QBIO Accelerating Biomedical Technologies from Incubation to Monetization Investor Presentation - QBioMed
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Accelerating Biomedical Technologies from Incubation to Monetization Investor M AY / J U N E 2 0 1 9 Presentation QBIO
Forward Looking Statements This 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. 2019-06-06 Copyright © 2019 Q BioMed Inc. 2
Rapid Biotech Growth Has Created an Opportunity Q BioMed leverages this opportunity by accessing undiscovered, undervalued biomedical technologies for investment, acceleration and monetization 2019-06-06 Copyright © 2019 Q BioMed Inc. 3
The Q BioMed Business Model IDENTIFY Preliminary scientific and commercial criteria review. Determining Criteria match and fit management's expectations and flexibility moves the asset to the next step. A N A LY Z E Due diligence is combined with a validation of management's development Asset and development plan and capital requirements. INVEST Performance-based capital is deployed to meet specific and mutually-agreed Capital attached to goals goals in each stage. Additional resources are infused to move the asset through development A C C E L E R AT E Increase investment and ownership stages and to a value-creating inflection point. MONETIZE Assets can be sold, licensed, joint-ventured or operated as cash flow positive Operate, partner, license, IPO or sell product lines. QBIO's goal is to maximize value for its shareholders. 2019-06-06 Copyright © 2019 Q BioMed Inc. 4
Management Team Denis Corin William Rosenstadt Dr. Rick Panicucci Ari Jatwes David Laskow-Pooley Robert Derham Chief Executive Officer Chief Legal Officer Pharmaceutical Development Business Development Analyst VP Product Development VP Orphan Products General Counsel Chairman of the Board Director Director Advisory Board Dr. Helen Tager- Dr. Susan Quaggin George Nikopoulos Dr. Amy Ripka Dr Nafeez Zawahir Dr Raj Apte Flusberg CSO, Manin Research CEO, Mannin Research Medicinal Chemistry Medical Advisor Washington University - Professor of Director, Feinberg Cardiovascular and BioChemistry and Molecular Genetics. Market Research Ophthalmology Psychology Renal Research Institute NIH Post Doc fellow. Columbia University and Methodist Paul A. Cibis Distinguished Professor Chief of Nephrology and Hypertension Hopital. of Ophthalmology and Visual Director of the Center in the Department of Medicine CME Reviewer WebMD Medscape. Sciences for Autism Research Charles H. Mayo, MD, Professor Large Pharma Consultant Excellence Professor of Medicine (Nephrology and Boston University Hypertension) Northwestern Kristin Keller Dr. John Jay Gargus Dr Jin Jeng Agency – Professor, Physiology & Biophysics Recombinant Protein Commercialization Director of Center for Autism Ophthalmology Lead Research and Translation (UCI CART) Northwestern Feinberg School of Medicine Professor, Pediatrics Assistant Professor of Medicine UC Irvine School of Medicine (Nephrology and Hypertension) 2019-06-06 Copyright © 2019 Q BioMed Inc. 5
Our Growing Portfolio of High-Value Assets ONCOLOGY OPHTHALMOLOGY RARE ORPHAN DISEASES VASCULAR DISEASES MAN-01 MAN-03 MAN-11 MAN-04 ™ GDF15 2019-06-06 Copyright © 2019 Q BioMed Inc. 6
A Growing Pipeline Mitigates Risk and Drives Shareholder Value PHASE PHASE PHASE DRUG CANDIDATE PRECLINICAL APPROVAL COMMERCIALIZATION 1 2 3 Radiopharmaceutical for metastatic cancer bone pain (Branded) Radiopharmaceutical for metastatic cancer bone pain (Generic) Rare pediatric non-verbal Autism Spectrum Disorder (Pre-IND 505b2) GDF15 Biomarker for glaucoma Chemotherapeutic for liver cancer MAN-01 Eye drops for glaucoma MAN-11 Biologic for glaucoma MAN-03 Acute kidney injury MAN-04 Cardiovascular Diseases 2019-06-06 Copyright © 2019 Q BioMed Inc. 7
Radio-Pharmaceutical: Metastron™ / Strontium Chloride 89 Injection Condition: Bone Pain - Cancer Metastases Addressable Market: ~110,000 yearly Technology Partner: BioNucleonics Inc and GE Healthcare Commercializing – Awaiting FDA Approval of Stage: Manufacturing Facility
THE CONDITION: PAINFUL BONE METASTESES from Prostate and Breast Cancer Prevalence 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 and 2,000,000 worldwide to be living with the painful condition *Source: American Cancer Society, 2016 Current Standards of Care 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: Pain Medications: Radiation Therapy Opioids Radiopharmaceuticals Orthopedic Procedures Sr89 is NON-NARCOTIC and can mitigate opioid use 2019-06-06 Copyright © 2019 Q BioMed Inc. 9
NON-OPIOID PAIN RELIEF from Metastatic Cancer • 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 2019-06-06 Copyright © 2019 Q BioMed Inc. 10
METASTESES SPREAD TO MULTIPLE SITES The Challenge of Bone Mets How Our Drug Works Bone Met (Tumor) Multiple skeletal metastases cannot be treated with External Beam Radiation • Imitates calcium in vivo and rapidly localizes to proliferating bone • 85% of breast and prostate cancer patients develop Bone Mets • Absorbs at a rate 10-fold higher in prostatic bone • 2 million people worldwide suffering and under treated metastases than in healthy bone • Few treatment option for multiple skeletal metastases • Retained in metastatic lesions enabling a larger radiation dose to metastases for up to 6 months 2019-06-06 Copyright © 2019 Q BioMed Inc. 11
METASTRON™ Effectively Palliates Cancer Bone Pain Study Patients (N) Dose Cancer Pain Relief Fuster 2000 40 4 mCi Breast 92% Kraeber-Bodere 2000 94 4 mCi Prostate 78% Turner 2001 93 4 mCi Prostate 63% Ashayeri 2002 27 4 mCi Prostate and Breast 81% Gunawardana 2004 13 4 mCi Prostate 57% Liepe 2007 15 4 mCi Prostate and Breast 72% 2019-06-06 Copyright © 2019 Q BioMed Inc. 12
METASTRON™ Offers Lasting Pain Relief Study Patients (N) Dose Cancer Pain Relief Median duration Fuster 2000 40 4 mCi Breast 92% 120 days Moderate bone involvement: 5 mos Kraeber-Bodere 2000 94 4 mCi Prostate 78% Extensive bone involvement: 2 mos Gunawardana 2004 13 4 mCi Prostate 57% 56 days 2019-06-06 Copyright © 2019 Q BioMed Inc. 13
METASTRON™ Improves Quality of Life • Treatment with METASTRON™ has led to a significant improvement in QoL for patients with metastatic bone disease associated with breast and castration-resistant prostate cancer • Treatment with METASTRON™ has been demonstrated to reduce or eliminate need for analgesics 2019-06-06 Copyright © 2019 Q BioMed Inc. 14
• A decrease of >50% in serum PSAV was observed in 37% of patients with hormone-refractory prostate cancer after treatment with METASTRON™ 6 • In a multicenter, RCT involving 126 patients with mCRPC, all of whom received external METASTRON™ May beam radiotherapy, additional treatment with METASTRON™ delayed disease progression Slow Metastatic [Porter_1993] Disease • Many patients show a reduced intensity of hot spots on bone scan compared with Progression pretreatment images.11,16 suggesting a possible tumoricidal effect from METASTRON™. • Case reports describe regression of osteoblastic and osteolytic bone metastases in patients with breast cancer and hepatocellular carcinoma after treatment with METASTRON™ 16,17 2019-06-06 Copyright © 2019 Q BioMed Inc. 15
METASTRON™ has been shown to extend clinical progression free survival (CPFS). • In the recent TRAPEZE randomized controlled trial of the clinical effectiveness and cost- effectiveness of chemotherapy with zoledronic acid (ZA), METASTRON, or both in men with bony metastatic castration- refractory prostate cancer, METASTRON was shown to improve CPFS, while ZA did not. • The METASTRON group was also associated with lower use of radiotherapies, abiraterone, ZA and METASTRON as concomitant medications, as well as fewer inpatient days, outpatient appointments and GP visits. 2019-06-06 Copyright © 2019 Q BioMed Inc. 16
METASTRON™: Increasing Evidence of an Overall Survival (OS) Benefit Metastron OS Data • In one study of 103 patients with mCRPC 50 randomized to doxorubicin alone or doxorubicin with METASTRON, a median 45 overall survival of 16.8 months and 27.7 40 months was seen, respectively 9 35 30 • In an earlier trial examining METASTRON vs 25 placebo in mPC and mCPRC patients, Buchali et al reported a survival rate 2 years after 20 the start of treatment of 46% in METASTRON 15 and 4% in placebo groups. 19 10 5 • In these clinical studies, differences in METASTRON dosing, baseline patient 0 Trapeze Study Buchali et al Kuroda PSA Tu et al Combo characteristics, and prior treatments are Metaston Other/Placebo likely to affect reported patient outcomes Future randomized, placebo-controlled studies may confirm the effect of METASTRON on overall survival 2019-06-06 Copyright © 2019 Q BioMed Inc. 17
METASTRON™ Investment Thesis FDA approved – Palliation Global Market Authorizations (22 countries) Medicare Reimbursed Commercially available for SALE in 2019 (Est FDA US Facility Approval) 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.) 2019-06-06 Copyright © 2019 Q BioMed Inc. 18
Our Competitors, Revenue Model and Launch Plan Treatment Comparative Analysis Characteristics Opioids Metastron (Sr89) Ramp Up to Action On the central nervous system Reduction of tumor mass Commercialization Pain Palliation Begins Within 15 to 20 min 1 to 2 weeks after administration Material Procurement Pain Palliation Last 3 – 4 Hours 3 to 12 Months (Average: C O M P L E T E D 6 months) Side Effects Confusion, depression, sleepiness, Transient mild myelo-suppression Manufacturing nausea, constipation, vomiting. Gradual between 4 to 8 weeks after I N P R O C E S S resistance, creating need of higher doses administration, with complete recovery within 3 months Need of Hospitalization Requires regular administration and No. Production Validation nursing care I N P R O C E S S “[Opioids] can lead to a lot of side effects because “I thought [strontium] was the coolest thing. Great then the patient is completely lethargic…like being responses. The pain dramatically improved in the in a fog.” – Oncology Nurse breast patients that had bone metastases.” – Radiation Oncologist Distribution I N P R O C E S S Potential Revenue Targets Indication Market Revenue Marketing Cancer Bone Pain 3000 – 6000 Doses @ $10000/Dose FY2021 Approx.: $25,000,0000 - $50M I N P R O C E S S 1500-3000 Patients Future Possibility 30 – 60,000 Doses @ $10,000/Dose FY 2023 Approx.: $250M – $500,000,000 Therapeutic Bone Cancer 5000 – 10000 Patients 5-10% of the Patient Population Launch and Sales in 2019 2019-06-06 Copyright © 2019 Q BioMed Inc. 19
METASTRON™ Is Commercially Ready for U.S. Sales and Distribution • Commercial team onboarded • Commercial infrastructure is in set-up mode: • Medical Information/Pharmacovigilance partner • Government contracting partner • Contract and telesales • Distribution partner identified - capabilities include: warehousing/inventory management; invoicing; customer service/ordering • Features a National Accounts sales team that calls on all major and independent nuclear pharmacies • Distributes in all 50 states • Reimbursement landscape and pricing strategy completed • Scientific platform completed • Creative advertising campaign and sales materials in development Copyright © 2019 Q BioMed Inc. 2019-06-06 20
Efforts to Maximize Uptake of METASTRON™ Establish scientific relevance and credibility • Create a METASTRON Key Opinion Leader (KOL) Advisory Board • Members will include key academic faculty, high volume treaters and METASTRON loyalists • Members will assist in developing phase IV clinical development plan, creation of publications, and deliver symposia at national conferences • Generate meta-analysis publication validating efficacy by Q4’19 Generate awareness and demand for METASTRON • Create awareness that METASTRON is “coming soon” through a teaser campaign in Q3-4’19 • Target primary customer base via digital channels and congresses • Deepen awareness and stimulate prescribing with brand launch campaign and sales efforts at manufacturing approval • Campaign communications and sales will reach customers through targeted digital Greatest Unmet Need? Awareness! “I used [strontium] a lot when it first came out. I loved it. And marketing, telesales and focused commercial team sales calls then Quadramet came out and they had the rep would constantly remind us…and switched over to Quadramet. Same • Extend reach and influence via robust scientific congress and speaker program results. I didn’t see anything different. I was just reminded about it.” – Radiation Oncologist Copyright © 2019 Q BioMed Inc. 2019-06-06 21
-001 Pharmaceutical: QBM-001 Sprinkle Formulation Rare Pediatric Minimally Verbal Autism Condition: Disorder 50,000 cases worldwide Addressable Market: 15,000 in US alone Technology Partner: ASDERA, LLC Stage: Pre-IND 505(b)2
THE CONDITION: RARE PEDIATRIC MINIMALLY VERBAL DISORDER- Autism Spectrum Disorder Prevalence Among the >60,000 US children who develop Autism Spectrum Disorders (ASD) every year, 20,000 become minimally or nonverbal and will have to rely on assisted living for the rest of their life. Of the estimated 20,000 diagnoses a year in the US, QBM-001 should be able to treat about 15,000. The lifetime cost of care is estimated at $5-10 M/person. Current cost to US healthcare is $200B per year. No treatment with lasting effects on how children develop Fundamental defects in social reciprocity and communication Repetitive and stereotypical behaviors Current Medications* and 2016 Sales Name Condition 2016 Sales Abilify® Irritability $2.0 B + (off Patent) Vyvanse® ADHD $2.0 B Risperdal® Aggression $3.0 B * These medications do not treat the condition, rather, they are psychotherapeutic interventions that ameliorate temperament/mood only. 2019-06-06 Copyright © 2019 Q BioMed Inc. 23
REGULATES FAULTY ION-CHANNELS to Allow Language Development NEURON PRUNING • 8-12 months – detection of early symptoms Children with ASD loose the ability to learn language once their language-specific neurons are naturally pruned • 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 HOW IT WORKS Diagnosis • ASD diagnosis or high-risk group with developmental delay 1 Mo. 6 Mos. 2 Yrs. 4 Yrs. 6 Yrs. • Tested for elevated serum markers • Genetically tested to exclude diseases that QBM-001 cannot treat At 2 years of age, the brain is actively developing neuron connections at the peak of the QBM-001 acts as an allosteric regulator of faulty membrane channels in leaning process. the brain that are known to cause migraines and/or seizures, thus allowing QBM-001 to potentially alleviate the condition and allow Around the age 2, the brain more actively prunes toddlers to actively develop language and avoid life-long speech and (eliminates) neurons that are not in use. intellectual disability of being nonverbal. When language development is impeded in this subset of ASD children, their language neurons do not activate and are targeted for pruning by the Results from two independent studies (Wittkowski, 2014) showed lack of language associated brain. with: poorly regulated membrane channels (excitation/inhibition imbalance) and included known ‘migraine’ genes. If you do not use it, you lose it. 2019-06-06 Copyright © 2019 Q BioMed Inc. 24
PRICE VS. COST: The Hard Facts and Emotional TRUTH 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 minimally verbal autism 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 POTENTIAL United States: 20,000 patients per year @ $100,000 - $2B Europe and ROW: 30,000 Patients per year @ 100,000 - $3B 2019-06-06 Copyright © 2019 Q BioMed Inc. 25
UTTROSIDE-B Pharmaceutical: UTTROSIDE-B Condition: Liver Cancer Addressable Market: 700,000 Aprx: 40,000/year in US Technology Partner: Oklahoma Medical Research Foundation Stage: Preclinical - Orphan Disease
THE CONDITION: LIVER CANCER The 10th Most Common Cancer Prevalence • 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 Current Standards of Care RADIATION SURGICAL High-energy x-rays or other particles destroy cancer Hepatectomy or liver transplantation cells DRUG TREATMENT CHEMOTHERAPY Tryosine kinase inhibitor antineoplastic agent, Radiofrequency ablation (RFA) and microwave therapy Nexavar™ THERMAL Percutaneous ethanol injection 2019-06-06 Copyright © 2019 Q BioMed Inc. 27
Chemotherapy IN VITRO IC-50 of Sorafenib is 5.8 uM in Hep G2 while Uttroside-B is 500 Uttroside-B appears to affect phosphorylated JNK (pro survival signaling) and capcase activity (apoptosis in liver cancer) 6000 A natural compound 5800 4000 Fractionated Saponin derived from S. nigrum Small molecule 2000 500 Steroid Glycoside 0 Uttrocide-B Sorafenib Uttroside B increases the cytotoxicity of a variety of liver cancer cell types • Up to 10x more potent than Sorafenib in pre clinical studies IN VIVO HepG2 Injected Into Mice Then Treated with 10mg of Uttroside-B for Cytotoxicity specific to cancerous liver cells One Month Provisional patent filed 200 Molecule syntheses completion June 2019 150 IND Ready Q4 2019 100 Sorafenib Tosylate (Nexavar™) is currently the only FDA- approved 50 drug for the first line treatment of liver cancer. 0 2017 sales exceed $1B Week 1 Week 2 Week 3 Week 4 Control Uttrocide B 2019-06-06 Copyright © 2019 Q BioMed Inc. 28
MAN-01 Pharmaceutical: MAN-01 Topical Drops Condition: Primary Open-Angle Glaucoma Addressable Market: 80 million patients worldwide Technology Partner: Mannin Research Inc. Stage: Preclinical
THE CONDITION: ELEVATED INTRAOCULAR PRESSURE (IOP) Primary Open-Angle Glaucoma Prevalence Current Standards of Care • 60 million patients worldwide • Pharmaceuticals • 8 million with bilateral • Laser Surgery blindness • Traditional surgery Patient Pain Points • Ineffective current standards of care • Compliance: Between 20% and 66% of patients do not use their medication as prescribed • Adherence: Fewer than 25% of patients use their eye drops continuously for 12 months Physician Paint Points • Intra-ocular pressure (IOP) is a risk factor but not an effective measuring tool • Increase compliance and adherence Market Pain Points • Market is seeking for new & better treatments (new MOAs) for glaucoma drugs • Innovation in drug design and improve drug delivery and availability 2019-06-06 Copyright © 2019 Q BioMed Inc. 30
P.O.C Data Shows Novel Relationship Between Angiopoietin-Tie2 and Elevated IOP While control eyes (A, C, F, and I) appeared normal, 8- to 9-week-old A1A2- (B, D, G, and J) and Tie2-cKO (E, H, and K) mice exhibited anterior chamber enlargement due to increased IOP (L). Optomotor response tests (M) showed impaired vision in mutant animals. Scale bars: 1 mm (F, G, and H) and 500 μm (I, J, and K). **P < 0.01 and ***P < 0.001 by Student’s 2-tailed t test. Error bars indicate SEM. No response (NR) indicates an optomotor response of less than 0.042 cycles per degree. J Clin Invest DOI: 10.1172/JCI77162 2019-06-06 Copyright © 2019 Q BioMed Inc. 31
Pathway Validated by Independent Researchers 2019-06-06 Copyright © 2019 Q BioMed Inc. 32
Lead Optimization Screening Program CHEMICAL SYNTHESIS PROJECTED PHASE I VE-PTP INHIBITION (IC50) GLAUCOMA CLINICAL TRIAL PERMEABILITY STUDIES SOLUBILITY STUDIES Q4 2019 / Q1 2020 IN VITRO TIE2 ACTIVATION ASSAY IN VIVO TIE2 ACTIVATION ASSAY PHARMACODYNAMICS PROJECTED LEAD CANDIDATE (EX-VIVO EYE OUTFLOW ASSAY) SELECTION OCULAR PENETRATION PHARMACOKINETICS Q2 2019 FULL RABBIT OCULAR PK DISEASE MODELS Data Available* *Access to Data Available under CDA 2019-06-06 COPYRIGHT © 2019 Q BIOMED INC. 33
General Synthetic Strategy GENERATED OVER 400+ COMPOUNDS 54% OF COMPOUNDS HAVE IC50
Novel Mechanism of Action with Potential to Treat Other Diseases MAN-01: Small Molecule for Glaucoma • First-in-class drug with novel MOA – Angiopoietin-Tie2 signaling pathway • 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 Glaucoma • Additional indications may include: • Acute Kidney Injury • Cardiovascular Disease • Infectious Diseases Treatment for Acute Kidney Injury, which contributes to high morbidity and mortality rate in a wide range of MAN-03 Acute Kidney Injury injuries, including common clinical care settings such as coronary artery bypass surgery, contrast-induced nephropathy and sickle cell nephropathy. Treatment with our pharmacologic small molecule will likely protect the lungs and slow disease progression in MAN-04 Cardiovascular Diseases patients with Pulmonary Artery Hypertension. Treatment may also provide protection to the myocardium in patients with Congestive Heart Failure and Myocardial Ischemia. 2019-06-06 Copyright © 2019 Q BioMed Inc. 35
GDF15 Biomarker & Companion Diagnostic: Growth Differentiation Factor 15 (GDF15) Condition: Monitoring Glaucomatous Neurodegeneration Addressable Market: 80 million glaucoma patients worldwide Technology Partner: Washington University in St. Louis Stage: Clinical using GDF15 as Biomarker; Preclinical Development of Companion Diagnostic Kit
GDF-15: Novel Biomarker for Glaucoma • Growth Differentiation Factor 15 (GDF15) is a member of the transforming growth factor (TGF-β) superfamily and was recently identified as a promising biomarker for glaucoma. • Discovered to be a biomarker for glaucoma by performing array analysis to identify chemokines, growth factors, TGFβ family members and other ligands whose expression increased in the optic nerve crush model of glaucoma but not in endotoxin- induced uveitis or light-induced retinal degeneration models. • Validated in both rat models of glaucoma and human patients and its expression correlated with disease severity. • GDF15 represents an attractive biomarker for glaucoma with distinct advantages (i.e., early detection) over conventional clinical tests and has the potential to be a first-in-class diagnostic test. Patent Application: 62/289,030 “GDF15 in glaucoma and methods of use thereof” 2019-06-06 Copyright © 2019 Q BioMed Inc. 37
MONITORING GLAUCOMATOUS NEURODEGENERATION • Accurate monitoring for evidence of disease progression is vital to preserve visual function of glaucoma patients • Desired goal of any glaucoma therapeutic intervention is neuroprotection, leading to survival of retinal ganglion cells (RGCs) • Physicians currently have only surrogate measures of glaucomatous neurodegeneration • No single examination or diagnostic test is able to accurately predict disease progression Tonometry (IOP measurement) Optical Coherence Examination of the Perimetry Tomography (OCT) Optic Nerve (Visual Field Testing) Pros: Pros: Pros: Pros: • Essential for assessing the • Automated • Can be performed routinely in a • Direct measurement of effectiveness of IOP lowering • Objectively quantifiable clinical seeing glaucoma in the patient’s treatment • Can be recorded by a visual function photograph Cons: Cons: Cons: Cons: • Values are affected by central • No reliable normative • Subjective (observer designates • Subjective (patients corneal thickness database the rim margin of the cup) respond when the light is • No direct correlation with projected) glaucomatous neurodegeneration 2019-06-06 Copyright © 2019 Q BioMed Inc. 38
Capital Markets Overview and Management Outlook
Q BioMed in the NEWS Capital Markets Q BioMed Inc Announces Acquisition of Cancer Pain Drug Metastron™ from GE Healthcare As of Dec 4, 2018 Strategic Acquisition Gives Company Ownership of Shares Outstanding 14,200,000 Market Cap $28.5 M Brand Name Drug and Related Market Authorizations in 22 Countries in Which Metastron™ Warrants Ave Price 4,8M $3.50 is Already Registered and Approved for Sale November 2018 Inside Ownership 25% Avg. Volume 50,000 30 day Float ~ 10,000,000 Year end November 30 Q BioMed Provides Important Update on QBM001 Developmental Drug Targeting a Non-Verbal and 3-Month Trading History Price $ 1.70 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 QBIO Biomed Inc. Announces Dr. Rajendra Apte Joins Advisory Board Distinguished Ophthalmology Specialist Brings Wealth of Experience SEPTEMBER 2018 2019-06-06 Copyright © 2019 Q BioMed Inc. 40
What to expect from us Metastron™ (Strontium Chloride 89) - FDA-approved Manufacturing underway - Awaiting FDA review of contract facility Revenue generation expected in 2H 2019 Ph4 Post Marketing Study for Expanded Therapeutic Label Q4 20 Revenue in 2019 QBM-001 Pre-IND Filing, Orphan Drug Filing 2H 2019 1.5year Pivotal Clinical Trial 1H 2020 Uttroside-B – Liver Cancer Complete pre-clinical and Prepare IND 2H 2019 Proof of Concept Studies H1 2020 File IND Q4 2019 MAN-01 Complete Molecule Optimization (Eye Drop) Initiate Pre-IND Studies 2H2019 – Clinical Trial IND Q4 2019 Additional Indications Formalized 2019 Pharma Partnership opportunities QBIO Potential up-list to national exchange in H2 2019 2019-06-06 Copyright © 2019 Q BioMed Inc. 41
Accelerating Biomedical Technologies from Incubation to Monetization Corporate 366 Madison Avenue New York, NY 10222 USA +1 (888) 357-2435 Executive & Investors QBIO Denis Corin, CEO dcorin@qbiomed.com qbiomed.com
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