Greetings, and welcome to Entera Bio's First Quarter '22 Update Conference Call. At this time, all participants are in a listen-only mode. The question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to turn the call over to Ramesh [ph] of Investor Relations. Thank you. You may begin..

Good morning, and welcome to the call. Joining me today are Spiros Jamas, our Chief Executive Officer; and Miranda Toledano, Chief Business Officer, Chief Financial Officer and Head of Strategy. A press release announcing Entera's financial and operating results for the first quarter ended March 31, 2022, was issued on May 12, 2022.

For those of you who have not received it, it is available on the company's website in the Investors section at www.enterabio.com.

Before we begin our prepared remarks, I would like to remind you that various statements the company makes during this call about future results and operations and financial positions, are -- or interpretations of data from completed and ongoing trials, business strategy and plans and objectives for the company's future operations are considered to be 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 the company's SEC filings and are available on the SEC EDGAR system and on the website. We encourage all investors to read the company's SEC filings.

All information we provide on this call is provided only as of today, and we may 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 would now like to turn the call over to Spiros Jamas. Go ahead, Spiros..

Good morning, everyone. We're aiming to keep this call brief because we already circulated our earnings release last week. I am pleased to announce that joining me on the call today is Miranda Toledano.

As we announced on Monday, Miranda, who has been a member of our Board of Directors since 2018 has now also become our Chief Business Officer and Chief Financial Officer. Miranda is an accomplished leader in biotechnology industry with almost 25 years of C-level strategic leadership and Wall Street experience.

I believe that the company will benefit significantly with Miranda as part of our leadership team, and her strategic experience is a perfect fit as we progress with global partnership discussions and continue development of our proprietary oral delivery platform. I'm happy to introduce Miranda Toledano..

Thank you very much, Spiros, and good morning, everyone. I'm truly excited to join Entera at this critical juncture in the company's history. As you all know, our lead program, EB613 is moving along to Phase III clinical development. Last year, Entera reported compelling efficacy and safety data from our Phase II dose-ranging study.

We believe EB613 has strong differentiation due to its unique oral route of administration, safety profile and mechanism of action, which is well validated for close to 20 years. As such, we hope to position EB613 as the first oral anabolic agent for the treatment of postmenopausal women at high risk of osteoporosis.

In addition, our analysis across community and specialist clinicians and early pre-commercial assessment to date points to a clear unmet need for an oral agent to significantly expand the PTH therapeutic class.

We are currently laser-focused on finalizing our registrational study plans and dialogue with FDA, and we look forward to updating you on these plans and the earlier pipeline soon. I will turn it back to Spiros to provide highlights from Q1 2022, which the company released last week. Thank you..

first, osteoporosis represents a large market of over 15 million patients in the U.S., yet approximately only 75% of the target population is not receiving any pharmacologic treatment.

Second, despite endocrinologists recognizing the clinical benefit of initiating anabolic treatments such as the currently injectable PTH agents for high-risk patients prior to first-line bisphosphonates, their high cost and patient's unwillingness to opt for a subcutaneous injection is limiting treatment.

Clinicians were receptive to EB613's efficacy based on our Phase II data as an anabolic treatment and its improved safety profile and its oral route of administration. Payers surveyed were favorable to EB613 and characterize the value proposition as a safe oral anabolic treatment option for osteoporosis patients.

A survey of high-prescribing doctors show that EB613 could become the preferred option in moderate-to-severe osteoporosis and substantially grow the anabolic market. I'll now move to a brief update on our technology platform and IP. We filed multiple U.S. patent applications this quarter.

We intended to expand our patent protection and support future developments as we continue to optimize our oral delivery platform. Furthermore, we continue to evaluate establishing material transfer agreements with potential strategic partners for proprietary molecules. Thank you very much for this update. And we look forward to taking your questions..

[Operator Instructions] Our first questions come from the line of Kalpit Patel with B. Riley..

Congrats on the appointment, Miranda. Maybe first, I'll start with the analytical study for EB613. I guess did you collect any data that shows what -- did you collect any data that shows what percentage or portion of prescribers would utilize an agent like EB613 before bisphosphonates maybe in that patient group with no prior history of fractures..

Thanks for your question. Yes, I mean, obviously, bisphosphonates are used as first line and a lot of the -- you have to go through a step therapy to bisphosphonates at first.

But the -- what was interesting was that payers, I mean, and prescribers were -- with the profile that we have with an oral anabolic, they really see an oral PTH moving up the chain and then even not requiring a step edit for -- to be used in this population.

So that's -- so these are very large sort of untreated population that could benefit from an oral anabolic and where payers I think would be willing to really to cover the product.

Does that answer the question?.

I think I might just add to it and thank you, Kalpit for your support. We have collected all of this data in a micro way. And I think our plan is we'll disseminate portions of the study to analysts in the coming months. We're going through also as we finalize the Phase III strategy.

But just to echo what Spiros said, because the potential for this drug is obviously oral and PTH is well validated, there is also quite a high level of enthusiasm from the clinical community of potentially cycling through or sequencing anabolic followed by antiresorptives and vice versa.

And we've seen that in precedent trials, right? So that data has been collected both qualitatively and quantitatively from the study that we conducted..

Okay, that's helpful. And then last quarter, you noted there was regional interest in developing EB613, particularly in Asia.

Can you give us any updates here on the progress of these discussions? And are you aiming to have something locked in before you initiate the pivotal study for EB613?.

Thanks, Kalpit. Yes, we are actively pursuing the deals both globally and also regionally as we've indicated before, and I mean our intention is to partner the asset globally. That would be our preferred path, and we really expect to be finishing something by the end of the year.

But I mean given the profile that we have in our Phase II data, it's a very attractive asset and the once-a-day oral kind of formulation. Again, it fits really well into the globally -- the osteoporosis problem are globally.

So our goal is to really generate deep, best collaboration that will commercialize the asset globally, and we're getting a lot of interest. We had already announced. Also we've retained the [indiscernible] bank, Torreya that has been working with us very well and generating a lot of inbound interest on partnering the asset..

[Operator Instructions] Our next questions come from the line of Nathan Weinstein with Aegis Capital..

I'd like to just start by asking about the optimization of the oral delivery platform.

Specifically, were there some attributes you could speak about that are being optimized? Or which features of the platform are most relevant to that process?.

Thanks for your question. Yes, so in general, the features that we're looking to optimize and it's captured in our new IP are really around the physical chemical [indiscernible] of the target molecules and so being able to handle sort of different charges on the molecules and also different molecular weights.

And so with all of that and always with the goal of really reducing the variability that you ultimately have to deal with oral delivery, and we've seen that our optimized platform, we're achieving not only higher bioavailability but also lower variability, and we're able to address more molecules with the new IP that we've generated.

And then, just one additional important aspect to our new -- the new IP that we filed is -- our new IP also includes some important excipients that are already approved by FDA.

So from a regulatory standpoint, there's fewer regulatory hurdles to incorporating those in new formulations that we are working on and there was also -- our scientists back at the lab were very -- did a lot of work in screening different molecules and things that could fit into our platform and we felt that the developments and the progress we made was significant, and that's why we filed the whole set of new patent applications.

And these also give us a whole new patent life -- fresh patent life..

Okay, great. Makes sense. Maybe just one question here on EB613. Right now, obviously, looking at postmenopausal women at high risk of osteoporosis.

But down the line, could it make sense to look at any other demographics?.

Yes. I mean, obviously -- similar demographics that FORTEO has used in or other anabolics for males would be one other possibility, I mean -- and we could be expanding to additional populations. I could have -- Art, do you want to speak to the different populations that an oral anabolic could be sort of pointed towards..

Sure. As Spiros pointed out, through the natural development cycle, first looks at the effectiveness of a drug in postmenopausal women with osteoporosis at high risk of fracture. That's the initial indication for injected teriparatide. Subsequently, the other target populations that would benefit from an anabolic are men with osteoporosis.

Typically, that would be an idiopathic osteoporosis, not just low testosterone, but it could include that as well as people treated with anti-inflammatory steroids like prednisone, and that's usually called glucocorticoid-induced osteoporosis.

So they would be subsequent target populations after an initial demonstration of efficacy in postmenopausal women with osteoporosis with high risk of facture..

[Operator Instructions] There are no further questions at this time. I would like to hand the call back over to Spiros Jamas for any closing comments..

Thank you very much, everybody, for dialing in for our update today. Obviously, we are very excited with the addition of Miranda to the leadership team of Entera.

As you can see, a lot is going on in the preparation for our Phase III for osteoporosis and expanding also our platform, and we look forward to further updates with you, and thank you for your support. Have a good day..

Thank you. This does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day..