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INVESTOR Presentation DECEMBER 2018 Accelerating Biomedical Technologies from Incubation to Monetization Q BIO

BIO€¦ · Global Market Authorizations (22 countries) Medicare Reimbursed Commercially available for SALE in Q1 2019 (Est FDA US Facility Approval) Gross Palliation Revenue expected

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Page 1: BIO€¦ · Global Market Authorizations (22 countries) Medicare Reimbursed Commercially available for SALE in Q1 2019 (Est FDA US Facility Approval) Gross Palliation Revenue expected

INVESTORPresentation

D E C E M B E R

2018

Accelerating Biomedical Technologies

from Incubation to Monetization

QBIO

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Forward Looking StatementsThis presentation contains "forward-looking statements" as that term is defined in Section 27A of the United States Securities Act of 1933, as amended and

Section 21E of the Securities Exchange Act of 1934, as amended. Statements in this presentation which are not purely historical are forward-looking

statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. These forward-looking statements generally

can be identified by phrases such as Q BioMed, Inc. (“QBIO”) or its management "believes," "expects," "anticipates," "foresees," "forecasts," "estimates" or

other words or phrases of similar importance. Such forward-looking statements include, among other things, the development, costs and results of new

business opportunities. Actual results could differ from those projected in these forward-looking statements which are made as of the date of this

presentation, and we assume no obligation to update any forward-looking statements. Our actual results may differ materially from those stated or implied

in such forward-looking statements, due to risks and uncertainties associated with our business, which include the risk factors disclosed in our public filings.

Although we believe that any beliefs, plans, expectations and intentions contained in this presentation are reasonable, there can be no assurance that any

such beliefs, plans, expectations or intentions will prove to be accurate. Investors should review all of the information set forth herein, and should also

understand the risk factors and the inherent uncertainties associated with new business opportunities and development stage. Any use of this information for

any purpose other than in connection with the consideration of an investment in Q BioMed Inc. may subject the user to criminal and civil liability.

This presentation does not constitute an offer to sell any securities or the solicitation of an offer to sell any securities by Q BioMed Inc.

P a g e ▕ 2

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Rapid Biotech Growth Has Created an Opportunity

Q BioMed leverages this opportunity by accessing undiscovered, undervalued

biomedical technologies for investment, acceleration and monetization

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m o n et i zeOperate, partner, license, IPO or sell

The Q BioMed Business Model

i n ve s tCapital attached to goals

acce le ra teIncrease investment and ownership

Preliminary scientific and commercial criteria review. Determining

management's expectations and flexibility moves the asset to the next step.

Due diligence is combined with a validation of management's

development and capital requirements.

Performance-based capital is deployed to meet specific and mutually-

agreed goals in each stage.

Additional resources are infused to move the asset through development

stages and to a value-creating inflection point.

Assets can be sold, licensed, joint-ventured or operated as cash flow positive

product lines. QBIO's goal is to maximize value for its shareholders.

i den t i f yCriteria match and fit

an a l yzeAsset and development plan

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Management Team

Advisory BoardJean-Jaques Mondoloni

Advisor Wombat

Capital

Dr. Helga Grupe

Wombat -Oncology

Dr. Jose de Chastonay

Wombat - Contract Services

Dr. Scott P Bruder

Wombat - Medical Devices,

Orthopedics

Andy Watson

Wombat - Diagnostics,

Companions,

Genomics, Life Science Tools

Dr Raj Apte

Washington University -

Ophthalmology

Dr. Tager-Flusberg

Boston University

Dr Nafeez Zawahir

Medical Advisor

Market Research

Dr. Susan Quaggin

CSO, Manin Resarch

George Nikopoulos

CEO, Mannin Research

Dr. Amy Ripka

Medicinal Chemistry

Mary Jane Rafii

Wombat - Ophthalmology

Kristin Keller

Agency – Commercialization

Lead

P a g e ▕ 5

Denis CorinChief Executive Officer

Chairman of the Board

William RosenstadtChief Legal Officer

General Counsel

Director

David Laskow-PooleyVP Product Development

Ari JatwesBusiness Development Analyst

Dr. Rick PanicucciPharmaceutical Development

Director

Robert DerhamVP Orphan Products

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Our Growing Portfolio of High-Value Assets

ONCOLOGY VASCULAR DISEASES RARE ORPHAN DISEASES

MAN-01 MAN-02

MAN-03 MAN-04

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A Growing Pipeline Mitigates Risk and Drives Shareholder Value

DRUG CANDIDATE PRECLINICAL PHASE

1

PHASE

2

PHASE

3

APPROVAL COMMERCIALIZATION

Radiopharmaceutical for metastatic cancer bone pain

Topical eyedrops for glaucoma

Rare pediatric non-verbal Autism Spectrum Disorder (Pre-IND 505b2)

Chemotherapeutic for liver cancer

MAN-01

P a g e ▕ 7

MAN-02

MAN-03

Kidney Disease

Cardiovascular Diseases

MAN-04 Infectious Diseases

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a Portfolio Asset

Radio-Pharmaceutical: Strontium Chloride 89 Injection

Condition: Bone Pain - Cancer Metastases

Addressable Market: ~110,000 yearly

Technology Partner: BioNucleonics Inc and GE Healthcare

Stage: Commercializing – Awaiting FDA Approval

of Manufacturing Facility

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PAINFUL BONE METASTESES from Prostate and Breast Cancer

▪ Pain is the most common sign of bone cancer, and may become more

noticeable as the tumor grows.

▪ Bone pain can cause a dull or deep ache in a bone or bone region (e.g., back,

pelvis, legs, ribs, arms).

▪ Treatment options include

▪ Sr89 is NON-NARCOTIC and can mitigate opioid use

Current Standards of Care

▪ 450,000* new breast and prostate cases are recorded each year

▪ 1 in 3 people will develop bone metastases from the spread of breast and

prostate cancer

▪ In a 2012 publication it was estimated that over 280,000 people in US to be

living with the painful condition

*Source: American Cancer Society, 2016

Prevalence

THE CONDITION:

Pain Medications:

OpioidsOrthopedic Procedures

Radiation Therapy

Radiopharmaceuticals

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▪ FDA-approved non-opioid for painful metastases

▪ Medicare and Health Care Reimbursed

▪ Broadly Indicated to relieve bone pain from skeletal metastases from

breast, lung prostate and other cancers

▪ Simultaneously targets all sites of metastatic bone pain

▪ ONE DOSE - Effective in 80% of patients and lasts average of 6 months

▪ Can be used with opioid based drugs and cancer therapeutics

▪ Studies demonstrated a prolonged progression-free result and overall

survival with acceptable toxicity

▪ Ph2 Trial showed 9-month survival benefit (vs 2 months in Blockbuster

competitor) – A Planned PH4 trial to confirm this will exponentially

increase potential revenue

NON-OPIOID PAIN

RELIEF from Metastatic Cancer

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METASTESES SPREAD TO MULTIPLE SITES

Bone Met

How Our Drug WorksThe Challenge of Bone Mets

• 85% of breast and prostate cancer patients develop Bone Mets• 2 million people worldwide suffering and under treated• Few treatment option for multiple skeletal metastases

• Imitates calcium in vivo and rapidly localizes to proliferating bone

• Absorbs at a rate 10-fold higher in prostatic bone metastases than in healthy bone

• Retained in metastatic lesions enabling a larger radiation dose to metastases for up to 6 months

Multiple skeletal metastases cannot be treated with External Beam Radiation

(Tumor)

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Investment Thesis

▪ FDA approved – Palliation

▪ Global Market Authorizations (22 countries)

▪ Medicare Reimbursed

▪ Commercially available for SALE in Q1 2019 (Est FDA US Facility Approval)

▪ Gross Palliation Revenue expected to be $20M-$40m p/a in year 3

▪ Requires 2,000 to 3,000 (out of 100k per year) patients to meet that revenue model

BLUE SKY

▪ Irradiates tumors and has been used in combination with CHEMOTHERAPY

▪ Increased survival by 9 months - MD Anderson/Lancet▪ https://www.ncbi.nlm.nih.gov/pubmed/11210994

▪ Phase 4 Clinical Program to amend label to THERAPEUTIC DRUG

▪ Potential Revenue $200M+ in Yr1 post Clinical trial (Current Competitor $800M/yr.)

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-001a Portfolio Biotechnology

Pharmaceutical: QBM-001 sprinkle

formulation

Condition:Rare Pediatric Non-Verbal

Disorder

Addressable

Market:50,000 cases worldwide

15,000 in US alone

Technology

Partner:ASDERA, LLC

Stage: Pre-IND 505(b)2

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Among the >60,000 US children who develop Autism Spectrum Disorders (ASD)

every year, 20,000 become nonverbal and will have to rely on assisted living for

the rest of their life. Of the estimated 20,000, QBM-001 should be able to treat

about 15,000.

▪ The lifetime cost of care is estimated at $10 M/person.

▪ No treatment with lasting effects on how children develop

▪ Fundamental defects in social reciprocity and communication

▪ Repetitive and stereotypical behaviors

RARE PEDIATRIC NON-VERBAL DISORDER-Autism Spectrum Disorder

THE CONDITION:

Prevalence

Name Condition 2016 Sales

Abilify® Irritability $2.0 B + (off Patent)

Vyvanse® ADHD $2.0 B

Risperdal® Aggression $3.0 B

Current *Medications and 2016 Sales

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*These medications do not treat the condition, rather they are psychotherapeutic

interventions that ameliorate temperament/mood only.

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Synapse Formation

• 8-12 months – detection of early symptoms

• 12-15 months – language regression

• Brain density in cortex (speech region) declines after 24

• Due to pruning, fMRI shows “patches of disorganization” seen in the cortex of the brain of non-verbal children older than 24 months

Results from two independent studies (Wittkowski, 2014) showed lack of language associated with:

poorly regulated membrane channels (excitation/inhibition imbalance) and included known

‘migraine’ genes.

HOW IT WORKS

Diagnosis

• ASD diagnosis or high-risk group with developmental delay

• Tested for elevated serum markers

• Genetically tested to exclude diseases that QBM-001 cannot treat

QBM-001 acts as an allosteric regulator of faulty membrane channels in the brain that are known to

cause migraines and/or seizures, thus allowing QBM-001 to potentially alleviate the condition and

allow toddlers to actively develop language and avoid life-long speech and intellectual disability of

being nonverbal.

NEURON PRUNING

1 Mo. 6 Mos. 2 Yrs. 4 Yrs. 6 Yrs.

Children with ASD loose the ability to learn language once their

language-specific neurons are naturally pruned

Around the age 2, the brain more actively prunes

(eliminates) neurons that are not in use.

When language development is impeded in this

subset of ASD children, their language neurons do

not activate and are targeted for pruning by the

brain.

If you do not use it, you lose it.

REGULATES FAULTY ION-CHANNELS to Allow Language Development

At 2 years of age, the brain is

actively developing neuron

connections at the peak of the

leaning process.

P a g e ▕ 1 5

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▪ There are NO drugs currently available to ameliorate this

condition.

▪ Orphan drugs (less than 200k patients) average price $100,000 per

year (EvaluatePharma).

▪ The alternative – estimated at $10m in direct costs and $10M in

lost productivity due to lifetime assisted living, supplemental

healthcare costs, and lost productivity of family members.

▪ Not measuring the severe emotional strain of never talking to

your child.

▪ This pediatric nonverbal disorder, where children lose or don’t

develop and manifest with ASD symptoms is rare and limited to

approximately 20,000 children a year in the US and about the

same in Europe, of which QBM-001 should be able to treat 15,000-

18,000 for 2-3 years.

MARKET POTENTIALUnited States: 20,000 patients per year @ $100,000 - $2B

Europe and ROW: 30,000 Patients per year @ 100,000 - $3B

PRICE VS. COSTThe Hard Facts and Emotional TRUTH

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UTTROSIDE-Ba Portfolio Biotechnology

Chemotherapy: UTTROCIDE-B

Condition: Liver Cancer

Addressable

Market:700,000 diagnoses/year

Technology

Partner:

Oklahoma Medical

Research Foundation

Stage: Preclinical

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More than 700,000 people worldwide are diagnosed each year

Estimated 39,230 adults in the United States will be diagnosed every year

Numbers have tripled since 1980

Poor 1-year survival rate

18% 5yr Survival

LIVER CANCERThe 10th Most Common Cancer

THE CONDITION:

RADIATION

High-energy x-rays or other

particles destroy cancer cells

DRUG TREATMENT

Tryosine kinase inhibitor

antineoplastic agent, Nexavar™

SURGICAL Hepatectomy or liver transplantation

CHEMOTHERAPYRadiofrequency ablation (RFA) and

microwave therapy

THERMAL

Percutaneous ethanol injection

Current Standards of Care

Prevalence

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P Uttroside-B appears to affect phosphorylated JNK (pro survival

signaling) and capcase activity (apoptosis in liver cancer)

▪ A natural compound

▪ Fractionated Saponin derived from S. nigrum

▪ Small molecule

▪ Steroid Glycoside

Uttroside B increases the cytotoxicity of a variety of liver

cancer cell types

• Up to 10x more potent than Sorafenib in pre clinical studies

Cytotoxicity specific to cancerous liver cells

Provisional patent filed

Molecule syntheses completion Dec 2018

IND Ready Q1 2019

Sorafenib Tosylate (Nexavar™) is currently the only FDA- approved drug

for the first line treatment of liver cancer. 2017 sales exceed $1B

500

5800

0

1000

2000

3000

4000

5000

6000

Uttrocide-B Sorafenib

ChemotherapyIN VITROIC-50 of Sorafenib is 5.8 uM in Hep G2 while

Uttrocide-B is 500

IN VIVOHepG2 Injected Into Mice Then Treated with 10mg of Uttrocide-

B for One Month

0

20

40

60

80

100

120

140

160

Week 1 Week 2 Week 3 Week 4

Control Uttrocide B P a g e ▕ 1 9

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MAN-01a Portfolio Biotechnology

Pharmaceutical: MAN-01 Topical Drops

Condition: Primary Open-Angle Glaucoma

Addressable Market: 60 million patients

worldwide

Technology Partner:

Stage: Preclinical

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60 million glaucoma patients worldwide

8 million with bilateral blindness

Typically no early warning signs. Therapy only slows progression

Vision with Glaucoma

Current Standards of Care

Medical (Pharmaceuticals)

Laser Surgery (Out-patient)

Traditional Surgery (In-patient)

Normal vision

Prevalence

INTRAOCULAR PRESSURE (IOP) and Primary Open-Angle Glaucoma

THE CONDITION:

P a g e ▕ 2 1

Market Is Seeking

Effective reduction in IOP

Innovative Drug Design

Increase compliance and adherence

Improved drug delivery and availability

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60.5

79.6

0

10

20

30

40

50

60

70

80

90

2010 2020

▪ First-in-class drug to treat Glaucoma

▪ Novel therapeutic addresses need for innovation

▪ Mechanism targets the critical Schlemm’s Canal The Schlemms Canal is responsible for 70%-90% of fluid

drainage in the eye

▪ Primary indication for Primary Open-Angle GlaucomaAdditional indications may include:

- Acute Kidney Injury

- Cardiovascular Disease

- Infectious Diseases

▪ Mannin Research accepted into Johnson & Johnson Innovation,

JLABS @ Toronto

Developing a novel eye-drop to treat Primary Open-Angle Glaucoma

utilizing the Angiopoietin-Tie2 Mechanism of Action

Source: W.H.O. 2010

Glaucoma Cases Expected to Increase 30% by 2020(millions of cases)

▲30%

Incre

ase

in C

ase

s

Public Market Comp Aerie Pharmaceuticals - AERI $1.85B MCAP*

P a g e ▕ 2 2

MAN-01

* As of December 6, 2018

Projected Phase I Glaucoma

Clinical Trial:

Q4 2019Projected Lead Candidate

Selection:

Q1 2019

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ADDITIONAL INDICATIONSPre-Clinical

Acute Kidney Injury

Treatment for Acute Kidney Injury, which contributes to high morbidity and mortality rate in a wide range of injuries, including common clinical care settings such as coronary artery bypass surgery, contrast-induced nephropathy and sickle cell nephropathy.

Cardiovascular Diseases

Treatment with our pharmacologic small molecule will likely protect the lungs and slow disease progression in patients with Pulmonary Artery Hypertension. Treatment may also provide protection to the myocardium in patients with Congestive Heart Failure and Myocardial Ischemia.

Interventions targeting Ang-Tie2 pathway have been shown to play an important role in reducing the severity of viral and bacterial infections such as influenza, sepsis, tuberculosis, anthrax, toxic shock syndrome, cerebral malaria and Ebola, by promoting positive host-directed therapeutic (HDT) responses

Infectious Diseases

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Capital Markets Overview &Management Expectations

Capital Markets Overview and

Management Outlook

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Q BioMed in the NEWS

Q BioMed Inc Announces Acquisition of Cancer Pain

Drug Metastron™ from GE Healthcare

Strategic Acquisition Gives Company Ownership of

Brand Name Drug and Related Market

Authorizations in 22 Countries in Which Metastron™

is Already Registered and Approved for Sale

November 2018

Q BioMed Provides Important Update on QBM001

Developmental Drug Targeting a Non-Verbal and

Minimally Verbal Patient Subset on the Autism

Spectrum

Company Further Develops Its Autistic Spectrum

Disorder (ASD) Drug Technology and Expects

Several Development Partnerships In Anticipation of

Clinical Program in 2019.

OCTOBER 2018

Q BioMed Announces Closing of $4M Financing

Biomed Inc. Announces Dr. Rajendra Apte Joins

Advisory Board

Distinguished Ophthalmology Specialist Brings

Wealth of Experience

SEPTEMBER 2018

3-Month Trading History

As of Dec 4, 2018

Shares Outstanding

Warrants

14,200,000

4,8M

Market Cap

Ave Price

$28.5 M

$3.50

Inside Ownership 25% Avg. Volume

30 day70,000

Float ~ 10,000,000 Year end November 30

Price $ 1.92 Dec 4

QBIO

Capital Markets

P a g e ▕ 2 5

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Metastron™ (Strontium Chloride 89) - FDA-approved

Manufacturing underway - Awaiting FDA review of CMO

Revenue generation expected in 1H 2019

Ph4 Post Marketing Study for Expanded Therapeutic Label Q4 19

Revenue in 2019

QBM-001

Pre-IND Filing, Orphan Drug Filing Q4 2018

1year Pivotal Clinical Trial 1H 2019

Uttroside-B – Liver Cancer

Complete pre-clinical and Prepare IND

Proof of Concept Studies Q1 2019

File IND Q2 2019

MAN-01

Complete Molecule Optimization (Eye Drop)

Initiate Pre-IND Studies 1H2018 – Clinical Trial 2019

Additional Indications Formalized 2019

Pharma Partnership opportunities

Potential up-list to national exchange in Q1 2019

What to expect from us

QBIOP a g e ▕ 2 6

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Corporate366 Madison AvenueNew York, NY 10222

USA

+1 (888) 357-2435

Executive & Investors

Denis Corin, CEO

[email protected]

qbiomed.com

Accelerating Biomedical Technologies

from Incubation to Monetization

QBIO