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StageZero Life Sciences Ltd. — Management Reports 2021
Apr 2, 2021
44586_rns_2021-04-01_36234b9b-c454-4fd9-994b-779e32385fe5.pdf
Management Reports
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STAGEZERO LIFE SCIENCES LTD. MANAGEMENT'S DISCUSSION AND ANALYSIS For the years ended December 31, 2020 & 2019 [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 year and three-month periods ended December 31, 2020, and it should be read in conjunction with the audited consolidated financial statements for the years ended December 31, 2020 and 2019, 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. The reporting currency is US dollars ("USD") unless otherwise specified. 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 Company's functional currency is the USD.
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 April 1, 2021.
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 a wholly-owned subsidiary company: StageZero Holdings Inc., which owns 100% of StageZero Life Sciences Inc. in the United States. As of December 31, 2020 and 2019, the Company's investments in Tianjin and GeneNews Diagnostics are valued at nil and had no activity during the periods discussed in this MD&A.
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 forwardlooking 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 as 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 in our share price; (iv) 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; (vi) 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 ColonSentry® or our other products gaining reimbursement by thirdparty 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; (xx) the current enterprise value assigned by the market; and (xxi) general business and economic conditions.
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 focused on developing and commercializing proprietary molecular diagnostic tests for early detection of diseases and for personalized health management, with a primary 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®. I It has the ability to detect virtually any disease or medical condition from a simple blood sample. The Sentinel Principle® technology is protected by pioneering foundational patents. The science behind the Sentinel Principle® led to the development of our flagship product, ColonSentry®, a blood-based test for assessing an individual's current risk of having colorectal cancer. Additionally, our program called Aristotle, focused on finding and staging multiple disease states in the body, has demonstrated the ability to detect multiple cancers from a single sample of blood.
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 circulating blood cells 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® , our diagnostic test for colorectal cancer, specifically measures 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.
Our flagship test, ColonSentry®, is offered to the U.S. population through our wholly-owned laboratory in Richmond, Virginia, and we offer early cancer diagnostics and risk stratification for colorectal, lung, prostate and breast cancers, through several novel, proprietary molecular diagnostic platforms. We have adopted a population health model whereby the early cancer diagnostic tests are offered as risk stratification at the beginning of the cancer diagnostic process so that those patients who are at highest risk are prioritized for advanced diagnostic procedures. The Company has added focus to its commercialization path by accelerating the adoption of our menu of proprietary cancer tests with hospitals, clinical integrated networks, physician groups and other healthcare organizations. We are currently in implementation discussions with several groups.
Covid-19
StageZero Life Sciences, due to its extensive knowledge of mRNA testing and its CLIA certified, CAP accredited laboratory, is uniquely positioned to offer testing for the SARS-CoV-2 virus. Since April, 2020 the Company is offering 2 types of COVID-19 tests: PCR, and antibody tests. The PCR tests identify an active infection. The antibody tests identify antibodies in the blood that are indicative of a past infection.
The Company has partnered with both current service providers and new service providers to offer the testing. The 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 any type of normality, lies with testing and a vaccine. We are pleased to be able to contribute to the testing. The US government has publicly stated that it wants to see 3 million COVID-19 tests done a day. This creates a massive opportunity and an urgent need.
Initial interest came from large employers and health care systems. The Company has 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 utilizing efficiencies that already exist.
Interest has come from the Mercer VIP Program, the City of Alpharetta, Georgia, Udo Test, amongst others.
TESTS OFFERED
Both on our own and in partnership with other groups, we are working to secure multi-year agreements with hospitals, clinically integrated networks, large physician groups and healthcare organizations for StageZero Life Sciences' risk assessment tests to assist in the early detection of cancer. This is in addition to the work that is being done with highrisk populations and their employers, and in the telemedicine arena. The multiple cancers from a single sample of blood that Aristotle will provide will significantly add to this.
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 one of the biggest killers 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 colonoscopy or stool-based tests continues to drive high noncompliance with recommended screening guidelines, resulting in late-stage detection when CRC is least curable.
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, less than 60% of the eligible population has been screened. Novel efforts to improve screening through risk stratification tools are essential to getting the 'unscreened' population to be screened, traditionally 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 gastroenterologistsfacilitate the discussion about colon cancer screening with the eligible population who have refused to undergo other tests such as colonoscopy or stool-based procedures.
EarlyCDT®-Lung
StageZero in-licensed EarlyCDT-Lung in 2014. However in 2019 the Company shifted its focus to later stage cancer diagnosis. StageZero can refer patients for the test, but it no longer processes the test in its lab.
Prostate Health Index ("PHI")
In April 2014, the PHI Test Agreement with Beckman, which allowed us to add Beckman's PHI test to our menu of cancer assays, was announced. The PHI test 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 more reliably determine the probability of cancer in patients with elevated PSA levels.
BreastSentry™
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.
StageZero Life Science, Limited Management's Discussion & Analysis [Expressed in US dollars, unless otherwise noted]
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 to develop 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.
Aristotle as potentially the first multiple, discrete cancer diagnostic test from a single sample of blood, will expand our offering into this commercial framework. This is a \$35 billion opportunity and the early diagnosis of cancer via an affordable, patient-friendly test will have an impact on the population level that is simply not achievable now.
COVID-19 Tests
On March 31, 2020 StageZero Life Sciences announced it was preparing to offer PCR and antibody tests for COVID-19. Testing was initiated in late April 2020.
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 specimens from individuals suspected of having COVID-19. Test results indicate whether the patient currently has the 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.
COMMERCIAL ACTIVITIES
The Company has a national, clinical reference laboratory specializing in personalized blood-based tests to find, understand and treat cancers, which operates from a single facility in Richmond, Virginia, that is capable of servicing the entire United States, Canada and Europe.
The Company is working to secure multi-year agreements with hospitals, integrated clinical networks, large physician groups and healthcare organizations for StageZero Life Sciences' risk assessment tests to assist in the early detection of cancer. This is in addition to work being done with high-risk populations, their employers and in the telemedicine arena.
The focus is on Four Primary Growth Areas:
Small Independent Medical Practices: Ranging in size from 1 to 10 providers, with reimbursement for the tests via billing to insurers and patient-pay, is an important sector of the market. We are steadily increasing the number of practices using our tests, especially on a routine, weekly basis and have significantly restructured and upgraded our billing procedures. We expect this segment to contribute about 10-15% of our test volume.
High-Risk Populations/self-funded employer plans: Early detection of cancer as well as risk stratification into normal, high and "raised" risk is of critical importance in workers exposed to carcinogens. The Company is working with multiple high-risk employer partners across the country and has initiated screening within these high-risk groups. We are also in discussion with several self-funded employer plans and have significant interest in our programs. Reimbursement to the Company is direct and either immediate, or within 45 days upon invoice.
TeleMedicine/Patient Directed Testing The global telehealth market was valued at US\$50 billion in 2018 and some predict it to reach US\$267 billion by 2026.1 Currently, 74% of employers in the United States now offer telemedicine as a covered benefit.2 Similarly, Americans age 45-54 and 65+ are most likely to delay needed care due to wait times.3 On average, it takes approximately twenty-one (21) days for a new patient to see a primary care provider4 and 66% of consumers are willing to use telehealth to get faster service and costs savings.5 According to the National Business Group on Health Plan Design Survey, large employers offering telemedicine is increasing.
Large Healthcare Systems Are one of our largest opportunities and we are in discussion with several large systems. The company is working on implementation of our programs into these systems. Implementation is complex as there are many stakeholders within a large system and all have to be coordinated. Contracts will be executed and announced once implementation is fully in place. Payment to the Company is by invoice and within 45 days.
Aristotle As potentially the first multiple cancer diagnostic test from a single sample of blood, will expand our offering into this commercial framework which is being expanded now. This is a \$35 billion opportunity, and the early diagnosis of cancer via an affordable, patient-friendly test will have an impact at the population level that is simply not achievable now.
We anticipate that the high-risk population/self-funded employer plans, the Patient Directed Testing/Telehealth and large healthcare systems will contribute approximately 85-90% of our test volume.
Flat Fee Model
The typical path to commercialization of new, novel diagnostics is often lengthy and involves many steps, with limited uptake and adoption. By offering the StageZero Life Sciences diagnostic testing portfolio through large healthcare systems and networks as well as to high-risk groups/employers and via telemedicine, we expect to be able to shorten this cycle, thereby driving adoption and increasing utilization of our tests. By contracting with StageZero Life Sciences to provide blood-based, early cancer risk stratification tests, a healthcare system has access to novel tests. StageZero Life Sciences receives an established payment amount for each processed sample. This model can be adopted if the healthcare system provides services through integrated provider networks, self-funded employee plans or value based reimbursement systems. Payment to the Company is therefore reliable and predictable.
Lab Operations
2019 saw the lab continue full operation and refine all systems. We had a request in 2018 from a local, known lab to share space with us and we decided to reduce our footprint and consolidate into approximately twenty -five percent of our previous space. This will save us approximately \$2.5 million in costs over the term of the lease. Operations are now more contiguous and streamlined, and we have expansion capability to meet increased testing for several years to come. We are now processing PCR and antibody tests for COVID-19 in addition to our cancer screening tests. Current capacity for COVID-19 testing is 1,000 tests per day.
Changes made to the billing system in 2019 brought certain functions in house. Recovery of reimbursement for tests previously run and billed continue, as do billing and recovery for current tests. Our focus in 2020 is to shorten the timeframe and improve the procedure for collection for tests run in the last twelve months of billings, new tests not yet billed as well as previous tests billed but not followed up to conclusion.
The Company's focus is now mostly on flat fee billing which is a more reliable predictor of revenue collection.
1 Fortune Business Insights: Telehealth: Global Market Analysis, Insights, and Forecast, 2019-2026.
2 Kaiser Permanente, "KFF Employer Health Benefits Survey 2018" (2018), online: https://www.kff.org/health-costs/report/2018-employerhealth-benefits-survey/.
3 American Well, "Telehealth Index: 2019 Consumer Survey" (2019), online: https://static.americanwell.com/app/uploads/2019/07/American-Well-Telehealth-Index-2019-Consumer-Survey-eBook2.pdf.
4 AthenaInsight, "The doctor will see you…sometime" (December 11, 2017), online:
<https://www.athenahealth.com/insight/sites/insight/files/12.11%20The%20doctor%20will%20see%20you%20...%20sometime.pdf>.
5 American Well, supra note 3.
MyCancerRisk:
.
The Company's MyCancerRisk Data Analytics™ Platform is being developed to track and analyze aggregate cancer screening data in order to monitor performance on testing and early intervention. This platform is expected to bring significant value to large healthcare systems and self-insured organizations who want to monitor compliance with cancer screening, risk stratify their patient populations, and improve early intervention.
FINANCING ACTIVITIES AND CAPITAL STRUCTURE
During 2020, we closed on significant financing initiatives to support the roll-out into our Four Primary Growth Area initiatives.
On January 24, 2020 the Company closed a unit financing (the "Unit Financing") and issued 2,107,527 units for gross proceeds of Cdn\$674,409. Each Unit ("Unit") consists of one common share plus one-half of one warrant at a price of Cdn\$0.32 per Unit. Each whole warrant is exercisable into one common share at an exercise price of Cdn\$0.48 for a period of thirty-six months from issuance, until January 24, 2023.
On February 19, 2020, the Company closed a private placement of convertible debentures (each a "Debenture") for gross proceeds of Cdn\$1,180,000. The Debentures, issued in increments of \$1,000, bear interest at a rate of 6% per annum, have a term of 18 months from the date of issue and are convertible in units ("Units") at a conversion price of \$0.32 per Unit. Each Unit consists of one (1) common share ("Common Share") of the Company and one-half (1/2) of a Common Share purchase warrant. Each whole warrant (a "Warrant") is exercisable into one Common Share of the Company at an exercise price of CAD\$0.56 per Common Share for a period of twenty-four (24) months from the date of issuance of the Debentures. Securities issued pursuant to the Offering are subject to a statutory hold period lasting four (4) months and a day after the issuance of the securities.
As the conversion price is variable due to currency differences, resulting in the recognition of an embedded derivative, the Company designated the entire convertible instrument as a financial liability at fair value through profit or loss and recognized any changes in the fair value in the consolidated statement of loss and comprehensive loss. The fair value of the convertible debenture was calculated using a combination of discounted cash flows using a discount rate of 35% and, option pricing models using the following inputs:
| Measurement Date |
Expected volatility Conversion Option/Unit Warrant* |
Risk-free interest rate Conversion Option/Unit Warrant |
|---|---|---|
| 19-Feb-20** | 160%/146% | 1.56%/1.48% |
| 6-Jul-20 | 158%/171% | 0.28%/0.26% |
| 9-Jul-20 | 170%/158% | 0.28%/0.29% |
| 28-Sep-20 | 164%/154% | 0.19%/0.24% |
| 29-Sep-20 | 163%/154% | 0.20%/0.23% |
| 27-Oct-20 | 163%/150% | 0.15%/0.19% |
| 31-Dec-20 | 115%/148% | 0.11%/0.16% |
* Where the transaction price is fair value and the valuation model uses unobservable inputs the valuation model is calibrated such that the result of the valuation technique equals the transaction price. The indicated volatility is prior to the calibration adjustment.
** On initial recognition there is a discount for lack of marketability ("DLOM") as a result of a four month statutory hold period was determined using a Finnerty Model with initial term of 4 mos. and volatility of 130%, in subsequent measurement periods, the hold period is expired and accordingly no DLOM is applied.
Fair value of convertible debenture [c]
| \$ | |
|---|---|
| At January 1, 2020 |
- |
| Issuance during the period |
891,845 |
| Revaluation during the period |
1,067,284 |
| Lese: Conversion |
(236,665) |
| Foreign exchange |
319,257 |
| At December 31, 2020 |
2,041,720 |
Short-term debt
During the year, the Company received a Cdn\$40,000. Canada Emergency business Account ("CEBA") loan from the Government of Canada via its commercial bank. The loan is interest free until December 31, 2022, with a maturity date of December 31, 2025.
If Cdn\$30,000 of the loan has been repaid by December 31, 2022, the remaining balance (maximum Cdn\$10,000) will be forgiven. Should the loan not be repaid by December 31, 2022, interest at 5% will be charged per annum commencing on January 1, 2023 until maturity on December 31, 2025. The loan is unsecured.
Public offering
On June 29, 2020 the Company has closed its previously announced public offering of 8,272,013 units of the Company (the "Units") at a price of \$0.56 per Unit (the "Offering Price") for aggregate gross proceeds of \$4,632,327 (the "Offering"). The Offering was made pursuant to an agency agreement effective June 22, 2020 with Echelon Wealth Partners Inc. and Clarus Securities Inc. (collectively, the "Agents"). Each Unit was comprised of one common share of the Company (each, a "Common Share") and one common share purchase warrant (each, a "Warrant"). Each Warrant is exercisable to purchase one Common Share at any time prior to June 29, 2023 at a price of \$0.72 per Common Share. The Units were offered and sold by way of a short form prospectus filed in each of the provinces of Alberta, British Columbia, and Ontario. The Company intends to use the net proceeds of the Offering to purchase new equipment and consumable materials to increase COVID-19 testing capacity at the Company's laboratory in Richmond, Virginia as well as complete validation of Aristotle®, the Company's pan-cancer test for the early identification of 10 discrete cancers from a single sample of blood, as described in more detail in the (final) short form prospectus of the Company dated June 22, 2020 (the "Prospectus"). As consideration for the services rendered by the Agents in connection with the Offering, the Company has paid the Agents a cash commission equal to 7% of the gross proceeds raised under the Offering and has granted the Agents non-transferable broker warrants equal to 7% of the number of Units sold under the Offering, exercisable at any time prior to June 29, 2023 at \$0.68 per Common Share (the "Broker Warrants"). The Company also issued to the Agents a total of 16,250 agents' compensation warrants exercisable into Common Shares on the same terms of exercise as the Broker Warrants. The Company also closed a concurrent non-brokered private placement offering of 951,121 Units at the Offering Price to a director of the Company in order to settle debts of \$532,628 owing by the Company.
On December 4, 2020 the Company closed a public offering of 9,243,700 units of the Company (the "Units") at a price of \$0.78 per Unit (the "Offering Price") for aggregate gross proceeds of Cdn\$7,210,086 (the "Offering"). The Offering was made pursuant to an agency agreement effective November 26, 2020 with Echelon Wealth Partners Inc. and Clarus SecuritiesInc. (collectively, the "Agents"). Each Unit was comprised of one common share of the Company (each, a "Common Share") and one-half of one common share purchase warrant (each whole warrant, a "Warrant"). Each Warrant is exercisable to purchase one Common Share at any time prior to December 4, 2023 at a price of \$1.10 per Common Share. The Units were offered and sold by way of a short form prospectus filed in each of the provinces of Alberta, British Columbia, and Ontario. The Company intends to use the net proceeds of the Offering to expand capacity to offer and conduct COVID-19 testing and to develop its existing product lines, including Aristotle®, the Company's pan-cancer test for the early identification of 10 discrete cancers from a single sample of blood, as described in more detail in the (final) short form prospectus of the Company dated November 26, 2020 (the "Prospectus"). As consideration for the services rendered by the Agents in connection with the Offering, the Company has paid the Agents a cash commission equal to 7% of the gross proceeds raised under the Offering and has issued to
StageZero Life Science, Limited Management's Discussion & Analysis [Expressed in US dollars, unless otherwise noted]
the Agents non-transferable broker warrants equal to 7% of the number of Units sold under the Offering, exercisable at any time prior to December 4, 2023 at \$0.85 per Common Share. The Company also completed a concurrent private placement of 325,456 Units at the Offering Price to an arm's length services provider in order to settle invoices of US\$193,119.04 owing by the Company.
OUTLOOK
At the heart of the Company's mission to improve health outcomes is our ability to provide physicians and their patients with actionable clinical data for cancer risk assessment and diagnosis. ColonSentry, as the first blood-based, early colorectal cancer diagnostic test to be developed from the Sentinel Principle platform has been validated in both a 10,000 patient prospective study and a 100,000 patient post-marketing study, which confirmed the strength of the science. Aristotle, our next-generation diagnostic test, can test for ten cancers from a single sample of blood, with data to date indicating high sensitivity and specificity across the individual cancers. The Sentinel Principle platform is therefore proven, not promised. It is anticipated that full clinical validation will be completed within two years.
Access to patient friendly, blood-based tests that can detect disease at its earliest stages is truly innovative, especially when multiple disease states can be screened for from a single sample of blood. Aristotle does that, in this case, for multiple cancers and will allow early diagnosis at the population health level. This has implications for self-funded employer plans which have employees in high-risk environments (Fire fighters, oil and gas, coal and chemical plants, pilots and flight attendants, drivers), large healthcare systems, especially those with outreach programs and benefit plans, the military, as well as individual States which have specific populations that need to be screened.
As a prelude to this in 2018, StageZero Life Sciences began the process of collecting and sharing aggregated data in an effort to build a data-driven product to help practices and healthcare systems better understand their patient populations and build more effective programs to improve patient compliance with cancer screening, preventive health programs, and early interventions. During 2019 we expanded this effort as we initiated research programs with key high-risk groups and focused on supporting these programs into the roll-out of our four distinct commercial paths. We expect data as an asset to continue to be a key strategy for us.
In 2020 and early 2021, we have:
- Aggressively expanded the programs under MyCancerRisk™ to High Risk Patient Populations and their employers. Pilot program data shows 34% of those tested had a raised risk result for cancer.
- Initiated the Patient Directed Testing program with 8,000+ draw sites and TeleHealth Physician Networks.
- Initiated test implementation planning with Large HealthCare Systems. This runs parallel with contract completion. Management's objective is to have test introduction logistics completed concurrent with signature of agreements.
- Consolidated planning with large employers of high-risk employees to initiate extensive screening programs.
- Continued to expand the Small Clinical Practice base and upgraded Billing and revenue collection systems.
- Initiated full clinical validation of Aristotle.
We continue to develop four distinct revenue streams:
- High Risk Patients payment collected immediately
- Telemedicine payment collected immediately or invoiced to Networks with payment within 45 days
- Large HealthCare Systems fixed price per test, invoiced and paid within 45 days
- Small Clinical Practices standard billing to insurers/CMS. Process being significantly upgraded.
SIGNIFICANT ACCOUNTING POLICIES
Significant accounting estimates and assumptions
The preparation of consolidated financial statements requires the use of estimates and assumptions to be made in applying the accounting policies that affect the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities. We base estimates and related assumptions on previous experience and other factors that we consider reasonable under the circumstances. These form the basis of assumptions about the carrying values of assets and liabilities that are not readily apparent from other sources.
We review estimates and underlying assumptions on an ongoing basis. We recognize revisions to accounting estimates in the period in which the estimate is revised if the revision affects only that period or in the period of the revision and future periods if the revision affects both current and future periods.
Significant accounts that require estimates as the basis for determining the stated amounts include share-based compensation, impairment analysis and fair value of warrants, structured notes, convertible debt and conversion liabilities.
Principles of Consolidation
The Company consolidates its wholly-owned subsidiaries, StageZero Holdings and StageZero Life Sciences Inc. Intercompany balances are eliminated in full.
Share-based compensation
The Company measures the cost of equity-settled transactions with employees by reference to the fair value of equity instruments at the date at which they are granted. Estimating fair value for share-based payments requires determining the most appropriate valuation model for a grant of such instruments, which is dependent on the terms and conditions of the grant. The estimate also requires determining the most appropriate inputs to the Black-Scholes option pricing model, including the expected life of the instrument, risk-free rate, volatility and dividend yield.
Fair value of warrants
In determining the fair value of the warrant liability, the Company used the Black-Scholes option pricing model with the following assumptions: volatility rate, dividend yield, risk-free rate and the remaining expected life of the warrant. The inputs used in the Black-Scholes model are taken from observable markets. In particular, changes in the fair value of the warrants can have a material impact on the reported loss or gain and comprehensive loss or gain for the applicable reporting period.
Fair value of structured notes, convertible debt and conversion liabilities
In determining the fair values of the structured notes, convertible debt and conversion liabilities, the Company used a binomial lattice model with the following assumptions: volatility rate, risk-free rate and the remaining expected life. The inputs used in the binomial lattice model are taken from observable markets. Changes in the fair value of the structured notes and conversion liabilities can have a material impact on the reported loss or gain and comprehensive loss or gain for the applicable reporting period. For certain convertible debentures, the Company designates the entire convertible instrument as a financial liability at fair value through profit and loss. The fair value of such instruments are determined using a combination of discounted cash flow, option pricing models and reference to recent transactions.
Impairment analysis
The Company assesses its intangible assets for recoverability whenever indicators of impairment exist. When the carrying value of an asset is greater than its recoverable amount, which is the higher of its value in use or fair value less costs to sell, an impairment loss is recognized.
Revenue recognition
Under IFRS 15, Revenue from Contracts with Customers ("IFRS 15"), revenue is recognized at an amount that reflects the consideration to which the entity expects to be entitled to in exchange for transferring goods or services to a customer.
The principles in IFRS 15 are applied using the following five steps:
-
- Identify the contract(s) with a customer
-
- Identify the performance obligations in the contract
-
- Determine the transaction price
-
- Allocate the transaction price to the performance obligations in the contract
-
- Recognize revenue when (or as) the entity satisfies a performance obligation
As detailed below, revenue is recognized to the extent that it is probable that the economic benefits will flow to the Company and the revenue can be reliably measured, regardless of when the payment is being made.
Cancer Testing
The Company performs diagnostic blood-based biomarker tests to screen for early cancer detection and risk assessment. Upon completion of the diagnostic tests, the results of the tests are made available to the caregiver or patient. The amount of revenue from billings is adjusted with certain third-party payers, taking into account contractually defined terms of payment and excluding taxes or duty and ultimate settlements cannot be reliably estimated until the cash is collected.
COVID Testing
As the COVID-19 pandemic transpired during early fiscal 2020, the Company pivoted to providing COVID-19 assessments using Polymerese Chain Reaction ("PCR") testing and antigen testing, which have been approved on an Emergency Use Authorization (EUA) by the FDA. The Company also entered into some agreements under which they would provide mobile testing facilities for customers.
In assessing the performance obligations the Company has determined that there are two separate performance obligations in these services, providing a test result from performing the PCR or antigen testing and providing mobile testing facilities.
The Company recognizes the revenues from these services when the performance obligation has been fulfilled and collection is reasonably assured.
Disaggregation of Revenue:
| Year ended December 31 |
||
|---|---|---|
| 2020 | 2019 | |
| \$ | \$ | |
| Cancer Testing |
473,063 | 138,704 |
| COVID Testing |
3678747 | - |
| Total | 4,151,810 | 138,704 |
New standards adopted
IFRS 16, Leases ("IFRS 16")
In January 2016, the IASB issued IFRS 16, a new standard that replaced IAS 17, Leases. IFRS 16 provides a single lessee accounting model, requiring the recognition of assets and liabilities for all leases, unless the lease term is less than 12 months or the underlying asset has a low value. IFRS 16 substantially carries forward the lessor accounting in IAS 17 with the distinction between operating leases and finance leases being retained.
The Company adopted IFRS 16 on January 1, 2019. Before adopting IFRS 16, the Company accounted for all lease payments from the operating lease directly in profit or loss. When the Company adopted IFRS 16 on January 1, 2019, all lease liabilities were recognized in the statement of financial position at the date of initial application.
FINANCIAL INSTRUMENTS AND FINANCIAL RISK-MANAGEMENT OBJECTIVES AND POLICIES
We are exposed to liquidity, credit and market risks; the management of these is overseen by the Company's senior management.
Financial instruments
The fair value of warrants is estimated using the Black-Scholes option pricing model incorporating various inputs including the underlying price volatility and discount rate. All other notes payable were initially recognized at fair value, and subsequently were measured at amortized cost using the effective interest rate method, whereby the fair value of the notes payable approximates their carrying value. As at December 31, 2020, the Company's warrant liability, conversion liability and notes payable, are carried on the consolidated statements of financial position at fair value and have been classified as Level 3, in the fair value hierarchy.
We have classified our financial instruments as follows:
| Financial assets at amortized cost |
Other financial liabilities at amortized cost |
Fair value through profit or loss |
Total | |
|---|---|---|---|---|
| At December 31, 2020 | \$ | \$ | \$ | \$ |
| Financial assets | ||||
| Cash and cash equivalents | 6,597,187 | - | - | 6,597,187 |
| Trade and other receivables | 73.955 | - | - | 73.955 |
| Financial liabilities | ||||
| Trade and other payables | - | 2,522,139 | - | 2,522,139 |
| Long-term liabilities | 67,340 | 67,340 | ||
| Warrant liability | - | - | 3,356,484 | 3,356,484 |
| Notes payable | - | 899,879 | 899,879 | |
| At December 31, 2019 | \$ | \$ | \$ | \$ |
| Financial assets | ||||
| Cash and cash equivalents | 71,124 | - | - | 71,124 |
| Trade and other receivables | 21,700 | - | - | 21,700 |
| Financial liabilities | ||||
| Trade and other payables | - | 2,842,015 | - | 2,842,015 |
| Long-term liabilities | 67,340 | 67,340 | ||
| Warrant liability | - | - | 997,233 | 997,233 |
| Conversion liability | - | - | 90,000 | 90,000 |
| Notes payable | - | 1,706,050 | - | 1,706,050 |
Liquidity risk
Liquidity risk represents the contingency that the Company is unable to gather the funds required with respect to our financial obligations at the appropriate time and under reasonable conditions. The Company attempts to manage this risk to ensure that it has sufficient liquidity at all times to be able to honor our current and future financial obligations under normal conditions and in exceptional circumstances. Financing strategies to ensure the management of this risk include accessing the capital markets through the issuance of equity or debt securities.
The Company's ability to continue as a going concern depends upon its ability to achieve profitable operations and raise additional capital. In the past three years, the Company has earned limited revenue. During 2019 and 2020, the Company completed a series of common share, structured notes payable, capital commitment, common share and warrant and convertible debenture financings. The Company expects to continue to pursue further financings as planned or until adequate cash flow from operations occurs.
The following table summarizes the maturity profile of our financial instruments as at December 31, 2020 and 2019: Financial instrument maturation periods
1 year or less 1 to 5 years 5 years or more Total
| At December 31, 2020 |
\$ | \$ | \$ | \$ |
|---|---|---|---|---|
| Financial assets |
||||
| Cash | 6,597,187 | - | - | 6,597,187 |
| Other receivable |
73.955 | - | - | 73.955 |
| Financial liabilities |
||||
| Trade and other payable |
1,870,140 | - | - | 1,925,327 |
| Convertible debenture |
808,985 | - | - | 808,985 |
| Note payable |
348,390 | 480,000 | 1,100,000 | 1,928,390 |
| Long-term liabilities |
- | 67,340 | - | 67,340 |
| Financial instrument maturation periods |
| 1 year or less |
1 to 5 years |
5 years or more |
Total | |
|---|---|---|---|---|
| At December 31, 2019 |
\$ | \$ | \$ | \$ |
| Financial assets |
||||
| Cash | 71,124 | - | - | 71,124 |
| Other receivable |
21,700 | - | - | 21,700 |
| Financial liabilities |
||||
| Trade and other payable |
2,842,015 | - | - | 2,842,015 |
| Note payable |
1,357,799 | 480,000 | 1,105,884 | 2,943,683 |
| Long-term liabilities |
- | 67,340 | - | 67,340 |
Credit risk
The Company's financial assets that are exposed to credit risk consist primarily of cash and cash equivalents and royalty and other receivables. Cash and cash equivalents consist of deposits with major commercial banks and are therefore subject to minimal credit risk.
As at December 31, 2020 and 2019, the Company had no accounts receivable associated with test or royalty revenue as both are recognized when cash is received. The Company's exposure to credit risks related to other receivables is discussed in above maturity profile of our financial instruments as at December 31, 2020 and 2019.
| At December 31, 2020 | At December 31, 2019 | |
|---|---|---|
| \$ | \$ | |
| Current | 73,955 | 21,700 |
| 31 to 60 days | - | - |
| 61 to 90 days | - | - |
| Over 90 days | - | - |
| Allowance for doubtful accounts | - | - |
| Total trade and other receivables, net | 73,955 | 21,700 |
Market risk
Market risk is the risk that the fair value or future cash flows of a financial instrument will fluctuate because of changes in market prices. Market risk comprises foreign exchange rate risk and interest rate risk.
Foreign exchange rate risk
The Company operates in Canada and the United States and transacts business primarily with US partners and suppliers. During the year ended December 31, 2020, a 5% appreciation (depreciation) in the Cdn\$ to US dollar foreign exchange rate, with all else being equal, would have affected net income by approximately \$47,425 [December 31, 2019 – \$371,658]. The Company's exposure to foreign currency changes for all other currencies is not material.
Interest rate risk
Interest rate risk is the risk that the fair value or future cash flows of a financial instrument will fluctuate because of changes in market interest rates. The interest rate for the Company's notes payable to HDL was renegotiated during the first quarter of 2016 and interest began to be accrued at Wall Street Journal Prime Rate plus 4.00% per annum effective April 1, 2016. The notes payable to a shareholder who is also a director, issued after 2017 are fixed at 5% per annum. The convertible debentures are fixed at 6%. Accordingly, there have been no significant impacts on the Company's consolidated statements of loss and comprehensive loss from changes in interest rates.
The remeasurement of the February 2020 Convertible Debentures (note 7) requires reassessment of the appropriate discount rate at each reporting period in determining the fair value. That discount rate could fluctuate depending on changes in interest rates as well as changes in the Company's credit risk. A 2% increase or decrease in the discount rate would have had an immaterial impact on the fair value of the instrument as at December 31, 2020.
COVID-19 Pandemic in 2020
In March 2020, the World Health Organization ("WHO") classified the COVID-19 outbreak as a pandemic based on the rapid increase in exposure globally. The full impact of the COVID-19 outbreak continues to evolve as of the date of this report. Management is actively monitoring the global conditions regarding financial impact, liquidity, operations, suppliers, industry, and workforce. Given the daily evolution of the COVID-19 outbreak and the global responses to curb its spread, the Company is not able to estimate the effects of the COVID-19 outbreak at this time.
SELECTED FINANCIAL INFORMATION
The following table sets forth selected financial information for the periods indicated:
Consolidated statements of financial position
| Year ended | Year ended | |
|---|---|---|
| At December 31, 2020 | At December 31, 2019 | |
| (in thousands of dollars) | \$ | \$ |
| Cash | 6,597 | 71 |
| Total current assets | 7,222 | 227 |
| Total non-current assets | 1,285 | 1,738 |
| Total assets | 8,507 | 1,965 |
| Total current liabilities | 5,567 | 4,219 |
| Total non-current liabilities | 4,173 | 2,237 |
| Total liabilities | 9,740 | 6,456 |
| Total shareholders' deficiency | (1,233) | (4,491) |
| Total liabilities and shareholders' deficiency | 8,507 | 1,965 |
Results of operations for the year ended December 31, 2020 and 2019
For the year ended December 31, 2020, we reported a consolidated net loss of \$3.1 million, or \$0.04 loss per common share, as compared with a consolidated net loss of \$3.5 million, or \$0.16 loss per common share for the same period in 2019.
Consolidated statements of loss and comprehensive loss
| Year ended | Year ended | |
|---|---|---|
| (in thousands of dollars, except per share amounts) | At December 31, 2020 | At December 31, 2019 |
| \$ | \$ | |
| Total revenues | 4,152 | 139 |
| Expenses | ||
| Cost of goods sold | 3,456 | 1,100 |
| General and administrative | 4,433 | 4,179 |
| Gain from revaluation of warrants | 1,396 | (2,434) |
| Change in fair value of conversion liabilities | - | (27) |
| Change in fair value of conversion debenture | 1,067 | - |
| Finance costs | 664 | 803 |
| Total expenses | 11,016 | 3,620 |
| Total comprehensive loss for the year | (6,864) | (3,481) |
| Basic and diluted loss per common share | (0.09) | (0.16) |
Results of Operations 2020
The results of the Company's operations yielded a total comprehensive loss for 2020 of \$6.9 million and comprehensive loss \$3.5 million in 2019, as a result of an increase of \$2.3 million, in cost of goods sold, a reduction in the revaluation of warrants, an increase of \$5.0 million in the fair value of conversion debenture and warrant revaluation, and an increase of \$0.3 million in in general and administrative expenses offset by an \$4.0 million increase in revenue.
Cost of Goods sold
| Year ended | Year ended | (Decrease) | |
|---|---|---|---|
| At December 31, 2020 |
At December 31, 2019 |
Increase | |
| \$ | \$ | \$ | |
| Direct labour | 353,362 | 158,868 | 194,494 |
| Direct materials | 2,109,748 | 2,192 | 2,107,556 |
| Indirect labour | 238,852 | 88,647 | 150,205 |
| Overhead | 754,293 | 849,908 | (95,615) |
| Total cost of goods sold | 3,456,255 | 1,099,615 | 2,356,640 |
Total cost of goods sold increased by 214% for the year ended December 31, 2020, compared with the same period in 2019, mainly due to the significant revenue increase.
General and Administrative Expenses
| Year ended | Year ended | (Decrease) | |
|---|---|---|---|
| At December 31, 2020 | At December 31, 2019 |
Increase | |
| (in thousands of dollars) | \$ | \$ | \$ |
| Headcount and office-related costs | 2,281,588 | 2,337,411 | (55,823) |
| Share-based compensation | 566,884 | 741,452 | (174,568) |
StageZero Life Science, Limited Management's Discussion & Analysis [Expressed in US dollars, unless otherwise noted]
| Public company costs | 485,732 | 553,047 | (67,315) |
|---|---|---|---|
| Professional fees | 686,841 | 295,744 | 391,097 |
| Depreciation | 29,666 | 59,617 | (29,951) |
| Foreign exchange loss | 381,364 | 192,056 | 189,308 |
| Total general and administrative expenses | 4,432,075 | 4,179,327 | 252,748 |
Total general and administrative expenses increased by 6% for the year ended December 31, 2020, compared with the same period in 2019 mainly due to increasing in professional fees.
Finance costs
Finance costs for the year ended December 31, 2020 were \$664,302 as compared with \$803,198 in the same period in 2019 primarily due to no commitment fee and no transaction costs relating to issuance of debt in 2019.
Finance costs for the years ended December 31, 2020 and 2019 are as follows:
| Year ended |
|||
|---|---|---|---|
| 2020 | 2019 | ||
| \$ | \$ | ||
| Interest on note payable to HDL |
108,963 | 110,219 | |
| Interest on note payable to shareholder and director |
18,332 | 39,870 | |
| Interest on convertible debenture |
94,357 | 396,275 | |
| Interest costs on lease liability |
98,770 | 115,112 | |
| Commitment fee |
- | 53,650 | |
| Transaction costs relating to issuance of debt |
- | 88,072 | |
| Transaction costs relating to financing |
343,880 | - | |
| 664,302 | 803,198 |
USE OF PROCEEDS
The Company began the period with \$0.07 million in available funds. During the year ended December 31, 2020, operations used \$3.3 million. During the same period, the Company received proceeds: \$8.0 million from public offering, \$0.9 million from the issuance of units for the Private Placement and \$0.7 million from issuance of convertible notes payable (net) was received, \$0.6 million from warrant exercise offset by a \$0.1 million payment of principal of the note payable to HDL and \$0.3 repayment of lease liability. The Company closed the year with \$6.5 million in available funds.
The planned use of proceeds from financings was to continue the expansion of StageZero's telehealth platform, increase marketing of the telehealth platform, prepare for product launches (notably, Aristotle®), and for general corporate purposes. The advent of the COVID-19 pandemic and associated business challenges, and the subsequent opportunity to introduce COVID-19 testing, directed the Company to add COVID-19 tests to StageZero's product line up, to scale up its Richmond Laboratory and to launch COVID-19 testing via StageZero's existing telehealth system.
LIQUIDITY AND CAPITAL RESOURCES Summary of cash flows
| Years ended December 31 |
||
|---|---|---|
| 2020 | 2019 | |
| \$ | \$ | |
| Cash flows related to operating activities | (3,181,877) | (4,590,869) |
| Cash flows related to financing activities | 9,780,259 | 4,859,141 |
|---|---|---|
| Cash flows related to investing activities | (72,319) | (33,376) |
Operating activities
The use of cash and cash equivalents in operating activities in the year ended December 31, 2020 was consistent with that of 2019.
Financing activities
As previously described in the section "Financing Activities and Capital Structure" the following tables summarize the relevant activities in the year end December 31, 2020.
Accounted through shareholders' deficiency
| Share capital | |||
|---|---|---|---|
| Shares | Amount | ||
| # | \$ | ||
| [note 9[b]] | |||
| Balance at January 1, 2020 | 33,986,373 | 80,283,079 | |
| Net loss for the period | - | - | |
| Share-based compensation | - | - | |
| Issuance of broker warrants | - | - | |
| Issuance of common shares with unit financing | 3,384,104 | 859,643 | |
| Issuance of common shares with warrant exercise | 2,660,809 | 1,013,868 | |
| Issuance of common shares with option exercise | 237,865 | 78,420 | |
| Issuance of common shares with public offering | 17,515,576 | 7,956,787 | |
| Conversion of structured note payable and convertible liability | 2,931,868 | 676,580 | |
| Share issuance costs | - | (1,535,512) | |
| Balance at December 31, 2020 | 60,716,595 | 89,332,865 | |
| Balance at January 1, 2019 | 19,204,860 | 76,819,572 | |
| Issuance of common shares with Unit financing | 7,327,818 | 1,602,752 | |
| Conversion of convertible note payable | 4,877,200 | 1,270,131 | |
| Conversion of structured note payable and convertible liability | 2,576,495 | 590,624 | |
| Balance at December 31, 2019 | 33,986,373 | 80,283,079 |
[i] 2019 Unit Private placements in March and April
On March 25, 2019 the Company closed the first tranche (the "First Tranche") of a unit financing (the "Unit Financing") and issued 2,500,000 units for gross proceeds of \$748,300 (Cdn\$1,000,000). Each Unit ("Unit"), issued at a price of Cdn\$0.40 per Unit, consists of one common share plus one-half of one warrant. Each whole warrant is exercisable into one common share at an exercise price of Cdn\$0.72 for a period of thirty-six months from issuance, until March 25, 2022. The Unit pricing of Cdn\$0.40 is at an approximately 16% discount to the 5-day VWAP of Cdn\$0.48 at February 8, 2019.
On April 23, 2019, the Company closed the second tranche (the "Second Tranche") of a unit financing (the "Unit Financing") and issued 796,875 units for gross proceeds of \$389,691 (Cdn\$510,000). Each Unit ("Unit"), issued at a price of Cdn\$0.64 per Unit, consists of one common share plus one-half of one warrant. Each whole warrant is exercisable into one common share at an exercise price of Cdn\$0.80 for a period of thirty-six months from issuance, until April 23, 2022. The Unit pricing of Cdn\$0.64 is at an approximately 15% discount to the 5-day VWAP of Cdn\$0.76 at February 27, 2019.
[ii] 2019 Unit Private placements in July
On July 10, 2019 the Company closed the first tranche (the "First Tranche") of a unit financing (the "Unit Financing") and issued 2,897,193 units for gross proceeds of \$2,009,405 (Cdn\$2,665,418). Each Unit ("Unit"), issued at a price of Cdn\$0.92 per Unit, consists of one common share plus one-half of one warrant. Each whole warrant is exercisable into one common share at an exercise price of Cdn\$1.48 for a period of thirty-six months from issuance, until July 10, 2022.
On July 24, 2019, the Company closed the second tranche (the "Second Tranche") of a unit financing (the "Unit Financing") and issued 1,133,749 units for gross proceeds of \$797,304 (Cdn\$1,043,050). Each Unit ("Unit"), issued at a price of Cdn\$0.92 per Unit, consists of one common share plus one-half of one warrant. Each whole warrant is exercisable into one common share at an exercise price of Cdn\$1.48 for a period of thirty-six months from issuance, until July 24, 2022.
[iii] 2020 Unit Private placement in January
On January 24, 2020 the Company closed a unit financing (the "Unit Financing") and issued 2,107,526 units for gross proceeds of \$516,917 (Cdn\$\$674,409). Each Unit ("Unit"), issued at a price of Cdn\$0.32 per Unit, consists of one common share plus one-half of one warrant. Each whole warrant is exercisable into one common share at an exercise price of Cdn\$0.48 for a period of thirty-six months from issuance, until January 24, 2023.
[iv] 2020 Unit Private placement in June
On June 29, 2020 the Company closed a unit financing (the "Unit Financing") and issued 951,120 units for gross proceeds of \$389,291 (Cdn\$532,628). Each Unit ("Unit"), issued at a price of Cdn\$0.56 per Unit, consists of one common share plus one warrant. Each whole warrant is exercisable into one common share at an exercise price of Cdn\$0.72 for a period of thirty-six months from issuance, until June 29, 2023.
[v] 2020 Public Offering in June
On June 29, 2020 the Company closed a public offering of 8,272,012 units of the Company (the "Units") at a price of \$0.56 per Unit (the "Offering Price") for aggregate gross proceeds of Cdn\$4,632,327 (the "Offering"). The Offering was made pursuant to an agency agreement effective June 22, 2020 with Echelon Wealth Partners Inc. and Clarus Securities Inc. (collectively, the "Agents"). Each Unit was comprised of one common share of the Company and one warrant. Each Warrant is exercisable to purchase one Common Share at any time prior to June 29, 2023 at a price of Cdn \$0.72 per Common Share.
[vi] 2020 Public Offering in December
On December 04, 2020 the Company closed a public offering of 9,243,700 units of the Company (the "Units") at a price of \$0.78 per Unit (the "Offering Price") for aggregate gross proceeds of Cdn\$7,210,086 (the "Offering"). The Offering was made pursuant to an agency agreement effective December 04, 2020 with Echelon Wealth Partners Inc. and Clarus Securities Inc. (collectively, the "Agents"). Each Unit was comprised of one common share of the Company and one warrant. Each Warrant is exercisable to purchase one Common Share at any time prior to December 04, 2023 at a price of Cdn \$1.10 per Common Share.
Stock options
There were 5,076,357 [December 31, 2019 –3,733,779] options outstanding; 4,157,607 [2019 – 2,768,205] of which were vested and exercisable at a weighted-average price per share of Cdn\$0.738 [2018 – Cdn\$1.04]. During the year ended December 31, 2020, 237,865 options were exercised, 332,058 options expired or were forfeited, and 1,912,500 options were granted [2019 – nil, 410,625 and 1,965,523, respectively].
Accounted through current and long-term liabilities
Notes payable
Notes payable consists of:
| At December 31, 2020 |
At December 31, 2019 |
|
|---|---|---|
| Note payable to HDL [a] |
671,489 | 692,525 |
| Note payable to shareholders and a director [b] |
228,390 | 684,897 |
| Convertible debenture [c] |
- | 328,628 |
|---|---|---|
| Total | 899,879 | 1,706,050 |
The notes payable were initially recognized at fair value, and subsequently they were measured at amortized cost using the effective interest rate method. The initial fair values were calculated using a valuation technique that uses parameters obtained from observable markets, including credit spread and interest rate volatility. The prevailing interest rate used in the valuation was 16% at initial recognition.
[a]Note payable to HDL
The note is owed to Health Diagnostic Laboratories Inc. (HDL) and the Company is required to make monthly payments of \$10,000 until the outstanding debt has been paid in full. The balance of the note is expected to be repaid in full by 2034.
[b] Note payable to shareholders and director
| At December 31, 2019 |
Addition | Imputed interest |
Principal and Interest Extinguishment |
Conversion | At December 31, 2020 |
|
|---|---|---|---|---|---|---|
| \$ | \$ | \$ | \$ | \$ | \$ | |
| Note payable to shareholders and director |
684,898.18 | - | 19,974.77 | (446,718.39) | (29,464) | 228,680.56 |
The above notes are all secured by a security interest in the Company's patents and trademarks.
[c] Convertible Debenture Private Placement in February 2020
The company closed a private placement of convertible debentures (each a "Debenture") for gross proceeds of Cdn\$1,180,000 on February 19, 2020 (the "Offering"). The Debentures, issued in increments of \$1,000, bear interest at a rate of 6% per annum, have a term of 18 months from the date of issue and are convertible in units ("Units") at a conversion price of \$0.32 per Unit. Each Unit consists of one (1) common share ("Common Share") of the Company and one-half (1/2) of a Common Share purchase warrant. Each whole warrant (a "Warrant") is exercisable into one Common Share of the Company at an exercise price of CAD\$0.56 per Common Share for a period of twenty-four (24) months from the date of issuance of the Debentures. Securities issued pursuant to the Offering are subject to a statutory hold period lasting four (4) months and a day after the issuance of the securities.
As the conversion price is variable due to currency differences, resulting in the recognition of an embedded derivative, the Company designated the entire convertible instrument as a financial liability at fair value through profit or loss and recognized any changes in the fair value in the consolidated statement of loss and comprehensive loss. The fair value of the convertible debenture was calculated using a combination of discounted cash flows, using a discount rate of 35% and option pricing models using the following inputs:.
| Measurement Date |
Expected volatility Conversion Option/Unit Warrant* |
Risk-free interest rate Conversion Option/Unit Warrant |
|---|---|---|
| 19-Feb-20** | 160%/146% | 1.56%/1.48% |
| 6-Jul-20 | 158%/171% | 0.28%/0.26% |
| 9-Jul-20 | 158%/170% | 0.28%/0.26% |
| 28-Sep-20 | 164%/154% | 0.19%/0.24% |
| 29-Sep-20 | 163%/154% | 0.20%/0.23% |
| 27-Oct-20 | 163%/150% | 0.15%/0.19% |
|---|---|---|
| 31-Dec-20 | 115%/148% | 0.11%/0.16% |
* Where the transaction price is fair value and the valuation model uses unobservable inputs the valuation model is calibrated such that the result of the valuation technique equals the transaction price. The indicated volatility is prior to the calibration adjustment.
** On initial recognition there is a discount for lack of marketability ("DLOM") as a result of a four month statutory hold period was determined using a Finnerty Model with initial term of 4 mos. and volatility of 130%, in subsequent measurement periods, the hold period is expired and accordingly no DLOM is applied.
Fair value of convertible debenture [c]
| \$ | |
|---|---|
| At January 1, 2020 |
- |
| Issuance during the period |
891,845 |
| Revaluation during the period |
1,067,284 |
| Lese: Conversion |
(236,665) |
| Foreign exchange |
319,257 |
| At December 31, 2020 |
2,041,720 |
[d] Short-term debt
During the year, the Company received a Cdn\$40,000 Canada Emergency business Account ("CEBA") loan from the Government of Canada via its commercial bank. The loan is interest free until December 31, 2022, with a maturity date of December 31, 2025.
If Cdn\$30,000 of the loan has been repaid by December 31, 2022, the remaining balance (maximum Cdn\$10,000) will be forgiven. Should the loan not be repaid by December 31, 2022, interest at 5% will be charged per annum commencing on January 1, 2023 until maturity on December 31, 2025. The loan is unsecured.
Warrants
The following warrants were issued and outstanding at December 31, 2020:
| Warrants | Exercisable into common shares |
Exercise Price |
Expiry date |
|
|---|---|---|---|---|
| # | # | Cdn\$ | ||
| Date issued: |
||||
| August 11, 2016 [GEM] |
42,337 | 42,337 | 1.6 | 11-Aug-21 |
| September 30, 2016 [GEM] |
205,959 | 205,959 | 1.6 | 30-Sep-21 |
| November 4, 2016 [GEM] |
125,000 | 125,000 | 1.6 | 4-Nov-21 |
| December 30, 2016 [GEM] |
162,500 | 162,500 | 1.6 | 30-Dec-21 |
| February 17, 2017 [GEM] |
201,250 | 201,250 | 1.6 | 17-Feb-22 |
| May 9, 2017 [GEM] |
12,952 | 12,952 | 1.6 | 9-May-22 |
| May 22, 2018 [Unitholders] |
970,780 | 970,780 | 0.96 | 22-May-21 |
| June 7, 2018 [Lind] |
1,691,475 | 1,691,475 | 0.768 | 7-Jun-21 |
| August 24, 2018 [Unitholders] |
18,750 | 18,750 | 0.96 | 24-Aug-21 |
| March 25, 2019 [Unitholders] |
1059766 | 1059766 | 0.72 | 25-Mar-22 |
|---|---|---|---|---|
| April 23, 2019 [Lind] |
319,094 | 319,094 | 1.528 | 23-Apr-22 |
| April 23, 2019 [Unitholders] |
220,797 | 220,797 | 0.96 | 23-Apr-22 |
| April 23, 2019 [Unitholders] |
398,437 | 398,437 | 0.8 | 23-Apr-22 |
| July 10, 2019 [Unitholders] |
1,448,596 | 1,448,596 | 1.48 | 10-Jul-22 |
| July 24, 2019 [Unitholders] |
566,874 | 566,874 | 1.48 | 24-Jul-22 |
| January 16, 2020 [Unitholders] |
944,477 | 944,477 | 0.48 | 16-Jan-23 |
| January 16, 2020 [Hampton Security Company] |
27746 | 27746 | 0.48 | 16-Jan-23 |
| February 19, 2020 [Hampton Security Company] |
202,343 | 202,343 | 0.56 | 19-Aug-21 |
| June 29, 2020 [Unitholders] |
951,120 | 951,120 | 0.72 | 29-Jun-23 |
| June 29, 2020 [Public Offering] |
8,271,887 | 8,271,887 | 0.72 | 29-Jun-23 |
| June 29, 2020 [National Bank Financial Inc.] |
297,645 | 297,645 | 0.68 | 29-Jun-23 |
| June 29, 2020 [Fidelity Clearing Canada ULC ] |
297,645 | 297,645 | 0.68 | 29-Jun-23 |
| July 8, 2020 [Unitholder ] |
31,250 | 31,250 | 0.56 | 18-Feb-22 |
| July 9, 2020 [Unitholder ] |
78,125 | 78,125 | 0.56 | 18-Feb-22 |
| September 28, 2020 [Unitholder ] |
54,688 | 54,688 | 0.56 | 18-Feb-22 |
| September 29, 2020 [Unitholder ] |
54,688 | 54,688 | 0.56 | 18-Feb-22 |
| October 27, 2020 [Unitholder ] |
15,625 | 15,625 | 0.56 | 18-Feb-22 |
| November 27, 2020 [Unitholder ] |
162,728 | 162,728 | 1.10 | 27-Nov-23 |
| December 04, 2020 [Public Offering] |
4,621,850 | 4,621,850 | 1.10 | 4-Dec-23 |
| December 04, 2020 [National Bank Financial Inc.] |
323,530 | 323,530 | 1.10 | 4-Dec-23 |
| December 04, 2020 [Fidelity Clearing Canada ULC ] |
323,530 | 323,530 | 1.10 | 4-Dec-23 |
| 24,103,444 | 24,103,444 | 1.10 | 4-Dec-23 |
[b] Warrants issued 2019 and 2020
Warrants issued in First Tranche of Unit Private Placement on March 25, 2019
In connection with the Unit Private Placement, on March 25, 2019, 1,250,000 warrants were issued, exercisable at a price of Cdn\$0.72 per common share, expiring on March 25, 2022.
In connection with the Unit Private Placement, on April 23, 2019, 398,437 warrants were issued and are exercisable at a price of Cdn\$0.80 per common share, expiring on April 23, 2022.
In connection with convertible note payable extinguishment on April 23, 2019 [Note 6(b)], 220,797 Warrants were issued and are exercisable at a price of Cdn\$0.96 per common share, expiring on April 23, 2022.
In connection with the Unit Private Placement, on July 10, 2019, 1,444,846 warrants were issued and are exercisable at a price of Cdn\$1.48 per common share, expiring on July 10, 2022.
In connection with the Unit Private Placement, on July 24, 2019, 566,874 warrants were issued and are exercisable at a price of Cdn\$1.48 per common share, expiring on July 24, 2022.
Warrants issued to Lind on January 9, 2019
The Company issued 2,361,163 Common Share purchase warrants ("Warrants") to Lind in respect of the Convertible Security on January 9, 2019. Each Warrant is exercisable for one Common Shares for 36 months at an exercise price
StageZero Life Science, Limited Management's Discussion & Analysis [Expressed in US dollars, unless otherwise noted]
of \$0.2752 per Common Share. The number of Warrants issued in connection with the Convertible Security are equal to 100% of the amount advanced by Lind (CDN\$500,000) divided by the VWAP of the Common Shares on the TSX for the five trading days immediately preceding the execution date of the Agreement. The Warrants provide for cashless exercise by the holder in the event that the Company ceases to be a foreign private issuer, as such term is defined under the United States Securities Act of 1933.
The Corporation will be entitled, in its sole discretion, to exercise its Acceleration Right, permitting it to accelerate the exercise of the warrants, upon the occurrence of an Acceleration Event, which is defined as thirty (30) consecutive trading days during which the Common Shares traded on the Exchange at a VWAP that is at least 300% of the Exercise Price, by delivering an Acceleration Notice to the Holder. An Acceleration Notice must include the following information: (i) identifying the thirty (30) consecutive trading days during which the Common Shares traded on the Exchange at a VWAP that is at least 300% of the Exercise Price, (ii) details of the VWAP calculation, and (iii) the new Expiry Date. An Acceleration Notice will be delivered by the Corporation to the Holder in the manner provided in section 9 on the date of the Acceleration Notice. The Corporation shall not deliver an Acceleration Notice if any Face Value amount on the Convertible Security remains outstanding, and any Acceleration Notice delivered in such circumstances shall be null and void.
Warrants issued to Lind on April 22, 2019
The Company issued 319,094 warrants to Lind in respect of the Additional Funding with an exercise price of CDN\$1.5272, which is 130% of the 5-day VWAP at April 10, 2019, and exercisable for 36 months. The number of warrants issued in connection with the Additional Funding is equal to 50% of the CDN\$750,000 advanced by Lind divided by the VWAP of the common shares of the company on the TSX for the five trading days immediately preceding the closing date.
Warrants issued for Unit Private Placement on January 16, 2020
In connection with the Unit Private Placement, January 16, 2020, 1,053,763 warrants were issued and are exercisable at a price of Cdn\$0.48 per common share, expiring on January 16, 2023.
Warrants issued to Hampton Security Company on January 16, 2020
The Company issued 27,737 warrants to Hampton Security Company in respect of the broker warrants for Unit Private Placement on January 16, 2020 with an exercise price of Cdn\$0.48, exercisable for 36 months. As these warrants were issued to a broker for financing services, the issuance was accounted for as share-based compensation and the fair value on issuance was recorded in contributed surplus.
Warrants issued to Hampton Security Company on February 19, 2020
The Company issued 202,343 warrants to Hampton Security Company in respect of the broker warrants for Convertible Debentures closed on February 19, 2020 with an exercise price of Cdn\$0.56, and exercisable for 18 months. As these warrants were issued to a broker for financing services, the issuance was accounted for as sharebased compensation and the fair value on issuance was recorded in contributed surplus.
Warrants issued for Unit Private Placement on June 29, 2020
In connection with the Unit Private Placement, June 29, 2020, 951,120 warrants were issued and are exercisable at a price of Cdn\$0.72 per common share, expiring on June 29, 2023.
Warrants issued for Public Offering on June 29, 2020
In connection with the Public Offering, June 29, 2020, 8,272,010 warrants were issued and are exercisable at a price of Cdn\$0.72 per common share, expiring on June 29, 2023.
Warrants issued to National Bank Financial Inc. on June 29, 2020
The Company issued 297,645 warrants to National Bank Financial Inc. in respect of the broker warrants for the Public Offering on June 29, 2020 with an exercise price of Cdn\$0.68, and exercisable for 36 months. As these warrants were issued to a broker for financing services, the issuance was accounted for as share-based compensation and share issuance costs and the fair value on issuance was recorded in contributed surplus.
Warrants issued to Fidelity Clearing Canada ULC on June 29, 2020
The Company issued 297,645 warrants to Fidelity Clearing Canada ULC in respect of the broker warrants for Public Offering on June 29, 2020 with an exercise price of Cdn\$0.68, and exercisable for 36 months. As these warrants were issued to a broker for financing services, the issuance was accounted for as share-based compensation and share issuance costs and the fair value on issuance was recorded in contributed surplus.
Warrants issued for Unit Private Placement on November 27, 2020
In connection with the Unit Private Placement, November 27, 2020, 162,728 warrants were issued and are exercisable at a price of Cdn\$1.10 per common share, expiring on November 27, 2023.
Warrants issued for Public Offering on December 04, 2020
In connection with the Public Offering, December 31, 2020, 4,621,850 warrants were issued and are exercisable at a price of Cdn\$1.10 per common share, expiring on December 04, 2023.
Warrants issued to National Bank Financial Inc. on December 04, 2020
The Company issued 323,530 warrants to National Bank Financial Inc. in respect of the broker warrants for the Public Offering on December 04, 2020 with an exercise price of Cdn\$1.10, and exercisable for 36 months. As these warrants were issued to a broker for financing services, the issuance was accounted for as share-based compensation and share issuance costs and the fair value on issuance was recorded in contributed surplus.
Warrants issued to Fidelity Clearing Canada ULC on December 04, 2020
The Company issued 323,530 warrants to Fidelity Clearing Canada ULC in respect of the broker warrants for Public Offering on December 04, 2020 with an exercise price of Cdn\$1.10, and exercisable for 36 months. As these warrants were issued to a broker for financing services, the issuance was accounted for as share-based compensation and share issuance costs and the fair value on issuance was recorded in contributed surplus.
Warrants issued due to the conversions for convertible debentures
The Company issued 234,375 warrants to unitholders in respect of the conversion of convertible debentures with the exercise price of Cdn\$0.56, and exercisable till February 18, 2022.
Adequacy of financial resources
The Company has earned limited revenue. The Company has been able to raise planned funds through private placements or other methods of financing has contributed to the Company's current financial situation where it has adequate cash resources. The activities of the Company leading to the launch of Aristotle will require the Company to continue to raise funds. COVID-19 has contributed to the financial status of the Company inasmuch as it is providing a steady revenue source from COVID-19 testing. Further details of financings completed and challenges addressed during 2019 and 2020 are discussed in detail above – see FORWARD LOOKING STATEMENTS AND GOING CONCERN UNCERTAINTY (page 2) and FINANCING ACTIVITIES AND CAPITAL STRUCTURE (page 3).
On January 24, 2020, the Company issued 2,107,526 units for gross proceeds of Cdn\$674,409 from a private placement. In addition, on February 19, 2020 the Company closed a private placement of convertible debentures (each a "Debenture") for gross proceeds of Cdn\$1,180,000
There can be no assurance that additional funding will be available on acceptable terms or at all, when and if required. If adequate funds are not available when required, the Company may have to substantially reduce or eliminate planned expenditures or delay programs designed to expand its commercial business. As there can be no certainty as to the resolution of the above matters, there is material uncertainty that may cast significant doubt about the Company's ability to continue as a going concern. – see FORWARD LOOKING STATEMENTS AND GOING CONCERN UNCERTAINTY (Page 2)
On June 29, 2020 the Company closed a public offering of 8,272,012 units of the Company (the "Units") at a price of \$0.56 per Unit (the "Offering Price") for aggregate gross proceeds of Cdn\$4,632,327 (the "Offering"). On December 04, 2020 the Company closed a public offering of 9,243,700 units of the Company (the "Units") at a price of \$0.78 per Unit (the "Offering Price") for aggregate gross proceeds of Cdn\$7,210,086 (the "Offering").
As at December 31, 2020, our cash balance was \$6.6 million [December 31, 2019 – \$0.07 million], we had a working capital \$1.7 million [December 31, 2019 – working capital deficiency of \$3.8 million] and a deficit of \$104 million [December 31, 2019 – \$97.3 million].
OFF-BALANCE SHEET ARRANGEMENTS
We do not engage in off-balance sheet accounting to structure any of our financial arrangements and do not have any interests in unconsolidated special-purpose or structured finance entities.
CONTRACTUAL OBLIGATIONS
The Company adopted IFRS 16 on January 1, 2019, which requires the recognition of assets and liabilities for all leases, unless the lease term is less than 12 months or the underlying asset has a low value.
On December 5, 2017, the Company renegotiated the lease of its premises effective January 1, 2018 to September 30, 2023. The property and office space lease bears interest at an estimated rate of 14.4%. The lease liability as at December 31, 2020 is \$600,224 (December 31, 2019 – 753,409). Effective August 1, 2018, the Company subleased 74.46% of its leased space for a commensurate share of the rental cost for the remaining term of its lease.
RELATED-PARTY TRANSACTIONS
The key management personnel of the Company at December 31, 2020 are the directors, including the Chairman and Chief Executive Officer and the interim Chief Financial Officer. A former director, who retired from the Board of Directors of the Company in September, 2019, is the Chairman of the Board for the Company's former third-party billing company and this same director has provided interim financing to the Company between December 2015 and December 2019. With the 2018 Unit Private Placement, this director participated for \$445,213 (Cdn\$561,770) in lieu of debt repayment in cash and received 877,765 common shares and 438,882 warrants. In a 2019 Unit Private Placement, this director participated for \$314,576 (Cdn\$411,183) in lieu of debt repayment in cash and received 446,937 common shares and 223,469 warrants. In a 2020 Unit Private Placement, this director participated for \$390,766 (Cdn\$532,628). in lieu of debt repayment in cash and received 951,120 common shares and 951,120 warrants.
A director and shareholder of the Company provided interim financing in 2019.
Compensation for key management personnel of the Company is detailed below for periods ended December 31, 2020 and 2019:
Year Ended December 31 2020 2019
| \$ | \$ | |
|---|---|---|
| Salaries, fees and short-term benefits |
524,283 | 505,533 |
| Share-based compensation |
431,058 | 602,074 |
| 955,340 | 1,107,607 |
As at December 31, 2020, key management personnel controlled 5.4% (2019-6.2%) of the issued and outstanding common shares of the Company and \$612,021 (2019-\$649,446) of compensation remains unpaid to current and former key management personnel.
Stock options held by key management personnel to purchase common shares have the following expiry dates and exercise prices:
| Number outstanding |
|||||
|---|---|---|---|---|---|
| Year issued |
Range of |
At | At | ||
| Year of expiry |
exercise prices per share |
December 31, 2020 |
December 31, 2019 |
||
| \$ | # | ||||
| 2015 | 2020 | 0.16 to 3.60 |
172,240 | 270,860 | |
| 2016 | 2021 | 1.08 to 1.52 |
88,750 | 159,167 | |
| 2017 | 2022 | 1.00 to 2.84 |
250,000 | 298,125 | |
| 2018 | 2023 | 0.64 to 0.88 |
381,250 | 531,250 | |
| 2019 | 2024 | 0.64 to 0.80 |
1,380,728 | 1,483,024 | |
| 2020 | 2025 | 0.40 to0.48 |
1,200,000 | - | |
| 3,472,968 | 2,742,425 |
SELECTED QUARTERLY FINANCIAL DATA
Selected quarterly financial data for our last eight fiscal quarters follows:
| in thousands of dollars, except per-share amounts |
2020 | 2019 as re-stated | ||||||
|---|---|---|---|---|---|---|---|---|
| Q4 | Q3 | Q2 (amended) |
Q1 (amended) |
Q4 | Q3 | Q2 | Q1 | |
| Revenues | 2,593 | 1,464 | 63 | 31 | 50 | 23 | 13 | 53 |
| Net gain (loss) | (1,522) | (2,350) | (274) | (2,436) | 613 | 1,884 | (406) | (4,430) |
| Basic and diluted loss per common share |
(0.02) | (0.05) | 0.00 | (0.07) | 0.02 | 0.08 | (0.02) | (0.29) |
RESPONSIBILITIES, CONTROLS AND POLICIES
Management's responsibility for financial reporting
Evaluation of disclosure controls and procedures
Our Chairman and CEO, and Interim Chief Financial Officer are responsible for establishing and maintaining disclosure controls and procedures for the Company. As such, we maintain a set of disclosure controls and procedures designed to ensure that information required to be disclosed in filings is recorded, processed, summarized and reported within the time periods specified by the Canadian Securities Administrators rules and forms. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management necessarily is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Our Chairman and CEO, and Interim Chief Financial Officer have evaluated our disclosure controls and procedures as at December 31, 2019 and have concluded that disclosure controls and procedures are effective.
Management's report on internal controls over financial reporting
Our Chairman and CEO, and Interim Chief Financial Officer are responsible for establishing and maintaining effective internal controls over financial reporting. Our internal controls over financial reporting are designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with IFRS. Because of their inherent limitations, internal controls over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.
Our Chairman and Chief Executive Officer, and Interim Chief Financial Officer evaluated the effectiveness of our internal controls over financial reporting as at September 30, 2020 and identified the material weakness outlined below.
Material weakness
The material weaknesses we identified in our internal controls over financial reporting at December 31, 2019 were as follows: We did not have sufficient accounting resources with relevant technical accounting skills to address issues related to the financial statement close process because of the size of the Company and its staff complement, we were not able to sufficiently design internal controls to provide the appropriate level of oversight regarding the financial recordkeeping and review of the Company's financial reporting. This weakness will continue to be addressed through 2020. See "Changes in Internal Controls Over Financial Reporting" below.
In making this assessment, management used the framework set forth by the Committee of Sponsoring Organizations of the Treadway Commission ("COSO") in Internal Control – Integrated Framework (2013).
Consistent with our stage of development, we continue to rely on risk-mitigating procedures during our financial closing process in order to provide comfort that the financial statements are presented fairly in accordance with IFRS.
Changes in internal controls over financial reporting
Our Chairman and Chief Executive Officer, and Interim Chief Financial Officer have evaluated whether there were changes to our internal controls over financial reporting during the year ended December 31, 2020 that have materially affected or are reasonably likely to materially affect our internal controls over financial reporting. No such changes were identified through evaluation of the Company. As the Company continues to improve its internal controls over financial reporting, we have engaged outside consultants, expert in the valuation of complex financial instruments and have begun monthly reviews of the Company's detailed accounting records, and quarterly on-site reviews of processes in place at the Company. In light of the remediation occurring, our internal controls are expected to be changed, but only once the planned changes are finalized.
RISKS AND UNCERTAINTIES
The information presented in the "Financial Instruments and Financial Risk Management Objectives and Policies" section presented on pages 11 to 13 and in the "Risks and Uncertainties" section on pages 29 to 36 in our annual MD&A and under the heading "Risk Factors" on pages 35 to 46 of our Annual Information Form for the year ended December 31, 2019 has not changed materially since December 31, 2019.
Additional information relating to StageZero Life Sciences can be found on SEDAR at www.sedar.com or on our website at www.stagezerolifesciences.com.