REG - Syncona Limited - Achilles reports Full Year 2021 Results
01/03/2022 13:00
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RNS Number : 2158D Syncona Limited 01 March 2022
Syncona Limited
Achilles reports Full Year 2021 Financial Results
01 March 2022
Syncona Ltd, a leading healthcare company focused on founding, building and
funding 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 full year 2021 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
Natalie Garland-Collins / Fergus Witt
Tel: +44 (0) 7714 916615
FTI Consulting
Ben Atwell / 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
founding 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 found, build and fund companies around exceptional science
to create a diversified portfolio of 15-20 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 2021 Financial
Results and Recent Business Highlights
- Patient data from higher dose cNeT as monotherapy and cNeT in combination
with checkpoint inhibitor expected in 2H 2022 -
- Strong cash position of $266 million supports clinical development and
manufacturing expansion into 2H 2024 -
London, UK 1 March 2022 - Achilles Therapeutics plc (NASDAQ: ACHL), a
clinical-stage biopharmaceutical company developing precision T cell therapies
to treat solid tumors, today announced its financial results for the fourth
quarter and year-ended December 31, 2021, and recent business highlights.
"In 2021, we generated clinical data demonstrating the unique ability of our T
cell platform to detect, quantify and track our clonal neoantigen-reactive T
cells, or cNeT, in vivo, giving us the analytical platform to elucidate the
mechanism of action of our cNeT product. cNeT dose is now being used in our
clinical trials as a release parameter, highlighting our differentiated
potential to develop potency assays that we believe are essential for the
successful development and regulatory approval of TIL-based therapies," said
Dr Iraj Ali, Chief Executive Officer of Achilles Therapeutics. "In the year
ahead, we will build on the important learnings from our first cohort of
patients by evaluating higher doses of our tumor-targeting cNeT therapies
alone and in combination with a checkpoint inhibitor. We look forward to
clinical readouts in our CHIRON and THETIS trials for non-small cell lung
cancer and melanoma, respectively, including 6-week clinical activity and
engraftment data in the second half of 2022.
Our unique ability to prospectively target and track clonal neoantigens is
possible through PELEUS™, our proprietary bioinformatics platform. PELEUS
was built on an advanced statistical framework to differentiate clonal from
subclonal mutations and is further enhanced using Artificial Intelligence in a
range of applications, including neoantigen prioritization. PELEUS is
validated through our exclusive access to the landmark TRACERx clinical study
of tumor evolution, which provides the extensive longitudinal sequencing data
of over 3,200 tumor samples that have been collected over five years from over
795 patients. The detailed genomic analysis from PELEUS allows us to identify
the unique clonal neoantigens of each patient. These clonal neoantigens are
protein markers that are present on all of an individual's cancer cells but
are absent from healthy tissue, making them ideal cancer targets. With this
information, our VELOS manufacturing process uses the natural biology of
dendritic cell antigen presentation to select and expand the T cells that are
able to recognize the clonal neoantigen targets present in a patient's tumor.
With these powerful, proprietary tools and our forthcoming clinical data, we
are well-positioned to advance our precision T cell therapy.
We expect to continue to expand our global footprint with increased
manufacturing capacity in the U.K., continued addition of clinical sites, and
establishment of our U.S. headquarters in Philadelphia which will house our
first U.S. R&D facility. With the capital raised in our successful IPO in
April 2021, we have $266 million in cash and cash equivalents to support the
clinical development of our cNeT therapy in melanoma, non-small cell lung
cancer, head and neck cancer, and other indications into the second half of
2024."
2021 Business Highlights and Recent Updates
· Established a U.S. headquarters in Philadelphia, PA which will
include an R&D facility
· Strengthened the Scientific Advisory Board and Board of Directors
with appointments of Alena Gros, Ph.D. and Ben Creelan, M.D. (Press Release
(https://ir.achillestx.com/news-releases/news-release-details/achilles-therapeutics-strengthens-scientific-advisory-board)
, February 2022) and Julie O'Neill and Markwin Velders, Ph.D. (Press Release
(https://ir.achillestx.com/news-releases/news-release-details/achilles-therapeutics-appoints-julie-oneill-board-directors-and)
, May 2021)
· Added to the NASDAQ Biotechnology Index (Press Release
(https://ir.achillestx.com/news-releases/news-release-details/achilles-therapeutics-added-nasdaq-biotechnology-index)
, December 2021) and the ICE Biotechnology Index
· Presented data at the ESMO I-O Congress on VELOS Process 2
manufacturing (Press Release
(https://ir.achillestx.com/news-releases/news-release-details/achilles-therapeutics-presents-positive-data-esmo-i-o-congress)
, December 2021) highlighting a median dose of 200m cNeT in pre-clinical GMP
runs, more than a 10-fold increase over the median dose manufactured with
Process 1
· Presented data at AACR (Press Release
(https://ir.achillestx.com/news-releases/news-release-details/achilles-therapeutics-demonstrates-cnet-product-characterization)
, April 2021) and SITC Annual Meetings (Press Release
(https://ir.achillestx.com/news-releases/news-release-details/achilles-therapeutics-presents-data-society-immunotherapy-cancer)
, November 2021) showing the detection, quantification and tracking of
patient-specific cNeT
· Received regulatory approval for the use of VELOS Process 2
manufacturing in the UK, France, Germany, and Spain in November 2021
· Presented details of the Material Acquisition Platform (MAP) at the
2021 ESGCT Congress, supporting the potential use of cNeT in a broad range of
solid tumor indications (Press Release
(https://ir.achillestx.com/news-releases/news-release-details/achilles-therapeutics-presents-data-2021-european-society-gene)
, October 2021)
· Expanded the Company's intellectual property estate, including the
grant of US and European patents supporting the approach of targeting clonal
neoantigens that are identified with the proprietary
PELEUS(TM) bioinformatics platform (Press Release
(https://ir.achillestx.com/news-releases/news-release-details/achilles-therapeutics-announces-grant-us-and-european-patents)
, August 2021)
· Raised gross proceeds of $175.5 million in an initial public offering
(Press Release
(https://ir.achillestx.com/news-releases/news-release-details/achilles-therapeutics-announces-closing-1755-million-initial)
, April 2021)
Financial Highlights
· Cash and cash equivalents: Cash and cash equivalents were $266.3
million as of December 31, 2021, as compared to $177.8 million as of December
31, 2020. The Company anticipates that its cash and cash equivalents are
sufficient to fund its planned operations into the second half of 2024,
including full funding of the ongoing Phase I/IIa CHIRON and THETIS clinical
trials
· Research and development (R&D) expenses: R&D expenses were
$11.8 million for the fourth quarter ended December 31, 2021, an increase of
$2.8 million compared to $9.0 million for the fourth quarter ended December
30, 2020. R&D expenses were $42.2 million for the year ended December 31,
2021, an increase of $19.6 million compared to $22.6 million for the year
ended December 31, 2020. The increase was primarily driven by increased
activity related to our ongoing clinical trials and overall R&D
· General and administrative (G&A) expenses: G&A expenses were
$6.7 million for the fourth quarter ended December 31, 2021, an increase of
$2.7 million compared to $4.0 million for December 31, 2020. G&A expenses
were $22.0 million for the year ended December 31, 2021, an increase of $10.9
million compared to the $11.1 million for the year ended December 31, 2020.
The increase was primarily driven by fees associated with the Company's public
company obligations, and an increase in headcount and related personnel costs
· Net loss: Net loss for the fourth quarter ended December 31, 2021 was
$18.2 million or $0.45 per share compared to $12.9 million or $9.32 per share
for the fourth quarter ended December 31, 2020. Net loss for the year ended
December 31, 2021 was $61.1 million or $2.13 per share compared to $33.2
million or $31.14 per share for the year ended December 31, 2020. The decrease
in loss per share is due in part to the increased number of shares following
the conversion and issuance of shares from the IPO
2022 Milestones and Upcoming Events
· Patient Dosing: Dose first patients with higher dose (Process 2) cNeT
monotherapy and cNeT in combination with a PD-1 inhibitor in 2Q 2022
· Higher-dose Monotherapy: Report additional patient data from
higher-dose cohort (Process 2) of cNeT monotherapy for the treatment of NSCLC
and melanoma in 2H 2022
· cNeT Combination: Report initial patient data from cNeT in
combination with a PD-1 inhibitor for the treatment of melanoma in 2H 2022
· Manufacturing Expansion: Increase manufacturing capacity in the
United Kingdom with GMP licensure of the Cell & Gene Therapy Catapult
facility in 2Q 2022
· Tumor Archiving Program: Initiate program in 1H 2022
Achilles will present at the 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 LSP: March 10, 2022
· Oppenheimer 32(nd) Annual Healthcare Conference: March 15 - 16, 2022
· Immuno-Oncology 360°: March 16 - 18, 2022
About Achilles Therapeutics
Achilles is a clinical-stage biopharmaceutical company developing 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.
Contacts:
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,
2021 2020
ASSETS
Current assets:
Cash and cash equivalents 266,319 $ 177,849
Prepaid expenses and other current assets 18,430 9,948
Total current assets 284,749 187,797
Non-current assets:
Property and equipment, net 17,743 13,369
Operating lease right of use assets 11,048 14,740
Deferred tax assets 26 4
Restricted cash 33 -
Other assets 3,507 3,008
Total non-current assets 32,357 31,121
TOTAL ASSETS $ 317,106 $ 218,918
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 3,722 $ 6,314
Income taxes payable - 7
Accrued expenses and other liabilities 10,906 6,590
Operating lease liabilities-current 4,482 3,712
Total current liabilities 19,110 16,623
Non-current liabilities:
Operating lease liabilities-non-current 7,777 12,271
Other long-term liability 691 652
Total non-current liabilities 8,468 12,923
Total liabilities 27,578 29,546
Commitments and contingencies
Shareholders' equity:
Ordinary shares, £0.001 par value; 40,603,489 and 4,389,920 shares 54 6
authorized,
issued and outstanding at December 31,2021 and 2020, respectively
Deferred shares, £92,451.851 par value, one share authorized, issued 128 -
and outstanding at December 31, 2021; Deferred shares, £0.001 par
value; 30,521 shares issued and outstanding at December 31,2020
Convertible preferred shares, £0.001 par value; no shares authorized, - 134
issued and outstanding as of December 31, 2021; 104,854,673 shares
authorized, issued and outstanding at December 31, 2020
Additional paid in capital 401,821 234,922
Accumulated other comprehensive income 6,636 12,322
Accumulated deficit (119,111 ) (58,012 )
Total shareholders' equity 289,528 189,372
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 317,106 $ 218,918
ACHILLES THERAPEUTICS PLC
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
Three Months Ended Twelve Months Ended
December 31, December 31,
2021 2020 2021 2020
OPERATING EXPENSES:
Research and development $11,807 $ 8,961 $ 42,224 $ 22,629
General and administrative 6,653 3,958 21,971 11,098
Total operating expenses 18,460 12,919 64,195 33,727
LOSS FROM OPERATIONS: (18,460) (12,919) (64,195) (33,727)
OTHER INCOME (EXPENSE), NET:
Other income (expense) 226 2 3,133 531
Total other income (expense), net 226 2 3,133 531
Loss before income taxes (18,234) (12,917) (61,062) (33,196)
Benefit (provision) for income taxes 4 (3) (37) (3)
Net loss (18,230) (12,920) (61,099) (33,199)
Other comprehensive (loss) income:
Foreign exchange translation adjustment 886 7,301 (5,686) 4,213
Comprehensive loss $ (17,344) $ (5,619) $ (66,785) $ (28,986)
Net loss per share attributable to ordinary shareholders-basic and diluted $ (0.45) $ (9.32) $ (2.13) $ (31.14)
Weighted average ordinary shares outstanding-basic and diluted 40,245,543 1,386,221 28,654,760 1,066,208
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