Trinity Delta Post-FDA approval commercial momentum is building

Post-FDA approval commercial momentum is building

Lighthouse | 29 September 2022

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ANGLE’s H122 results detail the multiple applications being actively pursued following the May FDA clearance of Parsortix to harvest cancer cells from patient blood for subsequent analysis in mBC (metastatic breast cancer). This clearance was a major endorsement for Parsortix use as a simple liquid biopsy to aid diagnosis and, importantly, guide treatments. The unrivalled flexibility, consistency, and clinical insights it provides mean that, even with difficult to diagnose tumours, Parsortix’s CTC harvesting platform can form the basis of multiple and varied diagnostic test formats.
Separately, positive outcomes from the Wilmot ovarian cancer clinical validation study were announced. This 144-patient study examined if a Parsortix blood test can be used to determine whether a suspect pelvic mass is malignant or not. A highly accurate & reliable diagnostic would be of great clinical value. In this study, Parsortix, combined with ANGLE’s Landscape+ ovarian assay and predictive algorithm reported an ROC-AUC (receiver operating characteristics curve) of 95.4% (90-100% is considered ‘excellent’), in line with the 2018 200-patient study (ROC-AUC of 95.1%).
The detailed data are: 90% sensitivity, 93% specificity, 86% PPV (positive predictive value), 95% NPV (negative predictive value), 7% FPR (false positive rate), 10% FNR (false negative rate), & 92% accuracy. For context, the physicians’ initial risk assessment for this cohort had 75% sensitivity, 86% specificity, 74% PPV, 87% NPV, 14% FPR, 25% FNR, 83% accuracy. Thus, the Parsortix CTC-based algorithm would help more accurate early triage of women with an abnormal pelvic mass to appropriate treatments.
The results highlighted progress in developing a series of in-house assays as well as traction in client acquisition within ANGLE’s clinical laboratories, where discussions with >20 potential customers are ongoing. These, and other activities, should act as important demonstrators of Parsortix’s utility and accelerators of market awareness, the creation of appropriate reimbursement codes, and adoption among the clinical customer base.
End-June 2022 cash and equivalents were £20.5m (end-December 2021: £31.8m), with R&D tax credits of £4.5m due in H222. July’s £18.9m (net) equity raise, coupled with effective cost control, means commercialisation plans are, under our forecasts, funded through to mid-2024.

Trinity Delta view: May’s FDA clearance was a major validation of Parsortix’s utility; with numerous further studies endorsing its value as a diagnostic in multiple tumour settings. Management’s challenge is addressing these wide-ranging potential uses in a systematic, effective, and efficient manner. H122 results highlight the strategy to address a variety of distinct diagnostic segments, with both near- and longer-term objectives, is gaining momentum. The recent £18.9m equity raise removes near-term financial uncertainty. We value ANGLE at £506m ($658m), equivalent to 215p/share, with significant upside once Parsortix’s positioning becomes clearer.

Lighthouse

29 September 2022


Price	64.0p
Market Cap	£166.7m
Primary exchange	AIM London
Sector	Healthcare
Company Code	AGL

Corporate client	Yes

Company description

ANGLE is a specialist diagnostics company. Its proprietary Parsortix technology can capture and harvest very rare cells, including CTCs (circulating tumour cells), from a blood sample. The FDA approval for its clinical use to guide precision cancer care will open up further multiple commercial opportunities.

Analysts

Lala Gregorek
lgregorek@trinitydelta.org
+44 (0) 20 3637 5043

Franc Gregori
fgregori@trinitydelta.org
+44 (0) 20 3637 5041

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