Investing.com
Published Apr 04, 2024 18:58
“ Provided interim Phase I/IIa update on clonal neoantigen reactive T cells in advanced NSCLC and melanoma “
“ Improved VELOS™ manufacturing process delivering higher cNeT doses “
“ Protocols updated to evaluate the benefit of enhanced host conditioning, with further data expected in 2H 2024 “
“ Strong cash position of $131.5 million supports operations through 2025 “
LONDON, April 04, 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 fourth quarter and year-ended December 31, 2023, and recent business highlights.
In 2023, we made important progress on the optimization of our VELOS™ manufacturing process with a significant improvement in cNeT doses delivered and are developing our understanding of the relationship between host conditioning and the engraftment of infused cNeT. We recently shared updated safety, tolerability and translational science data from checkpoint refractory patients that continue to be encouraging and reveal important mechanistic learnings about the factors driving durable T cell engraftment and the impact of immune evasion mechanisms at an antigen level. These learnings will inform the development of cNeT and related neoantigen vaccine and TCR-T therapies, said Dr Iraj Ali, Chief Executive Officer of Achilles Therapeutics. Looking ahead to 2024, we will evaluate 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 $131 million in cash, which supports operations through 2025, including the completion of the ongoing Phase I/IIa trials.
2023 and Year-to-Date 2024 Clinical Highlights
2023 and Year-to-Date 2024 Corporate Highlights
Financial Highlights
2024 Focus and Upcoming Events
Achilles will participate in the following upcoming conferences. Additional details will be available in the Events & Presentations section of the Company's website:
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 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, Emmalee Hoppe
+44 (0) 203 709 5000
achillestx@consilium-comms.com
ACHILLES THERAPEUTICS PLC Consolidated Balance Sheets (in thousands, except share and per share amounts) (expressed in U.S. Dollars, unless otherwise stated) | |||||||
December 31, | December 31, | ||||||
2023 | 2022 | ||||||
ASSETS | |||||||
CURRENT ASSETS: | |||||||
Cash and cash equivalents | $ | 131,539 | $ | 173,338 | |||
Prepaid expenses and other current assets | 14,094 | 23,242 | |||||
Total current assets | 145,633 | 196,580 | |||||
Property and equipment, net | 9,171 | 12,399 | |||||
Operating lease right of use assets | 4,372 | 8,081 | |||||
Deferred tax assets | 41 | 251 | |||||
Restricted cash | 33 | 33 | |||||
Other assets | 2,206 | 3,014 | |||||
Total non-current assets | 15,823 | 23,778 | |||||
Total assets | $ | 161,456 | $ | 220,358 | |||
LIABILITIES AND SHAREHOLDERS' EQUITY | |||||||
CURRENT LIABILITIES: | |||||||
Accounts payable | $ | 5,629 | $ | 5,187 | |||
Income taxes payable | - | 326 | |||||
Accrued expenses and other liabilities | 7,828 | 8,292 | |||||
Operating lease liabilities - current | 3,539 | 4,188 | |||||
Total current liabilities | 16,996 | 17,993 | |||||
NON-CURRENT LIABILITIES: | |||||||
Operating lease liabilities - non-current | 1,076 | 4,388 | |||||
Other long-term liability | 1,015 | 933 | |||||
Total non-current liabilities | 2,091 | 5,321 | |||||
Total liabilities | 19,087 | 23,314 | |||||
Commitments and contingencies | |||||||
SHAREHOLDERS' EQUITY: | |||||||
Ordinary shares, £0.001 par value; 41,082,948 and 40,932,727 shares authorized, issued and outstanding at December 31, 2023 and December 31, 2022, respectively | 54 | 54 | |||||
Deferred shares, £92,452.00 par value, one share authorized, issued and outstanding at December 31, 2023 and December 31, 2022, respectively | 128 | 128 | |||||
Additional paid in capital | 415,210 | 408,844 | |||||
Accumulated other comprehensive income | (13,071 | ) | (21,695 | ) | |||
Accumulated deficit | (259,952 | ) | (190,287 | ) | |||
Total shareholders' equity | 142,369 | 197,044 | |||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 161,456 | $ | 220,358 |
ACHILLES THERAPEUTICS PLC Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts) (expressed in U.S. Dollars, unless otherwise stated) | |||||||||||||||||||||||
Three Months Ended | Twelve Months Ended | ||||||||||||||||||||||
December 31, | December 31, | December 31, | December 31, | ||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
OPERATING EXPENSES: | |||||||||||||||||||||||
Research and development | $ | 15,892 | $ | 18,876 | $ | 58,246 | $ | 57,263 | |||||||||||||||
General and administrative | 3,622 | 3,958 | 17,009 | 21,120 | |||||||||||||||||||
Total operating expenses | 19,914 | 22,834 | 75,255 | 78,383 | |||||||||||||||||||
LOSS FROM OPERATIONS: | (19,914 | ) | (22,834 | ) | (75,255 | ) | (78,383 | ) | |||||||||||||||
OTHER INCOME (EXPENSE), NET: | |||||||||||||||||||||||
Other income (expense) | 1,389 | (1,181 | ) | 6,081 | 7,318 | ||||||||||||||||||
Total other income (expense), net | 1,389 | (1,181 | ) | 6,081 | 7,318 | ||||||||||||||||||
Loss before income taxes | (18,125 | ) | (24,015 | ) | (69,174 | ) | (71,065 | ) | |||||||||||||||
Provision for income taxes | (505 | ) | (41 | ) | (491 | ) | (111 | ) | |||||||||||||||
Net loss | (18,630 | ) | (24,056 | ) | (69,665 | ) | (71,176 | ) | |||||||||||||||
Other comprehensive (loss) income: | |||||||||||||||||||||||
Foreign exchange translation adjustment | 6,119 | 16,795 | 8,624 | (28,331 | ) | ||||||||||||||||||
Comprehensive loss | $ | (12,511 | ) | $ | (7,261 | ) | $ | (61,041 | ) | $ | (99,507 | ) | |||||||||||
Net loss per share attributable to ordinary shareholders”basic and diluted | $ | (0.46 | ) | $ | (0.61 | ) | $ | (1.74 | ) | $ | (1.82 | ) | |||||||||||
Weighted average ordinary shares outstanding”basic and diluted | 40,187,152 | 39,518,910 | 39,973,059 | 39,139,693 |
Written By: Investing.com
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