Tenax Therapeutics, Inc. (TENX) Q4 2015 Earnings Report, Transcript and Summary

Greetings and welcome to the Tenax Therapeutics Business Review in Conjunction with Filing of the Fiscal Year 2015 Annual Report conference call. At this time, all participants are in a listen-only mode. [Operator Instructions] As a reminder, this conference call is being recorded. It is now my pleasure to introduce your host Ms. Nancy Hecox, Executive VP of Legal Affairs and General Counsel. Thank you. You may begin.

Good morning and welcome to the earnings conference call for Tenax Therapeutics’ fourth quarter and fiscal year which ended April 30, 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 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 fourth quarter of fiscal year 2015, after which we will open the call for Q&A. Now, let me turn the call over to our CEO, John Kelley.

Thanks, Nancy, good morning everyone and thank you for joining us today. This is a very exciting time at Tenax as we execute on our multifaceted development plan for levosimendan and prepare for a very eventful calendar year 2015 with multiple potential inflection points. Most importantly we continue to see steady progress with the enrollment of our two late-stage ongoing studies for levosidendan. So let me give you an update. Starting with the Phase 3 LEVO-CTS study in low cardiac output syndrome. 131 patients are now enrolled in our Phase 3 LEVO-CTS trial in low cardiac output syndrome. That’s one more than what’s in the press release based on an enrollment early this morning. We have 51 hospitals activated and signed contracts in an additional seven sites which is one more than in the press release based on a contract that came in this morning. Including in that list, the Cleveland Clinic and our first Canadian site, there are another 18 sites where we are negotiating agreements. We now expect to have at least 70 total hospitals activated during the trial and expect enrollment to continue to grow as many of these sites increase their enrollment rate. 35 of our 51 sites have now enrolled their first patient. Our leading site has enrolled 15 patients so far. We are not yet satisfied with the current rate of enrollment. It has accelerated but it’s not yet where we would like it to be. That is why we have made the decision to expand to at least 70 activated hospitals. We continue to examine ways that we can help hospitals identify qualified patients and make it easier for them to enrol. We are adding additional resources that will allow us to increase our interactions with the sites. We are definitely seeing that increased communication from us to them correlates with increased enrollment. We are also extremely excited about the progress in molecular trial for septic shock, an indication that we believe has near term potential for regulatory filing in North America. Let me provide you with an update there. First, just as a reminder for anyone new to our story, in August 2014 we announced a collaboration with the 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. With that supplemental funding in hand, enrollment for this trial has increased significantly in recent months and there have now been 385 patients enrolled as of this past Tuesday out of an estimated 516 patients. That is compared to 250 patients as of March 16, 2015. The original plan for the trial projected a completion date in July of [2015] [ph]. With the addition of funding that we provided, that target was moved to December of this year. At the current rate of enrollment the trial will be complete before then with data readout sometime during 2016. During November of 2014, you will recall that we had a meeting with the US Food and Drug Administration to discuss the development of levosimendan in septic shock. That discussion included Dr. Anthony Gordon, the lead investigator of the LeoPARDS trial who also recently presented at our company analyst day in New York City. The agency provided us with guidance during that meeting on how the LeoPARDS data might be analyzed to support a regulatory filing. We have worked with our colleagues at Imperial College to develop a statistical analysis plan for this trial following the guidance from the U.S. Food and Drug Administration, and expect to submit that SAP to the FDA this summer. If positive, we believe the data from this trial would support a New Drug Application (NDA) for levosimendan in septic shock. We look forward to seeing that data with our UK colleagues next year. Meanwhile we are conducting proactive market modeling and commercial planning to inform our venture sales force for the low cardiac output syndrome indication and/or septic shock. Our management team has extensive experience with critical care commercial products and we believe that a targeted sales organization can effectively accomplish this type of launch and capture significant value represented by levosimendan. We look forward to providing more color around our launch plans and the potential LCOS and septic shock market closer to the data readout. With both of these indications, we are fortunate to be well capitalized with an efficient company structure that gives us more than sufficient runway to complete the Phase 3 LEVO-CTS study and file a potential new drug application with the FDA in calendar year 2016 while also supporting the LeoPARDS study in a potential NDA filing with it. Turning to other highlights in this quarter. We were very pleased to host our first company Analyst Day in New York City in April. The program highlighted our full year plan and development program and featured key members for the Tenax management team as well as outside figures that included European physicians with clinical experience using levosimendan. Steering committee members with the ongoing LEVO-CTS trial and cardiac surgery and Dr. Gordon with his insights on the LeoPARDS trial in the septic shock indication. The full slide deck and audio webcast of this program can be found on the events and presentations section of our IR website and the highlights from the substantial clinical evidence that gives us confidence in the potential of levosimendan in this critical indication. We were also able to highlight two recent publications on levosimendan which continued to point toward the potential benefit in both the septic shock and cardiac surgery. One of these was a meta analysis in the Journal of Critical Care which examined mortality reduction in severe sepsis and septic shock patients compared to standard inotropic therapy primarily dobutamine. The paper examines pertinent randomized trials in septic shock from existing academic publications and analyzes the pooled results to establish a primary outcome measure in mortality, alongside additional secondary outcomes. It paper concludes that levosimendan is associated with a significant mortality reduction compared to standard inotropic therapy with the need for a large and multicenter randomized trial like the ongoing LeoPARDS study. Our second paper in the Journal of Cardiac Surgery provided a meta-analysis on the role of levosimendan in cardiac surgery patients by pooling the result of 14 previous clinical studies, showing that levosimendan decreased early mortality in patients with reduced ejection fraction. Additional endpoint analysis showed a reduction in postoperative acute renal failure, a shorter stay in the intensive care unit, and a lower incidence of low cardiac output syndrome or LCOS for the levosimendan group in trials. Looking ahead to milestones during the next 18 months, we expect to report the following: 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. The full data set should be reported from the Phase 3 LEVO-CTS trial in calendar year 2016. Enrollment will be completed for the LeoPARDS trial for levosimendan in septic shock in late calendar year 2015 with data reported from the trial in calendar year 2016. To summarize. As we now enter the second half of calendar year 2015 we’ve made some remarkable progress at Tenax Therapeutics. [indiscernible] using our levosimendan program in late 2013 we’ve executed on a large cardiac surgery trial while also finding an additional indication for levosimendan that offers the potential of a near term regulatory filing for any positive data. As I noted earlier, we have sufficient capital on hand to accomplish our goals in calendar year 2016 while still keeping an eye open for additional strategic opportunities to continue to build a fully integrated critical care company. We look forward to keeping you updated during this exciting next 18 months. Now I’d 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 fiscal years ending April 30, 2015 and 2014, followed by a brief discussion of our cash position and burn-rate. Total operating expenses for the fiscal year ended April 30, 2015 were $14.9 million compared to $16.8 million in the prior year. Included in the current year operating expenses were approximately $1 million in non-cash charges for the write-down of intangible assets supporting the Oxycyte product candidates due to the decision earlier this year to suspend all of our development activities and focus all of our resources on levosimendan. General and administrative expenses for the fiscal year ended April 30, 2015 were $7.2 million compared to $13.8 million in the prior year. This reduction was due primarily to the recognized costs of stock based compensation in the prior year of approximately $8.3 million partially offset by increased costs incurred for external investor relations services, payroll and banking fees associated with the management of our marketable securities. Looking forward we anticipate G&A costs of approximately $6.5 million to $7 million over the next 12 months. Research and development expenses for the fiscal year ended April 30, 2015 were approximately $6.7 million compared to $3 million in the prior year. We incurred approximately $4.5 million in R&D costs for levosimendan in the current year. We recorded clinical trial costs of approximately $4 million for the management of the Phase 3 trial, including pass-through site activation and enrolled patient costs. In addition to the costs associated with the Phase 3 trial, we incurred expenses of approximately $515,000 to support the development of levosimendan for septic shock by providing financial support for the LeoPARDS trial. We incurred approximately $1.5 million in R&D costs for Oxycyte in the current year, a decrease of approximately $250,000 compared to the prior year. The decrease in Oxycyte development cost was due primarily to our decision to suspend development of the Oxycyte product and close-out all of our sites for the Phase 2b clinical trials for TBI. We recorded costs of approximately $850,000 for these close-out activities and we do not anticipate any significant additional costs in the future related to this trial. Additionally we incurred approximately $550,000 in costs associated with materials and manufacturing for Oxycyte in the current year. These costs were due primarily to early termination fees for API and clinical drug manufacturing supply agreement. Again we do not anticipate any significant additional costs in the future related to the development of Oxycyte. For the fiscal year ended April 30, 2015 we reported a net loss of $14.1 million or $0.50 per share, compared to a net loss of $19.5 million in the prior year. Included in the prior year net loss is approximately $2.2 million of non-cash charges for the amortization of interest expense on convertible notes which matured in June of last year. As of April 30, 2015 we had cash and cash equivalents, including the value of our investments in marketable securities totaling $48.1 million compared to $58.3 million at April 30, 2014. Overall for the remainder of calendar year 2015 and into calendar year 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 costs of approximately $2 million to $2.5 million per quarter. This increase in R&D spend will result in an overall annual burn rate of approximately $14 million to $16 million moving forward. With our existing capital, we have sufficient funds to complete our Phase 3 LEVO-CTS trial and to carry the program through a potential approval. Our clinical execution and efficient use of capital will give us the flexibility to continue to evaluate strategic opportunity for growth, including development 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 have sufficient capital to fund our operations through 2017. And with that, I will turn the call back over to the operator for Q&A.

[Operator Instructions] Our first question is coming from the line of Jeffrey Cohen with Ladenburg Thalmann.

Could you clarify, John, you mentioned that the first Canadian site was up, was that signed or activated or enrolled?

It’s a signed contract, Jeff, so we are still waiting for them to have I think their site inspection and be able to ship drug to them. So it’s not been activated yet but the contract is signed and I believe they have their approval for the study.

Okay. And if I recall correctly, you anticipate a handful of Canadian sites?

Yes. We have 10 sites that we have approved for enrollment in the trial and the other 9 we are going through contract negotiations. I think we’ve got one or two contracts that are being circulated for signature and the others we are in discussions with the budgets.

Okay, got it. And I was wondering if you could discuss and talk about the LEVO-CTS trial for a little bit. So it looks like they’re clipping at about 40 a month, so they’ll probably have a readout in the first half of 2016. So if the readout is positive, could you kind of extrapolate a bit as far as what that may mean for the company, some of the parameters that you may look at as you head toward a NDA filing with the FDA and size of the trial, cost of the trial et cetera?

Are you talking about the cardiac surgery trial or the septic shock trial?

For septic shock?

For septic shock, okay. Well, again what we have done is we’ve taken the feedback that we got from the FDA last year. We worked with the people at Imperial College of London and we’ve designed some secondary endpoints that we think fit the characteristics and qualifications that the FDA gave us to be suitable for clinical outcomes that they would consider to be meaningful. So we have three secondary endpoints that we’ve come up with. We believe the study has the power to show a difference between levosimendan and the standard of care arm on those secondary endpoints and if the results are positive, we will submit an NDA to the FDA. Now again the trial is going at the pace with -- it should complete enrollment sometime October, November of this year if they continue to go at the pace they’re currently going at. And as you said it’s about 40 patients per month and there are 385 right now, going to 516. What I don’t have, quite honestly, a very good handle on is how long it will take Imperial College of London to do the analysis of the data, and we’re going to have that discussion with them, they’re all on holiday right now, but when they get back from holiday, we’ll discuss with them what we might be able to do to help them with the analysis so that it’s done in a speedy fashion. After last patient is enrolled, they have about a 28-day follow up on those patients. So they should be able to close the database or lock their database sometime in November or December. We would hope we would see data from them in the first half of the year and assuming that’s the case, we would be in a position to file an NDA sometime in the second half of 2016. If we were to get the drug approved depending on what the results look like, that’s a market that is about 1400 hospitals that see the bulk of the septic shock patients, so we would start to put plans in place, people, sales force together to be able to get the 1400 hospitals.

And could you give us a rough estimate on what could potentially be the size of the US trial that would be required?

I don’t think, if the data from this trial, from the LeoPARDS trial is positive, I don’t think we would need to do another trial. I think we would have the data in hand to submit an NDA. Now again that’s all speculative, that’s based on feedback from the FDA from last year is that they consider septic shock to be an area of such high unmet medical need that showing any positive data on clinical outcomes, they would consider to be extremely important. But again depending on what the results of the trial would be, they might come back and say, okay, we want you to do another trial. There are several scenarios that you could contemplate. They could give us a conditional approval and ask us to do another trial. But that’s all going to depend on what the results look like from the current trial. We are encouraged by the meta-analysis that was just published that put together I think seven different trials and showed a very positive trend on, benefit on mortality and other clinical outcomes in septic shock. So we will see.

So best case as we should be thinking about is that an NDA gets filed in late 2016 and potentially you have a septic shock indication on the market 2017?

Yes.

Thank you. The next question is coming from the line of Vernon Bernardino with MLV & Company.

Just a little bit more on the LEVO-CTS team, commercial [section] [ph] team that you had mentioned, I assume some of those will overlap with a team that could market levosimendan in septic shock?

Yeah, Vernon, we would anticipate one team and the size of the team will be dependent on the indications that we have. If we have both septic shock and – if we have septic shock, that’s a team that we have to call on the 1400 hospitals. Within those 1400 hospitals, it would be the 700 hospitals would be cardiac surgery that would be most important. So I believe that one sales rep in a hospital would be able to handle both indications for the drug.

Regarding levosimendan and its prospects for a review, now do you think the FDA would consider levosimendan given it’s not been approved in the US, would require advisory committee, would they consider it a new chemical entity, what can you say about the discussion as far as levosimendan, [FDA’s view on] [ph] levosimendan as a chemical entity?

Yeah, certainly it would be considered a new chemical entity because it’s never been reviewed or approved in the United States for marketing. So definitely we would have that classification. Whether or not it would have to go through an advisory panel is a good question. You can make the argument that given that the drug is already approved in 60 plus countries with over 1 million patients on the drug and all of the studies that have already been published that really – it doesn’t need to go to an advisory panel but that’s my opinion, not the FDA. So we’ll have to see what they say.

And you had mentioned, back to LeoPARDS, sorry, for jumping around. And your last interaction with FDA was last year. Have you had interactions with FDA about LeoPARDS and statistical analysis plan at all?

We had the meeting last November. The FDA in the minutes that they gave us from the meeting, they actually provided us an example of the type of analysis that they thought would be pertinent to this trial. And we’ve pretty much followed that guidance. So we have not had the need to go back to them and what we would be giving them is a statistical analysis plan that will include the primary analysis that was planned by the LeoPARDS trial group and then secondary analysis that pretty much mirrored what they had suggested to us.

And then from me a housekeeping question, Michael. Now you are hesitant [ph] to file a transition record, how will that be handled as far as regulatory filing?

Okay. So our plan at this point, we will continue filing our quarters as we have historically. So we will be filing a quarterly report for the period, the three months ended July 31, and then we will file another Q for the three months ended October 31, and then we will file our transitional 10-Q for the eight months ended December 31, 2015. Beginning in calendar 2016, we will be on a traditional calendar reporting cycle.

And pardon my ignorance, it’s been a while since I looked at transition records. How will the fiscal year be recorded for the transition reported?

It’s really going to be a combination, for example, from a balance sheet perspective we will show comparative balance sheets for the eight months ended December 31 against 4/30/2015 and 4/30/2014. For the income statement it will be similar. It will be a combination of fiscal and short year financials in comparative form.

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

I guess first just to clarify, when you submit the SAP in septic shock, will that be part of an NDA submission, are you going to submit that, get some feedback and then go back with an NDA submission?

We will submit the SAP to the FDA just as a matter of practice so that they have it and can see it prior to us coming down and talk to them about an NDA submission. So it will be a separate submission to them. We are not really looking for approval of that. We’re just giving it to them for their information in their review, they may have comment back to us, they may not but as I said we are pretty much giving them what they asked us to do and then we’ll follow that up later next year with the data if it’s positive with an NDA submission.

And then you mentioned in the press release that – and also in the commentary the financial position, opportunities helping financial efforts, are there opportunities out there that you are looking at and anything that you are kind of interested about [ph]?

We’ve had actually a number of incoming inquiries from banks and others asking us to look at products and if we would be interested in some other critical care opportunities. I think we’ve evaluated four, five so far this year, nothing that we have viewed as attractive and not for us to put an investment into but we’ve got a couple more that we are looking at, nothing that we’ve progressed to the point where we are ready to do any type of deal but we continue to look at things that come our way.

And last question, as far as I could say, I know you’ve discontinued from your perspective but have you had any interest in the asset?

Not a lot of interest. Nothing that we feel would have any positive significant financial impact. End of Q&A

Thank you. It appears we have no additional questions at this time. I would like to turn the floor back over to management for any additional concluding comments. John Kelley: Well, thanks everyone for joining us again today. We are very pleased to provide the update to you with regard to the progress that we’ve made this last quarter with levosimendan and we are excited to keep you up to date on how things progress from here. So thanks a lot and have a great day.

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