Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 04, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-36579 | |
Entity Registrant Name | Adverum Biotechnologies, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 20-5258327 | |
Entity Address, Address Line One | 100 Cardinal Way | |
Entity Address, City or Town | Redwood City | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94063 | |
City Area Code | 650 | |
Local Phone Number | 656-9323 | |
Title of 12(b) Security | Common Stock, $0.0001 par value | |
Trading Symbol | ADVM | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 99,729,025 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001501756 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 84,430 | $ 34,195 |
Short-term investments | 118,834 | 270,993 |
Lease incentive receivables | 0 | 5,709 |
Prepaid expenses and other current assets | 9,979 | 6,248 |
Total current assets | 213,243 | 317,145 |
Operating lease right-of-use assets | 79,882 | 86,000 |
Property and equipment, net | 36,579 | 33,060 |
Restricted cash | 2,503 | 2,503 |
Deferred rent receivable | 0 | 769 |
Deposit and other long-term assets | 155 | 250 |
Total assets | 332,362 | 439,727 |
Current liabilities: | ||
Accounts payable | 846 | 1,387 |
Accrued expenses and other current liabilities | 16,539 | 18,047 |
Lease liability, current portion | 11,236 | 1,886 |
Total current liabilities | 28,621 | 21,320 |
Lease liability, net of current portion | 94,464 | 101,108 |
Other non-current liabilities | 940 | 1,114 |
Total liabilities | 124,025 | 123,542 |
Stockholders’ equity: | ||
Preferred stock | 0 | 0 |
Common stock | 10 | 10 |
Additional paid-in capital | 980,156 | 964,965 |
Accumulated other comprehensive loss | (1,953) | (714) |
Accumulated deficit | (769,876) | (648,076) |
Total stockholders’ equity | 208,337 | 316,185 |
Total liabilities and stockholders' equity | $ 332,362 | $ 439,727 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income Statement [Abstract] | ||||
License revenue | $ 0 | $ 0 | $ 0 | $ 7,500 |
Operating expenses: | ||||
Research and development | 23,849 | 24,069 | 77,078 | 66,657 |
General and administrative | 17,188 | 14,453 | 46,117 | 52,546 |
Total operating expenses | 41,037 | 38,522 | 123,195 | 119,203 |
Operating loss | (41,037) | (38,522) | (123,195) | (111,703) |
Other income, net | 923 | 160 | 1,450 | 572 |
Net loss before income taxes | (40,114) | (38,362) | (121,745) | (111,131) |
Income tax provision | (17) | 0 | (55) | 0 |
Net loss | (40,131) | (38,362) | (121,800) | (111,131) |
Other comprehensive loss: | ||||
Net unrealized loss on marketable securities | (127) | (55) | (1,189) | (139) |
Foreign currency translation adjustment | (30) | (51) | (50) | (123) |
Comprehensive loss | $ (40,288) | $ (38,468) | $ (123,039) | $ (111,393) |
Net loss per share — basic (in USD per share) | $ (0.40) | $ (0.39) | $ (1.23) | $ (1.13) |
Net loss per share — diluted (in USD per share) | $ (0.40) | $ (0.39) | $ (1.23) | $ (1.13) |
Weighted-average common shares used to compute net loss per share - basic (in shares) | 99,475 | 98,126 | 99,027 | 97,966 |
Weighted-average common shares used to compute net loss per share - diluted (in shares) | 99,475 | 98,126 | 99,027 | 97,966 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders’ Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive (Loss)/Income | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2020 | 97,549,000 | ||||
Beginning balance at Dec. 31, 2020 | $ 434,347 | $ 10 | $ 937,134 | $ (261) | $ (502,536) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation expense | 7,224 | 7,224 | |||
Issuance of common stock, net of issuance costs (in shares) | 121,000 | ||||
Issuance of common stock, net of issuance costs | 1,689 | 1,689 | |||
Common stock issued upon exercise of stock options (in shares) | 9,000 | ||||
Common stock issued upon exercise of stock options | 51 | 51 | |||
Common stock issued upon release of restricted stock units (in shares) | 248,000 | ||||
Foreign currency translation adjustments | (33) | (33) | |||
Unrealized loss on marketable securities, net | (22) | (22) | |||
Net loss | (28,436) | (28,436) | |||
Ending balance (in shares) at Mar. 31, 2021 | 97,927,000 | ||||
Ending balance at Mar. 31, 2021 | 414,820 | $ 10 | 946,098 | (316) | (530,972) |
Beginning balance (in shares) at Dec. 31, 2020 | 97,549,000 | ||||
Beginning balance at Dec. 31, 2020 | 434,347 | $ 10 | 937,134 | (261) | (502,536) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Foreign currency translation adjustments | (123) | ||||
Unrealized loss on marketable securities, net | (139) | ||||
Net loss | (111,131) | ||||
Ending balance (in shares) at Sep. 30, 2021 | 98,143,000 | ||||
Ending balance at Sep. 30, 2021 | 346,000 | $ 10 | 960,180 | (523) | (613,667) |
Beginning balance (in shares) at Mar. 31, 2021 | 97,927,000 | ||||
Beginning balance at Mar. 31, 2021 | 414,820 | $ 10 | 946,098 | (316) | (530,972) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation expense | 8,234 | 8,234 | |||
Issuance of common stock, additional issuance costs | (4) | (4) | |||
Common stock issued upon release of restricted stock units (in shares) | 17,000 | ||||
Common stock issued under employee stock purchase plan (in shares) | 176,000 | ||||
Common stock issued under employee stock purchase plan | 526 | 526 | |||
Foreign currency translation adjustments | (39) | (39) | |||
Unrealized loss on marketable securities, net | (62) | (62) | |||
Net loss | (44,333) | (44,333) | |||
Ending balance (in shares) at Jun. 30, 2021 | 98,120,000 | ||||
Ending balance at Jun. 30, 2021 | 379,142 | $ 10 | 954,854 | (417) | (575,305) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation expense | 5,326 | 5,326 | |||
Common stock issued upon release of restricted stock units (in shares) | 23,000 | ||||
Foreign currency translation adjustments | (51) | (51) | |||
Unrealized loss on marketable securities, net | (55) | (55) | |||
Net loss | (38,362) | (38,362) | |||
Ending balance (in shares) at Sep. 30, 2021 | 98,143,000 | ||||
Ending balance at Sep. 30, 2021 | 346,000 | $ 10 | 960,180 | (523) | (613,667) |
Beginning balance (in shares) at Dec. 31, 2021 | 98,381,000 | ||||
Beginning balance at Dec. 31, 2021 | 316,185 | $ 10 | 964,965 | (714) | (648,076) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation expense | 5,381 | 5,381 | |||
Common stock issued upon exercise of stock options (in shares) | 15,000 | ||||
Common stock issued upon exercise of stock options | 3 | 3 | |||
Common stock issued upon release of restricted stock units (in shares) | 371,000 | ||||
Foreign currency translation adjustments | 14 | 14 | |||
Unrealized loss on marketable securities, net | (723) | (723) | |||
Net loss | (37,908) | (37,908) | |||
Ending balance (in shares) at Mar. 31, 2022 | 98,767,000 | ||||
Ending balance at Mar. 31, 2022 | 282,952 | $ 10 | 970,349 | (1,423) | (685,984) |
Beginning balance (in shares) at Dec. 31, 2021 | 98,381,000 | ||||
Beginning balance at Dec. 31, 2021 | $ 316,185 | $ 10 | 964,965 | (714) | (648,076) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Common stock issued upon exercise of stock options (in shares) | 15,000 | ||||
Foreign currency translation adjustments | $ (50) | ||||
Unrealized loss on marketable securities, net | (1,189) | ||||
Net loss | (121,800) | ||||
Ending balance (in shares) at Sep. 30, 2022 | 99,728,000 | ||||
Ending balance at Sep. 30, 2022 | 208,337 | $ 10 | 980,156 | (1,953) | (769,876) |
Beginning balance (in shares) at Mar. 31, 2022 | 98,767,000 | ||||
Beginning balance at Mar. 31, 2022 | 282,952 | $ 10 | 970,349 | (1,423) | (685,984) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation expense | 4,942 | 4,942 | |||
Common stock issued upon release of restricted stock units (in shares) | 5,000 | ||||
Common stock issued under employee stock purchase plan (in shares) | 499,000 | ||||
Common stock issued under employee stock purchase plan | 362 | 362 | |||
Foreign currency translation adjustments | (34) | (34) | |||
Unrealized loss on marketable securities, net | (339) | (339) | |||
Net loss | (43,761) | (43,761) | |||
Ending balance (in shares) at Jun. 30, 2022 | 99,271,000 | ||||
Ending balance at Jun. 30, 2022 | 244,122 | $ 10 | 975,653 | (1,796) | (729,745) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation expense | 4,503 | 4,503 | |||
Common stock issued upon release of restricted stock units (in shares) | 457,000 | ||||
Foreign currency translation adjustments | (30) | (30) | |||
Unrealized loss on marketable securities, net | (127) | (127) | |||
Net loss | (40,131) | (40,131) | |||
Ending balance (in shares) at Sep. 30, 2022 | 99,728,000 | ||||
Ending balance at Sep. 30, 2022 | $ 208,337 | $ 10 | $ 980,156 | $ (1,953) | $ (769,876) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders Equity (Parenthetical) $ in Thousands | 3 Months Ended |
Mar. 31, 2021 USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Stock issuance costs | $ 5 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (121,800) | $ (111,131) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 4,816 | 3,323 |
Stock-based compensation expense | 14,826 | 20,784 |
Amortization of premium and accrued interest on marketable securities | (277) | 2,273 |
Loss on disposal of property and equipment | 101 | 0 |
Impairment of long-lived assets | 2,011 | 1,072 |
Other | (1,526) | (132) |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (3,468) | (3,493) |
Other assets | 864 | (109) |
Operating lease right-of-use asset | 3,092 | 2,825 |
Accounts payable | (543) | (587) |
Accrued expenses and other current liabilities | (272) | 3,253 |
Other non-current liabilities | 55 | 0 |
Lease liability and lease incentive receivable | 12,505 | (94) |
Net cash used in operating activities | (89,616) | (82,016) |
Cash flows from investing activities: | ||
Purchases of marketable securities | (81,782) | (328,275) |
Maturities of marketable securities | 232,899 | 384,882 |
Sales of marketable securities | 0 | 8,990 |
Purchases of property and equipment | (11,631) | (10,771) |
Net cash provided by investing activities | 139,486 | 54,826 |
Cash flows from financing activities: | ||
Proceeds from offerings of common stock, net of issuance costs | 0 | 1,685 |
Proceeds from issuance of common stock pursuant to option exercises | 3 | 51 |
Proceeds from employee stock purchase plan | 362 | 526 |
Repayment of loan | 0 | (240) |
Net cash provided by financing activities | 365 | 2,022 |
Net increase (decrease) in cash and cash equivalents and restricted cash | 50,235 | (25,168) |
Cash and cash equivalents and restricted cash at beginning of period | 36,698 | 63,423 |
Cash and cash equivalents and restricted cash at end of period | 86,933 | 38,255 |
Cash and cash equivalents | 84,430 | 32,971 |
Restricted cash | 2,503 | 5,284 |
Cash and cash equivalents and restricted cash at end of period | 86,933 | 38,255 |
Supplemental schedule of noncash investing and financing information | ||
Right-of-use assets obtained in exchange for lease liability | 0 | 84,005 |
Remeasurement of operating right-of-use assets | 2,842 | 0 |
Fixed assets in accounts payable, accrued expenses and other current liabilities | $ 168 | $ 2,675 |
Organization and Basis of Prese
Organization and Basis of Presentation | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Basis of Presentation | Organization and Basis of Presentation Adverum Biotechnologies, Inc. (the “Company” or “Adverum”) was incorporated in Delaware on July 17, 2006 and is headquartered in Redwood City, California. The Company is a clinical-stage company that aims to establish gene therapy as a new standard of care for a number of highly prevalent ocular diseases. The Company develops gene therapy product candidates intended to provide durable efficacy by inducing sustained expression of a therapeutic protein. The Company has not generated any revenue from the sale of products since its inception. The Company has experienced net losses since its inception and had an accumulated deficit of $769.9 million as of September 30, 2022. The Company expects to incur losses and have negative net cash flows from operating activities as it engages in further research and development activities. As of September 30, 2022, the Company had cash, cash equivalents and short-term investments of $203.3 million, which the Company believes will be sufficient to fund its operations for at least twelve months from the date of issuance of these financial statements. Basis of Presentation — The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) and follow the requirements of the Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. These unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments, which are necessary for a fair statement of the Company’s consolidated financial information. The results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the results to be expected for the full year or any other future period. The balance sheet as of December 31, 2021 is derived from the audited consolidated financial statements at that date but does not include all of the information required by U.S. GAAP for complete consolidated financial statements. The accompanying unaudited condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Use of Estimates The accompanying condensed consolidated financial statements have been prepared in accordance with U.S. GAAP. The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent liabilities and the reported amounts of expenses in the condensed consolidated financial statements and the accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to clinical trial accruals, fair value of assets and liabilities, impairment of long-lived assets, income taxes, and stock-based compensation. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results could differ from those estimates. Recent Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments – Credit Losses: Measurement of Credit Losses on Financial Instruments (“ Topic 326 ”) and also issued subsequent amendments to the initial guidance: ASU 2018-19, ASU 2019-04, ASU 2019-05, and ASU 2019-11. The standard requires that financial assets measured at amortized cost be presented at the net amount expected to be collected. The measurement of expected credit losses is based on historical experience, current conditions, and reasonable and supportable forecasts that affect collectability. Topic 326 also eliminates the concept of “other-than-temporary” impairment when evaluating available-for-sale debt securities and instead focuses on determining whether any impairment is a result of a credit loss or other factors. An entity will recognize an allowance for credit losses on available-for-sale debt securities rather than an other-than-temporary impairment that reduces the cost basis of the investment. Topic 326 will become effective for the Company on January 1, 2023. Early adoption is permitted. The Company does not expect the effect of adoption to be material. |
Fair Value Measurements and Fai
Fair Value Measurements and Fair Value of Financial Instruments | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements and Fair Value of Financial Instruments | Fair Value Measurements and Fair Value of Financial Instruments The authoritative guidance on the fair value hierarchy for disclosure of fair value measurements is as follows: Level 1 : Quoted prices in active markets for identical assets or liabilities. Level 2 : Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 : Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The fair value of Level 1 securities is determined using quoted prices in active markets for identical assets. Level 1 securities consist of highly liquid money market funds. Financial assets and liabilities are considered Level 2 when their fair values are determined using inputs that are observable in the market or can be derived principally from or corroborated by observable market data such as pricing for similar securities, recently executed transactions, cash flow models with yield curves, and benchmark securities. In addition, Level 2 financial instruments are valued using comparisons to like-kind financial instruments and models that use readily observable market data as their basis. U.S. government and agency securities, commercial paper, and corporate bonds are valued primarily using market prices of comparable securities, bid/ask quotes, interest rate yields and prepayment spreads and are included in Level 2. The following is a summary of the Company’s cash equivalents and short-term investments: September 30, 2022 Amortized Cost Basis Unrealized Gains Unrealized Estimated Fair Value (In thousands) Level 1: Money market funds $ 10,074 $ — $ — $ 10,074 Level 2: U.S. government and agency securities 81,323 2 (1,165) 80,160 Commercial paper 99,867 — (294) 99,573 Corporate bonds 2,059 — (49) 2,010 Total cash equivalents and short-term investments 193,323 2 (1,508) 191,817 Less: cash equivalents (72,987) (2) 6 (72,983) Total short-term investments $ 120,336 $ — $ (1,502) $ 118,834 December 31, 2021 Amortized Cost Basis Unrealized Gains Unrealized Estimated Fair Value (In thousands) Level 1: Money market funds $ 10,311 $ — $ — $ 10,311 Level 2: U.S. government and agency securities 62,268 — (218) 62,050 Commercial paper 177,215 1 (61) 177,155 Corporate bonds 47,323 — (39) 47,284 Total cash equivalents and short-term investments 297,117 1 (318) 296,800 Less: cash equivalents (25,808) — 1 (25,807) Total short-term investments $ 271,309 $ 1 $ (317) $ 270,993 As of September 30, 2022, $9.6 million of marketable securities have a remaining maturity between one During the nine months ended September 30, 2022, the Company performed an impairment test to measure certain laboratory equipment at fair value. The assets are measured at fair value using Level 3 inputs on a non-recurring basis as a result of the occurrence of certain triggering events indicating the carrying value of the assets may not be recoverable. Refer to Note 4, Balance Sheet Components for additional information. |
Balance Sheet Components
Balance Sheet Components | 9 Months Ended |
Sep. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Components | Balance Sheet Components Property and Equipment, Net Property and equipment, net consists of the following: September 30, 2022 December 31, 2021 (In thousands) Computer equipment and software $ 1,325 $ 1,224 Laboratory equipment 16,368 12,778 Furniture and fixtures 868 1,136 Leasehold improvements 34,336 26,701 Construction in progress 1,076 4,395 Total property and equipment 53,973 46,234 Less accumulated depreciation and amortization (17,394) (13,174) Property and equipment, net $ 36,579 $ 33,060 The Company performed an impairment analysis for certain laboratory equipment assets based on the identification of impairment indicators during the nine months ended September 30, 2022. The analysis determined that the fair value of the assets, which was determined using a market approach, was lower than the carrying value. As a result of the evaluation, an impairment charge of $2.0 million was recognized for the nine months ended September 30, 2022. The assets indicated as impaired were written down to their estimated fair value. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consist of the following: September 30, 2022 December 31, 2021 (In thousands) Employee compensation $ 8,604 $ 9,209 Accrued nonclinical, clinical and process development costs 6,580 4,953 State income tax payable 301 1,318 Accrued professional services 469 550 Other 585 2,017 Total accrued expenses and other current liabilities $ 16,539 $ 18,047 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Leases | LeasesSublease income for operating leases is recognized on a straight-line basis over the lease term and is classified as a reduction of rent expense in operating expenses. The difference between sublease income recorded and cash received from the subtenant accrues as a deferred rent receivable. In the three months ended September 30, 2022, the Company reassessed the probability of collection of the deferred rent receivable from the subtenant over the remaining term of a sublease. The Company assessed the collectability to be less than probable and recognized an adjustment to eliminate the deferred rent receivable as a current period adjustment to sublease income, resulting in an increase in general and administrative expenses in the three and nine month periods ended September 30, 2022. The deferred rent receivable as of December 31, 2021 and September 30, 2022 was $0.8 million and zero, respectively. As a result of the adjustment to eliminate the deferred rent receivable, sublease income for the three and nine months ended September 30, 2022 was a negative $4.1 million and a negative $0.8 million, respectively |
Equity Incentive Awards
Equity Incentive Awards | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Equity Incentive Awards | Equity Incentive Awards Stock Options The following table summarizes the Company’s option activity and related information: Number of Weighted- Balance at December 31, 2021 13,288 $ 9.34 Options granted 10,592 1.26 Options exercised (15) 0.19 Options forfeited (4,644) 5.42 Balance at September 30, 2022 19,221 $ 5.84 Exercisable as of September 30, 2022 5,302 $ 11.71 Options granted during the nine months ended September 30, 2022 include 2.5 million shares of performance-based non-qualified options with both performance and service vesting conditions. Restricted Stock Units (“RSUs”) The following table summarizes the Company’s RSUs activity and related information: Number of Units Weighted- Outstanding at December 31, 2021 2,126 $ 3.76 Granted 857 1.43 Vested and released (833) 3.40 Forfeited (426) 3.18 Outstanding at September 30, 2022 1,724 $ 2.92 RSUs granted during the nine months ended September 30, 2022 include 0.4 million shares of performance units with both performance and service vesting conditions. Stock-Based Compensation Expense The following table presents, by operating expense, the Company’s stock-based compensation expense: Three Months Ended Nine Months Ended 2022 2021 2022 2021 (In thousands) Research and development $ 1,432 $ 2,207 $ 5,195 $ 7,125 General and administrative 3,071 3,119 9,631 13,659 Total stock-based compensation expense $ 4,503 $ 5,326 $ 14,826 $ 20,784 |
Net Loss per Share
Net Loss per Share | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | Net Loss per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period. Diluted net loss per share is computed by giving effect to all potential dilutive common stock equivalents outstanding for the period using the treasury stock method. Outstanding stock options, RSUs, rights under the employee stock purchase plan (“ESPP”) and warrants are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share when their effect is dilutive. The following common stock equivalents outstanding at the end of the periods presented were excluded from the calculation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect: September 30, 2022 September 30, 2021 (In thousands) Stock options 19,221 13,859 Restricted stock units 1,724 2,593 ESPP 760 400 21,705 16,852 |
Restructuring
Restructuring | 9 Months Ended |
Sep. 30, 2022 | |
Restructuring and Related Activities [Abstract] | |
Restructuring | Restructuring In July 2022, the Company implemented a restructuring of operations, including reductions in both headcount and expenses, to prioritize its clinical development of ixoberogene soroparvovec (“Ixo-vec”), formerly referred to as ADVM-022, and focus its pipeline strategy on certain highly prevalent ocular diseases. Under the restructuring plan, the Company reduced its workforce by 75 employees (approximately 37%) as of July 6, 2022. Below is a summary of restructuring costs during the nine months ended September 30, 2022 and accrued restructuring costs as of September 30, 2022 : Severance and Benefits Costs Stock-Based Compensation Total (In thousands) Balance at January 1, 2022 $ — $ — $ — Charges 4,632 53 4,685 Cash payments made (4,539) — (4,539) Non-cash — (53) (53) Balance at September 30, 2022 $ 93 $ — $ 93 In the three and nine months ended September 30, 2022, the Company recorded $4.7 million of restructuring costs, of which $3.7 million was classified as research and development expenses and $1.0 million was classified as general and administrative expenses. Substantially all of the restructuring costs were incurred during the three months ended September 30, 2022, of which $4.5 million were paid. The Company expects the restructuring to be completed in the fourth quarter of 2022. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation — The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) and follow the requirements of the Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. These unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments, which are necessary for a fair statement of the Company’s consolidated financial information. The results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the results to be expected for the full year or any other future period. The balance sheet as of December 31, 2021 is derived from the audited consolidated financial statements at that date but does not include all of the information required by U.S. GAAP for complete consolidated financial statements. |
Use of Estimates | Use of Estimates The accompanying condensed consolidated financial statements have been prepared in accordance with U.S. GAAP. The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent liabilities and the reported amounts of expenses in the condensed consolidated financial statements and the accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to clinical trial accruals, fair value of assets and liabilities, impairment of long-lived assets, income taxes, and stock-based compensation. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results could differ from those estimates. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments – Credit Losses: Measurement of Credit Losses on Financial Instruments (“ Topic 326 ”) and also issued subsequent amendments to the initial guidance: ASU 2018-19, ASU 2019-04, ASU 2019-05, and ASU 2019-11. The standard requires that financial assets measured at amortized cost be presented at the net amount expected to be collected. The measurement of expected credit losses is based on historical experience, current conditions, and reasonable and supportable forecasts that affect collectability. Topic 326 also eliminates the concept of “other-than-temporary” impairment when evaluating available-for-sale debt securities and instead focuses on determining whether any impairment is a result of a credit loss or other factors. An entity will recognize an allowance for credit losses on available-for-sale debt securities rather than an other-than-temporary impairment that reduces the cost basis of the investment. Topic 326 will become effective for the Company on January 1, 2023. Early adoption is permitted. The Company does not expect the effect of adoption to be material. |
Fair Value Measurements and F_2
Fair Value Measurements and Fair Value of Financial Instruments (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of Cash Equivalents and Short-term Investments | The following is a summary of the Company’s cash equivalents and short-term investments: September 30, 2022 Amortized Cost Basis Unrealized Gains Unrealized Estimated Fair Value (In thousands) Level 1: Money market funds $ 10,074 $ — $ — $ 10,074 Level 2: U.S. government and agency securities 81,323 2 (1,165) 80,160 Commercial paper 99,867 — (294) 99,573 Corporate bonds 2,059 — (49) 2,010 Total cash equivalents and short-term investments 193,323 2 (1,508) 191,817 Less: cash equivalents (72,987) (2) 6 (72,983) Total short-term investments $ 120,336 $ — $ (1,502) $ 118,834 December 31, 2021 Amortized Cost Basis Unrealized Gains Unrealized Estimated Fair Value (In thousands) Level 1: Money market funds $ 10,311 $ — $ — $ 10,311 Level 2: U.S. government and agency securities 62,268 — (218) 62,050 Commercial paper 177,215 1 (61) 177,155 Corporate bonds 47,323 — (39) 47,284 Total cash equivalents and short-term investments 297,117 1 (318) 296,800 Less: cash equivalents (25,808) — 1 (25,807) Total short-term investments $ 271,309 $ 1 $ (317) $ 270,993 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Balance Sheet Related Disclosures [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net consists of the following: September 30, 2022 December 31, 2021 (In thousands) Computer equipment and software $ 1,325 $ 1,224 Laboratory equipment 16,368 12,778 Furniture and fixtures 868 1,136 Leasehold improvements 34,336 26,701 Construction in progress 1,076 4,395 Total property and equipment 53,973 46,234 Less accumulated depreciation and amortization (17,394) (13,174) Property and equipment, net $ 36,579 $ 33,060 |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consist of the following: September 30, 2022 December 31, 2021 (In thousands) Employee compensation $ 8,604 $ 9,209 Accrued nonclinical, clinical and process development costs 6,580 4,953 State income tax payable 301 1,318 Accrued professional services 469 550 Other 585 2,017 Total accrued expenses and other current liabilities $ 16,539 $ 18,047 |
Equity Incentive Awards (Tables
Equity Incentive Awards (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock Options Activity | The following table summarizes the Company’s option activity and related information: Number of Weighted- Balance at December 31, 2021 13,288 $ 9.34 Options granted 10,592 1.26 Options exercised (15) 0.19 Options forfeited (4,644) 5.42 Balance at September 30, 2022 19,221 $ 5.84 Exercisable as of September 30, 2022 5,302 $ 11.71 |
Schedule of Restricted Stock Units Activity | The following table summarizes the Company’s RSUs activity and related information: Number of Units Weighted- Outstanding at December 31, 2021 2,126 $ 3.76 Granted 857 1.43 Vested and released (833) 3.40 Forfeited (426) 3.18 Outstanding at September 30, 2022 1,724 $ 2.92 |
Schedule of Stock-Based Compensation Expense | The following table presents, by operating expense, the Company’s stock-based compensation expense: Three Months Ended Nine Months Ended 2022 2021 2022 2021 (In thousands) Research and development $ 1,432 $ 2,207 $ 5,195 $ 7,125 General and administrative 3,071 3,119 9,631 13,659 Total stock-based compensation expense $ 4,503 $ 5,326 $ 14,826 $ 20,784 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | The following common stock equivalents outstanding at the end of the periods presented were excluded from the calculation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect: September 30, 2022 September 30, 2021 (In thousands) Stock options 19,221 13,859 Restricted stock units 1,724 2,593 ESPP 760 400 21,705 16,852 |
Restructuring (Tables)
Restructuring (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Restructuring and Related Activities [Abstract] | |
Schedule of Restructuring Cost | Below is a summary of restructuring costs during the nine months ended September 30, 2022 and accrued restructuring costs as of September 30, 2022 : Severance and Benefits Costs Stock-Based Compensation Total (In thousands) Balance at January 1, 2022 $ — $ — $ — Charges 4,632 53 4,685 Cash payments made (4,539) — (4,539) Non-cash — (53) (53) Balance at September 30, 2022 $ 93 $ — $ 93 |
Organization and Basis of Pre_2
Organization and Basis of Presentation (Detail) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accumulated deficit | $ 769,876 | $ 648,076 |
Cash, cash equivalents, and short-term investments | $ 203,300 |
Fair Value Measurements and F_3
Fair Value Measurements and Fair Value of Financial Instruments - Summary of Cash Equivalents and Short-term Investments (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost Basis | $ 120,336 | $ 271,309 |
Unrealized Gains | 0 | 1 |
Unrealized Losses | (1,502) | (317) |
Estimated Fair Value | 118,834 | 270,993 |
Less: cash equivalents, amortized cost basis | (72,987) | (25,808) |
Less: cash equivalents, unrealized gains | (2) | 0 |
Less: cash equivalents, unrealized losses | 6 | 1 |
Less: cash equivalents, estimated fair value | (72,983) | (25,807) |
Money market funds | Level 1: | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost Basis | 10,074 | 10,311 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | 0 | 0 |
Estimated Fair Value | 10,074 | 10,311 |
U.S. government and agency securities | Level 2: | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost Basis | 81,323 | 62,268 |
Unrealized Gains | 2 | 0 |
Unrealized Losses | (1,165) | (218) |
Estimated Fair Value | 80,160 | 62,050 |
Commercial paper | Level 2: | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost Basis | 99,867 | 177,215 |
Unrealized Gains | 0 | 1 |
Unrealized Losses | (294) | (61) |
Estimated Fair Value | 99,573 | 177,155 |
Corporate bonds | Level 2: | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost Basis | 2,059 | 47,323 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | (49) | (39) |
Estimated Fair Value | 2,010 | 47,284 |
Total cash equivalents and short-term investments | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost Basis | 193,323 | 297,117 |
Unrealized Gains | 2 | 1 |
Unrealized Losses | (1,508) | (318) |
Estimated Fair Value | $ 191,817 | $ 296,800 |
Fair Value Measurements and F_4
Fair Value Measurements and Fair Value of Financial Instruments - Additional Information (Details) | Sep. 30, 2022 USD ($) |
Debt Securities, Available-for-sale [Line Items] | |
Marketable securities | $ 9,600,000 |
Marketable securities in an unrealized loss | 167,900,000 |
Marketable securities other-than-temporarily impaired | $ 0 |
Minimum | |
Debt Securities, Available-for-sale [Line Items] | |
Marketable securities term (in years) | 1 year |
Maximum | |
Debt Securities, Available-for-sale [Line Items] | |
Marketable securities term (in years) | 2 years |
Balance Sheet Components - Sche
Balance Sheet Components - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Dec. 31, 2021 | |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 53,973 | $ 46,234 |
Less accumulated depreciation and amortization | (17,394) | (13,174) |
Property and equipment, net | 36,579 | 33,060 |
Asset impairment charge | 2,000 | |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 1,325 | 1,224 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 16,368 | 12,778 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 868 | 1,136 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 34,336 | 26,701 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 1,076 | $ 4,395 |
Balance Sheet Components - Sc_2
Balance Sheet Components - Schedule of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Balance Sheet Related Disclosures [Abstract] | ||
Employee compensation | $ 8,604 | $ 9,209 |
Accrued nonclinical, clinical and process development costs | 6,580 | 4,953 |
State income tax payable | 301 | 1,318 |
Accrued professional services | 469 | 550 |
Other | 585 | 2,017 |
Total accrued expenses and other current liabilities | $ 16,539 | $ 18,047 |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2022 | Dec. 31, 2021 | |
Leases [Abstract] | |||
Deferred rent receivable | $ 0 | $ 0 | $ 769 |
Negative sublease income | $ 4,100 | $ 800 |
Equity Incentive Awards - Summa
Equity Incentive Awards - Summary of Stock Options Activity (Details) shares in Thousands | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Number of Options (in thousands) | |
Beginning balance (in shares) | shares | 13,288 |
Options granted (in shares) | shares | 10,592 |
Options exercised (in shares) | shares | (15) |
Options forfeited (in shares) | shares | (4,644) |
Ending balance (in shares) | shares | 19,221 |
Exercisable (in shares) | shares | 5,302 |
Weighted- Average Grant- Date Fair Value | |
Beginning balance (in USD per share) | $ / shares | $ 9.34 |
Options granted (in USD per share) | $ / shares | 1.26 |
Options exercised (in USD per share) | $ / shares | 0.19 |
Options forfeited (in USD per share) | $ / shares | 5.42 |
Ending balance (in USD per share) | $ / shares | 5.84 |
Exercisable (in USD per share) | $ / shares | $ 11.71 |
Equity Incentive Awards - Addit
Equity Incentive Awards - Additional Information (Details) shares in Thousands | 9 Months Ended |
Sep. 30, 2022 shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Options granted (in shares) | 10,592 |
Performance Units | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Options granted (in shares) | 2,500 |
RSUs granted (in shares) | 400 |
Equity Incentive Awards - Sum_2
Equity Incentive Awards - Summary of Restricted Stock Units Activity (Details) - Restricted stock units shares in Thousands | 9 Months Ended |
Sep. 30, 2022 $ / shares shares | |
Number of Units (in thousands) | |
Beginning balance (in shares) | shares | 2,126 |
Granted (in shares) | shares | 857 |
Vested and released (in shares) | shares | (833) |
Forfeited (in shares) | shares | (426) |
Ending balance (in shares) | shares | 1,724 |
Weighted- Average Grant- Date Fair Value | |
Beginning balance (in USD per share) | $ / shares | $ 3.76 |
Granted (in USD per share) | $ / shares | 1.43 |
Vested and released (in USD per share) | $ / shares | 3.40 |
Forfeited (in USD per share) | $ / shares | 3.18 |
Ending balance (in USD per share) | $ / shares | $ 2.92 |
Equity Incentive Awards - Sum_3
Equity Incentive Awards - Summary of Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 4,503 | $ 5,326 | $ 14,826 | $ 20,784 |
Research and development | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | 1,432 | 2,207 | 5,195 | 7,125 |
General and administrative | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 3,071 | $ 3,119 | $ 9,631 | $ 13,659 |
Net Loss per Share - Schedule o
Net Loss per Share - Schedule of Common Stock Equivalents Outstanding (Details) - shares shares in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from net loss per share (in shares) | 21,705 | 16,852 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from net loss per share (in shares) | 19,221 | 13,859 |
Restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from net loss per share (in shares) | 1,724 | 2,593 |
ESPP | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from net loss per share (in shares) | 760 | 400 |
Restructuring - Additional Info
Restructuring - Additional Information (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2022 USD ($) | Sep. 30, 2022 USD ($) | Jul. 06, 2022 employee | |
Restructuring Cost and Reserve [Line Items] | |||
Number of employees | employee | 75 | ||
Number of employees percentage | 37% | ||
Restructuring charges | $ 4,685 | ||
Restructuring cost paid | $ 4,500 | 4,539 | |
Research and Development Expense | |||
Restructuring Cost and Reserve [Line Items] | |||
Restructuring charges | 3,700 | ||
General and Administrative Expense | |||
Restructuring Cost and Reserve [Line Items] | |||
Restructuring charges | $ 1,000 |
Restructuring - Schedule of Res
Restructuring - Schedule of Restructuring Cost (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2022 | Sep. 30, 2022 | |
Restructuring Reserve [Roll Forward] | ||
Restructuring cost, beginning balance | $ 0 | |
Charges | 4,685 | |
Cash payments made | $ (4,500) | (4,539) |
Non-cash | (53) | |
Restructuring cost, ending balance | 93 | 93 |
Severance and Benefits Costs | ||
Restructuring Reserve [Roll Forward] | ||
Restructuring cost, beginning balance | 0 | |
Charges | 4,632 | |
Cash payments made | (4,539) | |
Non-cash | 0 | |
Restructuring cost, ending balance | 93 | 93 |
Stock-Based Compensation | ||
Restructuring Reserve [Roll Forward] | ||
Restructuring cost, beginning balance | 0 | |
Charges | 53 | |
Cash payments made | 0 | |
Non-cash | (53) | |
Restructuring cost, ending balance | $ 0 | $ 0 |