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04/08/2023 12:15
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RNS Number : 3674I Syncona Limited 04 August 2023
Syncona Limited
Achilles reports Q2 2023 Financial Results and Business Highlights
04 August 2023
Syncona Ltd, a leading healthcare company focused on creating, building and
scaling 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 30 June, 2023,
and an update on recent business highlights.
Key highlights included:
· Clinical and translational science data expected from 15 to 20
additional patients in the Phase I/IIa clinical trials in advanced non-small
cell lung cancer (NSCLC) and melanoma in Q4 2023
· Presented data on the neoRanker(TM) tool, a new module of
Achilles' proprietary AI-powered PELEUS™ platform which has the potential to
support the application of the platform in other modalities such as cancer
vaccines
· Strong cash position of $143.7 million supports operations
through 2025
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
Annabel Clark / Fergus Witt
Tel: +44 (0) 20 3981 7940
FTI Consulting
Ben Atwell / Natalie Garland-Collins / 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
creating 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 create, build and scale companies around exceptional
science to create a diversified portfolio of 20-25 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 2023 Financial Results and Recent
Business Highlights
- Clinical and translational science data expected in the fourth quarter of
2023 from the ongoing Phase I/IIa trials in NSCLC and melanoma -
- neoRanker(TM) immunogenicity prediction module of PELEUS™ increases the
likelihood of identifying multiple memory T cell responses -
- Strong cash position of $144 million supports operations through 2025 -
London, UK 4 August 2023 - Achilles Therapeutics plc (NASDAQ: ACHL), a
clinical-stage biopharmaceutical company developing AI-powered precision T
cell therapies targeting clonal neoantigens to treat solid tumors, today
announced its financial results for the quarter ended June 30, 2023, and
recent business highlights.
"We look forward to additional clinical data in the fourth quarter of this
year from our clonal neoantigen-reactive T cell (cNeT) therapy for the
treatment of advanced NSCLC (CHIRON) and metastatic malignant melanoma
(THETIS) and are encouraged by the improved manufacturing performance of our
VELOS™ Process 2," said Dr Iraj Ali, Chief Executive Officer of Achilles
Therapeutics. "We are also very excited about the developments in our
AI-driven bioinformatics platform PELEUS(TM). PELEUS uses a unique
multi-region approach to provide validated and accurate identification of
personalized clonal neoantigens. Our newly developed neoRanker(TM) tool is
trained on a proprietary dataset of over 10,000 neoantigens and we calculate
that it is potentially twice as good at identifying multiple memory T cell
responses than existing deep-learning models. We believe this could be highly
differentiated in the design of neoantigen vaccines and further strengthens
our leadership position in the field of neoantigen identification."
Business Highlights
· Introduced and presented data at the 7th Annual Immuno-Oncology
Summit Europe on the neoRanker(TM) tool, Achilles Therapeutics' new
immunogenicity prediction module of the AI-Powered PELEUS™ platform that
uniquely identifies the most potent clonal neoantigens. The new AI module
demonstrated potential superiority to commonly used AI tools (BigMHC) in
identifying and prioritizing targets for personalized antigen approaches,
supporting potential implementation into the Company's ongoing TIL-based
clinical programs in advanced non-small cell lung cancer (NSCLC) and melanoma,
and into other modalities including clonal neoantigen cancer vaccines
· US patent number 11,634,773 granted on technology exclusively
licensed by Achilles from the Francis Crick Institute, University College
London, and Cancer Research Horizons, for selecting neoantigens that are
presented by HLA molecules determined to be present in a patient's tumor
· Regained compliance with the minimum bid price requirement of Nasdaq
Listing Rule 5450(a)(1) on July 28, 2023, as confirmed by a written notice
received from the Listing Qualifications Department of The Nasdaq Stock
Market on July 31, 2023
Financial Highlights
· Cash and cash equivalents: Cash and cash equivalents were $143.7
million as of June 30, 2023, as compared to $173.3 million as of December 31,
2022. The Company anticipates that its cash and cash equivalents are
sufficient to fund its planned operations through 2025.
· Research and development (R&D) expenses: R&D expenses were
$13.8 million for the second quarter ended June 30, 2023, a decrease of $1.0
million compared to $14.8 million for the second quarter ended June 30, 2022.
The decrease was primarily driven by changes to R&D priorities.
· General and administrative (G&A) expenses: G&A expenses were
$4.3 million for the second quarter ended June 30, 2023, a decrease of $1.5
million compared to $5.8 million for the second quarter ended June 30, 2022.
This decrease was primarily driven by changes in cost allocations, as well as
lower professional fees and personnel costs.
· Net loss: Net loss for the second quarter ended June 30, 2023 was
$16.8 million or $0.42 per share compared to $17.3 million or $0.44 per share
for the second quarter ended June 30, 2022.
2H 2023 Focus and Upcoming Events
· Clinical Data: Report clinical and translational science data from 15
to 20 additional patients treated with cNeT monotherapy in NSCLC and melanoma,
and with a cNeT/anti-PD-1 checkpoint inhibitor combination in melanoma, in the
fourth quarter of the year
· Translational Science: Leverage the Company's translational science
platform to define the cNeT product features associated with clinical
responses
· Clinical Activity: Drive the potential for additional confirmed
responses in CHIRON and THETIS patients by delivering higher cNeT doses and
improved product design
· Manufacturing Development: Continue VELOS™ and PELEUS™
development to optimize cNeT dose and functionality
Members of the Achilles team will participate in the following upcoming
conferences. Additional details will be available in the Events &
Presentations
(https://www.globenewswire.com/Tracker?data=HGhxvCVo9d50sNDqiyTJKJO5Tf3lZZodMtXjCP8RmQDr1qpTiNd2ltkVzyDUPXIKZk7Kwq8IyzcZfDIJGM09b9FUmaKeKf1IlLBxUxqruhhQr_nJvXdVpDpNM4rlVin_oLwMCMOIW9lqtNdTmA0qjg==)
section of the Company's website:
· 11(th) Annual Immuno-Oncology Summit: August 7-9, 2023, Boston, MA
· Advanced Therapies Europe: September 6-7, 2023, Estoril, Portugal
· 5(th) Annual TIL Therapies Summit: October 2-4, 2023, Boston, MA
About Achilles Therapeutics
Achilles is a clinical-stage biopharmaceutical company developing AI-Powered
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.
For further information, please contact:
Investors:
Meru Advisors
Lee M. Stern
lstern@meruadvisors.com
Media:
Consilium Strategic Communications
Mary-Jane Elliott, Sukaina Virji, Melissa Gardiner
+44 (0) 203 709 5000
achillestx@consilium-comms.com (mailto: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,
2023 2022
ASSETS
Current assets:
Cash and cash equivalents $ 143,711 $ 173,338
Prepaid expenses and other current assets 31,499 23,242
Total current assets 175,210 196,580
Non-current assets:
Property and equipment, net 10,949 12,399
Operating lease right of use assets 8,373 8,081
Deferred tax assets 185 251
Restricted cash 33 33
Other assets 3,157 3,014
Total non-current assets 22,697 23,778
TOTAL ASSETS $ 197,907 $ 220,358
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 6,886 $ 5,187
Income taxes payable 7 326
Accrued expenses and other liabilities 7,569 8,292
Operating lease liabilities-current 4,656 4,188
Total current liabilities 19,118 17,993
Non-current liabilities:
Operating lease liabilities-non-current 3,972 4,388
Other long-term liability 974 933
Total non-current liabilities 4,946 5,321
Total liabilities 24,064 23,314
Commitments and contingencies (Note 12)
Shareholders' equity:
Ordinary shares, £0.001 par value; 40,946,239 and 40,932,727 shares 54 54
authorized, issued and outstanding at June 30, 2023 and
December 31, 2022, respectively
Deferred shares, £92,451.851 par value, one share authorized, issued 128 128
and outstanding at June 30, 2023 and December 31, 2022
Additional paid in capital 412,201 408,844
Accumulated other comprehensive loss (13,901 ) (21,695 )
Accumulated deficit (224,639 ) (190,287 )
Total shareholders' equity 173,843 197,044
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 197,907 $ 220,358
ACHILLES THERAPEUTICS PLC
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except share and per share amounts)
(expressed in U.S. Dollars, unless otherwise stated)
Three Months Ended June 30, Six Months Ended June 30,
2023 2022 2023 2022
OPERATING EXPENSES:
Research and development $ 13,774 $ 14,776 $ 27,642 $ 27,790
General and administrative 4,318 5,770 9,003 11,725
Total operating expenses 18,092 20,546 36,645 39,515
Loss from operations (18,092 ) (20,546 ) (36,645 ) (39,515 )
OTHER INCOME, NET:
Other income 1,212 3,271 2,303 4,900
Total other income, net 1,212 3,271 2,303 4,900
Loss before provision for income taxes (16,880 ) (17,275 ) (34,342 ) (34,615 )
Benefit (Provision) for income taxes 34 (14 ) (10 ) (29 )
Net loss (16,846 ) (17,289 ) (34,352 ) (34,644 )
Other comprehensive income:
Foreign exchange translation adjustment 3,817 (19,302 ) 7,794 (26,979 )
Comprehensive loss $ (13,029 ) $ (36,591 ) $ (26,558 ) $ (61,623 )
Net loss per share attributable to ordinary shareholders-basic and diluted $ (0.42 ) $ (0.44 ) $ (0.86 ) $ (0.89 )
Weighted average ordinary shares outstanding-basic and diluted 39,899,944 39,104,375 39,816,528 38,998,686
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