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.
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.
While the PVCT discussion has been going on, Thurs about 11AM Adam Feuerstein from Cramer’s “The Street” dropped a bomb and in a nano trade the price went from 6 to 2. He basically made the same points that our esteemed KSS made. Thank you Mark.
Maybe he’s following this thread.
Mention was made of Ecklonia cava. This is a marine algae. It by no means contains the most potent of biological antioxidants, or even a particularly strong antioxidant. It contains a polyphenol, similar in antioxidative potency to tannins in coffee and red wine, or to resveratrol, which is modest at best. There are no clinical studies in humans showing benefit. I would be quite cautious about claims for this or any supplement.
There seems to be a meme out there, contagious, that oxidation is all bad and that all antioxidation is good. This is not true. A great many biological reactions are ones in which one substance gets reduced and another oxidized, and most of these are normal and necessary. All oxidation means is that a moiety experiences a net loss of electrons. In reduction, substances gain electrons. The most potent biological reductant or antioxidant, given physiologic redox potential, is glutathione, owing to the sulfhydryl moieties on its cysteine residues. Key antioxidant enzymes are the various superoxide dismutases and catalase.
Quenching all oxidation is far from being a good thing, Some clinical evidence hints that people who load themselves chronically with antioxidants are likelier to die from infectious and malignant diseases because they are blunting the oxidative immune responses to those conditions. And there are of course many pathologic states representing impaired ability to execute oxidative reactions in vivo, such as Chediak Higashi syndrome.
Resveratrol is the polyphenol found in the skins of red grapes that many take as a supplement because of speculation that it lengthens life. In certain primitive model systems, it in fact does. There is no evidence it does so in mammals. Resveratrol upregulates the sirtuin family of molecules in vivo in an activity unrelated to antioxidation, and activity of these is linked to longevity in simple organisms. There is no evidence it is harmful clinically, but also absolutely no evidence of benefit. Resveratrol is certainly not a reason wine drinkers may live longer, as quantities ingested from wine are trivial. Over time, several people have come to me and pointed out that Harvard biologist David Sinclair, PhD, partnered up with Shaklee and that this should be taken as an endorsement for Shaklee products, particularly its resveratrol. Sinclair, of course, tore up that contract and stormed away from Shaklee after a few months because he felt they were being quite deceptive.
TRLPF is Trimel Pharma, a Canadian firm exploring intranasal testosterone gels, and inhalable powders for asthma. If there is a reason to be long this stock, I cannot find it. Trimel has done nothing but trundle downhill—appropriately, it seems—-since its debut. No insider has bought, ever. This company’s strategy seems to be to go after getting 5-10 per cent of the market for testosterone supplementation, and with that will declare itself a success. You could not pay me to use intranasal testosterone. There are many perfectly fine ways of delivering testosterone, including patches, gels, shots, and implantable sustained release pellets. The recently debuted Axiron allows it to be applied like deodorant. Not only will intranasal administration set off sneezing and lachrymation, we have no idea what this trophic factor will do long term to nasal tissue. If it provokes proliferation, then deformity, breathing difficulty, snoring and infection could result. The company is certainly trying to hint in its literature that its special way of giving testosterone may have special efficacy for female anorgasmia, and this verges on the fraudulent. Intranasal administration of anything other than therapeutic nasal sprays strikes me as ornate and Rube Goldbergish, fraught with risk, and likely to not hold favor with patients because the area in question is sensitive, fussy, and easily irritated. Doctors will never get behind prescribing nasal testosterone. Trimel’s “pipeline” is the size of a twizzler stick…it has absolutely nothing of interest in development.
Any chance you could provide the same analysis for ISCO?
Sophie R
Sophie: I think you may have mentioned this one earlier, and I had just not gotten around to it. Sorry. This one has been on my radar for a few years. At one time, ISCO was the sort of company that was being mentioned on quirky websites and bulletin boards that vanished by the next time you looked for them. It finally appears to be getting traction, doing some serious stem cell science, albeit in the face of enormous competition from the likes of Plurastem, Athersys and Mesoblast, among others. Their work presented last year at AASLD regarding efficacy of their hepatocyte-like stem cells ameliorating Crigler-Najjar disease (in an animal model) REALLY turned some heads. They have gotten the Duke Clinical Research Institute to take on their phase I study of stem cell therapy for Parkinsonism; while that is merely a phase I study, if there is any evidence of efficacy, this company could go supernova. My biggest concern is their cash position. They are a micro-cap company with shares at 22 cents, and at their current burn rate, it seems reasonable to assert they will need further rounds of financing. The trials they are contemplating will be quite expensive. I would certainly hold if you are in. I will keep watching it for positive news and for pullbacks if they float more shares. I do think meaningful news, that could move the stock, will not be til much later this year, but I will poke around and see what I can learn about timing of the Parkinson’s trial, when patients will have stem cells administered. I see this as having to go through hoops at a federal level yet before the trial can begin. This is their only really big clinical development thing going on, so quite a lot hinges on this trial. This company really has some stealth advantages as an investment…no one is following it, institutions own none of it, but insiders snapped up shares last year with news that Duke had agreed to do the phase I trial. If anything good comes of that trial, a feeding frenzy will result. I have to say I will be watching this one rather closely…..good science, highly relevant clinical goals, potentially disruptive/transformative methodology. ISCO has churned, marinaded, bobbed along for years like flotsam of dubious provenance, accomplishing nothing. Now finally for the first time, something IS happening that will move the stock, and it could be a shocking move up.
Any chance you could provide the same analysis for SRPT (SAREPTA)?
James
One other point I might make about ISCO is this. The liver cell work is nice, however…. Crigler-Najjar is devastating, but also exceptionally rare (it would be astronomically unlikely for an MD to see even one case in a career). This work was an example of what liver cell transplantation can do, but should not be pursued as a main therapeutic goal, because doing a study may be quite literally impossible for lack of patients. The approach is not ready for prime time in other liver disease patients because right now such cells must be given via the portal vein directly into the liver. This is dicey, as accessing that vein is not easy, and it scares hepatologists. In advanced liver disease, net portal flow slows because of hepatofugal flow owing to portal hypertension. If accidental thrombosis happens in that vein (and it commonly does in advanced liver disease), that is very bad. It doesn’t acutely kill the patient, but the patient can never be transplanted, will bleed repeatedly from varices, and cannot be TIPS-shunted. So I hope ISCO is smart enough to go all in for the Parkinsons indication, and backburner the liver work for now.
Dr. KSS. Thank you again for your analyses, which is easy to follow and makes sense to laypeople. Speaking of inhalers (TRLPF), what are your thoughts on Mankind (claims to be superior to injected insulin) and its insulin inhaler’s chances of FDA approval (2nd time around) and if so, being prescribed by doctors as an alternative to injected insulin. The stock has already climbed somwhat, but may have room.
Resveratrol interesting tidbit… Resveratrol (red wine) is a dual agonist of PPAR-a/B… same as Genfit’s GFT505.
http://www.ncbi.nlm.nih.gov/pubmed/20504373
now makes sense why the French are the ones to make a drug out it – lol.
Steve: Thanks for asking about Mannkind. I knew of it, but was not really familiar with it, and so have cast about this morning over coffee looking at papers and data. There are, of course, some obvious cautions that I am sure you are aware of (I will just point them out to bring other readers up to speed): this is a high beta stock with a nearly 22% short interest that insiders have been regularly dumping shares of for at least a year. Mannkind shares did not participate in what seems to have been a diffuse biotech rally in 2013.
One very great thing Mannkind has going for it is that one of its main advisors is Jay Skyler, MD, MACP. That actually does say a lot. I don’t know him personally, but one of my best friends is quite close to him. Skyler really is a living legend…I don’t mean legend in his own mind, but really probably the greatest diabetologist for type I diabetes of this generation. I don’t get so misty-eyed about big names, but that Skyler is seemingly behind this company says something. And its science is excellent. Its trials have been admirably done.
My thoughts about Mannkind are perhaps long and rambling, so please get comfortable. There is deja vu going on. We have seen inhalable insulin come and go as Exubera, developed by Nektar. Exubera had some profound problems. The worst was that there was a bafflingly nonlinear relationship between how many mg of powder one inhaled and how many insulin units one was getting. And there was the serious issue that doses were reckoned in mg, not units, which frustrated patients and secondarily irked doctors. But the hysteresis, the non-linearity of dosing was just totally unacceptable, and led to bad care and complications. So this treatment modality is tainted. Exubera was yanked. As you know, I am sure, there was also an unsettled concern about a few patients popping up with lung cancer. The lung is a great absorptive surface, but giving insulin this way is highly nonphysiologic. You are plopping a growth factor, an agent of proliferation, into lungs, and it will be years before we know whether that is safe long term.
Some things I do not like: I am sure I read some time back about an Irish company developing an inhalable aerosolized insulin. Mannkind’s is like Exubera: powdered crystalline insulin. The Irish company’s is liquid dissolved insulin. This is a threat. Also, for sake of full disclosure, I am long Novo Nordisk, which has been a quite rewarding position to be in, as Novo really controls the diabetes market. Novo are probably the best protein pharmaceutical chemists on the planet, have a formidable patent portfolio, and a deep bench of new insulins and GLP-1 agonists in development. I can’t prove it, but I would be surprised if Novo didn’t own patents pertaining to inhalables. I also notice, however, that Novo is not pursuing inhalables at present. This says much, I feel. They are aware of these and for some reason have no interest in them.
At some point I would like to do a longer post here explaining diabetes physiology and management to everybody. In fact, I believe that given space and people’s willingness to pay attention, I can probably explain it in such a way that the lay person may understand it better than most physicians do. Type I and type II diabetes have nothing in common, and what it taking place in type II is multi-system and nuanced. Incidentally, I was rather opposed to the SCOTUS appointment of Sonia Sotomayor for one reason: she has both type I and type II diabetes, and the risk of her having complications that impair her ability to function as a justice is extraordinary. No one factored that in.
Mannkind’s lead product is an inhalable ultrashort acting insulin to be used with meals. What will the market for this be? I honestly don’t believe there is much market for it. It will have no role in type II diabetes, which is far more prevalent than type I. The goal of type II care is avoidance of insulin—-we deploy GLP-1 agonists, DPP-IV inhibitors, metformin, thiazolidinediones, sulfonylureas and now even SGLT-2 inhibitors and turn to insulin only as a bitter last resort. The reason is that insulin hastens vascular disease in type II patients. The patients with type I are now all going to pumps, so they will not be helped by an inhaled insulin. And believe me there will be a high barrier to implementation of its use with physicians. The product will not allow type I patients totally to circumvent the need for injectable insulin, and so using it just makes the regimen complicated.
Mannkind’s most interesting pipeline product is its inhalable GLP-1 agonist (for type II; these don’t work in type I). Frankly there could be a huge market for this. Preliminarily, it doesn’t cause the nausea that injectable incretin mimetics do. And there are lots of type II patients who believe that giving in and finally agreeing to injecting anything is a Rubicon they do not want to cross. They have a fear that once they go to injections, their health will tank. If Mannkind’s inhalable GLP-1 is also found to cause weight loss in the way that liraglutide and exanetide do, then suddenly that product gets a big seat at the type II management table.
For me, given the price lability and the uncertain future of the insulin product vis a vis the FDA (there has been a serious postponement in approving it….still ferreting out why), I would not buy here. I have it on a watch list and am waiting for development news about the GLP-1 product. I think its shares will gyrate considerably, and I think there is a significant risk Novo may come out swinging as regards the GLP-1 agent because GLP-1 receptor agonists are very much Novo’s turf. I don’t know that for sure about the Novo situation, but prior to the disappearance of Exubera, they did sue for IP infringement.
Also note that Generex is having a clinical product called Orl-lyn(http://www.generextxind.com/oral-lyn.html), a buccal insulin spray which in not approved in USA. Generex licensed it to an Indian pharma called Shreya and Shreya had great Phase 3 results. They are awaiting approval from Drug Controller General office, India.
The product in india is called Recosulin. The chances of approval are high in India and is around the corner. Generex had issues with trials in USA and I suspect they will announce their go forward plans in USA after they get this moving in India. India is a HUGE market for diabetic(60m people with Type1 and 2). I read that the trials in USA was unsuccessful as the compliance was low because of usage materials being available only in English. Generex has problems with management as well. Their stock(GNBT) seems to be moving now and in on an uptrend.
Also note that Generex’s subsidiary Antigen Express(http://www.antigenexpress.com/) has P2 Breast Cancer Vaccine(AE37) whose preliminary results are awaited. Their initial P2 preliminary results were positive. I will appreciate if experts can provide some insights on 1. Oral-lyn and 2. AE37 vaccine
Blimey, NVO sp has only known one direction since 1985. Of course penicilin accidents can happen, but I cant imagine Novo Nordisk will let someone slide past their library of research/patents.
I promised this group I would comment again on Atheronova. To recap, it claims to have hyodeoxycholic acid in development as a “de-fatting” agent…..a drug it claims can cause atherosclerotic plaque in arteries to shrivel and recede. Two written missives to the company itself have gone unresponded to….very troubling. Makes me wonder if there actually IS a company, if there is a staff. I have spoken to contacts in the Russian Academy of Medical Sciences and Russian Society for Evidence Based Medicine. No one has heard of this company, this drug, or any trials. This is unsettling. Russia is a place where you can very much pay to have a trial come out the way you want, and it doesn’t cost much. The Russian academic community is deeply embroiled right now in a wide scandal: a private academic intregrity organization has recently presented data that the average Russian PhD disssertation is AT LEAST 30 per cent plagiarized. Russian physicians often “do” PhD’s as an add-on prestige thing because earning them there is extraordinarily easy, especially compared with the US (one great thing the US has going for it is that our PhDs are absolutely the toughest on the planet to earn; having a PhD from an American university really counts for a lot and is universally admired). Anyway, Russian physicians are ganging up to prevent their PhD dissertations from being assessed for plagiariasm by the outfit doing the scanning and analyzing. You don’t think they have anything to hide do you?
I recently asked ”So they are Russians…And?” guess this is my answer! Quick funny story that fits in. I regularly work for a Russian Embassy. The first time I went I was expecting body searches, Klashnicovs and burly guys in furry hats, so I felt v nervous. I was shown to the back room. I noticed the back door had a chair propped up against it. ”Whats that?’ Oh the lock broke last year!
The lock to the back door of the Rus embassy was broken and the best they could do was to stick a chair under the door handle !!!!!……..makes you think !
Thank you Karma, AHRO is out of my list…as Alan said, your opinion is very important to many of us here…so thanks again for sharing all your knowledge and your time…you have a great future as a “newsletter publisher” in Biotech stocks if you wish to follow it…count me in…
James
Alan: My relationship with NVO, CELG and CBST is a love whose month is ever May.
I suspect we could swap many a rapt anecdote about Russians. One of my closest friends is a former high-in-the-food-chain KGB agent.
I see your KGB agent and raise you several ambassadors over 20yrs 🙂
Also note that Generex is having a clinical product called Orl-lyn(http://www.generextxind.com/oral-lyn.html), a buccal insulin spray which in not approved in USA. Generex licensed it to an Indian pharma called Shreya and Shreya had great Phase 3 results. They are awaiting approval from Drug Controller General office, India.
The product in india is called Recosulin. The chances of approval are high in India and is around the corner. Generex had issues with trials in USA and I suspect they will announce their go forward plans in USA after they get this moving in India. India is a HUGE market for diabetic(60m people with Type1 and 2). I read that the trials in USA was unsuccessful as the compliance was low because of usage materials being available only in English. Generex has problems with management as well. Their stock(GNBT) seems to be moving now and in on an uptrend.
Also note that Generex’s subsidiary Antigen Express(http://www.antigenexpress.com/) has P2 Breast Cancer Vaccine(AE37) whose preliminary results are awaited. Their initial P2 preliminary results were positive. I will appreciate if experts can provide some insights on 1. Oral-lyn and 2. AE37 vaccine
Re BNIKF (BLT.AX) Monday 27th of January is Australia Day so their market (ASX) is currently closed.
This is a good read on GMOs and dangers of GMOs
http://www.responsibletechnology.org/posts/gmo-health-dangers/
Yikes! Thanks, something to send to my Congressional representatives, not that I expect they’ll pay much attention.
I apologize ahead of time if this Bloomberg Brief (link below) with Benitec CEO Peter French has already been posted on this great thread. This brief concerns the FDA giving the green light for Benitec to begin its clinical Phase 1/2a trial with their TT-034 ddRNAi therapeutic designed to cure Hep C with one shot. What stood out to me in the interview (since I’m a recent investor thanks to Dr Karma) was Mr French’s statement that he is of the opinion that the FDA feels TT-034 is a disruptive technology.
http://www.benitec.com/documents/140121_Bloomberg_QA.pdf
Link doesnt work for me.
Derh!! Ignore me….didnt notice pdf so was expecting a web site. Sorry
Karmaswimswami,
your opinion, as always, will be much appreciated.
NWBO signed an agreement for a large scale expansion of product manufacturing, handling and distribution.
I am just reading tea leaves, but wouldn’t this be an indication that they might have some early results in from their DCVax-L Phase III trial for GBM Brain cancer?
Or is this just a formality required by the FDA in a Phase III trial?
Sarepta (SRPT) has come up for discussion. This is a gnarly company in gnarly situation going after a gnarly disease (Duchenne muscular dystrophy).
We have talked a lot in recent weeks about RNA interference therapies as a means of shutting down production of pathogenic, undesirable or viral proteins. The Sarepta story builds on that. Certain proteins are not wholly undesirable, but have sections that confer pathology. If you could modify transcription and translation to make a gene product (a protein) lacking a defective strand, then you have a way to fix a disease. Muscular dystrophy is a disease in which genes encoding certain proteins needed for muscles have problematic segments. For example, type 1 muscular dystrophy is a disease in which a key muscle kinase is made by a gene that has hundreds to thousands of a pathogenic trinucleotide repeat. A strand of DNA encoding a gene is commonly made up of exons (which are read) and introns (which are ignored for the mRNA transcript). In Duchenne muscular dystrophy, exon 51 of the dystrophin gene is flawed. Causing a muscle cell to make an mRNA transcipt that splices out exon 51 but incorporates all the healthy exons is quite a trick, and that is what Sarepta has done with a morpholino oligonucleotide.
The stock is 50 per cent off its October 2013 highs because there was speculation that the FDA would approve etiplersen, SRPT’s candidate, for Duchenne without a phase III trial. The FDA declined. The stock has 30+% short interest now.
I don’t doubt the excellence and ingenuity of SRPT’s research, but I have doubts about management. Its chief goal is to get etiplersen approved, but keep in mind that this disease is rare. It afflicts about 1 in 3600 males, and mostly these males do not reproduce. I assert that this disease is gradually being bred out of the population with genetic counseling and fetus molecular diagnostics because it has a horrible prognosis….profound disability with agonizing death by about 25.
I somehow have instinctual doubts that etiplersen is going to make a big difference, though I cannot prove those doubts. Mostly these patients get both horrible skeletal muscle disease but also severe cardiomyopathy: baggy dilated hearts that do not pump effectively and are prone to lethal arrythmias. Cardiac muscle is just not amenable to molecular remodeling the way skeletal muscle is. So I fear that if etiplersen is approved, it will be an extremely expensive drug that confers a “dead cat bounce” on recipients: they may be able to walk a little better for a while, but won’t survive longer or have fewer complications. I am not meaning to sound callous to how these patients suffer. Duchenne is truly a horrible disease, and anything that can help these patients is good. But proof that etiplersen will turn Duchenne around, lead to better quality of life, reduce suffering is just not there. It is one thing for a giant like GSK to go after Duchenne and have its drug not succeed. That this is the biggest piece of a small pie for Sarepta makes the company really rather vulnerable.
SRPT has other aims: oligonucleotides to silence RNA expression in Ebola and Marburg viruses. Let’s face it: those are rare, doing studies of these agents will be profoundly problematic, and any market for them will be quite small. It has pursued an anti-influenza oligonucleotide, but as far as I can tell, that remains in phase I, and I do not know why. Therapeutics for flu are needed, as of course Tamiflu is quite literally placebo. To me, that would be a vital thing for them to chase, and yet that doesn’t seem to be happening. There has been no news from them on the flu front in some time.
I suggest not buying SRPT here. Whether to hold shares? I think the bad news is amply priced in right now, so it is probably a hold.
Has anyone looked at NVLX? It seems to be a P & D with many pumps daily, but the stock seems to be trending up quite nicely for the last one year.
Siva: Have you ever seen the show “Small Town Security” on the AMC channel? Nepotistic, rinky-dink, inbred, crude, crass redneck investigative agency doing dubious work? That is Nuvilex. We have covered it here before. Don’t go near. They’re just pretending to be a biotech firm because they’ve got cush jobs. They’ll play at this til people catch on to the ruse.
Thanks for the feedback on NVLX. A company that I have been watching from 3 cents though I didn’t get in until recently. I exited today with a 40% gain. It didn’t sound well to me even though I got in a couple of weeks back.
Thank you! I got in at $.16 and it’s at $.39 so I’m up 118%. Since the
phase II study of NVLX already beat Eli Lilly’s FDA approved study by 40%
with NO side effects. It’s been going up a little everyday. I’ll hang on for the ride after the Phase III study comes in and then the FDA approval. Hang on!
This doesn’t sound like a ruse to me offering $27 million funding:
Goldman Small Cap Research, a stock market research firm focused on the small cap and micro cap sectors, recently published a new research update on Nuvilex Inc. (OTCQB: NVLX). In the update, senior analyst Rob Goldman outlines his latest thesis.
“In our view, with institutional funding in place to a potential $27 million, Nuvilex has been transformed from an also-ran to a soon-to-be-prime time player in the biotech and medical marijuana arenas. Moreover, this funding agreement validates the Company’s technology and effectively de-risks the stock.”
Nuvilex is a biotechnology company with the rights to a novel cellulose-based live-cell encapsulation technology, called Cell-in-a-Box(TM), that will be used as a platform upon which treatments for several types of cancer, including advanced, inoperable pancreatic cancer, and diabetes are being built. Nuvilex’s treatment for pancreatic cancer involves the use of the widely used anticancer prodrug, ifosfamide, together with encapsulated live cells that convert ifosfamide into its active or “cancer-killing” form. Nuvilex’s subsidiary, Medical Marijuana Sciences, Inc., is dedicated to the development of cancer treatments based upon the well-known chemical constituents of marijuana. Nuvilex is exploring ways in which the Cell-in-a-Box(TM) technology may play a role in these efforts.
According to Goldman, now that an institution has validated the company, attention will be focused on fundamentals and a series of future milestones and executable events, which means a higher future valuation for the company and all three of its treatment categories: cancer, diabetes, and medicinal marijuana. Moreover, since all three categories address high profile, multi-billion dollar markets, the associated future valuation adjustments could be substantial as milestone events are executed.
About Goldman Small Cap Research: Led by former Piper Jaffray analyst and mutual fund manager Rob Goldman, Goldman Small Cap Research produces sponsored and non-sponsored small cap and micro cap stock research reports, articles, daily stock market blogs, and popular investment newsletters. Goldman Small Cap Research is not in any way affiliated with Goldman Sachs & Co.
A sponsored Goldman Small Cap Research report, update, newsletter, or article is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed. Please read all associated full disclosures, disclaimers, and analyst background on our website before investing. Neither Goldman Small Cap Research nor its parent is a registered investment adviser or broker-dealer with FINRA or any other agency. To download our research, view our disclosures, or for more information, visit http://www.goldmanresearch.com.
About Nuvilex, Inc. (OTCQB: NVLX): Nuvilex, Inc. is an international biotechnology firm focused on developing and preparing to commercialize treatments for cancer, diabetes and other diseases based on the live, therapeutically valuable, encapsulated cells platform. The Company is leveraging its cancer biology and clinical oncology research experience and expertise, particularly for use in oncology treatments, in addition to initiating oncology applications of medical marijuana. For more information visit: http://www.nuvilex.comhttp://us.lrd.yahoo.com/SIG=14q6n7t04/EXP=1305929345/**http%3A/http://www.globenewswire.com/newsroom/ctr%3Fd=218177%26l=7%26a=http://www.sunsienergies.com%26u=http%3A%2F%2Fhttp://www.sunsienergies.com%2F http://us.lrd.yahoo.com/SIG=14q6n7t04/EXP=1305929345/**http%3A/http://www.globenewswire.com/newsroom/ctr%3Fd=218177%26l=7%26a=http://www.sunsienergies.com%26u=http%3A%2F%2Fhttp://www.sunsienergies.com%2F.
Goldman Small Cap Research Rob Goldman, Analyst +1-410-609-7100 rob@goldmanresearch.com
Just my $.02!
I think that group has been part of paid promotions, it rings a bell. Worth checking to see who paid for the research report.
This was all I found Travis:
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BrokerBank Securities, Inc. is a member of the Financial Industry Regulatory Authority, CRD number #130116.
SOURCE BrokerBank Securities, Inc.
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