If you go to the clinicaltrials dot gov site, you will see an update from this week that both the phase 2 bladder cancer trial and the phase 2 triple negative breast cancer trial for 108 have been terminated. The given reason is (Poor recruitment).
Dodd had already mentioned that they would terminate the bladder cancer study to conserve resources, but they had not previously announced the termination of the breast cancer study...
So, that is one less study in the pipeline.
That leaves ongoing:
108 P3 endometerial (expeceted interim look in early 2015)
108 P2 prostate cancer (expected results at the end of this year if not further delayed...)
130 P2a cancer cachexia (expected results at the end of this year)
Also, their partner Spectrum is still running the P2 for Ozarelix for prostate cancer with results expected at the end of this year.
I guess canceling trials conserves money, but now all the eggs are pretty much in the endometrial trial basket, and if that fails, the company has little recourse...
noid, the likely nda approval of 130 is the reason for the increased volume and pps above $1. you may be undervaluing the revenue potential of 130. I am no fan of this company and it's management, but they do appear to be ramping up for marketing 130. without knowing the cost and pricing of 130 it's difficult to predict revenue but when compared to the current aghd procedure of approx. 3k per treatment one could guess 130 will be priced similarly. apply that to the number of patients annually you come up with a pretty impressive number for a simple diagnostic test. the reason the pps is not well above $2 right now is this companies history of screwing shareholders..
Great news! Look, the termination of 2 Phase II trials fits exactly with their stated goals of quickly becoming a commercial enterprise. Do you guys not get it? Phase II means that 108 in bladder and breast will not hit the market for another 4-5 years and millions of dollars. These guys have 130 hitting the market in probably 12 months from today, they will be building a 20 person sales force soon. They need an additional product to detail so they need to conserve cash and put it toward a "COMMERCIAL" product through an acquisition or in licensing. They have stated this several times recently. In fact, they need to out license or sell all early stage assets, shut down any R&D that is not Phase III and start focusing on near term cash generation. Bottom line they are transitioning from an R&D company to a COMMERCIAL ENTERPRISE in 2014. This fits completely with their stated objectives. I guess somehow that strategy was not picked up by some?
Strategy??? Dodd has been saying that since last April when he was hired and so far has made no progress towards acquiring a commercialized product...
And if they planned on ending the studies, why run them for an extra 9 months?? Why didn't he end them immediately.
Also, they were both open label studies. You would think if doctors started seeing efficacy in the first few treated patients, they wouldn't have been so slow to recruit. 12 patients in 3 years for the bladder cancer study!?
If their goal was to save money and shut down all other studies, they should have been honest and stated that to shareholders, rather than letting the information come out in a study update.
I will give Dodd credit if he can acquire a successful drug to commercialize... but right now the "strategy" is about as good as saying I plan on winning the lottery.
Even is 130 is approved and they can bring another drug to market, profitability is years away. There will be dilution before then (especially if they spend a large amount of money to buy a drug... of course, they could buy the drug itself with dilution.) Originally the P2 for bladder was supposed to end last year, but they could not recruit patients. Had they succeeded in the trial and announced successful results, it is highly likely the company would be trading for more today, and dilution would not be at these awful levels.
Why is this bad news? They already have a completed Phase 2 for Ovarian Cancer waiting for resources to go into Phase 3 for about 4 years. Is there any point in wasting money in additional phase 2 studies? In fact, this is pretty good news.
Two major indications are terminated and now everyone gets to hear pumpers try and convince anyone who will listen that its “pretty good news”??? I’m not sure how to even comment anymore. Company fails? Pumpers say its good news (They can now concentrate on better drugs). Company delays? Pumpers say its good news (Company taking their time to get it all perfect). Company dilutes? Pumpers say its good news (Company now has more cash to develop promising drugs). Company terminates clinical trials? Pumpers say it good news (why waste cash on Company touted indications). Does this company ever do anything wrong in the eyes of pumpers??? From over $70 a share to under a dollar in 12 years and it’s all smart and good planning from management in the minds of pumpers?
Honestly, do you have anything to add to your last post? The pipeline just shrank ….. AGAIN!!! ……. By two major indications and you see this as being “pretty good news”??? This company can do whatever they want and still seem to have a devoted following. Just a word of advice that I’m sure you will completely ignore since you view “ME” as being the enemy. If the company asks you to step up and drink some Koo-Aid, stop and think long enough to try and figure out how little you, as a shareholder, matter to their own ambition in this venture which has already made them rich. Try and understand, just once, that you are being purposely taken advantage of. This is in reality “pretty BAD news”. Which is the only kind of news this company ever produces for its shareholders and participants of their clinical trials. They claim to have met all of their objectives last year. So wait and see the amounts of bonuses passed out to one another this Spring. Which in the minds of Dudd and Turdpin is “pretty good news”. Good God.
What’s really funny about this is that the company only just released their latest investor presentation (January 2014) showing these now canceled trials as part of their ongoing pipeline. This is exactly what I mean about this company. The new investor presentation was only just released last week and now it turns out that they knowingly included ongoing trials that no longer exist. Was it intentional? The January 2014 investor presentation is already outdated and we’re only half way through January!!! The “amazing” pipeline continues to shrink almost by the month.
I guess that dilution will fix all problems? When will the next offering happen? Only Turdpin knows. So when does the company update the newly released presentation to reflect their diminishing pipeline progress? Next year after they receive a CLR from the FDA? I love how the new presentation shows that the company met all of its objectives last year. Must have been great to have been an investor through all of it. The new executives should come in handy while nothing happens all year. They both certainly seem to have hit the ground running. Just like Dudd did last year.
I think all the eggs were always in the endometrial trial. They would not of started a phase III trial in any of these anyway as it would cost too much, and failure of the endo trial would mean that they would likely not continue work on these in a phase III context. At least we have some numbers. With only 12 Bladder cases that gives 1/12 CR and if there were other PRs or just SDs, that would of been a good story in that disease stage. But it is incredibly difficult for just one or two sites to recurit the numbers of patients they wanted. But if each of the ~60 endometrial sites can recruit 7 patients in a year - that would be fantastic.
Sentiment: Strong Buy
Yes,the bladder cancer study was run out of only the university of Miami. The breast cancer study was also being run from Miami with two additional sites in Germany. Certainly nothing of the scale of the P3 Endometrial trial... still disappointing that these studies go away.
In particular, the bladder cancer study was open label... you would think if other patients from the first 12 had CR like Robert Chambers, then recruitment would have picked up...
Interesting to note:
For triple negative breast cancer they only got 7 out of 74 desired recruits.
For bladder cancer it waas 12 out of 64. What is really sad about that is they touted the miraculous recovery of their first patient in August 2011. In 2.5 years, they could only recruit an additional 11 patients?!