REG - Syncona Limited - Achilles reports Q3 2023 Financial Results

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14/11/2023 07:15

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RNS Number : 3718T  Syncona Limited  14 November 2023

Syncona Limited

Achilles reports Q3 2023 Financial Results and Recent Highlights

14 November 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 September,
2023, and an update on recent business highlights.

Key highlights included:

·     On track to dose 15-20 patients at the higher dose level with its
clonal neoantigen reactive T cells (cNeT) therapy by the end of 2023

·    Updated clinical and translational science data from the Phase I/IIa
trials in non small cell lung cancer (NSCLC) and melanoma will now be
published in Q1 CY2024, with additional data available in mid-CY2024

·      Strong cash position of $140.1 million supports operations
through CY2025

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 Third Quarter 2023 Financial Results and Recent
Highlights

 

- On track to dose 15-20 patients with higher dose cNeT by year-end 2023 -

 

- Clinical and translational science data update from the ongoing Phase I/IIa
trials in NSCLC and melanoma expected in Q1 2024 with additional data
available in mid-2024 -

 

- Strong cash position of $140 million supports operations through 2025 -

 

London, UK 13 November 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 September 30, 2023, and
recent business highlights.

 

"We are pleased with progress across the scientific field that continues to
demonstrate the importance of neoantigens as the most attractive targets in
solid-tumor oncology. We believe that our proprietary capability to identify
the most immunogenic clonal neoantigens, recently shared at ESGCT and SITC,
puts us in a strong position with our clonal neoantigen-reactive T cell (cNeT)
therapy and potentially other neoantigen targeting approaches," said Dr Iraj
Ali, Chief Executive Officer of Achilles Therapeutics. "Our Phase I/IIa
clinical trials evaluating cNeT therapy for the treatment of advanced NSCLC
(CHIRON) and metastatic malignant melanoma (THETIS) continue to progress and
we are on track to dose patients in line with our previous guidance. We look
forward to sharing our next clinical and translational data update in Q1
2024."

 

Recent Highlights

 

·    Presented posters (Abstract 437, Abstract 1312) at the Society for
Immunotherapy of Cancer (SITC) 38th Annual Meeting highlighting a significant
dose boost of reactive CD8 and CD4 cNeT from the optimized VELOS(TM)
manufacturing platform and the use of the PELEUS™ AI-powered bioinformatics
platform for the identification and validation of immunogenic clonal tumor
neoantigens.

·    Presented posters (P459, P485, P507) at the European Society of Gene
& Cell Therapy (ESGCT) 30th Annual Congress highlighting the favorable
cNeT phenotypic properties and polyfunctionality critical for precision
adoptive cell therapies and the expansion of cNeT from the blood of patients
with cancer.

·    Delivered an oral presentation at the mRNA Cancer Vaccines Summit
highlighting neoRanker™, a new AI-based tool for the selection of
immunogenic clonal tumor neoantigens for personalized therapies.

·    Delivered oral presentations at the 5(th) Annual TIL Therapies Summit
highlighting optimized manufacturing of AI-powered precision TIL therapies for
solid cancer, and the potency and fitness of cNeT.

·    Presented posters (P319, P407, P518) at the Seventh International
Cancer Immunotherapy Conference (CICON23) highlighting a precision adoptive
cell therapy process based on expansion of cNeT from blood of cancer patients.

 

Financial Highlights

 

·    Cash and cash equivalents: Cash and cash equivalents were $140.1
million as of September 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
$14.7 million for the third quarter ended September 30, 2023, an increase of
$4.1 million compared to $10.6 million for the third quarter ended September
30, 2022. 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
$4.4 million for the third quarter ended September 30, 2023, a decrease of
$1.0 million compared to $5.4 million for the third quarter ended September
30, 2022. This decrease was primarily driven by lower professional fees,
personnel costs and facilities spend.

·    Net loss: Net loss for the third quarter ended September 30, 2023,
was $16.7 million or $0.42 per share compared to $12.5 million or $0.32 per
share for the third quarter ended September 30, 2022.

 

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
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, Emmalee Hoppe

+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)

 

 

                                                                            September 30,               December 31,
                                                                            2023                        2022
 ASSETS
 Current assets:
 Cash and cash equivalents                                                  $         140,138           $        173,338
 Prepaid expenses and other current assets                                            15,354                     23,242
 Total current assets                                                                 155,492                    196,580
 Non-current assets:
 Property and equipment, net                                                          9,648                      12,399
 Operating lease right of use assets                                                  7,013                      8,081
 Deferred tax assets                                                                  185                        251
 Restricted cash                                                                      33                         33
 Other assets                                                                         2,967                      3,014
 Total non-current assets                                                             19,846                     23,778
 TOTAL ASSETS                                                               $         175,338           $        220,358
 LIABILITIES AND SHAREHOLDERS' EQUITY
 Current liabilities:
 Accounts payable                                                           $         5,352             $        5,187
 Income taxes payable                                                                 -                          326
 Accrued expenses and other liabilities                                               8,209                      8,292
 Operating lease liabilities-current                                                  4,620                      4,188
 Total current liabilities                                                            18,181                     17,993
 Non-current liabilities:
 Operating lease liabilities-non-current                                              2,731                      4,388
 Other long-term liability                                                            941                        933
 Total non-current liabilities                                                        3,672                      5,321
 Total liabilities                                                                    21,853                     23,314
 Commitments and contingencies (Note 12)
 Shareholders' equity:
 Ordinary shares, £0.001 par value; 40,782,948 and 40,932,727 shares                  54                         54

  authorized, issued and outstanding at September 30, 2023 and

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

  and outstanding at September 30, 2023 and December 31, 2022
 Additional paid in capital                                                           413,815                    408,844
 Accumulated other comprehensive loss                                                 (19,190   )                (21,695   )
 Accumulated deficit                                                                  (241,322  )                (190,287  )
 Total shareholders' equity                                                           153,485                    197,044
 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY                                 $         175,338           $        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 September 30,                                Nine Months Ended September 30,
                                                                                 2023                                2022                        2023                                2022
 OPERATING EXPENSES:
 Research and development                                                        $       14,712                      $       10,597              $       42,354                      $       38,387
 General and administrative                                                              4,384                               5,437                       13,387                              17,162
 Total operating expenses                                                                19,096                              16,034                      55,741                              55,549
 Loss from operations                                                                    (19,096     )                       (16,034     )               (55,741     )                       (55,549     )
 OTHER INCOME, NET:
 Other income                                                                            2,389                               3,599                       4,692                               8,499
 Total other income, net                                                                 2,389                               3,599                       4,692                               8,499
 Loss before provision for income taxes                                                  (16,707     )                       (12,435     )               (51,049     )                       (47,050     )
 Benefit (Provision) for income taxes                                                    24                                  (41         )               14                                  (70         )
 Net loss                                                                                (16,683     )                       (12,476     )               (51,035     )                       (47,120     )
 Other comprehensive income:
 Foreign exchange translation adjustment                                                 (5,289      )                       (18,147     )               2,505                               (45,126     )
 Comprehensive loss                                                              $       (21,972     )               $       (30,623     )       $       (48,530     )               $       (92,246     )
 Net loss per share attributable to ordinary shareholders-basic and diluted      $       (0.42       )               $       (0.32       )       $       (1.28       )               $       (1.20       )
 Weighted average ordinary shares outstanding-basic and diluted                          40,066,922                          39,313,764                  39,900,910                          39,104,866

 

 

 

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