Good morning. My name is Rob, and I will be your conference operator today. At this time, I would like to welcome everyone to the Entera Bio Second Quarter 2019 Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-an-answer session. Thank you. Bob Yedid from LifeSci Advisors, you may begin the conference call.

Thank you, and welcome to the call. Joining me today on the call is Adam Gridley, our Chief Executive Officer; Phillip Schwartz, our President of Research and Development; and Dana Yaacov-Garbeli, our Interim CFO. A press release announcing Entera's financial and operating results for the second quarter of 2019 was issued this morning. For those of you who have not yet seen it, it will be posted in the Investor Section of our Web site at www.enterabio.com, and is also available at the SEC's Web site. On this call this morning, we will share with you a business update and our financial results which will be followed by question-and-answer session. During today's call, we'll be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These include statements that address future operating, financial, or business performance or our strategies and expectations. Forward-looking statements are based on management's current expectations and beliefs, and involve significant risks and uncertainties that could cause actual results, developments, and business decisions to differ materially from those contemplated by those statements. Those risks and uncertainties include but are not limited to the timing and conduct of our clinical trials, the clinical utility of our product candidates, the timing or likelihood of regulatory filing and approvals, our intellectual property position, and our financial position as well as those described in the risk factors in our annual report on the Form 20-F and in future filings with the Securities and Exchange Commission. We encourage all investors to read our SEC filings. All information we provide on this conference call is provided only as of today, August 20, 2019, and we undertake no obligation to update any forward-looking statements we may make on this call on account of new information, future events, or otherwise. Finally, please be advised that today's call is being recorded and webcast. With those prepared remarks, I will now turn the call over to Entera's Chief Executive Officer, Adam Gridley. Adam?

Thank you, Bob. I am delighted to join Entera at this exciting time of the company's evolution. A special thanks to the board of directors and Dr. Phillip Schwartz, our President of R&D, for his warm welcome, and I very much look forward to a strong collaboration with him and the senior team. His vision as a co-founder was part of what attracted to me to this opportunity as well as the commitment by our board to fully transition from the entrepreneurial research-based organization with a tremendous heritage and scientific reputation to a public global organization developing novel delivery therapeutics for unmet needs. The recent addition to board of directors, senior medical advisors, and a significant research and license agreement with Amgen announced in December are all examples of the steps we are taking to transform the company, and I look forward to stepping in to accelerate the company's evolution. Whilst there's truly a dearth of novel delivery mechanisms to take what were historically injectable molecules and biologics and I believe Entera can solve the age old challenges of converting some clearly efficacious products into a daily oral pill whether it would be for acute indication such as hypoparathyroidism or in some cases the disease that requires strong compliance to prevent osteoporosis. Our patients and our partners within the biotechnology and pharmaceutical community are all seeking and demanding better delivery solutions. This is not a zero-sum game to provide a competitive entry to leading injectables. Instead, this is an opportunity to expand the patient population who are not treating their symptoms or disease state due to a lack of satisfactory options. Lastly, I believe there is significant value to be unleashed within our patent protected therapeutic development pipeline, and we believe we have not yet fully realized the promise of…

Thank you very much, Adam. It's really been a pleasure working with you, and I would like to give a really warm welcome to Adam, and I have really enjoyed working with him for the past week and a half. I would like to begin our discussion with our lead candidate for osteoporosis, EB613. Based on the recent guidance we received from the FDA in the pre-IND meeting, we have greatly accelerated the potential development pathway for this drug. In the formal meeting that is from our FDA meeting in late 2018, the FDA provided positive feedback and guidance regarding our development plans and the use of the 505 (b)(2) pathway for the approval of EB613 for the treatment of osteoporosis. In this meeting, the FDA confirmed that Entera produced bone mineral density BMD as a primary endpoint, rather than fracture incidence and a registration trial to support a new drug application or NDA. We believe this guidance will substantially reduce the time and funding required to commercialize our product. Utilization of the 505 (b)(2) pathway should allow us to move EB613 into Phase 3 studies in 2021 with a high degree of confidence, and if successful, we intend to apply for marketing approval as soon as possible after the Phase 3 is completed. Although the utilization of BMD as a primary endpoint would allow us to conduct a registration enabling study for EB613 on our own, we have initiated discussions with large pharma partners to conduct the Phase 3 trial and to commercialize the product. We announced in July that we initiated enrollment in the short Phase 2A double-blind placebo controlled dose ranging study evaluating three different doses in 160 patients. We will evaluate both safety and determine the optimal doses of EB613 to advance into a Phase 3…

Thanks, Phillip. As I noted earlier, the business development opportunity is for both our lead programs and exploratory programs are substantial, and our goal is to narrow our focus and execute on a number of potential programs over the coming years. To frame the opportunity, there are three main areas of focus on our ongoing discussions of leading biotechnology and pharmaceutical companies. First are those companies with leading injectable franchises that are now facing patent expirations as well as the growing threat of biosimilars. Secondly, they're intriguing biologics and proteins that have been identified by other companies than in many cases have proven efficacy, but cannot be utilized as injections for a number of medical and technical reasons. These drugs frequently are discontinued in the development pathway that may be effectively developed with our oral delivery platform, which is a great interest to potential partners. In this way, similar to some of our work with Amgen, we're enabling the development of drug which might have otherwise not been usable. Lastly, we believe there are certain regional deals in China for a certain other platform applications, for example, our global deals where we may license Eb613 or 612 to rapidly develop and commercialize these products. Part of my joining the company was to broaden and accelerate the efforts of a number of biopharma companies that are currently evaluating our technology. While we can't predict exactly how and when each of these parties may move to a formal agreement with Entera, we can share with you a bit of detail regarding our ongoing dialogue. At the Bioindustry Conference in Philadelphia in June, we had significant inbound interest from a variety of leading companies. Those discussions continue and, in many cases, lead to confidential material transfer agreements, where such parties will work with…

Thank you, Adam, and good morning everyone. Our quarter results appear in the financial statement for the three and the six months end of June 30, 2019 filed earlier today. Revenue for the six months ended June 30, 2019 were $72,000 from services provided to Amgen under our licensing revenue. Our total operating loss for the six months end of June 30, 2019 was $5.2 million. Research and Development Centers for the six months ended June 30, 2019 were $3.4 million largely comprised of salary and related expenses, materials, clinical manufacturing, and other clinical trials expenses. General and Administrative expenses for the six months ended June 30, 2019 were $1.7 million largely comprised of salary and related expenses, including share-based compensation, legal and DNO insurance expenses. Total cash out of June 30, 2019 was the $7.4 million, which we believe will find our operation for the balance of 2019, and we are evaluating the variety of measures to increase our liquidity and working capital need. I will now turn the call back to Adam for concluding remarks before we go to question-and-answer session. Adam.

Thanks, Dana. We appreciate everyone's ongoing support with Entera and in just a few short weeks I've come to appreciate the broad opportunity before us as well as what is required if you only realize this. We will be rapidly developing a cohesive product development, business development, and Investor Relations strategy that we'll share with you in the coming months. All of the ingredients are here to create tremendous value, a strong R&D and management team, leading board members with diverse experiences and background, large markets with the substantial unmet need that we believe can be addressed with our validated technology platform. My responsibility and commitment to each of our patients and shareholders is to clearly articulate our value proposition and set realizable milestones based on these market drive strategies. We will then allocate our resources accordingly and fund the company in a responsible manner to help maximize the true opportunity of this technology platform. Candidly, we would be remiss if we only developed an oral version of PTH when our team is already seen compelling data well outside of our lead candidates. In summary, for those lead candidates, we have a series of important value creating milestones over the next couple of years for lead programs. These include the completion of enrollment of our dose ranging study for EB613, filing INDs for both programs, and the results of our Phase 2 dose ranging study for EB613. Lastly, we believe we have a global development opportunity, and we are rapidly engaging with potential business development partners, not just to bring in non-dilutive capital or reassuring partnerships, but to further develop our pipeline outside of PTH several which could have an even bigger impact for patients and our lead programs. In summary, we'll be reporting on these milestones and our progress on future calls, and we look forward to rapidly repositioning Entera as one of the leading oral delivery companies in the biotechnology industry. We'll now open up the line for any questions. Operator, please open up the line.

Thank you. We'll now be conducting the question-and-answer session. [Operator Instructions] Thank you. First question is coming from the line of Naureen Quibria with Maxim Group. Please proceed with your question.

Hi, good morning. Congratulations to Adam Gridley on your new role with Entera. So I was just wondering, could you perhaps, you know, you alluded to this, but share your view on the current competitive landscape on osteoporosis, particularly the anabolic space. You've got Forteo, presently there's one biotech who's generic Forteo, their PDUFA is coming up shortly in October, you have Amgen Evenity, also an injectable that just got approved in April. So, in light of all these developments, you have Entera with obviously EB613 perhaps you could -- how do you see EB613 differentiate in this competitive landscape?

Hi, Naureen, this is Adam. Thank you for the kind welcome, and happy to start, and then I'll turn it over to Phillip to provide some feedback there. So I think our enthusiasm for the market actually continues to grow. I think the competitive entrants very much signaled the need that exists here for patients, and as we highlighted both in the press release and our script, there's just still a very small percentage of available women who could be treating their osteoporosis, but hesitate to do this compliance issues with injectables. So, we actually think that with a presentation such as an oral opportunity, such as EB613, we can in fact grow the market for those that aren't dealing with symptoms immediately it's hard to be able to treat such a disease, but if you were able to improve this from an ease of use and compliance perspective, we think that this would be seen very favorably, both from a patient perspective, and also we've heard from our surgeons as well that they would do this very favorably. Phillip, anything that you'd want to add?

Yes, thanks very much, Adam. Yes, I would concur with everything that Adam said. In addition to that, I'd like to add that Forteo, which is currently exceptionally well-tested and utilized throughout the world has one of the best safety profiles, and it's very well understood how it operates. The primary driver from preventing people from utilizing Forteo even though it has a relatively large amount of revenue, very, very few patients relatively take it. We believe that making an oral version of Forteo essentially or EB613, as Adam mentioned, most specifically expand the market. Currently less than, I believe, approximately 3% of the market is treated with any form of injection or infusion of those osteoporosis patients, who are treated, and 97% of the treated population is treated with some form of oral therapy. So, clearly, one of the major drivers to whether someone will adopt therapy or not, is whether it's an oral medication or not for this silent disease. Additionally, as Adam mentioned, a relatively small proportion of the population is actually being treated for osteoporosis at all, and I think that these are actually very, very positive development for us because as many of these new anabolic agents, specifically Evenity and some of the generic Forteo's hit the market, I think it will significantly increase awareness, and I think our drug as well as their drugs have the potential to increase the amount of patients being treated for osteoporosis, which is a really important goal just to get more people treated for osteoporosis given how serious the disease is.

Great, that's helpful. Thank you. And with regards to your actual program, and you know, you have the Phase 2B that initiated, could you perhaps elaborate a little bit more on the study? How do you think the pace of enrollment will be in? How do you actually think the results may inform the Phase 3 study design?

Thanks, Naureen. So, I'll start. As we noted, we just started enrolling patients over the last month or so, all of the sites are currently enrolling, we have a number of patients in screening now, and we expect that enrollment will complete in the coming quarters. The way that the study is designed was of course based on significant input from the agency, and we'll have data readouts on a rolling basis starting in 2020 first with some of the bone marker data, which we will be collecting at three months with approximately 50% of the patients, and then followed by some of the bone mineral density data coming out at three and six months. So, this is really a dose-ranging study intended to help inform the appropriate dose for the Phase 3. We believe that the design of the Phase 3 based on the feedback from the agency is very solid, very well-defined, and unlike some of the historical fracture studies we'll be using some of the same data to then inform that Phase 3 design. Phillip, anything you'd like to add to that?

Yes. I think, Naureen, in focusing on your question about how will inform our design at Phase 3, this trial is really designed to go ahead and not to statistically separate each of the doses. We think that will have a very, very strong trend, but in primary concern is that we wanted to make sure that we were reaching a threshold where all of the patients would be adequately treated. And right now, currently with our low dose, we believe that that may be the case, but we'd like to confirm that as well. Additionally, I would say that having this data, the bone marker data is incredibly valuable because bone marker data has relatively small amounts of background noise in the data, and this data will be very, very highly predictive of the outcome and a longer BMD, Bone Mineral Density study. So, in terms of understanding how we can power that Phase 3 study, additionally, all of this data will be exceptionally helpful as well.

Great, helpful again. So, final question from me with regards to your EB612 program, you mentioned that you have data in September, the full data reported, but there was no mention of the conference, and I was just wondering what the next steps would be for that particular program?

Excellent. So, this data will be presented at the American Society of Bone and Mineral Research as this is typically where we're presenting most of our data that will be a poster presentation. We do expect and the full dataset will be assembled for a feature publication on a peer review basis. That will also help inform our next steps from a regulatory perspective and how we may design that Phase 3 study. So, this is the next step of that data release, and you should expect additional input from us in the coming quarters on what that program will look like.

Great, thank you. That's it from me.

Thanks, Naureen.

Thank you. [Operator Instructions] Our next question is from the line of [indiscernible]. Please proceed with your question.

Good morning, and thanks for taking the questions, as well as Adam congrats on taking the helms of the company.

Thanks.

My first -- no problem, and my first question is for the EB613 in osteoporosis trial Phase 2 study. When you report the three month biomarker data, at that time that the date -- the blind will be broken or does this trial remain sort of blinded?

Excellent question. So, the data will not be unblinded. So per the protocol and per discussions with the agency, the trial will remain unblinded and randomized. It's actually possible to do this with some studies as the endpoints are measured by taking blood tests. We'll then continue to follow patients at three and six months for the bone mineral density as well. So this is all part of the plan. We're very sensitive to making sure that the conduct and the robust nature of the data collection will be not impaired by that.

So, we will have redid some unblinded the data and get some feedings, but we don't know the finals, sort of, breakdown between the two groups -- two or three groups of that?

Absolutely. So that interim data we think will actually be quite instructive, and naturally, we want to make sure that our investors and our patients have visibility to that ongoing process. So that was part of the group protocol definition. And then we will continue to report out on the top line basis the three and six month data. And given the significant interest both from patients, investigators, and then potential business development partners, we very much designed that, so we could be not only providing rolling updates in terms of top line data, but then that'll also allow us to start to engage with the FDA on the design of a potential Phase 3 study. So, this is all part of the original plan as we design this.

Okay, great. And maybe one more follow-up question, which is that the Amgen collaboration, I know you may have -- you may be limited to what you can say, but just curious, what's the general guidance you might have for the future, say, any kind of announcement from Amgen regarding the progression of that program?

Sure, excellent question. And you are correct, the details of the Amgen program are confidential, but we can share with you that our ongoing collaboration is proceeding in a very positive matter. Our teams are in a regular dialog and doing quite a bit of work at our laboratories in Israel. We would expect that as we get to material updates over the coming quarters, we'll continue to provide visibility to the first program that they're evaluating, and then any other material updates that come out of that. Thus far, and I'll ask Phillip for any further thoughts, the collaboration has been extremely positive, and I think both parties been very pleased with the progress we've made. Phillip, any additional color you can provide…

Thanks, Adam. No, I would just add to that also Amgen has also been doing experiments also in their facilities as well. I think that we're allowed to reveal that as well. Additionally, I would say that this is, as Adam mentioned, this is for the first program. We can say that Amgen is constantly evaluating and looking at additional programs that they wish to enter into this collaboration and to this agreement. And so, we're looking and in constant discussions and in constant assistance to them, helping evaluate which programs would be most appropriate.

Okay, great. That's very helpful. I'll maybe just tag on one more. Just could you remind us what's the economy for the Amgen deal, any milestone and other stuff going forward should they be realized?

Sure. So, I'll start. So, we did announce there's an upfront payment that we received back in December. This has the potential for well north of $270 million in milestones as it relates to the specific milestones that are still confidential, but there are typical development milestones associated with certain regulatory process as well as development progress. Along the way, we also of course receive reimbursement for any of the research activities conducted by our teams and in Israel as well. So, we will continue to provide updates from a financial perspective, but we're expecting that this will be a very positive outcome, and hopefully we'll continue to provide non-dilutive funding as we move forward as well.

Okay, great, thanks, and again, congrats on the progress.

Excellent. Thank you, Yale [ph].

Thank you. I will now turn the call back to Adam, for closing remarks.

Thank you, Operator, and thanks to everyone for taking the time this morning to join our call. We appreciate your continued support, and we look forward to meeting with many of you over the next few months, attending investor conferences and also providing an update to our patients, our investors, and our analyst on our third quarter call targeted for November. Have an excellent day. Thank you.

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.