REG - Syncona Limited - Achilles reports Q1 2022 Financial Results

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RNS Number : 9746K  Syncona Limited  10 May 2022

Syncona Limited

Achilles reports Q1 2022 Financial Results

10 May 2022

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 first quarter ended March 31, 2022,
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

Natalie Garland-Collins / Fergus Witt

Tel: +44 (0) 7714 916615

 

FTI Consulting

Ben Atwell / 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
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 First Quarter 2022 Financial Results and Recent
Business Highlights

 

- Dosed first patient with higher-dose (Process 2) cNeT for advanced NSCLC
(CHIRON) and initiated enrollment of cNeT + PD-1 inhibitor combination (THETIS
Cohort B) for metastatic malignant melanoma -

 

- Expanded global manufacturing by increasing capacity in the UK and
establishing a US clinical manufacturing partnership -

 

- Strong cash balance of $237 million supports all planned operations into 2H
2024 -

 

London, UK 10 May 2022 - 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 first
quarter ended March 31, 2022, and recent business highlights.

 

"We recently dosed the first patient with our higher-dose cNeT therapy in the
CHIRON clinical trial for the treatment of advanced non-small cell lung cancer
(NSCLC) and began enrollment in Cohort B of the THETIS clinical trial
evaluating cNeT in combination with a PD-1 checkpoint inhibitor for the
treatment of metastatic malignant melanoma. We expect to report initial
higher-dose monotherapy data from both CHIRON and THETIS as well as initial
combination data from THETIS Cohort B in the second half of 2022," said Dr
Iraj Ali, Chief Executive Officer of Achilles Therapeutics. "We also expanded
our global footprint, including increased clinical manufacturing capacity in
the United Kingdom and the United States, where we have established a US
headquarters in Philadelphia that will house our first US R&D facility, to
further support our clinical programs. Overall, our unique approach to
targeting clonal neoantigens, differentiated ability to detect, quantify and
track our cNeT products, and strong balance sheet continue to position us well
to execute across our upcoming value-creating catalysts."

 

Business Highlights

·    Dosed the first patient with higher-dose (Process 2) cNeT monotherapy
in the CHIRON clinical trial for advanced NSCLC.

·    Following a positive Independent Data Safety Monitoring Committee
review, initiated enrollment of THETIS Cohort B to evaluate cNeT therapy in
combination with a PD-1 checkpoint inhibitor for the treatment of metastatic
malignant melanoma.

·    Strengthened the Board of Directors with the addition of independent
member Bernhard Ehmer, MD.

·    Expanded global manufacturing by increasing capacity in the United
Kingdom with a GMP license obtained for the Cell & Gene Therapy Catapult
facility, and entered into a partnership agreement for clinical manufacturing
in the United States with the Center for Breakthrough Medicines, a contract
development and manufacturing organization in King of Prussia, Pennsylvania.

·    Hosted a key opinion leader webcast highlighting important data
selected from the 31 posters and presentations on the TRACERx study presented
at the 2022 American Association for Cancer Research Annual Meeting.

 

Financial Highlights

·    Cash and cash equivalents: Cash and cash equivalents were $236.9
million as of March 31, 2022, as compared to $266.3 million as of December 31,
2021. The Company anticipates that its cash and cash equivalents are
sufficient to fund its planned operations into the second half of 2024,
including full funding of the ongoing Phase I/IIa CHIRON and THETIS clinical
trials.

·    Research and development (R&D) expenses: R&D expenses were
$13.0 million for the first quarter ended March 31, 2022, as compared to $8.9
million for the first quarter ended March 31, 2021. 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
$6.0 million for the first quarter ended March 31, 2022, as compared to $4.8
million for the first quarter ended March 31, 2021. 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 first quarter ended March 31, 2022, was
$17.4 million or $0.45 per share compared to $13.8 million, or $8.38 per share
for the first quarter ended March 31, 2021.

 

2022 Milestones and Upcoming Events

·    Higher-dose Monotherapy: Report initial data from the higher-dose
cohort of patients undergoing cNeT monotherapy for the treatment of NSCLC and
melanoma in the second half of 2022.

·    cNeT Combination: Dose first melanoma patient with cNeT in
combination with a PD-1 checkpoint inhibitor in Cohort B of the THETIS
clinical trial and report initial data in the second half of 2022.

·    Manufacturing: Begin clinical cNeT production at the Cell & Gene
Therapy Catapult facility in the second half of 2022.

·    Tumor Archiving Program: Initiate program in the second quarter of
2022.

 

Achilles will present at the following medical and investor conferences in May
2022. Additional details will be available in the Events & Presentations
(https://ir.achillestx.com/events-and-presentations) section of the Company's
website:

·    BofA Securities 2022 Healthcare Conference: May 9-13, 2022

·    H.C. Wainwright Global Investment Conference: May 23-26, 2022

 

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 AI-Powered 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.

Investors:

Achilles Therapeutics

Lee M. Stern, VP, IR & External Communications
l.stern@achillestx.com

LifeSci Advisors

John Mullaly
jmullaly@lifesciadvisors.com

Media:

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)

expressed in U.S. Dollars, unless otherwise stated)

                                                                                  March 31,                 December 31,       
                                                                                  2022                      2021               
 ASSETS                                                                                                                       
 Current assets:                                                                                                              
 Cash and cash equivalents                                                         $       236,931           $        266,319   
 Prepaid expenses and other current assets                                                22,118                    18,430    
 Total current assets                                                                     259,049                   284,749   
 Non-current assets:                                                                                                          
 Property and equipment, net                                                              18,376                    17,743    
 Operating lease right of use assets                                                      11,070                    11,048    
 Deferred tax assets                                                                      26                        26        
 Restricted cash                                                                          33                        33        
 Other assets                                                                             3,636                     3,507     
 Total non-current assets                                                                 33,141                    32,357    
 TOTAL ASSETS                                                                      $       292,190           $        317,106   
 LIABILITIES AND SHAREHOLDERS' EQUITY                                                                                         
 Current liabilities:                                                                                                         
 Accounts payable                                                                  $       4,036             $        3,722     
 Income taxes payable                                                                     15                        -         
 Accrued expenses and other liabilities                                                   9,131                     10,906    
 Operating lease liabilities-current                                                      4,670                     4,482     
 Total current liabilities                                                                17,852                    19,110    
 Non-current liabilities:                                                                                                     
 Operating lease liabilities-non-current                                                  7,212                     7,777     
 Other long-term liability                                                                671                       691       
 Total non-current liabilities                                                            7,883                     8,468     
 Total liabilities                                                                        25,735                    27,578    
 Commitments and contingencies (Note 12)                                                                                      
 Shareholders' equity:                                                                                                        
 Ordinary shares, £0.001 par value; 40,754,227 and 40,603,489 shares                      54                        54        
 authorized, issued and outstanding at March 31, 2022 and December 31, 2021,
 respectively
 Deferred shares, £92,451.851 par value, one share authorized, issued and                 128                       128       
 outstanding at March 31, 2022 and December 31, 2021
 Additional paid in capital                                                               403,780                   401,821   
 Accumulated other comprehensive income (loss)                                            (1,041    )                6,636     
 Accumulated deficit                                                                      (136,466  )                (119,111  )
 Total shareholders' equity                                                               266,455                   289,528   
 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY                                        $       292,190           $        317,106   

ACHILLES THERAPEUTICS PLC

Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)

(in thousands, except share and per share amounts)

 

                                                                                 Three Months Ended March 31,
                                                                                 2022                             2021
 OPERATING EXPENSES:
 Research and development                                                        $      13,014                    $      8,876
 General and administrative                                                             5,955                            4,832
 Total operating expenses                                                               18,969                           13,708
 Loss from operations                                                                   (18,969     )                    (13,708    )
 OTHER INCOME, NET:
 Other income (expense)                                                                 1,629                            (45        )
 Total other income, net                                                                1,629                            (45        )
 Loss before provision for income taxes                                                 (17,340     )                    (13,753    )
 Provision for income taxes                                                             (15         )                    (12        )
 Net loss                                                                               (17,355     )                    (13,765    )
 Other comprehensive income:
 Foreign exchange translation adjustment                                                (7,677      )                    2,063
 Comprehensive loss                                                              $      (25,032     )             $      (11,702    )
 Net loss per share attributable to ordinary shareholders-basic and diluted      $      (0.45       )             $      (8.38      )
 Weighted average ordinary shares outstanding-basic and diluted                         38,891,822                       1,641,938

 

 

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