Investing is all about creating upside predictability in the investments we choose. This allows us to understand not only the risks in the investment, but also the likely payoff should management deliver on their roadmap.
Therefore, having management that is willing to commit to goals and follow through with their execution is very important. Yet, this is not to say that goals cannot be changed or replaced, as it's equally prudent to maintain an agile approach to business and ensure that things adapt.
A great way to examine for this “threat” is to review past milestones/goals and compare them to actual delivery. What we want to see is the timely completion of goals, or an acknowledged variable in them. What we do not want to see is goals changed or missed without any explanation.
In Immuron's case, the new managing director Steven Lydeamore has delivered a robust pipeline of goals across the company's four clinical programs. The investor presentation closest to him taking the role outlines this (
link).
Let's review how many of these goals were satisfied within the time range given or varied with an updated explanation/guidance.
2H 2022
File IND for single dose IMM-124E per date ETEC challenge clinical trial
Filed and announced on 5 December 2022.
Link
Submit complete response letter to FDA clinical hold for CampETEC clinical challenge study
Completed on 25 Jan 2023.
Link
Initiate ETEC IMM-124E CHIM clinical trial
Recruitment started on May 30 2023.
Link.
IMM-529 cGMP manufacture
Patent received on 17 Jan 2023 (
Link), but manufacture delayed until 2H 2023.
Initiate USU P3TD IMM-124E field clinical trial
First participants enrolled on Jan 18 2023 (
link)
Top line results for IMM-124E ETEC CHIM clinical trial
Disclosed on 7 June 2023 (
link)
Initiate NMRC ETEC CampETEC CHIM clinical trial
Disclosed on 11 September 2023 (
link)
Initiate NMRC CampETEC Campylobacter CHIM clinical trial
Disclosed on 7 June 2023 (
link)
IMM-529 IND pre-IND submission
Disclosed on 7 June 2023 (
link)
As we can see, the company has somewhat had success in meeting their timelines originally set out. A lot of this relates to the company's CampETC CHIM trial (targeting ETEC and Campylobacter) that was delayed as a result of an FDA hold, which was later resolved by at the expense of time. This is in addition to the highly unpredictable nature of most biotechnology and pharmaceutical development.
Yet in all cases of delay and variance, a timely update was provided informing shareholders of this change, in addition to an updated timeline. This is a great start as it wasn't simply ignored without commentary. What would be an improvement from here, is an explanation concerning the reason for the delay to provide additional transparency.
Overall, the company appears to have adhered to most of their timelines and we can therefore expect this to continue going forward. Immuron's latest timeline guidance is below.