Entera Bio Ltd.

Good morning and welcome to NTERRA VIAL's conference call to discuss the financial and operating results for the six-month ended June 30th, 2021. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To participate during that session, you will need to press star 1 on your telephone. I would now like to hand the conference over to Ramesh Ratan, the U.S.-based CFO of Interra. Please go ahead.

Good morning and welcome to the call. Joining me on today's call are Spiros Jamas, our CEO, Arthur Santora, our CMO, and Philip Schwartz, our President of R&D. A press release announcing Interra's financial and operating reserves for the first six months ended June 30, 2021, was issued earlier today. For those of you who have not yet seen it, it's available on the investor section of our website, www.enterrabio.com. On a 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 the call about the company's future results of operations financial position, our interpretation of data from the recently completed Phase II clinical trials of EB613, including the biomarker data released in the first quarter of 2021, our business strategy, and plans and objectives for our future operations are considered forward-looking statements within the meaning of the federal securities law. 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 the information we provide on this conference call is 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'll now turn the call over to Spiros Jamas.

Thank you, Ramesh. 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. We have hit several key milestones that have generated value for our shareholders and confirmed my confidence in our team and technology. and believe we're on a path to creating more value. We are working diligently to protect the intellectual property around Enterra's platform. In the second quarter, we announced that the European Patent Office granted a foundational patent addressing how all PTH formulations that are currently in clinical development for osteoporosis and hypo-PT. In the second quarter, we reported the ultimate and scientific validation that our Phase II clinical study of EB613, our oral PTH product for the treatment of osteoporosis, met its primary and key secondary endpoints. There is a linear and statistically significant dose response for PTH dose and the key anabolic biochemical markers P1NP and osteocalcin and bone mineral density, the clinical measure of bone density and strength. The abstract on the three-month biomarker results was accepted for presentation at the leading clinical bone disease conference, the ASBMR, in 2021. I believe these data are supporting business development efforts and will generate future value through strategic collaborations and partnerships. In addition, we have significantly strengthened our balance sheet, and I'm pleased to report a current cash balance of $28.1 million. The significant potential of Entera's 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, and six-month bone mineral density data from the completed Phase II clinical trial of EB613 in osteoporosis patients, and the data from a Phase IIa study of EB612 in hypothyroidism patients that was recently published in the Journal of Bone and Mineral Research. I'd like to now give you a snapshot of why we think EB613 is a tremendous opportunity in the osteoporosis market. EB613 is an oral formulation of human parathyroid hormone, Y234, or PTH, and is positioned to be the first oral, once-a-day, bone-building anabolic product to treat osteoporosis patients. The successful Phase II study has brought EB613 one step closer to potentially becoming available to the estimated 200 million people affected by osteoporosis worldwide. In the US alone, 54 million Americans have osteoporosis, or low bone mass, which places them at an increased risk of developing osteoporosis. One in two women and one in four men over 50 years of age will break a bone due to osteoporosis. In a therapeutic market this large, estimated at $4 billion annually today. Surprisingly, there are only three effective bone-building treatments available. Forteo, teriparatide, Tilos, abaloparatide, and Avenity, ramososumab. And all three are injectables. This may be one reason why only 5% of patients living with osteoporosis are treated. These injectables are also quite pricey, at a cost of $20,000 to $30,000 per year in the U.S. We believe that a safe and effective oral bone-building drug like EB613 may significantly increase the treatment market. This assumption was borne out in a research study we commissioned with an independent market research firm, which found that patients, physicians, payers, and providers are seeking more cost-effective solutions. Aside from the more patient-friendly oral delivery as an oral drug, EB613 can be far more cost-effective than injectables. We believe Enterra has a multi-billion dollar opportunity here by treating new patients who currently are not on either of the injectables. We estimate that there is a realizable opportunity for 10% market penetration with patients currently untreated. and at the cost that is 25% of today's injectable price, which translates to an over $20 billion plus potential to take share from the 50,000 patients treated with injectables today. Our Phase II clinical trial of VB613 was a six-month, double-blind, dose-ranging, placebo-controlled study in 161 postmenopausal female subjects with osteoporosis. or with low bone mineral density, or BMD. This study was conducted at four leading medical centers in Israel to evaluate the safety and efficacy of varying doses of EB613. The most important BMD endpoint, change in lumbar spine BMD after six months, was met. Subjects receiving the 2.5 milligram dose of EB613 showed a significant dose-related increase in BMD at the lumbar spine total hip, and femoral neck. At six months, the lumbar spine BMD increased by 3.78% as compared to placebo, with a P value of less than .008. The study's primary efficacy endpoint, a statistically significant increase in P1NP at three months, was also achieved. EB613 exhibited an excellent safety profile with no drug-related serious adverse events. I want to highlight two pieces of data that point to the performance of Enteris platform to deliver a peptide orally and achieving a controlled biologic effect. There was a significant dose response for the PTH dose in EB613 and the increase in lumbar spine BMD with a p-value of less than 0.0001. There was a significant dose response for the PTH dose in EB613 and the increase in month one P1NP with a P value of less than .001. We look forward to an end of phase two meeting with FDA to review these data and to discuss EB613's development program. With the FDA's agreement, we plan to conduct a single pivotal one-year phase three study comparing changes in lumbar spine BMD in patients treated with oral EB613 versus treatment with Forteo injections, as per a 505 each pathway. In this non-inferiority study, we would evaluate EB613's effect on spine BMD to be within 25% that of Forteo's or greater. Furthermore, EB613 had a significant impact on both femoral neck and total hip BMD at six months. In contrast, Significant increases in BMD of the femoral neck and total hip are usually not observed with foot-tail treatment at six months. We have also continued to support preclinical work in our collaboration with Amgen and 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 are focused on leveraging the platform technology to create additional value either through proprietary products such as DB613 and DB612 that can be developed by Interra alone or in collaboration with a partner or applying our technology to another company's compound such as that that we are doing in our collaboration with Amgen. As part of our BD efforts, we have signed material transfer agreements with three companies to demonstrate the feasibility of Interra's platform for oral delivery of various proprietary target molecules. These options potentially enable multiple partnering opportunities that can generate funding, news flow, and allow the company to share in the future value of multiple de-risked assets. Operationally, we have continued to monitor our expenses judiciously, raised cash for the use of our ATM program. I am pleased to say that our current cash on hand is sufficient to support our planned operations into the fourth quarter of 2022. I'll now turn the call to Ramesh Ratan, our US-based CFO, to cover the financial results.