UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington D.C. 20549

 

 

FORM 8-K

CURRENT REPORT

 

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

 

Date of Report (Date of Earliest Event Reported): August 12, 2014

 

 

CYTOSORBENTS CORPORATION

(Exact name of registrant as specified in its charter)

 

 

Nevada   000-51038   98-0373793
(State or other jurisdiction of incorporation)   (Commission File Number)   (I.R.S. Employer Identification No.)
 

7 Deer Park Drive, Suite K,

Monmouth Junction, New Jersey

 

08852

(Address of principal executive offices) (Zip Code)
           

Registrant’s telephone number, including area code: (732) 329-8885

 

Not Applicable

(Former name or former address, if changed since last report.)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

  ¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

  ¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

  ¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

  ¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 
  

 

Item 2.02 Results of Operations and Financial Condition.


On August 12, 2014, CytoSorbents Corporation (the “Company”) conducted a conference call during which members of its senior management team discussed financial results for the second quarter and six months ended June 30, 2014, a business update, and certain other information. The transcript of the conference call and the presentation used during the conference call are furnished herewith as Exhibits 99.1 and 99.2, respectively.

 

 On August 12, 2014, the Company issued a press release announcing its financial results for the second quarter and six months ended June 30, 2014. A copy of the press release is furnished herewith as Exhibit 99.3.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No. Description
99.1 Transcript of the CytoSorbents Corporation  Conference Call on August 12, 2014, 4:15pm EST.
99.2 CytoSorbents  Corporation Presentation.
99.3 CytoSorbents Corporation Press Release, dated August 12, 2014.

 

 
  

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

Dated: August 15, 2014 CYTOSORBENTS CORPORATION
     
  By: /s/ Dr. Phillip P. Chan
  Name: Dr. Phillip P. Chan
  Title:

President and

Chief Executive Officer

 

 



Exhibit 99.1

  

 

CytoSorbents Corporation (OTCBB: CTSO)

Q2 2014 Earnings and Operating Results Conference Call

August 12, 2014 @ 4:15 pm Eastern

 

This official company transcript has been edited for clarity and does not differ materially from the actual conference call. Slide numbers have been inserted to allow readers to follow along with the associated presentation.

 

Operator:

 

Good day, everyone and welcome to the CytoSorbents 2014 Second Quarter Financial Results Conference Call. Today’s call is being recorded and at this time I’d like to turn the conference over to Amy Vogel. Please go ahead.

 

Amy Vogel – Moderator:

 

Thank you operator and good afternoon. Welcome to CytoSorbents Second Quarter 2014 Operating and Financial Results Conference Call. With us today are:

 

·Dr. Phillip Chan, Chief Executive Officer and President
·Vincent Capponi, Chief Operating Officer
·Kathleen Bloch, Chief Financial Officer, and
·Dr. Christian Steiner, VP of Sales and Marketing from Germany

 

Before I turn the call over to Dr. Chan, I’d like to remind listeners that during the call, management's prepared remarks may contain forward-looking statements which are subject to risks and uncertainties. Management may make additional forward-looking statements in response to your questions today. Therefore, the Company claims protection under Safe Harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Actual results may differ from results discussed today and therefore, we refer you to a more detailed discussion of these risks and uncertainties in the Company's filings with the SEC. Any projections as to the Company's future performance represented by management include estimates today as of August 12, 2014 and the Company assumes no obligation to update these projections in the future as market conditions change.

 

During today’s conference call, we will first have an overview presentation covering the financial and operational highlights for the quarter by Dr. Chan and Ms. Bloch. We again have taken everyone’s submitted questions and will do our best to address them in the presentation, and

 
  

also in the Q&A session with management to follow. Thanks everyone again for participating. If we do not answer your question, we would ask that you contact the Company directly after the call today.

 

At this time, I would like to turn the call over to Dr. Phillip Chan. Please go ahead Dr. Chan.

 

Phillip Chan - CEO:

 

Thank you very much Amy and thank you to everyone for submitting your questions and making time to join the call today. Welcome. Unfortunately Chris Cramer, our VP of Business Development, is out sick, but I will cover some business development matters in my remarks.

 

Following a short introduction for new and potential investors, Kathy will go over our financial progress for the second quarter of 2014, followed by a discussion of our cardiac surgery trial, the potential application of CytoSorb® in Ebola treatment, some case report studies, and then a Q&A period.

 

I would also encourage investors to visit our website at www.CytoSorb®ents.com to obtain a copy of earlier transcripts and presentations. Also a recent interview by The Wall Street Transcript will also be available on our website very shortly that covers some additional questions today in greater detail.

 

Slide 4: With that let me turn to slide four. CytoSorbents is an emerging leader in the $20 billion critical care immunotherapy space. We are leading the prevention or treatment of life threatening inflammation in the intensive care unit.

 

Slide 5: Inflammation plays a major role in nearly every known disease. This could be life threatening conditions like sepsis, trauma, burn injury, influenza, Ebola virus infection, and others. It could also be autoimmune diseases like rheumatoid arthritis, inflammatory bowel disease, psoriasis and lupus, heart disease, peripheral artery disease, cancer, cancer cachexia, graft versus host disease, neurodegenerative diseases like Alzheimer’s, multiple sclerosis, Parkinson’s, and many, many others. The unfortunate part is that uncontrolled inflammation wreaks havoc on the body and can be deadly.

 

Slide 6: The problem with severe, uncontrolled inflammation is that it can cause cell death and organ injury, ultimately leading to organ failure. Organ failure is when vital organs like the heart, the brain, the kidneys, the lungs or the liver stop working and that is incompatible with life. Organ failure causes nearly half of all deaths in the ICU today, but little can be done to prevent or treat it. And this is where our technology comes in.

 

Slide 7: CytoSorb® removes the “fuel to the fire” of inflammation. CytoSorb® represents one of the most powerful immunotherapy tools to control inflammation. It is approved in the European Union as the only specifically approved extracorporeal cytokine filter and is clinically proven to reduce key cytokines in blood in critically-ill patients.

 

Its approved for use in any situation where cytokines are elevated and has been used safely in more than 3,000 human treatments with no serious device related adverse events reported.

 
  

Slide 8: The heart of the technology is a highly porous polymer bead roughly the size of a grain of salt. These beads have millions of pores and channels in every single bead allowing them to act like tiny sponges to remove harmful substances from blood, based on size as well as surface adsorption. It is protected by 32 issued U.S. patents and multiple applications pending. It is manufactured at our ISO 13485 certified facility in New Jersey, and it is one of the highest-grade medical sorbents on the medical market today.

 

Slide 9: The goal of CytoSorb® is to prevent or treat organ failure. Rather than letting patients spiral down the well of organ failure and inflammation, our goal is to try to stabilize these patients when they come into the intensive care unit thereby reducing the severity of illness and helping reduce the cost of ICU care. We believe that because of this and because of the many applications suitable for this technology, we have the potential to revolutionize critical care medicine.

 

Slide 10: CytoSorb® is currently marketed in 19 countries around the world, in fact its available for sale in all 28 countries in the European Union but it’s currently sold today directly in Germany, Austria and Switzerland and with established distribution in 16 other countries including the U.K., Ireland, Netherlands, Turkey, Russia, India, Taiwan and the Middle East covering approximately 1.7 billion lives. We are currently expanding to other EU countries and countries outside the EU that accept the CE mark.

 

Slide 11: The technology has also been the beneficiary of more than $15 million in U.S. Government support. This includes our almost $4 million five-year contract with DARPA under the Dialysis-Like Therapeutics program to treat sepsis, $1.15 million in a Phase I and Phase II SBIR contract with the U.S. Army for burn injury and trauma research and more than $3 million committed by the U.S. Air Force in funding a 30-patient human pilot study in trauma that the FDA has approved to move forward with. Skipping down to the bottom here, NHLBI, or the National Heart, Lung and Blood Institute, a division of NIH, is also supporting another product under advance development called HemoDefend that is designed to purify blood transfusion products in order to reduce transfusion reactions.

 

So with that, let me turn it over to Kathy to talk about our second quarter 2014 operating and financial highlights. Kathy?

 

Kathleen Bloch - CFO:

 

Thank you, Phil. Good afternoon everyone.

 

Slide 13: For today’s call, I will be providing an update regarding CytoSorbents’ revenues and I will also comment on the Company’s progress related to up-listing to a national exchange, either NASDAQ Capital Market or NYSE MKT.

 

As you will see, our comparative financial results demonstrate strong revenue growth.

 

For the first half of 2014, total revenue was approximately $2.1M, which is an increase of 215% compared to total revenues of approximately $663K for the first half of 2013.

 

 
  

Product sales for the first half of 2014 were approximately $1.2M, which is an increase of approximately 300% over product sales for the first half of 2013 of approximately $304K.

 

Grant income and other income for the first half of 2014 was approximately $854K, which is up 138% as compared to grant and other income of approximately $359K for the first half of 2013.

 

First half 2014 blended gross margins were approximately 36%, while our CytoSorb® product gross margins were approximately 63%.

 

Slide 14: Turning to the quarter ended June 30, 2014, product sales for the quarter were approximately $663K, that’s a 418% increase over product sales of approximately $128K for the second quarter of 2013.

 

Second quarter 2014 product sales were the highest quarterly product sales in the Company’s history. Gross margins on these product sales in the second quarter of 2014 were approximately 65%. Our grant and other income was approximately $361K for the second quarter of 2014, as compared to grant and other income of approximately $164K for the second quarter of 2013.

 

Total revenue for the second quarter of 2014 was approximately $1.0M which is an increase of 252% compared to total revenues of approximately $291K for the second quarter of 2013.

 

Slide 15: Now, we’ll look at the Company’s historical quarterly sales for each of the last eight quarters since we began commercialization of CytoSorb® in late 2012.

 

With our record, second quarter product sales of $663K, the Company has now posted its fourth consecutive quarter of double-digit quarter-over-quarter growth. Our current annual run rate is now in excess of $2.6M, as compared to an annual run rate of approximately $500K just one year ago. As always, at these early stages of commercialization, we continue to point out to our investors that we may experience quarter over quarter variations in sales. Many different factors influence each quarter’s sales results including when new distributors come on board, when CytoSorb® achieves final product registration in new territories, the timing of repeat orders, and other seasonal factors such as holidays in the territories where we sell our products, as well as many other factors. For example, Germany celebrated six public holidays during the second quarter which effectively shut the country down for days at a time.

 

Slide 16: This chart best depicts the rapid growth we are seeing in CytoSorb® sales. For each quarter, it summarizes the trailing twelve months of CytoSorb® sales and once again it continues to demonstrate the acceleration and upward trend that sales are taking overall. Sales for the twelve months ended June 30, 2014 were approximately $1.8M, as compared to sales for the twelve months ended June 30, 2013 of approximately $406K. This represents an increase of approximately $1.34 million, or a year-over-year product sales increase of 331%.

 

With regard to expectations, sales momentum remains strong, and we expect that this positive trajectory in the trailing 12 months sales will continue into the current quarter.

 

 
  

Our balance sheet remains secure with more than $9.6 million in cash and short-term investments at June 30, 2014, and we are continuing to execute on our stated path for the commercialization of CytoSorb®.

 

And now, I’d like to turn to the Company’s planned up-listing.

 

Slide 17: Management remains committed to up-listing to a major national exchange before the end of 2014 because of the many advantages it brings. Currently, we have few institutional investors, because most hedge funds, pensions, and mutual funds cannot invest in OTCBB companies that are penny stocks or less than a certain market cap. An up-listing removes this restriction and will enable these larger investors to take positions in our stock. We believe this will significantly improve trading volume in our stock, and thereby enhance liquidity for all investors.

 

We believe that an up-listing will also improve our visibility and credibility with the investment community. Many research analysts know our company and follow our progress, but do not cover us because we are an OTCBB penny stock. By removing this restriction, we would be a major step closer to expanding our research coverage. And importantly, a national market listing would also reduce our cost of capital and enable us access to more sources of capital.

 

Previously, we had met with representatives at the NASDAQ and the NYSE MKT and we’ve reviewed and evaluated the listing requirements for each exchange. We’ve already taken many steps to prepare for the up-listing, which I will review in some detail. In July 2014, we announced the Company’s consolidation of its SEC and international legal counsel with the global law firm, DLA Piper LLP. DLA Piper is one of the largest international business law firms with offices in most major markets around the world and legal expertise across a broad range of practice areas which include corporate and finance, litigation and arbitration, Sarbanes Oxley compliance, government affairs, labor law, intellectual property and technology, and tax. DLA Piper's expertise, particularly in the medical device sector, will be invaluable as we execute our transition to a nationally-listed company later this year. We have since adopted a Code of Business Conduct and Ethics and are currently updating our Insider Trading Policy, all of which are required governance items for the major exchanges.

 

We’ve also made numerous improvements to our system of internal controls over financial reporting, both here in the U.S. and in Germany, and we are currently in the process of selecting an independent third-party provider who will help to manage the documentation and testing of our system of internal controls, which is another requirement for a Company traded on a major exchange.

 

Other activities to meet the remaining listing requirements are also underway. For example, we are currently actively interviewing financial experts to serve on our Board of Directors and act as the Chairperson of our to-be-formed independent Audit Committee.

 

 
  

We are currently working to expose institutional investors to our story ahead of the up-listing. Creating demand on the other side of an up-listing is a key part of our strategy.

 

We are also working to simplify our capital structure. We expect to enact a reverse stock split to bring our stock price up to the minimum price required by the major exchanges, but this ratio will be dictated by the share price at the time of the up-listing. It is important for shareholders to understand that a reverse split does not change the value of your holdings. For example, if you have 1000 shares at $0.30 per share, that is valued at $300; after a 1 for 10 reverse split, you will have 100 shares at $3, also valued at $300. It is also important for shareholders to remember that we have repeatedly stated that we will execute the up-listing when the Company is ready and when we are experiencing major operational momentum—such as continued growth in sales, a new strategic partnership, advances in our U.S. Pivotal trial, to name a few—and that is the principal that continues to guide us overall in the up-listing process.

 

At this point I’d like to turn the call back to Phil. Phil?

 

Phillip Chan - CEO:

 

Thank you very much, Kathy. Now I’d like to go over some items and questions that shareholders have submitted particularly as they relate to our U.S. cardiac surgery pivotal trial plans and the Ebola outbreak.

 

Slide 19: Just to give you some background on cardiac surgery. There are approximately 1 million cardiac surgeries requiring cardiopulmonary bypass in the United States and in the European Union annually, with another half a million in the rest of the world, particularly in India and China.

 

These are done for many different reasons. One of the most common is for coronary artery bypass graft surgery for blocked heart arteries. Others include valve replacement, cardiac defect repair in congenital heart disease, for example, heart or lung transplantation, as well as LVAD or left-ventricular assist device implantation for heart failure.

 

The problem with cardiac surgery is that patients often develop inflammation due to many things that are associated with cardiac surgery starting from cracking open the chest, stopping the heart from beating, bypassing the blood into a heart lung machine, sucking up blood from the field with cardiotomy suction, blood transfusions, reversing heparin anticoagulation with protamine, and many other aspects of the surgery.

 

This can lead to a production of cytokines, activation of complement, and a release of free hemoglobin that work together to induce inflammation, causing cellular injury and organ injury ultimately leading to multiple organ failure, particular lung and kidney failure, in a certain percentage of patients.

 

In high risk surgical patients, the risk of developing kidney and lung failure could be as high as 30%. There has been no technology that is easily introduced into the heart lung machine blood circuit that can directly reduce cytokines, complement factors, free hemoglobin and other

 
  

inflammatory mediators, directly from the entire blood volume. Cell saver blood washing typically only treats salvaged blood.

Leukoreduction filters are used today to remove cytokine-producing white cells, but do not work to remove cytokines directly. This, we believe, is a multimillion dollar market that we may be able to address with our cytokine filter.

Slide 20: That being said, CytoSorb® can be used two different ways in cardiac surgery. One is intra-operatively in a bypass circuit, parallel to the main heart lung machine blood circuit, as you see on the left hand side. Or the device can be used with a standard dialysis machines to treat the patient after the surgery is done, when the patient is recovering in the intensive care unit.

Slide 21: When we first talked to you about this cardiac surgery trial, we were really focused on either the intra-operative usage of CytoSorb® to prevent post-operative complications, which is option number two, or the post-operative use of CytoSorb® to treat post-operative inflammation, which is number three.

In our discussions with our advisors, we have elected not to pursue the post-operative approach at the current time. However this approach is being pursued by many investigators in Europe.

Instead we are focused on the intra-operative usage of CytoSorb®. And now based on our discussions with our key advisors, there may be a third path that we could take, which is the use of our CytoSorb® therapy intra-operatively, but rather than looking at clinical endpoints such as a reduction in organ dysfunction, there maybe an opportunity to actually get approval for CytoSorb® in the United States based upon a demonstration of inflammatory biomarker reduction. This has a number of advantages over a traditional cardiac surgery trial that would be envisioned in number two in that it would be a shorter trial. It would be a less expensive trial. It would be a less risky trial. And instead of being a PMA, which is the most rigorous path for approval for medical devices through the FDA, this could potentially be a de novo 510(k) path.

So, although we have delayed our submission of the IDE application, what we’ve been doing with the time has been to do a lot of in vitro simulations looking at the reduction of inflammatory biomarkers. And I’m pleased to say that those results have been very satisfactory. So our goal right now, pending discussions with the FDA, is to potentially do an inflammatory biomarker reduction study, and we would expect to submit an IDE in the fourth quarter of 2014. Of course, this is dependent upon successful discussions with the FDA and an acceptance by the FDA of this trial strategy.

Slide 22: Along these lines, we have been encouraged by a recent paper, in fact the first paper published describing the intra-operative usage of CytoSorb® during cardiac surgery, in the journal KardioTechnik. This was a retrospective 40 patient cardiac surgery trial, where 20 patients received CytoSorb® therapy intra-operatively, and 20 patients did not, in the heart, lung machine circuit. This was a study done at the University of Munich, Grosshadern campus, which is one of the largest hospitals in Southern Germany. These patients underwent high risk surgery with hypothermic cardiac arrest and anterograde cerebral perfusion.

 
  

The treatment was associated with a statistically significant reduction in interleukin-6 and procalcitonin in the three day post-operative period, compared to control. This gives us visibility on a U.S. pivotal trial in cardiac surgery as it relates to a reduction in inflammatory markers. This paper can be found on our website for download.

Slide 23: Turning to the Ebola virus outbreak. Ebola is one of the most deadly viruses known with a very high mortality rate of 50% to 90% depending upon the strain. It is also very contagious and typically transmitted through contact of bodily fluids. Following an incubation phase up to three weeks, it has an abrupt onset of symptoms including high fever, chills, weakness and body pain followed by more severe symptoms including diarrhea, cough, headache, and bleeding with vomiting of blood or blood in the stool. It is often called Ebola hemorrhagic fever.

Patients typically die, with time of death from the onset of symptoms anywhere between 6 to 16 days, culminating in a cytokine release syndrome that stimulates deadly inflammation and ultimately organ failure.

One of the key reasons why Ebola is so deadly is its ability to evade the immune system resulting in an advanced infection that triggers an overactive immune response, leading to organ failure. It does so by initially suppressing the antiviral cytokine immune response, which then allows robust viral replication. It also causes the production and release of soluble viral glycoproteins. These normally coat the surface of the virus but when they are soluble, they are free floating and can interfere with white blood cell activation and also act as decoys so that antibodies cannot neutralize the virus.

The scientific rationale behind using CytoSorb® in Ebola virus is that we may help patients by reducing "cytokine storm" primarily, but also by potentially removing soluble glycoproteins which are about 50 kDa in size, which is right in the size range that CytoSorb® can remove, thereby delaying the onset of fatal inflammation and organ failure while buying the patient time for the immune system to kill the virus.

And when you look at patients who survived Ebola virus infection, they typically have very high titers of protective antibodies, and in fact these high titers of protective antibodies have been used to help transfer immunity to patients who are currently infected with the Ebola virus.

Slide 24: So could CytoSorb® help? This is one of the major questions that have been posed to us. Well, the 2014 Ebola epidemic in West Africa has been called an international emergency by the World Health Organization and continues to grow, already infecting nearly 1,900 people and claiming more than 1,000 lives. Based on estimates, the epidemic is expected to continue throughout the year.

There are now some experimental therapies being tried, but there is no definitive treatment for Ebola today. Our strategy for outreach includes reaching out to many different organizations including the World Health Organization, the FDA, the CDC, as well as government agencies such as USAMRIID, non-profit organizations, and also hospitals treating Ebola patients inside and outside of West Africa, particularly those in Europe and the United States where patients with advanced infection have been (at least some of them) have been sent.

 
  

The problem with treating patients directly inside West Africa is that the level of medical care is typically very poor, and only until you go to westernized medical centers do you have the ability to treat with dialysis-type products. When we have more information on the potential usage of CytoSorb® in this Ebola epidemic, we will of course let the public know.

Slide 25: So turning to business development, given Chris Cramer’s absence, let me remind you that our polymer bead technology enables a diverse and valuable pipeline. As you see here, CytoSorb® is used for critical care and high risk surgeries and has been CE mark-approved, but we have a number of products in development, as well as ones that we have not yet even disclosed publicly, where the products have the potential ability to be out-licensed and developed by other companies. One of our most advanced products under development that Vince will talk about a little bit later, is HemoDefend. This product is designed to try to help purify the contaminants out of the blood supply that can cause transfusion reactions and adverse outcomes including death.

Slide 26: Many of you have seen this slide before, but this is just here to reiterate the many areas where we touch medicine. It could be the renal dialysis space; it could be the critical care space, the catheter space, cardiac surgery, blood transfusion as well as biotech and immunotherapy. We have ongoing discussions with a number of these strategic partners for potential business relationships and we hope to have additional detail on those in the months to come prior to our up-listing.

A major strategic partnership that we currently have is with Biocon, which is the largest biotechnology company in India, often called the “Amgen of India.” Biocon has been seeing quite a bit of success after its launch of CytoSorb® in September 2013 in the country. And in fact they are one of our largest distributors in terms of distributor sales, and they continue to re-order product on a very regular basis. They have increased their commitment to CytoSorb® and are now hiring a dedicated sales force to help sell CytoSorb® in India, which is fantastic.

And in September, BioCon will be embarking on a city by city tour throughout India with one of our key opinion leaders to talk about the use and applications of CytoSorb® in the areas of critical care. They have already had a number of their own success stories that they are working to publish as well.

Slide 27: So I’d like to finish my comments with just a couple of case report studies that I think you would find very interesting. CytoSorb® has the ability to be used in any clinical situation where cytokines are elevated, and one of these situations which you have not heard of before is in acute graft dysfunction.

Acute graft dysfunction is a major complication after transplantation of solid organs. In this particular case, we are talking about liver transplantation and it is a life threatening event that requires emergency re-transplantation. Now as many of you know, the wait list is typically very long to get a matched donor organ for a specific patient. However, in an emergency re-transplantation they have no choice but to take a typically mismatched organ and to transplant it into the patient to try to help save the patient’s life.

 
  

The inflammatory response however in this case is very robust and accounts for most of the systemic complications and increased mortality in this procedure. This case involved a patient who is a 46-year old man with a history of liver cirrhosis, who underwent an initial liver transplantation that failed. He then underwent a second emergency liver transplant but with a liver that was ABO blood type incompatible. CytoSorb® was used during the re-transplantation surgery to stabilize the patient hemodynamically, and with the therapy he was able to be weaned off all vasopressor support by the end of the therapy.

Below you see a table looking at the effect on key cytokines during the first treatment which is called CytoSorb® number one, and then the second treatment which is called CytoSorb® number two. The legend below the table shows what T1, T2, T3 means. T1 means start of surgery, T2 mean after graft reperfusion, T3 means end of surgery, T4 and T5 mean before and after, respectively, the second CytoSorb® cartridge. And what they saw was that key cytokines such as IL-6, IL-8 and MCP-1, TNF and IL-10 were decreased significantly.

So not only were they seeing an improvement in hemodynamic stability, but they were also correlating this with a key reduction in inflammatory and certain anti-inflammatory cytokines. In this patient, liver function returned to normal five days after surgery and he left the post anesthesia care unit after seven days. At a 4 month outpatient follow up, the patient was doing very well with normal liver function. This case report study was presented by the surgeon at a major clinical conference.

Slide 28: On this next slide is a case of toxic shock syndrome. Many of you have heard of toxic shock syndrome before as it relates to the use of tampons, but it can happen in any Staphylococcal or Streptococcal infection. This is a case report of a 17 year old man who suffered an injury to his ankle and unexpectedly began to develop a fever. He rapidly deteriorated and was hospitalized the next day at a major hospital in Rotterdam, Netherlands where antibiotics were started immediately. However, he continued to decline and was admitted to the ICU where he went into shock.

The patient became globally red and swollen and was suspected to have toxic shock syndrome. Now on the right hand side are pictures of other patients; one is an infant with toxic shock syndrome and the other is the hands of an adult, and you can see the severe redness and peeling of skin that are common in what is called scalded skin syndrome. Toxic shock syndrome is a direct result of a toxin called Toxic Shock Syndrome Toxin number 1 (TSST-1) and toxins called exfoliatins that are released during a Staphylococcal infection that triggers the immune response and the release of large amounts of cytokines, that can lead to severe fever and shock, while the toxins attack the structure of the skin, causing a massive sloughing of the skin cells.

This patient was suspected to have toxic shock syndrome and they surgically explored the injured ankle revealing the Staphylococcal infection, thereby confirming the diagnosis. At this point, the patient was still in shock and developed respiratory failure requiring intubation.

At this time, it was decided to start the patient on CytoSorb® and within five minutes of treatment, his blood pressure began to increase, and after three hours of treatment the patient’s swelling and redness had completely resolved.

 
  

This is another case where the intervention of CytoSorb® was directly correlated with the improvement in the patient. The total CytoSorb® treatment was only 14 hours and the patient went on to a full recovery. This case report happened just very recently.

These are the types of successes that we continue to see, and I think these are encouraging to physicians that our device is actually helping to improve clinical outcomes and changing the course of patient’s disease.

That concludes our formal presentation. Let me turn it over now to Amy to begin the Q&A session.

 Amy Vogel - Moderator:

 Thank you Dr. Chan. Over the last week, we have collected a number of questions from investors.

 Q: Christian, could you please give us an update on sales and the development of the different markets.

 Christian Steiner

 Yes, of course. Thank you, Amy.

 We had another strong performance in the second quarter. We saw significant growth in sales in both our direct and distributor markets, and are very much on track with our sales plan for the year. Currently, direct sales of CytoSorb® still account for the majority of our product revenue and we were pleased to achieve our sales targets despite many public holidays and accompanying bridging days in Germany that make the second quarter, from a sales opportunity standpoint, a short quarter. Re-order volume of direct sales, probably the most important indicator of continued use and adoption, account for most of our direct sales and showed healthy 25% quarter-over-quarter growth. At certain hospitals, we are seeing that CytoSorb® is being regularly used for specific indications. That is the first step to becoming standard of care at those hospitals. Although the majority of our sales efforts are focused on our existing customers, we continue to expand our new customer base, with moderate quarter over quarter growth for new orders, following a substantial increase in Q1.

 Our Distributor business also continues to grow, with strong re-order performance from Turkey and India, in particular. As mentioned, we are waiting for final product registration in Russia and the Middle East, which we hope to get soon, and we just signed on Taiwan. To date, we have not yet had meaningful sales from these countries. However, the dialysis and blood purification markets are very strong there, and we expect these territories to be significant contributors to our revenue growth going forward. We also expect to expand distribution to a number of other countries by the end of the year, and are on track to do so.

 We also intensified our marketing efforts as discussed during the two previous investor calls. CytoSorb® therapy has been presented at several conferences by a number of users, for

 
  

example, at the International Liver Transplant Society Meeting in London where the use of CytoSorb® after liver transplant was discussed. What was particularly interesting was our CytoSorbents satellite symposium at the Joint Meeting of the German and Austrian Society for Internal Medicine and Critical Care Physicians. The attendance at our symposium was completely full, with almost 20% of the whole conference participating in our session. Furthermore, we have been invited by certain potential strategic partners to inform their customers about this new extracorporeal therapy at specialized conferences. We have participated in two of these meetings in Germany already, and a third one is planned to take place in Berlin later this year.

 

Q: What do you think is needed to establish CytoSorb® as a standard-of-care-therapy for septic shock or other indications?

 

Severe sepsis and septic shock are our largest target markets. They account for 10-20% of all ICU admissions. In other countries, such as India, nearly a quarter of all ICU patients have sepsis. But sepsis is a very complex disease, and no single patient is exactly alike. Historically, this has made sepsis very difficult to treat. We believe that CytoSorb® attacks sepsis in many ways that has not been possible before. CytoSorb® works to reduce cytokine storm to control deadly inflammation, but it can also remove certain bacterial toxins, and importantly, in animal models of sepsis, it can help redirect the activated immune system to target the infection and avoid injury to healthy organs.

 

To make CytoSorb® standard of care for sepsis requires that we develop strong medical evidence that the therapy works, and that we collaborate with medical societies, both nationally and internationally. We are currently considering a larger scale randomized controlled trial in sepsis, to take place in Germany, that should help answer this question. In the meantime, we have many investigator initiated studies in severe sepsis and septic shock that are either enrolling or are planned that will help generate additional data.

 

Furthermore, our international registry, which will help collect data on how CytoSorb® is best used, is currently online and in beta testing. The official launch is planned for World Sepsis Day in September. Also, as discussed earlier, we continue to see quite dramatic case reports where CytoSorb® has worked extremely well. We take these cases and try to learn as much as possible from them.

 

Finally, we need to show evidence also of economic benefit in order to achieve reimbursement worldwide. For CytoSorb®, if we can save just 1 or 2 days in the ICU, the therapy would already pay for itself. We have seen this many times already. We plan to include cost effectiveness measures in all of our major clinical trials.

 

Q: When will we begin to see data?

 

We currently are concentrating our efforts here in Europe to generate the appropriate medical evidence and are making a lot of progress. During the last quarter, two case reports in intensive care medicine, and a 20 vs 20 patient retrospective controlled study from University of Munich using CytoSorb® during cardiac surgery, have been published. We are reaching a stage where

 
  

there are many of these case reports being prepared with quite a number of key opinion leaders planning to either publish or report their positive experiences at regional, national and international conferences as well as at other medical centers, where we want to introduce CytoSorb® therapy.

 

We have a number of ongoing investigator-initiated studies for different applications. We hope to see data from two studies in cardiac surgery, one at the University of Hamburg Eppendorf, and one at the Medical University of Vienna, by either the end of this year or first quarter of next year. Recently, a major 100 vs 100 patient, prospective, randomized controlled study using CytoSorb® intra-operatively during cardiac surgery has been started at the University of Cologne. These are just some examples of studies where data is being generated. We expect to see much more data in the next 6 to 12 months.

 

Thanks very much Christian. Another topic on many people’s minds is the Air Force trauma trial, and grant programs such as DARPA. Vince, could you please elaborate a little regarding the progress in these programs?

 

Vince Capponi

 

Thank you, Amy. As we discussed in the last Investor update, the US Air Force-funded rhabdomyolysis trial is up and running, and we are working with the second site to bring this group on as soon as possible. We have been targeting critically injured patients with the very highest levels of myoglobin released from injured muscle. These patients are at the highest risk of developing acute kidney injury. However, this high threshold has made it difficult to find suitable patients to enroll who meet all of the inclusion and exclusion criteria of the trial. As a group, we are currently discussing with the US Air Force lowering this threshold to include patients with still very high levels of myoglobin, but at levels that are more commonly seen. We do not think that this will negatively impact the study, as the primary goal of the study is to reduce high levels of myoglobin.


Regarding the DARPA, DOD SBIR and HemoDefend SBIR, we continue to make progress on all three grants, having received approximately $358K in Q2 2014 grant revenue. We recently had an excellent discussion with the new Program Manager of the DARPA DLT program and are looking forward to finishing our Year 2 efforts and begin planning for Year 3, of our 5 year contract. During Year 3, we will be taking various new technologies that we have developed under the program, and beginning pilot scale production to produce enough devices for DARPA integrator, Battelle Labs, to test in large animal models.

 

We have currently completed the burn injury portion of our US Army Phase II SBIR contract and are working on the trauma injury model currently. This is a program that is very exciting, because we have been developing quite a number of new technologies. Once this is completed, we will discuss with the US Army about potentially advancing to a Phase III study.

 

We are also finishing our very ambitious Phase I HemoDefend SBIR contract with our collaborators at Dartmouth. We are currently summarizing the data in support for applying for a Phase II SBIR contract to further advance this application.

 

 
  

Concerning new grants, we have identified a number of additional grant opportunities that we believe are well-aligned with the CytoSorbents platform technology. These grants range from HemoDefend type applications to address blood quality, to the treatment of inflammatory conditions specifically associated with biowarfare. As we develop these opportunities, we will discuss them in the context of both financial benefit to the company and technology advancement in future updates. Securing non-dilutive funding to advance development of the CytoSorbents technology platform continues to be one of our key objectives.

 

Q: Thanks, Vince. Have you started construction on a new manufacturing facility given the uptick in sales?

 

We have begun several initiatives since our last update regarding capacity build. First we have begun certain infrastructure updates to our existing facility. These infrastructure updates will allow us to further increase our capacity to satisfy our near term needs as we pursue our next objective, a new plant build out. To that end, we have begun the process of looking at alternative options, including larger facilities, to provide both a near and long-term increase in manufacturing capacity. In addition, we have begun the process of identifying several engineering firms to quote on our plant design. The firms will help us with the facility modifications, equipment installations and start-up. The preliminary engineering we completed earlier will facilitate this process and should reduce the total time necessary to bring a new plant on line. Outsourcing of manufacturing always remains an option but for reasons of maintaining control over the know-how, controlling production lead times, and maximizing gross margins, we have elected to maintain this in-house.

 

Q: What is the current status of the development of HemoDefend™ product?

 

Regarding HemoDefend™, we have recently secured additional space for our process and equipment development engineering. Separating the HemoDefend development process from our manufacturing equipment allows us the ability to continue the process and equipment development testing without disruption to our manufacturing operations. Concurrently, we continue to work on the design to establish the best geometry and device size for the in-line filter application. As we progress down the HemoDefend development pathway, we will provide updates from time to time.

 

As an additional note, based on clinicaltrials.gov, and the Canadian counterpart, www.controlled-trials.com, it appears that the two large randomized controlled studies looking at the impact of age of blood in cardiac surgery patients, called the RECESS trial, and critically ill patients, called the ABLE trial, are completed. If not too soon, we may hear about the data, or at least top-line data, at the upcoming AABB, or American Association of Blood Banks, conference in late October. If one or both of these studies demonstrates increased risk with the transfusion of older blood, it could significantly elevate the value of approaches like HemoDefend that help purify the blood of degradation products like free hemoglobin that have long been associated with the increased risk of older blood.

 

 
  

Well, we seem to have covered the major questions. Dr. Chan, do you have any closing remarks?

 

Dr. Chan:

 

Thank you, Amy. Thank you everyone for being on the call today. If you have any additional questions, feel free to forward them to Ms. Amy Vogel at avogel@CytoSorbents.com and we will try to address them in our next update. Thank you again and have a great evening.

 

Operator: Thank you. That does conclude our conference for today. I’d like to thank everyone for their participation and have a great day.

 

 



Exhibit 99.2

 

Cyto Sorbents Corporation OTCBB: CTSO An Emerging Leader in Critical Care Immunotherapy Q2 2014 Review – August 12, 2014

 
  

Safe Harbor Statement Statements in this presentation regarding CytoSorbents Corporation and its operating subsidiary CytoSorbents, Inc that are not historical facts are forward - looking statements and are subject to risks and uncertainties that could cause actual future events or results to differ materially from such statements . Any such forward - looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 . It is routine for our internal projections and expectations to change . Although these expectations may change, we are under no obligation to inform you if they do . Actual events or results may differ materially from those contained in the projections or forward - looking statements . The following factors, among others, could cause our actual results to differ materially from those described in a forward - looking statement : our history of losses ; potential fluctuations in our quarterly and annual results ; competition, inability to achieve regulatory approval for our device, technology systems beyond our control and technology - related defects that could affect the companies’ products or reputation ; risks related to adverse business conditions ; our dependence on key employees ; competition for qualified personnel ; the possible unavailability of financing as and if needed ; and risks related to protecting our intellectual property rights or potential infringement of the intellectual property rights of third parties . This list is intended to identify only certain of the principal factors that could cause actual results to differ from those discussed in the forward - looking statements . Readers are referred to a discussion of important risk factors detailed in the Company’s Form 10 - K filed with the Securities and Exchange Commission on March 31 , 2014 and other reports and documents filed from time to time by us, which are available online at www . sec . gov .

 
  

3 Conference Call Participants Dr . Phillip Chan, MD, PhD Chief Executive Officer and President Vincent Capponi, MS Chief Operating Officer Kathleen Bloch, MBA, CPA Chief Financial Officer Dr . Christian Steiner, MD Vice President of Sales and Marketing Christopher Cramer, MS, MBA Vice President of Business Development (Absent) Moderator: Amy Vogel – CytoSorbents Corporation

 
  

4 Cyto Sorbents is an Emerging Leader in the $20B Critical Care Immunotherapy Space Leading the Prevention or Treatment of Life - Threatening Inflammation in the ICU

 
  

5 Inflammation Plays a Major Role in Nearly Every Known Disease • Life threatening conditions like sepsis & trauma • Autoimmune diseases like rheumatoid arthritis, inflammatory bowel, psoriasis, and lupus • Heart disease, peripheral artery disease • Cancer, cancer cachexia, graft vs host disease • Neurodegenerative diseases such as Alzheimer’s, multiple sclerosis (MS), Parkinson’s • Many, many others others Uncontrolled inflammation wreaks havoc on the body and can be deadly

 
  

6 Severe Inflammation Drives Organ Failure Organ failure occurs when vital organs stop working, causing nearly half of all deaths in the ICU, but little can be done to treat or prevent it today

 
  

7 Cyto Sorb ® Removes the Fuel to the Fire • CytoSorb ® represents a powerful immunotherapy to control inflammation • Approved in the European Union as the only specifically approved extracorporeal cytokine filter • Clinically proven to reduce key cytokines in blood in critically - ill patients • Approved for use in any situation where cytokines are elevated • Safe: More than 3,000 human treatments, with no serious device related adverse events reported

 
  

8 The Heart of the Technology The underlying blood purification technology is based on state - of - the - art biocompatible, highly porous polymer beads that act like tiny sponges to remove harmful substances from blood • Protected by 32 issued US patents and multiple applications pending • Manufactured at our ISO 13485 certified facility in New Jersey • One of the highest grade medical sorbents on the medical market today . Each bead is about the size of a grain of salt

 
  

9 Goal: To Prevent or Treat Organ Failure Sepsis ARDS Burn Injury Trauma Pancreatitis Influenza Surgical The Potential to Revolutionize Critical Care Medicine Improve Patient Outcome and Survival Decrease Costs Of ICU and Patient Care

 
  

10 Available for sale in all 28 countries in the EU. Sold direct in Germany, Austria, and Switzerland. Established distribution in the UK, Ireland, Netherlands, Turkey, Russia, India, Taiwan, and Middle East covering ~1.7 billion lives. Expanding to other EU countries and countries outside the EU that accept the CE Mark WMC Intensiv Med LLC Taiwan Cyto Sorb ® Marketed in 19 Countries

 
  

11 • US Dept of Health and Human Services awarded $0.5M grant (2010) for therapies that can save lives and reduce costs under the QTDP Program • NIH grant awarded $7M five year (2006 - 2010) to University of Pittsburgh and Dr. John Kellum to research CytoSorb bead for treatment of sepsis • NIH/NHLBI awarded $0.2M Phase I SBIR to advance the HemoDefend purification technology intended to improve the quality and safety of blood transfusions (2013 - present) $15+ Million in US Government Support • DARPA awarded $3.8M five year (2012 - present) contract as part of “Dialysis - Like Therapeutics” program to treat sepsis by removing cytokines and pathogen - derived toxins • U.S. Army awarded $1.15M SBIR contracts for trauma and burn injury research (2011 - present) • U.S. Air Force is funding a 30 - patient human pilot study in trauma valued at $3M (2013 - present). FDA approved trial that has begun enrollment

 
  

12 Q2 2014 Operating and Financial Highlights

 
  

13 First Half Comparative Revenue Results • First half 2014 total revenue of approximately $2.1M, an increase of 215% compared to total revenues of approximately $663K for the first half of 2013. • First half 2014 product sales were approximately $1.2M, an increase of 305% over first half 2013 product sales of approximately $304K. • Grant income for the first half of 2014 was approximately $854K, an increase of $495K or 138% as compared to grant income of approximately $359K for the first half of 2013. • First half 2014 blended gross margins were approximately 36%, with product gross margins of approximately 63%. Six Months Ended June 30, 2014 Six Months Ended June 30, 2013 % Incr . Product revenue $ 1,232 ,476 $ 304,067 305% Grant and other income 854,351 358,746 138% Total revenue $ 2,086,827 $ 662,813 215%

 
  

14 Q2 2014 Comparative Revenue Results • Second quarter 2014 total revenue of approximately $1.0M, an increase of 252% compared to total revenues of approximately $291K for the second quarter of 2013. • Product sales for the second quarter of 2014 product sales were approximately $663K, an increase of 418%, as compared to product sales for the second quarter of 2013 of $128K • Q2 2014 Product sales for the second quarter of 2014 were our highest ever quarterly product sales. • Gross margin on product sales in Q2 2014 was approximately 65%. Three Months Ended June 30, 2014 Three Months Ended June 30, 2013 % Incr . Product revenue $ 663,233 $ 127,969 418% Grant and other income 361,422 163,514 121% Total revenue $ 1,024,655 $ 291,483 252%

 
  

15 Continuing Strong Product Growth $13,679 $87,960 $176,098 $127,969 $203,561 $314,159 $569,243 $663,233 $0 $100,000 $200,000 $300,000 $400,000 $500,000 $600,000 $700,000 Q3 2012 Q4 2012 Q1 2013 Q2 2013 Q3 2013 Q4 2013 Q1 2014 Q2 2014 CytoSorb ® Product Sales Q2 2014 is the fourth consecutive quarter of double digit quarter over quarter growth 15

 
  

16 Product Sales (TTM) $151,574 $310,779 $405,706 $595,588 $821,787 $1,214,932 $1,750,196 $- $200,000 $400,000 $600,000 $800,000 $1,000,000 $1,200,000 $1,400,000 $1,600,000 $1,800,000 $2,000,000 Q4 2012 Q1 2013 Q2 2013 Q3 2013 Q4 2013 Q1 2014 Q2 2014 Trailing Twelve Month Product Sales Trend Line

 
  

17 The Path to Up - listing Completed: x Met with NYSE and NASDAQ x Evaluation of listing requirements x Transitioned to a new SEC counsel to provide guidance during up - listing process x Adopted Code of Business Conduct and Ethics x Updating our Insider Trading Policy x Improvements to our system of internal control In Process: • Fully Independent Audit Committee • Selecting third party providers to assist with documentation and testing of our system of internal controls • Increasing exposure to institutional investors • Simplify capital structure • Simultaneous reverse stock split with up - listing

 
  

18 U.S. Cardiac Surgery Pivotal Trial

 
  

19 Cardiac Surgery Stats Approximately 1MM Cardiopulmonary Bypass Surgeries in US and EU annually • Coronary artery bypass graft surgery • Open valve repair, cardiac defect repair • Heart or lung transplantation • LVAD implantation Patients often develop inflammation due to cytokine storm, complement activation, and free hemoglobin release during the surgery Organ dysfunction and failure, particularly lung and kidney failure, frequently result No technology has been able to easily and directly reduce cytokine storm, complement factors, and free hemoglobin except direct washing of blood Leukoreduction filters are used today to remove cytokine producing white cells, but do not work and cannot directly remove cytokines Cytokine Storm, Complement, etc. SIRS Multiple Organ Failure Free Hemoglobin Vascular / Kidney Injury

 
  

20 Intra - operative versus Post - Operative

 
  

21 U.S. Cardiac Surgery Pivotal Trial 2 1 1) Inflammatory Biomarker Reduction • Randomized controlled multi - center trial <150 patients • Enrich for cardiac surgery patients at high risk for inflammation and hemolysis and treat DURING surgery with CytoSorb in a bypass circuit • Primary endpoint: Reduction of inflammatory biomarkers • Regulatory path: De novo 510(k) 2) Intra - Operative Usage of CytoSorb to Prevent Post - operative Complications • Randomized controlled multi - center trial • Enrich for cardiac surgery patients at high risk for inflammation and hemolysis and treat DURING surgery with CytoSorb in a bypass circuit • Primary endpoint: Reduction in incidence of organ dysfunction • Regulatory path: PMA 3) Post - Operative Usage of CytoSorb to Treat Post - operative SIRS • Multi - center randomized controlled trial, PMA path • CytoSorb is used AFTER surgery to treat patients who develop SIRS • Primary endpoint: Relative reduction in incidence of organ dysfunction • Regulatory path: PMA Three potential paths to U.S. regulatory approval for CytoSorb in cardiac surgery, pending discussions with FDA. Expect to submit IDE application in Q4 2014

 
  

22 KardioTechnik 2014 Retrospective 40 patient cardiac surgery study • 20 patient (with CytoSorb) vs 20 patient (without CytoSorb) used intra - operatively with heart - lung machine • Patients underwent high risk surgery with hypothermic cardiac arrest and anterograde cerebral perfusion • Treatment was associated with statistically significant reduction of IL - 6 and PCT in the 3 day post - operative period • Gives visibility on U.S. pivotal trial in cardiac surgery 2 2

 
  

23 Ebola Virus • Ebola is one of the most deadly viruses known with a very high mortality rate of 50 - 90% depending upon the strain, and very contagious (bodily fluids) • Following an incubation phase of 2 - 21 days, has an abrupt onset of symptoms including high fever, chills, weakness and body pain, followed by more severe symptoms including diarrhea, cough, headache, and bleeding with vomiting of blood or blood in stool • Patients typically die with time to death (from onset of symptoms) of 6 - 16 days. Culminates in a cytokine release syndrome • Key to why Ebola is so deadly is its ability to evade the immune response, resulting in advanced infection that culminates in cytokine storm, deadly inflammation, and multiple organ failure • Initial suppression of the anti - viral cytokine immune response allows rampant viral replication • Release of soluble viral glycoproteins (sGP) that interfere with white blood cell activation and act as a decoy so that antibodies cannot neutralize the virus • CytoSorb may have benefit by reducing cytokine storm and sGP, buying time for the immune system to kill the virus

 
  

24 Could Cyto Sorb ® Help? The 2014 Ebola epidemic in West Africa, called an “international emergency” by the WHO, continues to grow and has already infected nearly 1,900 people, and claimed more than 1,000 lives. Epidemic is expected to continue throughout the year. Our Strategy for outreach: • WHO • FDA • CDC • Government agencies such as USAMRIID (US Army Medical Research Institute of Infectious Diseases) • Non - profit organizations • Hospitals treating Ebola patients inside/outside of West Africa • Europe • U.S. 2 4

 
  

25 Critical Care, High Risk Surgery Our Bead Technology Enables a Diverse and Valuable Pipeline Blood Collection & Transfusion CT Imaging, Interventional Radiology Contrast Sorb Drug Overdose, Chemo Removal Drug Sorb Beta Sorb Improving Dialysis Under Development CE Mark Approved

 
  

26 Potential for Strategic Partnerships* Cardiac Surgery Renal Dialysis Blood Transfusion Biotech and Immunotherapy Critical Care or Catheters *Companies listed here are used simply as examples of companies in these respective verticals. We make no other representations to our relationship with any of these companies .

 
  

27 Acute Graft Dysfunction Case Report Acute graft dysfunction after liver transplantation is a life - threatening event and requires emergency re - transplantation. The inflammatory response is responsible for most of the systemic complications and increased mortality • 46 year old man with a history of liver cirrhosis underwent an initial liver transplant that failed • Patient underwent a second emergency liver transplant, but ABO blood type incompatible • CytoSorb was used during the re - transplantation surgery to stabilize the patient hemodynamically with weaning off of vasopressor support • Key cytokines such as IL - 6, IL - 8, MCP - 1, TNF and IL - 10 decreased significantly • Liver function returned to normal 5 days after surgery and left the post - anethesia care unit after 7 days • At 4 month outpatient follow - up, patient was doing well with normal liver function T1: Start of surgery T2: After graft reperfusion T3: End of surgery T4: Before 2 nd CytoSorb T5: After 2 nd CytoSorb CytoSorb #1 CytoSorb #2

 
  

28 Toxic Shock Syndrome Case Report • 17 year old man suffered an injury to his ankle and unexpectedly began to develop fever • He rapidly deteriorated and was hospitalized the next day at a major hospital in Rotterdam, Netherlands where antibiotics were started immediately. He continued to decline and was admitted to the ICU where he went into shock. • Patient became globally red and swollen, and was suspected to have toxic shock syndrome. • Surgical exploration of the injured ankle revealed a Staphylococcal infection, confirming the diagnosis • Patient was still in shock and developed respiratory failure requiring intubation • Patient was started on CytoSorb and within 5 minutes his blood pressure increased • After three hours of treatment, the patient’s swelling and redness had resolved • Total CytoSorb ® treatment was only 14 hours. Patient went on to fully recover * * These pictures are not of the actual patient, but just examples of the scalded skin syndrome seen in patients with toxic shock syndrome and Staphylococcal infection

 
  

29 Phillip P. Chan, MD, PhD - CEO 7 Deer Park Drive, Suite K Monmouth Junction, NJ 08852 pchan@cytosorbents.com Cyto Sorbents Corporation OTCBB: CTSO The Rise of An Emerging Critical Care Immunotherapy Company Q&A Session

 

 



Exhibit 99.3

 

CytoSorbents Records Another Solid Quarter of Growth in Q2 2014

 

MONMOUTH JUNCTION, NJ--(August 12, 2014) - CytoSorbents Corporation (OTCQB: CTSO), a critical care immunotherapy company commercializing its CytoSorb® cytokine adsorber to treat critically-ill patients in multiple countries worldwide, reported second quarter financial and operational results for the three and six months ended June 30, 2014.

 

Q2 2014 Total Revenue of $1.0M, Driven by Record CytoSorb® sales of $663K. Trailing 12-month CytoSorb® Sales Increased to $1.8M

 

Recent Financial Highlights:

 

·Achieved record CytoSorb® sales of $663K, a 418% increase over $128K in the same period in 2013. Product sales were driven by continued usage and strong reorders from direct customers and distributors.
·Total revenue for the first six months of 2014 grew to $2.1M, a 215% increase over $663K in total revenue for the same period in 2013.
·CytoSorb® sales fueled much of the increase in total revenues, with $1.2M in sales in the first six months of 2014, a 305% increase from $304K in CytoSorb revenue in the first half of 2013. The first six months of sales have already exceeded CytoSorb sales of $822K for all of 2013.
·Product gross margins for Q2 2014 were approximately 65%.
·Trailing 12-month CytoSorb® sales increased to $1.8M, from $1.2M since the last quarter.
·Healthy cash and short term investments of $9.6M.

Recent Operational Highlights

 

·Established a second foothold into the growing Asian market through an exclusive distribution agreement in Taiwan with HemoScien Corporation. Submitted final product registration in Russia and the Middle East and are pending notification of approval.
·Biocon, our strategic distribution partner in India, is recruiting a dedicated sales force to sell CytoSorb® in India, and is sponsoring a September 2014 countrywide scientific symposium tour with a major CytoSorb® key opinion leader.
·On target with preparations to up-list to a national exchange later this year, with strengthening of our team through consolidation of our international and SEC legal counsel to DLA Piper.
 
  
·Continued protocol development and finalization, with plans to submit the IDE (Investigational Device Exemption) application for intra-operative usage of CytoSorb® to the FDA before the end of the year. Received validation of this treatment approach via the first published investigator initiated study using CytoSorb® therapy intra-operatively during cardiac surgery in the journal, Kardiotechnik. This retrospective study demonstrated that CytoSorb® usage led to a persistent reduction in key inflammatory markers such as IL-6 and procalcitonin in the post-operative period.
·A new sepsis research article by Dr. John Kellum and our collaborators at University of Pittsburgh was published in the journal, Critical Care, describing how CytoSorb® therapy redirects potentially dangerous activated immune cells away from otherwise healthy organs and toward the true site of infection in animals.
·The recent MERS (Middle Eastern Respiratory Virus) and Ebola virus epidemics have highlighted the need for potential adjunctive therapies such as CytoSorb® in deadly viral illnesses. CytoSorbents has expanded its communications with various organizations and is exploring multiple options to help make the technology available to those in need where possible.
·Ahead of World Sepsis Day on September 13, 2014, CytoSorbents announced its sponsorship of the 2014 German Sepsis Society Roger-Bone Award, in recognition of an outstanding publication in clinical sepsis research.

Dr. Phillip Chan, CytoSorbents’ Chief Executive Officer, commented “We are very pleased with the continued broad adoption and usage of CytoSorb® in our key direct, distributor, and partner markets. This is the fourth consecutive quarter where we have achieved double-digit quarter-over-quarter increases in product sales.”

 

Dr. Chan continued, “In the second half of this year, we anticipate that additional drivers of CytoSorb® sales will begin to come online, helping to further accelerate growth. For example:

 

·In our direct territories, our expanded sales and marketing team is doing an excellent job in drilling down into our accounts and spurring usage and end user demand amongst the daily treating physicians, for an increasing number of clinical applications, as well as in many departments in each hospital.

 

·A number of investigator-initiated studies are expected to be completed this year, with data available soon thereafter, particularly in cardiac surgery and critical illnesses. We believe this will help drive additional usage.

 

·We are seeing increasing uptake and reorders from key distributors and our strategic distribution partner, Biocon, as they achieve success in their marketing efforts and expand usage. We believe our financial results to date do not yet reflect the impact of anticipated sales from our distributors in major territories such as the Middle East, Russia, and Taiwan, where final product registration is pending.

 

 
  
·We are in active discussions with new distributors and potential partners to expand into major geographic territories throughout the world.”

 

“Most importantly, what is driving the expanded interest in CytoSorb®, and what is personally inspiring, are the continued case reports where our therapy has made a difference in a patient’s life and clinical outcome. This is a major driver in all that we do.”

 

“Please join us on the earnings call today at 4:15PM EDT where we will cover our progress in greater detail and address a number of questions that have been submitted by investors. The investor presentation and a written transcript of the conference call will be available within a week of the webcast on our website.”

 

Conference Call Details:

Date: Tuesday, August 12, 2014
Time: 4:15 PM Eastern
Participant Dial-In: 913-312-1269

Live Presentation Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1041083

An archived recording of the conference call will be available under the Investor Relations section of the Company’s website at http://www.cytosorbents.com/invest.htm

Financial Results for the First Six Months Ended June 30, 2014

 

For the six months ended June 30, 2014, the Company generated revenue of approximately $2,087,000 as compared to revenues of approximately $663,000 for the six months ended 2013, an increase of approximately $1,424,000 or 215%. Revenue from product sales was approximately $1,232,000 in the first half of 2014, as compared to approximately $304,000 in the first half of 2013, an increase approximately $928,000 or 305%. Product gross margins were approximately 63% for the six months ended June 30, 2014. Revenue from grants was approximately $850,000 in the first half of 2014, as compared to approximately $359,000 in the first half of 2013.

 

Our loss from operations for the six months ended June 30, 2014 was approximately $2,537,000, as compared to a loss from operations of approximately $2,829,000 for the six months ended June 30, 2013.

 

Financial Results for the Second Quarter Ended June 30, 2014

 

CytoSorbents generated revenues of approximately $1,025,000 and $291,000 for the three months ending June 30, 2014 and June 30, 2013, respectively. Product revenues were approximately $663,000 for the quarter ended June 30, 2014, as compared to product revenues of $128,000 for the quarter ended June 30, 2013. Additionally, grant revenue and other income was approximately $361,000 and $164,000 for the three month periods ended June 30, 2014 and 2013, respectively. Overall blended gross margins were approximately 35%, with product gross margins of approximately 65%.

 

Our loss from operations for the three months ending June 30, 2014 was approximately $1,383,000, as compared to a net loss from operations of approximately $1,407,000 for the three months ended June 30, 2013.

 

 
  

On June 30, 2014 our cash and short-term investments were approximately $9,623,000, as compared to cash balances of approximately $2,183,000 as of December 31, 2013. This increase in cash is a direct result of our March 2014 registered offering of our Common Stock from which we received approximately $9,451,000 in net proceeds.

 

For additional information please see the Company’s 10-Q report for the period ended June 30, 2014 filed on August 12, 2014 on http://www.sec.gov.

 

2014 Third Quarter Outlook

 

CytoSorbents has not historically given financial guidance on quarterly results until the quarter has been completed. With Q3 2014 still ongoing, we continue to see strong momentum in CytoSorb® usage and sales and expect our trailing 12 month CytoSorb® sales to easily continue its upward trend.

 

About CytoSorbents Corporation

 

CytoSorbents Corporation is a critical care focused immunotherapy company using blood purification to control severe inflammation -- with the goal of preventing or treating multiple organ failure in life-threatening illnesses. Organ failure is the cause of nearly half of all deaths in the intensive care unit, with little to improve clinical outcome. CytoSorb®, the Company's flagship product, is approved in the European Union as a safe and effective extracorporeal cytokine adsorber, designed to reduce the "cytokine storm" that could otherwise cause massive inflammation, organ failure and death in common critical illnesses such as sepsis, burn injury, trauma, lung injury, and pancreatitis. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. CytoSorbents has numerous products under development based upon this unique blood purification technology, protected by 32 issued US patents and multiple applications pending, including HemoDefend™, ContrastSorb, DrugSorb, and others. Additional information is available for download on the Company's website: http://www.cytosorbents.com/.

 

Forward-Looking Statements

 

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 31, 2014, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake

 
  

no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.

 

Please Click to Follow us on Facebook and Twitter

  

Company Contact:
CytoSorbents Corporation
Dr. Phillip Chan, MD, PhD
Chief Executive Officer
(732) 329-8885 ext. *823
pchan@cytosorbents.com

 

Investor Contact:
CytoSorbents Corporation

Amy Vogel

(732) 329-8885 ext. *825

avogel@cytosorbents.com

 

 
  

CYTOSORBENTS CORPORATION

(a development stage company)

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(amounts in thousands, except per share data)

 

   Six months ended June 30,   Three months ended June 30, 
   2014   2013   2014   2013 
   (Unaudited)   (Unaudited)   (Unaudited)   (Unaudited) 
Revenues                    
  Sales  $1,233   $304   $663   $128 
  Grant income   850    359    359    163 
  Other revenue   4    --    3    -- 
  Total revenues   2,087    663    1,025    291 
                     
Cost of revenue   1,329    453    666    199 
                     
Gross profit   758    210    359    92 
                     
Expenses:                    
  Research and development   583    1,412    347    708 
                      
  Legal, financial and other consulting       550    413    240    190 
                      
  Selling, general and administrative       2,162    1,214    1,155    601 
                      
  Total operating costs and expenses      3,295    3,039    1,742    1,499 
                     
Operating loss   (2,537)   (2,829)   (1,383)   (1,407)
Other expenses, net   291    215    471    8 
Net loss before benefit from income taxes   (2,828)   (3,044)   (1,854)   (1,415)
Benefit from income taxes   --    --    --    -- 
Net loss   (2,828)   (3,044)   (1,854)   (1,415)
Preferred stock dividend   2,489    1,203    1,374    616 
Net loss available to common shareholders  $(5,317)  $(4,247)  $(3,228)  $(2,031)
Earnings per share:                    
                      
  Basic and diluted earnings per share      $(0.02)  $(0.02)  $(0.01)  $(0.01)
  Basic and diluted weight average shares outstanding   283,424,589    227,299,644    301,195,959    231,583,119 
                     
Net loss  $(2,828)  $(3,044)  $(1,854)  $(1,415)
Other comprehensive loss:                    
    Currency translation adjustment   5    (3)   4    (1)
Comprehensive loss  $(2,823)  $(3,047)  $(1,849)  $(1,416)

 

 
  

CYTOSORBENTS CORPORATION

(a development stage company)

CONDENSED CONSOLIDATED BALANCE SHEETS

(amounts in thousands)

 

   June 30, 2014 (Unaudited)   December 31, 2013 
ASSETS:          
Cash and cash equivalents  $4,878   $2,183 
Grants and accounts receivable, net   330    453 
Short-term investments   4,745    -- 
Inventories   304    246 
Prepaid expenses and other current assets   365    605 
    Total current assets   10,622    3,487 
           
Property and  equipment, net   172    145 
Other assets   463    414 
    TOTAL ASSETS  $11,257   $4,046 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Accounts payable  $526   $787 
Accrued expenses and other current liabilities   639    362 
Deferred revenue   6    272 
Warrant liability   889    -- 
Convertible notes payable, net   709    1,644 
    Total current liabilities   2,769    3,065 
    TOTAL LIABILITIES   2,769    3,065 
           
Redeemable Series B Convertible Preferred Stock   17,718    15,246 
           
Total stockholders’ equity   (9,230)   (14,265)
           
TOTAL LIABILITIES AND STOCKHOLDER’S EQUITY  $11,257   $4,046 

 

 

 

CytoSorbents (NASDAQ:CTSO)
Historical Stock Chart
From Mar 2024 to Apr 2024 Click Here for more CytoSorbents Charts.
CytoSorbents (NASDAQ:CTSO)
Historical Stock Chart
From Apr 2023 to Apr 2024 Click Here for more CytoSorbents Charts.