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.
Matt, ARDM. Am currently DDing. I’m going to buy.
Grifois SA ,$43/share, has signed exclusive contract to license the dual release cipro inhaler paying up to $65M for further development and looking to buy $25M of their stock. The AERx inhaler is second generation and is not cipro bound. “”has successfully delivered 15 different drugs and biologics in himan trials.” Plus have an impressive single usage disposable strip dosage form, AERx Strip. Their specialities are drug interface aerosol delivery devices. nano drug packaging, ETC. I feel there is a lot there to appreciate.
Siva knows the most about POSC. I have been speaking with its CEO by e-mail.
The POSC situation, from my perspective, is deeply complex. It is all about positron-based imaging. To give some perspective, up til now, positron imaging has basically been a means of telling whether a spot, say on a chest x-ray, is cancer or not. A patient with HIV has a headache. She has a head CT. The head CT shows a mass. The differential for this mass in this patient is infection versus cancer. The patient is given F18-substituted deoxyglucose, and if the lesion lights up, it is because it is burning the glucose as a tumor does. It is thus a tumor and a biopsy is probably warranted. If it did not light up, it would be infectious and the patient might need an LP.
POSC aims to profit from the fact that positron-based imaging will soon come majorly online for evaluating the heart. A patient finds he is getting increasingly short of breath with exercise. He once smoked. His doctor is concerned this is coronary disease. But to go straight to heart cath is costly. It is better to start with non-invasive imaging. Older methods looked, for example, at thallium and the heart. Thallium is in the same column of the periodic table as potassium, and gets taken up by oxygenating myocardium. The key thing about mycocardium is that it is intensely oxygen-dependent. What kills in coronary disease are narrowings of heart arteries that cause reduced flow to distal areas. If imaging suggests a section of heart is not being vigorously perfused, cath is warranted, for diagnosis and for possible angioplasty and stenting.
How can one use positrons to image the heart? Sr-82 is an isotope that can be used to make Rb-82, and Rb behaves like potassium, taken up by oxygenating heart regions. POSC has some degree of control over national Sr-82 supply. Sr-82 is very long lived. Rb-82, made from Sr-82, has a half life of about 70 seconds and must be made “fresh.” POSC does not make the generators to derive Rb-82, but they are cheap. POSC does make a scanner, but so do others. The CEO tells me that the money is to be made from Sr-82 supplies, not the scanners.
This whole thing is like a complex chemical reaction. Somehow all of the following need to get initiated, but which goes first?
(a) hospitals must buy PET imagers
(b) third party payers must cover PET (Medicare DOES, if the patient has had an indeterminate single photon heart CT scan)
(c) there must be a good quick turnaround national supply chain for Sr-82. That infrastructure is not totally in place.
I can tell you that,, having trained at one of the mightiest cardiology programs in the world, big centers are going to PET, yes, but to a certain degree this is, again, cap-ex that may not improve standard of care. It is not hard to get cath paid for, and cathing is cheaper than treating MI’s, and when in doubt, the big programs cath.
All of this presupposes that rubidium is the preferred definitive isotope to use for cardiac PET. It may not be. A group at Cedars Sinai in LA is about to present data that a reagent based on F18 that zips into myocardial mitochondria, which are finely O2-dependent, actually gives much sharper PET images, that degree of uptake is more finely tuned to degree of perfusion, and that this thus may be more sensitive for picking up milder stenoses. If this approach finds favor, it takes away POSC’s appeal as a Sr-82 supplier.
It is perhaps worth noting that,ironically, the former CEO of ECTE is now the CEO of POSC. Both companies have charts with things in common, which include indolent share prices that have sat there for years. Thus far, the CEO has not told me anything that persuades me that there is a transformative event for POSC looming. And I feel one must emphasize that this is an area where big boys are playing: GE, Siemens, for starters. These companies are deep-sea battleships and by comparison, POSC is one guy down in Houston in a rowboat.
Dear Dr. KSS.
You said “(b) third party payers must cover PET Medicare DOES”…. After my recent series of chemo for NHL my Oncologist said “we’ll confirm your remission with a CT not a PET because Medicare only pays for TWO PET scans.” Do you happen to know if that’s the case?
Blessings,
Ken
Ken: Again, sorry about your NHL. I hope you have not had to have a mitoxantrone-based regimen for it, but you may have. My best friend’s father is in the throes of treatment for the same thing, but his is confounded by heavy abdomen involvement and problems with his GI tract made worse by him having diabetes. He has gastroparesis and enteropathy, in other works major motility problems, and has now been on TPN for nearly a year! I get pressed into service for advice often and my main issue is this: if he does not get off TPN he will die from that long before NHL comes near claiming him. People on TPN almost universally get fungal sepsis, and his risk of that is considerably higher because of neutropenia requiring antibiotics.
I have been told that, yes, that is a Medicare rule, no more than two scans for the same indication, but not an absolute ban on more than two scans. For myocardial PET, CMS is showing its usual “wisdom”….allowing it only if there has been a negative SPECT. And that is the problem with SPECT, that it often gives ambiguous data. The cardiology world wants to do away with SPECT and go all PET. And I don’t think that is unreasonable at all. SPECT is gaslight compared with PET for the heart. Most observers feel that if we went all PET and eliminated SPECT it would save money, as it is way more expensive to do SPECT then PET than just go straight to PET. I have dealt with so many soft calls from SPECT.
Dr KSS
The former CEO of ECTE is Patrick Mooney. The CEO of POSC is Patrick G Rooney. Two different folks.
Heart scans, also called angiogram is a way to detect how good the heart blood vessels are. It will help identify any blocks in the blood vessels. Two modalities exist today- SPECT and PET. Majority of the scans done today are using SPECT. Some advantages of PET over SPECT are :
1. PET images are clearer than SPECT
2. PET has lesser radiation exposure than SPECT. Several states are pushing legislatures with stringent norms against radiation exposure.
SPECT is done using Technetium-99m (derived from molybdenum-99 decay).
PET is done using Rubidium-82 (derived from Strontium-82 decay).
Here is my investment thesis for POSC:
Cardiac PET is a disintegrated market now and that causes instability. DOE produces Sr-82. Bracco owns Cardiogen-82(a portable generator that converts Sr to Rb). GE, Philips etc provide scanners .
The demand for PET procedures is increasing and there are several reports that highlights the decline of SPECT and the growth of PET in the coming years.
The limited supply of the dye, Sr-82 puts a great deal of constraint in the PET market and its growth.
DOE(Los Alamos, Brookhaven) is the ONLY source of Sr-82 today in the US and has expressed on many occasion that it is not their focus area.
Positron wants to provide stability to this disintegrated market. How, you may ask? Positron has Attrius, the only ‘PET only’ scanner (No CT – other scanners from GE etc have CT which is not required for cardio scans), Positron has DMF to process Sr-82, Positron has supply agreements for Sr-82, Positron has a deal with (Jubilant)Draximage for Rb generators and lifecycle management. As you see, it has all the ducks in the row but the question is – what is it waiting for? As I said before, in order for medical facilities to embrace PET procedures, we need to have a stable supply of Sr-82 and break the autonomy of Cardiogen that Bracco has today. Positron with its DMF will expand the Sr supply this year and Jubilant Draximage’s Rubyfill – a Rb generator will get approved by this year. These two events will mark the growth of PET procedures in the USA. Positron’s Attrius is approved in Canada and EU. Drax has stated that they will start to market Rubyfill in USA, Canada, EU and India.
The OS of POSC is 1.5b of which the float is about 750m. About 50% of the OS is with Solaris Opportunity fund, an investment fund run by the CEO. The CEO and insiders have invested a great deal of money into the company.
The stock ran from 5 cents to 31 cents in 2010 when a media outlet hyped up the NASDAQ market site event. Positron was to announce a partnership with Covidien for PosiRx(a radiopharma dispensing machine) but retracted later. It later said that it had to do so at the request of Covidien.
Forward looking events:
Positron has requested DOE its allocation of Sr for processing. Positron will start processing Sr that it receives from iThemba starting this month and will provide to Bracco and Drax. DOE allocating Sr for Positron, Positron starting commercial supply of Sr or Rubyfill getting approved are forward looking events and any such event will catapult POSC into multiple cent range. The stock has stabilized in the .006 to .01 cents in the last 12 months. I will invest a 1000$ now to look back in an year to see it at $10,000. The market cap of POSC is 12m now. This is for a company that has legitimate products, deals, IP, licenses and a forward looking business plan and hence I feel it is extremely undervalued. Unlike biotech stocks, the nuclear radiology field is complex to understand for the trading community to understand and provide liquidity to the stock. But when any one of a positive event occurs, the stock will be off to the races.
Doc any thoughts on IsoRay(ISR) that i posted about last night.A couple other people on the board were interested in company with one already in and the other wanting to buy.Thanks,Glenn
Glenn: I put some money back in the nineties into the company that got Pd “seeds” to market for brachytherapy for prostate cancer. IsoRay may be an appealing company. I get that it is a cesium-131 play and that the decay and radiative characteristics of it make it more favorable for brachytherapy than palladium I am confused, however, on these points, nad have scoured the net for 90 minutes about them and still not gotten clear answers;
(1) why is Cs-131 only coming into use now? It is not new, not recently discovered.
(2) does IsoRay have some degree over the control of the supply of Cs-131? I ask because with POSC there is a labyrinthine complex history by which it has control, or a considerable degree of control, over domestic Sr-82 supplies.
(3) cesium itself is a liquid at body temperature. Are these seeds encapsulated liquid?
(4) cesium is quite rare, harder to come by than palladium. Did this fact delay development. I guess what I am saying is: brachytherapy is now new. Cesium 131 is not new. Why just now in 2014 is Cs-131 gaining traction?
Typo: third line from bottom “not new” not “now new.”
Youre one scarey mother KSS…. do you ever get your ass kicked ?
George: Thanks for your views but I don’t feel that is what the literature says about inhaled antibiotics:
http://www.ncbi.nlm.nih.gov/pubmed/20146365
http://www.ncbi.nlm.nih.gov/pubmed/22888106
Cochrane meta-analysis:
http://www.ncbi.nlm.nih.gov/pubmed/23235659
A reason for inhaling tobramycin rather than injecting it is its nephrotoxicity when given iv (oral aminoglycosides do not get absorbed). But I see no evidence of virtue for inhaleds. And there is a serious serious cost issue. Know how much one ciprofloxacin 500 mg tab costs? About a buck. And that’s a high dose, but covers 12 hours. I strenuously doubt Aradigm’s inhalable ciprofloxacin will clock in a $2/day.
Much of this admittedly concerns outpatient maintenance therapy to prevent Pseudomonas-driven exacerbations versus acute management of an exacerbation. But as I read the science, there are still issues with getting inhaled antibiotics deep into lungs, and inhaleds seem more likely to lead to adventitious colonization of sputum with fungi such as Aspergillus that systemic drugs do.
Overall, I am interested in new approaches that will transform things. Inhaled cipro is at best a minor refinement in treating CF and I might prefer, for example, to be in gene therapy for CF, which is coming, rather than something that it rather mundane.
Thanks Doctor Kss for your time.You bring out some great points and I will try to dig a little deeper to get some answers.Cheers,Glenn
If there is a reason to be in MNTA, I am really not seeing it. I am not trying to burst anyone’s balloon, but making a Copaxone knock-off???Is that interesting and worthwhile? Copaxone on a good day is a dubious drug working by a dubious mechanism and has been called into question by many reviews including by the Cochrane group. The MS space is quite overloaded. I have never ever got more blurbs about new MS developments than I did last year. Not to be blunt, but Momenta is something of a bottom feeder company as I see it. Other companies sweat and spend billions developing drugs and then Momenta takes those drugs, tinkers with glycans, with sialic acid residues, with associated glycosaminoglycans and then rushes into the fray with something it can patent but that is only by sophistry, by technicality, different. It is like some obnoxious third grade kid who draws attention to himself by copying everything you do. I foresee them as laboring constantly under litigation. They certainly went over a cliff yesterday. I do not see why institutions hold so much of this company’s shares, but I hope they will soon think better of it. This company has a wildly chaotic chart, has seen insiders dumping shares as regularly as Old Faithful, and for utterly no reason has been near a billion in market cap. Seems like a sell/short to me.
Why have we ignored AMPE, in phase 3 on a very interesting arthritis med.?
See #878 or CtrlF Ampio
Kindergarten Investor has brought up Tetralogic Pharma, Kevin Buchi’s current company. KI has some dazzling ideas that she pulls up from her own digging around, and this could really be a good one.
A little about Buchi. We have talked about him here before. He ran Cephalon for a while. During that time it accomplished shocking things, good things. It devised and brought to market tiagabine, a truly visionary, revolutionary drug. We are all I am sure familiar with drugs like Valium. Valium and other benzodiazepines act by stimulating receptors for a neurotransmitter called gamma amino butyric acid (GABA). GABA receptors cause relief of anxiety, sleep, and muscle relaxation. The brain consists of synapses, where one nerve ends and can signal to another nerve using a neurotransmitter. Neurotransmitters are release into the synapse between nerves, stimulate the post synaptic nerve and then get taken up from the synapse by uptake pumps so that they do not keep acting. Well, tiagabine poisoned the GABA reuptake pump. So it was a drug that could chillax you but was not itself habit forming. It was not controlled, did not have abuse potential. It was marketed to treat epilepsy, but lots of us began using it off label for many things. For example, I was prescribing it for irritable bowel and it really worked! Then something bad happened: patients here and there began having seizures from being ON the drug. This wasn’t Buchi’s fault, but it just goes to show what extremes of great new drugs he has led in producing. Tiagabine is amazing. There will be attempts to replicate its benefits without the downsides. Imagine a drug that can really make you sleep at night but that is not abusable, not a controlled drug.
Many companies are working on restoring apoptosis mechanisms in cancer cells, often doing so by modulating this tyrosine kinase or that threonine kinase or p53 or bcl-2. Tetralogic is doing it via a pathway that activates caspases, cysteine aspartic proteinases, that really are the dynamite the blows up the house in apoptosis. My big concern is that their lead agent could cause apoptosis in noncancer cells, but I am gathering papers on it and studying up on it.
Keep at it KI! I nominate you for Indispensable Amaneunsis of Gumshoe.
Amanuensis. Sticky typing fingers today.
Has anyone heard of TrovaGene Inc: NASDAQ:TROV?
It was publicly recommended at a conference of Stansberry Research today.
They are supposedly working on urinalysis to track progress in treating certain cancers, but these guys are financial guys, and very vague on the science.
Don
DR KSS; From Gods lips to my ear. I learned long ago it is impossible to remember everything,about the best to hope for is remember where to find answer inre periodic table.
It looks like TLOG’s entire management team not only exercised options but bought almost 4 million shares of common stock on what appears to be the IPO? Dec. 17th, 2013. Confidence?
Hey Doc- longtime listener first time caller- thx for all you do here ive been following from day one (and love the Benny). Im an institutional salestrader. I can say that TLOG has seen some flippers from smart guys that got allocations which initially had me interested in this co. Maybe they felt too small for them or just didnt feel like doing the DD on it but was disappointed to see it nonetheless as some smart institutional backing wouldve made me feel better about this one. Doesnt mean it wont work by any means.
Side note – was wondering if you had thoughts on IMMU at all – i have heard very good things but of course thats usually all you hear in smallcap bio so thats what makes you so great- as has been said here its knowing what NOT to buy that is sometimes more important. Also re: A-Fib some stocks have been mentioned here and i like CRME quite a bit, any thoughts appreciated i know your busy so feel free to ignore. Anyway- best to you and others here who have built such an amazing chat.
Sorry, the chemistry teacher in me cannot let it slide: thallium is not in the same column as potassium, it is element #81 and you will find it in the column headed by boron. Rubidium yes, Thallium no. I imagine it was just a typo.
Jack: AMPE is quite interesting. I think i brought it up here last week, as it is having a secondary offering. I think it is worth considering. It will be an intra-articular injection of a derivative of albumin mainly for knee OA. I suspect they have good interim data on phase III and are doing the secondary to get this to market. I worry that often in mulling these companies we pursue diamonds, and kick rubies, gold nuggets, and emeralds out of the way as if they are detritus. They are not. Not every company is a ten bagger, and there is nothing wrong with some one, two and three baggers.
I guess that can be the rating system for Biotech Hedge Fund:
Market Caps sub 100M, 100 bag potential——Diamond
Market Cap sub 500M, 10 bag potential ——–Ruby
Market Cap sub 500M, 3 bag potential ———-Emerald
Blue Chips ————–(NOVO, CELG)—————-Gold Nugget
Stocks to Trade——————————————-Bitcoin
Stocks to Avoid——————————————-Detrius
Love it.
Addendum: Stocks to buy high and sell low—————Alans
Sorry Alan, it was just too easy.
No problem…I completely agree. See my earlier #820 advice.
Thanks Jim T for keeping me on my toes. I have an undergrad degree in chemistry also. My point was that vis a vis the myocardium, Th does behave just like K, goes intracellular in the setting of adequate oxygenation, and that was my point. In boning up on POSC a couple of weeks ago, I studied the periodic table in depth again and the Th thing slipped my mind. Sorry. Th is elsewhere. As an intern, I was told by an attending that Th was in the same column, and being a whippersnapper I corrected him. And now I went and made the same mistake.
Well Karma, I am glad to see that you can make a mistake; I was beginning to doubt your humanity : ) Seriously, you’ve been a great help to me and many others. I just hope that I occasionally throw out a few seeds that are helpful to others as well.
Hey Gang:
Here’s the latest details on AMPE – FDA trials schedule, i had to save as pdf to share it with you. Hope all can open it through this format. Info coming as soon as April.
AMPE
Ampio Pharmaceuticals, Inc. 2014-04-01 Phase 3 Randomized, Controlled Study to Evaluate Efficacy and Safety of Intra-articular Ampion for Osteoarthritis Pain in Knee
• Osteoarthritis
• Osteoarthritis, Knee • Ampion
AMPE
Ampio Pharmaceuticals, Inc. 2014-08-01 Phase 3 A Efficacy and Safety Study of Two Doses of Intra-Articular Injection of Ampion™ in Adults With Pain Due to Osteoarthritis of the Knee
• Osteoarthritis
• Osteoarthritis, Knee • Low Dose Ampion
• High Dose Ampion
• Placebo Low Dose 4 mL
• Placebo 10 mL
AMPE
Ampio Pharmaceuticals, Inc. 2014-06-01 Phase 3 A Safety and Efficacy Study of Oral Danazol (a Previously Approved Drug)in the Treatment of Diabetic Macular Edema
• Edema
• Macular Edema • Low Dose Danazol
• Placebo
Sorry info is out of chronological order. Cut and paste issues. Tried saving three ways: as word doc, pdf and zip file and could not get it to drop in. Lots of future news pushes coming!
Does the AMPE float of 42.1m include the secondary of 8.5m shares?
With that size float, would there be more shares coming in addition to the secondary?
Dr. KSS,
Just reading about the Conference on Retroviruses and Opportunistic Infections in Boston this coming week. The article says that tuberculosis will have to share the stage this year with news on the HIV and HCV front as well. It was on MedPageToday.com…Feb 28th.
Ken
KSS, have you any thoughts on Roblites suggestion of PARTRYS (PAB.ASX) Is it only available through ASX?
You mean Patrys, not Partrys. It is PATZF over the counter. You can always go to Yahoo Finance and enter the name in order to see what it trades as on different exchanges.
thanks james…will do
Patrys information I originally received from KSS entry. Did DD, I like.
Don Barrett, into TROV. SQNM too much blood too much competition.
AMPE owned for a long time. Felt it is a cancer posse not just a target agent. KSS I’m all ears…something as a child my mother never had corrected.
Siva: Thanks. My concern is that ECTE is trying to do a bit of cognitive-distortional voodoo on people. We agree that many ICU patients need glucometry. But CONTINUOUS glucometry? That was my point yesterday: it’s an abundance of data that does not change management. A blood glucose is in no way like the cardinal data of pulse, 02 sat, and blood pressure. In an absolute worst case scenario of needing q2h glucose determinations (and that frankly would be only for a type I diabetic in DKA) a nurse can do the readings, and despite what ECTE claims, it definitely does not take that nurse 2 hrs out of 12 hour shift to do Accuchecks. These patients commonly have central lines in, and a nurse (or phlebotomy tech) can put a syringe of a central line port and get blood to do a glucose reading and that takes 30 seconds max. Meanwhile, we have this CGM monitor just pouring out all this data….glucoses minute by minute….that are of no management/therapeutic value. A bad DKA’er might warrant insulin interventions every couple of hours, but for 98 per cent of ICU patients where glucose is an issue (which is at least 10 per cent of ICU patients but definitely not more than 30 per cent), insulin would be given at most every 6 hours. Which means 4 determinations per day. ECTE is trying to woo people into thinking that CONTINUOUS determination helps, but as we know from the misery of the Swan-Ganz catheter era, medicine is bad about devising ways to generate tons of information that are of no use in patient management. Pulse oximetry? Useful. Being hypoxemic can kill you quickly. Cardiac telemetry? Useful, as a rhythm disturbance is quickly lethal. But if you just gave 12 units of regular insulin sliding scale coverage to someone’s grandmother who has type II DM and is on the skids from urosepsis but will be fine in 1-2 days, sorry, but those next 6 hours of continuous glucose readings are of no value. They are an exuberant proliferation of meaningless numbers. If the glucose is 100, you will do nothing. If it is 250, you will do nothing for 6 more hours. If it is 50, she will have symptoms. What I predict will happen is that nurses will be turning the devices off. If it is on, they have to chart all of it, and it exhausts them. ECTE has hired some slick talking blow dried physician merchants for its videos trying to smooth talk everybody into how continuous glucometry is the next big thing, and sorry, but I do not see it. When I am an attending physician on an ICU patient one of my main goals is to take steps to keep the patient’s nurse from going bonkers with too many interventions and too much data. Thanks to O’Bomber Yes-We-Cannabis health care, hospitals are dangerous like at no time in American history because 100 per cent of nurses are dangerously toxically psychotically overworked. And that is because of budget cuts but also because of newfangled interventions that create work but not better care, that lead to more tasks but not better outcomes. After the average American nurse finishes nursing school now, know how long (s)he stays in nursing? On average, 5 years. Then they quit. They hate it. They would rather wait tables than be nurses because the system now officially expects too much of them. ECTE may claim CGM saves work, but it does not. it is just more meaningless data that has to be charted, one more screeching device to go wrong, one more alarm, one more thing to adjust, one more signal amid a psychotic chaos of signals in an ICU room. They have to ride shotgun on telemetry pads, line ports, pulse oximeters, Dubbhoff tubes, BP cuffs and Foley catheters. It is an orgy of tech. They have to give pills and shots and get bedpans. Now comes one more machine, one more patch of skin being taken up, one more device, one more set of numbers and alarms and things to go wrong, only in this case, 99.7 per cent of the data the machine spits out does not warrant an intervention. Do you think they will care? No, they will call physicians in the middle of the night and say, Doc, your patient just yanked off the CGM for the fourth time today and anyway you have only written for insulin at mealtimes,…. can I PLEASE stop doing continuous glucometry??? And then the charge nurse will hear this in what few hospitals buy these, and she will go to the CEO’s underling who touches base with her everyday, and word will get around that nurses are not keen on these toys they spent big coin on. And they will be shipped back to ECTE.
I know nothing about ECTE, but I completely recognise the nursing problem from our UK hospitals. Young people who enter the proffession think they will be tending the sick, wiping their foreheads and holding the hands of the poorly. Instead they become poorly paid, over stretched machine minders, data gatherers and software engineers. The public simply cannot understand where all the Florence Nightingales have gone. The solution is to get all these machines to stop buzzing 100 audible alarms and instead, communicate via a central computer that can analyse the data, so sound the alarm only when there’s something truly alarming. Now thats a share I would invest in.
I must agree with the good Dr. and his thoughts about glucose monitoring. Because my pituitary gland was removed, I am on complete hormone replacement therapy and as a consequence my glucose runs a bit high. I am on Kombiglze (metformin plus something else I can’t remember right now) to help control it. I was recently in the hospital for a week with pneumonia. In the ER ( my BP had dropped dangerously low) before being admitted they gave me cortisol to kickstart my system . This caused my glucose to go way up. I was classified diabetic on my chart. Bottom line: my glucose was checked only twice per day and medically altered as appropriate. Each check took less than a minute. I just don’t see how continuous monitoring would be of assistance, but I wish you well with your investment.
JIm: Kombiglyze is metformin with saxagliptin, a dipeptidyl peptidase IV inhibitor. DPP IV is a proteinase that degrades glucagon-like-peptide 1 secreted by the gut, which boost insulin output by islet cells in response to a meal. It’s a good drug and good that you are avoiding insulin and sulfonylureas.
The thing that got me curious about ECTE was non-invasive glucose monitoring, THAT’s interesting, and needs to come to prime time, and why such has not been perfected bumfuzzles me. But ECTE is a play on continuous monitoring. Its device has to be attached and calibrated and kept going. Detach it and its must be recalibrated. I’d love to see a medical device like a gentle finger clothespin that could read glucoses based on IR spectroscopy of finger capillary flow.
Siva: Sorry to have mistaken Pat Mooney and Pat Rooney. Seems I made a few mistakes yesterday, though I can tell you that when patients keep you up two nights in a row, you feel as if your name is Looney. And certainly there is eerie congruence, no? Both have been CEO’s of perennially underperforming companies. And actually there is a website out there where someone writes (I should have fact checked) that “the same guy has been behind both companies [ECTE and POSC]”
To return to POSC, however, these are my concerns:
(1) POSC has been around since at least 1994, Siva, and accomplished nothing. Its share price has gone inexorably, almost monotonically, down since then.
(2)POSC’s single biggest shareholder is Pat Rooney, with 48 million shares. Although that stake isn’t worth so much anymore, one would think that somebody with this much ostensible sweat equity in this company, which he has been with for at least 10 years, would translate into enthusiasm, the ability to be something of a jingo for the company when asked. He isn’t. I have communicated with him by email. Zero charisma.
(3) The SEC has brought action against Rooney for “using Solaris as a piggy bank” for POSC.
http://www.sec.gov/litigation/complaints/2011/comp22167.pdf
While this will settle, while it is not action against POSC itself, it raises questions about Rooney’s judgement and integrity. Solaris was an investment fund he ran.
(4) when I press Rooney about what will make POSC succeed, he says it is the Sr-82. But cardiac PET can be done with N, F, O as well, and emerging data suggest F may be the preferred way. Confronted with this, he says the lynchpin will be the Attrius scanner. But Siemens and GE have scanners that may be better. I have asked him, which is it Mr Rooney? The isotope, or the scanner? Both? Neither? I have gotten from him no clarity at all. But it seems clear now that there is no garden path for Rb from Sr being the preferred isotope.
(5) POSC is a 12 million dollar company. If they had a true lock-up on the means of doing PET, it seems to me this company would be subjected to a quick dust-up. Jeff Immelt could write a check for POSC and be done with this in 30 minutes. But it has sat there inert for 20 years. POSC came into being around the time cardiac PET debuted. Neither have caught on, and here is why….
(6) CT angio is giving awfully good results. Most hospitals now have multi-detector high-speed CT scanners that can do coronary angiography if the patient is just beta-blocked down for the scan (so that images do not blur)…..a little iv esmolol. The images are amazing….they are 4-D now (3-D plus color coding for temperature). Google “CT angio” and click on “images”….the pictures astound.
This recent full text study (http://circ.ahajournals.org/content/122/6/603.full) discloses that either CT angio or cardiac PET have 97 per cent negative predictive value, that they are equal. When they show positive results, one excels in the case of discrete stenoses (CT) while the other shines in cases of “ragged” multiple small lesions (PET). Good centers, academic centers, will probably do combined CT angio /PET with a distinct instrument. But for most hospitals out there, the question is whether to cath…not for diagnosis, but for intervention, and CT angio basically answers the question. It is newer, being adopted, but utilizes the scanner already in place with no new cap-ex and need to deal with a new isotope. CT angio/PET combined imaging is 98 per cent predictive, huge expense for a tiny increment in yield.
Dr KSS
All are great points, I will try to provide some commentary on this
#1. Correct, the company has existed since 1994. It surprises me how it existed without a sustainable business model for this many years. They had a SPECT scanner to sell and they thrived just on selling that plus services. Rooney took charge of Positron in 2009 as CEO, acquired Nukemed, the maker of PosiRX, acquired MIT(+ Jason Kitten) that has license to recycle spent Rb generators, got a DMF to process Sr, has Sr supply agreements with iThemba etc. They are in the best position now they have never been in the last 27 years. Of course the share price doesn’t reflect any of these accomplishments. When it comes to cardiac PET, Rb is the standard of care. F-18 still has a long way to go and there are server logistics issue in getting F-18 to clinics.
#2. Pat’s investment in Positron is much more than 48m shares. His email writing skills are well known and doesn’t come as a surprise to me. He can be funny at times but have noticed of late that he refrains to answer certain things, probably lessons learnt from the recent SEC issues.
#3. The stock tanked when the SEC issue cropped up in 2011. Last heard, he will escape with some penalty. Agree it is an embarrassment and can question his integrity.
#4. Cardiac PET can be done with N,F and O but none of them are preferred or current PET agent. Ammonia(N) and O-15 labeled water(O) is used as a back-up agent when Rb is not available. They both require onsite cyclotron and many facilities do not have them. As for F-18 for cardiology PET, these are still in trials. Lantheus is doing a P3 trial. The preliminary results were mixed and not entirely positive – http://www.molecularimaging.net/topics/molecular-imaging/biomarkers/mixed-results-phase-iii-flurpiridaz-pet-trial. We are still a few years away from making F-18 a mainstream cardiac PET agent if it is approved. Talking about the scanners, the Attrius PET scanner is a pure PET scanner. It doesn’t have the CT component as Semens and GE has. I’m told that CT is a redundant component and is not required for Cardiac catheter scans. Sr is the key and the preferred isotope for PET scans now and that will drive Attrius sales. An Indian behemoth Jubilant Draximage estimates the Rb generator market at 60m and is making plans to enter into USA, Canada, Europe and India by this year. That should tell you that when it comes to Cardiac PET, Sr is the isotope of choice. An F-18 agent can’t be flipped like a gadget even if is approved. From my understanding, making changes to nuclear cardiology process and systems is one hellaluva change. Very long way to go IMHO.
#5. Positron is a nano-cap company and trying to bring stability to the cardiac PET market. It is still a speculative play. The investment thesis is that it has made solid foundations in a market that is expected to grow.
#6. The images that CT angio shows is really astounding. Thanks for the reference. But my understanding is that a CT can’t examine biological functions, like blood flow or glucose metabolism of the heart. Can CTA with 3-D replace Catheter scans altogether?
The question that I ask myself is how much will be Positron valued when Sr-supply expands, when Ruby-fill gets approved or when DOE allocates Sr processing to Positron or when Positron launches a 70-Mev Cyclotron. I think it will be greater than the current value. What will happen to Rb based PET scans, will F-18 replace Rb and will CT replace Rb scans can be best answered in 5-7 years from now. By that time, I would have exited POSC and I hope my investments would have multiplied by then.
I meant severe logistics issue not server logistics issue in #1 above.
Has anything happened regarding BLT insider buying? I believe it was Siva and Doc who set up a sheet to monitor insider buying of Benitec and late February would be a good time to see if anyone was accumulating. Did you find any info? I am going to scour the ASX today and see if I can find any info on insiders.
POSC (Positron) was mentioned weeks ago, nanocap less than a penny, does it have any merit for a small speculation?
Thanks for clearing up the Patrys confusion, if you look you will see it referred to as Partrys a few times earlier and that is why I was confused. Anyway, does this warrant any attention as a possible buy?
Thanks Doc and all.
Mudpecker on HotCopper keeps bringing up BLT management errors…especially on the thread titled “Fate”….any takes on this KSS? He is long BLT, just wondering if his thoughts have any merit?
Nick: See Dr. KSS’s comments on Patrys, especially in comments 67 and 514 or responses to them. You can find comments on Patrys quickly by doing a “control-F” and entering Patrys in the search field.
Nick: I posted over there one cup of tea ago. Maybe I silenced him. People just do not realize how good mgmt is. This was a Rip van Winkle company. Literally in the course of one year it went from being sleepy and pre-clinical to nabbing Tacere and becoming clinical. Its performances with the FDA and gene therapy/nucl acid therapy ad coms were bravura and virtuoso. For an overseas company that has never done this before, never been before the FDA before, this is as perfect as it gets and I will not let them get bashed.
I agree with DR. KSS that the Benitec management is very honest, smart and yet very humble. They seem over elated with the 31m they recently raised. They fully deserve more than 31m for a superior technology that they are going into trials with. They need to be given a crash course of how many phony biotech companies in the USA raise multi million with elan and ease. I can only relate these phony companies with ayurvedic/herbal medicine traders on the streets in my country except these guys do it inside board room with coats and suits. Nuvilex and Galena are great examples.
I read your post over there and thanks.. his reply,”only time will tell”…I would rate that a 90% silencing in Phase I …now if TT-034 silences as well in Phase I…..lookout!
He has a role to play as skeptic, so that’s fine.