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Friday, 08/25/2017 8:26:11 AM

Friday, August 25, 2017 8:26:11 AM

Post# of 3283
2017 California Investor Conference

Some impressions/musings from the conference
- On the Ville-O-Meter, poziotinib has taken over 1st place in importance over Rolontis even though Rolontis is scheduled to be approved before pozi. And that’s in a little less than $5 billion market (4.1B in the US) even though Spectrum keeps on saying 6B. Note – I coined the phrase Ville O meter (since I’m the only one who uses this term) after Ville pointed out that Qapzola was placed behind another drug in the SPPI presentation back in ~2012 and questioning why would they do that; after the fact we know why- it failed the P3s back then).

- News about pozi- the 1st compassionate use pt still has stable disease after 9 months (aside - we previously found out from an abstract she had the HER2 mutation not EGFR). And some of you may be aware that the 2nd CU patient along w her husband post on INSPIRE. It’s a good read. She’s doing fine too. Dr. Raj mentioned her posting on Inspire (aside – some pts on the trial started posting there too).

- Regarding the ongoing pozi trial, 20 patients have consented and ~10 currently being dosed. Interim data will be presented by MD Anderson at the World Lung Cancer Conference in Oct. (Even though very interim, looking forward to what they got).

- Another pozi multi-centered trial w 87 pts will start up within next couple of months. Protocol approved and currently getting approvals at the IRB sites. My musings – I previously was thinking that the next trial in Exon 20 Insertion mutations would be pivotal i.e do a randomized P2 multi-center trial with an endpoint acceptable for accelerated approval. With 87 pts, it doesn’t seem like they have enough pts to do a randomized trial but if they do 2 (pozi plus SoC):1 (std of care) and they feel super confident that it will hit statistical significance (from observing the efficacy in the current trial) I guess they could do it but let’s say I’ll be surprised that will be the case.

- They mentioned the current pozi BC trial but didn’t give more than lip service to it. Musings- My spider sense tells me that the Korean abstract to be presented at ESMO ~ Sept 8th would not be to exciting. The only thing keeping me excited is that it being a ‘proffered’ presentation by definition will mean there will be more relevance to it. Will be tickled pink if news is exciting on that one.
Musings- At the 1st Q CC and at the healthcare conf back then they discussed posi in combo w T-DM1 in 2nd line BC. We’re not hearing that now. I assume it’s taken a back burner to the development of pozi in lung cancer. You only have so much money to go around.

- Current Rolontis P3 trial that finished recruiting ~ Aug 1st will be presented at ASCO in May-June 2018. Deadline for abstract is Feb and that’s when they will release top-line data. They are submitting NDA application in 2018 in the US and 2019 in the EU.

- Evomela has ~ 50% of the market w 10M in sales. Doing the math that makes Evomela mkt potential 80M.

- Q from the audience on market cap and why so low if you’re so good (Note- we didn’t hear the Q so basing what was asked on the response). Dr Raj started off by saying ‘Good question’. He said back in 2012 with Fusilev sales growing we were considered a revenue company and that perception, w 6 drugs on the market, is still there but if you are a value investor than you see a different profile. Gave an example of Puma that just had neratinib approved for neratinib in maintenance BC and is valued at $3B and that’s there only drug. Other companies that don’t have any products approved have close to a $10B MC. Once the street figures out that we are not a revenue company but a value company the MC will change.

- We already have 6 drugs that help pay the bills. Last year we only had a cash burn of ~ 20M. I (Dr. Raj) owns 10-12% of the company and it affects me significantly if we dilute share count so I try not to.

OK that’s enough, I gotta run.