Nancy Hecox - EVP, Legal Affairs, General Counsel, Corporate Secretary John Kelley - CEO Michael Jebsen - CFO

Jeffrey Cohen - Ladenburg Thalmann Brian Jeep - WallachBeth Capital Vernon Bernardino - MLV & Company

Good morning and welcome to Tenax Therapeutics Third Quarter Fiscal Year 2015 Conference Call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session at the end. Please be advised that this call is being recorded at Tenax's request. I would now like to turn the conference over to Nancy Hecox, Tenax's Executive Vice President, Legal Affairs, General Counsel and Corporate Secretary. Please proceed.

Thank you. Good morning everyone and welcome to Tenax Therapeutics third quarter fiscal year 2015 conference call. The news release with our financial results and corporate update became available at 6:00 a.m. today and will be found on our Web site at www.tenaxthera.com. You may also listen to a live webcast and replay of today's call on the Investors section of the Web site. Before we begin, let me remind you that statements made on today's call regarding matters that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the expected timing for the company's clinical trials, statements concerning the potential results of planned clinical trials, and future development milestones for the company's product candidates. Because such statements are subject to risks and uncertainties, actual results may vary materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Tenax's filings with the Securities and Exchange Commission. All forward-looking statements made on today's call speak only as of the date on which they are made. Tenax Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Joining me on the call today is John Kelley, Chief Executive Officer of Tenax Therapeutics who will discuss recent company highlights. Following John, Michael Jebsen, Tenax's Chief Financial Officer will review the company's financial results for the third quarter of fiscal year 2015, after which we will open the call for Q&A. Now, let me turn the call over to Tenax's CEO, John Kelley.

Thanks Nancy. Good morning everyone and thank you for joining us today. I'm pleased to share with you the progress that we have made over the past three months in executing our development plan for levosimendan. We did issue a press release this morning that outlines some of those achievements. I do, however, want to update that press release. When it was written, we had enrolled 41 patients in the LEVO-CTS trial. In the last 24 hours, we've added 3 more patients that have enrolled now bringing to the total as of this morning to 44 patients. As a reminder, LEVO-CTS is a double-blind randomized placebo controlled trial that will evaluate the use of levosimendan administered before cardiac surgery to reduce the incidence of low cardiac output syndrome and associated morbidity and mortality. We are planning to conduct this trial in approximately 60 hospitals across North America. To-date, we have activated 41 hospitals, one more than what's stated in the press release based on a new activation that occurred late yesterday afternoon. We have contract negotiations completed with in another 7 sites and another 13 hospitals where we are in discussions on their participation in the trial. We expect we will reach our goal of 50 U.S. sites activated by the end of March. For a complete list of sites that are recruiting patients, you can find that information on clinicaltrials.gov. We are very pleased with the high-quality of sites that have chosen to participate in the trial to-date. On our last call, we announced that we would also evaluate sites in Canada. In February, we received approvals from Health Canada to include Canadian hospitals in the LEVO-CTS trial. We have identified 11 possible sites and have begun discussions with them. As new hospitals come onboard, we have seen the pace of enrollment pick-up. The biggest challenge is shortening the time from activation of the hospital to enrollment of a first patient. Of the 41 hospitals activated, 18 have enrolled a patient so far. Two of the patients enrolled in the last 24 hours were each first patient's to those institutions. The third patient came from our leading enrolling hospital; it was their ninth so far. We believe that a large part of this process is communication with the study coordinator at the site and the lead investigator. To that end, we just conducted a teleconference between our leading enroller and the other activated sites. The focus of the discussion was on the process used to screen patients and identifying candidates to the trial. We plan to do conferences like this on a monthly basis. We are also in contact with sites on a daily basis. We believe that a big help in this enrollment process will be the recent addition of our Chief Medical Officer, Dr. Paula Bokesch. She comes to us with more than a decade of drug development experience in the critical care market including significant time with Cubist Pharmaceuticals and Hospira. With her development leadership and strong relationship with well-regarded medical institutions, she will be a key part of our team than before as we work to complete the LEVO-CTS trial and strategically advanced pipeline. As a Cardiac Anesthesiologist, she brings tremendous knowledge and experience to Tenax regarding the patients that were enrolled in our trial. In addition to the advancements with our own clinical studies over this past quarter, we were pleased to be able to highlight two recent publications on levosimendan that give us even more confidence and a positive read-out for LEVO-CTS in 2015. One of those is the recently released consensus paper in the International Journal of Cardiology, which came from a panel of 27 experts from 18 countries and detailed the preoperative use of levosimendan in cardiac surgery patients. Their conclusion generally supported our LEVO-CTS protocol, particularly the dosing regimen in use in low ejection fraction coronary artery bypass and valve surgery patients. And the author gave a strong rationale for the use of levosimendan in this study calling it a safety-net in the surgical setting, and highlighting how the drug works to improve haemodynamics and reduce the need for inotropic agents. The second publication appeared in the British Journal of Anesthesia as a meta-analysis assessing differences in mortality associated with various inodilator products that are commonly used in critical care patients. Their study included 46 trials published between 1995 and 2014 and concluded that levosimendan appears to be the most efficacious inodilator product to improve survival when used in cardiac surgery patients. This was of particular interest to us as it is the first large analysis comparing levosimendan to other products in this indication and provides strong support for rationale in developing levosimendan for a significant unmet need in North America. Another important aspect of the Tenax story is our emerging opportunity of levosimendan in septic shock. As you recall, in August 2014, we announced the collaboration with Imperial College London to provide $500,000 in supplemental funding to support the accelerated enrollment and completion of their ongoing LeoPARDS trial that’s levosimendan for Prevention of Acute Organ Dysfunction in Sepsis. The LeoPARDS trial is designed to determine whether levosimendan reduces the incidence and severity of acute organ dysfunction in adult patients who have septic shock, as well as evaluate its safety profile. As of March 17, 2015, the trial had enrolled 250 out of an estimated 516 patients. The trial should complete enrollment this year with data available in 2016. We announced in our last call that in November we held a meeting with the U.S. Food and Drug Administration to discuss the development of levosimendan in this indication. And that discussion included Dr. Anthony Gordon, the lead investigator of the LeoPARDS trial. The agency provided us with guidance and how the LeoPARDS data might be analyzed to support a regulatory filing. We have since been in discussion with Dr. Gordon and his team with regard to the trial’s statistical analysis plan to assess how we could meet the agency's guidance. We don't have an answer on that yet. But, we are actively working on it. As we look ahead further to 2015's upcoming milestone, we are very excited to be holding our first Analyst Day as a company on April 13 in New York City, which we hope many of you will be able to attend. We will also be webcasting the entire event on the IR section of our Web site. Our presenters for the day will include Dr. John Luber, a cardiothoracic surgeon from Tacoma, Washington, who is a member of the LEVO-CTS steering committee and the leading enroller so far in the trial. Dr. Giovanni Landoni from Milan, a Cardiac Anesthesiologist with hands on experience in levosimendan and a lead author on the recent meta-analysis I just referred. Dr. Wolfgang Toller from Graz, Austria, a member of steering committee also a Cardiac Anesthesiologist with over 10 years of experience using levosimendan in cardiac surgery and a lead author on the consensus paper I just referenced and Dr. Anthony Gordon from London, the lead investigator on the LeoPARDS trial. We will also be joined by some of our colleagues from Orion Pharma, who discovered and developed levosimendan. Official upcoming milestone will be an expected event rate inner [ph] analysis following enrollment of 200 patients in the LEVO-CTS trial this summer. Two interim analyses during LEVO-CTS trial testing for efficacy or futility after 50% and 70% of the planned primary endpoint events have been recorded late in calendar year 2015. Last patient enrollment of LEVO-CTS trial by the end of calendar year 2015; full data reported from Phase 3 LEVO-CTS trial in first calendar quarter of 2016; and data reported from LeoPARDS trial for levosimendan in septic shock in calendar year 2016. And now, I would like to turn the call over to our President and Chief Financial Officer, Michael Jebsen. Michael?

Thank you, John. I will begin today by summarizing our financial results for the nine-month period ending January 31, 2015 and 2014, followed by a brief discussion of our cash position and burn-rate after which we will open the call for questions. Total operating expenses for the nine months ended January 31, 2015 were $9.7 million compared to $6.4 million in the prior year. General and administrative costs increased approximately $750,000, and research and development costs increased approximately $2.5 million due to increases in consulting and other professional fees and the costs associated with conducting of our Phase III clinical trial for levosimendan. General and administrative expenses for the nine months ended January 31, 2015 were $4.9 million compared to $4.2 million in the prior year. This increase was due primarily the cost incurred for external Investor Relations and communications services and banking fees associated with the management of our marketable securities. Research and development expenses for the nine months ended January 31, 2015 were approximately $4.8 million compared to $2.2 million in the prior year in line with our strategy to focus our capital resources to the development of levosimendan. This increase in research and development expenses as compared to the same period and the prior year was due primarily to the costs incurred for conducting the Phase III LEVO-CTS study, and the cost to support LeoPARDS study for septic shock. These costs were partially offset by reductions in the cost incurred for the preclinical safety studies and the cost incurred related to stop TBI Phase 2b study for Oxycyte during the same period in the prior year. For the nine months ended January 31, 2015, we reported a net loss of $9.1 million or $0.32 per share compared to a net loss of $9.1 million or $2.56 per share in the prior year. Included in the prior year net loss is approximately $2.1 million of non-cash charges for the amortization of interest expense on convertible notes which matured in June of last year. As of January 31, 2015, we had cash and cash equivalents, including the value of our investments in marketable securities totaling $50.1 million compared to $58.3 million at April 30, 2014. Overall, for the remainder of fiscal 2015 and into fiscal 2016, we expect to see significant increases in R&D expenses as a result of the progression of the LEVO-CTS Phase 3 clinical study. As we finalize our site activation efforts and continue to see growth in our monthly enrollment rate, we anticipate LEVO-CTS clinical study cost of approximately $1.8 million to $2 million per quarter. This increase in R&D costs will result in an overall annual burn rate of approximately $14 million to $15 million moving forward. With our existing capital, we are well-positioned with sufficient funds to complete our Phase 3 LEVO-CTS trial and carry the program through potential approval. Our clinical execution and efficient use of capital still gives us the flexibility to continue to evaluate strategic opportunities for growth, including developments in our septic shock program and potential additional candidates that fit our pipeline strategy. And with that, I'll turn the call back over to the operator for questions and answers.

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Thank you. Our first question comes from the line of Jeffrey Cohen with Ladenburg Thalmann. Please proceed with your question.

Hi, good morning, John and Michael. Can you hear me, okay?

You are fine Jeff. How are you?

Just fine. So just a review on your timeline for 2016, you are saying, and reiterating I should say expecting 200 enrollees by the summer time, the 50% milestone to 70% milestone during the second half and you expect full enrollment by the end of the calendar year?

Yes. We are still reiterating what we said in the past with regard to that timeline.

Okay.

We are seeing enrollments with our site picking up and as we get all the hospitals activated and get all the hospitals enrolling patients we think that that is achievable.

Okay. Can you talk a little more about, you said the greatest gap seems to be between all the paper work completed at the site and time to first enrollment, is it just from the hospital standpoint you get more comfortable with the protocol and what they are looking for, or can you give us a little color there?

Well, I think it's a number of things. And I think it really is to some degree hospital depending. I think that we have seen the quickest hospital; I think they were able to go from activating the first patient enrolled in something like 23 to 24 days. One of the hospitals just enrolled a patients in about 100 days. So, really it’s depending on the hospital and the processes they use, how well trained their staff is, and what they are doing in terms of getting everybody involved in the program. So we are reaching out to all of the hospitals, we are having discussions with them. We are offering additional training. We are offering additional guidance, then connecting them with people that have been enrolling at sites, but I think it really comes down to what kind of screening processes they are using, how they are identifying patients to qualify for the trial, and then how are they having the discussions with those patients with regard to consenting them to be in the trial and then actually enrolling them in the trial.

Okay. Got it. One more for me, Michael, can you talk a little bit about your commentary on the burns, you said $14 million to $15 million for 2015, that's calendar 2015 and is that the total burn or could you give us a further breakdown as to how that might look for line item?

Sure. So that would be – imply that over the next four quarters, that's where the $14 million to $15 million will come. So I would expect that $2.5 million per quarter in R&D, maintaining about $4 million of overall G&A for the year.

Okay. Got it. And any update as far as your calendar quarters do change one quarter and what we could expect on that?

We are still evaluating the impact and the process of doing so, but we expect a final decision at our Board meeting next month.

Okay. So, until further notice expect the next quarter being April 30?

Regardless of their decision, we would have to file our K on April 30.

Got it, perfect. Thanks for taking the question guys. I appreciate it.

Thank you, Jeff.

Thank you. [Operator Instructions] The next question is from the line of Brian Jeep with WallachBeth Capital. Please proceed with your question.

Good morning. Thanks for taking my questions. First one, you mentioned in the press release potentially additional candidates that fit the critical care strategy. I was curious, how you are investing in potential additional candidates and ability to fund the potential subject development for levosimendan, if no addition of cash were was used [indiscernible] enough to you both?

At this point – hi, Brian, it's John. Yes, I think so. I mean we are not looking at considerable amount of money to be forwarded for septic shock at this point in time. That's $500,000 that we have invested. We are having discussions with Imperial College with regard to the staff planning [indiscernible]. And we will make a decision based on that as to whether or not we have enough data [indiscernible]. If we were to come up with other opportunities, I think we would evaluate those as in a business case or in terms of what the cost would be versus the opportunity and make a decision based on that. But, we believe that we have got sufficient cash to be opportunistic as we look at other opportunities.

Any other opportunity to have your eye on or is this just – if something happens, you come across, it's like a good faith, you have the ability to act?

I think, itis the latter, if something comes across our desk that is interesting, we will have the ability to act. I mean interestingly enough if we get approached by people and ask to look that assets because we are in a critical care state and the products we are – some of the procedures fit into that. So we had looked at a few possibilities and haven't acted yet. But, if something comes across our desk that looks interesting, we can act.

Okay. And one last question, on the 200 enrollees in interim analysis versus 50% and 70% interim analyses? Can you differentiate what we might expect, what your – what potential outcomes are for the two different types of interim analyses?

Well, the first one is based on number of patients like 200 patients and the point there was really just to take look and make sure was that we are seeing an exact rate with close to what we had modeled when we designed the trial. So the trial is based on the approximate, there will be 33% exempt rate in the placebo arm. We are not going to underline the trial. It's going to be a blinded look. So we will have to have a range of what we think the appropriate events would look like. Then, the possible outcomes there would be that – eventually looks and says everything looks fine, keep doing what you are doing. And you could say hey, it looks like you might be a little short on events, you might need to enrich the patient population a little bit. But, it's going to be general guidance with regard to – it looks fine or not. And I think what we would probably do and say is that just – but we are continuing with the trial or that we might have to make implied adjustments in the patients that we are enrolling. So that's the first check to enroll the patients. The 50% and 70% interim analyses are based on exempt rate, so 50% of expected events which would be somewhere around 200 events I believe to the trial or 200 total events to trial. So we will look at it and say there it's going to be tested with the trial. So in other words, no matter how many patients we enroll, we will see a difference between levosimendan and placebo. Or, it could be tested to say is the profound efficacy and the protocol to find that would be is based on a fewer endpoint at that point in time gap plus the use of [comp] [ph] and it's a pretty high hurdle that we have to reach. So the most likely outcome at 50% and 70% is that the care clinics using discounts continue with the trial.

And actually in –

Go ahead.

There is no futility here over on the efficacy provision in that 200 patients' enrolled peak or an office?

No. Again, there is going to be blind look at that rate settlement.

Okay. Thank you.

All right, Brian. Thank you.

Our next question is from the line of Vernon Bernardino with MLV. Please proceed with your question. Mr. Vernon, your line is open for questions.

Sorry, I was late. Thanks for taking my question. And congrats on the progress so far.

Thanks.

Since the press release was written that you had enrolled 3 additional subjects, was that in one side, I apologize if I missed it.

No. The three were enrolled in the last 24 hours and they are kept in different sites. Two of them, it is their first patient that they had enrolled, so new sites to the list. And the third patient actually came from the site that is as far as leading sites in terms of enrolling. So we have nine patients.

And so the size of the – considering the size of this study and you had mentioned 50% interim look for efficacy and futility and the second half of the year, you think do you anticipate the enrollment will continue at three or do you think it will accelerate or what is determining the rate of enrollment at this point?

Yes. We believe that is going to accelerate obviously because as we bring new sites on board and you got sites enrolling patients, what we have seen both our – one is the third patient, the second and third patient we will follow fairly in a reasonable amount of time. So I think that as I said earlier we have 41 sites that have been activated. We have 18 sites that are currently enrolling, patients have enrolled patients obviously we have got number of sites we need to get up enrolling. But as I do, we think that the pace will accelerate. And we take a lot of confidence in that from setting up the one site just been able to enroll nine patients so far and was going on in a pretty good curve in terms of how clinically we have been listing patients.

Okay. And I apologize for the blunt question, but I want to make sure that this is inline with I think as far as modeling is concerned. The more sites you have enrolled, the more patients' sites you have activated and the more patients you have enrolled, the more R&D is going to increase rather a linear relationship?

From the beginning we have budgeted this trial to increase, it is up to 60 sites. And so it really just became a timing issue, the marginal cost per patient, it moves the certain level of flat fee that is primarily fixed in the management of this trial. Their estimate is, it's a variable based on patients begin enrolled and sites being activated. So when I estimated that R&D costs on a quarterly basis coming at LEVO-CTS that incorporates what we budget the enrollment rates could be as we move through completion of this trial.

Okay, great. Thanks for taking my questions.

You are welcome.

Thank you.

[Operator Instructions] There are no questions. I will now turn the call back over to John Kelley for closing remarks.

Hi. Thank you. And thanks everyone for joining us this morning on our quarterly conference call. Once again, we are pleased to have shared with you the progress we have made in the last three months. And look forward to talking again in another three months and updating you on the trial. Everyone have a great day. And thanks again.

Ladies and gentlemen, this concludes today's conference call. Thank you once again for your participation. You may now disconnect. Everyone have a great day.