Tenax Therapeutics, Inc. (TENX) Q1 2015 Earnings Call Transcript
Published at 2014-09-24 11:14:05
John Kelley – Chief Executive Officer Michael Jebsen – Chief Financial Officer Nancy Hecox – General Counsel
Jeffrey Cohen – Ladenburg Thalmann
Greetings and welcome to the Tenax Therapeutics First Quarter 2015 Earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. (Operator Instruction) As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Nancy Hecox, General Counsel. Thank you. Ms. Hecox. You may begin.
Thank you, Kevin. Good morning and welcome to Tenax Therapeutics first quarter fiscal year 2015 conference call, the first since our name change from Oxygen Biotherapeutics, which we just announced last week. The company is now trading on the NASDAQ capital market under the ticker symbol, TENX. We continue to be headquartered in Morrisville, North Carolina. The news release with our financial results and corporate update became available at 8:00 am today and can be found on our website at www.tenaxthera.com. You may 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 this 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 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, and thank all of you for joining us. We are excited to be providing you with our first quarterly update call as Tenax Therapeutics Incorporated. The last 10 months have been truly transformative for the company. We have laid out a clear clinical and regulatory path forward that we are now focused on executing against in the coming quarters. With a new emphasis on critical care indications, we believe the name of Tenax Therapeutics fits our strategic direction moving forward. This direction includes the initiation of our Phase III LEVO-CTS trial and our work to activate all of the desired sites, the expansion of potential levosimendan opportunities with our support of the LeoPARDS trial of levosimendan in septic shock being conducted in the U.K., and the recent decision by our Board of Directors based on management’s recommendation to stop the Phase IIb traumatic brain injury trial for Oxycyte and consider strategic alternatives for that program. On the clinical front, we continue to roll out the Phase III program for levosimendan in low cardiac output syndrome with seven sites now activated and enrolling, including Columbia in New York and USC in California. We were pleased to announce earlier this week that the first patients had been enrolled in the trial. To date, we have active discussions ongoing at 68 sites, including 39 sites where contract discussions are underway and 15 of those where the budgets have been agreed to. We currently have a total of eight signed contracts, and we will be hosting an investigators’ meeting with all of the sites that are in the process in mid-October. We are aiming for a total of 55 to 60 sites with the expectation and goal that we will have all of them on board during the first calendar quarter of 2015. The process of activating sites has been a bit slower than anticipated but not at all unusual for a large-scale hospital-based trial such as this one. Budget agreements, contract negotiations and IRB approvals have to be done on a site-by-site basis and each situation is unique. Much of the timing is driven by the rules at each site and how their process is set up. As we see more hospitals activated with some of the larger sites coming onboard, we expect to see enrollment pick up. This is our main priority as a company during the next four to six months, and we are still expecting to have the last patient in the trial enrolled in the fourth calendar quarter of 2015 and the full data from the trial in the first calendar quarter of 2016. As a quick reminder on the LEVO-CTS trial details, the FDA has granted this development program fast-track status with approval of the Phase III protocol under special protocol assessment in confirmation that one successful trial will be sufficient for approval. LEVO-CTS is a multi-center, double-blind randomized placebo-controlled clinical trial that is testing the hypothesis that levosimendan reduces morbidity and mortality in cardiac surgery patients at risk for developing low cardiac output syndrome. The trial is designed to enroll 760 patients and we will be doing a full pharmacoeconomic evaluation of levosimendan treatment versus standard of care as part of the trial to help evaluate the full potential value. Just to touch again on the history of this drug, levosimendan is a calcium sensitizer that is approved in over 50 countries for acute decompensated heart failure. It has been used in over 800,000 patients to date with a significant portion of that use in cardiac surgery. There are numerous smaller trials published indicating that levosimendan can offer a significant benefit in this setting and we have what we believe is an optimal protocol for this study to show that potential benefit. We also believe that one of the compelling aspects of our story is the potential use of levosimendan in additional critical care indications where a low cardiac output state might exist. One of these areas of high unmet medical need is septic shock. We were very pleased to take advantage of an opportunity in August to provide a $500,000 grant to support the ongoing LeoPARDS trial in the U.K. evaluating levosimendan in septic shock. This is a randomized double-blind placebo-controlled multi-centre trial, and it is based on a number of smaller trials that indicate a potential benefit of levosimendan in this setting. The trial is being managed and primarily funded by the National Institute of Health Research and led by Imperial College London. It is evaluating if levosimendan reduces the incidence and severity of acute organ dysfunction in adult patients with septic shock and the safety profile of the drug. The trial began this past January and is looking to enroll a total of 516 patients. It was originally planned to take 24 months to complete with 74 patients currently enrolled. For a modest contribution, we were able to accelerate enrollment of this trial and see results earlier so we can determine if this indication would be a good target for development in North America. We believe that the contribution will help the trial enroll about 30% quicker, which could potentially take around six months off the original timeline. We would expect to see a readout of the data from this trial in calendar year 2016. This is an area of huge unmet medical need with 400,000 patients each year in the United States developing septic shock with a mortality rate of 50%. It is the leading cause of ICU admission in the United Kingdom and current standard of care with adrenalin-like drugs to support blood pressure has significant side effects. The mechanism of action of levosimendan as well as small clinical trials to date suggest the potential to avoid side effects and improve outcomes. We believe this is just one of a number of areas where the drug could have potential efficacy, and our financial strength allows us to be opportunistic around these types of situations. Finally, I want to discuss our recent announcement that we are halting the Phase IIb trial for Oxycyte in traumatic brain injury. This decision was solely a consequence of the continued slow trial enrollment, which simply made it impossible to complete this trial in a reasonable amount of time. We have struggled with enrollment issues from the start and tried a number of alternatives to correct the issue as the study progressed, but it just was not feasible. Given those difficulties, we decided in conjunction with our Board of Directors that stopping the trial was in the best interest of the company and its shareholders in order to efficiently utilize our resources. We are considering a number of possible alternatives for this program, including existing partnerships such as those that we have with the Army and Navy. Meanwhile, our main focus remains on executing the Phase III LEVO-CTS trial for levosimendan. Now let me turn the call over to Michael Jebsen to review the financial results for the past fiscal quarter.
Thank you, John. Total operating expenses for the quarter ended July 31, 2014 were $2.4 million compared to approximately $1.8 million for the same period in the prior year. General and administrative costs increased approximately $470,000 and research and development costs increased approximately $200,000 due to increases in personnel, legal and professional fees, and the costs associated with initiating the Phase III clinical trial for levosimendan. General and administrative expenses for the quarter ended July 31, 2014 were $1.4 million compared to $1.0 million in the prior year. This increase was due primarily to an increase in headcount and the costs incurred for external investor relations services. Research and development expenses for the quarter ended July 31, 2014 were $1 million compared to $800,000 in the prior year. The increase in R&D expenses was due primarily to the costs incurred for initiating the Phase III LEVO-CTS study, partially offset by a reduction in costs incurred for preclinical safety studies for Oxycyte as compared to the same quarter in the prior year. For the quarter ended July 31, 2014, we reported an overall net loss of $2.2 million or $0.08 per share compared to a net loss of $2.2 million or $2.06 per share in the same quarter the prior year. Included in the prior year net loss is approximately $650,000 of non-cash charges for the amortization of interest expense on convertible notes which matured in June of this year. As of July 31, 2014, we had cash and cash equivalents, including the value of our investments in marketable securities, totaling $56.4 million compared to $58.3 million at April 30, 2014. Overall for the remainder of fiscal 2015, we expect to see significant reductions in R&D expenses as a result of the decision to stop the Phase IIb TBI study overseas as we focus our capital resources on the clinical execution of our LEVO-CTS Phase III clinical study. Based on our existing capital, we are well positioned with sufficient funds to complete our Phase III LEVO-CTS trial and carry the program through potential approval. Our clinical execution and continued efficient use of capital will give us the flexibility to evaluate strategic opportunities for growth, including potential additional indications for levosimendan. With that, I’ll turn the call back over to the operator for Q&A.
[Operator instructions] Our first question today is coming from Jeffrey Cohen from Ladenburg Thalmann. Please proceed with your question. Jeffrey Cohen – Ladenburg Thalmann: Hey, good morning. Thanks for taking my questions.
Good morning, Jeff. Jeffrey Cohen – Ladenburg Thalmann: So firstly, one for Mike – would you anticipate any charges resulting from the halt of Oxycyte in the coming quarter, Q2?
We will continue to incur direct costs as we go through the process of shutting down that trial, but we don’t anticipate any significant costs as a result of the decision to stop the trial. Jeffrey Cohen – Ladenburg Thalmann: Okay, and John, could you review again – you said there were seven sites active in enrolling and you did name two of them, and discussions with how many?
We’ve had 68 hospitals to date that we’re actively having discussions with. Of those, 39 are in contract discussions and reviewing budgets, and I think we’ve got a total of eight signed contracts and 15 budgets that have been approved, so it’s really a matter of taking the 68 and moving them through the funnel. Jeffrey Cohen – Ladenburg Thalmann: Okay, so enrolling in eight currently, or seven active and enrolling?
Seven active to date. We’ve had two hospitals so far that have enrolled patients. Jeffrey Cohen – Ladenburg Thalmann: Okay, and you anticipate that number goes to 15 in what time frame and toward, call it 25 to 35 in what time frame?
Well, right now we have two additional hospitals that should be activated within the next few days. They’re literally at—you know, their IRBs have been approved, their contracts have been signed, and it’s just sort of buttoning up the paperwork and making sure they have drug on hand. So by the end of September we should have nine. I would anticipate that we’ll exceed 15 in October, and then by the end of this year, I think the goal is to be somewhere around 30 hospitals up and running with completion of enrollment in the first quarter. Jeffrey Cohen – Ladenburg Thalmann: Okay. Will you update us as far as the total aggregate number of enrollees prior to the event rate calculation at 200?
Say that again – update you in terms of the total number of sites? Jeffrey Cohen – Ladenburg Thalmann: Will you inform us as far as, say, 50 or 100 or 150 or 200 enrolled?
Oh, the progression of patients? As we continue to do these calls, we’ll continue to give you an update in terms of what the number of patients enrolled are. Jeffrey Cohen – Ladenburg Thalmann: Okay, and will you be announcing the event rate at 200?
Well, the check at 200 is just to make sure that the event rate looks okay, and the DSMB is the one that’s going to look at that, not us; so we’ll get some acknowledgment from the DSMB with regards to just continue to proceed, so they’re not necessarily going to give us a number and tell us what the event rate is, but they’ll let us know if we need to do anything corrective. Jeffrey Cohen – Ladenburg Thalmann: Okay, and you anticipate that that would be approximately 30%?
Well, 200 patients – yeah, somewhere in that range is probably right. Jeffrey Cohen – Ladenburg Thalmann: Okay, perfect. There has been some discussion in the past about you moving to a December fiscal year. When might that occur? Any color on that as far as time frame?
We anticipate if we do make that decision, we’ll make that formal decision in early calendar 2015 with a goal of completing the fiscal year December 31, 2015. Jeffrey Cohen – Ladenburg Thalmann: Okay, fantastic. Thanks for taking my questions, and good luck with the progression of the trial.
Thank you. (Operator Instructions) One moment please while we poll for further questions. We have reached the end of our question and answer session. I’d like to turn the floor back over to management for any further or closing comments.
All right, thank you. We appreciate everyone’s attention this morning. Thank you for joining us for this call, and we look forward to talking again to you soon. Have a good day.
Thank you, and that does conclude today’s teleconference. You may disconnect your lines at this time and have a wonderful day. We thank you for your participation today.