, 2020 | $ 4 | 466,254 | 16 | (179,816) | 286,458 |
Balance at ending (in shares) at Sep. 30, 2020 | 34,720,675 | ||||
Balance at beginning at Dec. 31, 2019 | $ 3 | 259,049 | (6) | (130,320) | 128,726 |
Balance at beginning (in shares) at Dec. 31, 2019 | 28,567,837 | ||||
Net loss | (79,207) | ||||
Balance at ending at Dec. 31, 2020 | $ 4 | 468,238 | (3) | (209,527) | 258,712 |
Balance at ending (in shares) at Dec. 31, 2020 | 34,741,649 | ||||
Balance at beginning at Mar. 31, 2020 | $ 3 | 260,481 | 45 | (142,206) | 118,323 |
Balance at beginning (in shares) at Mar. 31, 2020 | 28,671,222 | ||||
Exercise of stock options | 9 | 9 | |||
Exercise of stock options (in shares) | 3,202 | ||||
Vesting of restricted stock | 13 | 13 | |||
Issuance of common stock pursuant to ESPP purchases | 158 | 158 | |||
Issuance of common stock pursuant to ESPP purchases (in shares) | 9,255 | ||||
Stock-based compensation expense | 1,322 | 1,322 | |||
Net unrealized gain (loss) on short-term marketable securities | 45 | 45 | |||
Net loss | (16,207) | (16,207) | |||
Balance at ending at Jun. 30, 2020 | $ 3 | 261,983 | 90 | (158,413) | 103,663 |
Balance at ending (in shares) at Jun. 30, 2020 | 28,683,679 | ||||
Issuance of common stock upon closing of secondary public offering, net of issuance costs and underwriting fees | $ 1 | 202,553 | 202,554 | ||
Issuance of common stock upon closing of secondary public offering, net of issuance costs and underwriting fees (shares) | 6,012,390 | ||||
Exercise of stock options | 163 | 163 | |||
Exercise of stock options (in shares) | 24,606 | ||||
Vesting of restricted stock | 9 | 9 | |||
Stock-based compensation expense | 1,546 | 1,546 | |||
Net unrealized gain (loss) on short-term marketable securities | (74) | (74) | |||
Net loss | (21,403) | (21,403) | |||
Balance at ending at Sep. 30, 2020 | $ 4 | 466,254 | 16 | (179,816) | 286,458 |
Balance at ending (in shares) at Sep. 30, 2020 | 34,720,675 | ||||
Balance at beginning at Dec. 31, 2020 | $ 4 | 468,238 | (3) | (209,527) | 258,712 |
Balance at beginning (in shares) at Dec. 31, 2020 | 34,741,649 | ||||
Exercise of stock options | 24 | 24 | |||
Exercise of stock options (in shares) | 28,670 | ||||
Vesting of restricted stock | 9 | 9 | |||
Stock-based compensation expense | 2,364 | 2,364 | |||
Net unrealized gain (loss) on short-term marketable securities | 1 | 1 | |||
Net loss | (15,090) | (15,090) | |||
Balance at ending at Mar. 31, 2021 | $ 4 | 470,635 | (2) | (224,617) | 246,020 |
Balance at ending (in shares) at Mar. 31, 2021 | 34,770,319 | ||||
Balance at beginning at Dec. 31, 2020 | $ 4 | 468,238 | (3) | (209,527) | $ 258,712 |
Balance at beginning (in shares) at Dec. 31, 2020 | 34,741,649 | ||||
Exercise of stock options (in shares) | 123,523 | ||||
Net unrealized gain (loss) on short-term marketable securities | $ (14) | ||||
Net loss | (68,353) | ||||
Balance at ending at Sep. 30, 2021 | $ 4 | 476,521 | (17) | (277,880) | 198,628 |
Balance at ending (in shares) at Sep. 30, 2021 | 34,875,302 | ||||
Balance at beginning at Mar. 31, 2021 | $ 4 | 470,635 | (2) | (224,617) | 246,020 |
Balance at beginning (in shares) at Mar. 31, 2021 | 34,770,319 | ||||
Exercise of stock options | 393 | 393 | |||
Exercise of stock options (in shares) | 60,333 | ||||
Vesting of restricted stock | 9 | 9 | |||
Issuance of common stock pursuant to ESPP purchases | 215 | 215 | |||
Issuance of common stock pursuant to ESPP purchases (in shares) | 10,130 | ||||
Stock-based compensation expense | 2,436 | 2,436 | |||
Net unrealized gain (loss) on short-term marketable securities | (7) | (7) | |||
Net loss | (28,933) | (28,933) | |||
Balance at ending at Jun. 30, 2021 | $ 4 | 473,688 | (9) | (253,550) | 220,133 |
Balance at ending (in shares) at Jun. 30, 2021 | 34,840,782 | ||||
Exercise of stock options | 219 | 219 | |||
Exercise of stock options (in shares) | 34,520 | ||||
Vesting of restricted stock | 2 | 2 | |||
Stock-based compensation expense | 2,612 | 2,612 | |||
Net unrealized gain (loss) on short-term marketable securities | (8) | (8) | |||
Net loss | (24,330) | (24,330) | |||
Balance at ending at Sep. 30, 2021 | $ 4 | $ 476,521 | $ (17) | $ (277,880) | $ 198,628 |
Balance at ending (in shares) at Sep. 30, 2021 | 34,875,302 |
Consolidated Statements of Rede
Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) (Parenthetical) $ in Thousands | 3 Months Ended |
Sep. 30, 2020USD ($) | |
Condensed Consolidated Statements of Stockholders' Equity (Deficit) | |
Net issuance costs and underwriting fees | $ 906 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (68,353) | $ (49,496) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 7,412 | 4,106 |
Depreciation | 30 | 6 |
Non-cash lease expense | 151 | 147 |
Net amortization of premiums and discounts on short-term investments | 705 | (41) |
Unrealized foreign exchange gain and loss | (113) | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (3,229) | (4,539) |
Accounts payable | 3,469 | 3,689 |
Accrued expenses and other current liabilities | 7,076 | (1,183) |
Other liabilities | (2) | |
Operating lease liability | (134) | (96) |
Net cash used in operating activities | (52,986) | (47,409) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Purchase of short-term marketable securities | (43,561) | (106,041) |
Proceeds from sales of short-term marketable securities | 9,864 | |
Proceeds from maturities of short-term marketable securities | 73,841 | 68,660 |
Purchase of property and equipment | (143) | |
Net cash provided by (used in) investing activities | 30,280 | (27,660) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Proceeds from the issuance of common stock in follow-on public offering, net of issuance costs and underwriting fees | 202,554 | |
Proceeds from the exercise of stock options | 636 | 284 |
Proceeds from the issuance of common stock pursuant to employee stock purchase plan purchases | 215 | 158 |
Proceeds from the disgorgement of stockholders' short-swing profits, net | 52 | |
Payment of deferred offering costs | (492) | |
Net cash provided by financing activities | 359 | 203,048 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (22,347) | 127,979 |
Cash, cash equivalents and restricted cash at the beginning of the period | 187,390 | 64,848 |
Cash, cash equivalents and restricted cash at the end of the period | 165,043 | 192,827 |
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING INFORMATION: | ||
ROU asset obtained in exchange for operating lease liability | 1,751 | |
Change in net unrealizable gain (loss) on marketable securities | (14) | 22 |
Remeasurement of ROU asset and lease liability | $ 173 | |
Deferred offering costs included in accounts payable and accrued expenses and other current liabilities | $ 4 |
Nature of the business and basi
Nature of the business and basis of presentation | 9 Months Ended |
Sep. 30, 2021 | |
Nature of the business and basis of presentation | |
Nature of the business and basis of presentation | 1. Nature of the business and basis of presentation Akero Therapeutics, Inc., together with its wholly owned subsidiary Akero Securities Corporation, (“Akero” or the “Company”) is a cardio-metabolic nonalcoholic steatohepatitis, or NASH, company dedicated to developing pioneering medicines designed to restore metabolic balance and improve overall health. NASH is a severe form of nonalcoholic fatty liver disease, or NAFLD, characterized by inflammation and fibrosis in the liver that can progress to cirrhosis, liver failure, cancer and death. The Company’s lead product candidate, efruxifermin, or EFX, is an analog of fibroblast growth factor 21, or FGF21, which is an endogenously expressed hormone that protects against cellular stress and regulates metabolism of lipids, carbohydrates and proteins throughout the body. The Company conducted a Phase 2a clinical trial, the BALANCED study, to evaluate EFX in the treatment of biopsy-confirmed NASH patients. The main portion of this study in NASH patients with F1-F3 fibrosis showed EFX’s potential to reverse fibrosis, resolve NASH, improve liver health, improve glycemic control and improve lipoprotein profile. An expansion cohort in F4 NASH patients with compensated cirrhosis showed comparable results. The Company initiated a Phase 2b clinical trial, the HARMONY study, to evaluate EFX in the treatment of NASH patients with F2/F3 fibrosis in February 2021 and randomized the first patient in March 2021. The Company initiated a second Phase 2b clinical trial in F4 NASH patients with compensated cirrhosis, the SYMMETRY study, in July 2021. Based on clinical data to date, the Company believes EFX has the potential to be a highly-differentiated, best-in-class FGF21 analog and foundational NASH monotherapy. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, completion and success of clinical testing, development by competitors of new technological innovations, compliance with governmental regulations, dependence on key personnel and protection of proprietary technology and the ability to secure additional capital to fund operations. EFX will require extensive clinical testing prior to regulatory approval and commercialization. These efforts require significant amounts of additional capital, adequate personnel, and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales. Basis of presentation The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and include the accounts of the Company after elimination of all intercompany accounts and transactions. All adjustments necessary for the fair presentation of the Company’s condensed consolidated financial statements for the periods presented have been reflected. Liquidity In accordance with Accounting Standards Update (“ASU”) No. 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40) Since its inception, the Company has funded its operations primarily with proceeds from sales of redeemable convertible preferred stock and most recently with proceeds from its initial public offering (“IPO”) in June 2019 and a follow-on public offering of its common stock in July 2020. The Company has incurred recurring losses since its inception, including net losses of $68,353 and $49,496 for the nine months ended September 30, 2021 and 2020, respectively, and net losses of $79,207 and $43,755 for the years ended December 31, 2020 and 2019, respectively. In addition, as of September 30, 2021, the Company had an accumulated deficit of $277,880. The Company expects to continue to generate operating losses for the foreseeable future. As of November 12, 2021, the issuance date of these condensed consolidated financial statements, the Company expects that its existing cash, cash equivalents and short-term marketable securities of $215,081 as of September 30, 2021, will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the issuance date of these condensed consolidated financial statements. The Company expects that it will require additional funding beyond this time to complete the clinical development of EFX, commercialize EFX, if it receives regulatory approval, and pursue in-licenses or acquisitions of other product candidates. If the Company is unable to obtain funding, the Company will be forced to delay, reduce or eliminate some or all of its research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations. Although management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations, if at all. |
Summary of significant accounti
Summary of significant accounting policies | 9 Months Ended |
Sep. 30, 2021 | |
Summary of significant accounting policies | |
Summary of significant accounting policies | 2. Summary of significant accounting policies Unaudited interim financial statements The accompanying unaudited condensed consolidated financial statements have been prepared by the Company in accordance with GAAP for interim financial reporting and as required by Regulation S-X, Rule 10-01. The unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s audited annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of the Company’s condensed consolidated balance sheet as of September 30, 2021, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2021 and 2020, the condensed consolidated statements of stockholders’ equity (deficit) for the three and nine months ended September 30, 2021 and 2020 and the condensed consolidated statements of cash flows for the nine months ended September 30, 2021 and 2020. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2021 and 2020 are unaudited. The results for the three and nine months ended September 30, 2021 are not necessarily indicative of results to be expected for the year ending December 31, 2021, any other interim periods, or any future year or period. Use of estimates The preparation of the Company's condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the accrual of research and development expenses, the valuations of common stock and the valuation allowance for deferred tax assets. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates when there are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those Cash and cash equivalents The Company considers all highly liquid investments with original maturities of three months or less at the time of purchase to be cash equivalents. Cash equivalents consist primarily of amounts invested in money market accounts. Short-term marketable securities The Company invests in short-term marketable securities, primarily money market funds, commercial paper, U.S. treasury securities and corporate debt securities. The Company classifies its short-term marketable securities as available-for-sale securities and reports them at fair value in short-term marketable securities on the condensed consolidated balance sheets with related unrealized gains and losses included within accumulated other comprehensive gain (loss) on the condensed consolidated balance sheets. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity, which is included in other income on the condensed consolidated statements of operations and comprehensive loss. Realized gains and losses and declines in value judged to be other-than-temporary, if any, on available-for-sale securities are included in other income. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in other income. The Company regularly reviews all its investments for other-than-temporary declines in estimated fair value. This review includes the consideration of the cause of the impairment, including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity and duration of the unrealized losses, whether the Company has the intent to sell the securities and whether it is more likely than not that the Company will be required to sell the securities before the recovery of their amortized cost basis. When the Company determines that the decline in estimated fair value of an investment is below the amortized cost basis and the decline is other-than-temporary, the carrying value of the security will be reduced and a loss will be recorded for the amount of such decline. Restricted cash As of September 30, 2021 and December 31, 2020, the Company was required to maintain a separate cash balance of $108 for the benefit of the landlord in connection with the Company’s Gateway office space lease in South San Francisco, California (the “Gateway Lease”), which is classified within other assets (non-current) on the condensed consolidated balance sheets (see Note 11). As of December 31, 2020, the Company was required to maintain a separate cash balance of $40 to collateralize corporate credit cards with a bank, which is classified within other assets (non-current) on the condensed consolidated balance sheet. Concentrations of credit risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents and short-term marketable securities. Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company deposits its cash investments in financial institutions that it believes have high credit quality and has not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships. At September 30, 2021 and December 31, 2020, all of the Company's cash, cash equivalents and short-term investments were held at one accredited financial Property and equipment Property and equipment are stated at cost, less accumulated depreciation and amortization. Depreciation is provided using the straight-line method over the estimated useful lives of the assets, which is three years for furniture and equipment. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the improvements. Depreciation and amortization begins at the time the asset is placed in service. Leases The Company determines whether an arrangement is or contains a lease at inception by assessing whether the arrangement contains an identified asset and whether the Company has the right to control the identified asset. Right-of-use, or ROU, assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Lease liabilities are recognized at the lease commencement date based on the present value of future lease payments over the lease term. ROU assets are based on the measurement of the lease liability and are further adjusted by any lease payments made prior to or on lease commencement, lease incentives received and initial direct costs incurred, as applicable. The Company has elected to not recognize leases with a lease term of one year or less on its balance sheet. Operating lease costs included in the measurement of the lease are recognized on a straight-line basis over the lease term. Variable lease costs are expensed as incurred as an operating expense. The Company determines the lease classification and the present value of future lease payments at the time of the lease commencement using an incremental borrowing rate that it estimates based upon the Company’s credit risk and term of the lease. The interest rate implicit in lease contracts has not historically been readily determinable and the Company must therefore use the appropriate incremental borrowing rate to measure its leases. To estimate the incremental borrowing rate, a credit rating applicable to the Company is estimated using a synthetic credit rating analysis since the Company does not currently have a rating agency-based credit rating. Research and development costs Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred to discover, research and develop drug candidates, including personnel expenses, stock-based compensation expense, third-party license fees and external costs including fees paid to consultants, contract manufacturing organizations, or CMOs, and clinical research organizations, or CROs, in connection with drug product manufacturing, nonclinical studies and clinical trials, and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work, clinical trial database management, clinical trial material management and statistical compilation and analysis. Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are recorded as prepaid expenses. Such amounts are recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered or the services Costs incurred i n obtaining technology licenses are charged immediately to research and development expense if the technology licensed has not reached technological feasibility and has no alternative Research contract costs and accruals The Company has entered into various research and development and other agreements with commercial firms, researchers and others for provisions of goods and services. These agreements are generally cancelable, and the related costs are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research and development costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies or clinical trials, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ materially from the Company's estimates. Stock-based compensation The Company measures all stock-based awards granted to employees and nonemployees based on the fair value on the date of the grant and recognizes compensation expense for those awards over the requisite service period, which is generally the vesting period of the respective award, on a straight-line basis. The Company accounts for forfeitures as they occur. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model. Prior to the Company’s initial public offering, the exercise price for all stock options granted was at the estimated fair value of the underlying common stock as determined on the date of grant by the Company’s board of directors. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model, which requires inputs based on certain subjective assumptions, including the expected stock price volatility, the expected term of the option, the risk-free interest rate for a period that approximates the expected term of the option, and the Company's expected dividend yield. The Company went public in June 2019 and accordingly, lacks sufficient company-specific historical and implied volatility information for its shares traded in the public markets. Therefore, it estimates its expected share price volatility based on the historical volatility of publicly traded peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded share price. The expected term of the Company's stock options has been determined utilizing the "simplified" method for awards that qualify as "plain-vanilla" options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future. The fair value of each common stock award is estimated on the date of grant based on the fair value of the Company's common stock Compensation expense for purchases under the Employee Stock Purchase Plan is recognized based on the fair value of the common stock estimated based on the closing price of our common stock as reported on the date of offering, less the purchase discount percentage provided for in the plan. The Company classifies stock-based compensation expense in its condensed consolidated statement of operations and comprehensive loss in the same manner in which the award recipient's payroll costs are classified or in which the award recipient's service payments Comprehensive loss Comprehensive loss includes net loss as well as other changes in stockholders' equity (deficit) that result from transactions and economic events other than those with stockholders. The Company’s comprehensive loss is comprised of net loss and changes in unrealized gains and losses on its short-term marketable securities Emerging growth company The Company is an emerging growth company as defined in the Jumpstart Our Business Startups Act of 2012, as amended (the “JOBS Act”). Under the JOBS Act, companies have extended transition periods available for complying with new or revised accounting standards. The Company has elected this exemption to delay adopting new or revised accounting standards until such time as those standards apply. On the last business day of the second quarter in 2021, the aggregate market value of the Company shares held by non-affiliate stockholders exceeded $700 million. As a result, as of December 31, 2021, the Company will be considered a large accelerated filer as defined in Rule 12b-2 under the Exchange Act, and will cease to be an emerging growth company as defined in the JOBS Act. The Company will no longer be exempt from the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act, and our independent registered public accounting firm will evaluate and report on the effectiveness of internal control over financial reporting. The Company will also no longer be permitted to take advantage of reduced reporting requirements for smaller reporting companies. Recently adopted accounting pronouncements On January 1, 2021, the Company adopted Accounting Standard Update No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (ASU 2019-12), which simplifies the accounting for income taxes. ASU 2019-12 was effective beginning January 1, 2021. The adoption of this new standard did not have a material impact on our condensed consolidated financial statements. Recently issued accounting pronouncements not yet adopted In June 2016, the FASB issued No. ASU 2016-13, Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13 requires measurement and recognition of expected credit losses for financial assets. In November 2019, the FASB issued No. ASU 2019-10 to modify the effective date for ASU 2016-13 for other public business entities includes smaller reporting companies, as defined by the SEC. This guidance will become effective for the Company beginning in the first quarter of 2023. Early adoption is permitted. The Company is currently evaluating the impact that the adoption of ASU 2016-13 will have on its condensed consolidated financial statements. |
Fair value of financial assets
Fair value of financial assets and liabilities | 9 Months Ended |
Sep. 30, 2021 | |
Fair value of financial assets and liabilities | |
Fair value of financial assets and liabilities | 3. Fair value of financial assets and liabilities Certain assets and liabilities of the Company are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: ● Level 1—Quoted prices in active markets for identical assets or liabilities. ● Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. ● Level 3—Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The following is a summary of our financial assets measured at fair value on a recurring basis as of September 30, 2021 and December 31, 2020: September 30, 2021 Total Level 1 Level 2 Level 3 Money market funds $ 139,039 $ 139,039 $ — $ — Commercial paper 7,000 — 7,000 — Corporate debt securities 43,146 — 43,146 — $ 189,185 $ 139,039 $ 50,146 $ — December 31, 2020 Total Level 1 Level 2 Level 3 Money market funds $ 158,023 $ 158,023 $ — $ — Commercial paper 47,955 — 47,955 — Corporate debt securities 33,190 — 33,190 — $ 239,168 $ 158,023 $ 81,145 $ — Commercial paper and corporate debt securities were valued by the Company using quoted prices in active markets for similar securities, which represent a Level 2 measurement within the fair value hierarchy. The carrying values of the Company’s prepaid expenses and other current assets, accounts payable and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities. During the nine months ended September 30, 2021 and the twelve months ended December 31, 2020, there were no transfers between Level 1, Level 2 and Level 3. |
Short-term marketable securitie
Short-term marketable securities | 9 Months Ended |
Sep. 30, 2021 | |
Short-term marketable securities | |
Short-term marketable securities | 4. Short-term marketable securities The following is a summary of short-term marketable securities as of September 30, 2021 and December 31, 2020 September 30, 2021 Amortized cost Gross unrealized gains Gross unrealized losses Fair value Money market funds $ 139,039 $ — $ — $ 139,039 Commercial paper 7,000 — — 7,000 Corporate debt securities 43,163 — (17) 43,146 $ 189,202 $ — $ (17) $ 189,185 Cash equivalents $ 139,039 Short-term marketable securities 50,146 $ 189,185 December 31, 2020 Amortized cost Gross unrealized gains Gross unrealized losses Fair value Money market funds $ 158,023 $ — $ — $ 158,023 Commercial paper 47,955 — — 47,955 Corporate debt securities 33,193 — (3) 33,190 $ 239,171 $ — $ (3) $ 239,168 Cash equivalents $ 158,023 Short-term marketable securities 81,145 $ 239,168 As of September 30, 2021 and December 31, 2020, all of the Company’s short-term marketable securities had contractual maturities of less than one year. |
Accrued expenses and other curr
Accrued expenses and other current liabilities | 9 Months Ended |
Sep. 30, 2021 | |
Accrued expenses and other current liabilities | |
Accrued expenses and other current liabilities | 5. Accrued expenses and other current liabilities The following is a summary of accrued expenses and other current liabilities as of September 30, 2021 and December 31, 2020 September 30, 2021 December 31, 2020 Accrued external research and development expenses $ 14,148 $ 8,740 Accrued employee compensation and benefits 2,218 495 Accrued legal and professional fees 191 154 Short-term lease liability and other 199 294 $ 16,756 $ 9,683 |
Stockholder's equity (deficit)
Stockholder's equity (deficit) | 9 Months Ended |
Sep. 30, 2021 | |
Stockholder's equity (deficit) | |
Stockholder's equity (deficit) | 6. Stockholder’s equity (deficit) Common stock As of September 30, 2021 and December 31, 2020, the Company’s certificate of incorporation, as amended and restated, authorized the Company to issue 150,000,000 shares of $0.0001 par value common stock. Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. The holders of common stock, voting exclusively and as a separate class, have the exclusive right to vote for the election of directors of the Company. Common stockholders are entitled to receive dividends, as may be declared by the board of directors. Through September 30, 2021, no cash dividends had been declared or paid On June 24, 2019, the Company completed its IPO at which time the Company issued 6,612,500 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 862,500 additional shares of common stock, at a public offering price of $16.00 per share. The Company received $98,394, net of underwriting discounts and commissions, but before deducting offering costs paid by the Company, which were $2,942. Upon the closing of the IPO, all outstanding shares of convertible preferred stock converted into 21,056,136 shares of common stock. On July 10, 2020, the Company completed a follow-on public offering at which time the Company issued 6,012,390 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 784,224 additional shares of common stock, at a public offering price of $36.00 per share. The Company received $203,460 net of underwriting discounts and commissions, but before deducting offering costs paid by the Company, which were $906. On May 18, 2021, the Company filed a Form S-3 Registration Statement and the accompanying prospectus activating the at-the-market, or ATM, facility by entering into a sales agreement with J.P. Morgan Securities LLC, relating to shares of the Company’s common stock offered. Pursuant to the terms of the sales agreement, the Company may offer and sell shares of common stock, having an aggregate price of up to $100.0 million from time to time. The Company reserved 5,000,000 shares of common stock related to the ATM offering. During the three and nine months ended September 30, 2021, the Company did not make any sales under the ATM facility. As of September 30, 2021 and December 31, 2020, there were 34,875,302 and 34,741,649 shares of common stock issued outstanding The following shares of common stock were reserved for issuance as follows: September 30, 2021 December 31, 2020 Options outstanding under the 2018 Stock Option and Grant Plan 2,028,496 2,148,019 Options outstanding under the 2019 Stock Option and Incentive Plan 2,003,556 1,585,293 Options available for future grant 3,094,946 2,127,544 Common stock available for ATM program 5,000,000 — 2019 Employee Stock Purchase Plan 881,249 543,963 Total 13,008,247 6,404,819 Undesignated preferred stock The Company’s fourth amended and restated certificate of incorporation authorizes the Company to issue up to 10,000,000 shares of undesignated preferred stock, par value $0.0001 per share. There were no undesignated preferred shares issued or outstanding Restricted common stock In March 2017, the Company issued an aggregate of 226,400 shares of restricted common stock under restricted stock agreements with the founders. Pursuant to the terms of the agreements, the restricted common stock was initially subject to a vesting schedule over a four-year period commencing in January 2017 and culminating in January 2021. In March 2018, the Company amended the restricted stock agreements such that the restricted common stock became subject to a vesting schedule over a two-year period commencing in May 2018 and culminating in June 2020. As of September 30, 2021, all restricted stock issued to the founders is fully vested. In April, June and July 2019, the Company amended certain option grant agreements granted under the Company’s 2018 Stock Option and Grant Plan to allow certain holders the right to early exercise specified unvested options, subject to a repurchase right held by the Company equal to the lesser of the original exercise price per share or the fair value of the shares on the repurchase date. The unvested shares issued as a result of the early exercise are deemed restricted stock pursuant to a restricted stock agreement and a vesting schedule identical to the vesting schedule of the original grant agreement. The proceeds related to unvested restricted common stock are recorded as liabilities until the stock vests, at which point they are reclassified to additional paid-in capital. Common shares issued for the early exercise of options are included in issued and outstanding shares. As of September 30, 2021, all shares issued as a result of the early exercise are fully vested. The following table summarizes restricted stock activity since December 31, 2020: Grant-Date Fair Number of Shares Value Unvested restricted common stock as of December 31, 2020 33,614 $ 0.62 Shares vesting (33,614) 0.62 Unvested restricted common stock as of September 30, 2021 — - |
Stock-based awards
Stock-based awards | 9 Months Ended |
Sep. 30, 2021 | |
Stock-based awards | |
Stock-based awards | 7. Stock-based awards 2018 Stock option and grant plan The Company’s 2018 Stock Option and Grant Plan (the “2018 Plan”) provided for the Company to grant incentive stock options or nonqualified stock options, restricted stock awards and other stock-based awards to employees, directors and consultants of the Company. The 2018 Plan was administered by the board of directors or, at the discretion of the board of directors, by a committee of the board of directors. The exercise prices, vesting and other restrictions were determined at the discretion of the board of directors, or its committee if so delegated. The total number of shares of common stock that could have been issued under the 2018 Plan was 3,071,960 shares, of which 107,635 shares remained available for grant on June 18, 2019, the date that the Company’s 2019 Stock Option and Incentive Plan (the “2019 Plan”) became effective. Upon the effectiveness of the 2019 Plan, the 107,635 remaining shares available under the 2018 Plan were transferred and became available for issuance under the 2019 Plan. Shares of common stock underlying outstanding awards under the 2018 Plan that are forfeited, cancelled, held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding, reacquired by the Company prior to vesting, satisfied without the issuance of stock, expire or are otherwise terminated (other than by exercise) will be added to the shares of common stock available for issuance under the 2019 Plan. 2019 Stock option and incentive plan The 2019 Plan was adopted and approved by the Company’s board of directors in May 2019 and by the Company’s stockholders in June 2019. The 2019 Plan became effective on June 18, 2019 and replaced the Company’s 2018 Plan on that date. The 2019 Plan allows the board of directors or the compensation committee of the board of directors to make equity-based incentive awards to the Company’s officers, employees, directors or other key persons (including consultants). The number of shares initially reserved for issuance under the 2019 Plan was The 2019 Plan is administered by the board of directors or, at the discretion of the board of directors, by a committee of the board of directors. The exercise prices, vesting and other restrictions are determined at the discretion of the board of directors, or its committee if so delegated, except that the exercise price per share of stock options may not be less than 100% of the fair market value of the share of common stock on the date of grant and the term of stock option may not be greater than ten years. All incentive options granted to any person possessing more than 10% of the total combined voting power of all classes of shares may not have an exercise price of less than 110% of the fair market value of the common stock on the grant date. Stock options granted to employees, officers, members of the board of directors and consultants will typically vest over a four-year period. Shares that are expired, terminated, surrendered or canceled under the 2019 Plan without having been fully exercised will be available for future awards. 2019 Employee stock purchase plan The 2019 Employee Stock Purchase Plan (the “2019 ESPP”) was adopted and approved by the Company’s board of directors in May 2019 and by the Company’s stockholders in June 2019. The 2019 ESPP became effective on June 18, 2019, at which time 273,869 shares were reserved for issuance. The 2019 ESPP provides that the number of shares reserved and available for issuance will automatically increase each January 1, beginning on January 1, 2020 and each January 1 through January 1, 2029, by the least of (i) 1% of the outstanding number of shares of the Company’s common stock on the immediately preceding December 31, (ii) 410,803 shares or (iii) such number of shares as determined by the compensation committee. The 2019 ESPP was increased by 347,416 shares on January 1, 2021 and by 285,678 shares on January 1, 2020. Stock option valuation The assumptions that the Company used to determine the grant-date fair value of stock options granted to employees, directors and consultants as follows, presented on a weighted average basis: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Expected term (in years) 5.96 n/a 5.89 5.81 Expected volatility 70.04 % n/a 70.34 % 77.70 % Weighted average risk-free interest rate 0.91 % n/a 0.82 % 1.07 % Expected dividend yield 0.00 % n/a 0.00 % 0.00 % Stock options The following table summarizes the Company’s stock option activity since December 31, 2020: Weighted- Weighted- Average Average Aggregate Exercise remaining Intrinsic Number Price per contractual Value of Options Share term (years) (000's) Balance outstanding, December 31, 2020 3,733,312 $ 12.15 8.53 $ 52,498 Options granted 422,263 $ 25.71 Options exercised (123,523) $ 5.15 Balance outstanding, September 30, 2021 4,032,052 $ 13.79 7.98 $ 39,854 Exercisable, September 30, 2021 1,843,127 $ 10.20 7.63 $ 23,444 Vested and expected to vest, September 30, 2021 4,032,052 $ 13.79 7.98 $ 39,854 The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the Company’s common stock. The weighted average grant-date fair value per share of stock options granted during the three and nine months ended September 30, 2021 was $14.45 and $15.82, respectively. Stock-based compensation The following table summarizes the Company’s stock-based compensation expense during the three and nine months ended September 30, 2021 and 2020: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Classified within research and development expense $ 770 $ 378 $ 2,223 $ 1,115 Classified within general and administrative expense 1,842 1,168 5,189 2,991 Total stock-based compensation expense $ 2,612 $ 1,546 $ 7,412 $ 4,106 As of September 30, 2021, total unrecognized compensation cost related to unvested stock options was $22,511, which is expected to be recognized over a weighted average period of 2.0 years. In April, June and July 2019, certain option holders early exercised options to purchase 491,207 shares of common stock, at an average exercise price of $0.65 per share, for cash proceeds of $321 (See Note 6). Stock-based compensation expense related to these options will continue to be recognized over the requisite service period of the awards based on the grant-date fair value which was determined using the Black-Scholes option-pricing model. |
Amgen license agreement
Amgen license agreement | 9 Months Ended |
Sep. 30, 2021 | |
Amgen license agreement | |
Amgen license agreement | 8. Amgen license agreement In June 2018, the Company entered into a license agreement (the “Amgen Agreement”) with Amgen, Inc. (“Amgen”) pursuant to which the Company was granted an exclusive license to certain patents and intellectual property related to a long-acting FGF21 analog in order to commercially develop, manufacture, use and distribute FGF21 as a treatment for NASH and other serious metabolic diseases. The Amgen Agreement provides the Company with exclusive global rights to the licensed products and the right to grant sublicenses that cover EFX to third parties. In exchange for these rights, the Company made an upfront payment of $5,000 and issued 2,653,333 shares of Series A Preferred Stock with a fair value of $1,353 to Amgen. Amgen was also entitled to maintain a 10% ownership interest of the outstanding shares of the Company’s common stock, on a fully diluted and converted basis, through the second closing of the Company’s Series A Preferred Stock financing. In November 2018, in connection with the second closing of the Company’s Series A Preferred Stock financing, the Company issued 3,205,128 shares of Series A Preferred Stock to Amgen for a total value of $7,404, satisfying its anti-dilution obligation under the Amgen Agreement. Under the Amgen Agreement, the Company obligated to pay Amgen $7,500 in connection with dosing the first patient in a Phase 3 clinical trial, up to $30,000 in connection with marketing approvals, and aggregate milestone payments of up to $75,000 upon the achievement of specified commercial milestones for all products licensed under Under the Amgen Agreement, the Company is obligated to pay Amgen tiered royalties ranging from a low to high single-digit percentages on annual net sales of the licensed products, beginning on the first commercial sale of such licensed products in each country and expiring on a country-by-country basis on the latest of (i) the expiration of the last valid patent claim covering such licensed products in such country, (ii) the loss of regulatory exclusivity in such country, and (iii) ten years after the first commercial sale of such licensed product in such country. The royalty payments are subject to reduction under specified conditions The Company is solely responsible for all development, manufacturing, and commercial activities and costs of the licensed products, including clinical studies or other tests necessary to support the use of a licensed product. The Company is also responsible for costs related to the filing, prosecution and maintenance of The Amgen Agreement will remain in effect until the expiration of the royalty term in all countries for all licensed products. The Amgen Agreement may be terminated by either party with at least 90 days' notice in the event of material breach by the other party that remains uncured for 90 days, by either party for insolvency or bankruptcy of the other party and immediately by Amgen if the Company challenges the licensed patents. The Company may also terminate the Amgen Agreement with 90 days' written notice for discretionary reasons such as scientific, technical, regulatory or commercial issues During the three and nine months ended September 30, 2021 and 2020, the Company did not record any research and development expense in connection with the Amgen Agreement. |
Income taxes
Income taxes | 9 Months Ended |
Sep. 30, 2021 | |
Income taxes | |
Income taxes | 9. Income taxes During the three and nine months ended September 30, 2021 and 2020, the Company did no t record any income tax benefits for the net operating losses incurred or for the research and development tax credits generated in each period due to its uncertainty of realizing a benefit from those items. All of the Company’s operating losses since inception have been generated in the United States. On March 27, 2020, the Coronavirus Aid, Relief and Economic Security (CARES) Act, (the “Act”) was signed into law. The Act includes provisions relating to refundable payroll tax credits, deferment of the employer portion of certain payroll taxes, net operating loss carryback periods, alternative minimum tax credit refunds, modifications to the net interest deduction limitations and technical corrections to tax depreciation methods for qualified improvement property. The Company analyzed the provisions of the Act and determined there was no significant impact to its income tax provision for the three and nine months ended September 30, 2021. On December 27, 2020, the “Consolidated Appropriations Act, 2021” (the “CAA”) was signed into law. The CAA includes provisions meant to clarify and modify certain items put forth in CARES Act, while providing aid to businesses affected by the pandemic. The CAA allows deductions for expenses paid for by Paycheck Protection Program (“PPP”) and Economic Injury Disaster Loan (“EIDL”) Program, clarifies forgiveness of EIDL advances, and other business provisions. The Company analyzed the provisions of the CAA and determined there was no significant impact to its 2020 tax provision. On June 29, 2020, California signed Assembly Bill 85 (“A.B. 85”), was signed into law. A.B. 85, which includes several tax measures, provides for a three-year suspension of the use of net operating losses for medium and large businesses and a three-year cap on the use of business incentive tax credits to offset no more than $5 million of tax per year. Generally, A.B. 85 suspends the use of net operating losses for taxable years 2020, 2021, and 2022 for taxpayers with taxable income of $1 million or more.” Since the Company is not expected to generate California source taxable income of more than $1 million, no material impact is anticipated at this time. |
Net loss per share
Net loss per share | 9 Months Ended |
Sep. 30, 2021 | |
Net loss per share | |
Net loss per share | 10. Net loss per share Basic and diluted net loss per share attributable to common stockholders was calculated as follows: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Numerator: Net loss $ (24,330) $ (21,403) $ (68,353) $ (49,496) Denominator: Weighted average common shares outstanding, basic and diluted 34,862,116 34,002,769 34,807,439 30,381,671 Net loss per share, basic and diluted $ (0.70) $ (0.63) $ (1.96) $ (1.63) The Company excluded 42 shares and 53,679 shares of restricted common stock, presented on a weighted average basis, from the calculations of basic net loss per share for the three months ended September 30, 2021 and 2020, respectively, because those shares had not vested. The Company excluded 10,865 shares and 41,938 shares of restricted common stock, presented on a weighted average basis, from the calculations of basic net loss per share for the nine months ended September 30, 2021 and 2020, respectively, because those shares had not vested. The Company’s potentially dilutive securities, which include stock options and unvested restricted common stock, have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share is the same. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect: Three and nine months ended September 30, 2021 2020 Options to purchase common stock 4,032,052 3,158,642 Unvested restricted common stock — 48,501 4,032,052 3,207,143 |
Commitments and contingencies
Commitments and contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and contingencies | |
Commitments and contingencies | 11. Commitments and contingencies COVID-19 Pandemic In March 2020, the novel strain of coronavirus (“COVID-19”) was declared a pandemic by the World Health Organization. Efforts to contain the spread of COVID-19 intensified and the United States, Europe and Asia implemented severe travel restrictions, social distancing requirements, stay-at-home orders and delayed the commencement of non-COVID-19-related clinical trials, among other restrictions. The Company’s financial results for the three and nine months ended September 30, 2021 were not significantly impacted by COVID-19, however despite vaccination efforts, the Company cannot at this time predict the specific extent, duration, or full impact that the COVID-19 pandemic will have on its financial condition, operations, and business plans for the remainder of 2021 and into 2022, including the timing and enrollment of patients in its ongoing and future clinical trials and other expected milestones of its product candidate. Operating lease In February 2020, the Company entered into a seven-year agreement to occupy 6,647 square feet of office space in South San Francisco, California. The lease commenced on July 10, 2020 when the Company took occupancy of the leased space and the lease was determined to be operating classified. Under the agreement, the Company is required to make approximately $2,300 in total minimum payments during the term. The Company is also required to pay its proportionate share of building operating and tax costs after the first year under lease which are not included in the measurement of the lease and treated as variable lease cost and expensed when incurred. As of September 30, 2021, maturities of the Company’s operating lease liability was as follows: 2021 (remaining) $ 77 2022 312 2023 321 2024 331 2025 341 2026 and thereafter 559 Total future minimum lease payments 1,941 Less imputed interest (377) Present value of operating lease liabilities $ 1,564 As of September 30, 2021, the total lease liability noncurrent Accrued expenses and other current liabilities For the three and nine months ended September 30, 2021 and 2020, the components of operating lease cost were as follows: Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Lease cost: Statement of Operations Classification: Operating lease cost General and administrative expense $ 81 $ 73 $ 243 $ 186 Variable operating lease cost General and administrative expense — — — 43 Short-term lease cost Research and development expense — 8 — 32 Total operating lease cost $ 81 $ 81 $ 243 $ 261 Other information: Cash paid for amounts included in the measurement of operating lease liability $ 76 $ 18 $ 226 $ 135 Weighted average remaining lease term, in years 5.8 6.8 5.8 6.8 Weighted average discount rate 7.6% 7.6% 7.6% 7.6% Research and manufacturing commitments The Company has entered into agreements with contract research organizations and contract manufacturing organizations to provide services in connection with its nonclinical studies and clinical trials and to manufacture clinical development materials. As of September 30, 2021, the Company had non-cancelable purchase commitments under these agreements totaling $11,123. Indemnification agreements In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors and its executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not currently aware of any indemnification claims and has not accrued any liabilities related to such obligations in its condensed consolidated financial statements as of September 30, 2021. Legal proceedings The Company is not a party to any litigation and does not have contingency reserves established for any litigation liabilities. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses as incurred the costs related to such legal proceedings. |
Subsequent event
Subsequent event | 9 Months Ended |
Sep. 30, 2021 | |
Subsequent event. | |
Subsequent event | 12. Subsequent event The Company evaluated subsequent events through November 12, 2021, the date on which these financial statements were issued. Based on this evaluation, it was determined that no subsequent events occurred that require recognition or disclosure in its financial statements for the three and nine months ended September 30, 2021. |
Summary of significant accoun_2
Summary of significant accounting policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Summary of significant accounting policies | |
Unaudited interim financial statements | Unaudited interim financial statements The accompanying unaudited condensed consolidated financial statements have been prepared by the Company in accordance with GAAP for interim financial reporting and as required by Regulation S-X, Rule 10-01. The unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s audited annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of the Company’s condensed consolidated balance sheet as of September 30, 2021, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2021 and 2020, the condensed consolidated statements of stockholders’ equity (deficit) for the three and nine months ended September 30, 2021 and 2020 and the condensed consolidated statements of cash flows for the nine months ended September 30, 2021 and 2020. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2021 and 2020 are unaudited. The results for the three and nine months ended September 30, 2021 are not necessarily indicative of results to be expected for the year ending December 31, 2021, any other interim periods, or any future year or period. |
Use of estimates | Use of estimates The preparation of the Company's condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of expenses during the reporting period. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the accrual of research and development expenses, the valuations of common stock and the valuation allowance for deferred tax assets. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates when there are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those |
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 time of purchase to be cash equivalents. Cash equivalents consist primarily of amounts invested in money market accounts. |
Short-term marketable securities | Short-term marketable securities The Company invests in short-term marketable securities, primarily money market funds, commercial paper, U.S. treasury securities and corporate debt securities. The Company classifies its short-term marketable securities as available-for-sale securities and reports them at fair value in short-term marketable securities on the condensed consolidated balance sheets with related unrealized gains and losses included within accumulated other comprehensive gain (loss) on the condensed consolidated balance sheets. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity, which is included in other income on the condensed consolidated statements of operations and comprehensive loss. Realized gains and losses and declines in value judged to be other-than-temporary, if any, on available-for-sale securities are included in other income. The cost of securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in other income. The Company regularly reviews all its investments for other-than-temporary declines in estimated fair value. This review includes the consideration of the cause of the impairment, including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity and duration of the unrealized losses, whether the Company has the intent to sell the securities and whether it is more likely than not that the Company will be required to sell the securities before the recovery of their amortized cost basis. When the Company determines that the decline in estimated fair value of an investment is below the amortized cost basis and the decline is other-than-temporary, the carrying value of the security will be reduced and a loss will be recorded for the amount of such decline. |
Restricted cash | Restricted cash As of September 30, 2021 and December 31, 2020, the Company was required to maintain a separate cash balance of $108 for the benefit of the landlord in connection with the Company’s Gateway office space lease in South San Francisco, California (the “Gateway Lease”), which is classified within other assets (non-current) on the condensed consolidated balance sheets (see Note 11). As of December 31, 2020, the Company was required to maintain a separate cash balance of $40 to collateralize corporate credit cards with a bank, which is classified within other assets (non-current) on the condensed consolidated balance sheet. |
Concentrations of credit risk | Concentrations of credit risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents and short-term marketable securities. Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company deposits its cash investments in financial institutions that it believes have high credit quality and has not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships. At September 30, 2021 and December 31, 2020, all of the Company's cash, cash equivalents and short-term investments were held at one accredited financial |
Property and equipment | Property and equipment Property and equipment are stated at cost, less accumulated depreciation and amortization. Depreciation is provided using the straight-line method over the estimated useful lives of the assets, which is three years for furniture and equipment. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the improvements. Depreciation and amortization begins at the time the asset is placed in service. |
Leases | Leases The Company determines whether an arrangement is or contains a lease at inception by assessing whether the arrangement contains an identified asset and whether the Company has the right to control the identified asset. Right-of-use, or ROU, assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Lease liabilities are recognized at the lease commencement date based on the present value of future lease payments over the lease term. ROU assets are based on the measurement of the lease liability and are further adjusted by any lease payments made prior to or on lease commencement, lease incentives received and initial direct costs incurred, as applicable. The Company has elected to not recognize leases with a lease term of one year or less on its balance sheet. Operating lease costs included in the measurement of the lease are recognized on a straight-line basis over the lease term. Variable lease costs are expensed as incurred as an operating expense. The Company determines the lease classification and the present value of future lease payments at the time of the lease commencement using an incremental borrowing rate that it estimates based upon the Company’s credit risk and term of the lease. The interest rate implicit in lease contracts has not historically been readily determinable and the Company must therefore use the appropriate incremental borrowing rate to measure its leases. To estimate the incremental borrowing rate, a credit rating applicable to the Company is estimated using a synthetic credit rating analysis since the Company does not currently have a rating agency-based credit rating. |
Research and development costs | Research and development costs Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred to discover, research and develop drug candidates, including personnel expenses, stock-based compensation expense, third-party license fees and external costs including fees paid to consultants, contract manufacturing organizations, or CMOs, and clinical research organizations, or CROs, in connection with drug product manufacturing, nonclinical studies and clinical trials, and other related clinical trial fees, such as for investigator grants, patient screening, laboratory work, clinical trial database management, clinical trial material management and statistical compilation and analysis. Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are recorded as prepaid expenses. Such amounts are recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered or the services Costs incurred i n obtaining technology licenses are charged immediately to research and development expense if the technology licensed has not reached technological feasibility and has no alternative |
Research contract costs and accruals | Research contract costs and accruals The Company has entered into various research and development and other agreements with commercial firms, researchers and others for provisions of goods and services. These agreements are generally cancelable, and the related costs are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research and development costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies or clinical trials, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ materially from the Company's estimates. |
Stock-based compensation | Stock-based compensation The Company measures all stock-based awards granted to employees and nonemployees based on the fair value on the date of the grant and recognizes compensation expense for those awards over the requisite service period, which is generally the vesting period of the respective award, on a straight-line basis. The Company accounts for forfeitures as they occur. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model. Prior to the Company’s initial public offering, the exercise price for all stock options granted was at the estimated fair value of the underlying common stock as determined on the date of grant by the Company’s board of directors. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model, which requires inputs based on certain subjective assumptions, including the expected stock price volatility, the expected term of the option, the risk-free interest rate for a period that approximates the expected term of the option, and the Company's expected dividend yield. The Company went public in June 2019 and accordingly, lacks sufficient company-specific historical and implied volatility information for its shares traded in the public markets. Therefore, it estimates its expected share price volatility based on the historical volatility of publicly traded peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded share price. The expected term of the Company's stock options has been determined utilizing the "simplified" method for awards that qualify as "plain-vanilla" options. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future. The fair value of each common stock award is estimated on the date of grant based on the fair value of the Company's common stock Compensation expense for purchases under the Employee Stock Purchase Plan is recognized based on the fair value of the common stock estimated based on the closing price of our common stock as reported on the date of offering, less the purchase discount percentage provided for in the plan. The Company classifies stock-based compensation expense in its condensed consolidated statement of operations and comprehensive loss in the same manner in which the award recipient's payroll costs are classified or in which the award recipient's service payments |
Comprehensive loss | Comprehensive loss Comprehensive loss includes net loss as well as other changes in stockholders' equity (deficit) that result from transactions and economic events other than those with stockholders. The Company’s comprehensive loss is comprised of net loss and changes in unrealized gains and losses on its short-term marketable securities |
Emerging growth company | Emerging growth company The Company is an emerging growth company as defined in the Jumpstart Our Business Startups Act of 2012, as amended (the “JOBS Act”). Under the JOBS Act, companies have extended transition periods available for complying with new or revised accounting standards. The Company has elected this exemption to delay adopting new or revised accounting standards until such time as those standards apply. On the last business day of the second quarter in 2021, the aggregate market value of the Company shares held by non-affiliate stockholders exceeded $700 million. As a result, as of December 31, 2021, the Company will be considered a large accelerated filer as defined in Rule 12b-2 under the Exchange Act, and will cease to be an emerging growth company as defined in the JOBS Act. The Company will no longer be exempt from the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act, and our independent registered public accounting firm will evaluate and report on the effectiveness of internal control over financial reporting. The Company will also no longer be permitted to take advantage of reduced reporting requirements for smaller reporting companies. |
Recently issued accounting pronouncements and pronouncements not yet adopted | Recently adopted accounting pronouncements On January 1, 2021, the Company adopted Accounting Standard Update No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (ASU 2019-12), which simplifies the accounting for income taxes. ASU 2019-12 was effective beginning January 1, 2021. The adoption of this new standard did not have a material impact on our condensed consolidated financial statements. Recently issued accounting pronouncements not yet adopted In June 2016, the FASB issued No. ASU 2016-13, Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13 requires measurement and recognition of expected credit losses for financial assets. In November 2019, the FASB issued No. ASU 2019-10 to modify the effective date for ASU 2016-13 for other public business entities includes smaller reporting companies, as defined by the SEC. This guidance will become effective for the Company beginning in the first quarter of 2023. Early adoption is permitted. The Company is currently evaluating the impact that the adoption of ASU 2016-13 will have on its condensed consolidated financial statements. |
Fair value of financial asset_2
Fair value of financial assets and liabilities (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Fair value of financial assets and liabilities | |
Summary of assets that are measured at fair value on a recurring basis | September 30, 2021 Total Level 1 Level 2 Level 3 Money market funds $ 139,039 $ 139,039 $ — $ — Commercial paper 7,000 — 7,000 — Corporate debt securities 43,146 — 43,146 — $ 189,185 $ 139,039 $ 50,146 $ — December 31, 2020 Total Level 1 Level 2 Level 3 Money market funds $ 158,023 $ 158,023 $ — $ — Commercial paper 47,955 — 47,955 — Corporate debt securities 33,190 — 33,190 — $ 239,168 $ 158,023 $ 81,145 $ — |
Short-term marketable securit_2
Short-term marketable securities (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Short-term marketable securities | |
Summary of short-term marketable securities | The following is a summary of short-term marketable securities as of September 30, 2021 and December 31, 2020 September 30, 2021 Amortized cost Gross unrealized gains Gross unrealized losses Fair value Money market funds $ 139,039 $ — $ — $ 139,039 Commercial paper 7,000 — — 7,000 Corporate debt securities 43,163 — (17) 43,146 $ 189,202 $ — $ (17) $ 189,185 Cash equivalents $ 139,039 Short-term marketable securities 50,146 $ 189,185 December 31, 2020 Amortized cost Gross unrealized gains Gross unrealized losses Fair value Money market funds $ 158,023 $ — $ — $ 158,023 Commercial paper 47,955 — — 47,955 Corporate debt securities 33,193 — (3) 33,190 $ 239,171 $ — $ (3) $ 239,168 Cash equivalents $ 158,023 Short-term marketable securities 81,145 $ 239,168 |
Accrued expenses and other cu_2
Accrued expenses and other current liabilities (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Accrued expenses and other current liabilities | |
Schedule of accrued expenses and other current liabilities | September 30, 2021 December 31, 2020 Accrued external research and development expenses $ 14,148 $ 8,740 Accrued employee compensation and benefits 2,218 495 Accrued legal and professional fees 191 154 Short-term lease liability and other 199 294 $ 16,756 $ 9,683 |
Stockholder's equity (deficit)
Stockholder's equity (deficit) (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Stockholder's equity (deficit) | |
Schedule of common stock reserved for issuance | The following shares of common stock were reserved for issuance as follows: September 30, 2021 December 31, 2020 Options outstanding under the 2018 Stock Option and Grant Plan 2,028,496 2,148,019 Options outstanding under the 2019 Stock Option and Incentive Plan 2,003,556 1,585,293 Options available for future grant 3,094,946 2,127,544 Common stock available for ATM program 5,000,000 — 2019 Employee Stock Purchase Plan 881,249 543,963 Total 13,008,247 6,404,819 |
Summary of restricted stock activity | Grant-Date Fair Number of Shares Value Unvested restricted common stock as of December 31, 2020 33,614 $ 0.62 Shares vesting (33,614) 0.62 Unvested restricted common stock as of September 30, 2021 — - |
Stock-based awards (Tables)
Stock-based awards (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Stock-based awards | |
Schedule of assumptions used to determine grant-date fair value of stock options granted | Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Expected term (in years) 5.96 n/a 5.89 5.81 Expected volatility 70.04 % n/a 70.34 % 77.70 % Weighted average risk-free interest rate 0.91 % n/a 0.82 % 1.07 % Expected dividend yield 0.00 % n/a 0.00 % 0.00 % |
Summary of stock option activity | Weighted- Weighted- Average Average Aggregate Exercise remaining Intrinsic Number Price per contractual Value of Options Share term (years) (000's) Balance outstanding, December 31, 2020 3,733,312 $ 12.15 8.53 $ 52,498 Options granted 422,263 $ 25.71 Options exercised (123,523) $ 5.15 Balance outstanding, September 30, 2021 4,032,052 $ 13.79 7.98 $ 39,854 Exercisable, September 30, 2021 1,843,127 $ 10.20 7.63 $ 23,444 Vested and expected to vest, September 30, 2021 4,032,052 $ 13.79 7.98 $ 39,854 |
Summary of stock-based compensation expense | Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Classified within research and development expense $ 770 $ 378 $ 2,223 $ 1,115 Classified within general and administrative expense 1,842 1,168 5,189 2,991 Total stock-based compensation expense $ 2,612 $ 1,546 $ 7,412 $ 4,106 |
Net loss per share (Tables)
Net loss per share (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Net loss per share | |
Schedule of basic and diluted net loss per share attributable to common stockholders | Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Numerator: Net loss $ (24,330) $ (21,403) $ (68,353) $ (49,496) Denominator: Weighted average common shares outstanding, basic and diluted 34,862,116 34,002,769 34,807,439 30,381,671 Net loss per share, basic and diluted $ (0.70) $ (0.63) $ (1.96) $ (1.63) |
Schedule of computation of diluted net loss per share attributable to common stockholders | Three and nine months ended September 30, 2021 2020 Options to purchase common stock 4,032,052 3,158,642 Unvested restricted common stock — 48,501 4,032,052 3,207,143 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and contingencies | |
Schedule of maturity of the Company's operating lease liabilities | 2021 (remaining) $ 77 2022 312 2023 321 2024 331 2025 341 2026 and thereafter 559 Total future minimum lease payments 1,941 Less imputed interest (377) Present value of operating lease liabilities $ 1,564 |
Schedule of components of operating lease expense | Three Months Ended Nine Months Ended September 30, September 30, 2021 2020 2021 2020 Lease cost: Statement of Operations Classification: Operating lease cost General and administrative expense $ 81 $ 73 $ 243 $ 186 Variable operating lease cost General and administrative expense — — — 43 Short-term lease cost Research and development expense — 8 — 32 Total operating lease cost $ 81 $ 81 $ 243 $ 261 Other information: Cash paid for amounts included in the measurement of operating lease liability $ 76 $ 18 $ 226 $ 135 Weighted average remaining lease term, in years 5.8 6.8 5.8 6.8 Weighted average discount rate 7.6% 7.6% 7.6% 7.6% |
Nature of the business and ba_2
Nature of the business and basis of presentation (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Nature of the business and basis of presentation | ||||||||||
Net loss | $ 24,330 | $ 28,933 | $ 15,090 | $ 21,403 | $ 16,207 | $ 11,886 | $ 68,353 | $ 49,496 | $ 79,207 | $ 43,755 |
Accumulated deficit | 277,880 | 277,880 | $ 209,527 | |||||||
Cash, cash equivalents and short-term marketable securities | $ 215,081 | $ 215,081 |
Summary of significant accoun_3
Summary of significant accounting policies - Restricted cash (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Jun. 30, 2021 | Dec. 31, 2020 |
Summary of significant accounting policies | |||
Separate cash balance for the landlord | $ 108 | $ 108 | |
Separate cash balance to collateralize corporate credit cards with a bank | $ 40 | ||
Aggregate market value of stock | $ 700,000 |
Summary of significant accoun_4
Summary of significant accounting policies - Property and equipment (Details) | 9 Months Ended |
Sep. 30, 2021 | |
Furniture and equipment | |
Property and equipment | |
Estimated useful lives | 3 years |
Summary of significant accoun_5
Summary of significant accounting policies - Leases (Details) | Sep. 30, 2021 |
Summary of significant accounting policies | |
Lease term | 1 year |
Fair value of financial asset_3
Fair value of financial assets and liabilities - Recurring (Details) - Recurring - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | $ 189,185 | $ 239,168 |
Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 139,039 | 158,023 |
Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 7,000 | 47,955 |
Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 43,146 | 33,190 |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 139,039 | 158,023 |
Level 1 | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 139,039 | 158,023 |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 50,146 | 81,145 |
Level 2 | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | 7,000 | 47,955 |
Level 2 | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets | $ 43,146 | $ 33,190 |
Fair value of financial asset_4
Fair value of financial assets and liabilities - Textual (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Fair value of financial assets and liabilities | ||
Transfers from level 1 to level 2, Assets | $ 0 | $ 0 |
Transfers from level 2 to level 1, Assets | 0 | 0 |
Transfers from level 1 to level 2, Liabilities | 0 | 0 |
Transfers from level 2 to level 1, Liabilities | 0 | 0 |
Transfers into level 3 Assets | 0 | 0 |
Transfers out of level 3 Assets | 0 | 0 |
Transfers into level 3 liabilities | 0 | 0 |
Transfers out of level 3 liabilities | $ 0 | $ 0 |
Short-term marketable securit_3
Short-term marketable securities (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | $ 189,202 | $ 239,171 |
Gross unrealized losses | (17) | (3) |
Fair value | 189,185 | 239,168 |
Cash equivalents | 139,039 | 158,023 |
Short-term marketable securities | 50,146 | 81,145 |
Total | $ 189,185 | $ 239,168 |
Short-term contractual maturities | 1 year | 1 year |
Money market funds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | $ 139,039 | $ 158,023 |
Fair value | 139,039 | 158,023 |
Commercial paper | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | 7,000 | 47,955 |
Fair value | 7,000 | 47,955 |
Corporate debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | 43,163 | 33,193 |
Gross unrealized losses | (17) | (3) |
Fair value | $ 43,146 | $ 33,190 |
Accrued expenses and other cu_3
Accrued expenses and other current liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Accrued expenses and other current liabilities | ||
Accrued external research and development expenses | $ 14,148 | $ 8,740 |
Accrued employee compensation and benefits | 2,218 | 495 |
Accrued legal and professional fees | 191 | 154 |
Short-term lease liability and other | 199 | 294 |
Total accrued expenses and other current liabilities | $ 16,756 | $ 9,683 |
Stockholder's equity (deficit_2
Stockholder's equity (deficit) - Common stock (Details) $ / shares in Units, $ in Thousands | May 18, 2021USD ($)shares | Jul. 10, 2020USD ($)$ / sharesshares | Jun. 24, 2019USD ($)$ / sharesshares | Sep. 30, 2021Vote$ / sharesshares | Dec. 31, 2020$ / sharesshares | Jun. 18, 2019shares |
Class of Stock | ||||||
Common stock, shares authorized | 150,000,000 | 150,000,000 | ||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||
Number of votes per share | Vote | 1 | |||||
Cash dividend declared | $ / shares | $ 0 | |||||
Cash dividend paid | $ / shares | $ 0 | |||||
Common stock, shares issued | 34,875,302 | 34,741,649 | ||||
Common stock, shares outstanding | 34,875,302 | 34,741,649 | ||||
Common stock were reserved for issuance | ||||||
Options available for future grant | 13,008,247 | 6,404,819 | ||||
Options available for future grant | ||||||
Common stock were reserved for issuance | ||||||
Options available for future grant | 3,094,946 | 2,127,544 | ||||
Common stock available for ATM program | ||||||
Common stock were reserved for issuance | ||||||
Options available for future grant | 5,000,000 | 5,000,000 | ||||
2018 Stock option and grant plan | ||||||
Common stock were reserved for issuance | ||||||
Options available for future grant | 2,028,496 | 2,148,019 | 107,635 | |||
2019 Stock Option and Incentive plan | ||||||
Common stock were reserved for issuance | ||||||
Options available for future grant | 2,003,556 | 1,585,293 | ||||
2019 Employee Stock Purchase Plan | ||||||
Common stock were reserved for issuance | ||||||
Options available for future grant | 881,249 | 543,963 | ||||
Maximum | Common stock available for ATM program | ||||||
Class of Stock | ||||||
Share Issued value under agreement | $ | $ 100,000 | |||||
IPO | ||||||
Class of Stock | ||||||
Share Issued under agreement | 6,612,500 | |||||
Public offering price | $ / shares | $ 16 | |||||
Proceeds received, net of underwriting discounts and commissions | $ | $ 98,394 | |||||
Offering costs | $ | $ 2,942 | |||||
Number of shares converted | 21,056,136 | |||||
Follow Up Public Offering | ||||||
Class of Stock | ||||||
Share Issued under agreement | 6,012,390 | |||||
Public offering price | $ / shares | $ 36 | |||||
Proceeds received, net of underwriting discounts and commissions | $ | $ 203,460 | |||||
Offering costs | $ | $ 906 | |||||
Over allotment | Maximum | ||||||
Class of Stock | ||||||
Share Issued under agreement | 784,224 | 862,500 |
Stockholder's equity (deficit_3
Stockholder's equity (deficit) - Undesignated preferred stock and Restricted common stock (Details) - $ / shares | 1 Months Ended | ||
Mar. 31, 2018 | Mar. 31, 2017 | Sep. 30, 2021 | |
Restricted stock | |||
Class of Stock | |||
Shares issued (in shares) | 226,400 | ||
Stock options vesting period | 2 years | 4 years | |
Undesignated Preferred Stock | |||
Class of Stock | |||
Preferred stock, par value (in dollars per share) | $ 0.0001 | ||
Preferred stock, shares issued | 0 | ||
Preferred stock, shares outstanding | 0 | ||
Undesignated Preferred Stock | Maximum | |||
Class of Stock | |||
Preferred stock, shares authorized | 10,000,000 |
Stockholder's equity (deficit_4
Stockholder's equity (deficit) - Restricted stock activity (Details) - Restricted stock | 9 Months Ended |
Sep. 30, 2021USD ($)shares | |
Number of Shares | |
Beginning balance of unvested restricted common stock | shares | 33,614 |
Shares vesting | shares | (33,614) |
Grant-Date Fair Value | |
Beginning balance of unvested restricted common stock | $ | $ 0.62 |
Shares vesting | $ | $ 0.62 |
Stock-based awards - Textual (D
Stock-based awards - Textual (Details) - shares | Jun. 18, 2019 | Jun. 30, 2019 | Sep. 30, 2021 | Jan. 31, 2021 | Dec. 31, 2020 | Jan. 31, 2020 |
Share-based awards | ||||||
Number of shares remained available for grant | 13,008,247 | 6,404,819 | ||||
2018 Stock option and grant plan | ||||||
Share-based awards | ||||||
Number of shares of common stock issued | 3,071,960 | |||||
Number of shares remained available for grant | 107,635 | 2,028,496 | 2,148,019 | |||
2019 Stock option and incentive plan | ||||||
Share-based awards | ||||||
Number of shares remained available for grant | 107,635 | |||||
Number of shares initially reserved for issuance | 2,572,457 | |||||
Number of additional shares reserved for issuance | 1,389,665 | 1,142,713 | ||||
Percent of shares reserved and available for issuance automatically increase annually on January 1 | 4.00% | |||||
Percentage of exercise price per share of stock options | 100.00% | |||||
Percentage of minimum exercise price, holding more than 10% of voting power | 110.00% | |||||
Stock options vesting period | 4 years | |||||
2019 Employee stock purchase plan | ||||||
Share-based awards | ||||||
Number of shares initially reserved for issuance | 273,869 | |||||
Number of additional shares reserved for issuance | 347,416 | 285,678 | ||||
Percent of shares reserved and available for issuance automatically increase annually on January 1 | 1.00% | |||||
Number of shares reserved and available for issuance automatically increase annually on January 1 (in shares) | 410,803 | |||||
Maximum | 2019 Stock option and incentive plan | ||||||
Share-based awards | ||||||
Term of stock option | 10 years |
Stock-based awards - Stock opti
Stock-based awards - Stock option valuation (Details) | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | |
Assumptions to determine grant-date fair value of stock options granted | |||
Expected term (in years) | 5 years 11 months 15 days | 5 years 10 months 20 days | 5 years 9 months 21 days |
Expected volatility | 70.04% | 70.34% | 77.70% |
Weighted average risk-free interest rate | 0.91% | 0.82% | 1.07% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Stock based awards - Stock opti
Stock based awards - Stock option activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Sep. 30, 2021 | Dec. 31, 2020 | |
Number of Options | |||
Balance Outstanding, Beginning of the period (in shares) | 3,733,312 | ||
Options granted ( in shares) | 422,263 | ||
Options exercised ( in shares) | (123,523) | ||
Balance Outstanding, End of the period (in shares) | 4,032,052 | 4,032,052 | 3,733,312 |
Exercisable ( in shares) | 1,843,127 | 1,843,127 | |
Vested and expected to vest ( in shares) | 4,032,052 | 4,032,052 | |
Weighted-Average Exercise Price per Share | |||
Weighted-average exercise price, Beginning of the period (in dollars per share) | $ 12.15 | ||
Weighted-average exercise price, Granted (in dollars per share) | 25.71 | ||
Weighted-average exercise price, Exercised (in dollars per share) | 5.15 | ||
Weighted-average exercise price, End of the period (in dollars per share) | $ 13.79 | 13.79 | $ 12.15 |
Weighted-average exercise price, Exercisable ( in dollars per share ) | 10.20 | 10.20 | |
Weighted-average exercise price, Vested and expected to vest at end of the period (in dollars per share) | $ 13.79 | $ 13.79 | |
Weighted-Average remaining contractual term (years) and Aggregate Intrinsic Value | |||
Weighted-average remaining contractual term outstanding (in years) | 7 years 11 months 23 days | 8 years 6 months 10 days | |
Weighted-average remaining contractual term , Options Exercisable(in years) | 7 years 7 months 17 days | ||
Weighted-average remaining contractual term vested and expected to vest (in years) | 7 years 11 months 23 days | ||
Aggregate Intrinsic Value Balance outstanding | $ 39,854 | $ 39,854 | $ 52,498 |
Aggregate Intrinsic Value Exercisable | 23,444 | 23,444 | |
Aggregate Intrinsic Value Vested and Expected to vest | $ 39,854 | $ 39,854 | |
Weighted average grant-date fair value per share of stock options granted | $ 14.45 | $ 15.82 |
Stock based awards - Stock-base
Stock based awards - Stock-based compensation (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Jul. 31, 2019 | Jun. 30, 2019 | Apr. 30, 2019 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Stock-based compensation | |||||||
Total stock-based compensation expense | $ 2,612 | $ 1,546 | $ 7,412 | $ 4,106 | |||
Total unrecognized compensation cost related to unvested stock-based awards | 22,511 | $ 22,511 | |||||
Weighted average period of recognition for unrecognized compensation cost | 2 years | ||||||
Common Stock | |||||||
Stock-based compensation | |||||||
Issuance of restricted common stock upon early exercise of stock options (in shares) | 491,207 | 491,207 | 491,207 | ||||
Exercise price of common stock purchase | $ 0.65 | $ 0.65 | $ 0.65 | ||||
Proceeds from the early exercise of stock options in exchange for restricted common stock | $ 321 | $ 321 | $ 321 | ||||
Research and development expense | |||||||
Stock-based compensation | |||||||
Total stock-based compensation expense | 770 | 378 | $ 2,223 | 1,115 | |||
General and administrative expense | |||||||
Stock-based compensation | |||||||
Total stock-based compensation expense | $ 1,842 | $ 1,168 | $ 5,189 | $ 2,991 |
Amgen license agreement (Detail
Amgen license agreement (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Aug. 31, 2019 | Nov. 30, 2018 | Jun. 30, 2018 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||
Research and development expense | $ 19,470 | $ 17,379 | $ 54,048 | $ 39,207 | |||
Amgen Agreement | |||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||
Initial fair value of the anti-dilution right liability | $ 7,404 | ||||||
Payment for clinical trail | $ 2,500 | ||||||
Obligation for payment in connection with dosing of the first patient | 7,500 | ||||||
Amgen Agreement | Maximum | |||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||
Aggregate milestone payments upon the achievement of specified commercial milestones | 75,000 | ||||||
Payment in connection with dosing of the first patient | $ 30,000 | ||||||
Amgen Agreement | Amgen | |||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||
Ownership interest of the outstanding shares (as a percent) | 10.00% | ||||||
Amgen Agreement | Research and development expense | |||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||
Research and development expense | $ 0 | $ 0 | $ 0 | $ 0 | |||
Amgen Agreement | Amgen | |||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||
Upfront payment | $ 5,000 | ||||||
Amgen Agreement | Series A Preferred Stock | |||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||
Share Issued under agreement | 3,205,128 | ||||||
Amgen Agreement | Series A Preferred Stock | Amgen | |||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||
Share Issued under agreement | 2,653,333 | ||||||
Share Issued value under agreement | $ 1,353 |
Income taxes - Current income t
Income taxes - Current income tax provision (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Current income tax provision: | ||||
Income tax benefit related to operating losses and research and development tax credits | $ 0 | $ 0 | $ 0 | $ 0 |
Income tax benefits | $ 0 | $ 0 |
Net loss per share - Basic and
Net loss per share - Basic and Diluted (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Numerator: | ||||||||||
Net loss | $ (24,330) | $ (28,933) | $ (15,090) | $ (21,403) | $ (16,207) | $ (11,886) | $ (68,353) | $ (49,496) | $ (79,207) | $ (43,755) |
Denominator: | ||||||||||
Weighted average common shares outstanding, basic and diluted | 34,862,116 | 34,002,769 | 34,807,439 | 30,381,671 | ||||||
Net loss per share, basic and diluted | $ (0.70) | $ (0.63) | $ (1.96) | $ (1.63) | ||||||
Number of weighted average restricted common stock | 42 | 53,679 | 10,865 | 41,938 |
Net loss per share - Anti-Dilut
Net loss per share - Anti-Diluted (Details) - shares | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share | ||
Antidilutive shares excluded from the calculation of diluted earnings per share, total | 4,032,052 | 3,207,143 |
Options available for future grant | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share | ||
Antidilutive shares excluded from the calculation of diluted earnings per share, total | 4,032,052 | 3,158,642 |
Unvested restricted common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share | ||
Antidilutive shares excluded from the calculation of diluted earnings per share, total | 48,501 |
Commitments and contingencies_2
Commitments and contingencies (Details) $ in Thousands | Sep. 30, 2021USD ($) | Dec. 31, 2020USD ($) | Jul. 10, 2020ft² | Feb. 29, 2020USD ($) |
Commitments and contingencies | ||||
Initial lease term under the agreement | 1 year | |||
Lease agreement term | 7 years | |||
Square feet of office | ft² | 6,647 | |||
Minimum payments during the term | $ 2,300 | |||
Non-cancelable purchase commitments with contract research organizations and contract manufacturing organizations | $ 11,123 | |||
Total lease liability | $ 1,564 | |||
Operating Lease, Liability, Statement of Financial Position [Extensible List] | akro:AccruedExpensesAndOtherCurrentLiabilities us-gaap:OperatingLeaseLiabilityNoncurrent | |||
Operating lease liability, noncurrent | $ 1,365 | $ 1,516 | ||
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Operating lease liability, noncurrent | |||
Short-term Liabilities | $ 199 | |||
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accrued Expenses and Other Current Liabilities. |
Commitments and contingencies -
Commitments and contingencies - Maturities Of Operating Leases (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Lessee, Operating Lease, Liability, Payment, Due [Abstract] | |
2021 (remaining) | $ 77 |
2022 | 312 |
2023 | 321 |
2024 | 331 |
2025 | 341 |
2026 and thereafter | 559 |
Total future minimum lease payments | 1,941 |
Less imputed interest | (377) |
Present value of operating lease liabilities | $ 1,564 |
Commitments and contingencies_3
Commitments and contingencies - Components of operating lease expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Operating lease expense: | ||||
Total operating lease cost | $ 81 | $ 81 | $ 243 | $ 261 |
Other information: | ||||
Cash paid for amounts included in the measurement of operating lease liability | $ 76 | $ 18 | $ 226 | $ 135 |
Weighted average remaining lease term, in years | 5 years 9 months 18 days | 6 years 9 months 18 days | 5 years 9 months 18 days | 6 years 9 months 18 days |
Weighted average discount rate | 7.60% | 7.60% | 7.60% | 7.60% |
General and administrative expense | ||||
Operating lease expense: | ||||
Operating lease cost | $ 81 | $ 73 | $ 243 | $ 186 |
Variable operating lease cost | 43 | |||
Research and development expense | ||||
Operating lease expense: | ||||
Short-term lease cost | $ 8 | $ 32 |