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Hopefully partnership too.
https://seekingalpha.com/news/3294532-china-studying-ban-gas-vehicles
China Studying Ban On Gas Vehicles
Can't just be the sky is the limit. How many people are candidates for this drug each year and what percent can they convert? What kind of pricing do they expect?
What do you think market potential is for Ixmyelocel-T? I recently stumbled on vcel and feel like it should be much higher.
Finally a beat!! Looking forward to more of those.
Vtrading,
What are your thoughts now (roughly 4 months later)?
Lol. One step at a time..... How about CE first?
Sorry for the confusion.
"3. MAJOR INSIDE BUYING...as member of the Board. "
This speaks volumes - can't even begin to explain how big this is.
Strong buy!!
Nowhere near green.
I agree on that. It's been a brick wall in this trading range. Waiting for that unexpected pop. I have patience...........
Could be they partner out the trials on NT219 - maybe be with same partner they choose for KIT302???? Could be part of the BIG DEAL.
http://www.tyrnovo.co.il/the-effect
Proof of concept on this thing is through the roof.
I've seen this asked before but haven't seen a response. As an FYI I am long ktov.
Does anyone know what incentives the CEO has to sell this company outright? Does anyone know what kind of warrants or options he has?
Right. Ok, that's what I figured.
Staccani, how do you think the Livermultiscan is going to change things as for results? If say the results are inline with cohort 3 what would the Livermultiscan show - or is this completely unknown?
Summary
The NASH (non-alcoholic steatohepatitis) race is heating up again, thanks to Allergan's huge buyout of Tobira Therapeutics on Tuesday.
Galectin Therapeutics' own candidate has quietly come towards the data readout in the first of its two major NASH clinical trials.
There are reasonable, but far from conclusive, indications for a successful outcome.
Galectin Therapeutics (NASDAQ:GALT) is a micro biotechnology company (market cap: $76.13 million) focused on targeting galectin proteins. The lead product is also being investigated clinically in melanoma, but most of the attention on GR-MD-02 is on its potential to treat fibrosis caused by non-alcoholic steatohepatitis (NASH). There are no approved products for NASH, and GR-MD-02 has a Fast Track designation from the Food and Drug Administration (FDA). Shares have catapulted 70% the past two days since Allergan (NYSE:AGN) acquired Tobira Therapeutics (NASDAQ:TBRA), another NASH competitor (see Figure 1). It was a much-belated jumpstart to what should've been a longer run-up to the anticipated report of topline results for NASH-FX by the end of the month.
Figure 1. Players in Non-alcoholic Steatohepatitis
NASH-FX is a Phase 2 double-blind, parallel group, single center, randomized, controlled trial (RCT) evaluating the efficacy of GR-MD-02 using multiple non-invasive hepatic fibrosis imaging methods (see Figure 2). The primary endpoint is the change from baseline of liver fibrosis as determined by multi-parametric magnetic resonance imaging (MRI), a painless alternative to liver biopsy which has been clinically validated to accurately quantify liver fibrosis, iron, and steatosis. T1 maps the amount of extracellular fluid, which changes with inflammation and fibrosis. However, liver iron has a confounding effect on T1, so it is corrected by accounting for T2, which maps the amount of iron deposition.
The secondary endpoints are baseline-adjusted change using either magnetic resonance elastography (MRE) or FibroScan. These liver stiffness measurement techniques have been widely used to assess fibrosis and for predicting clinical outcomes, but are less reliable in certain situations. FibroScan cannot be used if there is significant fat or fluid between the chest wall and the liver. Recently, it was discovered that different FibroScan operators or some patient-related factors could lead to large short-term measurement variations within the same patient. MRE is more accurate than FibroScan (which is ultrasound-based), but requires testing centers to buy additional, expensive hardware. LiverMultiScan, specifically developed to be used with MRI to measure corrected T1, only involves a minor upgrade; it was cleared by the FDA last year.
Figure 2. NASH-FX Trial Design
Surprisingly small given the 6 million Americans afflicted by NASH with advanced (Stage 3) fibrosis, NASH-FX enrolled just 30 patients. This means the trial design team expect a large difference between the placebo and treatment groups which would be easily detectable. A dose escalation Phase 1 trial on GR-MD-02 revealed that the drug was safe and well tolerated, and had some effects on liver fibrosis at the highest dose tested. First, alpha-2 macroglobulin (A2M) was significantly reduced (see Figure 3). A2M is a protease inhibitor and one of the most studied serum biomarkers; it inhibits collagenase and many other proteases. During fibrosis, the normally low-density extracellular matrix (ECM) of a formerly healthy liver is degraded and replaced by denser, nonfunctional collagenous tissue. Thus, A2M reduction could be a direct marker of collagen metabolism and fibrosis reversal. Some evidence of this was confirmed by FibroScan, which was only available for the final cohort; after Day 63, significant reductions (at least 20%) in liver stiffness were found in 3 of 5 GR-MD-02 patients and none in the placebo group.
Figure 3. GR-MD-02 Phase 1 Trial
Galectin is confident that their drug will effect enough change in 112 days. Failure will set share prices back to the $1's or even lower. Fortunately, GR-MD-02 has two other shots at redemption within the next 12 months. First, GR-MD-02 is being investigated in combination with the checkpoint inhibitors Yervoy [from Bristol-Myers Squibb (NYSE:BMY)] and Keytruda [from Merck (NYSE:MRK)] in two separate Phase 1b trials in patients with advanced metastatic melanoma. Providence Portland Cancer Center, which is funding the studies, has "indicated that data from the Yervoy combination trial should be available by the end of the year," although it would be preliminary.
And then there is NASH-CX, a larger Phase 2 RCT in 290 NASH patients with cirrhosis (stage 4) that completed recruitment last quarter. As of June 30, 2016, the Company had $18.0 million cash, which management believes is sufficient to fund currently operations through the end of Q2 2017. Regrettably, it is not enough to last until the expected topline readout at the end of next year. To conclude, NASH-FX is a binary event. For brave investors, chances of success are probably 60-65% because of the very small sample size of the previous trial. It is suggested that traders straddle their options with October 21 $2.50 puts and calls.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Editor's Note: This article covers one or more stocks trading at less than $1 per share and/or with less than a $100 million market cap. Please be aware of the risks associated with these stocks.
Someone posted a good question.
When a deal is eventually made with big pharma what % royalties do you think KTOV will get? I'm really not sure with a drug like this since it's not a standard drug.
We may have awakened a sleeping giant!
Those of us on here for a while don't need an "assessment" report - we already know.
But if it gets more investors involved then great!
Regis, fantastic background report - thanks!
Yes, I agree.
I agree with JP on this one.
I am new to this board as well however, I have been investing for over 20 years. You can tell this company is doing great things, it's only natural for an eventual uplift to the Nasdaq. The requirements are to have a share price of somewhere between $2-$4 (I think it all depends on certain criteria). Of course, if the stock gets there on its own they won't need a reverse split however, more than likely it will require a reverse split.
Norchi is experienced in the market and I guarantee you he wants an eventual uplift to Nasdaq - whether he's said it or not.
Anyway, it's one of those rare times where the reverse split is a good thing. More than likely the stock would move up on the announcement.
Correct however that's not the fully diluted count. Can you update with the fully diluted count now?
Does anyone know when they are expected to start negotiating the rights? I didn't seem to see a time period for that. Is it after they file, or could it be ongoing now?
Same here - adding more.
Christmas in August!
Patent news was expected. It wasn't something that everyone didn't know.
That being said the valuation on this one is really low and I still believe long term much higher from here.
Huge volume day today..........hope it continues. Would like to get back to the old highs (pre dilution).
I think he means that the company can't comment on it to the public and they couldn't give a comment to the Rodman analyst either.
Meaning they are working on some sort of deal and can't comment.
I'm not going anywhere..... I guess in time we'll find out.
I agree, however they went about it the wrong way.
If you need cash for a new deal - make the deal and THEN announce a secondary to pay for it. In that scenario you might even see stock appreciation.
I'm here for the long term and continue to add at these levels. I appreciate thoughts and DD from everyone here. I'm still disappointed at this secondary - so many other ways to go about getting cash.
Now all of the sudden they're looking to raise additional capital? Focus on kit-302 - work on a deal that involves cash up front and then use that cash for whatever you need. Did they not know that this market would be brutal?
They're sitting on a gold mine and the digging is almost done - now was not the time for this.
Any thoughts?
Hey guys, long time reader - new poster here.
Love KTOV and have stock and some warrants too. Only problem with warrants is eventually (could be a few years away) if this company is doing well they might issue "special" dividends - could be $2 dividend (I've seen it before). I think you'd have time to execute your warrants in that case but if you didn't know about the div you wouldn't receive it holding the warrants.