TIDMSYNC
RNS Number : 4254V
Syncona Limited
09 August 2022
Syncona Limited
Achilles reports Q2 2022 Financial Results and Business
Highlights
09 August 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 second quarter ended June 30, 2022, and an update on recent
business highlights.
Key highlights from the announcement include:
-- Achilles expects to provide initial data from the higher dose
clinical cohorts of the Phase I/IIa clinical trials of its clonal
neoantigen-reactive T cell (cNeT) therapy in non-small cell lung
cancer (NSCLC) and melanoma in Q4 CY2022
-- The company's manufacturing facility at the Cell and Gene
Therapy Catapult has been approved by the UK Medicines and
Healthcare products Regulatory Agency to produce cNeT products to
support its ongoing Phase I/IIa clinical trials in NSCLC and
melanoma, significantly increasing Achilles' manufacturing
capacity
-- Cash balance of $202 million to support all planned
operations into Q2 CY2025, including completion of its ongoing
Phase I/IIa clinical trials
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
Annabel Clark / Natalie Garland-Collins / Fergus Witt
Tel: +44 (0) 20 3981 7940
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 Second Quarter 2022 Financial
Results and Recent Business Highlights
- Additional clinical data from the ongoing Phase I /IIa trials
in advanced NSCLC (CHIRON) and melanoma (THETIS) expected to be
available in Q4 2022 -
- Cell & Gene Therapy Catapult manufacturing facility
approved by MHRA for cNeT production in CHIRON and THETIS clinical
trials -
- Strong cash balance of $202 million supports all planned
operations into Q2 2025 -
London, UK 9 August 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 second quarter ended June 30, 2022,
and recent business highlights.
"We remain focused on advancing our lead clinical programs,
evaluating cNeT monotherapy in CHIRON for advanced non-small cell
lung cancer (NSCLC), and exploring both cNeT monotherapy and the
combination with a PD-1 checkpoint inhibitor in THETIS for
recurrent or metastatic malignant melanoma. We expect initial
activity, safety and translational science data in the fourth
quarter of this year from patients receiving higher-dose cNeT
products," said Dr Iraj Ali, Chief Executive Officer of Achilles
Therapeutics. "We are very pleased that the UK Medicines and
Healthcare products Regulatory Agency (MHRA) has now approved
Achilles' Cell and Gene Therapy Catapult Manufacturing Centre
(Catapult) site to produce cNeT products in the ongoing CHIRON and
THETIS clinical trials, significantly increasing our manufacturing
capacity for 2022 and beyond."
Business Highlights
-- On track to present additional clinical data in Q4 2022 from
the ongoing Phase I/IIa CHIRON and THETIS clinical trials in
patients with advanced NSCLC and recurrent or metastatic melanoma,
respectively.
-- Expanded global manufacturing capacity with the MHRA approval
of Achilles' Catapult facility for cNeT production in CHIRON and
THETIS 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, PA.
-- Awarded a EUR4 million ($4.2 million(1) ) research and
innovation award as part of a consortium to develop a
first-in-class smart bioprocessing manufacturing platform, with
EUR1.4 million ($1.5 million(1) ) allocated to Achilles.
-- Initiated the tumor archiving program (TAP) to study the
potential of producing cNeT from tumor material collected and
stored earlier in disease progression.
-- Strengthened the Company's leadership with the following
appointments: Bernhard Ehmer to the Board of Directors, James
Taylor as Chief Business Officer, and Cassian Yee, MD to the
Scientific Advisory Board.
-- Received the 2022 Pharmaceutical Industry Network Group
(PING) Innovation Award, acknowledging the innovation demonstrated
by the Company's work with clonal neoantigens to treat solid
tumors, including the Company's AI-powered PELEUS(TM)
bioinformatics platform and proprietary VELOS(TM) manufacturing
process.
Financial Highlights
-- Cash and cash equivalents: Cash and cash equivalents were
$201.6 million as of June 30, 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 quarter of 2025, including completion of the ongoing
Phase I/IIa CHIRON and THETIS clinical trials.
-- Research and development (R&D) expenses: R&D expenses
were $14.8 million for the second quarter ended June 30, 2022, as
compared to $10.8 million for the second quarter ended June 30,
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 $5.8 million for the second quarter ended June 30,
2022, as compared to $5.4 million for the second quarter ended June
30, 2021. The increase was primarily driven by an increase in
headcount and related personnel costs.
-- Net loss: Net loss for the second quarter ended June 30,
2022, was $17.3 million or $0.44 per share compared to $16.2
million, or $0.45 per share for the second quarter ended June 30,
2021.
Achilles will participate in the following investor and medical
conferences in August and September 2022. Additional details will
be available in the Events & Presentations section of the
Company's website:
-- BTIG Biotechnology Conference 2022: August 8 - 9, 2022
-- Phacilitate Advanced Therapies Europe: August 31 - September 1, 2022
-- H.C. Wainwright Annual Global Investment Conference: September 12 - 14, 2022
-- Cantor Fitzgerald's Cell & Genetic Medicines Conference: September 15, 2022
-- Immuno UK: September 29 - 30, 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.
(1) June 30, 2022 exchange rate of EUR1.000 = $1.043
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)
June 30, December 31,
2022 2021
--------- --------------
ASSETS
Current assets:
Cash and cash equivalents $ 201,595 $ 266,319
Prepaid expenses and other current assets 25,985 18,430
-------- ----------
Total current assets 227,580 284,749
-------- ----------
Non-current assets:
Property and equipment, net 17,626 17,743
Operating lease right of use assets 9,470 11,048
Deferred tax assets 26 26
Restricted cash 33 33
Other assets 2,983 3,507
-------- ----------
Total non-current assets 30,138 32,357
-------- ----------
TOTAL ASSETS $ 257,718 $ 317,106
======== ==========
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 6,651 $ 3,722
Income taxes payable 18 -
Accrued expenses and other liabilities 8,720 10,906
Operating lease liabilities-current 4,480 4,482
-------- ----------
Total current liabilities 19,869 19,110
Non-current liabilities:
Operating lease liabilities-non-current 5,640 7,777
Other long-term liability 621 691
-------- ----------
Total non-current liabilities 6,261 8,468
-------- ----------
Total liabilities 26,130 27,578
-------- ----------
Commitments and contingencies (Note 12)
Shareholders' equity:
Ordinary shares, GBP0.001 par value; 40,774,014 and 40,603,489 shares
authorized, issued and outstanding at June 30, 2022 and
December 31, 2021, respectively 54 54
Deferred shares, GBP92,451.851 par value, one share authorized, issued
and outstanding at June 30, 2022 and December 31, 2021 128 128
Additional paid in capital 405,504 401,821
Accumulated other comprehensive (loss) income (20,343) 6,636
Accumulated deficit (153,755) (119,111)
-------- ----------
Total shareholders' equity 231,588 289,528
-------- ----------
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 257,718 $ 317,106
======== ==========
A CHILLES THERAPEUTICS PLC
Condensed Consolidated Statements of Operations and
Comprehensive Loss (Unaudited)
(in thousands, except share and per share amounts)
Three Months Ended June 30, Six Months Ended June 30,
------------------------------- -----------------------------
2022 2021 2022 2021
---------------- ------------ --------------- -----------
OPERATING EXPENSES:
Research and development $ 14,776 $ 10,844 $ 27,790 $ 19,720
General and administrative 5,770 5,445 11,725 10,277
------------ ----------- ----------- ----------
Total operating expenses 20,546 16,289 39,515 29,997
------------ ----------- ----------- ----------
Loss from operations (20,546) (16,289) (39,515) (29,997)
OTHER INCOME, NET:
Other income 3,271 146 4,900 101
------------ ----------- ----------- ----------
Total other income, net 3,271 146 4,900 101
------------ ----------- ----------- ----------
Loss before provision for income
taxes (17,275) (16,143) (34,615) (29,896)
Provision for income taxes (14) (13) (29) (25)
------------ ----------- ----------- ----------
Net loss (17,289) (16,156) (34,644) (29,921)
------------ ----------- ----------- ----------
Other comprehensive income:
Foreign exchange translation
adjustment (19,302) (925) (26,979) 1,138
------------ ----------- ----------- ----------
Comprehensive loss $ (36,591) $ (17,081) $ (61,623) $ (28,783)
------------ ----------- ----------- ----------
Net loss per share attributable
to ordinary shareholders-basic
and diluted $ (0.44) $ (0.45) $ (0.89) $ (1.60)
============ =========== =========== ==========
Weighted average ordinary shares
outstanding-basic and diluted 39,104,375 35,683,187 38,998,686 18,756,599
============ =========== =========== ==========
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