Exactly right. The sooner mgmt gets this info to investors, the better. If the 57 survivors are mostly from the treatment arm, and its hard to believe there wasn't some survival advantage (unless Ph. I was "cooked," which I view as unlikely), that should show up in the numbers. If the survivors in the SOC arm were randomized later than the survivors in the treatment arm - also hard to believe -- that might explain why there is no clear survival advantage. Though I was fully hedged against the possibility of bad news, I have a large position here. I am losing patience with a mgmt that doesn't know when to be silent and when to speak up.
The current mkt. cap for this stock is a little over 50 million. Cash on hand is 30 million. No debt. Meanwhile, Ph. II, described everywhere as a disaster actually met an imp. secondary endpoint and was merely inconclusive as to OS -- this with a fair prospect of a long "tail" like Yervoy, etc. Meanwhile, shorts -- bless their black hearts -- continue to drive down the pps, which, with their help, may soon reach 80 cents a share or even less. I leave the rest to your imagination which, if some posts on this board are any guide are working overtime . . . .
Thanks for saving the day. Hope you get rich!
I would expect to see more volatility. Keep in mind how little it takes to move this stock. At the opening today it was down 1% on 575 shares. What we have here is a slow drip, drip down -- part of a risk-off trade affecting the entire market but with a focus on former high fliers. Take a look around. Virtually every developmental biotech is under pressure right now. That said, I have noticed that the stock rebounded sharply over the last three to four hours (following an early sell off), and that the rebound was driven by a number of 1000+ trades. Looks like we'll go out at 6.2, which is about where we started the day. As for possible bad news, after 13 long years I'm less concerned about deaths and major AEs among trial participants than I am about lackluster symptom improvement scores. We'll see shortly . . .
By the way, Fenix, are you in for the duration here? If I remember correctly, you've been in NYMX -- sometimes reluctantly -- at least since 2010.
That's correct. I'm using a triple-leveraged hedge on the S&P, double-leverage on the biotech sector and puts wherever they're warranted. To be clear, no hedge is perfect and I have taken losses like everyone else, the hedges included -- viz., the S&P. Not a great fan (as you may have noticed) of NWBO but do have a position there. I'm long on immunotherapy so have or had positions in INO, GALE, ONCS, BMY, PFE, CLDX, AGEN, along with NYMX and other bios.
Couldn't agree more. This study will rise or fall on the size and length of the tail and the subgroup analysis, just like all the other cancer immunotherapy trials, from BMY's Yervoy to NWBO's. We need more time for the data to "mature" as Yu and Gengos so delicately put it.
Good, thoughtful analysis. I'm holding a large, hedged postion to which I will be adding as soon as the dust settles.
Understand your impatience (and share some of your doubts), but try to keep in mind that this is and has been a very thinly-traded stock which moves on 1000 shr. trades. If there were material news -- good or bad -- I would expect more volume. While I don't discount the possibility of bad behavior, I don't think it likely based upon what I have seen of Dr. A and what I know as a former attorney for a SEC reg. co. That said, the silence is deafening -- reminding me of Dec. 2010 when our CEO was cooking up the deal with Ricordati, which he announced later that month. In my view, we're already in a biotech bear mkt., which given the overbought state of the overall market, could develop into a 10-20% correction. With that in mind, I have hedged my position here -- something you may wish to do as well. In any case, best of luck to you.
Good analysis, esp. your point about ICT 107 mimicking the behavior of other immunotherapies. Too bad we don't have more data. It would bring some much-needed clarity.
Exactly my point. Virtually every competently conducted cancer immunotherapy trial reveals a tail of survivors, whether its anti-inhibitors like Yervoy or vaccines like NWBO's.
Sure, got it. Some people here may remember that when you joined this bd -- David -- you called yourself "the God of Investment." As I say above, the game isn't over, so enjoy while you can. By the way, unless I miss my mark (and I've been doing this for 50 years), the market is extremely overbought at these levels, suggesting that it might not be a bad idea (if you're going to be long Tesla) to get a hedge.
Ignore the "Us" in the title. No idea where that came from . . . . .
57 people remain alive, 21 of them progression free with a stat. significant advantage of 2-3 months. If you compare IMUC's OS and PFS in the Ph. I study with typical GBM SOC OS and PFS, you will see a consistent 2-3 month advantage until mo. 18, then a growing divergence. If you look at the Ph. 1 nos. for OS at the 24th mo., you will see that roughly 75% survived, with only 20% surviving at the 24th mo. under SOC. Extrapolating these nos to the just reported Ph. II results, we would expect to see +/- 60 survivors in the IMUC arm and +/- 8 in the SOC arm. Instead, we have 57 survivors -- no breakout as yet as to the no. in the treatment arm -- with a clear, statistically significant divergence on PFS of two to three months -- close enough for horseshoes and almost exactly what CYTR reported yesterday as a blow out result in its Aldoxirubicin Soft Tissue Sarcoma study. We need more time. Will the divergence on PFS continue to widen with time? Do the tumors of those who died show evidence of immune response? Do the antigens on the tumors of long term survivors more closely match the antigens in the vaccine? Someone on the cc yesterday --- I believe it was Dr. Yu -- compared the inconclusive results re ICT 107's impact on OS with the interim results on Bristol Myers Ipilimumab. For those familiar with Yervoy's history, this is an apt comparison, not only because the first results were paradoxical but because they showed that the drug is actually a cure for a subgroup. I predicted that this would be the result here and I still believe it to be true. The game is not over.
A billion dollars-- in the right hands -- would not be excessive. In the wrong hands, this won't reach its potential -- typical asymmetric investment, though in this case the high risk has to do with the marketing not the drug. As you know, the symptom scale is highly subjective, which is not to say that it has no validity. Just that there's an issue here of pilot error, (poor aim by the doc) which complicates analysis of outcome. Why hasn't anyone noticed this sleepy co. before? Good question. My answer: 1.) they did notice it/them when the trials first got underway 13 yrs ago. The case for NX 1207 has always been based on cost benefit analysis and happy patients-- minor issues in an era when a cure for cancer may be in sight. 2.) mgmt did a poor job of hyping the drug's potential and sweet-talking big pharma and the street. (I suspect, based on Doc A's comments, that his problem with big pharma is partly political.) As I've noted before, Nymox has been financed on a shoestring, while its CEO has been paying himself a mere pittance -- at least until he went hog wild on his divorce, etc. There is a reason I keep talking about SPHS: inept though the roll out of its Nasdaq IPO certainly was, its S-1 explained what Dr. A refused to explain for fear he would be giving away a state secret -- namely how NX-1207 had to work. In short, doubters (and I was one) have had to look for validation in the Ricordati deal (40% royalties and $10 million.) Meanwhile, NX 1207 continues to receive high praise from urologists and men who have used it, even as it passes milestones on safety and efficacy. To sum up: I think this co. is a bona fide sleeper, neglected by the market (such things do happen), and a hit out of the park for those who stay the course. No guarantees, mind you. We're in biotech land here, which is to say, we can lose all of our money.
The proportion of elderly men afflicted with BPH, usually said to begin at 50% for 60 year olds, rises to 90% by 90. The real issue, as you point out, is "top of mind" knowledge of the existence of the drug and a place (i.e. urologist) to go to get it. The first part of this will require a mktg. budget the size of Cialis (which, by the way, is being touted as a cure for BPH); the second, better than O.K. reimbursement for the docs. What we need, in short, is an acquirer with a deep pocket. By the way, I think 2017 as the approval date for NX1207 is off by 2 years, unless there are unreported problems. 2015 is my best estimate, based on the fact that while BPH is not normally a life threatening condition, it is relatively expensive to treat with relatively poor outcomes, which should make NX1207 a sure winner on a cost benefit analysis basis.
We all agree on the price for one flu shot, but its incorrect to assume that one shot will be sufficient. As there is a study of repeated injections underway, it ought to be possible to get a sense -- from front line urologists or mgmt -- as to how many patients will need a second shot. Clearly, an annual mkt of 1 million shots is too low . . . anyone here have a better number?
See also following PR from Am. Soc. of Hem. (The studies in question were done by the Univ. of Penn, which has licensed the technology to Novartis. If you sense an emerging convergence between Novartis, U. of Pa. and Inovio, you're probably on the right track. ) "(NEW ORLEANS, December 7, 2013) – A series of advancements in genetically engineered cell therapies demonstrate early efficacy and safety in patients with blood disorders for whom standard treatments have been unsuccessful, according to data showcased today during the 55th American Society of Hematology (ASH) Annual Meeting and Exposition in New Orleans.
Today, many patients with newly diagnosed blood disorders – ranging from cancer to rare genetic conditions – respond well to modern treatment regimens. However, for more than half of newly treated patients, therapies fail to work or patients experience a relapse that may negatively affect their prognosis. Thankfully, an emerging field, dubbed "precision medicine," aims to improve success rates by attacking the specific targets that are responsible for a patient's disease. Using a patient's own re-engineered cells to attack their disease is an example of this approach. Building on the existing concept of turning the immune system into a disease-fighting weapon, this new field of medicine adds innovative technologies that transform healthy cells into "super" cells that can more effectively combat disease.
Several studies presented during the meeting detail results using one method known as chimeric antigen receptor (CAR) cell engineering. The CAR process starts when T cells (naturally occurring immune cells) are extracted from the blood of an individual and outfitted with two powerful features: a receptor on the outer cell surface that recognizes a protein called CD19 present on most leukemic cells and a powerful mechanism inside the cell that triggers it to expand and proliferate once attached to the targeted protein."