Wow, did I show up with first shares at precisely the time to buy, December 16th at 13.20. The only problem is, I had to ramp up fast, just bought 400 shares, so it was before the New Year that I had added another 4,100 shares, average is 14.39 so a sweet position in such a short time. This board is fantastic, so is that of HZNP and SYN, where I hold my biggest positions established long before OSIR. Very excited to be a shareholder of OSIR, great company with high expectations.
Homebuilder_watcher is a loyal, long term (and likely very profitable) investor in MDXG, which has suffered a recent $3.00 per share consolidation in share price to $8.69, over the inquiry into their marketing practices. I'm sure he's upset over that, and isn't here to support positive sentiment as regards forward valuations of OSIR, since they are going to take market share away from MDXG. Unless he has switched horses, he wants OSIR to fail.
I thought I would share the update I wrote for one of my friends that I turned on to Cytosorbents.
It has been an eventful month. On the financial side things are falling into place for growth. In December they did a reverse split to meet the share price requirements for up-listing to the Nasdaq capital markets and up-listed. They also reduced the authorized shares to 50 million. They also just completed a follow-on-offering of 1.25 million shares at $8.25 to raise about 10 million dollars, after costs, to fund marketing, more studies and increase manufacturing capacity. The follow-on offering prospectus also included a clause that allowed the underwriters to manipulated the stock price for stability during the process of the offering. I think that is why there was a price drop and it has stayed near the offering price. With the offering, the total outstanding shares is just about 25.5 million. Add in authorized warrants and option, the fully diluted share count is at about 27.7 million. With just under 5 million shares owned by one venture capital company linked the Cytosorbent’s founders the float is at about 23 million. That is not a lot of shares once things gain momentum.
I am fairly certain Cytosorbents has quite a bit of good PR they want to release, but according to the company they are in a “quiet period” as part of the offering. Nasdaq says that period ends on 2/8/2015, so I don’t expect much news or PR to start flowing until after that time.
One the regulatory side of things, they submitted an Investigational Device Exemption (IDE) application to the FDA on 12/30/2014. I’m not sure how familiar you are with the regulatory process, so I will share my research with you. With an IDE approval the company will be able to conduct a phase 3 pivotal cardiac surgery trial. When an IDE application is submitted the FDA sends a letter to the company acknowledging they received the application. That starts a 30 day clock running. In that 30 days the FDA can deny the application approve the application, request more information or data or not respond at all. No response is equivalent to an approval. Cytosorbents has been in constant communication with the FDA for years so I am pretty confident that at this point the IDE approval is almost a formality. Once the IDE is approved we can expect Cytosorbents to announce the planned start of the pivotal cardiac trial and get a better idea of the trial protocol. From my research and review of their August 2014 presentation, the IDE application PR and the recent OneMedForum presentation I think there are clues to what regulatory path they are planning to take. The August presentation listed 3 possible FDA regulatory approval pathways:
1. 501(k) – Cytosorb used intra-operatively during cardiac surgery with a primary outcome measure of reduced pro-inflammatory biomarkers
2. PMA (Pre Marketing Approval) – Cytosorb used intra-operatively during cardiac surgery with a primary outcome measure of reduced organ dysfunction
3. PMA (Pre Marketing Approval) – Cytosorb used post-operatively during cardiac surgery with a primary outcome measure of reduced organ dysfunction
If Cytosorb is classified a class 3 device they will have to go through one of the PMA paths. The PMA route is more rigorous and requires a larger study and more time. As I understand it class 3 devices are usually implantable devices, so I think Cytosorb will be a class 2. Class 2 devices can go through the 510(k) process instead of PMA if there is a substantially equivalent predicate device already approved or cleared by the FDA. Note that 510(k) results in a device that is “cleared” for marketing while PMA results in a device that is “Approved” for marketing. Not sure what the difference is. There has been some speculation among a group I talk with about Cytosorb that there may be an approved Leukoreduction filter that may qualify as a substantially equivalent predicate device for Cytosorb. Now take note that the IDE PR and OneMedForum presentation both mentioned “Intra-operative use of CytoSorb® represents an innovative new strategy to improve the safety of complex cardiac surgical cases, and to reduce inflammation generated during the surgery”. There was no specific mention of reduction in organ dysfunction, although that is obviously the ultimate goal. This leads me to believe they are looking for a primary outcome of reduced pro-inflammatory biomarkers, the 510(k) path. If they do go the 510(k) path I hope one of the secondary outcome measures is reduced organ dysfunction though. Also note that in the August presentation they specifically stated that regulatory path they choose would be decided based on feedback from the FDA, so the path they take will already have the FDA’s blessing.
The August 2014 presentation also said the 510(k) path would require a study of less than 150 patients. Couple this with the fact that Cytosorbents has MD’s on their cardiac advisory board that are from a number of large US university hospitals could lead to a trial that enrolls fairly quickly. If they choose to also use EU trial sites it could enroll very quickly as the device is actually approved in the EU, not experimental, and it has already been used on over 100 cardiac patients there.
The US cardiac trial will have a primary outcome measure of reduced pro-inflammatory biomarkers. The EU study that got Cytosorb CE mark approval in Europe had a similar primary outcome measure. There have also already been over 3500 human treatments with Cytosorb and the data from many of these has been collected in the International Cytosorb Registry database. Many pivotal FDA studies only have limited phase1 and phase 2 study data that can use to design the phase 3 study on. Cytosorbents however, has a large amount of data to base their pivotal study design on, which means they will go into it with a higher probability of success.
One Key opinion leader, Frank Born, the Head of the Perfusion Services, Department of Cardiac Surgery University Hospital Munich-Grosshadern, Germany stated in regard to Cytosorb "I can imagine this therapy will become established as the standard care in cardiac surgery and repeat cardiac surgical procedures in the next few years." That is a pretty powerful statement from someone who is using the device regularly. Also note that I think this quote is over a year old.
I think we will have the following upcoming catalysts to look forward to:
1. Q4 2014 sales results and shareholder letter
2. IDE approval
3. Start of Pivotal US cardiac trial
4. Announcement of a partner for the US cardiac study. They may go it alone, but a partner would be a big boost to ramp up sales and distribution quickly in the US if approved.
5. Marketing approval and start of sales in the 6 EU countries where Fresenius is their distribution partner. The contract with them states they must secure this approval within 6 months
6. Announcement of a pediatric version of Cytosorb. There are hints to this in development on the Cytosorb Registry web site.
7. Results of the US Air Force study on the use of Cytosorb for Rhabdomyolysis
8. Results of the EU cardiac study
9. Result of the EU dosing study. This has been going on for over a year at 8 trial sites
10. Announcement of the name of the top 4 cardiac company that is evaluating Cytosorb in France and a possible partnership. Rumor is that it may the Sorin Group.
11. Result of any of the other 40 + investigator initiated studies in the EU.
12. Licensing or possible partnership for the Hemodefend product.
13. Results of the ABLE study, hopefully supporting the need for a product like Hemodefend
14. Updates on other pipeline products: ContrastSorb, DrugSorb and BetaSorb
15. Update in the SBIR contract with the US army for burn treatment
16. Update on the DARPA contract
We had a late-day reversal from session lows 4.56 back up .13 to the close at 4.69. I think this could be the level where the stock pivots and heads back up, given organic demand for the stock by traders and institutions alike. That's my 2 cents worth, and further I agree the weekly chart is very strong in a steep uptrend.
Whoa, if that happens, it will coincide perfectly with my prediction post just made on the triangle wedge breakout. We are compressing daily to a point of confluence at the apex of the triangle. It's lining up gentlemen! Why do you think Tuesday for P1b?
Since the 'Kanzer dump' back in April, we've had a 10-month 'descending' triangle forming on the daily and weekly charts. Descending triangles technically have their bottom line horizontal, yet this bottom line is rising, therefore it's more of a falling wedge than a descending triangle. To see it, draw a line from the April 2013 high down through this weeks close, connecting the highs (cut straight through the overshoot highs of late August and early September). Doing the same along the weekly (or daily) lows. This gives you a down sloping triangle pattern that is coming to its apex in the next two weeks. Price movement is compressing with the end of the wedge closing down at its apex. Daily moves are nearly touching both the bottom and top of the wedge. Today we closed on the top line of the wedge 1.58. On the daily, during the last 10 trading sessions, we have touched this upper triangle line 8 out of 10 times! Given today's close on the line, we could see this consolidation pattern end in a dramatic up move, or breakout. I am not going to predict because I don't know, but accompanied by volume (if news) would make for a dramatic move. If nothing happens next week the wedge has about another week before this pattern plays out. I'd give it 70% odds of it happening without news, and 100% if we get positive news on SYN-004 efficacy results of Phase 1b. Thoughts?
Sentiment: Strong Buy
and we were down 2.77% on 11,900 total share volume? Boy does this company fly low under the radar! Wait until we hit our quarterly report and the big beat and forward guidance sends our shares over $1.20! Aren't a double ready to happen, for sure it seems, we must be the lowest risk one year hold and double around. Show me a better and I'll buy it.
Joke! Down from $7.98 last March, and hit bottom in December at 3.08 and now 3.65? I added 3,000 shares new position this week, after quick out and back for .50 first trade.
More like a $10 stock on a buy out or a $7 stock organically just on its own merits given time for the market to realize it didn't understand the trial results, and amidst the short attack. Organically, the stock is showing signs of recovery, but is being manipulated by the dark side.
If they are hitting your bid, you da winner@bid price, and the ask would drop to the sale price at the bid. Why would the ask jump if they are hitting your bid?
Oh dear Bender, you are so optimistic, but I fear you are setting yourself up a bit here with an unrealistic target. Now, given that the Brean Capital analyst said that they plan to build the stable of products up to 8-10 depending on what they are and when announced, that's the wild card. I noticed today that the stock we were tracking pretty close to last year, DEPO was up today 14.43% to just over $20. They were in tandem, so if that's your metric, and we are lagging that far as far as earnings go, you may be right. We just need TW to come out with a huge beat, and who knows? I think that won't be revealed until the earnings report in March however. At times I post my frustration here, but have learned not to use the keyboard to complain much. Felt like it yesterday, but the market swoon erased our gain. We were due for this, nice to be here over $15! See you at $20, where though? Notice I didn't say when!
While it did pause at the threshold of $15, back and forth for a while, it sliced right through it and kept on going up, that's the HZNP of old, the one I remember. Wow, what a day. About a year ago I was comparing this stock to DEPO, which at the time, both were trading around 13 or so. Then we hit the exclusions, and dropped, they went to a low of $10, but noticed today they were up 14.4% to $20. I actually held both then, larger here, smaller position there is no longer. I did miss their drop, stayed with our stock the entire time. I think we will be on the fast track now to catch back up to DEPO, the other stock LCI that does generics was up strong today too.
You had your chance, 4.58 I saw briefly, but didn't get that lucky, did get 3,000 at 4.64 to add to my stable, now holding 38K shares. This is a monster, if you didn't listen to Milano on the JPM conference, you really must, if you're serious about your investment here, he's very articulate, passionate, and I can just tell how he speaks that people will want to follow him, make a deal with him. I see this guy taking us to the promised land of biotech!
Sentiment: Strong Buy
I had purchased 3,000 more at 4.64, then it dropped to 4.58 and started back up, then it exploded up in a flash to 4.71, cool deal! Maybe this consolidation is over?
Just after I posted that, I put in an order but the price had already moved on me, but I did get a fill at 4.64 for 3,000 shares. I figure it's back soon to the upside, risk reward definitely in my favor. If it drops below this level again, I will get another lot and call it good at 40K shares.
The default move is down 3-5 cents in the morning regardless of whether it opened higher or not, then comes back a couple cents, and then tacks on two cents at the close to save the trend and chart. This is what can be said to be the spring coiling, or in other words, a sideways consolidation. The longer it does this, the higher the upside move IMHO, and of course, the stronger the support in this range. I am ready, all those in favor show yourselves!
For sure it will, but you must give it a chance to be traded in a less turbulent market. Tomorrow may be another down day, if it drops further I'm going to jump all over it! BUY!
Sentiment: Strong Buy
What I see on the chart are technical indicators showing the stock 'rolling over' with price vulnerable to a period of consolidation which started today. Sometimes with strong stocks this phase ends up being a sideways consolidation, and not much is given back. Or, more often the stock goes down to find support and it wasn't evident today until we reached the closing lows. I had an offer in for a few minutes at 16.22 and it didn't fill but started back up. I pulled the offer before it came back down, figuring I'd better wait to see what tomorrow brings. My most expensive buys were 16.15 and 16.20. Haven't sold any. Good luck.