StageZero Life Sciences Ltd.

ANNUAL INFORMATION FORM

For the year ended December 31, 2022

March 31, 2023

TABLE OF CONTENTS	TABLE OF CONTENTS
GENERAL INFORMATION ABOUT THIS ANNUAL INFORMATION FORM (“AIF”) .... 5
1.	CORPORATE STRUCTURE ............................................................................... 6
1.1	Name, address, and incorporation ......................................................................... 6
1.2	Inter-corporate relationships ................................................................................... 7
1.3	Corporate History ................................................................................................... 7
1.4	Commercial History ................................................................................................. 8
2.	GENERAL DEVELOPMENT OF THE BUSINESS .............................................. 9
	2022 Highlights (and 2023 subsequent events) ............................................................ 12
3.	DESCRIPTION OF BUSINESS AND PRODUCTS ............................................ 22
3.1	General ................................................................................................................. 22
3.2	Mission and strategy ............................................................................................. 23
	Mission .................................................................................................................. 23
	Strategy ................................................................................................................ 23
3.3	Industry overview and competitive environment .................................................. 25
3.4	Our competitive strengths..................................................................................... 27
3.5	Technology, Services and Products ..................................................................... 28
	The Sentinel Principle®......................................................................................... 28
	Aristotle ................................................................................................................. 29
	Background ........................................................................................................... 29
	Market and Sales .................................................................................................. 30
	Competition and Competitive Strengths ............................................................... 30
	ColonSentry®......................................................................................................... 30
	Background ........................................................................................................... 30
	Market and sales ................................................................................................... 31
	Competition and competitive strengths ................................................................. 32
	Prostate Health Index (“PHI”) Test ....................................................................... 33
	Background ........................................................................................................... 33
	PHI Test Agreement ............................................................................................. 33
	Market and sales ................................................................................................... 34
	Competition and competitive strengths ................................................................. 34
	BreastSentry™ ...................................................................................................... 34
	Background ........................................................................................................... 34
	Competition and competitive strengths ................................................................. 35
	COVID-19 Tests .................................................................................................... 36
	Potential future pipeline development and research ............................................ 36
	Book chapter ......................................................................................................... 36
	Peer-reviewed articles. ......................................................................................... 36
	Clinical Programs .................................................................................................. 37
3.6	Intellectual property .............................................................................................. 39
3.7	Human resources ................................................................................................. 40

3.8	Environment ......................................................................................................... 40
3.9	Regulatory framework .......................................................................................... 40
3.10	Reimbursement framework .................................................................................. 42
3.11	Facilities ................................................................................................................ 42
4.	RISK FACTORS ................................................................................................ 43
4.1	Capital requirements, financing and going concern ............................................. 43
4.2	No record of profit ................................................................................................. 44
4.3	Share price ........................................................................................................... 44
4.4	Dilution .................................................................................................................. 44
4.5	Public markets regulators ..................................................................................... 44
4.6	Other collaborations and strategic partnerships ................................................... 45
4.7	Markets and competition ...................................................................................... 45
4.8	Commercialization ................................................................................................ 46
4.9	Regulatory authorizations ..................................................................................... 48
4.10	Reimbursement .................................................................................................... 49
4.11	Legal claims and regulatory proceedings ............................................................. 49
4.12	Compliance with privacy laws .............................................................................. 50
4.13	Marketing and distribution .................................................................................... 50
4.14	Ability to manage corporate growth, commercial expansion and interruptions of
	operations ............................................................................................................. 50
4.15	Key personnel ....................................................................................................... 51
4.16	Foreign exchange rate risk ................................................................................... 51
4.17	Interest rate risk .................................................................................................... 51
4.18	StageZero Life Sciences Inc. as licensee in the event of bankruptcy of a licensor
	51
4.19	Material weakness in financial controls ................................................................ 52
4.20	Joint venture relationship...................................................................................... 52
4.21	Intellectual property .............................................................................................. 52
4.22	Patent infringement .............................................................................................. 53
4.23	Litigation ............................................................................................................... 53
4.24	Fluctuations in quarterly results ............................................................................ 54
4.25	Current enterprise value assigned by the market ................................................ 54
5.	DESCRIPTION OF CAPITAL STRUCTURE ..................................................... 54
5.1	Common shares ................................................................................................... 54
5.2	Preference shares ................................................................................................ 54
5.3	Special shares ...................................................................................................... 55
5.4	Warrants ............................................................................................................... 55
5.5	Stock options ........................................................................................................ 56
5.6	Dividends .............................................................................................................. 56
6.	MARKET FOR SECURITIES ............................................................................ 57
6.1	Trading prices and volumes ................................................................................ 57
7.	DIRECTORS AND OFFICERS .......................................................................... 57
7.1	Directors ............................................................................................................... 58
7.2	Officers ................................................................................................................. 59
8.	EXTERNAL ADVISORS .................................................................................... 59
9.	LEGAL PROCEEDINGS ................................................................................... 60
10.	INTEREST OF MANAGEMENT AND OTHERS IN MATERIAL TRANSACTIONS
	.......................................................................................................................... 60
11.	TRANSFER AGENT AND REGISTRAR ........................................................... 61
12.	MATERIAL CONTRACTS ................................................................................. 61

13. INTEREST OF EXPERTS ................................................................................. 61
14. AUDIT COMMITTEE ......................................................................................... 62
15. ADDITIONAL INFORMATION ........................................................................... 63
16. CAUTIONARY STATEMENTS .......................................................................... 63
APPENDIX A – GLOSSARY ........................................................................................ 64
APPENDIX B – CHARTER OF THE AUDIT COMMITTEE ........................................... 68
To fulfil its responsibilities and duties the Committee shall;........................................... 69
Documents/ reports review............................................................................................ 69
Independent auditors..................................................................................................... 69
Financial reporting processes and risk management..................................................... 70
Legal and regulatory compliance................................................................................... 71
Budgets......................................................................................................................... 72
General......................................................................................................................... 72

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 Inc. 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.

At the Company’s 2019 Annual General Meeting, shareholders approved an 8:1 consolidation of the Company’s shares. Under the terms of the consolidation, 8 shares previously authorized were consolidated into 1 share. For events reported in this AIF that occurred prior to that date, the number of shares and warrants are quoted at the pre-consolidation amounts.

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, 2021, 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.

StageZero Life Sciences , Limited – Annual Information Form5/63 [Expressed in US dollars, unless otherwise noted]

1. CORPORATE STRUCTURE 1.1 Name, address, and incorporation

StageZero Life Sciences, Ltd. (formerly GeneNews Limited, and prior that ChondroGene Limited and Lewis Brook Resources Ltd. (“Lewis Brook”)) was incorporated on February 20, 1997, pursuant to the Business Corporations Act (Ontario). Prior to January 1, 2015, the current active business of GeneNews Limited 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, possessed all the assets and was 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, Ltd, 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.

StageZero Life Sciences , Limited – Annual Information Form6/63 [Expressed in US dollars, unless otherwise noted]

1.2 Inter-corporate relationships

As of the date of this AIF, the Company’s inter-corporate relationships are shown below:

==> picture [359 x 182] intentionally omitted <==

The above image depicts the current legal entity structure of StageZero Life Sciences, Ltd as of the date of this AIF

On September 2, 2021 the Company completed the acquisition and establishment of Clinics Operations, Ltd., Care Oncology, Inc., SZ Physicians Holdings, Inc and COC Physicians, PC from Health Clinics Limited in an all-share transaction. The acquisition changed the Company’s intercorporate relationships to include new subsidiary companies which can be seen in the image above.

Our common shares have been publicly traded since June 2000 and are currently listed for trading on the TSX under the stock symbol “SZLS”. In July 2021 they began trading on the OTCQB under the stock symbol “SZLSF”.

1.3 Corporate History

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) was otherwise inactive.

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

StageZero Life Sciences , Limited – Annual Information Form7/63 [Expressed in US dollars, unless otherwise noted]

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, from 2016 to 2021 inclusive, our investments in Tianjin and GeneNews Diagnostics were valued at $nil, as we had limited to no activity in these companies during the periods presented therein. 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 with closing out these activities, estimated to be up to approximately USD $72,000.

1.4 Commercial History

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. During 2014, StageZero Life Sciences, Inc. added sales of Early CDT[®] -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. offered early cancer risk stratification diagnostics for colorectal, prostate and breast cancers, through several novel, proprietary molecular diagnostic platforms. 2014 was the build out of the lab by the 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. 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., 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. In this, StageZero was part of the solution to finding cancer early and was working with large healthcare groups to expand their reach and to assist them as part of the cost containment process. The Company was also continuing to service our regular base of physicians/practices, as well as actively recruiting new groups.

The IDL joint venture—personalized health management

In 2013, our subsidiary, StageZero Holdings Inc., signed an agreement with two private American companies, HDL and Cobalt, and established IDL (now StageZero Life Sciences Inc.), an accredited clinical laboratory, each holding 33 1/3% ownership. In 2015 the Company and Cobalt acquired HDL’s share, effectively increasing their respective share of ownership from 33⅓% to 50%. Effective March 15, 2016, the Company acquired Cobalt’s 50% share, thereby increasing the Company’s ownership of the laboratory to 100%. Until September 2021, the lab was our only source of revenue. Accordingly, the success of this lab was critical to our business. At initiation, each partner contributed the following expertise to the IDL operation:

StageZero Life Sciences , Limited – Annual Information Form8/63 [Expressed in US dollars, unless otherwise noted]

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 Chairman and Chief Executive Officer 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 cancers to its test services in 2014 and acquired rights to offer breast cancer testing in 2015.

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.

2. GENERAL DEVELOPMENT OF THE BUSINESS 2.1 Three year history

StageZero Life Sciences, Ltd. is a vertically integrated healthcare company dedicated to improving the early detection and management of cancer and other chronic diseases through next-generation diagnostics and unique telehealth programs that provide clinical interventions to assist patients who currently have cancer (COC Protocol - TREAT) as well as help patients reduce the risk of developing late-stage disease (AVRT™).

In the three most recently completed financial years, we have raised a total of new gross financing of $22.4 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):

table (in ‘000s):
	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	860		-		-	-	860
Conversion of structured note payable and conversion liabilities	2,932	677		-		-	-	677
Issuance of common shares with warrant exercise	2,661	1,014		-		-	-	1,014

StageZero Life Sciences , Limited – Annual Information Form9/63 [Expressed in US dollars, unless otherwise noted]

Issuance of common shares with option exercise	238	78	-	-	-	78
Issuance of common shares with public offering	17,516	7,957	-	-	-	7,957
Share issuance costs	-	(1,536)	-	-	-	(1,536)
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	-	-	-	-	128	128
Issuance of convertible notes	-	-	-	-	892	892
Revaluation of convertible notes					1,067	1,067
Conversion of convertible notes upon issuance of common shares	-	-	-	-	(1,141)	(1,141)
Foreign exchange	-	-	-	314	319	633
Balance, December 31, 2020	60,716	89,333	24,103	3,357	2,971	95,661
	Share capital		Warrants		Debt
	Number	Amount	Number	Amount	Financing	Total
	#	$	#	$	$	$
in thousands of dollars (except per
share amounts)
Balance, January 1, 2021	60,716	89,333	24,103	3,357	2,971	95,661
Issuance of common shares with acquisition	15,000	4,993	-	-	-	4,993
Conversion of convertible note payable	3,202	2,131	-	-	-	2,131
Issuance of common shares with warrant exercise	2,182	2,224	-	-	-	2,224
Issuance of common shares with option exercise	258	243	-	-	-	243
Issuance of common shares with private placement	9,375	1,865	-	-	-	1,865
Share issuance costs	-	(268)	-	-	-	(268)
Warrant Exercise during the period	-	-	(2,182)	(740)	-	(740)
Warrant expired during the year	-	-	(2,217)	(217)	-	-
Conversion of convertible notes upon issuance of Warrants	-	-	1,601	1,023	-	1,023
Warrant issued due to private placement	-	-	10,125	1,295	-	1,295
Revaluation of warrants	-	-	-	(2,355)	-	(2,355)
Imputed interest	-	-	-	-	125	125
Payment of principle	-	-	-	-	(120)	(149)
Revaluation of convertible notes	-	-	-	-	1,118	1,118
Conversion of convertible notes upon issuance of common shares	-	-	-	-	(3,173)	(3,173)
Foreign exchange	-	-	-	(3)	(25)	(28)
Balance, December 31, 2021	90,733	100,521	31,430	2,360	896	103,965

StageZero Life Sciences , Limited – Annual Information Form10/63 [Expressed in US dollars, unless otherwise noted]

	Share capital		Warrants		Debt
	Number	Amount	Number	Amount	Financing	Total
	#	$	#	$	$	$
in thousands of dollars (except per
share amounts)
Balance, January 1, 2022	90,733	100,521	31,430	2,360	896	103,777
Issuance of common shares in capital commitment	4,731	206				206
Issuance of common shares with private placement	10,000	798				798
Share issuance costs		(133)				(133)
Warrants extension in February, 2022				180
Warrant issued due to private placement			10,800	783		783
Warrant issued due to convertible debenture issuance			1,609	53		53
Warrants issued in capital commitment			4,731	137		137
Warrant expired during the year			(214)	(0.1)		(0.1)
Revaluation of warrants				(2,719)		(2,719)
Imputed interest					129	129
Payment of principle					(40)	(40)
Short-term loan					230	230
Issuance of convertible notes					137	137
Revaluation of convertible notes					32	32
Balance, December 31, 2021	105,464	101,392	48,356	794	1,384	103,391

StageZero Life Sciences , Limited – Annual Information Form11/63 [Expressed in US dollars, unless otherwise noted]

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
2022	$		$		$		$		$
Revenue		676		799		998		1,321	3,794
Net (loss) income		(9,498)		(45)		(1,282)		(590)	(11,415)
Basic loss per common share		(0.09)		(0.00)		(0.01)		(0.01)	(0.11)
2021		$		$		$		$	$
Revenue		2,477		405		684		1,502	5,068
Net (loss) income		(7,296)		4,330		(2,222)		(2,295)	(7,483)
Basic loss per common share		(0.12)		0.07		(0.03)		(0.03)	(0.11)
2020		$		$		$		$	$
Revenue		31		63		1,464		2,594	4,152
Net (loss) income		(2,436)		(274)		(2,632)		(1,522)	(6,864)
Basic loss per common share		(0.08)		(0.01)		(0.05)		(0.02)	(0.15)

Consolidated revenue for the year ended December 31, 2022 was $3,795,076 reflecting the sales of consulting services and tests. The revenue for the same period in 2021 was $5,068156 while the revenue for the same period in 2020 was $4,151,810 .

2022 Highlights (and 2023 subsequent events)

The year 2022 continued the transformation process that began in 2021. The launch of its flagship product Aristotle and the successful acquisition and integration of Care Oncology Clinics, positions the company to offer clients with solutions that can potentially improve cancer and other chronic disease outcomes through early detection and intervention.

The Company is now situated at the nexus of three of the fastest growing and most exciting sectors in healthcare: liquid biopsy, telehealth and early detection.

2023 Highlights

January 12, 2023 StageZero Life Sciences Announces Extension of Warrants Expiring in January 2023

February 2, 2023 StageZero Life Sciences Announces Change of Date of Special Meeting of Shareholders; Will Combine with AGM in Q2 2023

February 15, 2023 Results from METRICs Study Informs Expansion of StageZero's New Care Oncology Protocol

StageZero Life Sciences , Limited – Annual Information Form12/63 [Expressed in US dollars, unless otherwise noted]

2022 Highlights

February 2, 2022 StageZero Life Sciences Announces Warrant Extension

February 28, 2022 StageZero Life Sciences Announces CAD$1.87 Million Private Placement with Institutional Investor

March 3, 2022 StageZero Life Sciences Announces Closing of CAD$1.87 Million Private Placement with Institutional Investor

March 14, 2022 StageZero Life Sciences Announces Availability of COC Protocol in Europe

March 29, 2022 StageZero to Issue Q4 2022 Financial Results and Hold Conference Call on Friday April 1

March 31, 2022 StageZero Life Sciences Launches AVRT(TM) in the UK

April 1, 2022 StageZero Life Sciences, Ltd Announces Q4 2021 and Year End Financial Results and Operational Update

April 6, 2022 StageZero Life Sciences, Ltd Announces Corporate Update

May 13, 2022 StageZero to Issue Q1 2022 Financial Results and Hold Conference Call on Tuesday May 17

May 15, 2022 StageZero Life Sciences Launches COC Plus Worldwide

May 17, 2022 StageZero Life Sciences, Ltd Announces Q1 2022 Financial Results and Operational Update

May 25, 2022 StageZero Life Sciences Partners with DiagnoseAtHome to Offer Aristotle(R) Multi-Cancer Blood Test in Canada and USA

May 26, 2022 StageZero Life Sciences Announces Resignation of CFO

June 28, 2022 StageZero Life Sciences Announces Results on Resolutions at Annual and Special Meeting

August 12, 2022 StageZero to Hold Q2 2022 Operational and Financial Results Conference Call on Tuesday August 16, 2022

August 16, 2022 StageZero Life Sciences, Ltd Announces Q2 2022 Financial Results and Operational Update

August 18, 2022 StageZero Announces Solutions for Employers to Help Improve Cancer Outcomes

August 18, 2022 StageZero Life Sciences Announces Closing of Convertible Debenture Financing

November 11, 2022 StageZero to Hold Q3 2022 Operational and Financial Results Conference Call on Tuesday November 15, 2022

StageZero Life Sciences , Limited – Annual Information Form13/63 [Expressed in US dollars, unless otherwise noted]

November 15, 2022 StageZero Life Sciences, Ltd Announces Q3 2022 Financial Results and Operational Update

November 21, 2022 StageZero Life Sciences Ltd. Secures CAD $25 Million Capital Commitment from GEM Global Yield LLC SCS

2021 Highlights

The Company created multiple revenue channels, multiple program offerings and stress tested its processes and capabilities via agreements with large consumer companies while providing COVID testing between the US and Canada. COVID-19 and the demand for timely testing built our capabilities and helped to fuel our growth.

January 5, 2021 Keynotes, Educational Panels and 42 Canadian-Listed Public Companies to Present at the SNN Network Canada Virtual Event on January 6-7, 2021

January 6, 2021 StageZero Life Sciences to Present at the SNN Network Canada Virtual Event on Thursday, January 7, 2021

March 31, 2021 StageZero Announces 2020 Year End Analyst and Investor Call

April 1, 2021 StageZero Life Sciences Announces Signed Letter of Intent for the Acquisition of Health Clinics Limited

April 1, 2021 StageZero Life Sciences Announces Q4 2020 and Year End Financial Results and Operational Update

April 5, 2021 StageZero Life Sciences Introduces Aristotle, The First Multi-Cancer Test From A Single Sample of Blood

April 19, 2021 StageZero Life Sciences to Present at the Planet MicroCap Showcase: VIRTUAL on Thursday April 22, 2021

May 5, 2021 StageZero Life Sciences to Offer COVID-19 Saliva Test Kits Throughout Canada

May 11, 2021 StageZero Life Sciences Announces Rexall as Retailer for COVID-19 Saliva Test Kits Throughout Canada

May 12, 2021 StageZero to Issue Q1 2021 Financial Results and Hold Conference Call on Monday, May 17

May 17, 2021 StageZero Life Sciences Announces Q1 2021 Financial Results and Operational Update

June 2, 2021 StageZero Life Sciences Offers Drive-Up, COVID-19 PCR Travel Testing with Results Reported the Same Day

June 29, 2021 StageZero Life Sciences' Annual and Special Meeting Update Presentation Will Be Available Post Meeting

June 30, 2021 StageZero Life Sciences Announces Results of Annual and Special Meeting

July 12, 2021 StageZero Life Sciences Announces New Ticker Symbol for OTC Markets

July 29, 2021 StageZero Life Sciences Provides Update on Planned Acquisition of Health Clinics Limited

August 3, 2021 StageZero Life Sciences Appoints Matthew J. Pietras as CFO and COO

StageZero Life Sciences , Limited – Annual Information Form14/63 [Expressed in US dollars, unless otherwise noted]

August 5, 2021 StageZero Life Sciences Announces Extension of Warrants

August 11, 2021 StageZero to Issue Q2 2021 Financial Results and Hold Conference Call on Tuesday, August 17

August 16, 2021 StageZero Life Sciences Signs Definitive Agreement with Health Clinics Limited

August 17, 2021 StageZero Life Sciences Announces Q2 2021 Financial Results and Operational Update

September 2, 2021 StageZero Life Sciences Completes Acquisition of the Health Clinics Business

September 27, 2021 StageZero Life Sciences Announces Commencement of Trading on the OTCQB

October 7, 2021 StageZero Life Sciences Establishes On-Site Clinic for its Next-Generation Multi-Cancer Blood Test Aristotle(TM) in Richmond, Virginia

November 9, 2021 StageZero Life Sciences Corporate Update

November 9, 2021 StageZero to Issue Q3 2021 Financial Results and Hold Conference Call on Tuesday, November 16

November 11, 2021 StageZero Life Sciences and Teen Cancer America Join Forces to Help Improve Outcomes for Adolescents and Young Adults with Cancer

November 16, 2021 StageZero Life Sciences Announces Q3 2021 Financial Results

November 19, 2021 StageZero Life Sciences Introduces BORDERPASS(TM) COVID-19 PCR Testing for Travelers

November 22, 2021 StageZero Life Sciences ARISTOTLE(R) Multi-Cancer Blood Test Now Available in Greater Toronto Area

November 23, 2021 StageZero Life Sciences Announces CAD$4.2 Million Private Placement with Institutional Investors

November 24, 2021 InvestmentPitch Media Video Discusses StageZero Life Sciences, a Vertically Integrated Healthcare Company Offering Its Multi-Cancer Blood Test ARISTOTLE(R) to Residents of the Greater Toronto Area - Video Available on Investmentpitch.com

November 26, 2021 StageZero Life Sciences Announces Closing of CAD$4.2 Million Private Placement with Institutional Investors

December 6, 2021 StageZero Life Sciences Offers BORDERPASS(TM) COVID-19 PCR Test Kits for Travelers

December 10, 2021 StageZero Life Sciences, Ltd Announces Results of Special Meeting

December 10, 2021 StageZero Life Sciences, Ltd Announces Appointment of SRCO as Auditors

December 13, 2021 StageZero Life Sciences Named a COVID-19 Travel Testing Partner for Aruba

December 14, 2021 StageZero Life Sciences Announces Formation of Scientific Advisory Board

StageZero Life Sciences , Limited – Annual Information Form15/63 [Expressed in US dollars, unless otherwise noted]

2020 Highlights

January 3, 2020—Announced conversion of December 2016 Convertible Debentures that matured on December 23, 2019. CAD$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 CAD$674,409.

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 tobe 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 CAD$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.

StageZero Life Sciences , Limited – Annual Information Form16/63 [Expressed in US dollars, unless otherwise noted]

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 of CAD $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 SARSCoV-2 Virus.

October 19, 2020 – Announced a $5 Million Overnight Marketed Public Offering. Clarus Securities and Echelon Wealth Partners lead the offering.

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 CAD7.2 million.

December 7, 2020 - Announced the third quarter analyst and investor call. Announced Q3 revenue of $1.5M.

December 31, 2020 - Announced the appointment of new auditors McGovern Hurley and the resignation of BDO.

Financings and Capital Structure

2022 Capital Commitment Agreement in November

On November 21, 2022 the Company announced that it had entered into a capital commitment agreement (the "Agreement") with GEM Global Yield LLC SCS ("GGY") for a CAD $25 million

StageZero Life Sciences , Limited – Annual Information Form17/63 [Expressed in US dollars, unless otherwise noted]

Capital Commitment ("CC"). Draw downs are at the Company's discretion and subject to the following terms.

StageZero has the right, but not the obligation, to draw down under the CC for a term of 3 years. StageZero will issue draw down notices to GGY at the Company's discretion and timing. Common shares will be issued to GGY at a price per share equal to a 10 per cent discount to the market price of the common shares based on the immediately preceding 5-day volume weighted average price at the end of a draw down notice period. Draw-downs are subject to certain market out rights of GGY, GGY's holdings of StageZero's shares not exceeding 10% of StageZero's issued and outstanding shares at the time of the draw-down, and the aggregate number of Common Shares issuable pursuant to the CC, including shares issuable pursuant to the exercise of warrants, not exceeding 25% of StageZero's issued and outstanding common shares. StageZero has covenanted to seek shareholder approval with respect to any issuance of securities that may be issued to GGY exceeding 25% of the Company's issued and outstanding shares. GGY will hold freely trading common shares of the Company, backed up by a share lending facility provided by certain current shareholders with the aforementioned 10% and 25% percentage shareholding limitations.

As part of the Capital Commitment, StageZero will issue up to 13.4 million warrants to GGY, issued one for one against the first 13.4 million shares purchased by GGY under the CC. The warrants have an exercise price of CAD $0.14 per common share (so long as the market price for the common shares at the time of issuance of the warrants is less than CAD $0.14, and at market thereafter) and may be exercised for five years. On the first anniversary of the date of the Agreement, if the market price of StageZero' common shares is less than 90% of the then-current exercise price of the warrants, the exercise price of the warrants will adjust to 105% of the market price of the common shares at that time. The Company will be subject to certain penalties if it does not issue the 13.4 million warrants within 12 months of the initial execution of the Agreement. StageZero will also be required to pay GEM Investments America, LLC a 2% commitment fee equal to CAD $500,000 within twelve months from execution of the Agreement. StageZero may elect to pay the commitment fee in cash or stock. The Agreement has received the approval of the TSX.

Concurrently, with the execution of this Agreement, the parties to this Agreement shall complete a transaction ("Initial Offering") which Initial Offering shall close concurrently with the execution of this Agreement , pursuant to which the Company will draw down $280,000 by issuing Common Shares to the Investor at a price of $0.05918 per Common Share, being an approximate 25% discount to the Market Price, calculated based on the VWAP over the 5 trading days immediately preceding the Initial Offering. The Company will issue one Warrant to the Investor for each Common Share issued in connection with the Initial Offering and each such Warrant shall have an exercise price of $0.14.

2022 Convertible Debenture issuance in August

On August 18, 2022 the Company closed a private placement of units (each a "Unit") for gross proceeds of $177,000. Each Unit was composed of (i) a $1,000 unsecured convertible debenture ("Debenture"), bearing interest at a rate of 8% per annum, having a term of eighteen (18) months from the date of issuance and is convertible into common shares ("Common Shares") of the Company, at a conversion price of $0.11 per Common Share, and (ii) 9090 Common Share purchase warrants (each a "Warrant"). Each Warrant is exercisable into one (1) Common Share of the Company at an exercise price of CAD$0.15 per Common Share for a period of eighteen (18) months from the date of issuance of the Units. Securities issued pursuant to the Offering are subject to a statutory hold period lasting four (4) months and a day after the issuance of the securities. The net proceeds of the Private Placement will be used to accelerate the Company's Global Growth Strategy and further support the commercialization of Aristotle®, AVRT and TREAT.

2022 Unit Private Placement in March

On March 3, 2022 the Company closed its previously announced private placement of its common shares ("Common Shares") and warrants to purchase Common Shares ("Warrants") with an institutional investor for gross proceeds of approximately CAD$1.87 million (the "Private Placement"). Pursuant to the Private Placement, the Company issued 10,000,000 Common Shares and Warrants to purchase up to an aggregate of 10,000,000 Common Shares at a purchase price of

StageZero Life Sciences , Limited – Annual Information Form18/63 [Expressed in US dollars, unless otherwise noted]

CAD$0.187 per Common Share and associated Warrant. Each Warrant will entitle the holder to purchase one Common Share at an exercise price of CAD$0.2206 per Common Share for a period of four years following the issuance date.

2021 Unit Private Placement in November

On November 26, 2021 the Company closed a unit financing via private placement of its common shares ("Common Shares") and warrants to purchase Common Shares ("Warrants") with institutional investors for gross proceeds of approximately CAD$4.2 million (the "Private Placement"). Pursuant to the Private Placement, the Company issued 9,375,002 Common Shares and Warrants to purchase up to an aggregate of 9,375,002 Common Shares at a purchase price of CAD$0.448 per Common Share and associated Warrant. Each Warrant entitles the holder to purchase one Common Share at an exercise price of CAD$0.56 per Common Share for a period of four years following the issuance date.

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.

StageZero Life Sciences , Limited – Annual Information Form19/63 [Expressed in US dollars, unless otherwise noted]

Financings and Capital Structure

StageZero was obligated to issue 8,000,000 common shares to Health Clinics Limited contingent upon the achievement of certain revenue milestones and StageZero shareholder approval. While shareholder approval was received on December 10, 2021, at a special meeting, Health Clinics did not meet the milestones and therefore the obligation expired and Health Clinics did not receive the 8,000,000 common shares.

Note payable to shareholders and director

In 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

In 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.

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 matured 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 was 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 consisted of one common share and one-half of a warrant. Each whole warrant was 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 were only issuable to the holder if the holder choose the conversion option as payment upon demand. The note unit pricing of Cdn$0.095 was at a 5% premium to the market price of Cdn$0.09 at May 10, 2018.

If the notes were outstanding for the full twelve months, each holder was 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 was 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 matured 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 had 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

StageZero Life Sciences , Limited – Annual Information Form20/63 [Expressed in US dollars, unless otherwise noted]

Cdn$0.005 premium, totaling Cdn$0.05818. The number of common shares issuable by the Company upon conversion was calculated as the total accrued balance of principal and interest owing on the date of demand for conversion, converted from USD to Cdn$ 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.

During the year 2022, the Company issued additional demand note agreements with the above director for loans totaling $398,500 to the Company. The Notes were payable on demand with interest $11,392 charged at 8% per annum and were 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. In total, face value Cdn$3,272,619 of First CSFA was converted to common shares to Lind in connection with a Convertible Security Funding Agreement and the balance Cdn$27,381 was used to participate in warrant exercise. As at December 31, 2021, the balance of the CSFA was Nil [2020 - Nil].

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 shares for $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.

StageZero Life Sciences , Limited – Annual Information Form21/63 [Expressed in US dollars, unless otherwise noted]

Warrant Amendments

Warrants Expiration Date Extended

On January 12, 2023, the Company announced an extension to the expiry date of 6,492,420 warrants that were due to expire in January 2023. All of the affected warrants were extended until January 31, 2024. No warrants belonging to insiders were extended.

Warrants Expiration Date Extended

On February 4, 2022, the Company announced an extension to the expiry date of 5,478,845 warrants that were due to expire in 2022. All of the affected warrants were extended until January 31, 2023. No warrants belonging to insiders were extended.

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

On June 7, 2018, the Company issued 13,531,800 warrants to 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 days immediately 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.

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 and expired on August 24, 2021.

3. DESCRIPTION OF BUSINESS AND PRODUCTS

3.1 General

StageZero Life Sciences, Ltd. is a vertically integrated healthcare company whose mission is to improve cancer and chronic disease outcomes through early detection and intervention.

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

Clinical services are offered through our Care Oncology Business Units (UK and US) in the form of physician monitoring and intervention. There are three programs, described in more detail in the Product section below, TREAT,AVRT and COC Plus programs. Care Oncology UK primarily serves clients in the UK and Europe while Care Oncology US primarily serves clients in the US and Canada

StageZero Life Sciences , Limited – Annual Information Form22/63 [Expressed in US dollars, unless otherwise noted]

Laboratory diagnostic/detection test panels offered through the StageZero Life Sciences Business Unit are processed at the Company’s clinical laboratory, a CAP accredited and CLIA certified highcomplexity reference laboratory, in Richmond, Virginia. The current menu of tests, described in more detail in the Product section below, include Aristotle, ColonSentry, BreastSentry, phi, and COVID testing. These tests are primarily offered to clients in the US and Canada.

The combination of our mRNA-based multi-cancer test panel, Aristotle, and our innovative telehealth program focused on identifying the early warning signs of cancer and other chronic illnesses, AVRT, provides patients an opportunity to potentially detect the risk of cancer or other chronic illnesses early, thereby potentially reducing the risk of developing late-stage disease and the associated morbidity/mortality.

Further leveraging our telehealth platform, the TREAT program is specifically designed to provide adjuvant therapeutic solutions for patients already diagnosed with cancer whether they are on standard-of-care (SOC) treatments or in remission.

Our other laboratory tests are specifically designed to provide patients with information pertaining to their risk of Colorectal cancer, Breast cancer, Prostate cancer, or COVID infection.

Our full suite of Clinical and Laboratory products, and their corresponding compatibility, are specifically designed to help us achieve our stated mission, to improve cancer and chronic disease outcomes through early detection and intervention.

3.2 Mission and 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.

Mission

Our Mission, the notion that motivates us, and the passion that drives our every day, is: To Improve Cancer and Chronic Disease Outcomes Through Early Detection and Intervention .

Strategy

Achieving our mission requires a strategy and a tactical plan that is fluid and adaptable. Our strategy is designed to evolve as market dynamics, consumer behaviors and social interests change. As a result, we have designed our Global Growth Strategy to take into consideration both near-term tactical initiatives and long-term strategic ambitions.

Our Global Growth Strategy focuses on three distinct principles;

Deepening our capabilities
Broadening our offerings
Expanding our reach

Deepening our capabilities involves investing in research and development for the next generation of Aristotle. The Sentinel Principle, our patented gene signature platform, affords us the opportunity to distinguish the gene signature for a vast array of tumor types, and even the ability to differentiate the different stages of cancer within a particular tumor type. As such, we are investing in our nextgeneration sequencing (NGS) platform to not only detect the presence of additional tumor types, but

StageZero Life Sciences , Limited – Annual Information Form23/63 [Expressed in US dollars, unless otherwise noted]

also to potentially distinguish the stage of cancer, if a signal is detected. In the context of our Care Oncology Clinics, we have developed a strategy to deepen our capabilities by increasing our staff to include additional disciplines, such as nutritionists, physiologists and specialized nurses.

Broadening our offerings in the contest of Aristotle, also has direct reliance on the broad adaptability and applicability of the Sentinel Principle Platform. Just as we have the ability to detect the gene signatures of various tumor types at various stages, due to immunomodulation, so to do we have the ability to potentially detect the indication of other chronic illnesses, such as cardiovascular, metabolic, autoimmune, and neurological conditions. We intend to invest in the research and development of gene signatures among chronic illnesses. Furthermore, as a complement to this growth ambition, we intend to add Care Oncology physicians to our AVRT program to help meet the needs of patients at risk for these other chronic illnesses.

Expanding our reach is all about improving the accessibility of our solutions and the rich value that we can deliver to our patients through technology. We continue to expand our global footprint through product launches in new geographies and methodically building the operational infrastructure necessary to support the regions that we enter. We have also built our IT infrastructure to facilitate machine learning and artificial intelligence. As we build our data repository, integrate datasets and develop algorithms we envision the ability to further optimize and personalize our clinical solutions and laboratory tests. Lastly, we remain very focused on establishing clinical partnerships in strategically important regional centers to facilitate the global deployment of our integrated laboratory and clinical telehealth solutions.

The combination of these three distinct principles in our Global Growth Strategy positions us to achieve our mission and deliver a unique value proposition to consumers and patients, regardless of their medical condition.

There are elements of each of these principles that are considered near-term initiatives and longterm ambitions. We approach every step along our journey as one closer to achieving our long-term strategic ambitions.

Near-term Strategy

Our near-term strategy involves two distinct foundational components upon which the rest of our long-term global growth strategy depends. In the near-term we are focused on initiatives that compel both Commercial Growth and Product Evolution.

We are simultaneously working on several commercial growth initiatives, but none are more important to us than the commercial launch of our AVRT program in the United States and United Kingdom. We have designed and developed this program to meet the needs of consumers who want to take a pro-active interest in understanding their current health risks and through monitoring and consultation - applying an array of behavioral, dietary, supplementation, and therapeutic initiatives to mitigate their personal risks.

As it pertains to our tactical near-term commercial growth initiatives:
We are investing heavily in digital marketing campaigns and on-line advertising to targeted audiences to inform interested consumer about the capabilities and benefits of our products- specifically Aristotle, AVRT, and TREAT.
We continue to build partnerships and strategic alliances with laboratories in key geographies for the deployment of Aristotle in the US and Canada.
Our clinical practice is focused on building relationships with physicians and clinical practices where there is mutual opportunity to benefit our patients through a familiar, local referral network.
Our scientists and physicians are also critical in helping us to build relationships with civic organizations and charities that share our interests in early risk detection and intervention.
- Our Business Development team continues to promote the benefits of early detection and intervention our products offer to large, self-insured employers and municipalities

StageZero Life Sciences , Limited – Annual Information Form24/63 [Expressed in US dollars, unless otherwise noted]

Product Evolution is a critical element of our Global Growth Strategy, and inherently dependent on continuous research and development. In the near-term we are focused on:

Investing in our NGS platform, using the Sentinel Principle to determine the gene signature of additional tumor types, and simultaneously elucidate the distinctive gene signature among the different stages of tumor progression for each tumor type
Expanding upon the various sources of data collected, evaluated and integrated into the algorithms that underly AVRT program and its associated consultation and monitoring.
Further integration of machine learning and artificial intelligence into our clinical and laboratory development programs

3.3 Industry overview and competitive environment

The products of StageZero have the unique distinction of operating in three different sectors of the healthcare industry:

Liquid biopsy
Telehealth
Early detection/diagnosis

Each sector is well established and expected to grow substantially over the next few years. The Liquid biopsy sector has several large market participants including Grail, Freenome, and Foundation Medicine. The market for liquid biopsy is expected to be US$17B market in 2022.

The demand for telehealth solutions has increased dramatically over the last several years, driven in large part by the difficulties in accessing conventional healthcare during the COVID pandemic. As a result of their convenience and economic attributes, telehealth solutions are quickly becoming the preferred alternative to conventional in-person physician consultations. There are several large competitors in the telehealth sector, including Teladoc Health, Doctor on Demand, and MDLive. This sector is expected to grow toUS$475B by 2026.

Arguably, the fastest growing and most competitive among these sectors is the early detection and diagnosis sector. While there are several competitors in this sector presently developing multicancer early detection solutions, commercial competitors in this space often offer specific solutions that have the ability to detect just a singular tumor type. Several large market participants in this sector include Guardant Health, Exact Sciences, and Natera. Demand for early detection/diagnosis products are expected to balloon to US$250B market by 2026.

Its important to note that while each of these sectors have multiple companies operating within them individually, StageZero believes that it is the only company with a vertically integrated offering that is firmly situated in all three of these market sectors simultaneously.

The products that StageZero offers are firmly situated in each of the following market sectors:

Liquid Biopsy

Historically, our core business has been situated in the liquid biopsy sector. Clients were primarily patients, universities, government institutions, and large employers. However, with the acquisition of Care Oncology, and its clinical telehealth solutions, we decided to take advantage of the unique opportunity to shift focus to the direct-to-consumer market in a way that was previously less appealing. Large, self-insured employer groups remain an appealing market opportunity for the commercialization of our Aristotle test, but the potential to meet the unmet medical needs of consumers through our vertically integrated solutions (AVRT and Aristotle) affords us the opportunity to realize the benefit of synergistic solutions that are more relationshipbased, than transactional in nature. Furthermore, meeting the needs of individual consumers with

StageZero Life Sciences , Limited – Annual Information Form25/63 [Expressed in US dollars, unless otherwise noted]

our vertically integrated solutions minimizes our dependency on large transactional relationships involving Aristotle alone.

Early Detection

The early detection sector of healthcare is fast emerging as one of the most appealing in the industry as the healthcare system and consumers become more well aware of the dichotomy of the cost of illness versus the wealth of wellness. Furthermore, as technological advancements and medical discoveries emerge at an ever-accelerating pace the opportunity to identify the symptoms and signatures of specific diseases is improving. One notion among payors and physicians persists; It is always less burdensome to prevent an illness than it is to treat it. (National Prevention Council. National prevention strategy. Washington (DC): U.S. Department of Health and Human Services, Office of the Surgeon General; 2011)

As a result, there are multiple competitors presently in the process of developing early cancer risk detection platforms to improve upon current detection methods. The platforms under development involve a variety of different methods, such as screening for circulating tumor DNA (ctDNA) or DNA methylation patterns from whole blood, among others. Our competitors include large diagnostic, biotechnology, and telehealth companies, universities, and research institutions. Many of these competitors develop, manufacture, market and commercialize products and technologies that may compete with StageZero.

Telehealth Clinics

The COVID pandemic has significantly constrained medical resources and patient access to care. There has been an indisputable, and sustained, disruption to the traditional healthcare model involving in-person medical consultations and diagnostics (colonoscopies, mammograms, prostate exams, physicals, etc.). This has resulted in an increasing number of patients being diagnosed with cancer at a later stage cancer, when treatment options are fewer and less effective, increasing the incidence of cancer mortality. (Source: cancer.org Cancer Facts and Figures 2021).

As a result, patients have sought out an alternative. The demand for telehealth solutions is nearly forty times as much as it was prior to the pandemic (Source: Mckinsey.com Telehealth: A Quartertrillion-dollar post-COVID reality? 2021).

Importantly, our clinical solutions through Care Oncology (TREAT and AVRT) and our liquid biopsy testing solutions are delivered via telehealth and provide for early detection of risk factors associated with cancer and other chronic illnesses. Care Oncology is the clinic business that StageZero Life Sciences acquired in September 2021, through an equity-based transaction with Health Clinics Ltd.

Care Oncology offers three main programs: TREAT,AVRT and COC Plus.

TREAT (COC Protocol) is based on the METRICS Study (NCT02201381) (Agrawal S., Vamadevan P., Maziboku N., Bannister R., Swery R., Wilson S., Edwards S., Front. Pharmacol., 27 June 2019 |https://doi.org/10.3389/fphar.2019.00681). It is a clinically researched protocol that interrogates the interconnected intracellular pathways involved in cancer cell growth, proliferation, apoptosis, and angiogenesis, by focusing on metabolic pathways. TREAT is a clinically researched and personalized therapeutic regimen administered by experienced oncologists and intended for patients diagnosed with cancer of any type or at any stage, as an adjuvant therapy along with conventional cancer treatment.
AVRT involves physician consultation and monitoring to identify the early warning signs of cancer, and where necessary, intervening with therapies. Created by the physicians and scientists who developed the ground- breaking COC Protocol, AVRT uses a similar

StageZero Life Sciences , Limited – Annual Information Form26/63 [Expressed in US dollars, unless otherwise noted]

approach by identifying and targeting the inflammatory and metabolic pathways that may increase the risk of developing cancer and chronic disease. AVRT was launched in the US in late 2021.

COC Plus is a physician led program centered on nutrition and other health interventions to help address a patient's specific cancer and is designed to be used alongside standard of care. Created by the physicians and scientists who developed the groundbreaking COC Protocol, COC Plus is centered on nutrition, supplements and other health interventions specifically designed to impact key blood biomarkers proven to influence cancer prognosis. The specialty lab panel and subsequent interventions developed by our team are not routinely ordered by oncologists or family physicians.

Molecular Diagnostic tests

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 Aristotle test, continue to gain 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 continues to be 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 our lab in Richmond, Virginia is positioned well to take advantage of the projected growth in the molecular diagnostics market despite the presence of competitors. The successful launch of Aristotle and the broad applicability of the Sentinel Principle platform provide a significant commercial advantage, while we continue to develop additional capabilities for Aristotle.

3.4 Our competitive strengths

Our competitive strengths include the following:

The only vertically integrated single-source solution for the early detection of cancer and other chronic illnesses using a proprietary liquid biopsy platform that is fully integrated with clinical consultation/monitoring solutions- all delivered via telehealth.
Pioneers in molecular diagnostics
Proprietary platform technologies protected by multiple patents
Globally diversified team with operations in the United States, Canada and the United Kingdom
Our CAP Accredited and CLIA certified high-complexity national reference laboratory in, Richmond, Virginia
Aristotle, first mRNA-based multicancer test panel using a single sample of blood

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ColonSentry® test, the world’s first blood-based test for determining current risk for colorectal cancer
Clinical telehealth practice through Care Oncology subsidiary; offering multiple programs
• Highly skilled and experienced management team with decades of experience in commercial-stage and R&D-stage Life Sciences companies, both public and private
Multiple compatible and synergistic revenue streams that are relationship-based (as opposed to one-time, or transactional)
A robust Telehealth infrastructure that is positioned to benefit from an evolving paradigm shift in healthcare delivery and consumer demands.
A very sophisticated global network of physicians that have a broadly applicable but unique specialty.
A patented treatment protocol that is safe, well-tolerated, effective, globally accessible and cost efficient

3.5 Technology, Services and Products

Laboratory Testing Products

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 was protected by pioneering foundational patents that have since expired. The science behind the Sentinel Principle[®] led to the development of our first-generation commercialized test, ColonSentry[®] , a blood-based test for assessing an individual’s current risk of colorectal cancer (“CRC”) in patients who have refused other screening methods. Our second-generation flagship product Aristotle is a mRNA-based multi-cancer test panel using a single sample of blood

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.

StageZero, through its Sentinel Principle®, is one of the founders of the Liquid Biopsy principle. The Sentinel Principle is 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, the first-generation product developed using this platform, 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 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

StageZero Life Sciences , Limited – Annual Information Form28/63 [Expressed in US dollars, unless otherwise noted]

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.

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 other disease areas.

Aristotle

Background

The Company’s next generation test, Aristotle®, is the first ever mRNA multi-cancer panel for simultaneously screening for multiple cancers from a single sample of blood with high sensitivity and specificity for each cancer. Aristotle ® is the Company’s flagship test. It is a multi-cancer panel test, that has been validated as a Lab Developed Test (“LDT”).

Aristotle® is built on the Company’s patented technology platform, the Sentinel Principle. This underlying technology has been validated in more than 9,000 patients and used by more than 100,000 patients in North America. The Sentinel Principle®, is based on the concept that all clinical conditions and body states, including those resulting from disease or in response to treatment, generate characteristic gene expression signatures in the blood.

As blood circulates, communication occurs between cells in blood and tissue.
Subtle changes that occur in cells due to injury or disease trigger detectable changes in cell expression.
Profiling these changes generates unique molecular biomarkers that reflect disease activity.
These molecular biomarkers can be used to identify disease-specific signatures.
Gene expression signatures are discrete and specific to each disease state.

One of the strengths of the Sentinel Principle is its flexibility. Applying it to different disease areas enables our scientists to generate specific combinations of biomarkers for numerous applications and medical conditions.

The Science

Blood transcriptome can be used to generate highly discriminative multi-gene panels for disease detection. The transcriptome is the complete set of RNA transcripts present in a cell or tissue at any one time. Although a particular cell or tissue’s DNA, or genome, is essentially unchanging, its transcriptome will vary according to the current physiological status of the cell or tissue. It has been demonstrated that RNA profiles generated from circulating blood can be used to identify patients with a number of conditions, including: lung cancer bladder cancer, colorectal cancer (CRC), osteoarthritis, schizophrenia and bipolar disorder. With Aristotle, we have extended this approach and used single subject transcriptional signatures from a single blood sample to simultaneously assay for the detection of multiple diseases in a heterogenous human population.

StageZero Life Sciences , Limited – Annual Information Form29/63 [Expressed in US dollars, unless otherwise noted]

The peripheral blood interacts with the entire body, has a high rate of turnover and is highly dynamic as a key line of defense against insult and injury. Thus, the blood has the capacity to reflect physiological and pathological changes within the body through associated changes in cellular gene expression. This is an important concept for cancer diagnostics, as cancer can be considered a systemic disease, where tumors acting through the circulatory system can influence processes at distant sites even prior to metastases. These processes may alter gene expression and RNA transcripts within blood cells which in turn results in measurable changes useful for diagnosis, such as has been demonstrated for platelets in cancer patients.

Aristotle® uses mRNA technology to identify the molecular signatures of multiple cancer types and is built on the Company’s patented technology platform, the Sentinel Principle. This underlying technology has been validated in more than 9,000 patients and used by more than 100,000 patients in North America.

What Cancer Signatures Can Aristotle Detect?

Breast Cancer
Ovarian Cancer
Cervical Cancer
Endometrial Cancer
Liver Cancer
Colorectal Cancer
Stomach Cancer
Bladder Cancer
Prostate Cancer

Market and Sales

Aristotle® was commercially launched in 2021

Competition and Competitive Strengths

There are several competitors in the process of developing and commercializing liquid biopsy based early cancer detection tests, specifically Grail, Guardant Health and Exact Sciences. While their ambition is similarly aligned with ours each of them is approaching the solution with different methodologies. Some are isolating circulating tumor DNA (ctDNA) others are evaluating DNA methylation patterns, among other methodologies.

An advantage of Aristotle is that it relies upon the gene expression profiles of circulating white blood cells that have been immunoedited, and these modulations are detectable at the earliest stages of tumorigenesis.

ColonSentry[®]

Background

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

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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.

Market and sales

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 was 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.

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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. 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. 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.

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 was a multi-partner goal to improve colorectal cancer screening rates to 80% in the eligible population by 2018. At that time, less than 60% of the eligible population had been screened. Novel efforts to 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.

StageZero Life Sciences , Limited – Annual Information Form32/63 [Expressed in US dollars, unless otherwise noted]

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. was the first laboratory providing 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 StageZero Life Sciences Inc. 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 required 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.

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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 signed an agreement with the University of Texas MD Anderson Cancer Center (“MD Anderson”) and was pursuing interest from hospital groups and large physician practice groups for this test. The interest underlying this agreement was pursued but nothing of consequence materialized.

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 license 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

StageZero Life Sciences , Limited – Annual Information Form34/63 [Expressed in US dollars, unless otherwise noted]

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.

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 were forecast to be diagnosed in women and approximately 40,920 to 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.

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.

StageZero Life Sciences , Limited – Annual Information Form35/63 [Expressed in US dollars, unless otherwise noted]

COVID-19 Tests

StageZero Life Sciences launched PCR and antibody tests for COVID-19 in response to the pandemic.

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 antiSARS-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

Presently our Research and Development efforts are focused on broadening, deepening and expanding the capabilities of Aristotle. We are in the process of broadening the number of tumortypes that Aristotle can presently detect. Furthermore, we are deepening Aristotle’s ability to distinguish the likely stage of a potentially detected tumor, based on unique characteristics associated with the gene signature. Lastly, we intend to expand Aristotle to detect gene signatures associated with other chronic illnesses in other therapeutic areas, such as cardiovascular, autoimmune, metabolic, neurological, and others.

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

StageZero Life Sciences , Limited – Annual Information Form36/63 [Expressed in US dollars, unless otherwise noted]

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

Clinical Programs

On September 2, 2021, the Company acquired 100% of the shares of Clinics Operations Limited (“COL”), a company incorporated in the United Kingdom (“UK”) and, through the Company’s newly incorporated subsidiaries Care Oncology Inc.(“COI”) and Care Oncology Physicians (“COP”), the operating assets of Health Clinics USA Corp., both from Health Clinics Limited (“HCL”), the ultimate parent of both entities. COI and COL (collectively “CareOncology”) offers telemedicine-based clinical services in the USA and the UK. The clinic business is currently supporting two main offerings: the TREAT program and the AVRT program.

COC Protocol – TREAT

The Care Oncology Clinics offer a supervised treatment regimen (the COC Protocol) for people

StageZero Life Sciences , Limited – Annual Information Form37/63 [Expressed in US dollars, unless otherwise noted]

diagnosed with cancer of any type or stage. Developed by scientists and oncologists, the COC Protocol is intended for adjunctive administration alongside standard-of-care cancer therapy. It is an individualized therapeutic approach which seeks to simultaneously target multiple metabolic cancer pathways. The aim is to restrict cancer cell energy supply and use, which may make it more difficult overall for cancer cells to survive, grow and adapt to changing conditions in the body. As a result, such cells can potentially become more vulnerable to attack from cell-killing therapies such as radiotherapy and chemotherapy. Its patented COC Protocol incorporates a multifaceted approach, supported by peer-reviewed scientific studies, which highlight the potential of certain treatments to target the specific energy requirements of cancer cells, impacting their ability to grow and multiply. The addition of non-cytotoxic agents with well-established safety profiles seeks to impede the prospects of cancer cell survival, especially in a hostile environment, such as during chemotherapy, radiotherapy, immunotherapy, and hormone therapy.

AVRT

AVRT is an innovative doctor-led health program aimed at identifying and managing the fundamental drivers of cancer and other chronic diseases. The program includes a comprehensive online health evaluation; blood tests to measure your inflammation and metabolic function; and a telehealth consultation with a physician. The program is aimed at identifying and managing the fundamental drivers of cancer and other chronic diseases.

The Goals of the AVRT Program are Simple! We strive to enable patients to live as healthily as possible by empowering them to visualize and understand their health in a completely new way. By combining a comprehensive assessment of their past and current health behaviors with the measurement of key parameters in their blood, our expert doctors gain a deep understanding of individual risk factors that may drive the development or progression of chronic diseases including cancer.

The data we collect is translated into actionable insights that form the basis of our personalized recommendations, giving patients the very best chance of living better, for longer.

The initial consult includes:

A comprehensive online health evaluation
Access to advanced blood tests to measure for inflammation and metabolic function*
A telehealth consultation with a physician to review your personalized report and health management strategies.
The next iteration of the program will be an annual subscription model Our annual plan includes:
Ongoing personalized health management strategies designed to enable you to proactively improve your metrics.
Regular health screenings and blood tests to monitor your health under the supervision of experienced doctors.
Access to unlimited messaging and support along with helpful tips and advice to make consistently positive health choices.

The AVRT Program is positioned to address a significant unmet medical need. It is well established that roughly 50% of Cancers are still diagnosed in the late stages (1) and among 40% of the most common cancers it is understood that they are preventable (2). Furthermore, beyond cancer, recent data indicates that 45% of Americans suffer from at least one chronic disease (3)

The Company is committed to detecting cancer and chronic disease early, when they are highly treatable!

References

Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33.

American Institute of Cancer Research (AICR.org) accessed October 28, 2021

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Dempsey A, Chao S, Stamatiou D, et al., Aristotle: A single blood test for pan-cancer screening. Journal of Clinical Oncology. 2020; 38:15_suppl, e15037-e15037

COC Plus is a new physician led program centered on nutrition and other health interventions to help address a patient's specific cancer and is designed to be used alongside standard of care.

Created by the physicians and scientists who developed the groundbreaking COC Protocol, COC Plus is centered on nutrition, supplements and other health interventions specifically designed to impact key blood biomarkers proven to influence cancer prognosis. The specialty lab panel and subsequent interventions developed by our team are not routinely ordered by oncologists or family physicians.

Our COC Plus Program includes:

A lab order for a very specific set of blood tests to assess your metabolic and inflammatory status and guide our recommended interventions.
A comprehensive physician consultation with an experienced metabolic oncologist to map your interventional strategy.
And a Road Map to address any health issues with nutrition, supplements, and other strategies intended to improve health outcomes.
Like the COC protocol, this program is designed to be adjunctive to standard-of-care treatments, not replace them.

3.6 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, 2021, StageZero Life Sciences Inc had 1 issued U.S. patent and Clinics Operations Ltd, had 1 issued U.S. patent and 1 issued patent in Japan.

StageZero’s current patent portfolio is centered around it’s core technology, the Sentinel Principle[®] and it’s application to ColonSentry[®] . The patents under Clinics Operations Ltd pertain to the use of drugs for the treatment of cancer.

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.

StageZero Life Sciences , Limited – Annual Information Form39/63 [Expressed in US dollars, unless otherwise noted]

3.7 Human resources

As at December 31, 2022 we had 40 employees, including full-time, part-time staff and consultants. Neither the Company nor its subsidiaries are 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.

3.8 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.

3.9 Regulatory framework

Our tests, Aristotle ®, and ColonSentry®, provide personalized risk assessments for cancer ; they are offered as a laboratory-developed tests (“LDT”).

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. BreastSentry and Aristotle may be marketed as an LDT. Our laboratory is located in Virginia and offers a broad menu of tests including ColonSentry, BreastSentry, Aristotle, Prostate Health Index (PHI) and various COVID-19 tests. 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.

In Canada, health products and medical devices are regulated by Health Canada under the Food and Drug Act however, Health Canada does not regulate LDTs. Health Canada issues Medical Device Establishment Licenses (MDEL) to importers or distributors of all device classes to permit them to import or distribute a medical devices in Canada. StageZero holds an MDEL (#16778) for the distribution of class I and class IV devices which include COVID-19 saliva collection devices and COVID-19 rapid antigen tests. StageZero must comply with Health Canada and all applicable requirements. MDEL holders must demonstrate to Health Canada that they have met the regulatory requirements and have documented procedures in place, where applicable, related to the medical devices that they import or distribute. Failure to meet these requirements could result in the MDEL being revoked and StageZero being unable to import devices into Canada for specimen collection and/or testing. Changes in government regulations and policies, including regulations and policies of Health Canada that affect the classification, approval, and marketing of diagnostic tests and medical devices may adversely affect the company.

In addition, StageZero must comply with the Personal Information Protection and Electronic Documents Act (PIPEDA). PIPEDA applies to private-sector organizations across Canada that

StageZero Life Sciences , Limited – Annual Information Form40/63 [Expressed in US dollars, unless otherwise noted]

collect, use or disclose personal information in the course of a commercial activity. Organizations covered by PIPEDA must obtain an individual's consent when they collect, use or disclose that individual's personal information. Personal information can only be used for the purposes for which it was collected. If an organization is going to use it for another purpose, they must obtain consent again. Personal information must be protected by appropriate safeguards. All businesses that operate in Canada and handle personal information that crosses provincial or national borders in the course of commercial activities are subject to PIPEDA. Failure to comply with the PIPEDA 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.

In the US our clinic business must adhere to regulations that govern physicians. Physician practices in the United States need to comply with a number of issues, including but not limited to compliance with the regulations on getting paid by Medicare, Medicaid, and commercial payors; current and valid physician licensure in the states patients are seen in; licensure of the affiliated professional corporations; compliance with the Physician Anti-Kickback Regulations and Self-Referral (Stark) Law; compliance with the No Surprises Act which applies to all patients, including insured as well as self-pay and uninsured patients; avoiding Medicare & Medicaid Fraud & Abuse; and establishing a Compliance Action Plan.

In the United Kingdom (UK), Health and Social Care Services are regulated under the Care Quality Commission (CQC). The CQC establishes quality standards for clinical facilities, equipment, personnel, performance, consents, safe care and treatment. Any person (individual, partnership, or organisation) who provides regulated activity in England must be registered with the CQC. Failure to register or remain in good standing with the CQC is an offence. The Care Oncology Clinic, owned by StageZero, provides high quality outpatient treatment in an independent setting, and is registered and in good rating with the CQC. The Care Oncology Clinic complies with all CQC fundamental standards. Failure to comply with CQC requirements may result in suspension, revocation, or limitation of the clinics CQC rating, cancellation, or suspension of the clinics legal ability to treat and provide patient care including key programs such as TREAT and AVRT. 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 CQC that affect the delivery of patient care and patient care programs may adversely affect the company. Failure to comply with the General Data Protection Regulation (“GDPR”) and failure to maintain security of

StageZero Life Sciences , Limited – Annual Information Form41/63 [Expressed in US dollars, unless otherwise noted]

business information or systems or failure to provide adequate cyber security could lead to significant fines, litigation and reputational damage.

3.10 Reimbursement framework

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, Canada and the United Kingdom reimbursement is administered by both public and private commercial payers. Private commercial payers have been receptive to the Company’s submissions of reimbursement claims while we continue to develop a consistent reimbursement strategy.

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. This results in uncertainty as to cash flow associated with each test and/or longer collection time frames as a reimbursement claim is processed.

In 2016, the Company entered into a collaboration agreement with JTS Health Partners, 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 StageZero’s menu of proprietary cancer tests,. JTS was also expected to work to maximize the efficiency and effectiveness of the Company’s revenue cycle management operations. The Agreement had an initial term of five (5) years, but was terminated in 2019 by mutual consent.

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. 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 for newly licensed tests.

3.11 Facilities

Currently, and for the past few years the Company has maintained a mailing address and managed office space in Richmond Hill, Ontario. The space does not serve as everyday office space for any employees.

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 reacquired the space occupied by the sub-tenant on June 1, 2021.

The majority of services are provided via telehealth and the majority of staff work remotely. The Company does lease a clinic space on Harley Street in London, UK for its Care Oncology clinic.

StageZero Life Sciences , Limited – Annual Information Form42/63 [Expressed in US dollars, unless otherwise noted]

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.

4.1 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 diversified our revenue generating capabilities with the acquisition and integration of the Care Oncology Clinics, 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 2021 annual consolidated financial statements contains an "Emphasis of Matter" which includes the following statement:

“We draw your attention to Note 1 to the consolidated financial statements, which indicates that the Company incurred a net loss during the year ended December 31, 2021 and had a working capital deficit and a deficit at December 31, 2021. As stated in Note 1, these events or conditions, along with other matters as set forth in Note 1, indicate that material uncertainties exist that cast significant doubt on the Company’s ability to continue as a going concern. Our opinion is not modified in respect of this matter.”

As a result, our consolidated financial statements for the year ended December 31, 2021contain 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.

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

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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 $9.0 million for the year ended December 31, 2021, $3.1 million for the year ended December 31, 2020 and $4.6 million for the year ended December 31, 2019 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; telehealth and early diagnostics industries (the “Industries”). We may experience large fluctuations in our share price as is common to many public companies in the Industries. 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

StageZero Life Sciences , Limited – Annual Information Form44/63 [Expressed in US dollars, unless otherwise noted]

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 30, 2023.

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 expected that these collaborations would 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 expected their physicians to adopt our test menu on a contracted basis.

The Company entered into license or other agreements in order to sell diagnostic tests developed by third parties that were 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 Industries are 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 Industries are populated with larger and more sophisticated companies whose financial and human resources far outweigh ours. Any one or several of these competitors could announce findings or competitive approaches or

StageZero Life Sciences , Limited – Annual Information Form45/63 [Expressed in US dollars, unless otherwise noted]

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 some 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 inlicense.

The commercial success of Aristotle depends in large part on the success of digital marketing and on-line advertising campaigns, as this product is not qualified for reimbursement. Given the competition for liquid biopsy early detection cancer tests, there is no assurance that Aristotle will achieve material commercial success.

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.

StageZero Life Sciences , Limited – Annual Information Form46/63 [Expressed in US dollars, unless otherwise noted]

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 our tests at adequate levels, the commercial success of our technology would be constrained, and associated US revenues would be significantly limited.

StageZero Life Sciences , Limited – Annual Information Form47/63 [Expressed in US dollars, unless otherwise noted]

4.9 Regulatory authorizations

The industries are 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.

Our clinic businesses are regulated by the CQC in the United Kingdom and HIPPA and State Licensure of Physicians in the United States.

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.

Aristotle ®, 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 is 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 was 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

StageZero Life Sciences , Limited – Annual Information Form48/63 [Expressed in US dollars, unless otherwise noted]

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 patients 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 cost-effective, and reimbursement to patients 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.

StageZero Life Sciences , Limited – Annual Information Form49/63 [Expressed in US dollars, unless otherwise noted]

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, the United Kingdom and Canada 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 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 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 to 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 and clinical consultations, 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.

Since our clinical services are deployed via telehealth platforms, they too are largely dependent on computer and communications software, computer hardware systems and other information technology. Our clinical activities and performance could cease or suffer if our web-servers and telehealth platforms were to fail, or if we were unable to successfully expand their capacity when necessary.

StageZero Life Sciences , Limited – Annual Information Form50/63 [Expressed in US dollars, unless otherwise noted]

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 have 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 continues 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 internal capabilities. 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

The Company operates in the United Kingdom, Canada and the United States and transacts business primarily with US partners and suppliers. During the year ended December 31, 2021, 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 $65,813 [December 31, 2020 – $47,425]. The 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 6%.

The remeasurement of the February 2020 Convertible Debentures (note 8) 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.

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.

StageZero Life Sciences , Limited – Annual Information Form51/63 [Expressed in US dollars, unless otherwise noted]

4.19 Material weakness in financial controls

In connection with the preparation of financial statements for the year ended December 31, 2021, 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 52109 – 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, StageZero Holdings Inc., signed an agreement with two private American companies, HDL and Cobalt, and established IDL (now StageZero Life Sciences Inc.), an accredited clinical laboratory, each holding 33 1/3% ownership. In 2015 the Company and Cobalt acquired HDL’s share, effectively increasing their respective share of ownership from 33⅓% to 50%. Effective March 15, 2016, the Company acquired Cobalt’s 50% share, thereby increasing the Company’s ownership of the laboratory to 100%. Until September 2021, the lab was our only source of revenue. Accordingly, the success of this lab has been, and remains to be, critical to our business.

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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. Since issuance, all but one of the patents have expired. The COC Protocol is protected by a method of use patent that covers the use of drugs for the treatment of cancer, this patent has been issued in the US and Japan.

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

StageZero Life Sciences , Limited – Annual Information Form52/63 [Expressed in US dollars, unless otherwise noted]

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 would 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, and 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

StageZero Life Sciences , Limited – Annual Information Form53/63 [Expressed in US dollars, unless otherwise noted]

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 re-valuation of complex financial instruments and general economic conditions.

4.25 Current enterprise value assigned by the market

During the year ended December 31, 2022, our market capitalization fluctuated between approximately Cdn$6.3 million and Cdn$17.1 million. As at December 31, 2022, the market capitalization had decreased by approximately Cdn$90.0 million from the value at December 31, 2021. 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, 2022 there were common shares issued and outstanding and no preference shares or special shares outstanding. At December 31, 2022, there were 6,865,524 stock options exercisable into common shares on a one-for-one basis and 105,464,644 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.

5.1 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.

StageZero Life Sciences , Limited – Annual Information Form54/63 [Expressed in US dollars, unless otherwise noted]

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, 2022:

	Warrants	Exercisable into common shares	Exercise price	Expiry date
	#	#	Cdn$
Date issued:
25-Mar-19	722,606	722,606	0.72	31-Jan-23
23-Apr-19	319,094	319,094	1.528	31-Jan-23
23-Apr-19	220,797	220,797	0.96	31-Jan-23
23-Apr-19	390,626	390,626	0.8	31-Jan-23
10-Jul-19	1,448,595	1,448,595	1.48	31-Jan-23
24-Jul-19	566,874	566,874	1.48	31-Jan-23
16-Jan-20	765,103	765,103	0.48	16-Jan-23
16-Jan-20	25,000	25,000	0.48	16-Jan-23
19-Feb-20	202,343	202,343	0.56	18-Feb-22
29-Jun-20	951,120	951,120	0.72	29-Jun-23
29-Jun-20	8,234,306	8,234,306	0.72	29-Jun-23
29-Jun-20	8,125	8,125	0.68	29-Jun-23
29-Jun-20	297,645	297,645	0.68	29-Jun-23
8-Jul-20	31,250	31,250	0.56	18-Feb-22
9-Jul-20	78,125	78,125	0.56	18-Feb-22
15-Oct-20	50,782	50,782	0.56	18-Feb-22
15-Oct-20	54,688	54,688	0.56	18-Feb-22
27-Oct-20	15,625	15,625	0.56	18-Feb-22
27-Nov-20	162,728	162,728	1.1	27-Nov-23
4-Dec-20	4,621,856	4,621,856	1.1	4-Dec-23
4-Dec-20	323,530	323,530	1.1	4-Dec-23
25-Jan-21	62,500	62,500	0.56	18-Feb-22
28-Jan-21	273,438	273,438	0.56	18-Feb-22
29-Jan-21	490,625	490,625	0.56	18-Feb-22
29-Jan-21	343,750	343,750	0.56	18-Feb-22
25-Feb-21	23,438	23,438	0.56	18-Feb-22
1-Mar-21	9,375	9,375	0.56	18-Feb-22
9-Mar-21	234,375	234,375	0.56	18-Feb-22

StageZero Life Sciences , Limited – Annual Information Form55/63 [Expressed in US dollars, unless otherwise noted]

25-Mar-21	31,250	31,250	0.56	18-Feb-22
18-Aug-21	62,500	62,500	0.56	18-Feb-22
19-Aug-21	69,653	69,653	0.56	18-Feb-22
26-Nov-21	750,000	750,000	0.56	26-Nov-25
26-Nov-21	9,375,002	9,375,002	0.56	26-Nov-25
2-Mar-22	10,000,000	10,000,000	0.2206	2-Mar-26
2-Mar-22	800,000	800,000	0.2206	2-Mar-26
18-Aug-22	1,608,930	1,608,930	0.15	18-Feb-24
27-Nov-22	4,731,328	4,731,328	0.14	22-Nov-27
	48,356,982	48,356,982

5.5 Stock options

The following is a summary of the status of the Plan as at December 31, 2022 and 2021, and changes during the years then ended:

Year ended			Year ended December 31, 2021
December 31, 2022
Number of options Weighted-average exercise price			Number of options Weighted-average exercise price
# Cdn$			# Cdn$
Outstanding, beginning of year 6,019,899 0.6			5,076,360 0.76
Granted 2,740,000 0.076			1,500,000 0.37
Exercised - -			(258,336) 0.88
Expired or forfeited (1,894,375) 0.059			(298,125) 1.14
Outstanding, end ofyear 6,865,524 0.56			6,019,899 0.56
Exercisable, end ofyear 6,865,524 0.56			5,019,899 0.6

The following table summarizes information about stock options outstanding at December 31, 2022:

						Weighted-
Year	Year of	Range of exercise	Number	Number	Weighted-average	average
issued	expiry	prices per share	outstanding	exercisable	exercise price	remaining
						contractual life
		Cdn$	#	#	Cdn$	years
2022	2027	$0.15	2,740,000	2,740,000	$0.15	4.72
2020	2025	$0.44	1,681,250	1,681,250	$0.44	2.52
2018	2023	$0.64	118,750	118,750	$0.64	0.41
2019	2024	$0.80	1,862,399	1,862,399	$0.80	1.56
2018	2023	$0.88	453,750	453,750	$0.88	0.15
2017	2027	$1.52	9,375	9,375	$1.52	4.41
			6,865,524	6,865,524

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

StageZero Life Sciences , Limited – Annual Information Form56/63 [Expressed in US dollars, unless otherwise noted]

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”. The common shares began trading on the OTCQB on September 23, 2021 under the stock symbol “SZLSF”.

6.1 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, 2022:

Month	High C$	Low C$	Close C$	Volume
January2022	0.32	0.22	0.24	5,742,650
February2022	0.28	0.2	0.215	4,139,587
March 2022	0.215	0.165	0.17	5,850,378
April 2022	0.175	0.085	0.105	20,065,963
May2022	0.13	0.08	0.095	7,593,214
June 2022	0.11	0.075	0.085	2,935,873
July2022	0.09	0.075	0.085	2,102,655
August 2022	0.115	0.08	0.09	3,776,624
September 2022	0.095	0.07	0.08	1,550,335
October 2022	0.085	0.075	0.085	1,648,865
November 2022	0.085	0.065	0.07	2,630,987
December 2022	0.075	0.055	0.065	1,745,255

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

StageZero Life Sciences , Limited – Annual Information Form57/63 [Expressed in US dollars, unless otherwise noted]

(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.

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, 2022 is approximately 2.6% 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, 2021, 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.

StageZero Life Sciences , Limited – Annual Information Form58/63 [Expressed in US dollars, unless otherwise noted]

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.

7.2 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. EXTERNAL ADVISORS

8.1 Scientific Advisory Board

On December 14, 2021 the Company announced the formation of a Scientific Advisory Board.

The members of StageZero's Scientific Advisory Board include:

Barry Boyd, M.D. a practicing medical oncologist and pioneer in the field of integrative cancer care. He is an Assistant Clinical Professor of Medicine at the Yale School of Medicine and Senior Attending Medical Oncologist at the Yale-Smilow Cancer Center. Dr. Boyd founded the Integrative Medicine Program at Greenwich Hospital-Yale Health Systems and is the Founder and President of the Integrative Cancer Care Research Foundation. He is a graduate of Cornell Medical School and completed his medical residency at New York Hospital - Cornell Medical Center and Memorial Sloan Kettering Cancer Center and fellowship in Medical Oncology at New York Hospital - Cornell. He holds an M.S. and a M.Phil. from the Institute of Human Nutrition at Columbia University.

Jason Fung, M.D. a physician, researcher and New York Times best-selling author currently practicing nephrology in Toronto, Canada. Dr. Fung is the co-founder of The Fasting Method which

StageZero Life Sciences , Limited – Annual Information Form59/63 [Expressed in US dollars, unless otherwise noted]

provides education, tools and community needed to successfully implement intermittent fasting. His books, including The Obesity Code, The Complete Guide to Fasting, The Diabetes Code and The Cancer Code have challenged conventional thinking about these diseases and introduced dietary strategies to manage them.

Benjamin Bikman, Ph.D., a scientist and professor at Brigham Young University working to better understand the role of elevated insulin and nutrient metabolism in regulating obesity, diabetes and dementia. Dr. Bikman received his Ph.D. in Bioenergetics and was a postdoctoral fellow with the Duke-National University of Singapore in metabolic disorders.

9. LEGAL PROCEEDINGS

In connection with StageZero Holdings Inc. and Cobalt’s acquisition of HDL’s share of the Richmond, VA laboratory, each of the acquirers became indebted to HDL for $1 million. In 2016, when the Company acquired Cobalt’s 50% share, it also acquired Cobalt’s $1 million indebtedness to HDL, thereby owing HDL $2 million. 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 the Company 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, the Liquidating Trustee of the HDL Liquidating Trust (the “Liquidating Trust”), filed a Complaint against the Company in the United States Bankruptcy Court. After a motion to dismiss was filed by the Company, the parties reached a settlement agreement. The Company was to 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.

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 provided by HDL 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. 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.

10. 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

StageZero Life Sciences , Limited – Annual Information Form60/63 [Expressed in US dollars, unless otherwise noted]

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 with Rory Riggs 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. On October 28, 2020, $50,000 of the notes payable were converted to 156,335 common shares. As at December 31, 2021, the convertible notes payable balance is $238,389 including accrued interest payable, which approximates the fair value. The notes are secured by a security interest in the Company’s patents and trademarks.

11. 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.

12. MATERIAL CONTRACTS

Other than the acquisition-related contracts, those 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, 2021, 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.

13. INTEREST OF EXPERTS

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 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 09, 2021, the company accepted the resignation of McGovern Hurley and announced that it had retained SRCO Chartered Professional Accountants, as its auditor. SRCO is independent with respect to the Company within the meaning of the Rules of Professional Conduct of the Chartered Professional Accountants of Ontario.

StageZero Life Sciences , Limited – Annual Information Form61/63 [Expressed in US dollars, unless otherwise noted]

14. 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.

14.1 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 was 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 ofPaineWebber Inc.

14.2 External auditor service fees

The following table identifies the proposed fees for the 2022 and 2021 engagements.

Fees Audit fees1 Audit-related fees2 Tax fees3 All other fees Total	Year ended December 31, 2022 2021
	290,000 260,000 25,000 51,089 35,000 93,560 24,689 24,627 374,689 429,277

Notes:

1 Refers to the aggregate fees estimated (2021) and billed (2020) 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.

StageZero Life Sciences , Limited – Annual Information Form62/63 [Expressed in US dollars, unless otherwise noted]

15. ADDITIONAL INFORMATION

Additional information relating to StageZero, including our consolidated financial statements and MD&A for the year ended December 31, 2022, 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.

16. 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. They should not be relied upon as representing our estimates as at any subsequent date. We do not assume any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Specifically, this 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.

StageZero Life Sciences , Limited – Annual Information Form63/63 [Expressed in US dollars, unless otherwise noted]

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 An accountable care organization (ACO) is a healthcare organization characterized by organization (ACO): 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-forservice 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 These are United States federal regulatory standards that apply to all clinical laboratory Improvements Act of 1988, testing performed on humans in the United States, except clinical trials and basic as amended (CLIA): research. Centres for Medicare and This is a federal agency within the United States Department of Health and Human Medicaid (CMS) 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.

StageZero Life Sciences , Limited – Annual Information Form64/63 [Expressed in US dollars, unless otherwise noted]

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 An FOBT checks for blood that concealed (occult) in stool (feces). (FOBT):

Malaysian ringgit (MYR): Currency of Malaysia

The Healthcare The Healthcare Effectiveness Data and Information Set (HEDIS) is a tool used by more Effectiveness Data and than 90 %of America's health plans to measure performance on important dimensions Information Set (HEDIS): 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.

StageZero Life Sciences , Limited – Annual Information Form65/63 [Expressed in US dollars, unless otherwise noted]

quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR):

The Physician Quality Reporting System (PQRS):

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 doublestranded 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) 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):

Screening:

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.

Cancer screening involves efforts to detect cancer before symptoms appear. This may involve physical examination, blood, feces, saliva or urine test, or medical imaging.

StageZero Life Sciences , Limited – Annual Information Form66/63 [Expressed in US dollars, unless otherwise noted]

Medicare Advantage Star Rating System (STAR):

US Preventive Services Task Force (USPSTF):

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.

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.

StageZero Life Sciences , Limited – Annual Information Form67/63 [Expressed in US dollars, unless otherwise noted]

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.

StageZero Life Sciences , Limited – Annual Information Form68/63 [Expressed in US dollars, unless otherwise noted]

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

StageZero Life Sciences , Limited – Annual Information Form69/63 [Expressed in US dollars, unless otherwise noted]

least annually, a formal written statement delineating all relationships between the independent auditors and the Corporation.

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

StageZero Life Sciences , Limited – Annual Information Form70/63 [Expressed in US dollars, unless otherwise noted]

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

StageZero Life Sciences , Limited – Annual Information Form71/63 [Expressed in US dollars, unless otherwise noted]

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.

StageZero Life Sciences , Limited – Annual Information Form72/63 [Expressed in US dollars, unless otherwise noted]

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

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.

StageZero Life Sciences , Limited – Annual Information Form73/63 [Expressed in US dollars, unless otherwise noted]

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StageZero Life Sciences Ltd. — Annual Report 2022

44586_rns_2023-03-31_e4cf8bd8-117a-4b39-883a-d0912624a0ee.pdf