Asep Medical Holdings Inc · CSE:ASEP
Asep Medical — Investor Presentation (December 2021)
26 slides from Asep Medical's investor presentation, December 2021
Slide 1: Fighting Antibiotic Failure on Two Fronts
FIGHTING ANTIBIOTIC FAILURE ON TWO FRONTS asepmedical.com
Slide 2: A Rare Combination
A RARE COMBINATION ASEP brings both a novel diagnostic and a therapeutic approach to the urgent, multibillion-dollar problem of antibiotic failure. DIAGNOSTIC THERAPEUTIC Novel assay provides earlier, faster Patented pharmaceutical peptide diagnosis and a targeted treatment targets currently untreat
Slide 3: The Crisis: Widespread and Deadly
THE CRISIS: WIDESPREAD AND DEADLY* 49 million/year 10 to 1000x cases of sepsis more resistant to most antibiotics 11 million 0 sepsis deaths per year drugs approved for biofilms 100% 65% incidence of sepsis in COVID deaths of all infections are biofilms *data on file 3 ASEP MEDICAL | ADVANCING THE P
Slide 4: Multibillion Dollar Opportunity
MULTIBILLION DOLLAR OPPORTUNITY $41.9B Global Antibiotic Market CAGR: 3% Global MRSA Global Device Global CRS Global Ear Global Bacterial Global Urinary Global Wound Market* Infection Market Market Infection Market Vaginosis Tract Infections Care Market $1.0B $2.0B $2.1B $2.8B $4.5B $9.5B $20B CAGR:
Slide 5: Groundbreaking Diagnostic Technology
GROUNDBREAKING DIAGNOSTIC TECHNOLOGY Rapid diagnostic test delivers results in ~ 1 hour, allowing doctors to make better informed treatment decisions to improve sepsis survival rates. 5 ASEP MEDICAL | ADVANCING THE PARADIGM OF PATIENT CARE
Slide 6: Every Hour Counts
EVERY HOUR COUNTS 6 ASEP MEDICAL | ADVANCING THE PARADIGM OF PATIENT CARE
Slide 7: Diagnostic Advantages
DIAGNOSTIC ADVANTAGES Greater sensitivity and Earlier recognition of Reliable diagnosis for Next-generation molecular specificity than the SIRS sepsis, at a time when determining the most diagnostic focusing on (Systemic Inflammatory patients are admitted to appropriate treatment to patient-specific
Slide 8: Potent Therapeutic Technology
POTENT THERAPEUTIC TECHNOLOGY Proprietary peptide technology directly addresses the ineffectiveness of current treatment options by suppressing biofilm growth and reducing inflammation. 8 ASEP MEDICAL | ADVANCING THE PARADIGM OF PATIENT CARE
Slide 9: Attacking the Biofilm
ATTACKING THE BIOFILM MRSA Biofilm on Human Skin Our Peptide Destroys Biofilm Bacterial Biofilms are very Resistant Communities that grow on Body Surfaces 9 ASEP MEDICAL | ADVANCING THE PARADIGM OF PATIENT CARE
Slide 10: Urgent Unmet Needs
URGENT UNMET NEEDS • 0 approved treatments for biofilms Methicillin-resistant Staphylococcus Aureus • >2.8M antibiotic-resistant infections in (MRSA) contributes to US annually more deaths in the US per year than homicide, Parkinson’s, emphysema • The most dangerous ESKAPE pathogens include untreata
Slide 11: Peptide Technology Highlights
PEPTIDE TECHNOLOGY HIGHLIGHTS Antibiofilm Activity Antibiotic Synergy Safe and Effective in Animal Infection Models Potent activity against all major Work in combination with clinically relevant bacteria growing conventional antibiotics to Work in in vivo models of biofilm as antibiotic-resistant bi
Slide 12: Chronic Rhinosinusitis (CRS)
Initial Clinical Opportunity: CHRONIC RHINOSINUSITIS (CRS) CRS is a lifelong condition causing painful inflammation due to bacterial biofilm infection: • 242,000 emergency room visits annually • Antibiotics do NOT work — do NOT target the Biofilm — only treat symptoms NOT the cause • $30,000/year: c
Slide 13: Grant Funding
GRANT FUNDING Molecular Diagnostics Peptide Therapeutics All funding prior to current financing was non-dilutive, largely research grants: $3,387,000 CND $2,736,000 US $6,978,000 CND $3,600,000 CND $450,000 CND $250,000 CND $1,256,000 US $194,176 CND $527,000 US 13 ASEP MEDICAL | ADVANCING THE PARAD
Slide 14: Intellectual Property
INTELLECTUAL PROPERTY Diagnostics Therapeutics 1 PATENT FAMILY 3 PATENT FAMILIES + 1 UNDERWAY SEVERAL UNDERWAY 3 PATENTS AWARDED 12 PATENTS AWARDED Patent protection has been filed for the discovery of a Small Cationic Antimicrobial Peptides predictive gene expression signature at first clinical 8 P
Slide 15: The Share Structure
THE SHARE STRUCTURE Category # of Shares Issued & Outstanding 56,140,344 Warrants & Options 4,540,000 @ $0.50 Total Fully Diluted Shares 60,680,344 15 ASEP MEDICAL | ADVANCING THE PARADIGM OF PATIENT CARE
Slide 16: Timeline
TIMELINE Q1 Q2 Q3 Q4 Q5 Q6 Finalization of 510K Submission Strategic Partner DIAGNOSTICS Commercial Launch Final Clinical Validation FILE FOR APPROVAL Finalize Pre-clinical Development Development of IND Filing THERAPEUTICS Clinical Study Design & Pre-IND Meeting IND APPROVAL 16 ASEP MEDICAL | ADVAN
Slide 17: Investment Highlights
INVESTMENT HIGHLIGHTS Large Addressable Extensive Intellectual Novel Technologies Global Markets Property In the early diagnosis of sepsis With NO efficient clinical solutions and treatment of biofilm Infections Portfolio of both Diagnostics (unmet medical needs) and Therapeutics Experienced Near-te
Slide 18: Ancillary Slides
ANCILLARY SLIDES 18 ASEP MEDICAL | ADVANCING THE PARADIGM OF PATIENT CARE
Slide 19: Management Team
MANAGEMENT TEAM Rudy A. Mazzocchi Dr. Fadia Saad Dr. Robert Hancock Jennifer Gretchen Dr. Evan Haney Chairman / CEO Chief Bus. Dev. Officer Chief Operating Officer Chief Financial Officer Chief Scientific Officer • Over 30 years senior • Extensive track record in • Nearly 40 years research and • Str
Slide 20: Board of Directors
BOARD OF DIRECTORS Rudy A. Mazzocchi Dr. Robert Hancock Derrold Norgaard Tim Murphy Chairman / CEO Director Director / Chair – Audit Committee Director • Over 30 years senior executive • Nearly 40 years research and • Fellow of the Chartered • Seasoned business executive and management, technology a
Slide 21: Biofilm Associated Diseases and Affected Organs
BIOFILM ASSOCIATED DISEASES AND AFFECTED ORGANS BODY SYSTEM AFFECTED ORGANS DISEASES Upper and Lower Airways Bronchiectasis; Pneumonia; Tuberculosis Respiratory Upper and Lower Airways Cystic Fibrosis Middle Ear Otitis Media Ear, Nose and Throat Nasal cavity and Paranasal Sinuses Chronic Rhinosinusi
Slide 22: Validation Studies: ASEP Solution to CRS
VALIDATION STUDIES ASEP Solution to CRS ASEP Peptides address both Biofilm Infections and associated Inflammation and have demonstrated excellent results in Animal Models Imaged 5 Days Post-Infection Strong Anti-Bacterial Strong Anti-Inflammatory Response Response Nasal lavage 6 500 Bacterial recove
Slide 23: Designation Benefits
DESIGNATION BENEFITS Orphan Drug Designation Awardees are granted the following benefits from the FDA: • Lower hurdles to approval, longer exclusivity, lower market costs, faster uptake, premium pricing, favorable reimbursement, • Tax credits of 50% off the clinical drug testing cost awarded upon ap
Slide 24: Comparables – Molecular Diagnostics
COMPARABLES – MOLECULAR DIAGNOSTICS STOCK PHASE OF 2020 REVENUES MARKET CAP COMPANY CLINICAL INDICATIONS SYMBOL DEVELOPMENT ($MM USD) ($MM USD) Distinguish between sepsis and - Approved (SeptiCyte) - - non-infectious systemic inflammation Detection and identification of a broad range Approved in EU
Slide 25: Comparables – Therapeutics
COMPARABLES – THERAPEUTICS PHASE OF 2020 REVENUES MARKET CAP COMPANY STOCK SYMBOL CLINICAL INDICATIONS DEVELOPMENT ($MM USD) ($MM USD) Hospital-acquired or Ventilator-acquired Pre-clinical Pre-revenue - - bacterial pneumoniae - Prosthetic Joint infections Phase II Pre-revenue - POLN SW Pseudomonas a
Slide 26: CRS Regulatory Strategy
CRS REGULATORY STRATEGY • Pursue Orphan Drug status for CRS in PROJECTED REVENUE FOR cystic fibrosis patients—a high unmet ORPHAN DRUGS IN 2026 medical need, with no approved drugs. 255bn USD • Pursue “fast track” status for drugs addressing antimicrobial resistance— GLOBAL GROWTH (equivalent of orp
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