Achilles Therapeutics Reports Second Quarter 2024 Financial Results and Recent Business Updates
August 14 2024 - 7:00AM
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 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
TherapeuticsAchilles 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 StatementsThis
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 AdvisorsLee M.
Sternlstern@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) |
|
|
|
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 |
|
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