SAFE EFFICACIOUS AUTOLOGOUS TREATMENT OF CLI, PAD, … · • Good health and quality of life are key concerns with aging • Poor diet and lifestyle increase prevalence of conditions

SAFE EFFICACIOUS AUTOLOGOUS TREATMENT OF CLI, PAD, ANGINA, ISCHEMIC & DILATED CARDIOMYOPATHY

FEBRUARY 10, 2020 © HEMOSTEMIX INC. ALL RIGHTS RESERVED.

Tech Pioneer‘06

This presentation contains forward looking statements that reflect management’s expectations regarding the future growth and results of operational

performance including but not limited to the scientific, financial, competitive and business prospects of Hemostemix Inc. (“Hemostemix” or the

“Company”). This Presentation contains “forward-looking statements” and “forward-looking information” within the meaning of applicable securities

legislation. Forward-looking information is generally, but not always identified by words such as “may”, “would”, “could”, “will”, “likely”, “expect”,

“anticipate”, “believe”, “intend”, “plan”, “forecast”, “project”, “estimate”, “potential”, “might”, “seek”, “budget”, “outlook”, and other similar expressions. In

addition, forward looking statements include, but are not limited to, the Company’s assessment of and targets for the stem-cell industry, including the

potential opportunities and challenges in the current stem cell industry; matters pertaining to Hemostemix, including its strategy and anticipated and

potential transactions and the characteristics thereof; future acquisition opportunities, partnerships, licensing opportunities and joint ventures and its pro

forma impact to capitalization following the completion of any of the Company's business opportunities; matters pertaining to the Company’s future

research and development initiatives including future clinical trials, management’s estimated timelines regarding the Company’s clinical trials,

regulatory approvals for ACP-01 and NCP-01, and many other projected timelines including regulatory approvals of the Company’s submission(s);

financial modeling matters, including metrics pertaining to anticipated financial and operational performance of operations; and, any matters pertaining

to the potential for commercialization of its technology, sources and extent of necessary funding, manufacturing scalability and future business

outcomes.

Actual results, performance and achievement(s) could differ materially from that expressed in, or implied by, any forward-looking information in this

Presentation and, accordingly, investors should not place undue reliance on any such forward-looking information. Forward-looking information should

not be read as guarantees of future performance or results. Forward-looking information and results could differ materially from general business,

economic, competitive and regulatory risks now and in the future, including that the Company's current phase II clinical trial will be completed within

the timelines and on the terms currently anticipated. As well, results may be inconsistent with general assumptions about the economic environment

and stem cell industry environment, the business operations of Hemostemix including that each business will continue to operate in a manner

consistent with past practice and pursuant to certain industry expectations and current market conditions.

Any forward-looking statements speak only as of the date on which such statement is made and the Company disclaims any intention or obligation to

update or revise any forward-looking information as a result of new information, future events or otherwise, unless required by applicable law. New

factors emerge from time to time and it is not possible for management to predict how such factors impact the Company’s business, or the extent to

which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements.

Forward-looking information contained in this Presentation is based on the Company’s current estimates, expectations and projections, which the

Company believes are reasonable as of the current date. The Company can give no assurance that these estimates, expectations and projections will

prove to be correct. Historical statements should not be taken as a representation that such trends will be replicated in the future. No statement in this

Presentation is intended to be nor may be construed to be an investment recommendation or a profit forecast.

FORWARD-LOOKING INFORMATION

PAT E N T E D AU T O L O G O U S S T E M C E L L T H E R AP Y P L AT F O R M

Hemostemix Inc.

>300 Patients treated.

Abstract results show improvement in

83% of patients tested¹

91 patents cover five patent families

including automated production of

autologous peripheral blood-based

ACP-01 & NCP-01

Ongoing 20 Centre International Phase

II Clinical Trial for Critical Limb

Ischemia

ACP-01: Studied and clinically trialled for the treatment of ischemia-based conditions of:

Critical Limb Ischemia and

Peripheral Arterial Disease

Angina

Dilated Cardiomyopathy

Ischemic Cardiomyopathy

Future potential : Other

Cardiovascular Diseases

¹ Source: Abstract entitled: “Autologous Stem Cell Treatment for CLI Patients with No Revascularization Options: An Update of the Hemostemix ACP-01 Trial With 4.5 Year Followup”

HOW SCALABLE IS OUR PLATFORM? HEMISTEMIX – AT A GLANCE

Patented

• 91 Patents issued worldwide

• Automation of Production Patent

Expandable Platform

• ACP-01 – 5 indications

• NCP-01 - stroke model as an indication

• Machine engineered

Optimized Business Plan

• Lean structure

• Experienced management team

• World class Scientific Advisory Board

Key Partnerships

• License Negotiations Started

• By Indication by Country

Data Driven

• Historical Data >300 patients treated

• 12 Years of treatment History

• Multiple Trials (2) and Investigator led

studies (3) completed

Clinical Trials–Clinical Data

• 20 NA Sites : 56th patient enrollment

• Abstract results show 83% of patients (10 of

12) show improvement

• Futility Analysis to be completed when 42

patients achieve 26 weeks of follow-up.

THE IMPORTANCE OF CELL THERAPY

• Regenerative medicine is the leading

edge for biotech investment

• Unmet need for new less invasive,

less expensive non-surgical

treatments

• Right to try legislation approved in

the USA mirrors EU and SE Asia

autologous conventions of use

• There is a gradual shift away from

drugs toward personalized cell based

therapies

• Aging populations worldwide

• Good health and quality of life are key

concerns with aging

• Poor diet and lifestyle increase

prevalence of conditions of ischemia -

related diseases treatable with ACP-

01.

Disease Trends support need for

new therapies

Strong Government

and Public support

Population and

Lifestyle Factors

• CLI is a major global health

problem - incidence growing with

aging population

• CLI has limited treatment options–

significant amputations and high

cost to society

• Cardiovascular disease (“CVD”) is the

number one cause of deaths in North

America and worldwide causing

approximately 1 in 3 deaths

• Rising healthcare and economic costs-

CVD costs anticipated to double by 2035

in USA

• Type 2 diabetes is a global health

epidemic on the rise resulting in

increasing PAD and CLI diagnosis

ACP-01 DIFFERENTIATORS

Autologous. Proven safety and

efficacy

Blood draw: safer, less invasive

than fat or bone marrow

Global portfolio of 91 patents

Including automated production

Low Patient RisksSelf-donation, means no immune

rejection or disease transmission

High Cell ViabilityFresh cells in ready-to-use syringes,

no cryopreservation required

Simple ProtocolSafe and easy to perform in

outpatient clinic

No Ethical ConcernsStem cells derived

directly from patient

No Reported Safety IssuesNo mobilization drugs

needed to collect cells

ScalableSimple, cost-effective

production process

Non-surgical, enhanced cell therapy treatment for restoring circulation to blood starved tissues and organs

ACP-01 POTENTIAL MARKETSM U L T I P L E C U R R E N T A N D F U T U R E I N D I C AT I O N S P O T E N T I A L

Cardiovascular Disease

In the United States, total

costs of CVD in 2016 was $555B;

it is projected to be $1.1T by 2035

Critical Limb Ischemia

Peripheral Arterial Disease

Angina and CVD

Vascular Dementia

Ischemic Renal Disease

Ischemic Erectile Dysfunction Disease

CLI - Tip of the Iceberg

CLI - Estimated total costs up

to $248B¹ in US.

1Source: The Sage Group2Source: American Heart Association Report: Cardiovascular Disease: A costly Burden for America

WHY ACP-01 FOR CLI? IT SAVES LIMBS

Hope for CLI Patients Facing Amputation

Extract and enrich patient’s

own cell population from

peripheral blood

01Inject patient’s cell population

to form new blood vessels,

saving limb

02

Self-Donor

Uses patient’s own cells,

no immune rejection, no

observed safety issues

Simple

Cell harvest via blood draw

Quick

7 days from draw to

reinjection into patient’s limb

47 Days post ACP-01 Treatment

Befo

reA

fter

CLI WITH ACP-01 IMPROVEMENTS VISUALIZED

PHASE II TRIAL FOR CLI UPDATE

Phase II

Trial well

under wayCRO engagedMinimum 6 month and 12 month

follow-ups

20 sites on-boarded

FDA and Health Canada

approved

56th Patient treatment underway Multicenter in US and Canada

Randomized, placebo-controlled double blind

Phase II clinical trial to confirm the safety and efficacy of ACP-01

US FDA and Health Canada approved trial protocol

PHASE I I CLI TRIAL MILESTONES

A catalyst for future trialsProgression of the CLI Trial has opened the door for other ACP-01 clinical trials

Phase II CLI Trial

Study Completion⁴

Interim Data⁴

Patient Monitoring⁴

First Patient Treatment³

Site & Patient Recruiting⁴

US FDA Approval²

Health Canada Approval¹

CRO engaged

H2 2017 H1 2018 H2 2018 H1 2019 H2 2019 H1 2020 H2 2020

¹Health Canada Phase II Trial continuation approval received in December 2017. ²US FDA Phase II Clinical Trial continuation approval received April 2018.³First patient treatment under continued clinical trial announced May 3. 2018.⁴Anticipated timeline. See Forward-Looking Information.

ACP-01 STUDY AND TRIAL HISTORY

Type of Study Study Location Objective of StudyStudy

Design

Number of

SubjectsPatients Study Status

Pilot Safety/

FeasibilityThailand

To assess the feasibility and safety

of the implantationOpen label 6 Diagnosed CLI Completed

Phase 1b Safety

and EfficacyHungary

To assess safety or ex vivo expanded,

peripheral blood-derived, autologous

angiogenic cell precursors (ACPs)

in no option PAD patients

Open label 20 Diagnosed PAD

Completed

And

Published

Phase II Safety

and Efficacy

Canada and

United States

Time to major

amputation/mortality

Randomized

Double Blind

Placebo

Controlled

95 (Anticipate

Futility Analysis

to be

completed

when 42

patients

complete 26

weeks of

follow-up)

Diagnosed CLI In Progress

Clinical Trial

Safety/

Feasibility

ThailandTo assess the feasibility and safety of

intracoronary injectionOpen label

24 Planned (17

completed)Diagnosed Angina

Completed

And

Published

Safety and

EfficacyThailand

To determine the safety and efficacy of

intracoronary injection of ACPs in

relieving symptoms of angina pectoris

and congestive heart failure in chronic

ischemic heart disease subject with

maximal medical therapy and no option

for revascularization procedures

Open label 106

Diagnosis of severe

ischemic heart

disease with

continued angina

pain or heart failure

symptoms

Completed

Results Available

Safety and

Efficacy

Bangkok Heart

Hospital

INTRAMYOCARDIAL ANGIOGENIC

CELL PERCURSOR INJECTION FOR

CARDIOMYOPATHY, Asian

Cardiovascular & Thoracic Annals, 2008,

Vol. 16, No. 2, p 143 - 148,

Open label 41

Diagnosed Ischemic

Cardiomyopathy or

Dilated

Cardiomyopathy

Completed

And

Published

ACP-01 STUDY AND ABSTRACT RESULTS

ABSTRACT TTLE: AUTOLOGOUS STEM CELL TREATMENT FOR CLI PATIENTS WITH NO

REVASCULARIZATION OPTIONS: AN UPDATE OF THE HEMOSTEMIX ACP-01 TRIAL WITH 4.5 YEAR

FOLLOWUP Jonathan Misskey MD MHPE¹, Lynn Cunada, RN², Kyle Makofka³, Alan Jacobs MSEE. MD

PhD.³, Iris Zhong⁴, Thomas Lindsay MDCM⁴, York N. Hsiang, MB ChB., MHSc., FRCSCS¹ (¹Department of

Surgery, UBC, ²Vancouver Coastal Health, ³Hemostemix Inc, ⁴ Division of Vascular Surgery, Peter Munk

Cardiac Centre, University Health Network and Department of Surgery, University of Toronto)

Results: Twelve patients with CLI and no interventional options were enrolled (10 male, 2 female, mean age

76 years). Prior to treatment with ACP-01 or placebo, 3 patients had ischemic rest pain, 8 patients had

ulceration, and one patient had gangrene. Post treatment, one patient with unremitting rest pain and toe

gangrene required a below knee amputation, and one patient with gangrene of the first to third toes required a

forefoot amputation. Healing of ulcers and resolution of ischemic rest pain occurred in the other 10 (83%)

patients. There were no clinically significant safety issues. Outcomes have been maintained for up to 4.5

years (3.5 years for 2 patients, 3 years for 1 and 1 patient died after ulcer healing secondary to congestive

heart failure at 6 months).

Conclusions: Preliminary long-term results of ACP-01 autologous stem cell treatment in CLI patients with no

revascularization options are encouraging. Enrollment in the study is ongoing at medical centers in Canada

and the US. We recommend Vascular surgeons to discuss this study with their CLI patients who have no

further revascularization options available.

Source: AUTOLOGOUS STEM CELL TREATMENT FOR CLI PATIENTS WITH NO REVASCULARIZATION OPTIONS: AN

UPDATE OF THE HEMOSTEMIX ACP-01 TRIAL WITH 4.5 YEAR FOLLOWUP

ACP-01 STUDY AND ABSTRACT RESULTSSAFETY AND EFFICACY STUDY - Thailand:

Purpose: To assess the safety and efficacy of transcoronary injection of angiogenic cells precursors (ACPs) in

patientswith ischemic cardiomyopathy.

Methods: Between 2005 and 2008, 106 ischemic heart disease patients on maximal medical therapy and nooption for revascularization procedures who underwent transcoronary injection of ACPs at Chaophya hospital,Bangkok, Thailand were enrolled in the study. This study is a report of case series with non-randomized dataand without control cohort. Follow-up of patients were made mostly by patients' own cardiologists at 2, 4, 6 and12 months according to the protocol because majority of patients were from abroad.

Results: Baseline study:

• The mean age of 106 patients was 66 ± 10.6 years.

• Majority of patients had Canadian Cardiovascular Society (CCS) class and New York Heart Association

(NYHA) functional class III- IV. Most patients had poor left ventricular systolic function.

• At 1 year follow-up, there was significant improvement of CCS class from 2.63 ± 0.66 to 1.53 ± 0.76 (N = 39, p<

0.001) while NYHA functional class improved from 2.69± 0.56 to1.64 ± 0.83 (N=32,p< 0.001).

• Post treatment at 2-4 months, patients with poor left ventricular ejection fraction (LVEF ≤40%) at baseline, the LVEF

was increasedfrom34.4%± 16.4%to39.1%± 15.5%(N=39,p< 0.05).

• The quality of life by SF-36 version 2 Health Survey revealed that General Health and Physical functioning were

significantly improved. Procedural mortality rate was0%.

Conclusions: Transcoronary injection of ACPs improved cardiac function (increased LVEF), exercise capacity and

quality of life with high safety profile for ischemic cardiomyopathy patients with no-option revascularization.

Source: Transcoronary Injection of Angiogenic Cells Precursors an Autologous Stem Cell in Ischemic Cardiomyopathy: A Clinical study of 106 cases in Thailand. ASEAN HEART JOURNAL, Vol 17, No. 1, January 2009.

ACP-01 STUDY AND ABSTRACT RESULTSD I A G N O S E D A N G I N A C L I N I C A L T R I A L

Purpose:

To assess the safety and efficacy of intracoronary injection Angiogenic Cell Precursors (“ACP”s) based product for the treatment of

patients with chronic stable angina pectoris who were on maximal drug therapy.

Methods:

Twenty four patients were prospectively enrolled and treated with ACPs. The administration of the therapy was based upon identifying

ischemic but viable myocardium (SPECT-MIBI scan) in the distribution of occluded coronary arteries. ACPs were prepared from cells

separated from non-mobilized peripheral blood of each patient, cultured ex vivo and injected via a catheter with proximal balloon

occlusion of the coronary artery. The patients were assessed clinically pretreatment and at 1, 3 and 6 months after treatment using the

following parameters: Canadian Cardiovascular Society (“CCS”) Scale, six minute walk (“6MW”) test, exercise capacity as assessed by

metabolic equivalents (“MET”s) and SPECT-MIBI perfusion defect.

Preliminary Reported Results:

Twenty patients have completed 3 months follow up and 17 have completed 6 months follow up.

The clinical condition improved in all patients at 3 and 6 months vs. pretreatment:

• 6MW increasing from 333.65±26.56 to 414.95±28.54 meters at 3 months and to 413.25±33.17 meters at 6 months (both P<0.001);

• exercise capacity increasing from 5.62±0.52 to 6.73±0.64 METs at 3 months (P<0.004) and to 7.09±0.79 METs at 6 months (P<0.04);

• perfusion defect decreasing from 38.46±6.19% to 23.89±5.79% at 3 months (P<0.004) and to 21.05±5.16% at 6 months (P<0.005);

and

• mean CCS score decreasing from 2.1±0.19 to 1.05±0.05 at 3 months and to 1.18±0.13 at 6 months (both P<0.001).

• One patient died two weeks after the treatment due to acute myocardial infarction. Coronary angiography demonstrated occlusion in

an untreated artery and patency of the ACP-treated artery.

Conclusion:

ACP therapy for chronic stable angina seems to be safe and improves anginal symptoms at 3 and 6 months. Larger studies are being

initiated to evaluate the benefit of ACPs for the treatment of this and additional severe heart diseases.

Source: Circulation Journal Vol. 114 No. Suppl._18. Abstract 3682: Treatment of Patients with Severe Angina Pectoris Using Intracoronarily Injected Autologous Blood-Borne Angiogenic Cell Precursors. https://www.ahajournals.org/doi/10.1161/circ.114.suppl_18.II_786-c.

INDICATION PIPELINE

Candidate Indication

Development Phase

Status

Preclinical Clinical

ACP-01 • Critical limb ischemia • Phase II clinical trial

• Currently 20 sites and 56

patients enrolled.

• Trial ongoing

ACP-01

• PAD

• Angina Pectoris

• Ischemic & dilated

Cardiomyopathy

• Congestive Heart Disease

• Acute Myocardial Infraction

• Ischemic Renal Disease

• Vascular Dementia

• Erectile Dysfunction

• Preparing for Phase II Angina

Pectoris trial

• Seeking JV partners to fund

phase II trials in each

indication

• Safety trials completed

NCP-01

• Stroke

• Spinal Cord Injury

• Amyotrophic Lateral

Sclerosis (ALS)

• Preclinical

• Seeking JV Partners to fund

trials.

• In R&D

BCP-01

• Bone fractures

• Skeletal breaks

• Surgical procedures

• Preclinical

• Seeking JV Partners to fund

trials

• Preliminary R&D

M A N A G E M E N T A N D D I R E C T O R S

Thomas Smeenk, BA, President,

Interim CEO, Founder & Director

• Founder, President and VP

Business Development,

TheraVitae Inc., which went public

as Hemostemix Inc. QT.

• A finance and business

development executive with a

proven track record of bringing

new discoveries to market.

• A public company executive since

1996, serving most recently as

President & CEO of Broadway

Gold Mining Ltd, where he

completed a $30 million agreement

with Rio Tinto. Prior, VP Business

Development, Memex Inc.

(TSXV:MEM), a company he took

public; President & CEO of e-

Manufacturing Networks Inc.

(TSXV:OEE), a company he took

public; President and CEO of

Tyranex Gold Inc. and President

and CEO of IBI Corporation.

David L. Wood, Chairman of the

Board

• Founder and President of Zenith

Appraisal and Land Consulting Ltd.

and Double Check Consulting Inc.,

both private consulting entities

• Former Director and former CEO

and CFO OF DataMiners Capital

Corp., a NEX listed company.

• Former Director of Black Bull

Resources Inc., a mining company

formerly listed on the TSXV.

• Served on the Audit Committees

and as Board Chairman and

Director of various TSXV listed

companies from 1999-2013

• Professional appraiser and

obtained his designation from the

Appraisal Institute of Canada (AIC)

in 2001

Dr. Ronnie Hershman, M.D.,

F.C.C.S., Director

• Graduated Magna Cum Laude

from Sophie Davis Center for

Biomedical Research in 1980.

• Practicing Cardiologist since 1987

and Medical Director of NYU

Langone Long island Cardiac

Care.

• Pioneer in performing laser

assisted coronary angioplasty

• Entrepreneur and investor for more

than two decades

• Director and/or Officer of more

than nine life science companies

• Advisor to late stage life science

VC that has funded 24 companies

• Track record of investing in

companies that commercialize

technologies quickly and globally

S C I E N T I F I C A D V I S O R Y B O A R D

Dr. Alan Lumsden, M.D.

• Walter W. Fondren III Chair,

Medical Director of the Houston

Methodist DeBakey Heart and

Vascular Center and chair of the

Department of Cardiovascular

Surgery at Houston Methodist

Hospital since 2008

• Emory University in Atlanta -

completed his surgical residency

and vascular training leading to

position as Chief of the Division

of Vascular Surgery

• International reputation as a

leader in the field of

endovascular surgery. He

conducts FDA-mandated training

for surgeons nationwide and has

received millions of dollars for his

research from the National

Institutes of Health. He has

contributed more than 200

papers to medical literature.

Dr. Kumar L. Hari, PhD

• Chief Scientific Officer at cBio, a

private disease diagnostics and

tracking firm

• Expertise is in chromosome

biology, functional genomics, and

bioinformatics and oversaw the

development of the MRS and

PATRN platforms

• At cBio, Dr. Hari led the team in

engagements with the FDA,

various universities and other US

government organizations

• Former director of program

management efforts at the

California Institute of

Regenerative Medicine and at

the Myelin Repair Foundation

• PhD in Cell Biology from UC San

Diego

and a B.Sc. in Genetics from UC

Davis

Dr. Norman Wong, B.Sc (Hon),

M.Sc, M.D., FRCP(C)

• Co-Founder of Resverlogix Corp.

(TSX:RVX), and Chief Scientific

Officer since 2003

• Currently Professor of Medicine

and Biochemistry & Molecular

Biology and Director of the Libin

Gene/Cell Therapy Unit within

the Faculty of Medicine at the

University of Calgary

• Specializes in the areas of

Endocrinology,

Internal Medicine, Molecular

Biology,and Gene/Cell Therapy

• Author and co-author of over 275

articles and abstracts and has

been invited to sit on more than

40 national or international

panels and committees

• Consulted for leading

pharmaceutical companies,

including Eli Lilly, Merck Frost,

GlaxoSmithKline, Solvay

Pharmaceuticals and Abbott

Laboratories

SHARE CAPITAL OVERVIEW

Share capital structure as of December 31, 2019($CAD)

Number Ex. Price Expiry or Closing

Common Shares Issued and outstanding 300,898,610

Stock Options 20,783,736 $0.05-$0.10 Jan 2020-Mar 2024

Share Purchase Warrants¹ 3,934,851 $0.05-$0.65 Sep 2020-Dec 2020

Subtotal Fully Diluted 326,367,197

¹Share Purchase Warrants - details

Number Ex. Price Expiry

3,857,071 $0.05 Sept 15, 2020

77,780 $0.65 Dec 2, 2020

PERSONALIZED STEM CELL THERAPY TODAY

W O R L D E C O N O M I C F O R U M T E C H N O L O G Y P I O N E E R , 2 0 0 6

Shaping

The Future

of MedicineFor more Information please contact:

Suite 1150, 707-7th Avenue SW

Calgary, AB T2P 3H6

www.hemostemix.comThomas A. SmeenkPresident & Interim CEO

905-580-4170