Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
This long stagnation may be due to the kinds of delays we have come to expect, and that are to an extent to be expected.
As the stagnation period lengthens however, it is also possible that there are more substantial problems, particularly with the IND filing.
If there are such problems, I would expect some of the talent at the company (particularly Dr. Street) to move on.
This is another possible event that will give us some insight into where corx is headed.
Assuming that there is a sufficient trend in the SA data to warrant further work in this area, would it be possible for corx and its partner to specifically target SA in patients whose SA is at least exacerbated by chronic opioid use? Would this infringe on the IP sold to Biovail?
I've always liked this approach, because I think there are multiple mechanisms that give rise to SA, and at least some of these may be quite complicated to treat. In chronic opioid users, at least part of the SA is likely due to RD, which ampakines have been shown to treat with good efficacy. Thus, the reversal of the opioid-induced RD would likely lead more consistent efficacy in treating SA exacerbated by opioids. In addition, the fact that these patients will be sedated by the opioid may also mitigate the sleep-negating effect of ampakines.
The obvious reason why this is an attractive indication is that there is a huge pool of patients on chronic opioids. If ampakines could be incorporated into the formulation of these drugs (both to reduce SA and to lower the risk of RD-induced death), the company would be tapping into a market at least as big as the SA market.
A revealing commentary on another non-corx bb regarding the reacquisition of the SZ rights, and Varney's statement:
Mark Varney, Ph.D., President and Chief Executive Officer of Cortex. "Data from animal models suggests AMPAKINE compounds could treat the cognitive deficits that occur in as much as 75% of individuals with schizophrenia. In addition, recent animal work suggests AMPAKINE compounds like CX1739 could be effective therapies for depression, and could potentially provide a much more rapid onset of antidepressant activity and represent a completely new mechanism of treating this disorder. . . ."
To this one poster wrote:
>>It certainly would be interesting to know what he bases these statements on. Animal models need to be proven to correlate findings of effects in animals with clinical effects in humans. It's one thing to correlate seizures or cardiac toxicity that occur in several species and may be dose related. It's quite another to show a correlation with cognitive functioning in humans especially when it's difficult to show effects in humans period, and even more so when the human studies haven't even been done yet.
My hunch -- as a one-time regulatory lawyer -- is that one of Cortex's outside counsels has come to the conclusion that since there is no approved version of an Ampakine drug, for any indication (and, apparently, no filed NDA or ANDA either!), it cannot be an FDA matter.
Now, it may be an SEC matter, if such (putative) hyperbole is supporting the stock price -- but presumably, the outside counsel would say "you'll need to modify that, and really pull your horns in" when Cortex gets ready to actually file an NDA on any of the variants of Ampakine.
It sounds as though Biovail's RD program may be in trouble too then. Would they announce that this program was being discontinued? Can they resell the licence to someone else?
B thanks for finding this. I like this because it offers an easier path (via orphan disease) to gain FDA approval for an ampakine in a clinical condition requiring chronic use. The combination with mGluR agonists is also interesting, because the simultaneous upregulation of distinct glutamatergic pathways may unlock synergies with broad application to psychiatric, developmental (Rett Syndrome is a good candidate), and neurodegenerative diseases.
Where do you guys think we are on the real-soon-ometer re: SA, IND?
As a hobby for masochists, any guesses?
I foresee SA by end of Nov, no IND before Jan 2011
>>>because a broad psychiatry low-impact platform is probably the clearest route to a major license or being acquired.
...and this hinges on an IND being approved for an indication requiring chronic use of a low impact. That's what cratered cor in 2007, and it remains an extremely important milestone that they haven't yet reached.
Now that they have the option to revisit this, do you think that corx should continue its indication-based out-licencing strategy?
The minute they enter into an agreement with a partner to start a phase 2 ADHD study, they've effectively rebalkanized that molecule.
My sense is that they are pursuing this strategy out of necessity, because there are no partners out there willing to in-licence a compound for multiple indications, with commensurate upfront payments. Nonetheless, it would be best if corx entered into an ADHD deal with a company that would likely also be interested in in-licencing the same compound for other psychiatric indications.
None of this adds up to a hill of beans if the IND isn't approved.
It might make sense for corx to consider seeking an IND for SZ, since in the eyes of the FDA, the risk-reward profile for this more serious disorder may be different, and they may be more well-disposed to approving it.
Neuro (somewhat OT): do you have any thoughts on Galleon Pharmaceuticals? Do you think they have the pipeline and/or the management to challenge corx in seeking treatments for SA and opioid-induced respiratory depression?
This is a global problem on a par with malaria, and shouldn't be left to the marketplace. Even if a drug is developed, if a pharma owns the IP, none but the wealthy will be able to afford it for the duration of its patent life.
Nobody should have to endure AD. Eradicating this disease shouldn't be profit-driven, since everyone should have a right to treatment.
SA is an incredibly complicated syndrome, symptomatic of a broad disregulation of sympathetic tone. It is exacerbated by and exacerbates hypertension, obestiy, and diabetes (they are linked because they share many peptidergic regulatory pathways). It's possible, but in my opinion unlikely that SA will be amenable to a "silver bullet" drug.
The trial design will provide weak proof of anything. The drug is being tested for 1 night, and this is a chronic condition.
I hope they get some kind of a signal, but I think the enthusiasm here is premature.
I don't think IND will affect share price, but I do think that IND approval will allow a phase 2a trial to go forward, and I'm pretty confident that the result of that trial will be positive, based on the cx-717 results. Positive trial results will likely lead to a partnership and boost share price.
Furthermore, an ADHD partnership will reestablish ampakines' legitimacy, so that overall we'll be on better footing.
Insofar as I'm right about an eventual positive IND having little effect on share price (i.e. staying at or below $0.20), after the IND may be a pretty good time to buy. I won't be able to, but if I had the cash, and the IND were approved, that's when I'd buy.
I'm not all that hopeful, but patient with this thing.
>> I'm not even sure how much traction an approved IND will provide
It won't affect share price, but it will allow me to stop holding my breath.
If the IND fails for one reason or other, I'm not sure there is a way forward for corx.
Approval will create the possibility for these compounds to actually reach patients. There are many ways for corx to then screw things up, and/or for biology to fail to cooperate, but there is at least a way forward
Yeah, I was happy to see that. Imagine what might happen if they actually got hocus-pocus out of the SA data, or if the IND were approved.
It continues to baffle and bug me that a company with IP this valuable is on the verge of insolvency.
A way to position this presentation on the futility index is its impact on share-price. I predict no change: low volume, brownian motion. That's best case.
I hope the Tran explanation accounts for the delay in filing. It seems to me that corx could have negotiated with Tran about his departure date from corx to allow for a timely IND filing.
Whatever the case, if they don't have something filed by the end of Q3, we really do have a problem here.
Assuming the IND is filed, I think the profitability of CX-1739 will be eroded by regional indication-based outlicencing to raise funds. Although this is the least evil way to raise capital, it may complicate partnership down the road, since the market for the drugs to be developed will be reduced.
I'm beginning to think the only path to profitability for corx are the high-impacts, about which we know little.
real soon...
I just went through them. It looks like there will be no real news in this presentation: the SA trial has still not completed, but, as gfp predicted, they promise results in Oct. Similarly, they don't give any concrete information about the ADHD IND.
Based on their burn rate and current capital, they've got enough to get to June-July of next year.
They're interested in partnering in Europe or Asia, doling out commercialization rights in those regions to interested partners in exchange for operating funds.
They also state that they are open to M&A.
If the IND is approved, and CX1739 is used in clinical trials for ADHD, corx could turn around nicely. To a lesser extent, a good SA outcome would also offer a path to profitability.
This company is toast though, if it can't get its compounds approved for chronic use. That has to happen soon. All the new compounds are meaningless if none of them can be brought to the clinic.
Don't count on it. I think they would be required to reveal the results of the trial once the results were in. It's possible that the analysis is far enough along so that they can tweak the completion date so that it coincides with the presentation, but I don't think they can sit on the results for any length of time.
I expect nothing but further promisory notes of the "real soon" variety. I'm grateful that I'm not the one required to give the presentation; it's the stuff of anxiety dreams.
What I really want to find out about is the status of the IND. The longer that drags on, the more worried I am that there are problems of some kind with the compound, either pertaining to stability or toxicology. If they can't get a low-impact approved for chronic use, corx is toast.
The problem is that the trial they've completed is a weak one, whereas the trial for ADHD is more robust.
They'd have to weigh the risks of committing to SA on the strength of the effect of the drug on one night's sleep, vs more robust performance data on subjects taking the drug for weeks and then being tested (as was the case in the CX-717 ADHD trial).
By the way, this whole discussion highlights the flaws of cortex's outlicencing-by-indication business model. I just don't think it's realistic.
If they get suggestive/positive data for SA, I think they should allocate a different molecule to it, with a longer half-life or whatever, so that they can pursue ADHD with CX-1739
I'm still waiting for the IND submission/approval for CX-1739 in ADHD. If the FDA green-lights the trial, I will consider it a major step forward. I don't take this for granted at all.
hah hah hah. The statistician in in a hot-tub on Ibiza.
Even in a wildly optimistic scenario of ADHD approval, positive SA outcome, etc., the upside here is likely different than it would have been 3 years ago under the same circumstances; from today's NYT:
http://www.nytimes.com/2010/08/22/business/22invest.html?_r=1&hp
Renewed economic uncertainty is testing Americans’ generation-long love affair with the stock market.
Flight to Safety
Investors withdrew a staggering $33.12 billion from domestic stock market mutual funds in the first seven months of this year, according to the Investment Company Institute, the mutual fund industry trade group. Now many are choosing investments they deem safer, like bonds.
If that pace continues, more money will be pulled out of these mutual funds in 2010 than in any year since the 1980s, with the exception of 2008, when the global financial crisis peaked.
Small investors are “losing their appetite for risk,” a Credit Suisse analyst, Doug Cliggott, said in a report to investors on Friday.
.
.
.
It's ironic: Tran is going to Eurhythmics to develop novel antidepressants (here comes the rain again...) on the strength of his track record at Lilly, where he helped bring to market 2 antidepressants (Prozac Cymbalta), which the press-release itself states have been found to be ineffective in 66% of the patients who take them.
Onwards and upwards.
Jokes aside, in all the years I've followed this dismal stock, I've never seen 0 trades. Could this mean that trading in corx has been halted for some reason?
I don't know much about TA, but this looks alot like a "flat line".
If they need to do a financing before either the IND decision or the SA trial result come through, it will be bad.
can somebody provide an estimate of current funds, based on a reasonable estimate of burn-rate? When do they hit $3M in cash on hand?
I have no idea about when the SA results come out.
Something we could likely get a ball-park estimate on is how much cash on hand they have, assuming a ~$1M/mo burn rate (I'm not sure about the burn rate).
This projection will give us a sense of when corx absolutely needs to have somehting done to avoid serious trouble. Their lack of funds has to impose some discipline on their time-lines.
Off the top of my head, by October, they'll have ~$3M left. That's cutting it pretty fine.
If they submit the ADHD IND today, it could be as late as October before we find out whether they've been approved or not. Corx isn't necessarily going to disclose that they've submitted for the IND, so we may remain in the dark about that. It might make sense for them to do so however, just to dissipate the growing sense that this is a phantom company that has stopped doing anything.
I came across a TA site that argued that corx had formed a triple bottom. Apparently this formation predicts an increase in share-price.
I'd be grateful for the thoughts of the TA-minded people here on these charts:
http://stockcharts.com/charts/gallery.html?CORX
I don't consider it unsubstantiated cheer. Private foundations that fund biomedical research have a very different agenda than the BPs we're more familiar with. They don't care about profitability, they care about a cure. Be sure that if the project funded by the Michael J. Fox foundation generates good data, the foundation will provide more support.
The data that was included in a shareholder presentation some years back was impressive. A unilateral MPTP lesion to the substantia nigra killed off all substantia nigra neurons on the targeted side, and gave rise to a robust behavioral phenotype: the animals could only turn in one direction. Following treatment with the HI, the animals recovered the ability to turn in either direction, and immunohistochemistry revealed the presence of DA receptors on the lesioned side, consistent with neurogenesis.
If these findings are replicated, they are going to throw a bunch more dollars at corx. This constitutes disease reversal, currently unheard of in neurodegenerative disease. There are real questions about whether a treatment plan can be developed that will provide the benefits but avoid the risk of seizure, so this is far from a slam dunk, but good preclinical data will attract more support.
My own feeling is that the chances of corx making money are getting slimmer, due to industry consolidation and the deteriorating funding climate; at the same time, I think that if they do somehow make it, the pay-off will be greater than it would have been if more microcaps were competing for BP partners.
The odds are worse, the payoff is better. At these prices, it would certainly be worth the gamble to drop a few thousand to purchase a position that I payed $60K for. Whatever the ultimate outcome, I think it's a safe bet that this will be dead money for 2-3 months, which begs the question of why those of us who are long continue to park our pennies here. As alertmeipp has indicated, a short-term position in another stock would make some sense now. I just don't have the nerve or the will or the information.
If the HI data are good, corx might be able to get the foundation to act as a VC to fund the clinical trials that they would otherwise have to go to BP for.
The biggest hurdle with the HI is whether or not the side-effects are acceptable. If there's a dosage level that is clinically effective, but below the seizure-inducing threshold, this could generate a great deal of interest, because of the broad beneficial effects of BDNF in PD and AD.
What corx does over the next few months will determine whether I continue to hold this stock. They have two projects that they have to complete: the ADHD IND and the SA trial. A setback on the first would be disastrous; I've already written off SA, so if that comes out OK it will be a happy surprise.
The real make-or-break issue for me is whether they can actually complete either of these at close to their projected schedule. For a company as cash-poor as this one, if they can't reverse their pattern of missing deadlines, they will fail.
By year's end, if we're still in a holding pattern, I'm done, even if it means selling at 10 cents.
right around now.
This is very good news for PD patients. Slides from a cor presentation from a few years back showed very promising reversal of MPTP-induced cell death, and excellent recovery of function. It has bothered me that this very promising avenue of research appeared to be abandoned. I'm glad they've got some funds to work on this.
I don't think you're doing us, yourself, or them any favors by emailing them like this. While you might think that you've asked questions that they could respond to, that's a matter of opinion, and I think they are right to err on the side of caution.
Notice that in his email, Varney did nothing more than reiterate almost word-for-word what was said at the SHM. He's not going to tell you something new, period. The exchanges with Varney are all vaiants on "are we there yet?".
What's bothersome to me isn't their silence, it's that when they volunteer information about timelines, this information has been wildly off.
It's stupid; I don't see much added value with the merger.
It would have been really bad news if they'd opted for cash.
A nice review of the sector in Reuters: "Special Report: Big Pharma's stalled R&D machine"
http://www.reuters.com/article/newsOne/idUSTRE65F25Q20100616
It's a big picture most people here are familiar with, but sheds light on the environment corx is operating within. While the overall picture is grim, for a microcap with good IP, this could be a very good period, if they can just survive long enough to get drugs to late-stage. I think corx has at least the hope of making it, but it's a long shot.
A somewhat arbitrary exerpt:
Despite pouring billions into research -- more than $65 billion last year in the U.S. alone -- the number of new drugs launched annually has fallen 44 percent since 1997, according to CMR International, a Thomson Reuters subsidiary.
Big Pharma has also struggled over the past decade to produce the kind of big new hits that make the bulk of its money. As with other industries dominated by blockbusters -- think Hollywood movies or oil and gas exploration -- it's not easy to pick winners years in advance. Even after a drug gets approval, commercial success can be a hit-and-miss affair, as evidenced by lackluster sales of recent arrivals such as the keenly anticipated blood-thinner Effient from Eli Lilly and Co and Daiichi Sankyo Inc.
"Once you take into account all the drugs that have fallen by the wayside, the returns have been pretty bad," says Peter Fellner, a veteran with three decades experience in both pharmaceuticals and biotechnology. "It is a reverse alchemy calculation where you are taking a very large amount of gold and quite rapidly transmuting it into lead."
He may not be replying because, in surveying this bb, he has observed that nobody posts much here anymore, and thus there is likely less traffic, so why bother.
I don't think that he was responding to queries entirely because he wanted to remain responsive to shareholders, but also because he thought it might be a useful way to build interest in the company on this bb.
The problem is that CX-1739 is already 'taken' for ADHD
This isn't necessarily all bad. If SA is positive, and if the IND for ADHD goes through, then corx may find itself in a position where entities interested in inlicensing CX-1739 for ADHD will be competing with others interested in the SA indication, driving up the bid.
My sense is that they have other low-impacts that could be brought forward for either of these indications in the event that the CX-1739 deal goes for one indication only, and the terms of the deal preclude outlicencing the same compound for a second indication.
Finally, it could be that a partner could be found for both indications.
I'll be happy if they have this problem.