Timeline Speculation

DYOR. Analysis is highly-speculative - we only have indicative timeframes for some trials and guesswork is required for the others.
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I will revisit the analysis and the timeline as we receive updates.


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Speculation for trials timeframes

We've had start date for trials indicated/implied by announcements.

I've generally assumed 6 months for recruitment once a trial starts. The trials will be small and given the positive results from the Israel trial we can assume faster recruitment for the 5 x pathway trials than for the original Israel Trial ( doctors and patients will be aware of the success of that trial ).

We were given a reasonably precise timeframe for the Adult R/R AML trial, with Paediatric trial to be driven by early results from the Adult study. For the adult trial we were told 4-6 months for the trial to start, so I am assuming recruitment starting January 2021.

For MRD we were told in the transcript that there will be an application for grant funding in "the fall" (which would be the US season). Looking at previous grants it seems the time for grant award takes about 4 months. Allowing time for trial preparation, I'm assuming the trial could start recruiting around June 2021.

We were told when the preclinical study for Breast Cancer was started (announcement 14 May 2020) that this trial is planned to start "late 2020". I'm assuming recruitment starts December which would allow a first readout around September 2021.

For Ovarian Cancer I am assuming that the Preclinical work will start in the new year and a lag of 6 months for the trial to start recruiting.



Window for a Buyout

This timing could mean key readouts for Adult R/R AML and Breast Cancer by the end of 2021. This could be the earliest date that a potential buyer might be interested, assuming about 3 months after the readouts (buyout transactions can occur very quickly after positive readouts from trials).

I think we could heave readouts for MRD in 2022 and potentially ovarian cancer in the same year (although I have least certainty about the start time for an ovarian cancer trial). The final readout would be Paediatric R/R AML in early 2023. We don't have much to guide us on a Paediatric MRD trial, but I don't think it would start until after a first readout for the Adult MRD trial.

So based on speculated readout times for the trials, buyout window could be from the beginning of 2022 through to early 2023 ( although I think results from R/R AML and Breast Cancer would be enough to attracted buyout interest ).


Timeframe for Approval

Whilst not directly important for RACE, timeframe for approval is important for a potential buyer.

It's the MRD pathway that provides potential for approval via the accelerated 505 (b)(2) pathway.

The approval for BLINCYTO happened quite quickly. There was just 3 months between BLA submission and approval. I'm assuming up to 12 months for BLA submission, after the second readout from MRD ... although could potentially be much quicker.

https://www.drugs.com/history/blincyto.html



For a buyer, they could potentially have approval for MRD 18-24 months after a buyout transaction. That would be attractive! Potential first year revenues could be around USD $240M ( extrapolated from first year revenues for BLINCYTO, which is for ALL - AML has 3.2x the incidence of ALL in the US ...).