– Announced research collaboration with Arcturus Therapeutics to explore second-generation mRNA cancer vaccines using Achilles’ AI-powered, tumor-targeting technology –
– Provided interim Phase I/IIa update on the use of cNeT in Advanced NSCLC and Melanoma including first patients with enhanced host conditioning (EHC), with the first three EHC patients showing improved cNeT persistence and engraftment –
– Cash position of $95.1 million supports operations through 2025 –
LONDON, Aug. 14, 2024 (GLOBE NEWSWIRE) -- Achilles Therapeutics plc ( 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 second quarter ended June 30, 2024, and recent business highlights.
“During the second quarter we shared interim Phase I/IIa data from our ongoing CHIRON and THETIS TIL-based cNeT clinical trials and established an important research collaboration with Arcturus Therapeutics to explore the use of clonal neoantigens in second-generation personalized mRNA cancer vaccines”, said Dr Iraj Ali, Chief Executive Officer of Achilles Therapeutics. “Our insights into the factors that drive durable engraftment and immune evasion led us to add an additional cohort in the CHIRON and THETIS trials to evaluate cNeT persistence and clinical activity in patients with enhanced host conditioning (EHC). These findings, along with the cancer vaccine research collaboration, continue to illustrate the potential value of our platform, including the unparalleled capability of PELEUS to select tumor targets with the highest potential for immune system recognition in a variety of modalities including TIL, neoantigen vaccines, ADCs, and TCR-T therapies.
Our financial position remains strong with more than $95 million in cash, which we expect to support operations through 2025, including the completion of the ongoing Phase I/IIa trials and the Arcturus collaboration.”
Clinical and Business Updates
- Announced research collaboration with Arcturus Therapeutics to explore second-generation mRNA cancer vaccines
- Combines Achilles’ AI-powered, tumor-targeting technology with Arcturus’ self-amplifying mRNA platform
- Combined technologies have the potential to generate potent and durable T cell responses in pre-clinical IND-enabling studies
- Provided an interim Phase I/IIa update on the use of clonal neoantigen reactive T cells (cNeT) in advanced NSCLC and melanoma
- Dosed first EHC patients in CHIRON and THETIS, with the first three EHC patients showing improved cNeT persistence and engraftment
- Delivered 10 products containing over 100 million cNeT and five containing over one billion cNeT
- Matilde Saggese, MD, has been appointed as Interim Chief Medical Officer. Dr. Saggese has served as Vice President and Medical Director of Achilles Therapeutics since March 2021.
Financial Highlights
- Cash and cash equivalents: Cash and cash equivalents were $95.1 million as of June 30, 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 $13.6 million for the second quarter ended June 30, 2024, compared to $13.8 million for the second quarter ended June 30, 2023. The decrease was primarily driven by decreased activity in THETIS and lower personnel costs, partially offset by increased activity in CHIRON.
- General and administrative (G&A) expenses: G&A expenses were $4.2 million for the second quarter ended June 30, 2024, compared to $4.3 million for second quarter ended June 30, 2023. This decrease was primarily driven by lower personnel costs and lower insurance premiums.
- Net loss: Net loss for the second quarter ended June 30, 2024 was $16.4 million or $0.41 per share compared to $16.8 million or $0.42 per share for the second quarter ended June 30, 2023.
2024 Focus
- Clinical Data: Report clinical activity and translational science data from patients in CHIRON and THETIS, evaluating the benefit of EHC, with a meaningful data update expected in the second half of 2024
- Arcturus Collaboration: Ongoing evaluation of best-in-class, self-amplifying mRNA (sa-mRNA) personalized cancer vaccines (PCVs) targeting clonal neoantigens with the potential to generate IND-enabling data
- Translational Science: Leverage the Company’s unique bioinformatics platform to better understand the drivers associated with clinical responses
- 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
[email protected]
Media:
ICR Consilium
Sukaina Virji, Tracy Cheung, Dylan Wilks
+44 (0) 203 709 5000
[email protected]
| 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, | |||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 95,111 | $ | 131,539 | ||||
| Prepaid expenses and other current assets | 22,706 | 14,094 | ||||||
| Total current assets | 117,817 | 145,633 | ||||||
| Property and equipment, net | 6,954 | 9,171 | ||||||
| Operating lease right of use assets | 4,165 | 4,372 | ||||||
| Deferred tax assets | 41 | 41 | ||||||
| Restricted cash | 53 | 33 | ||||||
| Other assets | 2,156 | 2,206 | ||||||
| Total non-current assets | 13,369 | 15,823 | ||||||
| Total assets | $ | 131,186 | $ | 161,456 | ||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable | $ | 2,865 | $ | 5,629 | ||||
| Accrued expenses and other liabilities | 7,225 | 7,828 | ||||||
| Operating lease liabilities - current | 4,205 | 3,539 | ||||||
| Total current liabilities | 14,295 | 16,996 | ||||||
| NON-CURRENT LIABILITIES: | ||||||||
| Operating lease liabilities - non-current | 258 | 1,076 | ||||||
| Other long-term liability | 1,158 | 1,015 | ||||||
| Total non-current liabilities | 1,416 | 2,091 | ||||||
| Total liabilities | 15,711 | 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 June 30, 2024 and December 31, 2023, respectively | 54 | 54 | ||||||
| Deferred shares, £92,451.85 par value, one share authorized, issued and outstanding at June 30, 2024 and December 31, 2023, respectively | 128 | 128 | ||||||
| Additional paid in capital | 417,914 | 415,210 | ||||||
| Accumulated other comprehensive income | (14,015 | ) | (13,071 | ) | ||||
| Accumulated deficit | (288,606 | ) | (259,952 | ) | ||||
| Total shareholders’ equity | 115,475 | 142,369 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | 131,186 | $ | 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 | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Research and development | $ | 13,635 | $ | 13,774 | $ | 23,775 | $ | 27,642 | ||||||||
| General and administrative | 4,164 | 4,318 | 8,323 | 9,003 | ||||||||||||
| Total operating expenses | 17,799 | 18,092 | 32,098 | 36,645 | ||||||||||||
| LOSS FROM OPERATIONS: | (17,799 | ) | (18,092 | ) | (32,098 | ) | (36,645 | ) | ||||||||
| OTHER INCOME (EXPENSE), NET: | ||||||||||||||||
| Other income (expense) | 1,427 | 1,212 | 3,429 | 2,303 | ||||||||||||
| Total other income (expense), net | 1,427 | 1,212 | 3,429 | 2,303 | ||||||||||||
| Loss before income taxes | (16,372 | ) | (16,880 | ) | (28,669 | ) | (34,342 | ) | ||||||||
| (Provision) benefit for income taxes | (8 | ) | 34 | 15 | (10 | ) | ||||||||||
| Net loss | (16,380 | ) | (16,846 | ) | (28,654 | ) | (34,352 | ) | ||||||||
| Other comprehensive (loss) income: | ||||||||||||||||
| Foreign exchange translation adjustment | 195 | 3,817 | (944 | ) | 7,794 | |||||||||||
| Comprehensive loss | $ | (16,185 | ) | $ | (13,029 | ) | $ | (29,598 | ) | $ | (26,558 | ) | ||||
| Net loss per share attributable to ordinary shareholders—basic and diluted | $ | (0.41 | ) | $ | (0.42 | ) | $ | (0.71 | ) | $ | (0.86 | ) | ||||
| Weighted average ordinary shares outstanding—basic and diluted | 40,355,972 | 39,899,944 | 40,318,690 | 39,816,528 | ||||||||||||
