Achilles Therapeutics Reports Fourth Quarter and Year-End 2023 Financial Results and Recent Business Highlights
April 04 2024 - 5:45AM
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
- Provided an interim Phase I/IIa update on clonal neoantigen
reactive T cells in advanced NSCLC and melanoma from 18 new
patients, highlighting improved doses from the VELOS™ manufacturing
process and a favorable tolerability profile
- The VELOS™ manufacturing process delivered ~10-fold improvement
in the median cNeT dose (172 million) across the 18 patients in the
update, with 10 products over 100 million cNeT and five over one
billion cNeT
- First patients dosed in CHIRON and THETIS with enhanced host
conditioning to evaluate the benefit of increased lymphodepletion
intensity and Il-2 dosing aligned to standard TIL therapy, with
additional meaningful data expected in the fourth quarter of
2024
- Continued
development and improvements of the PELEUS™ clonal neoantigen
prediction platform
2023 and Year-to-Date 2024 Corporate
Highlights
- Publication in Nature Cancer from researchers affiliated with
Achilles and the DECOD-Ag consortium outlined the vast potential of
neoantigen immunogenicity prediction
- neoRanker™, a new AI-enabled neoantigen immunogenicity ranking
module of PELEUS™, outperformed current AI and non-AI
state-of-the-art methods for neoantigen immunogenicity
prediction
- U.S. patent 11,634,773 granted
covering treatment with an immunotherapy that targets a neoantigen
predicted to be presented by a human leukocyte antigen (HLA) allele
that has not been lost in a tumor, where loss of HLA alleles is
determined using a proprietary sequence-based method
- Regained
compliance with the minimum bid price requirement of Nasdaq Listing
Rule 5450(a)(1) on March 1, 2024, as confirmed by a written notice
received from the Listing Qualifications Department of
The Nasdaq Stock Market on March 4, 2024
Financial Highlights
- Cash and cash
equivalents: Cash and cash equivalents were $131.5 million
as of December 31, 2023, as compared to $173.3 million as of
December 31, 2022. The Company anticipates 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 $15.9 million
for the fourth quarter ended December 31, 2023, a decrease of $3.0
million compared to $18.9 million for the fourth quarter ended
December 31, 2022. R&D expenses were $58.2 million for the year
ended December 31, 2023, an increase of $0.9 million compared to
$57.3 million for the year ended December 31, 2022. The increase
was primarily driven by an increased focus on the ongoing clinical
trials.
- General and administrative
(G&A) expenses: G&A expenses were $3.6 million for
the fourth quarter ended December 31, 2023, a decrease of $0.4
million compared to $4.0 million for December 31, 2022. G&A
expenses were $17.1 million for the year ended December 31, 2023, a
decrease of $4.0 million compared to the $21.1 million for the year
ended December 31, 2022. This decrease was primarily driven by
lower personnel costs and lower legal and professional fees.
- Net loss: Net loss
for the fourth quarter ended December 31, 2023 was $18.6 million or
$0.46 per share compared to $24.1 million or $0.61 per share for
the fourth quarter ended December 31, 2022. Net loss for the year
ended December 31, 2023 was $69.7 million or $1.74 per share
compared to $71.2 million or $1.82 per share for the year ended
December 31, 2022.
2024 Focus and Upcoming Events
- 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 2H 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
- Clinical Activity:
Drive additional confirmed responses in CHIRON and THETIS patients
on cNeT therapy by delivering higher cNeT doses with enhanced host
conditioning
- Manufacturing
Development: Continue VELOS™ and PELEUS™ development to
optimize cNeT dose and functionality
Achilles will participate in the following
upcoming conferences. Additional details will be available in
the Events & Presentations section of the Company’s
website:
- Immuno-Oncology Summit Europe,
April 23 - 24, 2024, London
- LSX World Congress, April 29 - 30, 2024, London
- Chardan’s 8th Annual Cell Therapy Manufacturing Summit, April
29, 2024, Virtual
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 AdvisorsLee M.
Sternlstern@meruadvisors.com
Media:ICR ConsiliumSukaina Virji, Tracy Cheung,
Emmalee Hoppe+44 (0) 203 709 5000achillestx@consilium-comms.com
ACHILLES THERAPEUTICS PLCConsolidated
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 outstandingat 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 PLCConsolidated
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 |
|
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