Tenax Therapeutics, Inc. (TENX) Q1 2016 Earnings Report, Transcript and Summary

Greetings and welcome to the Tenax Therapeutics business review and update in conjunction with filing of the fiscal year 2016 first quarter financial report conference call. At this time, all participants are in a listen-only mode. [Operator Instructions]. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Ms. Nancy Hecox, General Counsel. Thank you. You may begin.

Good morning, everyone and welcome to the earnings conference call for Tenax Therapeutics' first quarter fiscal year 2016, which ended July 31, 2015. The news release with our financial results and corporate update became available at 6:00 a.m. today and can be found on the Investors section of our website at www.tenaxthera.com. You can also listen to a live webcast and replay of today's call on the Investors section of the website. 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 differ 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 were 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 first quarter of fiscal year 2016, after which we will open the call for Q&A. Now, let me turn the call over to John.

Thanks, Nancy. Good morning everyone and thank you for joining us today. Throughout this calendar year, we have continued to execute on our clinical plan for levosimendan in multiple indications. Our first priority continues to be to increase the enrollment pace of the ongoing Phase 3 LEVO-CTS trial in Low Cardiac Output Syndrome. As of this morning, we currently have 180 patients enrolled in the trial with 62 hospitals activated. That number includes five hospitals in Canada. We have also signed contracts with an addition of four sites and are in negotiations with another 11 sites. We still expect our total number of participating hospitals in the trial to reach 70 and we continue to be encouraged by our progress as we now have 47 hospitals that have enrolled at least one patient. Our top enrolling site just enrolled their 20th patients in 12 months. Speeding up this enrollment pace is our top concern and we have made significant efforts throughout this summer to address different areas that we believe will help increased the rate this fall to enable our planned topline data readout in calendar year 2016. These include identifying additional sites for the trial including expanding to Canada, increased communication with our current clinical sites. We have just hired two field based associates who will be in direct contact with the sites. Research with our investigators into how hospital sites can identify qualified patients and make it easier for them to enroll in the trial, active engagement with clinical sites by members of our trial steering committee including those with experience using the drug in the EU where it is currently marketed as Simdax and we have just submitted a protocol amendment to the FDA to adjust inclusion criteria to increase the possible number of patients that will qualify for this trial. With these improvements ongoing, we still expect to report data in calendar year 2016 with a potential new drug application following those results. Now turning to our septic shock program. Just as a reminder, if you are a newcomer to the Tenax story, 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 the ongoing LeoPARDS trial. This 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 to evaluate its safety profile. Septic shock is a life-threatening condition that causes blood pressure to fall dangerously compromising blood flow to vital organs such as the liver and kidney. This is an indication with an extremely high unmet need with an estimated 500,000 patients in the United States with up to 50% mortality rate. We were pleased to announce just last week that our company has become a national event partner for Sepsis Alliance in 2015 and 2016 to help raise awareness about sepsis and septic shock. Enrollment for this trial has continued to increase significantly with our support and there have now been 428 patients enrolled as of September 11, 2015 out of an estimated 516 patients. We currently anticipate that the trial will be completed before the end of this year with a data readout during calendar year 2016. Our regulatory strategy for septic shock remains unchanged. Following our discussion with the U.S. Food and Drug Administration during November 2014, which included Dr. Anthony Gordon, the lead investigator the LeoPARDS trial, the agency provided us with guidance on how this data might be analyzed to support a regulatory filing, specifically the type of endpoints that they believe would be clinically meaningful. We have since worked with Dr. Gordon's team to develop and submit a statistical plan to the agency in accordance with this guidance. This plan includes three secondary endpoints that we believe fit the characteristics and qualifications that the agency guided us towards. We believe that the study is powered to show a significant difference between levosimendan and the standard of care arm on these endpoints. And if positive, we believe that these data would support a regulatory filing. In that case, we would request a pre-NDA meeting with the FDA based on the positive results and will engage in discussion around a potentially accelerated regulatory review path such as priority review and breakthrough designation based on the significant unmet need in this indication. We look forward with our colleagues at Imperial College to seeing these results next year. On the corporate side, in August, we announced that James Mitchum has been nominated to be elected to our Board of Directors at the annual meeting of stockholders scheduled tomorrow on September 15, 2015. James is a highly regarded pharmaceutical executive with extensive experience in drug development and commercialization, including senior management roles with EUSA Pharma, Enturia, Sanofi-Aventis Japan and Aventis Pharma UK, among others. We believe that our company will benefit greatly from his voice and guidance on the Board as we continue to execute on our critical care pipeline strategy. Turning to upcoming milestones, we still expect to report the following, two interim analysis during LEVO-CTS trial testing for efficacy or futility after 50% and 70% of the planned primary endpoint events have been recorded, full data reported from Phase 3 LEVO-CTS trial in calendar year 2016, enrollment completed for LeoPARDS trial for levosimendan in septic shock in late calendar year 2015, data reported from the LeoPARDS trial in calendar year 2016 and updated regulatory strategy for levosimendan in septic shock following LeoPARDS readout in calendar year 2016. With that, I would like to turn the call over to Michael Jebsen, our President and CFO to go over the financials. Michael?

Thank you, John. I will begin today by summarizing our financial results for the three-month periods ending July 31, 2015 and 2014, followed by a brief discussion of our cash position and burn rate. Total operating expenses for the three months ended July 31, 2015 were $3.1 million compared to $2.4 million in the prior year. General and administrative costs decreased approximately $80,000 and research and development costs increased approximately $775,000 as compared to the same period in the prior year. This is due to increases in consulting and personnel costs and the costs associated with conducting the Phase 3 clinical trial for levosimendan. General and administrative expenses for the three months ended July 31, 2015 and 2014 were approximately $1.4 million. In the current period, we realized reductions in costs associated with our external investor relations firms partially offset by increased costs in payroll and consulting fees. We do not anticipate any significant additional charges to our G&A cost moving forward and we anticipate overall G&A costs of approximately $6.5 million for the year. Research and development expenses for the three months ended July 31, 2015 were approximately $1.7 million compared to $1 million in the prior year. The increase in R&D expenses as compared to the same period in the prior year was due primarily to the costs incurred for conducting the Phase 3 LEVO-CTS study, partially offset by eliminating all of the costs incurred for the clinical and preclinical safety studies for Oxycyte during the same period in the prior year. For the three months ended July 31, 2015, we reported a net loss of $3 million or $0.11 per share compared to a net loss of $2.2 million or $0.08 per share in the same period in the prior year. As of July 31, 2015, we had cash and cash equivalents, including the value of our investments in marketable securities totaling $43.9 million compared to $48.1 million at April 30, 2015. Overall for the remainder of calendar year 2015 and into 2016, we continue to expect to see increases in our quarterly 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 rates, we anticipate LEVO-CTS clinical study costs of approximately $2 million to $2.5 million per quarter. This increase in R&D spend will result in an overall burn rate of approximately $14 million to $16 million a year 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. Based on our existing capital resources and our anticipated growth in annual burn rate, we still have sufficient capital to fund our operations through calendar 2017. With that, I will turn the call back over to the operator for Q&A.

[Operator Instructions]. Our first question is coming line of Jeffrey Cohen with Ladenburg Thalmann. Please proceed with your question.

Hi. Good morning, John and Michael. Can you year me okay?

Just fine, Jeff.

Good morning. So John, could you talk a little bit about the inclusion criteria and what was submitted specifically as far as percentages and what you expect to hear in what time frame? And how that may affect the enrollment process?

Sure. Actually I think I said, we have just submitted the protocol amendment. We actually submitted it about a month and a half ago. So we should be hearing from the FDA sometime within the next week or so with regard to their agreement. Basically there is some things in the inclusion criteria, exclusion criteria that we needed to clean up, things like excluding patients with COPD that really wasn't necessary. It was causing some confusion. And then we also, based on where we currently stand, we have also looked at the changing the ejection fraction from 25% up to 35%. We think that that will significantly increase the number of patients eligible for enrollment. It might slightly increase the number of patients that we need to enroll in the trial because we expect to see slightly fewer events, but it's an event driven trial, so that is fine. So don't have feedback yet from the FDA. As soon as we get it, we will let everybody know.

Okay. And clarify the 25% to 35% ejection fraction which aren't increasing?

As you know, right now we are enrolling patients undergoing CABG with a 25% ejection fraction. If you are undergoing any type of valve procedure, it is 35%. This would just make it 35% across-the-board.

So potentially that speeds up the enrollment by?

Well, we think it increases the patient population by 200% to 300%. So it doubles or triples the number of patients available to be included in the trial.

Okay. And then second question, I guess Michael for you, on your commentary on R&D and overall burn. You talk about $14 million to $16 million for the year and with the G&A at, call it approximately, $6.5 million, then you are talking about approximately $9 million to $10 million for 2016 on the R&D line?

Correct. We are anticipating to start seeing the LEVO trial cost to hit $2 million and work its way to $2.5 million based on the type of growth in enrollment we have seen thus far.

Okay. And one more, if I may. How would you hypothesize that U.K. comes out with data on LeoPARDS ad could you comment just a little better on their expected time frame?

Well, right now it looks like they should probably, I mean they are at 428 patients that going to 516. They should probably conclude enrollment some time late October, early November. Their primary endpoint is out to 28 days. So say about a month later. So hopefully you would think that they would lock the database by the end of December. And then in terms of analysis, based on discussions that we have had with people at Imperial College of London, I would say two months to complete analysis of the data. I know that they would like to make a presentation of the data at some medical meetings that occur in the first half of the year.

Okay. Got it. Perfect. Thank you very much for taking the questions.

You are welcome.

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

Good morning. Firs question. I just want to make sure that, are you expecting topline data out of LeoPARDS first? Or will we be waiting for the full data set?

Well, you know that's a good question, Brian. The people at Imperial College of London, they do remind us that they continue to view this as an academic trial. They want to make sure that they have the opportunity to be the ones that break the news to the medical community and to report it first. So we are still working through details with them to what we will get and when we will get it. They understand that it's something that's highly important to us and that we would like to have access to the data as soon as possible, but our agreement with them basically says that they have the ownership of the data and the reporting of the data. So I am guessing we could get topline data from them, but they have yet to commit to what they will give us when. We just know that they want to report the results sometime in the first half of the year.

Okay. First half, even if it's the full data set.

Yes.

Okay. All right. And because it's an academic pursuit in their minds, would you expect that they would be more likely to go the full data set and the peer review journal route? Or do you think that there are still some academic benefit in the topline press release?

I think that they will want to present whatever data they can as soon as they can, particularly assuming that you have positive results. So, you know, again this is just my anticipation that they will do what they can to get something submitted to a medical meeting so that they can make a presentation with publication to follow. I think once the data has been announced publicly, we will have access to it.

Okay. On the inclusion criteria adjustments, excluding things like COPD, was that something that was written into the protocol because it would be nice to just have patients that were free of that? But now trying to accelerate enrollment, maybe it doesn't matter that much but in an ideal world, you would include patients like that? Or do you think it just has no impact whatsoever?

I don't think it has any impact. I mean the feedback we are getting from sites was that they were potentially excluding some patients and their further feedback was, if we are going to operate on somebody, we are only going to do it if we feel like they are able to come off the ventilator. So it's not that we are that concerned about their lung function. We wouldn't operate on them otherwise. So it was in there, I guess we were being ultraconservative and the feedback was, it's not necessary. We are not going to operate on somebody that's having difficulty breathing anyway.

Okay. And moving on to ejection fractions with the CABG patients, it doesn't, I guess my concern is and this is, I don't remember that well what are some of the past ABG studies were done with everything at 35%. Is there any concern that that may have been one of the hurdles for them to show statistical efficacy?

Well, actually the ABG studies were done in patients with heart failure and I don't think they even measured the ejection fraction. If they did, I don't think it's reported. So it's not a concern. I mean these are patients going into cardiac surgery. Most of the studies that have been done in cardiac surgery, the ejection fractions were 35% or less. There are some studies that were done with even higher ejection fractions. If you look at the meta-analysis that we had DCRI do for us and that was reported at the American College of Cardiology two years ago, they looked at patients with ejection fractions of 35% or less and they showed significant reductions in death, perioperative MI and patients requiring dialysis which are our endpoints. So we have got data that support that the effect of the drug is well-established in patients with ejection fractions of 35% or less. Wouldn't have done it otherwise.

Okay. Terrific. Thank you very much.

You are welcome.

Thank you. It appears we have no further questions at this time. So I would like to turn the floor back over to Mr. Kelley for any additional concluding comments.

All right. Well, thank you everyone. We appreciate that you joined us again today for our results call and we will continue to focus on increasing enrollment in LEVO-CTS and we look forward to the next time we are on this call reporting that perhaps LeoPARDS trial has completed enrollment. Have a great day. Thanks.

Ladies and gentlemen, this does conclude today's teleconference. We thank you for your participation and you may disconnect your lines at this time.