This is my summary of the current situation.OverviewImmuron is...

This is my summary of the current situation.

Overview

• Immuron is dual listed on the ASX (IMC) and NASDAQ (IMRN)
• Currently markets commercial products Travelan® and Protectyn®. Travelan® is the flagship product. It is an over-the-counter orally administered passive immunotherapeutic product indicated to reduce the risk of travelers’ diarrhea. Protectyn is marketed as an immune supplement to help maintain a healthy digestive function and liver.
• Cash balance of $18.5 million as of 31 Dec 2022

Why the market cap is so low at the moment

• As Immuron sells a travel related drug, it was impacted heavily by Covid and the reductions it caused to international travel
• Existing stock expired as people weren’t travelling due to Covid. Immuron then had issues scaling back up. They reached a situation where they were out of stock due to a bottleneck in the packaging part of the supply chain.
• IMM-124E-Travelan was put on clinical hold. As it is a new bovine colostrum product, the FDA wanted additional safety data above and beyond what was available.

They are in a good position to recover and then surpass the revenues they made pre-pandemic (around $2.5 million)

• Revenues should rebound with the return to pre-pandemic levels of international travel
• The supply chain capacity issue was addressed by contracting another packaging supplier
• There are strong growth prospects for existing products:
• They are evaluating a launch of Travelan® via distributors in international markets (Asia, Europe).They are also exploring options to expand B2B business in airlines, cruise ships, health & wellness segments.
• For the USA market, Immuron’s own shopfront on amazon.com will be introduced during FY23. Re-entry into retail pharmacies will be explored in FY23
• For the Canadian market, they are working towards relaunch into retail pharmacy in FY24
• Target for five years is to reach $15 million in revenue

Large potential to expand into new products

• Travelan® does not react with or alter the normal microbial community of a healthy gastrointestinal tract, unlike antibiotics and will not lead to antibiotic resistance, an increasing concern world-wide.
• As the products do not cross from the gut into the bloodstream, they potentially offer much improved safety and tolerability without sacrificing efficacy.
• Immuron believes its therapeutic drug candidates have the potential to transform the existing treatment paradigms for moderate to severe Campylobacteriosis, recurrent Clostridiodes difficile (C.difficle) infections, Enterotoxigenic Escherichia coli (ETEC) infections, Shigellosis (Bacillary dysentery) and travelers’ diarrhea (a digestive tract disorder that is commonly caused by pathogenic bacteria and the toxins they produce).
• The US Department of Defence (DOD) is interested in Immuron products. For example, it has provided a grant of US$4.45 million to examine a dosing regimen for Travelan® more suited for use by the military. It also currently has ongoing clinical trials, e.g. the Uniformed Services University will run a randomized clinical trial with Travelan® to evaluate the effectiveness for prophylaxis during deployment or travel to a high traveler’s diarrhea risk region. The US DOD is interested in Immuron because it deploys troops in regions around the world where the soldiers are commonly exposed to pathogens that can cause diarrhoea. Travelers diarrhoea hinders the fighting capability of those deployed soldiers.
• Immuron has a strategic investment of approximately £1.5m (A$2.6m) which acquired17.5% of Ateria Health; There is an option for further investment of £1.47m, expiring on 31 July 2023. The Ateria strategic investment establishes Immuron’s position in the large and growing IBS market which is complementary to Travelan®; both products focused on gut health. Ateria Health is a U.K. based biotech company that develops and distributes supplements for overall health, including products that strengthen the gut microbiome. Ateria has developed and recently launched a ground-breaking product JUVIA™ for the treatment of irritable bowel syndrome (IBS). Immuron and Alteria intend to enter into reciprocal distribution agreements for Travelan in the UK markets and Juvia in the Australian and North American markets.
• The Lumanity opportunity assessments that were completed indicate that the current products and R&D direction is well targeted
• IMM-124E-Travelan (Traveler’s Diarrhea ETEC challenge) – based on the estimated market size and pricing, the base case yearly revenue is project at $102M. For the clinical hold, a toxicology study was completed 20 December 2022 and submitted response letter for FDA questions 25 January 2022. FDA feedback was anticipated in March 2023.
• IMM-529 (Clostridioides difficile Infection and recurrence) - Based on the estimated market size, anticipated payer restrictions, pricing, and competition, the base case yearly revenue is projected at $93M.

Useful resources:

• https://www.immuron.com.au/
• Immuron (ASX:IMC / NASDAQ:IMRN) Investor Presentation
• Immuron (ASX:IMC): Interview with CEO Steve Lydeamore