Q4 2021 Entera Bio Ltd Earnings Call

For those of you who have not yet seen it.

Dot com.

Specifically.

On the duration and magnitude of such impact.

All investors to read our SEC filings.

Thank you Ramesh.

Thanks to everyone for joining the call this morning.

Enables the oral delivery of protein therapeutics.

We have hit several key milestones in.

Generating value for our shareholders.

One N P and Austrian Carson.

P value of less than 0.001.

And bone mineral density.

Oh, My God, I wish bone mass and strength.

Our six month bone mineral density results.

Ah you're prestigious late breaker.

The presentation also at ASP BMR.

This is important.

Huge presentation, although studies.

In collaboration with Amgen.

I'm really phase three endpoint.

At high risk of fracture.

Thank you Spiros and good morning, everyone.

Alternative.

Net para.

In October 2021 <unk>.

Now turn it over to Ramesh.

Our chief financial Officer for the United States.

Thank you Philip.

Our 2021 and 2020.

MTA agreements.

Research and development expense for the year ended December 31, 2021 consisted primarily of headcount related cost.

External costs.

The conduct of recently completed it would be 613 phase two clinical trial.

General and administrative expense for the year ended December .

Sure.

But primarily made up of salaries and related expenses, including share based compensation professional fees.

D&O insurance and legal fees.

Net loss for the year ended December 31st 2021 was $12 2 million or <unk> 47 dollar per ordinary share.

For the year ended December 31st 2020, net loss was $11 2 million or six seven daughter, our ordinary share diluted.

As of December 31st 2021, and Terra had cash and cash equivalents of $24 9 million.

And in our 10-K that we filed today, we will report approximately $21 7 million in cash and cash equivalents as of March was 2022.

Based on current operating plans, we expect our cash position will be sufficient to fund our operations into the fourth quarter of 2022.

I'll now turn the call back to Spiros for controlling remarks before we go to Q&A.

Thanks, so much.

The successful completion of the phase III osteoporosis study.

A major milestone given the extraordinary challenges related to the COVID-19 pandemic.

And I want to thank the patients investigators consultants and the entire <unk> team for their hard work and persistence and rigorously executing this clinical study.

I also want to thank our shareholders and directors and consultants for their support of terrorism mission 'twenty.

2021 wasn't an extraordinary execution yeah.

With our lead program progressing to phase III for the small $2 billion market. We expect 'twenty to 'twenty two will also be a year of execution and meaningful deals.

We are off to a good start this year with a key patent filing and numerous business development and strategic partnering discussions.

Antero is entering very exciting times with many big catalyst in the coming year.

Thanks to everyone for taking the time this morning listening to our review of operations. We look forward to providing you with regular updates on our progress in the coming months.

Have a good day.

Now take questions.

Thank you we will now be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May Press Star two if you would like to remove your question from the queue for participants using speaker equipment, it may be necessary to pick.

Up your handset before pressing the star keys, one moment, please while we poll for your questions.

Yeah.

Our first questions come from the line of <unk> Patel with B Riley. Please proceed with your questions.

Yes, hi, good morning, Thanks for taking our questions.

Spiros first confirm.

That you will be tight trading to the 2.5 milligram dose of <unk> 613 in the upcoming Phase III and then and then if you are titrating can you give us additional color on perhaps how you're designing this trial to mitigate any risks are for not showing non inferiority against for T O.

I know there were some differences in efficacy between the titrated, a non titrated dosing groups in the phase two.

So are there any certain jobs that you might be taking to offset these efficacy differences.

Potentially into phase III.

Yeah, Hi, Thanks for your.

Question, Yeah, so in terms of the titration.

The regimen, yeah, we really try to learn as much as we can from the phase two and apply that to the phase III study just sort of how are you.

Derisked for the year.

The impact of the titration so.

The phase two study as you know titrated over very prolonged period over two months to go from the.

The 0.5 milligram, one milligram dose up to the two five milligram dose and it took us two months to get to the matter of the two five milligram dose and then it was only for the four months out of the six patients were on the maximal two five milligram dose and and and so what we're instituting in.

The phase III study, we're still getting the same titration going from one five to the two five milligram dose, but we're going to institute a more accelerated titration just over two weeks versus the two months of the and in the Phase III study and so based on also review of the PK day.

And Oh, a while ago, but the face to outpace two results would feel that that titration well you will achieve that.

What we need.

Good thing about the titration as we saw in our phase two study.

In titrated that group only one patient dropped out so there was a very high Oh retention, you know about over 90% of patients.

Were titrated up to two five milligrams remained in the study which was a very good sign of the those that are the tolerability.

Those patients even though they were at the two five milligram dose for the school of.

Course of the.

The study and so and then one other element is that the phase III study is a 12 month study and so pace.

Patients will be on the full two five milligram dose.

Essentially yes.

The entire 12 month period.

And having this very rapid.

<unk> up to the the two five milligram dose.

Does that okay.

Sorry go ahead.

Yeah go ahead.

No I think that's very helpful. I, just I was going to ask what's the status of the phase III are there any additional gating factors before you actually commence the trial I think I think previously you guided to initiate in third quarter of this year is it still fair to assume that those time.

I remain on track.

Yes sure.

The timelines that we were guiding to a sort of second half of this year. So it could be a crowded third quarter over fourth quarter and I'm definitely for the second half of this year and some of the activities are going on I mean, we've we've signed up but you see our oh, there's going to be working with us.

On the study.

We're very busy and sort of identifying sites and on the on your part of the operational side and getting that aspect of the study operations are going up up and running and then we also are they are some refinements to the protocol based on all indications meeting with FDA FDA.

Some very useful.

Suggestions for the study design, which I think would improve the speed and improve the phase III study and so we're going through the process of updating the phase three protocol and once that we have the final phase three protocol, obviously will be growing with that and will.

We'll update the market when we have the you know the final phase III protocol and the stores I'm assuming about that.

Between the 600 to 800 patients there's still the.

Our current assumption and for the Phase III study.

Okay fair enough and how should we think about.

Business development opportunities for 613, I think you mentioned.

Some interest for 612, but.

But what about you know the lead program. There was some regional interests that you mentioned in the past for 613.

Those conversations still still ongoing.

Oh, yes.

Very much ongoing you, there's significant task or a regional especially Asia Asian interests.

<unk> also posted a very large market.

And that goes up those discussions are progressing extremely well and we've also though as we announced today, we've recruited Korea capital to work with us on the partner and global partnering.

For all of Us to propose this house that we think will put us in the best position to get.

Two I already have the best part of the best partnership for all our program and I've already gotten what can you help us get to the finish line of an approved product so globally and so we're really excited about the Torres coming on board and there are obviously, helping a lot then we have some strategic alliance in partnering.

Efforts, there's also substantial interest as Philip mentioned on all of hyperparathyroidism by asset there's a lot of interest a lot of companies, but sort of the.

With a presence in and as the orphan disease space.

A lot of interest and we also Oh, there's a high possibility of the collaborations.

And in that space as well.

Okay.

And one final question Spiros.

As a G L P to program the next.

Graham that we should expect you to enter into the clinic.

How should we think about timelines for advancement on this one.

Yep Yep.

We will be a sort of announcing a having a.

That's sort of Investor day too.

To discuss our platform and how next what's next API, we will select.

Going through our we've put together a very seasoned scientific advisory committee that is helping us select our next styles for API.

It was the best of the time.

Sure.

Between our platform and the properties of the API. So it's a big bank.

So it may be G. L P to but there are some other also very exciting possibilities are out there.

G L P as they're all software, maybe even bigger potential and Oh.

Bigger commercial opportunity and so what we're going through that process of prioritizing, which one which next to API. We will select Brown. Our next stop program. So expect to have an update probably in the first half of this year, we will update our investors and the market.

Alright, thanks, very much spiros, thanks for taking the questions.

Thanks, so much.

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.

Thank you and good morning, Spiro sand to the entire team congrats on the progress with the business in so many different areas.

I guess, just a couple of questions for me.

Firstly the revenue line continues to tick higher do you think you could make any directional comments on where that could go and then does that include both the amgen and new partnerships as well.

Yeah, Greg Hi, Nathan Yeah, Yeah, correct, Yeah, Great question, Yeah, good catch there on a revenue line.

Yeah. It is picking up in the right direction in that.

That is yes.

The bulk of the revenue was off from amgen's payments to entire IP on Amgen Cabos, all all in charter cost related to the Amgen.

Collaborations so that there's no sort of funding.

That entire contributes towards that partnership is all public by Amgen, but he has also been getting.

A number of new material transfer agreements, which are funded by the companies are renegotiating with so those companies are paying us to do these initial feasibility studies and so there is a that uptick in revenue is also related to that does it.

The higher number of MTA that we've signed we're getting that.

That initial sort of MTA funding and so that is a good kind of.

It's Jay.

Good Mike I would say that we expect.

To be entering into an <unk> and that's you know a large collaboration this year cause yeah on a new a new program. So very similar to Amgen, that's where you derisk, but that.

We will provide significant funding to ensure.

Okay.

Great. Thank you Spiro and just one question here on <unk> 613 in the studies to date can you just remind us what if any background therapies patients our on and then what might be allowed or not in the phase III study.

Yeah they were no.

I believe that Ah patients.

Could not be on any.

Got it got drugs for a number of years before for quite a long period before they were enrolled in the study and the same is the case for the phase III Alaska at.

At Sentara, Chief Medical Officer to just add a little more information on the went back on therapies patients.

We're on a we're not on the same store and then also how we're handling that for the phase III. If you could provide that.

Yeah sure.

All the patients had nutritional support in terms of supplemental dietary calcium if they needed it and the standard dose of vitamin D. Three that's right.

The nutrient vitamin D tree nut and activated analogue.

And spare part it out patients couldn't have been on active therapy at the time. They started this study however, you sort of say bisphosphonates.

As long as there's a number of years in the past was allowed and that's very common situation are you running into clinically.

No immediate transition as from the Bisphosphonate true E. P. P O five would be allowed a same or being in phase III.

It would be a very similar population who would be candidates for an austere anabolic. It's currently approved.

They wouldn't be transitioning directly from our prior therapy.

Like bisphosphonate or Denosumab.

Who are the intervention in the trial there'll be a gap of probably in the order of two to three years, depending on the truck.

Okay. Okay fine. So thank you for the detail there and I think that's that's it for me for now and congrats again on the progress it's nice to see you guys developing the businesses so much.

Thanks Nathan.

No.

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 now like to turn the call back over to Spiros Thomas for any closing comments.

Yes.

Good morning, everyone. Thank you so much for calling in for our earnings call.

As you can see we were really on the verge of some big catalysts.

For a point in time for an expanding and terrorists business and using our platform.

So value driver there always are really believed it can can become we have some very solid.

Solid clinical.

Clinical milestones this year with progression to phase III.

And you will be keeping you updated on both of our lead program, but also expanding opportunities with our platform.

Thank you very much have a good day.

This does conclude today's teleconference. We appreciate your participation you may disconnect your lines at this time.

Enjoy the rest of your day.