Summit Therapeutics (SMMT) 10-Q 15 Nov 21 2021 Q3 Quarterly report Financial data

Cover

Cover - shares	9 Months Ended
	Sep. 30, 2021	Nov. 08, 2021
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2021
Document Transition Report	false
Entity File Number	001-36866
Entity Registrant Name	Summit Therapeutics Inc.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	37-1979717
Entity Address, Address Line One	One Broadway, 14th Floor
Entity Address, City or Town	Cambridge
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02142
City Area Code	617
Local Phone Number	514-7149
Title of 12(b) Security	Common Stock, $0.01 par value per share
Trading Symbol	SMMT
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		97,714,447
Entity Central Index Key	0001599298
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2021
Document Fiscal Period Focus	Q3
Amendment Flag	false

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2021	Dec. 31, 2020
Current assets:
Cash	$ 80,248	$ 66,417
Accounts receivable	2,290	331
Prepaid expenses	8,409	9,547
Other current assets	1,191	1,523
Research and development tax credit receivable	10,072	9,856
Total current assets	102,210	87,674
Non-current assets:
Research and development tax credit receivable	11,314	0
Property and equipment, net	656	725
Right-of-use assets	1,884	554
Goodwill	2,001	2,030
Intangible assets, net	10,608	11,515
Total assets	128,673	102,498
Current liabilities:
Accounts payable	5,875	6,140
Accrued expenses	7,432	4,261
Other current liabilities	1,030	729
Lease liabilities	941	390
Deferred revenue	7,511	8,370
Total current liabilities	22,789	19,890
Non-current liabilities:
Deferred revenue	0	569
Lease liabilities	896	75
Other non-current liabilities	2,690	2,511
Total liabilities	26,375	23,045
Commitments and contingencies (Note 12)
Stockholders' equity:
Common stock, $0.01 par value: 250,000,000 shares authorized; 97,628,511 and 82,575,064 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively	976	826
Additional paid-in capital	377,213	293,367
Accumulated other comprehensive loss	(3,442)	(3,794)
Accumulated deficit	(272,449)	(210,946)
Total stockholders' equity	102,298	79,453
Total liabilities and stockholders' equity	$ 128,673	$ 102,498

Condensed Consolidated Balanc_2

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2021	Dec. 31, 2020
Statement of Financial Position [Abstract]
Common stock par value (in dollars per share)	$ 0.01	$ 0.01
Common stock, shares authorized (in shares)	250,000,000	250,000,000
Common stock, shares issued (in shares)	97,628,511	82,575,064
Common stock, shares outstanding (in shares)	97,628,511	82,575,064

Condensed Consolidated Statemen

Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Income Statement And Statement Of Comprehensive Income [Abstract]
Revenue	$ 1,309	$ 181	$ 1,558	$ 675
Operating expenses:
Research and development	19,943	13,726	62,245	40,210
General and administrative	5,662	6,846	15,831	16,192
Impairment of intangible assets	0	859	0	859
Total operating expenses	25,605	21,431	78,076	57,261
Other operating income	4,810	4,309	16,379	14,949
Operating loss	(19,486)	(16,941)	(60,139)	(41,637)
Other (expense) income, net	(113)	(858)	(1,364)	2,289
Loss before income tax	(19,599)	(17,799)	(61,503)	(39,348)
Income tax benefit	0	56	0	192
Net loss	$ (19,599)	$ (17,743)	$ (61,503)	$ (39,156)
Net loss per share:
Basic (in dollars per share)	$ (0.20)	$ (0.26)	$ (0.68)	$ (0.58)
Diluted (in dollars per share)	$ (0.20)	$ (0.26)	$ (0.68)	$ (0.58)
Weighted-average shares used to compute net loss per share:
Basic (in shares)	97,452,628	67,231,900	90,360,713	67,227,184
Diluted (in shares)	97,452,628	67,231,900	90,360,713	67,227,184
Other comprehensive (loss) income:
Foreign currency translation adjustments	$ (863)	$ 2,326	$ 352	$ (2,350)
Comprehensive loss	$ (20,462)	$ (15,417)	$ (61,151)	$ (41,506)

Condensed Consolidated Statem_2

Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands	Total	Common Stock	Additional Paid-In Capital	Accumulated Other Comprehensive (Loss)/Income	Accumulated Deficit
Beginning balance (in shares) at Dec. 31, 2019		67,178,054
Beginning balance at Dec. 31, 2019	$ 78,863	$ 672	$ 241,204	$ (4,764)	$ (158,249)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Fractional shares issued from reverse stock split (in shares)		3
Issuance of common stock from exercise of stock options (in shares)		53,846
Issuance of common stock from exercise of stock options	3		3
Stock-based compensation	1,188		1,188
Foreign currency translation adjustment	(2,350)			(2,350)
Net loss	(39,156)				(39,156)
Ending balance (in shares) at Sep. 30, 2020		67,231,903
Ending balance at Sep. 30, 2020	38,548	$ 672	242,395	(7,114)	(197,405)
Beginning balance (in shares) at Jun. 30, 2020		67,231,900
Beginning balance at Jun. 30, 2020	53,604	$ 672	242,034	(9,440)	(179,662)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Fractional shares issued from reverse stock split (in shares)		3
Stock-based compensation	361		361
Foreign currency translation adjustment	2,326			2,326
Net loss	(17,743)				(17,743)
Ending balance (in shares) at Sep. 30, 2020		67,231,903
Ending balance at Sep. 30, 2020	$ 38,548	$ 672	242,395	(7,114)	(197,405)
Beginning balance (in shares) at Dec. 31, 2020	82,575,064	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	(159)
Rights offering of common stock, net of offering costs (in shares)		14,312,976
Rights offering of common stock, net of offering costs	$ 74,841	$ 143	74,698
Issuance of common stock from exercise of stock options (in shares)	713,548	740,471
Issuance of common stock from exercise of stock options	$ 1,868	$ 7	1,861
Stock-based compensation	7,184		7,184
Imputed interest expense on promissory note payable to a related party	103		103
Foreign currency translation adjustment	352			352
Net loss	$ (61,503)				(61,503)
Ending balance (in shares) at Sep. 30, 2021	97,628,511	97,628,511
Ending balance at Sep. 30, 2021	$ 102,298	$ 976	377,213	(3,442)	(272,449)
Beginning balance (in shares) at Jun. 30, 2021		97,351,799
Beginning balance at Jun. 30, 2021	119,427	$ 974	373,882	(2,579)	(252,850)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Rights offering of common stock, net of offering costs	(41)		(41)
Issuance of common stock from exercise of stock options (in shares)		276,712
Issuance of common stock from exercise of stock options	730	$ 2	728
Stock-based compensation	2,644		2,644
Foreign currency translation adjustment	(863)			(863)
Net loss	$ (19,599)				(19,599)
Ending balance (in shares) at Sep. 30, 2021	97,628,511	97,628,511
Ending balance at Sep. 30, 2021	$ 102,298	$ 976	$ 377,213	$ (3,442)	$ (272,449)

Condensed Consolidated Statem_3

Condensed Consolidated Statements of Stockholders' Equity (Parenthetical) - USD ($) $ in Thousands	3 Months Ended	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2021
Statement of Stockholders' Equity [Abstract]
Offering costs	$ 41	$ 159

Condensed Consolidated Statem_4

Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Cash flows used in operating activities:
Net loss	$ (61,503)	$ (39,156)
Adjustments to reconcile net loss to net cash used in operating activities:
Gain on recognition of contingent consideration payable	0	(101)
Non-cash interest expense (income)	480	(296)
Unrealized foreign exchange gain	(646)	(40)
Loss on disposal of asset	2	0
Impairment of intangible assets	0	859
Amortization of operating right-of-use assets	765	252
Depreciation	251	267
Amortization of intangible assets	768	827
Stock-based compensation	7,184	1,188
Change in operating assets and liabilities:
Accounts receivable	(2,070)	(3,480)
Prepaid expenses	1,065	1,431
Other current assets	(82)	(294)
Research and development tax credit receivable	(11,607)	(3,497)
Deferred revenue	(1,336)	5,286
Accounts payable	(347)	(1,849)
Accrued liabilities	4,411	(1,196)
Operating lease liabilities	(743)	(341)
Net cash used in operating activities	(63,408)	(40,140)
Cash flows used in investing activities:
Purchases of property and equipment	(186)	(371)
Net cash used in investing activities	(186)	(371)
Cash flows provided by financing activities:
Proceeds from issuance of common stock from rights offering	75,000	0
Transaction costs on issuance of common stock from rights offering	(159)	0
Proceeds from related party promissory notes	110,000	0
Payments of debt issuance costs	(54)	0
Repayment of related party promissory notes	(110,000)	0
Proceeds from exercise of stock options	1,868	3
Net cash provided by financing activities	76,655	3
Effect of exchange rate changes on cash	770	(2,064)
Increase (decrease) in cash	13,831	(42,572)
Cash at beginning of the period	66,417	63,842
Cash at end of the period	80,248	21,270
Supplemental Disclosure of Cash Flow Information:
Cash paid for interest on related party promissory note	3	0
Cash paid for income taxes	6	9
Transaction costs included in accrued expenses	41	0
Lease assets obtained in exchange for operating lease liabilities	$ 2,124	$ 0

Nature of the Business and Oper

Nature of the Business and Operations and Recent Events	9 Months Ended
	Sep. 30, 2021
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Nature of the Business and Operations and Recent Events	Nature of the 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. Summit is a biopharmaceutical company focused on the discovery, development and commercialization of novel antibiotics for serious infectious diseases. Summit is conducting a Phase III clinical program focused on the infectious disease C. difficile infection (or "CDI"). It is also seeking to expand the product candidate portfolio through the development of new mechanism, precision antibiotics using the proprietary Discuva Platform. On September 18, 2020, Summit, a Delaware corporation, became the successor issuer to Summit Therapeutics plc, a public limited company incorporated under the laws of England and Wales with the Registrar of Companies of England and Wales, United Kingdom ("U.K."), for certain purposes under both the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, or the Exchange Act. Such succession occurred pursuant to a statutory scheme of arrangement under U.K. law pursuant to which all Summit Therapeutics plc outstanding ordinary shares were exchanged on a five-for-one basis for newly issued shares of Summit common stock and Summit became the holding company of Summit Therapeutics plc (the predecessor registrant and former holding company) and its subsidiaries (which is referred to as the "Redomiciliation Transaction"). Concurrently, Summit Therapeutics plc was converted into a private limited company under the laws of England and Wales and renamed Summit Therapeutics Limited. In addition, the warrants and stock options to purchase shares of Summit Therapeutics plc were canceled and replacement warrants and stock options to purchase common stock in Summit Therapeutics Inc. were issued. The scheme of arrangement was accounted for as an exchange of equity interests among entities under common control. All assets and liabilities of Summit Therapeutics plc were assumed by Summit, resulting in the retention of the historical basis of accounting as if they had always been combined for accounting purposes and the historical consolidated financial statements of Summit Therapeutics plc became the historical consolidated financial statements of Summit Therapeutics Inc. All share and per share data for periods prior to the Redomiciliation Transaction in the financial statements were retroactively reflected to be presented as shares of our common stock, par value $0.01 per share. Recent Events On May 12, 2021, the Company closed its rights offering, which was fully subscribed. The Company received aggregate gross proceeds from the rights offering of $75.0 million from the sale of 14,312,976 shares of the Company’s common stock, par value $0.01, at a price per share of $5.24. Issuance costs associated with the rights offering were immaterial. In connection with the closing of the rights offering, the Second Note (see Note 11) matured and became due and the Company repaid all principal and accrued interest thereunder using a portion of the proceeds from the rights offering. On August 11, 2021, based on a thorough review of the design and enrollment status of its two ongoing blinded Phase III Ri-CoDIFy trials, the Company announced that it combined its two blinded pivotal Phase III clinical trials evaluating ridinilazole versus vancomycin into a single study and presented this decision to the United States ("U.S.") Food and Drug Administration (the "FDA") as such. During September 2021, the Company received feedback from the FDA that the FDA did not agree with the change to the primary endpoint that the Company proposed and has subsequently implemented in its ongoing Phase III Ri-CoDIFy studies when combining the trials. The Company will provide the combined results to all stakeholders, as the top line results become available. These top line results will best inform all parties as to the next appropriate course of action regarding ridinilazole. The Company anticipates communicating these results during the first quarter of 2022.

Basis of Presentation, Use of E

Basis of Presentation, Use of Estimates, Re-Classification of Certain Prior Period Balances and Correction of Errors in a Prior Period	9 Months Ended
	Sep. 30, 2021
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Basis of Presentation, Use of Estimates, Re-Classification of Certain Prior Period Balances and Correction of Errors in a Prior Period	Basis of Presentation, Use of Estimates, Re-Classification of Certain Prior Period Balances and Correction of Errors in a Prior Period 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 September 30, 2021, and for the three and nine months ended September 30, 2021 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, 2020 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, 2020 filed with the U.S. Securities and Exchange Commission on March 31, 2021. The financial results of the Company's activities are reported in U.S. 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 September 30, 2021, however, the extent to which the COVID-19 pandemic impacts the Company's financial results for the remainder of 2021 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. Re-Classification of Prior Period Balances Certain prior period amounts within the condensed consolidated statements of comprehensive loss for the three and nine months ended September 30, 2020 have been re-classified to conform to the current period presentation. Specifically, a foreign currency loss of $1.3 million and a foreign currency gain of $2.0 million for the three and nine months ended September 30, 2020, respectively, previously included as part of total operating expenses within general and administrative expenses, has been reclassified to be presented as part of other (expense) income, net and net expenses of $0.7 million and $0.8 million for the three and nine months ended September 30, 2020, respectively, previously reported as research and development expenses, are now presented as general and administrative expenses in conformity with the current period presentation. Correction of Errors in Prior Periods During the quarter ended December 31, 2020, the Company identified a deferred tax asset relating to the acquired, carried forward, tax losses arising from the acquisition of Discuva Limited in December 2017 that was not included as part of the business combination accounting. Furthermore, the Company identified deferred tax assets relating to available carried forward group tax losses arising as a result of the acquisition of Discuva Limited in December 2017 that were not included in the Company's subsequent balances sheets. As a result, in the Company's previously issued condensed consolidated financial statements for the period ended September 30, 2020, the Company incorrectly recognized $0.4 million of goodwill and omitted the inclusion of deferred tax assets of $2.1 million in the balance sheet as of September 30, 2020. Since the Company's deferred tax liabilities and deferred tax assets both arise in the U.K. tax jurisdiction, accordingly these are offset on the condensed consolidated balance sheet. The Company records a full valuation allowance against the deferred tax assets in excess of the deferred tax liabilities, as the deferred tax liability represents future reversals of existing taxable temporary differences. The impact of these errors on net loss was a deferred tax benefit $0.1 million for the both the three and nine months ended September 30, 2020. The misstatement had no net impact on the Company’s condensed consolidated statements of cash flows. Management concluded that the correction was not material to previously issued consolidated financial statements. Since these errors were not material to any previously issued annual or interim financial statements, no amendments to previously filed financial statements were required. Consequently, the Company has corrected for these errors by revising the September 30, 2020 balances herein and in the annual financial statements on the Company's Form 10-K, filed on March 31, 2021.

Recently Issued or Adopted Acco

Recently Issued or Adopted Accounting Pronouncements	9 Months Ended
	Sep. 30, 2021
Accounting Changes and Error Corrections [Abstract]
Recently Issued or Adopted Accounting Pronouncements	Recently Issued or Adopted Accounting Pronouncements In October 2021, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("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. In December 2019, the FASB issued ASU No. 2019-12, "Income Taxes (Topic 740)." This ASU simplifies the accounting for income taxes by removing certain exceptions to the general principles in Topic 740. The amendments also improve consistent application and simplify U.S. GAAP for other areas of Topic 740 by clarifying and amending existing guidance. This ASU is effective for annual periods, and interim periods within those fiscal years, beginning after December 15, 2020. The Company adopted this ASU during the first quarter of 2021 and the adoption of this ASU did not have a material impact on its financial position, results of operations or cash flows. In January 2017, the FASB issued ASU 2017-04, "Intangibles - Goodwill and Other (Topic 350)." This ASU simplifies how an entity is required to test goodwill for impairment by eliminating the requirement to determine the fair value of individual assets and liabilities in order to calculate a reporting unit’s “implied” goodwill. This ASU is effective for annual or any interim goodwill impairment tests in fiscal years beginning after December 15, 2020. The Company performs its goodwill impairment test during the fourth quarter of each fiscal year. The Company does not expect the adoption of this ASU to have a material impact on its financial position, results of operations or cash flows.

Going Concern

Going Concern	9 Months Ended
	Sep. 30, 2021
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Going Concern	Going Concern During the three and nine months ended September 30, 2021, the Company incurred a net loss of $19.6 million and $61.5 million, respectively, and cash flows used in operating activities for the nine month period ended September 30, 2021 was $63.4 million. As of September 30, 2021, the Company had an accumulated deficit of $272.4 million, cash of $80.2 million, research and development tax credits of $21.4 million and accounts receivable of $2.3 million. 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. During the third quarter of 2021, the Company combined its Phase III clinical trials evaluating ridinilazole versus vancomycin into a single study. The combination of these studies is expected to lead to the acceleration of the readout of our clinical trial results, which the Company expects to receive in the first quarter of 2022. Assuming positive top-line data, the Company may accelerate its spending to prepare for regulatory filings and commercial readiness. Based on these circumstances, prior to considering management’s plans described below, the Company has determined that with its current financial resources, which includes its existing cash on hand, funding agreements, and research and development tax credits receivable, the Company would be able to operate into the third quarter of 2022. In order to continue to fund the operations of the Company beyond this time period and assuming positive top-line data in the first quarter of 2022, management has developed plans, which primarily consist of raising additional capital through some combination of equity or debt financings, and/or potentially new collaborations. 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, the Company will implement an alternative operating plan that scales back its operations, reduces cash expenditures, and focuses its available capital on a reduced number of activities and programs. Based on the Company's current funding arrangements and financial resources as of September 30, 2021 of $103.9 million, consisting of cash of $80.2 million, research and development tax credit receivables of $21.4 million, and accounts receivable of $2.3 million, and after considering management’s alternative operating plans, the Company would have the ability to fund its operating costs and working capital needs into the first quarter of 2023. The accompanying condensed 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 condensed 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	9 Months Ended
	Sep. 30, 2021
Segment Reporting [Abstract]
Segment Reporting	Segment Reporting The Company's chief operating decision makers (the "CODM function"), which are the Company’s Chief Executive Officer and Chief Operating Officer, utilize financial information to make decision about allocating resources and assessing performance for the entire Company, which is used in the decision-making process to assess performance. The CODM function views the Company’s operations and manage its business as a single reportable operating segment. The Company's single operating segment covers the Company’s research and development activities, primarily comprising the CDI program and antibiotic pipeline research activities. As the Company operates in 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. Substantially all of the Company's long-lived assets are held in the U.K. For details of revenue from external customers by geography refer to Note 6.

Revenue

Revenue	9 Months Ended
	Sep. 30, 2021
Revenue from Contract with Customer [Abstract]
Revenue	Revenue The following table summarizes revenue by category: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Revenue by category: (in thousands) Licensing agreements $ 1,309 $ 181 $ 1,558 $ 675 $ 1,309 $ 181 $ 1,558 $ 675 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 Nine Months Ended 2021 2020 2021 2020 Revenue by geography: (in thousands) Latin America $ 1,309 $ 181 $ 1,558 $ 675 $ 1,309 $ 181 $ 1,558 $ 675 The analysis of revenue by geography has been identified on the basis of the customer’s geographical location. Eurofarma Laboratórios S.A. On December 21, 2017, Summit announced it had entered into an exclusive license and commercialization agreement with Eurofarma Laboratórios S.A. ("Eurofarma"), pursuant to which the Company granted Eurofarma the exclusive right to commercialize ridinilazole in specified countries in South America, Central America and the Caribbean. The Company has retained commercialization rights in the rest of the world. Under the terms of the license and commercialization agreement with Eurofarma, the Company received an upfront payment of $2.5 million from Eurofarma in December 2017. In February 2020, the Company reached the first enrollment milestone and earned $1.0 million. In September 2021, the Company reached the second enrollment milestone and earned $1.25 million. 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 nine months ended September 30, 2021 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 and nine months ended September 30, 2020 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 September 30, 2021 and December 31, 2020, the current contract liability relating to the Eurofarma contract was $1.0 million and $0.8 million, respectively, and was recorded in current deferred revenue in the condensed consolidated balance sheet. As of September 30, 2021 and December 31, 2020, the non-current contract liability relating to the Eurofarma contract was $0 and $0.6 million, respectively, and was recorded in non-current deferred revenue in the condensed consolidated balance sheet. In addition, the Company could receive an additional $1.5 million 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 $1.0 million in development milestones, $2.4 million in commercial milestones and up to $18.0 million in sales milestones when cumulative net sales equal or exceed $100.0 million in the Eurofarma licensed territory. Each subsequent achievement of an additional $100.0 million in cumulative net sales will result in the Company receiving additional milestone payments, which, when combined with anticipated product supply transfer payments from Eurofarma paid to the Company in connection with a commercial supply agreement to be entered into between the two parties, will provide payments estimated to range from a mid-teens to high-teens percentage of cumulative net sales in the Eurofarma licensed territory. The Company estimates such product supply transfer payments from Eurofarma will range from a high single-digit to low double-digit percentage of cumulative net sales in the licensed territory.

Other Operating Income

Other Operating Income	9 Months Ended
	Sep. 30, 2021
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 Nine Months Ended 2021 2020 2021 2020 Other operating income by category: (in thousands) Funding income from BARDA (as defined below) $ 644 $ 1,607 $ 3,974 $ 7,715 Research and development tax credits 3,815 2,559 11,698 6,900 Grant income from CARB-X (as defined below) 351 143 707 334 $ 4,810 $ 4,309 $ 16,379 $ 14,949 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 and the U.S. Department of Health and Human Services, in support of the Company's Ri-CoDIFy clinical trials and regulatory development of ridinilazole. Under the terms of this contract, the Company was initially eligible to receive base period funding of $32.0 million. In addition, the contract included three option work segments that, if exercised in full by BARDA, would increase the total federal government funding under the contract to approximately $62.0 million. In August 2018, BARDA exercised one of the option work segments worth $12.0 million. In June 2019, BARDA increased the total value of the funding contract to up to $63.7 million; at this time, BARDA also exercised a second of the option work segments worth $9.6 million to bring the total amount of committed BARDA funding to $53.6 million. In January 2020, BARDA increased its award by $8.8 million to bring the total amount of the funding contract to $72.5 million and the total amount of committed BARDA funding to $62.4 million. The remaining federal government funding is dependent on BARDA in its sole discretion exercising the final independent option work segment, upon the achievement by the Company of certain agreed-upon milestones for ridinilazole. As of September 30, 2021, an aggregate of $55.8 million of the total committed BARDA funding had been received and the Company has recognized $49.6 million 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, clinical trials management and third-party manufacturing development activities are eligible for the SME regime and the Company expects such elements of expenditure will also continue to be eligible for the SME regime in future periods. As of September 30, 2021, the current and non-current research and development tax credit receivable was $10.1 million and $11.3 million, respectively. As of December 31, 2020, the current and non-current research and development tax credit receivable was $9.9 million 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 $4.1 million, with the possibility of up to another $3.7 million based on the achievement of future milestones. As of September 30, 2021, $0.2 million of grant funding from CARB-X has been received and the Company has recognized $0.7 million of cumulative income since contract inception. Grant income recognized during the three and nine months ended September 30, 2021 relates to SMT-738. Grant income recognized during the three and nine months ended September 30, 2020, consists of income from a sub-award from CARB-X for the Company's antibiotic pipeline research and development activities specifically relating to the DDS-01 series of antibiotics, targeting Neisseria gonorrhoeae , or N. gonorrhoeae , using our Discuva Platform. In the fourth quarter of 2020, the Company decided not to advance the DDS-01 series and to cease work on the gonorrhea program, and as such no further grant income is expected to be received from CARB-X under this sub-award.

Loss per Share

Loss per Share	9 Months Ended
	Sep. 30, 2021
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 Nine Months Ended 2021 2020 2021 2020 (in thousands, except share and per share data) Net loss $ (19,599) $ (17,743) $ (61,503) $ (39,156) Basic weighted average number of shares of common stock outstanding 97,452,628 67,231,900 90,360,713 67,227,184 Diluted weighted average number of shares of common stock outstanding 97,452,628 67,231,900 90,360,713 67,227,184 Basic net loss per share $ (0.20) $ (0.26) $ (0.68) $ (0.58) Diluted net loss per share $ (0.20) $ (0.26) $ (0.68) $ (0.58) 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. As of September 30, 2021 and 2020, 18,677,765 and 11,974,480 shares of common stock were excluded, respectively from the computation of diluted net loss per share as they would have been anti-dilutive.

Goodwill and Intangible Assets

Goodwill and Intangible Assets	9 Months Ended
	Sep. 30, 2021
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 and thus 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 September 30, 2021 and December 31, 2020, goodwill was $2.0 million for both periods. The changes in the carrying amount of intangible assets and accumulated impairment loss during the nine months ended September 30, 2021 and the year ended December 31, 2020 were as follows: September 30, 2021 December 31, 2020 Gross carrying amount Accumulated amortization and impairment Net Gross carrying amount Accumulated amortization and impairment Net (In thousands) Utrophin program acquired $ 4,470 $ (4,470) $ — $ 4,534 $ (4,534) $ — Discuva platform acquired 14,361 (3,753) 10,608 14,565 (3,050) 11,515 Option over non-financial asset 909 (909) — 921 (921) — Other patents and licenses 148 (148) — 150 (150) — $ 19,888 $ (9,280) $ 10,608 $ 20,170 $ (8,655) $ 11,515 Amortization expense was $0.8 million for both the nine months ended September 30, 2021 and 2020, respectively. During the year ended December 31, 2020, the Company recognized an impairment charge of $0.9 million relating to its option over a non-financial asset pursuant to an evaluation and option agreement with a collaboration partner. The partner was no longer conducting antibiotic candidate programs over which the Company had the option and thus, management assessed the fair value to be zero.

Stock-Based Compensation and Wa

Stock-Based Compensation and Warrants	9 Months Ended
	Sep. 30, 2021
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 September 30, 2021: Nine Months Ended Weighted average exercise price Outstanding at December 31, 2020 3,672,968 $ 2.90 Granted 11,028,725 $ 5.89 Forfeited (1,131,517) $ 3.77 Exercised (713,548) $ 2.62 Outstanding at September 30, 2021 12,856,628 $ 5.41 Exercisable at September 30, 2021 913,773 $ 2.62 During the third quarter of 2021, the Compensation Committee of the Board of Directors approved a modification to the Company's outstanding performance-based stock option awards for active employees which removed the performance-based vesting criteria from these awards. Following this modification, the option awards are subject only to previously existing time-based vesting conditions. The Company accounted for this change as a modification in accordance with the requirements of Accounting Standards Codification Topic 718. As a result, 9,250,000 options that were previously authorized that had not achieved a grant date became granted in September 2021 relating to the modification. The Company will recognize the newly assessed measurement date fair value of the awards as compensation expense over the remaining vesting period. The stock option activity above incorporates the modified awards. The total intrinsic value of all outstanding and exercisable stock options at September 30, 2021 was $8.6 million and $2.2 million, respectively. The following table summarizes restricted stock units granted in the form of nominal-cost options: Nine Months Ended Weighted average exercise price Outstanding at December 31, 2020 26,923 $ 0.07 Exercised (26,923) $ 0.07 Outstanding at September 30, 2021 — $ — The total stock-based compensation expense included in the Company's condensed consolidated statements of comprehensive loss was as follows: Three Months Ended Nine Months Ended 2021 2020 2021 2020 (in thousands) Research and development $ 1,337 $ 275 $ 3,251 $ 638 General and administrative 1,307 86 3,933 550 Total stock-based compensation expense $ 2,644 $ 361 $ 7,184 $ 1,188 Warrants The Company had outstanding and exercisable warrants of 5,821,137 with a weighted average exercise price of $1.56 as of September 30, 2021 and December 31, 2020.

Related Party Transactions

Related Party Transactions	9 Months Ended
	Sep. 30, 2021
Related Party Transactions [Abstract]
Related Party Transactions	Related Party Transactions 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 $55.0 million in exchange for the issuance by the Company of an unsecured promissory note (the “Initial Note”) in the amount of $55.0 million. 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 $55.0 million, 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, as such the Company recognized imputed interest of $0.1 million within additional paid in capital. For the nine months ended September 30, 2021, interest of $0.1 million and an immaterial amortized discount charge relating to the debt issuance cost were recognized related to the Initial Note. 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 $55.0 million in exchange for the issuance by the Company of an unsecured promissory note (the “Second Note”) in the amount of $55.0 million. 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. Pursuant to the terms of the Second Note, following consummation of the rights offering the Second Note matured and all principal and interest thereunder was repaid by the Company using a portion of the proceeds of the rights offering. For the nine months ended September 30, 2021, interest of $0.1 million accrued related to the Second Note and an immaterial discount was recognized. On May 12, 2021, Mr. Duggan, participated in the Company's rights offering and purchased a total of 11,365,921 shares of the Company’s common stock, par value $0.01, at a price of $5.24 per share. After giving effect to the rights offering, Mr. Duggan is the beneficial owner of approximately 71% of the Company’s outstanding common stock. Dr. Zanganeh, the Company's Chief Operating Officer, also participated in the Company’s rights offering, purchasing a total of 389,077 shares of the Company’s common stock, par value $0.01, at a price of $5.24 per share. For further details on the Rights Offering see Note 1. 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. Zanganeh, the Company's Chief Operating Officer, is the sole owner of MZA. The Sublease runs until September 2022, with monthly rent payments to MZA of approximately $60.0 thousand per month. 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 nine months ended September 30, 2021, payments of $0.2 million and $0.4 million, respectively, were made pursuant to the Sublease.

Commitment and Contingencies

Commitment and Contingencies	9 Months Ended
	Sep. 30, 2021
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	Commitments and Contingencies Fixed Asset Purchase Commitments As of September 30, 2021 and December 31, 2020, the Company had no capital commitments. 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. These contracts generally provide for termination upon notice, and therefore are cancellable contracts and are not required to be disclosed. 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, and is incorporated by reference herein. 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 September 30, 2021 and December 31, 2020. Legal Proceedings The Company is not currently subject to any material legal proceedings.

Basis of Presentation, Use of_2

Basis of Presentation, Use of Estimates, Re-Classification of Certain Prior Period Balances and Correction of Errors in a Prior Period (Policies)	9 Months Ended
	Sep. 30, 2021
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 September 30, 2021, and for the three and nine months ended September 30, 2021 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, 2020 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, 2020 filed with the U.S. Securities and Exchange Commission on March 31, 2021. The financial results of the Company's activities are reported in U.S. 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 September 30, 2021, however, the extent to which the COVID-19 pandemic impacts the Company's financial results for the remainder of 2021 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 October 2021, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("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. In December 2019, the FASB issued ASU No. 2019-12, "Income Taxes (Topic 740)." This ASU simplifies the accounting for income taxes by removing certain exceptions to the general principles in Topic 740. The amendments also improve consistent application and simplify U.S. GAAP for other areas of Topic 740 by clarifying and amending existing guidance. This ASU is effective for annual periods, and interim periods within those fiscal years, beginning after December 15, 2020. The Company adopted this ASU during the first quarter of 2021 and the adoption of this ASU did not have a material impact on its financial position, results of operations or cash flows. In January 2017, the FASB issued ASU 2017-04, "Intangibles - Goodwill and Other (Topic 350)." This ASU simplifies how an entity is required to test goodwill for impairment by eliminating the requirement to determine the fair value of individual assets and liabilities in order to calculate a reporting unit’s “implied” goodwill. This ASU is effective for annual or any interim goodwill impairment tests in fiscal years beginning after December 15, 2020. The Company performs its goodwill impairment test during the fourth quarter of each fiscal year. The Company does not expect the adoption of this ASU to have a material impact on its financial position, results of operations or cash flows.

Revenue (Tables)

Revenue (Tables)	9 Months Ended
	Sep. 30, 2021
Revenue from Contract with Customer [Abstract]
Summary of revenue by category	The following table summarizes revenue by category: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Revenue by category: (in thousands) Licensing agreements $ 1,309 $ 181 $ 1,558 $ 675 $ 1,309 $ 181 $ 1,558 $ 675
Summary of revenue by geography	The following table summarizes revenue by geography: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Revenue by geography: (in thousands) Latin America $ 1,309 $ 181 $ 1,558 $ 675 $ 1,309 $ 181 $ 1,558 $ 675

Other Operating Income (Tables)

Other Operating Income (Tables)	9 Months Ended
	Sep. 30, 2021
Other Income and Expenses [Abstract]
Components of other operating income by category	The following table sets forth the components of other operating income by category: Three Months Ended Nine Months Ended 2021 2020 2021 2020 Other operating income by category: (in thousands) Funding income from BARDA (as defined below) $ 644 $ 1,607 $ 3,974 $ 7,715 Research and development tax credits 3,815 2,559 11,698 6,900 Grant income from CARB-X (as defined below) 351 143 707 334 $ 4,810 $ 4,309 $ 16,379 $ 14,949

Loss per Share (Tables)

Loss per Share (Tables)	9 Months Ended
	Sep. 30, 2021
Earnings Per Share [Abstract]
Computation of basic and diluted net loss per share	The following table sets forth the computation of basic and diluted net loss per share: Three Months Ended Nine Months Ended 2021 2020 2021 2020 (in thousands, except share and per share data) Net loss $ (19,599) $ (17,743) $ (61,503) $ (39,156) Basic weighted average number of shares of common stock outstanding 97,452,628 67,231,900 90,360,713 67,227,184 Diluted weighted average number of shares of common stock outstanding 97,452,628 67,231,900 90,360,713 67,227,184 Basic net loss per share $ (0.20) $ (0.26) $ (0.68) $ (0.58) Diluted net loss per share $ (0.20) $ (0.26) $ (0.68) $ (0.58)

Goodwill and Intangible Assets

Goodwill and Intangible Assets (Tables)	9 Months Ended
	Sep. 30, 2021
Goodwill and Intangible Assets Disclosure [Abstract]
Schedule of intangible assets	The changes in the carrying amount of intangible assets and accumulated impairment loss during the nine months ended September 30, 2021 and the year ended December 31, 2020 were as follows: September 30, 2021 December 31, 2020 Gross carrying amount Accumulated amortization and impairment Net Gross carrying amount Accumulated amortization and impairment Net (In thousands) Utrophin program acquired $ 4,470 $ (4,470) $ — $ 4,534 $ (4,534) $ — Discuva platform acquired 14,361 (3,753) 10,608 14,565 (3,050) 11,515 Option over non-financial asset 909 (909) — 921 (921) — Other patents and licenses 148 (148) — 150 (150) — $ 19,888 $ (9,280) $ 10,608 $ 20,170 $ (8,655) $ 11,515

Stock-Based Compensation and _2

Stock-Based Compensation and Warrants (Tables)	9 Months Ended
	Sep. 30, 2021
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 September 30, 2021: Nine Months Ended Weighted average exercise price Outstanding at December 31, 2020 3,672,968 $ 2.90 Granted 11,028,725 $ 5.89 Forfeited (1,131,517) $ 3.77 Exercised (713,548) $ 2.62 Outstanding at September 30, 2021 12,856,628 $ 5.41 Exercisable at September 30, 2021 913,773 $ 2.62
Schedule of RSU activity	The following table summarizes restricted stock units granted in the form of nominal-cost options: Nine Months Ended Weighted average exercise price Outstanding at December 31, 2020 26,923 $ 0.07 Exercised (26,923) $ 0.07 Outstanding at September 30, 2021 — $ —
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 Nine Months Ended 2021 2020 2021 2020 (in thousands) Research and development $ 1,337 $ 275 $ 3,251 $ 638 General and administrative 1,307 86 3,933 550 Total stock-based compensation expense $ 2,644 $ 361 $ 7,184 $ 1,188

Nature of the Business and Op_2

Nature of the Business and Operations and Recent Events (Details) $ / shares in Units, $ in Millions	May 12, 2021USD ($)$ / sharesshares	Sep. 18, 2020	Sep. 30, 2021$ / shares	Dec. 31, 2020$ / shares
Subsidiary, Sale of Stock [Line Items]
Reverse stock split ratio		0.2
Common stock par value (in dollars per share)	$ 0.01		$ 0.01	$ 0.01
Rights offering
Subsidiary, Sale of Stock [Line Items]
Consideration received on sale of stock | $	$ 75
Shares issued in transaction (in shares) | shares	14,312,976
Share price (in dollars per share)	$ 5.24

Basis of Presentation, Use of_3

Basis of Presentation, Use of Estimates, Re-Classification of Certain Prior Period Balances and Correction of Errors in a Prior Period (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020	Dec. 31, 2020
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Research and development	$ 19,943	$ 13,726	$ 62,245	$ 40,210
General and administrative	5,662	6,846	15,831	16,192
Goodwill derecognized	(2,001)		(2,001)		$ (2,030)
Deferred tax benefit	$ 0	56	$ 0	192
Reclassification adjustment
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Research and development		(700)		(800)
General and administrative		700		800
Reclassification adjustment | General and administrative
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Foreign currency reclassification		1,300		(2,000)
Reclassification adjustment | Other (expense) income
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Foreign currency reclassification		(1,300)		2,000
Error correction adjustment
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Goodwill derecognized		400		400
Deferred tax assets		2,100		2,100
Deferred tax benefit		$ 100		$ 100

Going Concern (Details)

Going Concern (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020	Dec. 31, 2020
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Net loss	$ 19,599	$ 17,743	$ 61,503	$ 39,156
Net cash used in operating activities			63,408	$ 40,140
Accumulated deficit	272,449		272,449		$ 210,946
Cash	80,248		80,248		66,417
Research and development tax credits receivable	21,400		21,400
Accounts receivable	2,290		2,290		$ 331
Potential liquidity	$ 103,900		$ 103,900

Segment Reporting (Details)

Segment Reporting (Details)	9 Months Ended
	Sep. 30, 2021segment
Segment Reporting [Abstract]
Number of operating segments	1
Number of geographic regions	2

Revenue - Revenue by Category (

Revenue - Revenue by Category (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Revenue from External Customer [Line Items]
Revenue	$ 1,309	$ 181	$ 1,558	$ 675
Licensing agreements
Revenue from External Customer [Line Items]
Revenue	$ 1,309	$ 181	$ 1,558	$ 675

Revenue - Revenue by Geography

Revenue - Revenue by Geography (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Disaggregation of Revenue [Line Items]
Revenue	$ 1,309	$ 181	$ 1,558	$ 675
Latin America
Disaggregation of Revenue [Line Items]
Revenue	$ 1,309	$ 181	$ 1,558	$ 675

Revenue - Narrative (Details)

Revenue - Narrative (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2021	Dec. 31, 2020	Feb. 29, 2020	Dec. 31, 2017
Disaggregation of Revenue [Line Items]
Current contract liability	$ 7,511	$ 8,370
Noncurrent contract liability	0	569
Licensing agreements | EuroFarma
Disaggregation of Revenue [Line Items]
Deferred revenue, upfront payment				$ 2,500
Deferred revenue, enrollment milestone	1,250		$ 1,000
Current contract liability	1,000	800
Noncurrent contract liability	0	$ 600
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

Other Operating Income - Other

Other Operating Income - Other Operating Income by Category (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended		49 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021
Revenue from External Customer [Line Items]
Research and development tax credits	$ 3,815	$ 2,559	$ 11,698	$ 6,900
Other operating income	4,810	4,309	16,379	14,949
BARDA
Revenue from External Customer [Line Items]
Grant/Funding income	644	1,607	3,974	7,715	$ 49,600
Other grant funding counterparties
Revenue from External Customer [Line Items]
Grant/Funding income	$ 351	$ 143	$ 707	$ 334

Other Operating Income - Narrat

Other Operating Income - Narrative (Details) $ in Thousands	1 Months Ended					3 Months Ended		5 Months Ended	9 Months Ended		49 Months Ended
	May 31, 2021USD ($)	Jan. 31, 2020USD ($)	Jun. 30, 2019USD ($)	Aug. 31, 2018USD ($)	Sep. 30, 2017USD ($)option_segment	Sep. 30, 2021USD ($)	Sep. 30, 2020USD ($)	Sep. 30, 2021USD ($)	Sep. 30, 2021USD ($)	Sep. 30, 2020USD ($)	Sep. 30, 2021USD ($)	Dec. 31, 2020USD ($)
Research and Development Arrangement, Contract to Perform for Others [Line Items]
Current research and development tax credit receivable						$ 10,072		$ 10,072	$ 10,072		$ 10,072	$ 9,856
Non-current research and development tax credit receivable						11,314		11,314	11,314		11,314	$ 0
BARDA
Research and Development Arrangement, Contract to Perform for Others [Line Items]
Committed funding base					$ 32,000
Number of option segments | option_segment					3
Maximum funding value		$ 72,500	$ 63,700		$ 62,000
Committed funding increase		8,800	9,600	$ 12,000
Total committed funding		$ 62,400	$ 53,600
Funding received											55,800
Grant/Funding income						$ 644	$ 1,607		$ 3,974	$ 7,715	$ 49,600
CARB-X
Research and Development Arrangement, Contract to Perform for Others [Line Items]
Committed funding base	$ 4,100
Funding received								200
Grant/Funding income								$ 700
Funding increase based on achievement of future milestones	$ 3,700

Loss per Share - Computation of

Loss per Share - Computation of basic and diluted net loss per share (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Earnings Per Share [Abstract]
Net loss	$ (19,599)	$ (17,743)	$ (61,503)	$ (39,156)
Basic weighted average number of shares of common stock outstanding (in shares)	97,452,628	67,231,900	90,360,713	67,227,184
Diluted weighted average number of shares of common stock outstanding (in shares)	97,452,628	67,231,900	90,360,713	67,227,184
Basic net loss per share (in dollars per share)	$ (0.20)	$ (0.26)	$ (0.68)	$ (0.58)
Diluted net loss per share (in dollars per share)	$ (0.20)	$ (0.26)	$ (0.68)	$ (0.58)

Loss per Share - Narrative (Det

Loss per Share - Narrative (Details) - shares	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Earnings Per Share [Abstract]
Anti-dilutive shares excluded from diluted earnings per share (in shares)	18,677,765	11,974,480

Goodwill and Intangible Asset_2

Goodwill and Intangible Assets - Narrative (Details) - USD ($)	9 Months Ended		12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Dec. 31, 2020
Finite-Lived Intangible Assets [Line Items]
Goodwill	$ 2,001,000		$ 2,030,000
Amortization expense	$ 768,000	$ 827,000
Option over non-financial asset
Finite-Lived Intangible Assets [Line Items]
Impairment charge			900,000
Fair value of option over non-financial asset			$ 0

Goodwill and Intangible Asset_3

Goodwill and Intangible Assets - Carrying Amount of Intangible Assets and Accumulated Amortization and Impairment (Details) - USD ($) $ in Thousands	Sep. 30, 2021	Dec. 31, 2020
Finite-Lived Intangible Assets [Line Items]
Gross carrying amount	$ 19,888	$ 20,170
Accumulated amortization and impairment	(9,280)	(8,655)
Net	10,608	11,515
Software licenses | Utrophin program acquired
Finite-Lived Intangible Assets [Line Items]
Gross carrying amount	4,470	4,534
Accumulated amortization and impairment	(4,470)	(4,534)
Net	0	0
Software licenses | Discuva platform acquired
Finite-Lived Intangible Assets [Line Items]
Gross carrying amount	14,361	14,565
Accumulated amortization and impairment	(3,753)	(3,050)
Net	10,608	11,515
Option over non-financial asset
Finite-Lived Intangible Assets [Line Items]
Gross carrying amount	909	921
Accumulated amortization and impairment	(909)	(921)
Net	0	0
Other patents and licenses
Finite-Lived Intangible Assets [Line Items]
Gross carrying amount	148	150
Accumulated amortization and impairment	(148)	(150)
Net	$ 0	$ 0

Stock-Based Compensation and _3

Stock-Based Compensation and Warrants - Stock Option Activity (Details) - $ / shares	1 Months Ended	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2021
Number of share options
Beginning balance (in shares)		3,672,968
Granted (in shares)	9,250,000	11,028,725
Forfeited (in shares)		(1,131,517)
Exercise (in shares)		(713,548)
Ending balance (in shares)	12,856,628	12,856,628
Weighted average exercise price
Beginning balance (in dollars per share)		$ 2.90
Granted (in dollars per share)		5.89
Forfeited (in dollars per share)		3.77
Exercised (in dollars per share)		2.62
Ending balance (in dollars per share)	$ 5.41	$ 5.41
Stock option activity, additional disclosures
Exercisable, number of share options (in shares)	913,773	913,773
Weighted average exercise price, exercisable (in dollars per share)	$ 2.62	$ 2.62

Stock-Based Compensation and _4

Stock-Based Compensation and Warrants - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions	1 Months Ended	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2021	Dec. 31, 2020
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock options granted related to plan modification (in shares)	9,250,000	11,028,725
Aggregate intrinsic value, outstanding options	$ 8.6	$ 8.6
Aggregate intrinsic value, exercisable options	$ 2.2	$ 2.2
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	5,821,137
Non-option equity instruments exercisable (in shares)	5,821,137	5,821,137	5,821,137
Weighted average exercise price of non-option equity instruments outstanding (in dollars per share)	$ 1.56	$ 1.56	$ 1.56
Weighted average exercise price of non-option equity instruments exercisable (in dollars per share)	$ 1.56	$ 1.56	$ 1.56

Stock-Based Compensation and _5

Stock-Based Compensation and Warrants - Restricted Stock Unit Activity (Details) - RSUs	9 Months Ended
	Sep. 30, 2021$ / sharesshares
Number of shares
Beginning balance (in shares) | shares	26,923
Exercised (in shares) | shares	(26,923)
Ending balance (in shares) | shares	0
Weighted average exercise price
Beginning balance (in dollars per share) | $ / shares	$ 0.07
Exercised (in dollars per share) | $ / shares	0.07
Ending balance (in dollars per share) | $ / shares	$ 0

Stock-Based Compensation and _6

Stock-Based Compensation and Warrants - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	$ 2,644	$ 361	$ 7,184	$ 1,188
Research and development
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	1,337	275	3,251	638
General and administrative
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	$ 1,307	$ 86	$ 3,933	$ 550

Related party transactions (Det

Related party transactions (Details)	May 12, 2021$ / sharesshares	Apr. 20, 2021USD ($)	Mar. 26, 2021USD ($)ft²	Mar. 24, 2021USD ($)	Sep. 30, 2021USD ($)$ / shares	Sep. 30, 2021USD ($)$ / shares	Sep. 30, 2020USD ($)	Dec. 31, 2020$ / shares
Related Party Transaction [Line Items]
Proceeds from related party promissory notes						$ 110,000,000	$ 0
Imputed interest expense on promissory note payable to a related party						$ 103,000
Common stock par value (in dollars per share) | $ / shares	$ 0.01				$ 0.01	$ 0.01		$ 0.01
Rights offering
Related Party Transaction [Line Items]
Shares issued in transaction (in shares) | shares	14,312,976
Share price (in dollars per share) | $ / shares	$ 5.24
Additional Paid-In Capital
Related Party Transaction [Line Items]
Imputed interest expense on promissory note payable to a related party						$ 103,000
Chief Executive Officer
Related Party Transaction [Line Items]
Beneficial ownership percentage	71.00%
Chief Executive Officer | Rights offering
Related Party Transaction [Line Items]
Shares issued in transaction (in shares) | shares	11,365,921
Share price (in dollars per share) | $ / shares	$ 5.24
Chief Executive Officer | Initial Purchase Agreement
Related Party Transaction [Line Items]
Proceeds from related party promissory notes				$ 55,000,000
Notes payable				$ 55,000,000
Notes payable, estimated interest rate				2.40%
Notes payable, maturity triggering event, public offering proceeds threshold				$ 55,000,000
Notes payable, term				13 months
Interest expense						100,000
Chief Executive Officer | Initial Purchase Agreement | Additional Paid-In Capital
Related Party Transaction [Line Items]
Imputed interest expense on promissory note payable to a related party						100,000
Chief Executive Officer | Initial Purchase Agreement | 10 year US Treasury rate
Related Party Transaction [Line Items]
Notes payable, basis spread on variable rate				150.00%
Chief Executive Officer | Second Purchase Agreement
Related Party Transaction [Line Items]
Proceeds from related party promissory notes		$ 55,000,000
Notes payable		$ 55,000,000
Notes payable, estimated interest rate		2.40%
Interest expense						100,000
Chief Executive Officer | Second Purchase Agreement | 10 year US Treasury rate
Related Party Transaction [Line Items]
Notes payable, basis spread on variable rate		150.00%
Chief Operating Officer | Rights offering
Related Party Transaction [Line Items]
Shares issued in transaction (in shares) | shares	389,077
Share price (in dollars per share) | $ / shares	$ 5.24
Affiliated entity
Related Party Transaction [Line Items]
Area of premises subleased | ft²			4,500
Monthly expense from related party			$ 60,000
Payments to related party					$ 200,000	$ 400,000

Commitment and Contingencies (D

Commitment and Contingencies (Details) - USD ($)	Sep. 30, 2021	Dec. 31, 2020
Commitments and Contingencies Disclosure [Abstract]
Capital commitments	$ 0	$ 0