Do you think this is justified? These are non randomized data being compared to historical controls.
It depends on what you mean by "justified." I started buying this stock when the market cap was ~$25 million. (A cancer doc turned me onto it.) And I loaded up. The promise of a new drug for GBM from Genentech labs seemed a great investment opportunity. (Just how a nano-cap Australian biotech got the drug is a long story.) But even now with this spectacular run-up, the market cap is only ~$160 million. That's more than "justified," it seems to me.
The institutional ownership is miniscule. The stock was just unknown on The Street, up until the last couple of days. That should change now. And there will be more data this year. Furthermore, Paxalisib is now part of the AGILE study being run by GCAR.
GBM AGILE (NCT03970447) is intended to serve as the pivotal study for registration of paxalisib in key markets
Dr Ingo Mellinghoff (Memorial Sloan Kettering Cancer Center) and Dr Eudocia Q Lee (Dana-Farber Cancer Institute) have been named as Principal Investigators for the paxalisib arm; Dr Timothy Cloughesy (UCLA) is the Principal Investigator for the overall study
Kazia will pay an initial fee of US$ 5 million to GCAR, with further milestone payments payable throughout the course of the study
Just look at the principal investigators and who they are associated with. (Dr. Cloughesy is known by my cancer doc.)
Given all this, I would say that the market cap is more than "justified."