Greetings. Welcome to Entera Bio Fourth Quarter and Fiscal Year 2018 Earnings Conference Call. At this time, all participants are in listen-only mode. [Operator Instructions] As a reminder, this conference is being recorded. I'd now turn the conference over to your host Michael Wood of LifeSci Advisors. Mr. Wood, you may begin.

Thank you, operator. Good morning everyone and thank you for joining us on the Entera Bio fourth quarter and year end 2018 earnings conference call. On today's call, we're joined by Dr. Phil Schwartz, Chief Executive Officer and Mira Rosenzweig, Chief Financial Officer. Earlier today the company issued a press release for the quarter and full year 2018 results as well as a business update. The release is available on the company's website and also filed with the SEC. 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 strategies, expectations. Forward-looking statements are based on management's current expectations and belief significant risks and uncertainties that could cause actual results, developments, and business decisions to differ materially from those contemplated in those statements. Those risks and uncertainties, include but are not limited, to the timing and conduct of the company's clinical trials, the clinical utility of a company's product candidates, the timing or likelihood of regulatory filing approvals, intellectual property position, and the financial position, as well as those described in the risk factors in the company's annual report on Form 20-F and future filings with the SEC. So, I'd now like to turn the call over to Entera's Chief Executive Officer Dr. Phil Schwartz. Phil, please go ahead.

Thank you, Michael and thank you all for joining us today for our first conference call with investors and the analysts as a public company. 2018 was a very important year in the growth and evolution of Entera Bio. We signed a significant research collaboration and license agreement with Amgen, advanced our key clinical development programs, completed our IPO listing on the NASDAQ, and added considerable talent to our management team and Board of Directors. We are pleased with last year's progress and excited to start this year. We look forward to updating you on our progress as the year develops. From the perspective of Entera's strategy, there are two important ways in which we intend to create value. First, we offer a unique and powerful oral drug delivery technology that allows us to deliver large molecules and proteins orally rather than by injection. We intend to continue our strategy of leveraging our technology platform by exploring strategic collaboration and licensing agreements with biotech and pharmaceutical partners. Any future partnership could provide us with critical validation of our technology, access to potential non-dilutive capital and future sources of revenue in the form of milestone payments and royalty. The second part of the strategy is the advancement of our proprietary drug pipeline in osteoporosis, a multibillion-dollar opportunity and hypoparathyroidism, a rare indication for which we have been granted orphan drug designation, as well as several other indications. We will continue to opportunistically add new molecules to our pipeline as they present themselves. We have control of the development of these product candidates and can retain full global rights or out-license them as we see fit. The drug delivery platform we have developed is designed to act synergistically to transport and protect large molecules and biological therapeutics. As a reminder, the two…

Thank you, Phillip and hello everyone. I would like to sincerely thank Phillip and the rest of Entera's employees involved in excellence for the opportunity to work with them in the past five year. I wish Entera great success in the future. Our full results appearing the financial statements and our 20-F for the year ended December 31st, 2018 filed earlier today. Revenues for the year ended December 31st, 2018 were $500,000. The $500,000 revenues recognized in 2018 will be right from our agreements signed with Amgen under which we received an excess fee of $725,000 as Phillip mentioned earlier. We did not have any revenues filed today signing of the agreement with Amgen. Research and development expenses for the year ended December 31st, 2018 were $8.5 million compared to $2.8 million for year ended December 31st, 2017 an increase of $5.7 million. The increase was primarily due to an increase in expenses for materials, clinical manufacturing and production capabilities for advancement of clinical studies and certain pre-clinical activities. In addition, an increase in payments to subcontractors and CROs associated with the performance of the Phase 2 PK/PD clinical trial and increase in salaries and employee related expenses including share-based compensation expenses. There was also an increase in other R&D expenses mainly for regulatory matters. General and administrative expenses for the year ended December 31st, 2018 were $2.8 million compared to $8.6 million for the year ended December 31st, 2017, a decrease of $5.8 million. The decrease in G&A expenses was primarily due to the decrease in share-based compensation expenses offset by an increase in consulting services, legal and accounting fees related to our financing efforts, and insurance expenses. Financial income net for the year ended December 31st, 2018 was $0.6 million compared to $0.1 million for the year ended…

Thank you very much, Mira. We are really excited about the momentum we have in our business and we look forward to updating you on our progress going forward. With that, we would now like to open up the call to your questions. Operator?

Thank you. We'll now be conducting a question-and-answer session. [Operator Instructions] Thank you. Our first question is from the line of Jason McCarthy with Maxim Group. Please proceed with your question.

Hi. Good morning. This is actually Naureen Quibria on for Jason this morning. Congrats on the progress. I guess I want to start first with the EB613 program. I was just wondering now that you've completed your discussions with the FDA and you'll be starting the Phase 2 a dose reading study. Will that be actually done in Israel or will it be done here in the U.S.? And I wanted to also -- I was just wondering can you confirm also with regards to the Phase 3 program, with it confirms that you only have to do one study as opposed two.

Thanks very much. It's an excellent question. As regards to the Phase 2 a dose ranging study which involves 160 people, we're going to be looking at three different doses three different dose levels in that study. That study is a relatively small study and will be conducted at about four or five centers in Israel. We're going to be commencing that study in the coming weeks as I mentioned the first output of that study will be bone markers which are extremely highly predictive of the efficacy of the drug in terms of changing bone mineral density. And the second endpoint on that study will be bone mineral density which will read out after six months at the end of the study. As regards to clarity on the profile of whether we would have to do two Phase 3 or just one Phase 3 and the Phase 3 as we mentioned briefly in the 20-F would likely involve somewhere around 800 patients and would be obviously in numerous centers around the United States the European Union to come in terms of that that it would only be dependent on what the FDA would see in terms of our Phase 2 data if the Phase 2 data. If the Phase 2 data is confirmatory of the effects that we have on bone then there is a high probability or good likelihood that the FDA would allow us to do just one phase 3 pivotal study. This is not unusual for 505 (b)(2). If for some reason the results of our Phase 2 study were ambiguous then they might ask us to do an additional Phase 3 study or an additional Phase 2 study to add onto our Phase 3 study. I hope that addresses your question. Do you have another question perhaps? Or is that okay?

Yes, that's very helpful. Thank you so much. And can you just describe the Amgen collaboration a little bit? And are you able to provide the little more color on the indications that they may pursue?

No. We can't unfortunately. We're under confidentiality. Whatever we're able to review we revealed in the 20-F and the attached documents. We can't say that it's in the inflammatory space. I can tell you that in general the focus of the Amgen collaboration as we sort of alluded to her mentioned too is for being able to utilize the drugs which otherwise could not be utilized as an injection because of various factors that are involved. So, in other words it's a drug that they believe therapeutically works extremely well but they can't give it as an injection for any one of a myriad of reasons which I mentioned originally in my discussions in my opening remarks.

Sure. Yes. And that's very helpful. So, do you think you might be able to report similar partnerships within this year that might be exacting a lot?

It's possible. We are in discussions with a number of different potential partners. And it's definitely possible. I would say that probability of usually these things take a number of months to execute and the probability has gone up because we're dealing with multiple partners, but obviously we have no guarantee of what type of agreements will sign in the future. We're optimistic though.

Sure. And I have just one last question with regards to the EB612 program. You know you stated that with the results from the Phase 2 portion would likely report out mid-2019. So, if it's positive, would you expect to initiate a Phase 3 by the end of the year?

That theoretically would be possible. But I think that it would probably be limited by our bandwidth in terms of a company of our size and even our prioritization. At this point in time we really feel like osteoporosis is our priority. So, if we have sufficient capital to enlarge the company significantly and to be able to deal with two Phase 3 clinical trials simultaneously then we would go ahead and start that. But at this point in time, we're not planning on doing that right away. We may also try to partner that drugs just like we would try to partner the osteoporosis drug as I mentioned.

All right. Thank you so much. That's it for me.

Thank you.

Thank you. At this time, I’d like to turn the floor back to management for further remarks.

I would like to thank everyone for joining the call and look forward to reporting more good news and other good things later in the year, and everyone should have a great day. Thank you so much.

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