Entera Bio Ltd.

Good morning and welcome to Interra's BIOS conference call to discuss the financial and operating results for the year ended December 31st, 2020. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you'll need to press star one on your telephone. If you require any further assistance, please press star then zero. I would now like to turn the call over to John Lieber, the US-based CFO of Interra. Please go ahead.

Thank you, and welcome to the call. Joining me on today's call are Spiro Jamas, our CEO, Art Santora, our CMO, and Philip Schwartz, our President of R&D. A press release announcing Interra's financial and operating results for the year-end of December 31, 2020, was issued earlier today. For those of you who have not yet seen it, it is available on the Investor section of our website, www.interrabio.com. On our call this morning, we will share with you a business update and review of 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 make during this call about the company's future results of operations and financial position, our interpretation of interim data from the ongoing Phase II clinical trial of EB613, including the biomarker data released in the first quarter of 2021, the expected timing of data readouts from the ongoing Phase II clinical trial of EB613, Our business strategy and plans and objectives for our future operations are considered forward-looking statements within the meaning of the federal securities laws. Our forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. Specifically, developments related to the COVID-19 pandemic continue to evolve and the extent to which the pandemic will impact us in the future will depend on the duration and magnitude of such impact and on numerous factors that we 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 is provided only as of today, and we undertake no obligation to update any forward-looking statements we 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 Spiro Jamas.

Thank you, John, and thanks to everyone for joining the call this morning. I joined Interra in January 2021 based on the company's validated technology platform that enables the oral delivery of protein therapeutics and the talented and dedicated team. In the short time since I joined, we've hit several key milestones that have generated value for our shareholders and further confirmed my confidence in both our team, technology, and believe we have the ability to create more value. We have data showing that our platform works on eight molecules of broad characteristics and size. I believe these data will support business development discussions and generate future value through strategic collaborations and partnerships. In addition, the recent rise in our share price has enabled us to strengthen our balance sheet. And I'm pleased to say that we believe our current cash resources will fund the company into the second quarter of 2022. The significant potential of Interos technology platform to give patients a much needed oral alternative to treatments currently delivered via injection is supported by data from multiple clinical trials including the recently announced positive three-month bone biomarker data from the ongoing Phase II clinical trial of the EB613 in osteoporosis patients and the data from our Phase IIa study of the EB612 in hyperparathyroidism patients that was recently published in the Journal of Bone Mineral Research. With significant momentum coming out of 2020, we are focused on leveraging the platform technology to create additional value either through proprietary products such as EB613 and EB612 that can be developed either by Anterra alone or in collaboration with a partner or applying our technology to another company's compound such as what we are doing in our collaboration with Amgen. Each of these options potentially enables multiple partnering opportunities that can generate funding, news flow, and allow the company to share in the future value of multiple de-risked assets. While Art and Philip will go into greater detail on the clinical programs and platform, I would like to take a few minutes to provide an overview of the programs and some of our recent accomplishments. First, on EB613, our orally delivered human parathyroid hormone 1234, or PTH, positioned to be the first oral bone-building or osteoanabolic treatment for osteoporosis patients, we recently announced that the Phase II trial in women with osteoporosis or low bone mass met its primary endpoint. The complete three-month results from the trial showed a significant increase in the P1NP biomarker in the 2.5 milligram dose group after three months of treatment, of less than .04 compared to placebo. P1NP is a biomarker that indicates the rate of new bone formation. As a reminder, this Phase II clinical trial is a double-blind, dose-ranging, placebo-controlled study in postmenopausal female subjects with osteoporosis or low bone mineral density, or BMD. This trial has been conducted at four leading medical centers in Israel and has completed the enrollment of 161 subjects. The data comes on the heels of a number of other important milestones in 2020 for the EB613 development program. In August 2020, we announced the six-month interim bone mineral density data from the first 50% of patients in this trial. The data indicated EB613 has a meaningful and positive impact on lumbar spine BMD in a dose-dependent manner over a 0.5 to 1.5 milligram dose range and supported the earlier decision to add a 2.5 milligram dose. These data were important because increases in lumbar spine BMD have been associated with fracture reduction in patients treated with subcutaneous PTH and a change in lumbar spine BMD is now an accepted endpoint for regulatory approval of novel formulations of drugs like human PTH-1234 that have been shown to reduce the risk of fracture. Importantly, the BMD data reported to date do not include data from any subjects in the 2.5 milligram treatment arm. We expect to report the final results from this trial, including the six-month BMD data in the second quarter of 2021. In addition, in the fourth quarter of 2020, we announced the completion of the enrollment in the trial and the acceptance by the FDA of the US IND for EB613. The completion of enrollment was a major milestone given the extraordinary challenges related to the COVID pandemic and along with the IND acceptance, an important step forward to moving the program towards a pivotal phase three clinical trial. Assuming we continue to see positive BMD data from the EB613 phase two trial and subject to a successful post and the phase two meeting with the US Food and Drug Administration or FDA, we believe a phase three trial could begin in 2022. We believe the value proposition of EB613 is very strong due to the fact that only a small percentage of patients with osteoporosis are actually treated with subcutaneous PTH or other injected bone building drugs due to cost, convenience, and compliance challenges. The market research we conducted and reported last year points to a significant unmet need for an oral therapy that builds bone in the multi-billion dollar osteoporosis market. Turning to EB612 for hyperparathyroidism, data from a 2015 study were recently published in the journal of Bone Mineral Research, or JBMR. Philip will provide additional details, but in summary, EB612, when added to standard of care, led to a statistically significant decline in supplemental calcium usage, a key endpoint in the hyperpyothyroidism trials. We are focused on optimizing the formulation that we would intend to move forward. We have also continued to support preclinical work in our collaboration with Amgen, are pleased with the progress made to date and look forward to continuing to support the collaboration in accordance with Amgen's project plan and objectives. From a business development perspective, we have increased our efforts to leverage our technology platform and have an ongoing dialogue with several companies that are interested in exploring the use of our oral delivery platform with their injectable product candidates. We are focused on moving these conversations into formal Agreements. Operationally, we have continued to carefully monitor our expenses, judiciously raised cash through the use of our ATM program with Canaccord. I am pleased to say that our current cash on hand is sufficient to support our planned operations into the second quarter of 2022. I would like to now turn the call over to Dr. Art Santora, our Chief Medical Officer, to discuss the Phase II trial of EB613.