Immuron Limited · ASX:IMC
Immuron — Investor Presentation (January 2021)
22 slides from Immuron's investor presentation, Jan 11, 2021
Slide 1: Forging Commercial & Clinical Pathways Targeting Infectious Diseases with Oral Immunotherapies
FORGING COMMERCIAL & CLINICAL PATHWAYS TARGETING INFECTIOUS DISEASES WITH ORAL IMMUNOTHERAPIES – JANUARY, 2021 JERRY KANELLOS, Ph.D. Chief Executive Officer NASDAQ: IMRN ASX: IMC 1
Slide 2: Safe Harbor Statement
Certain statements made in this presentation are forward - looking statements and are based on Immuron’s current expectations, estimates and projections . Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “guidance” and similar expressions are intended to
Slide 3: Company Highlights
COMPANY HIGHLIGHTS 3 We are a commercial and clinical - stage biopharmaceutical company focusing on infectious diseases with oral immunoglobulin - based therapies • Validated Technology Platform – with One Registered Asset, Travelan® Generating Revenue • IMM - 124E & IMM - 529, in Clinical Developme
Slide 4: Capital Profile
CAPITAL PROFILE IMMURON LIMITED (ASX:IMC NASDAQ:IMRN) Current Top 10 Shareholders Current Company Market Capitalization AUD$49.90M ≈ USD$38.46M (6 th January 2021) US$20 million capital raise with HC Wainwright (24 July 2020) 1 ADS = 40 Ordinary Shares 4 Rank Holder Name Current Qty % 1 HSBC CUSTODY
Slide 5: Development Pipeline
DEVELOPMENT PIPELINE ImmuUren Commercial Products L2 ) IMM-124E. IMM-529 Naval Medical Research Center 6 Walter Reed Army Institute of Research PRE-CLINICAL PHASE | PHASE II PHASE III MARKET Travelan® - commercial product Australia Protectyn® - commercial product Australia Travelan® - commercial pro
Slide 6: Platform Overview: Oral Immunoglobulins
PLATFORM OVERVIEW: ORAL IMMUNOGLOBULINS D e v elopme n t of Highly Specific Vaccines Isolation of h yperimmune antibody - rich bovine colostrum Oral A n timic r obial therapeutics without drawbacks of antibiotics Toxin Neutralization + Clearance of targeted gut pathogens 6
Slide 7: Mechanism of Action - Targeting Enteric Pathogens
7 MECHANISM OF ACTION - TARGETING ENTERIC PATHOGENS P r e - Clin i c al Studies • Delivers high levels of orally active antibodies to specific enteric pathogenic bacteria which colonize the gastrointestinal tract and cause infection and disease. • Biological therapeutics which directly target the ma
Slide 8: US DoD R&D Collaboration Agreements
US DOD R&D COLLABORATION AGREEMENTS • Armed Forces Research Institute of Medical Sciences (AFRIMS) – June 2016 • Naval Medical Research Center (NMRC) – August 2016 • Walter Reed Army Institute of Research (WRAIR) – June 2016 • Travelan® binds 180 pathogenic strains of bacteria from infected personne
Slide 9: New U.S. DoD Research Collaboration to Evaluate a New Therapeutic Against Campylobacter
New U.S. Department of Defense Research Collaboration with Immuron to Develop and Clinically evaluate a New Therapeutic against Campylobacter 9 Key Highlights : AU $5.5 (USD $3.7) million funding approved by the U.S. Department of Defense to develop and clinically evaluate a new oral therapeutic t
Slide 10: Two Human Clinical Trials Planned
Two Human Clinical Trials Planned: To evaluate the efficacy of the New Drug in Moderate To Severe Camylobacteriosis and Infectious Diarrhea Caused by ETEC NMRC DRUG DEVELOPMENT PLAN Execute Prevention Trials 10 File IND with Plans for two Double - Blind, Placebo Controlled Prevention Trials Hold Pre
Slide 11: Background of Travelan: Plan to Expand Use
BACKGROUND OF TRAVELAN®: PLAN TO EXPAND USE Marketed in Australia, USA and Canada Status with FDA: IND 14,933* COMMERCIAL PRODUCT DRUG CANDIDATE IMM - 124E Plan to develop IMM - 124E as an approved drug in the USA targeting Travelers’ Diarrhea *IMM - 124E for treatment of NASH 11
Slide 12: What Is Travelers' Diarrhea?
WHAT IS TRAVELERS’ DIARRHEA? • Caused by consuming food or water infected with pathogens. Three or more unformed stools in 24 hours. • Bacterial pathogens are the predominant risk 1 . • Enterotoxigenic E. coli (ETEC) are the predominant pathogens 2,3 : 42% in Latin America 28% in Southeast Asia • Up
Slide 13: US Sales Forecast for Travelan if Approved as Drug by FDA
US SALES FORECAST FOR TRAVELAN®: IF APPROVED AS DRUG BY THE FDA Market potential figure derived from: 2014 figures of US citizens traveling to high risk destinations for TD (44.3 million) 1 and obtaining pretravel advice (22.2 million) 2 . Sources of pre - travel advice include primary care provider
Slide 14: IMM-124E Drug Development Plan
Revamp Travelan® for FDA approval as drug to reduce the risk of Travelers’ Diarrhea (TD) in travelers to endemic areas: IMM - 124E DRUG DEVELOPMENT PLAN Execute Field Trial and File Registration Package 14 File IND with Plan for Double - Blind, Placebo Controlled Field Trial in Travelers’ to TD Ende
Slide 15: Neutralizing Clostridioides difficile While Sparing the Microbiome: IMM-529
NEUTRALIZING CLOSTRIDIODES DIFFICILE , WHILE SPARING THE MICROBIOME IM M - 529 15
Slide 16: Clostridium Difficile Market Opportunity
CLOSTRIDIUM DIFFICILE MARKET OPPORTUNITY 16 1. http s//w ww. globaldata.com/global - clostridium - difficle - infection - market - approach - 2016 - 2026 2. Jagai, et.al., BMC Gastroenterology, 2014:14:211 Trends in gastroenteritis - associated mortality in the USA. 3. K. Desai, BMC Infect. Dis., 20
Slide 17: The Unmet Need
THE UNMET NEED • Current standard of care for C. difficile includes vancomycin, metronidazole & fidaxomicin • Therapies plagued by significant CDI recurrences ( * 1st relapse: 25%; 2nd: 40%; 3rd: 60%) underscoring need for new treatments • Growing resistance to vancomycin treatment • Some treatments
Slide 18: IMM-529 Opportunity
• IMM - 529 highly differentiated – neutralizes C. difficile but does not impact microbiome • Targets not only toxin B but also spores and vegetative cells responsible for recurrence • Potential use in combination with standard of care • Targets many isolates IMM - 529 OPPORTUNITY Toxin B 18
Slide 19: IMM-529 Drug Development Plan
Develop clinical protocol for FDA approval as drug to prevent recurrent Clostridiodes difficile Infection: IMM - 529 DRUG DEVELOPMENT PLAN Execute recurrence prevention trial 19 File IND with plan for placebo controlled trial for prevention of disease recurrence Hold pre - IND meeting to discuss cli
Slide 20: Immuron Reports Neutralizing Activity Against SARS-CoV-2
Immuron Reports Neutralizing activity Against SARS - CoV - 2 20 Key Points Immuron’s Hyper - immune Bovine Colostrum used to manufacture Travelan® and Protectyn® demonstrates antiviral activity against the COVID - 19 virus in laboratory studies Immuron’s technology platform offers a potential ne
Slide 21: Key Milestones Expected to Drive Value
KEY MILESTONES EXPECTED TO DRIVE VALUE Results from US Army Shigella animal studies & COVID - 19 Research Program expected in 2021 1H 2020 2H 2020 1H 2021 2H 2021 21 • Pre - IND Meeting to Discuss IMM - 124E Phase 3 Clinical Development • Pre - IND Meeting to Discuss Phase 2 NMRC Clinical Developmen
Slide 22: Thank You
THANK YOU Dr Jerry Kanellos – Chief Executive Officer • Over twenty years’ experience in pharmaceutical and biotechnology industries. • Former Chief Operating Officer of TransBio Ltd. Responsible for strategic identification, development and maintenance of global commercial partnerships, along with