EX-99.1 2 achl-ex99_1.htm EX-99.1 EX-99.1

Exhibit 99.1

 

img60901631_0.jpg 

 

Achilles Therapeutics Reports First Quarter 2024 Financial Results and Recent Business Highlights

– Provided interim Phase I/IIa update on clonal neoantigen reactive T cells in advanced NSCLC and melanoma –

– Evaluating the benefit of enhanced host conditioning with further data expected in 2H 2024 –

– Strong cash position of $112.3 million supports operations through 2025 –

London, May 8, 2024 – 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 first quarter ended March 31, 2024, and recent business highlights.

Just after the close of the first quarter, we shared the interim Phase I/IIa data from our ongoing CHIRON and THETIS TIL-based cNeT clinical trials which have given us important mechanistic learnings about the factors driving durable engraftment and immune evasion at an antigen level. These data continue to inform the development of cNeT and potentially other modalities like neoantigen vaccines and TCR-T therapies,” said Dr Iraj Ali, Chief Executive Officer of Achilles Therapeutics. “We are evaluating cNeT persistence and clinical activity in patients with enhanced host conditioning, and we plan to report a meaningful data update in the second half of 2024. Our financial position remains strong with more than $112 million in cash, which will support operations through 2025, including the completion of the ongoing Phase I/IIa trials.”

Clinical and Business Highlights

Provided an interim Phase I/IIa update on clonal neoantigen reactive T cells in advanced NSCLC and melanoma, highlighting improved doses from the VELOS™ manufacturing process and encouraging tolerability
Delivered ~10-fold improvement in the median cNeT dose (172 million), with 10 products over 100 million cNeT and five over one billion cNeT
Dosed first patients in CHIRON and THETIS with enhanced host conditioning, with additional data expected in the second half of 2024
Continued development of the PELEUS™ clonal neoantigen prediction platform

 


 

Presented “Targeting Clonal Neoantigens with Precision Cell Therapies” at the 10th Annual IO360 Conference

Financial Highlights

Cash and cash equivalents: Cash and cash equivalents were $112.3 million as of March 31, 2024, as compared to $131.5 million as of December 31, 2023. The Company believes 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 $10.1 million for the first quarter ended March 31, 2024, a decrease of $3.7 million compared to $13.9 million for the first quarter ended March 31, 2023. The decrease was primarily driven by lower personnel costs, partially offset by an increase of activity in the ongoing clinical trials.
General and administrative (G&A) expenses: G&A expenses were $4.2 million for the first quarter ended March 31, 2024, a decrease of $0.5 million compared to $4.7 million for first quarter ended March 31, 2023. This decrease was primarily driven by lower personnel costs and lower insurance premiums.
Net loss: Net loss for the first quarter ended March 31, 2024 was $12.3 million or $0.30 per share compared to $17.5 million or $0.44 per share for the first quarter ended March 31, 2023.

2024 Focus

Clinical Data: Report clinical activity and translational science data from patients in CHIRON and THETIS Cohort C, evaluating the benefit of enhanced host conditioning, with a meaningful data update expected in the second half of 2024
Translational Science: Leverage the Company’s world-class translational science platform to define the features associated with clinical response and to pursue rational design of the final cNeT product
Manufacturing Development: Continue VELOS™ and PELEUS™ development to optimize cNeT dose and functionality

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. Forward-looking statements in this press release include, but are not limited to, statements regarding the timing of the Company’s clinical and translational data updates and the Company’s beliefs about recent data updates, and expectations related to the Company’s cash runway and operating expenses and capital expense requirements. 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:

ICR Consilium
Sukaina Virji, Tracy Cheung, Dylan Wilks
+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)

March 31,

December 31,

2024

2023

ASSETS

CURRENT ASSETS:

Cash and cash equivalents

$112,322

 $131,539

Prepaid expenses and other current assets

19,104

 14,094

    Total current assets

131,426

 145,633

Property and equipment, net

8,107

 9,171

Operating lease right of use assets

3,965

 4,372

Deferred tax assets

41

 41

Restricted cash

33

 33

Other assets

2,169

 2,206

    Total non-current assets

14,315

 15,823

    Total assets

$145,741

 $161,456

LIABILITIES AND SHAREHOLDERS’ EQUITY

CURRENT LIABILITIES:

Accounts payable

$3,313

 $5,629

Accrued expenses and other liabilities

6,712

 7,828

Operating lease liabilities - current

3,628

 3,539

    Total current liabilities

13,653

 16,996

NON-CURRENT LIABILITIES:

Operating lease liabilities - non-current

584

 1,076

Other long-term liability

1,156

 1,015

       Total non-current liabilities

1,740

 2,091

       Total liabilities

15,393

 19,087

Commitments and contingencies

SHAREHOLDERS’ EQUITY:

Ordinary shares, £0.001 par value; 41,087,901 and 41,082,948 shares authorized,
   issued and outstanding at March 31, 2024 and December 31, 2023, respectively

54

 54

Deferred shares, £92,451.85 par value, one share authorized, issued and outstanding
   at March 31, 2024 and December 31, 2023, respectively

128

 128

Additional paid in capital

416,602

 415,210

Accumulated other comprehensive income

(14,210)

(13,071)

Accumulated deficit

(272,226)

(259,952)

    Total shareholders’ equity

130,348

 142,369

    TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY

$145,741

 $161,456

 

 

 

 

 

 

 

 

 

 

 


 

ACHILLES THERAPEUTICS PLC

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

(in thousands, except share and per share amounts)

(expressed in U.S. Dollars, unless otherwise stated)

 

 Three Months Ended

March 31,

2024

  

2023

 OPERATING EXPENSES:

  

  

  

 Research and development

 $ 10,140

  

 $ 13,868

 General and administrative

                4,159

  

                4,685

     Total operating expenses

             14,299

  

             18,553

 LOSS FROM OPERATIONS:

           (14,299)

  

           (18,553)

 OTHER INCOME (EXPENSE), NET:

 Other income (expense)

                2,002

                1,091

     Total other income (expense), net

                2,002

                1,091

 Loss before income taxes

           (12,297)

           (17,462)

 Benefit (provision) for income taxes

                          23

                     (44)

 Net loss

           (12,274)

           (17,506)

 Other comprehensive (loss) income:

 Foreign exchange translation adjustment

              (1,139)

                3,977

 Comprehensive loss

 $ (13,413)

 $ (13,529)

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

 $ (0.30)

 $ (0.44)

 Weighted average ordinary shares outstanding—basic and diluted

  40,281,407

  39,732,186