Preliminary Results for the year ended 31 December 2022
FDA CLEARANCE A MAJOR BREAKTHROUGH FOR PARSORTIX LIQUID BIOPSY
Parsortix system substantially out-performs standard of care for ovarian cancer diagnosis
Prostate cancer partnership signed with Solaris Health
Pipeline of opportunities growing strongly
ANGLE plc (AIM: AGL OTCQX: ANPCY), a world-leading liquid biopsy company, today announces audited preliminary results for the year ended 31 December 2022.
2022 was a breakthrough year for ANGLE, with both FDA clearance and excellent results from the ovarian cancer study. These achievements have placed ANGLE in a strong position to play a leading role in the emerging liquid biopsy market for personalised cancer care and is reflected in strong growth in unaudited revenues in Q1 2023 year-on-year.
· FDA De Novo clearance received for the Parsortix® PC1 Clinical System for its intended use with metastatic breast cancer (MBC) patients
- first ever FDA product clearance to harvest intact cancer cells from a patient blood sample for subsequent user-validated analysis
- multiple global distribution agreements secured to support commercial roll-out
· Increased pharma industry engagement post FDA clearance
- repeat contract, worth up to $1.2 million, from large-scale pharma customer
- assay development contract successfully delivers DNA Damage Repair (DDR) assay
- ISO 15189 accreditation received for the United States laboratory
· Ovarian cancer
- excellent headline results from ovarian study with ROC-AUC 95.4%
- results demonstrate clinical validity employing molecular analysis of cancer cells captured using the Parsortix system in a difficult to diagnose real-world setting
· Prostate cancer
- partnership established with Solaris Health, a major United States urology group to evaluate the Parsortix system in prostate cancer
- clinical study now underway and expected to complete during 2023
· Revenue £1.0 million (2021: £1.0 million) as previously communicated
· Loss for the year £21.7 million reflecting planned investment (2021: loss £15.0 million)
· Fundraising from institutional investors, including existing and new institutional investors, raising gross proceeds of £20.1 million (£18.9 million net of expenses)
· Cash and cash equivalents at 31 December 2022 of £31.9 million (2021: £31.8 million) with R&D Tax Credits due at 31 December 2022 of £2.8 million (2021: £4.5 million)
2023 Progress and Outlook
· 2023 product and services revenues both progressing well with unaudited Q1 2023 revenue strongly ahead year-on-year
· Pharma services business growing well with new customers, such as Crescendo Biologics, and a growing pipeline of opportunities under discussion
· Strong repeat pharma services business model being demonstrated with existing customers signing additional contracts
· Prostate cancer pilot study enrolment on track for headline data around the end of 2023
· Corporate deal signed with BioView for development of a HER2 breast cancer test, to deliver revenues of c. £1.2 million in the initial phase, and with the prospect of adding other large corporate partners in due course
· Encouraging initial results from third-party molecular tests on the Parsortix CTC harvests opening the potential for high value molecular tests in the future for pharma services and clinical use
· Shortly after the year-end, two new Non-Executive Directors were appointed strengthening the Board for the next phase of the Company's development
· Current pipeline of commercial opportunities supports management's confidence in delivering strong growth in 2023 and beyond
Garth Selvey, Non-Executive Chairman of ANGLE plc, commented:
"2022 was a breakthrough year for ANGLE with the world's first ever FDA product clearance for a system to harvest CTCs, intact living cancer cells, from metastatic breast cancer patient blood for subsequent analysis. This was followed by ANGLE's ovarian cancer study demonstrating the clinical validity of analysing Parsortix CTCs for real-world clinical applications.
We are executing on our strategy to commercialise the Parsortix system through: a product business, with distribution partners for Parsortix instruments and consumables; and a services business, to utilise the Parsortix system in cancer drug trials and as an accelerator and demonstrator to support product sales. In both business areas, ANGLE is looking to leverage corporate partnerships to accelerate multiple commercial opportunities through clinical validation, regulatory approval and reimbursement authorities.
The increasing number of published studies for a variety of cancer types combined with the FDA clearance have placed ANGLE in a strong position to play a leading role in the emerging liquid biopsy market for personalised cancer care. The CTCs harvested by the Parsortix system have wide applicability for diagnosis, treatment selection and monitoring to improve patient outcomes and reduce healthcare costs.
We are pleased to see that 2023 has started strongly and look forward to continued commercial progress in the year ahead."
Details of webcast
A virtual meeting for analysts will be held at 10:00 am BST today. A live webcast of the analyst meeting can be accessed via ANGLE's Investor Centre page, https://angleplc.com/investor-relations/regulatory-news/, with Q&A participation reserved for analysts only. Please register in advance and log on to the webcast approximately 5 minutes before 10:00 am on the day of the results. A recording of the webcast will be made available on ANGLE's website following the results meeting.