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StageZero Life Sciences Ltd. — Annual Report 2021
Apr 2, 2021
44586_rns_2021-04-01_6cdb9846-4e5d-4025-8430-11863f808d79.pdf
Annual Report
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STAGEZERO LIFE SCIENCES LTD.
ANNUAL INFORMATION FORM
For the year ended
December 31, 2020
March 31, 2021
| GENERAL INFORMATION ABOUT THIS ANNUAL INFORMATION FORM ("AIF") |
5 | |
|---|---|---|
| 1. | CORPORATE STRUCTURE5 |
|
| 1. 2. |
Name, address and incorporation 5 Inter-corporate relationships7 |
|
| 2. | GENERAL DEVELOPMENT OF THE BUSINESS 8 |
|
| 2020 Highlights (and 2021 subsequent events) |
11 | |
| Commercial developments at StageZero Life Sciences, Inc |
16 | |
| DESCRIPTION OF BUSINESS AND PRODUCTS 19 |
||
| 1. 2. |
General19 Mission and strategy21 |
|
| Find It. Understand It. Treat It |
21 | |
| The IDL joint venture—personalized health management |
21 | |
| Reimbursement |
24 | |
| Near-term Strategy |
24 | |
| Advantages of Our Solution |
24 | |
| MyCancerRisk™ | 25 | |
| 3. | Industry overview and competitive environment 25 |
|
| 4. 5. |
Our Competitive strengths26 Technology and products 26 |
|
| Principle® The Sentinel |
26 | |
| ColonSentry® | 27 | |
| Background | 27 | |
| Market and sales |
28 | |
| Competition and competitive strengths |
28 | |
| EarlyCDT®-Lung |
29 | |
| Prostate Health Index ("PHI") Test |
29 | |
| Background | 29 | |
| PHI Test Agreement |
30 | |
| Market and sales |
30 | |
| Competition and competitive strengths |
30 | |
| BreastSentry™ | 31 | |
| Background | 31 |
| Competition and competitive strengths |
32 | |
|---|---|---|
| COVID-19 Tests |
32 | |
| Potential future pipeline development and research |
32 | |
| Book chapter |
33 | |
| Peer-reviewed articles |
33 | |
| 6. | Intellectual property 34 |
|
| 7. | Human resources 34 |
|
| 8. | Environment 34 |
|
| 9. | Regulatory framework 34 |
|
| 10. | Reimbursement framework 35 |
|
| 11. | Facilities36 | |
| 4. | RISK FACTORS36 |
|
| 1. | Capital requirements, financing and going concern 36 |
|
| 4.2 | No record of profit37 |
|
| 4.3 | Share price 38 |
|
| 4.4 | Dilution38 | |
| 4.5 | Public markets regulators 38 |
|
| 4.6 | Other collaborations and strategic partnerships39 |
|
| 4.7 | Markets and competition 39 |
|
| 4.8 | Commercialization 40 |
|
| 4.9 | Regulatory authorizations41 |
|
| 4.10 | Reimbursement 42 |
|
| 4.11 | Legal claims and regulatory proceedings42 |
|
| 4.12 | Compliance with privacy laws 43 |
|
| 4.13 | Marketing and distribution 43 |
|
| 4.14 | Ability of manage corporate growth, commercial expansion and interruptions |
of |
| operations | 43 | |
| 4.15 | Key personnel44 |
|
| 4.16 | Foreign exchange rate risk 44 |
|
| 4.17 | Interest rate risk44 |
|
| 4.18 | StageZero Life Sciences Inc. as licensee in the event of bankruptcy of a 44 |
licensor |
| 4.19 | Material weakness in financial controls 44 |
|
| 4.20 | Joint venture relationship45 |
|
| 4.21 | Intellectual property 45 |
|
| 4.22 | Patent infringement 46 |
|
| 4.23 | Litigation 47 |
|
| 4.24 | Fluctuations in quarterly results47 |
|
| 4.25 | Current enterprise value assigned by the market 47 |
|
| 5. | DESCRIPTION OF CAPITAL STRUCTURE 47 |
|
| 1. | Common shares 47 |
|
| 5.2 | Preference shares 47 |
|
| 5.3 | Special shares 48 |
|
| 5.4 | Warrants 49 |
|
| 5.5 | Stock options 50 |
|
| 5.6 | Dividends 50 |
|
| 6. | MARKET FOR SECURITIES 51 |
|
| 1. | Trading prices and volumes 51 |
|
| 7. | DIRECTORS AND OFFICERS51 |
| 7.1 1. |
Directors 52 Officers 53 |
|
|---|---|---|
| 8. | LEGAL PROCEEDINGS 54 |
|
| 9. | INTEREST OF MANAGEMENT AND OTHERS IN MATERIAL TRANSACTIONS 55 |
|
| 10. | TRANSFER AGENT AND REGISTRAR 55 |
|
| 11. | MATERIAL CONTRACTS55 |
|
| 12. | INTEREST OF EXPERTS 56 |
|
| 13. | AUDIT COMMITTEE 56 |
|
| 14. | ADDITIONAL INFORMATION57 |
|
| 15. | CAUTIONARY STATEMENTS57 |
|
| APPENDIX | A – GLOSSARY 59 |
|
| APPENDIX | B – CHARTER OF THE AUDIT COMMITTEE 63 |
|
| To fulfil |
its responsibilities and duties the Committee shall; 64 |
|
| Documents/ | reports review64 |
|
| Independent auditors64 |
||
| Financial | reporting processes and risk management65 |
|
| Legal | and regulatory compliance66 |
|
| Budgets67 | ||
| General | 67 |
GENERAL INFORMATION ABOUT THIS ANNUAL INFORMATION FORM ("AIF")
This document is intended to provide material information about StageZero Life Sciences, Ltd. Unless otherwise indicated or unless the context requires otherwise, all references to "StageZero", "the Company" and "the Corporation" in this Annual Information Form ("AIF") refer to StageZero Life Sciences, Ltd. together with its subsidiaries. The use of "our", "we" and "us" in this document refers to StageZero Life Sciences or its management.
The Company name and the names of its subsidiaries were changed at the Company's 2019 Annual General Meeting. StageZero Life Sciences, Ltd. was previously GeneNews Limited, Stage Zero Holdings was previously GeneNews (USA) Inc. and StageZero Life Sciences Inc. was previously Innovative Diagnostic Labs ("IDL"). For ease of establishing clarity regarding what occurred at the time, previous names were used in selected topics in this AIF.
All dollar amounts in this AIF are expressed in US dollars ("USD"), and all references to "\$" are to the lawful currency of the United States unless indicated otherwise. All information provided in this AIF is provided as at December 31, 2019, except where stated otherwise.
Effective July 1, 2015, the Company changed its presentation and functional currency from Canadian dollars ("CAD", "Cdn\$" or "C\$") to USD, effective retrospectively and comparative information provided for 2015 and 2014 was therefore restated for this change in presentation currency. We believe that the USD presentation better reflects the total Company's business activities and improves investors' ability to compare our total financial results with other publicly traded businesses in our industry (most of which are based in the United States and report in USD) and it should result in less volatility in reported revenue.
1. CORPORATE STRUCTURE
1. Name, address and incorporation
StageZero Life Sciences, Ltd. (formerly GeneNews Limited, and prior that ChondroGene Limited and Lewis Brook Resources Ltd. ("Lewis Brook")) wasincorporated on February 20, 1997, pursuant to the Business Corporations Act (Ontario). Prior to January 1, 2015, the current active business of GeneNews was carried out by its wholly owned subsidiary, GeneNews Corporation (formerly ChondroGene Inc.), which was incorporated on September 8, 1998, pursuant to the Business Corporations Act (Ontario).
On May 23, 2000, ChondroGene Inc. (subsequently, GeneNews Corporation) amalgamated with Lewis Brook Holdings Ltd. ("Lewis Holdings"), a wholly owned subsidiary of Lewis Brook, such that the majority shareholders of ChondroGene Inc. became the majority shareholders of Lewis Brook (the "Reverse Takeover Transaction"). Following the Reverse Takeover Transaction, Lewis Brook filed articles of amendment on June 1, 2000, to change its name to ChondroGene Limited. In 2003, ChondroGene Limited acquired GeneNews Inc. in a share exchange transaction. Further articles of amendment were filed on October 20, 2006 to change the Company's name from ChondroGene Limited to GeneNews Limited in conjunction with the Company's listing on the Toronto Stock Exchange (the "TSX") under the stock symbol "GEN".
Effective January 1, 2015, GeneNews Limited completed a vertical short-form amalgamation pursuant to the Business Corporations Act (Ontario) with its wholly owned subsidiaries, GeneNews Corporation and GeneNews Inc. Pursuant to the amalgamation, all of the issued and outstanding shares of each of the subsidiaries were cancelled. The amalgamated corporation, also known as GeneNews Limited, possesses all the assets and is subject to all the obligations and liabilities of each of the amalgamating corporations. No securities of GeneNews were issued in connection with the amalgamation and our share capital remains unchanged. The amalgamation did not have any significant effect on our business or operations.
Effective June 20, 2019, the Company's name changed to StageZero Life Sciences, Limited, and the Company's symbol in connection with its listing on the TSX was updated from "GEN" to "SZLS".
The Company's registered office is 70 East Beaver Creek, Unit 30, Richmond Hill, Ontario, L4B 3B2, Canada.
2. Inter-corporate relationships
As of the date of this AIF, the Company's inter-corporate relationships are shown below:

At December 31, 2014, we had the following subsidiary companies: GeneNews Corporation, which performed all Company operations in Canada; GeneNews Inc., which held certain intellectual property but was otherwise inactive; and, GeneNews (USA), Inc. ("GeneNews (USA)"), which held a 33% interest in the US joint venture described below. GeneNews (USA) is otherwise inactive.
Effective January 1, 2015, GeneNews Limited completed a vertical short-form amalgamation pursuant to the Business Corporations Act (Ontario) with its wholly owned subsidiaries, GeneNews Corporation and GeneNews Inc.
GeneNews Limited had a wholly-owned subsidiary company, GeneNews (USA), Inc., which completed two step-up acquisitions of Innovative Diagnostic Laboratory, LLP ("IDL"), a limited joint venture partnership in the United States, by increasing its ownership position from 33⅓% to 50% (effective May 15, 2015) and to 100% (effective March 15, 2016).
The Company had two inactive investments in associates: a 49% share in a limited joint venture company in China, GeneNews Technologies Inc., Tianjin ("Tianjin"), and a 10% interest in GeneNews Diagnostics, Sdn. Bhd. ("GeneNews Diagnostics"), which was focused on commercialization of the Company's ColonSentry® product in Malaysia. We contributed research equipment to a joint operation with Shanghai Biochip Co. Ltd. ("Shanghai Biochip") to establish a joint research and development facility in China and we licensed ColonSentry® to Shanghai Biochip for commercialization of the test in China. Our strategic alliance agreement with Shanghai Biochip naturally terminated on July 25, 2015, as per the terms of the agreement. As at each of the years ending December 31, 2016 to 2019 inclusive, our investments in Tianjin and in GeneNews Diagnostics were valued at \$nil, and we had limited to no activity in these companies during the periods presented herein. We are winding down all of our operations in Asia. In 2015, we began discussions with our partner in China to take steps to terminate our joint venture in Tianjin, China, GeneNews Technologies Inc., Tianjin. It is currently inactive. We could potentially incur expenses in connection in closing out these activities, estimated to be up to approximately USD 72,000.
Our common shares have been publicly traded since June 2000 and are currently listed for trading on the TSX under the stock symbol "SZLS".
2. GENERAL DEVELOPMENT OF THE BUSINESS
2.1 Three year history
In the three most recently completed financial years, we have raised a total of new gross financing of \$17.9 million in a series of financings through the issuance of common shares, warrants and debt financing (comprising convertible debentures and notes payable), as summarized in the following table (in '000s):
| Share capital |
Warrants | Debt | ||||
|---|---|---|---|---|---|---|
| Number | Amount | Number | Amount | Financing | Total | |
| # | \$ | # | \$ | \$ | \$ | |
| in thousands of dollars (except per share amounts) | ||||||
| Balance, January 1, 2018 | 118,718 | 75,310 | 8,059 | 989 | 1,584 | 77,883 |
| Issuance of common shares in capital commitment | 9,037 | 805 | - | - | - | 805 |
| Issuance of common shares with Unit financing | 15,833 | 980 | - | - | - | 980 |
| Warrants issued with Unit financing and accounted as financial liability |
- | (387) | - | - | - | (387) |
| Conversion of structured note payable and conversion liabilities |
10,051 | 351 | - | - | - | 351 |
| Share issuance costs | - | (53) | - | - | - | (53) |
| Issuance of warrants with Unit financing | - | - | 7,916 | 387 | - | 387 |
| Issuance of Warrants shares in capital commitment | - | - | 13,532 | 620 | - | 620 |
| Expiry of warrants | - | - | (2,059) | - | - | - |
| Revaluation of warrants | - | - | - | (1,541) | - | (1,541) |
| New issuance of debt | - | - | - | - | 2,285 | 2,285 |
| Imputed interest | - | - | - | - | 231 | 231 |
| Payment of interest | - | - | - | - | (38) | (38) |
| Extinguishment of principal from issuance of Units | - | - | - | - | (445) | (445) |
| Conversion of convertible notes upon issuance of common shares |
- | - | - | - | (299) | (299) |
| Foreign exchange | - | - | - | (35) | (93) | (128) |
| Balance, December 31, 2018 | 153,639 | 77,006 | 27,448 | 420 | 3,225 | 80,651 |
| Share capital |
Warrants | Debt | ||||
| Number | Amount | Number | Amount | Financing | Total | |
| # | \$ | # | \$ | \$ | ||
| in thousands of dollars (except per share amounts) | ||||||
| Balance, January 1, 2019 (restated) | 153,639 | 76,820 | 27,448 | 420 | 2,859 | 80,099 |
| Issuance of common shares with Unit financing | 58,623 | 1,603 | - | - | - | 1,603 |
| Conversion of structured note payable and conversion liabilities |
39,018 | 1,270 | - | - | - | 1,270 |
| Issuance of warrants with Unit financing | - | - | 52,520 | 2,869 | - | 2,869 |
| Revaluation of warrants | - | - | - | (2,434) | - | (2,434) |
| New issuance of debt | - | - | - | - | 397 | 397 |
| Imputed interest | - | - | - | - | 527 | 527 |
| Payment of principle | - | - | - | - | (149) | (149) |
| Extinguishment of principal from issuance of Units | 20,612 | 591 | - | - | (768) | (177) |
StageZero Life Sciences, Limited – Annual Information Form9/63 [Expressed in US dollars, unless otherwise noted]
| Conversion of convertible notes upon issuance of common shares |
- | - | - | - | (1,207) | (1,207) |
|---|---|---|---|---|---|---|
| Foreign exchange | - | - | - | 142 | 47 | 189 |
| Balance, December 31, 2019 | 271,892 | 80,283 | 79,968 | 997 | 1,706 | 82,986 |
| Share capital |
Warrants | Debt | ||||
| Number | Amount | Number | Amount | Financing | Total | |
| # | \$ | # | \$ | \$ | \$ | |
| in thousands of dollars (except per share amounts) | ||||||
| Balance, January 1, 2020 (post-consolidation) | 33,986 | 80,283 | 9,996 | 997 | 1,706 | 82,986 |
| Issuance of common shares with Unit financing | 3,384 | 685 | - | - | - | 685 |
| Conversion of structured note payable and conversion liabilities |
2,932 | 677 | - | - | - | 677 |
| Issuance of common shares with warrant exercise | 2,661 | 913 | - | - | - | 913 |
| Issuance of common shares with option exercise | 238 | 46 | - | - | - | 46 |
| Issuance of common shares with public offering | 17,516 | 5,689 | - | - | - | 5,689 |
| Share issuance costs | - | (262) | - | - | - | (262) |
| Issuance of warrants with Unit financing | - | - | 2,398 | 416 | - | 416 |
| Issuance of warrants with Public Offering | - | - | 14,136 | 2,590 | - | 2,590 |
| Warrant Exercise during the period | - | - | (2,661) | (346) | - | (346) |
| Conversion of convertible notes upon issuance of Warrants |
- | - | 234 | 41 | - | 41 |
| Revaluation of warrants | - | - | - | (655) | - | (655) |
| Imputed interest | - | - | - | - | 129 | 129 |
| Extinguishment of principal from issuance of Units | - | - | - | - | (451) | (451) |
| Conversion of convertible notes upon issuance of common shares |
- | - | - | - | (355) | (355) |
| Foreign exchange | - | - | - | 314 | (32) | 282 |
| Balance, December 31, 2019 | 60,716 | 88,031 | 24,103 | 3,357 | 997 | 92,385 |
Results of operations for the three most recently complete financial years are summarized below:
| in thousands of dollars (except per share amounts) |
Q1 | Q2 | Q3 | Q4 | Total |
|---|---|---|---|---|---|
| 2020 | \$ | \$ | \$ | \$ | \$ |
| Revenue | 3,178 | 1,464 | 63 | 31 | 4,736 |
| Net (loss) income | 1,191 | (2,350) | (274) | (2,436) | (3,869) |
| Basic loss per common share | 0.02 | -0.05 | 0.00 | (0.07) | (0.06) |
| 2019 as re-stated | |||||
| Revenue | 50 | 23 | 13 | 53 | 139 |
| Net (loss) income | 713 | 2,233 | (505) | (5,922) | (3,481) |
| Basic loss per common share | 0.00 | 0.01 | (0.00) | (0.05) | (0.02) |
StageZero Life Sciences, Limited – Annual Information Form10/63 [Expressed in US dollars, unless otherwise noted]
| 2018 | \$ | \$ | \$ | \$ | \$ |
|---|---|---|---|---|---|
| Revenue | 4 | 13 | 98 | 71 | 186 |
| Net (loss) income | (579) | (2,632) | (669) | 188 | (3,692) |
| Basic loss per common share | 0.00 | (0.01) | (0.01) | (0.02) | (0.02) |
Consolidated revenue for the year ended December 31, 2020 was approximately \$4,736,546XX reflecting the sales of tests. The revenue for the same period in 2019 was \$139,000 while the revenue for the same period in 2018 was \$186,000.
2020 Highlights (and 2021 subsequent events)
2021 Highlights
January 6, 2021 Announced StageZero Life Sciences participation in the SNN Network Canada Virtual Event on Thursday, January 7, 2021.
2020 Highlights
January 3, 2020—Announced conversion of December 2016 Convertible Debentures that matured on December 23, 2019. Canadian \$621,000 of outstanding Debentures were converted.
January 13, 2020—Announced that it retained Fig House Communications to manage all aspects of the Company's investor relations program.
January 27, 2020—Announced that it closed a private placement financing of C\$674,408.80.
January 30, 2020—Announced that the Company is participating in Mercer's new vendor database in the U.S.. The Mercer internal vendor intelligence database is available to Mercer Consultants to be able to do streamlined health and benefits vendor research on behalf of their clients in the U.S.
February 21, 2020—Announced that the Company had closed a private placement Convertible Debenture Financing for gross proceeds of C\$1,180,000 on February 19, 2020.
March 31, 2020—Announced it had intended to issue its audited Financial Statements for the calendar year 2019, the Management Discussion and Analysis for the 3 month and 12‐month periods to 31 December 2019 and the Annual Information Form on March 30, 2020, in line with its normal reporting calendar. The Company now, however, due to disruption of the audit process caused by the Covid‐19 crisis, intends to rely on exemptions recently granted by Canadian securities regulatory authorities that allow it to delay the issue of the 2019 Financial Statements, the 2019 MD&A, and the 2019 AIF.
March 31, 2020—Announced that it is preparing to offer testing for COVID‐19 in both the U.S. and Canada. StageZero will offer both the serology point‐of‐care and lab‐based PCR tests.
April 3, 2020 - Announced StageZero Life Sciences publication of an abstract at the American Society of Clinical Oncology. The abstract was on the Company's pan cancer test Aristotle.
April 3, 2020 - Filed an amended Press Release: StageZero Life Sciences Financials Update.
April 20, 2020 - Announced the initiation of testing for COVID-19 in the USA. Tests offered were both the antibody serology test and the nasopharyngeal PCR test.
May 1, 2020 - Announced an update on testing for COVID-19 in the USA.
May 4, 2020 - Announced an enhanced relationship with Phleb-Finders for the provision of mobile phlebotomists.
May 12, 2020 – Announced completion of the convertible security funding agreement with LIND.
May 13, 2020 – Announced Fourth Quarter 2019 Results and Year End Investor Call. Then announced revised times on May 15 and May 19.
May 19, 2020 – Announced partnership with UDoTest to link physicians and their patients to urgent COVID-19 Testing.
May 20, 2020 – Announced Q4 and Full Year 2019 Results and provided a progress update.
May 20, 2020 – Announced a delay in the filing of the Q1 Filings.
June 1, 2020 – Announced Q1 2020 Progress Update.
June 1, 2020 – Announced an Overnight Marketed Public Offering with Clarus Securities and Echelon Wealth Partners as the Co-Leads.
June 18, 2020 – Announced the filing of Amended and Restated First Quarter Financial Statements and Management Discussion and Analysis.
June 23, 2020 - Announced Issuance of Receipt for Final Prospectus and Conditional Listing Approval.
June 29, 2020 - Announced Closing of Public Offering for Proceeds ofC \$4.6 million.
July 2, 2020 – Announced a Corporate Update.
August 14, 2020 – Announced Second Quarter Analyst and Investor Call.
August 17, 2020 – Announced a Q2 2020 Progress Update.
August 18, 2020 - Announced the results of the Annual and Special Meeting.
September 8, 2020 - Announced a Share Consolidation. The ratio of consolidation was 8 to 1 for the common shares.
September 18, 2020 - Announced the completion of the share consolidation.
October 8, 2020 – Announced the launch of Saliva PCR Testing for the Detection of the SARS-CoV-2 Virus.
October 19, 2020 – Announced a \$5 Million Overnight Marketed Public Offering. Clarus Securities and Echelon Wealth Partners lead the offering.
StageZero Life Sciences, Limited – Annual Information Form12/63 [Expressed in US dollars, unless otherwise noted]
November 13, 2020 – Announced that the Company was named as COVID-19 Testing Partner for Barbados. This entailed providing rapid testing services for travelers from U.S. and Canada.
November 17, 2020 – Announced an update on Financial Statements.
November 20, 2020 - Announced Q3, 2020 Financial Results and Operational Update.
November 23, 2020 – Announced an Operational Update.
November 26, 2020 – Announced the filing of reviewed Q3 Statements.
November 27, 2020 – Announced the issuance of the receipt for the final prospectus and conditional listing approval for the financing.
December 2, 2020 - Announced initiation of testing for travel to China.
December 4, 2020 – Announced the closing of the public offering for Proceeds of C7.2 million.
December 7, 2020 - Announced the third quarter analyst and investor call. Announced Q3 revenue of US1.5M.
December 31, 2020 - Announced the appointment of new auditors McGovern Hurley and the resignation of BDO.
2019 Highlights
January 28, 2019—Announced it has published a new study that further validates the stability of its proprietary test, ColonSentry®, as a tool to risk stratify patients who are non‐compliant with any form of Colorectal Cancer screening and prioritize patients who should be referred directly for colonoscopy versus other modalities for colorectal cancer screening.
March 25, 2019—Announced the closing of a \$1.0 million strategic private placement financing round and, due to high demand, launched and expect to close a second tranche by March 29, 2019.
March 28, 2019—Announced that the Company has launched the first of several initiatives to make patient‐directed testing available nationwide.
March 29, 2019—Announced that it will release its fourth quarter 2018 results before markets open on Tuesday, April 2, 2019.
April 2, 2019—Announced that the CDN \$510,000 second tranche of the private placement financing has closed. A total of 14 investors participated in the private placement for total gross proceeds of CDN \$510,000.
April 3, 2019—Announced operational and financial results for the three‐month and twelve‐month periods ended December 31, 2018 and provided a progress update on its business.
April 17, 2019—Announced the Company has launched its first telehealth program for marketing the Prostate Health Index (phi) directly to patients nationwide.
April 22, 2019—Announced that Lind Asset Management XI, LLC has increased its funding under the First Convertible Security of the Convertible Security Funding Agreement dated May 31, 2018 between the Company and Lind by CDN\$750,000.
May 9, 2019—Announced that it has launched the Company's first awareness campaign on prostate cancer. The campaign uses Gary the Prostate to explore prostate cancer symptoms, tests, and treatments.
StageZero Life Sciences, Limited – Annual Information Form13/63 [Expressed in US dollars, unless otherwise noted]
May 14, 2019—Announced that Gary the Prostate, the Company's national spokesperson for prostate cancer awareness, has been recently diagnosed with an elevated PSA.
May 16, 2019—Announced operational and financial results for the three‐month period ended March 31, 2019 and provided a progress update on its business.
June 10, 2019—Announced that it has signed a Global Licensing and Services Agreement with Oncore Pharma, Inc.
June 17, 2019—Announced that it will host a live webcast that includes an online presentation following the Company's Annual General Meeting of shareholders on Wednesday, June 19, 2019.
June 20, 2019—Reported that its shareholders voted in favor of all items of business, including the election of all nominee directors listed in the Company's management information circular dated May 15, 2019 at its annual and special meeting of shareholders held on June 19, 2019.
June 26, 2019—StageZero Life Sciences Ltd (formerly GeneNews) announced that beginning June 26, 2019, the Company will be trading under the ticker symbol (TSX: SZLS). Trading will continue in the Company's common shares under the new name, symbol, and CUSIP number. The Company officially changed its name from GeneNews Ltd. to StageZero Life Sciences Ltd on June 20, 2019.
July 9, 2019—Announced that it is partnering with Coastal Medical, a privately held sales organization in Savannah, GA, to increase outreach to physician practices and hospital systems throughout the Southeast. Coastal Medical is a regional sales organization specializing in selling advanced diagnostic testing solutions throughout the Southeast. Initial efforts will concentrate on selling StageZero testing in Atlanta and South Carolina and expand to other states.
July 11, 2019—Announced the first closing for \$2,665,418 of the \$3.708 million private placement financing round as approved by shareholders at the Company's Annual and Special Meeting. StageZero anticipates a final closing by July 19, 2019. The private placement is fully subscribed.
July 26, 2019—Announced the second closing for \$1,043,049 to complete the \$3.708 million private placement financing round as approved by shareholders at the Company's Annual and Special Meeting. The private placement is fully subscribed.
August 7, 2019—Announced that James Howard‐Tripp will be presenting at the ii6 Summit, August 8 at the Omni King Edward Hotel in Toronto. The event, which is sponsored by InvestorIntel, gives CEOs an opportunity to present their companies to multiple self‐directed, accredited investors.
August 12, 2019—Announced that it will release its second quarter 2019 operational results before markets open on August 14, 2019.
August 14, 2019—Announced operational results for the three‐month period ended June 30, 2019 and provided a progress update on its business.
September 12, 2019—Announced that the Company would be presenting at this year's Fall Investor Summit on September 16th‐17th in New York City.
October 2, 2019—Announced that the Company is gaining traction in patient‐directed testing following the launch of a new online marketing initiative for prostate cancer awareness month.
October 10, 2019—Announced that its licensing partner, Oncore Pharma, has signed a multi‐year agreement with BodyCheck NL for the distribution and sale of ColonSentry® throughout the Netherlands, Belgium, and Luxembourg (Benelux).
November 15, 2019—Announced Q3 2019 progress update, including operational results for the three‐month period ended September 30, 2019 and provided a progress update on its business.
November 14, 2019—Announced that it expanded the Company's telehealth presence with the addition of new partners, including an e‐Commerce platform and expansion of in‐home mobile phlebotomy.
November 13, 2019—Announced that it will host an investor call for third quarter 2019 results on November 15, 2019.
November 6, 2019—Announced that the ColonSentry® Blood test is now available to consumers through Online Telehealth Platform.
December 9, 2019—Announced that BreastSentry™ and Prostate Health Index tests were added to the licensing and services agreement with Oncore Pharma.
Financings and Capital Structure
2020 Unit Private placement in January
On January 24, 2020 the Company closed a unit financing (the "Unit Financing") and issued 2,107,527 units for gross proceeds of \$508,234 (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 thirtysix months from issuance, until January 24, 2023.
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 \$390,766 (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.
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.
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.
Note payable to shareholders and director
On April 23, 2019, one of the Holders extinguished convertible notes for \$250,000 dated May 3, 2018 with interest for 3,532,752 common shares and 1,766,376 Warrants
On July 2019, the note payable \$250,000 dated May 3, 2018 and principle \$49,234 of note dated October 31 with associated interest were returned to Holder.
In addition, during the period from October 3,2018 to December 31, 2019, the same director and shareholder of the Company loaned an additional \$440,000 to the Company. The related Notes are payable on demand with simple interest earned at 5% per annum and are secured by a security interest in the Company's patents and trademarks.
On December 23, 2019, 17,079,208 common shares of the Corporation were issued, to holders of 2019 Debentures, for a consideration of \$464,766 (Cdn\$621,000), pursuant to the conversion of the principal amount of the 2019 Debentures (the "Conversion Shares")., fixed the price of Cdn \$0.03636 per share, being 90% of the VWAP of the Common Shares on the Toronto Stock Exchange for the five consecutive trading days immediately preceding (but not including) December 23, 2019.
2019 Unit Private placements
On March 25, 2019 the Company closed the first tranche (the "First Tranche") of a unit financing (the "Unit Financing") and issued 20,000,000 units for gross proceeds of \$748,300 (Cdn\$1,000,000). Each Unit ("Unit") consists of one common share plus one-half of one warrant at a price of Cdn\$0.05 per Unit. Each whole warrant is exercisable into one common share at an exercise price of Cdn\$0.09 for a period of thirty-six months from issuance, until March 25, 2022. The Unit pricing of Cdn\$0.05 is at an approximately 16% discount to the 5-day VWAP of Cdn\$0.06 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 6,375,000 units for gross proceeds of \$389,691 (Cdn\$510,000). Each Unit ("Unit") consists of one common share plus one-half of one warrant at a price of Cdn\$0.08 per Unit. Each whole warrant is exercisable into one common share at an exercise price of Cdn\$0.10 for a period of thirty-six months from issuance, until April 23, 2022. The Unit pricing of Cdn\$0.08 is at an approximately 16% discount to the 5 day VWAP of Cdn\$0.095 at March 9, 2019.
On July 10, 2019 the Company closed the first tranche (the "First Tranche") of a unit financing (the "Unit Financing") and issued 23,177,546 units for gross proceeds of \$2,009,405 (Cdn\$2,665,418). Each Unit ("Unit") consists of one common share plus onehalf of one warrant at a price of Cdn\$0.115 per Unit. Each whole warrant is exercisable into one common share at an exercise price of Cdn\$0.185 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 9,069,999 units for gross proceeds of \$797,304 (Cdn\$1,043,050). Each Unit ("Unit") consists of one common share plus one-half of one warrant at a price of Cdn\$0.115 per Unit. Each whole warrant is exercisable into one common share at an exercise price of Cdn\$0.185 for a period of thirty-six months from issuance, until July 24, 2022.
2018 Highlights
Commercial developments at StageZero Life Sciences, Inc.
StageZero Life Sciences, Inc.. is a national clinical reference laboratory specializing in personalized blood-based tests to find, understand and treat cancers. It operates from a single facility in Richmond, Virginia, that is capable of servicing the entire United States.
Small Independent Practices: Ranging in size from 1 to 10 providers, with reimbursement for the tests via billing to insurers and patient-pay, these are an important sector of the market. StageZero Life Sciences, Inc. is steadily increasing the number of practices using our tests and has recently upgraded its billing procedures.
StageZero Life Sciences, Limited – Annual Information Form16/63 [Expressed in US dollars, unless otherwise noted] High-Risk Populations/employers: Early detection of cancer as well as risk stratification into normal, high and "raised" risk is of critical importance in workers exposed to carcinogens.
StageZero Life Sciences, Inc. has been working with multiple partners across the country and has initiated screening within these high-risk groups. Reimbursement to the Company is direct and either immediate, or within 45 days.
TeleMedicine: The emerging sector within healthcare. Patients want healthcare, including laboratory diagnostic testing, at their convenience without the need to travel or wait. To this end, StageZero Life Sciences, Inc. is building out its capability to "go to the patient", draw the blood, and provide not only the test results, but also the follow up required. We have country-wide blood draw services, much of it via mobile phlebotomists, and are working with several other laboratories and physician groups to ensure we can meet this need. This is an area of significant growth.
Large Healthcare Systems: Are one of our largest opportunities and we are in discussion with multiple large systems. StageZero Life Sciences, Ltd. 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 co-ordinated. Contracts will be executed once implementation is fully in place.
On May 17, 2018, StageZero Life Sciences, Ltd. announced that it partnered with AIM Laboratories, a privately held diagnostic laboratory in St Louis, Missouri to offer its tests to AIM's client base. AIM Laboratories operates a full-service reference lab focused on routine blood testing and specializing in therapeutic drug monitoring for prescribed and illicit drugs. It services about 20 States with particular strength in the Midwest.
On August 15, 2018, StageZero Life Sciences, Ltd. announced a partnership with Pittsburgh-based, LifeX™, a strategic engine for developing and nurturing cutting-edge, life-saving health solutions and bringing these innovations to market.
Financings and Capital Structure
Note payable to shareholders and director
On May 3, 2018, two shareholders of the Company, one of whom is a director, each loaned \$250,000 to the Company and were issued convertible notes (the "May 2018 Notes").
The May 2018 Notes mature upon the earlier of 1.) upon demand by the noteholders or 2.) May 3, 2019, with simple interest earned at 5% per annum. Each note is convertible at the holder's discretion into units of the Company at a subscription price of Cdn\$0.095 per note unit. Each note unit consists of one common share and one-half of a warrant. Each whole warrant is exercisable into one common share at a price of Cdn\$0.12 per common share for a period of three years from issuance. The note units are only issuable to the holder if the holder chooses the conversion option as payment upon demand. The note unit pricing of Cdn\$0.095 is at a 5% premium to the market price of Cdn\$0.09 at May 10, 2018.
If the notes are outstanding for the full twelve months, each holder is entitled to principal and interest of \$262,500 (Cdn\$358,117), or if converted into note units, 3,550,936 common shares and 1,775,468 Warrants. In total for both holders, the maximum number of common shares issuable upon the conversion of the notes is 10,652,808 common shares, consisting of 7,101,872 common shares underlying the notes and 3,550,936 common shares underlying the warrants. The warrants will only be issued upon the conversion of the May 2018 Notes. On April 23, 2019, one Holder converted above convertible notes for 3,532,752 common shares and 1,766,376 Warrants.
On October 25, 2018, the same shareholders and director of the Company loaned an additional \$200,000 to the Company. Additionally, the other shareholder loaned an additional \$50,000 to the Company. Both shareholders were issued convertible notes in consideration (the "October 2018 Notes").
The October 2018 Notes mature upon the earlier of 1) upon demand by the noteholders or 2) October 25, 2020, with simple interest earned at 5% per annum. The holders have the right to convert the accrued interest and principal into common shares of the Company throughout the term of the notes. The conversion rate was calculated as the 5-day volume weighted average price of the common shares of the Company for the period ending October 24, 2018 of Cdn\$0.053180 plus Cdn\$0.005 premium, totaling Cdn\$0.05818. The number of common shares issuable by the Company upon conversion is calculated as the total accrued balance of principal and interest owing on the date of demand for conversion, converted from USD to Cdn\$ at the Bank of Canada's exchange rate of USD to Cdn\$ on October 24, 2018 of 1.3029 and divided by the common share price in Cdn\$. The October 2018 Notes are secured by a security interest in the Company's patents and trademarks.
Convertible Debentures
On June 8, 2018, the Company entered into the Convertible Security Funding Agreement (the "CSFA") with Lind Asset Management XI, LLC ("Lind") for up to Cdn\$7.5 million in convertible securities. Under the terms of the Agreement, Lind advanced \$1,541,800, less a closing fee of Cdn\$100,000, in consideration for the issuance of a convertible security with a face value of Cdn\$2.4 million (the "First Convertible Security" of the "First Tranche"). Lind can increase the funding under the First Convertible Security by an additional Cdn\$1,000,000 during its thirty-month term.
The Agreement also provides for the issuance of a second convertible security on mutual agreement of the Company and Lind and satisfaction of conditions including that 75% of the face amount of the First Convertible Security has been repaid or converted, in which case Lind may fund up to another Cdn\$3,000,000 (the "Second CSFA"). Similar to the First CSFA, Lind can also increase the funding under the Second CSFA by up to Cdn\$1,500,000. If the Second CSFA occurs, the Company would pay Lind a closing fee equal to 5% of the amount advanced in the Second CSFA.
Share Capital
Pursuant to a June 9, 2016, capital commitment agreement (the "Agreement") with GEM Global Yield Fund LLC SCS ("GEM") for Cdn\$5 million Capital Commitment ("CC"), wherein the Company has the right, but not the obligation, to draw down under the CC for a term of three years,, the Company issued 9,037,500 common sharesfor \$805,201 in gross proceeds during the year ended December 31, 2018 [2017 – issued 6,039,600 common shares and 1,713,621 warrants and received \$1,211,256]
On May 22, 2018, the Company closed the first tranche (the "First Tranche") of a unit financing (the "Unit Financing") for gross proceeds of \$979,935 (Cdn\$1,242,601) each Unit consists of one common share plus one-half of one warrant at a price of Cdn\$0.08 per Unit. Each whole warrant is exercisable into one common share at an exercise price of Cdn\$0.12 for a period of thirty-six months, until May 22, 2021.
On August 24, 2018, the Company announced a second tranche closing (the "Second Tranche") of the Unit Financing, subject to shareholder approval. At its annual and special meeting of shareholders on June 28, 2018, shareholders voted for the issuance of up to 4,917,487 Units, representing 7,376,231 common shares. Insiders would not participate in the Second Tranche of the Unit Financing and it is not expected that the transaction will result in a change of control. Each Unit consists of one common share plus one-half of one warrant at a price of Cdn\$0.08 per Unit. Each whole warrant is exercisable into one common share at an exercise price of Cdn\$0.12 for a period of thirty-six months after the closing date of the Second Tranche of the Unit Financing. \$18,502 cash was received for issuing 300,000 shares and 150,000 warrants.
Warrant Amendments
Warrants issued in Second Tranche of Unit Private Placement on May 22, 2018
In connection with the Unit Private Placement 7,766,256 warrants were issued and are exercisable at a price of Cdn\$0.12 per common share expiring on May 22, 2021.
Warrants issued to Lind on June 7, 2018
StageZero Life Sciences, Limited – Annual Information Form18/63 [Expressed in US dollars, unless otherwise noted]
On June 7, 2018, the Company issued 13,531,800 warrantsto Lind in respect of the First Convertible Security, (CSFA) exercisable until June 7, 2021 at an exercise price of Cdn\$0.096 per share. The number of warrants issued in connection with the First CSFA are equal to 50% of the amount advanced by Lind (Cdn\$2,000,000) divided by the VWAP of the common shares of the Company on the TSX for the five trading daysimmediately preceding the closing date. In respect of the Second CSFA (if any), the Company has agreed to issue such number of warrants equal to 50% of the amount advanced by Lind in respect of the Second CSFA divided by the VWAP of the common shares for the five trading days immediately preceding the issuance of the Second CSFA. Warrants calculated in the same manner will also be issued to Lind if it elects to increase the size of any convertible security as described above. All subsequent warrants issued to Lind pursuant to the Agreement will be exercisable for 36 months from the date of issuance at an exercise price equal to 130% of the five-day VWAP of the common shares immediately prior to the applicable closing date. The Warrants provide for cashless exercise by the holder in the event that the Company ceases to be a foreign private issuer, as that term is defined under the United States Securities Act of 1933.
Warrant amendment 2018
On June 14, 2018, the Company announced a warrant exercise incentive program (the "2018 Program") designed to encourage the early exercise of its 2,059,052 outstanding and unlisted warrants (the "2018 Warrants") expiring August 15 and December 23, 2018, whereby the exercise price was reduced from Cdn\$0.50 to Cdn\$0.15, which is approximately a 100% premium above the market price of the 5-day volume-weighted average price of the Common Shares on the TSX ("VWAP") as at the close of business on May 24, 2018. The early exercise period commenced on June 29, 2018 at 9:00 a.m. (Eastern time) and terminated on July 27, 2018 at 4:30 p.m. (Eastern time)( the "Early Exercise Expiry Date"). At its annual and special meeting of shareholders on June 28, 2018, disinterested shareholders voted to extend the 2018 Program to Company insiders. As such, all 2018 Warrants were repriced. Ultimately, none of the 2018 Warrants were exercised and all such warrants remain outstanding and continue to be exercisable on their original terms.
Warrants issued in Second Tranche of Unit Private Placement on August 24, 2018
In connection with the Unit Private Placement on August 24 2018, 150,000 warrants were issued and are exercisable at a price of Cdn\$0.12 per common share expiring on August 24, 2021.
DESCRIPTION OF BUSINESS AND PRODUCTS
1. General
StageZero Life Sciences, Ltd. is focused on commercializing proprietary and third party clinical molecular diagnostic tests and, to a lesser extent, developing proprietary clinical molecular diagnostic tests for the early detection of diseases and personalized health management, with a primary focus on cancer-related indications. The Company's vision is to improve human health, reduce suffering and lower healthcare costs through early disease detection. Its history in the scientific development of innovative risk-assessment tests has established a strong foundation, understanding and desire to build diagnostic menus that allow clinicians to make more informed therapeutic decisions.
StageZero Life Sciences, Ltd. is a pioneer in the field of molecular diagnostics and has developed an approach to identifying unique RNA-based biomarkers from whole blood. This proprietary platform technology is called the Sentinel Principle®—it has the theoretical ability to detect any disease or medical condition from a simple blood sample. The Sentinel Principle® technology is protected by pioneering foundational patents.
StageZero, 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 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 blood gene expression profiles can be used to develop personalized signatures capable of differentiating patients with cancer from healthy patients across a broad spectrum of pathologies. ColonSentry® 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.
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 colorectal cancer ("CRC") in patients who have refused other screening methods.
A corporate reorganization at StageZero in 2013 focused operations on commercial growth through our newly formed joint venture, IDL, which is now StageZero Life Sciences, Inc. , which actively markets the ColonSentry® test throughout the United States. During 2014, StageZero Life Sciences, Inc. added sales of EarlyCDT®-Lung and Beckman Coulter Diagnostics' PHI test to those of the ColonSentry® test.
2014 and 2015 proved to be developmental years during which the joint venture, established to develop a full service, reference laboratory focused on early cancer diagnostics, built out StageZero Life Sciences, Inc..
Located in Richmond, Virginia, StageZero Life Sciences, Inc. offers early cancer risk stratification diagnostics for colorectal, prostate and breast cancers, and is to launch Aristotle, its multi-cancer panel for 10 individual cancers from a single sample of blood through several novel, proprietary molecular diagnostic platforms. 2014 was the build out of the lab by 3 joint venture partners, the launch of ColonSentry®, EarlyCDT®-Lung and the Prostate Health Index. The lab became operational, and we demonstrated that acceptance of our tests was high. 2015 was a year of consolidating the lab into a stand-alone, full-service facility where StageZero Holdings Inc. was buying out one partner and negotiating for sole control with the other. A footprint based on maximum efficiency and cost control was also established.
2016 saw sole control established, and on the strength of that a refinancing of the company and the launch of a new business model. StageZero Life Sciences, Ltd., and it's full service lab, StageZero Life Sciences, Inc., 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 diagnosis procedures. Our collaboration with JTS Health Partners, announced in March 2016, and the new focus on large healthcare providers was to accelerate our commercialization path and the subsequent adoption of StageZero Life Sciences, Inc.'s menu of proprietary cancer tests within hospitals, clinical integrated networks, physician groups and other healthcare organizations. Initial partnerships were with NueHealth LLC, announced in September 2016, and with a large, American Midwest, multi-specialty physician group, announced in March 2017.
Early in 2017, the lab resumed its full operations and rolled out BreastSentry™ while adding approximately 8,000 U.S. draw sites to expand patient access nationwide. In late 2017, MyCancerRisk™ was launched and began implementation planning for 3 large networks. JTS was assisting with the implementation of a new billing process to impact revenues. Invoicing for tests run but not billed during this transition period was expected to be submitted to payers in Q2 2018 and collected thereafter.
In this, StageZero is becoming part of the solution to finding cancer early and is working with large healthcare groups to expand their reach and work with them as part of the cost containment process. We are also continuing to service our regular base of physicians/practices, as well as actively recruiting new groups.
The Company was founded in 1998 and has been listed on the Toronto Stock Exchange since 2000. We have a strong management team with expertise in molecular diagnostics and global business development.
Operations fall principally into a single industry segment: molecular diagnostics. None of the Company's business is seasonal in nature operating within a single reportable segment.
2. Mission and strategy
Find It. Understand It. Treat It.
Our mission is to provide physicians with personalized clinical intelligence to improve health outcomes through early diagnosis of disease. Our goal is to provide a panel of traditional and genomic-based tests that aid in early cancer detection, guide treatment protocols and assist with monitoring of remission and recurrence.
The IDL joint venture—personalized health management
Prior to 2019, StageZero Life Sciences Inc. was Innovative Diagnostic Labs (IDL). We formed IDL in July 2013 with two partners, HDL and Cobalt, as the vehicle to commercialize ColonSentry® in the US market. IDL is a national clinical reference laboratory specializing in personalized bloodbased tests to find, understand and treat cancers. We are committed to helping StageZero become a leader in molecular diagnostics and personalized medicine and health management and a strong commercialization outlet for advanced cancer tests. With its multi-view approach to the diagnosis and treatment of cancer, IDL is working to assemble a menu of cancer assays that it can offer throughout the United States and other countries.
Start-up operations began during the third quarter of 2013 and included set-up and validation of lab facilities, technology transfer, training of laboratory personnel, application for and receipt of CLIA accreditation and other regulatory licenses, development of marketing materials, sales planning, and development of the ColonSentry® reimbursement strategy encompassing coding, coverage and payment by insurers for this test service. Although it operates from a single facility in Richmond, Virginia, it is capable of servicing customersthroughout the entire United States and other countries.
Physicians are able to order tests offered by StageZero though specialized requisitions supplied by StageZero. StageZero receives patient blood specimens at its Richmond, Virginia facility. Samples are accessioned, processed, and analyzed at our lab and a report is generated and sent to the ordering physician. Insurance companies are billed through a third party. Insurance companies may pay in full, in part or not at all. In addition, insurance payments may be incomplete if patients are required to pay a co-pay, coinsurance and/or deductible.
At initiation, each partner contributed the following expertise to the IDL operation:
GeneNews (now Stage Zero Life Sciences, Ltd.)
- Support for the commercialization effort for ColonSentry® by providing scientific knowledge-based services and licensing the key technology
- Managed ongoing business development activities for launch of comprehensive test panels
- HDL
- Ran the clinical laboratory and offered blood and other analyses as well as complete health risk assessment administration until December 2014 when IDL became responsible for these functions and StageZero Life Sciences, Ltd.'s Executive Chairman and Chief Financial Officer assumed key management roles at IDL.
Cobalt Healthcare ("Cobalt")
- Managed and oversaw US sales force
- Directed sales to primary care physicians, specialists and hospitals.
Building on the successful launch of ColonSentry® in 2013, IDL added tests for lung and prostate
StageZero Life Sciences, Limited – Annual Information Form21/63 [Expressed in US dollars, unless otherwise noted]
cancers to its test services in 2014 and acquired rights to offer breast cancer testing in 2015.
Effective May 15, 2015, our wholly owned subsidiary, GeneNews (USA), Inc., (now StageZero Holdings Inc.) entered into a purchase agreement with Cobalt and HDL under which it and Cobalt acquired HDL's one-third share of IDL.
In August 2015, the Company laid out a five-point action plan designed to reinvigorate the lab's business. This consisted of completing the transition of the lab's billings to a new third-party billing provider, bringing the contract sales force of Cobalt in-house, adding marketing and sales support, building out an inside-sales effort, establishing additional contractual relationships with hospital and large practice groups, and continuing to expand the Company's menu of advanced cancer assays.
Without adequate time or financial resources to fully execute its turn-around plan, test volumes and revenues declined. As a result of the deterioration in its business, the Company increasingly had to rely on financial support from the joint venture partners.
Terms of the Original Joint Venture Arrangements
IDL Joint Venture Agreement
The IDL joint venture was originally governed by a limited liability partnership agreement (the "IDL Agreement") dated as of May 15, 2013 between GeneNews (USA), HDL and Cobalt.Each partner owned 33 units or one-third of IDL.
Each partner had one vote for each IDL unit held and, unless otherwise required by the Delaware Revised Uniform Partnership Act, as amended (the "Act") or the IDL Agreement, all consents of the partners would require unanimous consent. Pursuant to the IDL Agreement, a management committee comprised of representatives of each partner was formed to manage the business of IDL. Each partner had one vote in respect of management committee decisions. The management committee could appoint officers of IDL and define their roles.
IDL was to continue in existence unless (a) the partners agreed to dissolve it or (b) a partner underwent an unapproved change of control. A partner could withdraw from IDL if IDL or another partner was not conducting its activities in material compliance with applicable healthcare laws or the IDL Agreement. In such circumstances, the withdrawing partner would offer is units to the other partners. If they did not wish to acquire the units, IDL would be dissolved. A partner was deemed to withdraw from IDL in the event of certain non-compliance with applicable laws or if the partner had been excluded from participation in any federal or state health care program. Upon a deemed withdrawal, the partner's units would be redeemed by IDL. The IDL Agreement limited the transferability of IDL units without partner consent and provided for a right of first refusal and cosale rights.
The partners of IDL did not have a right to receive any repayment of capital or have their interest in IDL appraised and paid out under the Act. The partners were subject to covenants restricting competitive activities in the United States of America and solicitation of customers and employees and independent contractors during the term of the partnership and for one year thereafter. These covenants did not restrict the Company from licensing, marketing or otherwise commercializing ColonSentry or any other test licensed by the Company to IDL, in New York or New Jersey at any time, or anywhere in the United States of America (i) after the point that the Company was no longer a partner in IDL or its deemed withdrawal, its withdrawal or expulsion pursuant to the terms of the IDL Agreement; or (ii) upon termination of the IDL License Agreement (as defined below), with respect to any tests licensed to IDL by the Company under an agreement other than the IDL License Agreement, upon the termination of such other agreement.
IDL License Arrangements
Pursuant to the license agreement between GeneNews and IDL dated as of May 15, 2013 (the "IDL License Agreement"), the Company granted IDL an exclusive license for certain technology related to the ColonSentry® test along with specified trademarks throughout the United States (excluding the states of New York and New Jersey, which were covered under an agreement with Enzo until July 2014; we have reacquired rights to this territory. Under the terms of the IDL License Agreement, IDL is required to pay a license fee to the Company equal to 24% of IDL's gross revenues collected from sales of the ColonSentry® tests, subject to a minimum license fee per contract year.
The initial term of the IDL License Agreement was five years with automatic renewals for additional terms of 1 year unless either party notified the others of its intention to not renew ninety (90) days prior to the end of the initial or renewal term. The parties could terminate the IDL License Agreement in the event of breach, certain insolvency events, or if it was shown that the ColonSentry® test was found to not measure the expression of specified genes to assess the likelihood of an individual having CRC. The Company could terminate the IDL License Agreement if IDL failed to pay license fees on time, or if IDL was not diligently developing and commercializing the ColonSentry® test or if the Management Agreement or Sales Agreement was terminated.
In addition to the arrangements under the IDL License Agreement, IDL agreed to pay the Company 24% of IDL's gross revenues collected from the sales of all other tests it sells.
During 2015, IDL's declining test volumes and revenues resulted in the deterioration in its business and IDL increasingly had to rely on financial support from the joint venture partners. It was unable to make payments to its partners, including to the Company for terms under the IDL License Agreement. The IDL License Agreement remains in effect at this time.
Management Agreement
HDL previously provided management, lab operations and administrative services to IDL pursuant to the Management Agreement. In the fourth quarter of 2014, some functions that were previously being externally managed by HDL, such as lab operations, human resources, finance, marketing and reimbursement, were brought in-house at IDL. HDL provided the IT infrastructure for accounting services, document storage and inventory logistics for IDL.
Pursuant to the Management Agreement, HDL received (a) 24% of the gross revenues of IDL plus (b) \$5,000 per month until February 1, 2015. IDL also reimbursed HDL for the expenses that HDL incurred for the benefit of IDL including the deemed cost of services provided to IDL by HDL outside of the scope of the Management Agreement. Prior to the externally managed function being brought in-house, one third of the amounts owed to HDL with respect to expenses were converted into contributions to IDL, based on the expectation that GeneNews and Cobalt would also each contribute equal amounts. Beginning in early 2015, management and administrative services expenses were paid from IDL accounts.
The initial term of the Management Agreement was five years and was automatically renewable for additional terms of 1 year unless either party notified the other of its intention not to renew ninety (90) days prior to the end of the initial or renewal term. Termination of the Management Agreement was possible in the event of breach, certain force majeure events or certain insolvency events or HDL could have terminated the Management Agreement if IDL failed to pay management fees in a timely manner.
The Management Agreement was terminated on May 15, 2015.
Sales Agreement
Until March 15, 2016 when GeneNews purchased Cobalt's interest in IDL, Cobalt provided exclusive sales support to IDL pursuant to the Sales Agreement. IDL was required to pay Cobalt a commission equal to 24% of gross revenues collected by IDL from sales of tests in the Territory. The Sales Agreement had a term of five years and would have been automatically renewable for one-year periods unless either party gave written notice of termination at least 90 days prior to the end of the initial or renewal term. Either party could have terminated the Sales Agreement upon a material or continuing breach by the other. In addition, IDL could have immediately terminated the Sales Agreement if Cobalt (i) made unauthorized use or disclosure of confidential information; (ii) violated applicable law or breached its business associate addendum; (iii) was convicted of fraud, embezzlement or theft; (iv) became insolvent or bankrupt or made a general assignment for the benefit of creditors or (v) ceased to do business. In addition, IDL could have terminated the Sales Agreement if Cobalt failed to meet 80% of its sales goals.
During 2015, IDL's test volumes and revenues declined resulting in the deterioration in its business. IDL increasingly had to rely on financial support from the joint venture partners and was unable to make timely payments to its partners, including to Cobalt for terms under the Sales Agreement.
On March 4, 2016, the Company announced that it had entered into a Unit Purchase Agreement (the "Purchasing Agreement") with Cobalt pursuant to which GeneNews' wholly-owned subsidiary, GeneNews (USA), Inc. acquired Cobalt's fifty percent (50%) ownership interest in IDL. Under terms of the Purchasing Agreement, GeneNews assumed all of Cobalt's liability relating to Cobalt's \$1 million Secured Demand Promissory Note payable to former IDL partner, HDL. No other consideration was paid.
The Sales Agreement was terminated effective March 15, 2016.
Reimbursement
Demonstrating value and qualifying for reimbursement by public and commercial US payers was key to the commercial success of diagnostic tests. IDL estimated that, in 2016, approximately 95% of its patients who elected to have the ColonSentry® test were covered by private insurers. Approximately 4% of patients undergoing the test were covered by Medicare/Medicaid and 1% of patients paid for the test directly. Reimbursement from Medicare was not yet possible as ColonSentry® has not been approved for coverage.
Achieving reimbursement is critical to IDL's commercialization plans. In addition to continuously working to improve collections under standard, third party billing, the Company developed a new business model focused on large healthcare providers. On March 29, 2016, the Company entered into a collaboration agreement (the "JTS Agreement") with JTS Health Partners ("JTS"), a leading national healthcare management consulting and professional services firm based in Atlanta, Georgia.
Under the JTS Agreement, JTS was to help accelerating adoption of IDL's menu of proprietary cancer tests, including its lead ColonSentry® blood-test for assessing an individual's current risk for colorectal cancer. JTS was also expected to work to maximize the efficiency and effectiveness of GeneNews' revenue cycle management operations. Through business acceleration efforts, both parties were to pursue and secure multi-year agreements with hospitals, clinical integrated networks, physician groups and healthcare organizations for GeneNews' risk assessment testing services, which assist healthcare professionals in the risk stratification of patient populations through early cancer detection. It was expected these agreements would be flat fee based and that billing and reimbursement would be undertaken by the hospitals and healthcare providers. Also, as part of the partnership, JTS was to assist GeneNews with refining its billing practices to help the Company maximize revenue collection. The Agreement had an initial term of five (5) years, and was renewable annually thereafter by mutual consent.
Near-term Strategy
Research indicates that as many as 40% of patients fail to adhere to their doctor's treatment recommendations (Source: The challenge of patient adherence: Ther Clin Risk Manag. 2005 Sep; 1(3): 189–199. Leslie R Martin, Summer L Williams. Kelly B Haskard, and M Robin DiMatteo). Patients' non-adherence to physician recommendations for cancer screenings puts lives in jeopardy since cancers found in later stages are harder to cure. As a result healthcare providers, health systems, and payers are actively seeking ways to improve cancer screening and early interventions that save lives and lower healthcare costs.
Advantages of Our Solution
We provide innovative diagnostics and patient education programs that improve cancer screening
rates. Our robust menu of proprietary tests aid value-based care organizations in
- cancer risk stratification
- improved compliance rates in patient populations
- lower cost of care for late stage cancers
- improved patient outcomes
- revenue creation within hospital systems
Currently StageZero Life Sciences Inc. offers risk assessment blood tests for the four most prevalent cancer types including lung, colon, prostate and breast.
MyCancerRisk™
In 2016, our CLIA lab launched the MyCancerRisk™ program to help improve patient adherence to cancer screening. Unlike other tests that identify cancer in its later stages, our tests can help identify early cancer indicators that give physicians the information they need to encourage patients to comply with national screening guidelines. Test results come with educational materials to help create teachable moments between physicians and patients about the importance of cancer screening.
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. In 2017, the Company began the process of collecting and sharing aggregated data in an effort to build a datadriven product to help practices and healthcare systems better understand their patient populations. They could build more effective programs to improve patient compliance with cancer screening, preventive health programs, and early interventions. During 2018 we expect to expanded this effort as we initiated research programs with key Cancer Research Centers. Data as an asset will continue to be key strategy for us.
In 2019, we:
- Aggressively expanded the programs under MyCancerRisk™ to the High Risk Patient Populations and their employers. Pilot program data showed 34% of those tested had a raised risk result for cancer. Full program testing is began in Q2.
- Implemented the direct-to-consumer program with the 8,000+ draw sites and Telemedicine Physician Networks.
- Initiated test utilization with Large HealthCare Systems. Planning for test implementation was running in parallel with contract completion. The objective was to have test introduction logistics completed with signature of agreements.
- Continued to expand our Small Clinical Practice base and upgrade our billing and revenue collection system.
We are now developing four distinct revenue streams in 2020:
- High-Risk Patients cash price collected immediately
- Telemedicine cash price 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.
We believe we have the right strategy, have the right agreements being put into place, the right products to make a difference, and can now begin to realize the company's full potential.
3. Industry overview and competitive environment
We operate within the biotechnology, molecular diagnostic and genomic biomarker industry (the "Industry"), which is characterized by extensive research and development efforts, rapid technological changes and intense competition. Our competitors include large diagnostic, biotechnology and other companies, universities; and research institutions. Many of these competitors develop, manufacture, market and commercialize products and technologies that may compete with StageZero.
The global market for diagnostic biomarkers is expected to reach about US\$115.45 billion in 2027, growing at a compound annual growth rate of 16% from 2013 to 2020. (Source: Reports & Data, December 11, 2020 www.reportsanddata.com).
The molecular diagnostic market is being driven by several factors, including further adoption of pharmacogenomics and personalized medicine, high disposable income, increased availability of various tests and an increase in chronic diseases as a result of population aging. Approximately 80% of treatment decisions are driven by results of in vitro diagnostic tests, yet diagnostic companies account for less than 2% of total healthcare expenditure (Source: Kalorama, Datamonitor and Visiongain reports).
Molecular diagnostic tests based on genomic technologies, such as our core Sentinel Principle® technology and the ColonSentry® test, are rapidly gaining prominence and acceptance because of their ability to detect and stage disease, monitor treatment and predict prognosis in a less invasive manner and with superior clinical performance to some traditional methods.
We potentially compete with companies and institutions offering both molecular and conventional diagnostic products and with companies focused on a single disease area or those that develop other technology platform-based tests. Competitive factors that can influence the success of a diagnostic test include clinical performance parameters such as sensitivity and specificity, invasiveness, acceptance by the medical community, price, reimbursement from state-sponsored health insurance programs such as Medicare and other third-party payers, distribution channels, and patent protection.
There is a need for better risk assessment at the primary care physician level to ensure that high-risk patients receive early follow-up testing. The Company believes that its restructuring and ownership of our lab in Richmond, Virginia have positioned it well to take advantage of the projected growth in the molecular diagnostics market despite the presence of competitors. The successful launch of ColonSentry® provides a solid commercial footing, while new tests are added to our menu of services.
4. Our Competitive strengths
Our competitive strengths include the following:
- Pioneer in molecular diagnostics
- Proprietary platform technology, which is protected by multiple patents
- Our full service, Richmond, Virginia based national reference laboratory
- ColonSentry® test, the world's first blood-based test for determining current risk for colorectal cancer
- Expanding menu of tests offered by us which allows one patient one visit to undergo multiple tests from the one visit.
- Strong management team
5. Technology and products
The Sentinel Principle®
The Sentinel Principle® is an award-winning fundamental technology developed by the Company. It is based on the premise that as blood circulates through the body, communication occurs between cells in blood and tissue. These cell to cell interactions induce changes in blood gene expression resulting in the presence of specific RNA molecules. Profiling these changes enables tests based on this technology to identify unique molecular signatures reflecting disease activity, which can then be used to develop disease-specific molecular diagnostic assays. The Company has used the Sentinel Principle® to develop disease-specific blood-based biomarkers as the basis for molecular diagnostic tests and to enable personalized health management.
The advantage of blood-based diagnostic tests is that blood samples can be obtained readily with little discomfort to patients. Biomarkers derived from RNA in blood provide an alternative to tissue
biopsy for the diagnosis and prognosis of disease. Conventional testing for some diseases, such as CRC, requires invasive, uncomfortable tests. Furthermore, other diseases, such as ovarian cancer, are difficult to diagnose and often manifest themselves only once the disease is too advanced to treat successfully. The Sentinel Principle® is revolutionary in its breadth of potential applications for comprehensive personalized health management. Simple blood testing at an early stage when diseases such as cancer are most curable, may be able to pre-screen asymptomatic individuals to assess current risk and detect previously difficult or cumbersome to diagnose conditions. . Other applications, such as staging disease, predicting response to treatment and monitoring for disease recurrence, may also be possible.
In addition to CRC, we have applied the Sentinel Principle® to more than 20 disease areas in our research although we have not developed any tests associated with these disease areas.
ColonSentry®
Background
Our lead product, ColonSentry®, is based on the Sentinel Principle® and is a blood-based molecular test to aid physicians in determining an individual's current risk of having CRC. ColonSentry® uses a molecular laboratory technology known as qRT-PCR (quantitative Real Time PCR) and is performed on total RNA isolated from a patient's blood. It measures the mRNA expression levels of the seven biomarkers we have identified as indicating CRC risk. The results are converted into a patient's personalized risk score for CRC using an algorithm. This approach targets at-risk patients who are non-compliant with colonoscopy guidelines. It offers significant health economic benefits, is expected to encourage more people to engage in CRC screening and is easily incorporated into a routine health examination.
CRC is the second leading cause of cancer deaths in both men and women and the most common cause of cancer deaths in non-smokers. Based on US National Cancer Institute ("NCI") Surveillance, Epidemiology, and End Results Program ("SEER") Incidence and the National Center for Health Statistics mortality statistics(rates from 2013–2015), 4.2% of men and women born today will be diagnosed with CRC at some time during their lifetime. From 2011 to 2015 the median age for diagnosis of CRC was 67 years. The age-adjusted incidence rate was 39.4 per 100,000 men and women per year. In 2015, in the United States there were approximately 1,332,085 men and women alive who had a history of CRC.
Without ColonSentry®, when CRC is diagnosed after the onset of symptoms, the prognosis is poor. However, if detected and treated early before the cancer has spread and generally before symptoms appear, more than 90 percent of patients may survive the disease. According to the American Cancer Society (ACS), each year there are approximately 1.2 million new cases of CRC worldwide and 600,000 deaths. The ACS estimates that in the U.S., approximately 140,000 people are diagnosed with CRC each year resulting in over 50,000 deaths annually. As a result, the American Cancer Society currently recommends that all individuals aged 50 or older undergo screening for CRC on a regular basis. Despite the proven ability of screening programs to prevent CRC deaths, many patients do not adhere to screening guidelines. Only about 40% of individuals comply and 60% of cancers are detected too late.
To demonstrate the clinical utility of ColonSentry®, in September 2013 we entered into an agreement with Geisinger Health System ("GHS") for a prospective study offering the ColonSentry® test to eligible patients (CRC screening is indicated but have refused colonoscopy). GHS offers both health-care services and insurance coverage to nearly three million patients throughout Pennsylvania. The purpose of this study was to compare rates of screening colonoscopy in patients for whom colonoscopy was recommended but had refused after utilizing one of the following methods: (i) Immunohistochemical Fecal Occult Blood Test (iFOBT) and (ii) the ColonSentry® blood test. Patient enrollment began in early 2014 and approximately 1,000 Geisinger subjects were asked to participate in this study. Upon study completion only 282 subjects had enrolled in the study. Subjects who agreed to undergo non-invasive screening were more likely to choose the ColonSentry® blood tests than iFOBT. This result will need to be confirmed in a larger study.
Analysis has been completed on our case review study, "A Retrospective Chart Review Study to Evaluate the Real-World Use of ColonSentry® Testing and Associated Outcomes." In this retrospective chart review study of 150 charts completed in 2014, statistically significant conclusions were not attained. We observed an increase in colonoscopy referrals for positive ColonSentry® results. This result needs to be confirmed in a larger study as well.
Market and sales
Until our restructuring in August 2013, we had focused our resources on developing marketing and distribution partnerships around the world for ColonSentry®. When we restructured, we refocused our efforts on expanding US commercialization through IDL (in all states except for New York and New Jersey).
ColonSentry® had previously been launched in the United States in the second quarter of 2012 (New York and New Jersey only) by Enzo, our first marketing partner. It was launched by GeneNews Diagnostics Sdn. Bhd. in Malaysia in the fourth quarter of 2011 and by Shanghai Biochip in China in the third quarter of 2012. Following our 2013 restructuring, the test is no longer actively marketed in Canada.
Under the JTS Agreement, announced March 31, 2016, JTS was expected to accelerate adoption of StageZero's menu of proprietary cancer tests, including its lead ColonSentry® blood-test for assessing an individual's current risk for colorectal cancer. JTS was also expected to work to maximize the efficiency and effectiveness of GeneNews' revenue cycle management operations. Through business acceleration efforts, both parties were to work to pursue and secure multi-year agreements with hospitals, clinical integrated networks, physician groups and healthcare organizations for StageZero's risk assessment testing services, which assist healthcare professionals in the risk stratification of patient populations through early cancer detection. As part of the partnership, JTS was expected to provide StageZero with management consulting services and to assist with the implementation of billing practices to help the Company maximize revenue collection.
Competition and competitive strengths
ColonSentry® is targeted at higher risk patients who are over 50 years old and who have refused colonoscopy or find current CRC screening options objectionable. A ColonSentry® test is easily incorporated into an individual's annual exam by primary care physicians. It requires only a simple blood draw, which is then delivered to StageZero for processing. In addition, unlike stool tests, ColonSentry® is not a yes or no test; it provides an individualized risk score for the patient.
There are numerous CRC screening and diagnostic methods already in use including colonoscopy, flexible sigmoidoscopy, guaiac-based fecal occult blood testing ("G-FOBT"), immunochemical FOBT and virtual colonoscopy. Poor patient compliance significantly limits these established methods. According to an American Cancer Society survey of 2010 data (Colorectal Cancer Facts & Figures 2014–2016), only 8.8 percent of Americans over the age of 50 comply with stool samples for CRC testing and less than 10% of stool collection kits given to patients are ever returned with a stool sample for testing. And for the same group, an average of only 56.4% get a CRC endoscopy. Average compliance is even lower in minority groups. Because of these limitations, a number of companies are developing new stool and blood-based tests for the detection of CRC. In 2014, Exact Sciences (NASDAQ:EXAS) received FDA approval and began selling its Cologuard test in the US market. Cologuard is a stool-based test that combines a standard Fecal Immunochemistry Test (FIT) and a series of molecular tests. In 2016, Epigenomics AG (Frankfurt Prime Standard:ECX, OTCQX:EPGNY) received FDA approval for its Epi proColon® test. It is a blood-based test that uses a single DNA biomarker called Septin9 to detect the presence of CRC. In Canada, Phenomenome Discoveries Inc. (Saskatoon, SK) launched a test called Cologic® that tests for a low level of a gastrointestinal tract free fatty acid in blood serum, which has been shown to be a risk factor for CRC. VolitionRx (Belgium; NYSE:VNRX) is in clinical trials with its Nu.Q Colorectal Cancer Screening Triage Test. This test works in conjunction with the current standard screening test, the fecal immunochemical test (FIT) and measures nucleosomes in the blood stream.
StageZero Life Sciences, Limited – Annual Information Form28/63
In addition to its likelihood of improving patient compliance with screening guidelines, ColonSentry® can help physicians monitor for so-called interval cancers. If polyps are missed by a colonoscopy, early-stage cancer can develop long before a 10-year interval. The 2012 guidelines of the US Multi-Society Task Force on Colorectal Cancer, which includes the American College of Gastroenterology, the American Gastroenterological Association and the American Society for Gastrointestinal Endoscopy, reports that up to 9% of cancers in the cancer registries were interval cancers, with the patients having had a colonoscopy in the 6 to 36 months before diagnosis with CRC. ColonSentry® can be used to monitor colonoscopy-compliant patients for interval cancers. It can also be used in elderly patients who have increased risk of complications from colonoscopy.
The American Cancer Society's 80-by-18 initiative is a multi-partner goal to improve colorectal cancer screening rates to 80% in the eligible population by 2018. At present, less than 60% of the eligible population has been screened. Novel effortsto improve screening through risk stratification tools are essential to getting the 'unscreened' population to be screened, whether through colonoscopy or stool-based procedures. ColonSentry®, as a risk stratification test, helps primary care physicians facilitate the discussion about colon cancer screening with eligible patients who have refused to undergo other tests such as colonoscopy, Cologuard or FIT. Importantly, alternative tests such as CT Colonography or Cologuard do not count towards population health measurements of CRC screening rates (The Healthcare Effectiveness Data and Information Set (HEDIS), The Physician Quality Reporting System (PQRS), The Medicare Advantage Star Rating System (STAR), or Medicare Accountable Care Organization (ACO)); which have limited uptake because the physicians/health systems do not get credit for ordering these services. Further, if these tests are performed and a positive result is found, the patient is no longer considered screening but is now diagnostic when referred for colonoscopy. This means the patient has a 20% financial responsibility for the colonoscopy, facility, anesthesia, pathology, etc. In comparison, ColonSentry® is a risk stratification test that leads to a USPSTF recommended test (FIT or colonoscopy) and preserves the patient still being seen as a preventive screening service, without financial responsibility, when referred for colonoscopy.
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") Test
Background
In April 2014, StageZero added Beckman Coulter Diagnostics 'PHI test to its menu of cancer assays. StageZero Life Sciences Inc. is the first laboratory selling this test across the United States. The PHI test is a simple blood test that, according to the Beckman Coulter U.S. Prostate Cancer Pivotal Study Report, is three times more specific in detecting prostate cancer than the widely used prostate-specific antigen ("PSA") test. As Beckman Coulter has previously stated, the improved specificity decreases the need for many men who test positive for elevated PSA levels to undergo a biopsy in order to attain a reliable diagnosis. The PHI results are intended to be used as an aid in distinguishing prostate cancer from benign prostatic conditions in men 50 years of age and older with total PSA results in 2 -10 ng/mL range and a negative digital rectal exam (DRE).
Prostate cancer is the most common form of cancer in men in the United States after skin cancer. Based on US National Cancer Institute ("NCI") Surveillance, Epidemiology, and End Results Program ("SEER") Incidence and the National Center for Health Statistics mortality statistics (rates from 2013–2015), 11.2% of men born today will be diagnosed with prostate cancer at some time during their lifetime. It was estimated that there would be 164,690 new cases of prostate cancer and an estimated 29,430 deaths in 2018. From 2011 to 2015 the median age for diagnosis of prostate cancer was 66 years. The age-adjusted incidence rate was 112.6 per 100,000 men per year. In 2015, in the United States, there were approximately 3,120,176 men alive who had a history of prostate cancer. Screening for the disease is usually by digital rectal examination and prostate-specific antigen ("PSA") assay. While PSA 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.
PHI Test Agreement
Beckman Coulter, Inc. ("Beckman") provides IDL with the materials and equipment associated with the PHI test pursuant to an agreement dated December 19, 2013, amended on June 25, 2014, amended on June 7, 2015 and further amended on December 1, 2017 (the "PHI Test Agreement"). The PHI Test Agreement has an initial term of 60 months which will be extended for 24 months and will now expire on December 10, 2022. It automatically renews for one year periods, unless StageZero is in default, Beckman provides the Company with 30 days' prior written notice of termination, or in the case of termination for cause, StageZero may terminate upon 60 days prior written notice to Beckman.
The agreement requires minimum annual purchase commitments by StageZero of approximately US\$5.1 million for each year of the contract. StageZero did not meet the minimum annual purchase commitment amount in 2014 and initiated discussions in late 2014 to renegotiate the terms of the PHI Test Agreement to better reflect the purchase requirements of the Company. Those negotiations were successfully completed in June 2015. In 2017, the minimum annual purchase commitment was renegotiated again to better reflect the purchase requirements of the Company. Pursuant to the terms of the PHI Test Agreement, beginning on the second anniversary of the agreement and each anniversary thereafter, the parties may renegotiate the agreement if the annual consumable or test volumes substantially decreased over the prior year and written notice is given within 30 days after the anniversary date of the intent to renegotiate.
In 2017, the agreement was amended so that in the event of a change in the marketplace that has a material adverse effect on StageZero, Beckman and the Company will meet in good faith to renegotiate the agreement.
Beckman may terminate the PHI Test Agreement upon a material or continuing breach of StageZero or if StageZero: (i) fails to make timely payment; (ii) becomes insolvent or bankrupt or makes a general assignment for the benefit of creditors; (iii) defaults under another agreement between the Company and Beckman (or any affiliate of either); (iv) attempts to sell, encumber or sublet the test materials; (v) submits credit or other information that is untrue or misleading in any material respect; (or) (vi) violates any other term or condition of the agreement and after receiving written notice, fails to correct the violation within 30 days. Upon such termination, Beckman may issue an invoice for all past due amounts, plus certain expenses, plus the lesser of (a) the amount that would have been paid for the materials and equipment if no discounts were given for bundling, or (b) an amount equal to 60% of the minimum annual purchase commitment amounts for the then current term.
Market and sales
StageZero has signed an agreement with the University of Texas MD Anderson Cancer Center ("MD Anderson") and is pursuing interest from hospital groups and large physician practice groups for this test.
Competition and competitive strengths
There are various competitors to PHI. Hologic (NASDAQ:HOLX) has developed the Progensa®PCA3 assay and is approved by the FDA. It is the first urine based molecular test that measures the concentration of prostate cancer gene 3 (PCA3) and PSA RNA molecules in postdigital rectal (DRE) male urine specimens. MDxHealth (Belgium, EBR:MDXH) is currently marketing SelectMDx and ConfirmMDx for prostate cancer. SelectMDx helps identify patients at increased risk for aggressive disease, thereby aiding in the selection of men for prostate biopsy. ConfirmMDx is intended for men with a previous negative prostate biopsy to aid urologists in
identifying truly negative men who may forego an unnecessary repeat biopsy procedure. OPKO Health (NASDAQ:OPK) is marketing 4Kscore Test. The test combines four prostate-specific kallikrein assay results with clinical information in an algorithm that calculates the individual patient's percent risk for aggressive prostate cancer. Exosome Diagnostics (Waltham, MA) is marketing ExoDx®Prostate(IntelliScore). It is a urine-based test to be used along with PSA and other factors (age, race and family history) to enable physicians to predict whether a patient presenting for an initial biopsy does not have high-grade prostate cancer.
BreastSentry™
Background
On October 14, 2014, we announced that we had in-licensed two biomarker assays, sphingotest® pro-NT and sphingotest® pro-ENK, that could aid physicians in identifying those women in the general population who have an elevated risk of breast cancer. These tests were developed by sphingotec GmbH, a German company that expanded into the United States. It is best known for the discovery and development of biomarker assays.
Pursuant to a license and cooperation agreement in respect of the two biomarker assays dated October 9, 2014 between GeneNews Corporation, IDL (GeneNews Corporation and IDL are the "Cooperation Partners") and sphingotec GmbH, sphingotec GmbH granted the Cooperation Partners a non-exclusive, non-transferable licence to use certain patents and know-how owned by sphingotec GmbH in the United States. The sole purpose of the agreement is the developing, validating, marketing, selling and using a laboratory developed test ("LDT"), developed and validated by IDL, using sphingotec GmbH's two biomarker assays ,sphingotest® pro-NT and sphingotest® pro-ENK. Pursuant to the agreement, sphingotec GmbH reserved the right to issue licenses in respect of the biomarkers for, among other formats, in-vitro diagnostic systems. The Cooperation Partners bear all costs relating to the validation of the LDT assays and provision of materials needed to perform the obligations under the agreement. The Cooperation Partners also bear the costs for technical support and consultancy by sphingotec employees. The agreement is for the later of (a) a five-year term (b) the expiration of certain sphingotec patents subject to the agreement; and (c) certain sphingotec know-how becoming public. The agreement is subject to extension by agreement of the parties. Pursuant to this agreement, the Cooperation Partners are required to pay a net royalty to sphingotec GmbH for each test and this net royalty will apply in any case, even if individual sphingotec GmbH patents should not issue or be invalidated later or part of the sphingotec GmbH know-how becomes public. BreastSentry™ was successfully launched in March 2017, with a first introduction via a multi-specialty physician group in the Midwest. An expanded launch across the US was initiated in the second quarter of 2017, with roll-out continuing throughout 2017.
Breast cancer is the third leading cause of cancer deaths in women in the United States. Based on US National Cancer Institute ("NCI") Surveillance, Epidemiology, and End Results Program ("SEER") Incidence and the National Center for Health Statistics mortality statistics (rates from 2013–2015), 12.4% of women born today will be diagnosed with breast cancer at some time during their lifetime. From 2011 to 2015 the median age for diagnosis of breast cancer was 62 years. The age-adjusted incidence rate was 126 per 100,000 women per year. In 2018 approximately 266,120 new cases of invasive breast cancer will be diagnosed in women and approximately 40,920 will die from the disease. In 2015, there were an estimated 3,418,124 women living with female breast cancer in the United States. As with most cancers, early identification of high-risk patients and intervention are the keys to improved clinical outcomes.
Many breast cancer cases are not due to genetic inheritance and, unlike other blood tests on the market that look for genetic indicators for breast cancer, sphingotest® pro-NT and pro-ENK are simple blood tests that may indicate a woman's risk for breast cancer. A study published in the peerreviewed Journal of the American Medical Association ("JAMA") in October 2012 demonstrated that the pro-NT level was an effective biomarker for the prediction of breast cancer regardless of a woman's genetic predisposition (O. Melander et al, Plasma Pro-Neurotensin Independently Predicts Cardiometabolic Diseases, Breast Cancer, and Death In Women, JAMA 2012; 308(14): 1469–75).
Market and sales
BreastSentry™ measures the fasting plasma levels of proneurotensin (pro-NT) and proenkephalin (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, to which has been added seven, key risk factors based on the Gail model in order to provide an additional level of personal data to create an enriched, personalized score. BreastSentry™ is used to determine a woman's five-year and lifetime risk for developing breast cancer.
As previously noted, BreastSentry™ was launched in March 2017, with a first introduction via a multi-specialty physician group in the Midwest. An expanded launch across the US is currently underway.
Competition and competitive strengths
There are various competitors of the sphingotest® pro-NT and sphingotest® pro-ENK biomarker assays. Genomic Health (NASDAQ:GHDX) has developed Oncotype Dx®. That test is able to predict the likelihood of chemotherapy benefit as well as the chance of cancer recurrence in earlystage breast cancer. The test is intended for use in all newly diagnosed patients with early-stage breast cancer who have node-negative or node-positive, estrogen receptor-positive, HER2-negative disease. Agendia (Irvine, CA) has developed Mammaprint® an FDA approved test. That test is used to assess the risk that a breast tumor will metastasize to other parts of the body and determine whether or not each patient will benefit from chemotherapy. Janssen Diagnostics (Raritan, NJ) has developed the CELLSEARCH® Circulating Tumor Cell blood test. That test assesses the prognosis of patients with metastatic cancer and monitors therapeutic response. It is FDA cleared and performed at Quest Diagnostics. Eventus Diagnostics, Inc. (Miami, FL) has developed the Octava Blue and Octava Pink tests that measure breast cancer specific autoantibodies in blood to detect the presence or absence of breast cancer in conjunction with an annual screening mammogram. Cynvenio Biosystems (Westlake Village, CA) has developed ClearID Breast Cancer test that measures circulating tumor cells in a whole blood sample. It utilizes next generation sequence analysis of tumor DNA isolated from blood. The test is currently marketed and sold in the US.
COVID-19 Tests
StageZero Life is offering PCR and antibody tests for COVID-19.
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.
In conjunction with clinical presentation and results of other laboratory tests, the COVID-19 IgG/IgM Antibody Test, 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 aids in the diagnosis of COVID-19. 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 patients and are shipped to our CLIA certified, CAP accredited lab in Richmond, Virginia.
Potential future pipeline development and research
We are currently focused on commercialization efforts through StageZero Life Sciences Inc., including the sourcing of additional tests to in-license from third parties. As a result, we are not actively pursuing in-house development of additional COVID tests, but are filing several EUA's for specific use of tests. We have also added a Respiratory Panel for the identification of multiple respiratory pathogens and are adding an Inflammatory Pathway Panel to supplement the cancer diagnostic program. Expansion of the number of cancers able to be detected by the Aristotle program remains a focus.
We have established collaborations and alliances with leading institutions to access well-defined clinical sample and data sets, as well as expert clinical guidance and insight from respected leaders in cancer, cardiovascular disease and neurological disorders. We also maintain relationships with many leading institutions including Brigham and Women's Hospital of Harvard Medical School, University Health Network at University of Toronto, University of California at San Francisco, New York University School of Medicine, Memorial Sloan Kettering Cancer Center in New York and Stanford University in California.
In recent years, we have published the results of our work in cancer biomarker testing in the following peer-reviewed papers and abstracts:
Book chapter
Chun Ren Lim , Michelle Mei Lin Lee , Samuel Chao, Adel Zaatar, Choong Chin Liew, Whole Blood Transcriptome and Other Biomarkers in Nasopharyngeal Cancer. Biomarkers in Cancer 2015, Springer Netherlands, 849--873, isbn 978-94-007-7681-4
Peer-reviewed articles.
Omar, Haniza et al. Blood Gene Signature for Early Hepatocellular Carcinoma Detection in Patients With Chronic Hepatitis B. Journal of Clinical Gastroenterology: February 2015 – Vol. 49 - Issue 2 - p 150–157
Burakoff, Robert et al. Blood-based Biomarkers Used to Predict Disease Activity in Crohn's Disease and Ulcerative Colitis. Inflammatory Bowel Diseases: May 2015 – Vol. 21 - Issue 5 p 1132–1140
Samuel Chao, Changming Cheng, Choong-Chin Liew, Mining the Dynamic Genome: A Method for Identifying Multiple Disease Signatures Using Quantitative RNA Expression Analysis of a Single Blood Sample. Microarrays 2015, 4(4), 671-689
Chun Ren Lim et al. Increasing Colonoscopy Compliance Using a Blood-Based Risk Assessment Test for Colorectal Cancer. Gastroenterology and Hepatology 2014; Vol. 1, No. 1, 8-10.
Chao S, Ying J, Liew G, Marshall W, Liew CC, Burakoff R. Blood RNA biomarker panel detects both left- and right-sided colorectal neoplasms: a case-control study. J Exp Clin Cancer Research 2013; 32:44
Liong, ML. Lim CR, Yang H, Chao S, Bong CW, Leong WS, Das PK, Loh CS, Lau BE,Yu CG, Ooi EJJ, Nam RK, PD Allen, Steele GS, Wassmann K, Richie JP, Liew CC. Blood-based Biomarkers of Aggressive Prostate Cancer. PLOS ONE 2012;7: e45802.
Zaatar AM, Lim CR, Bong CW, Lee MML, Ooi JJ, Suria D, Raman R, Chao S, Yang H, Neoh SB, Liew CC. Whole Blood Transcriptome Correlates with Treatment Response in Nasopharyngeal Carcinoma. J Exp Clin Cancer Research 2012; 31:76
Abstracts
Omar HB, Lim CR, Bong W, Siam TS, Hassan M, Menon J, Muthukaruppan R, Singh M, Abdullah N, Phoe O, Ding R, Huat P, Joo LE, Tan F, Chao S, Yang H, Liew CC. Biomarkers to predict risk of subsequent hepatocellular cancer in patients with chronic hepatitis B. 9th Liver Update. July 13, 2011. Petaling Jaya, Malaysia.
Zaatar AM, Lim CR, Bong W, Ooi EJJ, Lee M, Suria D, Raman R, Chao S, Yang H, Neoh SB,
Liew CC. Nasopharyngeal carcinoma biomarkers derived using peripheral blood transcriptome. 21st Asia Pacific Cancer Conference. November 10-12, 2011. Kuala Lumpur, Malaysia.
Liew CC, Omar H, Lim CR, Bong CW, Ooi EJJ, Lee M,Yu CG,Tan SS, Hassan M, Menon J, Muthukaruppan R, Singh M, Abdullah N, Ooi BP, Ding R, Low EJ, Tan F, Chao S, Yang H, Merican I. Blood signatures for early liver cancer detection in patients with chronic hepatitis B. ASCO Annual meeting. June 1-5, 2012. Chicago, ILL.
Other Publications
Novak DJ, Liew GJ, Liew CC. GeneNews Limited: bringing the blood transcriptome to personalized medicine. Pharmacogenomics. 2012; 13:381-385
Wassman Karl, GeneNews Limited: Personalized Medicine - How labs must prepare for genomic-based tests for cancer, Advance for Administrators of Laboratory; November 11, 2013 Vol. 22 • Issue 11
6. Intellectual property
We rely on a combination of patent applications, copyrights, trademarks, trade secret laws and confidentiality, material data transfer agreements, licenses, and invention assignment agreements to protect our intellectual property rights. We also rely upon unpatented trade secrets and improvements, unpatented know-how and continuing technological innovation to develop and maintain our competitive position. This cannot guarantee however, that other companies will not develop similar or superior technology, or that issued patents will not be circumvented.
As at December 31, 2020, we had 1 issued U.S. patent.
Our current patent portfolio is centered around our core technology, the Sentinel Principle® and our lead product, ColonSentry®. The related patents are protected in key current and potential future marketing jurisdictions such as the United States and Canada. We also have 6 core trademarks (both registered and pending), including the Company's house mark and families of marks built around the Sentinel Principle® and ColonSentry®, many of which are being protected in multiple jurisdictions. Failure to promptly pay maintenance fees or respond to action items may result in temporary or permanent abandonment of any such patents or trademarks with no option to reinstate. .
All employees and technical consultants working for the Company are required to execute confidentiality agreements in connection with their employment and consulting relationships. Confidentiality agreements provide that all confidential information developed or made known to others during the course of the employment, consulting or business relationships shall be kept confidential except in specified circumstances. Agreements with employees provide that all inventions conceived by the individual while employed by StageZero are the Company's exclusive property. However, such agreements cannot guarantee that breaches will not occur.
7. Human resources
As at December 31, 2020 we had 51 employees, including full-time, part-time staff and consultants. Neither the Company nor IDL is a party to any collective agreements and management considers employee relations to be good. Our operations have never been interrupted as a result of any labor dispute.
8. Environment
We are subject to various federal, state and provincial environmental laws and regulations. To the best our knowledge, we are in compliance in all material respects with all applicable provisions.
9. Regulatory framework
Our lead test, ColonSentry®, provides a personalized score for risk assessment for CRC in noncompliant patients; it is offered as a laboratory-developed test ("LDT") throughout most states in the USA.
In the United States, the marketing of clinical laboratory tests is regulated under the federal Clinical Laboratory Improvement Amendments of 1988 ("CLIA") and implementing regulations and any applicable state laws or regulations. CLIA establishes quality standards for all laboratories that perform testing on human specimens for the purpose of providing information for the diagnosis, prevention, or treatment of disease or impairment of, or the assessment of the health of human beings. CLIA requires such laboratories to be certified by the U.S. federal government. Mandates include compliance with various operational, personnel, facilities administration, quality and proficiency testing requirements intended to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. Under the CLIA framework, ColonSentry® may be marketed as an LDT. Our laboratory is located in Virginia and offers a broad menu of tests including ColonSentry® and BreastSentry™. StageZero must comply with CLIA and all applicable state requirements. StageZero received its CLIA certification of accreditation in 2013. It must comply with CLIA and all applicable state requirements in any particular state where it markets such tests. Failure to comply with CLIA requirements may result in suspension, revocation or limitation of a laboratory's CLIA certificate, cancellation or suspension of the laboratory's approval to receive reimbursement from Medicare and Medicaid as well as fines and criminal penalties. The imposition of the foregoing would have a material adverse effect on StageZero. Changes in government regulations and policies, including regulations and policies of the Food and Drug Administration that affect the classification, approval, and marketing of diagnostic tests may adversely affect the company. Failure to comply with the Health Insurance Portability and Accountability Act ("HIPAA"), the "Health Information Technology for Economic and Clinical Health" ("HITECH") Act and failure to maintain security of business information or systems or failure to provide adequate cyber security could lead to significant fines, litigation and reputational damage.
StageZero seeks to conduct its business in compliance with all regulatory requirements. The clinical laboratory testing industry is, however, subject to extensive regulation with respect to sales and billing practices, quality control and privacy of health information. There can be no assurance that those applicable statutes and regulations will not be interpreted or applied by a prosecutorial, regulatory or judicial authority in a manner that would adversely affect the Company. Claims for payment submitted by StageZero to federal healthcare programs (e.g., Medicare, Medicaid, TRICARE, etc.) are subject to various federal fraud and abuse laws (e.g., Anti-Kickback Statute, False Claims Act, etc.). Various US agencies establish regulations and enforce them by reviewing arrangements and relationships with physicians and other sources of referral. Violations may result in loss of billing privileges, exclusion from participation in federal healthcare programs, as well as civil fines and criminal sanctions. A related party of one of our partners in the original IDL jointventure, announced that it had been the subject of an investigation of various diagnostic laboratory industry practices, many of them common within the industry and that it was in settlement with the US Department of Justice in respect thereof. The statement indicated that the agreement with the DOJ would contain an explicit denial of any wrong doing but the company would be subject to a five-year corporate integrity agreement with the Office of the Inspector General of the U.S. Department of Health and Human Services. There can be no assurance that the regulatory authorities will not investigate the practices of laboratories in the industry, including ours, in respect of various diagnostic practices. Potential sanctions for violation of these statutes and regulations include significant fines and the loss of various licenses, certificates and authorizations which are critical to our business. This also could result in damage to StageZero's reputation and adversely impact the relationships of the Company with third parties and the ability to attract new licensing partners.
10. Reimbursement framework
StageZero Life Sciences, Limited – Annual Information Form35/63 [Expressed in US dollars, unless otherwise noted] Reimbursement is payment to providers of medical items and services by third-party insurers or payers and is an important element for commercializing diagnostic tests. Its main components of coverage, coding, payment and contracting work together to achieve routine optimal payment. In the United States, reimbursement is administered by both public and private commercial payers. The public system is primarily overseen by the Centers for Medicare and Medicaid Services ("CMS") and has undergone significant change, mainly as a result of changes in coding methodology that became effective on January 1, 2013. The codes that were used for ColonSentry® reimbursement claims in 2012 have been replaced by new codes. Private commercial payers have been receptive to the Company's submissions of ColonSentry® reimbursement claims while we continue to develop a consistent reimbursement strategy. As a result, coverage of ColonSentry® and reimbursement varies depending on the payor. As well, insurance companies may pay in full, in part or not at all and insurance payments may be incomplete if patients are required to pay a copay, coinsurance and or deductible. This results in uncertainty as to cash flow associated with each test and/or longer collection time frames as a reimbursement claim is processed.
Currently, additional tests offered by StageZero measure specific analytes and/or use standard testing procedures and are billed using specific codes. Changes in federal, state, local and thirdparty payer regulations may affect coverage or reimbursement for some or all clinical tests offered by StageZero and may adversely affect the Company. Additionally, fines, penalties, refunds, repayments and/or exclusion from Medicare and Medicaid programs would also adversely affect the Company. Further risks include costs arising from the inability to obtain coverage or reimbursement from newly licensed tests.
11. Facilities
The Company leased 1,570 square feet of office space located in Markham Ontario, Canada, for a three-year term commencing June 1, 2014, after a three-month rent-free period. Effective March 1, 2016, the Company sub-leased 100% of its premises for the remaining term of its lease to May 31, 2017, for approximately 70% of its rental cost, and effectively sold its furniture and equipment to the sub-tenant at that time
During 2017, StageZero re-negotiated the 5-year term of its lease of a 20,720 square foot space located in Richmond Virginia, United States, which now expires on September 30, 2023. The lease contains escalating rent provisions and has a \$100,000 leasehold improvement allowance. The space includes a functional laboratory. 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 would save us approximately \$2.5 million in costs over the term of the lease. The Company will be reacquiring the space occupied by the sub-tenant on June 1, 2021.
Our strategic alliance with Shanghai Biochip Co. Ltd. expired in accordance with its terms in July, 2015. Until that time, the jointly established Sentinel Centre for Personalized Medicine operated in a dedicated 2,500 square-foot laboratory provided by Shanghai BioChip Co. Ltd.
4. RISK FACTORS
We operate in a high-risk industry and are subject to numerous risks and uncertainties that may have an adverse effect on our business, results of operations and financial condition. An investment in StageZero Life Sciences and our securities should be carefully considered in light of the risks described below and the current economic and market conditions. These risks are not the only ones that StageZero faces. Additional risks that are not presently known to us or that we currently believe are immaterial may also significantly impair our business, results of operations and financial condition.
1. Capital requirements, financing and going concern
From inception to now, we have had no significant independent sources of income except for nominal sales of our product and proceeds from various collaborations, and we have accumulated significant losses. While we have added to StageZero's commercial test menu and believe this will lead to an increase in its commercial sales, there can be no guarantee that this will occur or will grow to a level necessary to finance our business. Our ability to operate profitably and generate positive cash flow in the future will be affected by a variety of factors, including the availability of additional capital to fund our operations, the formation of strategic partnerships to access marketing and distribution capabilities, our ability to penetrate the market with commercial products and our ability to obtain reimbursement coverage for the Company's tests.
For the foreseeable future, we continue to be financed from the proceeds of equity financings and, to the extent available, from debt. Revenues from sales of tests have been inconsistent. There can be no assurance that revenues from these sources will be anything more than nominal in the near term or will be sufficient to fund our operating costs.
Our ability to continue as a going concern is also contingent upon our ability to obtain additional sources of capital to finance operations in the future. Efforts will be required to obtain this additional capital, but there is no assurance that additional capital will be available on acceptable terms, if at all. Similarly, our revenue from sales is not sufficient to fund our operations. Inability to obtain sufficient additional capital may have a material adverse effect on the business, results of operations and/or financial condition. If additional financing is raised through the issuance of equity or convertible debt securities, the interests of the Company's shareholders may be diluted. The auditor's report issued in respect of the Company's 2019 annual consolidated financial statements contains an "Emphasis of Matter" which includes the following statement:
Without qualifying our opinion, we draw attention to Note 2 to the consolidated financial statements, which indicates that The Company reported a consolidated net loss of \$3.5 million for the year ended December 31, 2019 [December 31, 2018 – \$3.7 million]. As at December 31, 2019, the Company had a working capital deficiency of \$4.0 million [December 31, 2018 – \$4.4 million] and a deficit of \$97.3 million [December 31, 2017 – \$89.7 million].
As a result, our consolidated financial statements for the year ended December 31, 2020 contain a going concern note (note 1) with respect to this uncertainty. Substantial doubt about our ability to continue as a going concern may materially and adversely affect the price of our common shares, and it may be more difficult for us to obtain financing. The going concern note in our consolidated financial statements may also adversely affect our relationships with current and future collaborators and investors, who may grow concerned about the ability to meet our ongoing financial obligations. If potential collaborators decline to do business with us or potential investors decline to participate in any future financings because of such concerns, our ability to increase the Company's financial resources may be limited.
On May 4, 2016, the Company received a notice of default from HDL for missing two monthly payments under the terms of the Notes that were renegotiated in March 2016. On August 15, 2016, Richard Arrowsmith, as Liquidating Trustee of the HDL Liquidating Trust (the "Liquidating Trust"), filed a Complaint against the Company in the United States Bankruptcy Court, Eastern District of Virginia, Richmond Division (the "Bankruptcy Court"). The parties entered into negotiations and on March 1, 2017 reached a settlement agreement pursuant to which GeneNews (USA), Inc. would pay the Liquidating Trust an aggregate settlement amount of \$2,095,843, to be paid in a \$25,000 upfront payment and monthly payments of \$15,000 beginning March 1, 2017 to July 1, 2017, followed by monthly payments of \$10,000 until the outstanding debt has been paid in full. The Bankruptcy Court approved the settlement agreement and, on April 27, 2017, the action against the Company was dismissed with prejudice by the Bankruptcy Court.
We have prepared our financial statements on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. Our consolidated financial statements do not include any adjustment to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty.
4.2 No record of profit
We have incurred significant losses to date, and there can be no assurance that our future business activities will be profitable. Since our inception, we have incurred costs to develop and enhance our technology, to develop and commercialize our products and services, to establish strategic relationships, to acquire complementary technologies and to build administrative support systems. We have experienced negative operational cash flow to date. We incurred losses from operations of \$3.5 million for the year ended December 31, 2019, \$3.9 million for the year ended December 31, 2018 and \$2.9 million for the year ended December 31, 2017. Our ability to operate profitably and generate positive cash flow in the future will be affected by a variety of factors, including the Company's ability to generate revenue and our quarterly operating results, the pace at which we secure additional marketing partners and customers, our ability to further develop and test our technology on schedule and on budget, the intensity of the competition we experience and the availability of additional capital to pursue our business plan, including the development of new services. The inability to generate sufficient funds from operations is having a materially adverse effect on our business, results of operations and financial condition.
4.3 Share price
StageZero is an emerging company and operates within the biotechnology, molecular diagnostic and genomic biomarker industry (the "Industry"). We may experience large fluctuations in our share price as is common to many public companies in the Industry. Factors such as announcements relating to our science, products, patents or clinical studies, or regulatory or reimbursement changes, as well as the trading of our shares by insiders may have an adverse effect on the share price. In addition, our shares are currently lightly traded and have experienced substantial volatility in the past, often based on factors unrelated to our performance. These factors include global economic developments and market perceptions of the attractiveness of certain industries including the Industry, the limited extent of analytical coverage concerning our business if investment banks with research capabilities do not follow our securities, or reduced trading volume and general market interest in our securities, which may affect a holder's ability to trade significant numbers of our common shares and the size of our public float, which may limit the ability of some institutions to invest in our securities.
4.4 Dilution
We have issued convertible debt or equity securities, which may rank prior to the common shares and may do so in the future to fund potential acquisitions or investments, or for general corporate purposes. Our articles of amalgamation provide that StageZero has an unlimited number of nonvoting preference shares and voting special shares (entitling the holder to a dividend if and when declared by the Board in parity with the common shares and convertible into common shares) and of voting common shares that may be issued. If we issue convertible debt or equity securities to raise additional funds, our existing shareholders may experience dilution, and the new convertible debt or equity securities may have advantageous rights, preferences and privileges when compared to those of our existing shareholders. We are unable to predict the future amount of such issuances or dilution.
4.5 Public markets regulators
On the basis of the Company's financial condition, in January 2016, the Toronto Stock Exchange (the "TSX") placed the Company under remedial delisting review as we did not meet the TSX's requirements with respect to our working capital position and market capitalization. We requested to be provided additional time to regain compliance with the continued listing requirements of the TSX and we were granted until June 17, 2016 to demonstrate compliance with these continued listing requirements.
In March 2016, the Ontario Securities Commission (the "OSC") granted the Company a management cease trade order ("MCTO") which precluded members of management, specifically James Howard-Tripp, Executive Chairman, and Leslie Auld, then Chief Financial Officer, from trading the Company's common shares until such time as the cease trade order was no longer in effect. The Company complied with the provisions of the alternative information guidelines found in sections 4.3 and 4.4 of National Policy 12-203 Cease Trade Orders for Continuous Disclosure Defaults for as long as it was delayed in filing the annual and quarterly financial statements and related MD&A, CEO and CFO certificates and its' Annual Information Form. The Company filed its annual filings on May 27, 2016 and completed its March 31, 2016 quarterly filings on June 15, 2016.
On June 16, 2016, the TSX completed its Remedial Review Process and determined that the Company met the TSX's continued listing requirement. On this date, the OSC also lifted the MCTO on members of management of the Company. While the Company's financial position has improved since the public market regulators placed it on remedial delisting review and MCTOs were granted, there is no guarantee that the Company will not be subject to further reviews by the regulators.
StageZero filed its current annual filings on March 31, 2021.
4.6 Other collaborations and strategic partnerships
In 2016, GeneNews entered into a collaboration agreement with JTS Health Partners, a leading national healthcare management consulting and professional services firm based in Atlanta, Georgia and with NueHealth, LLC, a privately owned company that delivers value-based healthcare solutions and connects patients directly to physicians through integrated provider networks (or "IPNs") in the United States. In 2017, we entered into an agreement with a large, multi-specialty physician group in the American Midwest for use of our diagnostic tests. We expect that these collaborations will accelerate adoption of StageZero's menu of proprietary cancer tests, including its lead ColonSentry® blood-test for assessing an individual's current risk for colorectal cancer. With respect to our arrangement with JTS Health Partners, we expected that both parties would work to pursue and secure multi-year agreements for the Company's tests with hospitals, clinical integrated networks, physician groups and healthcare organizations. With respect to our arrangements with NueHealth, LLC and with the Midwest multi-speciality physician group, we expect their physicians to adopt our test menu on a contracted basis. Should these initiatives fail to materialize in a timely manner or to generate sufficient revenue, our ability to continue operations and pursue our objectives may be adversely affected.
The Company entered into license or other agreements in order to sell diagnostic tests developed by third parties that have been added to its menu of tests and may continue to do so in the future. These agreements include ones that are nonexclusive, short-term or subject to termination on notice and that require minimum license or other payments to be made by the Company. As a result, these arrangements may terminate earlier than desired or result in fewer sales and lower revenues than expected.
The success of any license arrangement to sell a diagnostic test developed by a third party is in part dependent on the financial health and reputation of the licensor and the intellectual property associated with the products and tests licensed to StageZero. See "Risk Factors – StageZero as licensee in the event of bankruptcy of a licensor."
We have also entered into a number of agreements and alliances with corporate, academic, hospital and physician collaborators. These collaborations are typical in the Industry. We are highly reliant on such alliances to facilitate our research and development and our commercialization programs. As an example, access to patient samples for research is essential to our continuing research. Although beneficial to us, these collaborations may expose us to additional risks. Should current collaborations and new alliances prove difficult or impossible to maintain, we may be adversely affected.
4.7 Markets and competition
The Industry is subject to rapid technological change, which may significantly alter the marketplace or result in changes in the regulatory and legislative environment. Our ability to successfully commercialize products or processes for diagnosing and managing colorectal cancer, prostate cancer, breast cancer and other diseases in our development pipeline may depend, in part, on future market conditions, which are impossible to predict. The Industry is populated with larger and more sophisticated companies whose financial and human resourcesfar outweigh ours. Any one or several of these competitors could announce findings or competitive approaches or products at any time that could diminish or even eliminate competitive advantages we currently hold. The failure to adapt to any of the factors noted above could have a material adverse effect on our business, results of operations and financial condition.
Health-care reform and controls on health-care spending may limit the price charged for any of our products or the amounts that can be sold. In particular, in the United States, the federal government and private insurers have changed the manner in which health-care services are provided and reimbursed. Changes in recent years include the controls on health-care spending, the creation of large purchasing groups and revisions to the methodology that Medicare uses for payment of laboratory tests. In the future, the US government may institute further controls and different reimbursement schemes and limits on Medicare and Medicaid spending or reimbursement. These controls, reimbursement schemes and limits might affect the revenues we could earn from sales of any products or tests in the United States. Uncertainties regarding future health-care reform and private market practices could adversely affect our ability to sell any products profitably in the United States. Election of new or different government officials in large market countries could lead to dramatic changes in pricing, regulatory approval legislation and reimbursement, which could have material impacts on product approvals and commercialization.
4.8 Commercialization
Successful commercialization of our products will depend on a number of factors, including our ability to:
- raise sufficient capital to fund current and future commercialization efforts;
- build a commercial team and supporting organizational infrastructure;
- establish partnerships and alliances with third parties to secure commercial capabilities that we may not wish to build;
- market and distribute our products;
- distinguish our products from others available on the market;
- obtain any necessary regulatory approvals for our facilities, products and processes;
- gain 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;
- educate physicians and change physician behavior to secure clinical adoption of our products;
- promote awareness of our products to increase market penetration; and
- publish in peer-reviewed journals.
There is no assurance that we will be successful in these areas.
We believe that there may be different applications for products successfully derived from our technologies and that the anticipated market for products under development will continue to expand. We cannot give assurance, however, that these beliefs will prove to be correct. The commercial viability of our products is yet to be established and we face competition from existing or new products. Physicians, patients, third-party payers or the medical community in general may not accept or use any products that we or our collaborative partners may develop or in-license.
Successful commercialization of ColonSentry® tests in the United States depends, in large part, on the availability of adequate reimbursement from public and private insurance plans. In part, we believe that obtaining a positive coverage decision and a favorable reimbursement rate from the Centers for Medicare and Medicaid Services ("CMS") or their contractors may be a necessary element in achieving material commercial success.
The US Preventive Services Task Force ("USPSTF") is an independent, volunteer panel of national experts in prevention and evidence-based medicine. USPSTF makes recommendations about clinical preventative services such as screenings, counseling services and preventive medications. With the passage of the Medicare Improvement for Patients and Providers Act of 2008, Congress allowed the US Department of Health and Human Services("HHS") to authorize Medicare coverage for services rated A or B by the USPSTF.
Recommendations from The American College of Gastroenterology are to start screening for colorectal cancer at age 45 in average risk individuals.
Third-party payers are increasingly attempting to contain health-care costs by limiting both coverage and the level of reimbursement for new health-care products. As a result, there is significant uncertainty as to whether the use of tests that incorporate new technology, such as ColonSentry®, will be eligible for coverage by third-party payers or, if eligible for coverage, what the reimbursement rates will be for those products. If we are unable to obtain positive coverage decisions from third-party payers or favorable rates of reimbursement for ColonSentry® tests at adequate levels, the commercial success of ColonSentry® technology would be constrained, and associated US revenues would be significantly limited.
4.9 Regulatory authorizations
The Industry is highly regulated. Ultimate commercial success may depend on our ongoing ability to obtain the necessary regulatory authorizations for facilities, products and processes. In addition, the process of obtaining regulatory authorization from governmental authorities to commercialize our products varies from country to country and by types of products and testing services. Depending on the circumstances, the process can be costly and time consuming, with ensuing delays in commercialization of a product or service. Regulatory authorization may be granted in part only or may be refused, which would negatively affect sales and profitability.
In the United States, medical devices, including screening tests, are subject to extensive regulation by the US Food and Drug Administration ("FDA") under the federal Food, Drug, and Cosmetic Act ("FD&C Act") and its implementing regulations as well as by other federal and state statutes and regulations. The laws and regulations govern, among other things, medical device development, testing, labeling, storage, premarket clearance or approval, advertising and promotion, and product sales and distribution.
To be commercially distributed in the United States, medical devices must receive an FDA clearance of a premarket notification ("510(k)") or a premarket approval ("PMA") pursuant to the FD&C Act prior to marketing, unless subject to an exemption. Devices deemed to pose relatively less risk are placed in either Class I or II. Many Class I devices and some Class II devices, are exempt from 510(k) premarket clearance. Those devices exempt from FDA premarket review must nonetheless comply with postmarket "general controls," unless the FDA has chosen to exercise "enforcement discretion" and not regulate them. Devices deemed by the FDA to pose the greatest risk are placed in Class III, requiring a PMA. The PMA pathway is costly, lengthy and uncertain. The PMA review process typically takes one to three years but can take longer. The FDA's 510(k) clearance pathway usually takes from three to twelve months, but it can last longer, particularly for a novel type of product.
ColonSentry® and BreastSentry™ are currently regulated as laboratory developed tests ("LDT") in the United States under the clinical laboratory improvement amendments ("CLIA") as well as applicable state laws. Generally, tests that are designed, developed, validated and used within a single laboratory have been considered to be LDTs. The FDA exercised enforcement discretion with respect to LDTs. On October 3, 2014, the FDA issued two draft guidance documents regarding oversight of LDTs. According to the draft guidance, the FDA intended to begin regulating LDTs using a risk-based, phased-in approach, in combination with continued exercise of enforcement discretion for certain regulatory requirements and certain types of LDTs. According to the draft guidance, all laboratories with LDTs—except for those only performing forensic testing or certain LDTs for transplantation, would need to comply with some basic statutory device requirements, regardless of the risks of the test, including adverse event reporting, corrections and removals reporting and registration and listing or notification. In addition, tests defined as high or moderate risk that are not subject to an exemption would need to be the subject of a PMA or 510(k) that is submitted to the FDA in a phased-in manner. The draft guidance has been the subject of considerable controversy, and it is unclear whether the proposed oversight regulations will be finalized, and if so, what they will contain. In addition, the US Congress may act to provide further direction to the FDA on the regulation of LDTs. In January 2017, the FDA released a discussion paper on LDTs. According to this paper, the FDA is considering grandfathering LDTs already on the market and focusing oversight on new and significantly modified LDTs of high or moderate risk. However, FDA would retain enforcement discretion on all LDTs and would enforce premarket review or other requirements if the FDA identified certain risks such as, but not limited to, absence of sufficient data to support its clinical or analytical validity, deceptive promotion or risk of serious adverse health consequences. As of this date, it is unclear as to whether the FDA will finalize this guidance.
Even if required regulatory authorizations are obtained for our products, we will be subject to ongoing government regulation. As well, the manufacture, marketing and sale of our products will be subject to strict and ongoing regulation. After a device, including a device exempt from FDA premarket review, is placed on the market in the United States, numerous regulatory requirements apply. These include the quality system regulation (which imposes elaborate testing, control, documentation and other quality assurance procedures), labeling regulations, registration and listing regulations, the medical device reporting regulation (which requires that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur), and the reports of corrections and removals regulation (which requires manufacturers to report recalls and field actions to the FDA if initiated to reduce a risk to health posed by the device or to remedy a violation of the FD&C Act). Compliance with such regulations may be expensive and may consume substantial financial and management resources. If we or any marketing collaborators fail to comply with applicable regulatory requirements, we may be subject to sanctions including fines, product recalls or seizures; injunctions; total or partial suspension of production; civil penalties; withdrawal of regulatory authorizations; or criminal prosecution. Any of these sanctions could delay or prevent the promotion, marketing or sale of our products.
4.10 Reimbursement
If we or our marketing partners cannot obtain acceptable prices or adequate reimbursement for our products, our ability to generate revenues is significantly diminished. Our ability to successfully commercialize products will depend significantly on the ability to obtain acceptable prices and the availability of coverage and reimbursement to the patient from third-party payers, such as government and private insurance plans. These third-party payers frequently require companies to provide predetermined discounts from list prices, and they are increasingly challenging the prices charged for medical products, including laboratory tests. Our products may not be considered costeffective, and reimbursement to the patient may not be available or sufficient to allow us to sell our products on a competitive basis. We and our marketing partners may not be able to negotiate favorable reimbursement rates for our products. In addition, the continuing efforts of third-party payers to contain or reduce the costs of health care through various means may limit our commercial opportunity and reduce any associated revenue and profits. We expect proposals to implement similar government control to continue. In addition, increasing emphasis on managed care will continue to put pressure on the pricing of medical and health-care products. Cost control initiatives could decrease the price that we or any current or potential collaborators could receive for any products and could adversely affect our profitability. In addition, in the United States and many other countries, changes to reimbursement policies and rules may affect the reimbursement of our products. If we fail to obtain acceptable prices or an adequate level of reimbursement for our products, the demand for products and their sales would be adversely affected or there may not be a commercially viable market.
4.11 Legal claims and regulatory proceedings
From time to time, StageZero may be involved in various legal claims and regulatory proceedings arising in the ordinary course of business. These could include arbitrations, class actions, civil litigation and investigations (including those described in more detail below). These matters may include, but are not limited to intellectual property disputes, professional liability, employee-related matters and inquiries, including subpoenas and other civil investigative demands. They would come from governmental bodies, Medicare, Medicaid or managed-care payer reviews of billing practices or requests for comment on allegations of billing irregularities that are brought to their attention through billing audits or third parties. Such inquiries may relate to the Company and to other healthcare providers.
StageZero operates in the clinical laboratory testing industry and therefore is vulnerable to being named in future suits brought under the qui tam provisions ("whistleblower provisions") of the United States False Claims Act and comparable state laws. Suits under these provisions typically allege that an entity has made false statements and/or certifications in connection with claims for payment from federal or state health-care programs. The suits may remain under seal (hence, unknown to StageZero) for some time while the government decides whether to intervene on behalf of the qui tam plaintiff. Such potential claims are an inevitable part of doing business in the healthcare field today.
We believe that StageZero complies in all material respects with all statutes, regulations and other requirements applicable to its operations. The clinical laboratory testing industry is, however, subject to extensive regulation with respect to sales and billing practices, quality control and privacy of health information. Many of these statutes and regulations have not yet been interpreted by the courts. There can be no assurance that these applicable statutes and regulations will not be interpreted or applied by a prosecutorial, regulatory or judicial authority in a manner that would adversely affect the Company. Potential sanctions for violation of these statutes and regulations include significant fines and the loss of various licenses, certificates and authorizations, which are critical to our business. Such actions could also result in damage to our reputation and adversely affect our relationships with third parties.
4.12 Compliance with privacy laws
StageZero is subject to privacy and security regulations in the United States with respect to the use and disclosure of protected health information. Subject to limited exceptions, the regulations restrict the Company's ability to use or disclose patient identifiable information without patient consent for purposes other than payment, treatment or health-care operations. There are significant fines or penalties for noncompliance with these requirements. In addition, any breach of its's security systems that results in personal information being obtained by unauthorized persons could adversely affect the reputation of the Company.
4.13 Marketing and distribution
Our ability to sell tests and testing services will depend on the effectiveness of our sales and marketing strategy and our capacity to hire key talented individuals in our team. StageZero has limited resources and may not be able to maintain an appropriately sized sales and marketing team. Also, other companies with more resources could potentially compete more aggressively and gain greater market share, which would hamper our revenues. In order to market our products we may, under certain circumstances or in certain countries, decide to rely on the marketing and sales forces of distributors with technical expertise and with supporting distribution capacity. To the extent that we rely on third parties to market and distribute our products, the commercial success of such products may be beyond our control. Moreover, there can be no assurance that we will conclude satisfactory alliances or contracts with health-care or medical service companies with the requisite marketing and distribution capabilities that we seek, or that such alliances or contracts will be beneficial to us. The loss of any of our distributors and marketing partners could have a material adverse effect on our business, financial condition or results of operations.
4.14 Ability of manage corporate growth, commercial expansion and interruptions of operations
Responding to consumer demands, expansion into other geographical markets and targeted growth in our business has placed and is likely to continue to place significant strains on our administrative and operational resources and our internal systems, procedures and controls. If we experience rapid acceptance of our tests, the need to manage such growth will add to the demands on our management, resources, systems, procedures and controls. There can be no assurance that our administrative infrastructure, systems, procedures and controls will be adequate to support our operations, or that our officers and personnel will be able to manage any significant expansion of operations. If we are unable to manage growth effectively, our business, financial condition and results of operations could be materially adversely affected.
We also depend on the efficient and uninterrupted operation of our single laboratory and its computer and communications software, computer hardware systems and other information technology, all located in Richmond, Virginia, US. Our activities and performance could cease or suffer if the laboratory or these systems were to fail or if we were unable to successfully expand their capacity when necessary.
Research and processes used by us and our partners require the use of sophisticated equipment, which may require a significant amount of time to obtain and install. Although we endeavor to properly maintain our equipment through proper service contracts and an inventory of key spare parts on hand, our activities could suffer if certain equipment or all or a portion of our facilities were to become inoperable for a period of time. This could occur for a variety of reasons, including catastrophic events such as weather-related damage, massive power failures, equipment failures and/or delays in obtaining components or replacements, construction delays or defects and other events that may be outside our control. Such a situation would result in a material adverse effect on our business, reputation, financial condition and results of operation.
4.15 Key personnel
We rely on certain key personnel for the management and development of our businesses. The experience, knowledge and contributions of our existing management team and our directors are and will continue to be important for the foreseeable future. As such, the loss of services from or retirement of such key personnel could have a material adverse effect on us. In addition, we expect to be seeking additional full-time employees to increase our in-house capability to manage and operate the lab. There is competition for qualified personnel, and there can be no assurance that we will be able to attract and retain such personnel necessary for our businesses.
4.16 Foreign exchange rate risk
We operate in Canada and the United States and transact business primarily with US partners and suppliers. Effective July 1, 2015, the Company changed its presentation and functional currency from Canadian dollars to USD, effective retrospectively. Comparative information provided for 2015 and 2014 was therefore restated for this change in presentation currency. We believe that the USD presentation better reflects the Company's total business activities and improves investors' ability to compare our total financial results with other publicly traded businesses in our industry (most of which are based in the United States and report in USD). and the change should result in less volatility in reported royalty revenue. 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 \$133,576 [December 31, 2019 – \$\$371,658The Company's exposure to foreign currency changes for all other currencies is not material.
4.17 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, while the note payable to a shareholder and director as was issued in 2016 is fixed at 2% per annum, the notes payable to shareholders and director, issued after 2017 are fixed at 5% per annum, and the convertible debentures are fixed at 8%.
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.
Accordingly, there have been no significant impacts on the Company's consolidated statements of loss and comprehensive loss from changes in interest rates.
4.18 StageZero Life Sciences Inc. as licensee in the event of bankruptcy of a licensor
Rather than owning all of the intellectual property on which it relies, the Company licenses certain intellectual property and is substantially dependent on such licenses in order to market and sell such products. In the event that the licensor of any license the Company holds files a petition in bankruptcy, there can be no assurance that the rights under its licenses will not be curtailed or otherwise affected, even if the Company actively pursues enforcement of the license agreement.
If a licensor files for bankruptcy, among other results, the licensed intellectual property may be sold to a third party and such sale may extinguish the Company's rights under any existing license agreements. This could cause a significant hardship for the Company as the licensee and could have a material adverse effect on its business, and therefore, our business.
4.19 Material weakness in financial controls
In connection with the preparation of financial statements for the year ended December 31, 2019, management identified a material weakness in internal controls over financial reporting. A material weakness of an issuer is defined as a deficiency or a combination of deficiencies in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of its annual or interim financial statements would not be prevented or detected on a timely basis.
The material weakness pertained to ineffective controls in the financial statement close process and to ineffective oversight of the financial recordkeeping and reporting of our interest in our subsidiaries. This was as a result of not having a sufficient number of accounting resources with relevant technical accounting skills to effectively and accurately prepare and review financial statements prior to finalization.
Since identifying the weakness, we have begun to remedy the respective material weaknesses through the continued development and implementation of formal policies, improved processes and documented procedures, as well as the continued sourcing of additional qualified finance resources. To this end we have retained outside consultants to assist us to disclose the details and accounting for our complex financial instruments and to oversee compliance with IFRS.
Although we are working on remedying the weakness as quickly as possible, we cannot at this time estimate how long it will take, and the initiatives may not prove to be successful in remedying the material weakness. If the remedial measures are insufficient to address these material weaknesses or if further significant deficiencies or material weaknesses in internal control over financial reporting are discovered or occur in the future, management's ability to evaluate the financial reporting may be adversely affected. This would affect certifications, when required, regarding the effectiveness of our internal controls over financial reporting required by National Instrument 52- 109 – Certification of Disclosure in our annual and interim filings. In addition, if we are not able to successfully remedy the material weakness, and if as a result StageZero is unable to produce accurate and timely financial statements or is required to restate its financial results, StageZero's stock price may be adversely affected.
4.20 Joint venture relationship
In 2013, our subsidiary, GeneNews (USA), Inc. (now StageZero Holdings), signed an agreement with two private American companies, HDL and Cobalt, and established IDL (now StageZero Life Sciences Inc.), an accredited clinical laboratory. GeneNews (USA), Inc. since completed two stepup acquisitions of IDL, by increasing its ownership position from 33⅓% to 50% effective May 15, 2015 and to 100% effective March 15, 2016. Until then, we and our partners jointly controlled IDL. Currently, the lab is our only source of revenue. Accordingly, the success of this lab is critical to our business. Before the full acquisition on March 15, 2016, we were dependent on both the continued revenues of the lab resulting from sales of tests in its menu and the contributions of Cobalt to the lab to contribute revenues to the Company and to reduce the Company's costs to support the lab, respectively.
Furthermore, the Company had no control over the business activities of its former joint venture partners or their affiliates. If the reputation of any of its former joint venture partners is negatively affected resulting from regulatory or civil proceedings, the reputation of the Company could be damaged as well. Such reputation damage could have a materially adverse effect on our business, relationships with current or potential strategic partners or licensors, customers, results of operations and financial condition. In addition, a partner or others that provide services to the Company may be found to conduct business, without the Company's knowledge, in a manner that is not consistent with applicable law. This could have a materially adverse effect on our business, results of operations and financial condition.
4.21 Intellectual property
Our success depends, in large part, on our ability to protect our competitive position through patents, trade secrets, trademarks and other intellectual property rights. The patent positions of healthcare and medical services firms, including ours, are uncertain and involve complex questions of law and fact for which important legal issues remain unresolved.
Ten key foundational U.S. patents related to our core technology platform, the Sentinel Principle®, have been issued, and we have maintained a robust portfolio across North America. Our commercial success or continued operations may be dependent upon the ability to obtain future patent issuances. However, there can be no guarantee they will be obtained, and if obtained that they will successfully prevent any subsequent infringements on these patents. Also, any patents issued or to be issued to us may not provide us with any competitive advantage. Our patents may be challenged by third parties in patent litigation, which is becoming widespread in the Industry. It is possible that third parties with products or processes that are very similar to ours will circumvent our patents by means of alternative designs or processes. We may be required to disclaim part of the term of certain patents. There may be prior publications or patent applications of which we are not aware that may affect the validity or enforceability of a patent claim. There also may be prior publications or patent applications that we do not view as affecting the validity or enforceability of a claim, but which may, nonetheless, ultimately be found to do so. No assurance can be given that our patents would be held by a court to be valid or enforceable if challenged, or that another party's technologies, products, services or activities would be found by a court to infringe on one or more of our patents. Applications for patents and trademarks in Canada, the United States and other global jurisdictions have been filed and are being actively pursued by the Company. Pending patent applications may not result in the issuance of patents, and we may not develop future products or services which are patentable. Beyond the inherent uncertainties regularly associated with the patenting process, the continued or future patentability of our products or services may be affected by the continually evolving legal underpinnings of the Industry.
We rely on our own trade secrets, know-how and other proprietary information. Although employees, consultants, advisors and collaborators are required to sign confidentiality agreements, these agreements may be breached and we may not have adequate remedies for such breaches. It is also possible that external parties could independently develop proprietary information and techniques substantially similar to ours or otherwise gain access to and exploit our know-how, trade secrets or other proprietary information. As a result, we may not be able to rely on our intellectual property to protect our products or services in the marketplace to achieve or maintain commercial success or to continue operations.
4.22 Patent infringement
Our commercial success may depend on our ability to operate without infringing the patents and other intellectual property rights of external parties. The presence of any such patents could negatively affect our ability to continue performing our activities. The products and services we are developing may require the use of certain technologies or the performance of certain activities for which licenses are required. Such licenses may be difficult to acquire on commercially reasonable terms, if at all. If we were to be sued for patent infringement, we may not have adequate resources to defend our position.
In a court of law our products or services may be found to infringe on patents that we either do not know about or do not believe we infringe upon. Moreover, patent applications are in some cases maintained in secrecy for long periods of time or until patents are issued. The publication of discoveries or inventions in the scientific or patent literature frequently occurs substantially later than the date on which these discoveries or inventions were made, on which related patent applications were filed. Because patents can take many years to issue, and because patent applications usually evolve in scope or change in subject matter during prosecution, there may exist pending applications of which we are unaware that may later result in issued patents that our activities infringe upon. The Industry has produced a proliferation of highly complex patents and it is not always clear to Industry participants, including us, which patents may cover any particular aspect of their activities at any given point in time. The coverage of patents is subject to interpretation by the courts and the interpretation is not always uniform or predictable. It may also be subject to unpredictable changes in the law. We are aware of and have reviewed certain other parties' patents relating to the identification and application of blood-based biomarkers generally and for colorectal cancer and other relevant indication areas. In the event of infringement or violation of another party's patent, we may not be able to secure licensing arrangements or make other arrangements at a reasonable cost. Any inability to secure licenses or alternative technology could result in delays in the introduction of our products or services, or lead to prohibition of the manufacture or sale of the products, or sale of the services.
4.23 Litigation
Patent litigation is costly and time consuming and may subject us to liabilities. Our involvement in any patent litigation, interference, opposition or other administrative proceedings will likely cause us to incur substantial expenses, and the efforts of our key personnel will be significantly diverted. In addition, an adverse determination in litigation could subject us to significant liabilities.
Securities legislation in Canada has changed to make it easier for shareholders to sue. These changes could lead to frivolous lawsuits, which could take substantial time, money, resources and attention or could force us to settle such claims rather than seek adequate judicial remedy or dismissal of such claims.
4.24 Fluctuations in quarterly results
We expect our quarterly operating results to fluctuate as a result of many factors. These include the Company's ability to generate revenue, changes in the demand for our technology, the introduction of competing technologies, market acceptance of such enhancements or services, delays in the introduction of such enhancements or services, changes in our pricing policies or those of our competitors, the ability of StageZero to obtain reimbursement for tests on a timely basis, the mix of services sold, foreign currency exchange rates and general economic conditions.
4.25 Current enterprise value assigned by the market
During the year ended December 31, 2020, our market capitalization fluctuated between approximately Cdn\$8.49 million and Cdn\$42.2 million. As at December 31, 2020, the market capitalization had increased by approximately Cdn\$29.0 million from the value at December 31, 2019. All stakeholders in our business may be affected by our current market capitalization and may ascribe a higher business risk to the Company as a result. This may have a material effect on our business, results of operations and financial condition.
5. DESCRIPTION OF CAPITAL STRUCTURE
The authorized share capital of the Company consists of an unlimited number of non-voting preference shares issuable in one or more series, an unlimited number of voting special shares, entitling the holder to a dividend if and when declared by the Board in parity with the common shares and convertible into common shares and an unlimited number of voting common shares.
As at December 31, 2020 there were 60,716,595 common shares issued and outstanding and no preference shares or special shares outstanding. At December 31, 2020, there were 4,157,607 stock options exercisable into common shares on a one-for-one basis and 24,103,444 share purchase warrants outstanding, exercisable into common shares on a one-for-one basis for each of the warrants . On September 8, 2020 the Company announced a share consolidation of 8 to 1.
1. Common shares
The holders of the common shares are entitled to vote at all meetings of shareholders except meetings at which only holders of a specified class of shares are entitled to vote. Holders of common shares are entitled to one vote for each common share held and, subject to the rights, privileges, restrictions and conditions attached to any other class of shares of the Company, to receive the remaining property of the Company in the event of liquidation, dissolution or winding up of the Company.
5.2 Preference shares
We have not issued any preference shares and do not anticipate the issuance of any preference shares in the foreseeable future. The preference shares may be issued at any time or from time to time in one or more series by our Board. The Board may determine the designation, rights, privileges, restrictions and conditions to be attached to the preference shares. Holders of the preference shares shall not be entitled to receive notice of, to attend or to vote at any meeting of the shareholders, except that holders shall be entitled to receive any notice of meetings of shareholders called for the purpose of authorizing the dissolution of the Company or the sale, lease or exchange of all or substantially all of the property of the Company. The preference shares of each series shall rank on parity with the preference shares of every other series with respect to dividends and return of capital in the event of the liquidation, dissolution or winding-up of the Company and shall be entitled to a preference over the common shares of the Company.
5.3 Special shares
We have not issued any special shares and do not anticipate the issuance of any special shares in the foreseeable future. Holders of any special shares would be entitled to receive notice of and to attend all meetings of the shareholders of the Company for which the holders of common shares are entitled to notice of and to vote at; holders of special shares would be entitled to one vote for each special share held. Holders of special shares would have the right to convert such special shares into common shares on a one for one basis, as adjusted for stock dividends, consolidations, subdivisions and similar reorganizations, and would also be entitled to receive equally share for share with the holders of the common shares all dividends of the Company.
5.4 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] |
205,958 | 205,958 | 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] |
970,790 | 970,790 | 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] |
1,062,500 | 1,062,500 | 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] |
398,436 | 398,436 | 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] |
944,478 | 944,478 | 0.48 | 16-Jan-23 |
| January 16, 2020 [Hampton Security Company] |
25,003 | 25,003 | 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 |
5.5 Stock options
The following is a summary of the status of the Plan as at December 31, 2020 and 2019, and changes during the years then ended:
| Year ended December 31, 2020 |
Year ended December 31, 2019 |
|||
|---|---|---|---|---|
| Number | Weighted average |
Weighted average |
||
| of options |
exercise price |
Number of options |
exercise price |
|
| # | Cdn\$ | # | Cdn\$ | |
| Outstanding, beginning of period |
3,733,779 | 0.902 | 2,178,881 | 1.44 |
| Granted | 1,912,500 | 0.44 | 1,965,524 | 0.80 |
| Exercised | (237,865) | 0.254 | - | - |
| Expired or forfeited |
(332,054) | 0.371 | (410,625) | 2.64 |
| Outstanding, end of period |
5,076,360 | 0.767 | 3,733,779 | 0.96 |
| Exercisable, end of period |
4,157,610 | 0.738 | 2,768,205 | 1.04 |
The following table summarizes information about stock options outstanding at December 31, 2020
| Range of exercise prices per share |
Number outstanding |
Weighted-average exercise price |
Weighted-average remaining contractual life |
|---|---|---|---|
| Cdn\$ | # | Cdn\$ | years |
| 0.08 to 0.80 |
3,849,899 | \$0.51 | 3.72 |
| 0.88 to 1.20 |
847,086 | \$0.94 | 1.53 |
| 1.28 to 2.40 |
341,875 | \$1.44 | 0.97 |
| 2.48 to 3.00 |
37,500 | \$2.44 | 0.24 |
| 5,076,360 | \$0.767 | 1.65 |
5.6 Dividends
We have not declared nor paid cash dividends on our common shares, and we do not anticipate paying any cash dividends on our common shares in the foreseeable future. We presently intend to retain future earnings, if any, to finance the expansion and growth of our business. Any future determination to pay dividends would be at the discretion of the Board and will depend on our financial condition, results of operations, capital requirements and any other factors that the Board deems relevant.
6. MARKET FOR SECURITIES
Our common shares commenced trading on the TSX under the stock symbol "SZLS" on June 20, 2019. Until that date, from October 26, 2006 the Company's shares were traded on the TSX under our former name, GeneNews Limited and the stock symbol "GEN". Prior to 2006, the Company's shares were traded on the TSX Venture Exchange under our earlier former name, ChondroGene Limited, and its former stock symbol, "CDG".
1. Trading prices and volumes
The following table sets forth the reported high, low and closing share prices, and the aggregate monthly volume of trading of the Company's common shares listed for trading on the TSX for the periods indicated during the year ended December 31, 2020:
| Month | High C\$ |
Low C\$ |
Close C\$ |
Volume |
|---|---|---|---|---|
| January 2019 |
0.065 | 0.40 | 0.650 | 16,212,418 |
| February 2019 |
0.120 | 0.050 | 0.120 | 32,791,750 |
| March 2019 |
0.205 | 0.125 | 0.170 | 82,963,613 |
| April 2019 |
0.175 | 0.125 | 0.130 | 21,568,326 |
| May 2019 |
0.150 | 0.080 | 0.080 | 10,744,627 |
| June 2019 |
0200 | 0.080 | 0.200 | 18,780,053 |
| July 2019 |
0.195 | 0.110 | 0.135 | 15,839,519 |
| August 2019 |
0.140 | 0.080 | 0.085 | 11,490,445 |
| September 2019 |
0.110 | 0.080 | 0.080 | 7,906,215 |
| October 2019 |
0.125 | 0.070 | 0.080 | 10,723,659 |
| November 2019 |
0.085 | 0.045 | 0.050 | 12,350,944 |
| December 2019 |
0.050 | 0.035 | 0.045 | 14,590,334 |
7. DIRECTORS AND OFFICERS
As at the date of this AIF, to the knowledge of the Company and except as noted below, none of our directors or executive officers is or has been within the last ten years:
(a) a director or executive officer of any company (including the Company) that while that person was acting in that capacity
- (i) was the subject of a cease trade or similar order or an order (an "Order") that denied the relevant company access to any exemption under securities legislation, for a period of more than thirty consecutive days;
- (ii) was subject to an event that resulted, after the director or executive officer ceased to be a director or executive officer, in the company being the subject of an Order; or
- (iii) within a year of that person ceasing to act in that capacity, became bankrupt, made a proposal under any legislation relating to bankruptcy or insolvency or was subject to or
instituted any proceedings, arrangement or compromise with creditors or had a receiver, receiver manager or trustee appointed to hold its assets; or
(b) has become bankrupt, made a proposal under any legislation relating to bankruptcy or insolvency, or become subject to or instituted any proceedings, arrangement or compromise with creditors, or had a receiver, receiver manager or trustee appointed to hold his or her assets; or
(c) has been subject to: (i) any penalties or sanctions imposed by a court relating to securities legislation or by a securities regulatory authority or has entered into a settlement agreement with a securities regulatory authority; or (ii) any other penalties or sanctions imposed by a court or regulatory body that would likely be considered important to a reasonable investor in making an investment decision.
On January 18, 2016, the Company received notice that the Toronto Stock Exchange (the "TSX") was reviewing the eligibility for continued listing on the TSX of the securities of the Company pursuant to Part VII of the TSX Company Manual. Based on extension requests submitted by the Company to the TSX, the Company was granted until June 17, 2016 to demonstrate compliance with the continued listing requirements (the "Listing Requirements") of the TSX, pursuant to the TSX's Remedial Review Process.
On March 29, 2016, the Company announced that it had applied for, and been granted a management cease trade order ("MCTO") by the Ontario Securities Commission (the "OSC") which precluded members of management from trading the Company's common shares until such time as the cease trade order was no longer in effect. The Company needed to satisfy the provisions of the alternative information guidelines found in sections 4.3 and 4.4 of National Policy 12-203 Cease Trade Orders for Continuous Disclosure Defaults for so long as it was delayed in filing the annual and quarterly financial statements and related MD&A, CEO and CFO certificates and its' Annual Information Form. The Company filed its annual filings on May 27, 2016 and completed its March 31, 2016 quarterly filings on June 15, 2016.
On June 16, 2016, the TSX completed its Remedial Review Process and determined that the Company met the TSX's continued listing requirement. Additionally on this date, the OSC lifted the MCTO on members of management of the Company.
The number of common shares collectively held by our directors and officers directly or indirectly as beneficial owner or over which control or direction is exercised as at December 31, 2020 is approximately 8% of the Company's total number of issued and outstanding shares, as more particularly described in the sections below.
7.1 Directors
Each director will hold office until the close of our next annual meeting of shareholders unless he or she resigns or the position becomes vacant because of the director's death, removal from the Board or any other reason prior to such meeting.
The name of each director, the year in which each person first became a director of the Company, the director's principal occupation and the number of the Company's common shares that each director held directly or indirectly as beneficial owner or over which control or direction is exercised as at December 31, 2020, are provided in the following table:
| Name and place of residence | Principal occupation or employment | Year first became a director |
No. of shares beneficially owned, directly or indirectly or over which control or direction is exercised |
|---|---|---|---|
| Rory Riggs(i) New York, United States |
CEO Locus Analytics LLC/Syntax LLC | 2000 | 1,796,329 |
| Garth MacRae Ontario, Canada |
Director of Dundee Corporation, Dundee Energy and Uranium Participation Corporation. |
2000 | 147,086 |
| James R Howard-Tripp (ii) Ontario, Canada |
Chairman and Chief Executive Officer and Director, StageZero Life Sciences Ltd. |
2002 | 232,759 |
| Harry Glorikian (iii) Massachusetts, United States |
Independent consultant | 2008 | 107,154 |
Mr. Riggs resigned his position as Chair of our Board in July 2013 and Mr. Howard-Tripp was appointed Executive Chairman at that time. Mr. MacRae (chair), and Mr. Riggs are members of our audit committee. Mr. Glorikian (chair) and Mr. Riggs are members of our compensation committee. The Board, as a whole, has responsibility for corporate governance and strategic matters.
During the past five years, all of the aforementioned directors have held the principal occupations shown above except as follows:
- (i) Mr. Riggs was Managing Member of Balfour LLC' in addition to his role as CEO of Locus Analytics LLC\Syntax LC since 2010;
- (ii) Mr. Howard-Tripp was appointed Executive Chairman in July 2013 and Chief Executive Officer on August 10, 2016., Prior to that he was an independent director of the Company since 2002; and
- (iii) Mr. Glorikian was co-founder of Scientia Advisors and continued with the company when it was purchased by Precision for Medicine in 2013. He has been an independent consultant since 2014.
1. Officers
The members of our Board confirm the Company's officers at the Board meeting that follows the Company's annual meeting of shareholders. As such, the officers hold their offices until they resign or successors are appointed.
The name and principal occupation of each officer and the year in which he or she first became an officer of the Company are provided in the following table:
| Name and place of residence |
Officer Since |
Principal occupation |
Number of common shares held directly or indirectly |
|---|---|---|---|
| James R. Howard-Tripp(i) Ontario, Canada |
2013 | Chairman and Chief Executive Officer and Director, StageZero Life Sciences Limited |
232,759 |
During the past five years the above-mentioned officers have held the principal occupations shown above except as follows:
(i) Mr. Howard-Tripp was appointed Executive Chairman in July 2013 and Chief Executive Officer on August 10, 2016. Prior to that he was an independent director of the Company since 2002 and President and Chief Executive Officer and a director of Labopharm Inc. until March 14, 2011.
8. LEGAL PROCEEDINGS
On March 4, 2016, the Company announced that it had entered into a Unit Purchase Agreement (the "Purchasing Agreement") with Cobalt pursuant to which GeneNews' wholly-owned subsidiary, GeneNews (USA), Inc., acquired Cobalt's fifty percent (50%) ownership interest in IDL. Under terms of the Purchasing Agreement, GeneNews assumed Cobalt's \$1 million Secured Demand Promissory Note (the "Note") payable to former IDL partner, HDL. No other consideration was to be paid. At the same time, GeneNews (USA), Inc. renegotiated the terms of its note payable and the Note. The revised terms for the total \$2 million notes payable due to HDL were the extended maturity date to May 31, 2017, initial principal payment of \$50,000, interest to accrue at Wall Street Journal Prime Rate plus 4.00% per annum effective April 1, 2016, monthly payments of \$40,000 beginning April 1, 2016, payment of up to \$250,000 if GeneNews (USA), Inc. received financing of more than \$2 million and payment of closing legal fees. In March 2016, GeneNews (USA), Inc. paid the initial principal payment of \$50,000 and \$5,000 in legal fees. On May 4, 2016, GeneNews (USA), Inc. received a notice of default from HDL for missing two monthly payments under the terms of the notes that were renegotiated in March 2016. On August 15, 2016, Richard Arrowsmith, as Liquidating Trustee of the HDL Liquidating Trust (the "Liquidating Trust"), filed a Complaint against GeneNews (USA), Inc. in the United States Bankruptcy Court, Eastern District of Virginia, Richmond Division (the "Bankruptcy Court"). On October 31, 2016, GeneNews (USA), Inc. filed a Motion to Dismiss and requested a hearing on the motion. The parties then entered into negotiations to try and resolve their dispute. On March 1, 2017 the parties reached a settlement agreement pursuant to which GeneNews (USA), Inc. would pay the Liquidating Trust an aggregate settlement amount of \$2,095,843, to be paid in a \$25,000 upfront payment and monthly payments of \$15,000 beginning March 1, 2017 to July 1, 2017, followed by monthly payments of \$10,000 until the outstanding debt has been paid in full. The Bankruptcy Court approved the settlement agreement and, on April 27, 2017, the action against GeneNews (USA), Inc. was dismissed with prejudice by the Bankruptcy Court.
On May 25, 2018 the Trustees for the Estate of HDL filed a claim against IDL for a total of \$178,801 for royalties for tests from May to September, 2015 totaling \$139,925 plus \$38,876 for money that represented a return of deposit from IDL's landlord in the respective period. The claim recognized that IDL had paid a total of \$83,031 against the claimed amount and that the balance was \$95,770. IDL filed a counterclaim for HDL's share of audit fees that it was responsible for prior to May 15, 2015 in the amount of \$139,789. Since then IDL wasrequired to produce numerous documents to the attorneys for the estate.
After significant negotiating, the case was settled for \$58,000, payable \$10,000 on signing the Settlement Agreement and \$2,000 per month for 24 months. No interest accrues to the settlement. The Settlement Agreement stated that no further actions would be taken.
9. INTEREST OF MANAGEMENT AND OTHERS IN MATERIAL TRANSACTIONS
Rory Riggs was the Chairman of the Board for a third-party billing company with whom we worked until 2018 and he has also provided interim debt financing to the Company. Thomas D. Stewart, Jr., who retired from the board of directors in September, 2019, is a co-founder of JTS Health Partners, which partnered with the Company in March 2016 to secure multi-year agreements with hospitals, clinically integrated networks, large physician groups and healthcare organizations for the Company's risk assessment tests to assist healthcare professionals in the early detection of cancer. He and JTS Health Partners have also participated in the Company's share financings and interim debt financings.
During the third quarter of 2016, the Company closed a non-brokered private placement. Of the approximately 9.8 million Units subscribed to, 2.5 million were used to make a partial payment of \$305,344 of the \$400,000 Demand Note issued by the Company in December 2015 to Rory Riggs. In addition, three directors of the Company, namely James Howard-Tripp, Garth MacRae and Thomas D. Stewart, Jr., participated in the Private placement, subscribing for 1,944,000 Units for gross proceeds of Cdn\$311,040, with Cdn\$100,000, in lieu of making a cash payment of amounts owed to one director for past services.
In 2017, the Company entered into additional convertible loan agreements with Rory Riggs for \$200,000 on August 28, \$100,000 on October 20, \$48,000 on December 4 and \$65,000 on December 19 [total of \$413,000] accruing interest at 5% per annum, repayable on demand for various terms. In total, \$303,781 in principal and interest was converted into 3,356,387 common shares. Also in 2017, the Company entered into additional loan agreement with him for \$70,000.
On August 31, 2017, the Company entered into a loan agreement for \$100,000 due and payable in November 30, 2017, accruing interest at 5% per annum, repayable on demand and was converted into 1,020,970 common shares for the total principal and interest on December 18, 2017.
On July 14, 2017, the Company announced the issuance of an aggregate of 2,279,078 common shares to make a payment of \$393,307 owing to participating directors, with the remaining outstanding balance of \$40,000 to be paid in cash. The conversion of payment obligations to common shares was calculated based on the five day volume-weighted average price (the "5 day VWAP") on May 26, 2017 of the common shares on the Toronto Stock Exchange, which was Cdn\$0.23, and the Bank of Canada's foreign exchange conversion rate from US to Canadian dollars at the close of business on May 28, 2017.
On June 29, 2020, \$390,766 of the notes payable was converted to 951,120 common shares. As at December 31, 2020, the convertible notes payable balance is \$228,390 including accrued interest payable. The notes are secured by a security interest in the Company's patents and trademarks.
10. TRANSFER AGENT AND REGISTRAR
Our transfer agent and registrar is TMX Trust Company, which is located at 100 Adelaide Street West, Suite 301, Toronto, Ontario M5H 4H1.
11. MATERIAL CONTRACTS
Other than contracts entered into in the ordinary course of business and those described in the MD&A corresponding to our consolidated financial statements for the year ended December 31, 2020, no material contracts were entered into within the most recently completed financial year,
nor are any entered before the most recently completed financial year. Contracts relating to COVID-19 testing had no minimum set requirements between parties.
12. INTEREST OF EXPERTS
Effective March 7, 2017, the Company accepted the resignation of Ernst & Young LLP and on March 17, 2017, the Company announced that it had retained Marcum, LLP, a leading independent public accounting and advisory services firm in the United States as its auditor. Marcum LLP was the auditor for the years ended December 31, 2016, 2017 and 2018 and wasindependent with respect to the Company within the meaning of the Rules of Professional Conduct of the Chartered Professional Accountants of Ontario. BDO Canada LLP was appointed as the Company's auditors for 2019 and 2020 and is independent with respect to the Company within the meaning of the Rules of Professional Conduct of the Chartered Professional Accountants of Ontario. . Effective December 14, 2020, the company accepted the resignation of BDO Canada LLP and announced that it had retained McGovern Hurley, Chartered Professional Accountants, as its auditor. McGovern Hurley isindependent with respect to the Company within the meaning of the Rules of Professional Conduct of the Chartered Professional Accountants of Ontario.
13. AUDIT COMMITTEE
Multilateral Instrument 52-110 – Audit Committees (including Form 52-110F1 – Audit Committee Information Required in an AIF) requires issuers to disclose certain information in their annual information forms with respect to the existence, charter and composition of an issuer's audit committee; the education and experience of its members; and the fees paid to external auditors. Our audit committee charter is attached as Appendix B to this AIF.
13.1 Composition of Audit Committee
Between January 1, 2016 and June 30, 2016, Garth MacRae and Rory Riggs were the two independent directors comprising our audit committee. Effective June 30, 2016, Thomas D. Stewart was appointed to the audit committee. Our audit committee was then composed of the three independent directors, Garth MacRae, Rory Riggs and Thomas D. Stewart, Jr., each of whom is financially literate. Mr. MacRae is the committee chair and is a chartered professional accountant. Mr. Riggs has substantial business experience related to financial statements and Mr. Stewart is a Certified Public Accountant (CPA) in the state of Georgia. Mr. Stewart resigned from the board of directors in September, 2019.
The education and relevant experience of each member of our audit committee, as at December 31, 2020, is described below.
Garth MacRae – Mr. MacRae is a Chartered Professional Accountant. He received his designation in Manitoba in 1957. He has been a member of the Ontario Institute of Chartered Professional Accountants since 1970. Mr. MacRae has been a director of Dundee Corporation, a merchant bank and financial services company since 1991. In addition, Mr. MacRae is a director of a number of other public and private companies, including emerging companies.
Rory Riggs – Mr. Riggs holds a BA from Middlebury College, Vermont, and an MBA from the Graduate School of Business, Columbia University, New York. Mr. Riggs is the past President of Biomatrix, Inc., a NYSE-listed company, which successfully developed and marketed Synvisc®, a leading product for treating osteoarthritis in the United States. Prior to working at Biomatrix, Mr. Riggs was Chief Executive Officer of RF&P Corporation, and he was also a Managing Director of PaineWebber Inc.
13.2 External auditor service fees
Effective May 15, 2019, the Company accepted the resignation of Marcum, LLP and on same day, the Company announced that it had retained BDO Canada LLP, a leading independent public accounting and advisory services from in Canada as its auditors for the year ended December 31, 2019. Effective December 14, 2020, the company accepted the resignation of BDO Canada LLP and announced that it had retained McGovern Hurley as its auditor. McGovern Hurley is independent with respect to the Company within the meaning of the Rules of Professional Conduct of the Chartered Professional Accountants of Ontario.
The following table identifies the proposed fees for the 2020 and 2019 engagements.
| Fees | Year ended December 31, 2020 |
Year ended December 31, 2019 |
|---|---|---|
| fees1 Audit |
245,000 | 217,300 |
| fees2 Audit-related |
Nil | Nil |
| fees3 Tax |
Nil | Nil |
| All other fees |
Nil | Nil |
| Total: | 245,000 | 217,300 |
Notes:
- 1 Refers to the aggregate fees estimated (2020) and billed (2019) for audit services.
- 2 Refers to the aggregate fees billed for assurance and related services that are reasonably related to the performance of the audit and are not reported under (1) above,
- 3 Refers to the aggregate fees estimated for filing the Corporation's tax returns and related tax advice.
The Audit Committee has adopted specific policies and procedures for the engagement of non-audit services as described in its mandate and reviews the engagement of non-audit services as required.
14. ADDITIONAL INFORMATION
Additional information relating to StageZero, including our consolidated financial statements and MD&A for the year ended December 31, 2020, may be found on SEDAR at www.sedar.com as well as on our website at www.stagezerolifesciences.com.
Additional information, including directors' and officers' remuneration and indebtedness, principal holders of our securities and securities authorized for issuance under the Company's stock option plan and securities authorized for issuance under equity compensation plans, if applicable, is contained in our management information circular prepared in connection with the Company's most recent annual meeting of shareholders.
15. CAUTIONARY STATEMENTS
This document contains certain forward-looking-statements identified by words such as "believe", "anticipate", "estimate", "expect", "intend", "may", "will", "would" or negative versions thereof and similar expressions, 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. We cannot guarantee the outcome of plans, intentions or expectations disclosed in our forward-looking statements and the reader 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. Tthey 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 document 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 of our laboratory in Richmond, Virginia and our ability to support the commercialization of our product and our 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 any 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, knowhow 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 AIF, 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 casts significant doubt about the Company's ability to continue as a going concern. We have not offered formal guidance on future revenue projections from sales of our test services.
APPENDIX A – GLOSSARY
The text following the technical terms in the following table is explanatory only and does not in any way alter the meanings of such terms.
| accountable care organization (ACO): |
An accountable care organization (ACO) is a healthcare organization characterized by a payment and care delivery model that seeks to tie provider reimbursements to quality metrics and reductions in the total cost of care for an assigned population of patients. A group of coordinated health care providers forms an ACO, which then provides care to a group of patients. The ACO may use a range of payment models (capitation, fee-for service with asymmetric or symmetric shared savings, etc.). The ACO is accountable to the patients and the third-party payer for the quality, appropriateness and efficiency of the health care provided. According to the Centers for Medicare and Medicaid Services (CMS), an ACO is "an organization of health care providers that agrees to be accountable for the quality, cost, and overall care of Medicare beneficiaries who are enrolled in the traditional fee-for-service program who are assigned to it." |
|---|---|
| Clinical Laboratory Improvements Act of 1988, as amended (CLIA): |
These are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. |
| Centres for Medicare and Medicaid (CMS) |
This is a federal agency within the United States Department of Health and Human Services (DHHS) that administers the Medicare program and works in partnership with state governments to administer Medicaid, |
| Colonoscopy: | Colonoscopy is the endoscopic examination of the colon and the distal part of the small bowel with a fiber optic camera on a flexible tube passed through the anus. It may provide a visual diagnosis (e.g. ulceration, polyps), and it grants the opportunity for biopsy or removal of suspected lesions. |
| colorectal cancer (CRC): |
This condition is also called colon cancer or bowel cancer and includes cancerous growths in the colon, rectum and appendix. |
| Coinsurance: | Coinsurance is a form of medical cost sharing in a health insurance plan that requires an insured person to pay a stated percentage of medical expenses after the deductible amount, if any, has been paid. Once any deductible amount and coinsurance are paid, the insurer is responsible for the rest of the reimbursement for covered benefits up to allowed charges; the individual could also be responsible for any charges in excess of what the insurer determines to be "usual, customary, and reasonable." Coinsurance rates may differ if services are received from an approved provider (i.e., a provider with whom the insurer has a contract or an agreement specifying payment levels and other contract requirements) or if received by providers not on the approved list. In addition to overall coinsurance rates, rates may also differ for different types of services. |
| Co-pay: | A co-pay is a form of medical cost sharing in a health insurance plan that requires an insured person to pay a fixed dollar amount when a medical service is received, regardless of the total charge for service. The insurer is responsible for the rest of the reimbursement. There may be separate co-pays for different services. For example, an enrollee may pay a \$20 co-pay for each doctor's office visit, \$100 for each day in the hospital, and \$10 for each prescription. Some plans require that a deductible first be met for some specific services before a co-pay applies. |
|---|---|
| Deductible: | A deductible is a fixed dollar amount during the benefit period, usually a year, which an insured person pays before the insurer starts to make payments for covered medical services. Plans may have both per individual and family deductibles. Some plans may have separate deductibles for specific services. Deductibles may differ if services are received from an approved provider or if received from providers not on the approved list. |
| Diagnosis: | Diagnosis is the identification of the nature and cause of anything. Diagnosis is used in many different disciplines with variations in the use of logics, analytics, and experience to determine the cause and effect relationships. |
| Deoxyribonucleic acid (DNA): |
DNA is a chemical that contains the genetic instructions used in the development and functioning of living cells (with the exception of RNA viruses). |
| Fecal occult blood test (FOBT): |
An FOBT checks for blood that concealed (occult) in stool (feces). |
| Malaysian ringgit (MYR): |
Currency of Malaysia |
| The Healthcare Effectiveness Data and Information Set (HEDIS): |
The Healthcare Effectiveness Data and Information Set (HEDIS) is a tool used by more than 90 %of America's health plans to measure performance on important dimensions of care and service. HEDIS consists of 71 measures across 8 domains of care. |
| Prostate specific antigen (PSA): |
Prostate-specific antigen is a protein produced by the cells of the prostate gland. PSA is present in small quantities in the serum of men with healthy prostates, but is often elevated in the presence of prostate cancer and in other prostate disorders. Rising levels of PSA over time are associated with both localized and metastatic prostate cancer. |
| quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR): |
In molecular biology, this is a laboratory technique based on the polymerase chain reaction (PCR), which is used to amplify and simultaneously quantify a targeted DNA molecule. It enables both detection and quantification (as absolute number of copies or relative amount when normalized to DNA input or additional normalizing genes) of one or more specific sequences in a DNA sample. The procedure follows the general principle of PCR; its key feature is that the amplified DNA is detected as the reaction progresses in real time, a new approach compared to standard PCR, where the product of the reaction is detected at its end. Two common methods for detection of products in real-time PCR are: (1) non-specific fluorescent dyes that intercalate with any double stranded DNA, and (2) sequence-specific DNA probes consisting of oligonucleotides that are labeled with a fluorescent reporter which permits detection only after hybridization of the probe with its complementary DNA target. Frequently, real-time PCR is combined with reverse transcription to quantify messenger RNA and non-coding RNA in cells or tissues. |
|---|---|
| The Physician Quality Reporting System (PQRS): |
The Physician Quality Reporting System (PQRS) is a quality reporting program that encourages individual eligible professionals (EPs) and group practices to report information on the quality of care to Medicare. PQRS gives participating EPs and group practices the opportunity to assess the quality of care they provide to their patients, helping to ensure that patients get the right care at the right time. By reporting on PQRS quality measures, individual EPs and group practices can also quantify how often they are meeting a particular quality metric. Beginning in 2015, the program will apply a negative payment adjustment to individual EPs and PQRS group practices who did not satisfactorily report data on quality measures for Medicare Part B Physician Fee Schedule (MPFS) covered professional services in 2013. Those who report satisfactorily for the 2015 program year will avoid the 2017 PQRS negative payment adjustment. PQRS was formerly known as the Physician Quality Reporting Initiative (PQRI). |
| Ribonucleic acid (RNA): |
RNA is one of the three major macromolecules (along with DNA and proteins) found in living cells Like DNA, RNA is made up of a long chain of components called nucleotides. RNA is associated with protein production and its sequence is specific for individual functions. |
| Screening: | Cancer screening involves efforts to detect cancer before symptoms appear. This may involve physical examination, blood, feces, saliva or urine test, or medical imaging. |
Medicare Advantage Star Rating System (STAR): For years, policymakers and health insurers have looked for ways to simultaneously reduce federal health care expenditures and ensure better quality care for patients. For both hospital services (Part A) and physician services (Part B), the Centers for Medicare and Medicaid Services (CMS) has implemented multiple programs to track providers' performance on various metrics and adjust payments accordingly—similar to efforts being imposed by private insurers. For Medicare Advantage (MA or Part C), CMS operates the Star Rating System. This system provides a relative quality score to Medicare Advantage Organizations (MAOs) on a 5-star scale based on their plans' performance on selected criteria, and is now used to determine whether or not an MAO will receive bonus payments and/or rebates for their enrollees.
US Preventive Services Task Force (USPSTF):
The US Preventive Services Task Force ("USPSTF") is an independent, volunteer panel of national experts in prevention and evidence-based medicine, and makes recommendations about clinical preventative services such as screenings, counseling services and preventive medications.
APPENDIX B – CHARTER OF THE AUDIT COMMITTEE
The Audit Committee (the "Committee") of StageZero Life Sciences, Ltd. (the "Corporation") is a committee of the Board of Directors which has responsibility to review the financial statements, accounting policies and reporting procedures of the Corporation.
This Charter of the Committee has been established and adopted by the Board of Directors in order to provide appropriate guidance to the Committee members as to their duties. The primary function of the Committee is to oversee the accounting and financial reporting and risk management processes of the Corporation and the audits of the financial statements of the Corporation, including the review and oversight of: the financial reports and other financial information provided by the Corporation to any governmental body or the public, the Corporation's systems of internal controls regarding finance, accounting, and legal and regulatory compliance that management and the Board have established and the Corporation's auditing, accounting and financial reporting processes generally. Consistent with this function, the Committee should encourage continuous improvement of, and should foster adherence to, the Corporation's policies, procedures and practices at all levels.
1. Purpose of the Committee
The Committee's primary duties and responsibilities are to:
- a) Serve as an independent and objective party to monitor the Corporation's financial reporting process and the system of internal controls.
- b) Monitor the independence and performance of the Corporation's external auditors and the internal auditing department (when established).
- c) Provide an open avenue of communication among the independent auditors, financial and senior management, the internal auditing department and the Board of Directors.
2. Composition of the Committee
The Committee shall be comprised of at least three directors, each of whom shall meet the independence and audit committee composition requirements of the Ontario Securities Commission and any exchange upon which securities of the Corporation are traded and any governmental or regulatory body exercising authority over the Corporation (each a "Regulatory Body" and collectively, the "Regulatory Bodies"), as in effect from time to time.
3. Member qualifications
All members of the Committee shall have a working familiarity with basic finance and accounting practices, and at least one member of the Committee shall have accounting or related financial management expertise commensurate with the financial complexity of the Corporation. Committee members may enhance their familiarity with finance and accounting by participating in educational programs conducted by the Corporation or an outside consultant.
The Committee shall have the right:
- (i) to inspect all the books and records of the Corporation and its subsidiaries;
- (ii) to discuss such accounts and records and any matters relating to the financial position of the Corporation with the officers and auditors of the Corporation and its subsidiaries; and
- (iii) to engage advisors, including to commission reports or supplemental information relating thereto. Any member of the Committee may require the auditors to attend any or every meeting of the Committee.
4. Member appointment and removal
Committee members shall be appointed annually by the Corporate Governance Committee and from time to time thereafter to fill vacancies on the Committee. A Committee member may be removed or replaced at any time at the discretion of the Corporate Governance Committee.
5. Responsibilities and duties
To fulfil its responsibilities and duties the Committee shall;
Documents/ reports review
a) Review with representatives of management and representatives of the independent auditors the Corporation's interim quarterly financial statements and the annual audited financial statements prior to their filing, as well as the related press release of the Corporation, and report thereon to the Board of Directors.
b) Satisfy itself, on behalf of the Board of Directors, that the Corporation's quarterly and annual audited financial statements are fairly presented in accordance with generally accepted accounting principles and recommend to the Board of Directors whether the quarterly and annual financial statements should be approved and included in the filings required by the Regulatory Bodies.
c) Satisfy itself, on behalf of the Board of Directors, that the information contained in the Corporation's quarterly financial statements, Annual Report to Shareholders and other financial publications, such as Management's Discussion and Analysis (MD&A), the Annual Information Form (AIF) (and similar documentation required by the Regulatory Bodies) and the information contained in a prospectus or registration statement does not contain any untrue statement of any material fact or omit to state a material fact that is required or necessary to make a statement not misleading, in light of the circumstances under which it was made.
d) Review material financial reports or other financial information of the Corporation submitted to any Regulatory Body or disclosed to the public.
e) Review such matters and questions relating to the financial position of the Corporation and its affiliates or the reporting related thereto as the Board of Directors may from time to time refer to the Committee.
f) Comply with all public disclosure requirements applicable to the Corporation. Submit appropriate reports for annual public disclosure requirements, including annual Management Information Circular.
Independent auditors
a) Recommend to the Board of Directors the appointment, compensation, retention (including the authority not to retain or to terminate) and oversight of any independent auditor engaged by the Corporation for the purpose of preparing or issuing an audit report or related work. The Board of Directors shall then put the selection of independent auditors to the vote of the Corporation's shareholders.
b) Recommend to the Board of Directors the funding necessary for compensation of any independent auditor and advise the Board of Directors of anticipated funding needs of the Committee.
c) Satisfy itself, on behalf of the Board of Directors, that the Corporation's auditors are "independent" of management and that they are ultimately accountable to the Board of Directors and the Committee as representatives of the shareholders, within the meaning given to such term in the rules and pronouncements of the Regulatory Bodies. Obtain from the independent auditors, at least annually, a formal written statement delineating all relationships between the independent auditors and the Corporation.
StageZero Life Sciences, Limited – Annual Information Form64/63 [Expressed in US dollars, unless otherwise noted]
d) Approve in advance any and all audit and non-audit assignments awarded to independent auditors and adopt and implement policies for such pre-approval and review all remuneration paid to independent auditors, including for such additional audit and non-audit services; to the extent necessary, any member of the Committee, acting independently, shall be authorized to approve in advance any and all audit and non-audit assignments awarded to independent auditors.
e) Review the performance and the remuneration of the independent auditors and recommend to the Board of Directors the discharge of the independent auditors when circumstances warrant.
f) Satisfy itself, on behalf of the Board of Directors, that the audit function has been effectively carried out and that any matter which the independent auditors wish to bring to the attention of the Board of Directors has been addressed and that there are no "unresolved differences" with the auditors. Be directly responsible for the resolution of any disagreements between management and the independent auditors regarding financial reporting matters.
Financial reporting processes and risk management
a) Review the audit plan of the independent auditors for the current year, review the integration of the external audit with the internal control program and review advice from the external auditors relating to management and internal controls and the Corporation's responses to the suggestions made therein.
b) Monitor the Corporation's internal accounting controls, informational gathering systems and management reporting on internal controls. In connection with fulfilling this responsibility, the Committee shall receive a report on at least an annual basis from the Corporation's chief executive officer and chief financial officer in connection with the such officers' evaluation of internal control over financial reporting as to (1) all significant deficiencies and material weaknesses in the design and operation of internal control over financial reporting which are reasonably likely to adversely affect the Corporation's ability to record, process, summarize, and report financial information; and (2) any fraud of which they are aware, whether or not material, that involves a member of management or other employees who have a significant role in the Corporation's internal control over financial reporting. The Committee shall direct the actions to be taken and/or make recommendations to the Board of Directors of actions to be taken to the extent such disclosure indicates the finding of any significant deficiencies in internal control over financial reporting or fraud.
c) Review with management and the auditors the relevance and appropriateness of the Corporation's accounting principles and policies and the Corporation's internal control over financial reporting and review and approve all significant changes to such policies.
d) Obtain annually from the independent auditors, in connection with an audit report and prior to the filing of such audit report, a report presenting the adequacy of the internal audit and financial controls, specifically including (1) critical accounting policies and practices to be used, (2) all material alternative treatments of financial information within generally accepted accounting principles that have been discussed with management, the ramifications of the use of these alternatives and the treatment preferred by the independent auditors, and (3) material communications between management and the independent auditor.
e) Satisfy itself, on behalf of the Board of Directors, that the Corporation has implemented appropriate systems of internal control over financial reporting and monitor the annual review and evaluation by management of internal control over financial reporting. The Committee shall also satisfy itself that the Corporation has implemented appropriate systems of internal control over the safeguarding of the Corporation's assets and other "risk management" functions (including the identification of significant risks and the establishment of appropriate procedures to manage those risks and the monitoring of corporate performance in light of applicable risks) affecting the Corporation's assets, management, financial and business operations and the health and safety of its employees and that these are operating effectively; make appropriate recommendations to the Board of Directors in connection with the foregoing.
f) Review and approve the Corporation's Investment and Treasury policies and monitor compliance with such policies.
g) Review and approve all related party transactions for potential conflict of interest situations on an ongoing basis. "Related party transactions" shall refer to transactions required to be disclosed pursuant to applicable securities regulations and stock exchange regulations or policies.
Legal and regulatory compliance
a) The Committee has authority to engage outside advisors as it determines necessary to carry out its duties.
b) Determine funding necessary for ordinary administrative expenses of the Committee and for compensation of any outside advisors to be engaged by the Committee and notify the Corporation of anticipated funding needs of the Committee.
c) Satisfy itself, on behalf of the Board of Directors, that all material statutory deductions have been withheld by the Corporation and remitted to the appropriate authorities.
d) Review, with the Corporation's principal external counsel, legal and regulatory matters that could have a material impact on the Corporation's financial statements.
e) Satisfy itself on behalf of the Board of Directors that all regulatory compliance issues have been identified and addressed and identify those that require further work.
f) Establish procedures for:
(i) the receipt, retention and treatment of complaints received by the Corporation regarding accounting, internal accounting controls, or auditing matters;
(ii) the confidential, anonymous submission by employees of the Corporation of concerns regarding questionable accounting or auditing matters (commonly referred to as the "Whistleblowing Policy"); and
(iii) any other material matter.
g) Cause the CEO to investigate any allegations that any officer or director of the Corporation, or any other person acting under the direction of any such person, took any action to fraudulently influence, coerce, manipulate, or mislead any independent public or certified accountant engaged in the performance of an audit of the financial statements of the Corporation for the purpose of rendering such financial statements materially misleading and, if such allegations prove to be correct, take or recommend to the Board of Directors appropriate disciplinary action. Notwithstanding the foregoing, if the person in question is the CEO, the investigation shall be undertaken by the Committee.
h) Review and recommend to the Board of Directors a Code of Ethics and Business Conduct, as well as a Trading Policy, as well as appropriate amendments to such policies from time to time; and implement and monitor compliance with such policies.
Code of Ethics and Business Conduct
a) the Code of Ethics and Business Conduct (the "Code") at a minimum shall (a) comply with any requirements established by any Regulatory Body or any other applicable statute, rule or regulation that the Committee deems relevant, (b) address conflicts of interest and full and fair disclosure and compliance with laws, (c) encourage reporting of any illegal or unethical behaviour and expressly prohibit retaliation of any kind for any such reports or complaints, (d) provide clear and objective standards for compliance with the Code and a fair process by which to determine violations thereof, and (e) contain an enforcement mechanism.
b) Review and assess the adequacy of the Code on a periodic basis. The Committee shall recommend any modifications to the Code to the Board of Directors for approval.
c) Collaborate with the Corporation's officers and legal counsel to disclose publicly any amendments to the Code required to be disclosed by any Regulatory Body.
d) Direct members of the Corporation's senior management to report any allegations of violations of or non-compliance with the Code to the Committee and to inform employees that such violations should be reported and to make themselves reasonably available to receive complaints of any such violations.
e) Be available to the Board of Directors and members of the Corporation's senior management team to consult with and to resolve reported violations or instances of non-compliance with the Code.
f) Instruct outside legal counsel to report to the Committee any evidence of a material violation of the Code by any officer or director of the Corporation or any other person acting under the direction of any such person or any agent thereof that are not appropriately addressed by the Corporation's CEO or, if the violation is made by the CEO, by the General Counsel.
g) Determine an appropriate response to material violations of or non-compliance with the Code including, at the discretion of the Committee, reporting any material violations of or noncompliance with the Code to any appropriate Regulatory Body.
Budgets
Review and recommend to the Board approval of operational, capital and other budgets proposed by management.
General
Perform any other activities consistent with this Charter, the Corporation's Bylaws and governing law, as the Committee or the Board of Directors deems necessary or appropriate.
6. Operations
- a) The Committee shall meet at least four times annually and as many additional times as required to carry out its duties effectively. Committee meetings shall be held at the call of the Committee Chair, or upon the request of two Committee members, and a majority of members shall constitute a quorum.
- b) The powers of the Committee may be exercised at a meeting at which a quorum is present in person or by telephone or other electronic means or by a resolution signed by all members entitled to vote on that resolution. Each Committee member (including the Chair) is entitled to one vote in Committee proceedings. The Chair does not have a second or casting vote.
- c) The Committee Chair shall develop the agenda for and conduct all meetings of the Committee at which he is present.
- d) Unless the Committee otherwise specifies, the Secretary of the Corporation shall act as secretary of the meetings of the Committee, and minutes shall be kept for each Committee meeting.
- e) In the absence of the Committee Chair, the Committee members shall appoint an Acting Chair.
- f) The Committee may at its discretion invite management to attend and participate in meetings of the Committee.
- g) Any Director is entitled to attend meetings of the Committee.
- h) A copy of the minutes of each meeting of the Committee shall be provided to each Director.
7. Reporting to the Board
StageZero Life Sciences, Limited – Annual Information Form67/63 [Expressed in US dollars, unless otherwise noted]
- a) The deliberations, decisions and recommendations of the Committee shall be reported to the Board in a timely manner.
- b) The Committee shall oversee the preparation and shall approve annually the Committee's report for inclusion in the Corporation's management information circular.
8. Annual evaluation of this Mandate, the Committee and its compliance with this Mandate
Annually, or more frequently at the request of the Secretary of the Corporation as a result of legislative or regulatory changes, the Committee shall:
- a) review and assess the adequacy of this Mandate taking into account all applicable legislative and regulatory requirements as well as any best practice guidelines recommended by regulators or stock exchanges with whom the Corporation has a reporting relationship and, if appropriate, recommend changes to the Mandate to the Board for its approval, except for minor technical amendments to this Mandate, authority for which is delegated to the Secretary of the Corporation, who will report any such amendments to the Board at its next regular meeting;
- b) appraise the Committee's performance including its ability to meet the requirements of this Mandate, in accordance with the evaluation process developed by the Committee and approved by the Board, and provide the results of the performance evaluation to the Board.
9. Miscellaneous
To assist the Committee in discharging its responsibilities, the Committee may conduct any investigation and have access to any officer, employee or agent of the Corporation, including any such officer, employee or agent seconded by the Corporation.
The Committee may, at the expense of the Corporation, retain advisors having particular expertise, and shall be entitled to rely in good faith upon any report of a lawyer, accountant, engineer, appraiser or other person whose profession lends credibility to a statement made by any such person.