6-K
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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 ☐

 

 

 

 

 


 

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on Forms F-3 (File No. 333-268239) and S-8 (File Nos. 333-270344, 333-263220, and 333-255063) to the extent not superseded by information subsequently filed or furnished (to the extent the Company expressly states that it incorporates such furnished information by reference) by the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.


 

 

 


 

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.

 

 

 

 

101.INS*

Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

101.SCH*

Inline XBRL Taxonomy Extension Schema Document.

101.CAL*

Inline XBRL Taxonomy Extension Calculation Linkbase Document.

101.DEF*

Inline XBRL Taxonomy Extension Definition Linkbase Document.

101.LAB*

Inline XBRL Taxonomy Extension Label Linkbase Document.

101.PRE*

Inline XBRL Taxonomy Extension Presentation Linkbase Document.

 

 

 

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 


 

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

 

 


EX-99.1

Exhibit 99.1

 

https://cdn.kscope.io/b54b9f93a569bcdf7033bb9c5f98c235-img60901631_0.jpg 

 

 

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

Introduced and presented data at the 7th Annual Immuno-Oncology Summit Europe on the neoRankerTM tool, Achilles Therapeutics’ new immunogenicity prediction module of the AI-Powered PELEUS™ platform that uniquely identifies the most potent clonal neoantigens. The new AI module demonstrated potential superiority to commonly used AI tools (BigMHC) in identifying and prioritizing targets for personalized antigen approaches, supporting potential implementation into the Company’s ongoing TIL-based clinical programs in advanced non-small cell lung cancer (NSCLC) and melanoma, and into other modalities including clonal neoantigen cancer vaccines
US patent number 11,634,773 granted on technology exclusively licensed by Achilles from the Francis Crick Institute, University College London, and Cancer Research Horizons, for selecting neoantigens that are presented by HLA molecules determined to be present in a patient’s tumor

 


 

Regained compliance with the minimum bid price requirement of Nasdaq Listing Rule 5450(a)(1) on July 28, 2023, as confirmed by a written notice received from the Listing Qualifications Department of The Nasdaq Stock Market on July 31, 2023

Financial Highlights

Cash and cash equivalents: Cash and cash equivalents were $143.7 million as of June 30, 2023, as compared to $173.3 million as of December 31, 2022. The Company anticipates that its cash and cash equivalents are sufficient to fund its planned operations through 2025.
Research and development (R&D) expenses: R&D expenses were $13.8 million for the second quarter ended June 30, 2023, a decrease of $1.0 million compared to $14.8 million for the second quarter ended June 30, 2022. The decrease was primarily driven by changes to R&D priorities.
General and administrative (G&A) expenses: G&A expenses were $4.3 million for the second quarter ended June 30, 2023, a decrease of $1.5 million compared to $5.8 million for the second quarter ended June 30, 2022. This decrease was primarily driven by changes in cost allocations, as well as lower professional fees and personnel costs.
Net loss: Net loss for the second quarter ended June 30, 2023 was $16.8 million or $0.42 per share compared to $17.3 million or $0.44 per share for the second quarter ended June 30, 2022.

2H 2023 Focus and Upcoming Events

Clinical Data: Report clinical and translational science data from 15 to 20 additional patients treated with cNeT monotherapy in NSCLC and melanoma, and with a cNeT/anti-PD-1 checkpoint inhibitor combination in melanoma, in the fourth quarter of the year
Translational Science: Leverage the Company’s translational science platform to define the cNeT product features associated with clinical responses
Clinical Activity: Drive the potential for additional confirmed responses in CHIRON and THETIS patients by delivering higher cNeT doses and improved product design
Manufacturing Development: Continue VELOS™ and PELEUS™ development to optimize cNeT dose and functionality

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:

11th Annual Immuno-Oncology Summit: August 7-9, 2023, Boston, MA
Advanced Therapies Europe: September 6-7, 2023, Estoril, Portugal
5th Annual TIL Therapies Summit: October 2-4, 2023, Boston, MA

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. 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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

 

 

 

 

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

 

 

 

 


 

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

 

 

 

 

 


EX-99.2
11

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

 

 

 

 

 

 


 

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


 

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


 

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