Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2020 | Nov. 11, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2020 | |
Document Transition Report | false | |
Entity File Number | 001-36866 | |
Entity Registrant Name | Summit Therapeutics Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 37-1979717 | |
Entity Address, Address Line One | One Broadway, 14th Floor | |
Entity Address, City or Town | Cambridge | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02142 | |
City Area Code | 617 | |
Local Phone Number | 514-7149 | |
Title of 12(b) Security | Common Stock, $0.01 par value per share | |
Trading Symbol | SMMT | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 82,260,004 | |
Entity Central Index Key | 0001599298 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Unaudited Condensed Consolidate
Unaudited Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Current assets | ||
Cash and cash equivalents | $ 21,270 | $ 63,842 |
Accounts receivable | 4,080 | 541 |
Prepaid expenses | 7,141 | 8,762 |
Other current assets | 1,667 | 1,399 |
Research and development tax credit receivables | 7,919 | 5,084 |
Total current assets | 42,077 | 79,628 |
Property, plant and equipment | 724 | 518 |
Right-of-use assets | 628 | 1,021 |
Goodwill | 2,335 | 2,392 |
Intangible assets | 11,101 | 13,120 |
Total assets | 56,865 | 96,679 |
Current liabilities | ||
Accounts payable | 2,493 | 4,471 |
Accrued expenses | 4,398 | 5,739 |
Other current liabilities | 354 | 366 |
Lease liabilities | 386 | 471 |
Deferred income | 7,111 | 2,615 |
Contingent consideration | 0 | 105 |
Total current liabilities | 14,742 | 13,767 |
Non-current liabilities | ||
Deferred income | 715 | 493 |
Lease liabilities | 162 | 422 |
Other non-current liabilities | 2,277 | 2,703 |
Deferred tax liability | 2,108 | 2,057 |
Total liabilities | 20,004 | 19,442 |
Commitments and contingencies | ||
Stockholders'equity | ||
Common stock, $0.01 par value: 250,000,000 shares authorized; 67,231,903 and 67,178,054 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively | 672 | 672 |
Additional paid-in capital | 242,395 | 241,204 |
Accumulated other comprehensive loss | (7,032) | (4,720) |
Accumulated deficit | (199,174) | (159,919) |
Total stockholders' equity | 36,861 | 77,237 |
Total liabilities and stockholders' equity | $ 56,865 | $ 96,679 |
Unaudited Condensed Consolida_2
Unaudited Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Common stock par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 250,000,000 | 250,000,000 |
Common stock, shares issued (in shares) | 67,231,903 | 67,178,054 |
Common stock, shares outstanding (in shares) | 67,231,903 | 67,178,054 |
Unaudited Condensed Consolida_3
Unaudited Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Income Statement And Statement Of Comprehensive Income [Abstract] | ||||
Revenue | $ 181 | $ 148 | $ 675 | $ 795 |
Operating expenses | ||||
Research and development | (14,387) | (9,951) | (40,979) | (32,586) |
General and administrative | (7,460) | (2,683) | (13,430) | (7,917) |
Impairment | (859) | 0 | (859) | 0 |
Total operating expenses | (22,706) | (12,634) | (55,268) | (40,503) |
Other operating income | 4,309 | 6,296 | 14,949 | 19,881 |
Operating loss | (18,216) | (6,190) | (39,644) | (19,827) |
Other income (expense), net | 416 | (75) | 296 | (231) |
Loss before income tax | (17,800) | (6,265) | (39,348) | (20,058) |
Income tax benefit (expense) | 99 | (111) | 93 | 13 |
Net loss | $ (17,701) | $ (6,376) | $ (39,255) | $ (20,045) |
Basic earnings (loss) per share (in dollars per share) | $ (0.26) | $ (0.20) | $ (0.58) | $ (0.63) |
Diluted earnings (loss) per share (in dollars per share) | $ (0.26) | $ (0.20) | $ (0.58) | $ (0.63) |
Other comprehensive income / (loss) | ||||
Foreign currency translation adjustment | $ 2,255 | $ (1,255) | $ (2,312) | $ (1,299) |
Total comprehensive loss | $ (15,446) | $ (7,631) | $ (41,567) | $ (21,344) |
Unaudited Condensed Consolida_4
Unaudited Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income(Loss) | Total Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2018 | 16,452,976 | ||||
Beginning balance at Dec. 31, 2018 | $ 32,170 | $ 165 | $ 166,628 | $ (6,571) | $ (128,052) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issue of common stock, net of offering costs (in shares) | 15,625,000 | ||||
Issue of common stock, net of offering costs | 24,501 | $ 156 | 24,345 | ||
Issuance on common stock from exercise of share options (in shares) | 20,975 | ||||
Issuance on common stock from exercise of stock options | 2 | 2 | |||
Stock-based compensation | 848 | 848 | |||
Unrealized gain (loss) on foreign currency translation adjustments | (1,299) | (1,299) | |||
Net loss | (20,045) | (20,045) | |||
Ending balance (in shares) at Sep. 30, 2019 | 32,098,951 | ||||
Ending balance at Sep. 30, 2019 | 36,177 | $ 321 | 191,823 | (7,870) | (148,097) |
Beginning balance (in shares) at Jun. 30, 2019 | 32,098,951 | ||||
Beginning balance at Jun. 30, 2019 | 43,564 | $ 321 | 191,579 | (6,615) | (141,721) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation | 244 | 244 | |||
Unrealized gain (loss) on foreign currency translation adjustments | (1,255) | (1,255) | |||
Net loss | (6,376) | (6,376) | |||
Ending balance (in shares) at Sep. 30, 2019 | 32,098,951 | ||||
Ending balance at Sep. 30, 2019 | $ 36,177 | $ 321 | 191,823 | (7,870) | (148,097) |
Beginning balance (in shares) at Dec. 31, 2019 | 67,178,054 | 67,178,054 | |||
Beginning balance at Dec. 31, 2019 | $ 77,237 | $ 672 | 241,204 | (4,720) | (159,919) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Fractional shares issued from reverse stock split (in shares) | 3 | ||||
Issuance on common stock from exercise of share options (in shares) | 53,846 | ||||
Issuance on common stock from exercise of stock options | 3 | 3 | |||
Stock-based compensation | 1,188 | 1,188 | |||
Unrealized gain (loss) on foreign currency translation adjustments | (2,312) | (2,312) | |||
Net loss | $ (39,255) | (39,255) | |||
Ending balance (in shares) at Sep. 30, 2020 | 67,231,903 | 67,231,903 | |||
Ending balance at Sep. 30, 2020 | $ 36,861 | $ 672 | 242,395 | (7,032) | (199,174) |
Beginning balance (in shares) at Jun. 30, 2020 | 67,231,900 | ||||
Beginning balance at Jun. 30, 2020 | 51,946 | $ 672 | 242,034 | (9,287) | (181,473) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Fractional shares issued from reverse stock split (in shares) | 3 | ||||
Stock-based compensation | 361 | 361 | |||
Unrealized gain (loss) on foreign currency translation adjustments | 2,255 | 2,255 | |||
Net loss | $ (17,701) | (17,701) | |||
Ending balance (in shares) at Sep. 30, 2020 | 67,231,903 | 67,231,903 | |||
Ending balance at Sep. 30, 2020 | $ 36,861 | $ 672 | $ 242,395 | $ (7,032) | $ (199,174) |
Unaudited Condensed Consolida_5
Unaudited Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Cash flows from operating activities | |||||
Net loss | $ (17,701) | $ (6,376) | $ (39,255) | $ (20,045) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||
(Gain)/loss on recognition of contingent consideration payable | (101) | 2 | |||
Other (income)/expense | (416) | 75 | (296) | 231 | |
Unrealized foreign exchange gain | (40) | 342 | |||
Depreciation of operating right-of-use assets | 252 | 283 | |||
Depreciation | 267 | 268 | |||
Amortization of intangible assets | 827 | 791 | $ 1,000 | ||
Loss on disposal of assets | 0 | 33 | |||
Impairment of intangible assets | 859 | 0 | 859 | 0 | |
Stock-based compensation | 1,188 | 848 | |||
Deferred income taxes | 99 | (120) | |||
Change in operating assets and liabilities: | |||||
Accounts receivable | (3,480) | 2,750 | |||
Prepaid expenses | 1,431 | 2,725 | |||
Other current assets | (294) | 641 | |||
Research and development tax credit receivable | (3,497) | 1,806 | |||
Deferred income | 5,286 | (2,608) | |||
Accounts payable | (1,849) | (521) | |||
Accrued liabilities | (1,196) | (244) | |||
Contingent consideration paid | 0 | (701) | |||
Lease liabilities | (341) | (342) | |||
Net cash used in operating activities | (40,140) | (13,861) | |||
Investing activities | |||||
Purchase of property, plant and equipment | (371) | (247) | |||
Purchase of intangible assets | 0 | (111) | |||
Net cash used in investing activities | (371) | (358) | |||
Financing activities | |||||
Proceeds from issue of share capital | 0 | 25,081 | |||
Transaction costs on share capital issued | 0 | (579) | |||
Proceeds from exercise of share options | 3 | 2 | |||
Net cash provided by financing activities | 3 | 24,504 | |||
(Decrease) / increase in cash and cash equivalents | (40,508) | 10,285 | |||
Effect of exchange rates on cash and cash equivalents | (2,064) | (787) | |||
Cash and cash equivalents at beginning of the year | 63,842 | 12,138 | 12,138 | ||
Cash and cash equivalents at end of the year | $ 21,270 | $ 21,636 | $ 21,270 | $ 21,636 | $ 63,842 |
Basis of presentation
Basis of presentation | 9 Months Ended |
Sep. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of presentation | Basis of presentation Summit Therapeutics Inc. ("Summit" or the "Company") is the successor to Summit Therapeutics plc, a company organized under the laws of the United Kingdom ("Summit U.K.") As part of the plan to cause the publicly traded parent company of Summit to be a Delaware corporation ( the "Redomiciliation Transaction") on September 18 2020, Summit and Summit U.K. completed a statutory scheme of arrangement under U.K. law pursuant to which all Summit U.K. outstanding ordinary shares were exchanged on a five-for-one basis for newly issued shares of Summit common stock and Summit U.K. became a wholly-owned subsidiary of Summit, which was retroactively reflected in our audited financial statements as filed in our current report on Form 8-K, filed on September 29, 2020. The scheme of arrangement was accounted for as an exchange of equity interests among entities under common control. All assets and liabilities of Summit U.K. were assumed by Summit, resulting in the retention of the historical basis of accounting as if they had always been combined for accounting and financial reporting purposes. The accompanying unaudited interim consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States ("GAAP") and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission. Accordingly, certain information and disclosures required by GAAP for complete consolidated financial statements are not included herein. These unaudited interim consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto of Summit Therapeutics Inc. and its consolidated subsidiaries (the "Company") which are included in the Current Report on Form 8-K, filed on September 29, 2020. In the opinion of management, the accompanying unaudited condensed consolidated financial statements contain all adjustments, consisting of a normal recurring nature, necessary for a fair statement of its financial position as of September 30, 2020, and its results of operations for the three months and nine months ended September 30, 2020 and 2019, and cash flows for the nine months ended September 30, 2020 and 2019. The balance sheet at December 31, 2019, was derived from audited annual financial statements but does not contain all of the footnote disclosures from the annual financial statements. The results of the period are not necessarily indicative of full year results or any other interim period. During the first quarter of 2020, there was a global outbreak of a novel coronavirus, or COVID-19, which was subsequently declared as a pandemic by the World Health Organization. The global impact of the outbreak rapidly evolved, triggering a period of global economic slowdown. The rapid development and fluidity of this situation precludes any prediction as to the ultimate adverse impact of COVID-19 on economic and market conditions. Management believes the estimates and assumptions underlying our unaudited interim consolidated financial statements are reasonable and supportable based on the information available as of September 30, 2020, however uncertainty over the ultimate impact COVID-19 will have on the global economy generally makes any estimates and assumptions as of September 30, 2020 inherently less certain than they would be absent the current and potential impacts of COVID-19. Actual results may ultimately differ from those estimates. |
Going concern
Going concern | 9 Months Ended |
Sep. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Going concern | Going concern The accompanying consolidated financial statements are prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of the business. As of September 30, 2020, the Company had an accumulated deficit of $199.2 million. During the three months and nine months ended September 30, 2020, the Company incurred a net loss of $17.7 million and $39.3 million, respectively, and used $40.1 million of cash in operating activities. The Company expects to continue to generate operating losses for the foreseeable future. As of September 30, 2020, the Company had cash and cash equivalents of $21.3 million. On November 5, 2020, the Company raised $50 million through a subscription and placing of new common shares through a private placement with certain existing shareholders. The net proceeds of the subscription and placing, together with the Company's existing cash resources and funding agreements, are expected to extend its cash runway into the fourth quarter of 2021. The Company expects to use these funds to support the continued Phase 3 clinical program of ridinilazole for the treatment and reduction of recurrence of C. difficile infection ('CDI'); preparatory activities to support commercial launch of ridinilazole, if approved; development of early-stage research projects; and general corporate purposes. The Company is evaluating various options to finance its cash needs through a combination of some, or all, of the following: equity offerings, collaborations, strategic alliances, grants and clinical trial support from government entities, philanthropic, non-government and not-for-profit organizations and patient advocacy groups, debt financings, and marketing, distribution or licensing arrangements. While the Company believes that funds would be available in this manner before the end of the fourth quarter of 2021, there can be no assurance that the Company will be able to generate funds, on terms acceptable to the Company, on a timely basis or at all, which would impact the Company’s ability to continue as a going concern. The failure of the Company to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on the Company’s business, results of operations and financial condition. Should the Company be unable to raise additional funding, management has the ability to take mitigating action to fund its operating expenses and capital expenditure requirements in relation to its clinical development activities for only a short period beyond 12 months from the date of issuance of these financial statements. These circumstances represent a material uncertainty which may cast and raise significant doubt on the Summit Group’s ability to continue as a going concern. The interim financial statements do not contain any adjustments that might result if the Summit Group was unable to continue as a going concern. |
New accounting standards
New accounting standards | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Changes and Error Corrections [Abstract] | |
New accounting standards | New accounting standards Recently adopted accounting standards In February 2016, the Financial Accounting Standards Board (“FASB”) issued new guidance on the measurement of current expected credit losses (“CECL”) on financial instruments. The new guidance has replaced the incurred loss methodology of recognizing credit losses on financial instruments with a methodology that estimates the expected credit loss on financial instruments and reflects the net amount expected to be collected on the financial instrument. The Company adopted this change in accounting principle as of January 1, 2020 using the modified retrospective method. Accordingly, financial information for periods prior to the date of initial application has not been adjusted. The adoption of the new CECL guidance had no material impact on the Company. Additional new accounting guidance became effective for the Company as of January 1, 2020 that the Company reviewed and concluded was either not applicable to its operations or had no material effect on its Consolidated Financial Statements in the current or future fiscal years. Recent accounting standards not yet adopted In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740), Simplifying the Accounting for Income Taxes. This ASU is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. The amendments in this ASU are intended to simplify the accounting for income taxes by removing certain exceptions to the general principles in Topic 740. The amendments are also intended to improve consistent application of and simplify GAAP for other areas of Topic 740 by clarifying and amending existing guidance. The Company is currently in the process of evaluating the impact of this ASU on the Company’s consolidated financial statements. The Company reviewed all other newly issued accounting pronouncements and concluded that they either are not applicable to the Company's operations or that no material effect is expected on the Company's Consolidated Financial Statements when adoption is required in the future. |
Segment reporting
Segment reporting | 9 Months Ended |
Sep. 30, 2020 | |
Segment Reporting [Abstract] | |
Segment reporting | Segment reporting The Company operates in one reportable segment: Drug Development. The chief operating decision-maker has been identified as the Executive Management Team. The Executive Management Team consists of the Chief Executive Officer, the Executive Vice President and the Chief Financial Officer. The Executive Management Team reviews the consolidated operating results regularly to make decisions about the financial and organizational resources and to assess overall performance. Since the Company operates in one operating segment, all required financial segment information can be found in the condensed consolidated financial statements. The Drug Development segment covers the Company’s research and development activities, primarily comprising the C. difficile infection ("CDI") program and antibiotic pipeline research activities. The corporate and other activities of Summit Therapeutics Ltd. (previously Summit Therapeutics plc), Summit (Oxford) Limited, Summit Therapeutics Sub Inc. and Discuva Limited, which comprise the costs incurred in providing the facilities, finance, human resource and information technology services, are incurred by the main segment of the Company. |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2020 | |
Revenue from Contract with Customer [Abstract] | |
Revenue | Revenue Three months ended September 30, Nine months ended September 30, 2020 2019 2020 2019 (in thousands) Analysis of revenue by category Licensing agreements $ 181 $ 148 $ 675 $ 795 $ 181 $ 148 $ 675 $ 795 Revenue recognized in the period consists of amounts received from the license and commercialization agreement with Eurofarma Laboratórios S.A., and amounts received from the license and collaboration agreement with Sarepta Therapeutics, Inc. which was terminated in August 2019. Three months ended September 30, Nine months ended September 30, 2020 2019 2020 2019 (in thousands) Analysis of revenue by geography: United States $ — $ — $ — $ 320 Latin America 181 148 675 475 $ 181 $ 148 $ 675 $ 795 The analysis of revenue by geography has been identified on the basis of the customer’s geographical location. Eurofarma Laboratórios S.A. On December 21, 2017, Summit announced it had entered into an exclusive license and commercialization agreement with Eurofarma Laboratórios S.A. ("Eurofarma"), pursuant to which the Company granted Eurofarma the exclusive right to commercialize ridinilazole in specified countries in South America, Central America and the Caribbean. The Company has retained commercialization rights in the rest of the world. Under the terms of the license and commercialization agreement with Eurofarma, the Company received an upfront payment of $2.5 million from Eurofarma in December 2017. In February 2020, the Company reached the first enrollment milestone and received $1.0 million. The terms of the contract have been assessed under ASC 606 and currently only the upfront payment and the first enrollment milestone is included in the transaction price. The upfront payment and first enrollment milestone were initially reported as deferred revenue in the balance sheet and are recognized as revenue over the development period. For the three months and nine months ended September 30, 2020 the Company recognized $0.2 million and $0.7 million of revenue related to the upfront payment and the first enrollment milestone and $0.1 million and $0.5 million for the three and nine months ended September 30, 2019, which related to the upfront payment in accordance with the Company's revenue recognition policy. The revenue is being recognized ratably over the performance period. In addition, the Company will be entitled to receive an additional $2.75 million in development milestones upon the achievement of staged patient enrollment targets in the licensed territory in one of the two planned Phase 3 clinical trials of ridinilazole. The Company is eligible to receive up to $21.4 million in development, commercial and sales milestones when cumulative net sales equal or exceed $100.0 million in the Eurofarma licensed territory. Each subsequent achievement of an additional $100.0 million in cumulative net sales will result in the Company receiving additional milestone payments, which, when combined with anticipated product supply transfer payments from Eurofarma paid to the Company in connection with a commercial supply agreement to be entered into between the two parties, will provide payments estimated to range from a mid-teens to high-teens percentage of cumulative net sales in the Eurofarma licensed territory. The Company estimates such product supply transfer payments from Eurofarma will range from a high single-digit to low double-digit percentage of cumulative net sales in the licensed territory. Sarepta Therapeutics, Inc. On October 4, 2016, Summit announced it had entered into an exclusive license and collaboration agreement with Sarepta Therapeutics, Inc. ("Sarepta"). In June 2018, the Company announced the discontinuation of the development of ezutromid after its Phase 2 clinical trial called PhaseOut DMD did not meet its primary or secondary endpoints. As part of the license and collaboration agreement with Sarepta, the Company agreed to collaborate with Sarepta on the research and development of the licensed products pursuant to a joint development plan through a joint steering committee comprised of an equal number of representatives from each party. From January 1, 2018, the Company was responsible for 55% of the budgeted research and development costs related to the licensed products, and Sarepta was responsible for 45% of such costs. Any costs in excess of 110% of the budgeted amount were borne by the party that incurred such costs. This development cost share income is recognized as part of licensing agreements revenue as the Company acted as a principal in the scope of the research and development activities of the agreement. The Company recognized cost share income for both wind-down activities in relation to PhaseOut DMD and next and future generation utrophin modulation development activities of $0.0 million during the three months ended September 30, 2020 and $0.3 million during the nine months ended September 30, 2019. Effective as of August 2019, the agreement with Sarepta was terminated with no material ongoing obligations for either party. |
Other operating income
Other operating income | 9 Months Ended |
Sep. 30, 2020 | |
Other Income and Expenses [Abstract] | |
Other operating income | Other operating income Three months ended September 30, Nine months ended September 30, 2020 2019 2020 2019 (in thousands) Analysis of other operating income by category Income recognized in respect of BARDA $ 1,607 $ 4,228 $ 7,715 $ 14,251 Grant income 143 227 334 775 Research and development credit 2,559 1,841 6,900 4,855 $ 4,309 $ 6,296 $ 14,949 $ 19,881 BARDA In September 2017, the Company was awarded a funding contract from the Biomedical Advanced Research and Development Authority ("BARDA"), an agency of the US government's Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, to fund a specified portion of the clinical and regulatory development activities of ridinilazole for the treatment and reduction of recurrence of CDI. Under the terms of this contract, the Company was initially eligible to receive base period funding of $32 million. In addition, the contract included three option work segments that, if exercised in full by BARDA, would increase the total federal government funding under the contract to approximately $62 million. In August 2018, BARDA exercised one of the option work segments worth $12 million. In June 2019, BARDA increased the total value of the funding contract to up to $63.7 million; at this time, BARDA also exercised a second of the option work segments worth $9.6 million to bring the total amount of committed BARDA funding to $53.6 million. In January 2020, BARDA increased its award by $8.8 million to bring the total amount of the funding contract to $72.5 million and the total amount of committed BARDA funding to $62.4 million. The remaining federal government funding is dependent on BARDA in its sole discretion exercising the final independent option work segment, upon the achievement by the Company of certain agreed-upon milestones for ridinilazole. As of September 30, 2020, an aggregate of $47.0 million of the total committed BARDA funding had been received and the Company has recognized $42.8 million of cumulative income since contract inception. CARB-X In July 2018, the Company was granted a sub-award of up to $4.5 million from the Trustees of Boston University under the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator program ("CARB-X"). Under the CARB-X award, the Company received an initial $2.0 million in funding from CARB-X in July 2018. In February 2020, CARB-X increased the value of the initial funding by $1.2 million. The remaining $2.5 million was split into two option segments. With the Company's decision not to advance the DDS-01 series of antibiotics and to cease work on the gonorrhea program, it is expected CARB-X will cover its remaining share of the work that has been funded under the award. During the three and nine months ended September 30, 2020, the Company recognized grant income from CARB-X of $0.1 million and $0.3 million , respectively (three and nine months ended September 30, 2019: $0.2 million and $0.8 million, respectively). Research and development credits The Company receives tax credits from research and development ("R&D") in the UK. As a company that carries out extensive research and development activities, we seek to benefit from two UK R&D tax credit cash rebate regimes: Small and Medium Enterprise, or SME, Program and the Research and Development Expenditure Credit ("RDEC") Program. Qualifying expenditures largely comprise employment costs for research staff, consumables, a proportion of relevant, permitted sub-contract costs and certain internal overhead costs incurred as part of research projects for which we do not receive income. Tax credits related to the SME Program and RDEC are recorded as other operating income, as they are similar to grant income, in the consolidated statements of operations and other comprehensive (loss)/income. Under both schemes, the Company receives cash payments. Based on criteria established by Her Majesty’s Revenue and Customs ("HMRC"), a portion of expenditures being carried in relation to our pipeline research and development, clinical trials management and third-party manufacturing development activities are eligible for the SME regime and we expect such elements of expenditure will also continue to be eligible for the SME regime for future accounting periods. |
Loss per share
Loss per share | 9 Months Ended |
Sep. 30, 2020 | |
Earnings Per Share [Abstract] | |
Loss per share | Loss per share The calculation of loss per share is based on the following data: Three months ended September 30, Nine Months ended September 30, 2020 2019 2020 2019 (in thousands, except per share data) Net loss $ (17,701) $ (6,376) $ (39,255) $ (20,045) Basic weighted average number of common stock outstanding 67,232 32,099 67,227 31,632 Diluted weighted average number of common stock outstanding 67,232 32,099 67,227 31,632 Basic loss per common stock from operations $ (0.26) $ (0.20) $ (0.58) $ (0.63) Diluted loss per common stock from operations $ (0.26) $ (0.20) $ (0.58) $ (0.63) The number of weighted average options and warrants that were not included in the diluted earnings per share calculation because the effect would have been anti-dilutive represented 11,974,480 and 4,131,511 shares of common stock at September 30, 2020 and 2019, respectively. |
Intangible assets
Intangible assets | 9 Months Ended |
Sep. 30, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible assets | Intangible assets September 30, 2020 December 31, 2019 (in thousands) Utrophin program acquired $ 4,275 $ 4,379 Discuva platform acquired 13,734 14,070 Option over non-financial assets 859 881 Other patents and licenses 142 432 Total intangible assets, gross 19,010 19,762 Less: Accumulated amortization 2,775 2,263 Impairment 5,134 4,379 Intangible assets, net of accumulated amortization $ 11,101 $ 13,120 Amortization expense was $0.8 million and $1.0 million, for the periods ended September 31, 2020 and December 31, 2019, respectively. We recognized impairment expenses of $0.9 million for the nine months ended September 30, 2020 related to our option over non-financial assets, which was written off in its entirety during the three months ended September 30, 2020. |
Financial instruments
Financial instruments | 9 Months Ended |
Sep. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
Financial instruments | Financial instruments The Company’s financial instruments consist primarily of cash and cash equivalents, accounts receivables, accounts payable and contingent considerations. We believe that the recorded values of cash and cash equivalents, accounts receivables, accounts payable approximate their current fair values because of their nature and respective maturity dates or durations. The fair value of our contingent consideration liability is determined based on “Level 3” inputs. Fair Value Measurement as of September 30, 2020 Level 1 Level 2 Level 3 Total Liabilities Contingent consideration $ — $ — $ — $ — Total $ — $ — $ — $ — Fair Value Measurement as of December 31, 2019 Level 1 Level 2 Level 3 Total Liabilities Contingent consideration $ — $ — $ 105 $ 105 Total $ — $ — $ 105 $ 105 |
Stock based compensation
Stock based compensation | 9 Months Ended |
Sep. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Stock based compensation | Stock Based Compensation The following table summarizes stock option activity as of September 30, 2020, and changes during the nine months ended September 30, 2020: Nine months ended September 30, 2020 Weighted average exercise price Outstanding at January 1, 2020 4,644,835 $ 1.80 Granted 6,070,557 $ 3.32 Lapsed / surrendered (4,562,049) $ 2.39 Number of outstanding options 6,153,343 $ 2.31 Exercisable at September 30, 2020 679,600 $ 2.00 The following table summarizes restricted stock units ("RSUs") granted in the form of a nominal-cost options as of September 30, 2020 and changes during the nine months ended September 30, 2020: Nine months ended September 30, 2020 Weighted average exercise price Outstanding at January 1 138,461 $ 0.07 Exercised during the period (53,846) $ 0.07 Number of outstanding RSUs 84,615 $ 0.07 The total intrinsic value of all outstanding options and exercisable options at September 30, 2020 was $3.8 million and $1.0 million, respectively. The following table summarizes consultant warrant activity as of September 30, 2020, and changes during the nine months ended September 30, 2020: Nine months ended September 30, 2020 Weighted average exercise price Outstanding at January 1 3,358,732 $ 1.44 Lapsed / surrendered (2,798,944) $ 1.44 Number of outstanding warrants 559,788 $ 1.44 The total intrinsic value of all outstanding warrants which are all exercisable at September 30, 2020 was $1.1 million. The following table summarizes stock-based compensation expense reflected in the consolidated statements of operations: Three months ended Nine months ended September 30, September 30, 2020 2019 2020 2019 (in thousands) Research and development $ 275 $ 135 $ 638 $ 561 General and administrative 86 109 550 287 $ 361 $ 244 $ 1,188 $ 848 |
Related-party transactions
Related-party transactions | 9 Months Ended |
Sep. 30, 2020 | |
Related Party Transactions [Abstract] | |
Related-party transactions | Related-party transactions On December 24, 2019, the Company completed a private placement with Mr. Robert W. Duggan, who subscribed for an aggregate of 33,231,410 shares of common stock, par value $0.01 per share, and warrants to purchase an aggregate of 4,984,711 shares of common stock at a subscription price of $1.43 for a Subscription Share plus a Subscription Warrant, pursuant to a securities purchase agreement he entered into with us. The exercise price of the Subscription Warrants is $1.58 per share. The Subscription Warrants are exercisable at any time in the period commencing on June 24, 2020, and ending on December 24, 2029. On November 5, 2020, the Company completed a private placement with Mr. Robert W. Duggan, who subscribed for an aggregate of 14,071,856 shares of common stock, and with the Mahkam Zanganeh Revocable Trust (an entity controlled by Dr. Maky Zanganeh), who subscribed for an aggregate of 149,701 shares of common stock, in each case at a subscription price of $3.34 per common share. On November 11, 2020, the Board of Directors of the Company elected Dr. Maky Zaganeh to serve as a member of the Board. Dr. Zanganeh is the sole stockholder of Maky Zanganeh and Associates, Inc. (“MZA”). Dr. Elaine Stracker, served as Interim Chief Operating Officer and an executive director from April 2020 to June 2020. She is the General Counsel and Senior Vice President for Corporate Development for MZA. The Company had a consultancy agreement with MZA from December 2019 through June 2020 to provide support into clinical operation activities related to the ongoing global Phase 3 clinical trials of ridinilazole for the treatment and reduction of recurrence of CDI, regulatory activities pertaining to a potential new drug application should the Phase 3 trials be successful and strategic planning support more generally for the ridinilazole program. The fees for such services under this consultancy agreement were $75,000 per month. In addition to such monthly fee, MZA was granted warrants to purchase 3,358,732 shares of common stock in the aggregate with an exercise price of $1.44 per share (the "Consultant Warrant"). The Consultant Warrant was a subject to quarterly vesting over a three year period from the date of grant, subject to MZA’s provision of consultancy services to the Company during such period. During the nine months ended September 30, 2020, $450,000 of consultancy fees were incurred by the Company and a warrant expense of $494,000 was recognized. On February 7, 2020, MZA, Dr. Zanganeh, Dr. Stracker and the Company entered into an assignment and assumption agreement (the “Assignment and Assumption Agreement”). Pursuant to the Assignment and Assumption Agreement, MZA assigned a portion of the Consultant Warrant to each of Dr. Zanganeh and Dr. Stracker. Dr. Zanganeh assumed a warrant to acquire 2,938,891 shares of common stock and Dr. Stracker assumed a warrant to acquire 419,841 shares of common stock. Upon termination of the MZA consulting agreement and Dr. Stracker's employment in June 2020, warrants to purchase 2,798,944 shares of common stock lapsed in accordance with the terms of the Consultant Warrant.. Dr. Zanganeh and Dr. Stracker have vested warrants to purchase 489,815 and 69,973 shares of common stock, respectively, which can be exercised through June 30, 2025 in accordance with the terms and conditions of that certain Warrant Agreement filed as Exhibit 4.2 to the Company's Current Report on Form 8-K dated September 18, 2020. |
Subsequent events
Subsequent events | 9 Months Ended |
Sep. 30, 2020 | |
Subsequent Events [Abstract] | |
Subsequent events | Subsequent events On November 5, 2020 |
Accounting Changes and Error Co
Accounting Changes and Error Corrections (Policies) | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Changes and Error Corrections [Abstract] | |
Recently adopted accounting standards and recent accounting standards not yet adopted | Recently adopted accounting standards In February 2016, the Financial Accounting Standards Board (“FASB”) issued new guidance on the measurement of current expected credit losses (“CECL”) on financial instruments. The new guidance has replaced the incurred loss methodology of recognizing credit losses on financial instruments with a methodology that estimates the expected credit loss on financial instruments and reflects the net amount expected to be collected on the financial instrument. The Company adopted this change in accounting principle as of January 1, 2020 using the modified retrospective method. Accordingly, financial information for periods prior to the date of initial application has not been adjusted. The adoption of the new CECL guidance had no material impact on the Company. Additional new accounting guidance became effective for the Company as of January 1, 2020 that the Company reviewed and concluded was either not applicable to its operations or had no material effect on its Consolidated Financial Statements in the current or future fiscal years. Recent accounting standards not yet adopted In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740), Simplifying the Accounting for Income Taxes. This ASU is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. The amendments in this ASU are intended to simplify the accounting for income taxes by removing certain exceptions to the general principles in Topic 740. The amendments are also intended to improve consistent application of and simplify GAAP for other areas of Topic 740 by clarifying and amending existing guidance. The Company is currently in the process of evaluating the impact of this ASU on the Company’s consolidated financial statements. The Company reviewed all other newly issued accounting pronouncements and concluded that they either are not applicable to the Company's operations or that no material effect is expected on the Company's Consolidated Financial Statements when adoption is required in the future. |
Revenue (Tables)
Revenue (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Revenue from Contract with Customer [Abstract] | |
Analysis of revenue by category | Three months ended September 30, Nine months ended September 30, 2020 2019 2020 2019 (in thousands) Analysis of revenue by category Licensing agreements $ 181 $ 148 $ 675 $ 795 $ 181 $ 148 $ 675 $ 795 |
Analysis of revenue by geography | Three months ended September 30, Nine months ended September 30, 2020 2019 2020 2019 (in thousands) Analysis of revenue by geography: United States $ — $ — $ — $ 320 Latin America 181 148 675 475 $ 181 $ 148 $ 675 $ 795 |
Other operating income (Tables)
Other operating income (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Other Income and Expenses [Abstract] | |
Analysis of other operating income by category | Three months ended September 30, Nine months ended September 30, 2020 2019 2020 2019 (in thousands) Analysis of other operating income by category Income recognized in respect of BARDA $ 1,607 $ 4,228 $ 7,715 $ 14,251 Grant income 143 227 334 775 Research and development credit 2,559 1,841 6,900 4,855 $ 4,309 $ 6,296 $ 14,949 $ 19,881 |
Loss per share (Tables)
Loss per share (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Earnings Per Share [Abstract] | |
Schedule of earnings per share, basic and diluted | The calculation of loss per share is based on the following data: Three months ended September 30, Nine Months ended September 30, 2020 2019 2020 2019 (in thousands, except per share data) Net loss $ (17,701) $ (6,376) $ (39,255) $ (20,045) Basic weighted average number of common stock outstanding 67,232 32,099 67,227 31,632 Diluted weighted average number of common stock outstanding 67,232 32,099 67,227 31,632 Basic loss per common stock from operations $ (0.26) $ (0.20) $ (0.58) $ (0.63) Diluted loss per common stock from operations $ (0.26) $ (0.20) $ (0.58) $ (0.63) |
Intangible assets (Tables)
Intangible assets (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of intangible assets | September 30, 2020 December 31, 2019 (in thousands) Utrophin program acquired $ 4,275 $ 4,379 Discuva platform acquired 13,734 14,070 Option over non-financial assets 859 881 Other patents and licenses 142 432 Total intangible assets, gross 19,010 19,762 Less: Accumulated amortization 2,775 2,263 Impairment 5,134 4,379 Intangible assets, net of accumulated amortization $ 11,101 $ 13,120 |
Financial instruments (Tables)
Financial instruments (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
Schedule of fair value measurements | Fair Value Measurement as of September 30, 2020 Level 1 Level 2 Level 3 Total Liabilities Contingent consideration $ — $ — $ — $ — Total $ — $ — $ — $ — Fair Value Measurement as of December 31, 2019 Level 1 Level 2 Level 3 Total Liabilities Contingent consideration $ — $ — $ 105 $ 105 Total $ — $ — $ 105 $ 105 |
Stock based compensation (Table
Stock based compensation (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of stock option activity | The following table summarizes stock option activity as of September 30, 2020, and changes during the nine months ended September 30, 2020: Nine months ended September 30, 2020 Weighted average exercise price Outstanding at January 1, 2020 4,644,835 $ 1.80 Granted 6,070,557 $ 3.32 Lapsed / surrendered (4,562,049) $ 2.39 Number of outstanding options 6,153,343 $ 2.31 Exercisable at September 30, 2020 679,600 $ 2.00 |
Schedule of RSU activity | The following table summarizes restricted stock units ("RSUs") granted in the form of a nominal-cost options as of September 30, 2020 and changes during the nine months ended September 30, 2020: Nine months ended September 30, 2020 Weighted average exercise price Outstanding at January 1 138,461 $ 0.07 Exercised during the period (53,846) $ 0.07 Number of outstanding RSUs 84,615 $ 0.07 |
Schedule of warrant activity | The following table summarizes consultant warrant activity as of September 30, 2020, and changes during the nine months ended September 30, 2020: Nine months ended September 30, 2020 Weighted average exercise price Outstanding at January 1 3,358,732 $ 1.44 Lapsed / surrendered (2,798,944) $ 1.44 Number of outstanding warrants 559,788 $ 1.44 |
Schedule of share based expenses | The following table summarizes stock-based compensation expense reflected in the consolidated statements of operations: Three months ended Nine months ended September 30, September 30, 2020 2019 2020 2019 (in thousands) Research and development $ 275 $ 135 $ 638 $ 561 General and administrative 86 109 550 287 $ 361 $ 244 $ 1,188 $ 848 |
Basis of presentation (Details)
Basis of presentation (Details) | Sep. 18, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Reverse stock split ratio | 0.2 |
Going concern (Details)
Going concern (Details) - USD ($) $ in Thousands | Nov. 05, 2020 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||||
Accumulated deficit | $ 199,174 | $ 199,174 | $ 159,919 | |||
Net loss | 17,701 | $ 6,376 | 39,255 | $ 20,045 | ||
Net cash used in operating activities | 40,140 | $ 13,861 | ||||
Cash and cash equivalents | $ 21,270 | $ 21,270 | $ 63,842 | |||
Subsequent event | Private placement | ||||||
Subsequent Event [Line Items] | ||||||
Consideration received on sale of stock | $ 50,000 |
Segment reporting (Details)
Segment reporting (Details) | 9 Months Ended |
Sep. 30, 2020segment | |
Segment Reporting [Abstract] | |
Number of reportable segments | 1 |
Number of operating segments | 1 |
Revenue - Analysis of revenue b
Revenue - Analysis of revenue by category (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Revenue from External Customer [Line Items] | ||||
Revenue | $ 181 | $ 148 | $ 675 | $ 795 |
Licensing agreements | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | $ 181 | $ 148 | $ 675 | $ 795 |
Revenue - Analysis of revenue_2
Revenue - Analysis of revenue by geography (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 181 | $ 148 | $ 675 | $ 795 |
United States | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | 0 | 0 | 0 | 320 |
Latin America | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 181 | $ 148 | $ 675 | $ 475 |
Revenue - Narrative (Details)
Revenue - Narrative (Details) - USD ($) $ in Thousands | Jan. 01, 2018 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Feb. 29, 2020 | Dec. 31, 2017 |
Disaggregation of Revenue [Line Items] | |||||||
Revenue recognized | $ 181 | $ 148 | $ 675 | $ 795 | |||
Licensing agreements | |||||||
Disaggregation of Revenue [Line Items] | |||||||
Revenue recognized | 181 | 148 | 675 | 795 | |||
Licensing agreements | Sarepta | |||||||
Disaggregation of Revenue [Line Items] | |||||||
Research and development costs, percentage of costs responsible | 45.00% | ||||||
Licensing agreements | EuroFarma | |||||||
Disaggregation of Revenue [Line Items] | |||||||
Deferred revenue, upfront payment | $ 2,500 | ||||||
Deferred revenue, enrollment milestone | $ 1,000 | ||||||
Revenue recognized related to upfront payment | 200 | $ 100 | 700 | 500 | |||
Revenue entitled to receive upon achieving patient enrollment targets | 2,750 | ||||||
Revenue entitled to receive upon achieving cumulative net sales targets | 21,400 | ||||||
Cumulative net sales target threshold | 100,000 | ||||||
Incremental cumulative net sales target threshold | $ 100,000 | ||||||
Licensing agreements | Sarepta | |||||||
Disaggregation of Revenue [Line Items] | |||||||
Research and development costs, percentage of costs responsible | 55.00% | ||||||
Research and development costs, amount borne by party incurred, threshold percentage of budged amount | 110.00% | ||||||
Revenue recognized | $ 0 | $ 300 |
Other operating income - Analys
Other operating income - Analysis of other operating income by category (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Revenue from External Customer [Line Items] | ||||
Income recognized in respect of BARDA | $ 1,607 | $ 4,228 | $ 7,715 | $ 14,251 |
Research and development credit | 2,559 | 1,841 | 6,900 | 4,855 |
Other operating income | 4,309 | 6,296 | 14,949 | 19,881 |
Grant | ||||
Revenue from External Customer [Line Items] | ||||
Grant income | $ 143 | $ 227 | $ 334 | $ 775 |
Other operating income - Narrat
Other operating income - Narrative (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 37 Months Ended | |||||||
Feb. 29, 2020USD ($)option_segment | Jan. 31, 2020USD ($) | Jun. 30, 2019USD ($) | Aug. 31, 2018USD ($) | Jul. 31, 2018USD ($) | Sep. 30, 2017USD ($)option_segment | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($) | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Income recognized in respect of BARDA | $ 1,607 | $ 4,228 | $ 7,715 | $ 14,251 | |||||||
Grant | |||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Grant income | $ 143 | $ 227 | $ 334 | $ 775 | |||||||
CARB-X | |||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Grant funding arrangement, maximum funding value | $ 4,500 | ||||||||||
Grant funding arrangement, committed funding base | $ 2,000 | ||||||||||
Grant funding arrangement, committed funding increase | $ 1,200 | ||||||||||
Grant funding arrangement, maximum funding value remaining | $ 2,500 | ||||||||||
Grant funding arrangement, number of option segments | option_segment | 2 | ||||||||||
BARDA | |||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||||
Research and development arrangement, committed funding base | $ 32,000 | ||||||||||
Research and development arrangement, number of option segments | option_segment | 3 | ||||||||||
Research and development arrangement, maximum funding value | $ 72,500 | $ 63,700 | $ 62,000 | ||||||||
Research and development arrangement, committed funding increase | 8,800 | 9,600 | $ 12,000 | ||||||||
Research and development arrangement, total committed funding | $ 62,400 | $ 53,600 | |||||||||
Research and development arrangement, funding received | $ 47,000 | ||||||||||
Income recognized in respect of BARDA | $ 42,800 |
Loss per share (Details)
Loss per share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Earnings Per Share [Abstract] | ||||
Net loss | $ (17,701) | $ (6,376) | $ (39,255) | $ (20,045) |
Basic weighted average number of common stock outstanding (in shares) | 67,232,000 | 32,099,000 | 67,227,000 | 31,632,000 |
Diluted weighted average number of common stock outstanding (in shares) | 67,232,000 | 32,099,000 | 67,227,000 | 31,632,000 |
Basic (loss) / earnings per common stock from operations (in dollars per share) | $ (0.26) | $ (0.20) | $ (0.58) | $ (0.63) |
Diluted (loss) / earnings per common stock from operations (in dollars per share) | $ (0.26) | $ (0.20) | $ (0.58) | $ (0.63) |
Anti-dilutive shares excluded from diluted earnings per share (in shares) | 11,974,480 | 4,131,511 |
Intangible assets - Schedule of
Intangible assets - Schedule of Intangible Assets (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Finite-Lived Intangible Assets [Line Items] | |||
Total intangible assets, gross | $ 19,010 | $ 19,762 | |
Less: Accumulated amortization | 2,775 | 2,263 | |
Impairment | 5,134 | 4,379 | |
Intangible assets, net of accumulated amortization | 11,101 | 13,120 | |
Amortization of intangible assets | 827 | $ 791 | 1,000 |
Software licenses | Utrophin program acquired | |||
Finite-Lived Intangible Assets [Line Items] | |||
Total intangible assets, gross | 4,275 | 4,379 | |
Software licenses | Discuva platform acquired | |||
Finite-Lived Intangible Assets [Line Items] | |||
Total intangible assets, gross | 13,734 | 14,070 | |
Option over non-financial assets | |||
Finite-Lived Intangible Assets [Line Items] | |||
Total intangible assets, gross | 859 | 881 | |
Impairment | 900 | ||
Other patents and licenses | |||
Finite-Lived Intangible Assets [Line Items] | |||
Total intangible assets, gross | $ 142 | $ 432 |
Financial instruments - Schedul
Financial instruments - Schedule of fair value measurements (Details) - Fair Value, recurring - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Liabilities | ||
Contingent consideration | $ 0 | $ 105 |
Total | 0 | 105 |
Level 1 | ||
Liabilities | ||
Contingent consideration | 0 | 0 |
Total | 0 | 0 |
Level 2 | ||
Liabilities | ||
Contingent consideration | 0 | 0 |
Total | 0 | 0 |
Level 3 | ||
Liabilities | ||
Contingent consideration | 0 | 105 |
Total | $ 0 | $ 105 |
Financial instruments - Narrati
Financial instruments - Narrative (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2020USD ($) | |
Contingent consideration | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Contingent consideration reversed to the consolidated statement of operations and other comprehensive loss | $ 0.1 |
Stock based compensation - Sche
Stock based compensation - Schedule of stock option activity (Details) | 9 Months Ended |
Sep. 30, 2020$ / sharesshares | |
Number of share options | |
Beginning balance (in shares) | shares | 4,644,835 |
Granted (in shares) | shares | 6,070,557 |
Lapsed / surrendered (in shares) | shares | (4,562,049) |
Ending balance (in shares) | shares | 6,153,343 |
Weighted average exercise price | |
Beginning balance (in dollars per share) | $ / shares | $ 1.80 |
Granted (in dollars per share) | $ / shares | 3.32 |
Lapsed / surrendered (in dollars per share) | $ / shares | 2.39 |
Ending balance (in dollars per share) | $ / shares | $ 2.31 |
Stock option activity, additional disclosures | |
Exercisable, number of share options (in shares) | shares | 679,600 |
Weighted average exercise price, exercisable (in dollars per share) | $ / shares | $ 2 |
Stock based compensation - Sc_2
Stock based compensation - Schedule of RSU and warrant activity (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2020 | Dec. 31, 2019 | |
RSUs | ||
Number of shares | ||
Beginning balance (in shares) | 138,461 | |
Exercised (in shares) | (53,846) | |
Ending balance (in shares) | 84,615 | |
Weighted average exercise price | ||
Exercise price (in dollars per share) | $ 0.07 | $ 0.07 |
Exercised (in dollars per share) | $ 0.07 | |
Warrants | ||
Number of shares | ||
Beginning balance (in shares) | 3,358,732 | |
Lapsed / surrendered (in shares) | (2,798,944) | |
Ending balance (in shares) | 559,788 | |
Weighted average exercise price | ||
Exercise price (in dollars per share) | $ 1.44 | $ 1.44 |
Lapsed / surrendered (in dollars per share) | $ 1.44 |
Stock based compensation - Narr
Stock based compensation - Narrative (Details) $ in Millions | Sep. 30, 2020USD ($) |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Aggregate intrinsic value, options outstanding | $ 3.8 |
Aggregate intrinsic value, exercisable options | 1 |
Warrants | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Intrinsic value of outstanding equity instruments other than options | 1.1 |
Intrinsic value of exercisable equity instruments other than options | $ 1.1 |
Stock based compensation - Sc_3
Stock based compensation - Schedule of share based expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share based expenses | $ 361 | $ 244 | $ 1,188 | $ 848 |
Research and development | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share based expenses | 275 | 135 | 638 | 561 |
General and administrative | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share based expenses | $ 86 | $ 109 | $ 550 | $ 287 |
Related-party transactions (Det
Related-party transactions (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 7 Months Ended | 9 Months Ended | ||||
Jun. 30, 2020 | Jun. 30, 2020 | Sep. 30, 2020 | Nov. 05, 2020 | Feb. 07, 2020 | Dec. 31, 2019 | Dec. 24, 2019 | |
Related Party Transaction [Line Items] | |||||||
Common stock par value (in dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 | ||||
Warrants | |||||||
Related Party Transaction [Line Items] | |||||||
Warrants lapsed (in shares) | 2,798,944 | ||||||
Assignment and Assumption Agreement | Warrants | |||||||
Related Party Transaction [Line Items] | |||||||
Warrants lapsed (in shares) | 2,798,944 | ||||||
Affiliated entity | Consulting Agreement | |||||||
Related Party Transaction [Line Items] | |||||||
Number of common stock shares into which warrants may be converted (in shares) | 3,358,732 | 3,358,732 | |||||
Exercise price of warrants (in dollars per share) | $ 1.44 | $ 1.44 | |||||
Monthly consultancy expense | $ 75 | ||||||
Quarterly vesting period | 3 years | ||||||
Affiliated entity | Consultancy fees | |||||||
Related Party Transaction [Line Items] | |||||||
Expenses from related party transactions | $ 450 | ||||||
Affiliated entity | Warrant vesting expense | |||||||
Related Party Transaction [Line Items] | |||||||
Expenses from related party transactions | $ 494 | ||||||
Beneficial owner | Assignment and Assumption Agreement | |||||||
Related Party Transaction [Line Items] | |||||||
Number of common stock shares into which warrants may be converted (in shares) | 2,938,891 | ||||||
Warrants vested (in shares) | 489,815 | 489,815 | |||||
Director | Assignment and Assumption Agreement | |||||||
Related Party Transaction [Line Items] | |||||||
Number of common stock shares into which warrants may be converted (in shares) | 419,841 | ||||||
Warrants vested (in shares) | 69,973 | 69,973 | |||||
Private placement | Subsequent event | |||||||
Related Party Transaction [Line Items] | |||||||
Share price (in dollars per share) | $ 3.34 | ||||||
Private placement | Chief Executive Officer | |||||||
Related Party Transaction [Line Items] | |||||||
Number of shares of common stock subscribed (in shares) | 33,231,410 | ||||||
Number of common stock shares into which warrants may be converted (in shares) | 4,984,711 | ||||||
Share price (in dollars per share) | $ 1.43 | ||||||
Exercise price of warrants (in dollars per share) | $ 1.58 | ||||||
Private placement | Chief Executive Officer | Subsequent event | |||||||
Related Party Transaction [Line Items] | |||||||
Number of shares of common stock subscribed (in shares) | 14,071,856 | ||||||
Share price (in dollars per share) | $ 3.34 | ||||||
Private placement | Affiliated entity | Subsequent event | |||||||
Related Party Transaction [Line Items] | |||||||
Number of shares of common stock subscribed (in shares) | 149,701 | ||||||
Share price (in dollars per share) | $ 3.34 |
Subsequent events (Details)
Subsequent events (Details) - Private placement - Subsequent event $ / shares in Units, $ in Millions | Nov. 05, 2020USD ($)$ / sharesshares |
Subsequent Event [Line Items] | |
Consideration received on sale of stock | $ | $ 50 |
Common stock, shares issued (in shares) | shares | 14,970,060 |
Share price (in dollars per share) | $ / shares | $ 3.34 |