UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 6-K

 

 

 

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16 of

the Securities Exchange Act of 1934

For the month of November 2022

Commission File Number: 001-40299

 

 

Achilles Therapeutics plc

(Exact name of registrant as specified in its charter)

 

 

245 Hammersmith Road

London W6 8PW

United Kingdom

Tel: +44 (0)20 8154 4600

(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)

 

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐

 

 

 

 

 

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Achilles Therapeutics Reports Third Quarter 2022 Financial Results and Recent Business Highlights

On November 8, 2022, Achilles Therapeutics plc (“Achilles” or the “Company”) issued a press release, a copy of which is furnished as Exhibit 99.1 to this Current Report on Form 6-K, reporting its financial results for the three and nine month periods ended September 30, 2022 and providing an update on recent business highlights. Furnished (i) as Exhibit 99.2 to this Current Report on Form 6-K are the Company’s unaudited consolidated financial statements for the three and nine month periods ended September 30, 2022 and (ii) as Exhibit 99.3 to this Current Report on Form 6-K is the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the three and nine month periods ended September 30, 2022.

The statements contained in this “Achilles Therapeutics Reports Third Quarter 2022 Financial Results and Recent Business Highlights” section of this Current Report on Form 6-K and the information contained in Exhibits 99.1 and 99.2 shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and is not incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.
 

 

 

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INDEX TO EXHIBITS

 

Number		Description
99.1		Press Release of Achilles Therapeutics plc dated November 8, 2022.
99.2		Unaudited Condensed Consolidated Financial Statements of Achilles Therapeutics plc for the three and nine month periods ended September 30, 2022.
99.3		Management’s Discussion and Analysis of Financial Condition and Results of Operations of Achilles Therapeutics plc for the three and nine month periods ended September 30, 2022.

 

 

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

				ACHILLES THERAPEUTICS PLC
Date: November 8, 2022				By:		/s/ Robert Coutts
						Robert Coutts
						Chief Financial Officer

 

 

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Exhibit 99.1

 

 

Achilles Therapeutics Reports Third Quarter 2022 Financial Results and Recent Business Highlights

 

- Interim update from the ongoing Phase I/IIa trials in advanced NSCLC (CHIRON) and melanoma (THETIS) to be presented at the ESMO Immuno-Oncology Annual Congress 2022 -

 

- Strong cash balance of $179.9 million supports all planned operations into Q2 2025 -

 

London, November 8, 2022 – Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing AI-powered precision T cell therapies to treat solid tumors, today announced its financial results for the third quarter ended September 30, 2022, and recent business highlights.

 

“This quarter we continued to advance our clinical programs and look forward to providing an update from our ongoing Phase I/IIa CHIRON and THETIS clinical trials in non-small cell lung cancer (NSCLC) and melanoma, respectively, at the ESMO Immuno-Oncology Annual Congress,” said Dr Iraj Ali, Chief Executive Officer of Achilles Therapeutics. “A poster entitled ‘Early Proof of Concept of Safety and Clinical Activity of Clonal Neoantigen Reactive T Cells,’ will be presented and available from December 6, 2022. We expect additional clinical data readouts across our programs throughout 2023 which, along with our strong cash balance, position Achilles well for the future.”

 

Financial Highlights

 

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Upcoming Events

 

Achilles will participate in the following investor and medical conferences. Additional details will be available in the Events & Presentations section of the Company’s website:

About Achilles Therapeutics

 

Achilles is a clinical-stage biopharmaceutical company developing AI-powered precision T cell therapies targeting clonal neoantigens: protein markers unique to the individual that are expressed on the surface of every cancer cell. The Company has two ongoing Phase I/IIa trials, the CHIRON trial in patients with advanced non-small cell lung cancer (NSCLC) and the THETIS trial in patients with recurrent or metastatic melanoma. Achilles uses DNA sequencing data from each patient, together with its proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient, and then develops precision T cell-based product candidates specifically targeting those clonal neoantigens.

 

Forward-Looking Statements

 

This press release contains express or implied forward-looking statements that are based on our management's belief and assumptions and on information currently available to our management. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future operational or financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should therefore not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

 

Investors:
Achilles Therapeutics
Lee M. Stern, VP, IR & External Communications
l.stern@achillestx.com

 

LifeSci Advisors
John Mullaly
jmullaly@lifesciadvisors.com

 

 

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Media:
Consilium Strategic Communications
Mary-Jane Elliott, Sukaina Virji, Melissa Gardiner
+44 (0) 203 709 5000
achillestx@consilium-comms.com

 

 

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ACHILLES THERAPEUTICS PLC

Condensed Consolidated Balance Sheets (Unaudited)

(in thousands, except share and per share amounts)

(expressed in U.S. Dollars, unless otherwise stated)
 

		September 30,				December 31,
		2022				2021
ASSETS
Current assets:
Cash and cash equivalents		$	179,890			$	266,319
Prepaid expenses and other current assets			18,797				18,430
Total current assets			198,687				284,749
Non-current assets:
Property and equipment, net			17,419				17,743
Operating lease right of use assets			8,472				11,048
Deferred tax assets			26				26
Restricted cash			33				33
Other assets			2,713				3,507
Total non-current assets			28,663				32,357
TOTAL ASSETS		$	227,350			$	317,106
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	7,516			$	3,722
Income taxes payable			59				—
Accrued expenses and other liabilities			7,445				10,906
Operating lease liabilities-current			4,036				4,482
Total current liabilities			19,056				19,110
Non-current liabilities:
Operating lease liabilities-non-current			4,952				7,777
Other long-term liability			726				691
Total non-current liabilities			5,678				8,468
Total liabilities			24,734				27,578
Commitments and contingencies (Note 12)
Shareholders’ equity:
Ordinary shares, £0.001 par value; 40,938,763 and 40,603,489 shares   authorized, issued and outstanding at September 30, 2022 and   December 31, 2021, respectively			54				54
Deferred shares, £92,451.851 par value, one share authorized, issued   and outstanding at September 30, 2022 and December 31, 2021			128				128
Additional paid in capital			407,155				401,821
Accumulated other comprehensive (loss) income			(38,490	)			6,636
Accumulated deficit			(166,231	)			(119,111	)
Total shareholders’ equity			202,616				289,528
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY		$	227,350			$	317,106

 

 

 

 

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ACHILLES THERAPEUTICS PLC

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

(in thousands, except share and per share amounts)

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2022				2021				2022				2021
OPERATING EXPENSES:
Research and development		$	10,597			$	10,697			$	38,387			$	30,417
General and administrative			5,437				5,041				17,162				15,318
Total operating expenses			16,034				15,738				55,549				45,735
Loss from operations			(16,034	)			(15,738	)			(55,549	)			(45,735	)
OTHER INCOME, NET:
Other income			3,599				2,806				8,499				2,907
Total other income, net			3,599				2,806				8,499				2,907
Loss before provision for income taxes			(12,435	)			(12,932	)			(47,050	)			(42,828	)
Provision for income taxes			(41	)			(16	)			(70	)			(41	)
Net loss			(12,476	)			(12,948	)			(47,120	)			(42,869	)
Other comprehensive income:
Foreign exchange translation adjustment			(18,147	)			(7,710	)			(45,126	)			(6,572	)
Comprehensive loss		$	(30,623	)		$	(20,658	)		$	(92,246	)		$	(49,441	)
Net loss per share attributable to ordinary shareholders—basic and diluted		$	(0.32	)		$	(0.34	)		$	(1.20	)		$	(1.69	)
Weighted average ordinary shares outstanding—basic and diluted			39,313,764				38,261,480				39,104,866				25,329,672

 

 

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Exhibit 99.2

INDEX TO FINANCIAL STATEMENTS

 

	Page
Condensed Consolidated Balance Sheets	2
Condensed Consolidated Statements of Operations and Comprehensive Loss	3
Condensed Consolidated Statements of Shareholders’ Equity	4
Condensed Consolidated Statements of Cash Flows	6
Notes to Condensed Consolidated Financial Statements	8

 

 

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ACHILLES THERAPEUTICS PLC

Condensed Consolidated Balance Sheets (Unaudited)

(in thousands, except share and per share amounts)

(expressed in U.S. Dollars, unless otherwise stated)

		September 30,				December 31,
		2022				2021
ASSETS
Current assets:
Cash and cash equivalents		$	179,890			$	266,319
Prepaid expenses and other current assets			18,797				18,430
Total current assets			198,687				284,749
Non-current assets:
Property and equipment, net			17,419				17,743
Operating lease right of use assets			8,472				11,048
Deferred tax assets			26				26
Restricted cash			33				33
Other assets			2,713				3,507
Total non-current assets			28,663				32,357
TOTAL ASSETS		$	227,350			$	317,106
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	7,516			$	3,722
Income taxes payable			59				—
Accrued expenses and other liabilities			7,445				10,906
Operating lease liabilities-current			4,036				4,482
Total current liabilities			19,056				19,110
Non-current liabilities:
Operating lease liabilities-non-current			4,952				7,777
Other long-term liability			726				691
Total non-current liabilities			5,678				8,468
Total liabilities			24,734				27,578
Commitments and contingencies (Note 12)
Shareholders’ equity:
Ordinary shares, £0.001 par value; 40,938,763 and 40,603,489 shares   authorized, issued and outstanding at September 30, 2022 and   December 31, 2021, respectively			54				54
Deferred shares, £92,451.851 par value, one share authorized, issued   and outstanding at September 30, 2022 and December 31, 2021			128				128
Additional paid in capital			407,155				401,821
Accumulated other comprehensive (loss) income			(38,490	)			6,636
Accumulated deficit			(166,231	)			(119,111	)
Total shareholders’ equity			202,616				289,528
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY		$	227,350			$	317,106

 

The accompanying notes are an integral part of these financial statements.

2

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ACHILLES THERAPEUTICS PLC

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

(in thousands, except share and per share amounts)

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2022				2021				2022				2021
OPERATING EXPENSES:
Research and development		$	10,597			$	10,697			$	38,387			$	30,417
General and administrative			5,437				5,041				17,162				15,318
Total operating expenses			16,034				15,738				55,549				45,735
Loss from operations			(16,034	)			(15,738	)			(55,549	)			(45,735	)
OTHER INCOME, NET:
Other income			3,599				2,806				8,499				2,907
Total other income, net			3,599				2,806				8,499				2,907
Loss before provision for income taxes			(12,435	)			(12,932	)			(47,050	)			(42,828	)
Provision for income taxes			(41	)			(16	)			(70	)			(41	)
Net loss			(12,476	)			(12,948	)			(47,120	)			(42,869	)
Other comprehensive income:
Foreign exchange translation adjustment			(18,147	)			(7,710	)			(45,126	)			(6,572	)
Comprehensive loss		$	(30,623	)		$	(20,658	)		$	(92,246	)		$	(49,441	)
Net loss per share attributable to ordinary shareholders—basic and diluted		$	(0.32	)		$	(0.34	)		$	(1.20	)		$	(1.69	)
Weighted average ordinary shares outstanding—basic and diluted			39,313,764				38,261,480				39,104,866				25,329,672

 

The accompanying notes are an integral part of these financial statements.

3

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ACHILLES THERAPEUTICS PLC

Condensed Consolidated Statements of Shareholders’ Equity

(unaudited)

(in thousands, except share amounts)

 

																						Accumulated
		Ordinary $0.001 par value								Deferred shares								Additional paid-in				other comprehensive				Accumulated
		Shares				Amount				Shares				Amount				capital				income (loss)				deficit				Total
Balance at December 31, 2021			40,603,489			$	54				1			$	128			$	401,821			$	6,636			$	(119,111	)		$	289,528
Issuance of ordinary shares			150,738				—				—				—				—				—				—				—
Share-based compensation expense			—				—				—				—				1,959				—				—				1,959
Unrealized gain/(loss) on foreign currency translation			—				—				—				—				—				(7,677	)			—				(7,677	)
Net loss			—				—				—				—				—				—				(17,355	)			(17,355	)
Balance at March 31, 2022			40,754,227			$	54				1			$	128			$	403,780			$	(1,041	)		$	(136,466	)		$	266,455
Issuance of ordinary shares			19,787				—				—				—				—				—				—				—
Share-based compensation expense			—				—				—				—				1,724				—				—				1,724
Unrealized gain/(loss) on foreign currency translation			—				—				—				—				—				(19,302	)			—				(19,302	)
Net loss			—				—				—				—				—				—				(17,289	)			(17,289	)
Balance at June 30, 2022			40,774,014			$	54				1			$	128			$	405,504			$	(20,343	)		$	(153,755	)		$	231,588
Issuance of ordinary shares			164,256				—				—				—				—				—				—				—
Share-based compensation expense			—				—				—				—				1,650				—				—				1,650
Issuance of ordinary shares under employee share purchase plan			493				—				—				—				1				—				—				1
Unrealized gain/(loss) on foreign currency translation			—				—				—				—				—				(18,147	)			—				(18,147	)
Net loss			—				—				—				—				—				—				(12,476	)			(12,476	)
Balance at September 30, 2022			40,938,763			$	54				1			$	128			$	407,155			$	(38,490	)		$	(166,231	)		$	202,616

 

The accompanying notes are an integral part of these financial statements.

 

4

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		Convertible preferred shares																						Accumulated
		Series A $0.001 par value				Series B $0.001 par value				Series C $0.001 par value				Ordinary $0.001 par value				Deferred shares				Additional paid-in		other comprehensive		Accumulated
		Shares		Amount		Shares		Amount		Shares		Amount		Shares		Amount		Shares		Amount		capital		income (loss)		deficit		Total
Balance at December 31, 2020		28,250,000		$36		52,192,070		$66		24,412,603		$32		4,389,920		$6		30,521		$—		$234,922		$12,322		$(58,012)		$189,372
Conversion of ordinary shares into    deferred shares		—		—		—		—		—		—		(18,262)		—		78,537		—		—		—		—		—
Share-based compensation    Expense		—		—		—		—		—		—		—		—		—		—		1,383		—		—		1,383
Unrealized gain/(loss) on foreign    currency translation		—		—		—		—		—		—		—		—		—		—		—		2,063		—		2,063
Net loss		—