Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Oct. 31, 2022 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2022 | |
Entity File Number | 001-38916 | |
Entity Registrant Name | Bicycle Therapeutics plc | |
Entity Incorporation, State or Country Code | X0 | |
Entity Tax Identification Number | 00-0000000 | |
Entity Address, Address Line One | Blocks A & B, Portway Building, Granta Park | |
Entity Address, City or Town | Great Abington, Cambridge, | |
Entity Address, Country | GB | |
Entity Address, Postal Zip Code | CB21 6GS | |
City Area Code | +44 | |
Local Phone Number | 1223 261503 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 29,689,471 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001761612 | |
Amendment Flag | false | |
Ordinary Shares | ||
Document Information [Line Items] | ||
Title of 12(b) Security | Ordinary shares, nominal value £0.01 per share* | |
No Trading Symbol Flag | true | |
Security Exchange Name | NASDAQ | |
American Depositary Shares | ||
Document Information [Line Items] | ||
Title of 12(b) Security | American Depositary Shares, each representing one ordinary share, nominal value £0.01 per share | |
Trading Symbol | BCYC | |
Security Exchange Name | NASDAQ |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 361,469 | $ 438,680 |
Accounts receivable | 0 | 1,000 |
Prepaid expenses and other current assets | 8,448 | 7,965 |
Research and development incentives receivable | 11,368 | 10,910 |
Total current assets | 381,285 | 458,555 |
Property and equipment, net | 16,220 | 3,123 |
Operating lease right-of-use assets | 13,484 | 14,666 |
Other assets | 6,159 | 3,448 |
Total assets | 417,148 | 479,792 |
Current liabilities: | ||
Accounts payable | 7,057 | 2,721 |
Accrued expenses and other current liabilities | 18,091 | 14,244 |
Deferred revenue, current portion | 16,404 | 19,273 |
Total current liabilities | 41,552 | 36,238 |
Long-term debt, net of discount | 30,232 | 29,873 |
Operating lease liabilities, net of current portion | 10,997 | 12,081 |
Deferred revenue, net of current portion | 41,736 | 52,067 |
Other long-term liabilities | 3,157 | 3,279 |
Total liabilities | 127,674 | 133,538 |
Commitments and contingencies (Note 11) | ||
Shareholders' equity: | ||
Ordinary shares, £0.01 nominal value; 57,820,181 and 55,295,420 shares authorized at September 30, 2022 and December 31, 2021, respectively; 29,678,431 and 29,579,364 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 385 | 384 |
Additional paid-in capital | 589,679 | 567,637 |
Accumulated other comprehensive loss | 528 | (3,388) |
Accumulated deficit | (301,118) | (218,379) |
Total shareholders' equity | 289,474 | 346,254 |
Total liabilities and shareholders' equity | $ 417,148 | $ 479,792 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - £ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Condensed Consolidated Balance Sheets | ||
Ordinary shares, nominal value | £ 0.01 | £ 0.01 |
Ordinary shares, shares authorized | 57,820,181 | 55,295,420 |
Ordinary shares, shares issued | 29,678,431 | 29,579,364 |
Ordinary shares, shares outstanding | 29,678,431 | 29,579,364 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||
Collaboration revenues | $ 3,040 | $ 4,333 | $ 11,278 | $ 7,926 |
Operating expenses: | ||||
Research and development | 22,752 | 10,513 | 56,890 | 31,924 |
General and administrative | 10,047 | 8,114 | 38,830 | 23,596 |
Total operating expenses | 32,799 | 18,627 | 95,720 | 55,520 |
Loss from operations | (29,759) | (14,294) | (84,442) | (47,594) |
Other income (expense): | ||||
Interest income | 1,991 | 24 | 3,117 | 61 |
Interest expense | (817) | (823) | (2,518) | (2,164) |
Total other income (expense), net | 1,174 | (799) | 599 | (2,103) |
Net loss before income tax provision | (28,585) | (15,093) | (83,843) | (49,697) |
Benefit from income taxes | (238) | (415) | (1,104) | (915) |
Net loss | $ (28,347) | $ (14,678) | $ (82,739) | $ (48,782) |
Net loss per share, basic | $ (0.96) | $ (0.59) | $ (2.79) | $ (2.06) |
Net loss per share, diluted | $ (0.96) | $ (0.59) | $ (2.79) | $ (2.06) |
Weighted average ordinary shares outstanding, basic | 29,676,021 | 25,039,990 | 29,643,502 | 23,719,124 |
Weighted average ordinary shares outstanding, diluted | 29,676,021 | 25,039,990 | 29,643,502 | 23,719,124 |
Comprehensives loss: | ||||
Net loss | $ (28,347) | $ (14,678) | $ (82,739) | $ (48,782) |
Other comprehensive income (loss): | ||||
Foreign currency translation adjustment | 902 | 313 | 3,916 | |
Total comprehensive loss | $ (27,445) | $ (14,365) | $ (78,823) | $ (48,782) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Shareholders' Equity - USD ($) $ in Thousands | Ordinary Shares Ionis Share Purchase Agreement | Ordinary Shares | Additional Paid-in Capital Ionis Share Purchase Agreement | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Ionis Share Purchase Agreement | Total |
Beginning balance at Dec. 31, 2020 | $ 266 | $ 249,947 | $ (3,193) | $ (151,560) | $ 95,460 | |||
Beginning balance (in shares) at Dec. 31, 2020 | 21,094,557 | |||||||
Increase (decrease) in shareholders' equity (deficit) | ||||||||
Issuance of ADSs upon exercise of share options | $ 1 | 283 | 284 | |||||
Issuance of ADSs upon exercise of share options (in shares) | 63,545 | |||||||
Issuance of ADSs, net of commissions and offering expenses | $ 33 | 58,742 | 58,775 | |||||
Issuance of ADSs, net of commissions and offering expenses (in shares) | 2,358,485 | |||||||
Share-based compensation expense | 3,821 | 3,821 | ||||||
Foreign currency translation adjustment | (58) | (58) | ||||||
Net loss | (16,191) | (16,191) | ||||||
Ending balance at Mar. 31, 2021 | $ 300 | 312,793 | (3,251) | (167,751) | 142,091 | |||
Ending balance (in shares) at Mar. 31, 2021 | 23,516,587 | |||||||
Beginning balance at Dec. 31, 2020 | $ 266 | 249,947 | (3,193) | (151,560) | 95,460 | |||
Beginning balance (in shares) at Dec. 31, 2020 | 21,094,557 | |||||||
Increase (decrease) in shareholders' equity (deficit) | ||||||||
Net loss | (48,782) | |||||||
Ending balance at Sep. 30, 2021 | $ 329 | 374,029 | (3,193) | (200,342) | 170,823 | |||
Ending balance (in shares) at Sep. 30, 2021 | 25,595,326 | |||||||
Beginning balance at Mar. 31, 2021 | $ 300 | 312,793 | (3,251) | (167,751) | 142,091 | |||
Beginning balance (in shares) at Mar. 31, 2021 | 23,516,587 | |||||||
Increase (decrease) in shareholders' equity (deficit) | ||||||||
Issuance of ADSs upon exercise of share options | $ 2 | 1,573 | 1,575 | |||||
Issuance of ADSs upon exercise of share options (in shares) | 125,666 | |||||||
Issuance of ADSs, net of commissions and offering expenses | $ 7 | 13,970 | 13,977 | |||||
Issuance of ADSs, net of commissions and offering expenses (in shares) | 482,299 | |||||||
Share-based compensation expense | 2,575 | 2,575 | ||||||
Foreign currency translation adjustment | (255) | (255) | ||||||
Net loss | (17,913) | (17,913) | ||||||
Ending balance at Jun. 30, 2021 | $ 309 | 330,911 | (3,506) | (185,664) | 142,050 | |||
Ending balance (in shares) at Jun. 30, 2021 | 24,124,552 | |||||||
Increase (decrease) in shareholders' equity (deficit) | ||||||||
Issuance of ADSs upon exercise of share options | $ 4 | 3,045 | 3,049 | |||||
Issuance of ADSs upon exercise of share options (in shares) | 257,389 | |||||||
Issuance of ADSs, net of commissions and offering expenses | $ 4 | $ 12 | $ 7,554 | 29,831 | $ 7,558 | 29,843 | ||
Issuance of ADSs, net of commissions and offering expenses (in shares) | 282,485 | 930,900 | ||||||
Share-based compensation expense | 2,688 | 2,688 | ||||||
Foreign currency translation adjustment | 313 | 313 | ||||||
Net loss | (14,678) | (14,678) | ||||||
Ending balance at Sep. 30, 2021 | $ 329 | 374,029 | (3,193) | (200,342) | 170,823 | |||
Ending balance (in shares) at Sep. 30, 2021 | 25,595,326 | |||||||
Beginning balance at Dec. 31, 2021 | $ 384 | 567,637 | (3,388) | (218,379) | $ 346,254 | |||
Beginning balance (in shares) at Dec. 31, 2021 | 29,579,364 | 29,579,364 | ||||||
Increase (decrease) in shareholders' equity (deficit) | ||||||||
Issuance of ADSs upon exercise of share options | $ 1 | 449 | $ 450 | |||||
Issuance of ADSs upon exercise of share options (in shares) | 30,074 | |||||||
Issuance of ADSs upon vesting of restricted share units (in shares) | 35,000 | |||||||
Share-based compensation expense | 10,198 | 10,198 | ||||||
Foreign currency translation adjustment | 920 | 920 | ||||||
Net loss | (27,564) | (27,564) | ||||||
Ending balance at Mar. 31, 2022 | $ 385 | 578,284 | (2,468) | (245,943) | 330,258 | |||
Ending balance (in shares) at Mar. 31, 2022 | 29,644,438 | |||||||
Beginning balance at Dec. 31, 2021 | $ 384 | 567,637 | (3,388) | (218,379) | $ 346,254 | |||
Beginning balance (in shares) at Dec. 31, 2021 | 29,579,364 | 29,579,364 | ||||||
Increase (decrease) in shareholders' equity (deficit) | ||||||||
Foreign currency translation adjustment | $ 3,916 | |||||||
Net loss | (82,739) | |||||||
Ending balance at Sep. 30, 2022 | $ 385 | 589,679 | 528 | (301,118) | $ 289,474 | |||
Ending balance (in shares) at Sep. 30, 2022 | 29,678,431 | 29,678,431 | ||||||
Beginning balance at Mar. 31, 2022 | $ 385 | 578,284 | (2,468) | (245,943) | $ 330,258 | |||
Beginning balance (in shares) at Mar. 31, 2022 | 29,644,438 | |||||||
Increase (decrease) in shareholders' equity (deficit) | ||||||||
Issuance of ADSs upon exercise of share options | 195 | 195 | ||||||
Issuance of ADSs upon exercise of share options (in shares) | 21,879 | |||||||
Share-based compensation expense | 5,673 | 5,673 | ||||||
Foreign currency translation adjustment | 2,094 | 2,094 | ||||||
Net loss | (26,828) | (26,828) | ||||||
Ending balance at Jun. 30, 2022 | $ 385 | 584,152 | (374) | (272,771) | 311,392 | |||
Ending balance (in shares) at Jun. 30, 2022 | 29,666,317 | |||||||
Increase (decrease) in shareholders' equity (deficit) | ||||||||
Issuance of ADSs upon exercise of share options | 159 | 159 | ||||||
Issuance of ADSs upon exercise of share options (in shares) | 12,114 | |||||||
Share-based compensation expense | 5,368 | 5,368 | ||||||
Foreign currency translation adjustment | 902 | 902 | ||||||
Net loss | (28,347) | (28,347) | ||||||
Ending balance at Sep. 30, 2022 | $ 385 | $ 589,679 | $ 528 | $ (301,118) | $ 289,474 | |||
Ending balance (in shares) at Sep. 30, 2022 | 29,678,431 | 29,678,431 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Shareholders' Equity (Parenthetical) - USD ($) $ in Millions | 3 Months Ended | ||
Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | |
Condensed Consolidated Statements of Shareholders' Equity | |||
Offering expenses | $ 0.9 | $ 0.4 | $ 1.8 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (82,739) | $ (48,782) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation expense | 21,239 | 9,084 |
Depreciation and amortization | 2,303 | 1,002 |
Non-cash interest | 359 | 347 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 348 | 5,544 |
Research and development incentives receivable | (3,064) | 1,318 |
Prepaid expenses and other current assets | (2,137) | (719) |
Operating lease right-of-use assets | 2,015 | (2,024) |
Other assets | (2,640) | (955) |
Accounts payable | 4,931 | 270 |
Accrued expenses and other current liabilities | 5,495 | (521) |
Operating lease liabilities | (1,446) | 2,123 |
Deferred revenue | (969) | 28,473 |
Other long-term liabilities | 503 | 481 |
Net cash used in operating activities | (55,802) | (4,359) |
Cash used in investing activities: | ||
Purchases of property and equipment | (17,539) | (963) |
Net cash used in investing activities | (17,539) | (963) |
Cash flows from financing activities: | ||
Proceeds from the issuance of ADSs, net of issuance costs | 102,595 | |
Issuance of ordinary shares pursuant to the Ionis share purchase agreement | 7,558 | |
Proceeds from the exercise of share options and sale of ordinary shares | 804 | 4,908 |
Proceeds from issuance of debt | 15,000 | |
Net cash provided by financing activities | 804 | 130,061 |
Effect of exchange rate changes on cash and cash equivalents | (4,674) | (1,205) |
Net (decrease) increase in cash and cash equivalents | (77,211) | 123,534 |
Cash and cash equivalents at beginning of period | 438,680 | 135,990 |
Cash and cash equivalents at end of period | 361,469 | 259,524 |
Supplemental disclosure of cash flow information | ||
Cash paid for interest | 2,099 | 1,753 |
Cash paid for income taxes | 1,203 | 87 |
Cash paid for amounts included in the measurement of operating lease liabilities | 2,245 | 676 |
Purchases of property and equipment included in accounts payable and accrued expenses | 318 | $ 298 |
Non-cash impact right-of-use asset and operating lease liabilities | $ 3,120 |
Nature of the business and basi
Nature of the business and basis of presentation | 9 Months Ended |
Sep. 30, 2022 | |
Nature of the business and basis of presentation | |
Nature of the business and basis of presentation | 1. Nature of the business and basis of presentation Bicycle Therapeutics plc (collectively with its subsidiaries, the “Company”) is a clinical-stage biopharmaceutical company developing a novel class of medicines, which the Company refers to as Bicycles Bicycles Bicycle ® Bicycle ® Bicycle ® Bicycle Bicycle The accompanying condensed consolidated financial statements include the accounts of Bicycle Therapeutics plc and its wholly owned subsidiaries, BicycleTx Limited, BicycleRD Limited and Bicycle Therapeutics Inc. All intercompany balances and transactions have been eliminated on consolidation. The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). Liquidity As of September 30, 2022, the Company had cash and cash equivalents of $361.5 million. The accompanying condensed consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. Since inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, and raising capital. The Company has funded its operations with proceeds from the sale of its ordinary shares and American Depositary Shares (“ADSs”), including in its initial public offering (“IPO”) completed in May 2019 and follow-on offering completed in October 2021, offerings pursuant to its at-the-market offering program (“ATM”), and prior to its IPO, offerings of its convertible preferred shares, as well as proceeds received from its collaboration arrangements (Note 9) and proceeds from a loan agreement with Hercules Capital, Inc. (“Hercules”) (Note 6). The Company has incurred recurring losses since inception, including net losses of $28.3 million and $82.7 million for the three and nine months ended September 30, 2022, respectively, and $14.7 million and $48.8 million for the three and nine months ended September 30, 2021, respectively. As of September 30, 2022, the Company had an accumulated deficit of $301.1 million. The Company expects to continue to generate operating losses in the foreseeable future. The Company expects that its cash will be sufficient to fund its operating expenses and capital expenditure requirements through at least twelve months from the issuance date of these interim condensed consolidated financial statements. The Company expects its expenses to increase substantially in connection with ongoing activities, particularly as the Company advances its preclinical activities and clinical trials for its product candidates in development. Accordingly, the Company will need to obtain additional funding in connection with continuing operations. If the Company is unable to raise funding when needed, or on attractive terms, it could be forced to delay, reduce or eliminate one or more of its research or drug development programs or any future commercialization efforts. There is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations, if at all. The Company is subject to risks common to companies in the biotechnology industry, including but not limited to, risks of delays in initiating or continuing research programs and clinical trials, risks of failure of preclinical studies and clinical trials, the need to obtain marketing approval for any drug product candidate that it may identify and develop, the need to successfully commercialize and gain market acceptance of its product candidates, if approved, dependence on key personnel and collaboration partners, protection of proprietary technology, compliance with government regulations, development by competitors of technological innovations, and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval prior to commercialization. Even if the Company’s research and development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales. |
Summary of significant accounti
Summary of significant accounting policies | 9 Months Ended |
Sep. 30, 2022 | |
Summary of significant accounting policies | |
Summary of significant accounting policies | 2. Summary of significant accounting policies The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, which was filed with the Securities and Exchange Commission (the “SEC”), on March 1, 2022 (the “2021 Annual Report”). Since the date of such consolidated financial statements, there have been no changes to the Company’s significant accounting policies, other than those disclosed below. Use of estimates The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the accrual for research and development expenses, revenue recognition, share-based compensation expense, valuation of right-of-use assets and liabilities, and income taxes, including the valuation allowance for deferred tax assets. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. Estimates are periodically reviewed in light of reasonable changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates or assumptions. Significant risks and uncertainties The Company currently operates in a period of economic uncertainty which has been significantly impacted by the ongoing COVID-19 pandemic, domestic and global monetary and fiscal policy, geopolitical instability, the ongoing war in Ukraine, rising inflation and interest rates, and fluctuations in monetary exchange rates. While the Company has experienced limited financial impacts at this time, the Company continues to monitor these factors and events and the potential effects each may have on the Company’s business, financial condition, results of operations and growth prospects. Unaudited interim financial information Certain information in the footnote disclosures of these financial statements has been condensed or omitted pursuant to the rules and regulations of the SEC. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto for the year ended December 31, 2021 included in the Company’s 2021 Annual Report. The accompanying condensed consolidated balance sheet as of September 30, 2022, condensed consolidated statements of operations and comprehensive loss, condensed consolidated statements of shareholders’ equity, and condensed consolidated statements of cash flows for the three and nine months ended September 30, 2022 and 2021, and the related financial information disclosed in these notes are unaudited. The unaudited interim financial statements have been prepared on the same basis as the audited annual financial statements for the year ended December 31, 2021, and, in the opinion of management, reflect all adjustments, consisting of normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2022, and the results of its operations and its cash flows for the three and nine months ended September 30, 2022 and 2021. The results for the three and nine months ended September 30, 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2022, any other interim periods, or any future year or period. Accounts receivable Government grants From time to time, the Company may enter into arrangements with governmental entities for the purpose of obtaining funding for research and development activities. The Company is reimbursed for costs incurred that are associated with specified research and development activities included in the grant application approved by the government authority. The Company recognizes government grant funding in the condensed consolidated statements of operations and comprehensive loss as the related expenses being funded are incurred. The Company classifies government grants received under these arrangements as a reduction to the related research and development expense incurred, and accrued but unpaid grant income is included in other current assets. The Company analyzes each arrangement on a case-by-case basis, and income is recognized when the Company concludes that it has reasonable assurance that it will comply with the conditions attached to the grant and the expenses have been incurred. There are no significant performance criteria other than to maintain satisfactory progress on the specified project, and there are no significant acceptance or recapture provisions associated with the government grants for the three and nine month periods ended September 30, 2022 and 2021, respectively. For the three and nine months ended September 30, 2022, the Company recognized $0.3 million and $1.1 million, respectively, and for the three and nine months ended September 30, 2021, the Company recognized $1.0 million and $2.9 million, respectively, as a reduction of research and development expense related to government grant arrangements. As of September 30, 2022, the Company has approximately $1.3 million of government grant funding remaining for future cost reimbursement through February of 2024. Recently adopted accounting pronouncements In June 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-13, Measurement of Credit Losses on Financial Instruments Financial Instruments — Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates adopted ASU 2016-13 as of January 1, 2022, on a prospective basis. The adoption did not have a material impact on the Company’s consolidated financial statements. In November 2021, the FASB issued ASU No. 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance |
Fair value of financial assets
Fair value of financial assets and liabilities | 9 Months Ended |
Sep. 30, 2022 | |
Fair value of financial assets and liabilities | |
Fair value of financial assets and liabilities | 3. Fair value of financial assets and liabilities Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: Level 1, Quoted prices in active markets for identical assets or liabilities; Level 2, Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data; Level 3, unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The carrying values of accounts receivable, research and development incentives receivable, other current assets, accounts payable and accrued expenses and other current liabilities approximate their fair values due to the short-term nature of these assets and liabilities. As of September 30, 2022, and December 31, 2021, the carrying value of the long-term debt approximates its fair value, which was determined using unobservable Level 3 inputs, including quoted interest rates from a lender for borrowings with similar terms. As of September 30, 2022, and December 31, 2021, there were no assets or liabilities measured at fair value on a recurring basis. Cash and cash equivalents The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. The Company had $276.1 million and $100.0 million of cash equivalents as of September 30, 2022, and December 31, 2021, respectively. |
Property and equipment, net
Property and equipment, net | 9 Months Ended |
Sep. 30, 2022 | |
Property and equipment, net | |
Property and equipment, net | 4. Property and equipment, net Property and equipment, net consisted of the following (in thousands): September 30, December 31, 2022 2021 Laboratory equipment $ 11,385 $ 6,746 Leasehold improvements 9,630 809 Computer equipment and software 403 143 Furniture and office equipment 822 225 22,240 7,923 Less: Accumulated depreciation and amortization (6,020) (4,800) $ 16,220 $ 3,123 Depreciation expense was $1.3 million and $2.2 million for the three and nine months ended September 30, 2022, respectively, and $0.3 million and $1.0 million for the three and nine months ended September 30, 2021, respectively. |
Accrued expenses and other curr
Accrued expenses and other current liabilities | 9 Months Ended |
Sep. 30, 2022 | |
Accrued expenses and other current liabilities | |
Accrued expenses and other current liabilities | 5. Accrued expenses and other current liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): September 30, December 31, 2022 2021 Accrued employee compensation and benefits $ 6,328 $ 6,429 Accrued external research and development expenses 7,223 3,980 Accrued professional fees 1,052 882 Current portion of operating lease liabilities 2,811 2,383 Other 677 570 $ 18,091 $ 14,244 |
Long-term debt
Long-term debt | 9 Months Ended |
Sep. 30, 2022 | |
Long-term debt | |
Long-term debt | 6. Long-term debt On September 30, 2020 (the “Closing Date”), Bicycle Therapeutics plc and its subsidiaries (the “Borrowers”) entered into a loan and security agreement (the “Loan Agreement”) with Hercules, which provided for aggregate maximum borrowings of up to $40.0 million, consisting of (i) a term loan of $15.0 million, which was funded on the Closing Date, (ii) subject to customary conditions, an additional term loan of up to $15.0 million available from the Closing Date through March 15, 2021, and (iii) subject to the Borrowers achieving certain performance milestones and satisfying customary conditions and available until March 15, 2022, an additional term loan of $10.0 million. On March 10, 2021 (“the Amendment Closing Date”), the Borrowers entered into the First Amendment to the Loan and Security Agreement (the “First Amendment to LSA”) with Hercules, in its capacity as administrative agent and collateral agent, and the lenders named in the First Amendment to LSA. Pursuant to the First Amendment to LSA, payments on borrowings under the Company’s debt facility with Hercules were interest-only until the first payment was due on August 1, 2023, which date was extended from November 1, 2022, followed by equal monthly payments of principal and interest through the scheduled maturity date on October 1, 2024 (the “Maturity Date”). If the Company achieved certain performance milestones, the interest-only period could be extended, with the first principal payment due on February 1, 2024, which date was extended from May 1, 2023. On the Amendment Closing Date and pursuant to the terms of the First Amendment to LSA, the Company borrowed the additional term loan of $15.0 million that had been available from September 30, 2020 to March 15, 2021. In November 2021, the performance milestones were achieved, and the interest only period was extended until February 1, 2024. On March 15, 2022, the additional term loan of $10.0 million expired unexercised. On July 15, 2022, the Borrowers entered into the Second Amendment to the Loan and Security Agreement (the “Second Amendment to LSA”) with Hercules. Pursuant to the Second Amendment to LSA, among other amendments, (a) the rate at which the borrowings under the Loan Agreement bear interest was decreased and capped at an annual rate equal to the lesser of (x) the greater of (i) 8.05% and (ii) the Wall Street Journal prime rate plus 4.55% and (y) 9.05% , (b) the interest-only period was extended to April 1, 2025, (c) the Maturity Date was extended to July 1, 2025, and (d) the Borrowers may request additional term loans, subject to satisfaction of customary conditions, in an aggregate principal amount of up to $45.0 million, and as such the aggregate maximum borrowings under the Loan Agreement increased to $75.0 million. At the Borrowers’ option, the Borrowers may prepay all or any portion greater than $5.0 million of the outstanding borrowings, subject to a prepayment premium equal to (i) 1.5% of the principal amount outstanding if the prepayment occurs after the first anniversary of the Closing Date but on or prior to December 31, 2023, and (ii) 1.0% of the principal amount outstanding if the prepayment occurs thereafter but prior to the Maturity Date. The Loan Agreement also provides for an end of term charge (the “End of Term Charge”), payable upon maturity or the repayment of obligations under the Loan Agreement, equal to 5.0% of the principal amount repaid. Borrowings under the Loan Agreement are collateralized by substantially all of the Borrower’s personal property and other assets, other than their intellectual property. Hercules has a perfected first-priority security interest in certain cash accounts. The Loan Agreement contains customary affirmative and restrictive covenants and representations and warranties, including a covenant against the occurrence of a change in control, as defined in the agreement. There are no financial covenants. The Loan Agreement also includes customary events of default, including payment defaults, breaches of covenants following any applicable cure period, cross acceleration to third-party indebtedness, certain events relating to bankruptcy or insolvency, and the occurrence of certain events that could reasonably be expected to have a material adverse effect. Upon the occurrence of an event of default, a default interest rate of an additional The Company incurred fees and transaction costs totaling $0.6 million associated with the initial term loan, which are recorded as a reduction to the carrying value of the long-term debt in the condensed consolidated balance sheets. The fees, transaction costs, and the End of Term Charge are amortized to interest expense through the Maturity Date using the effective interest method. The Company evaluated the First Amendment to LSA and the Second Amendment to LSA and concluded that these amendments represent modifications to the Loan Agreement, and as such, the fees and transaction costs associated with term loan will continue to be amortized to interest expense through the Maturity Date. The effective interest rate of the Hercules borrowings was 10.8% at September 30, 2022. The Company assessed all terms and features of the Loan Agreement in order to identify any potential embedded features that would require bifurcation. As part of this analysis, the Company assessed the economic characteristics and risks of the debt. The Company determined that all features of the Loan Agreement are clearly and closely associated with a debt host and, as such, do not require separate accounting as a derivative liability. Interest expense associated with the Loan Agreement for the three and nine months ended September 30, 2022, was $0.8 million and $2.5 million, respectively, and for the three and nine months ended September 30, 2021, was $0.8 million and $2.1 million, respectively. Long-term debt consisted of the following (in thousands): September 30, December 31, 2022 2021 Term loan payable $ 30,000 $ 30,000 End of term charge 624 376 Unamortized debt issuance costs (392) (503) Carrying value of term loan $ 30,232 $ 29,873 Future principal payments, including the End of Term Charge, are as follows (in thousands): Year Ending December 31, 2022 $ — 2023 — 2024 — 2025 31,500 Total $ 31,500 |
Ordinary shares
Ordinary shares | 9 Months Ended |
Sep. 30, 2022 | |
Ordinary shares | |
Ordinary shares | Each holder of ordinary shares is entitled to one vote per ordinary share and to receive dividends when and if such dividends are recommended by the board of directors and declared by the shareholders. Holders of ADSs are not treated as holders of the Company’s ordinary shares, unless they withdraw the ordinary shares underlying their ADSs in accordance with the deposit agreement and applicable laws and regulations. The depositary is the holder of the ordinary shares underlying the ADSs. Holders of ADSs therefore do not have any rights as holders of the Company’s ordinary shares, other than the rights that they have pursuant to the deposit agreement with the depositary. As of September 30, 2022, and December 31, 2021, the Company had not declared any dividends. As of September 30, 2022, and December 31, 2021, the Company’s authorized share capital consisted of 57,820,181 and 55,295,420 ordinary shares, respectively, with a nominal value of £0.01 per share. Authorized share capital, or shares authorized, comprises (i) the currently issued and outstanding ordinary shares, (ii) the remaining ordinary shares available for allotment under the existing authority granted to the Board at the annual general meeting held on June 28, 2021, (iii) ordinary shares issuable on the exercise of outstanding options and (iv) ordinary shares reserved for issuance under the Bicycle Therapeutics plc 2020 Equity Incentive Plan and/or the Bicycle Therapeutics plc 2019 Employee Share Purchase Plan. |
Share-based compensation
Share-based compensation | 9 Months Ended |
Sep. 30, 2022 | |
Share-based compensation | |
Share-based compensation | 8. Share-based compensation Employee incentive pool 2020 Equity Incentive Plan In June 2020, the Company’s shareholders first approved the Bicycle Therapeutics plc 2020 Equity Incentive Plan (the “2020 Plan”), under which the Company may grant market value options, market value stock appreciation rights or restricted shares, restricted share units (“RSUs”), performance RSUs and other share-based awards to the Company’s employees. The Company’s non-employee directors and consultants are eligible to receive awards under the 2020 Non-Employee Sub-Plan to the 2020 Plan. All awards under the 2020 Plan, including the 2020 Non-Employee Sub-Plan, will be set forth in award agreements, which will detail the terms and conditions of awards, including any applicable vesting and payment terms, change of control provisions and post-termination exercise limitations. In the event of a change of control of the Company, as defined in the 2020 Plan, any outstanding awards under the 2020 Plan will vest in full immediately prior to such change of control. The Company initially reserved up to 4,773,557 ordinary shares for future issuance under the 2020 Plan, representing 574,679 new shares, 544,866 shares that remained available for future issuance under the Company’s 2019 Share Option Plan (the “2019 Plan”) immediately prior to the effectiveness of the 2020 Plan and up to 3,654,012 shares subject to options that were granted under the 2019 Plan and that were granted pursuant to option contracts granted prior to the Company’s IPO, in each case that expire, terminate, are forfeited or otherwise not issued from time to time, if any. On June 27, 2022, the Company’s shareholders approved an amendment to the 2020 Plan (the “Amendment”) which increased the number of ordinary shares reserved for future issuance by 750,000 shares. Additionally, the number of ordinary shares reserved for issuance pursuant to the 2020 Plan will automatically increase on the first day of January of each year, initially commencing on January 1, 2021, in an amount equal to 5% of the total number of the Company’s ordinary shares outstanding on the last day of the preceding year, or a lesser number of shares determined by the Company’s board of directors. Pursuant to this “evergreen” provision, on January 1, 2022, the number of shares reserved for issuance under the 2020 Plan was increased by 1,478,968 shares. The Amendment extended the final date upon which an “evergreen” increase may occur under this provision from January 1, 2030, to January 1, 2032. As of September 30, 2022, there were 1,210,588 shares available for issuance. Share options issued under the 2020 Plan have a 10-year In 2022, the Company granted RSUs to non-employee directors and certain employees under the 2020 Plan. Each RSU represents the right to receive one of the Company’s ordinary shares upon vesting. RSUs granted to employees vest over a four-year service period with 25% of the award vesting on the first anniversary of the vesting commencement date and the remaining RSUs vest in 12 equal quarterly installments. Certain RSUs granted to the Company’s non-employee directors vest immediately upon grant. As of September 30, 2022, there were options to purchase 3,050,532 shares and RSUs for 187,725 shares outstanding under the 2020 Plan. 2019 Share Option Plan In May 2019, the Company adopted the 2019 Plan, which became effective in conjunction with the IPO. As of September 30, 2022, there were Share options previously issued under the 2019 Plan have a 10-year Employee Share Purchase Plan In May 2019, the Company adopted the 2019 Employee Stock Purchase Plan (the “ESPP”), which became effective in conjunction with the IPO. The Company initially reserved 215,000 ordinary shares for future issuance under this plan. The ESPP provides that the number of shares reserved and available for issuance will automatically increase each January 1, beginning on January 1, 2020 and each January 1 thereafter through January 1, 2029, by the lower of: (i) 1% of the outstanding number of ordinary shares on the immediately preceding December 31; (ii) 430,000 ordinary shares or (iii) such lesser number of shares as determined by the Compensation Committee. The number of shares reserved under the ESPP is subject to adjustment in the event of a split-up, share dividend or other change in the Company’s capitalization. The number of shares reserved for issuance under the ESPP was increased by 295,793 shares effective January 1, 2022. As of September 30, 2022, the total number of shares available for issuance under the ESPP was 901,675 ordinary shares. As of September 30, 2022, there have been no offering periods to employees under ESPP. Share-based compensation The Company recorded share-based compensation expense in the following expense categories of its condensed consolidated statements of operations and comprehensive loss (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Research and development expenses $ 2,637 $ 1,238 $ 7,643 $ 3,535 General and administrative expenses 2,731 1,450 13,596 5,549 $ 5,368 $ 2,688 $ 21,239 $ 9,084 Share options The following table summarizes the Company’s option activity since December 31, 2021: Number of Weighted Shares Weighted Average Aggregate Underlying Average Contractual Intrinsic Share Options Exercise Price Term Value (in years) (in thousands) Outstanding as of December 31, 2021 4,603,486 $ 14.97 8.13 $ 207,009 Granted 1,398,517 46.83 — — Exercised (64,067) 12.55 — — Forfeited (153,355) 25.86 — — Outstanding as of September 30, 2022 5,784,581 $ 22.41 7.82 $ 43,632 Vested and expected to vest as of September 30, 2022 5,784,581 $ 22.41 7.82 $ 43,632 Options exercisable as of September 30, 2022 3,177,177 $ 13.51 7.06 $ 35,164 The weighted average grant-date fair value of share options granted during the nine months ended September 30, 2022 and 2021 was $32.91 per share and $13.83 per share, respectively. The aggregate intrinsic value of share options is calculated as the difference between the exercise price of the share options and the fair value of the Company’s ordinary shares. The aggregate intrinsic value of share options exercised was $0.1 million and $1.3 million for the three and nine months ended September 30, 2022, respectively, and was $5.7 million and $9.4 million for the three and nine months ended September 30, 2021, respectively. Total share-based compensation expense for share options granted was $4.7 million and $17.1 million for the three and nine months ended September 30, 2022, respectively, and was $2.7 million and $9.1 million for the three and nine months ended September 30, 2021, respectively. Expense for non-employee consultants for the three and nine months ended September 30, 2022 and 2021 was immaterial. The following table presents, on a weighted average basis, the assumptions used in the Black-Scholes option-pricing model to determine the fair value of share options granted to employees and directors: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Risk-free interest rate 3.0 % 0.9 % 2.0 % 0.6 % Expected volatility 84.1 % 80.2 % 82.2 % 79.6 % Expected dividend yield — — — — Expected term (in years) 6.1 6.1 6.0 6.0 As of September 30, 2022, total unrecognized compensation expense related to the unvested employee and director share options was $52.7 million, which is expected to be recognized over a weighted average period of 3.0 years. Restricted share units The following table summarizes the Company’s RSU activity under the 2020 Plan since December 31, 2021: Number of Shares Weighted-Average Underlying RSUs Grant Date Fair Value Unvested at December 31, 2021 — $ — Granted 222,725 60.86 Vested (35,000) 60.86 Unvested at September 30, 2022 187,725 $ 60.86 The fair value of RSUs that vested during the three and nine months ended September 30, 2022, was zero and $2.1 million, respectively. Total share-based compensation expense for RSUs granted was $0.7 million and $4.1 million for the three and nine months ended September 30, 2022, respectively. As of September 30, 2022, the total unrecognized compensation expense related to unvested RSUs was $9.3 million, which is expected to be recognized over a weighted-average period of 3.3 |
Significant agreements
Significant agreements | 9 Months Ended |
Sep. 30, 2022 | |
Significant agreements | |
Significant agreements | 9. Significant agreements For the three and nine months ended September 30, 2022 and 2021, the Company recognized revenue for its collaborations with Ionis Pharmaceuticals, Inc. (“Ionis”), Genentech, the Dementia Discovery Fund (“DDF”), and AstraZeneca AB (“AstraZeneca”). The following table summarizes the revenue recognized in the Company’s condensed consolidated statements of operations and comprehensive loss from these arrangements (in thousands): Three Months Nine Months Ended Ended September 30, September 30, 2022 2021 2022 2021 Collaboration revenues Ionis $ 2,195 $ 2,066 $ 6,764 $ 2,066 Genentech 798 1,063 3,144 4,142 Dementia Discovery Fund 47 77 205 314 AstraZeneca — 1,127 1,165 1,404 Total collaboration revenues $ 3,040 $ 4,333 $ 11,278 $ 7,926 Ionis Agreements Ionis Evaluation and Option Agreement On December 31, 2020 (the “Effective Date”), the Company entered into an Evaluation and Option Agreement (the “Evaluation and Option Agreement”) with Ionis. Under the terms of the Evaluation and Option Agreement, the Company agreed to transfer Bicycles At any point during the term of the agreement and continuing through 30 days after the expiration of the Evaluation Period, Ionis had the option (the “Ionis Option”) to obtain an exclusive license to the Company’s intellectual property for the purpose of continued research, development, manufacture and commercialization of products within a particular application of the Company’s platform technology. The upfront payment of The Company concluded that the only performance obligation was a material right for the option to obtain an exclusive license. All other promises under the Evaluation and Option Agreement were immaterial in the context of the contract. The Company accounted for the million payment as deferred revenue as of December 31, 2020. On July 9, 2021, the Ionis Option was exercised upon the parties’ entry into a collaboration and license agreement as contemplated by the Evaluation and Option Agreement. The Company determined that the Ionis Option exercise constituted a continuation of the existing arrangement. Therefore, the million in deferred revenue under the Evaluation and Option Agreement was included in the transaction price of the collaboration and license agreement. Ionis Collaboration Agreement Following the exercise by Ionis of the Ionis Option granted pursuant to the Evaluation and Option Agreement, on July 9, 2021, the Company and Ionis entered into a collaboration and license agreement (the “Ionis Collaboration Agreement”). Pursuant to the Ionis Collaboration Agreement, the Company granted to Ionis a worldwide exclusive license under the Company’s relevant technology to research, develop, manufacture and commercialize products incorporating Bicycle Bicycles ”) intended for the delivery of oligonucleotide compounds directed to targets selected by Ionis for diagnostic, therapeutic, prophylactic and preventative uses in humans. Ionis will maintain exclusivity to all available targets unless it fails to achieve specified development diligence milestone deadlines. If Ionis fails to achieve one or more development diligence milestone deadlines, the Company has the right to limit exclusivity to certain specific collaboration targets, subject to the payment by Ionis of a low-single-digit million dollar amount per target as specified in the Ionis Collaboration Agreement. Each party will be responsible for optimization of such TfR1 Bicycles Bicycles , as specified by a research plan, and thereafter Ionis will be responsible for all future research, development, manufacture and commercialization activities. The Company will perform research and discovery activities including a baseline level of effort for a period of for no additional consideration. The parties will negotiate a commercially reasonable rate if additional research activities are agreed to be performed. For certain research and discovery activities that the Company is responsible for performing, the Company may use the assistance of a contract research organization (“CRO”). The Company has retained certain rights, including the right to use TfR1 Bicycles The activities under the Ionis Collaboration Agreement are governed by a joint steering committee (“JSC”) with an equal number of representatives from the Company and Ionis. The JSC will oversee the performance of the research and development activities. Upon first commercial sales of a licensed product, the JSC will have no further responsibilities or authority under the Ionis Collaboration Agreement. Under the Ionis Collaboration Agreement, Ionis made a non-refundable upfront payment of $31.0 million in addition to the $3.0 million already paid under the Option and Evaluation Agreement. Additionally, Ionis is obligated to reimburse the Company on a pass-through basis for expenses incurred in connection with research and discovery activities performed by a CRO. If Ionis is at risk of failing to achieve a specified development diligence milestone deadline, it can make up to three separate payments of a mid-single-digit million dollar amount to extend the development diligence milestone deadlines. On a collaboration target-by-collaboration target basis, Ionis will be required to make a low-single-digit million dollar payment upon acceptance of an investigational new drug application (“IND”) for the first product directed to such collaboration target (provided that Ionis will have a high single-digit million dollar credit to be applied towards the IND acceptance fee for In December 2021, the Company and Ionis entered into an amendment to the Ionis Collaboration Agreement (the “Ionis Amendment”). Ionis paid the Company services utilizing its proprietary phage screening technology to identify and optimize new product candidates that target the TfR1 receptor. The Company will perform the additional research services for an initial six-month period, which was extended in August 2022 for an additional three months, in exchange for consideration of $0.8 million. In October 2022, Ionis exercised an option it had for the Company to perform additional research services for an additional six months in exchange for the remaining consideration of $0.8 million. Either party may terminate the Ionis Collaboration Agreement for the uncured material breach of the other party or in the case of insolvency. Ionis may terminate the Ionis Collaboration Agreement for convenience on specified notice periods depending on the development stage of the applicable target, either in its entirety or on a target-by-target basis. Ionis Share Purchase Agreement Concurrently with the execution of the Ionis Collaboration Agreement on July 9, 2021, the Company entered into a share purchase agreement (the “Ionis Share Purchase Agreement”) with Ionis, pursuant to which Ionis purchased 282,485 of the Company’s ordinary shares (the “Ionis Shares”) at a price per share of $38.94, for an aggregate purchase price of approximately $11.0 million. Pursuant to the terms of the Ionis Share Purchase Agreement, Ionis has agreed not to, without the Company’s prior written consent and subject to certain conditions and exceptions, among other things, directly or indirectly acquire additional shares of the Company’s outstanding equity securities, seek or propose a tender or exchange offer, merger or other business combination involving the Company, solicit proxies or consents with respect to any matter, or undertake other specified actions related to the potential acquisition of additional equity interests in the Company (collectively, the “Standstill Restrictions”). The Standstill Restrictions will expire on the 18-month anniversary of the Ionis Share Purchase Agreement. The Share Purchase Agreement also provided that, subject to limited exceptions, Ionis could not sell any of the Ionis Shares until July 2022. The Company determined the fair value of the Ionis Shares to be $7.6 million, based on the closing price of the Company’s ADSs of $31.11 per ADS on the date of the Ionis Share Purchase Agreement, less a discount for lack of marketability associated with resale restrictions applicable to the Ionis Shares, which was recorded as a component of shareholders’ equity. The Company concluded that the premium paid by Ionis under the Ionis Share Purchase Agreement represents additional consideration for the goods and services to be provided under the Ionis Collaboration Agreement. As such, the total premium of Accounting analysis Upon execution of the Ionis Collaboration Agreement, the Company identified the following promises in the arrangement: i) a worldwide exclusive license to research, develop, manufacture and commercialize products incorporating TfR1 Bicycles Bicycles collaboration targets. The Company’s participation in the JSC was deemed immaterial in the context of the contract. The Company has concluded that the exclusive license to research, develop, manufacture and commercialize products Bicycles Bicycles that are not available in the marketplace. has been combined with the research and discovery activities into a single performance obligation. The Company concluded that the low-single-digit million dollar payments upon acceptance of an IND (and payment to extend the exclusive license to research, develop, manufacture and commercialize a product candidate for certain specific collaboration targets if Ionis fails to achieve specified development diligence milestone deadlines) is a customer option, as Ionis has the contractual right to choose to make the payment in exchange for the continued exclusive right to research, develop, manufacture and commercialize the product candidate, and the Company is not presently obligated to provide, and does not have a right to consideration, for the additional goods or services prior to Ionis’s exercise of the option. In assessing whether the options under the Ionis Collaboration Agreement represent material rights, the Company considered the additional consideration the Company would be entitled to upon the option exercise and the standalone selling price of the underlying goods and services. For the material rights identified above, the Company concluded that each of the options to obtain credits provided Ionis with a discount that it otherwise would not have received without entering into the Ionis Collaboration Agreement. The total transaction price was initially determined to be $38.0 million, consisting of the $31.0 million up front payment, the $3.0 million payment under the Option and Evaluation Agreement, that was credited against the total upfront payment payable pursuant to the Ionis Collaboration Agreement, the $3.4 million premium paid under the Ionis Share Purchase Agreement, and an estimated $0.6 million for the reimbursement of CRO costs. Additional variable consideration including development diligence milestone deadline extension payments, development and regulatory milestone payments, sales milestone payments and royalty payments was fully constrained as a result of the uncertainty regarding whether any of the milestones will be achieved. The transaction price was allocated to the performance obligations based on the relative estimated standalone selling prices of each performance obligation. The estimated standalone selling price of the Ionis combined licenses and research and discovery performance obligation was based on the nature of the licenses to be delivered, as well as the services to be performed and estimates of the associated effort and costs of the services, adjusted for a reasonable profit margin for what would be expected to be realized under similar contracts. The estimated standalone selling price for the material rights was determined based on the estimated value of the underlying goods and services, and the probability that Ionis would exercise the option. Allocation of Performance Obligations Transaction Price Combined licenses and research and discovery performance obligation $ 34,100 Four material rights associated with credits for IND Acceptance fees 3,900 $ 38,000 The Company is recognizing revenue related to amounts allocated to the combined licenses and research and discovery performance obligation using a proportional performance model over the period of service using input-based measurements including total full-time equivalent effort and CRO costs incurred to date as a percentage of total full-time equivalent effort and CRO costs expected, which best reflects the progress towards satisfaction of the performance obligation. The Company concluded that the Ionis Amendment will be accounted for as a separate contract, as the services are distinct from the Ionis Collaboration Agreement, and the price of the contract increased by an amount of consideration that reflects the Company’s standalone selling price. The Company concluded that the option does not contain a material right. The Company is recognizing the $0.8 million as revenue as the underlying services are performed using a proportional performance model over the period of service using input-based measurements of total full time equivalent efforts and external costs incurred to date as a percentage of total expected full time equivalent efforts and expected external costs, which best reflects the progress towards satisfaction of the performance obligation. For the three and nine months ended September 30, 2022, the Company recognized revenue of $2.2 million and $6.8 million, respectively, and the Company recognized revenue of $2.1 million for each of the three and nine months ended September 30, 2021. As of September 30, 2022, and December 31, 2021, the Company recorded deferred revenue of $22.2 million and $34.1 million, respectively, in connection with the Ionis Collaboration Agreement, Ionis Amendment, and Ionis Evaluation and Option Agreement. Genentech Collaboration Agreement On February 21, 2020, the Company entered into a Discovery Collaboration and License Agreement with Genentech, which was amended in November 2021 and June 2022 (as amended, the “Genentech Collaboration Agreement”). The collaboration is focused on the discovery and development of Bicycle Under the terms of the Genentech Collaboration Agreement, the Company received a $30.0 million upfront, non-refundable payment. The initial discovery and optimization activities are focused on utilizing the Company’s phage screening technology to identify product candidates aimed at two immuno-oncology targets (“Genentech Collaboration Programs”), which may also include additional discovery and optimization of Bicycles If Genentech elects for the Company to perform discovery and optimization services for certain Targeting Arms, the Company will be entitled to receive an additional advance payment for the additional research services. Genentech exercised its right to select a Targeting Arm for million each. If a Targeting Arm achieves specified criteria in accordance with the research plan, Genentech will be required to pay a further specified amount in the low single digit millions for each such Targeting Arm as consideration for the additional services to be provided. The Company granted to Genentech a non-exclusive research license under the Company’s intellectual property solely to enable Genentech to perform any activities under the agreement. The activities under the Genentech Collaboration Agreement are governed by a joint research committee (“JRC”) with representatives from each of the Company and Genentech. The JRC will oversee, review and recommend direction of each Genentech Collaboration Program, achievement of development criteria, and variations of or modifications to the research plans. After the Company performs the initial discovery and optimization activities in accordance with an agreed research plan and achieves specified criteria, Genentech will have the option to have the Company perform initial pre-clinical development and optimization activities in exchange for an additional specified milestone payment in the mid-single digit millions for each Genentech Collaboration Program (the “LSR Go Option”). Upon completion of such initial pre-clinical development and optimization activities for each Genentech Collaboration Program, Genentech will have the option to obtain an exclusive license to exploit any compound developed under such Genentech Collaboration Program in exchange for an additional specified payment in the mid to high single digit millions for each of the initial On a Genentech Collaboration Program by Genentech Collaboration Program basis, if Genentech elects to obtain exclusive development and commercialization rights and pays the applicable LSR Go Option and Dev Go Option fees, Genentech will be required to make milestone payments to the Company upon the achievement of specified development, regulatory, and initial commercialization milestones for products arising from each collaboration program, totaling up to $200.0 million. Specifically, the Company is eligible for additional development milestones totaling up to $65.0 million, as well as regulatory milestones of up to $135.0 million for each collaboration program. In addition, the Company is also eligible to receive up to $200.0 million in sales milestone payments on a Genentech Collaboration Program-by-Genentech Collaboration Program basis. In addition, to the extent any of the product candidates covered by the licenses conveyed to Genentech are commercialized, the Company would be entitled to receive tiered royalty payments on net sales at percentages ranging from the mid-single to low double-digits, subject to certain standard reductions and offsets. Royalties will be payable, on a product by product and country by country basis, until the later of the expiration of specified licensed patents covering such product in such country, or ten years from first commercial sale of such product in such country. Accounting analysis Upon the execution of the Genentech Collaboration Agreement, the Company has identified the following performance obligations: (i) Research license, and the related research and development and preclinical services through LSR Go for a first Genentech Collaboration Program (Genentech Collaboration Program #1); (ii) Research license, and the related research and development and preclinical services through LSR Go for a second Genentech Collaboration Program with a specified Targeting Arm (Genentech Collaboration Program #2); (iii) Material right associated with an option to a specified Targeting Arm for Genentech Collaboration Program #1; (iv) Two material rights associated with the LSR Go Option for Genentech Collaboration Program #1 and Genentech Collaboration Program #2, which includes research services to be provided through the Dev Go Option and an option to receive an exclusive license; (v) Material rights associated with certain limited substitution rights with respect to a limited number of collaboration targets; (vi) Two material rights related to each Genentech Expansion Option, which upon exercise include the services for an additional immuno-oncology target through the LSR Go Option, an LSR Go Option which includes the services to be provided through the Dev Go Option and an option to receive an exclusive license, limited substitution rights, and an option to select a specified Targeting Arm. The Company concluded that certain substitution rights that require the payment of additional consideration, which approximate the standalone selling price of the underlying services to be provided, do not provide the customer with a material right and therefore, are not considered as performance obligations and are accounted for as separate contracts upon exercise, if ever. The Company’s participation in the JRC was assessed as immaterial in the context of the contract. The Company has concluded that the research license is not distinct from the research and development services as Genentech cannot obtain the benefit of the research license without the Company performing the research and development services. The services incorporate proprietary technology and unique skills and specialized expertise, particularly as it relates to constrained peptide technology that is not available in the marketplace. As a result, for each research program, the research license has been combined with the research and development services into a single performance obligation. In addition, the Company concluded that the Dev Go Option is not distinct or separately exercisable from the LSR Go Option, as the customer cannot benefit from the Dev Go Option unless and until the LSR Go Option is exercised. In assessing whether the various options under the Genentech Collaboration Agreement represent material rights, the Company considered the additional consideration the Company would be entitled to upon the option exercise, the standalone selling price of the underlying goods, services, and additional options. For the material rights identified above the Company concluded that each of the options provided Genentech with a discount that it otherwise would not have received. The total transaction price was initially determined to be $31.0 million, consisting of the $30.0 million upfront fee and the additional $1.0 million for Genentech’s selection of a new Targeting Arm at inception. The Company utilizes the most likely amount method to determine the amount of research and development funding to be received. Additional consideration to be paid to the Company upon the exercise of options by Genentech and subsequent milestones are excluded from the transaction price as they relate to option fees and milestones that can only be achieved subsequent to the exercise of an option. In addition, other variable consideration for development milestones not subject to option exercises was fully constrained, as a result of the uncertainty regarding whether any of the milestones will be achieved. In March 2021, the Company achieved specified criteria in accordance with the research plan under the Genentech Collaboration agreement and therefore updated its estimate of the variable consideration to include an additional The transaction price was allocated to the performance obligations based on the relative estimated standalone selling prices of each performance obligation. The estimated standalone selling prices for the Genentech Collaboration Programs was based on the nature of the services to be performed and estimates of the associated effort and costs of the services, adjusted for a reasonable profit margin for what would be expected to be realized under similar contracts. The estimated standalone selling price for the material rights was determined based on the fees Genentech would pay to exercise the options, the estimated value of the underlying goods and services, and the probability that Genentech would exercise the option and any underlying options. Allocation of Performance Obligations Transaction Price Genentech Collaboration Program #1 Performance Obligation $ 4,019 Genentech Collaboration Program #2 Performance Obligation 8,037 Specified Targeting Arm Material Right Arm for Genentech Collaboration Program #1 352 Two material rights associated with the LSR Go Option for Collaboration Programs #1 and #2 12,400 Material rights associated with limited substitution rights 1,187 Two material rights for Expansion Options 7,005 $ 33,000 two two $7.4 million, and limited substitution material rights of $0.7 million, are recorded as deferred revenue and the Company will commence revenue recognition upon exercise or expiry of the respective option. Other variable consideration for development milestones not subject to option exercises was fully constrained as a result of the uncertainty regarding whether any of the milestones will be achieved. two During the three and nine months ended September 30, 2022, the Company recognized revenue of $0.8 million and $3.1 million, respectively, and during the three and nine months ended September 30, 2021, the Company recognized revenue of $1.1 million and $4.1 million, respectively. As of September 30, 2022, and December 31, 2021, the Company recorded $34.8 million and $34.4 million, respectively, of deferred revenue in connection with the Genentech Collaboration Agreement. AstraZeneca Collaboration Agreement In November 2016, the Company entered into a Research Collaboration Agreement (the “AstraZeneca Collaboration Agreement”) with AstraZeneca. The collaboration activities initially focused on two targets within respiratory, cardiovascular and metabolic disease, for which collaboration activities were terminated by AstraZeneca in October 2020 and March 2021, respectively. In May 2018, AstraZeneca exercised an option to nominate four additional targets (“Additional Four Target Option”). As a result, AstraZeneca was entitled to obtain research and development services from the Company with respect to Bicycle Bicycle payments, on a research program by research program basis. In addition, to the extent any of the drug candidates covered by the licenses conveyed to AstraZeneca are commercialized, the Company would be entitled to receive tiered royalty payments of mid-single digits based on a percentage of net sales, subject to certain reductions, including in certain countries where the licensed product faces generic competition. AstraZeneca may terminate the AstraZeneca Collaboration Agreement, entirely or on a licensed product by licensed product or country by country basis, for convenience. Accounting analysis Upon the execution of the Additional Four Target Option, the Company identified the following five performance obligations associated with the May 2018 AstraZeneca Agreement: (i) Research license and the related research and development services during the Bicycle Research Term for the third target (the “Target Three Research License and Related Services”); (ii) Material right associated with the development and exploitation license option for the third target (“Target Three Material Right”); (iii) Material right associated with the research services option, including the underlying development and exploitation license option for the fourth target (“Target Four Material Right”); (iv) Material right associated with the research services option, including the underlying development and exploitation license option for the fifth target (“Target Five Material Right”); and (v) Material right associated with the research services option, including the underlying development and exploitation license option for the sixth target (“Target Six Material Right”). The Company concluded that the fourth, fifth and sixth targets available for selection were options. Upon exercise, AstraZeneca obtained a research license and the related research and development services and an option to a development and exploitation license. The Company has concluded that the research services option, including the underlying development and exploitation license options related to each respective target resulted in a material right as the option exercise fee related to the development and exploitation license contained a discount that AstraZeneca would not have otherwise received. The research license and the related research and development services related to the fourth, fifth and sixth targets were not performance obligations at the inception of the arrangement, as they were optional services that would be performed if AstraZeneca selected additional targets and they reflected their standalone selling prices and did not provide the customer with material rights. The Company’s participation in the joint steering committee was assessed as immaterial in the context of the contract. The total transaction price was initially determined to be $5.7 million, consisting of the $5.0 million option exercise fee and research and development funding of an estimated $0.7 million. The research and development funding was provided based on the costs incurred to conduct the research and development services. The Company utilized the most likely amount method to determine the amount of research and development funding to be received. Additional consideration to be paid to the Company upon the exercise of the license options by AstraZeneca or upon reaching certain milestones was excluded from the transaction price as they related to option fees and milestones that can only be achieved subsequent to the license option exercise or are outside of the initial contact term. The transaction price was allocated to the performance obligations based on the relative estimated standalone selling prices of each performance obligation. The estimated standalone selling prices for each Research License and Related Services obligation was primarily based on the nature of the services to be performed and estimates of the associated effort and costs of the services, adjusted for a reasonable profit margin for what would be expected to be realized under similar contracts. The estimated standalone selling price for the material rights was determined based on the fees AstraZeneca would pay to exercise the license options, the estimated value of the License Option using comparable transactions, and the probability that (i) AstraZeneca would opt into the target development, and (ii) the license options would be exercised by AstraZeneca. Based on the relative standalone selling price, the allocation of the transaction price to the separate performance obligations was as follows (in thousands): Allocation of Performance Obligations Transaction Price Target Three Research License and Related Services $ 650 Target 3 Material Right 1,504 Target 4 Material Right 1,204 Target 5 Material Right 1,165 Target 6 Material Right 1,127 $ 5,650 The Company recognized revenue related to amounts allocated to the Target Three Research License and Related Services as the underlying services are performed using a proportional performance model over the period of service using input-based measurements of total full-time equivalent effort incurred to date as a percentage of total full-time equivalent time expected, which best reflected the progress towards satisfaction of the performance obligation. The amount allocated to the material rights is recorded as deferred revenue and the Company commences revenue recognition upon exercise of or upon expiry of the option. The optional future research license and the related research and development services related to the fourth, fifth and sixth targets reflect their standalone selling prices and do not provide the customer with a material right and, therefore, are not considered performance obligations and are accounted for as separate contracts. In June 2019, AstraZeneca selected a replacement target for the third target, and as such a new Research Term was started related to the Target Three Research License and Related Services. The total transaction price under the arrangement increased to $6.3 million for the additional research and development funding to be received. In October 2020, AstraZeneca terminated the collaboration activities related to the third target. As a result, deferred revenue related to the amount allocated to the Target 3 Material Right of $1.5 million was recognized during the year ended December 31, 2020. In August 2021, AstraZeneca terminated the collaboration activities related to the sixth target. As a result, deferred revenue related to the amount allocated to the Target 6 Material Right of $1.1 million was recognized during the year ended December 31, 2021. In June 2022, AstraZeneca terminated the collaboration activities related to the fifth target. As a result, deferred revenue related to the amount allocated to the Target 5 Material Right of $1.2 million was recognized during the second quarter of 2022. As of September 30, 2022, one research program was in the AZ Research Term, and the research and development services associated with the Bicycle Research Term for the fourth target have been completed. In January 2022, AstraZeneca elected to extend the AZ Research Term for the fourth target by 12 months. For the three and nine months ended September 30, 2022, the Company recognized no revenue and $1.2 million, respectively, related to the Additional Four Target Option and related contracts, and for the three and nine months ended September 30, 2021, the Company recognized revenue |
Income taxes
Income taxes | 9 Months Ended |
Sep. 30, 2022 | |
Income taxes | |
Income taxes | 10. Income taxes During the three and nine months ended September 30, 2022, the Company recorded an income tax benefit of $0.2 million and $1.1 million, respectively, and during the three and nine months ended September 30, 2021, the Company recorded an income tax benefit of $0.4 million and $0.9 million, respectively. The Company is subject to United Kingdom corporate taxation. Due to the nature of its business, the Company has generated losses since inception and has therefore not paid United Kingdom corporation tax. The Company's income tax benefit is mainly the result of deferred tax assets benefitted in the United States that do not have a valuation allowance against them because of profits that will be generated by an intercompany service agreement. The Company regularly assesses its ability to realize its deferred tax assets. Assessing the realization of deferred tax assets requires significant judgment. In determining whether its deferred tax assets are more likely than not realizable, the Company evaluated all available positive and negative evidence, and weighed the evidence based on its objectivity. After consideration of the evidence, including the Company’s history of cumulative net losses in the U.K., the Company has concluded that it is more likely than not that the Company will not realize the benefits of its U.K. deferred tax assets and accordingly the Company has provided a valuation allowance for the full amount of the net deferred tax assets in the U.K. The Company has considered the Company’s history of cumulative net profits in the United States, estimated future taxable income and concluded that it is more likely than not that the Company will realize the benefits of its United States deferred tax assets and has not provided a valuation allowance against the net deferred tax assets in the United States. The Company recorded a valuation allowance against all of its U.K. deferred tax assets as of September 30, 2022, and December 31, 2021. The Company intends to continue to maintain a full valuation allowance on its U.K. deferred tax assets until there is sufficient evidence to support the reversal of all or some portion of these allowances. The release of the valuation allowance would result in the recognition of certain deferred tax assets and an increase to the benefit from income taxes for the period the release is recorded. However, the exact timing and amount of the valuation allowance release are subject to change on the basis of the level of profitability that the Company is able to actually achieve. The benefit from income taxes shown on the condensed consolidated statements of operations differs from amounts that would result from applying the statutory tax rates to income before taxes primarily because of certain permanent expenses that were not deductible, U.K., federal and state research and development credits, as well as the application of valuation allowances against the U.K. deferred tax assets. |
Commitments and contingencies
Commitments and contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and contingencies | |
Commitments and contingencies | 11. Commitments and contingencies Leases On December 6, 2021, the Company entered into a lease of new office and laboratory space in Cambridge, United Kingdom. The lease has a contractual period of 10 years, but may be cancelled by the Company on the fifth anniversary of the lease commencement date. The lease term is five years, representing the non-cancelable lease period, as it is not reasonably certain that the lease will not be cancelled. The Company has a contractual right to renew the lease for a further ten-year period, which also may be cancelled after five years. The annual rent is approximately $3.0 million, payable quarterly in advance beginning in June 2022, following a six-month period of free rent. There was no deposit paid in conjunction with the lease. The Company recorded a right of use asset of approximately $11.6 million and a lease liability of approximately $11.1 million at the lease commencement date, based on the present value of future lease payments, discounted at a 6.9%, the Company’s estimated incremental borrowing rate at the commencement of the lease, over the lease term. Rent expense is recognized on a straight-line basis over the five year lease term, including the six month rent-free period. In October 2017, the Company entered into a lease agreement for office and laboratory space in Building 900, Babraham Research Campus, Cambridge, U.K., which expired on December 11, 2021. The annual rent was approximately $0.5 million. The Company had the right to renew the lease for five years commencing December 12, 2021. The renewal period was not included in the original lease term as it was not reasonably certain that the right would be exercised. In March 2021, the Company concluded that it was reasonably certain that it would exercise the lease renewal option, and accounted for the lease extension as a modification of the existing lease. The Company remeasured the right of use asset and lease liability by calculating the present value of expected lease payments, discounted at 7.70%, the Company’s estimated incremental borrowing rate at the date of the modification of the lease, over the new lease term. In December 2021, the lease was renewed. The annual rent for the new lease is approximately $0.6 million. Service charges are also payable based on floor area and are estimated to be approximately $0.2 million per year. In September 2017, Bicycle Therapeutics Inc. entered into a lease agreement for office and laboratory space in Lexington, Massachusetts, which commenced on January 1, 2018. In March 2022, Bicycle Therapeutics Inc. notified the landlord of its intent to exercise its option to extend the lease, originally set to expire on December 31, 2022, for a successive period through December 31, 2027. The successive period was not included in the original lease term as it was not reasonably certain that the option would be exercised. In March 2022, the Company accounted for the lease extension as a modification of the existing lease and remeasured the right of use asset and lease liability by calculating the present value of lease payments, discounted at 7.0%, the Company’s incremental borrowing rate, over the new lease term. In May 2022, the lease was extended. The payments for the modified lease are approximately $0.2 million remaining through December 31, 2022, $0.7 million in 2023, and increases annually pursuant to an escalation clause with the last year of the lease term having a per annum fixed rent obligation of $0.8 million. In conjunction with the lease agreement, Bicycle Therapeutics Inc. paid a security deposit of $0.2 million as well as prepaid rent of $0.1 million for the first month of the third, fourth, and fifth year of the lease. The Company identified and assessed the following significant assumptions in recognizing the right-of-use assets and corresponding lease liabilities: ● Expected lease term — The expected lease term includes both contractual lease periods and, when applicable, periods covered by an option to extend the lease when it is reasonably certain that the Company will exercise the extension option, or cancelable option periods when it is reasonably certain that the Company would not exercise such cancelation option. ● Incremental borrowing rate — The Company’s lease agreements do not provide an implicit rate. As the Company does not have any external borrowings for comparable terms of its leases, the Company estimated the incremental borrowing rate by comparing interest rates available in the market for similar borrowings and third-party quotations. ● Lease and non-lease components — In certain cases, the Company is also responsible for certain additional charges for operating costs, including insurance, maintenance, taxes, and other costs incurred, which are billed based on both usage and as a percentage of the Company’s share of total square footage. The amounts paid are considered non-lease components. The Company has elected the practical expedient which allows the non-lease components to be combined with the lease components. The payments for other operating costs are considered variable lease cost and are recognized in the period in which the costs are incurred. The components of the Company’s lease expense, which are recorded as a component of research and development expenses and general and administrative expenses in the condensed consolidated statement of operations and comprehensive loss are as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Operating lease cost $ 924 $ 273 $ 2,866 $ 773 Variable lease cost 410 222 1,005 444 Total lease cost $ 1,334 $ 495 $ 3,871 $ 1,217 The weighted average remaining operating lease term was 4.5 years and 4.6 years as of September 30, 2022 and 2021, respectively, and the weighted average discount rate was 7.03% and 7.89% as of September 30, 2022 and 2021, respectively. The following table summarizes the maturities of the Company’s operating leases as of September 30, 2022 (in thousands): Year Ending December 31, 2022 $ 868 2023 3,718 2024 3,740 2025 3,763 2026 3,045 2027 821 Present value adjustment (2,147) Total lease liabilities 13,808 Less: current lease liabilities (2,811) Long term lease liabilities $ 10,997 The Company has entered into various agreements with contract research organizations to provide clinical trial services, contract manufacturing organizations to provide clinical trial materials and with vendors for preclinical research studies, synthetic chemistry and other services for operating purposes. These payments are not included in the table of operating lease payments above since the contracts are generally cancelable at any time upon less than 90 days’ prior written notice. The Company is not contractually able to terminate for convenience and avoid any and all future obligations to these vendors. In some cases, we are contractually obligated to make certain minimum payments to the vendors, based on the timing of the termination notification and the exact terms of the agreement. Legal proceedings From time to time, the Company may become involved in various legal proceedings and claims, either asserted or unasserted, which arise in the ordinary course of business. The Company is currently not subject to any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of ASC 450, Contingencies Founder royalty arrangements At the time BicycleRD Limited was organized, BicycleRD Limited entered into a royalty agreement with its founders and initial investors (the “Founder Royalty Agreement”). Pursuant to the Founder Royalty Agreement, as amended, the Company will pay a royalty rate in the low single digit percentages on net product sales under the collaborations with Oxurion and AstraZeneca to its founders and initial investors, for a period of 10 years from the first commercial sale on a country-by-country basis. No royalties have been earned or paid under the Founder Royalty Agreement, as amended, to date. Indemnification obligations In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has indemnification obligations towards members of its board of directors and officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification arrangements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnification obligations. The Company is not aware of any claims under indemnification arrangements, and therefore it has not accrued any liabilities related to such obligations in its condensed consolidated financial statements as of September 30, 2022, and December 31, 2021. |
Net loss per share
Net loss per share | 9 Months Ended |
Sep. 30, 2022 | |
Net loss per share | |
Net loss per share | 12. Net loss per share Basic and diluted net loss per share was calculated as follows (in thousands, except share and per share amounts): Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Numerator: Net loss $ (28,347) $ (14,678) $ (82,739) $ (48,782) Denominator: Weighted average ordinary shares outstanding, basic and diluted 29,676,021 25,039,990 29,643,502 23,719,124 Net loss per share, basic and diluted $ (0.96) $ (0.59) $ (2.79) $ (2.06) The Company’s potentially dilutive securities, which are options to purchase ordinary shares and restricted share units for ordinary shares, have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted average number of ordinary shares outstanding used to calculate both basic and diluted net loss per share is the same. The Company excluded the following potentially dilutive ordinary shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share for the periods indicated because including them would have had an anti-dilutive effect: September 30, 2022 2021 Restricted ordinary shares 187,725 — Options to purchase ordinary shares 5,784,581 4,717,166 5,972,306 4,717,166 |
Related party transactions
Related party transactions | 9 Months Ended |
Sep. 30, 2022 | |
Related party transactions | |
Related party transactions | 13. Related party transactions The Company has entered into the Founder Royalty Agreement, as amended, with its founders and initial investors (Note 11). No royalties have been earned or paid under the Founder Royalty Agreement, as amended, to date. The Chairman of the Company’s board of directors is associated with Stone Sunny Isles Inc. and Stone Atlanta Estates LLC, the successor-in-interest to Stone Sunny Isles Inc., which provided consultancy services to the Company totaling $43,000 and $0.2 million during the three and nine months ended September 30, 2022, respectively, and $43,000 and $0.1 million during the three and nine months ended September 30, 2021, respectively. |
Geographic information
Geographic information | 9 Months Ended |
Sep. 30, 2022 | |
Geographic information | |
Geographic information | 14. Geographic information The Company operates in two geographic regions: the United States and the United Kingdom. Information about the Company’s long-lived assets, including operating lease right-of-use assets, held in different geographic regions is presented in the table below (in thousands): September 30, December 31, 2022 2021 United States $ 4,584 $ 1,095 United Kingdom 25,120 16,694 $ 29,704 $ 17,789 The Company’s collaboration revenues are attributed to the operations of the Company in the United Kingdom. |
Summary of significant accoun_2
Summary of significant accounting policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Summary of significant accounting policies | |
Use of estimates | Use of estimates The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the accrual for research and development expenses, revenue recognition, share-based compensation expense, valuation of right-of-use assets and liabilities, and income taxes, including the valuation allowance for deferred tax assets. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. Estimates are periodically reviewed in light of reasonable changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates or assumptions. |
Significant risks and uncertainties | Significant risks and uncertainties The Company currently operates in a period of economic uncertainty which has been significantly impacted by the ongoing COVID-19 pandemic, domestic and global monetary and fiscal policy, geopolitical instability, the ongoing war in Ukraine, rising inflation and interest rates, and fluctuations in monetary exchange rates. While the Company has experienced limited financial impacts at this time, the Company continues to monitor these factors and events and the potential effects each may have on the Company’s business, financial condition, results of operations and growth prospects. |
Unaudited interim financial information | Unaudited interim financial information Certain information in the footnote disclosures of these financial statements has been condensed or omitted pursuant to the rules and regulations of the SEC. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto for the year ended December 31, 2021 included in the Company’s 2021 Annual Report. The accompanying condensed consolidated balance sheet as of September 30, 2022, condensed consolidated statements of operations and comprehensive loss, condensed consolidated statements of shareholders’ equity, and condensed consolidated statements of cash flows for the three and nine months ended September 30, 2022 and 2021, and the related financial information disclosed in these notes are unaudited. The unaudited interim financial statements have been prepared on the same basis as the audited annual financial statements for the year ended December 31, 2021, and, in the opinion of management, reflect all adjustments, consisting of normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2022, and the results of its operations and its cash flows for the three and nine months ended September 30, 2022 and 2021. The results for the three and nine months ended September 30, 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2022, any other interim periods, or any future year or period. |
Accounts receivable | Accounts receivable |
Government grants | Government grants From time to time, the Company may enter into arrangements with governmental entities for the purpose of obtaining funding for research and development activities. The Company is reimbursed for costs incurred that are associated with specified research and development activities included in the grant application approved by the government authority. The Company recognizes government grant funding in the condensed consolidated statements of operations and comprehensive loss as the related expenses being funded are incurred. The Company classifies government grants received under these arrangements as a reduction to the related research and development expense incurred, and accrued but unpaid grant income is included in other current assets. The Company analyzes each arrangement on a case-by-case basis, and income is recognized when the Company concludes that it has reasonable assurance that it will comply with the conditions attached to the grant and the expenses have been incurred. There are no significant performance criteria other than to maintain satisfactory progress on the specified project, and there are no significant acceptance or recapture provisions associated with the government grants for the three and nine month periods ended September 30, 2022 and 2021, respectively. For the three and nine months ended September 30, 2022, the Company recognized $0.3 million and $1.1 million, respectively, and for the three and nine months ended September 30, 2021, the Company recognized $1.0 million and $2.9 million, respectively, as a reduction of research and development expense related to government grant arrangements. As of September 30, 2022, the Company has approximately $1.3 million of government grant funding remaining for future cost reimbursement through February of 2024. |
Recently adopted accounting pronouncements | Recently adopted accounting pronouncements In June 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-13, Measurement of Credit Losses on Financial Instruments Financial Instruments — Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates adopted ASU 2016-13 as of January 1, 2022, on a prospective basis. The adoption did not have a material impact on the Company’s consolidated financial statements. In November 2021, the FASB issued ASU No. 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance |
Property and equipment, net (Ta
Property and equipment, net (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Property and equipment, net | |
Schedule of property and equipment, net | Property and equipment, net consisted of the following (in thousands): September 30, December 31, 2022 2021 Laboratory equipment $ 11,385 $ 6,746 Leasehold improvements 9,630 809 Computer equipment and software 403 143 Furniture and office equipment 822 225 22,240 7,923 Less: Accumulated depreciation and amortization (6,020) (4,800) $ 16,220 $ 3,123 |
Accrued expenses and other cu_2
Accrued expenses and other current liabilities (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Accrued expenses and other current liabilities | |
Schedule of accrued expenses and other current liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): September 30, December 31, 2022 2021 Accrued employee compensation and benefits $ 6,328 $ 6,429 Accrued external research and development expenses 7,223 3,980 Accrued professional fees 1,052 882 Current portion of operating lease liabilities 2,811 2,383 Other 677 570 $ 18,091 $ 14,244 |
Long-term debt (Tables)
Long-term debt (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Long-term debt | |
Schedule of long term debt instruments | Long-term debt consisted of the following (in thousands): September 30, December 31, 2022 2021 Term loan payable $ 30,000 $ 30,000 End of term charge 624 376 Unamortized debt issuance costs (392) (503) Carrying value of term loan $ 30,232 $ 29,873 |
Schedule of maturities of long term debt | Future principal payments, including the End of Term Charge, are as follows (in thousands): Year Ending December 31, 2022 $ — 2023 — 2024 — 2025 31,500 Total $ 31,500 |
Share-based compensation (Table
Share-based compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Share-based compensation | |
Schedule of share based compensation expense | The Company recorded share-based compensation expense in the following expense categories of its condensed consolidated statements of operations and comprehensive loss (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Research and development expenses $ 2,637 $ 1,238 $ 7,643 $ 3,535 General and administrative expenses 2,731 1,450 13,596 5,549 $ 5,368 $ 2,688 $ 21,239 $ 9,084 |
Schedule of share option activity | Number of Weighted Shares Weighted Average Aggregate Underlying Average Contractual Intrinsic Share Options Exercise Price Term Value (in years) (in thousands) Outstanding as of December 31, 2021 4,603,486 $ 14.97 8.13 $ 207,009 Granted 1,398,517 46.83 — — Exercised (64,067) 12.55 — — Forfeited (153,355) 25.86 — — Outstanding as of September 30, 2022 5,784,581 $ 22.41 7.82 $ 43,632 Vested and expected to vest as of September 30, 2022 5,784,581 $ 22.41 7.82 $ 43,632 Options exercisable as of September 30, 2022 3,177,177 $ 13.51 7.06 $ 35,164 |
Schedule of assumptions used to determine the fair value of share options granted | Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Risk-free interest rate 3.0 % 0.9 % 2.0 % 0.6 % Expected volatility 84.1 % 80.2 % 82.2 % 79.6 % Expected dividend yield — — — — Expected term (in years) 6.1 6.1 6.0 6.0 |
Summarizes activity for RSUs under the 2020 Plan | Number of Shares Weighted-Average Underlying RSUs Grant Date Fair Value Unvested at December 31, 2021 — $ — Granted 222,725 60.86 Vested (35,000) 60.86 Unvested at September 30, 2022 187,725 $ 60.86 |
Significant agreements (Tables)
Significant agreements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Significant agreements. | |
Summary of revenue recognized from collaboration arrangements | Three Months Nine Months Ended Ended September 30, September 30, 2022 2021 2022 2021 Collaboration revenues Ionis $ 2,195 $ 2,066 $ 6,764 $ 2,066 Genentech 798 1,063 3,144 4,142 Dementia Discovery Fund 47 77 205 314 AstraZeneca — 1,127 1,165 1,404 Total collaboration revenues $ 3,040 $ 4,333 $ 11,278 $ 7,926 |
Summary of changes in the balances of the Company's contract assets and liabilities | The following table presents changes in the balances of the Company’s contract assets and liabilities (in thousands): Beginning Balance Impact of Ending Balance January 1, Exchange September 30, 2022 Additions Deductions Rates 2022 Contract liabilities: Deferred revenue Ionis collaboration deferred revenue $ 34,115 $ — $ (6,764) $ (5,190) $ 22,161 Genentech collaboration deferred revenue 34,436 10,000 (3,144) (6,475) 34,817 DDF collaboration deferred revenue 428 — (205) (53) 170 AstraZeneca collaboration deferred revenue 2,361 — (1,165) (204) 992 Total deferred revenue $ 71,340 $ 10,000 $ (11,278) $ (11,922) $ 58,140 Beginning Balance Impact of Ending Balance January 1, Exchange December 31, 2021 Additions Deductions Rates 2021 Contract liabilities: Deferred revenue Ionis collaboration deferred revenue $ 3,000 $ 36,002 $ (4,242) $ (645) $ 34,115 Genentech collaboration deferred revenue 27,579 13,000 (5,660) (483) 34,436 DDF collaboration deferred revenue 821 — (391) (2) 428 AstraZeneca collaboration deferred revenue 3,756 54 (1,404) (45) 2,361 Total deferred revenue $ 35,156 $ 49,056 $ (11,697) $ (1,175) $ 71,340 |
Summary of recognition of revenues as a result of changes in contract asset and contract liability balances | During the three and nine months ended September 30, 2022 and 2021, the Company recognized the following revenues as a result of changes in the contract asset and the contract liability balances in the respective periods (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Revenue recognized in the period from: Revenue recognized based on proportional performance $ 3,040 $ 3,206 $ 10,072 $ 6,263 Revenue recognized based on expiration of material rights — 1,127 1,206 1,507 Revenue recognized based on changes in transaction price — — — 156 Total $ 3,040 $ 4,333 $ 11,278 $ 7,926 |
Ionis | |
Significant agreements. | |
Summary of allocation of transaction price to separate performance obligations | Allocation of Performance Obligations Transaction Price Combined licenses and research and discovery performance obligation $ 34,100 Four material rights associated with credits for IND Acceptance fees 3,900 $ 38,000 |
Genentech | |
Significant agreements. | |
Summary of allocation of transaction price to separate performance obligations | Allocation of Performance Obligations Transaction Price Genentech Collaboration Program #1 Performance Obligation $ 4,019 Genentech Collaboration Program #2 Performance Obligation 8,037 Specified Targeting Arm Material Right Arm for Genentech Collaboration Program #1 352 Two material rights associated with the LSR Go Option for Collaboration Programs #1 and #2 12,400 Material rights associated with limited substitution rights 1,187 Two material rights for Expansion Options 7,005 $ 33,000 |
AstraZeneca | |
Significant agreements. | |
Summary of allocation of transaction price to separate performance obligations | Allocation of Performance Obligations Transaction Price Target Three Research License and Related Services $ 650 Target 3 Material Right 1,504 Target 4 Material Right 1,204 Target 5 Material Right 1,165 Target 6 Material Right 1,127 $ 5,650 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and contingencies | |
Schedule of components of lease expense | The components of the Company’s lease expense, which are recorded as a component of research and development expenses and general and administrative expenses in the condensed consolidated statement of operations and comprehensive loss are as follows (in thousands): Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Operating lease cost $ 924 $ 273 $ 2,866 $ 773 Variable lease cost 410 222 1,005 444 Total lease cost $ 1,334 $ 495 $ 3,871 $ 1,217 |
Schedule of maturities of operating leases | The following table summarizes the maturities of the Company’s operating leases as of September 30, 2022 (in thousands): Year Ending December 31, 2022 $ 868 2023 3,718 2024 3,740 2025 3,763 2026 3,045 2027 821 Present value adjustment (2,147) Total lease liabilities 13,808 Less: current lease liabilities (2,811) Long term lease liabilities $ 10,997 |
Net loss per share (Tables)
Net loss per share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Net loss per share | |
Schedule of basic and diluted net loss attributable to ordinary shareholders | Basic and diluted net loss per share was calculated as follows (in thousands, except share and per share amounts): Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Numerator: Net loss $ (28,347) $ (14,678) $ (82,739) $ (48,782) Denominator: Weighted average ordinary shares outstanding, basic and diluted 29,676,021 25,039,990 29,643,502 23,719,124 Net loss per share, basic and diluted $ (0.96) $ (0.59) $ (2.79) $ (2.06) |
Schedule of antidilutive securities excluded from computation of diluted net loss per share | September 30, 2022 2021 Restricted ordinary shares 187,725 — Options to purchase ordinary shares 5,784,581 4,717,166 5,972,306 4,717,166 |
Geographic information (Tables)
Geographic information (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Geographic information | |
Schedule of long-lived assets, including operating lease right-of-use assets, held in different geographic regions | Information about the Company’s long-lived assets, including operating lease right-of-use assets, held in different geographic regions is presented in the table below (in thousands): September 30, December 31, 2022 2021 United States $ 4,584 $ 1,095 United Kingdom 25,120 16,694 $ 29,704 $ 17,789 |
Nature of the business and ba_2
Nature of the business and basis of presentation - Liquidity (Details) - USD ($) $ 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 | Dec. 31, 2021 | |
Nature of the business and basis of presentation | |||||||||
Cash and cash equivalents | $ 361,469 | $ 361,469 | $ 438,680 | ||||||
Net loss | 28,347 | $ 26,828 | $ 27,564 | $ 14,678 | $ 17,913 | $ 16,191 | 82,739 | $ 48,782 | |
Accumulated deficit | $ 301,118 | $ 301,118 | $ 218,379 |
Summary of significant accoun_3
Summary of significant accounting policies (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 | |
Summary of significant accounting policies | |||||
Accounts receivable | $ 0 | $ 0 | $ 1,000 | ||
Reduction of research and development related to government grant arrangements | 300 | $ 1,000 | 1,100 | $ 2,900 | |
Government grant funding remaining for future cost reimbursement | $ 1,300 | $ 1,300 |
Fair value of financial asset_2
Fair value of financial assets and liabilities - Financial assets and liabilities measured at fair value (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Fair value of financial assets and liabilities | ||
Cash equivalents | $ 276,100 | $ 100,000 |
Recurring | ||
Fair value of financial assets and liabilities | ||
Liabilities at fair value | 0 | 0 |
Assets at fair value | $ 0 | $ 0 |
Property and equipment, net (De
Property and equipment, net (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 | |
Property and equipment, net | |||||
Property and equipment, gross | $ 22,240 | $ 22,240 | $ 7,923 | ||
Less: Accumulated depreciation and amortization | (6,020) | (6,020) | (4,800) | ||
Property and equipment, net | 16,220 | 16,220 | 3,123 | ||
Depreciation expense | 1,300 | $ 300 | 2,200 | $ 1,000 | |
Laboratory equipment | |||||
Property and equipment, net | |||||
Property and equipment, gross | 11,385 | 11,385 | 6,746 | ||
Leasehold improvements | |||||
Property and equipment, net | |||||
Property and equipment, gross | 9,630 | 9,630 | 809 | ||
Computer equipment and software | |||||
Property and equipment, net | |||||
Property and equipment, gross | 403 | 403 | 143 | ||
Furniture and office equipment | |||||
Property and equipment, net | |||||
Property and equipment, gross | $ 822 | $ 822 | $ 225 |
Accrued expenses and other cu_3
Accrued expenses and other current liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Accrued expenses and other current liabilities | ||
Accrued employee compensation and benefits | $ 6,328 | $ 6,429 |
Accrued external research and development expenses | 7,223 | 3,980 |
Accrued professional fees | 1,052 | 882 |
Current portion of operating lease liabilities | $ 2,811 | $ 2,383 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accrued expenses and other current liabilities | Accrued expenses and other current liabilities |
Other | $ 677 | $ 570 |
Accrued expenses and other current liabilities | $ 18,091 | $ 14,244 |
Long-term debt (Details)
Long-term debt (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||||||
Jul. 15, 2022 | Mar. 15, 2022 | Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Mar. 10, 2021 | Sep. 30, 2020 | |
Debt Instrument [Line Items] | ||||||||
Borrowing option to prepay subject to minimum debt outstanding | $ 5 | $ 5 | ||||||
End term charge rate | 5% | 5% | ||||||
Additional interest rate event of default | 5% | 5% | ||||||
Prepayment occurs in second year | ||||||||
Debt Instrument [Line Items] | ||||||||
Prepayment rate | 1.50% | 1.50% | ||||||
Prepayment occurs after year two | ||||||||
Debt Instrument [Line Items] | ||||||||
Prepayment rate | 1% | 1% | ||||||
Second Amendment to LSA | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument stated percentage | 8.05% | |||||||
Second Amendment to LSA | Prime Rate | ||||||||
Debt Instrument [Line Items] | ||||||||
Basis spread variable rate | 4.55% | |||||||
Second Amendment to LSA | Maximum | ||||||||
Debt Instrument [Line Items] | ||||||||
Term loan | $ 45 | |||||||
Debt instrument stated percentage | 9.05% | |||||||
Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Maximum borrowing | $ 75 | |||||||
Initial Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Fees and transaction costs | $ 0.6 | |||||||
Debt instrument effective percentage | 10.80% | 10.80% | ||||||
Interest expense | $ 0.8 | $ 0.8 | $ 2.5 | $ 2.1 | ||||
Loan and Security Agreement | Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Maximum borrowing | 40 | |||||||
Loan and Security Agreement | Initial Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Term loan | 15 | |||||||
Loan and Security Agreement | Additional Term Loan One | ||||||||
Debt Instrument [Line Items] | ||||||||
Term loan | $ 15 | 15 | ||||||
Additional term loan expired unexercised. | $ 10 | |||||||
Loan and Security Agreement | Additional Term Loan Two | ||||||||
Debt Instrument [Line Items] | ||||||||
Term loan | $ 10 |
Long-term debt - Debt (Details)
Long-term debt - Debt (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Long-term debt | ||
Term loan payable | $ 30,000 | $ 30,000 |
End of term charge | 624 | 376 |
Unamortized debt issuance costs | (392) | (503) |
Carrying value of term loan | $ 30,232 | $ 29,873 |
Long-term debt - Future Princip
Long-term debt - Future Principal Payments (Details) $ in Thousands | Sep. 30, 2022 USD ($) |
Long-term debt | |
2022 | $ 0 |
2023 | 0 |
2024 | 0 |
2025 | 31,500 |
Total | $ 31,500 |
Ordinary shares (Details)
Ordinary shares (Details) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 Vote £ / shares $ / shares shares | Dec. 31, 2021 $ / shares £ / shares shares | |
Ordinary shares | ||
Vote per ordinary share | Vote | 1 | |
Dividends declared | $ / shares | $ 0 | $ 0 |
Ordinary shares, shares authorized | shares | 57,820,181 | 55,295,420 |
Ordinary shares, nominal value | £ / shares | $ 0.01 | $ 0.01 |
Share-based compensation (Detai
Share-based compensation (Details) | 1 Months Ended | 9 Months Ended | ||||
Jun. 30, 2020 installment shares | May 31, 2019 shares | Sep. 30, 2022 installment shares | Jun. 27, 2022 shares | Jan. 01, 2022 shares | Dec. 31, 2021 shares | |
Stock option | ||||||
Share-based compensation. | ||||||
Shares outstanding | 5,784,581 | 4,603,486 | ||||
Employee Share Purchase Plan | ||||||
Share-based compensation. | ||||||
Number of shares reserved for issuance | 295,793 | |||||
Percentage of annual increase in reserves on total number of ordinary shares outstanding | 1% | |||||
Number of ordinary shares reserved for issuance | 215,000 | 901,675 | ||||
Number of shares available for issuance | 430,000 | |||||
2020 Plan | ||||||
Share-based compensation. | ||||||
Number of shares reserved for issuance | 4,773,557 | 1,210,588 | 750,000 | 1,478,968 | ||
Shares issued (in shares) | 574,679 | |||||
Percentage of annual increase in reserves on total number of ordinary shares outstanding | 5% | |||||
2020 Plan | Stock option | ||||||
Share-based compensation. | ||||||
Shares outstanding | 3,050,532 | |||||
Contractual life | 10 years | |||||
2020 Plan | Stock option | Non-employee Director | ||||||
Share-based compensation. | ||||||
Vesting period | 3 years | |||||
2020 Plan | Stock option | First anniversary | ||||||
Share-based compensation. | ||||||
Vesting Percentage | 25% | |||||
2020 Plan | Stock option | Employee | ||||||
Share-based compensation. | ||||||
Vesting period | 4 years | |||||
2020 Plan | Stock option | Employee | Remaining equal installments | ||||||
Share-based compensation. | ||||||
Number of equal monthly installments for vesting remaining awards | installment | 36 | |||||
2020 Plan | Restricted ordinary shares | ||||||
Share-based compensation. | ||||||
Vesting period | 4 years | |||||
Right to receive upon vesting | 1 | |||||
RSUs outstanding under the 2020 Plan. | 187,725 | |||||
2020 Plan | Restricted ordinary shares | First anniversary | ||||||
Share-based compensation. | ||||||
Vesting Percentage | 25% | |||||
2020 Plan | Restricted ordinary shares | Remaining equal installments | ||||||
Share-based compensation. | ||||||
Number of equal quarterly installments for vesting remaining awards | installment | 12 | |||||
2019 Plan | ||||||
Share-based compensation. | ||||||
Number of shares reserved for issuance | 544,866 | |||||
2019 Plan | Stock option | ||||||
Share-based compensation. | ||||||
Shares outstanding | 3,654,012 | 2,137,910 | ||||
Contractual life | 10 years | |||||
2019 Plan | Minimum | Stock option | ||||||
Share-based compensation. | ||||||
Vesting period | 3 years | |||||
2019 Plan | Maximum | Stock option | ||||||
Share-based compensation. | ||||||
Vesting period | 4 years | |||||
Pre-IPO Share Options and restricted shares | Stock option | First anniversary | ||||||
Share-based compensation. | ||||||
Vesting Percentage | 25% | |||||
Pre-IPO Share Options and restricted shares | Stock option | Remaining equal installments | ||||||
Share-based compensation. | ||||||
Number of equal monthly installments for vesting remaining awards | installment | 36 |
Share-based compensation - Shar
Share-based compensation - Share based compensation expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share based compensation expense | ||||
Total share-based compensation expense | $ 5,368 | $ 2,688 | $ 21,239 | $ 9,084 |
Research and development expenses | ||||
Share based compensation expense | ||||
Total share-based compensation expense | 2,637 | 1,238 | 7,643 | 3,535 |
General and administrative expenses | ||||
Share based compensation expense | ||||
Total share-based compensation expense | $ 2,731 | $ 1,450 | $ 13,596 | $ 5,549 |
Share-based compensation - Sh_2
Share-based compensation - Share Options (Details) - USD ($) $ / shares in Units, $ 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, 2021 | |
Additional Information | |||||
Total share-based compensation expense | $ 5,368 | $ 2,688 | $ 21,239 | $ 9,084 | |
Stock option | |||||
Number of Shares | |||||
Outstanding number of shares at beginning | 4,603,486 | ||||
Granted | 1,398,517 | ||||
Exercised | (64,067) | ||||
Forfeited | (153,355) | ||||
Outstanding number of shares at end | 5,784,581 | 5,784,581 | 4,603,486 | ||
Number of shares, vested and expected to vest | 5,784,581 | 5,784,581 | |||
Number of shares, options exercisable | 3,177,177 | 3,177,177 | |||
Weighted Average Exercise Price | |||||
Weighted average exercise price at beginning | $ 14.97 | ||||
Granted | 46.83 | ||||
Exercised | 12.55 | ||||
Forfeited | 25.86 | ||||
Weighted average exercise price at ending | $ 22.41 | 22.41 | $ 14.97 | ||
Weighted average exercise price, vested and expected to vest | 22.41 | 22.41 | |||
Weighted average exercise price, options exercisable | $ 13.51 | $ 13.51 | |||
Weighted Average Contractual Term | |||||
Weighted average contractual term, outstanding | 7 years 9 months 25 days | 8 years 1 month 17 days | |||
Weighted average contractual term, vested and expected to vest | 7 years 9 months 25 days | ||||
Weighted average contractual term ,options exercisable | 7 years 21 days | ||||
Aggregate Intrinsic Value | |||||
Aggregate intrinsic value outstanding | $ 43,632 | $ 43,632 | $ 207,009 | ||
Aggregate intrinsic value, vested and expected to vest | 43,632 | 43,632 | |||
Aggregate intrinsic value, options exercisable | 35,164 | $ 35,164 | |||
Additional Information | |||||
Granted | $ 32.91 | $ 13.83 | |||
Exercised | 100 | 5,700 | $ 1,300 | $ 9,400 | |
Total share-based compensation expense | $ 4,700 | $ 2,700 | $ 17,100 | $ 9,100 |
Share-based compensation - Assu
Share-based compensation - Assumptions used in the Black Scholes option pricing model to determine the fair value of share options (Details) - Stock option - Employees and directors - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based compensation. | ||||
Risk-free interest rate | 3% | 0.90% | 2% | 0.60% |
Expected volatility | 84.10% | 80.20% | 82.20% | 79.60% |
Expected term (in years) | 6 years 1 month 6 days | 6 years 1 month 6 days | 6 years | 6 years |
Unrecognized compensation expense | ||||
Total unrecognized compensation expense related to the unvested employee and director | $ 52.7 | $ 52.7 | ||
Unrecognized compensation cost expected to be recognized over a weighted average period | 3 years |
Share-based compensation - Rest
Share-based compensation - Restricted Share Units (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Restricted shares | ||||
Total share-based compensation expense | $ 5,368,000 | $ 2,688,000 | $ 21,239,000 | $ 9,084,000 |
Restricted ordinary shares | 2020 Plan | ||||
Number of Shares Underlying RSUs | ||||
Granted | 222,725 | |||
Vested | (35,000) | |||
Unvested restricted ordinary shares at ending | 187,725 | 187,725 | ||
Weighted Average Grant Date Fair Value | ||||
Granted | $ 60.86 | |||
Vested | 60.86 | |||
Weighted average grant date fair value unvested, Ending Balance | $ 60.86 | $ 60.86 | ||
Restricted shares | ||||
Fair value of employee restricted share awards vested | $ 0 | $ 2,100,000 | ||
Total share-based compensation expense | 700,000 | 4,100,000 | ||
Unrecognized compensation cost | $ 9,300,000 | $ 9,300,000 | ||
Weighted average Period | 3 years 3 months 18 days |
Significant agreements - Collab
Significant agreements - Collaboration revenues (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Significant agreements. | ||||
Collaboration revenues | $ 3,040 | $ 4,333 | $ 11,278 | $ 7,926 |
Ionis | ||||
Significant agreements. | ||||
Collaboration revenues | 2,195 | 2,066 | 6,764 | 2,066 |
Genentech | ||||
Significant agreements. | ||||
Collaboration revenues | 798 | 1,063 | 3,144 | 4,142 |
Dementia Discovery Fund | ||||
Significant agreements. | ||||
Collaboration revenues | 47 | 77 | 205 | 314 |
AstraZeneca | ||||
Significant agreements. | ||||
Collaboration revenues | $ 0 | $ 1,127 | $ 1,165 | $ 1,404 |
Significant agreements - Ionis
Significant agreements - Ionis Evaluation and Option Agreement (Details) - USD ($) $ in Thousands | 1 Months Ended | 9 Months Ended | 12 Months Ended | ||
Jul. 09, 2021 | Jan. 31, 2021 | Sep. 30, 2022 | Dec. 31, 2020 | Dec. 31, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Deferred revenue | $ 58,140 | $ 35,156 | $ 71,340 | ||
Ionis Evaluation and Option Agreement | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Term of the Evaluation Period (in months) | 4 months | ||||
Upfront cash payment | $ 3,000 | $ 3,000 | $ 3,000 | $ 3,000 | |
Threshold period of notice required for termination of agreement | 30 days | ||||
Deferred revenue | $ 3,000 | $ 34,100 |
Significant agreements - Ioni_2
Significant agreements - Ionis Collaboration Agreement (Details) $ in Millions | 1 Months Ended | 9 Months Ended | 12 Months Ended | ||
Jul. 09, 2021 USD ($) item | Dec. 31, 2021 USD ($) | Jan. 31, 2021 USD ($) | Sep. 30, 2022 USD ($) | Dec. 31, 2020 USD ($) | |
Ionis | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Period for which research and discovery activities will be performed with no additional consideration | 3 years | ||||
Upfront cash payment | $ 31 | ||||
Number of payments of a mid-single-digit million dollar, failing to achieve the specified development diligence | item | 3 | ||||
Number of collaboration targets | item | 4 | ||||
Number of years over which royalty is payable | 10 years | ||||
Ionis Evaluation and Option Agreement | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Upfront cash payment | $ 3 | $ 3 | $ 3 | $ 3 | |
Amended Ionis | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Upfront cash payment | $ 1.6 | ||||
Amended Ionis | Service for initial six month | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Upfront cash payment | 0.8 | ||||
Amended Ionis | Service for additional six month | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Upfront cash payment | $ 0.8 |
Significant agreements - Ioni_3
Significant agreements - Ionis Share Purchase Agreement (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | ||||
Jul. 09, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Aggregate purchase price | $ 29,843 | $ 13,977 | $ 58,775 | ||
Ionis Share Purchase Agreement | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Aggregate purchase price | $ 7,558 | ||||
Ionis | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Transaction price | $ 38,000 | $ 38,000 | |||
Ionis | Ionis Share Purchase Agreement | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Shares issued (in shares) | 282,485 | ||||
Purchase price per share | $ 38.94 | ||||
Aggregate purchase price | $ 11,000 | ||||
Fair value of shares held | 7,600 | ||||
Transaction price | $ 3,400 | ||||
Ionis | Ionis Share Purchase Agreement | American Depositary Shares | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Purchase price per share | $ 31.11 |
Significant agreements - Ioni_4
Significant agreements - Ionis (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Jul. 09, 2021 USD ($) item | Dec. 31, 2021 USD ($) | Jan. 31, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) item | Sep. 30, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Collaboration revenues | $ 3,040 | $ 4,333 | $ 11,278 | $ 7,926 | ||||
Deferred revenue | $ 71,340 | 58,140 | $ 58,140 | $ 35,156 | ||||
Ionis | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Number of material rights associated with future payments | item | 4 | |||||||
Number of collaboration targets | item | 4 | |||||||
Total transaction price initially determined | $ 38,000 | 38,000 | $ 38,000 | |||||
Upfront cash payment | 31,000 | |||||||
Estimated amount payable to CROs | 600 | |||||||
Expected period for satisfaction of performance obligations | 3 years | |||||||
Material rights exercise period | 4 years | |||||||
Collaboration revenues | 2,195 | $ 2,066 | $ 6,764 | $ 2,066 | ||||
Deferred revenue | 34,115 | 22,161 | 22,161 | 3,000 | ||||
Ionis | Combined licenses and research and discovery performance obligation | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Total transaction price initially determined | 34,100 | 34,100 | ||||||
Ionis | Four material rights associated with credits for IND Acceptance fees | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Total transaction price initially determined | $ 3,900 | 3,900 | ||||||
Ionis | Ionis Share Purchase Agreement | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Total transaction price initially determined | 3,400 | |||||||
Ionis Evaluation and Option Agreement | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Upfront cash payment | $ 3,000 | $ 3,000 | $ 3,000 | 3,000 | ||||
Deferred revenue | 34,100 | $ 3,000 | ||||||
Amended Ionis | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Upfront cash payment | 1,600 | |||||||
Collaboration revenues | 800 | |||||||
Amended Ionis | Service for initial six month | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Upfront cash payment | 800 | |||||||
Amended Ionis | Service for additional six month | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Upfront cash payment | $ 800 |
Significant agreements - Genent
Significant agreements - Genentech Collaboration Agreement (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Feb. 21, 2020 USD ($) item | Jun. 30, 2022 USD ($) | Oct. 31, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) item | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | Mar. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
Significant agreements. | ||||||||||
Collaboration revenues | $ 3,040 | $ 4,333 | $ 11,278 | $ 7,926 | ||||||
Deferred revenue | 58,140 | 58,140 | $ 71,340 | $ 35,156 | ||||||
Genentech | ||||||||||
Significant agreements. | ||||||||||
Number of potential development candidates | item | 4 | |||||||||
Upfront cash payment | $ 30,000 | |||||||||
Number of immuno oncology targets | item | 2 | |||||||||
Additional number of immuno oncology targets | item | 2 | |||||||||
Expansion Fee | $ 10,000 | |||||||||
Milestone payments, receivable | $ 2,000 | |||||||||
Transaction price | 31,000 | 33,000 | 33,000 | $ 33,000 | ||||||
Collaboration revenues | 798 | $ 1,063 | 3,144 | $ 4,142 | ||||||
Deferred revenue | 34,817 | $ 34,817 | 34,436 | $ 27,579 | ||||||
Genentech | Royalty | ||||||||||
Significant agreements. | ||||||||||
Number of years over which royalty is payable | 10 years | |||||||||
Genentech | Maximum | ||||||||||
Significant agreements. | ||||||||||
Milestone payments, receivable | 200,000 | |||||||||
Genentech | Development milestone | Maximum | ||||||||||
Significant agreements. | ||||||||||
Milestone payments, receivable | 65,000 | |||||||||
Genentech | Regulatory milestone | Maximum | ||||||||||
Significant agreements. | ||||||||||
Milestone payments, receivable | $ 135,000 | |||||||||
Genentech | Collaboration Program 1 Performance Obligation | ||||||||||
Significant agreements. | ||||||||||
Transaction price | 4,019 | $ 4,019 | ||||||||
Genentech | Collaboration Program 2 Performance Obligation | ||||||||||
Significant agreements. | ||||||||||
Transaction price | 8,037 | $ 8,037 | ||||||||
Genentech | Collaboration Program 3 Performance Obligation | ||||||||||
Significant agreements. | ||||||||||
Expansion Fee | 10,000 | |||||||||
Milestone payments, receivable | $ 1,000 | |||||||||
Transaction price | $ 11,000 | |||||||||
Material rights | 3,500 | |||||||||
Collaboration revenues | 6,400 | |||||||||
Genentech | Collaboration Program 3 Performance Obligation | Maximum | ||||||||||
Significant agreements. | ||||||||||
Period over which performance obligations will be performed | 3 years | |||||||||
Genentech | Collaboration Program 3 Performance Obligation | Minimum | ||||||||||
Significant agreements. | ||||||||||
Period over which performance obligations will be performed | 2 years | |||||||||
Genentech | Collaboration Program 4 Performance Obligation | ||||||||||
Significant agreements. | ||||||||||
Expansion Fee | $ 10,000 | |||||||||
Material rights | 3,500 | |||||||||
Collaboration revenues | 5,300 | |||||||||
Deferred revenue | $ 100 | |||||||||
Genentech | Collaboration Program 4 Performance Obligation | Maximum | ||||||||||
Significant agreements. | ||||||||||
Period over which performance obligations will be performed | 3 years | |||||||||
Genentech | Collaboration Program 4 Performance Obligation | Minimum | ||||||||||
Significant agreements. | ||||||||||
Period over which performance obligations will be performed | 2 years | |||||||||
Genentech | Specified Targeting Arm Material Right Arm Program One | ||||||||||
Significant agreements. | ||||||||||
Number of initial collaboration programs exercised | item | 1 | |||||||||
Option fee for development and exploitation rights | $ 1,000 | |||||||||
Milestone payments, receivable | $ 1,000 | |||||||||
Transaction price | 352 | $ 352 | ||||||||
Genentech | Material rights for associated and limited substitution rights | ||||||||||
Significant agreements. | ||||||||||
Transaction price | 1,187 | $ 1,187 | ||||||||
Deferred revenue | $ 700 | 700 | ||||||||
Genentech | Two material rights associated with the LSR Go Option for Collaboration Programs One And Two | ||||||||||
Significant agreements. | ||||||||||
Number of collaboration programs | item | 2 | 2 | ||||||||
Number of expansion option collaboration programs | item | 2 | |||||||||
Transaction price | 12,400 | $ 12,400 | ||||||||
Genentech | Material rights associated with the LSR Go Option for Collaboration Programs Three | ||||||||||
Significant agreements. | ||||||||||
Deferred revenue | $ 7,400 | |||||||||
Genentech | Material rights associated with the LSR Go Option for Collaboration Programs Four | ||||||||||
Significant agreements. | ||||||||||
Deferred revenue | $ 7,400 | |||||||||
Genentech | Two material rights for Expansion Options | ||||||||||
Significant agreements. | ||||||||||
Number of expansion option collaboration programs | item | 2 | |||||||||
Transaction price | $ 7,005 | $ 7,005 | ||||||||
Genentech | Collaboration Program One and Two Performance Obligation | ||||||||||
Significant agreements. | ||||||||||
Material rights exercise period | 4 years | |||||||||
Genentech | Collaboration Program One and Two Performance Obligation | Maximum | ||||||||||
Significant agreements. | ||||||||||
Regulatory, and initial commercialization milestones, payments receivable | $ 200,000 | |||||||||
Period over which performance obligations will be performed | 3 years | |||||||||
Genentech | Collaboration Program One and Two Performance Obligation | Minimum | ||||||||||
Significant agreements. | ||||||||||
Period over which performance obligations will be performed | 2 years |
Significant agreements - AstraZ
Significant agreements - AstraZeneca Collaboration Agreement (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
May 31, 2018 USD ($) employee | Nov. 30, 2016 item | Sep. 30, 2022 USD ($) | Jun. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Jun. 30, 2019 USD ($) | |
Significant agreements. | ||||||||||
Collaboration revenues | $ 3,040 | $ 4,333 | $ 11,278 | $ 7,926 | ||||||
Deferred revenue | 58,140 | 58,140 | $ 71,340 | $ 35,156 | ||||||
AstraZeneca | ||||||||||
Significant agreements. | ||||||||||
Option fee for development and exploitation rights | $ 5,000 | |||||||||
Research term | 3 years | |||||||||
Bicycle research term | 1 year | |||||||||
AstraZeneca research | 2 years | |||||||||
Additional research term | 12 months | |||||||||
Transaction price | $ 5,700 | |||||||||
Collaboration revenues | 0 | $ 1,127 | 1,165 | $ 1,404 | ||||||
Deferred revenue | 992 | 992 | 2,361 | 3,756 | ||||||
AstraZeneca | Development milestone | ||||||||||
Significant agreements. | ||||||||||
Transaction price | 700 | |||||||||
AstraZeneca | Development Milestone | Development milestone | ||||||||||
Significant agreements. | ||||||||||
Milestone payments, receivable | 29,000 | |||||||||
AstraZeneca | Regulatory Milestone | Regulatory milestone | ||||||||||
Significant agreements. | ||||||||||
Milestone payments, receivable | 23,000 | |||||||||
AstraZeneca | Commercial milestone | Commercial milestone | ||||||||||
Significant agreements. | ||||||||||
Milestone payments, receivable | $ 110,000 | |||||||||
AstraZeneca | Maximum | ||||||||||
Significant agreements. | ||||||||||
Additional research term | 15 months | |||||||||
AstraZeneca | 2016 Collaboration Agreement | ||||||||||
Significant agreements. | ||||||||||
Biological Targets | item | 2 | |||||||||
AstraZeneca | May 2018 Option Exercise | ||||||||||
Significant agreements. | ||||||||||
Number of FTE | employee | 2 | |||||||||
Transaction price | $ 5,000 | 5,650 | 5,650 | $ 6,300 | ||||||
AstraZeneca | May 2018 Option Exercise | Commercialization license per candidate | ||||||||||
Significant agreements. | ||||||||||
Customer option payment | $ 8,000 | |||||||||
AstraZeneca | May 2018 Option Exercise | Target Three Research License and Related Services | ||||||||||
Significant agreements. | ||||||||||
Transaction price | 650 | 650 | ||||||||
AstraZeneca | May 2018 Option Exercise | Target 3 Material Right | ||||||||||
Significant agreements. | ||||||||||
Transaction price | 1,504 | 1,504 | ||||||||
Collaboration revenues | $ 1,500 | |||||||||
AstraZeneca | May 2018 Option Exercise | Target 4 Material Right | ||||||||||
Significant agreements. | ||||||||||
Transaction price | 1,204 | 1,204 | ||||||||
AstraZeneca | May 2018 Option Exercise | Target 5 Material Right | ||||||||||
Significant agreements. | ||||||||||
Transaction price | 1,165 | 1,165 | ||||||||
Collaboration revenues | $ 1,200 | |||||||||
AstraZeneca | May 2018 Option Exercise | Target 6 Material Right | ||||||||||
Significant agreements. | ||||||||||
Transaction price | $ 1,127 | $ 1,127 | ||||||||
Collaboration revenues | $ 1,100 |
Significant agreements - Summar
Significant agreements - Summary of Contract Assets and Liabilities (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Contract liabilities: | ||
Beginning Balance | $ 71,340 | $ 35,156 |
Additions | 10,000 | 49,056 |
Deductions | (11,278) | (11,697) |
Impact of Exchange Rates | (11,922) | (1,175) |
Ending Balance | 58,140 | 71,340 |
Ionis | ||
Contract liabilities: | ||
Beginning Balance | 34,115 | 3,000 |
Additions | 0 | 36,002 |
Deductions | (6,764) | (4,242) |
Impact of Exchange Rates | (5,190) | (645) |
Ending Balance | 22,161 | 34,115 |
Genentech | ||
Contract liabilities: | ||
Beginning Balance | 34,436 | 27,579 |
Additions | 10,000 | 13,000 |
Deductions | (3,144) | (5,660) |
Impact of Exchange Rates | (6,475) | (483) |
Ending Balance | 34,817 | 34,436 |
Dementia Discovery Fund | ||
Contract liabilities: | ||
Beginning Balance | 428 | 821 |
Additions | 0 | 0 |
Deductions | (205) | (391) |
Impact of Exchange Rates | (53) | (2) |
Ending Balance | 170 | 428 |
AstraZeneca | ||
Contract liabilities: | ||
Beginning Balance | 2,361 | 3,756 |
Additions | 0 | 54 |
Deductions | (1,165) | (1,404) |
Impact of Exchange Rates | (204) | (45) |
Ending Balance | $ 992 | $ 2,361 |
Significant agreements - Deferr
Significant agreements - Deferred revenue (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred revenue | |||
Contract assets | $ 0 | $ 0 | |
Deferred revenue | 58,140 | 71,340 | $ 35,156 |
Deferred revenue material rights option | |||
Deferred revenue | |||
Deferred revenue | 3,200 | ||
Ionis | |||
Deferred revenue | |||
Deferred revenue | 22,161 | 34,115 | 3,000 |
Genentech | |||
Deferred revenue | |||
Deferred revenue | 34,817 | 34,436 | 27,579 |
Genentech | Deferred revenue material rights option | |||
Deferred revenue | |||
Deferred revenue | 25,300 | ||
AstraZeneca | |||
Deferred revenue | |||
Deferred revenue | 992 | $ 2,361 | $ 3,756 |
AstraZeneca | Target 4 and Target 5 Material Rights | |||
Deferred revenue | |||
Deferred revenue | $ 1,000 |
Significant agreements - Revenu
Significant agreements - Revenue recognition due to changes in contract assets and liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Significant agreements | ||||
Revenue recognized based on proportional performance | $ 3,040 | $ 3,206 | $ 10,072 | $ 6,263 |
Revenue recognized based on expiration of material rights | 1,127 | 1,206 | 1,507 | |
Revenue recognized based on changes in transaction price | 156 | |||
Total | $ 3,040 | $ 4,333 | $ 11,278 | $ 7,926 |
Significant agreements - Cancer
Significant agreements - Cancer Research UK (Details) - USD ($) $ in Millions | 1 Months Ended | |||
Dec. 13, 2016 | Dec. 31, 2019 | Sep. 30, 2022 | Dec. 31, 2021 | |
Research and development arrangement obligation to repay other parties | ||||
Contingent future milestones payments under research and development arrangement | $ 50.9 | $ 60.3 | ||
Other long term liabilities | ||||
Research and development arrangement obligation to repay other parties | ||||
Liability from research and development | $ 3.2 | $ 3.3 | ||
BT1718 | Minimum | ||||
Research and development arrangement obligation to repay other parties | ||||
Tiered royalties (percentage) | 70% | |||
BT1718 | Maximum | ||||
Research and development arrangement obligation to repay other parties | ||||
Tiered royalties (percentage) | 90% | |||
BT7401 | Minimum | ||||
Research and development arrangement obligation to repay other parties | ||||
Tiered royalties (percentage) | 55% | |||
BT7401 | Maximum | ||||
Research and development arrangement obligation to repay other parties | ||||
Tiered royalties (percentage) | 80% |
Income taxes (Details)
Income taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income taxes | ||||
Benefit from income taxes | $ 238 | $ 415 | $ 1,104 | $ 915 |
Commitments and Contingencies -
Commitments and Contingencies - Leases, Office and laboratory space Cambridge (Details) - USD ($) $ in Thousands | Dec. 06, 2021 | Sep. 30, 2022 | Mar. 31, 2022 | Dec. 31, 2021 | Oct. 31, 2017 | Sep. 30, 2017 |
Leases | ||||||
Operating lease right-of-use assets | $ 13,484 | $ 14,666 | ||||
Lease liabilities | 13,808 | |||||
Remainder of 2022 | 868 | |||||
2023 | 3,718 | |||||
New Office and laboratory space in Cambridge, United Kingdom | ||||||
Leases | ||||||
Leases, term of contract | 10 years | |||||
Leases term of contract, non cancelable | 5 years | |||||
Renewal term | 10 years | |||||
Annual rent | $ 3,000 | |||||
Rent free period | 6 months | |||||
Security deposit | $ 0 | |||||
Operating lease right-of-use assets | 11,600 | |||||
Lease liabilities | $ 11,100 | |||||
Discounted percentage for present value of lease payments | 6.90% | |||||
Office and laboratory space in Building 900, Babraham Research Campus, Cambridge | ||||||
Leases | ||||||
Renewal term | 5 years | |||||
Annual rent | 600 | $ 500 | ||||
Discounted percentage for present value of lease payments | 7.70% | |||||
Estimated service charges payable | $ 200 | |||||
Office and laboratory space in Lexington, Massachusetts | ||||||
Leases | ||||||
Annual rent | 800 | |||||
Security deposit | $ 200 | |||||
Prepaid rent | $ 100 | |||||
Discounted percentage for present value of lease payments | 7% | |||||
Remainder of 2022 | 200 | |||||
2023 | $ 700 |
Commitments and Contingencies_2
Commitments and Contingencies - Components of lease expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Commitments and contingencies | ||||
Operating lease cost | $ 924 | $ 273 | $ 2,866 | $ 773 |
Variable lease cost | 410 | 222 | 1,005 | 444 |
Total lease cost | $ 1,334 | $ 495 | $ 3,871 | $ 1,217 |
Weighted-average remaining operating lease term (years) | 4 years 6 months | 4 years 7 months 6 days | 4 years 6 months | 4 years 7 months 6 days |
Weighted-average discount rate | 7.03% | 7.89% | 7.03% | 7.89% |
Commitments and Contingencies_3
Commitments and Contingencies - Leases, Maturities of operating leases (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Dec. 31, 2021 | |
Commitments and contingencies | ||
2022 | $ 868 | |
2023 | 3,718 | |
2024 | 3,740 | |
2025 | 3,763 | |
2026 | 3,045 | |
2027 | 821 | |
Present value adjustment | (2,147) | |
Total lease liabilities | 13,808 | |
Less: current lease liabilities | $ (2,811) | $ (2,383) |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accrued Liabilities and Other Liabilities, Current | Accrued Liabilities and Other Liabilities, Current |
Long term lease liabilities | $ 10,997 | $ 12,081 |
Maximum days allowed for cancellation of contracts prior written notice | 90 days |
Commitments and Contingencies_4
Commitments and Contingencies - Founder Royalty arrangements (Details) | 9 Months Ended |
Sep. 30, 2022 USD ($) | |
Commitments and contingencies | |
Period of royalty payments agreed under arrangement | 10 years |
Royalties earned | $ 0 |
Net loss per share - Basic and
Net loss per share - Basic and diluted net loss per share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Numerator: | ||||
Net loss | $ (28,347) | $ (14,678) | $ (82,739) | $ (48,782) |
Denominator: | ||||
Weighted average ordinary shares outstanding, basic | 29,676,021 | 25,039,990 | 29,643,502 | 23,719,124 |
Weighted average ordinary shares outstanding, diluted | 29,676,021 | 25,039,990 | 29,643,502 | 23,719,124 |
Net loss per share, basic | $ (0.96) | $ (0.59) | $ (2.79) | $ (2.06) |
Net loss per share, diluted | $ (0.96) | $ (0.59) | $ (2.79) | $ (2.06) |
Net loss per share - Securities
Net loss per share - Securities excluded from the diluted per share calculation (Details) - shares | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Antidilutive securities | ||
Antidilutive securities (in shares) | 5,972,306 | 4,717,166 |
Restricted ordinary shares | ||
Antidilutive securities | ||
Antidilutive securities (in shares) | 187,725 | |
Options to purchase ordinary shares | ||
Antidilutive securities | ||
Antidilutive securities (in shares) | 5,784,581 | 4,717,166 |
Related party transactions (Det
Related party transactions (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Related party transactions | ||||
Royalties earned | $ 0 | |||
Consultancy services with Stone Sunny Isles Inc. | ||||
Related party transactions | ||||
Amount of transaction | $ 43,000 | $ 43,000 | $ 200,000 | $ 100,000 |
Geographic information (Details
Geographic information (Details) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 USD ($) segment | Dec. 31, 2021 USD ($) | |
Geographic information | ||
Number of geographic regions | segment | 2 | |
Long lived assets, including operating lease right of use assets | $ 29,704 | $ 17,789 |
United States | ||
Geographic information | ||
Long lived assets, including operating lease right of use assets | 4,584 | 1,095 |
United Kingdom | ||
Geographic information | ||
Long lived assets, including operating lease right of use assets | $ 25,120 | $ 16,694 |