REG - Syncona Limited - Achilles reports Q1 2023 Financial Results

SynconaAnnouncement

10/05/2023 12:30

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RNS Number : 9669Y  Syncona Limited  10 May 2023

Syncona Limited

Achilles reports Q1 2023 Financial Results and Business Highlights

10 May 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 first quarter ended 31 March, 2023,
and an update on recent business highlights.

Key highlights included:

·      Phase I/IIa clinical trials in advanced non-small cell lung
cancer (NSCLC) and melanoma progressing with additional clinical and
translational science data expected in Q4 2023

·      Strong cash position of $158.5 million supports operations into
mid-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 First Quarter 2023 Financial Results and Recent
Business Highlights

 

- Phase I/IIa clinical trials in NSCLC and melanoma progressing with
additional clinical and translational science data expected in the fourth
quarter of 2023 -

 

- Strong cash position of $158.5 million supports operations into mid-2025 -

 

London, UK 10 May 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 first quarter ended March 31, 2023,
and recent business highlights.

 

"We continue to make progress in our ongoing Phase I/IIa clinical trials
evaluating our clonal neoantigen-reactive T cell (cNeT) therapy for the
treatment of advanced NSCLC (CHIRON) and metastatic malignant melanoma
(THETIS). Additionally, we continue to further develop PELEUS™, our patented
AI-driven bioinformatics platform, that uses multi-region sequencing analysis
to provide what we believe is the best method to accurately identify clonal
neoantigens," said Dr Iraj Ali, Chief Executive Officer of Achilles
Therapeutics. "We are excited about the new AI immunogenicity prediction
capability of the PELEUS™ platform and are very pleased with the recent
grants of a US patent and MHRA Innovation Passport. We look forward to sharing
more about the PELEUS™ platform at an upcoming scientific meeting and
reporting additional clinical and translational science data in the fourth
quarter of this year, which builds on the encouraging clinical results
observed so far."

 

Business Highlights

 

·    Announced that the new neoantigen immunogenicity prediction
application of the PELEUS™ platform  can uniquely identify the most potent
clonal neoantigens for personalized cancer therapies, 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 covering the treatment of
patients with an immunotherapy targeting neoantigens based on tumor HLA status

·    Innovation Passport granted for the treatment of NSCLC under the
Innovative Licensing and Access Pathway (ILAP) by the Medicines and Healthcare
products Regulatory Agency (MHRA), the regulatory body of the United
Kingdom (UK), which aims to accelerate time to market and facilitate patient
access to medicines in the UK for life-threatening or seriously debilitating
conditions by providing the opportunity for enhanced regulatory and other
stakeholder input during development

Financial Highlights

 

·    Cash and cash equivalents: Cash and cash equivalents were $158.5
million as of March 31, 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 into the middle of 2025.

·    Research and development (R&D) expenses: R&D expenses were
$13.9 million for the first quarter ended March 31, 2023, an increase of $0.9
million compared to $13.0 million for the first quarter ended March 31, 2022.
The increase was primarily driven by increased activity related to our ongoing
clinical trials, as well as spend associated with expansion of our
manufacturing capacity and enhancements to PELEUS(TM) and VELOS(TM).

·    General and administrative (G&A) expenses: G&A expenses were
$4.7 million for the first quarter ended March 31, 2023, a decrease of $1.3
million compared to $6.0 million for the first quarter ended March 31, 2022.
This decrease was primarily driven by lower personnel costs.

·    Net loss: Net loss for the first quarter ended March 31, 2023 was
$17.5 million or $0.44 per share compared to $17.4 million or $0.45 per share
for the first quarter ended March 31, 2022.

 

2023 Focus

 

·    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 world-class
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

 

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.

 

About Innovation Passport and ILAP

 

ILAP was launched by the MHRA in January 2021 with an aim to accelerate the
development of and facilitate patient access to medicines. The Innovation
Passport is granted by the UK's ILAP Steering Group, which consists of
representatives from MHRA, the National Institute for Health and Care
Excellence (NICE), the Scottish Medicines Consortium (SMC), the All Wales
Therapeutics and Toxicology Centre (AWTTC) and the National Health Service
(NHS) England. It is the first step in the ILAP process and awarded to
companies developing therapies with the potential to offer significant benefit
to patients who have conditions that are life-threatening or seriously
debilitating. Additional information is available on the UK government
website
(https://www.gov.uk/guidance/innovative-licensing-and-access-pathway#overview)
.

 

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:

Meru Advisors

Lee M. Stern

ir@achillestx.com (mailto:ir@achillestx.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)

 

                                                                            March 31,                 December 31,
                                                                            2023                      2022
 ASSETS
 Current assets:
 Cash and cash equivalents                                                  $       158,460           $        173,338
 Prepaid expenses and other current assets                                          26,802                     23,242
 Total current assets                                                               185,262                    196,580
 Non-current assets:
 Property and equipment, net                                                        11,800                     12,399
 Operating lease right of use assets                                                7,216                      8,081
 Deferred tax assets                                                                185                        251
 Restricted cash                                                                    33                         33
 Other assets                                                                       3,139                      3,014
 Total non-current assets                                                           22,373                     23,778
 TOTAL ASSETS                                                               $       207,635           $        220,358
 LIABILITIES AND SHAREHOLDERS' EQUITY
 Current liabilities:
 Accounts payable                                                           $       7,650             $        5,187
 Income taxes payable                                                               304                        326
 Accrued expenses and other liabilities                                             5,955                      8,292
 Operating lease liabilities-current                                                4,038                      4,188
 Total current liabilities                                                          17,947                     17,993
 Non-current liabilities:
 Operating lease liabilities-non-current                                            3,563                      4,388
 Other long-term liability                                                          954                        933
 Total non-current liabilities                                                      4,517                      5,321
 Total liabilities                                                                  22,464                     23,314
 Commitments and contingencies
 Shareholders' equity:
 Ordinary shares, £0.001 par value; 40,938,453 and 40,932,727 shares                54                         54
 authorized, issued and outstanding at March 31, 2023 and

  December 31, 2022, respectively
 Deferred shares, £92,451.851 par value, one share authorized, issued               128                        128

  and outstanding at March 31, 2023 and December 31, 2022
 Additional paid in capital                                                         410,500                    408,844
 Accumulated other comprehensive (loss) income                                      (17,718   )                (21,695   )
 Accumulated deficit                                                                (207,793  )                (190,287  )
 Total shareholders' equity                                                         185,171                    197,044
 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY                                 $       207,635           $        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 March 31,
                                                                                 2023                             2022
 OPERATING EXPENSES:
 Research and development                                                        $      13,868                    $      13,014
 General and administrative                                                             4,685                            5,955
 Total operating expenses                                                               18,553                           18,969
 Loss from operations                                                                   (18,553     )                    (18,969     )
 OTHER INCOME, NET:
 Other income (expense)                                                                 1,091                            1,629
 Total other income, net                                                                1,091                            1,629
 Loss before provision for income taxes                                                 (17,462     )                    (17,340     )
 Provision for income taxes                                                      (44)                                    (15         )
 Net loss                                                                               (17,506     )                    (17,355     )
 Other comprehensive income:
 Foreign exchange translation adjustment                                                3,977                            (7,677      )
 Comprehensive loss                                                              $      (13,529     )             $      (25,032     )
 Net loss per share attributable to ordinary shareholders-basic and diluted      $      (0.44       )             $      (0.45       )
 Weighted average ordinary shares outstanding-basic and diluted                         39,732,186                       38,891,822

 

 

 

 

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