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RNS Number : 9746K
Syncona Limited
10 May 2022
Syncona Limited
Achilles reports Q1 2022 Financial Results
10 May 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
first quarter ended March 31, 2022, 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 / 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 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 First Quarter 2022 Financial
Results and Recent Business Highlights
- Dosed first patient with higher-dose (Process 2) cNeT for
advanced NSCLC (CHIRON) and initiated enrollment of cNeT + PD-1
inhibitor combination (THETIS Cohort B) for metastatic malignant
melanoma -
- Expanded global manufacturing by increasing capacity in the UK
and establishing a US clinical manufacturing partnership -
- Strong cash balance of $237 million supports all planned
operations into 2H 2024 -
London, UK 10 May 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 first quarter ended March 31, 2022,
and recent business highlights.
"We recently dosed the first patient with our higher-dose cNeT
therapy in the CHIRON clinical trial for the treatment of advanced
non-small cell lung cancer ( NSCLC) and began enrollment in Cohort
B of the THETIS clinical trial evaluating cNeT in combination with
a PD-1 checkpoint inhibitor for the treatment of metastatic
malignant melanoma. We expect to report initial higher-dose
monotherapy data from both CHIRON and THETIS as well as initial
combination data from THETIS Cohort B in the second half of 2022,"
said Dr Iraj Ali, Chief Executive Officer of Achilles Therapeutics.
"We also expanded our global footprint, including increased
clinical manufacturing capacity in the United Kingdom and the
United States, where we have established a US headquarters in
Philadelphia that will house our first US R&D facility, to
further support our clinical programs. Overall, our unique approach
to targeting clonal neoantigens, differentiated ability to detect,
quantify and track our cNeT products, and strong balance sheet
continue to position us well to execute across our upcoming
value-creating catalysts."
Business Highlights
-- Dosed the first patient with higher-dose (Process 2) cNeT
monotherapy in the CHIRON clinical trial for advanced NSCLC.
-- Following a positive Independent Data Safety Monitoring
Committee review, initiated enrollment of THETIS Cohort B to
evaluate cNeT therapy in combination with a PD-1 checkpoint
inhibitor for the treatment of metastatic malignant melanoma .
-- Strengthened the Board of Directors with the addition of
independent member Bernhard Ehmer, MD.
-- Expanded global manufacturing by increasing capacity in the
United Kingdom with a GMP license obtained for the Cell & Gene
Therapy Catapult facility, and entered into a partnership agreement
for clinical manufacturing in the United States with the Center for
Breakthrough Medicines, a contract development and manufacturing
organization in King of Prussia, Pennsylvania.
-- Hosted a key opinion leader webcast highlighting important
data selected from the 31 posters and presentations on the TRACERx
study presented at the 2022 American Association for Cancer
Research Annual Meeting.
Financial Highlights
-- Cash and cash equivalents: Cash and cash equivalents were
$236.9 million as of March 31, 2022, as compared to $266.3 million
as of December 31, 2021. 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 $13.0 million for the first quarter ended March 31, 2022, as
compared to $8.9 million for the first quarter ended March 31,
2021. 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 $6.0 million for the first quarter ended March 31,
2022, as compared to $4.8 million for the first quarter ended March
31, 2021. 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 first quarter ended March 31,
2022, was $17.4 million or $0.45 per share compared to $13.8
million, or $8.38 per share for the first quarter ended March 31,
2021.
2022 Milestones and Upcoming Events
-- Higher-dose Monotherapy: Report initial data from the
higher-dose cohort of patients undergoing cNeT monotherapy for the
treatment of NSCLC and melanoma in the second half of 2022.
-- cNeT Combination: Dose first melanoma patient with cNeT in
combination with a PD-1 checkpoint inhibitor in Cohort B of the
THETIS clinical trial and report initial data in the second half of
2022.
-- Manufacturing: Begin clinical cNeT production at the Cell
& Gene Therapy Catapult facility in the second half of
2022.
-- Tumor Archiving Program: Initiate program in the second quarter of 2022.
Achilles will present at the following medical and investor
conferences in May 2022. Additional details will be available in
the Events & Presentations section of the Company's
website:
-- BofA Securities 2022 Healthcare Conference: May 9-13, 2022
-- H.C. Wainwright Global Investment Conference: May 23-26, 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 AI-Powered
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.
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 Virji, Melissa Gardiner
+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,
2022 2021
--------- --------------
ASSETS
Current assets:
Cash and cash equivalents $ 236,931 $ 266,319
Prepaid expenses and other current assets 22,118 18,430
-------- ----------
Total current assets 259,049 284,749
-------- ----------
Non-current assets:
Property and equipment, net 18,376 17,743
Operating lease right of use assets 11,070 11,048
Deferred tax assets 26 26
Restricted cash 33 33
Other assets 3,636 3,507
-------- ----------
Total non-current assets 33,141 32,357
-------- ----------
TOTAL ASSETS $ 292,190 $ 317,106
======== ==========
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 4,036 $ 3,722
Income taxes payable 15 -
Accrued expenses and other liabilities 9,131 10,906
Operating lease liabilities-current 4,670 4,482
-------- ----------
Total current liabilities 17,852 19,110
Non-current liabilities:
Operating lease liabilities-non-current 7,212 7,777
Other long-term liability 671 691
-------- ----------
Total non-current liabilities 7,883 8,468
-------- ----------
Total liabilities 25,735 27,578
-------- ----------
Commitments and contingencies (Note 12)
Shareholders' equity:
Ordinary shares, GBP0.001 par value; 40,754,227 and 40,603,489 shares
authorized, issued and
outstanding at March 31, 2022 and December 31, 2021, respectively 54 54
Deferred shares, GBP92,451.851 par value, one share authorized, issued and
outstanding at
March 31, 2022 and December 31, 2021 128 128
Additional paid in capital 403,780 401,821
Accumulated other comprehensive income (loss) (1,041) 6,636
Accumulated deficit (136,466) (119,111)
-------- ----------
Total shareholders' equity 266,455 289,528
-------- ----------
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 292,190 $ 317,106
======== ==========
ACHILLES THERAPEUTICS PLC
Condensed Consolidated Statements of Operations and
Comprehensive Loss (Unaudited)
(in thousands, except share and per share amounts)
Three Months Ended March 31,
--------------------------------
2022 2021
----------------- ------------
OPERATING EXPENSES:
Research and development $ 13,014 $ 8,876
General and administrative 5,955 4,832
------------- -----------
Total operating expenses 18,969 13,708
------------- -----------
Loss from operations (18,969) (13,708)
OTHER INCOME, NET:
Other income (expense) 1,629 (45)
------------- -----------
Total other income, net 1,629 (45)
------------- -----------
Loss before provision for income taxes (17,340) (13,753)
Provision for income taxes (15) (12)
------------- -----------
Net loss (17,355) (13,765)
------------- -----------
Other comprehensive income:
Foreign exchange translation adjustment (7,677) 2,063
------------- -----------
Comprehensive loss $ (25,032) $ (11,702)
------------- -----------
Net loss per share attributable to ordinary shareholders-basic and
diluted $ (0.45) $ (8.38)
============= ===========
Weighted average ordinary shares outstanding-basic and diluted 38,891,822 1,641,938
============= ===========
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