Entera Bio Ltd.

Greetings and welcome to the Interrobio fourth quarter and year-end 2021 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the call over to Ramesh Ratan, Chief Financial Officer. Thank you. You may begin.

Good morning and welcome to the call. Joining me on today's call are Scott Johns, our CEO, Arthur Santora, our chief medical officer, and Philip Schwartz, our founder and president of R&D. A press release announcing NTERRA's financial and operating results for the full year ended December 31, 2021, was issued this morning. For those of you who have not yet seen it, it's available on the investor section of our website, www.nterrabio.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'd like to remind you that various statements we make during this call about the company's future results of operation and financial position, our importation of data from the recently completed phase two 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 expectation 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 is provided only as of today and undertake no obligation update any forward-looking statements you make on this call and 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 Sviraj Jamas.

Thank you, Ramesh. And thanks to everyone for joining the call this morning. I joined Interra because of the promise of the company's validated technology platform that enables the oral delivery of protein therapeutics and the talented, dedicated, and hardworking 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 are on the path to creating a very valuable business. In the second quarter of 2021, we reported the ultimate in 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 with a p-value of less than 0.001. and bone mineral density, the clinical marker of bone mass and strength. The three-month biomarker results were accepted and presented at the leading clinical bone disease conference, the ASBMR, last October 2021. Our six-month bone mineral density results were accepted and presented by our chief medical officer, Art Santora, as a prestigious late-breaker oral presentation. also at ASPMR. This is important peer-reviewed presentation of our studies. I believe these data will support business development efforts and will generate future value through strategic collaborations and partnerships. Separately, the data from our Phase IIa study of EB61T in hyperparathyroidism patients was published in the Journal of Bone Mineral Research. 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 Ontario 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. In addition to our expanding internal pipeline as part of our business development efforts, we have signed material transfer agreements with multiple biopharma companies to demonstrate the feasibility of Interis platform for oral delivery of various proprietary target compounds. These options potentially enable multiple partnering opportunities that can generate non-dilutive funding, news flow, and allow the company to share in the future value of multiple dearest assets. 2021 was definitely a year of execution. We ended 2021 with a successful end of phase two meeting with the FDA where we reviewed the phase two osteoporosis data, proposed phase three protocol, and other requirements for an NDA submission. The meeting was positive and confirmed the use of bone mineral density as a primary phase three endpoint. We are incorporating input from the FDA into the phase three study design and we are projecting a second half of 2022 start of the Phase III study. We strengthened our balance sheet, and I am pleased to report $24.9 million at year-end 2021. I'd like to 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 1234, or PTH. and is positioned to be the first oral, once-a-day, bone-building osteoanabolic 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 U.S. alone, 54 million Americans have osteoporosis or low bone mass, which places them at an increased risk for 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 over $7 billion annually today, surprisingly, there are only three effective bone-building treatments available. They are proteo or teraparatide, tymlos, abaloparatide, and a vanity, dromososumab. All three are injectables. This may be one reason why less than 5% of people living with osteoporosis are treated with anabolic drugs. These injectables are also quite pricey at a cost of between $20,000 and $35,000 per year in the U.S. We believe that a safe and effective oral bone-building drug like EB613 may significantly expand the number of patients being treated. More than 90% of all osteoporosis patients who are taking any form of pharmaceutical are being treated with an oral agent. An oral bone-building agent may not only get conversions from current injectable drugs, but may also attract many new patients currently not receiving any treatment. 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 oral solutions. Aside from the more patient-friendly oral delivery as an oral drug, EB-613 can be far more cost-effective than injectables. We believe Enterra has a multi-billion dollar opportunity here by treating new patients at high risk of fracture. We estimate there is a realizable opportunity for a 10% or greater market penetration for both treated and currently untreated patients. Even at a discount to current injectable therapies, this should translate to a potential multi-billion dollar market opportunity. I will now turn it over to Philip to review EB612, additional progress with our platform, and various business development activities.