Immuron Ltd (ASX:IMC, NASDAQ:IMRN) posted a revenue of $584,000 in H1 FY23, a growth of 153% compared to H1 FY22, with Australian sales contributing $287,000.
The biopharmaceutical company focused on the treatment of gut mediated diseases has two commercially available oral immunotherapeutic products – Travelan® and Protectyn®.
Travelan is an over-the-counter oral polyclonal antibody therapy that helps reduce the risk of travellers’ diarrhoea.
Immuron is set to initiate a clinical trial for Travelan (IMM-124E) this financial year and is supported by a strong balance sheet with cash and cash equivalates balance of A$18.5 million as of 31 December 2022.
Growing distribution network
Immuron has a strong retail network in Australia, which includes over 3,500 pharmacies.
In the US, Immuron’s key B2B customer is Passport Health - the largest provider of travel medicine services in the US.
Looking ahead, Immuron’s own shopfront on amazon.com will be introduced in the US during FY23 and re-entry into retail pharmacies will be explored.
The company is working towards a relaunch into Canadian retail pharmacy in FY24 and will also evaluate options to enter Asian and European markets through distributors.
FDA approval for Travelan IND application
In December 2022, Immuron announced US FDA approval to proceed with the clinical evaluation of Travelan.
The Investigational New Drug (IND) application to evaluate the safety and efficacy of a single dose of Travelan to prevent infectious diarrhea caused by Enterotoxigenic Escherichia Coli (ETEC) is now active.
Immuron will proceed with the phase two clinical trial which will evaluate Travelan in a controlled human infection model clinical trial design.
Immuron’s clinical programs.
USU clinical trial
In January 2023, the Uniformed Services University of the Health Sciences (USU) in Maryland, US initiated a clinical trial to evaluate Travelan.
USU has recruited 157 of 1032 study participants and expects to complete clinical trial enrolment in 18 months.
Along with the USU’s Infectious Diseases Clinical Research Program (IDCRP), the UK Ministry of Defence and the New York City Travel Clinic have undertaken to carry out the randomized, double-blind, placebo-controlled trial involving 1,302 volunteers.
The P3TD study is a randomized, double-blind, placebo-controlled multicenter clinical trial designed to evaluate the effectiveness of 2 commercially available nutraceuticals: a probiotic (Florastor®) and IMM-124E (Travelan®) verses a placebo, for prophylaxis during deployment or travel to a high TD risk region.
Addressable market & industry overview
