This is a rather pertinent question and I hope that everyone has done an adequate risk analysis here. If I may offer a few risks that have been mentioned before or I have personally considered and everyone should be aware of before getting carried away:
N.B. Please remember that some of these are highly unlikely and this is for illustrative purposes only. If you wanted to, you could use a Wilson's Matrix which I like to use as a simple way of measuring how threatening a given risk is.
Time-based risks
- Delays caused by third parties (e.g. ethics approval amongst a host of others that I am sure the team has to navigate for trials involving people's lives)
- During trials someone may die as a result of an unrelated cause, which will likely cause a lengthy halt as it is investigated
- Loss (through illness or resignation) of a pivotal researcher or team member that will require replacement or risk reducing trial's likelihood of success
Value-based risks
- Occurrence of a rare side-effect not yet observed in previous trials. This may result in a time-based delay, but can have a large effect on value depending on the nature of the side-effect (blood clots in vaccines anyone?).
- Failure of trial/s due to design, patient cohort, errors etc,
- Another competitor flying under the radar pulls a swifty and is faster at getting clinical results due to resources (see Keytruda). While highly unlikely, at the very least someone else may be able to get into clinic if fast-tracking and pharma may see it as a better value transaction or at least a bargaining chip in negotiations, leading to...
- Race's negotiating position is not as strong as we assume it will be. This could be because of one or more of the above risks being realised or some other "unknown unknown". It could also be the result of the concerns around approvals for additional indications and the like.
- Loss of any key management personnel for unforeseen reasons such as health or family issues, god forbid. This risk is massive because it will affect the likelihood of all other risks occurring.
- If we make it to FDA application prior to buyout, their opinion of the achieved results differs for some reason and they request a full phase 3 trial, undermining our negotiating position. While there is precedent for what Race is doing, it is becoming quite popular and perhaps the FDA is looking to add some constraints that we are unaware of to tighten up the pathway
Of course, I can hear you all say, "but management did xyz to reduce this risk". To that I say, precisely! The reason I am invested in Race is not just bisantrene, but management's execution. Let's look at just some of the de-risking taking place:
- Increased number of trials on different pathways so that an issue with one trial does not sink whole ship
- Options offer to all shareholders to shore up cash position. This is really a master stroke because with gains for shareholders AND minimal dilution they can strengthen their negotiating position significantly as pharma won't be able to use the card of "you're running out of cash and you need to make a deal now"
- Hiring of key personnel and advisors to increase trial robustness and decrease clinical trial design flaws etc.
- Similarly, added de-risking of FDA issues due to a great level of experience through the BOD and SAB
- AML trial taking place in Israel where ethics approval has already been achieved
Not to get long-winded, but all this is just one indicator of excellent management execution. This is why loss of key management personnel is such a massive risk here because their capabilities ARE Race's competitive advantage. Bisantrene will have competitors and if management isn't on top of things, it will become substitutable in a few years before we can realise any value. It is so hard to find a management team that ticks all the boxes of risk management, opportunity recognition and seizure, strategic reconfiguration and applying all this without undermining their core objective.
Final note on shareholder risk management to answer the question. I will personally offload a portion to de-risk where I cannot adequately estimate the chance of success. Currently for me, this will be when marketing or negotiations begin, only because of uncertainty at this time. I will re-assess based on our results, my knowledge, and communication from the business and other party's analysis. I may choose to hold all the way through depending on ongoing risk-assessment as I hope everyone will do!
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