Syncona Limited — Earnings Release 2022

Aug 9, 2022

National Storage Mechanism | Additional information

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.

[ENDS]

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 €4 million ($4.2 million1) research and innovation award as part of a consortium to develop a first-in-class smart bioprocessing manufacturing platform, with €1.4 million ($1.5 million1) 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™ bioinformatics platform and proprietary VELOS™ 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™ 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 €1.000 = $1.043

**Investors:

Achilles Therapeutics

Lee M. Stern, VP, IR & External Communications

[email protected]

LifeSci Advisors

John Mullaly

**[email protected]

**Media:

Consilium Strategic Communications**

Mary-Jane Elliott, Sukaina Virji, Melissa Gardiner

+44 (0) 203 709 5000

[email protected]

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, £0.001 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, £92,451.851 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

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,
		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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