SAFE EFFICACIOUS AUTOLOGOUS TREATMENT OF CLI, PAD,...

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SAFE EFFICACIOUS AUTOLOGOUS TREATMENT OF CLI, PAD, ANGINA, ISCHEMIC & DILATED CARDIOMYOPATHY Tech Pioneer‘06

Transcript of SAFE EFFICACIOUS AUTOLOGOUS TREATMENT OF CLI, PAD,...

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

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 A U T O L O G O U S S T E M C E L L T H E R A P Y P L AT F O R M

Hemostemix Inc.

500 Patients treated with significant efficacy - 83% - and safely;

91 global patents cover five patent families including automated production of autologous peripheral blood-based

ACP-01 & NCP-01

20 Centre International Phase II Clinical Trial for Critical Limb Ischemia:

83% efficacy in healing ulcers.

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

Critical Limb Ischemia and Peripheral Arterial Disease

$10.3 Billion

Angina: $9.45 Billion Dilated Cardiomyopathy: $180 M

Ischemic Cardiomyopathy: $990 M Next: Other Cardiovascular Diseases

$94 Billion

HOW SCALABLE IS OUR PLATFORM? AUTOMATED PRODUCTION PATENT

Patented •  91 Patents issued worldwide •  Automation of Prodcution Patent

Expandable Platform •  ACP01 – 5 findications •  NCP01 - stroke model as an indication •  Machine engineered

Optimized Business Plan •  Lean structure and experienced management team •  1 Machine x 150 patients @ $20,000 = $3,000,000/week

Key Partnerships

•  License Negotiations Started •  By Indication by Country

Data Driven

•  Historical Data >700 patients treated •  12 Years of treatment History •  Multiple Trials (2) and Investigator led

studies (3) completed

Clinical Trials–Clinical Data •  20 NA Sites : 56th enrollment •  83% Efficacy. No safety issues •  Futility Analysis when 42 patients completed

26 weeks of follow-up.

THE RESULTS OF ACP-01

•  Current trial: ACP-01 in CLI patients : 83% efficacy in healing of ulcers (10/12)

•  ACP-01 in 24 Severe Angina Pectoris Patients •  75% had objective improvement in perfusion

defect •  72% showed improvement in treadmill

exercise capacity as assessed by metabolic equivalents

•  ACP-01 in 41 Cardiomyopathy Patients •  Overall ejection fraction (“EF”) improved

significantly by 4.8% + - 7.5% at 149 + - 98 days postoperatively. NHYA functional class: significantly better

•  EF in 20 Ischemic cardiomyopathy: from 26.6% + - 5.8% to 33.6% + - 7.8%

•  EF in 21 dialated cardiomyopathy: 25.9% + - 9.8%

•  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 want to live with good health

•  Poor diet and lifestyle increase prevalence of conditions of ischemia - diseases treatable with ACP01.

•  Using one’s body to heal oneself is immunological, disease free and affordable – 1/2 price of a new car

ACP Trials and Studies in CLI, Angina, 2 types of Cardiomyopathy

Strong Government and Public support

Population and Lifestyle Factors

ACP-01 DIFFERENTIATORS

Autologous. Proven safe and efficacious.

Blood draw: safer, less invasive than fat or bone marrow

Global portfolio of 91 patents Including automated production

Low Patient Risks Self-donation, means no immune

rejection or disease transmission

High Cell Viability Fresh cells in ready-to-use syringes, no cryopreservation required

Simple Protocol Safe and easy to perform in

outpatient clinic

No Ethical Concerns Stem cells derived directly from patient

No Reported Safety Issues No mobilization drugs

needed to collect cells

Scalable Simple, cost-effective production process

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

ACP-01 MARKETS E A C H I N D I C A T I O N I S A C O M P A N Y M A K E R A N D L I C E N S A B L E

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

$10.3 Billion

Angina and CVD: $94 Billion

Vascular Dementia: $28 Billion

Ischemic Renal Disease: $92 Billion

Ischemic Erectile Dysfunction Disease: $5 Billion

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

01 Inject 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

Bef

ore

Afte

r CL I WITH ACP-01 IMPROVEMENTS VISUALIZED

PHASE I I TRIAL FOR CLI UPDATE

Phase II 20 Centres 56 Subject Dec 31,’19 CRO engaged Minimum 6 month and 12 month

follow-ups

UBC & U of T Led 20 sites on-boarded FDA and Health Canada

56th Patient treatment underway Multicenter results

Randomized, placebo-controlled double blind Phase II clinical trial is confirming 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 trials Progression 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

ACP-01 STUDY AND TRIAL HISTORY Type of Study Study Location Objective of Study Study

Design Number of Subjects Patients Study Status

Pilot Safety/ Feasibility Thailand To assess the feasibility and safety

of the implantation Open label 6 Diagnosed CLI Completed

Phase 1b Safety and Efficacy Hungary

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 Futility Analysis when 42 patients completed 26 weeks of follow-up

Diagnosed CLI In Progress

Clinical Trial Safety/ Feasibility Thailand To assess the feasibility and safety of intracoronary

injection Open label 24 Diagnosed Angina Completed And Published

Safety and Efficacy Thailand

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, "Forty-one patients with cardiomyopathy (mean age 58.5 years + - 13.3 years) underwent stem cell injection; 21 had dilated cardiomyopathy and 20 had ischemic cardiomyopathy. Overall ejection fraction improved significantly by 4.8% + - 7.5% at 149 + - 98 days postoperatively. It increased from 25.9% + - 9.8% in dilated cardiomyopathy, and from 26.6% + - 5.8% to 33.6% + - 7.8% in ischemic cardiomyopathy. New York Heart Association functional class was significantly better at 2 months in both groups.

Open label 41 Diagnosed Ischemic Cardiomyopathy or Dilated Cardiomyopathy

Completed And Published

INDICATION PIPELINE

Candidate Indication Development Phase

Status Preclinical Clinical

ACP-01 •  Critical limb ischemia •  Phase II clinical trial •  Expect no objection to trial

reduction. 6,12,24 month data by Dec. 2020.

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 •  Beginning JV Discussions •  JV Partner to Prepare pre-

IND submission to FDA for Phase II trial

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

Bryson Goodwin, CEO and Director

•  Managing Director of Synergy Capital Market Advisors, a boutique firm in Vancouver, BC, Canada providing investment banking to predominantly small cap and early stage companies

•  Practiced international executive with extensive experience in finance, management, investor relations and operations with both private and public companies.

Thomas Smeenk, BA, President and Director

•  Founder, Director, President and VP Business Development, TheraVitae Inc., which went public as Hemostemix Inc.

•  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.

Natasha Sever, CFO

•  Over 10 years experience in senior finance roles over a wide range of industries including mining, retail and technology

•  Extensive experience with company financings as well as TSX & ASX regulatory compliance

•  CPA designated in both Canada and Australia with a BCom from Edith Cowan University.

Yari Nieken, Director

•  Founder of Foremost Capital Inc., an exempt market dealer and continues to consult for numerous issuers in the healthcare, mineral extraction and wellness sectors.

•  He has served on the boards of several public and private issuers and has raised substantial capital in his career.

•  Formerly an investment adviser at Union Securities Corp. •  Mr. Nieken holds an MBA from the Sydney Graduate School of

Management and a BA from the University of British Columbia.

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

•  Director and former CEO /CFO OF DataMiners Capital Corp., a NEX listed company. Presently serves on the Audit Committee

•  Director of Black Bull Resources Inc., a mining company formerly listed on the TSXV. Presently serves on the Audit Committee

•  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

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

Common Share ($0.01) TSXV Approved 300,000,000 $0.01 January 2020

Total Issued 626,367,197

¹Share Purchase Warrants - details

Number Ex. Price Expiry

3,857,071 $0.05 Sept 15, 2020

77,780 $0.65 Dec 2, 2020

300,000,000 $0.05 January, 2021

PERSONALIZED STEM CELL THERAPY TODAY WORLD ECONOMIC FORUM TECHNOLOGY PIONEER, 2006

Shaping The Future of Medicine For more Information please contact:

Suite 1150, 707-7th Avenue SW Calgary, AB T2P 3H6

www.hemostemix.com Bryson Goodwin CEO 604-341-1531

Thomas Smeenk President 905-580-4170