TIDMSYNC

RNS Number : 8343R

Syncona Limited

09 November 2021

Syncona Limited

Achilles reports Third Quarter 2021 Financial Results

9 November 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 third quarter ended September 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. In addition, the Company will host a live webcast and conference call on Friday, November 12, 2021 at 1:30pm GMT to review the SITC presentations and provide a corporate update. The live webcast can be accessed in the Events & Presentations section of the Company's website.

[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 Third Quarter 2021 Financial Results and Recent Business Highlights

- Oral Presentation at European Society for Gene and Cell Therapy (ESGCT) demonstrated ability to generate potent anti-cancer cell therapy candidates in multiple solid tumor types -

- Society for Immunotherapy of Cancer ( SITC) abstracts highlight the ability to detect, quantify and track patient-specific cNeT and generate increased cNeT doses from VELOS(TM) Process 2 manufacturing -

- Conference call and webcast scheduled for Friday, November 12, 2021 at 8:30am ET to review SITC presentations and provide a corporate update -

London, UK 09 November 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 third quarter ended September 30, 2021, and recent business highlights.

"We have continued to make good progress during the third quarter and will share an update from the first eight patients across our CHIRON (non-small cell lung cancer, or NSCLC) and THETIS (melanoma) studies at the upcoming SITC meeting. Our unique ability to accurately quantify the tumor reactive component of each product and to track clonal neoantigen reactive T cells (cNeT) in the patients post-dosing is possible through the detailed genomic analysis of the tumor and prospective clonal neoantigen targeting afforded by our proprietary bioinformatics platform. We believe this best-in-class analytical capability will be critical for the successful development of TIL-based therapies," said Dr Iraj Ali, Chief Executive Officer of Achilles. "At SITC, we will also share details of our VELOS(TM) Process 2 manufacturing, which is able to routinely generate significantly higher doses of cNeT than our current Process 1. We will present further GMP scale data from VELOS Process 2 at the upcoming ESMO Immuno-Oncology Congress taking place December 8-11, 2021."

Business Highlights

-- Two abstracts for the SITC 36th Annual Meeting were published today - Poster 543, underscoring the ability to sensitively detect, quantify and track patient-specific cNeT during manufacture and post dosing, and Poster 193, highlighting our ability to generate increased doses of reactive cNeT from VELOS Process 2

-- Delivered an oral presentation at the 2021 European Society for Gene and Cell Therapy (ESGCT) Congress entitled, "Multicentre, prospective research protocol for development of a clonal neoantigen-reactive T cell therapy pipeline across multiple tumour types" highlighting the Company's Material Acquisition Platform (MAP) and supporting the potential use of cNeT in a broad range of solid tumor indications

-- Granted US patent US 11,098,121 and European patent EP3347039B covering a method of identifying cancer patients that are likely to respond to a checkpoint inhibitor (CPI) by determining the total number of clonal neoantigens or the ratio of clonal to sub-clonal neoantigens in patients' cancer cells

-- Enrolled the first patient in the United States at the Moffitt Cancer Center in the Phase I/IIa CHIRON clinical trial

-- In-licensed from Secarna Pharmaceuticals GmbH & Co antisense oligonucleotide technology and intellectual property for the ex vivo manufacture of a T cell pharmaceutical product

Financial Highlights

-- Cash and cash equivalents: Cash and cash equivalents were $281.9 million as of September 30, 2021, as compared to $177.8 million as of December 31, 2020. The Company anticipates that its cash 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 $10.7 million for the third quarter ended September 30, 2021, an increase of $5.4 million compared to $5.3 million for the third quarter ended September 30, 2020. R&D expenses were $30.4 million for the nine months ended September 30, 2021, an increase of $16.7 million compared to $13.7 million for the nine months ended September 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 $5.0 million for the third quarter ended September 30, 2021, an increase of $2.0 million compared to $3.0 million for the third quarter ended September 30, 2020. G&A expenses were $15.3 million for the nine months ended September 30, 2021, an increase of $8.2 million compared to the $7.1 million for the nine months ended September 30, 2020. 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 third quarter ended September 30, 2021 was $12.9 million or $0.34 per share compared to $8.2 million or $7.50 per share for the third quarter ended September 30, 2020. Net loss for the nine months ended September 30, 2021 was $42.9 million or $1.69 per share compared to $20.3 million or $21.16 per share for the nine months ended September 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

Achilles will present at the following medical and investor conferences in November and December 2021. Additional details will be available in the Events & Presentations section of the Company's website:

   --    Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting: November 10 - 14, 2021 
   --    Piper Sandler Annual Healthcare Conference:  November 29 - December 2, 2021 
   --    ESMO Immuno-Oncology Congress 2021: December 8 - 11, 2021 

In addition, the Company will host a live webcast and conference call on Friday, November 12, 2021 at 8:30am ET / 1:30pm UK to review the SITC presentations and provide a corporate update. The live webcast can be accessed in the Events & Presentations section of the Company's website. The conference call dial-in numbers for investors and analysts are (833) 732-1204 (toll free within the USA), 0800 0288438 (toll free within the United Kingdom) or (720) 405-2169 (outside the USA) with the access code 4795875.

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)

 
                                                                              September 30,     December 31, 
                                                                                  2021              2020 
                                                                             ---------------   -------------- 
ASSETS 
Current assets: 
Cash and cash equivalents                                                    $       281,875   $      177,849 
Prepaid expenses and other current assets                                             16,401            9,948 
                                                                                 -----------       ---------- 
Total current assets                                                                 298,276          187,797 
                                                                                 -----------       ---------- 
Non-current assets: 
Property and equipment, net                                                           16,378           13,369 
Operating lease right of use assets                                                   11,938           14,740 
Deferred tax assets                                                                        4                4 
Restricted cash                                                                           33                - 
Other assets                                                                           3,370            3,008 
                                                                                 -----------       ---------- 
Total non-current assets                                                              31,723           31,121 
                                                                                 -----------       ---------- 
TOTAL ASSETS                                                                 $       329,999   $      218,918 
                                                                                 ===========       ========== 
LIABILITIES AND SHAREHOLDERS' EQUITY 
Current liabilities: 
Accounts payable                                                             $         2,460   $        6,314 
Income taxes payable                                                                      36                7 
Accrued expenses and other liabilities                                                 8,472            6,590 
Operating lease liabilities-current                                                    4,398            3,712 
                                                                                 -----------       ---------- 
Total current liabilities                                                             15,366           16,623 
Non-current liabilities: 
Operating lease liabilities-non-current                                                8,881           12,271 
Other long-term liability                                                                643              652 
                                                                                 -----------       ---------- 
Total non-current liabilities                                                          9,524           12,923 
                                                                                 -----------       ---------- 
Total liabilities                                                                     24,890           29,546 
                                                                                 -----------       ---------- 
Commitments and contingencies (Note 12) 
Shareholders' equity: 
Ordinary shares, GBP0.001 par value; 40,603,489 and 4,389,920 shares 
 authorized, issued and outstanding at September 30, 2021 and December 
 31, 2020, respectively                                                                   54                6 
Deferred shares, GBP92,451.851 par value, one share authorized, issued and 
 outstanding at September 30, 2021; Deferred shares, GBP0.001 par value; 
 30,521 shares issued and outstanding December 31, 2020                                  128                - 
Convertible preferred shares, GBP0.001 par value; no shares authorized, 
 issued and outstanding as of September 30, 2021;104,854,673 shares 
 authorized, issued and outstanding at December 31, 2020                                   -              134 
Additional paid in capital                                                           400,058          234,922 
Accumulated other comprehensive income                                                 5,750           12,322 
Accumulated deficit                                                                 (100,881)         (58,012) 
                                                                                 -----------       ---------- 
Total shareholders' equity                                                           305,109          189,372 
                                                                                 -----------       ---------- 
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY                                   $       329,999   $      218,918 
                                                                                 ===========       ========== 
 

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

ACHILLES THERAPEUTICS PLC

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

(in thousands, except share and per share amounts)

 
                         Three Months Ended September 30,        Nine Months Ended September 30, 
                       ------------------------------------   ------------------------------------- 
                              2021                2020                2021                 2020 
                       -------------------   --------------   --------------------      ----------- 
OPERATING EXPENSES: 
    Research and 
     development       $            10,697   $        5,291   $             30,417      $    13,668 
    General and 
     administrative                  5,041            3,009                 15,318            7,140 
                           ---------------    -------------       ----------------       ---------- 
Total operating 
 expenses                           15,738            8,300                 45,735           20,808 
                           ---------------    -------------       ----------------       ---------- 
Loss from operations               (15,738)          (8,300)               (45,735)         (20,808) 
OTHER INCOME, NET: 
    Other income                     2,806               90                  2,907              529 
                           ---------------    -------------       ----------------       ---------- 
    Total other 
     income, net                     2,806               90                  2,907              529 
                           ---------------    -------------       ----------------       ---------- 
Loss before provision 
 for income taxes                  (12,932)          (8,210)               (42,828)         (20,279) 
    Provision for 
     income taxes                      (16)               -                    (41)               - 
                           ---------------    -------------       ----------------       ---------- 
Net loss                           (12,948)          (8,210)               (42,869)         (20,279) 
                           ---------------    -------------       ----------------       ---------- 
Other comprehensive 
income: 
    Foreign exchange 
     translation 
     adjustment                     (7,710)           3,501                 (6,572)          (3,088) 
                           ---------------    -------------       ----------------       ---------- 
Comprehensive loss     $           (20,658)  $       (4,709)  $            (49,441)     $   (23,367) 
                           ---------------    -------------       ----------------       ---------- 
Net loss per share 
 attributable to 
 ordinary 
 shareholders-basic 
 and diluted           $             (0.34)  $        (7.50)  $              (1.69)     $    (21.16) 
                           ===============    =============       ================       ========== 
Weighted average 
 ordinary shares 
 outstanding-basic 
 and diluted                    38,261,480        1,094,543             25,329,672          958,373 
                           ===============    =============       ================       ========== 
 

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

MSCFLFFVLDLAIIL

(END) Dow Jones Newswires

November 09, 2021 08:31 ET (13:31 GMT)

Syncona (LSE:SYNC)
Gráfica de Acción Histórica
De Dic 2021 a Ene 2022 Haga Click aquí para más Gráficas Syncona.
Syncona (LSE:SYNC)
Gráfica de Acción Histórica
De Ene 2021 a Ene 2022 Haga Click aquí para más Gráficas Syncona.