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RNS Number : 8343R
Syncona Limited
09 November 2021
Syncona Limited
Achilles reports Third Quarter 2021 Financial Results
9 November 2021
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
third quarter ended September 30, 2021 and 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. In addition, the Company will
host a live webcast and conference call on Friday, November 12,
2021 at 1:30pm GMT to review the SITC presentations and provide a
corporate update. The live webcast can be accessed in the Events
& Presentations section of the Company's website.
[S]
Enquiries
Syncona Ltd
Annabel Clay / Fergus Witt
Tel: +44 (0) 20 3981 7940
FTI Consulting
Ben Atwell / Natalie Garland-Collins / 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 Third Quarter 2021 Financial
Results and Recent Business Highlights
- Oral Presentation at European Society for Gene and Cell
Therapy (ESGCT) demonstrated ability to generate potent anti-cancer
cell therapy candidates in multiple solid tumor types -
- Society for Immunotherapy of Cancer ( SITC) abstracts
highlight the ability to detect, quantify and track
patient-specific cNeT and generate increased cNeT doses from
VELOS(TM) Process 2 manufacturing -
- Conference call and webcast scheduled for Friday, November 12,
2021 at 8:30am ET to review SITC presentations and provide a
corporate update -
London, UK 09 November 2021 - 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 third quarter ended September 30,
2021, and recent business highlights.
"We have continued to make good progress during the third
quarter and will share an update from the first eight patients
across our CHIRON (non-small cell lung cancer, or NSCLC) and THETIS
(melanoma) studies at the upcoming SITC meeting. Our unique ability
to accurately quantify the tumor reactive component of each product
and to track clonal neoantigen reactive T cells (cNeT) in the
patients post-dosing is possible through the detailed genomic
analysis of the tumor and prospective clonal neoantigen targeting
afforded by our proprietary bioinformatics platform. We believe
this best-in-class analytical capability will be critical for the
successful development of TIL-based therapies," said Dr Iraj Ali,
Chief Executive Officer of Achilles. "At SITC, we will also share
details of our VELOS(TM) Process 2 manufacturing, which is able to
routinely generate significantly higher doses of cNeT than our
current Process 1. We will present further GMP scale data from
VELOS Process 2 at the upcoming ESMO Immuno-Oncology Congress
taking place December 8-11, 2021."
Business Highlights
-- Two abstracts for the SITC 36th Annual Meeting were published
today - Poster 543, underscoring the ability to sensitively detect,
quantify and track patient-specific cNeT during manufacture and
post dosing, and Poster 193, highlighting our ability to generate
increased doses of reactive cNeT from VELOS Process 2
-- Delivered an oral presentation at the 2021 European Society
for Gene and Cell Therapy (ESGCT) Congress entitled, "Multicentre,
prospective research protocol for development of a clonal
neoantigen-reactive T cell therapy pipeline across multiple tumour
types" highlighting the Company's Material Acquisition Platform
(MAP) and supporting the potential use of cNeT in a broad range of
solid tumor indications
-- Granted US patent US 11,098,121 and European patent
EP3347039B covering a method of identifying cancer patients that
are likely to respond to a checkpoint inhibitor (CPI) by
determining the total number of clonal neoantigens or the ratio of
clonal to sub-clonal neoantigens in patients' cancer cells
-- Enrolled the first patient in the United States at the
Moffitt Cancer Center in the Phase I/IIa CHIRON clinical trial
-- In-licensed from Secarna Pharmaceuticals GmbH & Co
antisense oligonucleotide technology and intellectual property for
the ex vivo manufacture of a T cell pharmaceutical product
Financial Highlights
-- Cash and cash equivalents: Cash and cash equivalents were
$281.9 million as of September 30, 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 2023, including full funding of
the ongoing Phase I/IIa CHIRON and THETIS clinical trials
-- Research and development (R&D) expenses: R&D expenses
were $10.7 million for the third quarter ended September 30, 2021,
an increase of $5.4 million compared to $5.3 million for the third
quarter ended September 30, 2020. R&D expenses were $30.4
million for the nine months ended September 30, 2021, an increase
of $16.7 million compared to $13.7 million for the nine months
ended September 30, 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 $5.0 million for the third quarter ended September
30, 2021, an increase of $2.0 million compared to $3.0 million for
the third quarter ended September 30, 2020. G&A expenses were
$15.3 million for the nine months ended September 30, 2021, an
increase of $8.2 million compared to the $7.1 million for the nine
months ended September 30, 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 third quarter ended September 30,
2021 was $12.9 million or $0.34 per share compared to $8.2 million
or $7.50 per share for the third quarter ended September 30, 2020.
Net loss for the nine months ended September 30, 2021 was $42.9
million or $1.69 per share compared to $20.3 million or $21.16 per
share for the nine months ended September 30, 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
Upcoming Events
Achilles will present at the following medical and investor
conferences in November and December 2021. Additional details will
be available in the Events & Presentations section of the
Company's website:
-- Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting: November 10 - 14, 2021
-- Piper Sandler Annual Healthcare Conference: November 29 - December 2, 2021
-- ESMO Immuno-Oncology Congress 2021: December 8 - 11, 2021
In addition, the Company will host a live webcast and conference
call on Friday, November 12, 2021 at 8:30am ET / 1:30pm UK to
review the SITC presentations and provide a corporate update. The
live webcast can be accessed in the Events & Presentations
section of the Company's website. The conference call dial-in
numbers for investors and analysts are (833) 732-1204 (toll free
within the USA), 0800 0288438 (toll free within the United Kingdom)
or (720) 405-2169 (outside the USA) with the access code
4795875.
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.
Further information:
Lee M. Stern - VP, IR & External Communications
+1 (332) 373-2634
l.stern@achillestx.com
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)
September 30, December 31,
2021 2020
--------------- --------------
ASSETS
Current assets:
Cash and cash equivalents $ 281,875 $ 177,849
Prepaid expenses and other current assets 16,401 9,948
----------- ----------
Total current assets 298,276 187,797
----------- ----------
Non-current assets:
Property and equipment, net 16,378 13,369
Operating lease right of use assets 11,938 14,740
Deferred tax assets 4 4
Restricted cash 33 -
Other assets 3,370 3,008
----------- ----------
Total non-current assets 31,723 31,121
----------- ----------
TOTAL ASSETS $ 329,999 $ 218,918
=========== ==========
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 2,460 $ 6,314
Income taxes payable 36 7
Accrued expenses and other liabilities 8,472 6,590
Operating lease liabilities-current 4,398 3,712
----------- ----------
Total current liabilities 15,366 16,623
Non-current liabilities:
Operating lease liabilities-non-current 8,881 12,271
Other long-term liability 643 652
----------- ----------
Total non-current liabilities 9,524 12,923
----------- ----------
Total liabilities 24,890 29,546
----------- ----------
Commitments and contingencies (Note 12)
Shareholders' equity:
Ordinary shares, GBP0.001 par value; 40,603,489 and 4,389,920 shares
authorized, issued and outstanding at September 30, 2021 and December
31, 2020, respectively 54 6
Deferred shares, GBP92,451.851 par value, one share authorized, issued and
outstanding at September 30, 2021; Deferred shares, GBP0.001 par value;
30,521 shares issued and outstanding December 31, 2020 128 -
Convertible preferred shares, GBP0.001 par value; no shares authorized,
issued and outstanding as of September 30, 2021;104,854,673 shares
authorized, issued and outstanding at December 31, 2020 - 134
Additional paid in capital 400,058 234,922
Accumulated other comprehensive income 5,750 12,322
Accumulated deficit (100,881) (58,012)
----------- ----------
Total shareholders' equity 305,109 189,372
----------- ----------
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 329,999 $ 218,918
=========== ==========
(expressed in U.S. Dollars, unless otherwise stated)
ACHILLES THERAPEUTICS PLC
Condensed Consolidated Statements of Operations and
Comprehensive Loss (Unaudited)
(in thousands, except share and per share amounts)
Three Months Ended September 30, Nine Months Ended September 30,
------------------------------------ -------------------------------------
2021 2020 2021 2020
------------------- -------------- -------------------- -----------
OPERATING EXPENSES:
Research and
development $ 10,697 $ 5,291 $ 30,417 $ 13,668
General and
administrative 5,041 3,009 15,318 7,140
--------------- ------------- ---------------- ----------
Total operating
expenses 15,738 8,300 45,735 20,808
--------------- ------------- ---------------- ----------
Loss from operations (15,738) (8,300) (45,735) (20,808)
OTHER INCOME, NET:
Other income 2,806 90 2,907 529
--------------- ------------- ---------------- ----------
Total other
income, net 2,806 90 2,907 529
--------------- ------------- ---------------- ----------
Loss before provision
for income taxes (12,932) (8,210) (42,828) (20,279)
Provision for
income taxes (16) - (41) -
--------------- ------------- ---------------- ----------
Net loss (12,948) (8,210) (42,869) (20,279)
--------------- ------------- ---------------- ----------
Other comprehensive
income:
Foreign exchange
translation
adjustment (7,710) 3,501 (6,572) (3,088)
--------------- ------------- ---------------- ----------
Comprehensive loss $ (20,658) $ (4,709) $ (49,441) $ (23,367)
--------------- ------------- ---------------- ----------
Net loss per share
attributable to
ordinary
shareholders-basic
and diluted $ (0.34) $ (7.50) $ (1.69) $ (21.16)
=============== ============= ================ ==========
Weighted average
ordinary shares
outstanding-basic
and diluted 38,261,480 1,094,543 25,329,672 958,373
=============== ============= ================ ==========
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END
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