Q4 2020 Auris Medical Holding Ltd Earnings Call
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Good day, and thank you for standing by and welcome to the arithmetic cool to provide business updates on and three O. One program cool.
At this time all participants are in listen only mode. After the speaker presentation there'll be a question and answer session to ask a question during the session you and each press star one on your telephone.
I must advise you that this call is being recorded today Tuesday, the 13th of April 2021.
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Yeah, Matt on.
And earlier today Auris medical issued a news release announcing preclinical and clinical outcomes with a industrial one on detail on plans for market launch the release is available on the company's website.
Always medical adult Com and filed with the F C C.
During todays call well.
Oh, it was medical will be making forward looking statements.
Within the meaning of the private Securities Litigation Reform Act of 1995. These include statements that address future operating and financial.
Or business performance or the company's strategic strategies or expectations forward looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results developments and business decisions to differ materially.
And he from those contemplated by these statements these risks on fees.
These risks and uncertainties include but are not limited to the timing and conduct for the company's clinical trials.
Clinical utility of its products and.
Product candidate and the time and all likelihood of regularity filings and approvals the company's intellectual intellectual property position on its financial position as well as those described in the risk factors section in the company's annual report on form 20-F and future filings.
With the Securities Unexplained Commission. In addition, any forward looking statements represent Auris medical's views only on Oslo today and should not be relied on upon as representing the company's views I'll go on and.
Sick when states.
While the company may elect to update these forward looking statements on same point in the future. It specifically disclaims any obligation to do so even if its views change with what I would like to hand, the call over to Thomas <unk>. Please go ahead Sir.
Yeah.
Thank you operator.
Hello, everyone and thank you for taking the time to join our business update call, which is dedicated to the a M through one program.
We are very excited and proud about this program, which was concocted during the first COVID-19, Lockdown and launched barely seven months ago.
Since then we have made great progress on our way towards the launch of a safe effective and affordable and nasal spray for protection against the air borne viruses and elegance.
With our highly dedicated team at Auris medical and and close collaboration with great external service providers.
And I've been going at full speed.
<unk> jokingly I have called it our own operations warp speed.
During this call I will first provide a brief description of a M 301 before moving on to discussing the new preclinical and clinical data and allergy and viral infection.
Following that I will talk about our plans for the commercialization of a mcl, one and the market potential for the product.
Finally, we will open the call for any questions.
Moving to slide four I will now present, a M three or one a bit more in detail.
Every day, you breathe and just over 2000 gallons of ear and.
A huge amount about 90% of the ear that you inhale and rest of the body through your nose, which makes it the main gate to your respiratory system.
Apart from regulating the temperature and humidity find ear that your brief before it and just the lungs. You know this is also the key function of cleaning it.
There was a lot of desired particle matter that you want to keep out dust animals and their bacteria and viruses fungi.
The COVID-19 pandemic has provided us with a painful reminder of the dangerous that are floating and the ear as inhalation of Sars coronavirus too has been identified as one of the major transmission routes.
Fortunately your nose is equipped with some powerful defense mechanisms ranging from anatomical features the nasal mucosa and mucous release down to the sneezing reflects.
Let me close the act of the protective barrier against particles.
It's accretive mucus, which traps those particles.
Thanks to the movement of tiny hairs, so called SILEO, the mucus, including particles is clear from the nasal cavities into the throat and eliminate that why the digestive tract.
A cross section of the nasal mucosa is depicted on the slide on the niche the nose picture.
And unfortunately, however, the mucosa and protect the function.
Maybe compromised by injury.
Nasal dryness or irritation for example, during winter time due to low air humidity or due to the use of certain nasal sprays.
Also it may be over helped by the quantity or pathogenicity of inhaled particles.
If your body is allergic to particles such as Poland and these particles are abundant to a point that mucus clearance is not enough you.
You may experience, some allergic reaction and suffer from allergic rhinitis or hay fever.
You may catch up on all infection, such as influenza.
For COVID-19.
Onto slide five.
Yeah.
What is the a M to one nasal spray, we aim to complement and reinforce the body's natural defense to help mitigate the risks from the exposure to airborne Allergan and virus particles.
And 301 is based on a triple protect this effect.
By applying a thin protective layer on the nasal mucosa and physical barrier is established that prevents and health particles from contacting the nasal epitope and be telling them.
By trapping and health particles through electrostatic effects, which are then cleared naturally with mucus from the nasal cavities into the throat and eliminated why are the digestive tract.
And by unifying the nasal mucosa, and thus aiding its functionality.
On to slide six.
We have been developing a M 301, as a means for safe effective and affordable self protection and the face of risks from airborne viruses and elegance.
We believe that aims to a one on several attractive features.
First of all it is more than just the physical barrier.
Thanks to a M through a once electrostatic effects it actively traps particles.
A priori any charged particle, whereas the virus allergan or dirt can be trapped and this way.
And the particles are then natural and removed two get the wisdom mucus.
A second key feature is the absence of any active pharmaceutical ingredient.
And I'm sure one is drug free.
It has no pharmacological metabolic or immunological activity and its effects are purely physical nature.
This is why it can be considered and medical device.
A third key feature is the absence of preservatives and the formulation.
Preserving the health of the nasal mucosa is an important objective.
Especially for persons who are sensitive to airborne particle challenges.
Commonly used preservative and nasal sprays are well known to harm mucosal membranes and may provoke a stinging or burning sensation.
We are using a special preservative free nasal spray pump and employing a specific manufacturing process in line with our guiding principle of safety by design.
The force key feature is that a M three or one can help to protect for at least three hours, which we consider as quite convenient.
And even the best nasal spray is not of much help if it gets cleared rapidly from the nose and needs to be reapplied frequently.
As mentioned you have a very powerful cleaning mechanism inside your nose.
We designed our formulation for extended nasal residence time.
This is a gel emulsion.
And that needs to be briefly shake and prior to us.
Making it liquid and suitable for spring.
Once it is applied into the nose, the liquid turns into a gel again.
We have filed three provisional patent applications to date.
We will reveal more about the actual composition of Mcl, one and its mode of action in due course.
We have received quite a few inquiries about these things I hope you understand that here, we cannot disclose everything at this early stage.
With that we move on to slide seven.
Following the presentation of a M to one I will now turn on.
And to some fresh data that we have generated.
With the product and which we announced this morning.
We recently completed the treatment phase of the first clinical trial was aimed throw one now.
This was an open label randomized crossover study, which enrolled 36 patients with allergic rhinitis to grass pollen.
They received a single dose of am through a one nasal spray.
More of a comparator product prior to entering our so-called allergen challenge chamber.
And the chamber.
They were exposed to controlled quantities of grass and pollen India are for four hours.
The challenge was the repeat that whats the ultimate treatment following a washout period.
Study participants self reported common symptoms of allergic rhinitis on the total nasal symptoms score questionnaire or T. N S F.
I'm very pleased to report that preliminary analysis of the study outcomes show that a M. C. O on met the primary endpoint of non inferiority and the T. N S S relative to the comparator.
In addition, the treatment was well tolerated.
These results are key elements for obtaining market clearance.
For example for the planned five 10-K submission to the U S food and drug that Ministration F. D. A we will need to demonstrate substantial equivalents to a previously cleared similar device.
Furthermore, this study demonstrated that rapid onset and long durability of a M through one's protective effect as measured by a clinically relevant one point reduction and the team.
Two unprotected Paul and exposure.
On average the protective effect was maintained for at least three hours.
These clinical observations are in line with the results from our new and vitro study.
We used a barrier diffusion model to evaluate for how long a M 301 could act as a barrier to grass pollen.
The experiment was performed at 35 degrees Celsius, and 90% relative humidity to mimic conditions was and the nasal cavity.
Yes, they showed that a thin layer of a M through on blocked grass pollen for up to six hours the maximum duration of the experiment.
On to slide eight.
And turning to the use of a M 301 in viral infections.
And early this.
We announced the remarkable results from a study in a model of human nasal epithelial cells infected with Sars coronavirus too.
This model allows for testing the effects of airborne infection and mitigation strategies on their highly relevant conditions.
The cell culture is based on life reconstitute tissues from human donors.
Physiological relevant and even produces mucus.
Actually the testing conditions are more challenging than and the human knows since there is no support available from the immune system and from the natural mucociliary clearance and removing the particles into what normally would be the digestive track.
Yes, we could show and a model that aims 301 was highly effective in reducing the infectious viral titer and daily treatment, while started right before inoculation off to self with the virus.
72% and 96 hours post infection average wires titers for over 99% lower than and controls.
Obviously prevention this best especially when facing such a highly infectious and dangerous virus like Sars coronavirus too.
However, we were also interest in and testing aimed through a one when the infection was already running its course.
We therefore repeated the experiment in the human nasal epic tell them sell model, both initiated daily treatment only 24, Saudi hours passed and alkylation.
Saline and vehicle treated and untreated cell cultures surface controls.
As expected.
Sars coronavirus to replicate it efficiently and control cultures over four days.
Resulting in a rapid increase and viral titer.
I'm very pleased to report that daily treatment was aimed through one even with the late start after 24 to 30 hours resulted in an important and statistically significant deceleration of the wild type of growth compared to controls.
Yeah equivalent on the P value was smaller than point of one and the linear mixed effects model.
Day four of the experiment viral titers were $73, 7% to 94.5% times lower compared to controls.
On to slide nine.
Okay.
And as we are advancing with the development program.
It was up on time to give a M 301, finally, a proper name.
Was this and I'm very pleased to introduce <unk> been true to you today.
We are convinced that Ben trio as a brand name called ways well our key message.
And as little spray that will do good by offering a means for self protection.
The trio and the name refers to the product triple protect this effects barrier trapping and humidifiers mission.
Yeah.
On to slide 10.
We look forward to bringing <unk> to the market and making it available to consumers.
With the ongoing progress in the development and testing we.
We are on track to meet in the coming weeks, all essential requirements for marketing ventral and Europe on the day, so called CE Mark.
CE, marking indicates that our product has been assessed by and a manufacturer and deemed to meet those central European requirements.
We intend to launch the commercialization and selected European countries, starting in June 'twenty, 'twenty, one and so that's fairly soon and.
Employing various on an offline distribution channels.
We expect to expand market coverage rapidly during the second half of 'twenty, 'twenty, one including collaborations with future licensing partners.
The expansion will be supported by significant scalable contract manufacturing capacity.
Once it will be ready for CE Mark conformity.
We expect to be ready also for the submission of the five 10-K application to the F D. A.
With this we will request regulatory clearance for Ben trio and the intended use and allergy.
Regarding the intended use and viral infection and we continue to be engaged and a dialogue with the F. D. A on the applicable regulatory pathway.
Last but not least we are evaluating other countries and world regions as potential markets for been true.
With this let's move to slide 11.
What's been true we are addressing frequent conditions and globally large markets.
I think the numbers shown on this slide speak for themselves let.
Take allergies.
About 8% of the U S adult population have hay fever.
They are bit more than 11 million visits annually to physician offices was a primary diagnosis of allergic rhinitis.
The market size for over the counter allergy medicines in the U S.
It's about $4 billion in 2020.
For viral infections the numbers are even higher.
The human Rhinovirus is the most common cause of upper respiratory tract infections.
Revenues for cold and cough remedies in the U S are expected to exceed $12 billion and 2021.
Influenza has not been a big issue and this winter season.
But this was very exceptional.
Based on data from the U S centers for disease control and prevention influence our resulted in nine to 45 million illnesses 140000 to 810000, hospitalizations and 12000 to 61000 and Beth annually since 2000.
<unk> 10.
And last but not least there is the COVID-19, pandemic, which has taken a massive toll.
As of today, they have been more than one on debt and 36 million cases, and almost 3 million deaths very sadly.
We believe that the key strength off then trio is diverse until it T of its mode of action.
We have masks, we have social distancing.
We have vaccinations.
All these measures work and have their utility.
All have their pros and cons.
What's been trio, we aim to provide an additional means that she'll help us deal with all those particles in the air.
There is increasing evidence about an important relationship between air pollution or Paul and exposure.
And Patrick and self infection rates.
Which shows that clean air and a strong defense at the level of the nose.
Matter a lot.
With that I would.
Please continue to standby.
Youll Speaker will resume shortly please continue just on <unk>.
And you'll speak to more zoom shortly.
Once again, please continue to standby your conference will begin will be will continue shortly please continue just on by your conference will begin shortly we always just waiting for the speaker to rejoin US. Please standby. Thank you.
Okay. So somehow I dropped out of the line my apologies.
So.
I guess, well you hurt to the and here off the presentation and we.
And we could now open on the line for questions and my apologies here for this interruption.
Yeah.
Thank you and I'll begin the question and answer session. Please press star one on your telephone and wait for you.
Our names to be and I'm not style one.
Have a question on today's call.
Our first question comes from the line of Pizza right from an interest in True Act. Your line is open. Please ask your question.
You and Thomas Congratulations for the Fantastic news.
My first.
First question.
My first question is what are the other.
Prophylactic.
High risk patients are taking now to reduce the risk.
Covid.
And in light of that.
Is there a way that youre going to be able to fast track and a 500 10-K application.
And then I have a follow up on the back of that.
Yes so.
We believe that Oh entry all here is a compliment.
And for actually every day day for day.
I mean in the morning before you leave from you.
You're flat or are your house on your way to work.
You may apply it and.
Preventative fashion and.
And we see this primarily as a.
Preventive measure.
Now, we see a potential based on the most recent data here.
That even when and infection already got started that we can have an impact here on the course of the infection, obviously that work needs to be offers or confirmed these data, but we see here a nice combination of.
You mentioned and potentially also therapeutic effect. So that's how we are positioned. This now there are of course a lot of other.
Treatments or approaches methods available and I think all of them have a some type of utility and we have such a problem here with the pandemic. So therefore, it's it's very important that we have a lot of tools a lot of instruments.
Actually it has now.
Now to your second question about the five 10-K.
And so.
The five 10-K is as you know it's already an abbreviated regulatory.
The regulatory pathway.
Where you can basically benefit from the fact that.
On a similar device has was clear and sometime ago and what you need to demonstrate here is basically that you'll have a similar efficacy and.
Also safety profile as this clear its device.
And that process at a minimum we'll take 90 days now are based on data that was published on the average a five 10-K clearance and takes about and <unk>.
Five to six months or something like that so of course, we hope to go fast with that now this will be for for our allergy now for the virus indication. Since this is a something quite and you are there is actually no precedent with the F D. A.
And this is why we have and engaged here with the agency and a dialogue here to find the appropriate path forward, what what is that the best way for it now as you know there is also the emergency use authorization pathway that.
It could potentially be available. So this is something that of course is also here are part of our part of the picture for US. The main objective has been well to get ready here what is the technical dossier with the submission.
And all the data so that we can actually go for the CE Mark in Europe, and the Gulf War the submission in the U S and so we have been growing extremely fast and of course, we want to really go fast also to the market here and hopefully we can have.
Hum a good process very efficient process, we are quite confident on the product.
That's a very good safety profile, it's components are or quite well characterized that they have been around for some time.
It's essentially the combination of formulation work.
That is the innovation that we have done here. So we very much look forward to going through that process with the FDA.
Wonderful and then looking at it from the other side my thumb up as your conversations with contract manufacturers are you approaching that differently and.
The U S. A and Europe are they are they separate providers, you're working with if you could explain the strategy there somewhat and the ball and then also if you could comment on volume how and how quick do you think you can ramp this to satisfy the market needs.
Yes, so for on the contract manufacturing.
We are working here with a partner that is capable of supplying to.
U S and to the European market.
We have some additional capacity plans and now the capacity can be ramped up.
And quite quickly and we are.
We're talking here about a very meaningful quantities that we can actually supply to the market.
So at this point, well, we prove or prefer not to provide detailed capacity numbers, but well I as I can tell you.
It's pretty significant and we expect to ramp up here over the first couple of months.
And a very significant fashion.
Wonderful and I'll try and sneak one last one and if I could any any comments on pricing, yet where this or it's still too early.
And the two market well, it's well I mentioned, it should be affordable and I mean, it's by debt.
So it.
It is something that is affordable and for the public this is.
Going to be and over the counter product. So typically this and has to be paid.
I'm out of pocket by our consumers.
Now there are other products on the market, we believe that we have actually some.
Nice features that are very well support to your some premium pricing.
We have not.
<unk> decided.
On the final pricing yet but.
We really want to make it a success and affordable and accessible here too to the bigger public.
Congratulations fantastic news and the speed is amazing.
Okay. Thank you very much.
Yeah.
Thank you on next question comes from the line of Mark Osha from Miller Street. Your line is open. Please ask your question.
Sure.
Good work on your progress so far I do have one question.
This would be with regards due more to the allergy and the nuisance type of inhalants, rather than viruses, but have you ever done any comparisons do a nasal saline flushes.
And Ah Ah Ah baseline, they're not well tolerated and obviously and I'm sure you and product would be much more.
Tolerable.
Do you have any con Jasmine and comments about the new nasal saline flush method of removing antigens.
Yeah.
Yeah. So so are these saline flushes and these are irrigation.
They definitely have thought they serve a purpose.
However, I mean on what they what they do is very simple I mean basically you just.
Try to.
Get those particles are washed out now we have a different approach.
Approach here because.
This is not tool to wash out this is not very convenient and obviously, but rather you have if you have a knows that is that is working properly day knows. This is dealing with this are these particles the cleaning.
Around the clock I mean, it takes 15 20 minutes and then material is actually and discharged and it is gone and now what we are doing here is we are helping with this process and we are not only protecting covering the mucus.
And the mucosa.
We are also true.
Wrapping those particles and I mean, that's a key difference here two two this saline irrigation.
Which is essentially just by by force dilution.
Pushing in a liquid and then bringing this out no. This is a more physiological way if you like a more convenient. So it just helps you to remove these things and in a way that is how it. It goes normally and that is you have this one.
And we'll cleaning mechanism, we are helping with that.
And I hope this answers your question.
Yes, it does.
Very good and again, thank you and good luck and the future anxious to hear more.
Okay. Thank you very much.
No further questions at this time please continue.
Yeah.
Okay. Thank you operator, and thanks to everyone for joining this call and my apologies about the interruption towards the end.
So we are very excited about this program, we look forward to reporting further news.
And well usually I I conclude by saying are well taken care of your ears, Oh and of course, you should always take care of hokey ears.
Please take care also of your nose are very important, especially in these times here independently and thank you very much and goodbye.
Thank you that does conclude today's conference. Thank you to everyone who has participated in today's call you may now all disconnect.
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