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 2023

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 ☐

 

 

 

 

 

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Achilles Therapeutics Reports Third Quarter 2023 Financial Results and Recent Business Highlights

On November 13, 2023, Achilles Therapeutics plc (“Achilles” or the “Company”) issued a press release, a copy of which is furnished as Exhibit 99.1 to this Report on Form 6-K, reporting its financial results for the three and nine month periods ended September 30, 2023 and providing an update on recent business highlights. Furnished (i) as Exhibit 99.2 to this Report on Form 6-K are the Company’s unaudited consolidated financial statements for the three and nine month periods ended September 30, 2023 and (ii) as Exhibit 99.3 to this 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, 2023.

Incorporation by Reference

This Current Report on Form 6-K, including the exhibits hereto (except for the statements contained in the “Achilles Therapeutics Reports Third Quarter 2023 Financial Results and Recent Business Highlights” section of this Current Report on Form 6-K and Exhibit 99.1 hereto, which are not incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended (the “Securities Act”), or the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and shall not be deemed “filed” for the purposes of Section 18 of the Exchange Act), is incorporated by reference into the Company’s filings under the Securities Act, including the Company’s Registration Statements on Forms F-3 (File No. 333-268239) and S-8 (File Nos. 333-270344, 333-263220, and 333-255063) to the extent not superseded by information subsequently filed or furnished (to the extent the Company expressly states that it incorporates such furnished information by reference) by the Company under the Securities Act or the Exchange Act.

 

 

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INDEX TO EXHIBITS

Number		Description
99.1		Press Release of Achilles Therapeutics plc dated November 13, 2023.
99.2		Unaudited Condensed Consolidated Financial Statements of Achilles Therapeutics plc for the three and nine month periods ended September 30, 2023.
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, 2023.

 

 

 

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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 13, 2023				By:		/s/ Robert Coutts
						Robert Coutts
						Chief Financial Officer

 

 

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Exhibit 99.1

 

 

Achilles Therapeutics Reports Third Quarter 2023 Financial Results and Recent Highlights

– On track to dose 15-20 patients with higher dose cNeT by year-end 2023 –

– Clinical and translational science data update from the ongoing Phase I/IIa trials in NSCLC and melanoma expected in Q1 2024 with additional data available in mid-2024 –

– Strong cash position of $140 million supports operations through 2025 –

 

London, UK 13 November 2023 – Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing AI-powered precision T cell therapies targeting clonal neoantigens to treat solid tumors, today announced its financial results for the quarter ended September 30, 2023, and recent business highlights.

“We are pleased with progress across the scientific field that continues to demonstrate the importance of neoantigens as the most attractive targets in solid-tumor oncology. We believe that our proprietary capability to identify the most immunogenic clonal neoantigens, recently shared at ESGCT and SITC, puts us in a strong position with our clonal neoantigen-reactive T cell (cNeT) therapy and potentially other neoantigen targeting approaches,” said Dr Iraj Ali, Chief Executive Officer of Achilles Therapeutics. “Our Phase I/IIa clinical trials evaluating cNeT therapy for the treatment of advanced NSCLC (CHIRON) and metastatic malignant melanoma (THETIS) continue to progress and we are on track to dose patients in line with our previous guidance. We look forward to sharing our next clinical and translational data update in Q1 2024.”

 

Recent Highlights

 

 

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Financial Highlights

 

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 develop 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. Forward-looking statements in this press release include, but are not limited to, statements regarding the timing of the Company’s clinical and translational data updates and the Company’s beliefs about recent data updates, and expectations related to the Company’s operating expenses and capital expense requirements. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future

 

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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.

 

For further information, please contact:

 

Investors:
Meru Advisors

Lee M. Stern

lstern@meruadvisors.com

 

Media:

ICR Consilium
Sukaina Virji, Tracy Cheung, Emmalee Hoppe
+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,
		2023				2022
ASSETS
Current assets:
Cash and cash equivalents		$	140,138			$	173,338
Prepaid expenses and other current assets			15,354				23,242
Total current assets			155,492				196,580
Non-current assets:
Property and equipment, net			9,648				12,399
Operating lease right of use assets			7,013				8,081
Deferred tax assets			185				251
Restricted cash			33				33
Other assets			2,967				3,014
Total non-current assets			19,846				23,778
TOTAL ASSETS		$	175,338			$	220,358
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	5,352			$	5,187
Income taxes payable			—				326
Accrued expenses and other liabilities			8,209				8,292
Operating lease liabilities-current			4,620				4,188
Total current liabilities			18,181				17,993
Non-current liabilities:
Operating lease liabilities-non-current			2,731				4,388
Other long-term liability			941				933
Total non-current liabilities			3,672				5,321
Total liabilities			21,853				23,314
Commitments and contingencies (Note 12)
Shareholders’ equity:
Ordinary shares, £0.001 par value; 40,782,948 shares and 40,932,727 shares   authorized, issued and outstanding at September 30, 2023 and   December 31, 2022, respectively			54				54
Deferred shares, £92,451.851 par value, one share authorized, issued   and outstanding at September 30, 2023 and December 31, 2022			128				128
Additional paid in capital			413,815				408,844
Accumulated other comprehensive loss			(19,190	)			(21,695	)
Accumulated deficit			(241,322	)			(190,287	)
Total shareholders’ equity			153,485				197,044
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY		$	175,338			$	220,358

 

 

 

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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,
		2023				2022				2023				2022
OPERATING EXPENSES:
Research and development		$	14,712			$	10,597			$	42,354			$	38,387
General and administrative			4,384				5,437				13,387				17,162
Total operating expenses			19,096				16,034				55,741				55,549
Loss from operations			(19,096	)			(16,034	)			(55,741	)			(55,549	)
OTHER INCOME, NET:
Other income			2,389				3,599				4,692				8,499
Total other income, net			2,389				3,599				4,692				8,499
Loss before provision for income taxes			(16,707	)			(12,435	)			(51,049	)			(47,050	)
Benefit (Provision) for income taxes			24				(41	)			14				(70	)
Net loss			(16,683	)			(12,476	)			(51,035	)			(47,120	)
Other comprehensive income:
Foreign exchange translation adjustment			(5,289	)			(18,147	)			2,505				(45,126	)
Comprehensive loss		$	(21,972	)		$	(30,623	)		$	(48,530	)		$	(92,246	)
Net loss per share attributable to ordinary shareholders—basic and diluted		$	(0.42	)		$	(0.32	)		$	(1.28	)		$	(1.20	)
Weighted average ordinary shares outstanding—basic and diluted			40,066,922				39,313,764				39,900,910				39,104,866

 

 

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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	7

 

 

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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,
		2023				2022
ASSETS
Current assets:
Cash and cash equivalents		$	140,138			$	173,338
Prepaid expenses and other current assets			15,354				23,242
Total current assets			155,492				196,580
Non-current assets:
Property and equipment, net			9,648				12,399
Operating lease right of use assets			7,013				8,081
Deferred tax assets			185				251
Restricted cash			33				33
Other assets			2,967				3,014
Total non-current assets			19,846				23,778
TOTAL ASSETS		$	175,338			$	220,358
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	5,352			$	5,187
Income taxes payable			—				326
Accrued expenses and other liabilities			8,209				8,292
Operating lease liabilities-current			4,620				4,188
Total current liabilities			18,181				17,993
Non-current liabilities:
Operating lease liabilities-non-current			2,731				4,388
Other long-term liability			941				933
Total non-current liabilities			3,672				5,321
Total liabilities			21,853				23,314
Commitments and contingencies (Note 12)
Shareholders’ equity:
Ordinary shares, £0.001 par value; 40,782,948 shares and 40,932,727 shares   authorized, issued and outstanding at September 30, 2023 and   December 31, 2022, respectively			54				54
Deferred shares, £92,451.851 par value, one share authorized, issued   and outstanding at September 30, 2023 and December 31, 2022			128				128
Additional paid in capital			413,815				408,844
Accumulated other comprehensive loss			(19,190	)			(21,695	)
Accumulated deficit			(241,322	)			(190,287	)
Total shareholders’ equity			153,485				197,044
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY		$	175,338			$	220,358

 

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,
		2023				2022				2023				2022
OPERATING EXPENSES:
Research and development		$	14,712			$	10,597			$	42,354			$	38,387
General and administrative			4,384				5,437				13,387				17,162
Total operating expenses			19,096				16,034				55,741				55,549
Loss from operations			(19,096	)			(16,034	)			(55,741	)			(55,549	)
OTHER INCOME, NET:
Other income			2,389				3,599				4,692				8,499
Total other income, net			2,389				3,599				4,692				8,499
Loss before provision for income taxes			(16,707	)			(12,435	)			(51,049	)			(47,050	)
Benefit (Provision) for income taxes			24				(41	)			14				(70	)
Net loss			(16,683	)			(12,476	)			(51,035	)			(47,120	)
Other comprehensive income:
Foreign exchange translation adjustment			(5,289	)			(18,147	)			2,505				(45,126	)
Comprehensive loss		$	(21,972	)		$	(30,623	)		$	(48,530	)		$	(92,246	)
Net loss per share attributable to ordinary shareholders—basic and diluted		$	(0.42	)		$	(0.32	)		$	(1.28	)		$	(1.20	)
Weighted average ordinary shares outstanding—basic and diluted			40,066,922				39,313,764				39,900,910				39,104,866

 

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, 2022			40,932,727			$	54				1			$	128			$	408,844			$	(21,695	)		$	(190,287	)		$	197,044
Issuance of ordinary shares			5,726				—				—				—				4				—				—				4
Share-based compensation expense			—				—				—				—				1,652				—				—				1,652
Unrealized gain on foreign currency translation			—				—				—				—				—				3,977				—				3,977
Net loss			—				—				—				—				—								(17,506	)			(17,506	)
Balance at March 31, 2023			40,938,453			$	54				1			$	128			$	410,500			$	(17,718	)		$	(207,793	)		$	185,171
Issuance of ordinary shares			7,786				—				—				—				—				—				—				—
Share-based compensation expense			—				—				—				—				1,701				—				—				1,701
Unrealized gain on foreign currency translation			—				—				—				—				—				3,817				—				3,817
Net loss			—				—				—				—				—				—				(16,846	)			(16,846	)
Balance at June 30, 2023			40,946,239			$	54				1			$	128			$	412,201			$	(13,901	)		$	(224,639	)		$	173,843
Issuance of ordinary shares			4,820				—				—				—								—				—				—
Share-based compensation expense			—				—				—				—				1,609				—				—				1,609
Issuance of shares under employee share purchase plan			6,484				—				—				—				5								—				5
Forfeiture of ordinary shares			(174,595	)			—				—				—				—				—				—				—
Unrealized loss on foreign currency translation			—				—				—				—				—				(5,289	)							(5,289	)
Net loss			—				—				—				—				—				—				(16,683	)			(16,683	)
Balance at September 30, 2023			40,782,948			$	54				1			$	128			$	413,815			$	(19,190	)		$	(241,322	)		$	153,485

 

												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 Year Ended 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 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 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 shares under employee share purchase plan		493		—		—		—		1				—		1
Unrealized gain 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.

 

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ACHILLES THERAPEUTICS PLC

Condensed Consolidated Statements of Cash Flows

(unaudited)

(in thousands)

		Nine Months Ended September 30,
		2023				2022
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss		$	(51,035	)		$	(47,120	)
Adjustments to reconcile net loss to net cash used in operating activities
Depreciation and amortization			3,565				2,859
Loss on impairment			16				466
Changes in right of use assets and operating lease liabilities, net			(166	)			(528	)
Loss on disposal of property and equipment			—				(11	)
Non-cash loss on foreign currency remeasurement			(5	)			32
Non-cash share-based compensation			4,961				5,333
Changes in operating assets and liabilities
Prepaid expenses and other current assets			8,236				(3,992	)
Accounts payable			403				4,572
Income taxes payable			(326	)			59
Accrued expenses and other liabilities			(32	)			(1,780	)
Other long-term liabilities			—				175
Deferred tax assets			65				—
Other assets			58				(258	)
Net cash used in operating activities			(34,260	)			(40,193	)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property and equipment			(1,054	)			(5,497	)
Net cash used in investing activities			(1,054	)			(5,497	)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from the issuance of shares under the employee share purchase plan			9				1
Net cash provided by financing activities			9				1
Effect of exchange rate changes on cash, cash equivalents and restricted cash			2,105				(40,740	)
Net decrease in cash, cash equivalents and restricted cash			(33,200	)			(86,429	)
Cash, cash equivalents and restricted cash, beginning of period			173,371				266,352
Cash, cash equivalents and restricted cash, end of period		$	140,171			$	179,923
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Right of use assets obtained in exchange for new operating lease liabilities		$	2,109			$	2,124
Property and equipment purchases in accounts payable and accrued expenses		$	271			$	1,363

 

The following table provides a reconciliation of the cash, cash equivalents and restricted cash balances as of each of the periods, shown above:

 

		Nine Months Ended September 30,
		2023