There is nothing new to report. NKTR will remain blinded to the results for at least one year, except for the interim statement from the data monitoring committee.
Different stages in breast cancer treatment. Neratinib is for newly diagnosed patients prior to surgery. NKTR-102 is third line for MBC patients who cannot benefit from surgery. The drugs do not compete.
By extraordinary, I mean that NKTR-102 meets statistical significance for OS/HR superiority with only half the patients evaluated. The words "doesn't work" mean that TPC meets statistical significance for OS/HR superiority with only half the patients evaluated. Anything in the middle means the study continues.
The NKTR-102 interim report is going to come from the DMC, not NKTR. It will be one of the following three statements.
1. NKTR-102 demonstrates extraordinary efficacy, all patients will be switched to NKTR-102.
2. Results are indeterminate, study to continue.
3. NKTR-102 doesn't work, study is terminated.
Outcome (2) is most likely. With (2), NKTR will remain blinded to the patient outcomes.
No, haven't bought back in. Put a slug of the proceeds into the REIT MPW in the past month, which has a slightly lower return than NKTR from when I sold, the rest is still cash. I'm still wary of the two things hijacked mentioned in his more recent post, the AdCom meeting and a secondary.
ONCY announced Reolysin Phase II results for head and neck cancer today. AF shows how selective reporting and judicious use of subsets can make a failed study appear successful. Worth a read.
SLXP plan A for Relistor is to convince FDA that many years body of evidence for Relistor is sufficient to approve both subcu and oral for chronic pain, but AZN study is insufficient. Plan B is to convince FDA that preapproval CV outcomes study required for all non-hospice applications. If A and B fail, Relistor (subcu version) is relegated to niche applications and oral is dead.
$70M is factored into year end cash position. On the last CC, CFO John Nicholson said "As a reminder our year-end cash guidance includes the $70 million milestone payment from AstraZeneca for the acceptance of the U.S. NDA file for naloxegol which is expected this month."
What's important now is the March AdCom for mu-opioid antagonists. AZN/NKTR have been preparing diligently for it even though they haven't yet been invited to present. Now that the NDA is accepted, we'll see if an invitation occurs.
Here are two reasons why Canada runs acceptably to them. They have a free rider on prescription drug cost. They can price them at variable cost because the US picks up the fixed expense of drug development. Drug development expense includes costs for drugs that fail and never make the market. The US also is a relief valve for patients with the ability to pay and immediate need for medical procedures. Cities like Detroit, Buffalo and Seattle pick up a lot of high net worth Canadian patients. That window will shut if the US switches to single payer, there will be a lot of complaints if US citizens are forced to wait for resources that foreigners move ahead in line for.
There really isn't much to talk about. The business of producing discrete components for DoD applications is in a slow continuous decline to obsolescence over the next couple of decades. It's still big enough for a small niche player like SODI to make a comfortable living. Mr. Saraf essentially runs a one man show. He's not going to expand beyond the one location and isn't in position to grow to new technologies. So there is this mountain of cash and NOL's, and this issue is how the owners (us) can unlock its value.
Relistened to relevant CC section. Four factors were given for increased year end cash position. Mfg proceeds were $15M higher, $18M from delaying NKTR-181 Phase III, $5M capex reduction and reduced NKTR-102 BC Phase III cost because enrollment completed early. Mfg cash may not be all real if NKTR sold it out of inventory and it needs to be restocked, NKTR-102 savings are honest, so is capex reduction provided they actually cancelled and not postponed the expense.
Mr. Market seems to like what it heard, NKTR is up AH. I also see more clarity in the company's cash position. I'm still concerned about the AdCom, worst case is NKTR-118 is handed back to NKTR (like Exubera). Second worst case is approval money is delayed for years. Both would crush the stock.
All the reasons for the $50M were discussed but I wasn't in position to take notes while they were being gone over. A part of the $50M comes from delaying the start of the NKTR-181 Phase III until the middle of next year. I think Phase III would have started by now if the Phase II succeeded.
I don't plan to reenter until after the Adcom March 10-11 next year, unless the stock gets much cheaper than it is now. You could tell that it's a real make or break for the company by the extensive preparations being made for it, even though AZN and NKTR haven't even been invited yet.
Company is taking a phased approach to the Phase III, it sounds like efficacy evaluation will occur up front, other aspects will be delayed. That will push back the Phase III completion but conserve cash over the next year. Good news.
The downside to the huge cash position is that the volatility is much smaller. In the bad old days, you could expect KLIC to trade to the low single digits. Not any more.