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

2024-05-08

细胞疗法财报免疫疗法临床研究

– 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 08, 2024 (GLOBE NEWSWIRE) -- 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