is waiting for the inflection point
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Been following CTSO for over a decade and increasing my position with each step toward de-risking the company. I will not give exact numbers, but I am a senior level IT guy with more than 25 years experience and my current CTSO position is worth about twice my annual salary.
Fresenius certainly could pick up the company at some point but I don't think any premium that might be offered at current levels would even be considered.
I really don't think it is that easy. That is why the design of a trial for sepsis is so difficult due to the heterogeneity across cases. Two people could be exposed to the same bacterial infection and their immune systems could have complete different responses. Think of the infection as a fire. Start a fire in exact same spot of two 100% identicle houses. Think of the progression of the fire to fully to consuming the house as a cytokine storm response. Will the fire spread through the two houses in the exact same pattern? Highly unlikely. Likewise the immune response and cytokine levels of the same kind of infection in two different people will have very different patterns. I believe IL-6, IL-10 and TNF-alpha are some key cytokines that can be tested to gauge an out of control immune response. But their levels will vary in every case. That is the great thing about Cytosorb though. It targets a wide range of cytokines based the wide range of molecular weights it can absorb, plus it is concentration dependent. That means if certain cytokine are highly elevated and others are not, the elevated ones will be absorbed at a much higher rate than the others, restoring hemodynamic stability.
The M&A info is interesting, but even more interesting the the Aferetica info. They are the company in Itally that is releasing the system that uses cytosorb for transplant organs. I had no idea that Aferetica was formed by the CSO and the President of a potential Cytosorb competitor. I think it speak volumes for the validity of the Cutosorbents technology that those two men would leave their company to develop products that use the Cytosorb technology instead.
I think so. It is fairly rare for a study to get halted at the interim. Their financial situation is not great, but I am hoping they partner up for a commercialism move.
Biotech in general are my main investments other than the conservative investments in my 401K. Right now my biggest positions are in CRMD and CTSO, but have been in and out of a few others like Sprectral Medical, TRVN, CLSN, SRPT, etc.
Only CTSO. Good news that the trial protocol has been changed expand the potential pool of patients can be enrolled, which may help complete the study faster. The result, share price drop... LOL.
http://www.spectraldx.com/
It has been a few years since I looked into AEMD, but their product is quite a bit different.
TTOO seems to be more of a diagnostic tool meant to aid in starting sepsis SOC faster. Cytosorb may someday be the new SOC.
"targeting 15-20 active sites"
"9 active clinical trial sites, 7 additional sites nearing budget and contract finalization, and 9 additional sites completing start-up activities"
9+7+9 = 25?
I'm not sure of the current state of XL development. As far as I know there is no single test to identify sepsis but instead a combination of a number of symptoms are usually used to identify it. I think Spectral might have a test for gram negative bacteria.
As for buying in, there are frequent price drops in the 10 to 20 percent range. Not sure if it is shorts, MM or something else. I am also not sure if it will continue after this recent run up.
Cytosorb XL adds endotoxin removal, which is something that can trigger sepsis in cases of gram negative bacterial infections. I think this is the trigger in only about 20% of sepsis cases .The cytokine release issue in sepsis is a positive feedback loop which feeds itself. Cytosorb targets those cytokine to stop the loop. Endotoxins from gram negative bacteria are one of the ignition sources of the cytokine storm, so removing them with the cytokines is a win win situation. Check out Spectral. Also look for Brown University article on the topic. Nice to remove endotoxins, but it is usually too late to help the patient, because the cytokine storm has already started and is feeding itself.
No chance of anything being FDA approved without a trial. The crime is the denial of the EAP application for a device that has been used over 46,000 times without any safety issues. I don't know if they can reapply for EAP for sepsis based on surrogate endpoints, but with new FDA leadership it might be worth a shot.
He is in his late 70s if not 80. He is retired from medical sales. I believe the last company he worked for had something to do with diabetes testing. He lives in Coral Spring, FL. If he still around, I suspect he has a nice size long position after years of swing trading CTSO.
Has lowenstein posted anything in the last few years. I put her, I think they claimed to be female, on ignore about 7 years ago. As for Pearsby, is he still around? He was never a big Facebook poster, but his page is still around and none of his family has any posts mentioning him.
Great comment raptor. Many of us here for the investment opportunity at time lose sight of the potential serious positive impact to humanity in the number of lives saved and reduction in negative repercussions from some of the various serious illnesses Cytosorb can help with. Some kind of exclusivity agreement with one of multiple companies providing treatment for the same ailment would not sit right with me. If it is broadly approved in th EU to treat elevated cytokines, what are you going to do to a physician that chooses to use it to save a patient receiving treatment with a competitor's CAR T treatment? Are you going to sue him or her? That would be a PR disaster.
Cytosorb XL almost certainly has something different or in addition to what is used for Cytosorb in order to absorb the endotoxins from gram negative bacteria.
Potassium adsorber.
Nice! But Cytosorb is not a membrane filter/absorber. There have been a number of attempt at a membrane cytokine filter, including one by their partners, Fresenius.They key with Cytosorb is the polymer beads with microscopic channels that expose the blood the the equivalent surface area of 7 football fields. It is a not a drug, but a technology that can be applied in many aspects, depending on what they are coated with. That is why there are all the other pipeline products. Patents are nice!
I concur. Been following the company for over a decade and back when we were trading in the single digit pennies and it felt like we were drifting in the doldrums he was the only one keeping my interest up in the company. The company was an infant back then and what is most exciting is that it has only transitioned through to baby then toddler stages. Child, then teen ager and adult stages will take the company to a much higher level in the next few years.
The near term chance of de-listing has to be a huge positive as it certainly drops the chances of a reverse split. I would like to hear partnership news as the next catalyst, but I have a feeling that news might not come until after FDA feedback.
While some kind of exclusivity deal with one or the CAR T companies might be a good financial deal for CTSO, would it really be ethical?
It pretty much comes down to what they consider "material". For example if they were to make a deal with a US partner to market Cytosorb upon a successful phase 3 REFRESH trial that would not necessarily be material. Most companies would PR the hell out of it, but CTSO is so conservative, which is not necessarily a bad thing, because it did put them and shareholders into a fairly good financial situation. If there is a remote possibility of a partnership not bringing in more sales it is technically not a material event. However, if there was up-front payment to secure a partnership deal, approval not, that would be material. Of course this all my opinion.
Exactly what it looks like to me. But it is also part of a 10b5-1 trading plan. Execs setup plans with brokers to execute trades for them based on some parameters like: share price/percentage increace/trading volume, etc. It allows them to take some profit, even in blackout periods, without fear of accusation of or potential prosecution for insider trading.
It has to be a quirk with ihub. My brokerage accounts both match. I think we saw some profit taking today. There may be more, but I hope it holds at close to this level. I really think the EU/CAR T/ Dr. June angle has something to do with this move. However, this company has so many irons in the fire any one of them could boost it up to the next level. Paradigm shifting absorber device taking the place for treatment where an endless number of drugs have failed to prove efficacy, or proving more efficient than other SOC treatments (bilirubin and potassium removal as examples).
Is there after hours trading going on? Half the time I pull up CTSO in the IHub phone app is says the closing price was 14.5 and the other half says 14.4?
Wow. So many mistakes in that article. A positive article, mostly, but missing so many key points, plus the mistakes, make it a boarderline soft bash.
Sepsis is just a part of the story. Don't forget it can remove bilirubin, myoglobin and plasma free hemoglobin. A better catch all description Cytosorb might be "A device that restores hemodynamic stability". Then the company also has Hemodefend, Contrastsorb, the potassium filter and Cytosorb XL, which also removes endotoxin from gram negative bacterial infections.
CTSO. It is on the move for unknown reasons at the moment. Perhaps a combo of unannounced news and short covering. It could also be due to two companies receiving EU approval for their CAR T-Cell cancer therapy. CTSO main product is a cytokine filter and Cytokine Release Syndrome is the biggest and most dangerous side effect of CAR T. Their product is approve in the EU, so it could be put to use immediately. Just started their Phase 3 US trial a few months ago. Been safely used in over 46,000 human treatments and the company should reach operational profitability this quarter.
Great day for the two investments we have in common!
Short interest is about 9% of float. That could make this recent run up even more exciting. I want to see a big PR to turn this smoldering fire into a shorty conflagration!
Why are we not on the Nasdaq biggest gainers list today? Anything to get CTSO noticed by a wider audience is a good thing.
You may be correct. I don't know if the tender was for a bulk order of $400K for a 24 month supply or for a supplier to provide 400k worth of Cytosorb over the next 24 months.
Techzen posted it about 2 weeks ago. Please check his posts. I will try to find the link later.
Also don't forget about that Romanian tender order. Hopefully it will also hit the books this quarter.
Like CRMD, that other company I mentioned received CE mark approval a few years ago and chose to transition from R&D to commercialization on their own. It has been a slow (4+ years) agonizing processes. The point of operational profitability should happen this quarter. They are now just in the early stages of their first phase 3 US trial. This company is about the polar opposite of CRMD from a financial stand point. They are extremely conservative, with only ~32 million outstanding shares and about 25 million in cash.
Having followed this company's slow transaction to commercialization there is no way I would ever want to see CRMD try to go it alone. Granted, the highly likely FDA approval gives them a huge leg up, but building out a marketing and sales force is a huge undertaking. BO or partnership is the only way to go in my opinion. However, from a negotiation standpoint, for either option, their financial situation is not good. In my opinion you would want to go into any negotiation with a balance sheet that shows that you have the financial ability to go it alone if needed.
I don't remember if it was this board or another one, but someone mentioned the possibility of a loan. I'm sure everyone here would be all for non-dilutive financing. Another company I have a long position in, 10X what I have in CRMD, did get such a loan . There are companies that service the Biotech sector in this way.
Bridge Bank is a division of Western Alliance Bank, Member FDIC, the go-to bank for business in its growing markets. Bridge Bank was founded in 2001 in Silicon Valley to offer a better way to bank for small-market and middle-market businesses across many industries, as well as emerging technology companies and the private equity community.
www.cytosorbents.com/cytosorbents-closes-10-million-debt-financing-with-bridge-bank/
My bad. I thought they were on a different cycle. Those March calls might be a good deal. You don't have to hold them until the end. A good pop on FDA news could be a double for both the share price and those options, but it takes less $ to load up on the options. More bang does your buck if it goes your way. Unfortunately, it does not usually go your way buying calls.
What are you all thinking the June 2.50 calls might start at on Monday. I might pick some up for at a dime, but I think the ask will probably be higher than that.
I suspect inclusion in the Russell indexes is the main catalyst to this increase. Do these institutions buy at market or do they work to push the price down while they are trying to accumulate? I have my opinion on this question and think it might account for these big price swings from time to time on no new material information
-Approved in the EU
-Used in over 47,000 human treatments
-Strategic Partnerships with Fresenius Medical Care, Terumo, Biocon, and Dr. Reddys
-Phase 3 US FDA cardiac trial underway
-Germany sponsored endocarditus underway
-50+ IIT underway or in planning stages
-Hemodefend trial should start within the next year
-Received European regulatory approval to expand the use of CytoSorb to reduce bilirubin elevated in liver disease, and myoglobin
elevated in trauma, from blood
-Gross profit margin of 74%
-$25.3 million in cash and cash equivalents
-24th consecutive quarter of year-over-year quarterly growth
-Over the past three years, the compound growth rate of return (CAGR) on product sales was 67%
-Operating profitability should be reached this quarter, excluding trial costs
-New manufacturing plant online this month
-Pipeline products: Cytosorb XL, Potassium adsorber, contrast adsorber, drug adsorber, etc.
Check out clinical trials dot gov. I believe the "International Registry on the Use of the CytoSorb Adsorber", a 3000 patient observational study, is trying to collect the type of data you speak of.