ACHL Achilles Therapeutics PLC

 

 

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 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 Second Quarter 2023 Financial Results and Recent Business Highlights

On August 4, 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 six month periods ended June 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 six month periods ended June 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 six month periods ended June 30, 2023.

 

Incorporation by Reference

This Report on Form 6-K, including the exhibits hereto (except for the statements contained in the “Achilles Therapeutics Reports Second Quarter 2023 Financial Results and Recent Business Highlights” section of this 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 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on Forms F-3 (File No. 333-268239) and S-8 (File Nos. 333-270344, 333-263220, and 333-255063) to the extent not superseded by information subsequently filed or furnished (to the extent the Company expressly states that it incorporates such furnished information by reference) by the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 August 4, 2023.
99.2		Unaudited Condensed Consolidated Financial Statements of Achilles Therapeutics plc for the three and six month periods ended June 30, 2023.
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, 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: August 4, 2023				By:		/s/ Robert Coutts
						Robert Coutts
						Chief Financial Officer

 

 

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Exhibit 99.1

 

 

 

 

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

- Clinical and translational science data expected in the fourth quarter of 2023 from the ongoing Phase I/IIa trials in NSCLC and melanoma -

- neoRankerTM immunogenicity prediction module of PELEUS™ increases the likelihood of identifying multiple memory T cell responses -

- Strong cash position of $144 million supports operations through 2025 -

London, UK August 4, 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 June 30, 2023, and recent business highlights.

“We look forward to additional clinical data in the fourth quarter of this year from our clonal neoantigen-reactive T cell (cNeT) therapy for the treatment of advanced NSCLC (CHIRON) and metastatic malignant melanoma (THETIS) and are encouraged by the improved manufacturing performance of our VELOS™ Process 2,” said Dr Iraj Ali, Chief Executive Officer of Achilles Therapeutics. “We are also very excited about the developments in our AI-driven bioinformatics platform PELEUSTM. PELEUS uses a unique multi-region approach to provide validated and accurate identification of personalized clonal neoantigens. Our newly developed neoRankerTM tool is trained on a proprietary dataset of over 10,000 neoantigens and we calculate that it is potentially twice as good at identifying multiple memory T cell responses than existing deep-learning models. We believe this could be highly differentiated in the design of neoantigen vaccines and further strengthens our leadership position in the field of neoantigen identification.”

Business Highlights

 

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Financial Highlights

2H 2023 Focus and Upcoming Events

Members of the Achilles team will participate in the following upcoming 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

 

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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. 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.

For further information, please contact:

 

Investors:
Meru Advisors

Lee M. Stern

lstern@meruadvisors.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,
		2023				2022
ASSETS
Current assets:
Cash and cash equivalents		$	143,711			$	173,338
Prepaid expenses and other current assets			31,499				23,242
Total current assets			175,210				196,580
Non-current assets:
Property and equipment, net			10,949				12,399
Operating lease right of use assets			8,373				8,081
Deferred tax assets			185				251
Restricted cash			33				33
Other assets			3,157				3,014
Total non-current assets			22,697				23,778
TOTAL ASSETS		$	197,907			$	220,358
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	6,886			$	5,187
Income taxes payable			7				326
Accrued expenses and other liabilities			7,569				8,292
Operating lease liabilities-current			4,656				4,188
Total current liabilities			19,118				17,993
Non-current liabilities:
Operating lease liabilities-non-current			3,972				4,388
Other long-term liability			974				933
Total non-current liabilities			4,946				5,321
Total liabilities			24,064				23,314
Commitments and contingencies (Note 12)
Shareholders’ equity:
Ordinary shares, £0.001 par value; 40,946,239 and 40,932,727 shares   authorized, issued and outstanding at June 30, 2023 and   December 31, 2022, respectively			54				54
Deferred shares, £92,451.851 par value, one share authorized, issued   and outstanding at June 30, 2023 and December 31, 2022			128				128
Additional paid in capital			412,201				408,844
Accumulated other comprehensive loss			(13,901	)			(21,695	)
Accumulated deficit			(224,639	)			(190,287	)
Total shareholders’ equity			173,843				197,044
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY		$	197,907			$	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 June 30,								Six Months Ended June 30,
		2023				2022				2023				2022
OPERATING EXPENSES:
Research and development		$	13,774			$	14,776			$	27,642			$	27,790
General and administrative			4,318				5,770				9,003				11,725
Total operating expenses			18,092				20,546				36,645				39,515
Loss from operations			(18,092	)			(20,546	)			(36,645	)			(39,515	)
OTHER INCOME, NET:
Other income			1,212				3,271				2,303				4,900
Total other income, net			1,212				3,271				2,303				4,900
Loss before provision for income taxes			(16,880	)			(17,275	)			(34,342	)			(34,615	)
Benefit (Provision) for income taxes			34				(14	)			(10	)			(29	)
Net loss			(16,846	)			(17,289	)			(34,352	)			(34,644	)
Other comprehensive income:
Foreign exchange translation adjustment			3,817				(19,302	)			7,794				(26,979	)
Comprehensive loss		$	(13,029	)		$	(36,591	)		$	(26,558	)		$	(61,623	)
Net loss per share attributable to ordinary shareholders—basic and diluted		$	(0.42	)		$	(0.44	)		$	(0.86	)		$	(0.89	)
Weighted average ordinary shares outstanding—basic and diluted			39,899,944				39,104,375				39,816,528				38,998,686

 

 

 

 

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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,
		2023				2022
ASSETS
Current assets:
Cash and cash equivalents		$	143,711			$	173,338
Prepaid expenses and other current assets			31,499				23,242
Total current assets			175,210				196,580
Non-current assets:
Property and equipment, net			10,949				12,399
Operating lease right of use assets			8,373				8,081
Deferred tax assets			185				251
Restricted cash			33				33
Other assets			3,157				3,014
Total non-current assets			22,697				23,778
TOTAL ASSETS		$	197,907			$	220,358
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	6,886			$	5,187
Income taxes payable			7				326
Accrued expenses and other liabilities			7,569				8,292
Operating lease liabilities-current			4,656				4,188
Total current liabilities			19,118				17,993
Non-current liabilities:
Operating lease liabilities-non-current			3,972				4,388
Other long-term liability			974				933
Total non-current liabilities			4,946				5,321
Total liabilities			24,064				23,314
Commitments and contingencies (Note 12)
Shareholders’ equity:
Ordinary shares, £0.001 par value; 40,946,239 and 40,932,727 shares   authorized, issued and outstanding at June 30, 2023 and   December 31, 2022, respectively			54				54
Deferred shares, £92,451.851 par value, one share authorized, issued   and outstanding at June 30, 2023 and December 31, 2022			128				128
Additional paid in capital			412,201				408,844
Accumulated other comprehensive loss			(13,901	)			(21,695	)
Accumulated deficit			(224,639	)			(190,287	)
Total shareholders’ equity			173,843				197,044
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY		$	197,907			$	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 June 30,								Six Months Ended June 30,
		2023				2022				2023				2022
OPERATING EXPENSES:
Research and development		$	13,774			$	14,776			$	27,642			$	27,790
General and administrative			4,318				5,770				9,003				11,725
Total operating expenses			18,092				20,546				36,645				39,515
Loss from operations			(18,092	)			(20,546	)			(36,645	)			(39,515	)
OTHER INCOME, NET:
Other income			1,212				3,271				2,303				4,900
Total other income, net			1,212				3,271				2,303				4,900
Loss before provision for income taxes			(16,880	)			(17,275	)			(34,342	)			(34,615	)
Benefit (Provision) for income taxes			34				(14	)			(10	)			(29	)
Net loss			(16,846	)			(17,289	)			(34,352	)			(34,644	)
Other comprehensive income:
Foreign exchange translation adjustment			3,817				(19,302	)			7,794				(26,979	)
Comprehensive loss		$	(13,029	)		$	(36,591	)		$	(26,558	)		$	(61,623	)
Net loss per share attributable to ordinary shareholders—basic and diluted		$	(0.42	)		$	(0.44	)		$	(0.86	)		$	(0.89	)
Weighted average ordinary shares outstanding—basic and diluted			39,899,944				39,104,375				39,816,528				38,998,686

 

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

 

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