Syncona
Limited
Achilles
reports full year 2023 Financial Results
04 April 2024
Syncona Ltd, a leading life science
investor focused on creating, building and scaling global leaders
in life science, notes that its portfolio company, Achilles Therapeutics plc
(NASDAQ: ACHL) ("Achilles"), announced its financial results for
the full year ended December 31, 2023, and recent business
highlights.
The announcement can be accessed on
Achilles' investor website at https://ir.achillestx.com/press-releases and
the full text of the announcement from Achilles is contained
below.
[ENDS]
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About Syncona
Syncona's purpose is to invest to
extend and enhance human life. We do this by creating and building
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documentation, before investing.
Achilles Therapeutics Reports
Fourth Quarter and Year-End 2023 Financial Results and Recent
Business Highlights
-
Provided interim Phase I/IIa update on clonal neoantigen reactive T
cells in advanced NSCLC and melanoma -
-
Improved VELOSTM 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, UK 4 April 2024 -
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
VELOSTM 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
·
neoRankerTM, 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 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
|
|
|
|
|
|
|
|
|
|
|
| |