TIDMSYNC

RNS Number : 1387I

Syncona Limited

10 August 2021

Syncona Limited

Achilles reports Second Quarter 2021 Financial Results

10 August 2021

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, 2021 and 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

Annabel Clay / 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 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 2021 Financial Results and Recent Business Highlights

- Presentations of translational science data at AACR and ASCO illustrate crucial path to potency assay -

- Data from ten patients across CHIRON and THETIS studies anticipated in the fourth quarter of 2021 -

London, UK 10 August 2021 - 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, 2021, and recent business highlights.

"Achilles continued to make significant progress in the second quarter of 2021. We presented data at AACR and ASCO demonstrating that we can quantify the active clonal neoantigen-reactive T cell (cNeT) component and cNeT dose of our product. We were also able to track our cNeT post-dosing and describe phenotypic and functional characteristics. We believe that this critical capability will allow us to develop a potency assay which could be a crucial advancement in the TIL therapeutic space. We remain on target to report clinical and characterization data on ten patients that have received cNeT monotherapy across the CHIRON and THETIS trials in the fourth quarter," said Dr Iraj Ali, Chief Executive Officer of Achilles. "We continue to enroll and dose patients and have recruited our first US patient at the Moffitt Cancer Center. Also in the fourth quarter of 2021, we plan to begin enrolling patients using our Process 2 to deliver higher dose cNeT and to open a checkpoint combination cohort in our melanoma (THETIS) study to evaluate the addition of a PD-1 inhibitor to cNeT therapy."

Business Highlights

-- Closed an initial public offering of 9,750,000 ADRs at a public offering price of $18.00 per share for gross proceeds of $175.5 million.

-- Enrolled first US Patient in ongoing PI/IIa CHIRON study in non-small cell lung cancer at the Moffitt Cancer Center

-- Presented a poster at the 2021 ASCO Annual Meeting describing the ongoing phase I/IIa CHIRON clinical trial evaluating clonal cNeT in patients with advanced non-small cell lung cancer (NSCLC)

-- Presented data at the American Association of Cancer Research (AACR) annual meeting detailing the Company's comprehensive translational research program and insights into the in vivo dynamics of cNeT post-dosing and the potential to develop a potency-based release assay

-- Strengthened the Board of Directors and Scientific Advisory Board with the additions of Julie O'Neill and Markwin Velders, Ph.D., respectively

-- Received a Horizon 2020 grant as part of the Neoantigen Consortium, to collaborate on the development of a tool to predict neoantigen immunogenicity

Financial Highlights

-- Cash and cash equivalents : Cash and cash equivalents were $299.3 million as of June 30, 2021, as compared to $177.8 million as of December 31, 2020. Current cash and cash equivalents include net proceeds of $160.6 million from an initial public offering that closed in the second quarter. The Company anticipates that its c ash and cash equivalents are sufficient to fund its planned operations into the second half of 2023, including full funding of the ongoing Phase I/IIa CHIRON and THETIS clinical trials.

-- Research and development (R&D) expenses : R&D expenses were $10.8 million for the second quarter ended June 30, 2021, an increase of $6.3 million compared to $4.5 million for the second quarter ended June 30, 2020. R&D expenses were $19.7 million for the six months ended June 30, 2021, an increase of $11.3 million compared to $8.4 million for the six months ended June 30, 2020. 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 $5.4 million for the second quarter ended June 30, 2021, an increase of $3.0 million compared to $2.4 million for the second quarter ended June 30, 2020. G&A expenses were $10.3 million for the six months ended June 30, 2021, an increase of $6.2 million compared to the $4.1 million for the six months ended June 30, 2020. The increase was primarily driven by fees associated with the Company's IPO preparation, subsequent public company obligations, and an increase in headcount and related personnel costs.

-- Net loss : Net loss for the second quarter ended June 30, 2021 was $16.2 million or $0.45 per share compared to $6.9 million or $7.64 per share for the second quarter ended June 30, 2020. Net loss for the six months ended June 30, 2021 was $29.9 million or $1.60 per share compared to $12.1 million or $13.57 per share for the six months ended June 30, 2020. The decrease in loss per share is due in part to the increased number of shares following the conversion and issuance of shares from the IPO.

Upcoming Events

Dr Iraj Ali, Chief Executive Officer, will present at the following investor conferences in September 2021. Additional details will be available at https://ir.achillestx.com/events-and-presentations .

   --    Wells Fargo Virtual Healthcare Conference: Friday, September 10, 2021 
   --    H.C. Wainwright 23rd Annual Global Investment Conference: September 13-15, 2021 
   --    Oppenheimer Fall Healthcare Life Sciences & Med Tech Summit: September 20-23, 2021 

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 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.

Further information:

Lee M. Stern - VP, IR & External Communications

+1 (332) 373-2634

l.stern@achillestx.com

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, 
                                                                                    2021          2020 
                                                                                  --------   -------------- 
ASSETS 
Current assets: 
Cash and cash equivalents                                                         $299,317   $      177,849 
Prepaid expenses and other current assets                                           21,085            9,948 
                                                                                   -------       ---------- 
    Total current assets                                                           320,402          187,797 
                                                                                   -------       ---------- 
Non-current assets: 
Property and equipment, net                                                         16,611           13,369 
Operating lease right of use assets                                                 13,236           14,740 
Deferred tax assets                                                                      4                4 
Other assets                                                                         3,237            3,008 
                                                                                   -------       ---------- 
    Total non-current assets                                                        33,088           31,121 
                                                                                   -------       ---------- 
    TOTAL ASSETS                                                                  $353,490   $      218,918 
                                                                                   =======       ========== 
LIABILITIES AND SHAREHOLDERS ' EQUITY 
Current liabilities: 
Accounts payable                                                                  $  6,055   $        6,314 
Income taxes payable                                                                    19                7 
Accrued expenses and other liabilities                                               7,879            6,590 
Operating lease liabilities-current                                                  4,660            3,712 
                                                                                   -------       ---------- 
    Total current liabilities                                                       18,613           16,623 
Non-current liabilities: 
Operating lease liabilities-non-current                                             10,244           12,271 
Other long-term liability                                                              659              652 
                                                                                   -------       ---------- 
    Total non-current liabilities                                                   10,903           12,923 
                                                                                   -------       ---------- 
    Total liabilities                                                               29,516           29,546 
                                                                                   -------       ---------- 
Commitments and contingencies (Note 12) 
Shareholders ' equity: 
    Ordinary shares, GBP 0.001 par value; 40,603,489 and 4,389,920 shares 
     authorized, issued and outstanding at June 30, 2021 and December 
     31, 2020                                                                           54                6 
    Deferred shares, GBP 92,451.851 par value, one share authorized, issued and 
     outstanding at June 30, 2021; Deferred shares, GBP 0.001 par value; 30,521 
     shares issued and outstanding December 31, 2020                                   128                - 
    Convertible preferred shares, GBP 0.001 par value; no shares authorized, 
     issued and outstanding as of June 30, 2021;104,854,673 shares 
     authorized, issued and outstanding at December 31, 2020                             -              134 
Additional paid in capital                                                         398,265          234,922 
Accumulated other comprehensive income                                              13,460           12,322 
Accumulated deficit                                                                (87,933)         (58,012) 
                                                                                   -------       ---------- 
    Total shareholders ' equity                                                    323,974          189,372 
                                                                                   -------       ---------- 
    TOTAL LIABILITIES AND SHAREHOLDERS ' EQUITY                                   $353,490   $      218,918 
                                                                                   =======       ========== 
 

ACHILLES 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, 
                                  -------------------------------   ----------------------------- 
                                         2021             2020            2021            2020 
                                  ------------------   ----------   -----------------   --------- 
OPERATING EXPENSES: 
    Research and development      $           10,844   $    4,547   $          19,720   $   8,377 
    General and administrative                 5,445        2,395              10,277       4,131 
                                      --------------    ---------       -------------    -------- 
Total operating expenses                      16,289        6,942              29,997      12,508 
                                      --------------    ---------       -------------    -------- 
Loss from operations                         (16,289)      (6,942)            (29,997)    (12,508) 
OTHER INCOME (EXPENSE), NET: 
    Other income (expense)                       146           87                 101         439 
                                      --------------    ---------       -------------    -------- 
    Total other income 
     (expense), net                              146           87                 101         439 
                                      --------------    ---------       -------------    -------- 
Loss before provision for income 
 taxes                                       (16,143)      (6,855)            (29,896)    (12,069) 
    Provision for income taxes                   (13)           -                 (25)          - 
                                      --------------    ---------       -------------    -------- 
Net loss                                     (16,156)      (6,855)            (29,921)    (12,069) 
                                      --------------    ---------       -------------    -------- 
Other comprehensive income: 
    Foreign exchange translation 
     adjustment                                 (925)         (79)              1,138      (6,589) 
                                      --------------    ---------       -------------    -------- 
Comprehensive loss                $          (17,081)  $   (6,934)  $         (28,783)  $ (18,658) 
                                      --------------    ---------       -------------    -------- 
Net loss per share attributable 
 to ordinary shareholders - 
 basic and diluted                $            (0.45)  $    (7.64)  $           (1.60)  $  (13.57) 
                                      ==============    =========       =============    ======== 
Weighted average ordinary shares 
 outstanding - basic and diluted          35,683,187      896,831          18,756,599     889,540 
                                      ==============    =========       =============    ======== 
 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our Privacy Policy.

END

IR EAXPEFENFEEA

(END) Dow Jones Newswires

August 10, 2021 07:05 ET (11:05 GMT)

Syncona (LSE:SYNC)
Gráfica de Acción Histórica
De Oct 2021 a Nov 2021 Haga Click aquí para más Gráficas Syncona.
Syncona (LSE:SYNC)
Gráfica de Acción Histórica
De Nov 2020 a Nov 2021 Haga Click aquí para más Gráficas Syncona.