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

·8-min read
Achilles Therapeutics PLC
Achilles Therapeutics PLC

- Additional clinical data from the ongoing Phase I/IIa trials in advanced NSCLC (CHIRON) and melanoma (THETIS) expected to be available in Q4 2022 -

- Cell & Gene Therapy Catapult manufacturing facility approved by MHRA for cNeT production in CHIRON and THETIS clinical trials -

- Strong cash balance of $202 million supports all planned operations into Q2 2025 -

LONDON, Aug. 09, 2022 (GLOBE NEWSWIRE) -- 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 second quarter ended June 30, 2022, and recent business highlights.

“We remain focused on advancing our lead clinical programs, evaluating cNeT monotherapy in CHIRON for advanced non-small cell lung cancer (NSCLC), and exploring both cNeT monotherapy and the combination with a PD-1 checkpoint inhibitor in THETIS for recurrent or metastatic malignant melanoma. We expect initial activity, safety and translational science data in the fourth quarter of this year from patients receiving higher-dose cNeT products,” said Dr Iraj Ali, Chief Executive Officer of Achilles Therapeutics. “We are very pleased that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has now approved Achilles’ Cell and Gene Therapy Catapult Manufacturing Centre (Catapult) site to produce cNeT products in the ongoing CHIRON and THETIS clinical trials, significantly increasing our manufacturing capacity for 2022 and beyond.”

Business Highlights

  • On track to present additional clinical data in Q4 2022 from the ongoing Phase I/IIa CHIRON and THETIS clinical trials in patients with advanced NSCLC and recurrent or metastatic melanoma, respectively.

  • Expanded global manufacturing capacity with the MHRA approval of Achilles’ Catapult facility for cNeT production in CHIRON and THETIS and entered into a partnership agreement for clinical manufacturing in the United States with the Center for Breakthrough Medicines, a contract development and manufacturing organization in King of Prussia, PA.

  • Awarded a €4 million ($4.2 million1) research and innovation award as part of a consortium to develop a first-in-class smart bioprocessing manufacturing platform, with €1.4 million ($1.5 million1) allocated to Achilles.

  • Initiated the tumor archiving program (TAP) to study the potential of producing cNeT from tumor material collected and stored earlier in disease progression.

  • Strengthened the Company’s leadership with the following appointments: Bernhard Ehmer to the Board of Directors, James Taylor as Chief Business Officer, and Cassian Yee, MD to the Scientific Advisory Board.

  • Received the 2022 Pharmaceutical Industry Network Group (PING) Innovation Award, acknowledging the innovation demonstrated by the Company’s work with clonal neoantigens to treat solid tumors, including the Company’s AI-powered PELEUS™ bioinformatics platform and proprietary VELOS™ manufacturing process.

Financial Highlights

  • Cash and cash equivalents: Cash and cash equivalents were $201.6 million as of June 30, 2022, as compared to $266.3 million as of December 31, 2021. 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 $14.8 million for the second quarter ended June 30, 2022, as compared to $10.8 million for the second quarter ended June 30, 2021. The increase was primarily driven by increased activity related to our ongoing clinical trials and overall R&D.

  • General and administrative (G&A) expenses: G&A expenses were $5.8 million for the second quarter ended June 30, 2022, as compared to $5.4 million for the second quarter ended June 30, 2021. The increase was primarily driven by an increase in headcount and related personnel costs.

  • Net loss: Net loss for the second quarter ended June 30, 2022, was $17.3 million or $0.44 per share compared to $16.2 million, or $0.45 per share for the second quarter ended June 30, 2021.

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

  • BTIG Biotechnology Conference 2022: August 8 – 9, 2022

  • Phacilitate Advanced Therapies Europe: August 31 – September 1, 2022

  • H.C. Wainwright Annual Global Investment Conference: September 12 – 14, 2022

  • Cantor Fitzgerald’s Cell & Genetic Medicines Conference: September 15, 2022

  • Immuno UK: September 29 – 30, 2022

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.

1 June 30, 2022 exchange rate of €1.000 = $1.043

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)

 

June 30,

 

 

December 31,

 

 

2022

 

 

2021

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

$

201,595

 

 

$

266,319

 

Prepaid expenses and other current assets

 

25,985

 

 

 

18,430

 

Total current assets

 

227,580

 

 

 

284,749

 

Non-current assets:

 

 

 

 

 

Property and equipment, net

 

17,626

 

 

 

17,743

 

Operating lease right of use assets

 

9,470

 

 

 

11,048

 

Deferred tax assets

 

26

 

 

 

26

 

Restricted cash

 

33

 

 

 

33

 

Other assets

 

2,983

 

 

 

3,507

 

Total non-current assets

 

30,138

 

 

 

32,357

 

TOTAL ASSETS

$

257,718

 

 

$

317,106

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

$

6,651

 

 

$

3,722

 

Income taxes payable

 

18

 

 

 

 

Accrued expenses and other liabilities

 

8,720

 

 

 

10,906

 

Operating lease liabilities-current

 

4,480

 

 

 

4,482

 

Total current liabilities

 

19,869

 

 

 

19,110

 

Non-current liabilities:

 

 

 

 

 

Operating lease liabilities-non-current

 

5,640

 

 

 

7,777

 

Other long-term liability

 

621

 

 

 

691

 

Total non-current liabilities

 

6,261

 

 

 

8,468

 

Total liabilities

 

26,130

 

 

 

27,578

 

Commitments and contingencies (Note 12)

 

 

 

 

 

Shareholders’ equity:

 

 

 

 

 

Ordinary shares, £0.001 par value; 40,774,014 and 40,603,489 shares
authorized, issued and outstanding at June 30, 2022 and
December 31, 2021, respectively

 

54

 

 

 

54

 

Deferred shares, £92,451.851 par value, one share authorized, issued
and outstanding at June 30, 2022 and December 31, 2021

 

128

 

 

 

128

 

Additional paid in capital

 

405,504

 

 

 

401,821

 

Accumulated other comprehensive (loss) income

 

(20,343

)

 

 

6,636

 

Accumulated deficit

 

(153,755

)

 

 

(119,111

)

Total shareholders’ equity

 

231,588

 

 

 

289,528

 

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

$

257,718

 

 

$

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 June 30,

 

 

Six Months Ended June 30,

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

OPERATING EXPENSES:

 

 

 

 

 

 

 

 

 

 

 

Research and development

$

14,776

 

 

$

10,844

 

 

$

27,790

 

 

$

19,720

 

General and administrative

 

5,770

 

 

 

5,445

 

 

 

11,725

 

 

 

10,277

 

Total operating expenses

 

20,546

 

 

 

16,289

 

 

 

39,515

 

 

 

29,997

 

Loss from operations

 

(20,546

)

 

 

(16,289

)

 

 

(39,515

)

 

 

(29,997

)

OTHER INCOME, NET:

 

 

 

 

 

 

 

 

 

 

 

Other income

 

3,271

 

 

 

146

 

 

 

4,900

 

 

 

101

 

Total other income, net

 

3,271

 

 

 

146

 

 

 

4,900

 

 

 

101

 

Loss before provision for income taxes

 

(17,275

)

 

 

(16,143

)

 

 

(34,615

)

 

 

(29,896

)

Provision for income taxes

 

(14

)

 

 

(13

)

 

 

(29

)

 

 

(25

)

Net loss

 

(17,289

)

 

 

(16,156

)

 

 

(34,644

)

 

 

(29,921

)

Other comprehensive income:

 

 

 

 

 

 

 

 

 

 

 

Foreign exchange translation adjustment

 

(19,302

)

 

 

(925

)

 

 

(26,979

)

 

 

1,138

 

Comprehensive loss

$

(36,591

)

 

$

(17,081

)

 

$

(61,623

)

 

$

(28,783

)

Net loss per share attributable to ordinary shareholders—basic and diluted

$

(0.44

)

 

$

(0.45

)

 

$

(0.89

)

 

$

(1.60

)

Weighted average ordinary shares outstanding—basic and diluted

 

39,104,375

 

 

 

35,683,187

 

 

 

38,998,686

 

 

 

18,756,599