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Considering the current COVID situation, I think CTSO's share price should up there in the cloud but it is not. Look at some of the COVID stock plays doing the mega runs: NVAX, SRNE, CODX, IBIO, VXRT, INO. What I think is holding it back is that is still an unknown story on why it is medical breakthrough in reducing cytokine storm, the holy grail of the industry. In my opinion, they don't have the proper industry lead analyst coverage to make this run. It doesn't matter about revenue, outstanding shares of a company, etc, what matters is that investors think it is the part of the solution for the COVID crisis. The CTSO story (military grants, worldwide distribution, the many clinical studies, covid-19, significant cash, etc) just needs told in a way to get people excited.
Regarding "In April 2020, we submitted a white paper proposal to seek BARDA (“Biomedical Advanced Research and Development Agency”) funding under a Broad Agency Announcement (“BAA”) for a U.S. multi-center randomized controlled trial to treat critically-ill COVID-19 patients with respiratory failure on extracorporeal membrane oxygenation with CytoSorb blood purification. This followed a BARDA Coronawatch meeting where CytoSorb was deemed "Highly Relevant" in treating COVID-19. However, based upon an amendment to the BAA released on June 3, 2020, the areas of funding focus for the BAA were narrowed primarily to vaccines, COVID-19 therapeutics, and diagnostics, while suspending many other treatment areas, including the area of interest topic that we submitted under, “Immunomodulators or therapeutics targeting lung repair.” On July 17, 2020, BARDA notified us that it will not fund our study. "
https://www.sec.gov/Archives/edgar/data/1175151/000110465920084894/tm2025151-1_424b5.htm
They will use part of the cash raise to fund this study themselves. They are taking advantage of their access to COVID-19 patients given the current situation. It would help them gain approval faster and have the study published so that other doctors will use CytoSorb as treatment. Their very first trial in Germany was "Efficacy Study of CytoSorb Hemoperfusion Device on IL-6 Removal in ARDS/ALI Patients With Sepsis" ( https://clinicaltrials.gov/ct2/show/NCT00559130). As stated in here, "Mortality rates from acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) range from 38.5 to 65%, with the lower mortality in acute lung injury than in ARDS. ARDS/ALI is most often seen as part of a systemic inflammatory response syndrome (SIRS), particularly systemic sepsis."
They probably would conduct this trial to gain approval in the US. When they wrote this paper to seek BARDA approval, they would outlined how they would conduct the trial. They already have contacts in hospitals, etc in place, they just don't have the cash. The cash raise is for this trial, in my opinion. If this is the case, it is a excellent move on their part, we will know on August 4.
I agree, the next round will be discounted but not large. The HemoDefend U.S. pivotal trial is expected to start in late 2018-early 2019. I see financing for it happening between now and the Fall once they finalize the protocol for the trial.
Clints, unfortunately, they stated they will require additional financing. From the S-3 from last week:
Not to be forgotten is that they have been running a dosing study in Germany for the past few years. In Sept 2016, they introduced CytoSorb XL stating that they would be actively pursuing pre-clinical and clinical development of CytoSorb XL, the next generation. CytoSorb for use in sepsis requires a large pivotal trial for FDA approval. CytoSorb is their flagship product so they may go into the trial without partnering on it.
Kathy Bloch recently talked about how they try to get in cash while trying to limit shareholder dilution when possible. Dr Chan has said the same while back on the OTC listing. If cash is needed to advance their goals, then cash will be raised through the best means available to them. At the moment, I think it will be both the ATM and an offering. One pivotal trial is approx 8-12 million.
The following companies were part of the last offering (April 2017): Cowen and Company as the sole book-running manager and representative of the underwriters for the offering. Aegis Capital Corp, H.C. Wainwright & Co., B. Riley & Co., Maxim Group LLC and Northland Capital Markets are co-managers for the offering. Besides the questionable ValuEngine buy rating, has there been any other recent buy ratings outside the involved investment companies that raise cash?
Recent buy ratings upgrades this month:
May 9 HC Waingwright $14
May 9 B Riley $13
May 12 ValuEngine Buy to Strong Buy $?
May 14 Maxim Group $13
May 17 Cowen $11
With the exception of the BioTech Showcase which had investment and partnering (Vincent and Chris attended here), the rest of been focused on investment portion of the conferences this year.
Investment Conferences:
Jan 3 Biotech Showcase
Feb 6 Annual BIO CEO & Investor Conference
Feb 26 BTIG Healthcare Conference
March 12 38th Annual Cowen Healthcare Conference
April 9 HC Wainwright Annual Global Life Sciences Conference in Monte Carlo and Meetings in Frankfurt, Geneva, Zurich
May 21 B.Riley FBR Investor Conference
The company first stated they may need to raise additional capital for non-cash expenditures and clinical trial costs in the Q3 2017 report (Nov 9, 2017). Operating break-even do not include those. They would be better able to assess this need once the specific protocols are finalized with appropriate regulatory bodies. The company has let it known that they are pursuing the trials for REFRESH II and HemoDefend. In Q3 2017, they have cash on hand to fund into 2019 but they continue to use the ATM into mid-April 2018. The share price hit the 52-week high in May...IMO, this is an opportunity to use the ATM again and and could help with their possible offering especially with their low float.
The success fee is on $10 million not $5 million.
Biotech Showcase, Jan 8-10, San Francisco
http://www.ebdgroup.com/bts/core/participating-companies.php?_ga=2.95881500.1046073882.1514866661-2077374263.1514866661
Also, this to me, seem to indicate they had already filed before the Nov 9 report with knowledge that it takes 30 days for the FDA to respond and Dr Chan's confidence and statements that the trial could start in Q4:
"Meanwhile, we are working diligently to initiate our U.S.-based, REFRESH 2 cardiac surgery trial by the end of 2017. This pivotal, registration trial is designed to support U.S. regulatory approval of CytoSorb for complex cardiac surgeries like valve replacement. We have already met with the FDA to discuss our proposed trial design and will provide an update when we have more information on our investigational device exemption (IDE) application.
I do not think they will get declined either. There is a possibility that they filed later. Dr Chan was confident that it would start in Q4 so filing past mid November seem to living on the edge for him in case something doesn't go as planned. The 2015 FDA decline on the EAP news came out on Dec 21. From this point on, because it is heading in the holidays, I am expecting something negative to come out. I don't consider the IDE approval a big news item that will move the stock price but I view keeping on track to be important, which historically the company has not. I also want to know what the final protocol will be so that I can see how much money they will need.
The fda responds with a decision within 30 days of submission. To me it means the fda asked them to modify or have declined their submission. I think they have to tweak it some more or they are delaying the approval news for another week to continue the ATM.
Hmmmm, still no update on IDE application. Not a good sign. Pass the 30 days. The start of the trial moves to 2018.
My thoughts are this. Any cash raising will be completed in this quarter. The IDE news can be used to raise cash...Dr Chan mentioned a 400 patient pivotal trial for REFRESH 2 and potentially another one in Germany. In the last Nov 9 report, he said they may need more capital, "As a result of the receipt of additional proceeds under the Loan and Security Agreement in June 2017, and in conjunction with the closing of the equity financing in April 2017 and recent sales of the Company's common stock under the Controlled Equity Offering SM Sales Agreement, we believe we have sufficient liquidity to fund our operations into 2019; however, we may need to raise additional capital to fully fund pivotal trials in the United States and/or Germany. We will be better able to assess this need once the specific protocols are finalized with appropriate regulatory bodies."
Anything happening in 2017 will be quickly forgotten once January comes. They would want 2018 to be flush with cash and hit their operating break-even. With only half the month left and heading towards the Christmas/New Year break where most people aren't around, I would not expect any spectacular news. I think there will be cardiac partnership news but this would be announced next year. The cash raising that would be done now would be for the other trials. I would proceed with caution tomorrow and next week. As you may be aware, Fridays and holidays are good time to release bad news as it doesn't bring down the stock too much...although the share price looks like it will continue to go down.
IDE application update overdue. I think news will be used to time a cash raising.
Due to the video's release on Yahoo, I would not view it as an official company video expressing the current progress as of Nov 30. I'm not sure when it was filmed. If there were to be an update on the IDE application, it would be an official press release and not a video to the select few on Yahoo. I'm not able to view the video myself because I am out of the region.
From the transcript:
http://cytosorbents.com/wp-content/uploads/2017/11/CytoSorbents-Q3-2017-Earnings-Call-Transcript-11.9.17-Final.pdf
Brian Marckx:
Okay. Based on your expectations to start the study by the end of the year – the next seven or eight weeks – it sounds like you expect to hear back from the FDA relatively soon? Also, is your understanding that this will be sufficient as a pivotal study? Are those both fair assumptions?
Phillip Chan:
Yes, I think so. Although it is a tight timeline to get the study started by year end, we benefit from significant redundancy from REFRESH I and have been working in parallel to make sure we can stay on track. For example, we benefit from the fact that REFRESH I and REFRESH II are very similar type protocols where we are treating with CytoSorb intraoperatively. Also, in REFRESH II, we are looking at a subset of patients from REFRESH I, so we are actually narrowing the focus of the study. This will hopefully make it easier for the ethics committees to approve the protocol that will be similar to the one they approved for REFRESH I. We will also be starting in several of the clinical centers that conducted the REFRESH I trial, so the teams are already familiar with how to use CytoSorb. Finally, we have already negotiated the clinical trial agreements with many of our sites prior to REFRESH I, and would not expect the need for significant changes in the language. Because we have been working in parallel, we think that we are on track to get the study off the ground before the end of this year. We are certainly going to try.
Here is an old Cantor Fitzgerald powerpoint that I found helpful in understanding the ATM for those interested:
http://files.dlapiper.com/files/upload/At-the-Market-offerings.pdf
3% transaction cost
Thirty days for the FDA to respond back to company's IDE submission. My guess is that their meeting with the FDA and subsequent IDE application filing was sometime between Oct 18 to Nov 8. So by end of next week latest, we should know. Would make sense to time the news for the Dec 5 morning. In between, there could be news about the Italy launch of the Perlife system. Following that if they plan significant cash raising, it would most likely be done before Dec 22. However, they may continue to do the "at the market" (ATM) dilution so that it is not so noticeable to shareholders.
REFRESH I IDE submission (Dec 30, 2014):
https://www.prnewswire.com/news-releases/cytosorbents-submits-ide-application-to-fda-for-us-cytosorb-cardiac-surgery-trial-300014434.html
REFRESH I IDE approval - (Feb 2, 2015):
https://www.prnewswire.com/news-releases/cytosorbents-announces-fda-approval-to-commence-initial-us-cardiac-surgery-study-300028992.html
LD Micro Event - Dec 5 @ 10:30 AM, Los Angeles
https://www.ldmicro.com/events/presenter-schedule?day=1
Slow start this morning. Was hoping to see $7.50 by now. Any chance today?
Seems like $6.55 seem to be the average max on the last few runs.
Who did you talk to? If it were that easy, shareholders, especially CG and I would be calling them everyday to ask them if they are selling. I doubt the person you talked would know for sure. Dr Chan and Kathleen would keep that type of information confidential.
I do not know if they are selling at the market. All I noticed was this jump in volume but not in price when throughout the day, the movement in bid and ask was in very tight price range. There was alot on bid at 6.20 and not very much at 6.25.
I think they have a very good idea from the FDA meeting what the protocol will be and how many enrollees are required for the cardiac surgery. They had to write up the IDE application submission after their FDA pre-submission meeting. It's a formality of the FDA approving the IDE Application within 30 days in this case. Dr Chan is pretty confident that the REFRESH 2 will start this quarter. I think they want to raise enough money to cover studies for other products in the pipeline as well as cover some loan repayments. There maybe a potential partnership deal for the cardiac surgery but I think it will be signed and announced next year.
I've include the link on the IDE approval process:
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm046164.htm#fda_action
Vincent didn't say whether this is per quarter or per year. I had assumed it is per year.
A jump in volume at about 15:27-15:30 PM, with most share price at $6.25. Volume went from approximately 70K to 120K. How is that possible when there was wasn't that much offered at the ask?
This is from their October presentation regarding the design of REFRESH 2.
U.S. REFRESH 2 Pivotal Trial
• Plan to meet with the FDA shortly to confirm the clinical trial strategy and trial design for REFRESH 2 cardiac surgery, with goal to start trial 2H 2017
• REFRESH 2 is expected to be similar in design to REFRESH 1, but enriched with patients undergoing valve replacement patients, who have the highest levels of pfHb and at greatest risk for organ injury
• Preliminary trial design, pending discussions with the FDA:
• Plan to start with core sites from REFRESH 1
• 300-500 patient, 20-25 center randomized, controlled PMA trial
• Primary and secondary clinical and cost-effectiveness endpoints: Progression to acute kidney injury (AKI), incidence of stroke, time on mechanical ventilation, hemodynamic stability, days in the ICU
• Enrollment expected to complete within 2 years at 0.5 patients/month/site
• $10-12M cost spread out over 3 years – potential for strategic partner support
• Targeting 2019 completion, potential 2020 FDA approval
Can produce up to $35 million in sales in first phrase and up to $70 million in sales with the additional expansion. The manufacturing expansion is 80% complete. Regulatory authorities have been notified.
This is from the last shareholder letter, "The expected initiation of our U.S. cardiac surgery REFRESH 2 trial in the second half of 2017, pending FDA protocol approval, would establish a timeline for U.S. approval (potentially as early as 2020) for the first time. "
From the last 10K, "The Company has recently met with the FDA regarding REFRESH 2, intended to be a pivotal, registration trial for US approval, to discuss trial design and address any clinical and technical questions. In parallel, the Company initiated discussions with previous trial sites that participated in the REFRESH I study that are familiar with the CytoSorb device and intraoperative use during CPB. The Company believes using sites that previously participated in REFRESH I will accelerate the process of site startup and a planned fourth quarter 2017 launch of REFRESH 2."
I believe they have already submitted in their IDE application when they mentioned this: "Meanwhile, we are working diligently to initiate our U.S.-based, REFRESH 2 cardiac surgery trial by the end of 2017. This pivotal, registration trial is designed to support U.S. regulatory approval of CytoSorb for complex cardiac surgeries like valve replacement. We have already met with the FDA to discuss our proposed trial design and will provide an update when we have more information on our investigational device exemption (IDE) application."
The FDA has 30 days to respond back after an IDE application submission. If I recall from the last conference presentation on Oct 10, they had not had their meeting with the FDA. Taking into consideration when this was reported on Nov 9, the maximum date that CTSO would hear back from the FDA is about Dec 9. So 30 days from IDE submission, means CTSO would hear from them any day now since we don't know the exact day of submission but have an idea the latest would be Dec 9.
On Nov 9, CTSO reported that they sold shares in q3 and continued right up to Nov 7...to me this indicates that they are not finish selling yet. They will continue to sell until they hit their goal. Share price near the 52 week high, so I think anything above $6.
In terms of positive news that may bring the share price up, possible partnership for the pivotal trial for REFRESH II where the partner pays for trial, or addition of new partner or distributor. Start of REFRESH II but I don't consider this big news but some people may.
CTSO has provided opportunities to make a profit if a shareholder so wish. People who haven't sold all this time, may experience more anguish/frustration when they see the price go up and down. I recommend at least people have a small trading portion to sell on those unexpected run days.
They seem to like the last day of the quarter in obtaining money. For example, First quarter had the $10m cash raise, second quarter had the $5m bridge loan. For the third and forth quarter which was unexpected, they have the dilution with Cantor. I'm thinking there will be one more significant cash raising just before Christmas to take advantage of the holiday. Generally, holidays are quiet periods where most people will not be so focused on their investments. They will want to wrap up the dilution this quarter so that it is a fresh start in the new year. Besides the CytoSorb for cardiac surgery and sepsis pivotal trials, I suspect they want to start trials for use in other conditions. As long as we are near the 52 week high, raising more cash will be on their mind.
I disagree with your last point. I know that Dr Chan does care but he has to be guarded on what he says. I've have in the past seen Dr Chan's responses to worried shareholders, particularly during the times where the company was struggling to bring this product to approval and during the time in laying the ground work for generating data and interest of the product with very little way of getting cash to come in but to raise money and to get grants to do more research. They want the ball to keep rolling and need money to fund clinical studies in US and Germany, then that's what they need to do. He mentioned in the past about focusing on shareholder value creation and running the company rather than tune into the noise from impatient shareholders. I think Dr Chan has done an amazing job in bring the company with very little to this much. People need to sent in thanks rather than complaints all the time.
I do find it interesting that they let us know that there was dilution in Oct and Nov and may need to do more. It's their way of managing stock price and expectations, I guess. I don't view it as negative cause I know they will spend the money wisely. However short term, this is viewed as a negative from a trading view and may thrift the share price down below $6. I like the company very much but I always try to step back and view the big picture. Whether some view me as pumper or basher at times, know that I always state my true opinion.
I noticed that and think there will be negative reaction to it tomorrow. There is an unknown with what the FDA requires for the trial. And not sure yet if there will be a partner for the US trial. We are near the 52 week high so cash raising makes sense this period. I think it will continue throughout this month and next as long as we are above $6.
I initially thought about cash raising because of where the share price is right now. Near the 52 week high. In last Q2, they stated that with the current cash and revenue projection, they have enough cash to the end of next year. This is for operating expenses only. They would need more for clinical trials. The other big expenditure expected is the upgrade of their manufacturing which is expected to come online early 2018 but I think they would have taken this into account. Revenue will continue to grow as more countries start contributing. In looking at the inventory at the close of Q2, I don’t expect a big jump in revenue. I think new customers are being asked to register in the CytoSorb registry and start off as test users until they are comfortable using it and doing the knowledge transfer to other staff. Perhaps the CytoSorb devices are put in under Research or Sales Expenses for this.
True. It is reporting period after all.
Just looked on the Frankfurt stock exchange, the trading volume is down to a fifth of what was traded yesterday. As well, it is down 14 cents so far, but price is still holding steady, higher than average.
When I saw that the report will be on Thursday heading into a holiday weekend, I felt a little suspicious that the report will contain something that has come up that is negative which in turn will affect the share price. I think product revenue will be fine - following the trend line to break-even in 2018. I think it will be something else. Reporting on Friday will raise the alarm, reporting on a Thursday is borderline "could be OK, could be a little bad". I hope I am wrong.
Fresenius Medical Care (FMC) started it off with 6 countries, then worldwide, it seems logical that they would fund a large clinical study next as I already mentioned.
They are marketing CytoSorb for use in the FMC’s multiFiltrate and multiFiltratePRO acute care dialysis machines as well as their FMC’s CytoSorb-compatible blood tubing sets. FMC is already heavily in with their sales force and marketing. CytoSorb compliments well in their machines and their future goals in critical care and innovation. A reminder that many trials have failed in sepsis. Reducing cytokines level has been sought after for a while. CytoSorb is a need to have item (making it standard of care in critical care) rather than a nice to have item. It is in Fresenius best interest to maintain this relationship.
"To promote the success of CytoSorb®, Fresenius will also engage in the ongoing clinical development of the product. This includes the support and publication of a number of small case series and patient case reports as well as the potential for future larger, clinical collaborations."
https://www.prnewswire.com/news-releases/cytosorbents-announces-strategic-partnership-with-fresenius-medical-care-300009640.html
I note that certain activities late 2016 and early 2017 could possibility contribute to increase sales in 2nd half of 2017.
Partnership with Terumo for cardiac surgery use was announced Sept 12, 2016 for 6 European countries. On Dec 20, 2016 PR, Terumo launch sales into the 6 countries. They introduced the CytoSorb CPB Procedure Pack and have plans to introduce other kits. Success of this partnership could lead to future expansion. Along the same line as Frensius partnership, I'm thinking that there will be Terumo worldwide co-marketing agreement announcement soon. That includes partnering on the REFRESH II pivotal study. If this is the case, it would be nice to put the value of the study in the PR at $10-12 million since Dr Chan has let this information out a few times to really make the stock price pop. Enrolling patients into the cardiac study should run faster than for sepsis.
Three year partnership with Fresenius in critical care use was announced Dec 16, 2014 for 6 European countries. They initiated sales in the 6 countries in June 2016. On January 9 2017, they extended the 6 countries to 2019 and expanded the co-marketing agreement worldwide. It is expected that the co-marketing will commence worldwide starting in the second half of 2017. As part of the deal, FMC agrees to make guaranteed minimum quarterly orders and payments, evaluable every one and a half years. CytoSorbents talked about running some sepsis trials next year. (You may recall that there is an ongoing dosing study in EU as well) I think they will partner with Fresenius to run a pivotal study in the USA to gain FDA approval for the next generation CytoSorb XL. There is possiblity that the study results from the very first sepsis study (in Germany) or data from the CytoSorb registry will be accepted for the pilot study. The pilot study is small and its focused is mainly on safety of the device before continuing on to the pivotal study. You may recall that CytoSorb was declined under the EAP program. They need to run a large study for use in sepsis to be approved by the FDA.
If the potential partnerships are along the same line as the Aferetica one that was announced last month where it is paid for by the partner and CytoSorbents just provide the CytoSorb devices, the company will be saving considerable money. The value of the partnerships really need to be emphasized in the PR for investors to understand and in turn drive the stock price higher. Savings of $10-12 million for a 300-500 patient study really needs to be tooted! For two studies, that's a total $20-24 million that some big partners would be paying out of their accounts because they believe in the success of CytoSorb.
Rather than wonder about this and that, I've sent an email to Dr Chan to seek some clarification. I don't think he will respond but at least I know he will read it and take action if he deems it necessary. Or have a good laugh at the $59 price target.
I'm saying that Louis is misleading people into thinking it is a buyout with that statement. I do not believe there will be a buyout at this current time. You are right, no one knows outside the company, why would Louis? Unless he was insider information. If he did have this information, he would never let you know. He would be buying it himself. He teased his readers with giving out two microcaps, perhaps CTSO is a teaser. I think I saw one where he saves the greatest for one of his Alpha reports. That one probably costs more.
I recall anti-takeover provisions when I read the 10-Q. I don't know how open CTSO is a buyout at the current time "according to my research".
I'm saying that Louis is misleading people into thinking it is a buyout with that statement. I do not believe there will be a buyout at this current time. You are right, no one knows outside the company, why would Louis? Unless he was insider information. If he did have this information, he would never let you know. He would be buying it himself. He teased his readers with giving out two microcaps, perhaps CTSO is a teaser. I think I saw one where he saves the greatest for one of his Alpha reports. That one probably costs more.
I recall anti-takeover provisions when I read the 10-Q. I don't know how open CTSO is a buyout at the current time "according to my research".