Immuron Limited · ASX:IMC
Immuron — Investor Presentation (December 2021)
17 slides from Immuron's investor presentation, Dec 16, 2021
Slide 1: Forging Commercial & Clinical Pathways
For personal use only FORGING COMMERCIAL & CLINICAL PATHWAYS TARGETING INFECTIOUS DISEASES WITH ORAL IMMUNOTHERAPIES – DECEMBER, 2021 JERRY KANELLOS, Ph.D. CEO NASDAQ: IMRN ASX: IMC 1
Slide 2: Safe Harbor Statement
SAFE HARBOR STATEMENT For personal use only 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”
Slide 3: Company Highlights
COMPANY HIGHLIGHTS We are a commercial and clinical-stage biopharmaceutical company For personal use only focusing on infectious diseases with oral immunoglobulin-based therapies • Review of Strategic Plan • Review of R&D Project Pipeline o Travelan US Drug Development Plan o NMRC Drug Development P
Slide 4: Pipeline Development
For personal use only PIPELINE DEVELOPMENT 4
Slide 5: Travelan: Plan for Expanded Use
TRAVELAN®: PLAN FOR EXPANDED USE WITH PARTIAL SUPPORT BY US DOD FOR DOSE FINDING For personal use only DRUG CANDIDATE Immuron is pursuing a regulatory pathway to IMM-124E license Travelan® with the FDA via a Biologics Status with FDA: License Application (BLA) with a proposed IND 14,933 indication
Slide 6: Travelan Drug Development Plan
TRAVELAN® DRUG DEVELOPMENT PLAN Travelan® for FDA approval as biologic to reduce the risk of travelers’ For personal use only diarrhea (TD) in travelers to endemic areas: DoD-supported challenge trial File IND with Plan for Double- Blind, Placebo- Execute Field Assimilate Data Hold Pre-IND Trial
Slide 7: Rationale of Phase to be Supported by US DoD
RATIONALE OF PHASE 2 For personal use only TO BE SUPPORTED BY US DOD Travelan® efficacy studies were performed using two different doses (200 mg and 400 mg) 3 times a day Such a regimen is cumbersome for military troops deployed in austere environments and military field studies have shown that
Slide 8: Study Design & Timeline of the Phase
STUDY DESIGN & TIMELINE OF THE PHASE 2 For personal use only Randomized (1:1), double-blind, placebo-controlled trial in 60 healthy, adult subjects • Admission to inpatient facility (two repetitive cohorts) Product N • Once daily dosing of Travelan®/placebo • Challenge with 2x107 CFU of ETEC strai
Slide 9: Randomized Trial of Non-Antibiotic OTC Products in Travelers' Diarrhea (P4TD)
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL EVALUATING THE EFFICACY OF NON-ANTIBIOTIC OTC PRODUCTS IN TRAVELERS’ DIARRHEA (TD) PREVENTION (P4TD) For personal use only CURRENT STATUS – PLAN TO COMMENCE ENROLMENT APRIL 2022 Primary Objective: To evaluate the clinical efficacy of Travelan®, Fl
Slide 10: Efficacy of Non-Antibiotic OTC Products in TD Prevention (P4TD)
THE EFFICACY OF NON-ANTIBIOTIC OTC PRODUCTS IN TRAVELERS’ DIARRHEA (TD) PREVENTION (P4TD) For personal use only • The study products used in the clinical trial are considered dietary supplements not medicines approved by the FDA • Clinical Trial Design approved by IRB not FDA • Each product will be
Slide 11: NMRC Campetec Drug Development Plan
NMRC CAMPETEC DRUG DEVELOPMENT PLAN Two Human Clinical Trials Planned: To evaluate the efficacy of the New Drug in For personal use only Infectious Diarrhea Caused by ETEC and Moderate To Severe Camylobacteriosis File IND with Plans for two Assimilate Data Hold Pre-IND Double-Blind, Execute to S
Slide 12: NMRC Campetec Drug Development Plan: Current Status
NMRC CAMPETEC DRUG DEVELOPMENT PLAN CURRENT STATUS For personal use only • cGMP DRUG PRODUCT Manufacture Completed • CLINICAL STUDY IND Application – In progress FDA Review and Approval of IND – Q1 CY22 ETEC Study Initiation at John Hopkins – Q2 CY22 12
Slide 13: IMM-529 Drug Development Plan
IMM-529 DRUG DEVELOPMENT PLAN Develop clinical protocol for FDA approval as drug to prevent recurrent For personal use only Clostridiodes difficile Infection: File IND with Hold pre-IND plan for placebo Develop clinical meeting to controlled trial Execute registration discuss clinical for prevention
Slide 14: IMM-529 Drug Development Plan: Current Status
IMM-529 DRUG DEVELOPMENT PLAN CURRENT STATUS For personal use only • COLOSTRUM PRODUCTION Completed • DRUG SUBSTANCE cGMP manufacture – Q1 CY22 • DRUG PRODUCT cGMP manufacture – Q2 CY22 • CLINICAL DEVELOPMENT Clinical Protocol - Completed Clinical Sites & Principal Investigators – Identi
Slide 15: IMM-124E SARS-CoV-2 Research & Development Proposal
IMM-124E SARS-COV-2 RESEARCH & DEVELOPMENT PROPOSAL CURRENT STATUS For personal use only RESEARCH & DEVELOPMENT • Monash Research Services Agreement – Completed • Research Agreement with Doherty Institute - Executed • The Aims of this work are as follows: Testing of the neutralizing activity of th
Slide 16: Key Milestones Expected to Drive Value
KEY MILESTONES EXPECTED TO DRIVE VALUE For personal use only 1H 2H 1H 2H 2022 2022 2023 2023 • NMRC IND Submission • Topline Results • Topline Results • IMM-124E Infectious diarrhea (Q1 CY22) NMRC ETEC Study NMRC pivotal field clinical study • Initiate NMRC Phase Campylobacter • Initiate NMRC Phase
Slide 17: Thank You
THANK YOU For personal use only 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 par