REG - Syncona Limited - Achilles reports Q1 2024 Financial Results

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08/05/2024 12:15

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RNS Number : 6158N  Syncona Limited  08 May 2024

 

Syncona Limited

 

Achilles reports Q1 2024 Financial Results and Recent Business Highlights

 

8 May 2024

 

Syncona Ltd, a leading life science investor focused on creating, building and
scaling 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, 2024, and an update on recent
business highlights.

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 / 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 companies 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, across development stage and therapeutic areas, 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.

 

Syncona Limited seeks to achieve returns over the long term. Investors should
seek to ensure they understand the risks and opportunities of an investment
in Syncona Limited, including the information in our published documentation,
before investing.

Achilles Therapeutics Reports First Quarter 2024 Financial Results and Recent
Business Highlights

- Provided interim Phase I/IIa update on clonal neoantigen reactive T cells in
advanced NSCLC and melanoma -

- Evaluating the benefit of enhanced host conditioning with further data
expected in 2H 2024 -

- Strong cash position of $112.3 million supports operations through 2025 -

 

London, UK 8 May 2024 - 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, 2024,
and recent business highlights.

"Just after the close of the first quarter, we shared the interim Phase I/IIa
data from our ongoing CHIRON and THETIS TIL-based cNeT clinical trials which
have given us important mechanistic learnings about the factors driving
durable engraftment and immune evasion at an antigen level. These data
continue to inform the development of cNeT and potentially other modalities
like neoantigen vaccines and TCR-T therapies," said Dr Iraj Ali, Chief
Executive Officer of Achilles Therapeutics. "We are evaluating cNeT
persistence and clinical activity in patients with enhanced host conditioning,
and we plan to report a meaningful data update in the second half of 2024. Our
financial position remains strong with more than $112 million in cash, which
will support operations through 2025, including the completion of the ongoing
Phase I/IIa trials."

Clinical and Business Highlights

·    Provided an interim Phase I/IIa update on clonal neoantigen reactive
T cells in advanced NSCLC and melanoma, highlighting improved doses from the
VELOS™ manufacturing process and encouraging tolerability

·    Delivered ~10-fold improvement in the median cNeT dose (172 million),
with 10 products over 100 million cNeT and five over one billion cNeT

·    Dosed first patients in CHIRON and THETIS with enhanced host
conditioning, with additional  data expected in the second half of 2024

·    Continued development of the PELEUS™ clonal neoantigen prediction
platform

·    Presented "Targeting Clonal Neoantigens with Precision Cell
Therapies" at the 10th Annual IO360 Conference

Financial Highlights

·    Cash and cash equivalents: Cash and cash equivalents were $112.3
million as of March 31, 2024, as compared to $131.5 million as of December
31, 2023. The Company believes 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
$10.1 million for the first quarter ended March 31, 2024, a decrease of $3.7
million compared to $13.9 million for the first quarter ended March 31, 2023.
The decrease was primarily driven by lower personnel costs, partially offset
by an increase of activity in the ongoing clinical trials.

·    General and administrative (G&A) expenses: G&A expenses were
$4.2 million for the first quarter ended March 31, 2024, a decrease of $0.5
million compared to $4.7 million for first quarter ended March 31, 2023. This
decrease was primarily driven by lower personnel costs and lower insurance
premiums.

·    Net loss: Net loss for the first quarter ended March 31, 2024 was
$12.3 million or $0.30 per share compared to $17.5 million or $0.44 per share
for the first quarter ended March 31, 2023.

2024 Focus

·    Clinical Data: Report clinical activity and translational science
data from patients in CHIRON and THETIS Cohort C, evaluating the benefit of
enhanced host conditioning, with a meaningful data update expected in the
second half of 2024

·    Translational Science: Leverage the Company's world-class
translational science platform to define the features associated with clinical
response and to pursue rational design of the final cNeT product

·    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.

 

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. Forward-looking statements in this
press release include, but are not limited to, statements regarding the timing
of the Company's clinical and translational data updates and the Company's
beliefs about recent data updates, and expectations related to the Company's
cash runway and operating expenses and capital expense requirements. 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 (mailto:lstern@meruadvisors.com)

Media:

ICR Consilium

Sukaina Virji, Tracy Cheung, Dylan Wilks

+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,
                                                                              2024           2023
 ASSETS
 CURRENT ASSETS:
 Cash and cash equivalents                                                    $112,322        $131,539
 Prepaid expenses and other current assets                                    19,104          14,094
     Total current assets                                                     131,426         145,633
 Property and equipment, net                                                  8,107           9,171
 Operating lease right of use assets                                          3,965           4,372
 Deferred tax assets                                                          41              41
 Restricted cash                                                              33              33
 Other assets                                                                 2,169           2,206
     Total non-current assets                                                 14,315          15,823
     Total assets                                                             $145,741        $161,456
 LIABILITIES AND SHAREHOLDERS' EQUITY
 CURRENT LIABILITIES:
 Accounts payable                                                             $3,313          $5,629
 Accrued expenses and other liabilities                                       6,712           7,828
 Operating lease liabilities - current                                        3,628           3,539
     Total current liabilities                                                13,653          16,996
 NON-CURRENT LIABILITIES:
 Operating lease liabilities - non-current                                    584             1,076
 Other long-term liability                                                    1,156           1,015
        Total non-current liabilities                                         1,740           2,091
        Total liabilities                                                     15,393          19,087

 Commitments and contingencies
 SHAREHOLDERS' EQUITY:
 Ordinary shares, £0.001 par value; 41,087,901 and 41,082,948 shares          54              54
 authorized,
    issued and outstanding at March 31, 2024 and December 31, 2023,
 respectively
 Deferred shares, £92,451.85 par value, one share authorized, issued and      128             128
 outstanding
    at March 31, 2024 and December 31, 2023, respectively
 Additional paid in capital                                                   416,602         415,210
 Accumulated other comprehensive income                                       (14,210)       (13,071)
 Accumulated deficit                                                          (272,226)      (259,952)
     Total shareholders' equity                                               130,348         142,369
     TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY                               $145,741        $161,456

 

 

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,
                                                                                      2024                                                                 2023
  OPERATING EXPENSES:
                                           Research and development                    $         10,140                                                     $         13,868
                                           General and administrative                                 4,159                                                                4,685
                                               Total operating expenses                            14,299                                                               18,553
  LOSS FROM OPERATIONS:                                                                          (14,299)                                                             (18,553)
  OTHER INCOME (EXPENSE), NET:
                                           Other income (expense)                                     2,002                                                                1,091
                                               Total other income (expense), net                      2,002                                                                1,091
  Loss before income taxes                                                                       (12,297)                                                             (17,462)
                                           Benefit (provision) for income taxes                                 23                                                              (44)
  Net loss                                                                                       (12,274)                                                             (17,506)
  Other comprehensive (loss) income:
                                           Foreign exchange translation adjustment                  (1,139)                                                                3,977
  Comprehensive loss                                                                   $       (13,413)                                                     $       (13,529)
  Net loss per share attributable to ordinary shareholders-basic and diluted           $             (0.30)                                                 $             (0.44)
  Weighted average ordinary shares outstanding-basic and diluted                        40,281,407                                                           39,732,186

 

 

 

 

 

 

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