6-K

 

 

 

 

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): ☐

 

 

 

 

 


 

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.
 

 

 


 

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.

 

 

 


 

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

 

 


EX-99.1

Exhibit 99.1

https://cdn.kscope.io/64e2aec1971cfa5cc76bf227fafcbe83-img60901631_0.jpg 

 

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

Cash and cash equivalents: Cash and cash equivalents were $179.9 million as of September 30, 2022, as compared to $266.3 million as of December 31, 2021. The impact of translating our books and records from British Pounds Sterling into U.S. dollars had an unfavorable impact on the reported balance cash and cash equivalents. The net decrease reflects an underlying use of $45.7 million for operating and investing activities and a negative $40.7 million foreign exchange impact. The Company anticipates that its cash and cash equivalents are sufficient to fund its planned operations into the second quarter of 2025, including completion of the ongoing Phase I/IIa CHIRON and THETIS clinical trials.
Research and development (R&D) expenses: R&D expenses were $10.6 million for the third quarter ended September 30, 2022, as compared to $10.7 million for the third quarter ended September 30, 2021.
General and administrative (G&A) expenses: G&A expenses were $5.4 million for the third quarter ended September 30, 2022, as compared to $5.0 million for the third quarter ended September 30, 2021. The increase was primarily driven by an increase in personnel costs.
Net loss: Net loss for the third quarter ended September 30, 2022, was $12.5 million or $0.32 per share compared to $12.9 million, or $0.34 per share for the third quarter ended September 30, 2021.

 


 

 

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:

Jefferies London Healthcare Conference: November 15 – 17, 2022
TIDES Europe - Oligonucleotide & Peptide Therapeutics: November 16 – 18, 2022
Piper Sandler Annual Healthcare Conference: November 29 – December 1, 2022
ESMO Immuno-Oncology Congress 2022: December 7 – 9, 2022
J.P. Morgan Annual Healthcare Conference: January 9 – 12, 2023

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

 

 


 

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

 

 


 

 

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

 

 

 

 

 


 

 

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

 

 

 


EX-99.2

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

 

 

 

 

 

 


 

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


 

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


 

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


 

 

 

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

 

                    —

 

                        —

 

                           —

 

                  —

 

                         —

 

                    —

 

                   —

 

                  —