Achilles Therapeutics Reports First Quarter 2024 Financial Results and Recent Business Highlights
May 08 2024 - 6:00AM
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 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
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 ConsiliumSukaina Virji, Tracy Cheung,
Dylan Wilks+44 (0) 203 709 5000achillestx@consilium-comms.com
|
ACHILLES THERAPEUTICS PLCCondensed
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 PLCCondensed
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 |
|
Achilles Therapeutics (NASDAQ:ACHL)
Historical Stock Chart
From Oct 2024 to Nov 2024
Achilles Therapeutics (NASDAQ:ACHL)
Historical Stock Chart
From Nov 2023 to Nov 2024