Good morning. My name is Sonia, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Entera Bio Third 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. Adam Gridley, you may begin the conference call.

Good morning. Thank you and we welcome you to the call. Joining me today on the call are; Philip Schwartz, our President of R&D; Arth Santora, our Chief Medical Officer; and Dana Yaacov-Garbeli, our Interim CFO. A press release announcing Entera's financial and operating results for the third quarter of 2019 was issued this morning. For those of you who have not yet seen it, you'll find it posted in the Investor section of our website at www.enterabio.com, and it is also available at the SEC's website. On our 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 will 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 or expectations. Forward-looking statements are based on management's current expectations and belief, 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 section and 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, November 21, 2019, and we undertake no obligation to update any forward-looking statements we may make on this call on account of new information, future…

Thanks, Adam. In 2019, we initiated enrollment in a six months Phase 2 double-blind, placebo controlled dose-ranging study evaluating three different EB613 doses in 160 patients. This study is being conducted at four leading centers in Israel, is supported by a U.S.-based medical monitoring and operations team. And we are targeting post-menopausal women, who have low bone mineral density or BMD, either in the low osteopenic or osteoporotic range. We will evaluate those safety and determine the optimal doses of our EB613 oral PTH tablets, we’ll then advanced into a Phase 3 pivotal study. Trial will last six months with effects on biochemical markers of bone formation evaluated. In this case, P1NP, after three months and then BMD and safety endpoints evaluated over six months. Assuming a favorable outcome of this proof-of-concept study, we would then conduct a single, larger Phase 3, multi-center head-to-head, non-inferiority BMD endpoint study comparing Entera Bio's, EB613 oral PTH with Forteo injectable PTH over a six to 12 months treatment period. The active form of parathyroid hormone in Entera Bio's PTH EB613 tablets is Teriparatide. The same human PTH 1-34 peptide in injectable Forteo the well-tested pioneer, osteoanabolic drug, shown to reduce the risk of spine and non-spine fractures and utilized in over 1.5 million Osteo product women worldwide. Short-term bone marker data and BMD data have historically been very predictive of the anti-fracture efficacy of parathyroid hormone and similar osteoanabolic drugs and subsequent large fracture endpoint trials. Thus we believe the upcoming data readouts from the Phase 2 study in 2020 will be very meaningful and greatly increase the probability of success in Phase 3. The key milestones for this trial start first with projected patient enrollment completion in the first half of 2020. And we expect to see the interim and full three…

Thank you very much, Arth. Good morning, everyone. I'd like to provide you an update in two areas; first, our collaboration with Amgen for the development of an anti-inflammatory agent has progressed well, since we kicked-off this program in early 2019. In less than eight months, a number of studies have been conducted with what we believe are very positive results. Both teams are targeting, moving these old formulations into the next level of development and testing. Critical to the rapid development of this drug is Entera's ability to rapidly customize the formulation to meet the particular PK and pathology to be treated. In Amgen situation, Entera has been compelled to develop a very different formulation and new technological innovations in order to develop a drug with the appropriate PK/PD characteristics and targeted as required by Amgen. Second, we continue to evaluate new API's where technology platforms may have significant utility. Our Research and Development group has developed refined methods to rapidly determine a go/no go response to each API drug tested with the underlying tunable technology platform. Using a newly developed set of in vitro assays, the Entera R&D team is now able to cut the initial evaluation time in almost half. To-date, Entera has blocked more than seven different API's into preclinical animal testing. Preliminary proof of concept data supports working with large molecule biologic drugs from small 3 to 4 amino acid peptides to the humans, biological proteins with more than 100 amino acids. As we gain more experience and knowledge, we are better able to evaluate the applicability of the technology. So, it's also saving time by knowing, if a particular molecule or target class is not feasible. While we have to set a target to identify at least one most promising API target in 2019.…

Thanks, Phillip. Besides our Amgen collaboration, we continue to explore a variety of co-development opportunities and are currently seeking a new Head of Business Development to partner with Phillip and myself, help lead the various collaboration opportunities before us. As outlined last quarter, we are currently focusing in three main areas. Our first priority is to work with companies seeking to leverage our development and delivery capabilities to work with their internally developed compounds and/or injectables perhaps in a structure similar to the Amgen collaboration. The recent approval of Novo Nordisk oral GLP-1 agonist, which utilizes the same absorption enhancer that Entera uses, has stimulated great interest in our oral large molecule delivery systems. The approval of Novo’s drug not only validates our use of this particular absorption enhancement molecule and other indications, but also proves that it is possible to get an oral biological drug approved by FDA. Additionally, the Novo approval has the potential to ease our regulatory processes and has resulted in a substantial increase in the number of detailed discussions with several additional companies seeking to co-develop their molecules or APIs as oral therapies. Given the very tunable nature of our technology, many companies have approached us to help solve their particular drug delivery problems. Our second priority are the initial efforts and potential commercial and licensing arrangements around our lead EB613 oral PTH program in osteoporosis. Given the rather short development pathway to a Phase 3 study as identified with the FDA, we're starting to engage today with potential commercial partners who may have an interest in working with us on the Phase 3 program. For evaluating our opportunities to complete the global registration trial on osteoporosis on our own, or whether we choose to license this prior to a Phase 3, where leading pharmaceutical…

Thank you, Adam. Revenues for the nine months ended September 30, 2019 were $134,000 from services provided to Amgen under their licensing agreement. The cost of revenues includes direct salaries and related expenses. Total operating expenses, all of this for the nine months ended September 30, 2019 was $7.9 million. Research and development expenses for the nine months ended September 30, 2019 were $5.2 million largely comprised of salary and related expenses, materials, clinical manufacturing and clinical trials expenses. General and Administrative expenses for the nine months ended September 30, 2019 were $2.8 million largely comprised of salary and related expenses including share-based compensation and legal and DNO insurance expenses. Total cash as of September 30, 2019 was the $5.9 million, which we believe will fund our operation into the first quarter of 2020. I will now turn the call back to Adam for concluding remarks before we go to Q&A. Adam?

Thanks, Dana. We thank our patients, physicians and investors for their support of our efforts to bring an oral delivery technology and PTH to the market and to expand the utility of this novel platform. The recent research and interest in the off described Holy Grail target of oral large molecule drug delivery is resulting in a new focus for our Teams internally and partners externally. We believe 2020 will be an important year for us and a considerable inflection point for the company, where we expect the fruits of many years of efforts start to result in meaningful data readouts in our Phase 2 osteoporosis program. And our collaborations with Amgen may start to take us into potential preclinical and eventual clinical programs. We are making the requisite investments in our teams in both Jerusalem and in our new headquarters in Boston. And we'll build out our team responsibly and expand our pipeline in large markets with significant unmet needs. For our investors and partners, we believe we can both take share from existing blockbuster franchises, and more importantly, grow markets by giving patients a state, convenient, and effective oral administration alternative that may allow them to better treat and modulate their disease states. The growth of proteins and biologics across many of the newest blockbuster launches provides a strong growth opportunity for us, as we look at our next product target. These could be in well-established areas, such as growth hormone deficiency with oral growth hormone or osteoporosis with Oral PTH or more broadly into larger macro molecules of biologics. Our work on our internal programs, Amgen and to a various early research evaluations have given us further confidence regarding the utility of our platform to be extended to other proteins, peptides and biologics, some as large as…

Thank you. [Operator Instructions] Our first question comes from Jason McCarthy of Maxim Group. Your line is now open.

Hi. Good morning. This is Joanne Lee on for Jason. Thank you for taking the question and congratulations on the progress this quarter. So, I was wondering, with the recall of Takeda’s Natpara. Could you perhaps share your view on how this would impact the company's EB612 program, especially considering that the recall was mostly related to an inactive ingredient, which is unlikely to happen with an oral product? As such, has there been any shift in focus considering the development in the space?

Hi, Joanne. This is Adam. Thanks for the question, and thanks for joining the call this morning. Certainly, it's something that we along with the physicians and patients affected by this terrible disease are watching closely. I think what has happened is, that it has created a heightened awareness regarding the need for better therapies. We've seen, for example, one of the competitors who was looking at an injectable, such as incentive [ph], has been able to better recruit to their clinical trial for this really, really tough disease state. So, while it's been very unfortunate for patients and physicians, I think it is creating a heightened awareness for both of our programs and some of the others. As we think about how we're going to proceed with this program, this continues to be a very high priority. Some of the recent data that we’ve generated and reported back in September was quite compelling. And we're looking at our final formulation programs to determine how we potentially take this into a Phase 3 as well.

Thank you. That was helpful. And I'd like to see if you could give us a bit more of an idea on how large of a Phase 3 trial you need to take EB612 to registration in HPT, and would you expect it to be on a similar scale of Natpara’s P3, which was around 124 patients.

Sure. Great question, Joanne. Let me turn that over to Arth Santora, our Chief Medical Officer, and he can comment. I think you're right along the lines of what we would envision for Phase 3 as well, but Arth, any additional thoughts?

I just like to confirm what you said, it's an orphan indication, and it's very difficult to find patients with hyperthyroidism. So we would envision a Phase 3 program. It might be a little different and design, would probably include somewhere around 100, 150 patients tops. That's very typical for an orphan indication.

Thanks, Arth.

Great. Thanks again. Sorry. Yeah. That'll be all from me. Thank you.

Excellent. Thanks, Joanne. Appreciate you joining the call.

Thank you. [Operator Instructions] And this does conclude our question-and-answer session. I would now like to turn the call back over to Adam Gridley, for any closing remarks.

Thanks everyone for taking the time this morning to join the call. We look forward to speaking with you in the coming quarters and reporting progress on both our lead program for osteoporosis and also for hyperthyroidism. Have a good day, everyone.

Well, ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.