Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2020 | Aug. 03, 2020 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2020 | |
Entity Registrant Name | BICYCLE THERAPEUTICS PLC | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Interactive Data Current | Yes | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 19,284,370 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001761612 | |
Amendment Flag | false | |
Entity Ex Transition Period | true |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash | $ 96,910 | $ 92,117 |
Accounts receivable | 489 | 201 |
Prepaid expenses and other current assets | 4,318 | 4,884 |
Research and development incentives receivable | 10,814 | 6,944 |
Total current assets | 112,531 | 104,146 |
Property and equipment, net | 2,173 | 2,292 |
Operating lease right-of-use assets | 1,627 | 2,056 |
Other assets | 2,271 | 1,700 |
Total assets | 118,602 | 110,194 |
Current liabilities: | ||
Accounts payable | 3,338 | 1,949 |
Accrued expenses and other current liabilities | 8,221 | 6,144 |
Deferred revenue, current portion | 5,419 | 728 |
Total current liabilities | 16,978 | 8,821 |
Operating lease liabilities | 850 | 1,251 |
Deferred revenue, net of current portion | 27,663 | 4,929 |
Other long-term liabilities | 2,085 | 1,995 |
Total liabilities | 47,576 | 16,996 |
Commitments and contingencies (Note 12) | ||
Shareholders’ equity: | ||
Ordinary shares, £0.01 nominal value; 31,995,653 shares authorized at June 30, 2020 and December 31, 2019; 18,091,657 and 17,993,701 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively | 228 | 227 |
Additional paid‑in capital | 198,507 | 195,056 |
Accumulated other comprehensive loss | (3,720) | (1,535) |
Accumulated deficit | (123,989) | (100,550) |
Total shareholders’ equity | 71,026 | 93,198 |
Total liabilities and shareholders’ equity | $ 118,602 | $ 110,194 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - £ / shares | Jun. 30, 2020 | Dec. 31, 2019 |
Ordinary shares, nominal value | £ 0.01 | £ 0.01 |
Ordinary shares, shares authorized | 31,995,653 | 31,995,653 |
Ordinary shares, shares issued | 18,091,657 | 17,993,701 |
Ordinary shares, shares outstanding | 18,091,657 | 17,993,701 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||
Collaboration revenues | $ 1,571 | $ 1,522 | $ 2,700 | $ 7,906 |
Operating expenses: | ||||
Research and development | 7,958 | 6,537 | 15,728 | 12,813 |
General and administrative | 6,196 | 2,973 | 11,197 | 6,375 |
Total operating expenses | 14,154 | 9,510 | 26,925 | 19,188 |
Loss from operations | (12,583) | (7,988) | (24,225) | (11,282) |
Other income (expense): | ||||
Interest and other income, net | 371 | 90 | 583 | 154 |
Other expense, net | (2,184) | (5,377) | ||
Total other income (expense), net | 371 | (2,094) | 583 | (5,223) |
Net loss before income tax provision | (12,212) | (10,082) | (23,642) | (16,505) |
(Benefit from) provision for income taxes | (97) | 135 | (204) | 215 |
Net loss | (12,115) | (10,217) | (23,438) | (16,720) |
Net loss attributable to ordinary shareholders | $ (12,115) | $ (10,217) | $ (23,438) | $ (16,720) |
Net loss per share attributable to ordinary shareholders, basic and diluted | $ (0.67) | $ (1.40) | $ (1.30) | $ (4.08) |
Weighted average ordinary shares outstanding, basic and diluted | 18,077,770 | 7,298,139 | 18,024,314 | 4,101,564 |
Comprehensives Loss: | ||||
Net loss | $ (12,115) | $ (10,217) | $ (23,438) | $ (16,720) |
Other comprehensive income (loss): | ||||
Foreign currency translation adjustment | (1) | (1,512) | (2,185) | (432) |
Total comprehensive loss | $ (12,116) | $ (11,729) | $ (25,623) | $ (17,152) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Convertible Preferred Shares and Shareholders’ Equity (Deficit) - USD ($) $ in Thousands | Series A Convertible Preferred Shares | Series B1 Convertible Preferred Shares | Series B2 Convertible Preferred Shares | Ordinary Shares | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Total |
Beginning balance at Dec. 31, 2018 | $ 41,820 | $ 54,621 | $ 25,756 | |||||
Beginning balance (in shares) at Dec. 31, 2018 | 2,800,001 | 3,947,198 | 1,323,248 | |||||
Increase (decrease) in convertible preferred shares | ||||||||
Issuance of convertible preferred shares | $ 1,583 | |||||||
Issuance of convertible preferred shares (in shares) | 80,385 | |||||||
Ending balance at Mar. 31, 2019 | $ 41,820 | $ 54,621 | $ 27,339 | |||||
Ending balance (in shares) at Mar. 31, 2019 | 2,800,001 | 3,947,198 | 1,403,633 | |||||
Beginning balance at Dec. 31, 2018 | $ 10 | $ 1,857 | $ (1,751) | $ (69,942) | $ (69,826) | |||
Beginning balance (in shares) at Dec. 31, 2018 | 814,728 | |||||||
Increase (decrease) in shareholders' equity (deficit) | ||||||||
Issuance of restricted share awards | $ 1 | 103 | 104 | |||||
Issuance of restricted share awards (in shares) | 27,304 | |||||||
Issuance of ordinary shares upon exercise of share options (in shares) | 3 | |||||||
Share based compensation expense | 172 | 172 | ||||||
Foreign currency translation adjustment | 1,080 | 1,080 | ||||||
Net loss | (6,503) | (6,503) | ||||||
Ending balance at Mar. 31, 2019 | $ 11 | 2,132 | (671) | (76,445) | (74,973) | |||
Ending balance (in shares) at Mar. 31, 2019 | 842,035 | |||||||
Beginning balance at Dec. 31, 2018 | $ 41,820 | $ 54,621 | $ 25,756 | |||||
Beginning balance (in shares) at Dec. 31, 2018 | 2,800,001 | 3,947,198 | 1,323,248 | |||||
Beginning balance at Dec. 31, 2018 | $ 10 | 1,857 | (1,751) | (69,942) | (69,826) | |||
Beginning balance (in shares) at Dec. 31, 2018 | 814,728 | |||||||
Increase (decrease) in shareholders' equity (deficit) | ||||||||
Foreign currency translation adjustment | (432) | |||||||
Net loss | (16,720) | |||||||
Ending balance at Jun. 30, 2019 | $ 226 | 193,178 | (2,183) | (86,662) | 104,559 | |||
Ending balance (in shares) at Jun. 30, 2019 | 17,900,731 | |||||||
Beginning balance at Mar. 31, 2019 | $ 41,820 | $ 54,621 | $ 27,339 | |||||
Beginning balance (in shares) at Mar. 31, 2019 | 2,800,001 | 3,947,198 | 1,403,633 | |||||
Increase (decrease) in convertible preferred shares | ||||||||
Conversion of convertible preferred shares to ordinary shares | $ (41,820) | $ (54,621) | $ (27,339) | |||||
Conversion of convertible preferred shares to ordinary shares (in shares) | (2,800,001) | (3,947,198) | (1,403,633) | |||||
Beginning balance at Mar. 31, 2019 | $ 11 | 2,132 | (671) | (76,445) | (74,973) | |||
Beginning balance (in shares) at Mar. 31, 2019 | 842,035 | |||||||
Increase (decrease) in shareholders' equity (deficit) | ||||||||
Conversion of convertible preferred shares to ordinary shares | $ 146 | 123,634 | 123,780 | |||||
Conversion of convertible preferred shares to ordinary shares (in shares) | 11,647,529 | |||||||
Reclassification of warrant liability to additional paid-in capital and exercise of warrants | $ 9 | 10,018 | 10,027 | |||||
Reclassification of warrant liability to additional paid-in capital and exercise of warrants (in shares) | 702,557 | |||||||
Issuance of ADSs in initial public offering, net of underwriting discounts, commissions and offering expenses of $8.4 million | $ 59 | 56,469 | 56,528 | |||||
Number of shares issued (in shares) | 4,637,666 | |||||||
Issuance of restricted share awards | $ 1 | 292 | 293 | |||||
Issuance of restricted share awards (in shares) | 56,643 | |||||||
Issuance of ordinary shares upon exercise of share options | 21 | 21 | ||||||
Issuance of ordinary shares upon exercise of share options (in shares) | 14,301 | |||||||
Share based compensation expense | 612 | 612 | ||||||
Foreign currency translation adjustment | (1,512) | (1,512) | ||||||
Net loss | (10,217) | (10,217) | ||||||
Ending balance at Jun. 30, 2019 | $ 226 | 193,178 | (2,183) | (86,662) | 104,559 | |||
Ending balance (in shares) at Jun. 30, 2019 | 17,900,731 | |||||||
Beginning balance at Dec. 31, 2019 | $ 227 | 195,056 | (1,535) | (100,550) | $ 93,198 | |||
Beginning balance (in shares) at Dec. 31, 2019 | 17,993,701 | 17,993,701 | ||||||
Increase (decrease) in shareholders' equity (deficit) | ||||||||
Issuance of ordinary shares upon exercise of share options | 2 | $ 2 | ||||||
Issuance of ordinary shares upon exercise of share options (in shares) | 1,071 | |||||||
Issuance of ordinary shares upon exercise of warrants (in shares) | 21,435 | |||||||
Share based compensation expense | 2,121 | 2,121 | ||||||
Foreign currency translation adjustment | (2,184) | (2,184) | ||||||
Net loss | (11,324) | (11,324) | ||||||
Ending balance at Mar. 31, 2020 | $ 227 | 197,179 | (3,719) | (111,874) | 81,813 | |||
Ending balance (in shares) at Mar. 31, 2020 | 18,016,207 | |||||||
Beginning balance at Dec. 31, 2019 | $ 227 | 195,056 | (1,535) | (100,550) | $ 93,198 | |||
Beginning balance (in shares) at Dec. 31, 2019 | 17,993,701 | 17,993,701 | ||||||
Increase (decrease) in shareholders' equity (deficit) | ||||||||
Foreign currency translation adjustment | $ (2,185) | |||||||
Net loss | (23,438) | |||||||
Ending balance at Jun. 30, 2020 | $ 228 | 198,507 | (3,720) | (123,989) | $ 71,026 | |||
Ending balance (in shares) at Jun. 30, 2020 | 18,091,657 | 18,091,657 | ||||||
Beginning balance at Mar. 31, 2020 | $ 227 | 197,179 | (3,719) | (111,874) | $ 81,813 | |||
Beginning balance (in shares) at Mar. 31, 2020 | 18,016,207 | |||||||
Increase (decrease) in shareholders' equity (deficit) | ||||||||
Issuance of ordinary shares upon exercise of share options | 9 | 9 | ||||||
Issuance of ordinary shares upon exercise of share options (in shares) | 4,000 | |||||||
Issuance of ordinary shares upon exercise of warrants | $ 1 | 1 | ||||||
Issuance of ordinary shares upon exercise of warrants (in shares) | 71,450 | |||||||
Share based compensation expense | 1,319 | 1,319 | ||||||
Foreign currency translation adjustment | (1) | (1) | ||||||
Net loss | (12,115) | (12,115) | ||||||
Ending balance at Jun. 30, 2020 | $ 228 | $ 198,507 | $ (3,720) | $ (123,989) | $ 71,026 | |||
Ending balance (in shares) at Jun. 30, 2020 | 18,091,657 | 18,091,657 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Convertible Preferred Shares and Shareholders’ Equity (Parenthetical) $ in Millions | 3 Months Ended |
Jun. 30, 2019USD ($) | |
Condensed Consolidated Statements of Convertible Preferred Shares and Shareholders’ Equity | |
Offering expenses | $ 8.4 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (23,438) | $ (16,720) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | ||
Share-based compensation expense | 3,440 | 1,181 |
Depreciation and amortization | 615 | 443 |
Change in fair value of warrant liability | 0 | 5,381 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (332) | 4,955 |
Research and development incentives receivable | (4,446) | (3,518) |
Prepaid expenses and other current assets | 267 | (60) |
Operating lease right-of-use assets | 374 | 352 |
Other assets | (292) | (124) |
Accounts payable | 1,325 | 530 |
Accrued expenses and other current liabilities | 2,050 | (978) |
Lease liabilities | 4 | (351) |
Deferred revenue | 29,013 | (4,329) |
Other long-term liabilities | 233 | 429 |
Net cash provided by (used in) operating activities | 8,813 | (12,809) |
Cash used in investing activities: | ||
Purchases of property and equipment | (621) | (881) |
Net cash used in investing activities | (621) | (881) |
Cash flows from financing activities: | ||
Proceeds from the issuance of ADSs in initial public offering, net of issuance costs | 57,768 | |
Proceeds from the exercise of share options and sale of ordinary shares | 11 | 21 |
Proceeds from the exercise of warrants | 1 | 6 |
Net cash provided by financing activities | 12 | 59,129 |
Effect of exchange rate changes on cash | (3,411) | (283) |
Net increase in cash | 4,793 | 45,156 |
Cash at beginning of period | 92,117 | 63,380 |
Cash at end of period | 96,910 | 108,536 |
Supplemental disclosure of cash flow information | ||
Cash paid for income taxes | 38 | 73 |
Public offering costs accrued but not paid | 274 | 664 |
Cash paid for amounts included in the measurement of operating lease liabilities | 406 | 447 |
Purchases of property and equipment included in accounts payable and accrued expenses | $ 12 | |
Conversion of convertible preferred shares to ordinary shares upon closing of the initial public offering | 123,780 | |
Reclassification of warrant liability to additional paid-in capital | 10,021 | |
Series B2 Convertible Preferred Shares | ||
Cash flows from financing activities: | ||
Proceeds from issuance of convertible preferred shares, net of issuance costs | $ 1,334 |
Nature of the business and basi
Nature of the business and basis of presentation | 6 Months Ended |
Jun. 30, 2020 | |
Nature of 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 ® , for diseases that are underserved by existing therapeutics. Bicycles are a unique therapeutic modality combining the pharmacology usually associated with a biologic with the manufacturing and pharmacokinetic properties of a small molecule. The Company’s initial internal programs are focused on oncology indications with high unmet medical need. The Company’s lead product candidate, BT1718, is a Bicycle Toxin Conjugate (“BTC”) that is being developed to target tumors that express Membrane Type 1 matrix metalloproteinase. BT1718 is being investigated for safety, tolerability and efficacy in an ongoing Phase I/IIa clinical trial in collaboration with, and fully funded by, the Centre for Drug Development of Cancer Research UK. The Company is also evaluating BT5528, a second-generation BTC targeting Ephrin type‑A receptor 2 (“EphA2”), in a Company-sponsored Phase I/II trial as a monotherapy and in combination with nivolumab and plans to commence a Company-sponsored Phase I/II clinical trial of BT8009, a second-generation BTC targeting Nectin-4, in 2020 . The Company’s discovery pipeline in oncology includes Bicycle -based systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (TICAs™). Beyond oncology, the Company is collaborating with biopharmaceutical companies and organizations in therapeutic areas that include anti-bacterial, cardiovascular, ophthalmology, dementia and respiratory indications. 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 On May 28, 2019, the Company completed its initial public offering (the “IPO”), pursuant to which it issued and sold 4,333,333 American Depositary Shares (“ADSs”), representing the same number of ordinary shares at a public offering price of $14.00 per ADS. In addition, in June 2019, the Company issued and sold an additional 304,333 ADSs, pursuant to the partial exercise of the underwriters’ option to purchase additional ADSs. The aggregate net proceeds received by the Company from the IPO were $56.4 million, after deducting underwriting discounts and commissions of $4.5 million and offering expenses of $4.0 million. The Company is subject to risks common to companies in the biotechnology industry and in light of the ongoing COVID-19 pandemic, 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, 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. 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 sales of convertible preferred shares (Note 6), proceeds received from its collaboration arrangements (Note 10), proceeds from the IPO completed in May 2019. The Company has incurred recurring losses since inception, including $12.1 and $23.4 million for the three and six months ended June 30, 2020, respectively. As of June 30, 2020, the Company had an accumulated deficit of $124.0 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 substantial additional funding in connection with continuing operations. If the Company is unable to raise capital when needed, or on attractive terms, it could be forced to delay, reduce or eliminate its research or drug development programs or any future commercialization efforts. Although management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations, if at all. |
Summary of significant accounti
Summary of significant accounting policies | 6 Months Ended |
Jun. 30, 2020 | |
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, 2019 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, which was filed with the Securities and Exchange Commission (the “SEC”), on March 10, 2020 (the “2019 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 the 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 consolidated financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual for research and development expenses, revenue recognition, the fair value of ordinary shares and the valuation of the warrant liability prior to the Company’s IPO, share-based compensation expense, and income taxes. 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 and may be changed as new events occur and additional information is obtained. As of the date of issuance of these financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities . Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates or assumptions, and any such differences may be material to the Company’s financial statements. Significant Risks and Uncertainties With the global spread of the In addition, the Company is subject to other challenges and risks specific to its business and ability to execute its strategy, as well as risks and uncertainties common to companies in the biotechnology industry, including but not limited to: 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, 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. In addition, to the extent the ongoing COVID-19 pandemic adversely affects the Company’s business and results of operations, it may also have the effect of heightening many of the other risks and uncertainties discussed above. Unaudited Interim Financial Information Certain information in the footnote disclosures of the 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, 2019 included in the Company’s 2019 Annual Report. The accompanying condensed consolidated balance sheet at June 30, 2020, condensed consolidated statements of operations and comprehensive loss, condensed consolidated statements of convertible preferred shares and shareholders’ equity (deficit) for the three months and six months ended June 30, 2020 and 2019, and condensed consolidated statements of cash flows for the six months ended June 30, 2020 and 2019, 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, 2019, and, in the opinion of management, reflect all adjustments, consisting of normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of June 30, 2020, the results of its operations for the three and six months ended June 30, 2020 and 2019, and its cash flows for the six months ended June 30, 2020 and 2019. The results for the three and six months ended June 30, 2020 are not necessarily indicative of the results to be expected for the year ending December 31, 2020, any other interim periods, or any future year or period. Foreign currency and currency translation The functional currency is the currency of the primary economic environment in which an entity’s operations are conducted. On June 1, 2019, Bicycle Therapeutics plc adopted the U.S. dollar (“USD”) as its functional currency. Bicycle Therapeutics plc is a holding company that has no operating activities and its primary functions are to serve as a financing vehicle to fund the operations of the Company’s operating entities, to serve as the listing company needed to access U.S. capital markets, and to hold investments. Therefore, its financing source is the primary indicator of its cash flows and its functional currency. The change in functional currency from the British Pound Sterling is due to a change in the source of Bicycle Therapeutics plc’s financing and cash flows, which following the completion of the IPO is now primarily the U.S. dollar. Historically its financing had been in British Pound Sterling. The functional currency of Bicycle Therapeutics plc’s wholly owned non-U.S. subsidiaries, BicycleTx Limited and BicycleRD Limited, is the British Pound Sterling and the functional currency of its U.S. subsidiary, Bicycle Therapeutics Inc. is the USD. The functional currency of the Company’s subsidiaries is the same as the local currency. Monetary assets and liabilities denominated in currencies other than the functional currency are remeasured into the functional currency at rates of exchange prevailing at the balance sheet dates. Non-monetary assets and liabilities denominated in foreign currencies are remeasured into the functional currency at the exchange rates prevailing at the date of the transaction. Exchange gains or losses arising from foreign currency transactions are included in the determination of net loss for the respective periods. Adjustments that arise from exchange rate changes on transactions denominated in a currency other than the local currency are included in general and administrative expense in the condensed consolidated statements of operations and comprehensive loss as incurred. The Company recorded a foreign exchange gain of $0.1 million and $0.7 million during the three months ended June 30, 2020 and 2019, respectively, and foreign exchange gain of $1.4 million and $0.4 million for the six months ended June 30, 2020 and 2019, respectively. The Company translates the assets and liabilities of BicycleTx Limited and BicycleRD Limited into USD at the exchange rate in effect on the balance sheet date. Revenues and expenses are translated at the average exchange rate in effect during the period. Unrealized translation gains and losses are recorded as a foreign currency translation adjustment, which is included in the condensed consolidated statements of convertible preferred shares and shareholders’ equity (deficit) as a component of accumulated other comprehensive income (loss). Recently issued accounting pronouncements In June 2016, the FASB issued ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13 will change how companies account for credit losses for most financial assets and certain other instruments. For trade receivables, loans and held-to-maturity debt securities, companies will be required to recognize an allowance for credit losses rather than reducing the carrying value of the asset. ASU 2016-13 was effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments — Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates to amend the effective date of ASU 2016-13, for entities eligible to be smaller reporting companies as defined by the SEC, to be effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the potential impact that the adoption of ASU 2016-13 will have on the Company’s financial position and results of operations. In 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”). ASU 2019-12 simplifies the accounting for income taxes and will be effective beginning after December 15, 2020. The Company is currently evaluating the impact of ASU 2019-12 in the consolidated financial statements. |
Fair value of financial assets
Fair value of financial assets and liabilities | 6 Months Ended |
Jun. 30, 2020 | |
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 June 30, 2020 and December 31, 2019, 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 date of purchase to be cash equivalents. The Company had no cash equivalents at June 30, 2020 and December 31, 2019. |
Property and equipment, net
Property and equipment, net | 6 Months Ended |
Jun. 30, 2020 | |
Property and equipment, net | |
Property and equipment, net | 4. Property and equipment, net Property and equipment, net consisted of the following (in thousands): June 30, December 31, 2020 2019 Laboratory equipment $ 4,529 $ 4,326 Leasehold improvements 363 300 Computer equipment and software 176 229 Furniture and office equipment 165 120 5,233 4,975 Less: Accumulated depreciation and amortization (3,060) (2,683) $ 2,173 $ 2,292 Depreciation expense was $0.3 million and $0.6 million for the three and six months ended June 30, 2020, respectively, and $0.2 million and $0.4 million for the three and six months ended June 30, 2019, respectively. |
Accrued expenses and other curr
Accrued expenses and other current liabilities | 6 Months Ended |
Jun. 30, 2020 | |
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): June 30, December 31, 2020 2019 Accrued employee compensation and benefits $ 1,786 $ 2,514 Accrued external research and development expenses 4,143 2,055 Accrued professional fees 1,470 867 Current portion of operating lease liabilities 653 640 Other 169 68 $ 8,221 $ 6,144 |
Convertible preferred shares
Convertible preferred shares | 6 Months Ended |
Jun. 30, 2020 | |
Convertible preferred shares | |
Convertible preferred shares | 6. Convertible preferred shares The Company had issued Series A convertible preferred shares (“Series A Preferred Shares”), Series B1 convertible preferred shares (“Series B1 Preferred Shares”), and Series B2 convertible preferred shares (“Series B2 Preferred Shares”) (collectively the “Preferred Shares”). On May 26, 2017, the Company completed the issue of 3,562,583 Series B1 Preferred Shares at a price per share of £11.2278, for gross cash proceeds of $51.9 million. In addition, on October 27, 2017, an additional unaffiliated investor subscribed for a further 384,615 Series B1 Preferred Shares at a price per share of £13.00, for gross cash proceeds of $6.6 million. These two transactions are collectively referred to as “the Series B1 Financing.” In conjunction with the Series B1 Financing, the Company also issued warrants to subscribe for 743,287 Series B1 Preferred Shares to the subscribers of the Series B1 Preferred Shares (Note 7). The Company allocated a portion of the proceeds equal to the fair value of the warrants at the date of grant to the warrant liability, and the remaining amount was allocated to the Series B1 Preferred Shares. On December 20, 2018, the Company completed the issue of 1,323,248 Series B2 preferred shares at a price per Series B2 preferred share of £15.55, for gross cash proceeds of $26.1 million (the “Series B2 Financing”). In conjunction with the Series B2 Financing, the existing holders of warrants to subscribe for Series B1 preferred shares surrendered 194,911 warrants to subscribe for the same number of Series B1 preferred shares and the Company issued a further 194,911 warrants to subscribe for the same number of Series B1 preferred shares to the new investor. In conjunction with the Series B2 Financing, the Company designated all previously outstanding Series B preferred shares as Series B1 preferred shares. On January 3, 2019, the Company completed the issue of 80,385 Series B2 preferred shares at a price per share of £15.55, for gross cash proceeds of $1.6 million. In May 2019, the Company’s board of directors and shareholders approved the reorganization of the Company’s share capital by issuing ordinary shares as bonus shares to each holder of ordinary shares on the basis of 1.429 bonus shares for each ordinary share in issue (having the effect of a one for 1.429 share split (without having an impact on the nominal value of the ordinary shares)), which was effected on May 13, 2019 (the “Share Capital Reorganization”). All issued and outstanding share and per share amounts of ordinary shares and share options included in the accompanying consolidated financial statements have been adjusted to reflect this share split for all periods presented. Upon the closing of the IPO in May 2019, all of the Company’s outstanding convertible preferred shares automatically converted into 11,647,529 ordinary shares on a 1:1.429 basis. |
Warrant liability
Warrant liability | 6 Months Ended |
Jun. 30, 2020 | |
Warrant liability | |
Warrant liability | 7. Warrant liability On May 26, 2017, the Company issued 200,000 warrants to subscribe for Series A Preferred Shares at £0.01 each, which were exercisable at any time after May 26, 2017 provided that they had not otherwise lapsed in accordance with their terms. The warrants to subscribe for Series A Preferred Shares expired upon the earlier of (i) 10 years from their issuance date, or (ii) upon an IPO or exit unless an exercise delay notice was provided by the Series A warrant holder, in which case they expire 12 months following an IPO or exit. On May 28, 2019, in conjunction with the completion of the IPO, 120,000 warrants to subscribe for Series A Preferred Shares were exercised for 171,480 ordinary shares. The holders of the remaining 80,000 warrants, which were exercisable into 114,320 ordinary shares following the completion of the IPO, as adjusted for the impact of the Share Capital Reorganization (Note 6), provided the Company with an exercise delay notice. As of June 30, 2020, all of the warrants have been exercised. On May 26, 2017, in conjunction with the issuance of 3,562,583 Series B1 Preferred Shares at a price per share of £11.2278, the Company issued 627,903 warrants to subscribe for Series B1 Preferred Shares with an exercise price of £0.01. In addition, on October 27, 2017, in conjunction with the issuance of 384,615 Series B1 Preferred Shares the Company issued a further 115,384 warrants to subscribe for Series B1 Preferred Shares with an exercise price of £0.01. In conjunction with the Series B2 Financing, the existing holders of warrants to subscribe for Series B1 preferred shares surrendered 194,911 warrants to subscribe for the same number of Series B1 preferred shares and the Company issued a further 194,911 warrants to subscribe for the same number of Series B1 preferred shares to the new investor. The transfer of warrants between investors did not have an impact to the valuation of the warrant liability, as this represents a transaction between shareholders and the Company did not issue any new instruments or change the rights and preferences of the underlying warrants to subscribe for Series B1 preferred shares. On March 7, 2019, the holders of the Series B1 warrants to subscribe for Series B1 Preferred Shares agreed that 50% of the warrants would be exercised in conjunction with the IPO and 50% of the warrants would expire. The Company assessed this event as a modification to the terms of the Series B1 warrants and, remeasured the warrant liability immediately before and immediately after the modification, which resulted in an incremental change in fair value of $0.1 million, which is included in other expense for the six months ended June 30, 2019. On May 28, 2019, in conjunction with the completion of the IPO, all Series B1 Preferred share warrants were exercised for 531,077 ordinary shares, as adjusted for the impact of the Share Capital Reorganization (Note 6). Prior to the completion of the IPO, the warrants to subscribe for Series A and Series B1 Preferred Shares were recorded as a liability and remeasured to fair value at each reporting date. Changes in the fair value of the warrant liability were recognized as other expense, net in the condensed consolidated statements of operations and comprehensive loss. Upon the closing of the IPO on May 28, 2019, warrants that were not exercised in conjunction with the IPO automatically became warrants to subscribe for ordinary shares, and met the criteria to be classified as shareholders’ equity (deficit). As such, following the final remeasurement on May 28, 2019, the Company reclassified the carrying value of the warrant liability to additional paid-in-capital in the condensed consolidated balance sheet. The Company recorded other expense of zero and $2.2 million related to the remeasurement of the warrant liability during the three months ended June 30, 2020 and 2019, respectively, and zero and $5.4 million for the six months ended June 30, 2020 and 2019, respectively. |
Ordinary shares
Ordinary shares | 6 Months Ended |
Jun. 30, 2020 | |
Ordinary shares | |
Ordinary shares | 8. 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 June 30, 2020 and December 31, 2019, the Company has not declared any dividends. As of June 30, 2020 and December 31, 2019, the Company’s authorized capital share consisted of 31,995,653 ordinary shares with a nominal value of £0.01 per share. |
Share-based compensation
Share-based compensation | 6 Months Ended |
Jun. 30, 2020 | |
Share-based compensation | |
Share-based compensation | 9. Share‑based compensation Employee incentive pool 2020 Share Option Plan In June 2020, the Company’s shareholders 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, performance restricted share units 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. 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, 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. As of June 30, 2020, there were 4,773,557 shares available for issuance and no share 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 June 30, 2020, there were 2,645,465 options to purchase ordinary shares outstanding under the 2019 Plan. In conjunction with the adoption of the 2020 Plan, all shares available for future issuance under the 2019 Plan as of June 29, 2020 became available for issuance under the 2020 Plan and the Company ceased making awards under the 2019 Plan. The 2020 Plan is the successor of the 2019 Plan. Share options previously issued under the 2019 Share Option Plan have a 10 year contractual life, and generally either vest monthly over a three year service period, or over a four‑year service period with 25% of the award vesting on the first anniversary of the commencement date and the balance thereafter in 36 equal monthly installments. Certain awards granted to our non-employee directors were fully vested on the date of grant. The exercise price of share options issued under the 2019 Share Option Plan is not less than the fair value of ordinary shares as of the date of grant. Pre-IPO Share Options and restricted shares Prior to the IPO, the Company issued share options and ordinary shares, as administered by the board of directors, using standardized share option and share subscription agreements. As of June 30, 2020, there were 1,008,547 pre-IPO share options outstanding. Options granted, as well as restricted shares granted as employee incentives prior to the IPO, typically vest over a four‑year service period with 25% of the award vesting on the first anniversary of the commencement date and the balance thereafter in 36 equal monthly installments and expire no later than 10 years from the date of grant. Certain equity awards were issued in 2017 and 2018 for which 20% of the award vests upon the first anniversary of the vesting start date, 60% vests thereafter in 36 equal monthly installments, and 20% vest upon the earlier of the fourth anniversary of the vesting start date, or the achievement of a specified revenue threshold from the Company’s collaboration arrangements. Options issued to U.K. employees prior to the IPO generally had an exercise price of £0.01 per share. The exercise price for share options granted to U.S. employees, had an exercise price that was not less than the fair value of ordinary shares as determined by the board of directors as of the date of grant. Prior to the IPO, the Company’s board of directors valued the Company’s ordinary shares based on input from management, considering the most recently available valuation of ordinary share performed by an independent third‑party valuation firm as well as additional factors which may have changed since the date of the most recent contemporaneous valuation through the date of grant. Employee Share Purchase Plan (“ESPP”) 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 least 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 our capitalization. On January 1, 2020, the total number of shares available for issuance under the ESPP was increased by 179,937 ordinary shares pursuant to this provision. Once the Company commences offerings under the ESPP, each offering to the employees to purchase shares under the ESPP will begin on each June 1 and December 1 and will end on the following November 30 and May 31, respectively. On each purchase date, which will fall on the last date of each offering period, ESPP participants will purchase ordinary shares at a price per share equal to 85% of the lesser of (1) the fair market value of the shares on the offering date or (2) the fair market value of the shares on the purchase date. The occurrence and duration of offering periods under the ESPP are subject to the determinations of the Company’s compensation committee. As of June 30, 2020, 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 Six Months Ended June 30, June 30, 2020 2019 2020 2019 Research and development expenses $ 522 $ 291 $ 1,195 $ 399 General and administrative expenses 797 614 2,245 782 $ 1,319 $ 905 $ 3,440 $ 1,181 Share options The following table summarizes the Company’s option activity since December 31, 2019: Weighted Weighted Average Aggregate Number of Average Contractual Intrinsic Shares Exercise Price Term Value (in years) (in thousands) Outstanding as of December 31, 2019 2,634,346 $ 9.57 9.04 $ 2,868 Granted 1,174,434 10.88 — — Exercised (5,071) 2.29 — — Forfeited (149,697) 10.72 — — Outstanding as of June 30, 2020 3,654,012 $ 9.91 8.94 $ 21,378 Vested and expected to vest as of June 30, 2020 3,654,012 $ 9.91 8.94 $ 21,378 Options exercisable as of June 30, 2020 1,168,098 $ 8.06 8.18 $ 9,655 The weighted average grant‑date fair value of share options granted during the six months ended June 30, 2020 and 2019 was $7.08 per share and $8.26 per share, respectively. Total share-based compensation expense for share options granted was $1.3 million and $3.4 million for the three and six months ended June 30, 2020, respectively, and $0.6 million and $0.8 million for the three and six months ended June 30, 2019, respectively. Expense for non-employee consultants for the three months and six months ended June 30, 2020 and 2019 was immaterial. 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 immaterial and $0.1 million for the three and six months ended June 30, 2020, respectively, and $0.1 million for each of the three and six months June 30, 2019. 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 Six Months Months Ended Ended June 30, June 30, 2020 2019 2020 2019 Risk-free interest rate 0.4 % 2.2 % 1.5 % 2.2 Expected volatility 76.8 % 78.0 % 74.1 % 78.1 Expected dividend yield — — — — Expected term (in years) 6.1 5.8 6.0 5.9 As of June 30, 2020, total unrecognized compensation expense related Restricted shares The Company had granted restricted shares with service‑based vesting conditions. In The fair value of employee restricted share awards vested, based on estimated fair values of the ordinary shares underlying the restricted share awards on the day of vesting, was zero during each of the three and six months ended June 30, 2020, and $0.6 million and $0.7 million during the three and six months ended June 30, 2019, respectively. As of June 30, 2020, there was |
Significant Agreements
Significant Agreements | 6 Months Ended |
Jun. 30, 2020 | |
Significant Agreements | |
Significant Agreements | 10. Significant agreements For the three and six months ended June 30, 2020 and 2019, the Company had collaboration agreements with Genentech Inc. (“Genentech”), AstraZeneca AB (“AstraZeneca”), Sanofi (formerly Bioverativ), Oxurion (formerly ThromboGenics), and the Dementia Discovery Fund (“DDF”). The following table summarizes the revenue recognized in the Company’s condensed consolidated statements of operations and comprehensive loss from the Company’s collaboration agreements (in thousands): Three Months Six Months Ended Ended June 30, June 30, 2020 2019 2020 2019 Collaboration revenues AstraZeneca $ 319 $ 362 $ 731 $ 787 Sanofi — 57 — 6,016 Dementia Discovery Fund 56 103 112 103 Material transfer agreement — 1,000 — 1,000 Genentech 1,196 — 1,857 — Total collaboration revenues $ 1,571 $ 1,522 $ 2,700 $ 7,906 AstraZeneca Collaboration Agreement Summary of Agreement — 2016 Agreement In November 2016, the Company entered into a Research Collaboration Agreement (the “AstraZeneca Collaboration Agreement”) with AstraZeneca. The collaboration is focused on the research and development of Bicycle peptides that bind to up to six biological targets. After discovery and initial optimization of such Bicycle peptides, AstraZeneca will be responsible for all research and development, including lead optimization and drug candidate selection. AstraZeneca has option rights, at drug candidate selection, which allow it to obtain development and exploitation license rights with regard to such drug candidate. The initial research obligation focuses on two targets within respiratory, cardiovascular and metabolic disease. AstraZeneca also had an option to nominate up to four additional targets at any point up to the second anniversary of the agreement (“Additional Four Target Option”). The exercise of this option right resulted in an option fee payable to the Company of $5.0 million and the research obligations and rights consistent with the obligations and rights related to the initial two targets discussed below. Under the AstraZeneca Collaboration Agreement, the Company is obligated to use commercially reasonable efforts to perform research activities on the initial two targets, under mutually agreed upon research plans. The research plans include two discrete parts, on a research program by research program basis: (i) the Bicycle Research Term, which is focused on the generation of Bicycle peptide libraries using the Company’s peptide drug discovery platform, to be screened against selected biological targets and optimization of promising compounds, with the goal of identifying compounds that meet the criteria set by the parties, and (ii) the AZ Research Term, during which AstraZeneca may select certain compounds and continue research activities on those compounds, at its sole expense, with the goal of identifying compounds that satisfy the relevant pharmacological and pharmaceutical criteria for clinical testing. AstraZeneca may, at its sole discretion, approve any compound to be progressed into drug development and, upon the selection of each drug candidate, AstraZeneca is to pay $8.0 million as an option fee, in order to obtain worldwide development and exploitation rights. Each research program is to continue for an initial period of three years (the “Research Term”), including one year for the Bicycle Research Term and two for the AZ Research Term. AstraZeneca may extend the Research Term for each research program by twelve months (or fifteen months, if needed to complete certain toxicology studies). The Research Term for a specific program can be shorter if it is ceased due to a screening failure, a futility determination, abandonment by AstraZeneca, or upon selection of a drug candidate. AstraZeneca has certain substitution rights should a screening failure or futility determination be reached but is obligated to fund these additional efforts related to substitution. Under the terms of the AstraZeneca Collaboration Agreement, the Company granted to AstraZeneca, for each research program, a right and license (with the right to sublicense) to certain background and platform intellectual property, for the duration of the applicable Research Term, to the extent necessary or useful for AstraZeneca to conduct the activities assigned to it in the applicable research plan, but for no other purpose. The activities under the AstraZeneca Collaboration Agreement are governed by a joint steering committee (“JSC”) formed by an equal number of representatives from the Company and AstraZeneca. The JSC oversees and reviews each research program. Among other responsibilities, the JSC monitors and reports on research progress and it is responsible to ensure open and frequent exchange between the parties regarding research program activities. AstraZeneca is obligated to fund two full time equivalents (“FTE”) during the Bicycle Research Term, for each research program, based on an agreed upon FTE reimbursement rate. Payment is made quarterly in advance of services being provided. AstraZeneca has the option to obtain development and commercialization licenses associated with each designated drug candidate in return for a fee of $8.0 million per drug candidate. In addition, AstraZeneca is required to make certain milestone payments to the Company upon the achievement of specified development, regulatory and commercial milestones. More specifically, for each research program, the Company is eligible to receive up to $29.0 million in development milestone payments and up to $23.0 million in regulatory milestone payments. The Company is also eligible for up to $110.0 million in commercial milestone payments, on a research program by research program basis. Development milestone payments are triggered upon initiation of a defined phase of clinical research for a drug candidate. Regulatory milestone payments are triggered upon approval to market a product candidate by the United States Food and Drug Administration (“FDA”) or other global regulatory authorities. Commercial milestone payments are triggered when an approved pharmaceutical product reaches certain defined levels of net sales by the licensee. In addition, to the extent any of the product 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. Royalty payments are subject to certain reductions, including in certain countries where AstraZeneca faces generic competition. Due to the uncertainty of pharmaceutical development and the high historical failure rates generally associated with drug development, the Company may not receive any additional milestone payments or royalty payments from AstraZeneca. Either party may terminate the AstraZeneca Collaboration Agreement if the other party has materially breached or defaulted in the performance of any of its material obligations and such breach or default continues after the specified cure period. Either party may terminate the AstraZeneca Collaboration Agreement in the event of the commencement of any proceeding in or for bankruptcy, insolvency, dissolution or winding up by or against the other party that is not dismissed or otherwise disposed of within a specified time period. 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 The Company has identified the following performance obligations: (i) research license and the related research and development services during the Bicycle Research Term for the first target (the “Target One Research License and Related Services”), (ii) research license and the related research and development services during the Bicycle Research Term for the second target (the “Target Two Research License and Related Services”). The Company concluded that the Additional Four Target Option is not a material right, as the option does not provide a discount that AstraZeneca otherwise would not have received. The Company’s participation in the joint steering committee 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 during the Bicycle Research Term as AstraZeneca 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. The total transaction price was initially determined to be $1.2 million, consisting solely of research and development funding. 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 the license options by AstraZeneca or upon reaching certain milestones is excluded from the transaction price as they relate to option fees and milestones that can only be achieved subsequent to the 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 the Target One Research License and Related Services and the Target Two Research License and Related Services are 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 what would be expected to be realized under similar contracts. The transaction price allocated to each performance obligation was initially $0.6 million. The Company will recognize revenue related to amounts allocated to the Research License and Related Services as the underlying services are performed over the one year Research Term 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 and will remeasure its progress towards completion at the end of each reporting period, which best reflects the progress towards satisfaction of the performance obligation. In October 2017, AstraZeneca selected a replacement target for the first target, and as such a new Research Term was started related to the Target One Research License and Related Services. In addition, both programs were extended. The total transaction price under the arrangement increased to $2.0 million for the additional research and development funding received. For each of the three and six months ended June 30, 2020, the Company recognized zero, and for the three and six months ended 2019, the Company recognized $25,000 and $0.2 million, respectively, of collaboration revenue related to the Target One and Target Two Research License and Related Services for its Collaboration Agreement with AstraZeneca. As of June 30, 2020, and December 31, 2019, the Company recorded zero deferred revenue in connection with the 2016 AstraZeneca Collaboration Agreement. May 2018 AstraZeneca Option Exercise — Additional Four Targets Under the AstraZeneca Collaboration Agreement, AstraZeneca was granted an option to nominate up to four additional targets at any point up to the second anniversary of the agreement (“Additional Four Target Option”). In May 2018, AstraZeneca made an irrevocable election to exercise the Additional Four Target Option. As a result, AstraZeneca is entitled to obtain research and development services with respect to Bicycle peptides that bind to up to four additional targets, along with license rights to those selected targets, in exchange for an option fee of $5.0 million, which was paid by AstraZeneca to the Company in January 2019. AstraZeneca is obligated to fund two FTEs during the Bicycle Research Term, for each research program, based on an agreed upon FTE reimbursement rate. Payment is made quarterly in advance of services being provided. AstraZeneca has the option to obtain worldwide development and commercialization licenses associated with each designated drug candidate in return for a fee of $8.0 million per drug candidate, upon the selection of such drug candidate, after which AstraZeneca would be required to fund development and commercialization costs, and to pay regulatory and commercial milestone payments and royalties to the Company as for the other products developed under the AstraZeneca Collaboration Agreement. Accounting Analysis Upon the execution of the agreement, the Company has identified the following five performance obligations associated with the AstraZeneca May 2018 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 are options. Upon exercise, AstraZeneca will obtain a research license and the related research and development services and an option to a development and exploitation license. The Company has concluded that each research services option, including the underlying development and exploitation license options related to each respective target, results in a material right as the option exercise fee related to the development and exploitation license contains 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 are not performance obligations at the inception of the arrangement, as they are optional services that will be performed if AstraZeneca selects additional targets and they reflect their standalone selling prices and do 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 determined to be $5.7 million at the inception of the arrangement, 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 is being provided based on the costs that are incurred to conduct the research and development services. 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 the license options by AstraZeneca or upon reaching certain milestones are excluded from the transaction price as they relate 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 is 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 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 at the inception of the arrangement is 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 will recognize 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 reflects the progress towards satisfaction of the performance obligation. The amount allocated to the material rights is recorded as deferred revenue and the Company will commence 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. During the year ended December 31, 2019, the Company commenced research and development services related to the fourth and fifth targets. For the three and six months ended June 30, 2020, the Company recognized $0.3 million and $0.7 million, respectively, and for the three and six months ended June 30, 2019 the Company recognized $0.3 million and $0.6 million, respectively, of revenue for the Target Three Research License and Related Service and research and development services for the fourth target and fifth targets related to the May 2018 AstraZeneca Option Exercise. As of June 30, 2020, and as of December 31, 2019, the Company recorded $4.8 million and $4.9 million of deferred revenue, respectively, in connection with the May 2018 AstraZeneca Option Exercise and related contracts. Sanofi Collaboration Agreement (formerly Bioverativ) Summary of Agreement In August 2017, the Company entered into a Collaboration Agreement with Bioverativ Inc., which was acquired by Sanofi in March 2018 (“Sanofi”). Under the collaboration agreement with Sanofi (the “Sanofi Collaboration Agreement”), the Company provided research and development services focused on up to three collaboration programs; (i) Sickle cell disease, (ii) Hemophilia, and (iii) and a third program (“Program 3”), which was an optional program, to be defined. The option expired in November 2018 unexercised. The Company used its bicyclic peptide screening platform to perform research and development services for the programs and Sanofi had the ability to select a collaboration product for each program and obtain a license to develop and exploit the selected collaboration product for an additional option fee. Under the terms of the Sanofi Collaboration Agreement, the Company granted to Sanofi, for each collaboration program, a non‑exclusive, sublicensable (through multiple tiers), worldwide license under certain intellectual property of the Company to conduct the activities assigned to Sanofi in the applicable research plan for the duration of the applicable Research Term, but for no other purpose. The activities under the Sanofi Collaboration Agreement were governed by a joint steering committee (“Sanofi JSC”) formed by an equal number of representatives from the Company and Sanofi. The Sanofi JSC oversaw, review and recommends direction of each collaboration program and variations of or modifications to the research plans. Sanofi could terminate the Sanofi Collaboration Agreement, entirely or on a program by program, licensed product by licensed product or country by country basis, for convenience upon not less than 30 days prior written notice to the Company. Accounting Analysis The Company identified the following four performance obligations associated with the Sanofi Collaboration Agreement: (i) Research License and the related research and development services during the BV Bicycle Research Term for Sickle cell program (the “Sickle Cell Research License and Related Services”), (ii) Research License and the related research and development services during the BV Bicycle Research Term for Hemophilia program (the “Hemophilia Research License and Related Services”), (iii) Material right associated with the sickle cell program development and exploitation license option (“Sickle Cell License Option Material Right”), and (iv) Material right associated with the hemophilia program development and exploitation license option (“Hemophilia License Option Material Right”). The Company concluded that the option to obtain screening services on the additional Program 3 target was not a material right, as the option did not provide a discount that Sanofi otherwise would not have received. The Company’s participation in the Sanofi JSC was assessed as immaterial in the context of the contract. Research license and the related research and development services related to the Joint Research Term were not performance obligations at the inception of the arrangement, as they were optional services that will be performed if Sanofi selects collaboration compounds for lead optimization. The amount paid by Sanofi for the services during the Joint Research Team did not reflect a discount that the customer would otherwise receive and do not provide the customer with material rights. The total transaction price was initially determined to be $14.2 million, consisting of the $10.0 million upfront payment and non‑refundable research and development funding of $4.2 million. The Company could receive reimbursement of FTE costs and external costs associated with work under the Joint Research Term, milestone payments during the Joint Research Term, as well as upon exercise of the license options. These variable amounts were excluded from the transaction price as they relate to fees and milestones that can only be achieved subsequent to the exercise of an option. 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 Research License and Related Services is 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 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 Sanofi would pay to exercise the license options, the estimated value of the license option using comparable transactions, and the probability that the license options would be exercised by Sanofi. Based on the relative standalone selling price, the allocation of the transaction price to the separate performance obligations at the inception of the arrangement is as follows (in thousands): Allocation of Performance Obligations Transaction Price Sickle Cell Research License and Related Services $ 1,405 Hemophilia Research License and Related Services 2,811 Sickle Cell License Option Material Right 5,286 Hemophilia License Option Material Right 4,698 $ 14,200 The Company recognized revenue related to amounts allocated to the Sickle Cell Research License and Related Services and the Hemophilia Research License and Related Services obligations as the underlying services were 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 was recorded as deferred revenue and the Company commended revenue recognition when the underlying option was exercised or upon expiry of the option. During the year ended December 31, 2019, Sanofi extended the research and development services on both programs. The arrangement consideration increased to $14.9 million. On March 28, 2019, Sanofi notified the Company that it would not exercise the Sickle Cell License Option. As a result, the amount allocated to the Sickle Cell License Option Material Right of $5.3 million was recognized into revenue during the three months ended June 30, 2019. The collaboration with Sanofi was terminated effective October 23, 2019, and as a result, deferred revenue related to amounts allocated to the Hemophilia License Option Material Right were recognized in the fourth quarter of 2019. The Company recognized zero of collaboration revenue for the three and six months ended June 30, 2020, respectively, and $0.1 million and $6.0 million for the three and six months ended June 30, 2019, respectively, related to its collaboration with Sanofi. As of June 30, 2020 and December 31, 2019 the Company recorded zero deferred revenue related to its collaboration with Sanofi. Oxurion Collaboration Agreement Summary of Agreement In August 2013, the Company entered into a Research Collaboration and License Agreement with Oxurion (the “Oxurion Collaboration Agreement”). Under the Oxurion Collaboration Agreement, the Company was responsible for identifying Bicycle peptides related to the collaboration target, plasma kallikrein, for use in various ophthalmic indications. Oxurion is responsible for further development and product commercialization after the defined research screening is performed by the Company. Under the Oxurion Collaboration Agreement, the Company was obligated to perform specified research activities in accordance with the research plan, which includes two stages. Stage I, now completed, focused on the screening of targets using the Company’s Bicycle peptide discovery platform with the goal of identifying compounds that meet the criteria set by the parties, and Stage II, during which Oxurion has continued research activities on selected Bicycle peptides with the goal of identifying compounds for further development and commercialization. The Company is not obligated or expected to perform any research services during Stage II of the research plan. The Company granted certain worldwide intellectual property rights to Oxurion for the development, manufacture and commercialization of licensed compounds associated with plasma kallikrein. The Oxurion Collaboration Agreement provided for an upfront payment of €1.0 million and potential additional research and development funding, at an agreed upon FTE rate, should the research effort require more than one FTE or the research plan be amended or extended by Oxurion. In addition, Oxurion is required to make certain milestone payments to the Company upon the achievement of specified research, development, regulatory and commercial events. More specifically, for each collaboration program, the Company is eligible to receive up to €8.3 million in research and development milestones of which €1.8 million has been received as of June 30, 2020. In addition, the Company is eligible to receive up to €16.5 million upon achievement of certain regulatory milestone payments (e.g. €5 million for granting first regulatory approval in either the United States or EU for the first indication). In addition, to the extent any of the collaboration products covered by the licenses granted to Oxurion are commercialized, the Company would be entitled to receive tiered royalty payments of mid‑single digits based on a percentage of net sales. Either party may terminate the Oxurion Collaboration Agreement if the other party has materially breached any of its material obligations and such breach continues after the specified cure period. Either party may terminate the Oxurion Collaboration Agreement in the event of the commencement of any proceeding in or for bankruptcy, insolvency, dissolution or winding up by or against the other party that is not dismissed or otherwise disposed of within a specified time period. Oxurion may terminate the Oxurion Collaboration Agreement, entirely or on a program by program, licensed product by licensed product or country by country basis, for convenience upon not less than 90 days prior written notice to the Company. In November 2017, the parties executed the First Deed of Amendment to the Oxurion Collaboration Agreement (“First Amendment”). The First Amendment confirms that THR‑149 has been selected as a development compound under the Oxurion Collaboration Agreement and that Stage II of the research plan has been completed. The First Amendment provided for additional research services to be performed by the Company related to the identification of two additional compounds for Oxurion, in its discretion, to select as development compounds. As for the work under the Oxurion Collaboration Agreement, the Company will perform the work under Stage I of the research plan, which will be funded at a specified FTE rate, plus any direct out of pocket expenses, and Oxurion will be responsible for Stage II research and any development after the selection of a development compound. Additional milestones and royalties were added for the potential additional licensed compounds, consistent with those of the initial Oxurion Collaboration Agreement. The Company is not obligated or expected to perform any research services during Stage II of the research plan. Accounting Analysis Under the Oxurion Collaboration Agreement, all licenses were granted and research services to be provided by the Company were fully completed and revenue associated with those obligations was fully recognized prior to January 1, 2016. Under the First Amendment, the Company has identified a single performance obligation associated with the performance of research services associated with Stage I of the research plan for which the Company was reimbursed for its services at a specified FTE reimbursement rate plus out of pocket costs which were recognized on a proportional performance basis as the associated FTE efforts and costs were incurred, which best reflected the progress towards satisfaction of the performance obligation. None of the unpaid development or regulatory milestones have been included in the transaction price, as all milestones are not considered probable at June 30, 2020 and December 31, 2019. The research services under the First Amendment were completed in 2018. The Company recognized zero in revenue during each of the three and six months ended June 30, 2020 and 2019. As of June 30, 2020, and December 31, 2019 the Company recorded zero deferred revenue related to its collaboration with Oxurion. Dementia Discovery Fund Agreement In May 2019, the Company entered into a collaboration with the DDF to use Bicycle technology for the discovery and development of novel therapeutics for dementia (the “DDF Collaboration Agreement”). Under the terms of the DDF Collaboration Agreement, the Company and DDF will collaborate to identify Bicycles that bind to clinically validated dementia targets (the “DDF Research Plan”). The Company is obligated to use commercially reasonable efforts to perform research activities under the DDF Research Plan. DDF shall not be directly engaged in the conduct of any research activities under the arrangement |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2020 | |
Income Taxes | |
Income Taxes | 11. Income Taxes During the three and six months ended June 30, 2020, the Company recorded an income tax benefit of $0.1 million and $0.2 million, respectively. During the three and six months ended June 30, 2019, the Company recorded an income tax provision of $0.1 million and $0.2 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’s income tax provision recognized represents income tax payable in the United States on profits generated from an intercompany service arrangement. 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 United Kingdom, and 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 United Kingdom. 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 June 30, 2020 and December 31, 2019. 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) provision for 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 | 6 Months Ended |
Jun. 30, 2020 | |
Commitments and Contingencies | |
Commitments and Contingencies | 12. Commitments and Contingencies Leases 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 and expires on December 31, 2022. Bicycle Therapeutics Inc. has the option to extend for a successive period which is not included in the lease term as it is not reasonably certain that the option will be exercised. 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 deposit is recorded in other assets in the condensed consolidated balance sheets. The Company has recorded a right‑of‑use asset (inclusive of the impact of prepaid rent) and corresponding lease liability, by calculating the present value of lease payments, discounted at 9%, the incremental borrowing rate, over the lease term. 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 expires on December 21, 2021. The annual rent is approximately $0.5 million. The Company has the right to renew the lease for five years commencing December 21, 2021, which is not included in the lease term as it is not reasonably certain that the right will be exercised. Service charges are also payable based on floor area and are estimated to be approximately $0.1 million per year. In conjunction with the 2017 lease agreement, the Company paid a security deposit of $0.6 million, which is recorded in other assets in the condensed consolidated balance sheets. The Company has recorded a right‑of‑use asset and corresponding lease liability, by calculating the present value of lease payments, discounted at 7.75%, the incremental borrowing rate, over the lease term. 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, cancelable option periods when it is reasonably certain that the Company would exercise such options. The Company has not included any option periods in the expected lease term as it is not reasonably certain that the Company will exercise such options. · 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 Six Months Months June 30, June 30, 2020 2020 Operating lease cost $ 220 $ 443 Variable lease cost 164 303 Total lease cost $ 384 $ 746 Weighted‑average remaining operating lease term (years) 2.2 2.2 Weighted‑average discount rate 8.59 % 8.59 % The following table summarizes the maturities of the Company’s operating leases as of June 30, 2020 (in thousands): Year Ending December 31, 2020 $ 443 2021 753 2022 443 2023 — Present value adjustment (136) Total lease liabilities $ 1,503 Less: current lease liabilities (653) Long term lease liabilities $ 850 The Company has entered into various agreements with 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. Under such agreements, the Company is contractually obligated to make certain minimum payments to the vendors, with the payments in the event of a termination with less than 90 days’ notice based on the timing of the termination and the exact terms of the agreement. Legal proceedings From time to time, the Company or its subsidiaries may become involved in various legal proceedings and claims, either asserted or unasserted, which arise in the ordinary course of business. In September 2016, the Company’s subsidiary, Bicycle RD Limited (“BicycleRD”), filed a complaint in the District Court of The Hague (the “District Court”) against Pepscan Systems B.V. and its affiliates (“Pepscan”) to contest the right of Pepscan to terminate a non‑exclusive patent license agreement entered into with Pepscan in 2009. BicycleRD included a conditional claim for a ruling that the licensed patent relevant to BicycleRD’s activities is invalid. In response, Pepscan counterclaimed for injunctive relief and unquantified damages. The Company is vigorously prosecuting its claims and defending against those of Pepscan. The Company does not believe that a loss is probable or estimable at this time, and as such, the Company has not recorded a liability related to the Pepscan litigation as of June 30, 2020 and December 31, 2019. Should the Company not be successful in maintaining its rights to Pepscan’s patent or in the Company’s alternative demand that the patent be invalidated, commercialization of the Company’s lead product could be delayed. As the Pepscan patent is expected to expire prior to the expected commercialization date of the product, the Company does not believe that the legal proceedings could have a material adverse effect on the Company’s business and operating results. Founder Royalty arrangements At the time BicycleRD was organized, BicycleRD entered into a royalty agreement with its founders and initial investors (the “Founder Royalty Agreement”). Pursuant to the Founder Royalty Agreement, as amended in May 2017, the Company will pay a royalty rate in the low single digit percentages on net product sales that could be generated 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 royalty arrangements 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 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 June 30, 2020 and December 31, 2019. |
Net loss per share
Net loss per share | 6 Months Ended |
Jun. 30, 2020 | |
Net loss per share | |
Net loss per share | 13. Net loss per share Basic and diluted net loss per share attributable to ordinary shareholders was calculated as follows (in thousands, except share and per share amounts): Three Months Ended Six Months Ended June 30, June 30, 2020 2019 2020 2019 Numerator: Net loss attributable to ordinary shareholders $ (12,115) $ (10,217) $ (23,438) $ (16,720) Denominator: Weighted average ordinary shares outstanding, basic and diluted 18,077,770 7,298,139 18,024,314 4,101,564 Net loss per share attributable to ordinary shareholders, basic and diluted $ (0.67) $ (1.40) $ (1.30) $ (4.08) The Company’s potentially dilutive securities which include share options, and which prior to the completion of the IPO included convertible preferred shares, warrants to subscribe for Series A and Series B1 Preferred Shares, and unvested restricted 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 attributable to ordinary shareholders 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 attributable to ordinary shareholders for the periods indicated because including them would have had an anti‑dilutive effect: Six Months Ended June 30, 2020 2019 Warrants to subscribe for convertible preferred shares (as adjusted to reflect the impact of the share capital reorganization and issuance of bonus shares (Note 6)) (1)(2) — 114,320 Options to purchase ordinary shares 3,654,012 2,615,949 3,654,012 2,730,269 (1) On March 7, 2019, the holders of the Series B1 warrants to subscribe for Series B1 Preferred Shares agreed that 50% of the warrants would be exercised in conjunction with the IPO and 50% of the warrants would expire. (2) At June 30, 2019, 80,000 warrants are outstanding which are exercisable into 114,320 ordinary shares. |
Benefit plans
Benefit plans | 6 Months Ended |
Jun. 30, 2020 | |
Benefit plans | |
Benefit plans | 14. Benefit plans The Company established a defined‑contribution savings plan under Section 401(k) of the Code (the “401(k) Plan”). The 401(k) Plan covers all U.S. employees and allows participants to defer a portion of their annual compensation on a pre‑tax basis. Matching contributions to the 401(k) Plan may be made at the discretion of the Company’s board of directors. During the three months ended June 30, 2020 and 2019 the Company made contributions totaling $38,000 and $25,000, respectively, to the 401(k) Plan. During each of the six months ended June 30, 2020 and 2019, the Company made contributions totaling $0.1 million to the 401(k) Plan. The Company provides a pension contribution plan for its employees in the United Kingdom, pursuant to which the Company may match employees’ contributions each year (“U.K Plan”). During each of the three months ended June 30, 2020 and 2019 the Company made contributions totaling $0.1 million to the U.K. Plan. During each of the six months ended June 30, 2020 and 2019, the Company made contributions totaling $0.2 million to the U.K. Plan. |
Related party transactions
Related party transactions | 6 Months Ended |
Jun. 30, 2020 | |
Related party transactions | |
Related party transactions | 15. Related party transactions The Company has entered into the Founder Royalty Agreements with its founders and initial investors (Note 12). No royalties have been earned or paid under the Founder Royalty Agreements to date. The Chairman of the Company’s Board of Directors is associated with Stone Sunny Isles Inc., which provided consultancy services to the Company totaling $0.1 million during each of the three and six month periods ended June 30, 2020, and zero during each of the three and six month periods ended June 30, 2019. The former Chairman of the Company’s Board of Directors is associated with 10X Capital Inc., which provided consultancy services to the Company totaling zero during each of the three and six month periods ended June 30, 2020, and zero and $50,000 during the three and six months ended June 30, 2019, respectively. |
Geographic information
Geographic information | 6 Months Ended |
Jun. 30, 2020 | |
Geographic information | |
Geographic information | 16. 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): June 30, December 31, 2020 2019 United States $ 1,823 $ 2,017 United Kingdom 1,977 2,331 $ 3,800 $ 4,348 The Company’s collaboration revenues are attributed to the operations of the Company in the United Kingdom. |
Subsequent events
Subsequent events | 6 Months Ended |
Jun. 30, 2020 | |
Subsequent events | |
Subsequent events | 17. Subsequent events On June 5, 2020, the Company entered into a Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. and Oppenheimer & Co. Inc. (the “Sales Agents”) with respect to an at-the-market offering program (“ATM”) under which the Company may offer and sell, from time to time at its sole discretion, ADSs through the Sales Agents, representing the same number of ordinary shares, having an aggregate offering price of up to $50.0 million. On July 7, 2020, the Company sold 1,192,713 ADSs, representing the same number of ordinary shares at a public offering price of $15.50 per ADS ordinary share pursuant to the Sales Agreement, for gross proceeds of $18.5 million, resulting in net proceeds of $17.6 million after deducting sales commissions and offering expenses of $0.9 million. |
Summary of significant accoun_2
Summary of significant accounting policies (Policies) | 6 Months Ended |
Jun. 30, 2020 | |
Summary of significant accounting policies | |
Use of estimates | Use of estimates The preparation of the 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 consolidated financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual for research and development expenses, revenue recognition, the fair value of ordinary shares and the valuation of the warrant liability prior to the Company’s IPO, share-based compensation expense, and income taxes. 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 and may be changed as new events occur and additional information is obtained. As of the date of issuance of these financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments or revise the carrying value of its assets or liabilities . Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates or assumptions, and any such differences may be material to the Company’s financial statements. |
Significant Risks and Uncertainties | Significant Risks and Uncertainties With the global spread of the In addition, the Company is subject to other challenges and risks specific to its business and ability to execute its strategy, as well as risks and uncertainties common to companies in the biotechnology industry, including but not limited to: 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, 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. In addition, to the extent the ongoing COVID-19 pandemic adversely affects the Company’s business and results of operations, it may also have the effect of heightening many of the other risks and uncertainties discussed above. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information Certain information in the footnote disclosures of the 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, 2019 included in the Company’s 2019 Annual Report. The accompanying condensed consolidated balance sheet at June 30, 2020, condensed consolidated statements of operations and comprehensive loss, condensed consolidated statements of convertible preferred shares and shareholders’ equity (deficit) for the three months and six months ended June 30, 2020 and 2019, and condensed consolidated statements of cash flows for the six months ended June 30, 2020 and 2019, 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, 2019, and, in the opinion of management, reflect all adjustments, consisting of normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of June 30, 2020, the results of its operations for the three and six months ended June 30, 2020 and 2019, and its cash flows for the six months ended June 30, 2020 and 2019. The results for the three and six months ended June 30, 2020 are not necessarily indicative of the results to be expected for the year ending December 31, 2020, any other interim periods, or any future year or period. |
Foreign currency and currency translation | Foreign currency and currency translation The functional currency is the currency of the primary economic environment in which an entity’s operations are conducted. On June 1, 2019, Bicycle Therapeutics plc adopted the U.S. dollar (“USD”) as its functional currency. Bicycle Therapeutics plc is a holding company that has no operating activities and its primary functions are to serve as a financing vehicle to fund the operations of the Company’s operating entities, to serve as the listing company needed to access U.S. capital markets, and to hold investments. Therefore, its financing source is the primary indicator of its cash flows and its functional currency. The change in functional currency from the British Pound Sterling is due to a change in the source of Bicycle Therapeutics plc’s financing and cash flows, which following the completion of the IPO is now primarily the U.S. dollar. Historically its financing had been in British Pound Sterling. The functional currency of Bicycle Therapeutics plc’s wholly owned non-U.S. subsidiaries, BicycleTx Limited and BicycleRD Limited, is the British Pound Sterling and the functional currency of its U.S. subsidiary, Bicycle Therapeutics Inc. is the USD. The functional currency of the Company’s subsidiaries is the same as the local currency. Monetary assets and liabilities denominated in currencies other than the functional currency are remeasured into the functional currency at rates of exchange prevailing at the balance sheet dates. Non-monetary assets and liabilities denominated in foreign currencies are remeasured into the functional currency at the exchange rates prevailing at the date of the transaction. Exchange gains or losses arising from foreign currency transactions are included in the determination of net loss for the respective periods. Adjustments that arise from exchange rate changes on transactions denominated in a currency other than the local currency are included in general and administrative expense in the condensed consolidated statements of operations and comprehensive loss as incurred. The Company recorded a foreign exchange gain of $0.1 million and $0.7 million during the three months ended June 30, 2020 and 2019, respectively, and foreign exchange gain of $1.4 million and $0.4 million for the six months ended June 30, 2020 and 2019, respectively. The Company translates the assets and liabilities of BicycleTx Limited and BicycleRD Limited into USD at the exchange rate in effect on the balance sheet date. Revenues and expenses are translated at the average exchange rate in effect during the period. Unrealized translation gains and losses are recorded as a foreign currency translation adjustment, which is included in the condensed consolidated statements of convertible preferred shares and shareholders’ equity (deficit) as a component of accumulated other comprehensive income (loss). |
Recently issued accounting pronouncements | Recently issued accounting pronouncements In June 2016, the FASB issued ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13 will change how companies account for credit losses for most financial assets and certain other instruments. For trade receivables, loans and held-to-maturity debt securities, companies will be required to recognize an allowance for credit losses rather than reducing the carrying value of the asset. ASU 2016-13 was effective for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments — Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates to amend the effective date of ASU 2016-13, for entities eligible to be smaller reporting companies as defined by the SEC, to be effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Early adoption is permitted. The Company is currently evaluating the potential impact that the adoption of ASU 2016-13 will have on the Company’s financial position and results of operations. In 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”). ASU 2019-12 simplifies the accounting for income taxes and will be effective beginning after December 15, 2020. The Company is currently evaluating the impact of ASU 2019-12 in the consolidated financial statements |
Property and equipment, net (Ta
Property and equipment, net (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Property and equipment, net | |
Schedule of property and equipment, net | Property and equipment, net consisted of the following (in thousands): June 30, December 31, 2020 2019 Laboratory equipment $ 4,529 $ 4,326 Leasehold improvements 363 300 Computer equipment and software 176 229 Furniture and office equipment 165 120 5,233 4,975 Less: Accumulated depreciation and amortization (3,060) (2,683) $ 2,173 $ 2,292 |
Accrued expenses and other cu_2
Accrued expenses and other current liabilities (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
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): June 30, December 31, 2020 2019 Accrued employee compensation and benefits $ 1,786 $ 2,514 Accrued external research and development expenses 4,143 2,055 Accrued professional fees 1,470 867 Current portion of operating lease liabilities 653 640 Other 169 68 $ 8,221 $ 6,144 |
Share-based compensation (Table
Share-based compensation (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
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 Six Months Ended June 30, June 30, 2020 2019 2020 2019 Research and development expenses $ 522 $ 291 $ 1,195 $ 399 General and administrative expenses 797 614 2,245 782 $ 1,319 $ 905 $ 3,440 $ 1,181 |
Schedule of share option activity | Weighted Weighted Average Aggregate Number of Average Contractual Intrinsic Shares Exercise Price Term Value (in years) (in thousands) Outstanding as of December 31, 2019 2,634,346 $ 9.57 9.04 $ 2,868 Granted 1,174,434 10.88 — — Exercised (5,071) 2.29 — — Forfeited (149,697) 10.72 — — Outstanding as of June 30, 2020 3,654,012 $ 9.91 8.94 $ 21,378 Vested and expected to vest as of June 30, 2020 3,654,012 $ 9.91 8.94 $ 21,378 Options exercisable as of June 30, 2020 1,168,098 $ 8.06 8.18 $ 9,655 |
Schedule of assumptions used to determine the fair value of share options granted | Three Six Months Months Ended Ended June 30, June 30, 2020 2019 2020 2019 Risk-free interest rate 0.4 % 2.2 % 1.5 % 2.2 Expected volatility 76.8 % 78.0 % 74.1 % 78.1 Expected dividend yield — — — — Expected term (in years) 6.1 5.8 6.0 5.9 |
Significant Agreements (Tables)
Significant Agreements (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Significant agreements. | |
Summary of revenue recognized from collaboration arrangements | The following table summarizes the revenue recognized in the Company’s condensed consolidated statements of operations and comprehensive loss from the Company’s collaboration agreements (in thousands): Three Months Six Months Ended Ended June 30, June 30, 2020 2019 2020 2019 Collaboration revenues AstraZeneca $ 319 $ 362 $ 731 $ 787 Sanofi — 57 — 6,016 Dementia Discovery Fund 56 103 112 103 Material transfer agreement — 1,000 — 1,000 Genentech 1,196 — 1,857 — Total collaboration revenues $ 1,571 $ 1,522 $ 2,700 $ 7,906 |
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): Balance at Impact of Balance at Beginning of Exchange End of Period Additions Deductions Rates Period Period ended June 30, 2020 Contract assets $ — $ — $ — $ — $ — Contract liabilities: Deferred revenue AstraZeneca collaboration deferred revenue 4,913 271 (33) (344) 4,807 DDF collaboration deferred revenue 744 — (112) (50) 582 Genentech collaboration deferred revenue — 31,000 (1,857) (1,450) 27,693 Total deferred revenue $ 5,657 $ 31,271 $ (2,002) $ (1,844) $ 33,082 Balance at Impact of Balance at Beginning of Exchange End of Period Additions Deductions Rates Period Period ended December 31, 2019 Contract assets $ — $ 149 $ (149) $ — $ — Contract liabilities: Deferred revenue AstraZeneca collaboration deferred revenue 4,727 58 (35) 163 4,913 Sanofi collaboration deferred revenue 9,908 — (9,984) 76 — DDF collaboration deferred revenue — 1,114 (394) 24 744 Total deferred revenue $ 14,635 $ 1,172 $ (10,413) $ 263 $ 5,657 |
Summary of recognition of revenues as a result of changes in contract asset and contract liability balances | During the three and six months ended June 30, 2020 and 2019, 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 Six Months Ended June 30, June 30, 2020 2019 2020 2019 Revenue recognized in the period from: Revenue recognized based on proportional performance $ (1,251) $ (113) $ (2,002) $ (138) Revenue recognized based on expiration of material rights — — — (5,286) Total $ (1,251) $ (113) $ (2,002) $ (5,424) |
AstraZeneca | |
Significant agreements. | |
Summary of allocation of transaction price to separate performance obligations | Based on the relative standalone selling price, the allocation of the transaction price to the separate performance obligations at the inception of the arrangement is 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 |
Sanofi | |
Significant agreements. | |
Summary of allocation of transaction price to separate performance obligations | Based on the relative standalone selling price, the allocation of the transaction price to the separate performance obligations at the inception of the arrangement is as follows (in thousands): Allocation of Performance Obligations Transaction Price Sickle Cell Research License and Related Services $ 1,405 Hemophilia Research License and Related Services 2,811 Sickle Cell License Option Material Right 5,286 Hemophilia License Option Material Right 4,698 $ 14,200 |
Genetech | |
Significant agreements. | |
Summary of allocation of transaction price to separate performance obligations | Based on the relative standalone selling price, the allocation of the transaction price to the separate performance obligations is as follows (in thousands): Allocation of Performance Obligations Transaction Price Genentech Collaboration Program #1 Performance Obligation $ 3,775 Genentech Collaboration Program #2 Performance Obligation 7,550 Specified Targeting Arm Material Right Arm for Genentech Collaboration Program #1 330 Two material rights associated with the LSR Go Option for Collaboration Programs #1 and #2 11,650 Material rights associated with limited substitution rights 1,115 Two material rights for Expansion Options 6,580 $ 31,000 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
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 Six Months Months June 30, June 30, 2020 2020 Operating lease cost $ 220 $ 443 Variable lease cost 164 303 Total lease cost $ 384 $ 746 Weighted‑average remaining operating lease term (years) 2.2 2.2 Weighted‑average discount rate 8.59 % 8.59 % |
Schedule of maturities of operating leases | The following table summarizes the maturities of the Company’s operating leases as of June 30, 2020 (in thousands): Year Ending December 31, 2020 $ 443 2021 753 2022 443 2023 — Present value adjustment (136) Total lease liabilities $ 1,503 Less: current lease liabilities (653) Long term lease liabilities $ 850 |
Net loss per share (Tables)
Net loss per share (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Net loss per share | |
Schedule of basic and diluted net loss attributable to ordinary shareholders | Basic and diluted net loss per share attributable to ordinary shareholders was calculated as follows (in thousands, except share and per share amounts): Three Months Ended Six Months Ended June 30, June 30, 2020 2019 2020 2019 Numerator: Net loss attributable to ordinary shareholders $ (12,115) $ (10,217) $ (23,438) $ (16,720) Denominator: Weighted average ordinary shares outstanding, basic and diluted 18,077,770 7,298,139 18,024,314 4,101,564 Net loss per share attributable to ordinary shareholders, basic and diluted $ (0.67) $ (1.40) $ (1.30) $ (4.08) |
Schedule of antidilutive securities excluded from computation of net loss per share attributable to ordinary shareholders | Six Months Ended June 30, 2020 2019 Warrants to subscribe for convertible preferred shares (as adjusted to reflect the impact of the share capital reorganization and issuance of bonus shares (Note 6)) (1)(2) — 114,320 Options to purchase ordinary shares 3,654,012 2,615,949 3,654,012 2,730,269 (1) On March 7, 2019, the holders of the Series B1 warrants to subscribe for Series B1 Preferred Shares agreed that 50% of the warrants would be exercised in conjunction with the IPO and 50% of the warrants would expire. At June 30, 2019, 80,000 warrants are outstanding which are exercisable into 114,320 ordinary shares. |
Geographic information (Tables)
Geographic information (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
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): June 30, December 31, 2020 2019 United States $ 1,823 $ 2,017 United Kingdom 1,977 2,331 $ 3,800 $ 4,348 |
Nature of the business and ba_2
Nature of the business and basis of presentation - Initial public offering (Details) $ / shares in Units, $ in Millions | May 28, 2019shares | Mar. 28, 2019$ / sharesshares | Jun. 30, 2019shares | Jun. 30, 2019USD ($)shares | Jun. 30, 2020USD ($) |
Share capital reorganization and share split | |||||
Offering expenses | $ | $ 8.4 | ||||
Ordinary Shares | |||||
Share capital reorganization and share split | |||||
Shares issued (in shares) | 4,637,666 | ||||
Conversion of convertible preferred shares to ordinary shares (in shares) | 11,647,529 | ||||
IPO | |||||
Share capital reorganization and share split | |||||
Shares issued (in shares) | 4,333,333 | ||||
Share issue price | $ / shares | $ 14 | ||||
Proceeds from IPO, net | $ | $ 56.4 | ||||
Underwriting discounts and commissions | $ | 4.5 | ||||
Offering expenses | $ | $ 4 | ||||
IPO | Ordinary Shares | |||||
Share capital reorganization and share split | |||||
Conversion of convertible preferred shares to ordinary shares (in shares) | 11,647,529 | ||||
Conversion ratio | 0.6997 | ||||
Over allotment option | |||||
Share capital reorganization and share split | |||||
Shares issued (in shares) | 304,333 |
Nature of the business and ba_3
Nature of the business and basis of presentation- Liquidity (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Nature of business and basis of presentation | |||||||
Net loss | $ 12,115 | $ 11,324 | $ 10,217 | $ 6,503 | $ 23,438 | $ 16,720 | |
Accumulated deficit | $ 123,989 | $ 123,989 | $ 100,550 |
Summary of significant accoun_3
Summary of significant accounting policies - Foreign currency and currency translation (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Summary of significant accounting policies | ||||
Foreign exchange gains (loss) | $ 0.1 | $ 0.7 | $ 1.4 | $ 0.4 |
Fair value of financial asset_2
Fair value of financial assets and liabilities - Financial assets and liabilities measured at fair value (Details) - Recurring - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 |
Fair value of financial assets and liabilities | ||
Assets at fair value | $ 0 | $ 0 |
Liabilities at fair value | $ 0 | $ 0 |
Fair value of financial asset_3
Fair value of financial assets and liabilities - Cash and cash equivalents (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Fair value of financial assets and liabilities | ||
Cash equivalents | $ 0 | $ 0 |
Property and equipment, net (De
Property and equipment, net (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Property and equipment, net | |||||
Property and equipment, gross | $ 5,233 | $ 5,233 | $ 4,975 | ||
Less: Accumulated depreciation and amortization | (3,060) | (3,060) | (2,683) | ||
Property and equipment, net | 2,173 | 2,173 | 2,292 | ||
Depreciation expense | 300 | $ 600 | 200 | $ 400 | |
Laboratory equipment | |||||
Property and equipment, net | |||||
Property and equipment, gross | 4,529 | 4,529 | 4,326 | ||
Leasehold improvements | |||||
Property and equipment, net | |||||
Property and equipment, gross | 363 | 363 | 300 | ||
Computer equipment and software | |||||
Property and equipment, net | |||||
Property and equipment, gross | 176 | 176 | 229 | ||
Furniture and office equipment | |||||
Property and equipment, net | |||||
Property and equipment, gross | $ 165 | $ 165 | $ 120 |
Accrued expenses and other cu_3
Accrued expenses and other current liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Accrued expenses and other current liabilities | ||
Accrued employee compensation and benefits | $ 1,786 | $ 2,514 |
Accrued external research and development expenses | 4,143 | 2,055 |
Accrued professional fees | 1,470 | 867 |
Current portion of operating lease liabilities | 653 | 640 |
Other | 169 | 68 |
Accrued expenses and other current liabilities | $ 8,221 | $ 6,144 |
Convertible preferred shares (D
Convertible preferred shares (Details) $ / shares in Units, $ in Millions | May 28, 2019shares | Mar. 28, 2019$ / sharesshares | Jan. 03, 2019USD ($)shares | Dec. 20, 2018USD ($)shares | Oct. 27, 2017USD ($)shares | May 26, 2017USD ($)shares | May 31, 2019 | Jun. 30, 2019shares | Jan. 03, 2019£ / shares | Dec. 20, 2018£ / shares | Oct. 27, 2017£ / shares | May 26, 2017£ / shares |
Convertible preferred shares | ||||||||||||
Number of bonus shares for each ordinary share | 1.429 | |||||||||||
IPO | ||||||||||||
Convertible preferred shares | ||||||||||||
Number of shares issued (in shares) | 4,333,333 | |||||||||||
Share issue price | $ / shares | $ 14 | |||||||||||
Ordinary Shares | ||||||||||||
Convertible preferred shares | ||||||||||||
Number of shares issued (in shares) | 4,637,666 | |||||||||||
Conversion of convertible preferred shares to ordinary shares (in shares) | 11,647,529 | |||||||||||
Ordinary Shares | IPO | ||||||||||||
Convertible preferred shares | ||||||||||||
Conversion of convertible preferred shares to ordinary shares (in shares) | 11,647,529 | |||||||||||
Conversion ratio | 0.6997 | |||||||||||
Series B1 Convertible Preferred Shares | ||||||||||||
Convertible preferred shares | ||||||||||||
Number of shares issued (in shares) | 384,615 | 3,562,583 | ||||||||||
Share issue price | £ / shares | £ 13 | £ 11.2278 | ||||||||||
Gross proceeds from issues of shares | $ | $ 6.6 | $ 51.9 | ||||||||||
Numbers of warrants issued | 194,911 | 743,287 | ||||||||||
Number of warrants surrendered | 194,911 | |||||||||||
Series B2 Convertible Preferred Shares | ||||||||||||
Convertible preferred shares | ||||||||||||
Number of shares issued (in shares) | 80,385 | 1,323,248 | ||||||||||
Share issue price | £ / shares | £ 15.55 | £ 15.55 | ||||||||||
Gross proceeds from issues of shares | $ | $ 1.6 | $ 26.1 |
Warrant liability - Warrants in
Warrant liability - Warrants information (Details) $ in Thousands | May 28, 2019shares | Mar. 07, 2019 | Dec. 20, 2018shares | Oct. 27, 2017£ / sharesshares | May 26, 2017£ / sharesshares | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($)shares | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($)shares |
Warrants information | |||||||||
Number of shares issued for warrant exercise | 171,480 | ||||||||
Remaining warrants exercisable | 80,000 | 80,000 | 80,000 | ||||||
Number of shares into which remaining warrants is exercisable | 114,320 | ||||||||
Change in fair value of preferred stock warrant liability | $ | $ 0 | $ 2,200 | $ 0 | $ 5,381 | |||||
Other expenses | |||||||||
Warrants information | |||||||||
Change in fair value of preferred stock warrant liability | $ | $ 100 | ||||||||
Series A Preferred Shares | |||||||||
Warrants information | |||||||||
Numbers of warrants issued | 200,000 | ||||||||
Exercise price of warrants | £ / shares | £ 0.01 | ||||||||
Warrants exercisable term | 10 years | ||||||||
Warrants expiration term following an IPO or exit | 12 months | ||||||||
Number of warrants exercised | 120,000 | ||||||||
Series B1 Preferred Shares | |||||||||
Warrants information | |||||||||
Numbers of warrants issued | 194,911 | 115,384 | 627,903 | ||||||
Exercise price of warrants | £ / shares | £ 0.01 | £ 0.01 | |||||||
Number of shares issued for warrant exercise | 531,077 | ||||||||
Number of shares issued (in shares) | 384,615 | 3,562,583 | |||||||
Share issue price | £ / shares | £ 11.2278 | ||||||||
Number of warrants surrendered | 194,911 | ||||||||
Percentage of warrants exercisable in conjunction with the IPO | 50.00% | ||||||||
Percentage of warrants to expire in conjunction with the IPO | 50.00% |
Warrant liability - Roll-forwar
Warrant liability - Roll-forward of fair values of warrant liability (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Roll-forward of the fair values of the Company’s warrant liability | ||||
Change in fair value of warrant liability | $ 0 | $ 2,200 | $ 0 | $ 5,381 |
Ordinary shares (Details)
Ordinary shares (Details) | 6 Months Ended | |
Jun. 30, 2020Vote£ / sharesshares | Dec. 31, 2019£ / sharesshares | |
Ordinary shares | ||
Vote per ordinary share | Vote | 1 | |
Ordinary shares, shares authorized | shares | 31,995,653 | 31,995,653 |
Ordinary shares, nominal value | £ / shares | £ 0.01 | £ 0.01 |
Share-based compensation (Detai
Share-based compensation (Details) | Jan. 01, 2020shares | Jun. 30, 2020$ / sharesshares | May 31, 2019shares | Jun. 30, 2020$ / sharesshares | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2019$ / sharesshares | May 27, 2019£ / shares |
Stock option | ||||||||
Share-based compensation. | ||||||||
Shares outstanding | 3,654,012 | 3,654,012 | 2,634,346 | |||||
Exercise price | $ / shares | $ 9.91 | $ 9.91 | $ 9.57 | |||||
Employee Share Purchase Plan | ||||||||
Share-based compensation. | ||||||||
Percentage of annual increase in reserves on total number of ordinary shares outstanding | 1.00% | |||||||
Number of ordinary shares reserved for issuance | 215,000 | |||||||
Number of shares available for issuance | 430,000 | |||||||
Increase in number of ordinary shares reserved for issuance | 179,937 | |||||||
Percentage of ordinary shares at a price per share equal to the fair market value on offering date or purchase date | 85.00% | |||||||
2020 Plan | ||||||||
Share-based compensation. | ||||||||
Number of shares reserved for issuance | 4,773,557 | 4,773,557 | ||||||
Number of shares issued (in shares) | 574,679 | |||||||
Percentage of annual increase in reserves on total number of ordinary shares outstanding | 5.00% | |||||||
Shares outstanding | 0 | 0 | ||||||
2019 Plan | ||||||||
Share-based compensation. | ||||||||
Number of shares reserved for issuance | 544,866 | 544,866 | ||||||
2019 Plan | Stock option | ||||||||
Share-based compensation. | ||||||||
Shares outstanding | 2,645,465 | 2,645,465 | ||||||
Contractual life | 10 years | |||||||
2019 Plan | Stock option | First anniversary | ||||||||
Share-based compensation. | ||||||||
Vesting Percentage | 25.00% | |||||||
2019 Plan | Stock option | 36 equal monthly installments | ||||||||
Share-based compensation. | ||||||||
Number of equal monthly installments for vesting remaining awards | 36 months | |||||||
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 | ||||||||
Share-based compensation. | ||||||||
Shares outstanding | 1,008,547 | 1,008,547 | ||||||
Contractual life | 10 years | |||||||
Vesting period | 4 years | |||||||
Pre-IPO Share Options and restricted shares | Stock option | First anniversary | ||||||||
Share-based compensation. | ||||||||
Vesting Percentage | 25.00% | |||||||
Pre-IPO Share Options and restricted shares | Stock option | 36 equal monthly installments | ||||||||
Share-based compensation. | ||||||||
Number of equal monthly installments for vesting remaining awards | 36 months | |||||||
Pre-IPO Share Options and restricted shares | Stock option | United Kingdom | ||||||||
Share-based compensation. | ||||||||
Exercise price | £ / shares | £ 0.01 | |||||||
Pre-IPO Share Options and restricted shares | Performance based option | First anniversary | ||||||||
Share-based compensation. | ||||||||
Vesting Percentage | 20.00% | 20.00% | ||||||
Pre-IPO Share Options and restricted shares | Performance based option | 36 equal monthly installments | ||||||||
Share-based compensation. | ||||||||
Vesting Percentage | 60.00% | 60.00% | ||||||
Number of equal monthly installments for vesting remaining awards | 36 months | 36 months | ||||||
Pre-IPO Share Options and restricted shares | Performance based option | Earlier of the fourth anniversary | ||||||||
Share-based compensation. | ||||||||
Vesting Percentage | 20.00% | 20.00% |
Share-based compensation - Shar
Share-based compensation - Share based compensation expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Share based compensation expense | ||||
Total share-based compensation expense | $ 1,319 | $ 905 | $ 3,440 | $ 1,181 |
Research and development expenses | ||||
Share based compensation expense | ||||
Total share-based compensation expense | 522 | 291 | 1,195 | 399 |
General and administrative expenses | ||||
Share based compensation expense | ||||
Total share-based compensation expense | $ 797 | $ 614 | $ 2,245 | $ 782 |
Share-based compensation - Sh_2
Share-based compensation - Share options (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
Additional Information | |||||||
Total share-based compensation expense | $ 1,319 | $ 905 | $ 3,440 | $ 1,181 | |||
Ordinary Shares | |||||||
Number of Shares | |||||||
Exercised | (4,000) | (1,071) | (14,301) | (3) | |||
Stock option | |||||||
Number of Shares | |||||||
Outstanding number of shares at beginning | 2,634,346 | 2,634,346 | |||||
Granted | 1,174,434 | ||||||
Exercised | (5,071) | ||||||
Forfeited | (149,697) | ||||||
Outstanding number of shares at end | 3,654,012 | 3,654,012 | 2,634,346 | ||||
Number of shares, vested and expected to vest | 3,654,012 | 3,654,012 | |||||
Number of shares, options exercisable | 1,168,098 | 1,168,098 | |||||
Weighted Average Exercise Price | |||||||
Weighted average exercise price at beginning | $ 9.57 | $ 9.57 | |||||
Granted | 10.88 | ||||||
Exercised | 2.29 | ||||||
Forfeited | 10.72 | ||||||
Weighted average exercise price at ending | $ 9.91 | 9.91 | $ 9.57 | ||||
Weighted average exercise price, vested and expected to vest | 9.91 | 9.91 | |||||
Weighted average exercise price, options exercisable | $ 8.06 | $ 8.06 | |||||
Weighted Average Contractual Term | |||||||
Weighted average contractual term, outstanding | 8 years 11 months 9 days | 9 years 15 days | |||||
Weighted average contractual term, vested and expected to vest | 8 years 11 months 9 days | ||||||
Weighted average contractual term ,options exercisable | 8 years 2 months 5 days | ||||||
Aggregate Intrinsic Value | |||||||
Aggregate intrinsic value outstanding | $ 21,378 | $ 21,378 | $ 2,868 | ||||
Granted | $ 7.08 | $ 8.26 | |||||
Exercised | 100 | $ 100 | $ 100 | $ 100 | |||
Aggregate intrinsic value, vested and expected to vest | 21,378 | 21,378 | |||||
Aggregate intrinsic value, options exercisable | 9,655 | $ 9,655 | |||||
Additional Information | |||||||
Granted | $ 7.08 | $ 8.26 | |||||
Total share-based compensation expense | 1,300 | 600 | $ 3,400 | $ 800 | |||
Exercised | $ 100 | $ 100 | $ 100 | $ 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 | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Share-based compensation. | ||||
Risk-free interest rate | 0.40% | 2.20% | 1.50% | 2.20% |
Expected volatility | 76.80% | 78.00% | 74.10% | 78.10% |
Expected term (in years) | 6 years 1 month 6 days | 5 years 9 months 18 days | 6 years | 5 years 10 months 24 days |
Unrecognized compensation expense | ||||
Total unrecognized compensation expense related to the unvested employee and director | $ 14.5 | $ 14.5 | ||
Unrecognized compensation cost expected to be recognized over a weighted average period | 2 years 9 months 18 days |
Share-based compensation - Rest
Share-based compensation - Restricted shares (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | |
Restricted shares | |||||
Total share-based compensation expense | $ 1,319 | $ 905 | $ 3,440 | $ 1,181 | |
Restricted ordinary shares | |||||
Number of shares | |||||
Unvested restricted ordinary shares at beginning | 0 | ||||
Unvested restricted ordinary shares at ending | 0 | 0 | |||
Restricted shares | |||||
Unvested restricted ordinary shares | 0 | 0 | 0 | ||
Total share-based compensation expense | $ 0 | 300 | $ 0 | 400 | |
Restricted ordinary shares | Employees and directors | |||||
Restricted shares | |||||
Unrecognized compensation cost | $ 0 | ||||
Restricted ordinary shares | Employee | |||||
Restricted shares | |||||
Fair value of employee restricted share awards vested | $ 0 | $ 600 | $ 0 | $ 700 |
Significant agreements - Collab
Significant agreements - Collaboration revenues (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Significant agreements. | ||||
Collaboration revenues | $ 1,571 | $ 1,522 | $ 2,700 | $ 7,906 |
AstraZeneca | ||||
Significant agreements. | ||||
Collaboration revenues | 319 | 362 | 731 | 787 |
Sanofi | ||||
Significant agreements. | ||||
Collaboration revenues | 0 | 57 | 0 | 6,016 |
Dementia Discovery Fund | ||||
Significant agreements. | ||||
Collaboration revenues | 56 | 103 | 112 | 103 |
Material transfer agreement | ||||
Significant agreements. | ||||
Collaboration revenues | 0 | 1,000 | $ 1,000 | |
Genetech | ||||
Significant agreements. | ||||
Collaboration revenues | $ 1,196 | $ 0 | $ 1,857 |
Significant agreements - AstraZ
Significant agreements - AstraZeneca Collaboration Agreement (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||||||
May 31, 2019employee | May 31, 2018USD ($) | Aug. 31, 2017 | Nov. 30, 2016USD ($)employeeitem | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | Dec. 31, 2019USD ($) | Jul. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Oct. 31, 2017USD ($) | |
Significant agreements. | ||||||||||||
Collaboration revenues | $ 1,571,000 | $ 1,522,000 | $ 2,700,000 | $ 7,906,000 | ||||||||
Deferred revenue | 33,082,000 | 33,082,000 | $ 5,657,000 | $ 14,635,000 | ||||||||
AstraZeneca | ||||||||||||
Significant agreements. | ||||||||||||
Biological Targets | item | 6 | |||||||||||
Term (in years) | 3 years | |||||||||||
Term, Bicycle Research Team (in years) | 1 year | |||||||||||
Term, AZ Research (in years) | 2 years | |||||||||||
Number of FTE | employee | 2 | |||||||||||
Collaboration revenues | 319,000 | 362,000 | 731,000 | 787,000 | ||||||||
Deferred revenue | 4,807,000 | 4,807,000 | 4,913,000 | $ 4,727,000 | ||||||||
AstraZeneca | Development milestone | ||||||||||||
Significant agreements. | ||||||||||||
Transaction price | $ 700,000 | |||||||||||
AstraZeneca | Target One | ||||||||||||
Significant agreements. | ||||||||||||
Transaction price | $ 2,000,000 | |||||||||||
AstraZeneca | Target Two | ||||||||||||
Significant agreements. | ||||||||||||
Transaction price | $ 600,000 | |||||||||||
AstraZeneca | Target Three Research License and Related Services | ||||||||||||
Significant agreements. | ||||||||||||
Collaboration revenues | 300,000 | 300,000 | 700,000 | 600,000 | ||||||||
AstraZeneca | Commercialization license per candidate | ||||||||||||
Significant agreements. | ||||||||||||
Customer option payment | 8,000,000 | |||||||||||
AstraZeneca | Development Milestone | Development milestone | ||||||||||||
Significant agreements. | ||||||||||||
Customer option payment | 29,000,000 | |||||||||||
AstraZeneca | Regulatory Milestone | Regulatory milestone | ||||||||||||
Significant agreements. | ||||||||||||
Customer option payment | 23,000,000 | |||||||||||
AstraZeneca | Commercial milestone | Commercial milestone | ||||||||||||
Significant agreements. | ||||||||||||
Customer option payment | $ 110,000,000 | |||||||||||
AstraZeneca | Minimum | ||||||||||||
Significant agreements. | ||||||||||||
Term extension (in years) | 12 months | |||||||||||
AstraZeneca | Maximum | ||||||||||||
Significant agreements. | ||||||||||||
Term extension (in years) | 15 months | |||||||||||
AstraZeneca | 2016 Collaboration Agreement | ||||||||||||
Significant agreements. | ||||||||||||
Biological Targets | item | 2 | |||||||||||
Option fee for development and exploitation rights | $ 8,000,000 | |||||||||||
Transaction price | $ 1,200,000 | |||||||||||
Deferred revenue | 0 | 0 | 0 | |||||||||
AstraZeneca | 2016 Collaboration Agreement | Target One and Target Two Research License and Related Services | ||||||||||||
Significant agreements. | ||||||||||||
Collaboration revenues | 0 | $ 25,000 | 0 | $ 200,000 | ||||||||
AstraZeneca | May 2018 Option Exercise | ||||||||||||
Significant agreements. | ||||||||||||
Biological Targets | item | 4 | |||||||||||
Option fee for development and exploitation rights | 5,000,000 | $ 5,000,000 | ||||||||||
Number of FTE | employee | 2 | |||||||||||
Customer option payment | $ 8,000,000 | |||||||||||
Transaction price | 5,650,000 | 5,650,000 | $ 6,300,000 | |||||||||
Deferred revenue | 4,800,000 | 4,800,000 | $ 4,900,000 | |||||||||
AstraZeneca | May 2018 Option Exercise | Target Three Research License and Related Services | ||||||||||||
Significant agreements. | ||||||||||||
Transaction price | 650,000 | 650,000 | ||||||||||
AstraZeneca | May 2018 Option Exercise | Target 3 Material Right | ||||||||||||
Significant agreements. | ||||||||||||
Transaction price | 1,504,000 | 1,504,000 | ||||||||||
AstraZeneca | May 2018 Option Exercise | Target 4 Material Right | ||||||||||||
Significant agreements. | ||||||||||||
Transaction price | 1,204,000 | 1,204,000 | ||||||||||
AstraZeneca | May 2018 Option Exercise | Target 5 Material Right | ||||||||||||
Significant agreements. | ||||||||||||
Transaction price | 1,165,000 | 1,165,000 | ||||||||||
AstraZeneca | May 2018 Option Exercise | Target 6 Material Right | ||||||||||||
Significant agreements. | ||||||||||||
Transaction price | $ 1,127,000 | $ 1,127,000 |
Significant agreements - Sanofi
Significant agreements - Sanofi Collaboration Agreement (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Aug. 31, 2017 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Significant agreements. | |||||||
Revenue recognized by non exercising of option | $ 0 | $ 0 | $ 5,286 | ||||
Revenue from collaborative arrangement | 1,571 | 1,522 | $ 2,700 | 7,906 | |||
Deferred revenue | 33,082 | 33,082 | $ 5,657 | $ 14,635 | |||
Development milestone | |||||||
Significant agreements. | |||||||
Non refundable payment for services during the BV Bicycle Research Term | 4,200 | ||||||
Sanofi | |||||||
Significant agreements. | |||||||
Total transaction price initially determined | $ 14,200 | 14,900 | |||||
Upfront cash payment | 10,000 | ||||||
Non refundable payment for services during the BV Bicycle Research Term | 4,200 | ||||||
Revenue from collaborative arrangement | 0 | 57 | 0 | $ 6,016 | |||
Deferred revenue | $ 0 | $ 0 | $ 0 | $ 9,908 | |||
Sanofi | Sickle Cell Research License and Related Services | |||||||
Significant agreements. | |||||||
Total transaction price initially determined | 1,405 | ||||||
Sanofi | Hemophilia Research License and Related Services | |||||||
Significant agreements. | |||||||
Total transaction price initially determined | 2,811 | ||||||
Sanofi | Sickle Cell License Option Material Right | |||||||
Significant agreements. | |||||||
Total transaction price initially determined | 5,286 | ||||||
Revenue recognized by non exercising of option | $ 5,300 | ||||||
Sanofi | Hemophilia License Option Material Right | |||||||
Significant agreements. | |||||||
Total transaction price initially determined | $ 4,698 |
Significant agreements - Oxurio
Significant agreements - Oxurion Collaboration Agreement (Details) $ in Thousands, € in Millions | 3 Months Ended | 6 Months Ended | ||||||
Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2020EUR (€) | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Significant agreements. | ||||||||
Revenue from collaborative arrangement | $ | $ 1,571 | $ 1,522 | $ 2,700 | $ 7,906 | ||||
Deferred revenue | $ | $ 33,082 | $ 5,657 | $ 14,635 | |||||
Oxurion | ||||||||
Significant agreements. | ||||||||
Threshold period of notice required for termination of agreement | 90 days | 90 days | ||||||
Revenue from collaborative arrangement | $ | $ 0 | $ 0 | $ 0 | $ 0 | ||||
Deferred revenue | $ | $ 0 | |||||||
Oxurion | Development milestone | ||||||||
Significant agreements. | ||||||||
Upfront cash payment | € 1 | |||||||
Potential milestone payments | 8.3 | |||||||
Revenue under contracts with customer from milestone payment | 1.8 | |||||||
Oxurion | Regulatory milestone | ||||||||
Significant agreements. | ||||||||
Potential milestone payments | 16.5 | |||||||
Oxurion | Granting first regulatory approval or first indication | ||||||||
Significant agreements. | ||||||||
Potential milestone payments | € 5 |
Significant agreements - Dement
Significant agreements - Dementia Discovery Fund Agreement (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
May 31, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | |
Significant agreements. | |||||||
Collaboration revenues | $ 1,571 | $ 1,522 | $ 2,700 | $ 7,906 | |||
Deferred revenue | 33,082 | 33,082 | $ 5,657 | $ 14,635 | |||
Dementia Discovery Fund | |||||||
Significant agreements. | |||||||
Upfront cash payment | $ 1,100 | ||||||
Potential milestone payments | $ 700 | ||||||
Threshold period for exercising option to establish a jointly-owned new company | 90 days | ||||||
Option to purchase ownership of new entity | 34.00% | ||||||
Threshold period of notice required for termination of agreement | 60 days | ||||||
Transaction price | $ 1,100 | ||||||
Collaboration revenues | 56 | $ 103 | 112 | $ 103 | |||
Deferred revenue | $ 582 | $ 582 | $ 744 | ||||
Dementia Discovery Fund | NewCo | |||||||
Significant agreements. | |||||||
Option to purchase ownership of new entity | 66.00% | ||||||
Threshold period in which Newco shall have the right to initiate a new research program | 2 years | ||||||
Dementia Discovery Fund | NewCo | Maximum | |||||||
Significant agreements. | |||||||
Total voting rights related to ownership interests | 50.00% |
Significant agreements - Materi
Significant agreements - Material Transfer Agreement (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||
Oct. 31, 2020 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Significant agreements. | |||||
Collaboration revenues | $ 1,571 | $ 1,522 | $ 2,700 | $ 7,906 | |
Material transfer agreement | |||||
Significant agreements. | |||||
Upfront cash payment | $ 1,000 | ||||
Threshold period for receipt of revenue after receipt of the materials and related data package | 30 days | ||||
Collaboration revenues | $ 0 | $ 1,000 | $ 1,000 |
Significant agreements - Genete
Significant agreements - Genetech Collaboration Agreement (Details) $ in Thousands | Feb. 21, 2020USD ($)item | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) |
Significant agreements. | |||||||
Collaboration revenues | $ 1,571 | $ 1,522 | $ 2,700 | $ 7,906 | |||
Deferred revenue | 33,082 | 33,082 | $ 5,657 | $ 14,635 | |||
Genetech | |||||||
Significant agreements. | |||||||
Number of Potential development candidates | item | 4 | ||||||
Upfront cash payment | $ 30,000 | ||||||
Number of immuno oncology targets | item | 2 | ||||||
Expansion Fee | $ 10,000 | ||||||
Number of collaboration programs | item | 2 | ||||||
Transaction price | $ 31,000 | ||||||
Collaboration revenues | 1,196 | $ 0 | 1,857 | ||||
Deferred revenue | 27,693 | $ 27,693 | |||||
Period over which performance obligations will be performed | 2 years | ||||||
Material rights exercise period | 4 years | ||||||
Genetech | Royalty | |||||||
Significant agreements. | |||||||
Number of years over which royalty is payable | 10 years | ||||||
Genetech | Maximum | |||||||
Significant agreements. | |||||||
Additional number of immuno oncology targets | item | 2 | ||||||
Regulatory, and initial commercialization milestones, payments receivable | $ 200,000 | ||||||
Genetech | Development milestone | Maximum | |||||||
Significant agreements. | |||||||
Sales milestone payments, receivable | 65,000 | ||||||
Genetech | Regulatory milestone | Maximum | |||||||
Significant agreements. | |||||||
Sales milestone payments, receivable | 135,000 | ||||||
Genetech | Collaboration Program 1 Performance Obligation | |||||||
Significant agreements. | |||||||
Transaction price | 3,775 | ||||||
Genetech | Collaboration Program 2 Performance Obligation | |||||||
Significant agreements. | |||||||
Regulatory, and initial commercialization milestones, payments receivable | 8,000,000,000 | ||||||
Transaction price | $ 7,550 | ||||||
Genetech | Specified Targeting Arm Material Right Arm Program One | |||||||
Significant agreements. | |||||||
Number of initial collaboration programs exercised | item | 1 | ||||||
Sales milestone payments, receivable | $ 1,000 | ||||||
Transaction price | 330 | ||||||
Genetech | Two material rights associated with the LSR Go Option for Collaboration Programs One And Two | |||||||
Significant agreements. | |||||||
Transaction price | 11,650 | ||||||
Genetech | Material rights for associated and limited substitution rights | |||||||
Significant agreements. | |||||||
Transaction price | $ 1,115 | ||||||
Genetech | Two material rights for Expansion Options | |||||||
Significant agreements. | |||||||
Number of expansion option collaboration programs | item | 2 | ||||||
Transaction price | $ 6,580 | ||||||
Genetech | Collaboration Program One and Two Performance Obligation | Maximum | |||||||
Significant agreements. | |||||||
Sales milestone payments, receivable | $ 200,000 | ||||||
Genetech | Material rights | |||||||
Significant agreements. | |||||||
Deferred revenue | $ 19,700 | $ 19,700 |
Significant agreements - Summar
Significant agreements - Summary of Contract Assets and Liabilities (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2020 | Dec. 31, 2019 | |
Contract assets | ||
Balance at the beginning of year | $ 0 | $ 0 |
Additions | 149 | |
Deductions | (149) | |
Impact of exchange rates | 0 | |
Balance at the end of year | 0 | |
Contract liabilities: | ||
Balance at the beginning of year | 5,657 | 14,635 |
Additions | 31,271 | 1,172 |
Deductions | (2,002) | (10,413) |
Impact of exchange rates | (1,844) | 263 |
Balance at the end of year | 33,082 | 5,657 |
AstraZeneca | ||
Contract liabilities: | ||
Balance at the beginning of year | 4,913 | 4,727 |
Additions | 271 | 58 |
Deductions | (33) | (35) |
Impact of exchange rates | (344) | 163 |
Balance at the end of year | 4,807 | 4,913 |
Sanofi | ||
Contract liabilities: | ||
Balance at the beginning of year | 0 | 9,908 |
Additions | 0 | |
Deductions | (9,984) | |
Impact of exchange rates | 76 | |
Balance at the end of year | 0 | 0 |
Dementia Discovery Fund | ||
Contract assets | ||
Balance at the beginning of year | 744 | 0 |
Additions | 1,114 | |
Deductions | (394) | |
Impact of exchange rates | 24 | |
Balance at the end of year | 744 | |
Contract liabilities: | ||
Balance at the beginning of year | 744 | |
Deductions | (112) | |
Impact of exchange rates | (50) | |
Balance at the end of year | 582 | $ 744 |
Genetech | ||
Contract liabilities: | ||
Additions | 31,000 | |
Deductions | (1,857) | |
Impact of exchange rates | (1,450) | |
Balance at the end of year | $ 27,693 |
Significant agreements - Deferr
Significant agreements - Deferred revenue (Details) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Deferred revenue | |||
Deferred revenue | $ 33,082 | $ 5,657 | $ 14,635 |
AstraZeneca | |||
Deferred revenue | |||
Deferred revenue | 4,807 | $ 4,913 | $ 4,727 |
AstraZeneca | Target 3, Target 4, Target 5 and Target 6 Material Rights | |||
Deferred revenue | |||
Deferred revenue | $ 4,500 |
Significant agreements - Revenu
Significant agreements - Revenue recognition due to changes in contract assets and liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Significant Agreements | ||||
Revenue recognized based on proportional performance | $ (1,251) | $ (113) | $ (2,002) | $ (138) |
Revenue recognized based on expiration of material rights | 0 | 0 | (5,286) | |
Total | $ (1,251) | $ (113) | $ (2,002) | $ (5,424) |
Significant agreements - Cancer
Significant agreements - Cancer Research UK (Details) - USD ($) $ in Millions | Dec. 13, 2016 | Dec. 31, 2019 | Dec. 31, 2016 | Jun. 30, 2020 |
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 | $ 2 | $ 2.1 | ||
Commercialization license per candidate | ||||
Research and development arrangement obligation to repay other parties | ||||
Refunding the costs and expenses incurred in case of termination (as a percent) | 50.00% | |||
BT1718 | Minimum | ||||
Research and development arrangement obligation to repay other parties | ||||
Tiered royalties (percentage) | 70.00% | |||
BT1718 | Maximum | ||||
Research and development arrangement obligation to repay other parties | ||||
Tiered royalties (percentage) | 90.00% | |||
BT7401 | Minimum | ||||
Research and development arrangement obligation to repay other parties | ||||
Tiered royalties (percentage) | 55.00% | |||
BT7401 | Maximum | ||||
Research and development arrangement obligation to repay other parties | ||||
Tiered royalties (percentage) | 80.00% |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Income Taxes | ||||
Benefit from income taxes | $ 97 | $ (135) | $ 204 | $ (215) |
Commitments and Contingencies -
Commitments and Contingencies - Leases, Office and laboratory space in Cambridge and Lexington, Massachusetts (Details) - Office and laboratory space in Lexington, Massachusetts $ in Millions | 1 Months Ended |
Sep. 30, 2017USD ($) | |
Leases | |
Security deposit | $ 0.2 |
Payment under the lease | $ 0.1 |
Discounted percentage for present value of lease payments | 9.00% |
Commitments and Contingencies_2
Commitments and Contingencies - Leases, Office and laboratory space in Building 900, Babraham Research Campus, Cambridge (Details) - Office and laboratory space in Building 900, Babraham Research Campus, Cambridge $ in Millions | Oct. 31, 2017USD ($) |
Leases | |
Annual rent | $ 0.5 |
Renewal term | 5 years |
Estimated service charges payable | $ 0.1 |
Security deposit | $ 0.6 |
Discounted percentage for present value of lease payments | 7.75% |
Commitments and Contingencies_3
Commitments and Contingencies - Leases, Components of lease expense (Details) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2020USD ($) | Jun. 30, 2020USD ($) | |
Commitments and Contingencies | ||
Operating lease cost | $ 220 | $ 443 |
Variable lease cost | 164 | 303 |
Total lease cost | $ 384 | $ 746 |
Weighted-average remaining operating lease term (years) | 2 years 2 months 12 days | 2 years 2 months 12 days |
Weighted-average discount rate | 8.59% | 8.59% |
Commitments and Contingencies_4
Commitments and Contingencies - Leases, Maturities of operating leases (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2020 | Dec. 31, 2019 | |
Commitments and Contingencies | ||
2020 | $ 443 | |
2021 | 753 | |
2022 | 443 | |
Present value adjustment | (136) | |
Total lease liabilities | 1,503 | |
Less: current lease liabilities | (653) | $ (640) |
Long term lease liabilities | $ 850 | $ 1,251 |
Maximum days allowed for cancellation of contracts prior written notice | 90 days |
Commitments and Contingencies_5
Commitments and Contingencies - Founder Royalty arrangements (Details) - Founders and initial investors - Royalty Agreements $ in Thousands | 6 Months Ended |
Jun. 30, 2020USD ($) | |
Founder Royalty arrangements | |
Period of royalty payments agreed under arrangement | 10 years |
Royalties paid | $ 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 | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Numerator: | ||||
Net loss attributable to ordinary shareholders | $ (12,115) | $ (10,217) | $ (23,438) | $ (16,720) |
Denominator: | ||||
Weighted average ordinary shares outstanding, basic and diluted | 18,077,770 | 7,298,139 | 18,024,314 | 4,101,564 |
Net loss per share attributable to ordinary shareholders, basic and diluted | $ (0.67) | $ (1.40) | $ (1.30) | $ (4.08) |
Net loss per share per share -
Net loss per share per share - Securities excluded from the diluted per share calculation (Details) - shares | Mar. 07, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | May 28, 2019 |
Antidilutive securities | ||||
Antidilutive securities (in shares) | 3,654,012 | 2,730,269 | ||
Remaining warrants exercisable | 80,000 | 80,000 | ||
Warrants to subscribe for convertible preferred shares (as adjusted to reflect the impact of the share capital reorganization and issuance of bonus shares | ||||
Antidilutive securities | ||||
Antidilutive securities (in shares) | 114,320 | |||
Percentage of warrants exercise in conjunction with IPO | 50.00% | |||
Percentage of warrants expire | 50.00% | |||
Number of ordinary shares for warrants exercise | 114,320 | |||
Options to purchase ordinary shares | ||||
Antidilutive securities | ||||
Antidilutive securities (in shares) | 3,654,012 | 2,615,949 |
Benefit plans (Details)
Benefit plans (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
United States | 401(k) Plan | ||||
Benefit plans | ||||
Contributions made | $ 38,000 | $ 25,000 | $ 100,000 | $ 100,000 |
Foreign Plan | U.K. Plan | ||||
Benefit plans | ||||
Contributions made | $ 100,000 | $ 100,000 | $ 200,000 | $ 200,000 |
Related party transactions (Det
Related party transactions (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Consultancy services with 10X Capital Inc. | ||||
Related party transactions | ||||
Amount of transaction | $ 0 | $ 0 | $ 0 | $ 50,000 |
Consultancy services with Stone Sunny Isles Inc. | ||||
Related party transactions | ||||
Amount of transaction | $ 100,000 | $ 0 | $ 100,000 | $ 0 |
Geographic information (Details
Geographic information (Details) $ in Thousands | 6 Months Ended | |
Jun. 30, 2020USD ($)segment | Dec. 31, 2019USD ($) | |
Geographic information | ||
Number of geographic regions | segment | 2 | |
Long lived assets, including operating lease right of use assets | $ 3,800 | $ 4,348 |
United States | ||
Geographic information | ||
Long lived assets, including operating lease right of use assets | 1,823 | 2,017 |
United Kingdom | ||
Geographic information | ||
Long lived assets, including operating lease right of use assets | $ 1,977 | $ 2,331 |
Subsequent events (Details)
Subsequent events (Details) - USD ($) $ / shares in Units, $ in Millions | Jul. 07, 2020 | Jun. 05, 2020 | Jun. 30, 2019 |
Subsequent events | |||
Offering expenses | $ 8.4 | ||
At the market offering | |||
Subsequent events | |||
Maximum aggregate offering price | $ 50 | ||
At the market offering | Subsequent events | |||
Subsequent events | |||
Shares issued (in shares) | 1,192,713 | ||
Share issue price | $ 15.50 | ||
Gross proceeds before discounts and commissions | $ 18.5 | ||
Net proceeds | 17.6 | ||
Offering expenses | $ 0.9 |