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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/ and the full text of the announcement
from Achilles is contained below.
[S]
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(TM), 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 , February 2022) and Julie O'Neill and Markwin
Velders, Ph.D. ( Press Release , May 2021)
-- Added to the NASDAQ Biotechnology Index ( Press Release ,
December 2021) and the ICE Biotechnology Index
-- Presented data at the ESMO I-O Congress on VELOS Process 2
manufacturing ( Press Release , 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 , April 2021) and SITC
Annual Meetings ( Press Release , 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 , 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
, August 2021)
-- Raised gross proceeds of $175.5 million in an initial public
offering ( Press Release , 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 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 360deg: 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(TM)
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
LifeSci Advisors
John Mullaly
jmullaly@lifesciadvisors.com
Media:
Consilium Strategic Communications
Mary-Jane Elliott, Sukaina Virdi, Melissa Gardiner
+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,
---------------------
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, GBP0.001 par value; 40,603,489 and 4,389,920 shares
authorized,
issued and outstanding at December 31,2021 and 2020, respectively 54 6
Deferred shares, GBP92,451.851 par value, one share authorized, issued
and outstanding at December 31, 2021; Deferred shares, GBP0.001 par
value; 30,521 shares issued and outstanding at December 31,2020 128 -
Convertible preferred shares, GBP0.001 par value; no shares authorized,
issued and outstanding as of December 31, 2021; 104,854,673 shares
authorized, issued and outstanding at December 31, 2020 - 134
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
------------------------- ------------------------- -------------------------- -------------------------
(18, 460 (64, 195
LOSS FROM OPERATIONS: ) (12,919) ) (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 (18, 230
loss ) (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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