Greg Gin - Head, IR Brian Leuthner - President and Chief Executive Officer Bert Marchio - Chief Accounting and Administrative Officer and Interim CFO.

Vamil Divan - Credit Suisse Paul Matties - Leerink Partners Jason Butler - JMP Securities George Zavoico - Jones Trading.

Good day, ladies and gentlemen. Welcome to the Edge Therapeutics Second Quarter 2017 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..

Thank you, Michelle. Good morning, everyone and thank you for joining us today. Today, we reported our second quarter 2017 financial results and recent corporate highlights. Joining me this morning are Brian Leuthner, President and CEO; and Bert Marchio, Chief Accounting and Administrative Officer and Interim CFO.

Brian and Bert will make 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 webcast, click the Investor's link on the top navigation menu, then click on News & Events, then Events & Presentations on the left side. There will be a taped replay of this call, which will be available approximately two hours after the call’s 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 statements 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..

Thanks, Greg. What I’ll do today is, well, first of all good morning everyone. And what I am going to do is, I’ll begin with a high level summary of our second quarter and recent results before handing the call over to Bert for a review of our financial performance.

During the second quarter and in recent weeks, I’ve had discussions with many investors as the level of interest in Edge increases with the key milestones drawing near for our Phase 3 NEWTON 2 study of EG-1962.

As you may recall, our NEWTON 2 study is designed to support potential registrations throughout the world for EG-1962 as a treatment for aneurysmal subarachnoid hemorrhage.

We are comparing EG-1962 directly to the standard of care oral nimodipine and we are excited about the EG-1962’s potential to improve patient outcome by delivering targeted and sustained nimodipine drug exposure to the injured brain, while potentially avoiding dose-limiting side-effects, especially hypotension.

As a reminder, EG-1962 is being developed under U.S., in the EU orphan drug and U.S. fast track designation. Right now, we remain focused on the NEWTON 2 study and patient enrollment for NEWTON 2 is ongoing.

Investigator interest in the study continues to be strong around the globe and we now have 68 centers randomizing patients in North America, Europe, the Middle East, namely Israel and Australasia.

Our clinical operations team continues to focus on site and data monitoring and on providing ongoing training to investigators and the clinical staff to ensure the quality of the data and also on appropriate patient selection for the study.

Our clinical team and our clinical research organization have conducted many site visits around the world and we continue to provide 24/7 medical monitoring to field questions from investigators and research coordinators. Now regarding our timeline, we remain on track for key milestones from our NEWTON 2 study.

In particular, we continue to expect to report top-line results according to the timelines that we’ve discussed on prior calls including if needed, full study data readout in late 2018. Now there will be points in the coming quarters however, where valuable data will be assessed.

So first, in late 2017, we expect the NEWTON 2 independent Data Monitoring Committee or DMC to conduct a preplanned non-binding analysis for futility upon completion of the 90-day follow-up visit of the first 150 patients. Now if the DMC can recommend one of two possible outcomes from this analysis.

One is to continue to study its plan or two, stop the study due to futility. Now the futility analysis doesn’t make any assessment for efficacy, so there is no statistical penalty for this analysis.

Second, in late first quarter 2018, we expect the DMC to conduct a formal interim analysis for efficacy upon completion of the 90-day follow-up visit of the first 210 patients in NEWTON 2. At the interim, there is a possibility that DMC can recommend to stop this study for robust efficacy.

However, I want to emphasize that there is a higher threshold for stopping the study for overwhelming efficacy at the interim time point.

Now, in the event that results from the interim analysis are sufficiently positive, meaning greater than about a 20% absolute difference and the proportion of favorable outcomes among EG-1962 treated patients, versus oral nimodipine patients, then the DMC could recommend stopping the study.

Now in this case, we would meet with the FDA and other health authorities to discuss submission of a market application. If this level of efficacy does not materialize, the study could continue to enroll up to 374 patients with top-line full data available to report in late 2018.

Now, as a key point here is, our customers, the neurosurgeons and neurointensivists, to them, a clinically meaningful benefit is around a 10% to 15% absolute difference in outcome and the sample size of our study is designed to detect that effect at 374 patients.

Now, as a point of reference, our Phase 2 NEWTON North American study for EG-1962 showed a 32% absolute difference between the two groups, that’s EG-1962 and oral nimodipine in the proportion of favorable outcomes across all tolerated doses. So that’s essentially an update on what we expect in late 2017 and 2018.

Now, since our last quarterly call, we’ve also made some great progress with some important regulatory and pre-commercial activities for EG-1962. We received a product-specific pediatric waiver from the European Medicine Association, the EMA for EG-1962 that applies to all subsets of the pediatric population.

This waiver represents an important milestone in the regulatory process in Europe and will allow us to submit a marketing authorization application for EG-1962 to the EMA following completion of the NEWTON 2 study without the requirement to conduct clinical studies in a pediatric population either pre-approval or post-approval.

So let’s switch to pre-commercial activities for EG-1962. In planning for the scenario in which the DMC recommends stopping the NEWTON 2 study at the interim analysis, we made the decision to invest now in our manufacturing and supply chain capabilities.

With the supply agreement with Oakwood Laboratories that we announced last month, we achieved an important step in establishing the supply of EG-1962 for potential commercialization. We believe that this will provide adequate supply to address the estimated demand of EG-1962 at initial product launch and soon thereafter.

Now, let me turn to our activities to further develop EG-1962. We are evaluating alternative routes of administration to expand the population of subarachnoid hemorrhage patients who may benefit from EG-1962.

This includes our ongoing, controlled safety and pharmacokinetic study of EG-1962 delivered directly into the basal cisterns of the brain in patients with a ruptured brain aneurysm.

With this study, we are focusing on those patients that undergo microsurgical clipping for securing of their ruptured brain aneurysm, but who do not – who are not otherwise eligible for the NEWTON 2 study.

Now, we have enrolled several subjects to-date and plan to enroll a total of 12 adult subjects for this study, 9 of the 12 will receive EG-1962, while three subjects will receive oral nimodipine. So the pharmacokinetic safety incidence of delayed ischemia and clinical outcomes will also be assessed in this study.

Now we expect the data from this study to be available in late 2017. Now, over the longer-term, for EG-1962, we envision developing other ways for doctors to administer EG-1962 to any patient with subarachnoid hemorrhage who can potentially benefit from the medicine.

Another potential way to administer EG-1962 to subarachnoid hemorrhage patients is via an intrathecal or a lumbar administration into the cerebrospinal fluid or CSF via a single injection into the lumbar region of the spine.

During the second quarter, we initiated an analyst study looking at the safety and pharmacokinetics of delivering EG-1962 via a single lumbar puncture. We hope to initiate a clinical trial in 2018 with lumbar administration.

In addition to helping additional subarachnoid hemorrhage patients, we are excited about the potential to use lumbar administration of EG-1962 to address other serious conditions with high unmet medical needs and whether a few available treatment options. Before I turn the call over to Bert, let me briefly comment on our business development efforts.

We continue to look at opportunities including collaborating with other companies to utilize our Precisa development platform, as well as acquisitions, in-licensing, partnering and other strategic options.

We are assessing the landscape for some mid to advance-stage products in areas where we have core expertise at Edge including the most obvious which is the CNS or central nervous system and that’s specifically in the neurology and neurosurgery area, but we also have clinical and commercial expertise in acute hospital conditions in the cardiovascular area.

So for example, cardiology or cardiac surgery, acute oncology and also pulmonary. So with that, I’ll turn the call over to Bert for a financial review.

Bert?.

Thank you, Brian. As of June 30, 2017, cash, cash equivalents and marketable securities were $108.7 million, compared to $106.4 million at the end of the year and $95.6 million at March 31 2017. Our cash burn of approximately $9.3 million was in line with our projections.

During the second quarter, we completed a registered direct offering of common stock that brought in $18 million of gross proceeds and we trued down the remaining $5 million of our credit facility with Hercules.

Research and development expenses for the second quarter were $9 million, inclusive of approximately $0.8 million of non-cash stock compensation expenses. R&D expenses in the second quarter reflected increased spending on our ongoing NEWTON 2 study for EG-1962, spending on other clinical programs and increases in personnel costs.

General and administrative expenses were $4.2 million for the second quarter including approximately $0.8 million of non-cash stock compensation expense. G&A spending during the second quarter reflected legal and professional fees, personnel-related costs and other expense. We reported a net loss of $13.5 million in the second quarter.

As of July 25th, we had 30.9 million shares outstanding. As we look ahead, we expect operating expenses to increase as we continue enrolling subjects in our NEWTON 2 study of EG-1962 and as we continue to advance our other development programs including lumbar and cisternal and build our infrastructure.

Based on our current plans, we expect our cash and cash equivalents to be sufficient to fund our operations through the end of 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..

Thanks Bert. So, in closing, let me summarize our upcoming milestones. We look forward to our NEWTON 2 study’s upcoming data readout beginning in late 2017, top-line efficacy results from the interim analysis in late first quarter 2018 and if needed, the top-line results from the full study in late 2018.

Now, there remains a significant unmet medical need to improve outcomes in patients with subarachnoid hemorrhage and we look forward to receiving EG-1962 data in the coming quarters.

So we are also looking forward to data readout from our EG-1962 cisternal PK study and to advancing the lumbar administration of EG-1962 and a second Precisa-based product into the clinic in 2018. Thank you, again for joining us today.

We appreciate your continued support and look forward to updating you as we continue to advance through NEWTON 2 and other developments at EDGE. Operator, we are ready to take questions now. .

[Operator Instructions] Our first question comes from Vamil Divan, Credit Suisse. Your line is open. .

Great, thanks so much for the call and for taking my questions.

So just a couple if I could regarding the two you mentioned, the futility analysis late this year, you said it was non-binding, can you just explain what you mean by non-binding futility analysis? I think it’s a DMC recommend stopping the study you would need to listen at them maybe I am just misinterpreting what you mean.

And then, second on the interim, you went through some of what you are looking for in terms of the primary endpoint and what would be needed for the study to be stopped at that point.

Is there any sort of protections you have or any sort of plans just on some of the – certain important secondary endpoints around the health economic endpoints and might stay on some of those things just so that it hits on the primary – and have not being able to show enough on the secondary where it might you commercially? So if you can address those two? Thanks..

Sure, thanks, Vamil. So, okay, the first question is going to be around futility. So, yes, we – as you know the futility analysis is routine practice for a pivotal study. When we talk about this analysis as non-binding, it is truly non-binding.

The DMC can make a recommendation and generally as you do go along with the recommendation in the – from the DMC, but this is a scenario where it is set up that it is non-binding.

So, the second thing with regards to the second question around NEWTON 2, yes, we have, - so right now, we are looking at the primary endpoint being that proportional difference and favorable outcome between those treated with 1962 versus oral on the Glasgow outcomes were extended.

The secondary endpoint is the MoCA scale and interestingly enough, the MoCA generally trends along with the GOSE scale. Again, we are powering and we are only looking at the primary endpoints at the interim.

We will obviously look to see what happens with the MoCA, but generally, we have seen that the MoCA trends along with where the GOSE, but again, the study is powered based on the primary endpoint.

Does that answer the question?.

Okay, yes, it does. All right, thank you. .

Thanks, Vamil. .

Our next question comes from Paul Matties of Leerink Partners. Your line is open. .

Great, thanks so much. A few questions. One of them, Brian, I just wanted to again clarify the futility analysis.

If the DMC were to tell you that, their analysis being that the study was futile, but Edge decided to continue to proceed, would we on the outside in the investment community know that’s the case? How might the result of this analysis be communicated?.

Yes, and again, the futility analysis, other routine practices, this one is a little different because we are withholding the standard of care. So the futility analysis includes a combination of a statistical analysis which everyone is familiar with.

But also there is a clinical judgment by the DMC of how the two groups are performing in comparison to each other. So, if indeed, came back and we wanted to have discussions, the Chief Medical Officer, Mr. Herbert Faleck and Loch Macdonald will have a discussion with the DMC.

So, I think on that area, that’s how the process would be and we haven’t really discussed, we have discussed internally, but obviously have to let people know the results of that discussion at the futility point. .

Okay, thanks. And then, just clarifying, Brian on the powering, see you’ve talked about this first interim analysis being powered for something like a 20% drug placebo numerical difference on the rate of favorable outcomes.

What does this assume for the performance of the oral nimodipine control arm? Does it assume better than usual performance like Phase 2 or does it assume a performance rate that’s more in line with the historical data?.

Yes, so when we sized this study initially, we assumed with several data points that we looked at from a historical perspective, we were conservative in doing that. So we assumed that the oral nimodipine would do 28%, which is what we saw in the NEWTON study, the phase 2 study.

Historically, there is some other historical data points where oral did worse. But we assume that 28% on oral nimodipine would have a favorable outcome. So with that, we’d need to see roughly at the interim approximately about a 20% absolute difference. So if you do the math, you would need to see a favorable outcome rate of about 48% with EG-1962. .

Okay, thanks. And one last one.

Can you just talk a little bit about how internally you are contemplating success or failure with respect to the intra cisternal study?.

Yes, I mean, with the cisternal one, we are looking really at PK and because, we’ve got a large amount of data both in the animals, but as well as in humans, we’ve got immune looking that PK. So we are really looking at these plasma concentrations and the safety of these cisternal administration.

Obviously, we will be looking at from DCI and also the – like I said the intense of DCI and then we will be looking at the outcome, but we are really also looking at the safety. The primary purpose was really safety and PK on that. .

Okay, great. Thanks so much..

Thanks, Paul. .

Our next question comes from Jason Butler of JMP Securities. Your line is open. .

Hi, thanks for taking the questions. Just, first one about the lumbar animal study.

Can you just talk about what this trial can teach you about – administration and how you can compare and contrast the data to what you saw from animal studies with both cisternal and intrathecal administration?.

Sure, thanks. Hi, Jason.

So the question is, whether we are looking at in the animal PK study? And again, we have got now a very large database of animals that we are looking at around PK, given that our whole tox program that we did with both the intraventricular and the cisternal and then what we are doing here is, we are looking again at the PK, whether the plasma concentration if you administer it via lumbar, does it perform similarly in the animals as it did with the – as it did in the EVD administration.

And I think, from that perspective in the subarachnoid hemorrhage, I think that’s important. And then, I think that does potentially open it up to areas outside of subarachnoid hemorrhage. So, since the 80s, nimodipine has been studied in many different indications.

In fact, if you just go on clintrials.gov, you can just get a sense of the many conditions where it’s been evaluated. So we are beginning to receive some interest from investigators and we are talking to them about perhaps what are their indications outside of subarachnoid hemorrhage EG-1962 might have the best fit.

So that’s kind of why we are really interested. We can use it potentially in subarachnoid hemorrhage patients that don’t have an EVD and don’t undergo microsurgical clipping.

So we can address the larger population – the other half of the population that we can’t get in subarachnoid hemorrhage but as well in other potential indications outside subarachnoid hemorrhage. .

Okay, great. And then, just a question on business development priorities.

I know, the timelines here was it’s off to ten points, but just from a big picture perspective, are you contemplating completing something in-licensing or acquiring another asset before the 1962 interim results are available or is this something we should think about once we have data from 1962?.

Yes, so, with business development basically, we just want to say, we are actively looking for a potential asset. Our goal here is to build a fully integrated biotechnology company.

Really our strategy is, we are going to look at EG-1962 and exploit every other possible use that we could have with 1962 where this is in subarachnoid hemorrhage or outside, we are then looking at other Precisa-based programs or products. Obviously, we have 1964. We have got some other ones that we are looking at internally.

But then if there are – if other companies have assets that maybe using our Precisa development platform could enhance that product. We are looking there. But then we are also looking for other areas or other products that would stick within our core expertise in-house.

So that’s kind of what we are doing and we are actively doing that along with developing EG-1962. .

Okay, great. Thanks for taking the questions..

Thank you, Jason..

[Operator Instructions] Our next question comes from George Zavoico of Jones Trading. Your line is open..

Hi, everyone. Thanks for the update. Much appreciated. Two questions, one about the basal cistern application.

Is that pretty – are you going to be limit that to the basal cistern, the number of cisterns in the brain? And the basal cistern is probably where a lot of the - or many of the subarachnoid hemorrhages occur because of the basilar artery comes out of or a bifurcate.

So, just one question about that and follow-up on that is, how much of an enlargement of your eligible population would that add to, to the way you are already administrating through the EVD?.

Sure, thanks for the question, George.

So the first question is, when you look at the basal cisterns or the other cisterns, potentially you could put this in and we focused on the basal cistern because our customers, neurosurgeons have come to us and asked us about this kind of study, if they are already operating in microsurgical clipping, they have access to the basal cistern.

So, I think, based on what our customers, the neurosurgeons are asking for, that’s why we designed the study to look at the basal cisterns. And then the second question was, the incremental part? So, yes.

So if you – we are still doing finalization of kind of the market segments, but I think we are pretty comfortable about half of the patients out there will have a external ventricular drain. So we can capture that. Over the last ten years, the amount of microsurgical clipping to treat the ruptured aneurysm has decreased pretty significantly.

Right now, I think somewhere around 30% - maybe, 30%, 35% of all aneurysms are clipped. So I think, it’s clearly a smaller market than the EVD and I think there is other – and I think probably the lumbar – the opportunity in lumbar is a little bit bigger than the cisternal.

But we haven’t specifically quantified those numbers, but we do believe that the EVD is probably at least half the patients out there and then probably lumbar can capture them and then, again, the neurosurgeons have come to us asking about looking at this – the cisternal administration.

So, collectively, we want to make sure that we are providing an avenue that if a patient that suffers a subarachnoid hemorrhage can benefit from EG-1962 that we’ve looked at the safety and everything. So that they could potentially benefit from the analysis. .

Just to make sure I heard clearly, such that the microsurgical clipping procedure is – the frequency that is decreasing or just increasing?.

Yes, it’s decreasing. Endovascular coiling, endovascular coiling is becoming more prevalent going forward and microsurgical clipping is going down throughout the globe actually. .

And even with coiling, you still have access to the subarachnoid space, yourself just a coil to the hemorrhage side?.

But you are on the inside of that. So, an endovascular coiling on the inside of the basal. .

Yes, and you go on and put another hole in it – into it to put it into the subarachnoid space, right?.

Correct, correct, correct, yes. .

Yes, okay.

My next is about the supply chain and Oakwood, this just happened a couple months ago, I guess, what’s the first step there? Is there going to be – do you scale or you transferring the manufacturing now? What’s the first couple of steps that they are going to do now to prepare for the commercialization?.

Yes, no, Oakwood made their Phase 3 supply. So, now we are just working with them. We are happy that we’ve gotten agreement on the commercial supply and just our CMC team is working closely with those guys to continue to get things rolling for any event that we actually hit the interim. I mean, internally how we operated.

We plan on hitting a positive win on the interim we have to make sure from a manufacturing perspective, we have drug to supply and all that, but clearly on a financial perspective, the way we look at things is, we look at that we are going out to 374 patients, so that we have enough money to take it through full data readout at 374 with the cushion.

And I think that’s the important thing I mentioned earlier. If you talk to neurosurgeons, they will say, we’d like to see an absolute difference of 10% to 15%. That’s key for them. That’s a clinically meaningful point. So that’s what we sized the study at 374.

So, if we don’t hit at the interim, we are still – if we win at 374, that is still very clinically meaningful for our customers at that 10% to 15%. .

Okay, got it. Thank you very much. .

Thank you..

There are no further questions. I’d like to turn the call back over to Brian Leuthner for any closing remarks. .

No, just again, later this year and 2018 is going to be a very exciting year for Edge. And we appreciate everyone’s support and thank you very much. Have a nice day. .

Ladies and gentlemen, this conference will be available for replay after 11:30 AM Eastern Time today through August 15th at 11:59 PM Eastern. You may access the remote replay at any time by dialing 855-859-2056 and entering access code 53280120. International participants dial 404-537-3406 and access code 53280120.

Those numbers again are 855-859-2056 and 404-537-3406, access code 53280120. That does conclude our conference for today. Thank you for your participation in today’s conference. You may now disconnect at this time..