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November 18, 2022 Newswires
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Management Discussion and Analysis

Canadian Equity Markets (Alternative Disclosure) via PUBT

STAGEZERO LIFE SCIENCES LTD.

MANAGEMENT'S DISCUSSION AND ANALYSIS

For the three-month and nine-month periods ended September 30, 2022 and 2021

[Expressed in US dollars unless otherwise noted]

The following discussion and analysis ("MD&A") provides management's perspective on the financial position and results of operations of StageZero Life Sciences Ltd. ("StageZero Life Sciences" or the "Company") on a consolidated basis for the three-month and nine-month periods ended September 30, 2022 and 2021, and it should be read in conjunction with the audited consolidated financial statements for the years ended December 31, 2021 and 2020, which have been prepared by management in accordance with International Financial Reporting Standards ("IFRS") as issued by the International Accounting Standards Board ("IASB") and using the accounting policies described therein. While the presentation currency of the consolidated enterprise remains United States dollars (USD) the functional currency of Clinics Operations Ltd. is Great British Pounds (GBP). The most recent audited consolidated financial statements and annual information form ("AIF") are available on SEDAR at www.sedar.com and on the StageZero Life Sciences website: www.stagezerolifesciences.com.

The audit committee of the board of directors (the "Audit Committee") and the board of directors (the "Board") have reviewed and approved the contents of this MD&A, which was current as at November 14, 2022.

The use of "Company" and "StageZero Life Sciences" in all forms refers to StageZero Life Sciences Ltd. and its subsidiaries, unless otherwise noted. The use of "our", "we" and "us" in this document refers to StageZero Life Sciences or its management. Our registered offices are located in Richmond Hill, Ontario, Canada, near Toronto, and we have the following wholly owned subsidiary companies, StageZero Holdings Inc., which owns 100% of our US subsidiaries, StageZero Life Sciences Inc., Care Oncology Inc. and SZ Physician Holdings, Inc. In addition, Clinics Operations Limited in the UK is owned by StageZero Life Sciences, Ltd.

FORWARD-LOOKING STATEMENTS AND GOING CONCERN UNCERTAINTY

This MD&A contains certain forward-looking statements identified by words such as "believe", "anticipate", "estimate", "expect", "intend", "may", "will", "would" and similar expressions as well as negative variations thereof, although not all forward-looking statements contain these identifying words. There are a number of risks, uncertainties and other factors that could cause our actual results to differ materially from those indicated or implied by forward- looking statements. See "Risk Factors". We cannot guarantee the outcome of plans, intentions or expectations disclosed in forward-looking statements and you should not place undue reliance on these forward-looking statements. Any forward-looking statements represent our estimates at the time such statements are made only, and they should not be relied upon as representing our estimates as at any subsequent date. We do not assume any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Specifically, this MD&A contains forward-looking statements regarding (i) our ability to secure new financing on reasonable terms and continue to operate as a going concern; (ii) the success and profitability and our ability to support the commercialization of our product and in-licensed tests; (iii) the impact of the trading patterns on our share price;

  1. the impact of dilution on existing shareholders given the nature of new financings which we obtain; (v) the impact of regulators' actions, including the Toronto Stock Exchange and the Ontario Securities Commission on our business;
  1. the success of our collaborations and strategic partnerships to generate sufficient revenue to support our operations; (vii) the demand for our products; (viii) our ability to obtain any necessary regulatory approvals for our products and processes; (ix) the likelihood of our products gaining reimbursement by third-party payers, such as private health insurers, managed-health organizations and state-sponsored health insurance plans for each jurisdiction in which our products are offered; (x) our ability to protect our competitive position through patents, trade secrets, trademarks, know-how and other intellectual property rights; (xi) our compliance with privacy laws; (xii) our sales, marketing and distribution strategy; (xiii) our ability to manage corporate growth, commercial expansion and interruptions of operations; (xiv) changes to key personnel; (xv) changes to foreign exchange rates; (xvi) changes in interest rates; (xvii) litigation; (xviii) material weakness in financial controls; (xix) fluctuations in quarterly results;
  1. the current enterprise value assigned by the market; and (xxi) general business and economic conditions.

StageZero Life Science, Limited

Management's Discussion & Analysis

[Expressed in US dollars, unless otherwise noted]

In developing the forward-looking statements in this MD&A, we have applied several material assumptions, including those related to general business and economic conditions as well as our ability to attract new financing on reasonable terms.

As there can be no certainty as to the outcome of the above matters, there is material uncertainty that may cast significant doubt about the Company's ability to continue as a going concern.

BUSINESS

StageZero Life Sciences is a vertically integrated healthcare company devoted to improving the early detection and management of cancer and other chronic diseases through leading-edge molecular diagnostics and clinical interventions.

On September 2, 2021, the Company acquired 100% of the shares of Clinics Operations Limited ("COL"), a company incorporated in the United Kingdom ("UK") and, through the Company's newly incorporated subsidiaries CareOncology Inc.("COI") and CareOncology Physicians ("COP"), the operating assets of Health Clinics USA Corp., both from Health Clinics Limited ("HCL"), the ultimate parent of both entities

COI and COL (collectively "CareOncology") offers telemedicine-based clinical services globally with a focus in the US and the UK through three specific clinical programs, the CareOncology Protocol (TREAT), COC Plus and AVRT.

StageZero Life Sciences, Inc. is focused on developing and commercializing proprietary molecular diagnostic tests for early detection of diseases and for personalized health management, with an initial focus on cancer-related indications. We have developed a powerful approach to identifying unique RNA-based biomarkers from whole blood. We call this proprietary platform technology the Sentinel Principle®. It has the ability to detect virtually any disease or medical condition from a simple blood sample. The science behind the Sentinel Principle® led to the development of our first commercial product, ColonSentry®, a blood-based test for assessing an individual's current risk of having colorectal cancer. Our newest program called Aristotle®, also developed using the Sentinel Principle®, is the first mRNA-basedmulti-cancer detection panel using a single sample of blood and focuses on detecting cancer early, when interventions can often be most effective.

StageZero Life Sciences, through its Sentinel Principle®, is one of the founders of the Liquid Biopsy principle. The Sentinel Principle® is an award-winning technology developed by StageZero Life Sciences based on the scientific observation that gene signatures among components circulating in the blood reflect, in a detectable way, what is occurring throughout the body. This is a result of the constant and dynamic interaction of blood with cells, tissues, and organs of the human body. Many clinical studies have demonstrated that gene expression profiles from blood can be used to develop personalized signatures capable of differentiating patients with cancer from healthy patients across a broad spectrum of pathologies. ColonSentry® and Aristotle® specifically measure gene expression in white blood cells. Tumors are known to affect the gene expression profiles of circulating white blood cells. This occurs due to a unique interaction between tumor cells and the immune system that has been referred to as "immunoediting." Immunoediting is the response of the immune system to a tumor and comprises three stages: elimination (in which the immune system identifies cancerous and/or precancerous cells and attempts to eradicate them), equilibrium (in which the surviving tumor cells begin mutating rapidly), and escape (in which tumor cells proliferate uncontrollably, leading to tumor progression). Each of these stages induces leukocyte gene expression changes that constitute a unique, detectable molecular signature.

We offer early cancer diagnostics and risk stratification via Aristotle, our multi-cancer panel for the detection of multiple discrete cancers from a single sample of blood as well as individual tests for colorectal, prostate and breast cancers, through several novel, molecular diagnostic platforms at our wholly owned CAP accredited and CLIA certified high-complexity laboratory in Richmond, Virginia. The Company continues to focus our commercialization strategy on the adoption of our proprietary cancer tests with clinical integrated networks, physician groups, employers, and consumers. See Liquid Biopsy Testing below.

.

MD & A

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StageZero Life Science, Limited

Management's Discussion & Analysis

[Expressed in US dollars, unless otherwise noted]

The Company initiated COVID-19 testing in April 2020, had high volume until early 2022 and now provides a walk in facility in Richmond VA . See COVID Tests below.

With the acquisition and integration of CareOncology, StageZero Life Sciences' business expanded to include two new clinical offerings that facilitate revenue accumulation and acceleration beyond lab-based testing. The Company expanded its offering to include programs geared towards early detection (AVRT) and treatment (TREAT and COC Plus.). During Q3, the Company further refined its program offerings to better meet the needs of current patients and the requests from new patients.

Early cancer screening is not only important, but identification of attendant risk factors and then introduction of risk factor modification programs are essential.

StageZero/CareOncology has been positioned for exactly this purpose:

  • Aristotle, the first ever mRNA multi-cancer panel for simultaneously screening for multiple cancers from a single sample of blood, to screen for cancer today;
  • the CareOncology metabolic pathway screen, researched and developed for screening for those risk factors that contribute to developing cancer tomorrow;
  • the CareOncology Risk Factor Modification programs to guide risk reduction for patients that flag positive (initially demonstrated in the glioblastoma study publication 2), with oversight from experienced metabolic oncologists that are linked via telehealth.

AVRT is a patient-centric, personalized care plan that specializes in identifying and treating the early warning signs of cancer and other chronic diseases. Created by the physicians and scientists who developed the COC Protocol, AVRT uses similar approaches to detect and target the inflammatory and metabolic pathways that have been demonstrated to increase the risk of developing cancer and other chronic diseases.

The Metabolic Pathway Panel & Risk Modification Program

As obesity, diabetes, chronic inflammation, and insulin resistance are known risk factors for the development of many cancers, the physicians and scientists who developed the ground-breaking COC Protocol have established a program that addresses these early warning signs. The program identifies and targets the inflammatory and metabolic pathways and includes:

  • A Metabolic Pathway Panel which specifically identifies metabolic and inflammatory health markers that are proven precursors for developing cancer
  • An in-depth consultation with a metabolic oncologist
  • Risk Modification that may involve specific evidence-based medications and supplements and lifestyle guidance and coaching.

Access to a digital health platform that captures all information and recommendations in an easy-to-understand format and provides bespoke information to improve patient understanding and provide simple, practical guidance on how to optimize metabolic health in a proportionate, tolerable manner.

TREAT, based on the METRICS Study (NCT02201381)1, is a clinically researched and personalized therapeutic regimen administered by experienced oncologists and intended for patients diagnosed with cancer of any type or at any stage, as an adjuvant therapy along with conventional cancer treatment. TREAT employs the patented COC Protocol2 that intends to interrogate the interconnected intracellular pathways involved in cancer cell growth, proliferation, apoptosis, and angiogenesis, by focusing on metabolic pathways.

  1. Agrawal S., Vamadevan P., Maziboku N., Bannister R., Swery R., Wilson S., Edwards S., Front. Pharmacol., 27 June 2019 |https://doi.org/10.3389/fphar.2019.00681
  2. Care Oncology Protocol is protected by United States Patent US9622982B2

MD & A

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2

StageZero Life Science, Limited

Management's Discussion & Analysis

[Expressed in US dollars, unless otherwise noted]

In May 2022, the Company added the COC Plus Program. COC Plus is a new physician led program centered on nutrition and other health interventions to help address a patient's specific cancer and is designed to be used alongside standard of care. See CareOncology Consultation Programs below.

Liquid Biopsy Testing and Clinical Consultation Programs

STAGEZERO LIFE SCIENCES LIQUID BIOPSY TESTING PROGRAMS

Our flagship test, Aristotle, a multi-cancer panel for the detection of multiple discrete cancers from a single sample of blood is being offered from StageZero specifically to self-funded employers, clinical and healthcare systems as well as directly to patients. It is also offered within the AVRT program through CareOncology, our clinic business.

Even with the introduction of Aristotle, there remains interest in cancer tests intended to detect the risk of specific tumor types. ColonSentry®, is a proprietary test offered through our wholly owned CAP accredited and CLIA certified high-complexity laboratory in Richmond, Virginia. In addition, we offer early cancer diagnostics and risk stratification for prostate and breast cancers through several novel, molecular diagnostic platforms.

Aristotle®

Aristotle is the first multiple discrete cancer diagnostic test from a single sample of blood with high specificity and sensitivity. The Female panel test has been validated for ovarian, breast, endometrial, cervical, colorectal, bladder stomach, liver, and nasopharyngeal cancers. The Male panel test has been validated for prostate, colorectal, bladder, stomach, liver, and nasopharyngeal cancers. The ability to facilitate early diagnosis of multiple cancers via an affordable, patient-friendly test will impact management of cancer at the population level in a way that has not been achievable until now. Aristotle is accessed via AVRT, our physician-driven interventional program for the detection of the early risk of cancer.

ColonSentry®

The ColonSentry® test assesses an individual's current risk, or probability, of having colorectal cancer through a convenient, and revolutionary blood test. Colorectal cancer ("CRC") is among the leading causes of cancer-related deaths in the United States, claiming more than 50,000 lives per year. Although CRC is a preventable and treatable form of cancer when detected early, people often delay or avoid being tested until symptoms appear. Patient discomfort with common test options like colonoscopies or stool-based tests continues to drive high non-compliance with recommended screening guidelines, resulting in late-stage diagnosis of CRC when treatment options are limited, and outcomes are poorer.

The American Cancer Society's 80-by-18 initiative had a multi-partner goal to improve colorectal cancer screening rates to 80% in the eligible population by the end of 2018. At present, a large proportion of the eligible population has not been screened and screening levels have further decreased with the advent of COVID-19lock-downs. Novel efforts to improve screening through risk stratification tools are essential to getting the 'unscreened' population to be screened, traditionally done through colonoscopy (90% of the screened population) or stool-based (10%) procedures. ColonSentry®, as a blood-based risk stratification test, helps primary care physicians and gastroenterologists facilitate the discussion about colon cancer screening with the eligible population who have refused to undergo other tests such as colonoscopies or stool-based procedures.

Prostate Health Index ("PHI")

The PHI test, licensed from Beckman, is a convenient blood test that is three times more specific in detecting prostate cancer than the prostate-specific antigen ("PSA") test. While the PSA test is currently the most widely used screening test for prostate cancer, it is generally recognized that PSA results can often indicate the possibility of prostate cancer when none is present. The PSA test is based on the fact that men with higher levels of PSA are more likely to have prostate cancer. However, higher levels of PSA can also be caused by a benign enlargement or inflammation of the prostate, leading to many false positives for cancer and ultimately unnecessary, invasive biopsies with an increased potential for patient harm. The PHI test helps physicians distinguish prostate cancer from benign conditions by using three different PSA markers (PSA, free PSA and pro2 PSA) as part of a sophisticated calculation to determine the probability of cancer more reliably in patients with elevated PSA levels.

BreastSentry™

MD & A

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3

StageZero Life Science, Limited

Management's Discussion & Analysis

[Expressed in US dollars, unless otherwise noted]

In October 2014, we in-licensed two blood-based biomarker assays-pro-NT and pro-ENK-intended to aid physicians in identifying those women who are at risk for developing breast cancer. These assays were developed by Sphingotec GmbH, known for the discovery and development of biomarker assays.

BreastSentry™ measures the fasting plasma levels of Neurotensin (pro-NT) and Enkephalin (pro-ENK), which are highly predictive of a woman's risk for developing breast cancer. Various longitudinal studies have shown that elevated levels of pro-NT and decreased levels of pro-ENK are strong, independent risk factors for the development of breast cancer. The combined test levels have been incorporated into a sophisticated algorithm in order to provide an additional level of personal data to create an enriched, personalized score. BreastSentry™ is used to determine a woman's risk for developing breast cancer relative to the risk in an average risk population.

Breast cancer is the second leading cause of cancer deaths in women in the United States and is exceeded only by lung cancer.

Many breast cancer cases are not due to genetic inheritance and, unlike other blood tests on the market that look for genetic indicators for the possibility of developing breast cancer, pro-NT and pro-ENK are biomarkers that, when measured in a convenient blood test, indicate the current level of a woman's risk for breast cancer. The tests may be particularly applicable to those 50% of women who have dense breast tissue and where mammograms have less utility. BreastSentry™ has been validated as a laboratory developed test.

COVID-19 Tests

Due to the Company's extensive knowledge of mRNA testing and its CLIA certified, CAP accredited laboratory, it is uniquely positioned to offer testing for the SARS-CoV-2 virus. Beginning inApril 2020, the Company began offering several types of COVID-19 tests: PCR, antibody and antigen tests. The PCR and antigen tests identify an active infection. The antibody tests identify antibodies in the blood that are indicative of a recent or past infection.

The Company partnered with both current service providers and new service providers to offer the testing. Our primary tests offered are from Thermo Fisher Scientific, BTNX Inc. and Beckman Coulter.

By utilizing current relationships and in-house expertise that was created for our cancer screening tests, the Company has been able to pivot to serve a substantial need. The path to returning to an ordinary lifestyle relies heavily on vaccines and testing. We are pleased to be able to contribute by offering COVID testing solutions.

Initial interest came from small to large employers, municipalities, and health care systems. The Company decided to focus on delivering testing to frontline workers via employers, utilizing our Telehealth platform. Our marketing channels for our cancer screening tests focus on healthcare groups, large employers, physician groups and individuals. The Company is approaching COVID-19 testing in the same way, thereby relying upon established operational efficiencies.

Requests for testing have come from the Mercer VIP Program, the County of Maricopa, Arizona, Udo Test, healthcare systems, national airlines, steel and manufacturing companies as well as Fortune 500 companies, amongst others.

The COVID-19-PCR test is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, anterior nares and saliva specimens from individuals suspected of having COVID-19. Test results indicate whether the patient currently has a COVID-19 infection.

The COVID-19 IgG/IgM Antibody Test is an in-vitro immunoassay for the direct and qualitative detection of anti- SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human serum, plasma or venipuncture whole blood to aid in the diagnosis of COVID-19 in conjunction with clinical presentation and results of other laboratory tests. Detection of IgM antibodies indicates recent infection, while IgG antibodies gradually appear and increase in the late stage of infection. It is not known how long these antibodies persist in the blood after infection. This test is for professional in-vitro diagnostic use only. Blood samples are drawn from the patient and shipped to our CLIA certified, CAP accredited lab in Richmond, Virginia.

MD & A

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This is an excerpt of the original content. To continue reading it, access the original document here.

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Disclaimer

StageZero Life Sciences Ltd. published this content on 18 November 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 18 November 2022 17:19:20 UTC.

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