Angle plc Announces Business News

ANGLE plc, a leading liquid biopsy company in the world, has provided a report on business progress and an unaudited update for trading for 2022.

2022: A breakthrough year

GUILDFORD SURREY/ACCESSWIRE/January 5, 2023 2022 was a landmark year for ANGLE. It received the FDA’s world-first product approval for a system that can harvest cells from patients blood to be analysed. This followed a long and hard work by the Company over 6 years. These efforts included extensive dialog with FDA and submission of more than 400 technical documents. The Company also processed over 16,000 samples in order to show system performance. This was followed up by ANGLE’s pivotal ovarian carcinoma study, which produced best-in-class results of 93% and 90% respectively. These numbers are far superior to the standard of care in the detection and treatment of ovarian tumors.^(r) System for clinical decision making in real life

These accomplishments have put ANGLE in a position to lead the US$ 100 Billion liquid biopsy market. This is personalised cancer care. ANGLE provides intact cells for analysis. It also gives the best sample for guiding treatment decisions. ANGLE has three key elements in its plan to commercialize the Parsortix System. These include a pharma business that will use the Parsortix systems in drug trial trials for early revenue, a corporate partnership company to integrate Parsortix with downstream analytical techniques, and a product-business with partners from different regions to distribute Parsortix consumables and instruments.

Take action to manage market conditions

ANGLE, like many other businesses in this sector, has faced wider market and economic headwinds. These have intensified during the second quarter of 2019. ANGLE responded to market conditions by moving quickly after FDA approval in July 2022 to raise PS20.1million (PS18.9million net of expenses). This was to help the Company commercialise its plans up to mid-2024. ANGLE then began a restructuring of H2 operations to expand the cash runway to H2 2024 to meet the challenges of the market.

These proposed changes to UK’s R&D tax credit scheme made it 50% more costly to do R&D in Canada than in the UK. This led to Company closing its Canadian operations. All R&D will be centralized at Company facilities in UK. This change has been implemented quickly by the Company, and it has just completed an orderly winding down of its Canadian facilities.

It was also decided to shift the focus of development of downstream molecular analyses of Parsortix-harvested cancer cells to third-party platforms, in place of the Company’s HyCEAD Ziplex platform. Although the latter was highly sensitive and effective in analysing Parsortix liquid biopsy specimens, it required substantial ongoing investment in order to allow for the assay to become a product (as opposed only being offered by ANGLE clinical labs). Third-party molecular platforms, with their improved sensitivity and lower cost, now have an extensive inventory of products on the market that can be used for Parsortix new applications.

ANGLE has experienced a slower commercial acceleration since FDA clearance. However, the Company continues to pursue its strategy and fulfill the potential of Parsortix. Management team will be focusing their resources on the Company and expecting 2023 to bring more progress for ANGLE, in preparation for rapid growth. However, this could take longer until broader market conditions stabilize.

Unaudited Trading Update for 2022 and Outlook 2023

The cost-control measures taken and Canadian operations closed are expected to result in cost savings of PS2.6million by 2023, and PS4.0million per year thereafter. This closure resulted not in cash write-offs for intangible assets or tangible assets of c. PS1,000,000 and closure costs of c. PS1,000,000.

Expected cash at the year-end 2022 will be close to expectations, at around PS32 million. The Company also has no debt. The reported revenue for 2022 will be slightly higher than the expected PS1 million. Operating loss is for the same year at approximately PS22 million. This excludes one-off closing costs for Canada. Due to market delays and the impact of a variety of sales, approximately PS0.5 million in revenue is not expected to be recognized in 2023.

The current market environment has made it difficult for many pipeline opportunities to be created. Some customers have shifted their focus to longer term assets, while others are taking extra buyer care. Although revenue for 2023 will show strong growth, it is likely that they will be significantly below market expectations.

The Company already received several orders in January. This may be a sign that customers are awaiting their budget year to begin. Both the pharma and product sales pipelines are strong and growing. The Company’s distribution network expansion is progressing according to plan. The company remains optimistic about the future of the business and is delivering commercial milestones, increasing revenues, and controlling costs.

Opportunities for growth

The pharma services pipeline is experiencing significant expansion

Near term revenue potential in large-scale cancer drug trials markets where ANGLE has a distinct advantage continues to be available for the pharma services industry. With FDA approval, pharma has more opportunities and potential customers for pharma services. Numerous new clients and projects are currently being discussed, even with large pharma companies. The sales process of pharma services is often slow and some opportunities have been delayed by market conditions. The business has a lot of repeat customers, and the prospects are very optimistic for its rapid growth. We are looking forward to sharing more updates.

Accreditation of laboratories is a step forward

ANGLE is seeking accreditation for its US and UK clinical labs to support its pharma service business. ANGLE is happy to announce that ISO 15189 accreditation has been granted for the United States lab. The UK laboratory will be receiving this accreditation soon. It is a significant achievement that demonstrates that ANGLE clinical laboratories adhere to internationally recognized quality standards. For pharma service customers, this is especially important as it provides evidence that laboratories have been subjected to external inspections by recognized organisations. CLIA accreditation is required to manage patients in the United States. Registration and preparation are complete. The process will end once LDTs (laboratory-developed tests) have been offered by the labs.

Partnerships between corporations

ANGLE has been in talks with potential partners regarding the development of an assay to detect breast cancer’s HER-2 status. This programme is now more urgent due to recent developments regarding the approval of drugs that are “HER-2-low” status.

ANGLE reviewed third-party molecular system reviews and has concentrated its resources to evaluate the Parsortix sample performance in conjunction with several third-party downstream DNA sequencing technology. These initial results have shown encouraging signs and ANGLE hopes this will lead to partnerships with technology suppliers who want to include “content” in their product offerings.

Establishing a network with distribution partners

ANGLE is committed to generating longer-term product revenue. ANGLE expanded its commercial operations staff in the past year. Following FDA approval, ANGLE established international agreements with partners to create an oncology-focused distribution network in Europe. This includes Germany, Austria Czech Republic, Switzerland, France, Germany, China and India. Other geographies are under consideration. All of these partners provide invaluable sales, service and support to their markets. Our expectation is that product sales will increase gradually, with growth being spurred by downstream assays and clinical utility processes.

Adoption assays development

ANGLE developed a series of imaging tests (branded Portrait) to help support the adoption of its technology.⁺), and molecular assays.⁺To analyse cancer cells taken by Parsortix, click here. These tests are intended to create a menu of ANGLE’s pharma service business. They will also be used to sell products to third parties through the expanding distribution network that is compatible with the Parsortix.

Assay for ovarian carcinoma: refinement of plans

ANGLE carefully considered which commercial route to take after the positive results of its ovarian carcinoma study. The Landscape was designed to maximise commercial potential, recognize the increased sensitivity and lower costs of molecular systems that have an existing installed base and is geared towards maximising the market.⁺ A third-party molecular platform will be used to optimize ovarian assay. At the moment, several candidates are being tested. The optimised assay may be validated using patient samples from studies that have been completed. This approach has the advantage that it leverages the existing third-party installed base, providing them with content. It will also allow for a more extensive product-based marketing strategy to ovarian cancer.

Prostate cancer research is moving forward

ANGLE continues to use the Parsortix system for prostate cancer screenings in conjunction with Solaris Health Holdings, LLC / MidLantic Urology LLC. Solaris plans to market a Parsortix prostate test annually to its 729,000 patients in 2023.

Andrew Newland (Angle Founder and Chief Executive) commented on the matter:
It has been a great year for ANGLE with FDA approval and outstanding results from our ovarian cancer research. Although we haven’t seen the anticipated revenue growth, we see a strong pipeline and are excited by our engagement with major pharmaceutical companies as well as medtech and clinical labs around the world. ANGLE is able to execute its commercial and strategic plans. Despite the market challenges, we are cautiously optimistic about the future.

More information is available here

This announcement may be regarded by the Company as inside information, in accordance with the EU Market Abuse Regulation (596/2014).. This information will be considered public upon publication via regulatory information services.

For Frequently Used Terms, please see the Company’s website on https://angleplc.com/investor-relations/glossary/

Notes to editors

About ANGLE plc www.angleplc.com
ANGLE, a liquid biopsy company that offers sample-to-answer services is a global leader. The Parsortix is ANGLE’s patent-protected circulating tumor cell harvesting technology.^(r) system.

ANGLE’s Parsortix^(r) FDA approved for use in metastatic breast carcinoma. It is the only FDA-approved medical device that can harvest intact cancer cells from blood.

Use intended

Parsortix^(r) The PC1 system, an in vitro diagnostic tool that enriches circulating tumor cells (CTCs), from peripheral blood taken in K₂Patients with metastatic breast carcinoma received EDTA tubes. This system uses a Parsortix cell separator cassette, a microfluidic chamber to extract cells that are a specific size from blood cells. Parsortix PC1 uses the cells in the cassette to extract them for subsequent downstream analyses. Any downstream test must be validated by the end user. The standalone device, as indicated, does not identify, enumerate or characterize CTCs and cannot be used to make any diagnostic/prognostic claims for CTCs, including monitoring indications or as an aid in any disease management and/or treatment decisions.

Parsortix allows for a liquid biopsy, which is a quick blood test that provides the metastatic breast cells in the body to the user. This format can be used for many types of downstream analysis. It is built on the microfluidic technology that can capture cells according to their size and compression. It is independent of epitopes and captures all types of CTCs, including mesenchymal, epithelial and EMTing CTCs. CTCs can be taken from the system to provide a full picture of cancer. They are able to perform DNA, RNA, and protein analyses as well as clinical examinations. CTC analysis, which is non-invasive and not like tissue biopsy, can be repeated whenever necessary. Because cancer evolves over time, and patients have a medical need to know the current status of their tumors, this is crucial. The Parsortix system allows for the culture of live CTCs, which can then be used to test the tumor’s response to other drugs.

Parsortix technology has been granted 26 patents worldwide, including in the United States, China and Australia. Three large families of patents, which cover the Parsortix technology, are currently being developed around the world.

The Parsortix is a US-based company.^(r) FDA has granted PC1 a Class II Classification for its use in metastatic breast cancer patients. FDA approval is considered the gold standard worldwide. Parsortix, the FDA-approved system to harvest CTCs and then analyze them is first by ANGLE. ANGLE applied the IVD CE Mark for the same purpose in Europe to the same system.

ANGLE also conducted three 200-subject clinical studies as part of a program to create an ovarian carcinoma pelvic mass triage testing. The results showed best in class accuracy of 95.4%, specificity of 93% and sensitivity of 90%. The Parsortix system is considered the best sample for liquid biopsy analysis. It recovers living cells from cancer and provides prospective information.

ANGLE is a member of major corporations such as QIAGEN and Philips, which has formed formal partnerships with top-notch cancer centers. It also works closely with CTC translational research clients. The Key Opinion Leaders are responsible for identifying applications that have clear medical utility and securing clinical data to support that utility. Our own research in metastatic breast and ovarian cancers and our KOLs’ peer-reviewed papers and posters from 33 independent centres are proving the Parsortix system has many benefits.

ANGLE established two clinical services labs in the UK and USA to speed up the commercialisation of Parsortix and to act as demonstration sites for product development. These laboratories provide services to global pharmaceutical and biotech clients for Parsortix use in cancer drug trial trials. Once the tests have been validated and accredited, they will be able to offer Laboratory Developed Tests (LDTs), for patient management.

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SOURCE: ANGLE plc