Q1 2022 Entera Bio Ltd Earnings Call

Greetings and welcome to one terabyte.

First quarter 'twenty to update conference call at this time, all participants are in a listen only mode a.

A question and answer session will follow the formal presentation.

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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 rich <unk> with Investor Relations. Thank you may begin.

Good morning, and welcome to the call. Joining me today are Spiros, Thomas our Chief Executive Officer, and Miranda Teledyne, Oh, Chief Business Officer, Chief Financial Officer, and head of strategy.

A press release announcing and terrorist financial and operating results for the first quarter ended March 31st 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 Dot Antero bio dot 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 Companys future operations are considered to be forward looking statements within the meaning of the federal Securities laws. All forward looking statements are based upon current expectations that involve risks changes in circumstances assumptions and uncertainties spin.

Typically 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's 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 Thomas go ahead Spyros.

Yeah.

Good morning, everyone.

We're aiming to keep this call brief because we already circulated all earnings release last week.

I'm pleased to announce the joining me on the call today.

And that's on a downhill.

As we announced on Monday.

Who has been a member of our board of directors since 2018.

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 strategic experience.

Perfect fit.

As we progress with global partnership discussions and continued development of our proprietary oral delivery platform.

Well I'm happy to introduce our Miranda totally Donald.

Thank you very much theres. Some good morning, everyone I'm truly excited to join in terror at this critical juncture in the company's history.

As you all know our lead program E. B 613 is moving along its a phase three clinical development.

Yeah in fact, we reported compelling efficacy and safety data from our phase two dose ranging study.

We believe E V 613 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 it would be 613 as the first oral and.

The Baltic agent for the treatment of postmenopausal women at high risk of osteoporosis.

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

We are currently laser focused on finalizing a 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 spiro's to provide highlights from Q1, 2022 which the company released last week. Thank you.

Thank you Miranda.

As part of a pre pivotal study planning, we completed a comprehensive market and analytics study concerning E D. Six months free and its potential as the first of all anabolic and first oral PTH product available to post menopausal women at high risk of osteoporosis.

The study focused on understanding treatment paradigms and quantifying the U S market potential of VB six dollar tree by evaluating prescriber health plan and managed care inputs.

The key conclusions from this study included first osteoporosis represents a large market of over 15 million patients in the U S. Yet approximately only 75% of the childhood population is not receiving any pharmacologic treatment.

Second despite the endocrinologists, recognizing the clinical benefit of initiating antibiotic treatments such as the currently our injectable PTH agents for high risk patients prior to first line Bisphosphonates, the high cost and patients' unwillingness to opt for a subcutaneous <unk>.

Jackson is limiting treatment.

So nations where receptor to E. B six months free efficacy based on our phase two data as an anabolic treatment and its improved safety profile and that's the oral route.

Administration.

He is certainly very favorable true E. B six month, three and characterize the value proposition is there.

Safe oral anabolic treatment option for osteoporosis patients.

A survey of high prescribing doctors show that E V. Six months, where you could become the preferred option and moderate to severe osteoporosis and substantially grow the anabolic market.

Well well move to a brief update on all types of technology platform and I T.

We filed multiple U S patent applications are this quarter intended to expand all patent protection.

Supports future developments as we continue to optimize our oral delivery platform.

Furthermore, we continue to evaluate establishing material transfer agreements with potential strategic partners proprietary molecules.

Thank you very much for this update and we look forward to taking your questions.

Thank you we will now be conducting a question and answer session.

We would like to ask a question. Please press star one on your telephone keypad.

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Our first questions come from the line of Capex or chat with B. Riley. Please proceed with your questions.

Yes, hi, good morning, and congrats on the appointment Miranda maybe first I'll start with the analytical studies for <unk> 613.

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 <unk> 613 before bisphosphonates.

Maybe in that patient group with no prior history of fractures.

Okay.

Yeah.

Got it.

No. Thanks.

Thanks for your question, Yeah, I mean, obviously you know Bisphosphonates all used first line.

Well a lot of this.

Do you have to go through a step therapy to this fast when they accept firms, but what was interesting was that.

Payers and prescribers.

What's the profile that we have with a novel antibiotic.

Please see the Yahoo, and oral PTH moving up the chain.

Not requiring a step at it for it to be a to be used in the salt and its population. So as I said, that's sort of at least a very large untreated population that.

I think that Oh from problems and all along the Baltic and with payers I think it would be we'd be willing okay.

It's too early to Pablo product.

Mhm.

I think John's question.

Yeah.

I think I might just add to it and thank you kept at Sierra support we have collected all of the states are and then micro away and I think our plan is well disseminate.

Portions of the study to analysts in the coming months, where we're going through and also as we finalize the phase three <unk> strategy, but just to echo what Stan said because the the potential for this drug is is obviously aisle and PTH is as well.

Alidade said there is also quite a high level of enthusiasm from the clinical community.

Ah.

That's potentially cycling through our sequencing anabolic followed by and she was so upset and vice versa, and we've seen that in precedent child's right. So that data has been collected both qualitatively and quantitatively. The study that we conducted.

Okay. That's that's helpful and then last quarter you.

If there was regional interest in developing E V 613, particularly in Asia.

Can you give us any updates here on the progress of these actions and are you aiming to have something locked in before you initiate the pivotal study for <unk> 613.

Yeah.

But yeah, we are actively pursuing a lot of the deals both globally and also our region. He is as we've indicated before.

Our intention is to populate the assets globally that that would be our preferred path.

And predicts we'd really expect to see.

Finishing something by the end of it yeah, but I mean, given the profile that we have in our phase II data.

It's it's it's a very attractive asset and the once a day oral kind of formation again, it fits really well into the globally, but he also ferocious called me on my globally. So yeah, Mike I'll I'll go on to really generate the best Oh This collaboration.

That will finish.

Nationalized assets globally and.

But we're getting a lot of interest we had already announced so we retained that theyre very experienced a bank a trend that has been working out what else are very well and are generating.

Generating a whole lot of inbound interest on partnering the asset.

Okay. Thank you thanks for taking the questions.

Thank you.

Thank you as a reminder, if you would like to ask a question. Please press star one on your telephone keypad.

Our next questions come from the line of Nathan Weinstein with Aegis capital. Please proceed with your questions.

Oh.

Good morning, Spiro some miranda thanks for taking my questions I'd like to just start by asking about the optimization of the oral delivery platform I'm, specifically, where there's some attributes you could speak about that are being optimizer, which features of the platform are most relevant to that process.

Yeah. Good morning, Nathan Yeah, I'll tell you. Thanks for your question Yeah. So in general the fee.

We're looking to optimize and to capture them all new I P. O ran well really around the physical chemical players characteristics of the target molecules and so being able to handle all so different charges on the molecules and also the different molecular way.

<unk>.

So with all of that I'm always with the goal of that really are reducing the variability that you ultimately have to deal with them.

All delivery and we've seen that with our optimized platform we're achieving.

Not only higher bioavailability, but also a lower variability and we were able to address more molecules.

With the new IP.

We generated and then just one additional important aspect to our new the new IP that we filed as well, but all new IP also includes some important except in slipped are already approved by FDA. So from a regulatory standpoint up yeah.

So there's fewer regulatory.

Those two incorporating those in new formulations that we are working on and that was all solved all scientists back at the lab, we're very sorry.

There's a lot of work in screening different molecules and things that could fit into our platform and that we felt would be.

The developing so the progress we made was significant and that's why we filed the whole set of new patent applications and these also gave us a whole new patent life French patent life.

Okay.

Okay, great. Thanks Girls makes sense, maybe just one question here on E. B 613, now right now obviously looking at post menopausal women at high risk of osteoporosis, but down the line could it make sense to look at any other demographics.

Oh, yes, I mean, obviously.

Similar demographics up for sale.

Using the other anabolic so yeah, all males will be one novel possibility Oh, yeah I mean.

It could be expanded.

Two additional populations I could have a art do you want to speak to the different populations that are yeah in Orlando, but it could be so pointed towards.

Yeah.

Sure.

There is a spirit parted out sort of a natural development cycle first looks at the effectiveness of a drug and postmenopausal women with osteoporosis at high risk of fracture.

That's the initial indication for injected Terry paradigm.

Subsequently.

The other target populations that would benefit from an anabolic or 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 steroid like prednisone, that's usually called glucocorticoid.

Induced osteoporosis, so they would be subsequent target.

Populations after an initial.

The demonstration of efficacy in.

Post menopausal women with osteoporosis at high risk of fracture.

Okay, great. Thanks, so much actually I really appreciate the color there and I. Appreciate you guys taking my questions.

Alright that makes sense.

Thank you as a reminder, if you would like to ask a question. Please press star one on your telephone keypad.

There are no further questions at this time I would like to hand, the call back over to Cheryl Chavez for any closing comments.

Thank you very much everybody for dialing in for all update today, obviously, we're very excited with the addition of Miranda.

The leadership team more than Terry as you can see a lot is going on in the preparation for our phase III for osteoporosis and extending old small platform.

And we look forward to a full raw updates with you and thank you for your support.

Have a good day.

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