Edge Therapeutics' (EDGE) CEO Brian Leuthner on Q4 2016 Results - Earnings Call Transcript

| About: Edge Therapeutics (EDGE)

Edge Therapeutics Inc. (NASDAQ:EDGE)

Q4 2016 Earnings Conference Call

March 02, 2017 08:30 AM ET

Executives

Greg Gin - Head, IR

Brian Leuthner - President and CEO

Andrew Einhorn - CFO

Analysts

Brandon Folkes - Guggenheim Securities

Jason Butler - JMP Securities

Paul Matties - Leerink Partners

Operator

Good day, ladies and gentlemen and welcome to the Edge Therapeutics Fourth Quarter and Full-Year 2016 Conference Call. At this time, all participants are in a listen-only mode. After management's prepared remarks, there will be a question-and-answer session, and instructions will follow at that time. As a reminder, this conference call is being recorded.

I would now like to introduce your host for today’s conference, Greg Gin, of Edge Therapeutics. Please go ahead.

Greg Gin

Thank you, operator. Good morning everyone and thank you for joining us. Today, we reported our fourth quarter and full-year 2016 financial results and recent corporate highlights. Joining me this morning are Brian Leuthner, President and CEO; and Andy Einhorn, Chief Financial Officer. Brian and Andy will make brief prepared remarks and then we’ll open up the call for Q&A.

Before we begin, let me note that the press release we issued this morning is available on our website at www.edgetherapeutics.com. In addition, the live webcast of this call is also available on our website. To access the website, click the Investor's link on the top navigation menu, then click on News & Events, then Events & Presentations on the left navigation menu. There will be taped replay of this call which, will be available approximately two hours after the call conclusion and will remain available for seven days. The operator will provide the replay instructions at the end of today's call.

Today's conference call may contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent that any statements made on this call contain information that is not historical, these statements are forward-looking and are not guarantees of future performance and involve risks and uncertainties including those noted in this morning's press release and Edge's financials filings with the SEC.

Investors, potential investors, and other listeners are urged to consider these factors carefully in evaluating the forward-looking statements and are cautioned not to place undue reliance on such forward-looking statements. Actual results may differ materially from those projected in the forward-looking statements. Edge specifically disclaims any intent or obligation to update these forward-looking statements, except as required by law.

With that, I will now turn the call over to Brian.

Brian Leuthner

Thanks, Greg. I would like to welcome everyone to our call this morning. 2016 was a year of great execution at Edge Therapeutics. We achieved several key milestones across multiple events in our business, as we are focused on advancing the development of EG-1960 for Aneurysmal subarachnoid hemorrhage. And as many of you know, this is a field with limited treatment options for patients and frankly without a new medicine approved in almost 30 years.

Our significant progress is the result of the team's fully alignment -- for being fully aligned here and focused on execution to bring our potentially lifesaving treatment, EG-1962 to those patients who have suffered this catastrophic condition called a Subarachnoid Hemorrhage, or better known as a ruptured brain aneurysm.

So, as we look to continue our momentum, we believe that we are operationally and financially well positioned to execute our corporate growth strategy through achievement of our key clinical milestones. Let's begin with our lead program, EG-1962 for aneurysmal subarachnoid hemorrhage. Following our strong results in the Phase 2 NEWTON North American study, we initiated our attributable Phase 3 NEWTON this past July.

NEWTON 2 is a global randomized, double-blind, placebo-controlled study of EG-1962 versus the standard of care, which has currently oral Nimodipine, and that’s targeted to enroll up to 374 adult patients in about 80 sites throughout the world. We designed the NEWTON 2 study largely based on our promising Phase 2 NEWTON study results. That is the same patient population, the same competitor and the same assessment for efficacy. So, as we aim to reproduce the positive efficacy and safety results that were seen in the Phase 2 study.

Now as a reminder EG-1962 is being developed under U.S. and EU orphan drug and U.S. fast track designations. We continue to focus on activating clinical sites for NEWTON 2, including many of the world centers of excellence for treating this condition. And this includes leading academic sensors and high volume ruptured brain aneurysm treatment centers.

Its important to note that many of these sites have experienced conducting clinical trials in subarachnoid hemorrhage and include many of the sites from our original NEWTON study. This experience is very important to ensure selection of appropriate patients and to adhere to the study protocol. As you can see up on clinicaltrials.gov, we currently have 43 clinical study sites actively screening for patients throughout the world. NEWTON 2 remains on track with our previously stated anticipated time line for top line data from the pre-specified interim analysis in the first quarter of 2018 and for a read out of the top line results from the full study in late 2018.

Now in addition to activating these experience sites, we are equally focused on ensuring that the quality of the NEWTON 2 -- on the quality of the NEWTON 2 study. Our clinical team is hosting ongoing training sessions with investigators and the research coordinators. In fact, in the first training session, we had over a 160 investigators and researchers on the webcast from all over the world, which have tested the global interest in the study, and frankly the recognized unmet medical need in this area. We have also a very active medical monitoring process, in which study investigators can call our medical monitoring team 24/7. And finally, we continue to have a high-degree of onsite monitoring by our clinical team along with our clinical research organization.

So bottom line, we continue to do all of the necessary things in order to minimize variability and maintain the highest of quality for NEWTON 2 as we expand the number of sites up to about 80 for NEWTON 2 from that 20 that we have in the Phase 2 NEWTON study. Speaking about the NEWTON study, last week we presented a new analysis of exploratory data from our Phase 2 NEWTON North American study at the International Stroke Conference in Houston, Texas. The poster and the data outline the comparison of the outcome results from using the extended Glasgow Outcome Scale, the GOS-E and the NEWTON North American study with other exploratory outcome measures that were gathered in the study, including the modified ranking scale. The results of the analysis show that the GOS-E and the modified ranking scale gave similar results on patient outcome after aneurysmal subarachnoid hemorrhage.

Now shifting gears for a quick update on this external study that we are looking at using EG-1962. As we said, our NEWTON 2 studies investigating EG-1962 administered through an external ventricular drain compared to oral nimodipine. And according to our market research, this method of delivery for EG-1962 captures about 50% of the aneurysmal subarachnoid hemorrhage patients. So what we are seeking to do with this external study is to potentially expand that patient population for EG-1962 outside of those patients that require an EVD, and we'll focus on patients that undergo microsurgical clipping for the securing of the ruptured brain aneurysm, that do not have an external ventricular drain in place.

So little [indiscernible] and about the study, this is an open label study and it will investigate the safety and pharmacokinetic profile of EG-1962, administered directly into the basal cisterns of the brain, and again will compare to oral nimodipine, and this will be in a group of 12 adult subjects with aneurysmal subarachnoid hemorrhage. Nine of the subjects will receive treatment with EG-1962, while three subjects will receive the standard of care. Again, that's oral nimodipine.

Clinical outcomes will be assessed as well. So this external study is an open for enrollment at two sites right now that are extremely for patients her in North America and we expect to have another one to two sites, have then come along online in 2017. So we expect and anticipate data readouts from this study in 2017.

In addition, we do plan on conducting some preclinical work on another alternative delivery approach for EG-1962 and patients that don’t require an EVD. So in 2017, we plan to conduct animal studies looking at the safety and the pharmacokinetics of delivering EG-1962 via a single lumbar puncture. So this method would entail the administration of a single injection of EG-1962 into the cerebrospinal fluid via a catheter in the lumbar region of the lower back. Now if successful, and depending on the magnitude of effects that we would see in preventing this delayed deterioration in the NEWTON 2 study, we believe that both intracysternal external and lumbar administration together with the intraventricular administration, can establish EG-1962 as a prophylactic treatment to improve outcomes in a majority of patients that suffer on aneurysmal subarachnoid hemorrhage.

Now I would like to turn briefly to our pipeline. In addition to EG-1962, we're investing in the development of additional product candidates from our Precisa platform for other acute neurological conditions as well as conditions outside the brain. So as a reminder Precisa is our proprietary programmable, biodegradable polymer based development platform that enables targeted delivery of therapeutics with high and sustained drug exposure to save an injury. So in 2017, we're focused on preclinical work in order to identify a second Precisa based product which depending obviously on the pre-clinical results could advance into the clinic in 2018.

And now, I'll turn it over to Andy and he will go over the financial review.

Andrew Einhorn

Thank you, Brian. I'm pleased to report that Edge is in a strong financial position. Earlier today we issued a press release detailing our financial results for the fourth quarter and full year 2016. Cash and cash equivalents at December 31, totaled a 106.4 million. Research and development expenses in the fourth quarter were $6.8 million inclusive of approximately $568,000 of non-cash stock compensation expenses, and for the full year 2016, R&D expenses for $24.8 million, including 2.2 million of non-cash stock compensation expense. R&D expenses during 2016 reflected spending on our NEWTON 2 study for EG-1962, which commenced in mid-2016, spending on other clinical programs and increases in personnel costs.

General and administrative expenses were $4.2 million for the fourth quarter, including approximately $708,000 of non-cash stock compensation expense. For all of 2016, G&A expenses were $14.7 million, including $3.1 million of non-cash stock compensation expense. G&A spending during 2016 reflected increased personnel costs, facilities cost and professional fees. We reported a net loss of $9.5 million in the fourth quarter and $38.8 million for the full year 2016. As of February 24, 2017, we had 29 million shares outstanding.

As we look ahead, we expect operating expenses to increase as we continue adding sites and enrolling subjects in our NEWTON 2 study of EG - 1962, and as we continue to advance our other development programs and continues to build our infrastructure. Based on our current plans, we expect our cash and cash equivalents to be sufficient to fund our operations through the full data readout from our NEWTON 2 study, which is anticipated to occur in late 2018.

And now I'll turn it back over to Brian.

Brian Leuthner

Thanks, Andy. So in summary, we are focused on delivering further progress towards our anticipated interim and full data read outs from our Phase 3 and NEWTON 2 study in the first quarter of 2018 and late 2018 respectively. In the meantime, we look forward to enrolling the first patient and reporting data from the cysternal study of EG - 1962 this year and we're operationally and financially well positioned to execute our corporate growth strategy. So thank you again for everyone joining us today. We appreciate your continued support, and we look forward to updating you as we continue to advance through NEWTON 2 and other developments, here at Edge.

Operator, we're ready to take some questions now.

Question-and-Answer Session

Operator

Thank you. [Operator Instructions] And our first question comes from Paul Matteis of Leerink Partners. Your line is now open. And our next question comes from Louise Chen of Guggenheim Securities. Your line is open.

Brandon Folkes

Hi, it's Brandon Folkes, on for Louise. Could you just give us a bit more color in terms of how the enrollment is progressing for the NEWTON study, compared to your expectations and how we should think about reimbursements and payment for EG-1962, especially in light of, if you do get the intracysternal and lumbar administration successfully through? Thank you.

Brian Leuthner

Sure. Thanks Brendon. First from an enrollment standpoint, it's on track. Earlier we gave -- we continue to give guidance that we look to have the interim analysis in first quarter 2018 and full data readout by the end of 2018. So we are on track from that. From a reinvestment standpoint, Dan Brennan, our COO and our team, and his team is looking at the reimbursement. Obviously we know this hospital product is going to be reimbursed through DRG and there are several mechanisms that we can work with, but we're really looking at the whole patient journey. The patients starts in the hospital. Most of them go to rehab and then their journey doesn’t end from there. So we're really trying to identify the charges that are involved in those areas, but clearly we have to wait and see a lot on what the results are going to be for the NEWTON 2 study and the magnitude of effect. But clearly if we're better and I'd say better more effective, it doesn’t cause hypotension single administrations, I would expect to see price to the premium.

Operator

Thank you. And our next question comes from Jason Butler of JMP Securities. Your line is now open.

Jason Butler

Just a question about the data you presented last week or a recent -- at the staff meetings, is there anything what you can say when you look at the different endpoints that speaks to the overall variability of the measurements and clearly, it's an outcome measure, but is one endpoint more or less variable then the other. And then the last question, I know that there was no placebo on here, but anything that you have -- is there any additional data from the modified rank that gives you confidence in your assumptions for the powering of the Phase 3 trial? Thank you.

Brian Leuthner

So the data that we presented in that poster that – at the International Stroke – really to us, the primary takeaway was that no matter what scale you use on a functional outcome, whether it would be the Glasgow Outcome Score extended or the modified ranking, that they track in parallel pretty much from it with each other. And some of the other outcome endpoints that we looked at, again at the moco [ph] which is a secondary, it seemed to be consistent with what we saw from a Glasgow Outcome Score, at least run in similar trends. So that was again something that we wanted to look at in the Phase 2, that determined which one that we will protect, potentially take into the Phase 3. But the key here is really that point around the modified ranking and the Glasgow Outcome Score extended running in the same path on the functional outcome.

Jason Butler

Okay, great and then just on the cysternal study, when you think about the differences in the patient populations, that they get a catheter or don’t get a catheter, is there anything that would read to what your expectations for the benefit -- magnitude of benefit you would see through cysternal delivery.

Brian Leuthner

No I think -- I think part of it is whether they get the catheter. That has to do with, whether they have hydrocephalus or from that prospective. So really what we're doing in the cysternal study is we're looking at sick patients again, but that are treated with microsurgical clipping. So they are not getting coiling, and they did not need a external ventricular drain for medical management. So there is a portion of that population that doctors have come to us and said, if this medicine works in the NEWTON 2, what kind of data might you have to actually provide in those patients that don’t have an external ventricular drain.

Operator

Thank you. And our next question comes from Vamil Divan of Credit Suisse. Your line is now open.

Unidentified Analyst

Hi this is actually Barbara [ph] for Vamil. So on your NEWTON 2 study, I was trying to understand, how many patients do you think will be at the sites that were also active in the first NEWTON study?

Brian Leuthner

I'm sorry Barbara [ph]. I couldn’t quite hear your question. Could you repeat it, please?

Unidentified Analyst

Sure, I was asking on how many patients in the NEWTON 2 study do you think will be from -- will also be from the active sites in the first NEWTON study, in terms of overlap?

Brian Leuthner

Well I think, most of the sites that were used or were involved in the NEWTON study are part of the NEWTON 2. In fact, our two leading enrollers are NEWTON sites. So we think -- again, part of that depends on where the aneurisms occur. Clearly most of the studies, or most of the sites in NEWTON are involved in the NEWTON 2, but we can't determine what that distribution is as far as when patients who going to have aneurisms and where they are going to be.

Unidentified Analyst

Sure, and just checking if is there is any update on the number of patients that you expect to be treated annually? Are we still looking at 17,500 patients or is there a change in how you're thinking about this, given the other purchase that your thinking about right now.

Brian Leuthner

So we're doing a lot of work to try to really identify and further identify that target population. We do know there is an ICD9 code 430, that has around subarachnoid hemorrhage. So that's not just aneurismal. So Dan, Brandon and his team are trying to look what's in that number. And again, the market research that we continue to do about the consistency of how many patients actually who have a ruptured aneurism get in external ventricular drain still continues to be about 50%. So those are the numbers. We will continue to get more clarity as we try to use other sources to dig down into that for ICD9 430. So we'll continue to look at it, but right now we're looking at that 175 or so.

Operator

Thank you. [Operator Instructions] Our next question comes from Paul Matties of Leerink Partners. Your line is now open.

Paul Matties

I'm sorry if this question has been asked. My line has just been dropping on and off. But I was wondering if you could give an update on the number of sites that are open for NEWTON 2, and maybe just expound it on the degree to which the IRB [ph] and getting sites opened in a reasonable timeframe, how easy that's been relative to your expectations. Then I have a quick follow on the [Indiscernible]?

Brian Leuthner

Sure. I'll answer that first question right. 43 sites are actively screening patients throughout the world right now, compared to 21 sites at the time of our third quarter call. I can tell you our clinical team is really executing well, and frankly the whole organization is supporting their efforts to get these sites. How easy, how hard it is to get these academics centers? Our expectations is there just a lot of paperwork and diligence at the hospitals. These are very-very sick patients and I would say our team learned a lot from NEWTON, and we're doing -- the team is doing a really good job on getting that up. The other thing I would say is the enthusiasm on the other end of the investigators. I mentioned this during the call, we're doing a lot of training and working with the sites from a quality perspective and everything. That first conference call webcast that we had, 160 PIs and research co-coordinators participate from throughout the world. So there is general excitement, I think partly because of the study but partly because this is such an unmet medical need to be the studies. So I think from that standpoint we're pleased.

Paul Matties

Great and so Brian just to conceptualize it, it's this tracking in line with what you are expecting when you outlined the timing of an interim analysis of full data?

Brian Leuthner

Yes, so exactly. Our timelines haven’t changed. We've been looking at sites and really focused our initial efforts on sites that have higher volume patients and then continue to go out. So we've got a potpourri of centers but we did focus initially on the sites that saw a large volume. So yes, we are very pleased and as we continue to say, we're looking on the timeline standpoint, the interim, still looking at the first quarter of 2018 and then really the full data is what we pay attention to, and we're on target to finish up by the end of 2018.

Paul Matties

Great, thanks. And then maybe just one on the secondary endpoints, Brian. You and I have talked about how it's important to generate clinical data that's intertwined with pharmacokinetic outcomes. Beyond the primary, can you talk about how well powered you are to show a benefit on length of ICU stay and length of hospital stay, and how important you think these measures are to ultimately selling the drug. Thanks so much.

Brian Leuthner

Sure. Thanks for that question Paul. Well I think -- from a ICU and length of stay in the hospital, we are gathering that data just like we did in the NEWTON study. I think as you recall, we reduced the ICU like to stay in NEWTON, the Phase 2 study by about 3.5 days of median time and then the median hospital length of stay, we reduced by about 2.5 days. But always, as you know, we always talked about -- these patients are really sick. On the median time, they are in the hospital for almost a month. And they are also in the ICU for almost 20 days or so. And then two-thirds of them in NEWTON got released to a rehab center or long term care facility. So clearly these are really sick patients, but we do look at -- the nice thing about our end point, our primary end point is Glasgow Outcome Score extended. And one of the key components between a favorable and an unfavorable outcome is the ability of that patient to go back work in some manner. So here is a great example of where our primary end point, not only is very meaningful from a regulatory prospective. Obviously that’s what FDA wants. But from a health economic standpoint, taking these patients that are on average 50 years old or so -- the other day we have someone in his 30s. These are young people and we're looking to actually get them back to normal and back to work, we believe sends a strong health economic message to our payers. So that’s kind of prospective. Did that answer your question Paul?

Paul Matties

Yes. Thank you very much.

Operator

Thank you. [Operator Instructions] And ladies and gentleman this does conclude our question and answer sessions. I’d now like to turn the call back over to Brian Leuthner for any further closing remarks.

Brian Leuthner

No remarks. I just wanted to say thank you again for everyone for dialing in and listening, for asking those great questions, and we appreciate your support. Thanks again and have a nice week.

Operator

Well, ladies and gentleman, this conference will be available for replay after 11:30 AM Eastern today through March 09, 2017, 11:59 PM Eastern. You may access the replay at any time by dialing 1800-585-8367 and entering the access code 650-67-360. International participants dial 404-537-3406. These numbers again are 1800-585-8367 and 404-537-3406. Access codes, 650-67-360. That does concludes our conference for today. Thank you for your participation. You may now disconnect.

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