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RNS Number : 4254V

Syncona Limited

09 August 2022

Syncona Limited

Achilles reports Q2 2022 Financial Results and Business Highlights

09 August 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 second quarter ended June 30, 2022, and an update on recent business highlights.

Key highlights from the announcement include:

-- Achilles expects to provide initial data from the higher dose clinical cohorts of the Phase I/IIa clinical trials of its clonal neoantigen-reactive T cell (cNeT) therapy in non-small cell lung cancer (NSCLC) and melanoma in Q4 CY2022

-- The company's manufacturing facility at the Cell and Gene Therapy Catapult has been approved by the UK Medicines and Healthcare products Regulatory Agency to produce cNeT products to support its ongoing Phase I/IIa clinical trials in NSCLC and melanoma, significantly increasing Achilles' manufacturing capacity

-- Cash balance of $202 million to support all planned operations into Q2 CY2025, including completion of its ongoing Phase I/IIa clinical trials

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

Annabel Clark / Natalie Garland-Collins / Fergus Witt

Tel: +44 (0) 20 3981 7940

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 Second Quarter 2022 Financial Results and Recent Business Highlights

- Additional clinical data from the ongoing Phase I /IIa trials in advanced NSCLC (CHIRON) and melanoma (THETIS) expected to be available in Q4 2022 -

- Cell & Gene Therapy Catapult manufacturing facility approved by MHRA for cNeT production in CHIRON and THETIS clinical trials -

- Strong cash balance of $202 million supports all planned operations into Q2 2025 -

London, UK 9 August 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 second quarter ended June 30, 2022, and recent business highlights.

"We remain focused on advancing our lead clinical programs, evaluating cNeT monotherapy in CHIRON for advanced non-small cell lung cancer (NSCLC), and exploring both cNeT monotherapy and the combination with a PD-1 checkpoint inhibitor in THETIS for recurrent or metastatic malignant melanoma. We expect initial activity, safety and translational science data in the fourth quarter of this year from patients receiving higher-dose cNeT products," said Dr Iraj Ali, Chief Executive Officer of Achilles Therapeutics. "We are very pleased that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has now approved Achilles' Cell and Gene Therapy Catapult Manufacturing Centre (Catapult) site to produce cNeT products in the ongoing CHIRON and THETIS clinical trials, significantly increasing our manufacturing capacity for 2022 and beyond."

Business Highlights

-- On track to present additional clinical data in Q4 2022 from the ongoing Phase I/IIa CHIRON and THETIS clinical trials in patients with advanced NSCLC and recurrent or metastatic melanoma, respectively.

-- Expanded global manufacturing capacity with the MHRA approval of Achilles' Catapult facility for cNeT production in CHIRON and THETIS 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, PA.

-- Awarded a EUR4 million ($4.2 million(1) ) research and innovation award as part of a consortium to develop a first-in-class smart bioprocessing manufacturing platform, with EUR1.4 million ($1.5 million(1) ) allocated to Achilles.

-- Initiated the tumor archiving program (TAP) to study the potential of producing cNeT from tumor material collected and stored earlier in disease progression.

-- Strengthened the Company's leadership with the following appointments: Bernhard Ehmer to the Board of Directors, James Taylor as Chief Business Officer, and Cassian Yee, MD to the Scientific Advisory Board.

-- Received the 2022 Pharmaceutical Industry Network Group (PING) Innovation Award, acknowledging the innovation demonstrated by the Company's work with clonal neoantigens to treat solid tumors, including the Company's AI-powered PELEUS(TM) bioinformatics platform and proprietary VELOS(TM) manufacturing process.

Financial Highlights

-- Cash and cash equivalents: Cash and cash equivalents were $201.6 million as of June 30, 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 quarter of 2025, including completion of the ongoing Phase I/IIa CHIRON and THETIS clinical trials.

-- Research and development (R&D) expenses: R&D expenses were $14.8 million for the second quarter ended June 30, 2022, as compared to $10.8 million for the second quarter ended June 30, 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 $5.8 million for the second quarter ended June 30, 2022, as compared to $5.4 million for the second quarter ended June 30, 2021. The increase was primarily driven by an increase in headcount and related personnel costs.

-- Net loss: Net loss for the second quarter ended June 30, 2022, was $17.3 million or $0.44 per share compared to $16.2 million, or $0.45 per share for the second quarter ended June 30, 2021.

Achilles will participate in the following investor and medical conferences in August and September 2022. Additional details will be available in the Events & Presentations section of the Company's website:

   --    BTIG Biotechnology Conference 2022: August 8 - 9, 2022 
   --    Phacilitate Advanced Therapies Europe: August 31 - September 1, 2022 
   --    H.C. Wainwright Annual Global Investment Conference: September 12 - 14, 2022 
   --    Cantor Fitzgerald's Cell & Genetic Medicines Conference: September 15, 2022 
   --    Immuno UK: September 29 - 30, 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.

(1) June 30, 2022 exchange rate of EUR1.000 = $1.043

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)

 
                                                                             June 30,     December 31, 
                                                                               2022           2021 
                                                                             ---------   -------------- 
ASSETS 
Current assets: 
Cash and cash equivalents                                                    $ 201,595   $      266,319 
Prepaid expenses and other current assets                                       25,985           18,430 
                                                                              --------       ---------- 
   Total current assets                                                        227,580          284,749 
                                                                              --------       ---------- 
Non-current assets: 
Property and equipment, net                                                     17,626           17,743 
Operating lease right of use assets                                              9,470           11,048 
Deferred tax assets                                                                 26               26 
Restricted cash                                                                     33               33 
Other assets                                                                     2,983            3,507 
                                                                              --------       ---------- 
   Total non-current assets                                                     30,138           32,357 
                                                                              --------       ---------- 
   TOTAL ASSETS                                                              $ 257,718   $      317,106 
                                                                              ========       ========== 
LIABILITIES AND SHAREHOLDERS' EQUITY 
Current liabilities: 
Accounts payable                                                             $   6,651   $        3,722 
Income taxes payable                                                                18                - 
Accrued expenses and other liabilities                                           8,720           10,906 
Operating lease liabilities-current                                              4,480            4,482 
                                                                              --------       ---------- 
   Total current liabilities                                                    19,869           19,110 
Non-current liabilities: 
Operating lease liabilities-non-current                                          5,640            7,777 
Other long-term liability                                                          621              691 
                                                                              --------       ---------- 
   Total non-current liabilities                                                 6,261            8,468 
                                                                              --------       ---------- 
   Total liabilities                                                            26,130           27,578 
                                                                              --------       ---------- 
Commitments and contingencies (Note 12) 
Shareholders' equity: 
   Ordinary shares, GBP0.001 par value; 40,774,014 and 40,603,489 shares 
    authorized, issued and outstanding at June 30, 2022 and 
    December 31, 2021, respectively                                                 54               54 
   Deferred shares, GBP92,451.851 par value, one share authorized, issued 
    and outstanding at June 30, 2022 and December 31, 2021                         128              128 
Additional paid in capital                                                     405,504          401,821 
Accumulated other comprehensive (loss) income                                  (20,343)           6,636 
Accumulated deficit                                                           (153,755)        (119,111) 
                                                                              --------       ---------- 
   Total shareholders' equity                                                  231,588          289,528 
                                                                              --------       ---------- 
   TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY                                $ 257,718   $      317,106 
                                                                              ========       ========== 
 

A CHILLES THERAPEUTICS PLC

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

(in thousands, except share and per share amounts)

 
                                    Three Months Ended June 30,       Six Months Ended June 30, 
                                  -------------------------------   ----------------------------- 
                                        2022             2021            2022            2021 
                                  ----------------   ------------   ---------------   ----------- 
OPERATING EXPENSES: 
   Research and development       $         14,776   $     10,844   $        27,790   $    19,720 
   General and administrative                5,770          5,445            11,725        10,277 
                                      ------------    -----------       -----------    ---------- 
Total operating expenses                    20,546         16,289            39,515        29,997 
                                      ------------    -----------       -----------    ---------- 
Loss from operations                       (20,546)       (16,289)          (39,515)      (29,997) 
OTHER INCOME, NET: 
   Other income                              3,271            146             4,900           101 
                                      ------------    -----------       -----------    ---------- 
   Total other income, net                   3,271            146             4,900           101 
                                      ------------    -----------       -----------    ---------- 
Loss before provision for income 
 taxes                                     (17,275)       (16,143)          (34,615)      (29,896) 
   Provision for income taxes                  (14)           (13)              (29)          (25) 
                                      ------------    -----------       -----------    ---------- 
Net loss                                   (17,289)       (16,156)          (34,644)      (29,921) 
                                      ------------    -----------       -----------    ---------- 
Other comprehensive income: 
   Foreign exchange translation 
    adjustment                             (19,302)          (925)          (26,979)        1,138 
                                      ------------    -----------       -----------    ---------- 
Comprehensive loss                $        (36,591)  $    (17,081)  $       (61,623)  $   (28,783) 
                                      ------------    -----------       -----------    ---------- 
Net loss per share attributable 
 to ordinary shareholders-basic 
 and diluted                      $          (0.44)  $      (0.45)  $         (0.89)  $     (1.60) 
                                      ============    ===========       ===========    ========== 
Weighted average ordinary shares 
 outstanding-basic and diluted          39,104,375     35,683,187        38,998,686    18,756,599 
                                      ============    ===========       ===========    ========== 
 

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