Interim Results for the six months ended 30 June 2022
FDA CLEARANCE A MAJOR BREAKTHROUGH FOR PARSORTIX LIQUID BIOPSY
Prostate cancer partnership signed with Solaris Health
Positive ovarian cancer headline results announced today
GUILDFORD, UK / ACCESSWIRE / September 29, 2022 / ANGLE plc ("ANGLE" or "the Company") (AIM:AGL)(OTCQX:ANPCY), a world leading liquid biopsy company, today announces its unaudited interim financial results for the six months ended 30 June 2022.
FDA De Novo clearance received for the Parsortix® system for its intended use with metastatic breast cancer (MBC) patients
first ever FDA product clearance to harvest cancer cells from a patient blood sample for subsequent user-validated analysis
first mover advantage for intact cancer cell analysis in the global liquid biopsy market
with FDA clearance and CE Mark in place, commercial roll-out underway with global distributor network being established
Global pharma services business momentum encouraging
additional $1.2 million contract from first large-scale pharma services customer in new clinical trial
increased pharma industry engagement post FDA clearance
excellent progress with first bespoke assay customer with DNA damage repair assay successfully developed
Analysis of samples from ovarian cancer clinical verification study completed
excellent headline results with ROC-AUC 95.4%, as separately announced today
results demonstrate clinical validity employing molecular analysis of cancer cells captured using the Parsortix system in a difficult to diagnose real world setting
Partnership established with Solaris Health, a major United States urology group
collaboration to evaluate the Parsortix system in prostate cancer clinical studies, addressing major unmet medical needs
Solaris Health offers route to market through its extensive patient base
Revenue for the half-year £0.4 million (H1 2021: £0.3 million)
Loss for the half-year £9.2 million (H1 2021: £7.7 million) reflecting planned investment
Cash and cash equivalents at 30 June 2022 of £20.5 million (31 December 2021: £31.8 million)
Post period end, a further £20.1 million (£18.9 million net of expenses) was raised in a placing which was supported by new and existing institutional investors in both the UK and United States as well as senior management
Pharma services business momentum - discussions in progress with more than twenty biopharma companies offering a pipeline of opportunities for new contracts as we move through the end of this year and into 2023. Almost all potential customers are interested in bespoke assay development
Global sales and distribution network being established with first contracts in negotiation and initial seeding of instruments anticipated
Accreditation of clinical laboratories in final stages offering ability to offer validated tests for both pharma services and patient management in coming months
New product roll-out to accelerate with a pipeline of sample-to-answer imaging and molecular solutions being finalised for offer to customers
Numerous discussions in progress with potential partners including medtech companies, downstream assay providers and clinical laboratories regarding selected Parsortix based assays
Continued investment in clinical studies to provide clinical evidence to support long term growth
Garth Selvey, Non-Executive Chairman of ANGLE plc, commented:
"I am delighted that during the period the FDA granted a De Novo Class II classification for the Parsortix system for use in harvesting cancer cells from metastatic breast cancer patient blood for subsequent user-validated analysis. Clearance substantially differentiates ANGLE from the competition and is expected to significantly accelerate commercial adoption of the system in both research and clinical settings.
ANGLE's global pharma services business is gaining traction, with a notable increase in potential customer engagement in the weeks post-FDA clearance and subsequently. We are pleased to see repeat business already coming through from an early major customer and the successful development of our first bespoke assay for another as we start to build our service offering 'menu'.
Demonstration of clinical utility is a key strategic goal for the Company. The positive headline results for the ovarian cancer pelvic mass triage test announced today provide a real world example of the value of molecular analysis of the Parsortix harvest of circulating tumour cells and support the Company's view that this is the "best sample" for analysis for a liquid biopsy.
Shortly after the period end, ANGLE successfully completed a fundraising of £20.1 million (£18.9 million net of expenses). Recognising the current adverse market conditions and wider macroeconomic environment, ANGLE continues to keep a tight focus on building revenues, controlling costs and maximising the cash runway within available funds whilst ensuring key commercial milestones are delivered."
Details of webcast
A virtual meeting and webcast for analysts will be held at 11:00 am BST today. If you wish to attend, please register in advance and log on to the webcast approximately 5 minutes before 11.00 am. Details of how to attend can be accessed via https://angleplc.com/investor-relations/corporate-presentations/.
For further information:
+44 (0) 1483 343434
Andrew Newland, Chief Executive
Berenberg (NOMAD and Joint Broker)
+44 (0) 20 3207 7800
Jefferies (Joint Broker)
+44 (0) 20 7029 8000
The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the EU Market Abuse Regulation (596/2014). Upon the publication of this announcement via a regulatory information service, this information is considered to be in the public domain.
For Frequently Used Terms, please see the Company's website on https://angleplc.com/investor-relations/glossary/
These Interim Results may contain forward-looking statements. These statements reflect the Board's current view, are subject to a number of material risks and uncertainties and could change in the future. Factors that could cause or contribute to such changes include, but are not limited to, the impact of the COVID-19 pandemic, the general economic climate and market conditions, as well as specific factors including the success of the Group's research and development activities, commercialisation strategies, the uncertainties related to clinical study outcomes and regulatory clearance, obtaining reimbursement and payor coverage, acceptance into national guidelines and the acceptance of the Group's products by customers.
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SOURCE: ANGLE plc
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