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Novel product / unique mechanism
Levosimendan is a novel, first-in-class calcium sensitizer/K-ATP activator that provides:
oxygen sparing improvements in myocardial contractility
reductions in afterload
potential cardioprotective effects
Unmet medical need
Currently there are no drugs indicated for the prevention or the treatment of LCOS.
The FDA has granted fast track status for the “development of levosimendan to reduce morbidity and mortality in cardiac surgery patients at risk for developing low cardiac output syndrome.”
Low LVEF cardiac surgery patients represent a high risk population who experience a higher incidence of LCOS and worse outcomes.
Levosimendan has the potential to improve outcomes in these high risk patients.
FDA fast track status
The FDA has granted fast track status based on the drug’s potential to fill a serious unmet medical need, and has agreed to the Phase 3 trial protocol under a Special Protocol Assessment (SPA). FDA has provided guidance that a single successful trial will be sufficient to support approval of levosimendan in the U.S.
Tenax therapeutics is collaborating with Imperial College London on the LeoPARDS Trial
Tenax Therapeutics has provided supplemental funding to support the accelerated enrollment and completion of the ongoing LeoPARDS Trial (Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis) awarded by the Efficacy and Mechanism Evaluation (EME) Programme and funded by the Medical Research Council (MRC) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC-NIHR partnership.
The LeoPARDS trial is designed to determine whether levosimendan reduces the incidence and severity of acute organ dysfunction in adult patients who have septic shock, as well as evaluate its safety profile. Septic shock represents an area of very high unmet medical need, as the condition is associated with high mortality, morbidity and critical care costs. Given the limited treatment options that exist and the prior research data regarding the potential benefits of levosimendan in septic shock patients, the EME Programme awarded funding of the LeoPARDS trial, which will be led by Imperial College London.
Funding a study without receiving any benefit ? Don't think so.
Funding a study without having discussed with FDA if data is submittable in the US? Don't think so either.
250 patients enrolled and going strong, half way already !
Leopards UK trial
leopards-trial.org/
Wallach Beth's price target for TENX $12 for End 2015!
Wallach Beth named "Best Broker-Dealer Overall" Feb, 2015
www.wallachbeth.com/assets/pdf/2015bestbdwbc.pdf
Levo-CTS trial - Duke University Hospital, as the principal investigator, is now also recruiting,
trial is moving and most likely accelerating....,GLTA
https://clinicaltrials.gov/ct2/show/study/NCT02025621?show_locs=Y#locn
Responsible Party: Tenax Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02025621
Other Study ID Numbers: TNX-LVO-01
Study First Received: December 18, 2013
Last Updated: March 11, 2015
Health Authority: United States: Food and Drug Administration
thanks for that, it looks like they are not better than any other bank or broker, all crooks?!
Luckily they do not conduct the trials in the UK and USA on Levosimendan and in the end the market (demand/supply) will decide what TENX is worth. It may go down so you can loose 100% , it may go up and if it goes up then it goes up incredibly because when this gets approval in the UK and USA- buckle up - this stock will more than just double from here!
to me it is worth the gamble but thanks for all red flags.
The recently published meta-analysis about Levosimendan shows a completely different picture about market potential, efficacy and existing comparable products in the market. www.ncbi.nlm.nih.gov/pubmed/25652947
Possibly you also know better than professors, doctors, anaesthesiologists,cardiologists and intensive care specialists.
In any event have a happy and fulfilled life...i stay long...
you definitely have a point. the last claim is in 2009 ? anything actual or recently? 1 million in 10 years is not too bad compared with all other banks, which are fined in the hundreds of millions for manipulating, defrauding, misleading and other offenses. A banking license seems to be a qualification for legalized crime. The list of fined banks is probably longer than the one for not fined, pretty much a reflection of the todays world, sad but true. LT is probably the least crooked company out there.
But still the professors and specialists might not have received a "back-hander" when releasing their meta study about Levosimendan,
Let's keep fingers crossed that a few honest people are still remaining and that the data of the test will show the results needed to get FDA approval.
Tenax Therpeutics has luckily sufficient funds to complet the phase 3 study and who knows, we might be surprised and this stock will go up based on results and not on dreams
Ladenburg Thalmann is a respected boutique investment house and their analyst report is officially published. Possibly you know better than certified and acknowledged analysts?!
The recently published meta-analysis about Levosimendan shows a completely different picture about market potential and efficacy. www.ncbi.nlm.nih.gov/pubmed/25652947 Possibly you know better than professors, doctors, anaesthesiologists,cardiologists and intensive care specialists?
Trade sale and merger prices can not be compared and certainly not weighed on future market potential of a product or technology in early stage, even phase 2. your rhetorical and cynical question is complete nonsense as you well know. Do you know the valuation of the first equity rounds of Facebook, Amgen, Biogen Idec, Actelion etc.? Opportunity and synergy, paired with timing and network, ability to sell and market, create those early stage deals and it is always a give and take negotiation and yes the 4.8 million are justified, but every entrepreneur would know that. Some prefer a smaller piece of the big cake, if that's what it takes to get the opportunity going.
Levosimendan in LCOS $600 million U.S. market.
FACTS
- Ladenburg Thalmann believes that Levosimendan has a market potential of $600 million in the US market just for LCOS.
- Institutional investors are holding over 50% of the shares of Tenax Therapeutics. They are in for the long term as the potential of this product, its indications and the strategy presented, convinced them to invest.
- This company has changed for the good and trials are moving with sufficient funds in place to finish phase 3.
- In addition, the FDA granted fast track status, which potentially indicates (if data is as expected) that this product could be generating revenues faster then the market is currently expecting.
Opinion
This stock is massively undervalued compared to other companies with phase 3 and phase 2 trials ongoing. The current stock price might be justified if only looking at the track record of this company , past management skills and strength of short acting companies. But the upside today is much greater than the downside (well, hopefully, and actually not that difficult, as the stock is down over 95% since 2008) and absolutely worth the gamble at this stage. The potential of this stock being much higher in 12 month is not only possible but is most likely - obviously conditional to the data of the trials (this product is approved in over 50 countries already and if management is not able to have set up a protocol which will clearly pass the FDA, then this stock does not deserve to be traded at all.
The current market capitalisation of just about $80 million reflects the market opinion, which translates in,
-no trust, no capability, no market potential, no chance of good data, no management skills to potentially monetize on the opportunity, no nothing...I personally disagree with most of those assumptions.... GLTA
244 patients enrolled in LeoPARDS trial http://leopards-trial.org/
38 locations recruiting LEVO-CTS https://clinicaltrials.gov/ct2/show/study/NCT02025621?show_locs=Y#locn
All on track, buckle up, in a few more month we might see a different trend in the stock price. GLTA
interesting, stay long!
http://www.ncbi.nlm.nih.gov/pubmed/25652947
CONCLUSION:
Levosimendan seems to be the most efficacious inodilator to improve survival in cardiac surgery.
Ladenburg Thalmann;
We believe this drug represents an estimated $600 million U.S. market.
at least you could laugh today , mission accomplished, some see the glass always half empty, very sad but everyone's own choice.
Some institutional investors seem to be bullish on this stock and they see the potential,(they put their money where their mouth is) it looks like it is worth the gamble for them. This company has changed for the good and trials are moving with funds in place and FDA fast track status, we could all be in for a nice surprise.
I am long and I stay long and will increase the position steadily, you do not need to feel sorry for any longs as it is everyone's own decision out of free will.
As said, worth the gamble...
Ladenburg Thalmann
Jeffrey Cohen
Creation of a Critical Care Focused Company with a U.S. Phase III Levosimendan (SIMDAX) Trial. Initiating Coverage with Buy Rating and Price Target of $10.50.
We are initiating coverage of Oxygen Biotherapeutics (OXBT) with a Buy rating and price target of $10.50.
On October 21, 2013 Oxygen Biotherapeutics, Inc. announced that they had signed a definitive agreement to acquire certain assets of privatelyheld Phyxius Pharma which is focused on the North American development and near-term commercialization of levosimendan (trade name Simdax) to prevent and treat cardiac surgery patients at risk for developing low cardiac output syndrome (LCOS). We believe this drug represents an estimated $600 million U.S. market.
Levosimendan is a calcium sensitizer which was developed for intravenous use (24 hour) in hospitalized patients with Acutely Decompensated Heart Failure (ADHF). The compound was first approved in Sweden during 2000 and is currently manufactured and marketed in 53 countries by Orion Pharmaceuticals (€20.63-ORNBV, NR) of Espoo, Finland and has produced revenues of €44 million Euros ($60
million USD) during CY-2012. The drug is also marketed within certain Latin American countries by Abbott Laboratories ($39.57-ABT, NR) who also had owned rights to certain other territories which were sold back to Orion in 2009.
The drug has a plethora of published clinical studies, clinical trials, health economic data and meta-analysis and has been administered to more than 600,000 patients to date. The drug’s administration regimen and more specific use (indications) has evolved significantly through clinical experience and includes the decrease (or virtual elimination) of loading (bolus) doses and dramatically increased use specific for cardiac surgeries (mitral valve replacement and Coronary Artery Bypass Grafting (CABG)).
We believe that the Company has taken into account the drug’s vast experience in designing what we believe to be a well thought out Phase III protocol which utilizes all of the European experience throughout the past decade, coupled with a focus on cardiac surgery patients classified with Low Cardiac Output Syndrome (LCOS).
Oxygen Biotherapeutics, Inc. is based in Morrisville, North Carolina. The Company has approximately 14 employees as of Q2-2014 (October, 2013) and is also conducting a Phase II trial in Europe studying perfluorocarbon (PFC) therapeutic oxygen carrier (Oxycyte) for Traumatic Brain Injury (TBI).
We anticipate that Levosimendan could become commercially available in the U.S. during CY-2017 (and in Canada during CY-2018) and we have modelled in peak revenues of $244.4 million during FY-2023 prior to anticipated generic competition. Our price target of $10.50 is based upon the net present value (NPV) of discounted cash flows (DCF) to the Company through FY-2027 with peak free cash flow of $42.3 million during FY-2023. We are using a 15% annual discount rate and 20 million outstanding shares for our calculation.
Assumptions, market potential and "if and when's", paired with demand/supply of shares and of course the influence of bashers reflect the share price / market capitalisation, which in Tenx's case is currently about 100 million$. The multi billion dollar questions is the "potential" of this drug in the tested indication, is there a market? is there competition? is there management skills, knowledge and network to monetize on the potential?
Some of the professional investors in TENX are normally very realistic and ready to take a "gamble". In this sort of stock, the reward of those investors is expected to be or needs to have a potential of 10 folding the investment,( otherwise they do not touch such a stock) as in experience the portfolio consists of over 50% total wipe outs. I am not stating that TENX is a 10 : 1 winner nor a wipe out but taking the above points into consideration, I am tempting to say that it is worth the gamble. FDA approval with a large market share potential should reflect in $$$ and such a company could be a billion $ company If and when...
LCOS can be considered a form of acute heart failure (AHF). In the same way that AHF produces high mortality in non-surgical patients, LCOS is a major cause of perioperative death in patients undergoing cardiac surgery. LCOS is, however, a peculiar form of AHF as it differs from the latter in etiology, prognosis, and treatment, all of which are influenced by the combination of surgery and anesthesia. Do not compare apples with pears! Abbott went for ADHF (Acute Decompensated Heart Failure)
Although LCOS is not implicated in all deaths after cardiac surgery, it can likely be said to have a part in the majority of deaths. LCOS prolongs the period of invasive monitoring and mechanical ventilation, both of which increase infection rates and are largely responsible for the deterioration in renal functioning. In that sense as well, LCOS' impact on mortality is apparent. In fact, LCOS can be considered a complication of cardiac surgery which directly causes further complications.
Although the general principles for treating AHF apply in the case of LCOS, there are nevertheless some clear differences. Adequate oxygenation should be ensured by using mechanical ventilation and the usual anesthetic care. In surgical patients with low output, hypertension is not present and vasodilatation should be approached with caution in patients who are already usually vasodilated.
Given that contractility is affected by myocardial ischemia stemming from use of an aortic clip, inflammatory response, and some anesthetic drugs, inotropic agents are used in the operating theater and in the immediate postoperative context much earlier and in higher doses that in non-surgical patients. Balloon counterpulsation or mechanical ventricular assistance are also usually used much earlier and more frequently than in non-surgical patients.
pssst back... with your statement you keep calling the FDA , TENX CEO and lead investigator John H. Alexander from Duke (DRCI) a liar and implement that they are misguiding and frauding investors and tax payers money!
if there would be products which help, there would be no LCOS anymore, common sense !
no market for LCOS? talk to the US-families and friends of the victims who suffered and died of LCOS... your comments are not only ignorant they are unethical and misleading....
You suggest that the FDA is wasting time and tax payers money to approve a phase 3-fast track study, you say that the FDA is on purpose misguiding? you seriously believe the FDA does not see the need of such an indication being treated? maybe you should discuss your opinion with the FDA...
LEVO-CTS Phase 3 trial designed to assess the benefits of levosimendan in cardiac surgery patients at risk of developing low cardiac output syndrome (LCOS).
“We are pleased to begin this important Phase 3 study, which has been designed in consultation with leading cardiovascular experts and investigators to provide a clear answer on the potential of levosimendan to prevent complications after high-risk cardiac surgery,” said John Kelley, CEO of Tenax Therapeutics. “We look forward to working with our colleagues at Duke Clinical Research Institute and the other cardiac surgery centers and hospitals involved in the trial, as we continue to activate many additional clinical sites in the months ahead.”
LEVO-CTS is a multi-center, double blind, randomized, placebo-controlled clinical trial that is testing the hypothesis that levosimendan reduces morbidity and mortality in cardiac surgery patients at risk for developing (LCOS). The U.S. Food and Drug Administration (FDA) has already granted Fast Track status for levosimendan in this LCOS indication, and agreed to the Phase 3 protocol design under Special Protocol Assessment (SPA) with guidance that this single successful trial will be sufficient to support approval.
“The LEVO-CTS trial design will test levosimendan in the prevention of LCOS in high-risk patients undergoing cardiac surgery – an area of high unmet medical need and one where several smaller published clinical trials have suggested potential benefit,”[color=red][/color] said lead investigator John H. Alexander, M.D., MHS, Director of Cardiovascular Research, Duke Clinical Research Institute (DCRI). “We are pleased to be getting started with enrollment and are projected to have results in early 2016.”
The LEVO-CTS trial is being led by DCRI and will take place at approximately 50 major cardiac surgery centers in North America. It is seeking to enroll 760 patients undergoing coronary artery bypass graft surgery or mitral valve surgery that are at risk for developing LCOS.
The trial is event-driven, and includes a review of the event rate after the first 200 patients have been randomized in the trial. Two interim analyses will test for efficacy or futility after 50% and 70% of the planned primary endpoint events have been recorded.
no market for LCOS? talk to the US-families and friends of the victims who suffered and died of LCOS... your comments are not only ignorant they are unethical and misleading....
You suggest that the FDA is wasting time and tax payers money to approve a phase 3-fast track study, you say that the FDA is on purpose misguiding? you seriously believe the FDA does not see the need of such an indication being treated? maybe you should discuss your opinion with the FDA...
LEVO-CTS Phase 3 trial designed to assess the benefits of levosimendan in cardiac surgery patients at risk of developing low cardiac output syndrome (LCOS).
“We are pleased to begin this important Phase 3 study, which has been designed in consultation with leading cardiovascular experts and investigators to provide a clear answer on the potential of levosimendan to prevent complications after high-risk cardiac surgery,” said John Kelley, CEO of Tenax Therapeutics. “We look forward to working with our colleagues at Duke Clinical Research Institute and the other cardiac surgery centers and hospitals involved in the trial, as we continue to activate many additional clinical sites in the months ahead.”
LEVO-CTS is a multi-center, double blind, randomized, placebo-controlled clinical trial that is testing the hypothesis that levosimendan reduces morbidity and mortality in cardiac surgery patients at risk for developing (LCOS). The U.S. Food and Drug Administration (FDA) has already granted Fast Track status for levosimendan in this LCOS indication, and agreed to the Phase 3 protocol design under Special Protocol Assessment (SPA) with guidance that this single successful trial will be sufficient to support approval.
“The LEVO-CTS trial design will test levosimendan in the prevention of LCOS in high-risk patients undergoing cardiac surgery – an area of high unmet medical need and one where several smaller published clinical trials have suggested potential benefit,” said lead investigator John H. Alexander, M.D., MHS, Director of Cardiovascular Research, Duke Clinical Research Institute (DCRI). “We are pleased to be getting started with enrollment and are projected to have results in early 2016.”
The LEVO-CTS trial is being led by DCRI and will take place at approximately 50 major cardiac surgery centers in North America. It is seeking to enroll 760 patients undergoing coronary artery bypass graft surgery or mitral valve surgery that are at risk for developing LCOS.
The trial is event-driven, and includes a review of the event rate after the first 200 patients have been randomized in the trial. Two interim analyses will test for efficacy or futility after 50% and 70% of the planned primary endpoint events have been recorded.
for a few days we see a seller coming in almost at the same time starting to load off or selling short..., quite a bold move as both trails are moving as planned (Levo phase 3-34 sites recruiting and phase 2 (leopards UK) 205 patients enrolled. There might be data in Q3 for the UK trial and this might move this stock back into double digit $ range, before Levo data hits the market in Q1'16 and stock goes to 20 box and more, GLTA
go for it , please.....
wrong move Mr. fortune teller, shares are not hidden and officially declared and do not challenge Hal Mintz, he will eat you for breakfast but i am happy for you to try, that will be very interesting has he has as many friends as you have in the investigation world....
news about progress on both trials!
http://finance.yahoo.com/news/tenax-therapeutics-announces-appointment-paula-124500176.html
Announcement of new CMO and what does the stock? right, no volume increase, no action, no nothing, this stock seems to be haunted and doomed. All that potential with Oxycyte and Levosimendan destroyed by greed and incapacity. Thousands of brain injured people and families still have to suffer, and our army boys will not receive help and support from that drug at all , bloody shame on those executives!
wow, this is what I call positiv thinking ! well done. but it needs 2 for a transaction, so somebody also sold this number of shares... the little interest there was in this stock is evaporating. It looks like there will be no news for months and this will send this stock (unfortunately) much lower as with time more investors will give in to the lackluster soul of this company and sell out, especially as they can make money with other stocks (almost every other stock), this company seems to die slowly but surely, no news is bad news here !
please ask the company, would be very interesting to see their answer, if they answer at all, but careful you might wake them up from there 8 hours daily break... 0900-1700
any idea why the main investigator - DUKE - is not enrolling? not that data from others would be worth less but it is strange or not?
Duke University Hospital Not yet recruiting
Raleigh, North Carolina, United States, 27710
Contact: Rajendra Mehta, MD raj.mehta@duke.edu
Why?
No update, no nothing, again, what are they doing (TENX) the whole day long to justify their pay?
Very frustrating to say the least …..
...and does anyone know what is happening with the JV with Aurum-Bioscience, UK, for stroke? what is happening with the Glucose Biosensor to Glucometrics? what is happening with Dermacyte and the license agreement with Valor SA, Switzerland (there should be money coming in, which can not be seen in the filing?! What is happening with DCS (decompression) and SCI (spinal) with the Navy and wound healing and TBI with the Army? Obviously too many question marks for any new investor to buy this stock as communication is not amongst their strength...
why is Duke University as the principle and lead Investigator not yet recruiting? http://www.clinicaltrials.gov/ct2/show/NCT02025621?term=levosimendan&rank=12
It still does not add up, something is wrong here.
I really wonder what the management is doing on a daily basis and how on earth can such compensations be justified? trials are outsourced, protocols are most likely jointly produced but mainly outsourced, filings can easily be outsourced, so what is MJ doing? accounting? not really a difficult job as there are just outgoings...blimps has a point...many things have been changed in this company but most likely it needs another "clean-out" before this will be fruitful for share holders...
the obvious what I see is that he is invested in TenX with some funds which he is managing and also personally according to the filing, he converted his bond into shares, yes at adjusted low levels, but he could let the company go bust easily and pick it up for nothing, he didn't. I think he was one amongst a few who stood up against Stern at the time and bought Levosimedan to the company. To me it looks like he is all in and is sitting in the same boat. He must have just one interest which is to push the stock price higher…, to be honest, I personally to not care what his performance is in other ventures, as with 30 years of age the entrepreneurial spirit is indefinite, as long as he puts he interest in the success of the company and consequently in a much higher share price, what else could he want than success and succeeding with this investment?
please do not beat around the bush, that is not you, if you have something solid and true, which is relevant to this stock, just bring it up as you did in the past
what a joke… I would like to know what the investors must know who put in 60 million a few month ago, or did the management prevaricate them? ! if so we will have an even harder awakening and the stock will crash, eventually a law suit will follow, stock halted and company gone….., I am sooooooooooooooooo hoping that I am wrong here, wondering what blimps is referring to with the hidden allegations towards Pepin…..enlighten us please…..
company is funded until mid 2017, phase 3 patient enrollment has started, very reputable university is conducting and leading the trials, FDA granted fast track status, the product is already approved in over 50 countries world wide, everything is on track, market capitalization is around 100 Million USD, for a phase 3 company this might be on the lower end.
What is wrong?! - this simply does not add up as the stock price is loosing ground spiritless almost every session since the name change a few weeks ago and since the announcement of phase 3 start. Trust in management must be next to zero and trust in their ability to make this happen, almost inexistent. Many well paid board members and overpaid management people who do not seems to do much at all (there are just filings after filings, which btw can be easily outsourced at much lower cost), does not make investors feeling confident about this. I wonder what all those people are doing on a daily basis, it might be advisable that they at least visit a basic course in communication, as the jokers who present and speak for the company seem to be emotionless and it is more interesting watching paint dry than listen to them. The stock price movement most likely reflects investors feeling towards the management but then again how on earth could they convince investors to put 60 Million into this operation? They must obviously know more than joe public does, as said, it simply does not add up…..
it could be that the company does some cash management, mid term investment 1-2 years, as they do not need the cash on the bank account, and invested in corporate bonds or money market, that might be why it is included in cash and cash equivalent position.
I do not believe that they have bought back own shares, this would pretty suicidal and not reflect the statement that the operation is funded until mid 2017...
back to the "good" old times? stock price wise ?
http://finance.yahoo.com/q/bc?s=OXBT&t=my&l=on&z=l&q=l&c=
I do hope on Sep 24 update call - patient enrollment phase 3 will be announced otherwise this would be a real set back (again), phase 3 patient enrollment suppose to start in Q3 - summer - , keeping fingers crossed…..
hope you are right!
always good to read and to realize why investors invested 60 million recently, there is a plan!
http://smallcapir.com/oxygen-biotherapeutics-inc-nasdaq-oxbt-late-stage-clinical-trials-could-bode-well-for-shareholders/, just download the pdf.
thanks for the reminder. As a fact the stock went down and down but I believe this is a turning point, regardless my cost price, the opportunity is here. With patient enrollment phase 3, the stock price will react on the potential, if management is able or willing to get a product (not shares) on the market, we will see. You obviously made up your mind and correct, most shorts made their money in the last years but I have a feeling that we are very close to a turning point in history of this company. if I would know and if I could read a crystal ball, I probably would not spend my time reading and writing comments on a msg board, rather enjoy life with all its options. GLTA
short squeeze not yet , you will see, countdown is running , less than 4 weeks with an early fire work possible..
, remember the days with millions of shares changing hands? call me a dreamer but i believe in a double digit share price without split
, long
over 1.38 million shares officially short, looking forward to a proper squeeze and short covering in the next few weeks, this is destined to go double digit soon…, fly robin fly, get it to the sky
could it be that warrant holder (management @2.6) are cashing in by buying put options and just exercise and deliver at option maturity ?! latest put option trades at 7.5 and recent filing of warrant exercise at 2.6 ! Hope it is not…….
put option sep 7.50 open interest 7000 ! this looks like a hedge . some have been traded @3.23 almost cash settlement at the time. but where there is a seller there is a buyer…. patient enrollment Levo phase 3 any day from now….
looks like 5700 puts have been rolled to September contract …this might be a larger shareholder who is just hedging part of the position as a play…, phase 3 enrollment is around the corner and other news about data should follow..GLTA