Key Investment Highlights for StageZero Life Sciences, Ltd
StageZero Life Sciences, Ltd (“StageZero” or “the Company”) is a revenue-generating innovator in the liquid biopsy space, focused on developing and commercializing proprietary blood-based diagnostic solutions to aid in the detection of cancer at the earliest possible stage, as well as other disease states.
The Company’s proprietary Sentinel Principle® technology platform is a liquid biopsy technology that uses a blood sample to detect cancer and other disease. The technology is based on the scientific observation that circulating blood reflects, in a detectable way, what is occurring throughout the body. Thus, by conducting a minimally invasive blood draw, the Company can analyze the blood sample to detect cancer and other diseases.
StageZero believes that its products can improve a patient’s prognosis. Early detection of cancer has been proven to improve survival rates and quality of life, and yet 40% of screenable cancers are diagnosed late.
The science behind the Sentinel Principle® led to the development of the Company’s flagship product, ColonSentry®, a blood-based test for assessing an individual’s risk of having colorectal cancer (CRC). Initially developed from a clinical study involving approximately 10,000 subjects, ColonSentry® was commercialized in 2014 and has been used successfully in over 100,000 patients throughout the U.S.
ColonSentry® is a patient-friendly, blood-based test that can be easily incorporated into a patient’s routine annual exam, providing significant clinical advantages: (1) patients are two-times more likely to comply with a colonoscopy following an elevated ColonSentry® score; (2) it increases the effectiveness of colonoscopies, detecting 2.1 to 4.7 times more CRC lesions following a ColonSentry® test; and (3) it provides financial benefits reducing healthcare costs by more than 20% through early interventions.
StageZero also offers diagnostics tests to assess the probability of having four of the most prevalent cancers: CRC, lung (EarlyCDT®-Lung), prostate (Prostate Health Index [phi]), and breast cancer (BreastSentry™).
StageZero is utilizing its Sentinel Principle® technology for the development of its next generation test, Aristotle™, expected to launch in 2021. Aristotle™ is a multi-cancer panel for the simultaneous screening of 10 cancers (CRC, prostate, cervical, endometrial, breast, ovarian, liver, bladder, nasopharyngeal, and stomach cancer) from a single blood sample.
The Company is also planning to expand the applications of Aristotle™ beyond oncology, to help in the diagnosis of disease in gastroenterology, neurology, cardiology, and autoimmune disorders.
The Company’s commercialization strategy aims to shorten the lengthy market-entry process of new diagnostic tests, targeting four market segments: (1) physician practices; (2) telemedicine–consumer directed; (3) large healthcare systems; and (4) large employers/high risk populations.
On March 2019, StageZero launched its first nationwide telehealth initiative, making its phi test available for online purchase through its portal com. The Company has begun to process initial patient orders.
The Company has experienced early success with a Midwest hospital system. It has initiated a contract with a large healthcare system to offer its array of cancer screening tools and has engaged with other healthcare groups.
In the large employer/high risk market, StageZero began screening firefighter groups, and has been engaged with another large employer, with over 100,000 employees, for the use of its products.
The Company also operates a CAP-accredited and CLIA-certified laboratory based in Richmond, Virginia that conducts sample processing for the ColonSentry® test as well as for the licensed biomarker tests for lung, breast, and prostate cancers.
StageZero’s long term goals center around two key milestones: achieving profitability (2020) and launching the Aristotle™ test (2021). As of September 30, 2019, the Company had $411,445 in cash and cash equivalents.