Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

TGTX release vs Spectrum non-release of interim data.

I had to follow-up on you being a little suspicious that Spectrum did not release interim Z20 EGFRex20in pozi data like TGTX did with their interim data. Looking at TGTX news, I see a big reason why TGTX had no compunction in providing interim data to (what appears to be) a pivotal study is they needed to do a financing IMHO. They released the data, Share Price goes up 40%, and TGTX does their financing a couple of days later. The need for financing is a constant battle w biotechs. With over 300M in the bank (Spectrum announced the Completion of the Sale of its Marketed Portfolio on Fri), Spectrum can more conservatively wait for top line data later this year. It makes no difference to them since they won’t be doing any financing in the near future. So in their eyes, if the SP goes up now it would be nice but the bottom line is for the SP to go up closer to pozi news. And I’m expecting, with the earlier 1m scan, DoR and ORRs to go up in the Z20 study. From slide 9 in the Presentation, you can visually see that DoR would be about 1 month more and Dr Heymach said at WL that if they were using Z20 criteria of 1 m scans their RRs would be about 55%. And hopefully, a less reduced dosing schedule will also make a subtle difference. So, unless MDACC screwed up the interpretation of the scans in their study, I’m expecting very positive top-line, not interim results, later in the year. I always think of Dr Heymach’s response to a Q at WL 2017. Quoting/paraphrasing:

When we designed the study, we were looking at 20 to 30% RRs, were the rates we considered to be exciting…so RRs of 30% is extremely promising. PFS – we’re looking for 4 months as an intriguing one, and 6 – 7m, everyone would be extremely excited.

So, I’m not concerned, nor suspicious, that topline news won’t be released till the fourth Q but I do wish their internal clock would be a little faster. Let me clarify that a little. I’m not concerned but I am somewhat bummed that they’re taking the conservative approach. Kind a like big pharma, no?

Ps I previously posted how I can see the agency reevaluating BTD but that’s something that no one can count on or expect but if it happens, they’d be getting it done the right way i.e. under the radar.