Q2 2021 Entera Bio Ltd Earnings Call
[music].
Yeah.
Good morning, and welcome to <unk> conference call to discuss the financial and operating results for the six months ended June 32021.
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 one on your telephone.
I would now like to hand, the conference over to <unk>. The U S based CFO oven Tara. Please go ahead.
Good morning, and welcome to the call joining me on the today's call our speakers John laws our CEO.
Chris <unk>, our CMO and Phillip Schwartz, our president of R&D.
A press release announcing that.
When Ashland all picking those.
Six months ended June 30th 2021 was issued earlier today.
For those of you who have not yet seen it it's available on the investors section of our website www and tela bio dot com.
On a Congress 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 radio statements. We make during the call about the company's future results of operations.
We position our deprecation of data from the recently completed phase two clinical trials of <unk> one three.
Including the biomarker data lease or the first quarter of <unk> 41.
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 COVID-19, pandemic continue to evolve and the extent to which the pandemic will impact us in the future.
On the duration and magnitude of Richard back and on numerous factors that you 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.
We undertake no obligation update any forward looking statements.
On this call on account of new information future events or otherwise.
Finally, we.
Please be advised that todays call is being recorded and webcast.
I'll turn the call over to scripted dramas.
Thank you Ramesh and thanks to everyone for joining the call. This morning.
I joined in Terra in January 2021 based on the company's validated technology platform that enables the auto delivery approaching therapeutics and a talented and dedicated team.
We have hit several key milestones that have generated value for our shareholders and confirms my confidence in our team and technology and.
And believe we're on a path to creating more value.
We are working diligently to protect the intellectual property around in Paris platform.
In the second quarter, we announced that the European patent office granted a foundational patent addressing how all PTH formulations.
Currently in clinical development for osteoporosis, and Hypo P T.
Also.
In the second quarter, we reported the ultimate and scientific validation.
Our phase two clinical study of VB 613.
O P th product for the treatment of US Europe closest met its primary and key secondary endpoints.
There is a linear had statistically significant dose response for PTH dose and the key anabolic bio chemical markers P. One N P and Austral Carlson.
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.
A S BMR.
2021.
I believe these dates are supporting business, because I've been ethics 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 entellus technology platform to give patients a much needed all alternatives to treatments currently delivered via injection.
Supported by data from multiple clinical trials, including the recently announced positive three months bone biomarker data and six month bone mineral density data from the completed phase two clinical trial of E. B six months really in osteoporosis patients.
And the data from a phase Iia study of E. B 612, and hydropower Arabism 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 it would be 613 is a tremendous opportunity in the osteoporosis market.
He would be 613 is an oral formulation of human parathyroid hormone like 234 or PTH.
And is positioned to be the first oral once a day bone building anabolic product to treat osteoporosis patients.
The successful phase two study has boggy would be 6131 step closer to potentially becoming available to the estimated 200 million people affected by offshore courses worldwide.
In the U S 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 for men over 50 years of age or break a bone due to osteoporosis.
That's very pudic market. This large estimated at $4 billion annually today surprisingly there are only three effective bone building treatments available for Teo third paratype, Kinloss abaloparatide and they've entity on the social map and all three are injectables.
This may be one reason why only 5% of patients living with osteoporosis are treated.
These injectables also quite pricey at a cost of $20000 to $30000.
Here in the U S.
We believe that a safe and effective all bone building blocks like each country may significantly increase the treatment market.
Assumption was borne out in a research study, we commissioned with an independent market research firm, which found patients physicians payers and providers are seeking more cost effective solutions.
Aside from a more patient friendly auto delivery as an oral drug you'd be 613 can be far more cost effective than injectables.
We believe in China has a multibillion dollar opportunity here.
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 treated.
And that's a cost that is 25% of today's injectable price, which translates to an over $20 billion plus potential.
To take share from the 50000 patients treated with Injectables today.
Our phase two clinical trial of VB 613 was a six month double blind dose ranging placebo controlled study in 161 post menopausal female subjects with osteoporosis.
So bone mineral density or BMD.
The study was conducted at four leading medical centers in Israel to evaluate the safety and efficacy of varying doses of VB six country.
Most important BMD endpoint change in lumbar spine BMD after six months was met.
Subjects, receiving the two five milligram dose of VB six month, three showed a significant dose related increase in BMD at Columbus spine.
Total hip and femoral neck.
At six months, the lumbar spine BMD increased by $3 seven 8% as compared to placebo with a P value of less than 0.008.
The study's primary efficacy endpoint is statistically significant increase in P. One N P. At three months was also achieved.
It would be 613 exhibited an excellent safety profile with no drug related serious adverse events.
I want to highlight two pieces of data to point to the performance of insurance platform to deliver a peptide orally and achieving a controlled biologic effect.
There was a significant dose response for the PTH dose and you'd be 613, and the increase in lumbar spine D. M D with a P value of less than 0.0001.
It was a significant dose response for the PTH dose and you'd be six months.
And the increase in month, one pier one in Pea with a P value of less than 0.001.
We look forward to an end of phase two meeting with FDA to review these data and to discuss E V. Six one threes development program.
With the FDA is agreement.
Plan to conduct a single pivotal Wahid a phase III study comparing changes the number spine BMD in patients treated with all you'd be 613 versus treatment with photo injections.
<unk> five or <unk> pathway.
In this non inferiority study, we would evaluate it would be six one threes effect on spine BMD to be within 25% that are photos or greater.
Furthermore, E B six months, we 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 I, usually not observed with <unk> treatment at six months.
We have also continued to support preclinical work and 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 problem.
From a business development perspective, we are focused on leveraging that platform technology to create additional value either through proprietary products segment.
603, and you'd be 612 that can be developed by antero alone or in collaboration with a partner well applying our technology to another company's compounds such as that that we're doing in our collaboration with Amgen.
That's part of our BD efforts, we have signed material transfer agreements with three companies to demonstrate the feasibility of insurance 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 derisked assets.
Operationally, we have continued to monitor our expenses judiciously raised cash for their use of our ATM program.
I'm pleased to say that our current cash on hand.
To support our planned operations into the fourth quarter of 2022.
I'll now turn the call to our macro tower space CFO to cover the financial results.
Thank you Spyros.
Revenues for the six months ended June 30 of 2021 were 266000.
As compared to 94000 for the six months ended June 32020.
But revenues in both quarters attributable to the R&D services provided to Amgen.
Cost of revenues for the six months ended June 32031, and June 30 of 2020, 121017, 73000, respectively and were comprised of salaries and related expenses in connection with the R&D services provided to Amgen.
Total operating expenses for the six months ended June 30 of 2021.
$5.2 million and included $2.4 million in research and development expenses, and $2.8 billion and general and administrative expenses.
Research and development expenses for the six months ended June 30th 'twenty 'twenty. One consisted primarily of headcount related costs and external costs related to the conduct of the recently completed you'd be 613 phase two clinical trial.
General and administrative expenses for the six months ended June 30th Great. 'twenty. One was primarily made up of salary and related expenses, including share based compensation professional fees D&O insurance expense and legal fees.
Financial expenses net for six months ended June 30th 2021 and 2020 are mainly resulting from the remeasurement of warrants issued in connection with our 2018 initial public offering and a private placement in December 2019.
Which include a second closing in February 2020.
Increase of $9.9 million in the six months ended June 30 of 2021.
Attributed to the increase in the fair value of the warrants mainly due to an increase in our market share price.
As of June 30 of 2021, Antero had cash and cash equivalents of $26.9 million and in our 6K that'd be filed today.
Approximately $28.1 million in cash and cash equivalents as of August eight 2021.
Based on our current operating plans, we expect our 2021 operating loss to be approximately $13 million.
Subject to the expected timing of product development programs, including <unk> 613, and subject to any continuing impact of COVID-19 on our operations.
As a result, we believe 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 concluding remarks before we go to Q&A.
Thanks, so much.
We are excited about the recently reported phase two clinical results for E B six country.
We believe that the market opportunity in osteoporosis and substantial because the majority of patients that could benefit from an antibiotic treatment.
Main untreated.
Facial results demonstrated a clear dose response, using our platform to deliver PTH R&D and to achieve significant clinical improvement.
This is excellent clinical validation.
Further we have strengthened our balance sheet now at $28.1 million, enabling us to generate data showing that our proprietary platform works on molecules abroad characteristics time flies.
To fuel our business development efforts, we have signed material transfer agreements with a number of companies to demonstrate feasibility of the tap platform for their proprietary molecules.
I believe these data will support.
And discussions and generate future value through strategic collaborations and partnerships.
Yeah.
If you'd like to ask a question at this time. Please press. The Star then the number one key on your Touchtone telephone.
To withdraw your question.
The pound key.
Again that is star then one if you'd like to ask a question at this time.
Okay.
Our first question comes from <unk> Patel with B Riley.
Yeah. Good morning. Thanks.
Thanks for taking my questions and congrats on the recent progress.
Just a couple from me first for the planned phase III trial.
Can you share the non inferiority bar in terms of the BMD increase that you expect at.
At 12 months that you think could be sufficient to meet that 25% are non impurity level and then you know.
I think you mentioned, the 10% market penetration rate.
On the call just curious if you can provide more color on how you derived that estimate and perhaps what gives you the confidence in achieving that goal. Thanks.
Okay.
Yeah.
Heck up at Oh.
Thanks very much.
Yeah for your question.
Turning to priority margin.
Uh huh.
Obviously, reviewing our phase two results, which obviously, we're very very.
Very strong in terms of.
What we showed at the height that you bought five milligram dose for the.
Lumbar spine BMD, but also we also showed increases in femoral neck in total hip and we're sort of evaluating how to incorporate that in trial with primary endpoints and the.
And then the statistical assumptions.
We would use for non inferiority.
We're sort of evaluating all of that will update the market once we have a clear.
The new updated plan based on a new sort of phase two results.
Uh huh.
Spirits, maybe if I could just add to that and in terms of the endpoint. So.
Most of the <unk> studies had.
Between six and 8% increase in spine BMD at 12 months.
And.
So in order to be plus or -25%, we would have to achieve something like somewhere between.
5% to 10% approximately in in order to have a.
Non inferiority, but it depends a lot on the statistics, though just to give you a general range of what.
What was achieved in various trials.
Okay, and then the 10% market penetration.
Can provide more color there.
Sure Yeah.
Yeah, Philip could gear.
<unk> will provide more that was based on that the market survey that was done.
And.
I mean, what we're seeing.
The market.
The injectable anabolic not achieving sort of it.
Achieving very low penetration single digit across the across.
Across the board when you look at all of them are social matters.
And Uh huh.
I'm Kim loss.
So that leaves the site, there's a much higher number of patients that are eligible for anabolic agents and are receiving.
Receiving these injectables so that's from a high level, that's where the big GAAP is.
So.
Just to add to that that in in general in our survey when we spoken to physicians at others.
It's quite clear that less than 5% of the overall treated patients are treated with injectable medications and is the primary driver.
For physician choice and for patient choice in terms of which medication. They are used to treat osteoporosis, which is a silent disease something that people can't feel and especially for the elderly.
That population is very sensitive to taking injections, especially for a silent disease, which they can't steal they don't want to be bothered with it.
Therefore, with the introduction of a new oral agents typically you see a very very large increase, especially when they have novel mechanisms of action.
Which PTH does as compared to the other oral agents.
We would anticipate that given the fact that it's an oral.
With lower significantly the resistance that patients and physicians have to utilizing an agent, which is anabolic which is capable of building bone and reversing some of the damage and symptoms that are attributable to osteoporosis on a payer level. We'd also imagine that payers would also.
Be enthusiastic about this.
Because the cost of fractures that result from osteoporosis is incredibly high and if they could get a larger proportion of their population to be treated with an oral as well as to be treated with the oral that's an anabolic that would have very very significant benefits and therefore, there would be multiple parties driving.
The market share of our drug.
Assuming that we're successful.
Okay. Thanks for taking the questions.
Yeah.
As a reminder that is star then one to ask a question.
Our next question comes from Vicky Titan with heightened advisory.
Hello.
Good morning, guys.
Good progress being made I've got two questions.
First on the FDA meetings.
Coming up what are the timing of that meetings in terms of and when you meet when do you expect some kind of a comment back feedback from them.
And my second question is regarding this.
Transfer of technology.
Yeah, we're working with three different outfit, so what's kind of it.
Timing of gains on those.
Expectations for this transfer our proprietary technology.
Okay.
Yes, Thanks, Greg.
Nice to hear you and yes. So your first question on the timing of the FDA meetings that we're requesting an end what's called an end of phase two meeting with FDA, which is a it's a standard meeting at the development that we're at and.
The timing of that I mean, we've said, it's the second quarter I mean, sorry, the second half of this year that we will have.
Our end of phase II meeting and Thats still what.
What we're holding to.
Once we have a confirmed date, we'll probably update the market on.
On that and that.
Typically for that we will provide our full phase two results as well as our proposed phase III protocol and then FDA will review that and we'll have as we can.
The physical meeting with FDA to get FDA feedback and the key thing for the end of Phase two meeting is to get full agreement from FDA on the phase III design and what will be required to support approval for sure. He would be 613 for the treatment of osteoporosis.
And and we still expect there will be a one pivotal study one phase III study will be required under this sort of 505 btu phosphate and where we're taking we're taking with FDA.
Hum.
So it's within that.
Within this before the end of the year within the in the second half.
All of that will happen.
With regards to them the material transfer agreements and the.
Evaluation of our platform with other companies our molecules.
That is ongoing right now we're in we're conducting experiments right now of evaluating.
Number of other companies are our products are without platform that generally involves some animal studies and to demonstrate that our platform is working and all we haven't validated models to do that and.
We have a lot of momentum going and what about the.
The interest in the platform and what was the number of companies and.
I mean I expect we.
It should be a reserve.
Be able to announce a updates on potential partnerships.
By the end of the year.
Yeah.
Yes, Thank you and just a quick follow up.
With the E B 613.
And you are working or waiting for the FDA meetings.
Also.
In process.
Meeting with other people other companies too to see if there is any potential for a JV that it would be 613.
Yes, yes, yes, yes, absolutely we're in a number of discussions both.
Both with clubs.
<unk> companies are companies that have focused and so the osteoporosis market in China for example, as well as our European companies and companies with global interests spell a global a.
Global while show process.
Marketing and those are progressing well I mean, obviously the the final the BMD data has been very helpful.
Proving that all platforms.
Platform is working and we're getting a.
BMD increase that you would expect for the syndication and so yeah. We'll those are progressing well. It shows we have something obviously that will let the market know on a potential collaboration.
Thank you very much good luck.
Again that is star then one if you'd like to ask a question at this time.
Okay.
Sure.
I'm showing no further questions I'd like to turn the call back to stereos for closing remarks.
Yeah.
Yeah. Thank you everybody for calling in and for your very good questions.
And Oh yeah.
Yeah, I already made my closing remarks.
In the previous setting.
Setting, obviously, we're very happy with the cash position and improved passenger sugar company with $28.1 million.
And cash right now positioning us in a very strong.
Moving forward and with Oh path forward with that at the end of phase two meeting with yesterday and he also will be having a number of presentations at the ash DMR. Although you know the details of our phase two results will be presented.
Our annual board meeting so we'll be we'll have a number of very good events.
I'll discuss our results.
You very much for your interest there.
[laughter].
This concludes today's conference call. Thank you for participating you may now disconnect.
[music].
Okay.
[music].
[music].
[music].
Good morning, and welcome to Antero Vials conference call to discuss the financial and operating results for the six months ended June 32021.
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 the session you will need to press star one on your telephone.
I would now like to hand, the conference over to Ramesh routes on the U S based CFO oven Tara. Please go ahead.
Good morning, and welcome to the call joining me on the today's call Osprey go to Thomas our CEO Chris.
Centuri, our CMO and Phillip Schwartz, our president of R&D.
A press release announcing and I can tell.
Financial and operating results for the first six months ended June 30th 2021 was issued earlier today.
For those of you who have not seen it it's available on the investors section of our website Www <unk> 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 would like to remind you that radio statements. We make during the call about the company's future results of operations and financial position our interpretation of data from the recently completed phase two clinical trials of <unk> three.
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.
And circumstances.
And uncertainties scratch.
Specifically developments related to COVID-19, pandemic continue to evolve and the extent to which the pandemic will impact us in the future.
The duration and magnitude of such impact and on numerous factors that they may not be able to accurately predict.
These risks are described more fully in our SEC filings and are available under SEC.
She is 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 update any forward looking statements. We may make on this call on account of new information future events or otherwise.
Finally, we.
Please be advised that today's call is being recorded and webcast.
I'll turn the call over to scripted dramas.
Thank you Ramesh and thanks to everyone for joining the call. This morning.
I joined the Terror in January 2021 based on the company's validated technology platform that enables the oral delivery of protein therapeutics and a talented and dedicated team.
We have hit several key milestones that have generated value for our shareholders and confirms my confidence in our team and technology and.
And believe we're on a path to creating more value.
We are working diligently to protect the intellectual property around in Paris platform.
In the second quarter, we announced that the European patent office granted a foundational patent addressing how all PTH formulations.
Currently in clinical development for osteoporosis, and Hypo P T.
Also.
In the second quarter, we reported the ultimate and scientific validation.
Our phase two clinical study of VB 613, all oral PTH product for the treatment of osteoporosis methods primary key secondary endpoints.
There is a linear that's statistically significant dose response for PTH dose and the key anabolic bio chemical markers P. One N P and austral Carlson and bone mineral density.
Cynical measure bone density and strengths.
The abstract on the three month biomarker results was accepted for presentation.
At the leading clinical bone disease Conference T. A S BMR.
In 2021.
I believe these data supporting business developing assets that 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 terrorists technology platform to give patients a much needed all alternatives to treatments currently delivered via injection.
Courted by data from multiple clinical trials.
The recently announced positive.
Three months ago, and biomarker data and six month bone mineral density data from the completed phase two clinical trial of E. B six months really in osteoporosis patients.
And the data from a phase Iia study of E V 612, and hydro Arabism 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 it would be six months free is a tremendous opportunity in the osteoporosis market.
He would be 613 is an oral formulation of human parathyroid hormone.
So at four O P T H.
It's positioned to be the first oral once a day bone building anabolic product to treat osteoporosis patients.
The successful phase two study has bought E. B 6131 step closer to potentially becoming available to the estimated 200 million people affected by offshore of course is worldwide.
In the U S alone 54 million Americans have I'll show process.
Bone mass, which places them at an increased risk of developing osteoporosis.
The one in two women and one for men over 50 years of age or break a bone due to osteoporosis.
Therapeutic market. This large estimated at $4 billion annually today surprisingly there are only three effective bone building treatments available photo sharing parricide Kinloss abaloparatide.
They've entity on the social map and all three high Injectables.
This may be one reason why only 5% of patients living with osteoporosis are treated.
These injectables also quite pricey at a cost of $20000 to $30000 per year in the U S.
We believe that a safe and effective Aro bone building blocks like each country may significantly increase the treatment market.
The assumption was borne out in a research study, we commissioned with an independent market research firm, which found patients physicians payers and providers are seeking more cost effective solutions.
From a more patient friendly auto delivery as an oral drug he'd be 613 can be far more cost effective than injectables.
Believe in Terra has a multibillion dollar opportunity here by treating new patients who currently are not on either of the injectables.
Estimate that there is a realizable opportunity for 10% market penetration with patients currently treated.
And that's a cost that is 25% of today's injectable price, which translates to an over $20 billion plus potential.
To take share from the 50000 patients treated with Injectables today.
Our phase two clinical trial of VB 613 was a six month double blind dose ranging placebo controlled study in <unk>.
<unk> hundred 61 post menopausal female subjects with osteoporosis.
So bone mineral density or BMD.
Study was conducted at four leading medical centers in Israel to evaluate the safety and efficacy of varying doses of VB six country.
Most important BMD endpoint change in lumbar spine BMD after six months was met.
Subjects, receiving the two five milligram dose of VB six month three sure.
Significant dose related increase in BMD at Columbus spine, total hip and femoral neck.
At six months, the lumbar spine BMD increased by $3 seven 8% as compared to placebo with a P value of less than 0.008.
The study's primary efficacy endpoint is statistically significant increase in P. One N P or three months was also achieved.
It would be 613 exhibited an excellent safety profile with no drug related serious adverse events.
I want to highlight two pieces of data to point to the performance of insurance platform to deliver a peptide orally and achieving a controlled biologic effect.
There was a significant dose response for the PTH dose and he'd be 613, and the increase in lumbar spine BMD with a P value of less than 0.0001.
It wasn't a significant dose response for the PTH dosing will be six months and the increase in month one P. One in pea 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 E V. Six one threes development program.
The areas of agreement, we plan to conduct a single pivotal why do you get to a phase III study comparing changes in lumbar spine BMD in patients treated with all you'd be six one theory Roche.
This treatment with photo injections asper, a five or five gets you a pathway.
In this non inferiority study, we would evaluate it would be six one threes effect on spine bnb to be within 25% that are photos or greater.
Furthermore, E B six months, we had a significant impact on both.
Femoral neck, and total hip BMD at six months in contrast significant increases in BMD at the femoral neck and total hip I, usually not observed with <unk> treatment at six months.
We have also continued to support preclinical work.
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 that platform technology to create additional value either through proprietary products.
It would be 613, and you'd be 612 that can be developed by antero alone or in collaboration with a partner well applying our technology to another company's compounds such as that that we're 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 insurance 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 derisked assets.
Operationally, we have continued to monitor all expenses judiciously raised cash for their use of our ATM program.
I am pleased to say that our current cash on hand.
To support our planned operations into the fourth quarter of 2022.
I'll now turn the call to a natural time, all U S based CFO to cover the financial results.
Thank you Spyros.
Revenues for the six months ended June cut your 2021 were 266000.
As compared to 94000 for the six months ended June 30th 2020.
With revenues in both quarters attributable to the R&D services provided to Amgen.
The cost of revenues for the six months ended June 30th Jordan 31, and June 30 of 2020, 121000, and somebody talk 73000, respectively and were comprised of salaries and related expenses in connection with the R&D services provided to Amgen.
Talking about total operating expenses for the six months ended June 30 of 2021 were $5.2 million and included $2.4 million in research and development expenses and $2.8 billion in general and administrative expenses.
Research and development expenses for the six months ended June 30th 2020.
One consisted primarily of headcount related costs and external costs related to the conduct of the recently completed you'd be 613 phase two clinical trial.
General and administrative expenses for the six months ended June 30th Great. 'twenty. One was primarily made up of salary and related expenses, including share based compensation professional fees D&O insurance expense and legal fees.
Financial expenses net for six months ended June 30th 2021 'twenty two 'twenty are mainly resulting from the remeasurement of warrants issued in connection with our 2018 initial public offering and a private placement in December 2019.
Which is sort of a second closing in February 'twenty 'twenty.
The increase of $9.9 million in the six months ended June 30 of 2021.
Attributed to the increase in the fair value of the warrants mainly due to an increase in our market share price.
As of June 30 of 2021, Antero had cash and cash equivalents of $26.9 million and in our 6K that'd be fine today. They report approximately $28.1 million in cash and cash increments as of August eight 2021.
Based on our current operating plans, we expect our 2021 operating loss to be approximately $13 million.
This is subject to the expected timing of product development programs, including it'd be 613, and subject to any continuing impact of COVID-19 on our operations.
As a result, we believe our cash position will be sufficient to fund our operations into the fourth quarter of 2022.
I'll now turn the call back to spiro's for concluding remarks before we go to Q&A.
Thanks, so much.
We're excited about the recently reported phase II clinical results for E B six country.
We believe that the market opportunity in osteoporosis is substantial because the majority of patients that could benefit from an antibiotic treatment remain untreated.
Facial results demonstrated a clear dose response, using our platform to deliver PTH R&D and to achieve significant clinical improvement.
This is excellent clinical validation.
Further we have strengthened our balance sheet now at $28.1 million, enabling us to generate data showing that our proprietary platform works on molecules abroad characteristics time flies.
To fuel our business development efforts, we have signed material transfer agreements with a number of companies to demonstrate feasibility of the entire platform for their proprietary molecules I.
I believe these data will support us.
Up in discussions and generate future value through strategic collaborations and partnerships.
Yeah.
If you'd like to ask a question at this time. Please press. The Star then the number one key on your Touchtone telephone.
To withdraw your question press the pound key.
That is star then one if you'd like to ask a question at this time.
Yeah.
Our first question comes from <unk> Patel with B Riley.
Hey, Yeah. Good morning, Thanks for taking my questions and congrats on the recent progress.
Just a couple from me first for the planned phase III trial.
Can you can you share the non inferiority bar in terms of the BMD increase that you expect.
At 12 months that you think could be sufficient to meet that 25% are non impurity level and then.
I think you mentioned, the 10% market penetration rate.
On the call just curious if you can provide more color on how you derived that estimate and perhaps what gives you the confidence in achieving that goal. Thanks.
Okay.
Yeah.
I kept it Oh.
Thanks very much.
Yeah for your questions.
Turning to argue margin.
We are obviously reviewing our phase two results, which obviously, we're very very.
Very strong in terms of.
What we showed at behind what you bought five milligram dose for the.
Lumber spine BMD, but also we also showed increases in femoral neck in total hip and we're sort of evaluating how to incorporate that in trial with primary endpoints.
And then the statistical assumptions that we would use for non inferiority.
Yeah, we're sort of evaluating all of that will update the market once we have it.
Sure.
New updated plan based on our new surface to our results.
Oh.
Spirits, maybe if I could just add to that and in terms of the endpoint. So.
Most of the for Teo studies had between six and 8% increase in spine BMD at 12 months.
And.
So in order to be plus or -25%, we would have to achieve something like somewhere between a.
5% to 10% approximately.
In order to have a non inferiority.
It depends a lot on the statistics, though just to give you a general range of.
What was achieved in various trials.
Okay, and then the 10% market penetration.
Can you provide more color there.
Okay.
Sure Yeah.
Yeah, Philip could you.
Provide more oh that was based on that the market survey that was done.
And.
I mean, what we're seeing.
In the market.
Yeah, the injectable anabolic, so not achieving sort of it.
On achieving very low penetration single digit across the.
Across the board when you look at all of them are social matters.
And and.
I'm Kim loss.
So that leaves a statin.
A much higher number of patients that are eligible for anabolic agents and are receiving.
Receiving these injectables.
That's great from a high level, that's where the.
GAAP is.
So.
I'll just add to that that in in general in our survey when we spoken to physicians at others.
It's quite clear that less than 5% of the Opel law treated patients are treated with injectable medication.
And is the primary driver for physician choice and for patient choice in terms of which medication. They are used to treat osteoporosis, which is a silent disease something that people can't feel and especially for the elderly.
That population is very sensitive to taking injections, especially for a silent disease, which they can't steal they don't want to be bothered with it.
Therefore, it is with the introduction of a new oral agents typically you see a very very large increase, especially when they have novel mechanisms of action, which P. T H does as compared to the other oral agents.
We would anticipate that given the fact that it's an oral we would lower significantly the resistance that patients and physicians have to utilizing an agent, which is anabolic which is capable of building bone and reversing some of the damage and symptoms that are attributable to osteoporosis on a pay.
Your level, we'd also imagine that payers would also be enthusiastic about this.
Cause the cost of fractures that result from osteoporosis is incredibly high and if they could get a larger proportion of their population to be treated with an oral as well as to be treated with the oral that's an anabolic that would have very very significant benefits and therefore, there would be multiple parties driving.
The market share of our drug.
Assuming that we're successful.
Okay. Thanks for taking the questions.
Yeah.
As a reminder that is star then one to ask a question.
Our next question comes from Vicky Titan with like an advisory.
Yes.
Hello I'm.
Good morning, guys.
Good progress being made I've got two questions.
First on the FDA meetings.
Coming up what are the timing of that meetings in terms of and when you meet and do you expect some kind of a comment back feedback from them.
And my second question is regarding this.
Transfer of.
Oh technology.
Yeah, we're working with Teva.
Outfit, so what's kind of it.
Timing of gains on those.
Dictations for their transfer our proprietary technology.
Okay.
Yeah.
Yes. Thanks.
Nice to hear you and yes. So your first question on the timing of the FDA meet.
King.
We're requesting an end what's called an end of phase two meeting with FDA, which is a it's a standard.
Meeting at the development that we're at and.
The timing of that I mean, we've said, it's the second quarter I mean, sorry, the second half of this year, but we will have our end of phase II meeting and that's still what we're.
And what we're holding to and.
You know once we have a confirmed date, we'll probably update the market on.
On that and that.
Typically for that we will provide our full phase two results as well as our proposed phase III protocol, and then FDA will review that and we'll have it.
The physical meeting with FDA to get FDA feedback and the key thing for the end of Phase two meeting is to get full agreement from FDA on the phase III design and what will be required to support approval for sure. It would be 613 for the treatment of osteoporosis.
And <unk> and we still expect there will be a one pivotal study and one phase III study will be required under the sort of five O five btu phosphate and where we're taking we're taking with FDA.
So it's more than that.
Within this before the end of the year within the in the second half.
All of that will happen.
With regards to them the material transfer agreements on the.
Evaluation of our platform with other companies our molecules.
That is ongoing right now we're in we're conducting experiments right now of evaluating.
Number of other companies are a product without platform that generally involves some animal studies and to demonstrate that our platform is working and all we haven't validated models to do that and.
We have a lot of momentum going and what's the the the interest in the platform and what was the number of companies and.
I mean, I expect we should be there.
We should be able to announce a updates on potential partnerships.
By the end of the year.
Okay.
Yes, Thank you and just a quick follow up E B 613.
And you are working who are waiting for the FDA meetings, how do you also.
In process.
Meeting with other people other companies too to see if there is any potential for JV that it'd be 613.
Yes yesterday, yes, absolutely yeah, we're in a number of discussions.
Both of them.
<unk> companies are companies that have focus and so they'll show process markets in China for example, as well as our European companies and companies with global interests spell a global a global Walsh your process marketing and those are progressing well I mean, well.
Obviously the final the BMD data has been very helpful.
Proving that out.
Platform is working and we're getting a.
BMD increase like you would expect for this indication and so yeah, we'll those are progressing well it shows.
We have something obviously, we'll let the market know on a potential collaboration.
Thank you very much good luck.
Again that is star then one if you'd like to ask a question at this time.
Okay.
Sure.
I'm showing no further questions I'd like to turn the call back to Spyros for closing remarks.
Yeah.
Yeah. Thank you everybody for calling in for your very good questions and Uh Huh.
I already made my closing remarks.
And in the previous guidance setting.
Setting, obviously, we're very happy with the cash position and improved passenger show the company was $28.1 million.
Cash right now positioning us in a very strong.
Moving forward and with Oh path forward with the end of phase two meeting with FDA.
And he also will be having a number of presentations at the ash DMR. Although you know the details of our phase two results will be presented.
Our annual board meeting so we'll be we'll have a number of very good events.
A discussion on our results. So thank you very much for your interest there.
[laughter].
This concludes today's conference call. Thank you for participating you may now disconnect.