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 May 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 First Quarter 2022 Financial Results and Recent Business Highlights

On May 10, 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 month period ended March 31, 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 month period ended March 31, 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 month period ended March 31, 2022.

The statements contained in this “Achilles Therapeutics Reports First 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 May 10, 2022.
99.2		Unaudited Condensed Consolidated Financial Statements of Achilles Therapeutics plc for the three month period ended March 31, 2022.
99.3		Management’s Discussion and Analysis of Financial Condition and Results of Operations of Achilles Therapeutics plc for the three month period ended March 31, 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: May 10, 2022				By:		/s/ Robert Coutts
						Robert Coutts
						Chief Financial Officer

 

 

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Exhibit 99.1

 

 

 

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

 

- Dosed first patient with higher-dose (Process 2) cNeT for advanced NSCLC (CHIRON) and initiated enrollment of cNeT + PD-1 inhibitor combination (THETIS Cohort B) for metastatic malignant melanoma -

 

- Expanded global manufacturing by increasing capacity in the UK and establishing a US clinical manufacturing partnership -

 

- Strong cash balance of $237 million supports all planned operations into 2H 2024 -

 

London, UK 10 May 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 first quarter ended March 31, 2022, and recent business highlights.

 

“We recently dosed the first patient with our higher-dose cNeT therapy in the CHIRON clinical trial for the treatment of advanced non-small cell lung cancer (NSCLC) and began enrollment in Cohort B of the THETIS clinical trial evaluating cNeT in combination with a PD-1 checkpoint inhibitor for the treatment of metastatic malignant melanoma. We expect to report initial higher-dose monotherapy data from both CHIRON and THETIS as well as initial combination data from THETIS Cohort B in the second half of 2022,” said Dr Iraj Ali, Chief Executive Officer of Achilles Therapeutics. “We also expanded our global footprint, including increased clinical manufacturing capacity in the United Kingdom and the United States, where we have established a US headquarters in Philadelphia that will house our first US R&D facility, to further support our clinical programs. Overall, our unique approach to targeting clonal neoantigens, differentiated ability to detect, quantify and track our cNeT products, and strong balance sheet continue to position us well to execute across our upcoming value-creating catalysts.”

 

Business Highlights

 

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Financial Highlights

 

2022 Milestones and Upcoming Events

 

Achilles will present at the following medical and investor conferences in May 2022. Additional details will be available in the Events & Presentations section of the Company’s website:

 

 

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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

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

 

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)

 

		March 31,				December 31,
		2022				2021
ASSETS
Current assets:
Cash and cash equivalents		$	236,931			$	266,319
Prepaid expenses and other current assets			22,118				18,430
Total current assets			259,049				284,749
Non-current assets:
Property and equipment, net			18,376				17,743
Operating lease right of use assets			11,070				11,048
Deferred tax assets			26				26
Restricted cash			33				33
Other assets			3,636				3,507
Total non-current assets			33,141				32,357
TOTAL ASSETS		$	292,190			$	317,106
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	4,036			$	3,722
Income taxes payable			15				—
Accrued expenses and other liabilities			9,131				10,906
Operating lease liabilities-current			4,670				4,482
Total current liabilities			17,852				19,110
Non-current liabilities:
Operating lease liabilities-non-current			7,212				7,777
Other long-term liability			671				691
Total non-current liabilities			7,883				8,468
Total liabilities			25,735				27,578
Commitments and contingencies (Note 12)
Shareholders’ equity:
Ordinary shares, £0.001 par value; 40,754,227 and 40,603,489 shares   authorized, issued and outstanding at March 31, 2022 and   December 31, 2021, respectively			54				54
Deferred shares, £92,451.851 par value, one share authorized, issued   and outstanding at March 31, 2022 and December 31, 2021			128				128
Additional paid in capital			403,780				401,821
Accumulated other comprehensive (loss) income			(1,041	)			6,636
Accumulated deficit			(136,466	)			(119,111	)
Total shareholders’ equity			266,455				289,528
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY		$	292,190			$	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 March 31,
		2022				2021
OPERATING EXPENSES:
Research and development		$	13,014			$	8,876
General and administrative			5,955				4,832
Total operating expenses			18,969				13,708
Loss from operations			(18,969	)			(13,708	)
OTHER INCOME, NET:
Other income (expense)			1,629				(45	)
Total other income, net			1,629				(45	)
Loss before provision for income taxes			(17,340	)			(13,753	)
Provision for income taxes			(15	)			(12	)
Net loss			(17,355	)			(13,765	)
Other comprehensive income:
Foreign exchange translation adjustment			(7,677	)			2,063
Comprehensive loss		$	(25,032	)		$	(11,702	)
Net loss per share attributable to ordinary shareholders—basic and diluted		$	(0.45	)		$	(8.38	)
Weighted average ordinary shares outstanding—basic and diluted			38,891,822				1,641,938

 

 

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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)

		March 31,				December 31,
		2022				2021
ASSETS
Current assets:
Cash and cash equivalents		$	236,931			$	266,319
Prepaid expenses and other current assets			22,118				18,430
Total current assets			259,049				284,749
Non-current assets:
Property and equipment, net			18,376				17,743
Operating lease right of use assets			11,070				11,048
Deferred tax assets			26				26
Restricted cash			33				33
Other assets			3,636				3,507
Total non-current assets			33,141				32,357
TOTAL ASSETS		$	292,190			$	317,106
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	4,036			$	3,722
Income taxes payable			15				—
Accrued expenses and other liabilities			9,131				10,906
Operating lease liabilities-current			4,670				4,482
Total current liabilities			17,852				19,110
Non-current liabilities:
Operating lease liabilities-non-current			7,212				7,777
Other long-term liability			671				691
Total non-current liabilities			7,883				8,468
Total liabilities			25,735				27,578
Commitments and contingencies (Note 12)
Shareholders’ equity:
Ordinary shares, £0.001 par value; 40,754,227 and 40,603,489 shares   authorized, issued and outstanding at March 31, 2022 and   December 31, 2021, respectively			54				54
Deferred shares, £92,451.851 par value, one share authorized, issued   and outstanding at March 31, 2022 and December 31, 2021			128				128
Additional paid in capital			403,780				401,821
Accumulated other comprehensive (loss) income			(1,041	)			6,636
Accumulated deficit			(136,466	)			(119,111	)
Total shareholders’ equity			266,455				289,528
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY		$	292,190			$	317,106

 

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

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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 March 31,
		2022				2021
OPERATING EXPENSES:
Research and development		$	13,014			$	8,876
General and administrative			5,955				4,832
Total operating expenses			18,969				13,708
Loss from operations			(18,969	)			(13,708	)
OTHER INCOME, NET:
Other income (expense)			1,629				(45	)
Total other income, net			1,629				(45	)
Loss before provision for income taxes			(17,340	)			(13,753	)
Provision for income taxes			(15	)			(12	)
Net loss			(17,355	)			(13,765	)
Other comprehensive income:
Foreign exchange translation adjustment			(7,677	)			2,063
Comprehensive loss		$	(25,032	)		$	(11,702	)
Net loss per share attributable to ordinary shareholders—basic and diluted		$	(0.45	)		$	(8.38	)
Weighted average ordinary shares outstanding—basic and diluted			38,891,822				1,641,938

 

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

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ACHILLES THERAPEUTICS PLC

Condensed Consolidated Statements of Shareholders’ Equity

(unaudited)

(in thousands, except share amounts)

 

		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, 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

 

 

		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

 

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)

		Three Months Ended March 31,
		2022				2021
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss		$	(17,355	)		$	(13,765	)
Adjustments to reconcile net loss to net cash used in operating activities
Depreciation and amortization			1,053				789
Changes in right of use assets and operating lease liabilities, net			(370	)			527
Gain on disposal of property and equipment			(11	)			—
Non-cash loss on foreign currency remeasurement			5				—
Non-cash share-based compensation			1,959				1,383
Changes in operating assets and liabilities
Prepaid expenses and other current assets			(4,052	)			(2,429	)
Accounts payable			423				(4,593	)
Income taxes payable			15				12
Accrued expenses and other liabilities			(2,070	)			957
Other assets			(232	)			(104	)
Net cash used in operating activities			(20,635	)			(17,223	)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property and equipment			(1,862	)			(2,376	)
Net cash used in investing activities			(1,862	)			(2,376	)
CASH FLOWS FROM FINANCING ACTIVITIES:
Payment of initial public offering costs			—				(914	)
Net cash used in financing activities			—				(914	)
Effect of exchange rate changes on cash, cash equivalents and restricted cash			(6,891	)			1,926
Net decrease in cash, cash equivalents and restricted cash			(29,388	)			(18,587	)
Cash, cash equivalents and restricted cash, beginning of period			266,352				177,849
Cash, cash equivalents and restricted cash, end of period		$	236,964			$	159,262
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Right of use assets obtained in exchange for new operating lease liabilities		$	1,354			$	239
Property and equipment purchases in accrued expenses		$	1,006			$	679
Deferred offering costs included in accrued expenses		$	230			$	1,539

 

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

 

		Three Months Ended March 31,
		2022				2021
Cash and cash equivalents		$	236,931			$	159,262
Restricted cash			33				—
Total cash, cash equivalents and restricted cash			236,964				159,262

 

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

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ACHILLES THERAPEUTICS PLC

Notes to Condensed Consolidated Financial Statements

1. Nature of the business

Achilles Therapeutics plc (formerly Achilles TX Limited) and subsidiaries, or the Company, is a biopharmaceutical company developing transformative precision T cell therapies to treat multiple types of solid tumors. The Company is focused on advancing immuno-oncology therapeutics by exploiting its pioneering work in the field of tumor evolution and clonal neoantigens.

 

The Company is a public limited company originally incorporated pursuant to the laws of England and Wales in November 2020 as a private limited company named Achilles TX Limited, with nominal assets and liabilities, for the purposes of becoming the ultimate holding company for Achilles Therapeutics UK Limited (formerly Achilles Therapeutics Limited). Achilles Therapeutics UK Limited was incorporated in May 2016 under the laws of England and Wales and its registered office and principal place of business is currently 245 Hammersmith Road, London W6 8PW. Achilles TX Limited and Achilles Therapeutics Holdings Limited (a wholly owned direct subsidiary of Achilles TX Limited formed in November 2020 for the purpose of becoming the direct holding company of Achilles Therapeutics UK Limited and Achilles Therapeutics US, Inc.) have not conducted any operations prior to the corporate reorganization other than activities incidental to their formation.

 

The Company has devoted its efforts principally to research and development since formation. The Company has not yet completed product development, filed for or obtained regulatory approvals for any products, nor verified the market acceptance and demand for such products. As a result, the Company is subject to risks that are common to emerging companies in the biotech industry, including the uncertainties of the product discovery and development process, dependence on key individuals, development of the same or similar technological innovations by the Company’s competitors, protection of proprietary technology, compliance with government regulations and approval requirements, the Company’s ability to access capital and uncertainty of market acceptance of products.

Going concern

The Company has historically been loss making and anticipates that it will continue to incur losses for the foreseeable future and had an accumulated deficit of $136.5 million as of March 31, 2022. The Company has funded these losses principally through the issuance of ordinary and preferred shares. The Company expects to continue to incur operating losses and negative cash outflows until such time as it generates a level of revenue that is sufficient to support its cost structure.

The spread of COVID-19 has impacted the global economy and has impacted the Company’s operations, including the interruption of preclinical and clinical trial activities and potential interruption to supply chains. The Company has maintained operations at its GMP manufacturing and research and development sites through 2021 to date. The Company continues to assess the impact COVID-19 may have on its ability to advance the development of drug candidates or to raise financing to support the development of drug candidates, but no assurances can be given that this analysis will enable it to avoid part or all of any impact from the spread of COVID-19 or its consequences, including downturns in business sentiment generally or in its sector in particular.

 

As of March 31, 2022, the Company had cash and cash equivalents of $236.9 million. The Directors have reviewed the financial projections of the Company for the 12 months subsequent to the date of issuance of these financial statements including consideration of severe but plausible scenarios that may affect the Company in that period. These show that the Company will be able to pay (or otherwise discharge) its debts as they fall due immediately following the date of signing of this Balance Sheet and for the period considered by the forecast.

 

Accordingly, the financial statements have been prepared on a basis that assumes the Company will continue as a going concern and which contemplates the realization of assets and settlement of liabilities and commitments as they fall due in the ordinary course of business for at least 12 months from the date of issuance of the financial statements.

2. Summary of significant accounting policies

The Company's significant accounting policies are described in Note 2, Summary of Significant Accounting Policies, to the financial statements for the year ended December 31, 2021 in the Form 20-F filed with the Securities and Exchange

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Commission (the “SEC”) on March 1, 2022. There have been no material changes to the significant accounting policies during the three months ended March 31, 2022 except as described below.

Basis of presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America or U.S. GAAP.

 

The unaudited condensed consolidated interim financial statements have been prepared on the same basis as the audited annual consolidated financial statements as of and for the year ended December 31, 2021, and, in the opinion of management, reflect all adjustments, consisting of normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of March 31, 2022, the results of its operations and comprehensive loss for the three months ended March 31, 2022, its statements of shareholders’ equity for the three months ended March 31, 2022 and 2021 and its statements of cash flows for the three months ended March 31, 2022 and 2021.

 

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 results for the three months ended March 31, 2022 are not necessarily indicative of the results to be expected for the year ended December 31, 2022, any other interim periods, or any future year or period. The balance sheet information as of December 31, 2021, was derived from the audited financial statements included in the Company's Form 20-F filed with the SEC on March 1, 2022. These interim financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2021, and the notes thereto, which are included elsewhere in the Company’s Form 20-F filed with the SEC on March 1, 2022.

Recent accounting pronouncements

 

In November 2021, the FASB issued ASU 2021-10, “Government Assistance – Topic 832 – Disclosures by Business Entities about Government Assistance,” which increases the transparency of government assistance including the disclosure of (1) the types of assistance, (2) an entity’s accounting for the assistance, and (3) the effect of the assistance on an entity’s financial statements. The amendments in this Update require the following annual disclosures about transactions with a government that are accounted for by applying a grant or contribution accounting model by analogy: 1. Information about the nature of the transactions and the related accounting policy used to account for the transactions. 2. The line items on the balance sheet and income statement that are affected by the transactions, and the amounts applicable to each financial statement line item. 3. Significant terms and conditions of the transactions, including commitments and contingencies. ASU 2021-10 is effective for annual periods beginning after December 15, 2021; however, early adoption is permitted. The new guidance was adopted on January 1, 2022 and will be effective for the year ended December 31, 2022. This guidance is not expected to have a material impact on the Company’s financial statements and related disclosures.

3. Fair Value of Financial Instruments

The following tables show assets measured at fair value on a recurring basis as of March 31, 2022 and December 31, 2021 (in thousands):

 

March 31, 2022

Level 1

Level 2

Level 3

Cash equivalents: