TimingsSome thoughts on timings for the Phase II ---> AA pathway.
Imminent data release, meaning sometime in Q4. Let's be generous and assume mid November.
Once presented, ONCY will then need to develop its big Phase II trial protocol and get that approved, so I would anticipate the "earliest" mBC trial start would be Q2 2025. Bracelet-1 showed a PFS for the PTX + Pela cohort demonstrated a PFS of 9.5 months, with monotherapy of just 6.3 months. - excellent!
So with an end point of PFS, and 180 patients, I would expect that ONCY won't have statistical data before Q3 2026. Also bear in mind that this would be the first clinical trial that ONCY will have run by themselves.
The cash runway is only into H1 2025, and the current burn has been just to keep Kirk Look in gold plated razor blades, so if this trial can be converted into accelerated approval midway, they probably need a around 40 million to get them there.
The true inflection point in determining the fate of ONCY's success will be that conversion to accelerated approval, whereupon they can start generating revenue whilst running their phase IV.
But the question remains, how will they pay for this... afterall they're talking about going it alone... which of itself raises two questions for me.
1) Why is no-one interested in partnering with them if this is a sure shot on goal?
2) Will they do a reverse split again, to fund the trial... announced in Q1 2025 ?
Whilst the data is always promising and compelling, it has never been conclusive... and 2025 and 2026 will be cash bleed years.
I'd be interested to know what the resident pumpers think..?