In my 8 yrs listening to quarterly CC's this was the best.
PPHM is a "hybrid" model biopharmacuetical co able to generate revenue with AVID while they spend money for R&D. Able to keep the burn rate in check and increased revenue guidance going forward for AVID. Backlog thru 2014. Smallest cash burn (3.6M) that I can remember.
King did a retake of the Cowen presentation in regards to Ph2 NSCLC. Nothing new about the switching....just emphasized it led to "very conservative but compelling OS data". In Q&A the analyst for Roth asked how that played with potential BP partners. The gist of the response was that they agreed with the "conservative approach" of analyzing the data and it may give a buffer when looking at PH3 trial data that normally are not as robust/bullish due to size/powering?
Analysts seemed to want to drill down on the Pancreatic trial. Shan said the doubling of response rate in a very advanced disease group was encouraging. There is an "immune mechanism" at work and BAVI needs time to work,,need relatively healthier patients(subgroup analysis?) to have time to work. When pressed if PPHM could/would present at ASCO more detailed data the response was they could with a "knowing chuckle".
I thought the best part was Garnick's presentation of what the Regulatory Group was doing. He said they were very busy analyzing and preparing the BAVI data for submission for PH3. They will go with a 600 patient trial with midterm analysis. There is a "clear signal of clinical efficacy"...."strong package of data" .
What got my attention is when he said in reference to PH2 trial data in NSCLC, "very few and far between Ph2 trials show such good overall survival data". We have a "highly efficacious product". He's highly confident we have the data to go to Ph3.
According to Garnick we have the 3 things necessary for Ph3 submission (he should know)
1. Dose 3mg
2. Summary of safety data...."extremely good"
3.Significant efficacy
I would of liked to hear more detail in regard to the dose switching, though with the legal process that probably couldn't happen. PPHM management sounded like a group that knows it will be joining the big leagues and will stay modest and conservative with their forward looking statements.
In concluding the call "we can look forward to some near term milestones"....
AH action bodes well for tomorrow, cash burn down, revenues increasing and heading to Ph3 with Bavi/Cotara....even the outstanding share totals show little dilution. Best I've felt in years!
be well,
eastcoastguy
AI
