Yes, I'm liking my 200,000 shares long. Binary event is approaching for them.
1. Will their REGAL trial halt for efficacy at 60 events (deaths) Interim Analysis with a hazard ratio of 0.52? Essentially, is the median overall survival (MOS) of their drug extend by double (Ex: 24 months vs 12 months)? If it halts, it is headed to $15 straight away. Currently, no futility or safety concerns with drug reported since the trial started 3 years ago so that is essentially off the table.
2. If they don't get halt for efficacy at 60 events for Interim Analysis, the trial will continue to conclusion at 80 events (deaths) which will likely take the trial until Q1 2025. The need a hazard ratio of 0.62 at Final Analysis to have immediately successful trial results. There are cases were a hazard ratio slightly above that number could still gain approval because the secondary endpoints on toxicity are likely to be met. In short, current best available treatments come with lots of side effects.
3. Shorts will cut the stock to $0.80/share if 60 events does not get halt for efficacy because the company will need to dilute. The only thing that stops dilution before REGAL trial completes (if it has to go to 80 events) would be settlement with 3DMedical which owes them at least $13M minimum or their other drug SLS009 (Phase 2 AML patients with ASX1 mutation showing 100% response rate) gets a partnership deal.
Place your bets.
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