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Immuron Ltd — Investor Presentation 2019
Aug 15, 2019
35121_rns_2019-08-15_80d3dee0-35d9-477d-a4c2-b1f5d3f10b54.pdf
Investor Presentation
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FORGING COMMERCIAL & CLINICAL PATHWAYS
TARGETING INFECTIOUS DISEASES WITH ORAL IMMUNOTHERAPIES – AUGUST 2019
GARY S. JACOB, Ph.D. CEO
NASDAQ: IMRN ASX: IMC
1
SAFE HARBOR STATEMENT
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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 identify forward-looking statements.
Although Immuron believes the forward-looking statements are based on reasonable assumptions, they are subject to certain risks and uncertainties, some of which are beyond Immuron’s control, including those risks or uncertainties inherent in the process of both developing and commercializing technology. As a result, actual results could materially differ from those expressed or forecasted in the forward-looking statements.
The forward-looking statements made in this presentation relate only to events as of the date on which the statements are made. Immuron will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances or unanticipated events occurring after the date of this presentation except as required by law or by any appropriate regulatory authority.
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2
COMPANY HIGHLIGHTS
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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
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IMM-124E & IMM-529, in Clinical Development for Treatment of Gastrointestinal Disorders and C. difficile Infections
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Plan for Accelerated R egulatory Path to Approval for IMM-124E (Travelan®) as Drug to Prevent Travelers’ Diarrhea in USA
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3
DEVELOPMENT PIPELINE: TWO-PRONGED PLAN
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1
2
| DEVELOPMENT STAGE | DEVELOPMENT STAGE | DEVELOPMENT STAGE | DEVELOPMENT STAGE | DEVELOPMENT STAGE | HIGHLIGHTS | |
|---|---|---|---|---|---|---|
| PRE-CLINICAL | PHASE 1 | PHASE 2 | PHASE 3 | MARKET | ||
| ANTI-INFLAMMATORY PROGRAMS | ||||||
| Travelan® | Commercial product - Australia Commercial product - Canada Health Canada NPN 80046016 (2015) TGA ARTG Aust L106709 (2004) |
|||||
| Commercial product - USA Dietary supplement (2015) |
||||||
| IMM-124E (Travelan®) PLAN TO DEVELOP AS DRUG TO PREVENT TRAVELERS’ DIARRHEA IN USA |
||||||
| IMM-529 TO PREVENT RECURRENCE IN C. DIFFICILE PATIENTS |
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4
PLATFORM OVERVIEW: ORAL IMMUNOGLOBULINS
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Toxin
Neutralization
+
Oral
Isolation of
Development Antimicrobial Clearance of
hyperimmune
of Highly
therapeutics targeted gut
antibody-rich
Specific without pathogens
bovine
Vaccines
drawbacks of
colostrum
antibiotics
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5
MECHANISM OF ACTION -TARGETING ENTERIC PATHOGENS
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Pre-Clinical
Studies
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Delivers high levels of orally active antibodies to specific enteric pathogenic bacteria which colonize the gastrointestinal tract and cause infection and disease.
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Biological therapeutics which directly target the major pathogenic virulent components;
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Molecules which facilitate bacterial adhesion to host cell intestinal epithelium
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Surface layer proteins which contribute to bacterial colonization and motility
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Endotoxins and enterotoxins that cause disease
With Travelan[®] : Bacteria neutralized by Travelan[® ] antibodies
Without Travelan[®] : Bacteria attach to gut wall and infect
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6
US DOD R&D COLLABORATION AGREEMENTS
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Collaboration on Development of a Shigella-Specific Therapeutic
-
Armed Forces Research Institute of Medical Sciences (AFRIMS) – June 2016
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Naval Medical Research Center (NMRC) – August 2016
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Walter Reed Army Institute of Research (WRAIR) – June 2016
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Travelan® binds 180 pathogenic strains of bacteria from infected personnel deployed in Bhutan, Cambodia, Nepal and Thailand
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7
BACKGROUND OF TRAVELAN®: PLAN TO EXPAND USE
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COMMERCIAL PRODUCT
DRUG CANDIDATE IMM-124E
Marketed in Australia, USA and Canada
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Plan to develop IMM-124E as an approved drug to prevent Travelers’ Diarrhea
Status with FDA: IND 14,933*
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*IMM-124E for treatment of NASH
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8
WHAT IS TRAVELERS’ DIARRHEA?
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Caused by consuming food or water infected with pathogens. Three or more unformed stools in 24 hours.
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Bacterial pathogens are the predominant risk[1] .
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Enterotoxigenic E. coli (ETEC) are the predominant pathogens[2,3] : 42% in Latin America 28% in Southeast Asia
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Up to 70% of travelers suffer from travelers’ diarrhea[4] .
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1 – Steffen, R. 2017 Epidemiology of travelers’ diarrhea. Journal of Travel Medicine 24(1)
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2 – Leder, K. 2015 Advising Travelers about Management of Travelers’ Diarrhea. Australian Family Physician, vol 44 No. 1-2 Jan. Feb 2015
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- 3 – Castelli et. al., Epidemiology of Travelers’ Diarrhea, J. Travel Medicine 2001; 8 (Suppl2) S26-S30 4 – CDC Yellow Book 2018, Chapter 2 Travelers’ Diarrhea.
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9
ANTIBIOTIC RESISTANCE: OPPORTUNITY FOR TRAVELAN®
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International Society of Travel Medicine, 2017 guidelines for treating Travelers’ Diarrhea included[1] :
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Antibiotics should NOT be used routinely, except patients at high risk of complications
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Rifaximin recommended when antibiotic prophylaxis is indicated
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Fluoroquinolones not recommended for prophylaxis[2]
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Insufficient evidence to recommend prebiotics or probiotics
The opportunity: Travelan®, the alternative to antibiotic treatment of TD
- 1 Riddle et al. 2017. Guidelines for the prevention and treatment of travelers’ diarrhea: a graded expert panel report. Journal of Travel Medicine 24(1).
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- 2 Tribble, D. 2017 Resistant pathogens as causes of traveler’s diarrhea globally and impact(s) on treatment failure and recommendations. Journal of Travel Medicine 24(1)
10
TRAVELAN® AS A DRUG TO PREVENT TRAVELERS’ DIARRHEA
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Travelan® evaluated in two randomised, double-blind, placeboControlled Human Infection Model challenge clinical trials
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90 healthy volunteers in Study 1 & 2
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Published in Scandinavian Journal of Gastroenterology
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STUDY 1: 30 participants
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PLACEBO IMM-124E
400mg TID
15 15
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Oral challenge with O78 ETEC strain (H10407)
Diarrhea was defined as passage of two or more unformed stools during 48 hour period within 72 hours of the challenge
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RESULTS: Travelan® provided over 90% prophylactic efficacy against diarrhea due to infection by the major strain of E.coli that causes TD
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Otto et al. 2011 Randomized Control Trials using a tablet formulation of hyperimmune bovine colostrum to prevent diarrhea caused by ETEC in volunteers. Scandinavian Journal of Gastroenterology, 2011; 46: 862–868.
11
SUMMARY OF RESULTS FROM STUDY 1
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| Treatment Group Placebo Colostrum_p_ |
Treatment Group Placebo Colostrum_p_ |
Treatment Group Placebo Colostrum_p_ |
||
|---|---|---|---|---|
| Number of volunteers | 15 | 15 | ||
| Number of volunteers with diarrhea | 11 (73%) | 1 (7%) | 0.0005 | |
| Number of diarrheal stools/volunteer (mean + SEM) | 4.4±0.9 | 0.4±0.4 | 0.0004 | |
| Mean number of diarrheal stools per volunteer with diarrhea (mean and range) |
6 (2 – 8) | 6 (6) | NS | |
| Abdominal pain | 5 (33%) | 0 (0%) | 0.04 | |
| ETEC H10407 isolated from feces after challenge | 15 (100%) | 12 (80%) | NS |
*Fisher’s exact test or Student’s t-test (two-tailed) as appropriate. NS, not significant
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12
TRAVELAN®: ORAL CHALLENGE STUDY PREVENTION OF SHIGELLOSIS (BACILLARY DYSENTERY) IN PRIMATES*
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12 juvenile rhesus monkeys randomly assigned to Travelan® (n=8) or placebo (high protein milk powder) (n=4) treatment groups
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Travelan® or placebo (500mg) was administered 2x daily for 6-days, starting on day 0
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Each monkey challenged with 2.8 x 10[9] Shigella flexneri 2a intragastrically on day 3
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Travelan® /placebo treatment stopped on day-6. Monkeys monitored through to day 14
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Faecal samples taken 2 x daily and cultured to establish presence/absence of Shigella flexneri
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Animals continually monitored for clinical signs
*Collaborative animal model study with AFRIMS & WRAIR
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13
RESULTS OF TRAVELAN® SHIGELLA CHALLENGE STUDY*
3 x10[9] S. flexneri
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Travelan® group
S. flexneri was undetectable in
consecutive fecal samples by day 7
in 4 of 6 (67%) survivors and by day
“Travelan®” x 6 days No Treatment x 8 days 9 in the remaining 2 (33%)
survivors
DAYS 1 2 3 4 5 6 7 8 9 10 11 12 13 14
“Placebo” x 6 days
Placebo control group
1
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= last day of S. flexneri consecutive +ve stool culture
*Collaboration with AFRIMS & WRAIR
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14
IMM-124E DRUG DEVELOPMENT PLAN
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Revamp Travelan® for FDA approval as drug to prevent Travelers’ Diarrhea in travelers to endemic areas:
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File IND with
Hold Pre-IND Single Double- Execute
Assimilate Data
Meeting to Blind & Placebo Prevention Trial
to Support
Discuss Merits of Controlled Trial and File
Literature-Based
505(b)(2) for Prevention of Registration
FDA Submission
Application Travelers’ Package
Diarrhea
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15
TRAVELAN® COMMERCIAL PROFILE: INCREASING SALES ADDRESSING LARGE MARKETS
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Immuron Sales
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2019 Global market - US $630M Expected to reach US $890M by 2024 at 7% CAGR[1]
- https://www.marketwatch.com/press-release/at-71-cagrtravelers-diarrhea-therapeutics-market-size-to-reach-usd890-million-by-2024-2019-05-08
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$3,000,000
$2.68M
$2,500,000
$2.01M
$2,000,000
$1.38M
$1,500,000
$1,000,000
$500,000
$0
FY17A FY18A FY19B
AUD
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16
US SALES FORECAST FOR TRAVELAN®: IF APPROVED AS DRUG TO PREVENT TD
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MARKET POTENTIAL FOR TRAVELAN® SALES:
USD >$100 MILLION
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, travel medicine specialist, company doctors, pharmacist, and travel agencies[2] . Our forecast utilizes a very conservative estimate for % of US citizens purchasing Travelan® after seeking pre-travel advice.
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U.S. Department of Commerce, International Trade Administration, National Travel and Tourism Office. U.S. Citizen Traffic to Overseas Regions, Canada & Mexico 2014. Monthly Statistics, U.S.Outbound Travel by World Regions. 2014. Available at: http://travel.trade.gov/view/m-2014-O-001/index.html. Accessed June 26, 2015.
-
Mathyas Wang , MD , Thomas D. Szucs , MD, MBA, MPH, LLM , and Robert Steffen , MD. Economic Aspects of Travelers ’ Diarrhea. Journal of Travel Medicine, Volume 15, Issue 2, 2008, 110–118
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17
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COMPETITOR MARKET ANALYSIS – ANTI-DIARRHEAL DRUGS
| Drug | Indication | Dosing | Ave cost – 2 week trip |
Revenue USD Millions (Year) |
|---|---|---|---|---|
| FDA APPROVED DRUG TREATMENTS FOR DIARRHEA | ||||
| PEPTO BISMOL (BSS) | Relief for heartburn, nausea, indigestion, upset stomach and diarrhea. |
2 tabs QID | $20.971 | 82.6 (2013)2 |
| IMMODIUM | Decrease the frequency of diarrhea in TD, gastroenteritis, inflammatory bowel disease, and short bowel syndrome. |
2 tabs (2 mg) | $17.331 (48 caplets) |
82.5 (2013)2 |
| CIPROFLOXACIN (FLUOROQUINOLINE) |
Bacterial infections. | 500 mg | $44.523 | 40.8 (2015)3 |
| RIFAXIMIN | Treatment of Travelers’ Diarrhea. | 3 caps (200 mg) TID |
$6574 | |
| PRESENTLY, THERE IS NO FDA APPROVED DRUG TO PREVENT TRAVELERS’ DIARRHEA | ||||
| TRAVELAN® | Dietary Supplement. | 3 caps (200 mg) TID |
$30 – 30 caplets |
0.7 (2019)5 |
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Amazon.com
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Top 10 OTC brands for digestives by revenue in the USA in 2013
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Almalki et. al., Utilization, spending & price trends for quinolones in the US, Pharmacoecon Open 2017 Jun: 1(2): 123-131
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Drugs.com Xifaxan (rifaximin) price guide. Cost of Xifaxan oral tablet 200 mg ~$657 for 30 tablets
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- US Sales for Travelan – FY2019
18
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NEUTRALIZING CLOSTRIDIUM DIFFICILE , WHILE SPARING THE MICROBIOME
IMM-529
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19
CLOSTRIDIUM DIFFICILE MARKET OPPORTUNITY
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Clostridium difficile ( C. difficile ) is a bacterium that causes diarrhea and more serious intestinal conditions such as colitis
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Therapeutic market expected to grow from USD $630 million in 2016 to over $1.7 billion by 2026 – CAGR 15%[1]
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Leading cause of gastroenteritis-associated mortality in U.S.[2]
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Approx. 44,500 patients[3] died in 2014 from C. difficile infections (U.S.)
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Potential orphan disease (7 years market exclusivity and premium pricing)
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https//www.globaldata.com/global-clostridium-difficle-infectionmarket-approach-2016-2026
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Jagai, et.al., BMC Gastroenterology, 2014:14:211 Trends in gastroenteritis-associated mortality in the USA.
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K. Desai, BMC Infect. Dis., 2016,16:303
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20
THE UNMET NEED
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Current standard of care for C. difficile includes vancomycin, metronidazole & fidaxomicin
-
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Therapies plagued by significant CDI recurrences ( 1st relapse: 25%; 2nd: 40%; 3rd: 60%) underscoring need for new treatments
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Growing resistance to vancomycin treatment
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Some treatments are administered intravenously rather than via the gut where C. difficile resides
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- *Isobel Ramsay, Nicholas Brown and David Enoch. Recent Progress for the Effective Prevention and Treatment of Recurrent Clostridium difficile Infection. Infectious Diseases: Research and Treatment Volume 11: 1–4 (2018). DOI: 10.1177/1178633718758023
21
IMM-529 OPPORTUNITY
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IMM-529 highly differentiated – neutralizes C. difficile but does not impact microbiome
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Targets not only toxin B but also spores and vegetative cells responsible for recurrence
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Potential use in combination with standard of care
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Targets many isolates
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Toxin B
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22
THE C. DIFFICILE PREVENTION OF RECURRENT CDI MOUSE MODEL*
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C57BL/6 mice 6–7 weeks
C. difficile challenge Administration of water
(10 [3] spores) or IMM-529
Day -10 -1 0 +8
Antibiotics in drinkingwater to
induce susceptibility to C. difficile Vancomycin treatment
ceases
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Monitor:
-
Weight loss
-
Physiological appearance
Administration of vancomycin alone or vancomycin + IMM-529 12 hour post infection
- Activity
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- Diarrhoea
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*Collaboration with Prof. Dena Lyras, Monash University, Australia
23
IMM-529 ANIMAL MODEL ‘RECURRENCE’ STUDY
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Relapse Study
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All studies statistically significant
Demonstrated ~80% survival rate (7/9) vs. ~10% survival rate in control group (1/9)
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24
THE C. DIFFICILE PREVENTION MOUSE MODEL
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C57BL/6 mice 6–7 weeks Vancomycin or
IMM-529 administration
Day -10 -3 -2 -1 0
Antibiotics in drinkingwater to C. difficile challenge
induce susceptibility to C. difficile (10 [3] spores)
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Monitor:
Antibiotics in drinkingwater to induce susceptibility to C. difficile
- Weight loss
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-
Physiological appearance
-
Activity
-
Diarrhoea
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*Collaboration with Prof. Dena Lyras, Monash University, Australia
25
IMM-529 ANIMAL MODEL STUDY
All studies statistically significant
Prevention Study
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Demonstrated 80% efficacy without use of antibiotics
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26
IMM-529 DRUG DEVELOPMENT PLAN
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Develop clinical protocol for FDA approval as drug to prevent recurrent Clostridium difficile Infection:
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File IND with
Hold pre-IND
Develop clinical plan for placebo
meeting to Execute
registration controlled trial
discuss clinical recurrence
strategy for FDA for prevention of
protocol and prevention trial
submission disease
strategy
recurrence
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27
COMPETITOR MARKET ANALYSIS – CDI
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| Company | Drug | Type | Status | |
|---|---|---|---|---|
| Reduce recurrence of CDI | ||||
| Zinplava (bezlotoxumab) IV Monoclonal Antibody FDA approved 2016 |
||||
| SER-109 Oral microbiome therapeutic Phase 3 |
||||
| CP101 Oral microbiome therapeutic Phase 2 |
||||
| Treatment of Primary CDI | ||||
| Ridinilazole Oral antibiotic Phase 3 |
||||
| Cadazolid Oral antibiotic Failed Phase 3 |
||||
| SER-262 Oral microbiome therapeutic Phase 1b |
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*As of March 25, 2019
28
KEY MILESTONES EXPECTED TO DRIVE VALUE
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2H 1H 2H 1H 2019 2020 2020 2021 • Pre-IND Meeting to • Initiate Phase 3 • Phase 3 IMM• File Discuss IMM-124E Clinical Trial on 124E TD 505(b)(2) NDA Literature-Based IMM-124E TD Clinical Data for IMM-124E 505(b)(2) prevention study Available TD prevention study • IMM-124E ASH • Pre-IND Meeting • Initiate U.S. Clinical Trial Top Line on IMM-529 C. Phase 2 trial Results difficile program on IMM-529 to Results from US Army trials expected • Pediatric NAFLD treat recurrent 2019/2020 CDI Top Line Results
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29
MANAGEMENT
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Chief Executive Officer of Immuron Limited since November 16, 2018.
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Over 30 years of experience in pharmaceutical and biotechnology - including R&D, operations, business development and capital financing.
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Co-founder and founding CEO of Synergy Pharmaceuticals.
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Co-inventor of TRULANCE® (plecanatide), an FDA approved drug to treat chronic GI disorders.
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Raised over USD $500 million of capital in the public markets to support Synergy from founding to approval of TRULANCE® in 2017.
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Ph.D. in Biochemistry; University of Wisconsin-Madison and BS in Chemistry from the University of Missouri.
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Former Acting CEO of Immuron Ltd. Over twenty years’ experience in pharmaceutical and biotechnology industries.
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Former Chief Operating Officer of TransBio Ltd. Responsible for strategic identification, development and maintenance of global commercial partnerships, along with development, management and IP portfolio, R&D and technology transfer.
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Leadership roles in business development, project management, IP portfolio management, R&D, senior management.
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Consultant to academic institutes, private and publicly listed companies and government departments specializing in development and commercialization strategies.
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PhD in medicine from the University of Melbourne.
30
BOARD OF DIRECTORS – CHAIRMAN & EXECUTIVE VICE CHAIRMAN
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Dr Roger Aston
CHAIRMAN - B. Sc. (Hons), PhD.
Dr Aston has more than 20 years experience in the pharmaceutical and biotech industries. He was Chief Executive Officer of Mayne Pharma Group Limited, after leading HalcyGen’s acquisition of Mayne Limited in 2009. He has extensive experience with FDA and EU product registration, clinical trials, global licensing, private placement fundraising and prospectus preparation. Dr Aston has held numerous other board positions in the sector including with Clinuvel Limited, HalyGen Limited and Ascent Pharma Health Limited, recently acquired by Watson.
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Peter Anastasiou
EXECUTIVE VICE CHAIRMAN - BBSc
Mr. Anastasiou has extensive business experience in a wide range of organisations. He has been a successful entrepreneur from and early age with his first biotech venture, Neuro Developments Australia, seeded at age 24. Mr. Anastasiou was the founder of Investment Group Grandlodge, and ACS International both of which have generated significant wealth through Investment and Management
NON-EXECUTIVE DIRECTORS
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Dr Gary Jacob
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Stephen Anastasiou
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Daniel Pollock
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Professor Ravi Savarirayan
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- Richard Jay Berman
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COMPANY CAPITALIZATION
Immuron Limited Ordinary Shares ADS Equivalent [1]
Shares 176,780,906 4,419,523
Options [2] 44,683,744 1,117,094
Warrants [3] 27,760,000 694,000
Total 249,224,650 6,230,617
Information prepared as at 15 Aug 2019
Share Price (15 August 2019):
AUD $0.125
1. 1 ADS represents 40 ordinary shares
2. Options - Exercise price range: AUD $0.468 to $1.944 (Expiring from 27 Nov 2019 to 15 March 2023)
Market Capitalization: AUD
3. Exercise price of AUD $10.00 per ADS (Expiring 13 June 2022)
$22 Million
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