Syncona
Limited
Achilles
reports Q1 2024 Financial Results and Recent Business
Highlights
8 May 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 first quarter ended 31
March, 2024, and an update on recent business
highlights.
The announcement can be accessed
on Achilles' website at: https://ir.achillestx.com/ 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
First Quarter 2024 Financial Results and Recent Business
Highlights
-
Provided interim Phase I/IIa update on clonal neoantigen reactive T
cells in advanced NSCLC and melanoma -
-
Evaluating the benefit of
enhanced host conditioning with further data expected in 2H
2024 -
-
Strong cash position of $112.3 million supports
operations through 2025 -
London, UK 8 May 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 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 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
lstern@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)
|
|
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
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
|
|
|
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
|