REG - Syncona Limited - Achilles reports Q4 and full year 2022 Results
07/03/2023 12:15
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RNS Number : 1724S Syncona Limited 07 March 2023
Syncona Limited
Achilles reports Q4 and full year 2022 Financial Results and Business
Highlights
07 March 2023
Syncona Ltd, a leading healthcare company focused on creating, building and
scaling a portfolio of global leaders in life science, notes that its
portfolio company, Achilles Therapeutics Plc (Nasdaq: ACHL) ("Achilles"),
announced its financial results for the fourth quarter and year-ended 31
December 2022, and an update on recent business highlights.
The announcement can be accessed on Achilles' website at:
https://ir.achillestx.com/ (https://ir.achillestx.com/) and the full text of
the announcement from Achilles is contained below.
ENDS
Enquiries
Syncona Ltd
Annabel Clark / Fergus Witt
Tel: +44 (0) 20 3981 7940
FTI Consulting
Ben Atwell / Natalie Garland-Collins / Julia Bradshaw / 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 a portfolio of global leaders in life science 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 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.
Achilles Therapeutics Reports Fourth Quarter and Year-End 2022 Financial
Results and Recent Business Highlights
- Demonstrated early proof-of-concept for cNeT therapy in heavily pre-treated
advanced NSCLC patients -
- Exhibited power of translational science platform by correlating
anti-tumor activity of cNeT with targeting of clonal neoantigens -
- Strong cash position of $173.3 million supports operations into mid-2025 -
London, UK 7 March 2023 - 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, 2022, and recent business highlights.
"In 2022, we were pleased to deliver early proof-of-concept data supporting
the promise of our clonal neoantigen-reactive T cell, or cNeT, therapy. We
presented data from a heavily pre-treated non-small cell lung cancer (NSCLC)
patient demonstrating sustained tumor reduction correlated with the durable
expansion of our cNeT product candidate. Importantly, these data link clonal
neoantigen target engagement to mechanism of action," said Dr Iraj Ali, Chief
Executive Officer of Achilles Therapeutics. "Looking ahead to 2023, we will
continue to dose more patients with higher cNeT doses to potentially drive
additional confirmed responses and expand the clinical data set in our NSCLC
and melanoma programs. Our financial position remains strong with $173 million
in cash, which supports operations into the middle of 2025, including the
completion of the ongoing Phase I/IIa trials."
"The increased manufacturing capacity from the addition of the Cell & Gene
Therapy Catapult site in Stevenage, U.K. has accelerated our overall dosing
capability. The additional data expected this year from the CHIRON lung cancer
monotherapy trial and the THETIS melanoma monotherapy and checkpoint
combination trial will expand our ability to identify patient and product
characteristics that impact clinical response using our translational science
platform. This differentiated capability to proactively influence product
attributes in the VELOS™ manufacturing process is a key benefit of cNeT
therapy that is not possible with a standard TIL product."
2022 and Year-to-Date 2023 Clinical Highlights
· Presented an interim Phase I/IIa update at the ESMO IO Congress in
December 2022 that highlighted early proof-of-concept data from 14 treated
patients, supporting durable clinical benefit of cNeT therapy that included
confirmed partial response and stable disease in heavily pre-treated patients
with advanced NSCLC
· Continued optimization of the up-front TIL extraction in the VELOS™
manufacturing process, resulting in improved TIL yields and increased cNeT
doses
· Dosed the first THETIS Cohort B patient (checkpoint combination) and
the first U.S. and French CHIRON patients
· Continued development and improvements of our PELEUS™ clonal
neoantigen prediction platform
2022 Corporate Highlights
· Expanded manufacturing capacity with the addition of the Cell &
Gene Therapy Catapult in the U.K. and entered into a partnership for future
manufacturing in the U.S.
· Granted U.S. patent 11,504,398 on immunotherapies targeting clonal
neoantigens identified by the Achilles Clonality Engine (ACE) including
vaccine, antibody, and autologous T cell therapy approaches
· Bolstered executive leadership with the appointment of James Taylor
as Chief Business Officer
(https://ir.achillestx.com/news-releases/news-release-details/achilles-therapeutics-appoints-james-taylor-chief-business)
· Strengthened Board of Directors with the appointment of Bernhard
Ehmer and expanded the Scientific Advisory Board with the appointments of
Cassian Yee, M.D., Alena Gros, Ph.D. and Ben Creelan, M.D.
(https://ir.achillestx.com/news-releases/news-release-details/achilles-therapeutics-appoints-bernhard-ehmer-board-directors)
· Achilles appointed leader of the Horizon Europe-funded
Consortium that was awarded a €4 million grant to advance personalized cell
therapy manufacturing
· Honored with a 2022 Cancer Research Horizon Innovation &
Entrepreneurship Award as the 'Startup Achievement of the Year' and the 2022
PING Innovation Award for the innovation demonstrated by the Company's work
with clonal neoantigens to treat solid tumors
Financial Highlights
· Cash and cash equivalents: Cash and cash equivalents were $173.3
million as of December 31, 2022, as compared to $266.3 million as of December
31, 2021. With increased focus on the ongoing Phase I/IIa CHIRON and THETIS
clinical trials and deprioritization of non-core activities, the Company
anticipates that its cash and cash equivalents are sufficient to fund its
planned operations into the middle of 2025. The decrease in cash and cash
equivalents in 2022 reflects an underlying use of $67.1 million for operating
activities and purchases of property and equipment, as well as a $25.9 million
foreign exchange effect as the Company retranslates cash and cash equivalents
at the prevailing U.S. dollar period rate. The Company's functional currency
and underlying cash and cash equivalents are mainly held in British pounds
sterling and translated into U.S. dollars for financial reporting.
· Research and development (R&D) expenses: R&D expenses were
$18.9 million for the fourth quarter ended December 31, 2022, an increase of
$7.1 million compared to $11.8 million for the fourth quarter ended December
30, 2021. R&D expenses were $57.3 million for the year ended December 31,
2022, an increase of $15.0 million compared to $42.2 million for the year
ended December 31, 2021. The increase was primarily driven by increased
activity related to our ongoing clinical trials, as well as spend associated
with expansion of our manufacturing capacity and enhancements to PELEUS(TM)
and VELOS(TM).
· General and administrative (G&A) expenses: G&A expenses were
$4.0 million for the fourth quarter ended December 31, 2022, a decrease of
$2.7 million compared to $6.7 million for December 31, 2021. G&A
expenses were $21.1 million for the year ended December 31, 2022, a decrease
of $0.9 million compared to the $22.0 million for the year ended December 31,
2021. 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, 2022 was
$24.1 million or $0.61 per share compared to $18.2 million or $0.45 per share
for the fourth quarter ended December 31, 2021. Net loss for the year ended
December 31, 2022 was $71.2 million or $1.82 per share compared to $61.1
million or $2.13 per share for the year ended December 31, 2021.
2023 Focus and Upcoming Events
· Clinical Data: Report clinical activity and translational science
data from 15 to 20 additional patients treated with cNeT monotherapy in NSCLC
and melanoma and with cNeT/anti-PD-1 checkpoint inhibitor combination in
melanoma
· 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 and improved
product design
· 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://ir.achillestx.com/events-and-presentations) section of the Company's
website:
· BioCapital Europe, Organized by EQT Life Sciences: March 9, 2023,
Amsterdam
· Oppenheimer 32(nd) Annual Healthcare Conference: March 14, 2023,
Virtual
· European Lung Cancer Congress (ELCC) 2023: March 29 - April 1, 2023,
Copenhagen
· Bio-Europe Spring: March 20-22, 2023, Basel
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. 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.
Investors:
Achilles Therapeutics
Lee M. Stern, VP, IR & External Communications
l.stern@achillestx.com (mailto:l.stern@achillestx.com)
LifeSci Advisors
John Mullaly
jmullaly@lifesciadvisors.com (mailto:jmullaly@lifesciadvisors.com)
Media:
Consilium Strategic Communications
Mary-Jane Elliott, Sukaina Virdi, Melissa Gardiner
+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,
2022 2021
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 173,338 $ 266,319
Prepaid expenses and other current assets 23,242 18,430
Total current assets 196,580 284,749
Property and equipment, net 12,399 17,743
Operating lease right of use assets 8,081 11,048
Deferred tax assets 251 26
Restricted cash 33 33
Other assets 3,014 3,507
Total non-current assets 23,778 32,357
Total assets $ 220,358 $ 317,106
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 5,187 $ 3,722
Income taxes payable 326 -
Accrued expenses and other liabilities 8,292 10,906
Operating lease liabilities - current 4,188 4,482
Total current liabilities 17,993 19,110
NON-CURRENT LIABILITIES:
Operating lease liabilities - non-current 4,388 7,777
Other long-term liability 933 691
Total non-current liabilities 5,321 8,468
Total liabilities 23,314 27,578
Commitments and contingencies
SHAREHOLDERS' EQUITY:
Ordinary shares, £0.001 par value; 40,932,727 and 40,603,489 shares 54 54
authorized, issued and outstanding at December 31, 2022 and 2021, respectively
Deferred shares, £92,452.00 par value, one share authorized, issued and 128 128
outstanding at December 31, 2022 and 2021, respectively
Additional paid in capital 408,844 401,821
Accumulated other comprehensive income (21,695) 6,636
Accumulated deficit (190,287) (119,111)
Total shareholders' equity 197,044 289,528
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 220,358 $ 317,106
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,
2022 2021 2022 2021
OPERATING EXPENSES:
Research and development $ 18,876 $ 11,807 $ 57,263 $ 42,224
General and administrative 3,958 6,653 21,120 21,971
Total operating expenses 22,834 18,460 78,383 64,195
LOSS FROM OPERATIONS: (22,834) (18,460) (78,383) (64,195)
OTHER INCOME (EXPENSE), NET:
Other income (expense) (1,181) 226 7,318 3,133
Total other income (expense), net (1,181) 226 7,318 3,133
Loss before income taxes (24,015) (18,234) (71,065) (61,062)
Benefit (provision) for income taxes (41) 4 (111) (37)
Net loss (24,056) (18,230) (71,176) (61,099)
Other comprehensive (loss) income:
Foreign exchange translation adjustment 16,795 886 (28,331) (5,686)
Comprehensive loss $ (7,261) $ (17,344) $ (99,507) $ (66,785)
Net loss per share attributable to ordinary shareholders-basic and diluted $ (0.61) $ (0.45) $ (1.82) $ (2.13)
Weighted average ordinary shares outstanding-basic and diluted 39,518,910 40,245,543 39,139,693 28,654,760
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