Good morning and welcome to Entera Bio’s 2019 Financial and Operating Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] I would now like to hand the conference over to Jon Lieber, the U.S. based CFO of Entera. Please go ahead.

Thank you and welcome to the call. Joining me on today’s call are Adam Gridley, our CEO, Philip Schwartz, our President of R&D; and Arth Santora, our CMO. A press release announcing Entera's financial and operating results for the fourth quarter and full-year ended December 31 2019 was issued earlier today. For those of you who have not yet seen it, it is available in the Investor section of our website at www.enterabio.com. On our call this morning, we will share with you a business update and review our financial results, which will be followed by a question-and-answer session. Before we begin our prepared remarks, I would like to remind you that various statements we made during this call about the company’s future results of operations and financial position, business strategy, and plans and objectives for our future operations are considered forward-looking statements within the meeting of the Federal Securities Laws. Our forward-looking statements are based on current expectations that involve risks, changes in circumstances, assumptions and uncertainties. In particular, the COVID-19 pandemic is rapidly evolving and has created a significant amount of uncertainty. The extent to which the COVID-19 pandemic impacts us will depend on the duration and magnitude of such impact and will depend on numerous factors that the company may not be able to accurately predict. These risks are described more fully in our SEC filings and are available on the SEC’s EDGAR system and on our website. We encourage all investors to read our SEC filings. All of the information we provide in this conference call provided only as of today, 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. I will now turn the call over to Adam Gridley.

Thank you, Jon and thanks to everyone for joining the call this morning especially given the challenges we’re all facing due to the spread of COVID-19. We've been rapidly evolving our plans to address the changing government regulations and the spread of the virus around the world. Our priority today is to protect the health of our patients, employees and local communities without creating unnecessary disruptions to the company's primary goals. Before moving into our 2019 business update and corporate objectives for 2020, I want to thank our employees, our investigators, and our patients for their support and participation in our Phase 2 clinical trial for EB613 and osteoporosis. These are clearly unique times and we very much appreciate everyone's continued perseverance and vigilance. When I joined the company in the third quarter of 2019, we committed to our stakeholders that we would be myopically focused on the execution of our most important business objectives. And I believe we’re well positioned financially and operationally to achieve a number of important goals this year. However, we cannot predict the impact of the Coronavirus outbreak will have on our Phase 2 clinical trial and our employees. During 2019, we chose to refocus our efforts where we believe our technology platform will provide patients novel therapeutic options for large disease states and create the most value for our shareholders. To that end, we pivoted to focus on EB613, our orally delivered parathyroid hormone or PTH program and initiated the dose ranging placebo controlled Phase 2 clinical trial in postmenopausal women with osteoporosis or low bone mineral density BMD. We will discuss EB613 and the data we expect to generate in more detail later on the call. But I'm pleased to say that as of today, we've enrolled 98 patients or approximately 60% of…

Thanks Adam. Based on the feedback from our meeting with the FDA November of 2018, we initiated a Phase 2 multicenter dose ranging trial of EB613 in approximately 160 osteoporosis patients at four leading osteoporosis centers in Israel in July 2019. The trial which includes a six month treatment period is being conducted to evaluate both the safety of EB613 and to identify the optimal dose that we will select to advance into a single Phase 3 pivotal non-inferiority BMD trial versus subcutaneous parathyroid hormone, subject to positive Phase 2 data. Through our four arms in the Phase 2 trial of 40 patients each, one placebo arm and three different EB613 doses, 0.5 milligrams, 1.0 milligrams and 1.5 milligrams of oral PTH. Based on our prior data showing the maximal concentration of PTH in the blood, sometimes referred to as C max and an average concentration referred to as AUC after a dose of EB613, we believe these doses encompass potential optimal dose equivalent to a 20-microgram injection of Forteo. In this trial, we are evaluating the effects of EB613 on bone mineral density or BMD after six months and multiple biochemical markers including P1NP, a bone formation marker and CTX, a bone resorption marker both three and six months as well as a standard set of safety assessments. Specifically, the study has two primary endpoints, the change in bone formation marker P1NP after three months, and the change in spine BMD over six months. Because of the long history of the use of injectable PTH, Forteo to treat osteoporosis and the non-correlation of the improvement in biomarkers of bone formation rate in BMD to treatment of the underlying disease, we Entera believe that the biomarker and related BMD data from the trial will be indicative of the potential anti-fracture…

Thank you very much, Arth. Good morning, everyone. Our collaboration with Amgen for the development of an oral anti-inflammatory agent continues to progress. In late 2019, Amgen elliptically continues a collaboration, which triggered the ongoing financial support for the year 2020. Over the last 12 months, the teams have been working well together and Amgen has completed several studies that have included the evaluation of different formulations we have provided to Amgen and we are pleased with results to-date. We believe our technology is performing well and that we have been able to rapidly create different formulations with different PK/PD profiles to support Amgen’s activity. Turning to other research activities for 2020, we’re focused primarily on two objectives. The development of our platform as it relates to the evaluation of new API for active pharmaceutical ingredient, and formulation development for EB612. We believe that each of these areas has the potential to generate value through either additional validation of our technology platform and or through potential business development activities. In the area of API or additional drug development, we continue to evaluate new API's that can benefit from the application of our technology. As a reminder, we have a newly developed set of in-vitro assays that has enabled us to significantly reduce the initial evaluation time of new API. To-date, Entera has brought several API's into preclinical animal testing and preliminary proof-of-concept data. And this data indicates that we can work with a variety of large molecule drugs ranging in size from small three to four amino acid peptide to very large proteins with more than 100 kilograms. We intend to leverage this work and have a goal to build our platform by adding two new targets in 2020 for potential future developments. In addition to screening the potential molecules based on the attributes that we think would lend themselves to our technology, we will also be evaluating candidates based on criteria including market size, unmet needs, and the overall development and regulatory testing. With respect to EB612, our product for hypoparathyroidism, we intend to conduct additional formulation and development activities to determine an appropriate formulation that will enable us to prepare to the potential initiation in 2021 of an additional Phase 2b or Phase 3 clinical trial of EB612 for the treatment of hypoparathyroidism. As a reminder, the clinical trials to support approval product of products to treat hypoparathyroidism are often small, for example Natpara, the leading injectable was approved on the basis of a single 120 patients, Phase 3 clinical trial. Given the likely size of the Phase 3 clinical trial, we believe we could develop and commercialize this on our own. But we also believe that we should evaluate collaboration that leverage our existing resources. I'll now turn it back to Adam to provide an update on our business development opportunity.

Thanks Phillip. Besides our Amgen collaboration, we continue to explore a variety of co-development and collaboration opportunities. In 2020, we have three initiatives. Our first priority is to work with companies seeking to leverage our development and delivery capabilities to work with their internally developed compounds and injectables perhaps in the structure similar to the Amgen collaboration. The recent approval of Novo Nordisk oral semaglutide GLP-1 agonist, which utilize the same absorption enhancer that Entera uses has stimulated great interest in our oral large molecule delivery system. The approval of Novo’s drug not only validates our use of this particular absorption enhancer molecule and other indications but also proves that it is possible to get an oral biological drug approved by the 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 their APIs as oral therapies. Given the very tuneable nature of our technologies through the synergistic combination of absorption enhancers, and protease inhibitors, many companies have approached us to help solve their drug delivery problems. We believe our unique capabilities of reducing variability and increasing bioavailability offers distinct advantages versus other oral delivery technologies. Our second business development initiative is the initial efforts and potential commercial and licensing arrangements around EB613 given our upcoming Phase 2 readouts in the coming quarters, and the rather short development pathway to a Phase 3 study, we're currently in confidential discussions with several potential commercial partners who may have interest in working with us on the Phase 3 program. We're evaluating our opportunities to either complete the global registration trial on osteoporosis on our own or licenses prior to a Phase 3 for leading pharmaceutical companies…

Thank you, Adam. Revenues for the year-ended December 31 2019 were $236,000 and more attributable to R&D services provided to Amgen as part of the collaboration. The cost of revenue includes direct salaries and related past year costs. Total operating expenses for the year-ended December 31 2019 were $11.5 million and included $7.2 million in research and development expenses and $4.3 million in general and administrative expenses. R&D expense for the year-ended December 31 2019 consisted primarily of headcount related costs also related to the initiation and context of the EB613 Phase 2 clinical trial and consulting expenses and fees related to the preparation of an IND application for EB613. General and administrative expense for the year-ended December 31 2019 was primarily made up of salary and related expenses include share based compensation, legal and accounting fees and DNO insurance expense. Net comprehensive loss was $10.8 million and included a gain on the change in fair value of warrant liabilities. Basic and diluted loss per ordinary share was $0.89. As a reference point, we currently have approximately 18 million primary shares outstanding and 26 million fully diluted shares outstanding. At December 31 2019, Entera had cash and cash equivalents of $15.2 million. And December cash balance excludes approximately $0.8 million net of expenses received in February 2020 in connection with the final closing of the December 2019 private placements and in our 20-F filed today, we recorded $13.7 million in cash and cash equivalents as of March 16, 2020. Based on current operating expense and the expected timing of product development programs and subject to the impact on our operations of COVID-19, we expect our 2020 operating loss to be between $10 million and $12 million based on steps already taken to preserve our cash to extend our runway into a further visibility to the impact of COVID-19 on our clinical milestones and the overall financial markets. We currently believe our current cash position will fund operations into the second quarter of 2021. I will now turn the call back to Adam for concluding remarks before we go to Q&A.

Thanks Jon. We appreciate everyone's patience and support during these uncertain times. 2019 was a year of transition and execution and we ended the year in a very strong financial position with substantial value creating milestones coming in 2020. We continue to have conviction regarding our long-term development strategies. Yet, we're mindful on the rapidly evolving COVID-19 challenges, both in Israel for ongoing Phase 2 study and on our employees. And also in the United States where financial markets have seen considerable disruption. We will continue to be careful stewards of our human capital, our financial resources, and seek to proactively and rapidly pivot in a manner that preserves our product development initiatives, advances our business development opportunities and positions us for rapid growth as these uncertainties abate. Our 2020 milestones for our osteoporosis program continue to be our first priority and while our current estimates assume a delay in completing full enrolment of patients into at least the third quarter of 2020. We do anticipate meeting our original timeline of the three month biomarker data for the first 50% of patients in the second quarter of this year. We also anticipate that we will have additional visibility to the impact on the continued enrolment of the Phase 2 trial in Israel and we'll continue to update our stakeholders as we received material updates, including in our upcoming first quarter 2020 financial results call targeted for mid-May of 2020. Operator, please open up the line for questions.

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

This is Naureen on for Jason, hope everyone's safe and well. Obviously, given the COVID-19 situation a lot of timelines and trials have been impacted. There have been a lot of disruptions. So I was wondering, I understand timelines may not be met. And that said, I'm sorry I missed it. But can you remind us again, what caveats or milestones we might expect in 2020 from Entera in addition to the three months biomarker data interview?

Sure and thanks Naureen. Appreciate the question. And indeed, we still have a plan for a milestone rich 2020. The original plan had contemplated the first biomarker in the second quarter, the full three month biomarkers in the third quarter and then bone mineral density data in the fourth quarter and that was the six month primary endpoint. So we still have plans for the initial three months interim biomarker data, which is one of the primary endpoints and that will be in the second quarter, so sometime in the next couple of months. The benefit of the great progress we've made on enrolment is that we're already about 60% enrolled, and so that 50% mark is still on target. Obviously, it's hard to predict how long that this temporary suspension will result in. But our goal is to hopefully get things restarted in the next couple of months. And then we would anticipate if things were pushed out by one quarter, we would still have the full three months biomarker data and completion of the trial this year. So we're still optimistic. The investigators and patients are quite enthusiastic and indeed, still trying to enroll. However, we are going to comply with the Ministry of Health requirements in Israel, and make sure that our patients are safe in that process. So we're still pretty optimistic about 2020. This is still a very considerable data set that we'll be reporting and expect to be bringing that forward to our investors soon.

Great, that's helpful. And you've been engaged with a lot of people in other regions. Could there be any announcements this year?

It's hard to predict exactly when those would be announced. But indeed, that is part of our significant strategy in a number of a couple of areas. So first, of course is the lead program. So EB613 independent of this most recent delay, we think there's a lot of interest, given the very short development timeline and the ability to run one Phase 3 trial. So we've had very active discussions in China, in Japan, looking at Korea and actually as those regions start to come back on post-COVID, we're accelerating our efforts there. And naturally, we’re all getting used to working virtually here in the United States and in Europe and Israel as well. So I don't anticipate that those activities slow down. And as we think about this time period, we're in fact trying to accelerate those. So that is one of our major focuses right now to that lead program, there's also quite a bit of interest in hypoparathyroidism program, particularly in Japan. We have a higher rate of thyroid cancer than other regions. And then as we noted, Phillip has leading a number of our R&D initiatives to look at new compounds, very similar to the original Amgen deal that we did, where we were looking at completely new compounds outside of parathyroid hormone. And the recent approval by Novo, of course with SNAC which is a similar absorption enhancer, I think has led to a lot of interest. So we continue to accelerate on each of those. We think that's an important part of our overall value creation initiative. And would anticipate that over the next couple of months, even though we're virtual those activities are likely to accelerate.

And one last one for me. Can you comment on the Amgen partnership. Obviously, you can't comment on the drug target, but perhaps as Amgen elected to select additional programs, have been any discussions around that or is it too premature?

Sure, generally speaking, it's too premature for us to comment on that. But perhaps Phillip, our President of R&D can comment on how the overall program is going and give a little bit of color on that. Phillip?

Yes, sure. Thanks, Adam. Yes, the program is moving along, we're going into, we've done a number of preclinical studies. And Amgen is now doing a number of preclinical studies in their hands as well. Unfortunately, recently, as it's been in the news, there are 1,000 location has shut down for the moment, but we hope that it will be coming back up in the near future. With regards to other models, we have discussed other molecules and we continue to have very active conversations regarding other molecules as well. And sometime in the future, perhaps we'll try to test out some of those molecules. And that would lead obviously to them deciding perhaps that they would like to pursue one of those molecules is that. Just as a reminder, I'd like to point out that the molecules that Amgen has been interested in and continues to be interested in are not necessarily molecules that are, there are currently injectables that they need to convert into oral formulations because of the convenience factor or other things often molecules that are injectables do not work as injections. And therefore, it can take a molecule which previously was not useful as an injection or not therapeutically effective and turn it into a therapeutically effective, a therapeutically effective medication. So that really widens the field, especially when the failure in drug development is so frequent and very, very few molecules actually make it to the market by offering another chance for people to take molecules which may not work with one form of administration and converting them to another form of administration. We're actually giving companies a second chance to try to use molecules, which may be very effective in the target but can't be administered as an injection. Adam, do you want to go on?

Thanks Phillip. So Naureen, I think we're very pleased with the progress thus far. We were just at Amgen a couple of months ago and expect that this program will continue in earnest. And we're also looking at ways that we can incense great data to be able to look at new compounds. So very excited about that and we think that that potentially broadens the opportunity for other partners as well.

[Operator Instructions] And the next question comes from Eric Rubenstein with Intuitive Venture Partners. Your line is now open.

Adam, thanks for the follow-up. Could you please discuss or in any more detail the two additional molecules that you're thinking about going forward on. In other words, just what areas of focus they are in?

At this juncture, those molecules are potentially confidential. However, we can comment Eric on the number of molecules that we've looked at, naturally our product portfolio has utility in molecules up to 150 kilo adults. We've been looking at a wide range of potential API's. As Phillip noted, in some cases, they aren't just injectable. So in the case of parathyroid hormone, our lead program we're taking a well-known injectable, otherwise known as Forteo, and we believe that we can convert that into an oral pill with all of the efficacy and safety benefits but at a fraction of the cost. So those continue to be one area where there are obvious injectables that we could then improve the cost compliance and convenience challenges. Alternately, we've looked at other compounds such as growth hormone, we've naturally started to look at other areas in other therapeutic spots outside of the anti-inflammatory space. And in many cases folks are coming to us. The obvious question that we always get is can you do monoclonal antibodies. We're not sure yet, but we're evaluating that. And we continue to look at how we can extend that portfolio.

Thank you. I'm not showing any further questions at this time. I would now like to turn the call back over to Adam Gridley for closing remarks.

Thanks to all. Thanks to everyone for taking the time this morning to join our call. We look forward to speaking with you in the couple of weeks. Be safe and have a good day.

Ladies and gentlemen, this concludes today’s conference call. Thank you for participating. You may now disconnect.