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Syncona Limited LSE:SYNC London Ordinary Share GG00B8P59C08 ORD NPV
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Syncona Limited Achilles reports Q1 2022 Financial Results

10/05/2022 1:02pm

UK Regulatory (RNS & others)


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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/ and the full text of the announcement from Achilles is contained below.

[S]

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 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(TM) 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, GBP0.001 par value; 40,754,227 and 40,603,489 shares 
 authorized, issued and 
 outstanding at March 31, 2022 and December 31, 2021, respectively                      54               54 
Deferred shares, GBP92,451.851 par value, one share authorized, issued and 
 outstanding at 
 March 31, 2022 and December 31, 2021                                                  128              128 
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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END

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May 10, 2022 08:02 ET (12:02 GMT)

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