REG - Syncona Limited - Achilles reports full year 2023 Financial Results
04/04/2024 12:00
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RNS Number : 3490J Syncona Limited 04 April 2024
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
(https://ir.achillestx.com/press-releases) and the full text of the
announcement from Achilles is contained below.
ENDS
Enquiries
Syncona Ltd
Annabel Clark / Fergus Witt
Tel: +44 (0) 7714 916615
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Ben Atwell / Natalie Garland-Collins / Tim Stamper
Tel: +44 (0) 20 3727 1000
About Syncona
Syncona's purpose is to invest to extend and enhance human life. We do this by
creating and building companies to deliver transformational treatments to
patients in areas of high unmet need.
Our strategy is to create, build and scale companies around exceptional
science to create a diversified portfolio of 20-25 globally leading healthcare
businesses, across development stage and therapeutic areas, for the benefit of
all our stakeholders. We focus on developing treatments for patients by
working in close partnership with world-class academic founders and management
teams. Our balance sheet underpins our strategy enabling us to take a
long-term view as we look to improve the lives of patients with no or poor
treatment options, build sustainable life science companies and deliver strong
risk-adjusted returns to shareholders.
Syncona Limited seeks to achieve returns over the long term. Investors should
seek to ensure they understand the risks and opportunities of an investment
in Syncona Limited, including the information in our published 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 VELOS(TM) 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 VELOS(TM)
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(TM), 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
(https://www.globenewswire.com/Tracker?data=HGhxvCVo9d50sNDqiyTJKJO5Tf3lZZodMtXjCP8RmQDr1qpTiNd2ltkVzyDUPXIKZk7Kwq8IyzcZfDIJGM09b9FUmaKeKf1IlLBxUxqruhhQr_nJvXdVpDpNM4rlVin_oLwMCMOIW9lqtNdTmA0qjg==)
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 8(th) 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 (mailto:lstern@meruadvisors.com)
Media:
ICR Consilium
Sukaina Virji, Tracy Cheung, Emmalee Hoppe
+44 (0) 203 709 5000
achillestx@consilium-comms.com (mailto: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 54 54
authorized,
issued and outstanding at December 31, 2023 and December 31, 2022,
respectively
Deferred shares, £92,452.00 par value, one share authorized, issued and 128 128
outstanding
at December 31, 2023 and December 31, 2022, respectively
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
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