Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 04, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2022 | |
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 | 2882 Sand Hill Road, Suite 106 | |
Entity Address, City or Town | Menlo Park | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94025 | |
City Area Code | 617 | |
Local Phone Number | 514-7149 | |
Title of 12(b) Security | Common Stock, $0.01 par value per share | |
Trading Symbol | SMMT | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 98,122,356 | |
Entity Central Index Key | 0001599298 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash | $ 57,335 | $ 71,791 |
Accounts receivable | 238 | 1,464 |
Prepaid expenses | 5,393 | 7,161 |
Other current assets | 2,300 | 1,201 |
Research and development tax credit receivable | 14,132 | 15,695 |
Total current assets | 79,398 | 97,312 |
Non-current assets: | ||
Research and development tax credit receivable | 2,323 | 0 |
Property and equipment, net | 1,095 | 694 |
Right-of-use assets | 2,017 | 2,790 |
Goodwill | 1,806 | 2,009 |
Intangible assets, net | 8,900 | 10,399 |
Other assets | 179 | 170 |
Total assets | 95,718 | 113,374 |
Current liabilities: | ||
Accounts payable | 3,574 | 4,374 |
Accrued expenses | 5,513 | 7,197 |
Accrued compensation | 1,906 | 4,125 |
Lease liabilities | 684 | 1,091 |
Deferred revenue and other income | 3,231 | 7,939 |
Other current liabilities | 265 | 897 |
Total current liabilities | 15,173 | 25,623 |
Non-current liabilities: | ||
Lease liabilities, net of current portion | 1,322 | 1,691 |
Other non-current liabilities | 2,594 | 2,776 |
Promissory note payable to a related party | 25,312 | 0 |
Total liabilities | 44,401 | 30,090 |
Commitments and contingencies (Note 15) | ||
Stockholders' equity: | ||
Preferred stock, $0.01 par value, 20,000,000 shared authorized; none issued and outstanding at June 30, 2022 and December 31, 2021, respectively | 0 | 0 |
Common stock, $0.01 par value: 250,000,000 shares authorized; 98,122,356 and 98,039,540 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively | 981 | 980 |
Additional paid-in capital | 391,220 | 384,049 |
Accumulated other comprehensive loss | (3,168) | (2,197) |
Accumulated deficit | (337,716) | (299,548) |
Total stockholders' equity | 51,317 | 83,284 |
Total liabilities and stockholders' equity | $ 95,718 | $ 113,374 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized (in shares) | 20,000,000 | 20,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
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) | 98,122,356 | 98,039,540 |
Common stock, shares outstanding (in shares) | 98,122,356 | 98,039,540 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Income Statement And Statement Of Comprehensive Income [Abstract] | ||||
Revenue | $ 235 | $ 57 | $ 485 | $ 249 |
Operating expenses: | ||||
Research and development | 9,008 | 23,923 | 29,564 | 42,302 |
General and administrative | 6,933 | 5,984 | 13,592 | 10,169 |
Total operating expenses | 15,941 | 29,907 | 43,156 | 52,471 |
Other operating income | 3,014 | 6,120 | 7,821 | 11,569 |
Operating loss | (12,692) | (23,730) | (34,850) | (40,653) |
Other expense, net | (4,079) | (686) | (3,318) | (1,251) |
Net loss | $ (16,771) | $ (24,416) | $ (38,168) | $ (41,904) |
Net loss per share: | ||||
Basic (in dollars per share) | $ (0.17) | $ (0.27) | $ (0.38) | $ (0.48) |
Diluted (in dollars per share) | $ (0.17) | $ (0.27) | $ (0.38) | $ (0.48) |
Weighted-average shares used to compute net loss per share: | ||||
Basic (in shares) | 99,654,092 | 92,065,957 | 99,627,701 | 88,110,285 |
Diluted (in shares) | 99,654,092 | 92,065,957 | 99,627,701 | 88,110,285 |
Comprehensive loss: | ||||
Net loss | $ (16,771) | $ (24,416) | $ (38,168) | $ (41,904) |
Other comprehensive (loss) income: | ||||
Foreign currency translation adjustments | 789 | 540 | (971) | 1,215 |
Comprehensive loss | $ (15,982) | $ (23,876) | $ (39,139) | $ (40,689) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2020 | 82,575,064 | ||||
Beginning balance at Dec. 31, 2020 | $ 79,453 | $ 826 | $ 293,367 | $ (3,794) | $ (210,946) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Rights offering of common stock, net of offering costs (in shares) | 14,312,976 | ||||
Rights offering of common stock, net of offering costs | 74,882 | $ 143 | 74,739 | ||
Issuance of common stock from exercise of stock options (in shares) | 463,759 | ||||
Issuance of common stock from exercise of stock options | 1,138 | $ 5 | 1,133 | ||
Stock-based compensation | 4,540 | 4,540 | |||
Imputed interest on promissory note payable to a related party | 103 | 103 | |||
Foreign currency translation adjustment | 1,215 | 1,215 | |||
Net loss | (41,904) | (41,904) | |||
Ending balance (in shares) at Jun. 30, 2021 | 97,351,799 | ||||
Ending balance at Jun. 30, 2021 | 119,427 | $ 974 | 373,882 | (2,579) | (252,850) |
Beginning balance (in shares) at Mar. 31, 2021 | 82,919,522 | ||||
Beginning balance at Mar. 31, 2021 | 64,405 | $ 829 | 295,129 | (3,119) | (228,434) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Rights offering of common stock, net of offering costs (in shares) | 14,312,976 | ||||
Rights offering of common stock, net of offering costs | 74,882 | $ 143 | 74,739 | ||
Issuance of common stock from exercise of stock options (in shares) | 119,301 | ||||
Issuance of common stock from exercise of stock options | 241 | $ 2 | 239 | ||
Stock-based compensation | 3,672 | 3,672 | |||
Imputed interest on promissory note payable to a related party | 103 | 103 | |||
Foreign currency translation adjustment | 540 | 540 | |||
Net loss | (24,416) | (24,416) | |||
Ending balance (in shares) at Jun. 30, 2021 | 97,351,799 | ||||
Ending balance at Jun. 30, 2021 | $ 119,427 | $ 974 | 373,882 | (2,579) | (252,850) |
Beginning balance (in shares) at Dec. 31, 2021 | 98,039,540 | 98,039,540 | |||
Beginning balance at Dec. 31, 2021 | $ 83,284 | $ 980 | 384,049 | (2,197) | (299,548) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of shares under stock purchase and award plans (in shares) | 82,816 | ||||
Issuance of common stock under stock purchase plans and exercise of stock options | $ 187 | $ 1 | 186 | ||
Issuance of common stock from exercise of stock options (in shares) | 11,995 | ||||
Stock-based compensation | $ 6,492 | 6,492 | |||
Imputed interest on promissory note payable to a related party | 493 | 493 | |||
Foreign currency translation adjustment | (971) | (971) | |||
Net loss | $ (38,168) | (38,168) | |||
Ending balance (in shares) at Jun. 30, 2022 | 98,122,356 | 98,122,356 | |||
Ending balance at Jun. 30, 2022 | $ 51,317 | $ 981 | 391,220 | (3,168) | (337,716) |
Beginning balance (in shares) at Mar. 31, 2022 | 98,122,356 | ||||
Beginning balance at Mar. 31, 2022 | 64,407 | $ 981 | 388,328 | (3,957) | (320,945) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation | 2,496 | 2,496 | |||
Imputed interest on promissory note payable to a related party | 396 | 396 | |||
Foreign currency translation adjustment | 789 | 789 | |||
Net loss | $ (16,771) | (16,771) | |||
Ending balance (in shares) at Jun. 30, 2022 | 98,122,356 | 98,122,356 | |||
Ending balance at Jun. 30, 2022 | $ 51,317 | $ 981 | $ 391,220 | $ (3,168) | $ (337,716) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2021 | Jun. 30, 2021 | |
Statement of Stockholders' Equity [Abstract] | ||
Offering costs | $ 118 | $ 118 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Cash flows used in operating activities: | ||
Net loss | $ (38,168,000) | $ (41,904,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Non-cash interest expense | 941,000 | 315,000 |
Unrealized foreign exchange loss (gain) | 2,366,000 | (1,495,000) |
Amortization of operating right-of-use assets | 558,000 | 470,000 |
Depreciation | 168,000 | 170,000 |
Amortization of intangible assets | 480,000 | 512,000 |
Stock-based compensation | 6,492,000 | 4,540,000 |
Change in operating assets and liabilities: | ||
Accounts receivable | 1,160,000 | (704,000) |
Prepaid expenses | 1,231,000 | 3,968,000 |
Other current assets | (1,383,000) | 195,000 |
Research and development tax credit receivable | (2,426,000) | (7,854,000) |
Deferred revenue and other income | (4,132,000) | (1,554,000) |
Accounts payable | (721,000) | 672,000 |
Accrued liabilities | (1,078,000) | 3,730,000 |
Accrued compensation | (3,085,000) | (453,000) |
Other long-term assets | (27,000) | 0 |
Operating lease liabilities | (594,000) | (451,000) |
Net cash used in operating activities | (38,218,000) | (39,843,000) |
Cash flows used in investing activities: | ||
Purchases of property and equipment | (654,000) | (190,000) |
Net cash used in investing activities | (654,000) | (190,000) |
Cash flows provided by financing activities: | ||
Proceeds from the issuance of common stock for rights-offering | 0 | 75,000,000 |
Transaction costs related to the issuance of common stock for rights-offering | 0 | (105,000) |
Proceeds from related party promissory notes | 25,000,000 | 110,000,000 |
Re-payment of related party promissory notes | 0 | (110,000,000) |
Payment of related party promissory notes issuance costs | 0 | (54,000) |
Proceeds received related to employee stock awards | 187,000 | 1,138,000 |
Net cash provided by financing activities | 25,187,000 | 75,979,000 |
Effect of exchange rate changes on cash | (771,000) | 1,023,000 |
(Decrease) Increase in cash | (14,456,000) | 36,969,000 |
Cash at beginning of the period | 71,791,000 | 66,417,000 |
Cash at end of the period | 57,335,000 | 103,386,000 |
Supplemental Disclosure of Cash Flow Information: | ||
Cash paid for interest on related party promissory notes | 0 | 85,000 |
Cash paid for income taxes | 0 | 6,000 |
Transaction costs included in accrued expenses | 0 | 13,000 |
Lease assets obtained in exchange for operating lease liabilities | $ 0 | $ 2,124,000 |
Nature of Business and Operatio
Nature of Business and Operations and Recent Events | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business and Operations and Recent Events | Nature of Business and Operations and Recent Events Nature of Business and Operations The terms "Summit" and the "Company" refer to Summit Therapeutics Inc. and its subsidiaries. The Company is a biopharmaceutical company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet healthcare needs. The Company's novel pipeline of product candidates is designed with the goal to become the patient-friendly, new-era standard-of-care medicines. The Company's lead product candidate, ridinilazole, is a novel first-in-class drug that is engaged in a global Phase III clinical trial program. On December 20, 2021, the Company announced topline results for the Phase III Ri-CoDIFy study evaluating ridinilazole for treating patients suffering from Clostridioides difficile infection, also known as C. difficile infection, or CDI. The Company's second product candidate, SMT-738, was announced in May 2021 for combating multidrug resistant infections, specifically carbapenem-resistant Enterobacteriaceae (“CRE”) infections. SMT-738 is the first of a novel class of precision antibiotics that has entered into preclinical development. The Company has two additional discovery-phase assets in its pipeline with undisclosed targets in the therapeutic area of oncology. The Company intends to expand its pipeline portfolio by developing further new era product offerings in the therapeutic area of oncology and/or product offerings that are designed to work in harmony with the human gut microbiome. Recent Events On June 22, 2022, the Company announced a rights offering for its existing shareholders to participate in the purchase of additional shares of its common stock. The rights offering commenced on July 18, 2022, and the associated subscription rights expired on August 8, 2022. Aggregate gross proceeds from the rights offering were $100,000 from the sale of approximately 103,000,000 shares of the Company's common stock at a price of $0.97 per share. Issuance costs were approximately $100. In connection with the closing of the rights offering, the 2022 Note, which is defined in Note 11, matured and became due, and the Company repaid all principal and accrued interest thereunder using a portion of the proceeds from this rights offering on August 10, 2022. On July 27, 2022, the Company held a Special Meeting of Stockholders (the "Special Meeting") whereby the following matters were submitted to a vote of the Company’s stockholders at the Special Meeting: (i) an amendment to the Company’s Restated Certificate of Incorporation, dated September 18, 2020, to increase the number of authorized shares of common stock by 100,000,000 (from 250,000,000 to 350,000,000); and (ii) an amendment to the Summit Therapeutics Inc. 2020 Stock Incentive Plan (the “Plan”) to increase the number of shares of the Company’s common stock issuable under the Plan by 8,000,000 shares. |
Basis of Presentation and Use o
Basis of Presentation and Use of Estimates | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation and Use of Estimates | Basis of Presentation and Use of Estimates Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States ("U.S. GAAP") and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission. Accordingly, certain information and disclosures required by U.S. GAAP for complete consolidated financial statements are not included herein. All intercompany accounts and transactions have been eliminated in consolidation. The interim financial data as of June 30, 2022, and for the three and six months ended June 30, 2022 are unaudited; however, in the opinion of management, the interim data includes all adjustments, consisting of normal recurring adjustments, necessary for a fair statement of the results for the interim periods. The condensed consolidated balance sheet presented at December 31, 2021 has been derived from the consolidated audited financial statement as of that date. The results of the period are not necessarily indicative of full year results or any other interim period. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto of the Company which are included in the Summit Annual Report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission on March 17, 2022. The financial results of the Company's activities are reported in United States Dollars. The progression of the COVID-19 pandemic continues to evolve and its enduring impact on the Company's business remains uncertain. Management believes the estimates and assumptions underlying its unaudited interim financial statements are reasonable and supportable based on the information available as of June 30, 2022, however, the extent to which the COVID-19 pandemic impacts the Company's financial results for the remainder of 2022 and beyond will depend on future developments that are highly uncertain and cannot be predicted at this time. Use of Estimates The preparation of these unaudited condensed consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent liabilities at the date of the unaudited condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. On an on-going basis, management evaluates its estimates and judgments, including those related to revenue recognition, accrued research and development expenses, stock-based compensation, intangible assets, goodwill, other long-lived assets and income taxes. Management bases its estimates and judgments on historical experience and on various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. |
Recently Issued or Adopted Acco
Recently Issued or Adopted Accounting Pronouncements | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Changes and Error Corrections [Abstract] | |
Recently Issued or Adopted Accounting Pronouncements | Recently Issued or Adopted Accounting Pronouncements In November 2021, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2021-10, " Government Assistance (Topic 832)." This ASU increases the transparency of government assistance including the disclosure of (1) the types of assistance, (2) an entity's accounting for the assistance, and (3) the effect of the assistance on an entity's financial statements as diversity currently exists in the recognition, measurement, presentation and disclosure of government assistance received by business entities because of the lack of specific authoritative guidance in U.S. GAAP. This ASU is effective for annual periods, and interim periods within those fiscal years, beginning after December 15, 2021. Early application of this ASU is permitted. The Company adopted and applied the amendments of this ASU to its disclosures during the fourth quarter of 2021 and the application of this ASU did not have a material impact on its financial position, results of operations or cash flows. In October 2021, the FASB issued ASU No. 2021-08, "Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers." This ASU improves the accounting for acquired revenue contracts with customers in a business combination by addressing diversity in practice and inconsistency relating to: 1) recognition of an acquired contract liability and 2) payment terms and their effect on subsequent revenue recognized by the acquirer. The amendments in this ASU require acquiring entities to apply Topic 606 to recognize and measure contract assets and contract liabilities in a business combination, whereas current U.S. GAAP requires that the acquirer measure such assets and liabilities at fair value on the acquisition date. This ASU is effective for annual periods, and interim periods within those fiscal years, beginning after December 15, 2022. The Company will apply this ASU on a prospective basis for business combinations once this ASU is effective and at that time will be able to determine the potential impact on its financial position, results of operations or cash flows. |
Liquidity and Capital Resources
Liquidity and Capital Resources | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Liquidity and Capital Resources | Liquidity and Capital Resources During the three and six months ended June 30, 2022, the Company incurred a net loss of $16,771 and $38,168, respectively, and cash flows used in operating activities for the six months ended June 30, 2022 was $38,218. As of June 30, 2022, the Company had an accumulated deficit of $337,716, cash of $57,335, current and long-term research and development tax credits of $16,455 and accounts receivable of $238. The Company expects to continue to generate operating losses for the foreseeable future. Until the Company can generate substantial revenue and achieve profitability, the Company will need to raise additional capital to fund its ongoing operations and capital needs. On June 22, 2022, the Company announced a rights offering for its existing shareholders to participate in the purchase of additional shares of its common stock. The rights offering commenced on July 18, 2022, and the associated subscription rights expired on August 8, 2022. Aggregate gross proceeds from the rights offering were $100,000 from the sale of approximately 103,000,000 shares of the Company's common stock at a price of $0.97 per share. Issuance costs were approximately $100. In connection with the closing of the rights offering, the 2022 Note, which is defined in Note 11 , matured and became due and the Company repaid all principal and accrued interest thereunder using a portion of the proceeds from this rights offering on August 10, 2022. Based on the Company's current funding arrangements and financial resources as of June 30, 2022, and after considering net proceeds from the rights offering, and the repayment of the 2022 Note, the Company has the ability to fund its operating costs and working capital needs for more than twelve months from the date of issuance on this quarterly report on Form 10-Q. Depending on the Company's future liquidity needs, it may need to seek additional funding in the future. The Company continues to evaluate options to further finance its cash needs for its product candidates through a combination of some, or all, of the following: equity and debt offerings, collaborations, strategic alliances, grants and clinical trial support from government entities, philanthropic, non-government and not-for-profit organizations. There is no assurance, however, that additional financing will be available when needed or that management of the Company will be able to obtain financing on terms acceptable to the Company. If the Company is unable to obtain funding when required in the future, the Company could be required to delay, reduce, or eliminate research and development programs, product portfolio expansion, or future commercialization efforts, which could adversely affect its business prospects. 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. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classifications of liabilities that might result from the outcome of this uncertainty. |
Segment Reporting
Segment Reporting | 6 Months Ended |
Jun. 30, 2022 | |
Segment Reporting [Abstract] | |
Segment Reporting | Segment Reporting The Company's chief operating decision makers (the "CODM function"), which are the Company's Co-CEOs, Mr. Robert W. Duggan and Dr. Maky Zanganeh, utilize financial information to make decisions about allocating resources and assessing performance for the entire Company. The CODM function approves of key operating and strategic decisions, including key decisions in clinical development and clinical operating activities, entering into significant contracts, such as revenue contracts and collaboration agreements and approves the Company's consolidated operating budget. The CODM function views the Company’s operations and manages its business as a single reportable operating segment. The Company's single reportable operating segment covers the Company’s research and development activities, primarily comprising of the CDI program and antibiotic pipeline research activities. As the Company operates as one operating segment, all required financial segment information can be found in the condensed consolidated financial statements. The Company operates in two geographic regions: the U.K. and the U.S. The following table summarizes the Company's long-lived assets, which include the Company's property and equipment, net and right-of-use assets by geography: June 30, 2022 December 31, 2021 United Kingdom $ 2,777 $ 2,762 United States 335 722 $ 3,112 $ 3,484 For details of revenue from external customers by geography refer to Note 6. |
Revenue
Revenue | 6 Months Ended |
Jun. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Revenue | Revenue The following table summarizes revenue by category: Three Months Ended June 30, Six Months Ended Revenue by category: 2022 2021 2022 2021 Licensing agreements $ 235 $ 57 $ 485 $ 249 Revenue recognized in the period consists only of amounts received from the license and commercialization agreement with Eurofarma Laboratórios S.A. The following table summarizes revenue by geography: Three Months Ended June 30, Six Months Ended Revenue by geography: 2022 2021 2022 2021 Latin America $ 235 $ 57 $ 485 $ 249 The analysis of revenue by geography has been identified on the basis of the customer’s geographical location. The following table summarizes the deferred revenue relating to Eurofarma Laboratórios S.A. and deferred other income relating to BARDA (as defined in Note 7), respectively: 2022 2021 Beginning deferred revenue and other income, January 1 (1) $ 7,939 $ 8,939 Additions 252 2,027 Amount of deferred revenue and other income recognized in the statement of operations (4,370) (3,580) Foreign currency adjustments (590) 119 Ending deferred revenue and other income, June 30 (2) $ 3,231 $ 7,505 ____________ (1) Beginning deferred revenue and other income as of January 1, 2022 and 2021 included $7,939 of current and $0 of long-term deferred revenue and other income, and $8,370 of current and $569 of long-term deferred revenue and other income, respectively. (2) Ending deferred revenue and other income as of June 30, 2022 and 2021 included $3,231 of current and $0 of long-term deferred revenue and other income, and $7,140 of current and $365 of long-term deferred revenue and other income, respectively. As of June 30, 2022, deferred revenue is comprised of $227 and $3,096 relating to Eurofarma and BARDA (as defined in Note 7), respectively. As of January 1, 2022, deferred revenue is comprised of $756 and $7,183 relating to Eurofarma and BARDA, respectively. Refer to Note 7 below for further details regarding other income recognized under the BARDA contract. 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 $2,500 from Eurofarma in December 2017. In February 2020, the Company reached the first enrollment milestone and earned $1,000. In September 2021, the Company reached the second enrollment milestone and earned $1,250. The terms of the contract have been assessed under Accounting Standards Codification 606 and currently only the upfront payment and the first two enrollment milestone payments are included in the transaction price. These payments are initially recorded as deferred revenue in the balance sheet and are recognized as revenue ratably over the performance period. Revenue recognized during the three and six months ended June 30, 2022 related to the upfront payment and the first two enrollment milestones earned in accordance with the Company's revenue recognition policy. Revenue recognized during the three months and six months ended June 30, 2021 related to the upfront payment and the first enrollment milestone earned in accordance with the Company's revenue recognition policy. The revenue is being recognized ratably over the performance period to reflect the transfer of control to the customer occurring over the time period that the research and development services are provided by the Company. This output method is, in management’s judgment, the best measure of progress towards satisfying the performance obligation. As of June 30, 2022 and December 31, 2021, the current contract liability relating to the Eurofarma contract was $227 and $756, respectively, and was recorded in current deferred revenue in the condensed consolidated balance sheet. In addition, the Company could receive an additional $1,500 in development milestones upon the achievement of staged patient enrollment targets in the licensed territory in the combined Phase III clinical trial of ridinilazole. The Company is eligible to receive a further $1,000 in development milestones, $2,400 in commercial milestones and up to $18,000 in sales milestones when cumulative net sales equal or exceed $100,000 in the Eurofarma licensed territory. Each subsequent achievement of an additional $100,000 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. |
Other Operating Income
Other Operating Income | 6 Months Ended |
Jun. 30, 2022 | |
Other Income and Expenses [Abstract] | |
Other Operating Income | Other Operating Income The following table sets forth the components of other operating income by category: Three Months Ended June 30, Six Months Ended Other operating income by category: 2022 2021 2022 2021 Funding income from BARDA (as defined below) $ 1,251 $ 1,560 $ 3,885 $ 3,330 Research and development tax credits 810 4,204 2,506 7,883 Grant income from CARB-X (as defined below) 953 356 1,430 356 $ 3,014 $ 6,120 $ 7,821 $ 11,569 BARDA (as defined below) In September 2017, the Company was awarded a funding contract from the Biomedical Advanced Research and Development Authority ("BARDA"), part of the Office of the Assistant Secretary for Preparedness and Response at the United States Department of Health and Human Services, in support of the Company's Ri-CoDIFy clinical trials and clinical development of of ridinilazole. The awarded contract was originally worth up to $62,000. In June 2019 and again in January 2020, BARDA increased the value of the contract such that it is now worth up to $72,500 and brought the total amount of committed funding to $62,400. The remaining federal government funding was 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. This option work segment was never exercised by BARDA. The contract ran through April 2022 and was extended through December 2022 as a no cost contract, solely to close out open activities. As of June 30, 2022, based on translation of historical foreign currency amounts in the period received and recognized, an aggregate of $58,036 of the total committed BARDA funding had been received and the Company has recognized $54,210 of cumulative income since contract inception. Research and development tax credits Income from research and development ("R&D") tax credits, consists of R&D tax credits received in the U.K. The Company benefits from two U.K. R&D tax credit cash rebate regimes: Small and Medium Enterprise Program ("SME Program") and the Research and Development Expenditure Credit Program ("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 the Company does not receive income. Tax credits related to the SME Program and RDEC Program are recorded as other operating income in the condensed consolidated statements of comprehensive loss. Under both schemes, the Company receives cash payments that are not dependent on the Company’s pre-tax net income levels. Based on criteria established by Her Majesty’s Revenue and Customs, a portion of expenditures being carried out in relation to the Company's pipeline research and development activities are eligible for the SME regime. As of June 30, 2022, the current and non-current research and development tax credit receivable was $14,132 and $2,323, respectively. As of December 31, 2021, the current and non-current research and development tax credit receivable was $15,695 and $0, respectively. CARB-X (as defined below) In May 2021, the Company announced the selection of a new preclinical candidate, SMT-738, from the DDS-04 series for development in the fight against multidrug resistant infections, specifically carbapenem-resistant Enterobacteriaceae ("CRE") infections. Simultaneously, the Company announced it had received an award from the Trustees of Boston University under the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator program ("CARB-X") to progress this candidate through preclinical development and Phase 1a clinical trials. The award commits initial funding of up to $4,100, with the possibility of up to another $3,700 based on the achievement of future milestones. As of June 30, 2022, $1,244 of grant funding from CARB-X has been received, $230 is in accounts receivable for amounts billed, $1,108 is unbilled and included in other current assets as an unbilled receivable and the Company has recognized $2,582 of cumulative income since contract inception. During the quarter-ended June 30, 2022, CARB-X announced changes to its funding arrangements and terms and conditions. As a result, the current arrangement concluded as of June 30, 2022, and the Company is in discussions with CARB-X to negotiate a new agreement for the remainder of the program. |
Loss per Share
Loss per Share | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Loss per Share | Loss per Share The following table sets forth the computation of basic and diluted net loss per share: Three Months Ended Six Months Ended 2022 2021 2022 2021 Net loss $ (16,771) $ (24,416) $ (38,168) $ (41,904) Basic weighted average number of shares of common stock outstanding 99,654,092 92,065,957 99,627,701 88,110,285 Diluted weighted average number of shares of common stock outstanding 99,654,092 92,065,957 99,627,701 88,110,285 Basic net loss per share $ (0.17) $ (0.27) $ (0.38) $ (0.48) Diluted net loss per share $ (0.17) $ (0.27) $ (0.38) $ (0.48) Basic net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the diluted net loss by the weighted-average number of common shares outstanding for the period, including potentially dilutive common shares. Since the Company was in a loss position for all periods presented, basic net loss per share is the same as diluted net loss per share for all periods as the inclusion of all potential common share equivalents outstanding would have been anti-dilutive. Because the rights offering exercise price of $0.97 per share was less than the closing price of $1.00 per share on August 8, 2022, the expiration of the rights offering, the Company has retroactively adjusted earnings per share for the bonus element for all periods presented. The following potentially dilutive securities were excluded from the computation of the diluted net loss per share of common stock for the periods presented because their effect would have been anti-dilutive: As of June 30, 2022 2021 Options to purchase common stock 17,127,593 5,233,097 Warrants 5,821,137 5,821,137 Shares expected to be purchased under employee stock purchase plan 125,834 — 23,074,564 11,054,234 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 6 Months Ended |
Jun. 30, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets | Goodwill and Intangible Assets Goodwill is measured as the excess of the cost of the acquisition over the sum of the amounts assigned to tangible and identifiable intangible assets acquired less liabilities assumed. The Company assigns assets acquired (including goodwill) and liabilities assumed to one or more reporting units as of the date of acquisition. Typically acquisitions related to a single reporting unit do not require the allocation of goodwill to multiple reporting units. If the products obtained in an acquisition are assigned to multiple reporting units, the goodwill is distributed to the respective reporting units as part of the purchase price allocation process. Goodwill and purchased intangible assets are reviewed for impairment annually during the fourth quarter of each fiscal year and whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. The process of evaluating the potential impairment of goodwill and intangible assets requires significant judgment. The Company regularly monitors current business conditions and other factors including, but not limited to, adverse industry or economic trends and lower projections of profitability that may impact future operating results. As of June 30, 2022 and December 31, 2021, goodwill was $1,806 and $2,009, respectively. Changes in goodwill during the three and six months ended June 30, 2022 and 2021, respectively, are the result of foreign currency movements. As of June 30, 2022, there have been no cumulative goodwill impairments recognized. Intangible assets, net of accumulated amortization, impairment charges and adjustments are summarized as follows: June 30, 2022 December 31, 2021 Gross carrying amount Accumulated amortization and impairment Net Gross carrying amount Accumulated amortization and impairment Net Utrophin program acquired $ 4,034 $ (4,034) $ — $ 4,487 $ (4,487) $ — Discuva platform acquired 12,960 (4,060) 8,900 14,416 (4,017) 10,399 Option over non-financial asset 820 (820) — 912 (912) — Other patents and licenses 134 (134) — 148 (148) — $ 17,948 $ (9,048) $ 8,900 $ 19,963 $ (9,564) $ 10,399 For the three and six months ended June 30, 2022, amortization expense was $232 and $480, respectively. For the three and six months ended June 30, 2021, amortization expense was $257 and $512, respectively. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Leases | Leases The Company has operating leases for real estate. The Company does not have any finance leases. During the six months ended June 30, 2021, the Company recorded $2,124 of additional right-of-use assets related to a new lease that commenced during the period for its Menlo Park, California, U.S. location. There were no new right-of-use assets recorded during the six months ended June 30, 2022. The carrying value of the right-of-use assets as of June 30, 2022 and December 31, 2021 was $2,017 and $2,790, respectively. |
Promissory Note Payable to a Re
Promissory Note Payable to a Related Party | 6 Months Ended |
Jun. 30, 2022 | |
Related Party Transactions [Abstract] | |
Promissory Note Payable to a Related Party | Promissory Note Payable to a Related Party On March 10, 2022, Mr. Robert W. Duggan, entered into a Note Purchase Agreement (the “2022 Note”), pursuant to which he has loaned the Company $25,000 in exchange for the issuance by the Company of an unsecured promissory note in the amount of $25,000. The 2022 Note accrues interest at a rate per annum equal to the prime rate as reported in the Wall Street Journal , which was 3.25% as of the effective date and 4.75% as of June 30, 2022. The 2022 Note, including all accrued interest, becomes due upon the earlier of (i) the consummation of a registered public offering with net proceeds of no less than $25,000 or (ii) 18 months from the date of issuance of the 2022 Note. Debt issuance costs associated with the 2022 Note were immaterial and expensed as incurred. The balance of the promissory note was $25,312 and includes $312 of accrued interest as of June 30, 2022. Interest expense incurred by the Company for the three and six months ended June 30, 2022 was $257 and $312, respectively. The Company recorded $493 of imputed interest on the 2022 Note to additional paid in capital for the difference between the stated rate of the note and the deemed market rate of interest. The 2022 Note in the amount of $25,000, plus accrued interest has been repaid to Mr. Robert W. Duggan on August 10, 2022 in connection with the completion of the rights offering with aggregate gross proceeds of $100,000. For the three and six months ended June 30, 2021, the Company recorded interest expense and imputed interest related to the March 24, 2021 Note Purchase Agreement with Mr. Robert W. Duggan ("the Initial Note"), for $55,000 which was subsequently rescinded and replaced by a second note ("the Second Note"), of the same amount, and paid in full in May 2021, as described further in Note 14. Interest expense incurred by the Company for the three and six months ended June 30, 2021 relating to the Initial Note and Second Note was $216 and $242, respectively. The Company recorded $103 of imputed interest on the Initial Note and Second Note to additional paid in capital for the difference between the stated rate of the notes and the deemed market rate of interest. March 24, 2021 Note Purchase Agreement On March 24, 2021, Mr. Duggan, the Company's Executive Chairman and Chief Executive Officer and primary stockholder, entered into a Note Purchase Agreement (the “Initial Purchase Agreement”) pursuant to which he loaned the Company $55,000 in exchange for the issuance by the Company of an unsecured promissory note (the “Initial Note”) in the amount of $55,000. The Initial Note was to accrue interest at a rate per annum equal to 150% of the applicable 10 Year US Treasury rate, as adjusted monthly. The rate was initially estimated to be approximately 2.4%. The terms of the Initial Note were that it would mature and become due upon the earlier of (i) the consummation of a registered public offering with net proceeds of no less than $55,000, or (ii) 13 months from the date of issuance of the Initial Note. On April 20, 2021, the Company determined, with Mr. Duggan’s agreement, to rescind both the Initial Purchase Agreement and the Initial Note issued thereunder, and repaid the principal amount of the Initial Note in full, without interest or penalty. April 20, 2021 Note Purchase Agreement On April 20, 2021, subsequent to the repayment of the Initial Note, Mr. Duggan entered into a second Note Purchase Agreement (the “Second Purchase Agreement”) pursuant to which he loaned the Company $55,000 in exchange for the issuance by the Company of an unsecured promissory note (the “Second Note”) in the amount of $55,000. The Second Note accrued interest at a rate per annum equal to 150% of the applicable 10 Year US Treasury rate, as adjusted monthly (initially estimated to be approximately 2.4%). The Company was permitted to prepay any portion of the Second Note at its option without penalty. May 12, 2021 Rights Offering On May 12, 2021, the Company closed its rights offering, which was fully subscribed. Aggregate gross proceeds from the rights offering of $75,000 from the sale of 14,312,976 shares of the Company's common stock, of which 11,365,921 shares were purchased by Mr. Robert W. Duggan and 389,977 shares were purchased by Dr. Maky Zanganeh, at price of $5.24 per share. In connection with the closing of the rights offering, the Second Note, issued by the Company in favor of Mr. Robert W. Duggan, matured and became due and was repaid using a portion of the proceeds from the rights offering. March 26, 2021 Sublease Agreement with Maky Zanganeh and Associates, Inc. On March 26, 2021, the Company entered into a sublease with Maky Zanganeh and Associates, Inc. ("MZA") consisting of 4,500 square feet of office space at 2882 Sand Hill Road, Menlo Park, CA (the “Sublease”). Dr. Maky Zanganeh, the Company's Co-Chief Executive Officer and President, is the sole owner of MZA. The sublease runs until September 2022. The rent payable under the terms of the sublease is equivalent to the proportionate share of the rent payable by MZA to the third-party landlord, based on the square footage of office space sublet by the Company, and no mark-up has been applied. During the three and six months ended June 30, 2022, payments of $179 and $358, respectively, were made pursuant to the sublease. During the three and six months ended June 30, 2021 payments of $174 and $203, respectively were made to the landlord. July 25, 2022 First Amendment to Sublease Agreement with Maky Zanganeh and Associates, Inc. On July 25, 2022 the Company entered into a first amendment, dated July 19, 2022, to its existing sublease agreement with MZA, described above. The existing sublease term which is currently scheduled to expire on September 30, 2022 was extended for a period of thirty-nine months from October 1, 2022 through December 31, 2025. The rent payable under the terms of the sublease is equivalent to the proportionate share of the net payable by MZA to the third-party landlord, based on the square footage of office space sublet by the Company, and no mark-up has been applied. July 29, 2022 Second Amendment to Sublease Agreement with Maky Zanganeh and Associates, Inc. On July 29, 2022, the Company entered into a second amendment, dated August 1, 2022, to its existing sublease agreement with MZA, described above. The second amendment has an effective date of August 1, 2022 .The second amendment includes an additional 1,277 square feet (the "Expansion Premises") of office space at 2882 Sand Hill Road, Menlo Park, CA. The rent payable under the terms of the sublease is equivalent to the proportionate share of the net payable by MZA to the third-party landlord, based on the square footage of office space sublet by the Company, and no mark-up has been applied. March 10, 2022 Note Purchase Agreement On March 10, 2022, the Company entered into a Note Purchase Agreement (the "2022 Note"), with Mr. Duggan, pursuant to which Mr. Duggan loaned the Company $25,000 in exchange for the issuance by the Company of an unsecured promissory note in the amount of $25,000. The 2022 Note accrued interest at a rate per annum equal to the prime rate as reported in the Wall Street Journal , which was 3.25% as of the effective date and 4.75% as of June 30, 2022. The 2022 Note, including accrued interest, became due upon the earlier of (i) the consummation of a registered public offering with net proceeds of no less than $25,000 or (ii) 18 months from the date of issuance of the 2022 Note, and was repaid on August 10, 2022. 2022 Rights Offering On June 22, 2022, the Company announced a rights offering for its existing shareholders to participate in the purchase of additional shares of its common stock. The rights offering commenced on July 18, 2022, and the associated subscription rights expired on August 8, 2022. Aggregate gross proceeds received from the rights offering were $100,000 from the sale of approximately 103,000,000 shares of common stock. Mr. Robert W. Duggan and Dr. Maky Zanganeh fully subscribed to their respective basic subscription rights and oversubscribed, at a price of $0.97 per share. Issuance costs were approximately $100. In connection with the closing of the rights offering, the 2022 Note matured and became due, and the Company repaid all principal and accrued interest thereunder using a portion of the proceeds from this rights offering on August 10, 2022. |
Other Expense, Net
Other Expense, Net | 6 Months Ended |
Jun. 30, 2022 | |
Other Income and Expenses [Abstract] | |
Other Expense, Net | Other expense, net The following table sets forth the components of Other expense, net by category: Three Months Ended June 30, Six Months Ended Other expense, net by category: 2022 2021 2022 2021 Foreign currency losses $ 3,412 $ 389 $ 2,482 $ 851 Loan interest expense 653 216 805 242 Other expenses 14 81 31 158 $ 4,079 $ 686 $ 3,318 $ 1,251 Other expense, net was $4,079 and $3,318 for the three and six months ended June 30, 2022, respectively, which primarily consisted of unfavorable changes in foreign currency. |
Stock-Based Compensation and Wa
Stock-Based Compensation and Warrants | 6 Months Ended |
Jun. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation and Warrants | Stock-Based Compensation and Warrants The Company currently grants stock options to employees and directors under the 2020 Stock Incentive Plan (the "2020 Plan") and formerly, the Company granted stock options under the 2016 Long Term Incentive Plan (the "2016 Plan"). The 2020 Plan is administered by the Compensation Committee of the Company's Board of Directors. The 2020 Plan is intended to attract and retain employees and directors and provide an incentive for these individuals to assist the Company to achieve long-range performance goals and to enable these individuals to participate in the long-term growth of the Company. The following table presents the stock option activity for both the 2016 Plan and the 2020 Plan as of June 30, 2022: Six Months Ended Weighted average exercise price Outstanding at December 31, 2021 13,797,556 $ 5.55 Granted 6,126,381 $ 1.35 Forfeited (2,784,349) $ 5.04 Exercised (11,995) $ 1.86 Outstanding at June 30, 2022 17,127,593 $ 4.14 Exercisable at June 30, 2022 2,390,153 $ 4.65 The total intrinsic value of all outstanding and exercisable stock options at June 30, 2022 was $0. On June 28, 2022, the Compensation Committee of the Company's Board of Directors approved a grant of 4,180,000 options to certain executives of the Company at a price of $1.06 per share. The shares will vest based upon certain market-based performance conditions and have an expiration date of June 28, 2032. Total fair value for these awards is not material. The total stock-based compensation expense included in the Company's condensed consolidated statements of comprehensive loss was as follows: Three Months Ended Six Months Ended 2022 2021 2022 2021 Research and development $ 264 $ 1,591 $ 2,138 $ 1,914 General and administrative 2,232 2,080 4,354 2,626 Total stock-based compensation expense $ 2,496 $ 3,671 $ 6,492 $ 4,540 Warrants The Company had outstanding and exercisable warrants of 5,821,137 with a weighted average exercise price of $1.56 as of June 30, 2022 and December 31, 2021. |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2022 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Promissory Note Payable to a Related Party On March 10, 2022, Mr. Robert W. Duggan, entered into a Note Purchase Agreement (the “2022 Note”), pursuant to which he has loaned the Company $25,000 in exchange for the issuance by the Company of an unsecured promissory note in the amount of $25,000. The 2022 Note accrues interest at a rate per annum equal to the prime rate as reported in the Wall Street Journal , which was 3.25% as of the effective date and 4.75% as of June 30, 2022. The 2022 Note, including all accrued interest, becomes due upon the earlier of (i) the consummation of a registered public offering with net proceeds of no less than $25,000 or (ii) 18 months from the date of issuance of the 2022 Note. Debt issuance costs associated with the 2022 Note were immaterial and expensed as incurred. The balance of the promissory note was $25,312 and includes $312 of accrued interest as of June 30, 2022. Interest expense incurred by the Company for the three and six months ended June 30, 2022 was $257 and $312, respectively. The Company recorded $493 of imputed interest on the 2022 Note to additional paid in capital for the difference between the stated rate of the note and the deemed market rate of interest. The 2022 Note in the amount of $25,000, plus accrued interest has been repaid to Mr. Robert W. Duggan on August 10, 2022 in connection with the completion of the rights offering with aggregate gross proceeds of $100,000. For the three and six months ended June 30, 2021, the Company recorded interest expense and imputed interest related to the March 24, 2021 Note Purchase Agreement with Mr. Robert W. Duggan ("the Initial Note"), for $55,000 which was subsequently rescinded and replaced by a second note ("the Second Note"), of the same amount, and paid in full in May 2021, as described further in Note 14. Interest expense incurred by the Company for the three and six months ended June 30, 2021 relating to the Initial Note and Second Note was $216 and $242, respectively. The Company recorded $103 of imputed interest on the Initial Note and Second Note to additional paid in capital for the difference between the stated rate of the notes and the deemed market rate of interest. March 24, 2021 Note Purchase Agreement On March 24, 2021, Mr. Duggan, the Company's Executive Chairman and Chief Executive Officer and primary stockholder, entered into a Note Purchase Agreement (the “Initial Purchase Agreement”) pursuant to which he loaned the Company $55,000 in exchange for the issuance by the Company of an unsecured promissory note (the “Initial Note”) in the amount of $55,000. The Initial Note was to accrue interest at a rate per annum equal to 150% of the applicable 10 Year US Treasury rate, as adjusted monthly. The rate was initially estimated to be approximately 2.4%. The terms of the Initial Note were that it would mature and become due upon the earlier of (i) the consummation of a registered public offering with net proceeds of no less than $55,000, or (ii) 13 months from the date of issuance of the Initial Note. On April 20, 2021, the Company determined, with Mr. Duggan’s agreement, to rescind both the Initial Purchase Agreement and the Initial Note issued thereunder, and repaid the principal amount of the Initial Note in full, without interest or penalty. April 20, 2021 Note Purchase Agreement On April 20, 2021, subsequent to the repayment of the Initial Note, Mr. Duggan entered into a second Note Purchase Agreement (the “Second Purchase Agreement”) pursuant to which he loaned the Company $55,000 in exchange for the issuance by the Company of an unsecured promissory note (the “Second Note”) in the amount of $55,000. The Second Note accrued interest at a rate per annum equal to 150% of the applicable 10 Year US Treasury rate, as adjusted monthly (initially estimated to be approximately 2.4%). The Company was permitted to prepay any portion of the Second Note at its option without penalty. May 12, 2021 Rights Offering On May 12, 2021, the Company closed its rights offering, which was fully subscribed. Aggregate gross proceeds from the rights offering of $75,000 from the sale of 14,312,976 shares of the Company's common stock, of which 11,365,921 shares were purchased by Mr. Robert W. Duggan and 389,977 shares were purchased by Dr. Maky Zanganeh, at price of $5.24 per share. In connection with the closing of the rights offering, the Second Note, issued by the Company in favor of Mr. Robert W. Duggan, matured and became due and was repaid using a portion of the proceeds from the rights offering. March 26, 2021 Sublease Agreement with Maky Zanganeh and Associates, Inc. On March 26, 2021, the Company entered into a sublease with Maky Zanganeh and Associates, Inc. ("MZA") consisting of 4,500 square feet of office space at 2882 Sand Hill Road, Menlo Park, CA (the “Sublease”). Dr. Maky Zanganeh, the Company's Co-Chief Executive Officer and President, is the sole owner of MZA. The sublease runs until September 2022. The rent payable under the terms of the sublease is equivalent to the proportionate share of the rent payable by MZA to the third-party landlord, based on the square footage of office space sublet by the Company, and no mark-up has been applied. During the three and six months ended June 30, 2022, payments of $179 and $358, respectively, were made pursuant to the sublease. During the three and six months ended June 30, 2021 payments of $174 and $203, respectively were made to the landlord. July 25, 2022 First Amendment to Sublease Agreement with Maky Zanganeh and Associates, Inc. On July 25, 2022 the Company entered into a first amendment, dated July 19, 2022, to its existing sublease agreement with MZA, described above. The existing sublease term which is currently scheduled to expire on September 30, 2022 was extended for a period of thirty-nine months from October 1, 2022 through December 31, 2025. The rent payable under the terms of the sublease is equivalent to the proportionate share of the net payable by MZA to the third-party landlord, based on the square footage of office space sublet by the Company, and no mark-up has been applied. July 29, 2022 Second Amendment to Sublease Agreement with Maky Zanganeh and Associates, Inc. On July 29, 2022, the Company entered into a second amendment, dated August 1, 2022, to its existing sublease agreement with MZA, described above. The second amendment has an effective date of August 1, 2022 .The second amendment includes an additional 1,277 square feet (the "Expansion Premises") of office space at 2882 Sand Hill Road, Menlo Park, CA. The rent payable under the terms of the sublease is equivalent to the proportionate share of the net payable by MZA to the third-party landlord, based on the square footage of office space sublet by the Company, and no mark-up has been applied. March 10, 2022 Note Purchase Agreement On March 10, 2022, the Company entered into a Note Purchase Agreement (the "2022 Note"), with Mr. Duggan, pursuant to which Mr. Duggan loaned the Company $25,000 in exchange for the issuance by the Company of an unsecured promissory note in the amount of $25,000. The 2022 Note accrued interest at a rate per annum equal to the prime rate as reported in the Wall Street Journal , which was 3.25% as of the effective date and 4.75% as of June 30, 2022. The 2022 Note, including accrued interest, became due upon the earlier of (i) the consummation of a registered public offering with net proceeds of no less than $25,000 or (ii) 18 months from the date of issuance of the 2022 Note, and was repaid on August 10, 2022. 2022 Rights Offering On June 22, 2022, the Company announced a rights offering for its existing shareholders to participate in the purchase of additional shares of its common stock. The rights offering commenced on July 18, 2022, and the associated subscription rights expired on August 8, 2022. Aggregate gross proceeds received from the rights offering were $100,000 from the sale of approximately 103,000,000 shares of common stock. Mr. Robert W. Duggan and Dr. Maky Zanganeh fully subscribed to their respective basic subscription rights and oversubscribed, at a price of $0.97 per share. Issuance costs were approximately $100. In connection with the closing of the rights offering, the 2022 Note matured and became due, and the Company repaid all principal and accrued interest thereunder using a portion of the proceeds from this rights offering on August 10, 2022. |
Commitment and Contingencies
Commitment and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Fixed Asset Purchase Commitments As of June 30, 2022 and December 31, 2021, the Company had no capital commitments. Lease Commitments The Company leases office and laboratory space. There have been no material changes to the Company's lease commitments as of December 31, 2021 which were disclosed in the Company's Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 17, 2022, other than the termination of the Company's short-term, Cambridge, Massachusetts office lease as a result of moving its corporate headquarters to Menlo Park, California and the two amendments to the Sublease Agreement with Maky Zanganeh and Associates, Inc. as described in Footnote 14. Other Commitments The Company enters into contracts in the normal course of business with various third parties for clinical trials, preclinical research studies and testing, manufacturing and other services and products for operating purposes. Most contracts provide for termination upon notice, and therefore are cancellable contracts. There have been no material changes to the Company's contractual commitments as of December 31, 2021 which were disclosed in the Company's Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 17, 2022 other than the changes to its lease commitments described above. Indemnifications The Company has entered into its standard form Indemnification Agreement for directors and executive officers, which was filed as Exhibit 10.1 to the Company's Current Report on Form 8-K filed with the Securities and Exchange Commission on September 18, 2020. The Indemnification Agreement provides that, subject to the provisions of the Delaware General Corporation Law, the Company is required, among other things, to indemnify its directors or executive officers for certain expenses, including attorneys' fees, judgments, fines, and settlement amounts of the types customarily incurred by them in connection with any action or proceeding arising out of their service as one of the Company's directors or executive officers. The Company believes the fair value for these indemnification obligations is minimal. Accordingly, the Company has not recognized any liabilities relating to these obligations at June 30, 2022 and December 31, 2021. Legal Proceedings The Company is not currently subject to any material legal proceedings. |
Basis of Presentation and Use_2
Basis of Presentation and Use of Estimates (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States ("U.S. GAAP") and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission. Accordingly, certain information and disclosures required by U.S. GAAP for complete consolidated financial statements are not included herein. All intercompany accounts and transactions have been eliminated in consolidation. The interim financial data as of June 30, 2022, and for the three and six months ended June 30, 2022 are unaudited; however, in the opinion of management, the interim data includes all adjustments, consisting of normal recurring adjustments, necessary for a fair statement of the results for the interim periods. The condensed consolidated balance sheet presented at December 31, 2021 has been derived from the consolidated audited financial statement as of that date. The results of the period are not necessarily indicative of full year results or any other interim period. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto of the Company which are included in the Summit Annual Report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission on March 17, 2022. The financial results of the Company's activities are reported in United States Dollars. The progression of the COVID-19 pandemic continues to evolve and its enduring impact on the Company's business remains uncertain. Management believes the estimates and assumptions underlying its unaudited interim financial statements are reasonable and supportable based on the information available as of June 30, 2022, however, the extent to which the COVID-19 pandemic impacts the Company's financial results for the remainder of 2022 and beyond will depend on future developments that are highly uncertain and cannot be predicted at this time. |
Use of Estimates | Use of Estimates The preparation of these unaudited condensed consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent liabilities at the date of the unaudited condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. On an on-going basis, management evaluates its estimates and judgments, including those related to revenue recognition, accrued research and development expenses, stock-based compensation, intangible assets, goodwill, other long-lived assets and income taxes. Management bases its estimates and judgments on historical experience and on various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. |
Recently Issued or Adopted Accounting Pronouncements | Recently Issued or Adopted Accounting Pronouncements In November 2021, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2021-10, " Government Assistance (Topic 832)." This ASU increases the transparency of government assistance including the disclosure of (1) the types of assistance, (2) an entity's accounting for the assistance, and (3) the effect of the assistance on an entity's financial statements as diversity currently exists in the recognition, measurement, presentation and disclosure of government assistance received by business entities because of the lack of specific authoritative guidance in U.S. GAAP. This ASU is effective for annual periods, and interim periods within those fiscal years, beginning after December 15, 2021. Early application of this ASU is permitted. The Company adopted and applied the amendments of this ASU to its disclosures during the fourth quarter of 2021 and the application of this ASU did not have a material impact on its financial position, results of operations or cash flows. In October 2021, the FASB issued ASU No. 2021-08, "Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers." This ASU improves the accounting for acquired revenue contracts with customers in a business combination by addressing diversity in practice and inconsistency relating to: 1) recognition of an acquired contract liability and 2) payment terms and their effect on subsequent revenue recognized by the acquirer. The amendments in this ASU require acquiring entities to apply Topic 606 to recognize and measure contract assets and contract liabilities in a business combination, whereas current U.S. GAAP requires that the acquirer measure such assets and liabilities at fair value on the acquisition date. This ASU is effective for annual periods, and interim periods within those fiscal years, beginning after December 15, 2022. The Company will apply this ASU on a prospective basis for business combinations once this ASU is effective and at that time will be able to determine the potential impact on its financial position, results of operations or cash flows. |
Segment Reporting (Tables)
Segment Reporting (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Segment Reporting [Abstract] | |
Summary of long-lived assets by geography | The following table summarizes the Company's long-lived assets, which include the Company's property and equipment, net and right-of-use assets by geography: June 30, 2022 December 31, 2021 United Kingdom $ 2,777 $ 2,762 United States 335 722 $ 3,112 $ 3,484 |
Revenue (Tables)
Revenue (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Summary of revenue by category | The following table summarizes revenue by category: Three Months Ended June 30, Six Months Ended Revenue by category: 2022 2021 2022 2021 Licensing agreements $ 235 $ 57 $ 485 $ 249 |
Summary of revenue by geography | The following table summarizes revenue by geography: Three Months Ended June 30, Six Months Ended Revenue by geography: 2022 2021 2022 2021 Latin America $ 235 $ 57 $ 485 $ 249 |
Summary of deferred revenue and other income | The following table summarizes the deferred revenue relating to Eurofarma Laboratórios S.A. and deferred other income relating to BARDA (as defined in Note 7), respectively: 2022 2021 Beginning deferred revenue and other income, January 1 (1) $ 7,939 $ 8,939 Additions 252 2,027 Amount of deferred revenue and other income recognized in the statement of operations (4,370) (3,580) Foreign currency adjustments (590) 119 Ending deferred revenue and other income, June 30 (2) $ 3,231 $ 7,505 ____________ (1) Beginning deferred revenue and other income as of January 1, 2022 and 2021 included $7,939 of current and $0 of long-term deferred revenue and other income, and $8,370 of current and $569 of long-term deferred revenue and other income, respectively. (2) Ending deferred revenue and other income as of June 30, 2022 and 2021 included $3,231 of current and $0 of long-term deferred revenue and other income, and $7,140 of current and $365 of long-term deferred revenue and other income, respectively. |
Other Operating Income (Tables)
Other Operating Income (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Other Income and Expenses [Abstract] | |
Summary of other operating income by category | The following table sets forth the components of other operating income by category: Three Months Ended June 30, Six Months Ended Other operating income by category: 2022 2021 2022 2021 Funding income from BARDA (as defined below) $ 1,251 $ 1,560 $ 3,885 $ 3,330 Research and development tax credits 810 4,204 2,506 7,883 Grant income from CARB-X (as defined below) 953 356 1,430 356 $ 3,014 $ 6,120 $ 7,821 $ 11,569 |
Loss per Share (Tables)
Loss per Share (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of net loss per share | The following table sets forth the computation of basic and diluted net loss per share: Three Months Ended Six Months Ended 2022 2021 2022 2021 Net loss $ (16,771) $ (24,416) $ (38,168) $ (41,904) Basic weighted average number of shares of common stock outstanding 99,654,092 92,065,957 99,627,701 88,110,285 Diluted weighted average number of shares of common stock outstanding 99,654,092 92,065,957 99,627,701 88,110,285 Basic net loss per share $ (0.17) $ (0.27) $ (0.38) $ (0.48) Diluted net loss per share $ (0.17) $ (0.27) $ (0.38) $ (0.48) |
Schedule of potentially dilutive securities excluded from the computation of loss per share | The following potentially dilutive securities were excluded from the computation of the diluted net loss per share of common stock for the periods presented because their effect would have been anti-dilutive: As of June 30, 2022 2021 Options to purchase common stock 17,127,593 5,233,097 Warrants 5,821,137 5,821,137 Shares expected to be purchased under employee stock purchase plan 125,834 — 23,074,564 11,054,234 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of intangible assets | Intangible assets, net of accumulated amortization, impairment charges and adjustments are summarized as follows: June 30, 2022 December 31, 2021 Gross carrying amount Accumulated amortization and impairment Net Gross carrying amount Accumulated amortization and impairment Net Utrophin program acquired $ 4,034 $ (4,034) $ — $ 4,487 $ (4,487) $ — Discuva platform acquired 12,960 (4,060) 8,900 14,416 (4,017) 10,399 Option over non-financial asset 820 (820) — 912 (912) — Other patents and licenses 134 (134) — 148 (148) — $ 17,948 $ (9,048) $ 8,900 $ 19,963 $ (9,564) $ 10,399 |
Other Expense, Net (Tables)
Other Expense, Net (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Other Income and Expenses [Abstract] | |
Schedule of other expense, net | The following table sets forth the components of Other expense, net by category: Three Months Ended June 30, Six Months Ended Other expense, net by category: 2022 2021 2022 2021 Foreign currency losses $ 3,412 $ 389 $ 2,482 $ 851 Loan interest expense 653 216 805 242 Other expenses 14 81 31 158 $ 4,079 $ 686 $ 3,318 $ 1,251 |
Stock-Based Compensation and _2
Stock-Based Compensation and Warrants (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of stock option activity | The following table presents the stock option activity for both the 2016 Plan and the 2020 Plan as of June 30, 2022: Six Months Ended Weighted average exercise price Outstanding at December 31, 2021 13,797,556 $ 5.55 Granted 6,126,381 $ 1.35 Forfeited (2,784,349) $ 5.04 Exercised (11,995) $ 1.86 Outstanding at June 30, 2022 17,127,593 $ 4.14 Exercisable at June 30, 2022 2,390,153 $ 4.65 |
Schedule of stock-based compensation expense | The total stock-based compensation expense included in the Company's condensed consolidated statements of comprehensive loss was as follows: Three Months Ended Six Months Ended 2022 2021 2022 2021 Research and development $ 264 $ 1,591 $ 2,138 $ 1,914 General and administrative 2,232 2,080 4,354 2,626 Total stock-based compensation expense $ 2,496 $ 3,671 $ 6,492 $ 4,540 |
Nature of Business and Operat_2
Nature of Business and Operations and Recent Events (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 6 Months Ended | ||||||
Aug. 08, 2022 | Jul. 27, 2022 | May 12, 2021 | Aug. 08, 2022 | Jun. 30, 2022 | Jun. 30, 2021 | Jul. 26, 2022 | Dec. 31, 2021 | |
Subsequent Event [Line Items] | ||||||||
Issuance costs | $ 0 | $ 105 | ||||||
Common stock, shares authorized (in shares) | 250,000,000 | 250,000,000 | ||||||
Subsequent event | ||||||||
Subsequent Event [Line Items] | ||||||||
Increase to number of authorized shares (in shares) | 100,000,000 | |||||||
Common stock, shares authorized (in shares) | 350,000,000 | 250,000,000 | ||||||
Subsequent event | 2020 Stock Incentive Plan | Common Stock | ||||||||
Subsequent Event [Line Items] | ||||||||
Increase to number of shares of common stock issuable (in shares) | 8,000,000 | |||||||
Rights offering | ||||||||
Subsequent Event [Line Items] | ||||||||
Proceeds from offering | $ 75,000 | |||||||
Shares issued in transaction (in shares) | 14,312,976 | |||||||
Offering price (in dollars per share) | $ 5.24 | |||||||
Rights offering | Subsequent event | ||||||||
Subsequent Event [Line Items] | ||||||||
Proceeds from offering | $ 100,000 | $ 100,000 | ||||||
Shares issued in transaction (in shares) | 103,000,000 | |||||||
Offering price (in dollars per share) | $ 0.97 | $ 0.97 | ||||||
Issuance costs | $ 100 | $ 100 |
Liquidity and Capital Resourc_2
Liquidity and Capital Resources (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
Aug. 08, 2022 | May 12, 2021 | Aug. 08, 2022 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||||||
Net loss | $ 16,771 | $ 24,416 | $ 38,168 | $ 41,904 | ||||
Net cash flows used in operating activities | 38,218 | 39,843 | ||||||
Accumulated deficit | 337,716 | 337,716 | $ 299,548 | |||||
Cash | 57,335 | 57,335 | 71,791 | |||||
Current and long-term research and development tax credits | 16,455 | 16,455 | ||||||
Accounts receivable | $ 238 | 238 | $ 1,464 | |||||
Subsequent Event [Line Items] | ||||||||
Issuance costs | $ 0 | $ 105 | ||||||
Rights offering | ||||||||
Subsequent Event [Line Items] | ||||||||
Proceeds from offering | $ 75,000 | |||||||
Shares issued in transaction (in shares) | 14,312,976 | |||||||
Offering price (in dollars per share) | $ 5.24 | |||||||
Subsequent event | Rights offering | ||||||||
Subsequent Event [Line Items] | ||||||||
Proceeds from offering | $ 100,000 | $ 100,000 | ||||||
Shares issued in transaction (in shares) | 103,000,000 | |||||||
Offering price (in dollars per share) | $ 0.97 | $ 0.97 | ||||||
Issuance costs | $ 100 | $ 100 |
Segment Reporting - Narrative (
Segment Reporting - Narrative (Details) | 6 Months Ended |
Jun. 30, 2022 segment country | |
Segment Reporting [Abstract] | |
Number of operating segments | segment | 1 |
Number of geographic regions in which the Company operates | country | 2 |
Segment Reporting - Long-lived
Segment Reporting - Long-lived assets by geography (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Long-lived assets | $ 3,112 | $ 3,484 |
United Kingdom | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Long-lived assets | 2,777 | 2,762 |
United States | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Long-lived assets | $ 335 | $ 722 |
Revenue - Revenue by Category (
Revenue - Revenue by Category (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenue from External Customer [Line Items] | ||||
Revenue | $ 235 | $ 57 | $ 485 | $ 249 |
Licensing agreements | ||||
Revenue from External Customer [Line Items] | ||||
Revenue | $ 235 | $ 57 | $ 485 | $ 249 |
Revenue - Revenue by Geography
Revenue - Revenue by Geography (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 235 | $ 57 | $ 485 | $ 249 |
Latin America | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenue | $ 235 | $ 57 | $ 485 | $ 249 |
Revenue - Deferred revenue and
Revenue - Deferred revenue and other income (Details) - USD ($) $ in Thousands | 6 Months Ended | |||
Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |
Change in Contract with Customer, Liability [Roll Forward] | ||||
Beginning deferred revenue and other income | $ 7,939 | $ 8,939 | ||
Additions | 252 | 2,027 | ||
Amount of deferred revenue and other income recognized in the statement of operations | (4,370) | (3,580) | ||
Foreign currency adjustments | (590) | 119 | ||
Ending deferred revenue and other income | 3,231 | 7,505 | ||
Current deferred revenue and other income | 3,231 | 7,140 | $ 7,939 | $ 8,370 |
Long-term deferred revenue and other income | $ 0 | $ 365 | $ 0 | $ 569 |
Revenue - Narrative (Details)
Revenue - Narrative (Details) $ in Thousands | 6 Months Ended | ||||||
Jun. 30, 2022 USD ($) milestone | Dec. 31, 2021 USD ($) | Sep. 30, 2021 USD ($) | Jun. 30, 2021 USD ($) | Dec. 31, 2020 USD ($) | Feb. 29, 2020 USD ($) | Dec. 31, 2017 USD ($) | |
Disaggregation of Revenue [Line Items] | |||||||
Deferred revenue | $ 3,231 | $ 7,939 | $ 7,505 | $ 8,939 | |||
Current contract liability | 3,231 | 7,939 | $ 7,140 | $ 8,370 | |||
Licensing agreements | EuroFarma | |||||||
Disaggregation of Revenue [Line Items] | |||||||
Deferred revenue | $ 227 | 756 | $ 2,500 | ||||
Deferred revenue, enrollment milestone | $ 1,250 | $ 1,000 | |||||
Number of enrollment milestones included in transaction price | milestone | 2 | ||||||
Current contract liability | $ 227 | 756 | |||||
Revenue entitled to receive upon achieving patient enrollment targets | 1,500 | ||||||
Revenue entitled to receive upon achieving additional development milestones | 1,000 | ||||||
Revenue entitled to receive upon achieving commercial milestones | 2,400 | ||||||
Revenue entitled to receive upon achieving cumulative net sales targets | 18,000 | ||||||
Cumulative net sales target threshold | 100,000 | ||||||
Incremental cumulative net sales target threshold | 100,000 | ||||||
Licensing agreements | BARDA | |||||||
Disaggregation of Revenue [Line Items] | |||||||
Deferred revenue | $ 3,096 | $ 7,183 |
Other Operating Income - Other
Other Operating Income - Other Operating Income by Category (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 58 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | |
Revenue from External Customer [Line Items] | |||||
Research and development tax credits | $ 810 | $ 4,204 | $ 2,506 | $ 7,883 | |
Other operating income | 3,014 | 6,120 | 7,821 | 11,569 | |
BARDA | |||||
Revenue from External Customer [Line Items] | |||||
Funding /Grant income | 1,251 | 1,560 | 3,885 | 3,330 | $ 54,210 |
Other grant funding counterparties | |||||
Revenue from External Customer [Line Items] | |||||
Funding /Grant income | $ 953 | $ 356 | $ 1,430 | $ 356 |
Other Operating Income - Narrat
Other Operating Income - Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 14 Months Ended | 58 Months Ended | ||||
May 31, 2021 | Sep. 30, 2017 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2022 | Dec. 31, 2021 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Current research and development tax credit receivable | $ 14,132 | $ 14,132 | $ 14,132 | $ 14,132 | $ 15,695 | ||||
Non-current research and development tax credit receivable | 2,323 | 2,323 | 2,323 | 2,323 | 0 | ||||
Accounts receivable | 238 | 238 | 238 | 238 | $ 1,464 | ||||
BARDA | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Maximum funding value | $ 62,000 | 72,500 | |||||||
Total committed funding | 62,400 | ||||||||
Funding received | 58,036 | ||||||||
Income earned | 1,251 | $ 1,560 | 3,885 | $ 3,330 | 54,210 | ||||
CARB-X | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Funding received | 1,244 | ||||||||
Income earned | 2,582 | ||||||||
Committed funding base | $ 4,100 | ||||||||
Funding increase based on achievement of future milestones | $ 3,700 | ||||||||
Accounts receivable | 230 | 230 | 230 | 230 | |||||
Unbilled receivable | $ 1,108 | $ 1,108 | $ 1,108 | $ 1,108 |
Loss per Share - Computation of
Loss per Share - Computation of net loss per share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Earnings Per Share [Abstract] | ||||
Net loss | $ (16,771) | $ (24,416) | $ (38,168) | $ (41,904) |
Basic weighted average number of shares of common stock outstanding (in shares) | 99,654,092 | 92,065,957 | 99,627,701 | 88,110,285 |
Diluted weighted average number of shares of common stock outstanding (in shares) | 99,654,092 | 92,065,957 | 99,627,701 | 88,110,285 |
Basic net loss per share (in dollars per share) | $ (0.17) | $ (0.27) | $ (0.38) | $ (0.48) |
Diluted net loss per share (in dollars per share) | $ (0.17) | $ (0.27) | $ (0.38) | $ (0.48) |
Loss per Share - Narrative (Det
Loss per Share - Narrative (Details) - $ / shares | Aug. 08, 2022 | Jun. 28, 2022 | May 12, 2021 |
Subsequent Event [Line Items] | |||
Share price (in dollars per share) | $ 1.06 | ||
Rights offering | |||
Subsequent Event [Line Items] | |||
Offering price (in dollars per share) | $ 5.24 | ||
Subsequent event | |||
Subsequent Event [Line Items] | |||
Share price (in dollars per share) | $ 1 | ||
Subsequent event | Rights offering | |||
Subsequent Event [Line Items] | |||
Offering price (in dollars per share) | $ 0.97 |
Loss per Share - Potentially di
Loss per Share - Potentially dilutive securities excluded from the computation of loss per share (Details) - shares | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive shares excluded from diluted earnings per share (in shares) | 23,074,564 | 11,054,234 |
Options to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive shares excluded from diluted earnings per share (in shares) | 17,127,593 | 5,233,097 |
Warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive shares excluded from diluted earnings per share (in shares) | 5,821,137 | 5,821,137 |
Shares expected to be purchased under employee stock purchase plan | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive shares excluded from diluted earnings per share (in shares) | 125,834 | 0 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets - Narrative (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |||||
Goodwill | $ 1,806,000 | $ 1,806,000 | $ 2,009,000 | ||
Cumulative goodwill impairments | 0 | 0 | |||
Amortization expense | $ 232,000 | $ 257,000 | $ 480,000 | $ 512,000 |
Goodwill and Intangible Asset_3
Goodwill and Intangible Assets - Schedule of intangible assets (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Finite-Lived Intangible Assets [Line Items] | ||
Gross carrying amount | $ 17,948 | $ 19,963 |
Accumulated amortization and impairment | (9,048) | (9,564) |
Net | 8,900 | 10,399 |
Software licenses | Utrophin program acquired | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross carrying amount | 4,034 | 4,487 |
Accumulated amortization and impairment | (4,034) | (4,487) |
Net | 0 | 0 |
Software licenses | Discuva platform acquired | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross carrying amount | 12,960 | 14,416 |
Accumulated amortization and impairment | (4,060) | (4,017) |
Net | 8,900 | 10,399 |
Option over non-financial asset | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross carrying amount | 820 | 912 |
Accumulated amortization and impairment | (820) | (912) |
Net | 0 | 0 |
Other patents and licenses | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross carrying amount | 134 | 148 |
Accumulated amortization and impairment | (134) | (148) |
Net | $ 0 | $ 0 |
Leases (Details)
Leases (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Leases [Abstract] | |||||
Additional right-of-use assets recorded | $ 0 | $ 2,124,000 | |||
Right-of-use assets | $ 2,017,000 | 2,017,000 | $ 2,790,000 | ||
Fixed lease costs | $ 377,000 | $ 344,000 | $ 589,000 | $ 483,000 |
Promissory Note Payable to a _2
Promissory Note Payable to a Related Party (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||||
Jun. 30, 2022 | Mar. 10, 2022 | Mar. 24, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Related Party Transaction [Line Items] | ||||||||
Proceeds from related party promissory notes | $ 25,000 | $ 110,000 | ||||||
Balance of promissory note | $ 25,312 | $ 25,312 | 25,312 | $ 0 | ||||
Imputed interest | 396 | $ 103 | 493 | 103 | ||||
Additional Paid-In Capital | ||||||||
Related Party Transaction [Line Items] | ||||||||
Imputed interest | 396 | 103 | 493 | 103 | ||||
Chief Executive Officer | 2022 Note | ||||||||
Related Party Transaction [Line Items] | ||||||||
Proceeds from related party promissory notes | $ 25,000 | |||||||
Promissory note | $ 25,000 | |||||||
Interest rate | 4.75% | 3.25% | ||||||
Notes payable, maturity triggering event, public offering proceeds threshold | $ 25,000 | |||||||
Notes payable, maximum term | 18 months | |||||||
Balance of promissory note | $ 25,312 | 25,312 | 25,312 | |||||
Accrued interest | $ 312 | 312 | 312 | |||||
Interest expense | $ 257 | 312 | ||||||
Chief Executive Officer | 2022 Note | Additional Paid-In Capital | ||||||||
Related Party Transaction [Line Items] | ||||||||
Imputed interest | $ 493 | |||||||
Chief Executive Officer | Initial Note | ||||||||
Related Party Transaction [Line Items] | ||||||||
Proceeds from related party promissory notes | $ 55,000 | |||||||
Promissory note | 55,000 | |||||||
Notes payable, maturity triggering event, public offering proceeds threshold | $ 55,000 | |||||||
Notes payable, maximum term | 13 months | |||||||
Chief Executive Officer | Initial Note and Second Note | ||||||||
Related Party Transaction [Line Items] | ||||||||
Interest expense | $ 216 | 242 | ||||||
Chief Executive Officer | Initial Note and Second Note | Additional Paid-In Capital | ||||||||
Related Party Transaction [Line Items] | ||||||||
Imputed interest | $ 103 |
Other Expense, Net (Details)
Other Expense, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Other Income and Expenses [Abstract] | ||||
Foreign currency losses | $ 3,412 | $ 389 | $ 2,482 | $ 851 |
Loan interest expense | 653 | 216 | 805 | 242 |
Other expenses | 14 | 81 | 31 | 158 |
Other expense, net | $ 4,079 | $ 686 | $ 3,318 | $ 1,251 |
Stock-Based Compensation and _3
Stock-Based Compensation and Warrants - Stock Option Activity (Details) | 6 Months Ended |
Jun. 30, 2022 $ / shares shares | |
Number of share options | |
Beginning balance (in shares) | shares | 13,797,556 |
Granted (in shares) | shares | 6,126,381 |
Forfeited (in shares) | shares | (2,784,349) |
Exercise (in shares) | shares | (11,995) |
Ending balance (in shares) | shares | 17,127,593 |
Weighted average exercise price | |
Beginning balance (in dollars per share) | $ / shares | $ 5.55 |
Granted (in dollars per share) | $ / shares | 1.35 |
Forfeited (in dollars per share) | $ / shares | 5.04 |
Exercised (in dollars per share) | $ / shares | 1.86 |
Ending balance (in dollars per share) | $ / shares | $ 4.14 |
Stock option activity, additional disclosures | |
Number of share options, exercisable (in shares) | shares | 2,390,153 |
Weighted average exercise price, exercisable (in dollars per share) | $ / shares | $ 4.65 |
Stock-Based Compensation and _4
Stock-Based Compensation and Warrants - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | ||
Jun. 28, 2022 | Jun. 30, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Aggregate intrinsic value, outstanding options | $ 0 | ||
Aggregate intrinsic value, exercisable options | $ 0 | ||
Stock options granted (in shares) | 6,126,381 | ||
Share price (in dollars per share) | $ 1.06 | ||
Certain executives | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock options granted (in shares) | 4,180,000 | ||
Warrants | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Non-option equity instruments outstanding (in shares) | 5,821,137 | 5,821,137 | |
Non-option equity instruments exercisable (in shares) | 5,821,137 | 5,821,137 | |
Weighted average exercise price of non-option equity instruments outstanding (in dollars per share) | $ 1.56 | $ 1.56 | |
Weighted average exercise price of non-option equity instruments exercisable (in dollars per share) | $ 1.56 | $ 1.56 |
Stock-Based Compensation and _5
Stock-Based Compensation and Warrants - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation expense | $ 2,496 | $ 3,671 | $ 6,492 | $ 4,540 |
Research and development | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation expense | 264 | 1,591 | 2,138 | 1,914 |
General and administrative | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Stock-based compensation expense | $ 2,232 | $ 2,080 | $ 4,354 | $ 2,626 |
Related party transactions (Det
Related party transactions (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||||||||
Aug. 08, 2022 USD ($) $ / shares | Jun. 30, 2022 | Mar. 10, 2022 USD ($) | May 12, 2021 USD ($) $ / shares shares | Apr. 20, 2021 USD ($) | Mar. 24, 2021 USD ($) | Aug. 08, 2022 USD ($) $ / shares shares | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jul. 29, 2022 ft² | Jul. 25, 2022 | Mar. 26, 2021 ft² | |
Related Party Transaction [Line Items] | ||||||||||||||
Proceeds from related party promissory notes | $ 25,000 | $ 110,000 | ||||||||||||
Issuance costs | 0 | 105 | ||||||||||||
Rights offering | ||||||||||||||
Related Party Transaction [Line Items] | ||||||||||||||
Proceeds from offering | $ 75,000 | |||||||||||||
Shares issued in transaction (in shares) | shares | 14,312,976 | |||||||||||||
Offering price (in dollars per share) | $ / shares | $ 5.24 | |||||||||||||
Rights offering | Subsequent event | ||||||||||||||
Related Party Transaction [Line Items] | ||||||||||||||
Proceeds from offering | $ 100,000 | $ 100,000 | ||||||||||||
Shares issued in transaction (in shares) | shares | 103,000,000 | |||||||||||||
Offering price (in dollars per share) | $ / shares | $ 0.97 | $ 0.97 | ||||||||||||
Issuance costs | $ 100 | $ 100 | ||||||||||||
Chief Executive Officer | Rights offering | ||||||||||||||
Related Party Transaction [Line Items] | ||||||||||||||
Shares issued in transaction (in shares) | shares | 11,365,921 | |||||||||||||
Chief Executive Officer | Initial Note | ||||||||||||||
Related Party Transaction [Line Items] | ||||||||||||||
Proceeds from related party promissory notes | $ 55,000 | |||||||||||||
Promissory note | $ 55,000 | |||||||||||||
Notes payable, estimated interest rate | 2.40% | |||||||||||||
Notes payable, maturity triggering event, public offering proceeds threshold | $ 55,000 | |||||||||||||
Notes payable, maximum term | 13 months | |||||||||||||
Chief Executive Officer | Initial Note | 10 year US Treasury rate | ||||||||||||||
Related Party Transaction [Line Items] | ||||||||||||||
Notes payable, basis spread on variable rate | 150% | |||||||||||||
Chief Executive Officer | Second Note | ||||||||||||||
Related Party Transaction [Line Items] | ||||||||||||||
Proceeds from related party promissory notes | $ 55,000 | |||||||||||||
Promissory note | $ 55,000 | |||||||||||||
Notes payable, estimated interest rate | 2.40% | |||||||||||||
Chief Executive Officer | Second Note | 10 year US Treasury rate | ||||||||||||||
Related Party Transaction [Line Items] | ||||||||||||||
Notes payable, basis spread on variable rate | 150% | |||||||||||||
Chief Executive Officer | 2022 Note | ||||||||||||||
Related Party Transaction [Line Items] | ||||||||||||||
Proceeds from related party promissory notes | $ 25,000 | |||||||||||||
Promissory note | 25,000 | |||||||||||||
Notes payable, maturity triggering event, public offering proceeds threshold | $ 25,000 | |||||||||||||
Notes payable, maximum term | 18 months | |||||||||||||
Interest rate | 4.75% | 3.25% | ||||||||||||
Affiliated entity | ||||||||||||||
Related Party Transaction [Line Items] | ||||||||||||||
Area of premises subleased | ft² | 4,500 | |||||||||||||
Payments to related party | $ 179 | $ 174 | $ 358 | $ 203 | ||||||||||
Affiliated entity | Subsequent event | ||||||||||||||
Related Party Transaction [Line Items] | ||||||||||||||
Area of premises subleased | ft² | 1,277 | |||||||||||||
Sublease extension term | 39 months | |||||||||||||
Chief Operating Officer | Rights offering | ||||||||||||||
Related Party Transaction [Line Items] | ||||||||||||||
Shares issued in transaction (in shares) | shares | 389,977 |
Commitment and Contingencies (D
Commitment and Contingencies (Details) | Jul. 29, 2022 amendment | Jun. 30, 2022 USD ($) | Dec. 31, 2021 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |||
Capital commitments | $ | $ 0 | $ 0 | |
Affiliated entity | Subsequent event | |||
Related Party Transaction [Line Items] | |||
Number of amendments to the Sublease Agreement | amendment | 2 |