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 August 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 Second Quarter 2022 Financial Results and Recent Business Highlights

On August 9, 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 six month periods ended June 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 six month periods ended June 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 six month periods ended June 30, 2022.

The statements contained in this “Achilles Therapeutics Reports Second 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 August 9, 2022.
99.2		Unaudited Condensed Consolidated Financial Statements of Achilles Therapeutics plc for the three and six month periods ended June 30, 2022.
99.3		Management’s Discussion and Analysis of Financial Condition and Results of Operations of Achilles Therapeutics plc for the three and six month periods ended June 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: August 9, 2022				By:		/s/ Robert Coutts
						Robert Coutts
						Chief Financial Officer

 

 

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Exhibit 99.1

 

 

 

 

 

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

 

- Additional clinical data from the ongoing Phase I/IIa trials in advanced NSCLC (CHIRON) and melanoma (THETIS) expected to be available in Q4 2022 -

 

- Cell & Gene Therapy Catapult manufacturing facility approved by MHRA for cNeT production in CHIRON and THETIS clinical trials -

 

- Strong cash balance of $202 million supports all planned operations into Q2 2025 -

 

London, UK 9 August 2022 – Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, today announced its financial results for the second quarter ended June 30, 2022, and recent business highlights.

 

“We remain focused on advancing our lead clinical programs, evaluating cNeT monotherapy in CHIRON for advanced non-small cell lung cancer (NSCLC), and exploring both cNeT monotherapy and the combination with a PD-1 checkpoint inhibitor in THETIS for recurrent or metastatic malignant melanoma. We expect initial activity, safety and translational science data in the fourth quarter of this year from patients receiving higher-dose cNeT products,” said Dr Iraj Ali, Chief Executive Officer of Achilles Therapeutics. “We are very pleased that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has now approved Achilles’ Cell and Gene Therapy Catapult Manufacturing Centre (Catapult) site to produce cNeT products in the ongoing CHIRON and THETIS clinical trials, significantly increasing our manufacturing capacity for 2022 and beyond.”

 

Business Highlights

 

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Financial Highlights

 

Achilles will participate in the following investor and medical conferences in August and September 2022. 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 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 AI-Powered PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient, and then develop precision T cell-based product candidates specifically targeting those clonal neoantigens.

 

Forward-Looking Statements

 

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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.

 

1 June 30, 2022 exchange rate of €1.000 = $1.043

 

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

LifeSci Advisors
John Mullaly
jmullaly@lifesciadvisors.com

 

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)

 

		June 30,				December 31,
		2022				2021
ASSETS
Current assets:
Cash and cash equivalents		$	201,595			$	266,319
Prepaid expenses and other current assets			25,985				18,430
Total current assets			227,580				284,749
Non-current assets:
Property and equipment, net			17,626				17,743
Operating lease right of use assets			9,470				11,048
Deferred tax assets			26				26
Restricted cash			33				33
Other assets			2,983				3,507
Total non-current assets			30,138				32,357
TOTAL ASSETS		$	257,718			$	317,106
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	6,651			$	3,722
Income taxes payable			18				—
Accrued expenses and other liabilities			8,720				10,906
Operating lease liabilities-current			4,480				4,482
Total current liabilities			19,869				19,110
Non-current liabilities:
Operating lease liabilities-non-current			5,640				7,777
Other long-term liability			621				691
Total non-current liabilities			6,261				8,468
Total liabilities			26,130				27,578
Commitments and contingencies (Note 12)
Shareholders’ equity:
Ordinary shares, £0.001 par value; 40,774,014 and 40,603,489 shares   authorized, issued and outstanding at June 30, 2022 and   December 31, 2021, respectively			54				54
Deferred shares, £92,451.851 par value, one share authorized, issued   and outstanding at June 30, 2022 and December 31, 2021			128				128
Additional paid in capital			405,504				401,821
Accumulated other comprehensive (loss) income			(20,343	)			6,636
Accumulated deficit			(153,755	)			(119,111	)
Total shareholders’ equity			231,588				289,528
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY		$	257,718			$	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 June 30,								Six Months Ended June 30,
		2022				2021				2022				2021
OPERATING EXPENSES:
Research and development		$	14,776			$	10,844			$	27,790			$	19,720
General and administrative			5,770				5,445				11,725				10,277
Total operating expenses			20,546				16,289				39,515				29,997
Loss from operations			(20,546	)			(16,289	)			(39,515	)			(29,997	)
OTHER INCOME, NET:
Other income			3,271				146				4,900				101
Total other income, net			3,271				146				4,900				101
Loss before provision for income taxes			(17,275	)			(16,143	)			(34,615	)			(29,896	)
Provision for income taxes			(14	)			(13	)			(29	)			(25	)
Net loss			(17,289	)			(16,156	)			(34,644	)			(29,921	)
Other comprehensive income:
Foreign exchange translation adjustment			(19,302	)			(925	)			(26,979	)			1,138
Comprehensive loss		$	(36,591	)		$	(17,081	)		$	(61,623	)		$	(28,783	)
Net loss per share attributable to ordinary shareholders—basic and diluted		$	(0.44	)		$	(0.45	)		$	(0.89	)		$	(1.60	)
Weighted average ordinary shares outstanding—basic and diluted			39,104,375				35,683,187				38,998,686				18,756,599

 

 

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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	5
Notes to Condensed Consolidated Financial Statements	6

 

 

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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)

		June 30,				December 31,
		2022				2021
ASSETS
Current assets:
Cash and cash equivalents		$	201,595			$	266,319
Prepaid expenses and other current assets			25,985				18,430
Total current assets			227,580				284,749
Non-current assets:
Property and equipment, net			17,626				17,743
Operating lease right of use assets			9,470				11,048
Deferred tax assets			26				26
Restricted cash			33				33
Other assets			2,983				3,507
Total non-current assets			30,138				32,357
TOTAL ASSETS		$	257,718			$	317,106
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	6,651			$	3,722
Income taxes payable			18				—
Accrued expenses and other liabilities			8,720				10,906
Operating lease liabilities-current			4,480				4,482
Total current liabilities			19,869				19,110
Non-current liabilities:
Operating lease liabilities-non-current			5,640				7,777
Other long-term liability			621				691
Total non-current liabilities			6,261				8,468
Total liabilities			26,130				27,578
Commitments and contingencies (Note 12)
Shareholders’ equity:
Ordinary shares, £0.001 par value; 40,774,014 and 40,603,489 shares   authorized, issued and outstanding at June 30, 2022 and   December 31, 2021, respectively			54				54
Deferred shares, £92,451.851 par value, one share authorized, issued   and outstanding at June 30, 2022 and December 31, 2021			128				128
Additional paid in capital			405,504				401,821
Accumulated other comprehensive (loss) income			(20,343	)			6,636
Accumulated deficit			(153,755	)			(119,111	)
Total shareholders’ equity			231,588				289,528
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY		$	257,718			$	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 June 30,								Six Months Ended June 30,
		2022				2021				2022				2021
OPERATING EXPENSES:
Research and development		$	14,776			$	10,844			$	27,790			$	19,720
General and administrative			5,770				5,445				11,725				10,277
Total operating expenses			20,546				16,289				39,515				29,997
Loss from operations			(20,546	)			(16,289	)			(39,515	)			(29,997	)
OTHER INCOME, NET:
Other income			3,271				146				4,900				101
Total other income, net			3,271				146				4,900				101
Loss before provision for income taxes			(17,275	)			(16,143	)			(34,615	)			(29,896	)
Provision for income taxes			(14	)			(13	)			(29	)			(25	)
Net loss			(17,289	)			(16,156	)			(34,644	)			(29,921	)
Other comprehensive income:
Foreign exchange translation adjustment			(19,302	)			(925	)			(26,979	)			1,138
Comprehensive loss		$	(36,591	)		$	(17,081	)		$	(61,623	)		$	(28,783	)
Net loss per share attributable to ordinary shareholders—basic and diluted		$	(0.44	)		$	(0.45	)		$	(0.89	)		$	(1.60	)
Weighted average ordinary shares outstanding—basic and diluted			39,104,375				35,683,187				38,998,686				18,756,599

 

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

 

		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			—				—				—				—				—				—				—				—				—				—				—				—				(13,765	)			(13,765	)
Balance at March 31, 2021			28,250,000			$	36				52,192,070			$	66				24,412,603			$	32				4,371,658			$	6				109,058			$	—			$	236,305			$	14,385			$	(71,777	)		$	179,053
Effect of corporate reorganization including conversion of   preferred share to ordinary share			(28,250,000	)			(36	)			(52,192,070	)			(66	)			(24,412,603	)			(32	)			26,481,831				34				(109,057	)			128				(28	)			—				—				—
Issuance of ordinary shares in initial public offering, et of issuance costs    of $2,726