UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q


	☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

	For the quarterly period ended March 31, 2021

	OR

	☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number 001-37368

ADAPTIMMUNE THERAPEUTICS PLC

(Exact name of Registrant as specified in its charter)


England and Wales	Not Applicable
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)

60 Jubilee Avenue, Milton Park

Abingdon, Oxfordshire OX14 4RX

United Kingdom

(Address of principal executive offices)

(44) 1235 430000

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol	Name of each exchange on which registered

American Depositary Shares, each representing 6 Ordinary Shares, par value £0.001 per share	ADAP	The Nasdaq Global Select Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ⌧ Yes ◻ No

Indicate by check mark whether the registrant has submitted electronically, every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ⌧ Yes ◻ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer⌧	Accelerated filer ◻
Non-accelerated filer◻	Smaller reporting company ◻
	Emerging growth company☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standard provided pursuant to Section 13(a) of the Exchange Act. ◻

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ⌧ No

As of May 4, 2021, the number of outstanding ordinary shares par value £0.001 per share of the Registrant is 932,984,520.

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PART I — FINANCIAL INFORMATION

Item 1. Financial Statements.

ADAPTIMMUNE THERAPEUTICS PLC

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share data)


	March 31,		December 31,
	2021		2020
Assets
Current assets
Cash and cash equivalents	$	32,432	$	56,882
Marketable securities - available-for-sale debt securities		285,512		311,335
Other current assets and prepaid expenses		41,349		29,935
Total current assets		359,293		398,152

Restricted cash		4,604		4,602
Operating lease right-of-use assets, net of accumulated amortization		18,326		18,880
Property, plant and equipment, net of accumulated depreciation of $32,703 (2020: $31,097)		27,739		27,778
Intangibles, net of accumulated amortization		1,619		1,730
Total assets	$	411,581	$	451,142

Liabilities and stockholders’ equity
Current liabilities
Accounts payable	$	4,116	$	6,389
Operating lease liabilities, current		2,845		2,773
Accrued expenses and other accrued liabilities		22,263		27,079
Deferred revenue, current		2,083		2,832
Total current liabilities		31,307		39,073

Operating lease liabilities, non-current		19,897		20,938
Deferred revenue, non-current		50,565		49,260
Other liabilities, non-current		655		644
Total liabilities		102,424		109,915

Stockholders’ equity
Common stock - Ordinary shares par value £0.001, 1,038,249,630 authorized and 932,817,168 issued and outstanding (2020: 1,038,249,630 authorized and 928,754,958 issued and outstanding)		1,331		1,325
Additional paid in capital		941,569		935,706
Accumulated other comprehensive loss		(10,224)		(10,048)
Accumulated deficit		(623,519)		(585,756)
Total stockholders' equity		309,157		341,227

Total liabilities and stockholders’ equity	$	411,581	$	451,142

See accompanying notes to unaudited condensed consolidated financial statements.

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ADAPTIMMUNE THERAPEUTICS PLC

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except share and per share data)


	Three months ended
	March 31,
	2021		2020
Revenue	$	434	$	761
Operating expenses
Research and development		(24,506)		(21,264)
General and administrative		(13,817)		(9,261)
Total operating expenses		(38,323)		(30,525)
Operating loss		(37,889)		(29,764)
Interest income		425		730
Other (expense) income, net		(1)		937
Loss before income taxes		(37,465)		(28,097)
Income taxes		(298)		(70)
Net loss attributable to ordinary shareholders	$	(37,763)	$	(28,167)

Net loss per ordinary share
Basic and diluted	$	(0.04)	$	(0.04)

Weighted average shares outstanding:
Basic and diluted		931,088,810		739,753,371

See accompanying notes to unaudited condensed consolidated financial statements.

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ADAPTIMMUNE THERAPEUTICS PLC

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(In thousands)



	Three months ended
	March 31,
	2021		2020
Net loss	$	(37,763)	$	(28,167)
Other comprehensive (loss) income, net of tax
Foreign currency translation adjustments, net of tax of $0 and $0		(3,001)		17,911
Foreign currency gains (losses) on intercompany loan of a long-term investment nature, net of tax of $0 and $0		3,048		(19,651)
Unrealized holding losses on available-for-sale debt securities, net of tax of $0 and $0		(223)		(586)
Total comprehensive loss for the period	$	(37,939)	$	(30,493)

See accompanying notes to unaudited condensed consolidated financial statements.

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ADAPTIMMUNE THERAPEUTICS PLC

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGE IN EQUITY

(In thousands, except share data)



						Accumulated
				Additional		other				Total
	Common	Common		paid in		comprehensive		Accumulated		stockholders'
	stock	stock		capital		loss		deficit		equity
Balance as of 1 January 2021	928,754,958	$	1,325	$	935,706	$	(10,048)	$	(585,756)	$	341,227
Net loss	—		—		—		—		(37,763)		(37,763)
Issuance of shares upon exercise of stock options	4,062,210		6		529		—		—		535
Other comprehensive loss	—		—		—		(176)		—		(176)
Share-based compensation expense	—		—		5,334		—		—		5,334
Balance as of March 31, 2021	932,817,168	$	1,331	$	941,569	$	(10,224)	$	(623,519)	$	309,157

See accompanying notes to unaudited condensed consolidated financial statements.

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ADAPTIMMUNE THERAPEUTICS PLC

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGE IN EQUITY

(In thousands, except share data)



						Accumulated
				Additional		other				Total
	Common	Common		paid in		comprehensive		Accumulated		stockholders’
	stock	stock		capital		loss		deficit		equity
Balance as of 1 January 2020	631,003,568		943		585,623		(7,264)		(455,664)		123,638
Net loss	—		—		—		—		(28,167)		(28,167)
Other comprehensive loss	—		—		—		(2,326)		—		(2,326)
Issuance of shares upon exercise of stock options	4,610,772		6		888		—		—		894
Issuance of shares upon completion of public offering	144,900,000		190		90,360		—		—		90,550
Share-based compensation expense	—		—		1,448		—		—		1,448
Balance as of March 31, 2020	780,514,340	$	1,139	$	678,319	$	(9,590)	$	(483,831)	$	186,037

See accompanying notes to unaudited condensed consolidated financial statements.

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ADAPTIMMUNE THERAPEUTICS PLC

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)


	Three months ended
	March 31,
	2021		2020
Cash flows from operating activities
Net loss	$	(37,763)	$	(28,167)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		1,436		1,711
Share-based compensation expense		5,334		1,448
Unrealized foreign exchange losses (gains)		1,249		(1,745)
Amortization on available-for-sale debt securities		1,499		150
Other		1,299		175
Changes in operating assets and liabilities:
Increase in receivables and other operating assets		(11,155)		(3,193)
Increase in non-current operating assets		—		(259)
Decrease in payables and other current liabilities		(8,601)		(2,708)
Increase in deferred revenue		162		49,445
Net cash (used in) provided by operating activities		(46,540)		16,857

Cash flows from investing activities
Acquisition of property, plant and equipment		(1,152)		(192)
Acquisition of intangibles		(133)		(152)
Maturity or redemption of marketable securities		84,646		26,364
Investment in marketable securities		(61,599)		(97,967)
Net cash provided by (used in) investing activities		21,762		(71,947)

Cash flows from financing activities
Proceeds from issuance of common stock, net of issuance costs		—		90,550
Proceeds from exercise of stock options		534		894
Net cash provided by financing activities		534		91,444

Effect of currency exchange rate changes on cash, cash equivalents and restricted cash		(204)		(502)
Net (decrease) increase in cash, cash equivalents and restricted cash		(24,448)		35,852
Cash, cash equivalents and restricted cash at start of period		61,484		54,908
Cash, cash equivalents and restricted cash at end of period	$	37,036	$	90,760

See accompanying notes to unaudited condensed consolidated financial statements.

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ADAPTIMMUNE THERAPEUTICS PLC

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Note 1 — General

Adaptimmune Therapeutics plc is registered in England and Wales. Its registered office is 60 Jubilee Avenue, Milton Park, Abingdon, Oxfordshire, OX14 4RX, United Kingdom. Adaptimmune Therapeutics plc and its subsidiaries (collectively “Adaptimmune” or the “Company”) is a clinical-stage biopharmaceutical company primarily focused on providing novel cell therapies to people with cancer. We are a leader in the development of T-cell therapies for solid tumors. The Company’s proprietary platform enables it to identify cancer targets, find and develop cell therapy candidates active against those targets and produce therapeutic candidates for administration to patients.

The Company is subject to a number of risks similar to other biopharmaceutical companies in the early stage of clinical development including, but not limited to, the need to obtain adequate additional funding, possible failure of preclinical programs or clinical programs, the need to obtain marketing approval for its cell therapies, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of its cell therapies, the need to develop a reliable commercial manufacturing process, the need to commercialize any cell therapies that may be approved for marketing, and protection of proprietary technology. If the Company does not successfully commercialize any of its cell therapies, it will be unable to generate product revenue or achieve profitability. The Company had an accumulated deficit of $623,519,000 as of March 31, 2021.

Note 2 — Summary of Significant Accounting Policies

(a) Basis of presentation

The condensed consolidated financial statements of Adaptimmune Therapeutics plc and its subsidiaries and other financial information included in this Quarterly Report are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and are presented in U.S. dollars. All significant intercompany accounts and transactions between the Company and its subsidiaries have been eliminated on consolidation.

The unaudited condensed consolidated financial statements presented in this Quarterly Report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K filed with the SEC on February 25, 2021 (the “Annual Report”). The balance sheet as of December 31, 2020 was derived from audited consolidated financial statements included in the Company’s Annual Report but does not include all disclosures required by U.S. GAAP. The Company’s significant accounting policies are described in Note 2 to those consolidated financial statements.

Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from these interim financial statements. However, these interim financial statements include all adjustments, consisting only of normal recurring adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period. The interim results are not necessarily indicative of results to be expected for the full year.

(b) Use of estimates in interim financial statements

The preparation of interim financial statements, in conformity with U.S. GAAP and SEC regulations, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the interim financial statements and reported amounts of revenues and expenses during the reporting period. Estimates and assumptions are primarily made in relation to valuation allowances relating to deferred tax assets, revenue recognition, and estimation of the incremental borrowing rate for operating leases. If actual results differ from the Company’s estimates, or to the extent these estimates are adjusted in future periods, the Company’s results of operations could either benefit from, or be adversely affected by, any such change in estimate.

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(c) Fair value measurements

The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. The fair value hierarchy prioritizes valuation inputs based on the observable nature of those inputs. The hierarchy defines three levels of valuation inputs:

Level 1 - Quoted prices in active markets for identical assets or liabilities

Level 2 - Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly

Level 3 - Unobservable inputs that reflect the Company's own assumptions about the assumptions market participants would use in pricing the asset or liability

The carrying amounts of the Company’s cash and cash equivalents, restricted cash, accounts receivable, accounts payable and accrued expenses approximate fair value because of the short-term nature of these instruments. The fair value of marketable securities, which are measured at fair value on a recurring basis is detailed in Note 6, Fair value measurements.

(d) New accounting pronouncements

Adopted in the period

Convertible instruments and contracts in an entity’s own stock

On January 1, 2021, the Company adopted ASU 2020-06 - Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity's Own Equity (Subtopic 815-40)—Accounting for Convertible Instruments and Contracts in an Entity's Own Equity, which simplifies the accounting for convertible instruments and contracts in an entity’s own stock. The guidance was adopted on a modified retrospective basis, whereby the guidance is applied to transactions outstanding as of the beginning of the fiscal year in which the guidance is adopted. The guidance has not had a material impact on the Company’s condensed consolidated financial statements.

To be adopted in future periods

Measurement of credit losses on financial instruments

In June 2016, the FASB issued ASU 2016-13 - Financial Instruments - Credit losses, which replaces the incurred loss impairment methodology for financial instruments in current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The guidance is effective for the fiscal year beginning January 1, 2020, including interim periods within that fiscal year. In November 2019, the FASB issued ASU 2019-10 which resulted in the postponement of the effective date of the new guidance for eligible smaller reporting companies (as defined by the SEC), including the Company, at that time to the fiscal year beginning January 1, 2023; however, earlier adoption is permitted, and the Company may choose to implement the guidance in an earlier fiscal year. The guidance must be adopted using a modified-retrospective approach and a prospective transition approach is required for debt securities for which an other-than-temporary impairment had been recognized before the effective date. The Company is currently evaluating the impact of the guidance on its condensed consolidated financial statements.

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Note 3 — Revenue

The Company has two contracts with customers: a collaboration and license agreement with GSK and a collaboration agreement with Astellas.

Revenue comprises the following categories (in thousands):


	Three months ended
	March 31,
	2021		2020

Development revenue	$	434	$	761
	$	434	$	761

The amount of the transaction price that is allocated to performance obligations that are unsatisfied or partially satisfied under the agreement as of March 31, 2021 was $64,137,000. Of this, $15,300,000 is allocated to the rights granted for each of the two independent Astellas targets, $7,400,000 is allocated to research services and rights under the co-exclusive license for each of the second and third co-development targets under the collaboration agreement with Astellas, $18,500,000 is allocated to research services and rights granted under the co-exclusive license for the first Astellas co-development target, and $237,000 is allocated to research services for the third target under the agreement with GSK.

Future development, regulatory and sales milestones under both agreements are not considered probable as of March 31, 2021 and have not been included in the transaction price. Reimbursement of the research funding over the co-development period under the Astellas agreement is variable consideration and included in the transaction price as of March 31, 2021 to the extent that a significant reversal of revenue is not probable.

The Company expects to recognize revenue for the two independent Astellas targets at a point-in-time upon commencement of the licenses in the event of nomination of the targets, while revenue for the remaining performance obligations will be recognized as development progresses.

Note 4 — Loss per share

The dilutive effect of 113,556,283 and 93,106,607 stock options outstanding as of March 31, 2021 and 2020 respectively have been excluded from the diluted loss per share calculation for the three months ended March 31, 2021 and 2020, because they would have an antidilutive effect on the loss per share for the period.

Note 5 — Accumulated other comprehensive loss

The Company reports foreign currency translation adjustments and the foreign exchange gain or losses arising on the revaluation of intercompany loans of a long-term investment nature within Other comprehensive (loss) income. Unrealized gains and losses on available-for-sale debt securities are also reported within Other comprehensive (loss) income until a gain or loss is realized, at which point they are reclassified to Other (expense) income, net in the Condensed Consolidated Statement of Operations.

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The following table shows the changes in Accumulated other comprehensive (loss) income (in thousands):


	Accumulated		Accumulated			Total
	foreign		unrealized			accumulated
	currency		gains (losses) on			other
	translation		available-for-sale			comprehensive
	adjustments		debt securities			(loss) income

Balance at January 1, 2021	$	(10,158)	$	110	$	(10,048)
Foreign currency translation adjustments		(3,001)		—		(3,001)
Foreign currency gains on intercompany loan of a long-term investment nature, net of tax of $0		3,048		—		3,048
Unrealized holding losses on available-for-sale debt securities, net of tax of $0		—		(223)		(223)
Balance at March 31, 2021	$	(10,111)	$	(113)	$	(10,224)


	Accumulated		Accumulated		Total
	foreign		unrealized		accumulated
	currency		gains (losses) on		other
	translation		available-for-sale		comprehensive
	adjustments		debt securities		(loss) income

Balance at January 1, 2020	$	(7,302)	$	38	$	(7,264)
Foreign currency translation adjustments		17,911		—		17,911
Foreign currency losses on intercompany loan of a long-term investment nature, net of tax of $0		(19,651)		—		(19,651)
Unrealized holding losses on available-for-sale debt securities, net of tax of $0		—		(586)		(586)
Balance at March 31, 2020	$	(9,042)	$	(548)	$	(9,590)

Note 6 — Fair value measurements

Assets and liabilities measured at fair value on a recurring basis based on Level 1, Level 2, and Level 3 fair value measurement criteria as of March 31, 2021 are as follows (in thousands):


			Fair value measurements using
	March 31,		Level 1		Level 2		Level 3
	2021
Assets:
Corporate debt securities	$	279,507	$	279,507		—		—
Agency bonds		6,005		—		6,005		—
	$	285,512	$	279,507	$	6,005	$	—

The Company estimates the fair value of available-for-sale debt securities with the aid of a third party valuation service, which uses actual trade and indicative prices sourced from third-party providers on a daily basis to estimate the fair value. If observed market prices are not available (for example securities with short maturities and infrequent secondary market trades), the securities are priced using a valuation model maximizing observable inputs, including market interest rates.

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Note 7 — Marketable securities – available-for-sale debt securities

As of March 31, 2021, the Company has the following investments in marketable securities (in thousands):


				Gross		Gross		Aggregate
	Remaining	Amortized		Unrealized		Unrealized		Estimated
	Contractual Maturity	Cost		Gains		Losses		Fair Value
Available-for-sale debt securities:
Corporate debt securities	Less than 3 months	$	54,372	$	15	$	(11)	$	54,376
Corporate debt securities	3 months to 1 year		114,136		35		(39)		114,132
Agency bonds	1 year to 2 years		5,999		6		—		6,005
Corporate debt securities	1 year to 2 years		111,119		53		(173)		110,999
		$	285,626	$	109	$	(223)	$	285,512

The aggregate fair value (in thousands) and number of securities held by the Company (including those classified as cash equivalents) in an unrealized loss position as of March 31, 2021 and 31 December, 2020 are as follows:



	March 31, 2021						December 31, 2020
	Fair market value of investments in an unrealized loss position		Number of investments in an unrealized loss position		Unrealized losses		Fair market value of investments in an unrealized loss position		Number of investments in an unrealized loss position		Unrealized losses
Marketable securities:
Corporate debt securities	$	199,148		37	$	(223)	$	157,985		30	$	(158)

As of March 31, 2021, the securities in an unrealized loss position are not considered to be other than temporarily impaired because the impairments are not severe and have been for a short duration. No securities have been in an unrealized loss position for more than one year. The Company does not intend to sell the debt securities in an unrealized loss position and believes that it has the ability to hold the debt securities to maturity.

Note 8 — Other current assets

Other current assets consisted of the following (in thousands):


	March 31,		December 31,
	2021		2020
Corporate tax receivable	$	31,141	$	20,585
Prepayments		5,689		6,314
Clinical materials		1,576		2,086
Other current assets		2,943		950
	$	41,349	$	29,935

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Note 9 — Accrued expenses and other current liabilities

Accrued expenses and other current liabilities consisted of the following (in thousands):


	March 31,		December 31,
	2021		2020
Accrued clinical and development expenditure	$	13,577	$	13,081
Accrued employee expenses		5,836		11,825
Other accrued expenditure		2,459		2,126
Other		391		47
	$	22,263	$	27,079

Note 10 — Contingencies and commitments

On January 7, 2021, the Company entered into an agreement with a third party, whereby the third party is responsible for the development, manufacture, submission of regulatory filings and commercialization of a companion diagnostic for the detection of the MAGE-A4 biomarker. The Company shall compensate the third party for its performance of activities under the agreement based on milestone payments and reimbursement of direct expenses. The agreement is non-exclusive and the third party can sell the companion diagnostic to other parties. Once the companion diagnostic is approved and launched, the Company guarantees a minimum revenue to the third party. The agreement can be terminated by the Company and the third party upon 60 days’ notice, if certain conditions are met.

Note 11 — Share-based compensation

The following table shows the total share-based compensation expense included in the unaudited consolidated statements of operations (in thousands):


	Three months ended
	March 31,
	2021		2020
Research and development	$	2,375	$	978
General and administrative		2,959		470
	$	5,334	$	1,448

The following table shows information about share options and options which have a nominal exercise price (similar to restricted stock units (RSUs)) granted:


	Three months ended
	March 31,
	2021		2020
Number of options over ordinary shares granted		14,803,056		10,229,280
Weighted average fair value of ordinary shares options	$	0.75	$	0.51
Number of additional options with a nominal exercise price granted		12,663,792		6,060,696
Weighted average fair value of options with a nominal exercise price	$	1.03	$	0.74

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes included in this Quarterly Report. The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and related notes appearing elsewhere in this Quarterly Report and the audited consolidated financial statements and notes thereto and management’s discussion and analysis of financial condition and results of operations for the year ended December 31, 2020, included in our Annual Report on Form 10-K that was filed with the SEC on February 25, 2021. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of this Quarterly Report and our Annual Report on Form 10-K for the year ended December 31, 2020, our actual results could differ materially from the results described in, or implied by, these forward-looking statements.

Overview

We are a clinical-stage biopharmaceutical company focused on providing novel cell therapies to people with cancer. We are a leader in the development of T-cell therapies for solid tumors and have seen responses in six solid tumors in clinical trials.

Our proprietary platform enables us to identify cancer targets, find and develop cell therapy candidates active against those targets and produce therapeutic candidates for administration to patients. Our cell therapy candidates include Specific Peptide Enhanced Affinity Receptor (“SPEAR”) T-cells, which use genetically engineered T-cell receptors; next generation T-cell Infiltrating Lymphocytes (“TiLs”) where a patient’s own T-cells are co-administered with our next generation technology, and HLA-independent TCRs (“HiTs”) where surface proteins are targeted independently of the peptide-HLA complex.

As the COVID-19 pandemic continues, we remain focused on ensuring the safety of our workforce and continuing, where possible, to safely treat patients with our cell therapies. We continue to work with our clinical sites to ensure that patients are treated as soon as clinical sites are able to do so . Our facilities in the United States (“U.S.”) and the United Kingdom (“U.K.”) remain open to support manufacturing and delivery of our existing cell therapies as well as research and development of new cell therapies. Further information on risks related to COVID-19 is provided in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2020.

We have multiple clinical trials ongoing:

●

SPEARHEAD-1 Phase 2 Trial with afamitresgene autoleucel (“afami-cel”): A registration directed Phase 2 clinical trial is underway in synovial sarcoma and myxoid round cell liposarcoma (“MRCLS”) indications in which the MAGE-A4 antigen is expressed. Subject to the successful conclusion of the SPEARHEAD-1 trial during the first half of 2021 and filing of a Biologics License Application in 2022, we plan to commercially launch afami-cel for treatment of synovial sarcoma. Initial data from this trial will be presented at the American Society of Clinical Oncology (ASCO) on June 4, 2021. Orphan Drug designation for afami-cel for the treatment of soft tissue sarcomas has been granted in the European Union and U.S. together with Regenerative Medicine Advanced Therapy (RMAT) designation in the U.S. for the treatment of synovial sarcoma and access to the Priority Medicines (“PRIME”) Regulatory Support initiative by the European Medicines Agency (“EMA”) for afami-cel for the treatment of synovial sarcoma.

●

SPEARHEAD-2 Phase 2 Trial with afami-cel: A Phase 2 trial combining afami-cel with pembrolizumab in patients with head and neck cancer expressing the MAGE-A4 antigen is underway at clinical sites in the United States.

●

SURPASS Phase 1 Trial with ADP-A2M4CD8: Enrollment is ongoing in a Phase 1 trial for our next generation SPEAR T-cells, ADP-A2M4CD8, focusing on treatment of patients with lung, gastroesophageal, head and neck and bladder cancers in which the MAGE-A4 antigen is expressed. This next generation SPEAR T-cell utilizes the same engineered T-cell receptor as afami-cel, but with the addition of a CD8α homodimer. The addition of the CD8α homodimer has been shown in vitro to increase cytokine release and SPEAR T-cell potency. Based on the responses seen in the Phase 1 clinical trial using afami-cel and initial responses seen in the SURPASS trial, we are planning to initiate a Phase 2 clinical trial with ADP-A2M4CD8 in esophageal and esophagogastric (“EGJ”) cancers in mid-2021.

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●

ADP-A2AFP Phase 1 Trial: We continue treating patients in our Phase 1 trial designed to evaluate the safety and anti-tumor activity of our alpha fetoprotein (“AFP”) specific therapeutic candidate for the treatment of hepatocellular carcinoma (“HCC”). A further cohort has also been initiated for patients with tumors other than HCC that express the AFP antigen.

●

Afami-cel Phase 1 Trial – Radiation Sub-study: Our Phase 1 clinical trial of afami-cel in urothelial, melanoma, head and neck, ovarian, non-small cell lung, esophageal and gastric, synovial sarcoma and MRCLS cancers has now completed enrollment. A radiation sub-study of this trial remains open and is assessing whether low-dose radiation enhances T-cell tumor trafficking and responses.

We have an active preclinical pipeline of cell therapy candidates with the aim of delivering five new cell therapies to the clinic in the next five years. The pipeline includes new autologous SPEAR T-cells, SPEAR T-cells addressing alternative HLA-types, next generation SPEAR T-cells, next-generation TILs and HiTs. Data from the Company’s HiT mesothelin program will be presented at the American Society of Gene & Cell Therapy (ASGCT) in May 2021. We are also developing allogeneic or “off-the-shelf” cell therapies utilizing a proprietary allogeneic platform.

We have a strategic collaboration program ongoing with Astellas (through its wholly owned subsidiary Universal Cells) in relation to up to three targets with the aim of co-developing T-cell therapy candidates directed to those targets and utilizing our allogeneic platform for “off-the-shelf” cell therapies. The first target subject to the collaboration is the mesothelin target to which a HiT cell therapy is being developed and a second target has now been nominated by Astellas. We also have a number of development and research collaborations including our collaboration with GSK for the development, manufacture and commercialization of TCR therapeutic candidates for up to five programs, a clinical and pre-clinical alliance agreement with MD Anderson Cancer Center and research collaborations with Alpine, Noile-Immune and CCIT.

Financial Operations Overview

Revenue

The Company has two contracts with customers: the GSK Collaboration and License Agreement and the Astellas Collaboration Agreement.

The GSK Collaboration Agreement

The GSK Collaboration and License Agreement consists of multiple performance obligations. GSK nominated its third target under the Collaboration and License Agreement in 2019, and the Company received $3.2 million following the nomination of the target, which is being recognized as revenue as development progresses.

The Astellas Collaboration Agreement

In January 2020, the Company entered into a collaboration agreement with Astellas. The Company received $50.0 million as an upfront payment after entering into the agreement. Under the agreement the parties will agree on up to three targets and will co-develop T-cell therapies directed to those targets pursuant to an agreed research plan. For each target, Astellas will fund co-development up until completion of a Phase 1 trial for products directed to such target. In addition, Astellas was also granted the right to develop, independently of Adaptimmune, allogeneic T-cell therapy candidates directed to two targets selected by Astellas. Astellas will have sole rights to develop and commercialize products resulting from these two targets.

The agreement consists of the following performance obligations: (i) research services and rights granted under the co-exclusive license for each of the three co-development targets and (ii) the rights granted for each of the two independent Astellas targets. The revenue allocated to the co-development targets is recognized as the development of products directed to the targets progresses up until completion of a Phase 1 trial. The revenue allocated to each of the research licenses for the targets being independently developed by Astellas will be recognized when the associated license commences, which is upon designation of a target by Astellas.

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Our results of operations and cash flows will be subject to fluctuations due to changes in foreign currency exchange rates, which could harm our business in the future. We seek to minimize this exposure by maintaining currency cash balances at levels appropriate to meet forthcoming expenditure in U.S. dollars and pounds sterling. To date, we have not used hedging contracts to manage exchange rate exposure, although we may do so in the future.

Taxation

We are subject to corporate taxation in the United Kingdom and the United States. We incur tax losses and tax credit carryforwards in the United Kingdom. No deferred tax assets are recognized on our U.K. losses and tax credit carryforwards because there is currently no indication that we will make sufficient taxable profits to utilize these tax losses and tax credit carryforwards. On 3 March 2021, the UK government announced that the rate of corporation tax would increase to 25% in 2023, with lower rates and tapered relief to be applied to companies with profits below £250,000.

We benefit from reimbursable tax credits in the United Kingdom through the SME R&D Tax Credit Scheme as well as the RDEC Scheme which are presented as a deduction to research and development expenditure.

Our subsidiary in the United States has generated taxable profits due to a Service Agreement between our U.S. and U.K. operating subsidiaries and is subject to U.S. federal corporate income tax of 21%. Due to its activity in the United States, and the sourcing of its revenue, the U.S. subsidiary is not currently subject to any state or local income taxes. The Company also benefits from the U.S Research Tax Credit and Orphan Drug Credit.

In the future, if we generate taxable income in the United Kingdom, we may benefit from the United Kingdom’s “patent box” regime, which would allow certain profits attributable to revenues from patented products to be taxed at a rate of 10%. As we have many different patents covering our products, future upfront fees, milestone fees, product revenues, and royalties may be taxed at this favorably low tax rate.

U.K. Value Added Tax (“VAT”) is charged on all qualifying goods and services by VAT-registered businesses. An amount of 20% of the value of the goods or services is added to all relevant sales invoices and is payable to the U.K. tax authorities. Similarly, VAT paid on purchase invoices paid by Adaptimmune Limited and Adaptimmune Therapeutics plc is reclaimable from the U.K. tax authorities.

Critical Accounting Policies and Significant Judgments and Estimates

The preparation of our unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities, and the revenues and expenses incurred during the reported periods. We base our estimates on historical experience and on various other factors that we believe are relevant under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. The accounting policies considered to be critical to the judgments and estimates used in the preparation of our financial statements are disclosed in the Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report.

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Results of Operations

Comparison of Three Months Ended March 31, 2021 and 2020

The following table summarizes the results of our operations for the three months ended March 31, 2021 and 2020, together with the changes to those items (in thousands):


	Three months ended
	March 31,
	2021		2020		Increase/decrease
Revenue	$	434	$	761	$	(327)	(43)	%
Research and development expenses		(24,506)		(21,264)		(3,242)	15	%
General and administrative expenses		(13,817)		(9,261)		(4,556)	49	%
Total operating expenses		(38,323)		(30,525)		(7,798)	26	%
Operating loss		(37,889)		(29,764)		(8,125)	27	%
Interest income		425		730		(305)	(42)	%
Other (expense) income, net		(1)		937		(938)	(100)	%
Loss before income taxes		(37,465)		(28,097)		(9,368)	33	%
Income taxes		(298)		(70)		(228)	326	%
Loss for the period	$	(37,763)	$	(28,167)	$	(9,596)	34	%

Revenue

Revenue decreased by 43% to $0.4 million in the three months ended March 31, 2021 compared to $0.8 million for the three months ended March 31, 2020. Revenue will vary depending on the progress of the development activities.

Research and Development Expenses

Research and development expenses increased by 15% to $24.5 million for the three months ended March 31, 2021 from $21.3 million for the three months ended March 31, 2020.

Our research and development expenses comprise the following (in thousands):


	Three months ended
	March 31,
	2021		2020		Increase/decrease
Salaries, materials, equipment, depreciation of property, plant and equipment and other employee-related costs⁽¹⁾	$	19,202	$	15,384	$	3,818	25	%
Subcontracted expenditure		10,832		7,311		3,521	48	%
Manufacturing facility expenditure		2,445		1,687		758	45	%
Share-based compensation expense		2,375		978		1,397	143	%
In-process research and development costs		151		968		(817)	(84)	%
Reimbursements receivable for research and development tax and expenditure credits		(10,499)		(5,064)		(5,435)	107	%
	$	24,506	$	21,264	$	3,242	15	%

(1)	These costs are not analyzed by project since employees may be engaged in multiple projects simultaneously.

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The net increase in our research and development expenses of $3.2 million for the three months ended March 31, 2021 compared to the same period in 2020 was primarily due to the following:

●

an increase of $3.8 million in salaries, materials, equipment, depreciation of property, plant and equipment and other employee-related costs, which is mainly driven by an increase in the average number of employees engaged in research and development

●

an increase of $3.5 million in subcontracted expenditure due to increases in costs related to the development of a companion diagnostic (CDx) assay and an increase in clinical trial costs as we prepare for a Phase 2 clinical trial with ADP-A2M4CD8 in esophageal and esophagogastric (“EGJ”) cancers

●

an increase of $1.4 million in share-based compensation expense primarily due to higher option grants in 2021 because of an increase in the number of employees; and

●

an increase of $5.4 million in reimbursements receivable for research and development tax and expenditure credits, which is driven by an increase in qualifying costs identified.

Our subcontracted costs for the three months ended March 31, 2021 were $10.8 million, compared to $7.3 million in the same period of 2020. This includes $7.9 million of costs directly associated with our afami-cel, ADP-A2M4CD8 and ADP-A2AFP SPEAR T-cells and $2.9 million of other development costs.

Our research and development expenses are highly dependent on the phases and progression of our research projects and will fluctuate depending on the outcome of ongoing clinical trials. We expect that our research and development expenses will increase in future periods as we continue to invest in our translational sciences and other research and development capabilities.

General and Administrative Expenses

General and administrative expenses increased by 49% to $13.8 million for the three months ended March 31, 2021 from $9.3 million in the same period in 2020. Our general and administrative expenses consist of the following (in thousands):


	Three months ended
	March 31,
	2021		2020		Increase/decrease
Salaries, depreciation of property, plant and equipment and other employee-related costs	$	6,965	$	5,759	$	1,206	21	%
Other corporate costs		3,892		3,031		861	28	%
Share-based compensation expense		2,960		471		2,489	528	%
	$	13,817	$	9,261	$	4,556	49	%

The net increase in our general and administrative expenses of $4.6 million for the three months ended March 31, 2021 compared to the same period in 2020 was largely due to:

●

an increase of $1.2 million in salaries, depreciation of property, plant and equipment and other employee-related costs, as a result of an increase in the average number of employees in the three months ended March 31, 2021 compared to the same period in 2020; and

●

an increase of $2.5 million in share based compensation, due to option forfeits in the three months ended March 31, 2020, and higher option grants in 2021 because of an increase in the number of employees.

We expect that our general and administrative expenses will increase in the future as we expand our operations and move towards commercial launch.

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Income Taxes

Income taxes increased to a charge of $298,000 for the three months ended March 31, 2021 from a charge of $70,000 for the three months ended March 31, 2020. Income taxes arise in the United States due to our U.S. subsidiary generating taxable profits. We incur losses in the United Kingdom.

Liquidity and Capital Resources

Sources of Funds

Since our inception, we have incurred significant net losses and negative cash flows from operations. We financed our operations primarily through sales of equity securities, cash receipts under our collaboration arrangements and research and development tax and expenditure credits. From inception through to March 31, 2021, we have raised:

●

$854.4 million, net of issuance costs, through the issuance of shares;

●

$203.2 million through collaborative arrangements with GSK and Astellas; and

●

$59.2 million in the form of reimbursable U.K. research and development tax credits and receipts from the U.K. RDEC Scheme.

We use a non-GAAP measure, Total Liquidity, which is defined as the total of cash and cash equivalents and marketable securities, to evaluate the funds available to us in the near-term. A description of Total Liquidity and reconciliation to cash and cash equivalents, the most directly comparable U.S. GAAP measure, are provided below under “Non-GAAP measures”.

As of March 31, 2021, we had cash and cash equivalents of $32.4 million and Total Liquidity of $317.9 million. We regularly assess Total Liquidity against our activities and make decisions regarding prioritization of those activities and deployment of Total Liquidity. We believe that our Total Liquidity will be sufficient to fund our operations, based upon our currently anticipated research and development activities, planned capital spending, and planned commercialization costs into early 2023. This belief is based on estimates that are subject to risks and uncertainties and may change if actual results differ from management’s estimates.

Cash Flows

The following table summarizes the results of our cash flows for the three months ended March 31, 2021 and 2020 (in thousands).


		Three months ended
		March 31,
	2021		2020
Net cash (used in) provided by operating activities	$	(46,540)	$	16,857
Net cash provided by (used in) investing activities		21,762		(71,947)
Net cash provided by financing activities		534		91,444
Cash, cash equivalents and restricted cash		37,036		90,760

Operating Activities

Net cash used in operating activities was $46.5 million for the three months ended March 31, 2021 compared to net cash provided by operating activities of $16.9 million for the three months ended March 31, 2020. Our activities typically result in net use of cash in operating activities. The receipt of the $50.0 million upfront payment from Astellas in January 2020 resulted in net cash provided by operating activities for the three months ended March 31, 2020. Excluding the impact of this, the net cash used in operating activities for the three months ended March 31, 2021 increased due to an increase in operating expenditure.

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Net cash used in operating activities of $46.5 million for the three months ended March 31, 2021 comprised a net loss of $37.8 million and a net cash outflow of $19.5 million from changes in operating assets and liabilities, offset by non-cash items of $10.8 million. The changes in operating assets and liabilities include the impact of a $10.5 million increase in reimbursements receivable for research and development tax credits. The non-cash items consisted primarily of depreciation expense on plant and equipment of $1.4 million, share-based compensation expense of $5.3 million, unrealized foreign exchange losses of $1.2 million, amortization on available-for-sale debt securities of $1.5 million and other items of $1.3 million.

Investing Activities

Net cash provided by investing activities was $21.8 million for the three months ended March 31, 2021 compared to net cash used in investing activities of $71.9 million for the three months ended March 31, 2020. The net cash provided by (used in) investing activities for the respective periods consisted primarily of:

●

purchases of property and equipment of $1.1 million and $0.2 million for the three months ended March 31, 2021 and 2020, respectively;

●

cash outflows from investment in marketable securities of $61.6 million and $98.0 million for the three months ended March 31, 2021 and 2020, respectively, and cash inflows from maturity or redemption of marketable securities of $84.6 million and $26.3 million for the three months ended March 31, 2021 and 2020, respectively.

The Company invests surplus cash and cash equivalents in marketable securities. In the three months ended March 31, 2021, the investments in marketable securities were reduced to fund the Company’s ongoing operations. In the three months ended March 31, 2020, the Company increased its investments in marketable securities with proceeds from its public offering.

Financing Activities

Net cash provided by financing activities was $0.5 million and $91.4 million for the three months ended March 31, 2021 and 2020, respectively. The net cash provided by financing activities in the three months ended March 31, 2021 consisted of proceeds from share option exercises. For the three months ended March 31, 2020, the net cash provided by financing activities consisted of net proceeds from public offerings of $90.5 million and proceeds from share option exercises of $0.9 million.

Non-GAAP Measures

Total Liquidity (a non-GAAP financial measure)

Total Liquidity (a non-GAAP financial measure) is the total of cash and cash equivalents and marketable securities. Each of these components appears in the condensed consolidated balance sheet. The U.S. GAAP financial measure most directly comparable to Total Liquidity is cash and cash equivalents as reported in the condensed consolidated financial statements, which reconciles to Total Liquidity as follows (in thousands):


	March 31,		December 31,
	2021		2020
Cash and cash equivalents	$	32,432	$	56,882
Marketable securities - available-for-sale debt securities		285,512		311,335
Total Liquidity	$	317,944	$	368,217

We believe that the presentation of Total Liquidity provides useful information to investors because management reviews Total Liquidity as part of its management of overall liquidity, financial flexibility, capital structure and leverage. The definition of Total Liquidity includes investments, which are highly-liquid and available to use in our current operations, such as marketable securities.

Off-Balance Sheet Arrangements

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.

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Item 6. Exhibits.

The following exhibits are either provided with this Quarterly Report on Form 10-Q or are incorporated herein by reference:


Exhibit Number		Description of Exhibit

31.1**		Certification of Principal Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2**		Certification of Principal Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1**		Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2**		Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101**		The following financial information from Adaptimmune Therapeutics plc’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2021, formatted in iXBRL (Inline eXtensible Business Reporting Language): (i) Unaudited Condensed Consolidated Balance Sheets as of March 31, 2021 and December 31, 2020, (ii) Unaudited Condensed Consolidated Statements of Operations for the three months ended March 31, 2021 and 2020, (iii) Unaudited Condensed Consolidated Statements of Comprehensive (Loss) Income for the three months ended March 31, 2021 and 2020, (iv) Unaudited Condensed Consolidated Statements of Change in Equity for the three months ended March 31, 2021 and 2020, (v) Unaudited Condensed Consolidated Statements of Cash Flows for three months ended March 31, 2021 and 2020 and (vi) Notes to the Unaudited Condensed Consolidated Financial Statements.

104**		Cover Page Interactive data File (formatted in Inline XBRL and contained in Exhibit 101)

* Previously filed.

** Filed herewith.


	ADAPTIMMUNE THERAPEUTICS PLC


Date: May 6, 2021	/s/ Adrian Rawcliffe
	Adrian Rawcliffe
	Chief Executive Officer


Date: May 6, 2021	/s/ Gavin Wood
	Gavin Wood
	Chief Financial Officer


PART I — FINANCIAL INFORMATION		4

Item 1.	Financial Statements:	4

	Unaudited Condensed Consolidated Balance Sheets as of March 31, 2021 and December 31, 2020	4

	Unaudited Condensed Consolidated Statements of Operations for the three months ended March 31, 2021 and 2020	5

	Unaudited Condensed Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2021 and 2020	6

	Unaudited Condensed Consolidated Statements of Change in Equity for the three months ended March 31, 2021 and 2020	7

	Unaudited Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2021 and 2020	9

	Notes to the Unaudited Condensed Consolidated Financial Statements	10

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	16

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	25

Item 4.	Controls and Procedures	25

PART II — OTHER INFORMATION		25

Item 1.	Legal Proceedings	25

Item 1A.	Risk Factors	26

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	26

Item 3.	Defaults Upon Senior Securities	26

Item 4.	Mine Safety Disclosures	26

Item 5.	Other Information	26

Item 6.	Exhibits	27

Signatures		28