Robert Morris is helming a biotech-focused stock newsletter that’s called Biotech Supertrader (modesty has no place in the world of newsletter promotions, of course), and I’ve never covered this letter before so I thought I ought to have a look at the latest teaser we’ve been asked about.
Morris, incidentally, has been featured in our pages before — but that was back when he was editor of China Stock Insider at the same publisher. That letter, like almost all China-focused investment newsletters, seems to have disappeared quietly into that good night … which probably tells you that it’s time to invest in China again, since the newsletter publishers are ignoring the Middle Kingdom and rushing out their pitches about biotech and tech stocks. At the time, Morris was teasing NQ Mobile (NQ), which has turned out to be pretty good if you bought it down there in the $6-8 neighborhood (though it’s been a wild ride).
So now what’s he pitching for his Biotech Supertrader?
Well, the destruction of “Man’s deadliest disease”, of course. Here’s how the teaser gets our attention:
“This Tiny, Unknown Biotech is About to Unleash Its ‘Holy Grail’ Drug on Man’s Deadliest Disease
“Their ‘Guided Missile Approach’ Could Save Thousands of Lives Each Year
“It’s about to become the most talked about advancement in cancer treatment in our lifetimes and you can lock in a life-transforming fortune if you act quickly….
“I’m urging my subscribers to load up on this stock NOW….
“I’ve just uncovered a tiny, unknown biotechnology company with a new cancer drug in phase 3 clinical trials which is showing remarkable success at treating several types of cancer.
“Their scientists have found an innovative approach to cancer care which involves a breakthrough in treatment. It goes deep inside the inner workings of our cells.
“Plus, this medicine looks to be many times more effective and with fewer side effects than the chemo, radiation, and drug therapies currently available.”
If there’s one thing that investors know can make them rich and make them feel good about themselves and the world, it’s a cure for cancer — we’ve seen that effective cancer treatments can and do (occasionally) turn little biotech stocks into gigantic successes, so the dream lives on that you’re going to catch one of these lottery tickets and own the next Genentech. Will we be so lucky? Well, let’s see which one he’s pitching:
“When this drug wins FDA approval – which I believe it will – this small company’s $4.16 stock price will go straight to the moon.
“And the market for this drug is absolutely huge!
“You see, this small biotech is targeting its new drug, let’s call it ‘drug S’, at cancers of the blood and bone marrow. And it is already in very promising phase 3 trials for these two types of cancer.
“But here’s where it gets really interesting. It looks like the drug this company is developing will also work on other types of cancer!
“There are positive signs it works on Non-Small Cell Lung Cancer (NSCLC) too. There are 1.1 million people with this type of malignancy. Just in the United States alone there are over 300,000 patients with this disease according to The American Cancer Society. Each desperate for a cure.
“Plus it looks like ‘drug S’ may turn out to be an effective treatment for ovarian Cancer. There are more than 204,000 new cases of ovarian cancer diagnosed worldwide each year with 22,280 of these in the United States according to the National Cancer Institute estimates.”
So … who is it? Thinkolator sez this is Cyclacel Pharmaceuticals (CYCC)
Cyclacel is indeed a little biotech around $4 (it closed at $4.35 yesterday), with a market capitalization of only about $80 million — so be careful, we’re a big enough group here that if just a small percentage of Stock Gumshoe readers got enthused about this stock it could drive the shares up, less than a million dollars worth of shares trade each day (Biotech Supertrader says they limited their readership to 750 people — I don’t know if that’s still their cap or if they’ve hit it, but we’ll have more folks than that reading this free article).
And like many biotech stocks, it’s got some impressive scientists and it’s been losing money for a long time as they’ve been searching for a viable drug (their current lead drug also was a big focus of theirs back when it was in Phase 1 trials five or more years ago, so that’s a good reminder of the time these things take, it’s just starting Phase 3 trials now). It looks like they must have gone public in 2004, when they were about eight years old, and a quick scan of ten years of their financials over at Morningstar indicates that they’ve never generated more than a token amount of revenue (meaning, they’ve probably had some research collaboration payments or partnership funding, but never got a product to market), and have accumulated more than $250 million in losses to date. And had two reverse splits to keep the price from sinking far into penny territory.
So that’s not unusual, but it means that — as with all developmental-stage biotechs — it’s not about the financials or the fundamentals, it’s about what’s going to happen in their clinical trials and whether things are going well enough that they can continue to finance the trials … which get much more expensive as you progress through Phase 2 and Phase 3.
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All I know about them so far is that they say they’ve got enough cash to get through enrollment in their key Phase 3 study for “drug S” (which is sapacitabine) as of September when they last updated their investor presentation, but I know nothing about the science or the competing cancer drugs that are out there or how fabulous this particular one might be, so I asked our favorite medical writer, Doc Gumshoe (who, yes, is not a doctor) to check them out quickly and chime in. Here’s what he could share after looking into them for a few minutes (he’s just looking at the medical stuff, not so much the “investor presentations”):
- Cyclacel’s Prospects
Cyclacel has three drugs in development at this time, and is involved in eight clinical trials with these drugs, not including two clinical trials that have been terminated. Their top contender is sapacitabine which targets the division of cancer cells. If you can prevent cancer cells from dividing and reproducing, you have the cancer whipped, so targeting cancer cell division (or mitosis, which is the technical term) is a highly promising avenue for treating cancer. However, we need to take note of the fact that sapacitabine is one of a large number of drugs that propose to fight cancer by this method.
At present, all eight of Cyclacel’s clinical trials involve sapacitabine. Of these, at least one has been completed – a Phase 1 study of the safety and pharmacology of the drug. Four others are current, with no information about results. These are likely Phase 1 or small Phase 2 studies, to assess safety, determine what a correct dose might be, and evaluate whether the drug does what it’s supposed to do in human subjects with the target diseases, which in this case include acute myeloid leukemia (AML), cutaneous T-cell lymphoma, and some advanced solid tumors. Prior to the clinical trials, sapacitabine has demonstrated impressive results in delaying the spread of metastatic liver cancers in mice.
From what I can gather from public sources (i.e., the NIH Clinical Trials Registry), there is one Phase 3 trial, which started recruiting patients in February of 2013 and is expected to be completed in late 2015. The trial is in elderly patients with AML, and compares alternating cycles of sapacitabine and decitabine with decitabine alone. Decitabine (Dacogen) is FDA-approved for treating AML and also targets cancer cells’ replication by attacking their DNA.
It is possible that the Phase 3 trial by itself could lead to FDA approval for sapacitabine, depending on the strength of the results. However, that trial would not get the drug approved for use as monotherapy, since it is not being investigated as monotherapy. My guess is that Cyclacel is planning more trials of sapacitabine as monotherapy, perhaps in younger patients. And my further guess is that FDA approval is still quite a long way off.
Sapacitabine is also in a Phase 3 trial with cyclophosphamide and rituximab for the treatment of relapsed chronic lymphocytic leukemia. Cyclophosphamide (marketed under several trade names) is a well-established chemotherapy agent used in a number of cancers, and has led to remission in many cases; however, it is associated with truly harrowing adverse effects. Rituximab (Rituxan, Genentech) is used not only in cancers but in some autoimmune diseases. And sapacitabine is also being studied in patients with previously-treated non-small-cell lung cancers.
Although the piece from Biotech Supertrader said that the drug – identified as “drug S” –is also a promising treatment for ovarian cancer, I find no clue that it is being studied in such patients. [ed note: that’s because that “promise” is in the lab still, not in people — they had a press release about this in the Fall, “75% of Ovarian Cancer Patient Samples Highly Sensitive to Sapacitabine”, not studied in patients but on patient samples]
Cyclacel has two other drugs in development: selicilib and a drug designated as CYC116. One selicilib study has been terminated, and in a second Phase 1 study, selicilib is used with sapacitabine in patients with advanced solid tumors. Remember, however, that Phase 1 studies are many rungs of the ladder below what’s needed to gain FDA approval.
CYC116 is an aurora kinase inhibitor, meaning that it blocks the action of an intracellular enzyme that facilitates cancer cell mitosis. This is a promising avenue of cancer treatment, however, the traffic on this avenue is fairly heavy, and includes several other classes of drugs including tyrosine kinase inhibitors, and taxol based agents such as paclitaxel (Taxol, Bristol Myers Squibb); docetaxel (Taxotere, Sanofi-Aventis), Abraxane (a newer formulation of paclitaxel from Celgene) and others.
CYC116 supposedly also inhibits vascular endothelial growth factor (VEGF), which induces the growth of blood vessels that nourish cancer cells. Inhibiting VEGF is a well-established means of combating cancer, and CYC116 could hardly be characterized as a radically new departure in cancer treatment.
The one trial involving this agent has been terminated. That, of course, does not mean that development of CYC116 stops dead in its tracks – there are many reasons why a trial can be terminated, and ours is not to speculate without more information.
Beyond those three drugs, it’s hard to guess what Cyclacel may have up its corporate sleeve. It is certainly true that a successful cancer drug – even if only moderately successful– can be transformational for the biotech that develops the drug. But the drugs that Cyclacel has under development do not appear to this skeptical observer to be radically new departures in cancer treatment.
It’s important to remember, when trying to estimate the likelihood of a single drug demonstrating sufficient efficacy and safety to gain FDA approval and market share, that the competitive field is vast. As I mentioned earlier, Cyclacel has a total of 8 clinical trials in process at this time.
For the sake of perspective, it’s worth knowing that at present there are 41,445 cancer trials being conducted. So those are the odds.
So there you have it — it’s almost impossible to find a development-stage biotech whose financials look great or that makes your heart go pit-a-pat over their valuation, especially in a biotech bull market like we’ve seen over the past year or so, and Cyclacel doesn’t jump out as spectacular on that front either, not unless you’re a big believer in the promise of their specific drug. They’re a small stock and they don’t get much attention, other than from the analysts who probably helped them sell shares in secondary offerings in recent years, and there aren’t any major “skin in the game” insiders as far as I can tell (the CEO owns $1 million worth of shares, but he gets paid more than that every year), and there’s only one really focused owner on the institutional side that seems to have any kind of biotech focus (Eastern Capital owns about 7% of the shares, roughly $5 million worth … don’t know much about them).
So I don’t see a lot to make them stand out other than Robert Morris’ apparent enthusiasm for the shares (which certainly goes over the top, he calls his special report “The End of Cancer Worries Forever“), and I don’t know enough about the science to be a believer (though, to be fair, I almost never speculate on developmental biotechs because they’re so hit-driven and I’m not smart enough to be a hit-picker in the sector). It is at least encouraging that they are enrolling patients for Phase 3, and that they probably won’t have to raise more money before they have some indication of how the trial is going, but sometime in the next year or two they’re probably going to have to either get good results from this trial that let them raise cash at a good price, or have promising enough results that some big pharma company wants to jump in and help fund development of “drug S” (or just buy up the whole company, as happens with some regularity when a little biotech gets promising results).
Oh, and they are presenting at an investor conference next week, so maybe they’ll have something interesting to share then. As you can tell, this one doesn’t jump into my cup of tea … but these kinds of stocks almost never do. Sound interesting to you? Interested in the science or the lottery-ticket possibilities of $80-million developmental biotechs? Have any experience with Robert Morris or know whether or not we should consider him a biotech savant? Let us know with a comment below.
About Organovo: my mind is open, but I am a long way from persuaded that this is a worthy stock to be in. I have followed it since its debut. It has a $720 million market cap with no revenue, an 18 per cent short interest, only one insider purchase ever, and a preceding 12 months filled with insider sales, mostly on exercised options.
I worry that when people read about this company and its 3-D bioprinted liver system, they get images of a miniature liver sitting in a Petri dish. They may think that this tech could somehow lead eventually to ex vivo cultivation of livers that can be implanted. This is a long way from the truth. What Organovo is coming up with are tissue culture systems with some three dimensionality. But looking at their pictures of what they have accomplished for their 3-D livers, these are wildly unlike actual livers. There is cellular chaos. I see no evidence of bile ductules, and only limited evidence of vascular structures being formed in festoons of disarray. Hepatocytes are not organized into lobules, there are no portal tracts, and no distinct portal or central venules.
Let’s discuss the liver. What does it do? Three things, fundamentally. It makes protein, mainly albumin, which preserves oncotic pressure and keeps plasma from leaking into tissues, and clotting factors. It makes bile, which is a mixture of bile salts and cholesterol. Bile is made by hepatocytes, secreted into bile ducts, and into the gut, where it acts to emulsify fat for absorption. Bile salts are absorbed in the distal small bowel, trafficked back to liver, and put back into bile ducts in a process we called enterohepatic circulation.
Finally, it detoxifies. The liver is armed deeply with an array of enzymes, called cytochromes P450, that have an extremely broad repertoire of enzymatic tricks that they can pull on chemicals that are absorbed: they can cleave them, add chemical groups, remove chemical groups….react with them in one of a million ways to destroy the chemical. A chemical enters the liver and gets beaten up in a thousand ways til it succumbs. The liver is good at this, which is why I need to emphasize this point: most drugs are not liver toxic. The liver can really detoxify anything. Its ability to beat up an absorbed molecule exists in tremendous excess capacity.
Drug-related liver toxicity can manifest itself in two ways: injury to hepatocytes, which manifests itself mainly as an elevation in blood levels of alanine leucine aminotransferase (ALT), which is released when a liver cell dies. Or the drug can cause toxicity as regards biliary excretion, manifesting itself in a rise in bilirubin, which when elevated beyond 3.5 mg/dL will tinge the whites of your eyes yellow. It is harder for a drug to cause bilirubin elevations because bile elaboration is redundant, and when this happens it is a sign of more severe injury. However, I think it is safe to say that drugs that cause permanent liver injury, where their effects are not reversible upon drug withdrawal, are vanishingly rare. There are a few arcane ones. The liver has tremendous capacity to heal itself, something the Greeks recognized as the basis for the myth of Prometheus. If you underwent surgical removal of up to three quarters of your liver, what remains would undergo such intense regeneration as to afford a normal-size liver within two weeks.
Right now drugs are pre-clinically assessed for liver toxicity in two ways: by incubation of them with cultured hepatocytes, followed by microscopic examination; if drugs seem OK by this method, they are then given to lab animals. I see no basis for arguing that an Organovo 3-D “liverette” will give better data as regards direct toxicity to hepatocytes than will ordinary cell culture. Meanwhile, I noted above that when I review slides of their liver models, I do not see evidence of structures resembling bile ductules. I thus see no reason to predict that the system will be any good at predicting biliary injury and bilirubin elevations. The cpmpany’s literature is highly mum on the specifics of how long it takes one of their systems to be derived, and how long it lasts. However, they claim to be contructing these models out of normal cells, including normal (not transformed, malignant) hepatocytes. For reasons we do not yet understand, but clearly have much to do with “vital humors,” hepatocytes in culture do not live long or thrive despite optimal care. My concern thus is that what Organovo is selling is a very short-lived system. When we speak of “liver cells,” we do not mean hepatocytes. Those are one type of cells in liver. “Liver cells” include hepatocytes, cholangocytes, endothelial cells, stellate cells, macrophages, lymphocytes…..and despite sincere efforts, Organovo has not managed to recreate a model liver with all of these. And I doubt doing so is possible.
Their rech may have applicability as they explore other 3-D cell culture systems, such as breast tissue. They may be able to devise 3-D cancer cell tissue culture as well. But for their non-cancer cell cultures, those cells will continue to be deeply constrained by the same rules as 2-D cell culture, which is that non-malignant cells survive only for a fleeting time in cells culture despite nutrients, fetal bovine serum, amino acids and vitamins. We do not understand why they do not survive long, but they do not. When it comes to the actual body and survival there of its cells, there is quite a “ghost in the machine” we have yet to define or replicate.
My feeling is that for the nonce, drug makers may stick with ordinary cell culture and animal trials. Nothing will ever obviate the need for phase I studies in humans, and prime parameters followed in those are ALT, alkaline phosphatase and bilirubin. So what, then, does Organovo really change about drug development? I sincerely wonder if their approach may make it more costly rather than less.
Subramania, Innate is so thinly traded on the “Pink Sheets’ or
over the counter bulletin board, it doesn’t present obvious chart technical indicators.
For instance, there have been only 6 trades generating 1500 shares traded today with a price range of 13.79 at the open to 13.25 right now. There is a $ gap from $10 Monday to $13 on Tuesday. Normally, based on daily volumes, one could tell if the gap is going to get filled, 13 back to 10, which they commonly due, but there again without some volume I can’t tell. The 10 to 13 jump was due to a love fest between NVO and Innate where Innate got a nifty piece of technology to develope from NVO. For Innate’s research NVO is going to buy an additional, big chunk of their shares which is a form of payment to Innate for the future discovery work with the technology. Plus, it is quieting in that it proves a greater commitment by NVO in being more invlove fiannacially with Innate. I think the 10 to 13 jump is based on that share buy and is now baked into the $13 level. Also another, older story, is that Bristal Myers has pulled the plug on their adaptive immune system ( T cell based strategies) which I can’t explain technically ( after all I am a lighting salesman) but are the directions that IMUC, (which just had a failed FDA study), DNDN, GALE and others are taking. Bristol sees Innate as the new world of IMMUNO ONCOLOGY cancer research. Innate has shown as much as 300% greater survival rates in preliminary HUMAN studies. That’s a big deal. No chimericas for these guys. Those mice are really only good for growing ears on their backs. That’s another story.
Re:commission, unlike Scott Trade my broker doesn’t include discount trades on foreign desks.
Thanks! I will look into buying this one on every dip! I have lost close to 80k investing in DNDN & the recent IMUC debacle. Really want to invest in some really promising ones to get back on track. thanks a lot.
rob, You can look up the chart at yahoo finance as IPH.PA. It’s in euro. For IPHYF, 52 wks range is $3.07 – $14.49.
All: The below appeared on Fierce Biotech a short while ago. Worth reading.
Does anyone know how we could get our hands on information about what went on at the JP Morgan Healthcare Conference, about who said what? I hope no one got in on Dicerna. I think we said here it would tank.
“North Carolina’s Argos Therapeutics ($ARGS) raked in $45 million in a below-its-range Wall Street debut, sticking a so-so endcap on an otherwise colossal week for biotech IPOs in which drug developers banked more than $500 million.
Argos flipped about 5.6 million shares at $8 apiece, well below the company’s planned $13 to $15 range and totaling less than the $60 million it once sought. But despite the downsize, Argos’ cash infusion will help it get lead candidate AGS-003 through a Phase III trial in patients with renal cell carcinoma. The drug uses a patient’s own dendritic cells to fight cancer growth, harvesting white blood cells to craft a personalized immunotherapy and then reinjecting it. In a Phase II study pairing AGS-003 with Pfizer’s ($PFE) sunitinib, the combo clocked a median overall survival of 30.2 months, compared to 14.7 months for sunitinib alone, and Argos is looking to duplicate those results in its late-stage program.
And thus concludes the biggest week of the now-yearlong biotech IPO boom, as Argos’ pricing makes for 8 successful debuts adding up to $502 million in new funds. (Kidney drug developer NephroGenex was expected to make a $40 million debut on Friday, but the offering never materialized.) Eleven Biotherapeutics ($EBIO), Revance Therapeutics ($RVNC) and Egalet ($EGLT) hit the market on Thursday for a net $196 million, and uniQure ($QURE), Auspex Pharmaceuticals ($ASPX), Genocea Biosciences ($GNCA) and Biocept ($BIOC) went public Wednesday for a total of $261 million.
Next week looks nearly as busy, too, with Flexion Therapeutics, Amedica, Eagle Pharmaceuticals and Semler Scientific all expected to pull off IPOs by Valentine’s Day. If each goes according to plan, the group would haul in $168 million and bring the industry’s fortnight-long sum to $670 million.
But despite all the glittering optimism going in, the luster on 2014’s biotech IPO class is seeming to wear off on investors. As IPO research outfit Renaissance Capital points out, quite a few of those companies have seen their share values drop since hitting Wall Street, and many had to slash prices and beef up offerings just to get there. Even early-year all-stars Dicerna Pharmaceuticals ($DRNA) and Ultragenyx ($RARE) have seen their shares fall sharply since respectively tripling and doubling on day one, according to Renaissance.
And the field is only going to get more crowded: The buzz at last month’s J.P. Morgan Healthcare conference was that at least 25 biotechs were making the roadshow rounds with hopes of a first-quarter IPO.”
A new twist in the HCV race: I just got a pre-publication copy of a paper from Gilead that will appear tomorrow in Lancet. Long story short: for its approved agent sofosbuvir and its soon-to-be-filed new agent ledipasvir, the data suggest that 8 weeks of the two, rather than 12, is sufficient for a great many patients. GILD should go up on this news as it augurs approval of ledipasvir and suggests the company’s two drug regimen is likelier to be favored by third party payers.
I’m going to start rivaling Frank for my poor timing – I sold Gilead last week thinking that good news on the Benitec front could cause GILD to fall substantially. Ah well, all my biotech positions are quite small and I did make a profit on the sale so it could have been worse 🙂
Kerry; just noticed your comment ,I sincerely hope I am not contagious. I have many reminders/scars of mistakes— sometimes not remember successes so well.
I see that Benitec traded close to 172k shares today. The volume seems to be increasing. Meanwhile TKMR, ARWR and DRNA all are on a tear. Dr. KSS for Benitec 2014 maybe the year!
Subramania: Definitely look at QRXPY. I haven’t taken a position yet but I really think I will. I feel it was oversold in December because of the delay in FDA approval. Many companies come out with “old wine in new skins” painkiller preparations, but this morphine oxycodone blend, which was specifically chosen because it combines intensity of pain control with duration and minimizes side effects, really could become a big seller for acute, post-operative pain, if it is marketed correctly. Their version for chronic pain will be quite tamper and abuse resistant. It may not make the huge pop that a brand new drug in a new class would make, but there is a huge market, and right now success is not priced in. If MoxDuo is approved, the company is likely to be acquired. This stock has been marinading forever waiting for something to happen, and now it probably will, and yet almost no one is covering it or aware of it. Let me know what you think. I am not convinced I will buy, but think I will.
Dr. KSS i will surely look into QRXPY. currently i have taken positions in BNIKF, RNN, RXII, CLTX, XNCR. I sold off my entire position in BPTH, PBIO, ONCS, TNXP. I might sell CLTX if it pops to around $10. As each ADR is equal to 10 shares so i expect $10 soon with all the big boys invested in it. I will buy Innate pharma for sure when it dips. Thought of buying some shares of ICPT when it dropped to $285 but it just rocketed up again.
So funny Dr. Karma…you are trying to figure out if you are going to buy and I am sure i was not the only one who already bought simply because you said you liked the company a lot…
I went to their website, read all the presentations and articles I was able to find and finally bought a couple thousand shares…lets see but I like the product, how close they are to the approval and all the marketing deals they already have in place…
Thanks for sharing all your knowledge with us…
Subrmania: Also don’t rule out Cellceutix (CTIX). I got long on it. My view is that the brilacidin antibiotic ALONE is worth way more than what the company trades for. I feel that a lot of people diss antibiotics. No one stays on antibiotics. Lots of companies shun that side of the business. But here we have one that is (1)novel, class by itself, (2) seemingly resistance proof,(3) likely to get orphan designation for oral mucositis from chemo, (4) non toxic, (5) vast antibacterial activity…it works by popping holes in bacteria cell walls. I could be full of it, but I still think this one could get a marketing nod without phase III. It is about to enroll for a phase II versus daptomycin (Cubicin) for skin infections. This one has yet to start and may not finish til the fall of this year. It would have to complete before the drug could be approved. But I am keen on it.
Solid move up on RNN today.
I am watching ICPT alongside you. Despite all of the hoopla, what I notice is that no one with liver expertise is saying much about it, so I will. The drug in question, obeticholic acid, is an agonist of the farnesoid X receptor. It is the first known agonist. However, subsequent to the FLINT trial, high throughput screening showed that the anthelmithic drug ivermectin also binds there, which means other good ligands may exist. Also, the FXR receptor shuts down bile salt production by the liver. THis concerns me and no one is noticing it! Bile is a mixture of bile salts and cholesterol. Cholesterol does not dissolve in water, and needs bile salts to stay dissolved. Shut down bile salt production and BING! You start making cholesterol stones in the gallbladder. Because of their common obesity, NASH patients are already at gallstone risk. When NASH patients begin rolling in in biliary colic from obetichlic acid, lawyers will prick up their ears. Because the drug shuts down bile salt formation, less cholesterol is eliminated in the bile. Therefore, cholesterol surges on the drug. This is not good….a drug that requires another drug to manage its ill effects. Finally, even though the company is hoping for a primary biliary cirrhosis indication, right now the evidence is that the old standby bile salt drug ursodiol, combined with bezafibrate, is more effective for PBC, and cheaper. Meanwhile, GenFit’s drug is coming along. Weight loss strategies help NASH and GenFit’s drug will do a bang-up job at NASH. I think ICPT needs to cool way off before people get in. The drug will probably get approved, BUT I feel its market will be quite a bit smaller than predicted.
Dr. KSS Yes CTIX is on my watch list but got scared due to P53. From what i have read none of the companies have been successful. Maybe i will initiate a long position like 1000 shares. ICPT has a price point of $872 by Merrill Lynch(BOFA). Do you really think it will cool off? What would be a good entry point? Thanks for all your insights.
Also take a look at TNXP. I rode it from $4 to $15 and it went up to $20 within the past two months. Excellent board and they have a sure shot to success. They also recently did a secondary for $15 a share.
I owned CTIX for about 6 months as I like it as well. I’ve been puzzled as to why it hasn’t been more popular with investors and finally sold it to buy something that would do more than just sit there and look pretty in my portfolio. Has it been getting any traction lately? The company has an interesting and fairly robust pipeline of some different types of compounds. Thank you for your coverage of this one Dr. KSS. I probably wasn’t patient enough. Even if they just get the antibiotic compound approved it should make a very nice move. If I am remembering correctly, they bought the rights to a few promising compounds from a struggling company for bargain basement prices.
So, has anyone bought CYCC as a result of this article and discussion? Come out, come out and confess, whoever you are, LOL and tell us why exactly did you buy it and do you have any regrets? Not me – I bought last year after dilution.
Speaking of dilution, CYCC President just promised not to dilute for another year.
And, speaking of dilution again – it can happen any day with DARA – it is selling some totally nonexciting cancer medicines and waiting for orphan drug designation of another nonexciting medicine, but it is not priced into the stock at all, so will be huge upside if granted. And I m going to buy it after dilution for a trade.
And thank you Cowen for pumping this pig SNSS today and letting me reload my short position which dwindled down to almost nothing before that. I’d like to smoke whatever that analyst is smoking, that stuff must be good. Just kidding, the analyst is surely totally objective and the fact that Cowen holds some 500k shares of SNSS that they want to get rid of surely has nothing to do with this. My-my, short SNSS and long CYCC is going to be so rewarding as their market caps are going to cross sometime later this year.
Oh youre so clever. Actually I bought before I started this discussion via GS. But Im happy to stay put for now.
Subramania: Yikes! You don’t want to be long TNXP. All this company is doing is try to get FDA indications for cyclobenzaprine for PTSD and fibromyalgia. This is a nonsense drug that has been generic for decades. It just gives people a buzz and a little muscle relaxation. Even IF the FDA approves it for those indications physicians will say, OK then, and write for the generic, which is pennies! This will NEVER catch on at all. No insurer is going to pay for a fancy version of cyclobenzaprine when patients can get it for 10 bucks for a 30-day supply. Take the money and scram! This is just one step removed from a pure scam operation. I predict it will be approved for fibromyalgia and turned down for PTSD. So what as regards FM? It is already being used for that by doctors and has been for decades. If I were a shorting person I would short this dog! Please get out.
Dr. KSS thanks for your advice. I am not long TNXP. I was and sold it around mid $15s. Yes i do believe it will get approved for FM. They did the capital raise for PTSD trials. Anyway good to know your side on this!
Any thoughts on IDRA, ATHX. Lots of folks and SA authors are very bullish about these stocks. Thanks as always for your valuable inputs!
Dr. Am I correct in thinking you would have similar view of Alcobra ADHD proprietary?
Subra: I have a small position in ATHX and think it looks promising. It had a nice move up today and has done well in 2014.
Any thoughts from anyone on Advaxis (ADVX) which had a nice right up today or yesterday on Seeking Alpha? They have a large pipeline although mainly preclinical compounds and are int the immunology field of which I am a fan. The company looks intriguing and a apparently made a splash at the San Fran Conference recently.
Re. Advaxis I meant a write up on SA not a right up! –long day
I saw an article in SA detailing how ADXS is a better play when compared to INO. Any thoughts on that David?
I think that author likes ATHX better as he feels as if it has been rather uncovered and under appreciated at least until recently. INO has had a lot more run up and coverage so I think that was the main point he was making.
Victor: I agree totally that SNSS is primed for catastrophe. A rotten company with a dry pipeline and an also-ran AML drug in a field of AML drugs that is growing. That they had to do add-on patients for the vosaroxin trial last year, in a quixotic quest for statistical significance, should have tipped people off to bail.
DARA definitely has a exceptionally uninteresting array of candidate drugs. Not a one of them will matter 6 months after they are approved. I seriously do not know how those people have any desire to go to work every day, because watching concrete harden would be more interesting than working on those asinine drugs they have. But with a market cap of $17 million, you’re right. Any approval will cause a price surge.
David: I was initially none too keen on CTIX’s p53 program, in part because approaches to that pathway (trying to enhance p53 function to overcome cancer) have failed. But with further perusal of the literature, I am forced to rethink that. In animal models of several different kinds of tumor, CTIX’s agent appears to shrink those tumors just as much as chemotherapy does. Which implies that a chemo/Kevetrin combo could shine. Another cool thing about Kevetrin is that CTIX is continuing to bump up the dose in phase I, as they have not yet reached a maximum tolerated dose. The FDA authorized them going from a max dose of 110 mg/sq meter to 130, if memory serves.
Obviously phase II is a way off for Kevetrin, but there are rumors out of Pfizer having an interest in it, as it would doverail well with PFE onc. Kevetrin may really shine in two kinds of cancers that are really impervious to chemo: melanoma and renal cell. I think it may take a little longer for something to move CTIX shares. Completing Kevetrin phase I with a plan to embark on phase II would help. I predict it will head way upward however once some analyst actually finally looks at it. It is now ignored. Hard to see Pfizer buying it as Pfizer isn’t in antibiotics, but I think Cubist may taken in interest in brliacidin. All conjecture though hardly baseless.
Advaxis tomorrow.
Re: Post 411 David B. ICPT Wow that stock has made incredible 52 week move from .03 to 11.7 with a market cap of only 53Million
Check out USNU it was pumped hard today, but responded with a 168% gain, 96% if you got in first thing at 9:30.
This could have legs as a strictly technical short term trade. However their product is a gammaknife and they “operate a facility at NYU medical center” kinda vague. However, the technicals look interesting….gotta make sure there is enough volume if trading it.
I should have said that USNU may have legs once the technicals improve. Their fundamentals are actually solid for the market cap.
Happy Anniversary! Hard to believe we’ve all been enjoying this thread for a month now. Some of us bringing more than a fair share of it to the table, other just quietly reading and learning. I just wanted to express my thankfulness for this thread. I feel blessed to be a part of it, even if mostly as a spectator. Dr. Karma, Siva, Alan Harris, Tanglewood, S.S., Robert Paglee, William Tweedie, George, and a few other that aren’t coming to mind at the moment, thank you for your contributions to this. They are appreciated….. Dr. Karma, thank you giving us so much for free. For steering us clear of possible financial landmines and for pointing out companies with great potential. You are a rock star! P.S. Thank you for making this possible, Travis!
Awesome thread, knowledge and specific industry insight! I’m pretty noob to both investing and to this site, so thanks to Travis and the GS team. I’ve only signed up for the free newsletter 2 days ago as there are a million to choose from and I wanted to get the low down on many of them, which was the attraction to this site. I’m pretty convinced I’ll upgrade to the next level pretty soon though as the info that I’ve read so far, including these comments are bloody amazing. The depth of knowledge of some of you guys is unbelievable, with honourable mention to Dr Karmaswimswami, aka Dr K, Dr DSS, and Swami, for your time, energy and commitment to the cause, for it’s certainly made today a thought provoking day having read the everyone’s post from the beginning.
Incidentally I’m in Australia and will be looking very closely at QRX (KRX Pharma) and (BLT) Benitec, probably taking a position early this week. QRX closed at .825(AUD) following <70k sales, while BLT closed at .83(AUD) following around 136k sales. Thanks again everyone.
Oh yeah, now I know why doctor’s get us in and out of a consult in 10 mins lol!
I came across TapImmune (TPIV) when they were mentioned by a friend in the field and I am trying to figure them out. First off: it is a terrible chart, but they do speak of a vaccine expression ‘delivery system’ rather than a specific molecule, so the potential use applications are much wider. But what does ‘delivery system’ mean? I can’t create a picture in my head just yet (probably a big red flag) and was wondering if anyone here knew why ‘delivery’ might differentiate efficacy.
From a company article : “The novel platform is termed TapImmune’s PolyStartTM technology and has been strategically designed to directly enhance the immune system’s ability to stimulate either or BOTH cytotoxic killer and helper T-cell reactive proprietary peptides, known and expected to be associated with one, or more importantly, ANY cancer, infectious disease or bio-threat.
Specifically the PolyStart and PAA (Peptide Antigen Array) technologies are straight forwardly and easily managed as a rapid versatile plugin-and-play system meaning that they can be configured to produce peptides for any desired pathogen. We believe that our combined PolyStart and PAA technologies provide the highest level of expression of any comparable system deployed to date. Our technology platform is functionally distinct from conventional single target immunotherapies such as Herceptin, and can be administered to a much broader patient population.”
Have a nice weekend – here, we are finally getting some needed No. Calif rain. Thanks, jt
Also: they are in a Phase I with the Mayo Clinic so early days.
And the last paragraph of their press release said “CEO Glynn Wilson said “We believe that our newly developed PolyStart™ technology represents a significant technical advance and the recently announced deal between Roche and Innovio for what could be in excess of $400 million is an excellent example of the type of early stage technology transactions that are possible given the right technology and the right environment.”
Their shares popped 9+% on Friday 2/7.
Hmm…their Corporate presentation has not been updated since 2012. They’ve been around since 1999. http://www.clinicaltrials.gov shows only one clinical trial, started July 2012, with estimated completion date July 2015.