Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 04, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2022 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2022 | |
Entity Registrant Name | Homology Medicines, Inc | |
Entity Central Index Key | 0001661998 | |
Trading Symbol | FIXX | |
Current Fiscal Year End Date | --12-31 | |
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 | 57,480,610 | |
Entity File Number | 001-38433 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 47-3468154 | |
Entity Address, Address Line One | One Patriots Park | |
Entity Address, City or Town | Bedford | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 01730 | |
City Area Code | 781 | |
Local Phone Number | 301-7277 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Title of 12(b) Security | Common Stock, $0.0001 par value per share | |
Security Exchange Name | NASDAQ | |
Document Quarterly Report | true | |
Document Transition Report | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 43,162 | $ 108,382 |
Short-term investments | 157,912 | 47,491 |
Assets held for sale | 28,907 | |
Prepaid expenses and other current assets | 12,130 | 7,129 |
Total current assets | 213,204 | 191,909 |
Equity method investment | 27,132 | |
Property and equipment, net | 1,415 | 2,252 |
Right-of-use assets | 20,900 | 15,607 |
Restricted cash | 0 | 1,953 |
Total assets | 262,651 | 211,721 |
Current liabilities: | ||
Accounts payable | 4,835 | 2,366 |
Accrued expenses and other liabilities | 16,970 | 11,406 |
Operating lease liabilities | 1,489 | 246 |
Deferred revenue | 1,958 | 3,208 |
Total current liabilities | 25,252 | 17,226 |
Non-current liabilities: | ||
Operating lease liabilities, net of current portion | 28,338 | 23,688 |
Deferred revenue, net of current portion | 1,156 | |
Total liabilities | 53,590 | 42,070 |
Commitments and contingencies (Note 8) | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value, 10,000,000 shares authorized; no shares issued and outstanding at September 30, 2022 and December 31, 2021 | ||
Common stock, $0.0001 par value; 200,000,000 shares authorized; 57,480,610 and 57,150,274 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively | 6 | 6 |
Additional paid-in capital | 604,354 | 593,784 |
Accumulated other comprehensive loss | (457) | (7) |
Accumulated deficit | (394,842) | (424,132) |
Total stockholders’ equity | 209,061 | 169,651 |
Total liabilities and stockholders' equity | $ 262,651 | $ 211,721 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 57,480,610 | 57,150,274 |
Common stock, shares outstanding | 57,480,610 | 57,150,274 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Statement of Comprehensive Income [Abstract] | ||||
Collaboration revenue | $ 802 | $ 1,677 | $ 2,406 | $ 33,169 |
Operating expenses: | ||||
Research and development | 25,854 | 23,987 | 71,202 | 69,439 |
General and administrative | 7,810 | 8,351 | 29,991 | 26,054 |
Total operating expenses | 33,664 | 32,338 | 101,193 | 95,493 |
Loss from operations | (32,862) | (30,661) | (98,787) | (62,324) |
Other income (expense): | ||||
Gain on sale of business | 0 | 0 | 131,249 | 0 |
Interest income | 1,269 | 53 | 1,775 | 143 |
Total other income | 1,269 | 53 | 133,024 | 143 |
Income (loss) before income taxes | (31,593) | (30,608) | 34,237 | (62,181) |
Benefit from (provision for) income taxes | 46 | 0 | (816) | 0 |
Loss from equity method investment | (2,179) | 0 | (4,131) | 0 |
Net income (loss) | $ (33,726) | $ (30,608) | $ 29,290 | $ (62,181) |
Net income (loss) per share-basic | $ (0.59) | $ (0.54) | $ 0.51 | $ (1.14) |
Net income (loss) per share-diluted | $ (0.59) | $ (0.54) | $ 0.51 | $ (1.14) |
Weighted-average common shares outstanding-basic | 57,447,192 | 57,106,639 | 57,372,399 | 54,704,410 |
Weighted-average common shares outstanding-diluted | 57,447,192 | 57,106,639 | 57,901,298 | 54,704,410 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Statement of Comprehensive Income [Abstract] | ||||
Net income (loss) | $ (33,726) | $ (30,608) | $ 29,290 | $ (62,181) |
Other comprehensive loss: | ||||
Change in unrealized gain (loss) on available for sale securities, net | (416) | (7) | (450) | (5) |
Total other comprehensive loss | (416) | (7) | (450) | (5) |
Comprehensive loss | $ (34,142) | $ (30,615) | $ 28,840 | $ (62,186) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (UNAUDITED) - USD ($) $ in Thousands | Total | Equity Method Investee | Follow-on Offering [Member] | Common Stock | Common Stock Follow-on Offering [Member] | Additional Paid-in Capital | Additional Paid-in Capital Equity Method Investee | Additional Paid-in Capital Follow-on Offering [Member] | Accumulated Other Comprehensive Gain (Loss) | Accumulated Deficit |
Beginning balance at Dec. 31, 2020 | $ 195,995 | $ 5 | $ 524,358 | $ (328,368) | ||||||
Beginning balance, Shares at Dec. 31, 2020 | 50,265,575 | |||||||||
Issuance of common stock in follow-on offering, net of discounts and issuance costs | 1,454 | 1,454 | ||||||||
Vesting of common stock from option exercises | 4 | 4 | ||||||||
Vesting of common stock from option exercises, Shares | 1,011 | |||||||||
Issuance of common stock from option exercises | 143 | 143 | ||||||||
Issuance of common stock from option exercises, Shares | 55,277 | |||||||||
Issuance of common stock pursuant to employee stock purchase plan | 446 | 446 | ||||||||
Issuance of common stock pursuant to employee stock purchase plan, Shares | 48,792 | |||||||||
Issuance of common stock, net of discounts and issuance costs | 1,454 | 1,454 | ||||||||
Issuance of common stock, net of discounts and issuance costs, Share | 114,914 | |||||||||
Stock-based compensation | 3,883 | 3,883 | ||||||||
Other comprehensive gain (loss) | (23) | $ (23) | ||||||||
Net income (loss) | (1,073) | (1,073) | ||||||||
Ending balance at Mar. 31, 2021 | 200,829 | $ 5 | 530,288 | (23) | (329,441) | |||||
Ending balance, Shares at Mar. 31, 2021 | 50,485,569 | |||||||||
Beginning balance at Dec. 31, 2020 | 195,995 | $ 5 | 524,358 | (328,368) | ||||||
Beginning balance, Shares at Dec. 31, 2020 | 50,265,575 | |||||||||
Other comprehensive gain (loss) | (5) | |||||||||
Net income (loss) | (62,181) | |||||||||
Ending balance at Sep. 30, 2021 | 198,571 | $ 6 | 589,119 | (5) | (390,549) | |||||
Ending balance, Shares at Sep. 30, 2021 | 57,149,978 | |||||||||
Beginning balance at Mar. 31, 2021 | 200,829 | $ 5 | 530,288 | (23) | (329,441) | |||||
Beginning balance, Shares at Mar. 31, 2021 | 50,485,569 | |||||||||
Issuance of common stock in follow-on offering, net of discounts and issuance costs | $ 49,744 | $ 1 | $ 49,743 | |||||||
Vesting of common stock from option exercises | 4 | 4 | ||||||||
Vesting of common stock from option exercises, Shares | 1,011 | |||||||||
Issuance of common stock from option exercises | 2 | 2 | ||||||||
Issuance of common stock from option exercises, Shares | 4,071 | |||||||||
Issuance of common stock, net of discounts and issuance costs | $ 49,744 | $ 1 | $ 49,743 | |||||||
Issuance of common stock, net of discounts and issuance costs, Share | 6,596,306 | |||||||||
Stock-based compensation | 4,473 | 4,473 | ||||||||
Other comprehensive gain (loss) | 25 | 25 | ||||||||
Net income (loss) | (30,500) | (30,500) | ||||||||
Ending balance at Jun. 30, 2021 | 224,577 | $ 6 | 584,510 | 2 | (359,941) | |||||
Ending balance, Shares at Jun. 30, 2021 | 57,086,957 | |||||||||
Vesting of common stock from option exercises | 3 | 3 | ||||||||
Vesting of common stock from option exercises, Shares | 773 | |||||||||
Issuance of common stock from option exercises, Shares | 117 | |||||||||
Issuance of common stock pursuant to employee stock purchase plan | 380 | 380 | ||||||||
Issuance of common stock pursuant to employee stock purchase plan, Shares | 62,131 | |||||||||
Stock-based compensation | 4,226 | 4,226 | ||||||||
Other comprehensive gain (loss) | (7) | (7) | ||||||||
Net income (loss) | (30,608) | (30,608) | ||||||||
Ending balance at Sep. 30, 2021 | 198,571 | $ 6 | 589,119 | (5) | (390,549) | |||||
Ending balance, Shares at Sep. 30, 2021 | 57,149,978 | |||||||||
Beginning balance at Dec. 31, 2021 | 169,651 | $ 6 | 593,784 | (7) | (424,132) | |||||
Beginning balance, Shares at Dec. 31, 2021 | 57,150,274 | |||||||||
Issuance of common stock from RSU vesting | 87,140 | |||||||||
Issuance of common stock from option exercises | 1 | 1 | ||||||||
Issuance of common stock from option exercises, Shares | 293 | |||||||||
Issuance of common stock pursuant to employee stock purchase plan | 439 | 439 | ||||||||
Issuance of common stock pursuant to employee stock purchase plan, Shares | 147,871 | |||||||||
Stock-based compensation | 4,051 | 4,051 | ||||||||
Other comprehensive gain (loss) | 7 | 7 | ||||||||
Net income (loss) | 92,105 | 92,105 | ||||||||
Ending balance at Mar. 31, 2022 | 266,254 | $ 6 | 598,275 | (332,027) | ||||||
Ending balance, Shares at Mar. 31, 2022 | 57,385,578 | |||||||||
Beginning balance at Dec. 31, 2021 | 169,651 | $ 6 | 593,784 | (7) | (424,132) | |||||
Beginning balance, Shares at Dec. 31, 2021 | 57,150,274 | |||||||||
Other comprehensive gain (loss) | (450) | |||||||||
Net income (loss) | 29,290 | |||||||||
Ending balance at Sep. 30, 2022 | 209,061 | $ 6 | 604,354 | (457) | (394,842) | |||||
Ending balance, Shares at Sep. 30, 2022 | 57,480,610 | |||||||||
Beginning balance at Mar. 31, 2022 | 266,254 | $ 6 | 598,275 | (332,027) | ||||||
Beginning balance, Shares at Mar. 31, 2022 | 57,385,578 | |||||||||
Stock-based compensation | 3,143 | $ 21 | 3,143 | $ 21 | ||||||
Other comprehensive gain (loss) | (41) | (41) | ||||||||
Net income (loss) | (29,089) | (29,089) | ||||||||
Ending balance at Jun. 30, 2022 | 240,288 | $ 6 | 601,439 | (41) | (361,116) | |||||
Ending balance, Shares at Jun. 30, 2022 | 57,385,578 | |||||||||
Issuance of common stock from RSU vesting | 16,450 | |||||||||
Issuance of common stock pursuant to employee stock purchase plan | 124 | 124 | ||||||||
Issuance of common stock pursuant to employee stock purchase plan, Shares | 78,582 | |||||||||
Stock-based compensation | 2,771 | $ 20 | 2,771 | $ 20 | ||||||
Other comprehensive gain (loss) | (416) | (416) | ||||||||
Net income (loss) | (33,726) | (33,726) | ||||||||
Ending balance at Sep. 30, 2022 | $ 209,061 | $ 6 | $ 604,354 | $ (457) | $ (394,842) | |||||
Ending balance, Shares at Sep. 30, 2022 | 57,480,610 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities: | ||
Net income (loss) | $ 29,290 | $ (62,181) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 997 | 6,280 |
Noncash lease expense | 969 | 869 |
Loss from equity method investment | 4,131 | 0 |
Stock-based compensation expense | 9,965 | 12,582 |
(Amortization of premium) accretion of discount on short-term investments | (872) | 664 |
Loss on disposal of property and equipment | 6 | |
Gain on sale of business | (131,249) | 0 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (5,301) | (2,133) |
Accounts payable | 2,711 | (1,123) |
Accrued expenses and other liabilities | 5,672 | 225 |
Deferred revenue | (2,406) | (32,609) |
Operating lease liabilities | (369) | (1,901) |
Net cash used in operating activities | (86,462) | (79,321) |
Cash flows from investing activities: | ||
Purchases of short-term investments | (157,460) | (97,391) |
Maturities of short-term investments | 47,461 | 5,000 |
Proceeds from sale of business | 130,000 | |
Purchases of property and equipment | (1,276) | (2,058) |
Net cash provided by (used in) investing activities | 18,725 | (94,449) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock in follow-on public offering, net of discounts and issuance costs | 49,744 | |
Proceeds From Issuance Of Common Stock Pursuant To ATM Financing Net Of Discounts And Issuance Costs | 1,454 | |
Proceeds from issuance of common stock pursuant to employee stock purchase plan | 563 | 825 |
Proceeds from issuance of common stock from option exercises | 1 | 145 |
Net cash provided by financing activities | 564 | 52,168 |
Net change in cash, cash equivalents and restricted cash | (67,173) | (121,602) |
Cash, cash equivalents and restricted cash, beginning of period | 110,335 | 218,705 |
Cash, cash equivalents and restricted cash, end of period | 43,162 | 97,103 |
Supplemental disclosures of noncash investing and financing activities: | ||
Reclassification of liability for common stock vested | 12 | |
Property and equipment additions included in accounts payable | 34 | |
Property and equipment additions included in accrued expenses and other liabilities | 8 | |
Unrealized gain (loss) on available for sale securities, net | $ (450) | $ (5) |
Nature of Business and Basis of
Nature of Business and Basis of Presentation | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF BUSINESS AND BASIS OF PRESENTATION | 1. NATURE OF BUSINESS AND BASIS OF PRESENTATION Nature of Business —Homology Medicines, Inc. (the “Company”) is a clinical-stage genetic medicines company dedicated to translating proprietary gene therapy and gene editing technology into novel treatments for patients with rare genetic diseases with significant unmet medical needs by curing the underlying cause of the disease. The Company was founded in March 2015 as a Delaware corporation. Its principal offices are in Bedford, Massachusetts. Since its inception, the Company has devoted substantially all of its resources to recruiting personnel, developing its technology platform and advancing its pipeline of product candidates through discovery, preclinical and clinical trials, developing and implementing manufacturing processes, building out manufacturing and research and development space, and maintaining and building its intellectual property portfolio. The Company is subject to a number of risks similar to those of other companies conducting high-risk, early-stage research and development of product candidates. Principal among these risks are dependency on key individuals and intellectual property, competition from other products and companies, and the technical and regulatory risks associated with the successful research, development and manufacturing of its product candidates. The Company’s success is dependent upon its ability to continue to raise additional capital in order to fund ongoing research and development, conduct clinical trials, obtain regulatory approval of its products, further expand access to manufacturing capacity, successfully commercialize its products, generate revenue, meet its obligations, and, ultimately, attain sustainable profitable operations. On March 10, 2022, the Company closed its previously announced transaction with Oxford Biomedica plc ("Oxford"), to establish a new adeno-associated virus ("AAV") vector manufacturing company, Oxford Biomedica Solutions ("OXB Solutions") that provides AAV vector process development and manufacturing services to biotechnology companies. Under the terms of the agreement, the Company contributed its manufacturing team of 125 experts, manufacturing facility and equipment, manufacturing-related intellectual property and know-how and certain other assets. Oxford paid the Company $ 130.0 million of upfront cash and invested $ 50.0 million of cash to fund the new company in exchange for an 80 percent owners hip interest, while Homology retained a 20 percent ownership interest in the new company and received a put option on this ownership position (see Note 5). On April 6, 2021, the Company completed a follow-on public offering of its common stock. The Company sold 6,596,306 shares of its common stock at a price of $ 7.58 per share and received net proceeds of $ 49.7 million, after deducting offering expenses of $ 0.3 million. Under the terms of the underwriting agreement, the Company also granted the underwriter an option exercisable for 30 days to purchase up to an additional 989,445 shares of its common stock at a price of $ 7.58 per share. The underwriters did not exercise this option. The offering closed on April 9, 2021. The shares were sold pursuant to the Company’s effective shelf registration statement on Form S-3, as amended, and a related prospectus supplement filed with the Securities and Exchange Commission (“SEC”) on April 8, 2021. On March 12, 2020, the Company filed a Registration Statement on Form S-3 (File No. 333-237131) (as amended, the “Shelf”) with the SEC in relation to the registration of common stock, preferred stock, debt securities, warrants and/or units of any combination thereof for a period up to three years from the date of the filing. The Shelf became effective on March 12, 2020. The Company also simultaneously entered into a sales agreement with Cowen and Company, LLC (“Cowen”), as sales agent, providing for the offering, issuance and sale by the Company of up to an aggregate of $ 150.0 million of its common stock from time to time in “at-the-market” offerings under the Shelf (the “ATM”). In connection with the filing of certain post-effective amendments to the Shelf, the sales agreement prospectus supplement now covers the offering, issuance and sale by the Company of up to an aggregate of $ 148.4 million of its common stock. The Company did no t sell any shares of common stock under the Sales Agreement during the nine months ended September 30, 2022. As of September 30, 2022 , there remained $ 148.4 million of common stock available for sale under the ATM. To date, the Company has not generated any revenue from product sales and does not expect to generate any revenue from the sale of product in the foreseeable future. Through September 30, 2022, the Company has financed its operations primarily through public offerings of its common stock, the issuance of convertible preferred stock, and with proceeds from its transaction with Oxford (see Note 5), its collaboration and license agreement with Novartis Institutes of BioMedical Research, Inc. (“Novartis”) (see Note 11) and its private placement with Pfizer (see Note 12). During the nine months ended September 30, 2022, the Company recorded net income of $ 29.3 million, primarily due to the gain recorded pursuant to the closing of the transaction with Oxford and as of September 30, 2022, had $ 394.8 million in accumulated deficit. The Company expects to incur additional operating losses and negative operating cash flows for the foreseeable future. Based on current projections, management believes that cash and cash equivalents and short-term investments as of September 30, 2022 will enable the Company to continue its operations for at least one year from the date of this filing. In the absence of a significant source of recurring revenue, the continued viability of the Company beyond that point is dependent on its ability to continue to raise additional capital to finance its operations. There can be no assurance that the Company will be able to obtain sufficient capital to cover its costs on acceptable terms, if at all. Basis of Presentation — The accompanying unaudited condensed consolidated financial statements have been prepared by the Company in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the rules and regulations of the SEC for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2021, included in the Company's Annual Report on Form 10-K on file with the SEC. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements. In the opinion of management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments which are necessary for a fair statement of the Company’s financial position as of September 30, 2022, and consolidated results of operations for the three and nine months ended September 30, 2022 and 2021, and cash flows for the nine months ended September 30, 2022 and 2021. Such adjustments are of a normal and recurring nature. The results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2022 . |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Principles of Consolidation —The Company’s condensed consolidated financial statements include the accounts of the Company and its subsidiary, Homology Medicines Securities Corporation, a wholly owned Massachusetts corporation, for the sole purpose of buying, selling, and holding securities on the Company’s behalf. All intercompany balances and transactions have been eliminated in the condensed consolidated financial statements. Use of Estimates —The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, and expenses, and the disclosure of contingent assets and liabilities as of and during the reporting period. The Company bases its estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, revenue recognition, accrued research and development expenses and the valuation of the Company's equity method investment. The Company assesses estimates on an ongoing basis; however, actual results could materially differ from those estimates. Comprehensive Income (Loss) —Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. The Company’s only element of other comprehensive income (loss) is unrealized gains and losses on available-for-sale investments. Cash and Cash Equivalents and Restricted Cash —Cash and cash equivalents consist of standard checking accounts, money market accounts and certain investments. The Company considers all highly liquid investments with original or remaining maturities at the time of purchase of 90 days or less to be cash equivalents. Restricted cash consists of cash serving as collateral for letters of credit issued for security deposits for the Company’s facility leases in Bedford, Massachusetts. The following table provides a reconciliation of cash, cash equivalents, and restricted cash to amounts shown in the condensed consolidated statements of cash flows: September 30, 2022 2021 (in thousands) Cash and cash equivalents $ 43,162 $ 95,829 Restricted cash — 1,274 Total cash, cash equivalents and restricted cash $ 43,162 $ 97,103 Short-Term Investments —Short-term investments represent holdings of available-for-sale marketable securities in accordance with the Company’s investment policy and cash management strategy. Short-term investments have maturities of greater than 90 days at the time of purchase and mature within one year from the balance sheet date. Investments in marketable securities are recorded at fair value, with any unrealized gains and losses reported within accumulated other comprehensive income as a separate component of stockholders’ equity until realized or until a determination is made that an other-than-temporary decline in market value has occurred. Any premium or discount arising at purchase is amortized and/or accreted to interest income and/or expense over the life of the underlying security. Such amortization and accretion, together with interest on securities, are included in interest income in the Company’s condensed consolidated statements of operations. The cost of marketable securities sold is determined based on the specific identification method and any realized gains or losses on the sale of investments are reflected as a component of other income. Equity Method Investment —The Company uses the equity method of accounting to account for an investment in an entity that it does not control, but in which it has the ability to exercise significant influence over operating and financial policies. The Company's proportionate share of the net income or loss of the entity is included in consolidated net earnings. Judgments regarding the level of influence over the equity method investment include consideration of key factors such as the Company's ownership interest, representation on the board of directors or other management body and participation in policy-making decisions. Under the equity method of accounting, the Company’s investment is initially recorded at fair value on the condensed consolidated balance sheets. Upon initial investment, the Company evaluates whether there are basis differences between the carrying value and fair value of the Company’s proportionate share of the investee’s underlying net assets. Typically, the Company amortizes basis differences identified on a straight-line basis over the underlying assets’ estimated useful lives when calculating the attributable earnings or losses, excluding the basis differences attributable to in-process research and development that has no alternative future use. If the Company is unable to attribute all of the basis differences to specific assets or liabilities of the investee, the residual excess of the cost of the investment over the proportional fair value of the investee’s assets and liabilities is considered to be equity method goodwill and is recognized within the equity investment balance, which is tracked separately within the Company’s memo accounts. The Company subsequently records in the condensed consolidated statements of operations its share of income or loss of the other entity within other income/expense, which results in an increase or decrease to the carrying value of the investment. If the share of losses exceeds the carrying value of the Company’s investment, the Company will suspend recognizing additional losses and will continue to do so unless it commits to providing additional funding; however, if there are intra-entity profits this can cause the investment balance to go negative. The Company evaluates its equity method investments for impairment whenever events or changes in circumstances indicate that a decline in value has occurred that is other than temporary. Evidence considered in this evaluation includes, but would not necessarily be limited to, the financial condition and near-term prospects of the investee, recent operating trends and forecasted performance of the investee, market conditions in the geographic area or industry in which the investee operates and the Company’s strategic plans for holding the investment in relation to the period of time expected for an anticipated recovery of its carrying value. If the investment is determined to have a decline in value deemed to be other than temporary it is written down to estimated fair value. At September 30, 2022 , the Company accounted for its investment in OXB Solutions using the equity method of accounting (see Note 5). Offering Costs —The Company capitalizes incremental legal, professional accounting and other third-party fees that are directly associated with equity financings as other current assets until the transactions are completed. After equity financings are complete, these costs are recorded in stockholders’ equity as a reduction of additional paid-in capital generated as a result of the offering. Leases —The Company determines if an arrangement is a lease at contract inception. The Company’s contracts are determined to contain a lease when all of the following criteria based on the specific circumstances of the arrangement are met: (1) there is an identified asset for which there are no substantive substitution rights; (2) the Company has the right to obtain substantially all of the economic benefits from the identified asset; and (3) the Company has the right to direct the use of the identified asset. At the commencement date, operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of future lease payments over the expected lease term. The Company’s lease agreements do not provide an implicit rate. As a result, the Company utilizes an estimated incremental borrowing rate to discount lease payments, which is based on the rate of interest the Company would have to pay to borrow a similar amount on a collateralized basis over a similar term. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or lease incentives received. Operating lease cost is recognized over the expected term on a straight-line basis. The expected lease term includes noncancelable lease periods and, when applicable, periods covered by an option to extend the lease if the Company is reasonably certain to exercise that option, as well as periods covered by an option to terminate the lease if the Company is reasonably certain not to exercise that option. Variable lease cost is recognized as incurred. The Company acts as sublessor related to a sublease of a portion of the Company's headquarters that is now occupied by OXB Solutions (see Note 13). Fixed sublease payments received are recorded as a reduction to lease cost. Right-of-use assets are periodically evaluated for impairment. Although Homology assigned all of its right, title and interest in, to and under this lease to OXB Solutions, the Company remains jointly and severally liable for the payment of rent under this lease and was not released from being the primary obligor under such lease. Therefore, the related right-of-use asset and operating lease liability were not derecognized and remain on the Company’s condensed consolidated balance sheets. Research and Development Costs —Research and development costs are charged to expense as incurred. Research and development expense consists of expenses incurred in performing research and development activities, including salaries and benefits, materials and supplies, preclinical and clinical expenses, stock-based compensation expense, depreciation of equipment, contract services, and other outside expenses. Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks using information provided to the Company by its vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as prepaid expense or accrued research and development expense. Income Taxes— The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the Company’s condensed consolidated financial statements and tax returns. Deferred tax assets and liabilities are determined based upon the differences between the financial statement carrying amounts and the tax bases of existing assets and liabilities and for loss and credit carryforwards, using enacted tax rates expected to be in effect in the year in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if it is more likely than not that these assets may not be realized. The Company determines whether it is more likely than not that a tax position will be sustained upon examination. The tax benefit to be recognized for any tax position that meets the more-likely-than-not recognition threshold is calculated as the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement. If it is not more likely than not that a position will be sustained, none of the benefit attributable to the position is recognized. The Company accounts for interest and penalties related to uncertain tax positions as part of its provision for income taxes. Since inception, the Company has provided a valuation allowance for the full amount of the net deferred tax assets as the realization of the net deferred tax assets has not been determined to be more likely than not. The Company recorded an income tax benefit of less than $ 0.1 million and income tax provision of $ 0.8 million for the three and nine months ended September 30, 2022, respectively . The year-to-date tax provision predominately results from the gain associated with the sale of the Company's manufacturing business due to the transaction with Oxford (see Note 5), offset by available federal and state net operating loss carryforwards and research and development tax credits which are subject to certain limitations as to their utilization. The Company did no t record an income tax provision (benefit) for the three and nine months ended September 30, 2021 . Revenue Recognition— Revenue is recognized in accordance with FASB Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”). Under ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine the appropriate amount of revenue to be recognized for arrangements determined to be within the scope of ASC 606, the Company performs the following five steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect consideration it is entitled to in exchange for the goods or services it transfers to the customer. The promised goods or services in the Company’s arrangements would likely consist of a license, rights to the Company’s intellectual property or research, development and manufacturing services. Performance obligations are promised goods or services in a contract to transfer a distinct good or service to the customer and are considered distinct when (i) the customer can benefit from the good or service on its own or together with other readily available resources and (ii) the promised good or service is separately identifiable from other promises in the contract. In assessing whether promised goods or services are distinct, the Company considers factors such as the stage of development of the underlying intellectual property, the capabilities of the customer to develop the intellectual property on its own or whether the required expertise is readily available and whether the goods or services are integral or dependent to other goods or services in the contract. The Company estimates the transaction price based on the amount expected to be received for transferring the promised goods or services in the contract. The consideration may include fixed consideration and variable consideration. At the inception of each arrangement that includes variable consideration, the Company evaluates the amount of consideration to which the Company expects to be entitled to. The Company utilizes either the most likely amount method or expected value method to estimate the amount expected to be received based on which method best predicts the amount expected to be received. The amount of variable consideration that is included in the transaction price may be constrained and is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. The Company’s contracts may include development and regulatory milestone payments that are assessed under the most likely amount method and constrained until it is probable that a significant revenue reversal would not occur. Milestone payments that are not within the Company’s control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. At the end of each reporting period, the Company re-evaluates the probability of achievement of such development and regulatory milestones and any related constraint, and if necessary, adjust its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaboration revenue in the period of adjustment. For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from the Company’s collaboration arrangement. The Company allocates the transaction price based on the estimated standalone selling price of each performance obligation. The Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. The Company utilizes key assumptions to determine the stand-alone selling price, which may include other comparable transactions, pricing considered in negotiating the transaction and the estimated costs. Variable consideration is allocated specifically to one or more performance obligations in a contract when the terms of the variable consideration relate to the satisfaction of the performance obligation and the resulting amounts allocated are consistent with the amounts the Company would expect to receive for the satisfaction of each performance obligation. The consideration allocated to each performance obligation is recognized as revenue when control is transferred for the related goods or services. For performance obligations which consist of licenses and other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress. The Company evaluates the measure of progress for its over-time arrangements at each reporting period and, if necessary, updates the measure of progress and revenue recognized. Net Income (Loss) per Share— Basic net income (loss) per share is computed by dividing net income (loss) by the weighted-average number of common shares outstanding during the period. Diluted net income (loss) per share is computed using the weighted-average number of common shares outstanding during the period and, if dilutive, the weighted-average number of potential shares of common stock. The weighted-average number of common shares included in the computation of diluted net income (loss) gives effect to all potentially dilutive common equivalent shares, including outstanding stock options, restricted stock units and unvested shares of common stock. Common stock equivalent shares are excluded from the computation of diluted net income (loss) per share if their effect is antidilutive. In periods in which the Company reports a net (loss) attributable to common stockholders, diluted net (loss) per share attributable to common stockholders is generally the same as basic net (loss) per share attributable to common stockholders, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. Recent Accounting Pronouncements —The Jumpstart Our Business Startups Act of 2012 permits an emerging growth company to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. As an emerging growth company, the Company has elected to take advantage of this extended transition period. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”) to improve financial reporting by requiring more timely recording of credit losses on loans and other financial instruments held by financial institutions and other organizations. ASU 2016-13 requires the measurement of all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. ASU 2016-13 also requires enhanced disclosures to help investors and other financial statement users better understand significant estimates and judgments used in estimating credit losses, as well as the credit quality and underwriting standards of an organization’s portfolio. ASU 2016-13 is effective for the Company beginning January 1, 2023, with early application permitted. The Company is currently evaluating the impact the adoption of this standard will have on its condensed consolidated financial statements. |
Short-Term Investments
Short-Term Investments | 9 Months Ended |
Sep. 30, 2022 | |
Investments Disclosure [Abstract] | |
SHORT-TERM INVESTMENTS | 3. SHORT-TERM INVESTMENTS The Company may invest its excess cash in fixed income instruments denominated and payable in U.S. dollars, including U.S. treasury securities, commercial paper, corporate debt securities and asset-backed securities in accordance with the Company’s investment policy that primarily seeks to maintain adequate liquidity and preserve capital. The following table summarizes the Company’s short-term investments as of September 30, 2022 and December 31, 2021: As of September 30, 2022 Amortized Unrealized Unrealized Fair Value (in thousands) Commercial paper $ 74,632 $ — $ — $ 74,632 US Treasury securities 64,648 2 ( 313 ) 64,337 Corporate debt securities 19,089 — ( 146 ) 18,943 Total $ 158,369 $ 2 $ ( 459 ) $ 157,912 As of December 31, 2021 Amortized Unrealized Unrealized Fair Value (in thousands) Commercial paper $ 27,992 $ — $ — $ 27,992 Corporate debt securities 19,506 — ( 7 ) 19,499 Total $ 47,498 $ — $ ( 7 ) $ 47,491 The Company utilizes the specific identification method in computing realized gains and losses. The Co mpany had no realized gains and losses on its available-for-sale securities for the three and nine months ended September 30, 2022 and 2021. The c ontractual maturity dates of all of the Company’s investments are less than one year . |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | 4. FAIR VALUE MEASUREMENTS The Company’s financial instruments consist of cash and cash equivalents, short-term investments, restricted cash and accounts payable. The carrying amount of cash, restricted cash and accounts payable are each considered a reasonable estimate of fair value due to the short-term maturity. Assets measured at fair value on a recurring basis were as follows: Description September 30, Quoted Prices Significant Other Significant (in thousands) Cash equivalents: Money market mutual funds $ 43,162 $ 43,162 $ — $ — Total cash equivalents $ 43,162 $ 43,162 $ — $ — Short-term investments: Commercial paper $ 74,632 $ — $ 74,632 $ — US Treasury securities 64,337 — 64,337 — Corporate debt securities 18,943 — 18,943 — Total short-term investments $ 157,912 $ — $ 157,912 $ — Total financial assets $ 201,074 $ 43,162 $ 157,912 $ — Description December 31, Quoted Prices Significant Other Significant (in thousands) Cash equivalents: Money market mutual funds $ 108,323 $ 108,323 $ — $ — Total cash equivalents $ 108,323 $ 108,323 $ — $ — Short-term investments: Commercial paper $ 27,992 $ — $ 27,992 $ — Corporate debt securities 19,499 — 19,499 — Total short-term investments $ 47,491 $ — $ 47,491 $ — Total financial assets $ 155,814 $ 108,323 $ 47,491 $ — Short-term securities are valued using models or other valuation methodologies that use Level 2 inputs. These models are primarily industry-standard models that consider various assumptions, including time value, yield curve, volatility factors, default rates, current market and contractual prices for the underlying financial instruments, as well as other relevant economic measures. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace. There were no transfers between fair value measurement levels during the three and nine months ended September 30, 2022 and 2021 . |
Equity Method Investment
Equity Method Investment | 9 Months Ended |
Sep. 30, 2022 | |
Equity Method Investment, Summarized Financial Information [Abstract] | |
EQUITY METHOD INVESTMENT | 5. EQUITY METHOD INVESTMENT Summary of Transaction On March 10, 2022, the Company closed its previously announced transaction with OXB Solutions, Oxford Biomedica (US), Inc., ("OXB"), and Oxford, pursuant to the Equity Securities Purchase Agreement (the "Purchase Agreement"), dated as of January 28, 2022, by and among Homology, OXB Solutions and Oxford, whereby, among other things, Homology and Oxford agreed to collaborate to operate OXB Solutions, which provides AAV vector process development and manufacturing services to pharmaceutical and biotechnology companies (the "OXB Solutions Transaction"). Pursuant to the terms of the Purchase Agreement and a contribution agreement (the "Contribution Agreement") entered into between Homology and OXB Solutions prior to the closing of the OXB Solutions Transaction (the "Closing"), Homology agreed to assign and transfer to OXB Solutions all of its assets that are primarily used in the manufacturing of AAV vectors for use in gene therapy and gene editing products, but excluding certain assets related to manufacturing or testing of Homology's proprietary AAV vectors (collectively, the "Transferred Assets"), in exchange for 175,000 common equity units in OXB Solutions ("Units"), representing 100 percent (100%) of the ownership interest of OXB Solutions, and OXB Solutions assumed from the Company, and agreed to pay, perform and discharge when due, all of the Company's duties, obligations, liabilities, interests and commitments of any kind under, arising out of or relating to the Transferred Assets. Effective as of the Closing, Homology sold to OXB, and OXB purchased from Homology, 130,000 Units, (the "Transferred Units") in exchange for $ 130.0 million of cash consideration. In connection with the Closing, OXB contributed $ 50.0 million in cash to OXB Solutions in exchange for an additional, newly issued 50,000 Units. Immediately following the Closing, (i) OXB owned 180,000 Units, representing 80 percent (80%) of the fully diluted equity interests in OXB Solutions, and (ii) Homology owned 45,000 Units, representing 20 percent (20%) of the fully diluted equity interests in OXB Solutions. Pursuant to the Amended and Restated Limited Liability Company Agreement of OXB Solutions (the "OXB Solutions Operating Agreement") which was executed in connection with the Closing, at any time following the three-year anniversary of the Closing, (i) OXB will have an option to cause Homology to sell and transfer to OXB, and (ii) Homology will have an option to cause OXB to purchase from Homology, in each case all of Homology's equity ownership interest in OXB Solutions at a price equal to 5.5 times the revenue for the immediately preceding 12-month period (together, the "Options"), subject to a maximum amount of $ 74.1 million. Pursuant to the terms of the OXB Solutions Operating Agreement, Homology is entitled to designate one director to the Board of Directors of OXB Solutions, which is currently Arthur Tzianabos, Homology's former Chief Executive Officer and current Chairman of the Board. Further, Tim Kelly, Homology's former Chief Operating Officer, now serves as the Chief Executive Officer and Chairman of the Board of OXB Solutions. At December 31, 2021, the Company presented $ 28.9 million of fixed assets transferred to OXB Solutions as a current asset under the caption of “assets held for sale” in its consolidated balance sheet. Equity Method of Accounting The Company has significant influence over, but does not control, OXB Solutions through its noncontrolling representation on OXB’s board of directors and the Company’s equity interest in OXB Solutions. In addition, the Company and OXB Solutions have intra-entity transactions through a series of agreements entered into in conjunction with the OXB Solutions Transaction (see Note 13 for details), OXB Solutions granted certain licenses to the Company, and the Company has representation on the joint steering committee which oversees the activities governed by the Supply Agreement. Accordingly, the Company does not consolidate the financial statements of OXB Solutions and accounts for its investment using the equity method of accounting. The Company recorded its equity method investment in OXB Solutions at fair value upon deconsolidation of OXB Solutions as of the Closing. The fair value of the equity method investment was determined based on the market approach. This approach estimated the fair value of OXB Solutions based on the implied value for the entity using the consideration paid, including the Options, for a controlling interest in OXB Solutions at the entity’s formation. As part of its fair value analysis, the Company determined that the Options are embedded in the common equity units because the Options are not legally detachable or separately exercisable. Accordingly, the equity method investment and the Options represent one unit of account and the fair value recorded reflects the value of the equity interest and the Options. The valuation included certain subjective assumptions including discounts for lack of control and marketability given the consideration paid for OXB Solutions was for a controlling interest in the entity and the Company owns a noncontrolling interest. As of March 10, 2022, the Closing, the fair value of the Company’s investment in OXB Solutions was $ 31.2 million and the Company recorded a gain of $ 131.2 million on the sale of its manufacturing business in other income in the Company's condensed consolidated statements of operations. The gain was computed as follows: (in thousands) March 10, 2022 Cash received $ 130,000 Plus: Fair value of equity method investment 31,223 Less: Carrying value of transferred assets ( 29,974 ) Gain on sale of business $ 131,249 In addition, the Company records its share of income or losses from OXB Solutions on a quarterly basis. For the three and nine months ended September 30, 2022, the Company recorded $ 2.2 million and $ 4.1 million, respectively, representing its share of OXB Solution's net loss during for each such period. As of September 30, 2022, the carrying value of the equity method investment was $ 27.1 million. |
Property and Equipment, Net
Property and Equipment, Net | 9 Months Ended |
Sep. 30, 2022 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT, NET | 6. PROPERTY AND EQUIPMENT, NET Property and equipment, net consists of the following: As of September 30, 2022 December 31, 2021 (in thousands) Laboratory equipment $ 6,017 $ 5,857 Computers and purchased software 1,596 1,596 Furniture and fixtures 645 645 Property and equipment, at cost 8,258 8,098 Less: accumulated depreciation and amortization ( 6,843 ) ( 5,846 ) Property and equipment, net $ 1,415 $ 2,252 Depreciation expense for the three and nine months ended September 30, 2022 was approximately $ 0.3 million and $ 1.0 million, respectively, compared to $ 2.1 million and $ 6.3 million, respectively for the three and nine months ended September 30, 2021 . The Company had no disposals of property and equipment during the three and nine months ended September 30, 2022 and less than $ 0.1 million of disposals during the three and nine months ended September 30, 2021 . |
Accrued Expenses and Other Liab
Accrued Expenses and Other Liabilities | 9 Months Ended |
Sep. 30, 2022 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES AND OTHER LIABILITIES | 7. ACCRUED EXPENSES AND OTHER LIABILITIES Accrued expenses and other liabilities consist of the following: As of September 30, 2022 December 31, 2021 (in thousands) Accrued research and development expenses $ 10,784 $ 2,193 Accrued compensation and benefits 4,048 7,805 Accrued professional fees 817 1,371 Accrued income taxes 816 - Accrued other 505 37 Total accrued expenses and other liabilities $ 16,970 $ 11,406 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 8. COMMITMENTS AND CONTINGENCIES Operating Leases —In September 2016, the Company entered into a noncancelable operating lease beginning in November 2016 for office, laboratory and manufacturing space in Bedford, Massachusetts, that expired in October 2021 , with an option for an additional three-year term that was not exercised. In 2018, the Company entered into a sublease agreement for the entire leased premises. The rent commencement date of the sublease was December 2018, and the sublease terminated on the scheduled termination date of the original lease. Under the terms of the sublease, the subtenant was obligated to pay the Company aggregate base rent of approximately $ 2.7 million over the term of the sublease, based on the same level of rent the Company was obligated to pay the landlord, in addition to a passthrough of operating expenses and real estate taxes charged by the landlord. In December 2017, the Company entered into a noncancelable operating lease for approximately 67,000 square feet of research and development, manufacturing and general office space in Bedford, Massachusetts. Prior to a subsequent amendment described below, the lease was set to expire in February 2027 with an option for an additional five-year term. Rent became due under the lease in two phases; rent on the first 46,000 square feet started in September 2018 and rent on the remaining 21,000 square feet started in March 2019 . The initial annual base rent was $ 39.50 per square foot and increases by three percent annually. The Company is obligated to pay, on a pro-rata basis, real estate taxes and operating costs related to the premises. The lease agreement entered into in December 2017 allowed for a tenant improvement allowance not to exceed $ 10.9 million, which the Company received in full, to be applied to the total cost of tenant improvements to the leased premises. The unamortized balance of the tenant improvement allowance was included in deferred rent incentives and has been recorded as a reduction to operating right-of-use asset upon adoption of the new leasing standards. In November 2021, the Company entered into an amendment of its December 2017 lease agreement (the “Lease Amendment”) for its corporate headquarters in Bedford, Massachusetts. The Lease Amendment increases the space under lease by approximately 23,011 square feet (the "Expansion Premises") and extended the expiration date of the existing premises under the lease from February 2027 to June 2030. The payment term with respect to the Expansion Premises commences on the earlier of (i) the date of the Substantial Completion of the Tenant’s Work (as both terms are defined in the Lease Amendment), (ii) the Company’s occupancy of any portion of the Expansion Premises, and (iii) May 1, 2022, and continues for a period of ten years and five months. The term of the Expansion Premises and the existing premises are not coterminous. Annual base rent for the existing premise under the Lease Amendment is approximately $ 4.7 million beginning on March 1, 2027, and increases by three percent annually; annual base rent for the Expansion Premises is approximately $ 1.4 million per year and increases by three percent annually. The Lease Amendment allows for tenant improvement allowances not to exceed $ 6.3 million in the aggregate. The Lease Amendment was accounted for as a lease modification and the right-of-use asset and operating lease liability for the existing premises were remeasured at the modification date, which resulted in an increase of $ 10.9 million to both the right-of-use asset and operating lease liabilities. In February 2022, the Company revised its assumption for when it expects to utilize the tenant improvement allowances. This change in assumption was accounted for as a lease modification and the right-of-use asset and operating lease liability for the existing premises were remeasured at the modification date, which resulted in an increase of $ 0.2 million to both the right-of-use asset and operating lease liabilities. In March 2022, in accordance with its transaction with OXB Solutions, the Company assigned all of its right, title and interest in, to and under its corporate headquarters lease to OXB Solutions and entered into a sublease agreement whereby OXB Solutions subleased certain premises in its facility to Homology. However, as the Company has not been released from being the primary obligor under such lease, the related right-of-use asset and operating lease liability were not derecognized and remain on the Company’s balance sheet and the Company acts as sublessor to OXB Solutions for accounting purposes. See Note 13 for details. In September 2022, the Company concluded that 100 % of the tenant improvement allowances would be utilized by OXB Solutions. This change in assumption was accounted for as a lease modification and the right-of-use asset and operating lease liability for the existing premises were remeasured at the modification date, which resulted in an increase of $ 6.1 million to both the right-of-use asset and operating lease liabilities. The Company maintained letters of credit, secured by restricted cash, for security deposits totaling $ 2.0 million as of December 31, 2021 in conjunction with its leases. The Company had no security deposit or restricted cash as of September 30, 2022. The following table summarizes operating lease costs, variable lease costs and sublease income: Nine months ended September 30, 2022 2021 (in thousands) Operating lease costs $ 2,826 $ 1,869 Variable lease costs 1,698 1,636 Sublease income ( 1,210 ) ( 705 ) Net lease cost $ 3,314 $ 2,800 The maturities of the Company's operating lease liabilities and minimum lease payments as of September 30, 2022 were as follows: For the Years Ending December 31, Amount 2022 1,101 2023 4,444 2024 4,578 2025 4,715 Thereafter 31,123 Total undiscounted lease payments $ 45,961 Less: imputed interest ( 16,134 ) Present value of operating lease liabilities $ 29,827 The following table summarizes the lease term and discount rate as of September 30, 2022: As of September 30, 2022 Weighted-average remaining lease term (years) Operating leases 8.5 Weighted-average discount rate Operating leases 10.6 % The following table summarizes the supplemental cash flow information related to the Company's operating lease: Nine months ended September 30, 2022 2021 (in thousands) Cash paid for amounts included in the measurement of lease liabilities $ 2,226 $ 2,901 Increase in lease liabilities and right-of-use assets due to lease remeasurements $ 6,262 $ — Legal Proceedings —On March 25, 2022, the Company and certain of its executives were named as defendants in a putative securities class action lawsuit filed in the United States District Court for the Central District of California; Pizzuto v. Homology Medicines, Inc., No. 2:22–CV–01968 (C.D. Cal 2022). The complaint alleges that the Company failed to disclose certain information regarding efficacy and safety in connection with a Phase I/II HMI-102 clinical trial, and seeks damages in an unspecified amount. The case is in its early stages. The Company believes the claims alleged lack merit and has filed a motion to transfer venue and a motion to dismiss. As the outcome is not presently determinable, any loss is neither probable nor reasonably estimable. |
Stock Incentive Plans
Stock Incentive Plans | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
STOCK INCENTIVE PLANS | 9. STOCK INCENTIVE PLANS 2015 Stock Incentive Plan In December 2015, the Company’s Board of Directors adopted the 2015 Stock Incentive Plan (the “2015 Plan”), which provided for the grant of qualified incentive and nonqualified stock options or restricted stock awards to the Company’s employees, officers, directors, advisors, and outside consultants. Stock options generally vest over a four-year period and expire ten years from the date of grant. Certain options provide for accelerated vesting if there is a change in control, as defined in the 2015 Plan. At September 30, 2022 , there were no additional shares available for future grant under the 2015 Plan. 2018 Incentive Award Plan In March 2018, the Company’s Board of Directors adopted and the Company’s stockholders approved the Homology Medicines, Inc. 2018 Incentive Award Plan (the “2018 Plan” and, together with the 2015 Plan, the “Plans”), which became effective on the day prior to the first public trading date of the Company’s common stock. Upon effectiveness of the 2018 Plan, the Company ceased granting new awards under the 2015 Plan. The 2018 Plan provides for the grant of incentive stock options, nonqualified stock options, restricted stock awards, restricted stock units, stock appreciation rights and other stock or cash-based awards to employees and consultants of the Company and certain affiliates and directors of the Company. The number of shares of common stock initially available for issuance under the 2018 Plan was 3,186,205 shares of common stock plus the number of shares subject to awards outstanding under the 2015 Plan that expire, terminate or are otherwise surrendered, cancelled, forfeited or repurchased by the Company on or after the effective date of the 2018 Plan. In addition, the number of shares of common stock available for issuance under the 2018 Plan is subject to an annual increase on the first day of each calendar year beginning on January 1, 2019, and ending on and including January 1, 2028, equal to the lesser of (i) 4 % of the Company’s outstanding shares of common stock on the final day of the immediately preceding calendar year and (ii) such smaller number of shares of common stock as determined by the Company’s Board of Directors, provided that not more than 20,887,347 shares of common stock may be issued under the 2018 Plan upon the exercise of incentive stock options. Therefore, on January 1, 2022, an additional 2,286,010 shares were added to the 2018 Plan, representing 4 % of total common shares outstanding at December 31, 2021. As of September 30, 2022, there wer e 2,328,589 s hares available for future grant under the 2018 Plan. 2018 Employee Stock Purchase Plan In March 2018, the Company’s Board of Directors adopted and the Company’s stockholders approved the Homology Medicines, Inc. 2018 Employee Stock Purchase Plan (the “2018 ESPP”). The 2018 ESPP allows employees to buy Company stock through after-tax payroll deductions at a discount from market value. The 2018 ESPP is intended to qualify as an “employee stock purchase plan” under Section 423 of the Internal Revenue Code. The number of shares of common stock initially available for issuance under the 2018 ESPP was 353,980 shares of common stock plus an annual increase on the first day of each calendar year, beginning on January 1, 2019, and ending on and including January 1, 2028 equal to the lesser of (i) 1 % of the Company’s outstanding shares of common stock on the final day of the immediately preceding calendar year and (ii) such smaller number of shares of common stock as determined by the Company’s Board of Directors, provided that not more than 4,778,738 shares of common stock may be issued under the 2018 ESPP. Therefore, on January 1, 2022, an additional 571,502 shares were added to the 2018 ESPP, representing 1 % of total common shares outstanding at December 31, 2021. As of September 30, 2022, there were 1,776,431 s hares available for future issuance under the 2018 ESPP. Under the 2018 ESPP, employees may purchase common stock through after-tax payroll deductions at a price equal to 85 % of the lower of the fair market value on the first trading day of an offering period or the last trading day of an offering period. The 2018 ESPP generally provides for offering periods of six months in duration that end on the final trading day of each February and August. In accordance with the Internal Revenue Code, no employee will be permitted to accrue the right to purchase stock under the 2018 ESPP at a rate in excess of $ 25,000 worth of shares during any calendar year during which such a purchase right is outstanding (based on the fair market value per share of the Company’s common stock as of the first day of the offering period). During the nine months ended September 30, 2022 , 226,453 s hares were issued under the 2018 ESPP for aggregate proceeds to the Company of $ 0.6 million. During the nine months ended September 30, 2021 , 110,923 shares were issued under the 2018 ESPP for aggregate proceeds to the Company of $ 0.8 million. Pursuant to the 2018 ESPP, the Company recorded stock-based compensation of less than $ 0.1 m illion during the three and nine months ended September 30, 2022. During the three and nine months ended September 30, 2021, s tock-based compensation expense pursuant to the 2018 ESPP was $ 0.1 million . Stock Options The fair value of each option award is estimated on the date of grant using the Black-Scholes option pricing model, with the assumptions noted in the table below. Expected volatility for the Company’s common stock was determined based on an average of the historical volatility of a peer group of publicly traded companies that are similar to the Company. The expected term of options was calculated using the simplified method, which represents the average of the contractual term of the option and the weighted-average vesting period of the option. The Company uses the simplified method because it does not have sufficient historical option exercise data to provide a reasonable basis upon which to estimate expected term. The assumed dividend yield is based upon the Company’s expectation of not paying dividends in the foreseeable future. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for periods commensurate with the expected term of the award. The Company recognizes forfeitures as they occur. The assumptions used in the Black-Scholes option pricing model are as follows: Three months ended September 30, Nine months ended September 30, 2022 2021 2022 2021 Expected volatility 70.1 % 66.3 % - 71.7 % 68.7 % - 70.1 % 64.6 % - 71.7 % Weighted-average risk-free interest rate 3.2 % - 3.66 % 0.81 % - 1.03 % 1.46 % - 3.66 % 0.50 % - 1.20 % Expected dividend yield — % — % — % — % Expected term (in years) 6.25 6.25 5.5 - 6.25 5.5 - 6.25 Underlying common stock fair value $ 1.82 -$ 2.82 $ 6.36 -$ 7.75 $ 1.78 -$ 4.17 $ 6.36 -$ 13.91 The following table summarizes the Company’s stock option activity for the nine months ended September 30, 2022: Number of Weighted- Weighted- Aggregate (in thousands) Outstanding at January 1, 2022 7,624,306 $ 14.25 7.5 $ 2,069 Granted 2,895,055 $ 2.70 Exercised ( 293 ) $ 2.71 Cancelled/Forfeited ( 899,370 ) $ 9.92 Outstanding at September 30, 2022 9,619,698 $ 11.18 7.3 $ 717 Vested and expected to vest at 9,619,698 $ 11.18 7.3 $ 717 Exercisable at September 30, 2022 5,716,593 $ 13.29 6.3 $ 717 The total intrinsic value of options exercised during the nine months ended September 30, 2022 and 2021 was insignificant and $ 0.6 million, respectively. The weighted-average grant date fair value per share of options granted during the nine months ended September 30, 2022 and 2021 wa s $ 1.72 a nd $ 7.50 , respectively. Stock Awards Modifications As part of the transaction with OXB Solutions (see Note 5), the Company transferred employees to OXB Solutions and modified certain of its existing stock awards (options and restricted stock units) granted to these transferred employees to permit such individuals to continue vesting in their awards as they are employed by and provide services to OXB Solutions. The modification of the unvested stock awards to continue vesting was accounted for as a Type III (improbable to probable) modification under FASB ASC Topic 718, Compensation—Stock Compensation ("ASC 718") . Accordingly, the Company reversed all compensation cost previously recorded on the awards that were not expected to vest under the original terms. Total compensation cost reversed in the three months ended March 31, 2022 was less than $ 0.1 million. Total compensation cost of $ 0.8 million, equal to the modification date fair value, will be recognized over the remaining service period. A portion of this total compensation cost will be included as a component of the loss from equity method investment. The modification of the vested stock awards to permit transferred employees to exercise their options over the remaining life of the award, rather than the 90-day window for terminated employees, is accounted for as a modification under ASC 718. Accordingly, the Company recognized incremental compensation cost on the modification date in an amount equal to the difference between the fair value of the awards before and after modification. The fair value of the awards immediately before modification assumes a 90-day expected term, whereas the fair value immediately after assumes an expected term equal to the remaining life of the modified options. Total incremental compensation cost recognized in the three months ended March 31, 2022 was $ 0.4 million. Restricted Stock Units The fair values of restricted stock units (“RSUs”) are based on the fair market value of the Company’s common stock on the date of grant. Each RSU represents a contingent right to receive one share of the Company’s common stock upon vesting. In general, RSUs vest annually in two or three equal installments. The following table summarizes the Company’s RSU activity for the nine months ended September 30, 2022: Number of Weighted- Outstanding at January 1, 2022 307,600 $ 12.75 Granted 400,495 $ 2.70 Vested ( 103,590 ) $ 12.66 Forfeited ( 77,546 ) $ 6.32 Outstanding at September 30, 2022 526,959 $ 6.08 Stock-based Compensation Expense The Company recognizes compensation expense for awards to employees based on the grant date fair value of stock-based awards on a straight-line basis over the period during which an award holder provides service in exchange for the award, which is generally the vesting period. The Company recorded stock-based compensation expense related to stock options, shares purchased under the 2018 ESPP and restricted stock units as follows: Three months ended September 30, Nine months ended September 30, 2022 2021 2022 2021 (in thousands) Research and development $ 889 $ 2,145 $ 4,143 $ 6,304 General and administrative 1,882 2,081 5,822 6,278 $ 2,771 $ 4,226 $ 9,965 $ 12,582 As of September 30, 2022, there wa s $ 15.8 mi llion of unrecognized compensation expense related to unvested employee and non-employee share-based compensation arrangements granted under the Plans. The unrecognized compensation expense is estimated to be recognized over a period of 2.4 years at September 30, 2022 . |
Net Income (Loss) Per Share
Net Income (Loss) Per Share | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
NET INCOME (LOSS) PER SHARE | 10. NET INCOME (LOSS) PER SHARE Basic net income (loss) per share is computed by dividing net income (loss) by the weighted-average number of common shares outstanding during the applicable period. Diluted net income (loss) per share incorporates the additional shares issuable upon assumed exercise of stock options and the vesting of restricted stock units, except in such case when their inclusion would be anti-dilutive. Three months ended September 30, Nine months ended September 30, (in thousands, except per share amounts) 2022 2021 2022 2021 Numerator: Net income (loss) $ ( 33,726 ) $ ( 30,608 ) $ 29,290 $ ( 62,181 ) Denominator: Weighted-average common shares outstanding-basic 57,447,192 57,106,639 57,372,399 54,704,410 Dilutive securities — — 528,899 — Weighted-average common shares outstanding-diluted 57,447,192 57,106,639 57,901,298 54,704,410 Net income (loss) per share-basic $ ( 0.59 ) $ ( 0.54 ) $ 0.51 $ ( 1.14 ) Net income (loss) per share-diluted $ ( 0.59 ) $ ( 0.54 ) $ 0.51 $ ( 1.14 ) For the three months ended September 30, 2022 and for the three and nine months ended September 30, 2021, the effect of dilutive securities, including stock options, restricted stock units and unvested common stock from early exercise of options, was excluded from the denominator for the calculation of diluted net loss per share because the Company recognized a net loss in each of those periods and their inclusion would be anti-dilutive. Anti-dilutive securities excluded for the three months ended September 30, 2022 and 2021 were 9,933,508 and 6,891,252 , respectively, and for the nine months ended September 30, 2022 and 2021 were 9,048,927 and 6,630,582 , respectively. |
Collaboration and License Agree
Collaboration and License Agreement | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
COLLABORATION AND LICENSE AGREEMENT | 11. COLLABORATION AND LICENSE AGREEMENT In November 2017, the Company entered into a collaboration and license agreement with Novartis (as amended, the “Collaboration Agreement”) for the research, development, manufacturing and commercialization of products using the Company’s gene-editing technology for the treatment of certain ophthalmic targets and sickle cell disease. On February 26, 2021, Homology received notice from Novartis that they had elected to terminate the Collaboration Agreement with the Company with respect to the remaining ophthalmic target under the Collaboration Agreement and as a result, the Company regained worldwide exclusive rights to this target. Accordingly, the notice served as notice of Novartis’ termination of the Collaboration Agreement in its entirety, which became effective on August 26, 2021. The Company recognized revenue under the Collaboration Agreement over time using a cost-to-cost method, which it believed best depicted the transfer of control to the customer. The delivery of the termination notice caused a change in the estimate of total costs to satisfy the single performance obligation under the Collaboration Agreement. The cumulative effect of revisions to the total estimated costs to complete the Company’s single performance obligation was recorded in the current period when the changes were identified and amounts could be reasonably estimated. As such, the Company recognized a cumulative effect adjustment of approximate ly $ 26.9 mi llion in collaboration revenue in the nine months ended September 30, 2021. As the Collaboration Agreement terminated in 2021, there was no revenue recorded for the nine months ended September 30, 2022. During the three and nine months ended September 30, 2021 , the Company recognized revenue under the Collaboration Agreement of $ 0.9 million and $ 30.8 million, respectively, of which $ 0.8 million and $ 30.2 million was included in deferred revenue at the beginning the period. There was no accounts receivable or deferred revenue on the Company's condensed consolidated balance sheets related to the Collaboration Agreement in either period presented. |
Pfizer Stock Purchase Agreement
Pfizer Stock Purchase Agreement | 9 Months Ended |
Sep. 30, 2022 | |
Pfizer Inc. | |
PFIZER STOCK PURCHASE AGREEMENT | 12. PFIZER STOCK PURCHASE AGREEMENT On November 9, 2020, the Company entered into a common stock purchase agreement (the “Stock Purchase Agreement”) with Pfizer Inc. (“Pfizer”), pursuant to which the Company agreed to issue and sell to Pfizer 5,000,000 shares of the Company’s common stock through a private placement transaction (the “Private Placement”) at a purchase price of $ 12.00 per share, for an aggregate purchase price of $ 60.0 million. The shares of common stock sold to Pfizer were subject to a one-year lock-up from closing, during which time Pfizer was prohibited from selling or otherwise disposing of such shares. Under the Stock Purchase Agreement, Pfizer was granted an exclusive right of first refusal (the “ROFR”) for a 30-month period (the “ROFR Period”) beginning on the date of the closing of the Private Placement (collectively, the “ROFR Provision”), to negotiate a potential collaboration on the development and commercialization of HMI-102 and HMI-103. Pfizer may exercise its right of first refusal under the ROFR Provision one time for each of HMI-102 and HMI-103 during the ROFR period. In addition to the ROFR, the Stock Purchase Agreement provides for an information sharing committee (the “Information Committee”), comprised of representatives of each company, which will serve as a forum for sharing information regarding the development of HMI-102 and HMI-103 during the ROFR Period. The Company recorded the issuance of common stock at its estimated fair value of $ 52.0 million, which reflects a discount for the lack of marketability of the shares. The remaining $ 8.0 million of aggregate purchase price was allocated to the other elements of the Stock Purchase Agreement, which represent a contract with a customer. The Company concluded that the Information Committee represents the only performance obligation under the contract. The ROFR does not provide Pfizer with a material right and is therefore not a performance obligation. As such, the Company allocated the $ 8.0 million to the Information Committee obligation. The Company recognizes revenue over time as the measure of progress, which it believes best depicts the transfer of control to Pfizer. The Information Committee will meet regularly over the ROFR Period to share information which results in recognition of the transaction price over the 30-month ROFR Period. During the three and nine months ended September 30, 2022, the Company recognized collaboration revenue of $ 0.8 million and $ 2.4 million, respectively, compared to $ 0.8 million and $ 2.4 million, respectively for the three and nine months ended September 30, 2021. As of September 30, 2022 and December 31, 2021, there was approximately $ 2.0 million and $ 4.4 million, respectively of deferred revenue related to the Company’s obligation to Pfizer. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2022 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | 13. RELATED PARTY TRANSACTIONS Oxford Biomedica Solutions LLC As described in Note 5, the Company has significant influence over, but does not control, OXB Solutions through its noncontrolling representation on OXB Solution’s board of directors and the Company’s equity interest in OXB Solutions. In March 2022, concurrently with the closing of the transaction with OXB Solutions, the Company entered into certain ancillary agreements with OXB Solutions including a supply agreement, a lease assignment and assumption agreement, a sublease agreement and a transitional services agreement. Supply Agreement Pursuant to the terms of the Manufacturing and Supply Agreement with OXB Solutions entered into in March 2022 (the "Supply Agreement"), the Company has agreed to purchase from OXB Solutions at least 50 % of its clinical supply requirements of AAV-based products during the initial term of the supply agreement. The Supply Agreement will provide for an initial term of three years, which may be extended for an additional one-year term. Under the Supply Agreement, the Company is committed to purchase a minimum number of batches of drug substance and drug product, as well as process development services, totaling approximately $ 27.5 million in 2022 and $ 29.7 million in 2023. There are no minimum purchase commitments in year three of the Supply Agreement. After the initial term, the Company will have the right to terminate the Supply Agreement for convenience or other reasons specified in the Supply Agreement upon prior written notice. Either party may terminate the Supply Agreement upon an uncured material breach by the other party or upon the bankruptcy or insolvency of the other party. During the three and nine months ended September 30, 2022 , the Company recorded purchases of drug substance from OXB Solutions related to the Supply Agreement of $ 6.0 million and $ 7.5 million, respectively, as well as purchases of process development services of approximately $ 2.2 million and $ 10.2 million, respectively. These amounts are included within research and development expenses on the Company's condensed consolidated statements of operations. As of September 30, 2022 , the amount due to OXB Solutions under the Supply Agreement was $ 7.3 million and was included in accrued expenses and other liabilities on the Company's condensed consolidated balance sheets. Lease Assignment and Sublease Agreement As described in Note 8, the Company leases space for research and development, manufacturing and general office space in Bedford, Massachusetts. The Company and OXB Solutions entered into a lease assignment and assumption agreement pursuant to which Homology assigned all of its right, title and interest in, to and under this lease to OXB Solutions and a sublease agreement whereby OXB Solutions subleased certain premises in its facility to Homology. However, as the Company remains jointly and severally liable for the payment of rent under this lease, the Company has not been released from being the primary obligor under such lease and therefore the related right-of-use asset and operating lease liability were not derecognized and remain on the Company’s condensed consolidated balance sheets. Therefore, the Company is recording sublease income from OXB Solutions as if it were subleasing the space to OXB Solutions. During the nine months ended September 30, 2022, the Company recorded sublease income of $ 1.2 million related to the sublease agreement with OXB Solutions. This amount was recognized as a reduction to lease expense in the Company's condensed consolidated statements of operations. Transitional Services Agreement Under the transitional services agreement with OXB Solutions (the “Services Agreement”), the Company is performing certain services for the benefit of OXB Solutions and OXB Solutions is performing certain services for the benefit of the Company. The term of the Services Agreement will not exceed eighteen months and lasts until the earlier of termination for convenience, termination for cause in the event of an uncured material breach, termination as a result of bankruptcy of either party, and expiration or termination of the only remaining outstanding service as set forth in the Services Agreement. Each company is fully reimbursing the other for these services. Expenses incurred by the Company for services provided by OXB Solutions recognized under the Services Agreement total ed $ 0.2 million and $ 0.5 million for the three and nine months ended September 30, 2022, respectively, and are presented within research and development expenses in the condensed consolidated statements of operations as the services related to facilities support within the Company's research and development labs. As of September 30, 2022 , the amount due to OXB Solutions under the Services Agreement was $ 0.1 million and was included in accrued expenses and other liabilities on the Company's condensed consolidated balance sheets. The Company provided finance, human resources, IT and legal services to OXB Solutions under the Services Agreement and recognized $ 0.8 million and $ 1.7 million, respectively, for the three and nine months ended September 30, 2022, for amounts to be reimbursed by OXB Solutions as a reduction to general and administrative expense in the Company's condensed consolidated statements of operations. As of September 30, 2022 , the Company had a receivable balance of $ 5.5 million from OXB Solutions which was recorded as a component of prepaid expenses and other current assets in the Company's condensed consolidated balance sheets. This receivable balance included $ 3.7 million for amounts paid by the Company to vendors on OXB Solutions' behalf. |
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 by the Company in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the rules and regulations of the SEC for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2021, included in the Company's Annual Report on Form 10-K on file with the SEC. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements. In the opinion of management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments which are necessary for a fair statement of the Company’s financial position as of September 30, 2022, and consolidated results of operations for the three and nine months ended September 30, 2022 and 2021, and cash flows for the nine months ended September 30, 2022 and 2021. Such adjustments are of a normal and recurring nature. The results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2022 . |
Principles of Consolidation | Principles of Consolidation —The Company’s condensed consolidated financial statements include the accounts of the Company and its subsidiary, Homology Medicines Securities Corporation, a wholly owned Massachusetts corporation, for the sole purpose of buying, selling, and holding securities on the Company’s behalf. All intercompany balances and transactions have been eliminated in the condensed consolidated financial statements. |
Use of Estimates | Use of Estimates —The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, and expenses, and the disclosure of contingent assets and liabilities as of and during the reporting period. The Company bases its estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, revenue recognition, accrued research and development expenses and the valuation of the Company's equity method investment. The Company assesses estimates on an ongoing basis; however, actual results could materially differ from those estimates. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) —Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. The Company’s only element of other comprehensive income (loss) is unrealized gains and losses on available-for-sale investments. |
Cash and Cash Equivalents and Restricted Cash | Cash and Cash Equivalents and Restricted Cash —Cash and cash equivalents consist of standard checking accounts, money market accounts and certain investments. The Company considers all highly liquid investments with original or remaining maturities at the time of purchase of 90 days or less to be cash equivalents. Restricted cash consists of cash serving as collateral for letters of credit issued for security deposits for the Company’s facility leases in Bedford, Massachusetts. The following table provides a reconciliation of cash, cash equivalents, and restricted cash to amounts shown in the condensed consolidated statements of cash flows: September 30, 2022 2021 (in thousands) Cash and cash equivalents $ 43,162 $ 95,829 Restricted cash — 1,274 Total cash, cash equivalents and restricted cash $ 43,162 $ 97,103 |
Short-Term Investments | Short-Term Investments —Short-term investments represent holdings of available-for-sale marketable securities in accordance with the Company’s investment policy and cash management strategy. Short-term investments have maturities of greater than 90 days at the time of purchase and mature within one year from the balance sheet date. Investments in marketable securities are recorded at fair value, with any unrealized gains and losses reported within accumulated other comprehensive income as a separate component of stockholders’ equity until realized or until a determination is made that an other-than-temporary decline in market value has occurred. Any premium or discount arising at purchase is amortized and/or accreted to interest income and/or expense over the life of the underlying security. Such amortization and accretion, together with interest on securities, are included in interest income in the Company’s condensed consolidated statements of operations. The cost of marketable securities sold is determined based on the specific identification method and any realized gains or losses on the sale of investments are reflected as a component of other income. |
Equity Method Investment | Equity Method Investment —The Company uses the equity method of accounting to account for an investment in an entity that it does not control, but in which it has the ability to exercise significant influence over operating and financial policies. The Company's proportionate share of the net income or loss of the entity is included in consolidated net earnings. Judgments regarding the level of influence over the equity method investment include consideration of key factors such as the Company's ownership interest, representation on the board of directors or other management body and participation in policy-making decisions. Under the equity method of accounting, the Company’s investment is initially recorded at fair value on the condensed consolidated balance sheets. Upon initial investment, the Company evaluates whether there are basis differences between the carrying value and fair value of the Company’s proportionate share of the investee’s underlying net assets. Typically, the Company amortizes basis differences identified on a straight-line basis over the underlying assets’ estimated useful lives when calculating the attributable earnings or losses, excluding the basis differences attributable to in-process research and development that has no alternative future use. If the Company is unable to attribute all of the basis differences to specific assets or liabilities of the investee, the residual excess of the cost of the investment over the proportional fair value of the investee’s assets and liabilities is considered to be equity method goodwill and is recognized within the equity investment balance, which is tracked separately within the Company’s memo accounts. The Company subsequently records in the condensed consolidated statements of operations its share of income or loss of the other entity within other income/expense, which results in an increase or decrease to the carrying value of the investment. If the share of losses exceeds the carrying value of the Company’s investment, the Company will suspend recognizing additional losses and will continue to do so unless it commits to providing additional funding; however, if there are intra-entity profits this can cause the investment balance to go negative. The Company evaluates its equity method investments for impairment whenever events or changes in circumstances indicate that a decline in value has occurred that is other than temporary. Evidence considered in this evaluation includes, but would not necessarily be limited to, the financial condition and near-term prospects of the investee, recent operating trends and forecasted performance of the investee, market conditions in the geographic area or industry in which the investee operates and the Company’s strategic plans for holding the investment in relation to the period of time expected for an anticipated recovery of its carrying value. If the investment is determined to have a decline in value deemed to be other than temporary it is written down to estimated fair value. At September 30, 2022 , the Company accounted for its investment in OXB Solutions using the equity method of accounting (see Note 5). |
Offering Costs | Offering Costs —The Company capitalizes incremental legal, professional accounting and other third-party fees that are directly associated with equity financings as other current assets until the transactions are completed. After equity financings are complete, these costs are recorded in stockholders’ equity as a reduction of additional paid-in capital generated as a result of the offering. |
Leases | Leases —The Company determines if an arrangement is a lease at contract inception. The Company’s contracts are determined to contain a lease when all of the following criteria based on the specific circumstances of the arrangement are met: (1) there is an identified asset for which there are no substantive substitution rights; (2) the Company has the right to obtain substantially all of the economic benefits from the identified asset; and (3) the Company has the right to direct the use of the identified asset. At the commencement date, operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of future lease payments over the expected lease term. The Company’s lease agreements do not provide an implicit rate. As a result, the Company utilizes an estimated incremental borrowing rate to discount lease payments, which is based on the rate of interest the Company would have to pay to borrow a similar amount on a collateralized basis over a similar term. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or lease incentives received. Operating lease cost is recognized over the expected term on a straight-line basis. The expected lease term includes noncancelable lease periods and, when applicable, periods covered by an option to extend the lease if the Company is reasonably certain to exercise that option, as well as periods covered by an option to terminate the lease if the Company is reasonably certain not to exercise that option. Variable lease cost is recognized as incurred. The Company acts as sublessor related to a sublease of a portion of the Company's headquarters that is now occupied by OXB Solutions (see Note 13). Fixed sublease payments received are recorded as a reduction to lease cost. Right-of-use assets are periodically evaluated for impairment. Although Homology assigned all of its right, title and interest in, to and under this lease to OXB Solutions, the Company remains jointly and severally liable for the payment of rent under this lease and was not released from being the primary obligor under such lease. Therefore, the related right-of-use asset and operating lease liability were not derecognized and remain on the Company’s condensed consolidated balance sheets. |
Research and Development Costs | Research and Development Costs —Research and development costs are charged to expense as incurred. Research and development expense consists of expenses incurred in performing research and development activities, including salaries and benefits, materials and supplies, preclinical and clinical expenses, stock-based compensation expense, depreciation of equipment, contract services, and other outside expenses. Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks using information provided to the Company by its vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the consolidated financial statements as prepaid expense or accrued research and development expense. |
Income Taxes | Income Taxes— The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the Company’s condensed consolidated financial statements and tax returns. Deferred tax assets and liabilities are determined based upon the differences between the financial statement carrying amounts and the tax bases of existing assets and liabilities and for loss and credit carryforwards, using enacted tax rates expected to be in effect in the year in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if it is more likely than not that these assets may not be realized. The Company determines whether it is more likely than not that a tax position will be sustained upon examination. The tax benefit to be recognized for any tax position that meets the more-likely-than-not recognition threshold is calculated as the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement. If it is not more likely than not that a position will be sustained, none of the benefit attributable to the position is recognized. The Company accounts for interest and penalties related to uncertain tax positions as part of its provision for income taxes. Since inception, the Company has provided a valuation allowance for the full amount of the net deferred tax assets as the realization of the net deferred tax assets has not been determined to be more likely than not. The Company recorded an income tax benefit of less than $ 0.1 million and income tax provision of $ 0.8 million for the three and nine months ended September 30, 2022, respectively . The year-to-date tax provision predominately results from the gain associated with the sale of the Company's manufacturing business due to the transaction with Oxford (see Note 5), offset by available federal and state net operating loss carryforwards and research and development tax credits which are subject to certain limitations as to their utilization. The Company did no t record an income tax provision (benefit) for the three and nine months ended September 30, 2021 . |
Revenue Recognition | Revenue Recognition— Revenue is recognized in accordance with FASB Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”). Under ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine the appropriate amount of revenue to be recognized for arrangements determined to be within the scope of ASC 606, the Company performs the following five steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect consideration it is entitled to in exchange for the goods or services it transfers to the customer. The promised goods or services in the Company’s arrangements would likely consist of a license, rights to the Company’s intellectual property or research, development and manufacturing services. Performance obligations are promised goods or services in a contract to transfer a distinct good or service to the customer and are considered distinct when (i) the customer can benefit from the good or service on its own or together with other readily available resources and (ii) the promised good or service is separately identifiable from other promises in the contract. In assessing whether promised goods or services are distinct, the Company considers factors such as the stage of development of the underlying intellectual property, the capabilities of the customer to develop the intellectual property on its own or whether the required expertise is readily available and whether the goods or services are integral or dependent to other goods or services in the contract. The Company estimates the transaction price based on the amount expected to be received for transferring the promised goods or services in the contract. The consideration may include fixed consideration and variable consideration. At the inception of each arrangement that includes variable consideration, the Company evaluates the amount of consideration to which the Company expects to be entitled to. The Company utilizes either the most likely amount method or expected value method to estimate the amount expected to be received based on which method best predicts the amount expected to be received. The amount of variable consideration that is included in the transaction price may be constrained and is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. The Company’s contracts may include development and regulatory milestone payments that are assessed under the most likely amount method and constrained until it is probable that a significant revenue reversal would not occur. Milestone payments that are not within the Company’s control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. At the end of each reporting period, the Company re-evaluates the probability of achievement of such development and regulatory milestones and any related constraint, and if necessary, adjust its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaboration revenue in the period of adjustment. For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from the Company’s collaboration arrangement. The Company allocates the transaction price based on the estimated standalone selling price of each performance obligation. The Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. The Company utilizes key assumptions to determine the stand-alone selling price, which may include other comparable transactions, pricing considered in negotiating the transaction and the estimated costs. Variable consideration is allocated specifically to one or more performance obligations in a contract when the terms of the variable consideration relate to the satisfaction of the performance obligation and the resulting amounts allocated are consistent with the amounts the Company would expect to receive for the satisfaction of each performance obligation. The consideration allocated to each performance obligation is recognized as revenue when control is transferred for the related goods or services. For performance obligations which consist of licenses and other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress. The Company evaluates the measure of progress for its over-time arrangements at each reporting period and, if necessary, updates the measure of progress and revenue recognized. |
Net Loss per Share | Net Income (Loss) per Share— Basic net income (loss) per share is computed by dividing net income (loss) by the weighted-average number of common shares outstanding during the period. Diluted net income (loss) per share is computed using the weighted-average number of common shares outstanding during the period and, if dilutive, the weighted-average number of potential shares of common stock. The weighted-average number of common shares included in the computation of diluted net income (loss) gives effect to all potentially dilutive common equivalent shares, including outstanding stock options, restricted stock units and unvested shares of common stock. Common stock equivalent shares are excluded from the computation of diluted net income (loss) per share if their effect is antidilutive. In periods in which the Company reports a net (loss) attributable to common stockholders, diluted net (loss) per share attributable to common stockholders is generally the same as basic net (loss) per share attributable to common stockholders, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements —The Jumpstart Our Business Startups Act of 2012 permits an emerging growth company to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. As an emerging growth company, the Company has elected to take advantage of this extended transition period. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”) to improve financial reporting by requiring more timely recording of credit losses on loans and other financial instruments held by financial institutions and other organizations. ASU 2016-13 requires the measurement of all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. ASU 2016-13 also requires enhanced disclosures to help investors and other financial statement users better understand significant estimates and judgments used in estimating credit losses, as well as the credit quality and underwriting standards of an organization’s portfolio. ASU 2016-13 is effective for the Company beginning January 1, 2023, with early application permitted. The Company is currently evaluating the impact the adoption of this standard will have on its condensed consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents, and restricted cash to amounts shown in the condensed consolidated statements of cash flows: September 30, 2022 2021 (in thousands) Cash and cash equivalents $ 43,162 $ 95,829 Restricted cash — 1,274 Total cash, cash equivalents and restricted cash $ 43,162 $ 97,103 |
Short-Term Investments (Tables)
Short-Term Investments (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Investments Disclosure [Abstract] | |
Summary of Short Term Investments | The following table summarizes the Company’s short-term investments as of September 30, 2022 and December 31, 2021: As of September 30, 2022 Amortized Unrealized Unrealized Fair Value (in thousands) Commercial paper $ 74,632 $ — $ — $ 74,632 US Treasury securities 64,648 2 ( 313 ) 64,337 Corporate debt securities 19,089 — ( 146 ) 18,943 Total $ 158,369 $ 2 $ ( 459 ) $ 157,912 As of December 31, 2021 Amortized Unrealized Unrealized Fair Value (in thousands) Commercial paper $ 27,992 $ — $ — $ 27,992 Corporate debt securities 19,506 — ( 7 ) 19,499 Total $ 47,498 $ — $ ( 7 ) $ 47,491 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets Measured at Fair Value on Recurring Basis | Assets measured at fair value on a recurring basis were as follows: Description September 30, Quoted Prices Significant Other Significant (in thousands) Cash equivalents: Money market mutual funds $ 43,162 $ 43,162 $ — $ — Total cash equivalents $ 43,162 $ 43,162 $ — $ — Short-term investments: Commercial paper $ 74,632 $ — $ 74,632 $ — US Treasury securities 64,337 — 64,337 — Corporate debt securities 18,943 — 18,943 — Total short-term investments $ 157,912 $ — $ 157,912 $ — Total financial assets $ 201,074 $ 43,162 $ 157,912 $ — Description December 31, Quoted Prices Significant Other Significant (in thousands) Cash equivalents: Money market mutual funds $ 108,323 $ 108,323 $ — $ — Total cash equivalents $ 108,323 $ 108,323 $ — $ — Short-term investments: Commercial paper $ 27,992 $ — $ 27,992 $ — Corporate debt securities 19,499 — 19,499 — Total short-term investments $ 47,491 $ — $ 47,491 $ — Total financial assets $ 155,814 $ 108,323 $ 47,491 $ — |
Equity Method Investment (Table
Equity Method Investment (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Equity Method Investment, Summarized Financial Information [Abstract] | |
Gain on sale of equity method investment | The gain was computed as follows: (in thousands) March 10, 2022 Cash received $ 130,000 Plus: Fair value of equity method investment 31,223 Less: Carrying value of transferred assets ( 29,974 ) Gain on sale of business $ 131,249 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net consists of the following: As of September 30, 2022 December 31, 2021 (in thousands) Laboratory equipment $ 6,017 $ 5,857 Computers and purchased software 1,596 1,596 Furniture and fixtures 645 645 Property and equipment, at cost 8,258 8,098 Less: accumulated depreciation and amortization ( 6,843 ) ( 5,846 ) Property and equipment, net $ 1,415 $ 2,252 |
Accrued Expenses and Other Li_2
Accrued Expenses and Other Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consist of the following: As of September 30, 2022 December 31, 2021 (in thousands) Accrued research and development expenses $ 10,784 $ 2,193 Accrued compensation and benefits 4,048 7,805 Accrued professional fees 817 1,371 Accrued income taxes 816 - Accrued other 505 37 Total accrued expenses and other liabilities $ 16,970 $ 11,406 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Operating Lease Costs, Variable Lease Costs and Sub Lease Income | The following table summarizes operating lease costs, variable lease costs and sublease income: Nine months ended September 30, 2022 2021 (in thousands) Operating lease costs $ 2,826 $ 1,869 Variable lease costs 1,698 1,636 Sublease income ( 1,210 ) ( 705 ) Net lease cost $ 3,314 $ 2,800 |
Schedule of Operating Lease Liabilities and Minimum Lease Payments | The maturities of the Company's operating lease liabilities and minimum lease payments as of September 30, 2022 were as follows: For the Years Ending December 31, Amount 2022 1,101 2023 4,444 2024 4,578 2025 4,715 Thereafter 31,123 Total undiscounted lease payments $ 45,961 Less: imputed interest ( 16,134 ) Present value of operating lease liabilities $ 29,827 |
Schedule of Lease Term and Discount Rate | The following table summarizes the lease term and discount rate as of September 30, 2022: As of September 30, 2022 Weighted-average remaining lease term (years) Operating leases 8.5 Weighted-average discount rate Operating leases 10.6 % |
Schedule of Operating Lease Liabilities | The following table summarizes the supplemental cash flow information related to the Company's operating lease: Nine months ended September 30, 2022 2021 (in thousands) Cash paid for amounts included in the measurement of lease liabilities $ 2,226 $ 2,901 Increase in lease liabilities and right-of-use assets due to lease remeasurements $ 6,262 $ — |
Stock Incentive Plans (Tables)
Stock Incentive Plans (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock Options Valuation Assumptions Using a Black-Scholes Option Pricing Model | The assumptions used in the Black-Scholes option pricing model are as follows: Three months ended September 30, Nine months ended September 30, 2022 2021 2022 2021 Expected volatility 70.1 % 66.3 % - 71.7 % 68.7 % - 70.1 % 64.6 % - 71.7 % Weighted-average risk-free interest rate 3.2 % - 3.66 % 0.81 % - 1.03 % 1.46 % - 3.66 % 0.50 % - 1.20 % Expected dividend yield — % — % — % — % Expected term (in years) 6.25 6.25 5.5 - 6.25 5.5 - 6.25 Underlying common stock fair value $ 1.82 -$ 2.82 $ 6.36 -$ 7.75 $ 1.78 -$ 4.17 $ 6.36 -$ 13.91 |
Summary of Option Activity under Plans | The following table summarizes the Company’s stock option activity for the nine months ended September 30, 2022: Number of Weighted- Weighted- Aggregate (in thousands) Outstanding at January 1, 2022 7,624,306 $ 14.25 7.5 $ 2,069 Granted 2,895,055 $ 2.70 Exercised ( 293 ) $ 2.71 Cancelled/Forfeited ( 899,370 ) $ 9.92 Outstanding at September 30, 2022 9,619,698 $ 11.18 7.3 $ 717 Vested and expected to vest at 9,619,698 $ 11.18 7.3 $ 717 Exercisable at September 30, 2022 5,716,593 $ 13.29 6.3 $ 717 |
Summary of Company's RSU Activity | The following table summarizes the Company’s RSU activity for the nine months ended September 30, 2022: Number of Weighted- Outstanding at January 1, 2022 307,600 $ 12.75 Granted 400,495 $ 2.70 Vested ( 103,590 ) $ 12.66 Forfeited ( 77,546 ) $ 6.32 Outstanding at September 30, 2022 526,959 $ 6.08 |
Schedule of Stock-Based Compensation Expense | The Company recorded stock-based compensation expense related to stock options, shares purchased under the 2018 ESPP and restricted stock units as follows: Three months ended September 30, Nine months ended September 30, 2022 2021 2022 2021 (in thousands) Research and development $ 889 $ 2,145 $ 4,143 $ 6,304 General and administrative 1,882 2,081 5,822 6,278 $ 2,771 $ 4,226 $ 9,965 $ 12,582 |
Net Income (Loss) Per Share (Ta
Net Income (Loss) Per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Anti-dilutive Effect Excluded from Computation of Diluted Net Loss Per Share Attributable to Common Stockholders | Diluted net income (loss) per share incorporates the additional shares issuable upon assumed exercise of stock options and the vesting of restricted stock units, except in such case when their inclusion would be anti-dilutive. Three months ended September 30, Nine months ended September 30, (in thousands, except per share amounts) 2022 2021 2022 2021 Numerator: Net income (loss) $ ( 33,726 ) $ ( 30,608 ) $ 29,290 $ ( 62,181 ) Denominator: Weighted-average common shares outstanding-basic 57,447,192 57,106,639 57,372,399 54,704,410 Dilutive securities — — 528,899 — Weighted-average common shares outstanding-diluted 57,447,192 57,106,639 57,901,298 54,704,410 Net income (loss) per share-basic $ ( 0.59 ) $ ( 0.54 ) $ 0.51 $ ( 1.14 ) Net income (loss) per share-diluted $ ( 0.59 ) $ ( 0.54 ) $ 0.51 $ ( 1.14 ) |
Nature of Business and Basis _2
Nature of Business and Basis of Presentation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |||||||||||
Mar. 10, 2022 | Apr. 06, 2021 | Nov. 09, 2020 | Mar. 12, 2020 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||||||||
Proceeds from Sale of Equity Method Investments | $ 130,000 | ||||||||||||
Net proceed from issuance of common stock | $ 49,744 | ||||||||||||
Net income | $ (33,726) | $ (29,089) | $ 92,105 | $ (30,608) | $ (30,500) | $ (1,073) | 29,290 | $ (62,181) | |||||
Accumulated deficit | $ 394,842 | 394,842 | $ 424,132 | ||||||||||
Oxford Biomedica Plc Member | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||||||||
Upfront Payment Received | 130,000 | ||||||||||||
Proceeds from Sale of Equity Method Investments | $ 50,000 | ||||||||||||
Maximum | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||||||||
Proceeds through future financings | $ 148,400 | ||||||||||||
Common Stock | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||||||||
Issuance of common stock, net of discounts and issuance costs, Share | 114,914 | ||||||||||||
Follow-on Offering [Member] | Common Stock | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||||||||
Issuance of common stock, net of discounts and issuance costs, Share | 6,596,306 | 6,596,306 | |||||||||||
Shares issued price per share | $ 7.58 | ||||||||||||
Net proceeds after deducting underwriting discounts and commissions and offering expenses | $ 49,700 | ||||||||||||
Common stock offering expenses | $ 300 | ||||||||||||
Underwriters Option | Common Stock | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||||||||
Issuance of common stock, net of discounts and issuance costs, Share | 989,445 | ||||||||||||
Shares issued price per share | $ 7.58 | ||||||||||||
Private Placement | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||||||||
Issuance of common stock, net of discounts and issuance costs, Share | 5,000,000 | ||||||||||||
Shares issued price per share | $ 12 | ||||||||||||
Net proceed from issuance of common stock | $ 60,000 | ||||||||||||
ATM | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||||||||
Issuance of common stock, net of discounts and issuance costs, Share | 0 | ||||||||||||
Proceeds through future financings | $ 148,400 | ||||||||||||
ATM | Oxford Biomedica Plc Member | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||||||||
Sale of Stock, Percentage of Ownership after Transaction | 80% | ||||||||||||
ATM | Homology Member | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||||||||
Sale of Stock, Percentage of Ownership after Transaction | 20% | ||||||||||||
ATM | Maximum | |||||||||||||
Organization Consolidation And Presentation Of Financial Statements Disclosure [Line Items] | |||||||||||||
Proceeds through future financings | $ 150,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | Sep. 30, 2021 |
Accounting Policies [Abstract] | |||
Cash and cash equivalents | $ 43,162 | $ 108,382 | $ 95,829 |
Restricted cash | 0 | $ 1,953 | 1,274 |
Total cash, cash equivalents and restricted cash | $ 43,162 | $ 97,103 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Additional Information) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Tax positions, description | The Company determines whether it is more likely than not that a tax position will be sustained upon examination. The tax benefit to be recognized for any tax position that meets the more-likely-than-not recognition threshold is calculated as the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement. If it is not more likely than not that a position will be sustained, none of the benefit attributable to the position is recognized. | |||
Benefit from (provision for) income taxes | $ 46 | $ 0 | $ (816) | $ 0 |
Minimum [Member] | ||||
Benefit from (provision for) income taxes | $ (100) |
Short-Term Investments - Summar
Short-Term Investments - Summary of Short Term Investments (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Schedule Of Cash Cash Equivalents And Available For Sale Securities [Line Items] | ||
Cash equivalents and short-term investments, Amortized Cost | $ 158,369 | $ 47,498 |
Cash equivalents and short-term investments, Unrealized Gains | 2 | 0 |
Cash equivalents and short-term investments, Unrealized Losses | (459) | (7) |
Cash equivalents and short-term investments, Fair Value | 157,912 | 47,491 |
Commercial Paper | ||
Schedule Of Cash Cash Equivalents And Available For Sale Securities [Line Items] | ||
Cash equivalents and short-term investments, Amortized Cost | 74,632 | 27,992 |
Cash equivalents and short-term investments, Unrealized Gains | 0 | 0 |
Cash equivalents and short-term investments, Unrealized Losses | 0 | 0 |
Cash equivalents and short-term investments, Fair Value | 74,632 | 27,992 |
Corporate Debt Securities | ||
Schedule Of Cash Cash Equivalents And Available For Sale Securities [Line Items] | ||
Cash equivalents and short-term investments, Amortized Cost | 19,089 | 19,506 |
Cash equivalents and short-term investments, Unrealized Gains | 0 | 0 |
Cash equivalents and short-term investments, Unrealized Losses | (146) | (7) |
Cash equivalents and short-term investments, Fair Value | 18,943 | $ 19,499 |
US Treasury Securities | ||
Schedule Of Cash Cash Equivalents And Available For Sale Securities [Line Items] | ||
Cash equivalents and short-term investments, Amortized Cost | 64,648 | |
Cash equivalents and short-term investments, Unrealized Gains | 2 | |
Cash equivalents and short-term investments, Unrealized Losses | (313) | |
Cash equivalents and short-term investments, Fair Value | $ 64,337 |
Short-Term Investments - Additi
Short-Term Investments - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Cash Cash Equivalents And Available For Sale Securities [Abstract] | ||||
Realized gains and losses on available-for-sale securities | $ 0 | $ 0 | $ 0 | $ 0 |
Contractual maturity date of investments | less than one year |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Assets Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments | $ 157,912 | $ 47,491 |
Fair Value, Measurements, Recurring | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents, fair value | 43,162 | 108,323 |
Short-term investments | 157,912 | 47,491 |
Financial assets, fair value | 201,074 | 155,814 |
Fair Value, Measurements, Recurring | Money Market Mutual Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents, fair value | 43,162 | 108,323 |
Fair Value, Measurements, Recurring | Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments | 74,632 | 27,992 |
Fair Value, Measurements, Recurring | US Treasury Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments | 64,337 | |
Fair Value, Measurements, Recurring | Corporate Debt Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments | 18,943 | 19,499 |
Fair Value, Measurements, Recurring | Quoted Prices (Unadjusted) in Active Markets for Identical Assets (Level 1) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents, fair value | 43,162 | 108,323 |
Financial assets, fair value | 43,162 | 108,323 |
Fair Value, Measurements, Recurring | Quoted Prices (Unadjusted) in Active Markets for Identical Assets (Level 1) | Money Market Mutual Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash equivalents, fair value | 43,162 | 108,323 |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments | 157,912 | 47,491 |
Financial assets, fair value | 157,912 | 47,491 |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | Commercial Paper | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments | 74,632 | 27,992 |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | US Treasury Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments | 64,337 | |
Fair Value, Measurements, Recurring | Significant Other Observable Inputs (Level 2) | Corporate Debt Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Short-term investments | $ 18,943 | $ 19,499 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | ||||
Transfers between fair value measure levels | $ 0 | $ 0 | $ 0 | $ 0 |
Equity Method Investment (Addit
Equity Method Investment (Additional Information) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Mar. 10, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||
Gain on sale of business | $ 131,249 | $ 0 | $ 0 | $ 131,249 | $ 0 | |
Equity method investment cash consideration | 27,132 | 27,132 | ||||
Carrying value of the equity method investment | 27,100 | 27,100 | ||||
Maximum [Member] | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||
Equity method investment cash consideration | 74,100 | 74,100 | ||||
OXB Solutions | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||
Assets held for sale | $ 28,900 | |||||
Fair value of investment | 31,200 | |||||
Gain on sale of business | $ 131,200 | $ 2,200 | $ 4,100 | |||
Equity method investments, ownership description | The valuation included certain subjective assumptions including discounts for lack of control and marketability given the consideration paid for OXB Solutions was for a controlling interest in the entity and the Company owns a noncontrolling interest. | |||||
Equity method investment, description of principal activities | Homology will have an option to cause OXB to purchase from Homology, in each case all of Homology's equity ownership interest in OXB Solutions at a price equal to 5.5 times the revenue for the immediately preceding 12-month period (together, the "Options"), subject to a maximum amount of $74.1 million. | |||||
OXB | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||
Transferred units | 130,000 | |||||
Equity Securities Purchase Agreement | OXB Solutions | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||
Common Unit, Issued | 175,000 | |||||
Contributed cash | $ 50,000 | |||||
Additional units issued | 50,000 | |||||
Equity method investment, ownership percentage | 100% | |||||
Equity Securities Purchase Agreement | Homology | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||
Equity method investment, ownership percentage | 20% | |||||
Ownership interests, units | 45,000 | |||||
Equity Securities Purchase Agreement | OXB | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||
Transferred units, value | $ 130,000 | |||||
Equity method investment, ownership percentage | 80% | |||||
Ownership interests, units | 180,000 |
Equity Method Investment - Sche
Equity Method Investment - Schedule of equity method investment fair value (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Mar. 10, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Equity Method Investment, Summarized Financial Information [Abstract] | |||||
Cash received | $ 130,000 | ||||
Plus: Fair value of equity method investment | 31,223 | ||||
Less: Carrying value of transferred assets | (29,974) | ||||
Gain on sale of business | $ 131,249 | $ 0 | $ 0 | $ 131,249 | $ 0 |
Property and Equipment, Net - S
Property and Equipment, Net - Schedule of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, at cost | $ 8,258 | $ 8,098 |
Less: accumulated depreciation and amortization | (6,843) | (5,846) |
Property and equipment, net | 1,415 | 2,252 |
Laboratory Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, at cost | 6,017 | 5,857 |
Computers and Purchased Software | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, at cost | 1,596 | 1,596 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, at cost | $ 645 | $ 645 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Property Plant And Equipment [Line Items] | ||||
Depreciation | $ 300 | $ 2,100 | $ 997 | $ 6,280 |
Disposal of property and equipment | $ 0 | $ 100 | $ 0 | $ 100 |
Accrued Expenses and Other Li_3
Accrued Expenses and Other Liabilities - Schedule of Accrued Expenses and Other Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Accrued research and development expenses | $ 10,784 | $ 2,193 |
Accrued compensation and benefits | 4,048 | 7,805 |
Accrued professional fees | 817 | 1,371 |
Accrued income taxes | 816 | 0 |
Accrued other | 505 | 37 |
Total accrued expenses and other liabilities | $ 16,970 | $ 11,406 |
Commitment and Contingencies -
Commitment and Contingencies - Additional Information (Details) | 1 Months Ended | 9 Months Ended | ||||
Feb. 02, 2022 USD ($) | Dec. 31, 2017 ft² Phase $ / ft² | Nov. 30, 2017 USD ($) ft² | Sep. 30, 2016 | Sep. 30, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Commitment And Contingencies [Line Items] | ||||||
Sublease aggregate base rent obligation | $ 2,700,000 | |||||
Tenant improvement allowance | $ 6,300,000 | |||||
Security deposit | 0 | $ 2,000,000 | ||||
Increase in Lease Liability | $ 200,000 | 10,900,000 | ||||
Increase (Decrease) in right-of-use asset | $ 200,000 | 10,900,000 | ||||
OXB Solutions | ||||||
Commitment And Contingencies [Line Items] | ||||||
Increase in Lease Liability | 6,100,000 | |||||
Increase (Decrease) in right-of-use asset | $ 6,100,000 | |||||
Tenant improvement allowances percentage | 100% | |||||
Maximum | ||||||
Commitment And Contingencies [Line Items] | ||||||
Tenant improvement allowance | $ 10,900,000 | |||||
Bedford, Massachusetts | ||||||
Commitment And Contingencies [Line Items] | ||||||
Operating lease beginning year and month | 2016-11 | |||||
Operating lease expiration year and month | 2027-02 | 2027-02 | 2021-10 | |||
Operating lease agreements additional term | 3 years | |||||
Sublease aggregate base rent obligation | $ 1,400,000 | $ 4,700,000 | ||||
Office space leased | ft² | 67,000 | 23,011 | ||||
Lessee, operating lease, lease not yet commenced, renewal term | 5 years | |||||
Number of phases | Phase | 2 | |||||
Initial annual base rent per square foot | $ / ft² | 39.50 | |||||
Percentage increase in initial annual base rent per square foot. | 3% | 3% | ||||
Bedford, Massachusetts | Phase One | ||||||
Commitment And Contingencies [Line Items] | ||||||
Office space leased | ft² | 46,000 | |||||
Rent due date | 2018-09 | |||||
Bedford, Massachusetts | Phase Two | ||||||
Commitment And Contingencies [Line Items] | ||||||
Office space leased | ft² | 21,000 | |||||
Rent due date | 2019-03 |
Commitment and Contingencies _2
Commitment and Contingencies - Schedule of Operating Lease Costs, Variable Lease Costs and Sub Lease Income (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease costs | $ 2,826 | $ 1,869 |
Variable lease costs | 1,698 | 1,636 |
Sublease income | (1,210) | (705) |
Net lease cost | $ 3,314 | $ 2,800 |
Commitments and Contingencies -
Commitments and Contingencies - Schedule of Operating Lease Liabilities and Minimum Lease Payments (Details) $ in Thousands | Sep. 30, 2022 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2022 | $ 1,101 |
2023 | 4,444 |
2024 | 4,578 |
2025 | 4,715 |
Thereafter | 31,123 |
Total undiscounted lease payments | 45,961 |
Less: imputed interest | (16,134) |
Present value of operating lease liabilities | $ 29,827 |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Lease Term and Discount Rate (Details) | Sep. 30, 2022 |
Commitments and Contingencies Disclosure [Abstract] | |
Weighted-average remaining lease term (years), Operating leases | 8 years 6 months |
Weighted-average discount rate, Operating leases | 10.60% |
Commitments and Contingencies_3
Commitments and Contingencies - Summary of Cash Paid for Company's Operating Lease Liabilities (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Cash paid for amounts included in the measurement of lease liabilities | $ 2,226 | $ 2,901 |
Increase in lease liabilities and right-of-use assets due to lease remeasurements | $ 6,262 | $ 0 |
Stock Incentive Plans - Additio
Stock Incentive Plans - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Jan. 01, 2021 | Mar. 31, 2018 | Sep. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Aggregate proceeds from shares issued under the plan | $ 563,000 | $ 825,000 | ||||||
Stock-based compensation | $ 2,771,000 | $ 4,226,000 | 9,965,000 | 12,582,000 | ||||
Total intrinsic value of options exercised | $ 600,000 | $ 600,000 | ||||||
Weighted-average grant date fair value per share for options granted | $ 1.72 | $ 7.50 | ||||||
Share-Based Goods and Nonemployee Services Transaction, Modification of Terms, Incremental Compensation Cost | $ 400,000 | |||||||
Compensation cost, Total | 800,000 | |||||||
Total compensation cost reversed | $ 100,000 | |||||||
2015 Stock Incentive Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Stock option vesting period | 4 years | |||||||
Stock options expiration period | 10 years | |||||||
Number of additional shares available for future grant | 0 | 0 | ||||||
2018 Incentive Award Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Number of shares available for issuance | 3,186,205 | |||||||
Allowed annual percentage increase in shares authorized as percentage of outstanding shares of common stock | 4% | 4% | ||||||
Maximum shares of common stock may be issued | 20,887,347 | |||||||
Number of additional shares added to the plan | 2,286,010 | |||||||
Number of shares outstanding available for future grant | 2,328,589 | 2,328,589 | ||||||
2018 Employee Stock Purchase Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Number of shares available for issuance | 353,980 | |||||||
Allowed annual percentage increase in shares authorized as percentage of outstanding shares of common stock | 1% | 1% | ||||||
Number of additional shares added to the plan | 571,502 | |||||||
Number of shares outstanding available for future grant | 1,776,431 | 1,776,431 | ||||||
Maximum shares allowed to be issued under ESPP | 4,778,738 | |||||||
Purchase of common stock through payroll deductions expressed in percentage of fair market value | 85% | |||||||
Common stock offering period | 6 months | |||||||
Number of shares issued to the plan | 226,453 | 110,923 | ||||||
Aggregate proceeds from shares issued under the plan | $ 600,000 | $ 800,000 | ||||||
Stock-based compensation | $ 100,000 | $ 100,000 | 100,000 | $ 100,000 | ||||
Excess of accrued right to purchase stock | 25,000,000 | |||||||
2015 and 2018 Stock Incentive Plans | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Unrecognized compensation expense | $ 15,800,000 | $ 15,800,000 | ||||||
Unrecognized compensation expense estimated to be recognized over period | 2 years 4 months 24 days |
Stock Incentive Plans - Schedul
Stock Incentive Plans - Schedule of Stock Options Valuation Assumptions Using a Black-Scholes Option Pricing Model (Details) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected volatility, minimum | 70.10% | 66.30% | 68.70% | 64.60% |
Expected volatility, maximum | 71.70% | 70.10% | 71.70% | |
Weighted-average risk-free interest rate, minimum | 3.20% | 0.81% | 1.46% | 0.50% |
Weighted-average risk-free interest rate, maximum | 3.66% | 1.03% | 3.66% | 1.20% |
Expected dividend yield | 0% | 0% | 0% | 0% |
Expected term (in years) | 6 years 3 months | 6 years 3 months | ||
Maximum | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term (in years) | 6 years 3 months | 6 years 3 months | ||
Underlying common stock fair value | $ 2.82 | $ 7.75 | $ 4.17 | $ 13.91 |
Minimum | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Expected term (in years) | 5 years 6 months | 5 years 6 months | ||
Underlying common stock fair value | $ 1.82 | $ 6.36 | $ 1.78 | $ 6.36 |
Stock Incentive Plans - Summary
Stock Incentive Plans - Summary of Option Activity under Plans (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | ||
Number of Options, Outstanding at Beginning Balance | 7,624,306 | |
Number of Options, Granted | 2,895,055 | |
Number of Options, Exercised | (293) | |
Number of Options, Cancelled/Forfeited | (899,370) | |
Number of Options, Outstanding at Ending Balance | 9,619,698 | 7,624,306 |
Number of Options, Vested and expected to vest at June 30, 2022 | 9,619,698 | |
Number of Options, Exercisable at June 30, 2022 | 5,716,593 | |
Weighted-Average Exercise Price per Share, Outstanding at Beginning Balance | $ 14.25 | |
Weighted-Average Exercise Price per Share, Granted | 2.70 | |
Weighted-Average Exercise Price per Share, Exercised | 2.71 | |
Weighted-Average Exercise Price per Share, Cancelled/Forfeited | 9.92 | |
Weighted-Average Exercise Price per Share, Outstanding at Ending Balance | 11.18 | $ 14.25 |
Weighted-Average Exercise Price per Share, Vested and Expected to vest at March 31, 2022 | 11.18 | |
Weighted-Average Exercise Price Per Share, Exercisable at March 31, 2022 | $ 13.29 | |
Weighted Average Remaining Contractual Term, Outstanding | 7 years 3 months 18 days | 7 years 6 months |
Weighted Average Remaining Contractual Term, Vested and Expected to vest at March 31, 2022 | 7 years 3 months 18 days | |
Weighted Average Remaining Contractual Term, Exercisable at March 31, 2022 | 6 years 3 months 18 days | |
Aggregate Intrinsic Value, Outstanding Ending Balance | $ 717 | $ 2,069 |
Aggregate Intrinsic Value, Vested and Expected to vest at March 31, 2022 | 717 | |
Aggregate Intrinsic Value, Exercisable at June 30, 2022 | $ 717 |
Stock Incentive Plans - Summa_2
Stock Incentive Plans - Summary of RSU Activity (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of Options, Outstanding at Beginning Balance | 7,624,306 | |
Number of Options, Granted | 2,895,055 | |
Number of Options, Outstanding at Ending Balance | 9,619,698 | |
Weighted-average grant date fair value per share for options granted | $ 1.72 | $ 7.50 |
RSU Member | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of Options, Outstanding at Beginning Balance | 307,600 | |
Number of Options, Granted | 400,495 | |
RSU Vested | (103,590) | |
RSU, Forfeited | (77,546) | |
Number of Options, Outstanding at Ending Balance | 526,959 | |
Weighted-Average Grant Date Fair Value, Outstanding | $ 12.75 | |
Weighted-average grant date fair value per share for options granted | 2.70 | |
Weighted-Average Grant Date Fair Value, Vested | 12.66 | |
Weighted-Average Grant Date Fair Value, Forfeited | 6.32 | |
Weighted-Average Grant Date Fair Value, Outstanding | $ 6.08 |
Stock Incentive Plans - Sched_2
Stock Incentive Plans - Schedule 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 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation | $ 2,771 | $ 4,226 | $ 9,965 | $ 12,582 |
Research and Development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation | 889 | 2,145 | 4,143 | 6,304 |
General and Administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation | $ 1,882 | $ 2,081 | $ 5,822 | $ 6,278 |
Net Income (Loss) Per Share - S
Net Income (Loss) Per Share - Schedule of Anti-dilutive Effect Excluded from Computation of Diluted Net Loss Per Share Attributable to Common Stockholders (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Earnings Per Share [Abstract] | ||||||||
Net income (loss) | $ (33,726) | $ (29,089) | $ 92,105 | $ (30,608) | $ (30,500) | $ (1,073) | $ 29,290 | $ (62,181) |
Weighted-average common shares outstanding-basic | 57,447,192 | 57,106,639 | 57,372,399 | 54,704,410 | ||||
Dilutive securities | $ 0 | $ 0 | $ 528,899 | $ 0 | ||||
Weighted-average common shares outstanding-diluted | 57,447,192 | 57,106,639 | 57,901,298 | 54,704,410 | ||||
Net income (loss) per share-basic | $ (0.59) | $ (0.54) | $ 0.51 | $ (1.14) | ||||
Net income (loss) per share-diluted | $ (0.59) | $ (0.54) | $ 0.51 | $ (1.14) |
Net Income (Loss) Per Share (Ad
Net Income (Loss) Per Share (Additional Information) (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Earnings Per Share [Abstract] | ||||
Anti-dilutive securities | 9,933,508 | 6,891,252 | 9,048,927 | 6,630,582 |
Collaboration and License Agr_2
Collaboration and License Agreement - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Collaboration agreement revenue recognized | $ 802 | $ 1,677 | $ 2,406 | $ 33,169 | |
Novartis | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Collaboration agreement revenue recognized | 26,900 | ||||
Novartis | Collaborative Arrangement | |||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | |||||
Collaboration Revenue | 0 | ||||
Collaboration agreement revenue recognized | $ 900 | $ 30,800 | |||
Deferred revenue | 800 | 800 | $ 30,200 | ||
Accounts receivable | $ 0 | $ 0 |
Pfizer Stock Purchase Agreeme_2
Pfizer Stock Purchase Agreement - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Nov. 09, 2020 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Proceeds from issuance of common stock in follow-on public offering, net of discounts and issuance costs | $ 49,744 | |||||
Collaboration agreement revenue recognized | $ 802 | $ 1,677 | 2,406 | 33,169 | ||
Pfizer Inc. | ||||||
Common stock estimated fair value | $ 52,000 | |||||
Stock purchase agreement remaining allocated value | 8,000 | |||||
Allocated Information Committee obligation | $ 8,000 | |||||
Pfizer Inc. | Collaborative Arrangement | ||||||
Collaboration agreement revenue recognized | 800 | $ 800 | 2,400 | $ 2,400 | ||
Deferred revenue | $ 2,000 | $ 2,000 | $ 4,400 | |||
Private Placement | ||||||
Issuance of common stock, net of discounts and issuance costs, Shares | 5,000,000 | |||||
Shares issued price per share | $ 12 | |||||
Proceeds from issuance of common stock in follow-on public offering, net of discounts and issuance costs | $ 60,000 | |||||
Common stock purchase agreement condition | The shares of common stock sold to Pfizer were subject to a one-year lock-up from closing, during which time Pfizer was prohibited from selling or otherwise disposing of such shares. |
Related Party Transactions (Add
Related Party Transactions (Additional Information) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Related Party Transaction [Line Items] | |||||||
Sublease income | $ 1,210 | $ 705 | |||||
General and administrative | $ 7,810 | $ 8,351 | 29,991 | $ 26,054 | |||
Prepaid expenses and other current assets | 12,130 | 12,130 | $ 7,129 | ||||
Oxford Biomedica [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Sublease income | 1,200 | ||||||
Expenses recognized under the transitional services | (200) | (500) | |||||
Amount due to OXB Solutions | 100 | 100 | |||||
General and administrative | 800 | 1,700 | |||||
Prepaid expenses and other current assets | 5,500 | 5,500 | |||||
Receivables from affiliates | 3,700 | 3,700 | |||||
Supply Agreement [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Recorded purchases | $ 7,300 | ||||||
Supply Agreement [Member] | Oxford Biomedica [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Clinical supply requirements | 50% | ||||||
Purchases of drug substance | 6,000 | $ 7,500 | |||||
Recorded purchases | $ 2,200 | $ 10,200 | |||||
Supply Agreement [Member] | Oxford Biomedica [Member] | Forecast [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Purchase Commitment Amount | $ 29,700 | $ 27,500 |
Subsequent Events (Additional I
Subsequent Events (Additional Information) (Details) | 1 Months Ended | |||
Dec. 31, 2017 ft² | Nov. 30, 2017 USD ($) ft² | Sep. 30, 2016 | Sep. 30, 2022 USD ($) | |
Subsequent Event [Line Items] | ||||
Tenant improvement allowance | $ 6,300,000 | |||
Maximum | ||||
Subsequent Event [Line Items] | ||||
Tenant improvement allowance | $ 10,900,000 | |||
Bedford, Massachusetts | ||||
Subsequent Event [Line Items] | ||||
Office space leased | ft² | 67,000 | 23,011 | ||
Operating lease beginning year and month | 2016-11 | |||
Operating lease expiration year and month | 2027-02 | 2027-02 | 2021-10 | |
Percentage increase in initial annual base rent | 3% | 3% |