Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

3rd Q CC impressions.

There were 2 and a half pieces of big news we wanted to hear that we didn’t hear before 1) they submitted their BTD request for relapsed EGFR ex20 mutation NSCLC patients and they expect to hear back from the agency before year end. Yes, we expected this but it's good to get confirmation so the naysayers don't start speculating on the death of Spectrum :) 2) they expect to close enrollment on relapsed EGFR pts in the 1st Q 2019 and that timeline for it being fully enrolled is for the full allotment of 87 patients. Once that happens that gets the ball moving on expectations and 3) or more like a half a loaf is EU enrollment sites are initiated (previously they mentioned that they will have 8 EU sites), the half a loaf that isn’t there is that patients are not on the trial yet. I guess this is mitigated by all the patients they need for the trial will be recruited by end of Q1.

They mentioned both Spectrum and MD Anderson will soon be initiating a pozi pan-tumor basket study. I’m still not understanding why MDA needs to run their own trial and not be a part od Spectrum's trial. It only makes sense if, like it occurred in the NSCLC trial, they start it 6m earlier than Spectrum would be able to start theirs but if they start around the same time they’ll just be competing w each other. We’ll see.

And I’m munching on this one; it’s a little intriguing what else they submitted for BTD since MDA data was a subset. I guess safety data on all the other pts that were on various trial including Korea. May be CMC info? Not really important, it's just that curios minds would like to know.

Thomas Riga
Yes, so Adnan, we've had several engagements with the agency to understand what they were looking for, so what they were requesting wasn't identical to that of the World Lung Presentation, but it was a subset.

And regarding this Q by David Buck

Yes, so was whether or not to go it alone with poziotinib in Europe and then also whether you your key ROLONTIS look to out licensed and [indiscernible]?

Most of the discussion was about Rolontis which is of secondary importance to me

Right now if we have do it our self we certainly are capable of doing that. And I do want to say that our plan would be sometime in 2019, would be the time we start focusing on the EMA and filing an EMA for ROLONTIS. So we are excited about that. Remember David, that's the reason in our second trial we got 20 sites in Europe because when you file in the EMA, you like - they like to have European patients in the trial and that's exactly why we did that.

Really, the pozi discussion got short shrift and the same thing happened at a recent CC. I would love to hear a more detailed answer to that. Perhaps the analyst at Jefferies 2018 London Healthcare Conference next week on the 14th can ask a similar Q but only about pozi and keep Rolontis out of it? I would love to hear a little more detail if like are they in serious discussions now? Or do they want more data on BTD before opening up serious discussions (this is what I think)? Multiple suitors? As of now you’d have to assume discussions are far and few in between.

I think you have to give a shout out to the burn through of only $8M in cash this Q. They ended the quarter with $167 million in cash, last Q they had $174M and as KG states they only went through $8M in cash in between Qs. At this rate it will last them for 20 Qs to burn that cash but in actuality it’s ~8 Qs since they do financings when cash gets to ~$100M. That takes them to the end of 2020. I’m assuming they’ll keep their CASI marketable securities. The share price should be considerable higher in 2020 when they do go to the well assuming they have BTD and a NDA is smack in the middle of discussions. I don’t think Rolontis will change the money equation since as it looks now, in 2020, they won’t be getting into too many formularies which for the most part make their decisions earlier in the year.

Having said all that ie kudos for their cash burn, I wouldn’t mind if their cash burn doubles if they can get combo trials going up the kazoo. There’s a lot of promise w combos and the sooner the better.

The previous total revenue guidance was between $95 million to $115 million and now w 2 months to go they narrowed it to between $100 million to $110 million. And all things being equal, looks like it’ll come in at ~105M at EOY. So they’re going to hit a bulls eye on their original guidance. It nice not having revenue surprises.

So we heard about submitting BTG, that the trial for EGFR will be fully recruited in the 1st Q, the EU sites will start patients on trial soon, and their revenue projections are consistent. And what we should hear about before the end of the year is BTD status, Rolontis BLA submission, and hopefully, the pan tumor trials(). Not bad.