Good morning, and welcome to Altomira Therapeutics Conference Call. On today's call, Thomas Mayer, Altomira's Chairman and Chief Executive Officer, will provide an update on the company's Pentrio program. During today's call, we will make forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These include statements that address future operating, financial or business performance or the company's 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 from those contemplated by these statements.
These risks and uncertainties include, but are not limited to, the timing and conduct of the company's clinical trials the clinical utility of its product candidates the timing or likelihood of regulatory filings and approvals the company's intellectual property position and 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 and Exchange Commission. In addition, any forward looking statements represent Altomira Therapeutics' views only as of today and should not be relied upon as representing the company's views as of any subsequent date. While the company may elect to update these forward looking statements at some point in the future, it specifically disclaims any obligation to do so even if its views change. With that, I hand the call over to Thomas.
Thank you, Paul. Hello, everyone, and thank you for taking the time to join us today as we provide a business update on Ventrio. For the benefit of those who are new to Ultomiris story, I will begin with a brief discussion on ventrilo's mechanism of action and how it works with other interventions to help prevent and treat infections and allergies. I will then briefly review Bensural's market potential and the efficacy data we have gathered to date. For the main part, I will discuss our launch, marketing and regulatory strategy for Bensio and its implementation in the EU, U.
S. And other international markets. BENTRIO is an over the counter or OTC nasal spray that is drug free and preservative free and designed to provide triple protection against airborne viruses and allergens. First, it helps to protect the nasal mucosa by acting as physical barrier. 2nd, it traps airborne particles by electrostatic effects.
And 3rd, Bencho humidifies the nasal mucosa, thus aiding its functionality as the body's natural defense against airborne particles. Importantly, Bensio's proprietary gel formulation allows for an extended residence time within the nose to provide protection for at least 3 hours. We envision individuals using Benjio as one of several precautions they can take to prevent airborne viral infections. We like to refer for this to the so called Swiss cheese model of infection prevention because no single intervention is 100% effective at preventing a viral infection. But much like stacking layers of whole written Swiss cheese, layering multiple interventions could increase protection significantly.
In the case of SARS coronavirus 2, these layers could include vaccination, masks, social distancing, proper indoor ventilation and of course ventrio. Because of its ability to protect against different kinds of airborne viruses, Bencho can be used to help protect against many respiratory diseases, including human rhinovirus, the most common cause of upper respiratory tract infection, influenza and of course SARS CoV-two. According to the Centers For Disease Control and Prevention, influenza has caused between 9,000,000 45,000,000 illnesses, 100 and 40,000 to 8 100 and 10000 hospitalizations and 12,000 to 61,000 deaths in the U. S. Every year since 2010.
Influenza was largely a non event during last winter, most likely due to the protective measures against COVID-nineteen. As a consequence, natural immunity to flu is probably at its lowest for years around the world, experts say. They see a fairly high likelihood that influenza will stage comeback in the coming winter season. Regarding COVID-nineteen, 219,000,000 people have been infected worldwide so far and the infection has caused over 4,500,000 deaths. Ventrilo protects also against airborne allergens, for example, from grass pollen, animal hair or house dust mite.
Around 7.8% of the adult U. S. Population has allergic rhinitis or hay fever, while 11,100,000 visits to physician offices resulted in a primary diagnosis of allergic rhinitis. Last year, dollars 4,000,000,000 worth of OTC allergy medications were sold in the U. S.
The OTC market for cough and cold remedies is estimated to reach $12,000,000,000 in the U. S. This year. Simply put, Bantuo's market potential is substantial. We previously filed 4 provisional patent applications with the U.
S. Patent and Trademark Office to help ensure this significant market opportunity is well protected. These patent filings have recently been converted into a non provisional application whose key claim is directed toward aqueous compositions comprising a muco adhesive polymer and clay particles. In addition, an international patent application has been filed, potentially covering dozens of international markets. BENTU has been test for its efficacy, safety and tolerability in numerous preclinical and clinical studies.
It has been shown to significantly decrease viral titers of SARS CoV-two and influenza A in functional human nasal epithelia. Daily application of BENTRIO for 4 days starting 10 minutes prior to inoculation with SARS CoV-two resulted in a viral titer reduction by more than 99% compared to saline control. When treatment was started 24 or 30 hours post inoculation, epithelia had 12 or 14 fold lower titer than the controls. In the same model, daily application of Fenjoy for 4 days resulted in 84% and 77% reduction in H1N1 viral load when administered 10 minutes before and 24 hours after inoculation, respectively, compared to saline treated controls. These studies demonstrate that Benjiro is very effective.
As a prophylactic and because it can significantly decelerate viral titer growth many hours after inoculation, it is also quite effective as a treatment post viral exposure. Ventrilo has demonstrated also efficacy in allergic rhinitis patients. In a clinical pollen chamber study 4 hours before controlled our exposure, patients allergic to grass pollen received either a single dose of Bensio or a methylcellulose powder spray, a marketed comparator. The study met its primary endpoint. Participants given Bensio reported a statistically significant decrease in mean total nasal symptoms score of 1.11 points compared with participants exposed to pollen without bencho nasal spray protection.
In addition, this study demonstrated a rapid onset of 20 to 40 minutes and a long protective effect of 4 hours. In addition to showing that ventur was well tolerated, this study established ventrilo's substantial equivalence to the marketed comparator with superior efficacy ratings from both patient clinicians. We are currently planning to conduct 2 additional clinical studies in allergy, 1 for house dust allergy as a challenge study and one for seasonal allergic rhinitis. These studies will be conducted in Canada and Australia. Further, we are preparing for a clinical trial to evaluate the efficacy of Benjieux, primarily in the prevention, but also in the treatment of acute COVID-nineteen.
The trial is designed as what is referred to as household study, where a household is put under quarantine upon one of its members testing positive for COVID-nineteen. The other household members will receive ventral for prophylaxis or placebo. The household member triggering the quarantine will receive ventral placebo to evaluate the therapeutic effect. The study will take place in India. We are awaiting approval by the Drugs Controller General of India anytime now.
The primary focus of our current marketing campaign is on the need for extra protection against SARS CoV-two. We are targeting in particular people who are at increased risk of exposure due to their professional work, people with increased need for protection due to an underlying health condition, as well as people caring for the health of their loved ones. Bensio may be used by children 6 years and older. Users may be either unvaccinated or vaccinated individuals who are concerned about breakthrough infections, particularly as we continue to see the emergence of new variants of the virus. As we approach the winter season, influenza is an increasing concern and common colds are occurring more frequently.
While perennial allergic rhinitis, for example, from house dust mites is occurring year round And as we will head into the next environmental allergy season in the northern hemisphere, we will increasingly focus our marketing campaign also on the allergy indication. We are currently focusing on building the BENTRIO brand through targeted digital campaigns combined with classic instruments rather than blanket and very expensive direct to consumer marketing. That strategy is showing early signs of success with the ventrio.com website already receiving about 2,500 visitors per day in Germany, our first market, and this number keeps going up. Bensural's initial 12 month shelf life is best suited for online sales. Therefore, our initial focus has been on online pharmacies.
We are also in the process of setting up an online store where customers can purchase Venturo directly. Our strategy in select other European countries and internationally is to market venturo in select other European countries and internationally in a B2B model, business to business, targeting distributors in order to have a lot of boots on the ground. As with any new product, stability data is collected on an ongoing basis. By now, we have already reached 18 months and we anticipate that Benchure's test shelf life will continue to increase. With this, we are now moving into the 2nd stage of Benchure's launch where we will target also classic bricks and mortar pharmacies, which still account for the majority of the market.
Let me now elaborate a bit further in detail about our launch activities beginning with Europe. In May of this year, bencho was CE marked as a Class 1 medical device under the EU's medical device directive. While the CE mark allows us to market bencho across the 26 EU member states and a few related countries, Each country has its own requirements that may relate to language, labeling and advertising rules. There are also differences in market structure, shopping preferences and logistics that need to be considered. In late July, we reached a significant milestone by launching Ventrue in the 1st European countries, marking our transition from a development stage to commercial stage company.
We initially launched Venture in Germany followed by Austria and we intend to expand market coverage to other select EU countries during the remainder of this year. Our initial focus is on leading and fast growing online pharmacies such as SHOP Apotheque, which translates to SHOP Pharmacy and has 7,000,000 customers and Medicamenter per click, which translates to drugs by click and has 3,500,000 customers. Sales through these leading online pharmacies have started. We expect them to continue to grow and we plan to add further such platforms. Promotional activities are being progressively expanded to France, Italy and Spain with other EU countries to follow with the support from digital campaigns on Google, Facebook, YouTube and Instagram.
In the second phase of our EU launch, we will target traditional pharmacies, which as mentioned, still have a higher market share than online pharmacies. As I previously mentioned, the results from Benjiele's pollen chamber study demonstrated substantial equivalence to a predicate device, which allows us to use the U. S. Food and Drug Administration's 510 pathway for the allergy indication. To that end, following a pre submission meeting with the agency in May, we are pleased to confirm that we just reached a major milestone by submitting a 510 pre market notification for Benjiele to the FDA.
The average review time for this kind of submission is about 6 months, but of course the exact timing is out of our heads. Once cleared, we anticipate partnering Ventrilo for the U. S. Market rather than commercializing it on our own. There are no predicate devices in the U.
S. That would allow for the use of the 510 pathway for Benjurel's prevention and treatment of viral infections. Accordingly, we have sought advice from the FDA to determine the applicable regulatory pathway for Bantou in this indication. Our hope is that it will qualify as a medical device also for viral infections and not be considered a drug by the agency. International markets outside of the U.
S. And Europe also offer great business development opportunities for BENTRIO. We keep receiving inquiries from all over the world, while our experienced business development team is also proactively targeting partners in certain key countries. These are largest countries and or countries with large unmet needs, such as those with low SARS CoV-two vaccination rates. I'm very pleased to say that we have already signed letters of understanding with distributors in 2 key Southeast Asian countries with Venturo's national registrations being initiated.
We consider our pipeline of leads with international distributors exciting. In summary, Ventrio addresses multibillion dollar markets. We have in place a robust intellectual property strategy to protect this opportunity. Ventrio has demonstrated efficacy in preventing and treating both viral infections and allergy symptoms. In the near term, we expect to launch additional clinical trials to evaluate BENTRIO's ability to prevent and treat COVID-nineteen and allergies in more detail.
In Europe, we have launched Benjio in the 1st markets through online channels and are increasing brand awareness based on digital campaigns. In international markets, we are seeing a great level of interest in the product and we got going with our first two distributors in Southeast Asia. Last but not least, we have submitted our 510 pre market application for Bantriol's allergy indication in the U. S, taking an important step forward on our way towards bringing the nasal spray to this key market as well. With that, I would now like to turn the call back to the operator, who will open the line for questions.
Thank you. Ladies and gentlemen, the floor is now open for questions. Your first question is coming from Jim Molloy from Alliance Global Partners. Jim, your line is live.
Hi, good morning, Thomas, or good afternoon. Thank you for taking my questions. Thank you for the presentation. I was wondering if you could talk a little bit about the potential size in the U. S.
I know you mentioned you're looking for the 510 and on the viral infection you're trying to figure out whether it's going to be a device or a drug. Can you walk through the relative merits of each opportunity in the U. S. And how a device or drug for the viruses, viral infection impacts timing?
Yes. Good morning, Jim. Yes. So we have since the beginning, we have been focusing here first and foremost on the 510 pathway as it allows to reach the market relatively quickly. And here it was clear that we are talking about the allergy indication.
Now I think the allergy indication on its own is already a very significant one. I mean, I mentioned the size of the market here for OTC medication. What is important here to understand is there are quite a few products out there that are based here on antihistamines or corticosteroids. And we believe that they will continue to play a major role here, especially in case of highly acute allergic reactions. However, with Benjio here, we have something that is drug free, completely drug free, and it's also preservative free.
So we see here definitely a nice part of the market that so far has been not very well addressed. There are a few products out there. Well, one of them is a predicate device, but we definitely see a lot of upside potential here. And then the And then the other potential use here is the product in combination with one of the classic ones. So consider that if there is a allergy season that is on while you use ventral here before you go out and expose yourself here to pollen.
And if you can manage with this in a natural fashion, fantastic. Now if it becomes really strong severe, you may need to take some antihistamine. So that would be then reserved for, let's say, more severe periods during the allergy season. So there are as a standalone or in combination, there is a great potential out there. Now getting to the viral infection, obviously here and we are seeing a lot of and hearing a lot of inquiries from the U.
S. And we would love to bring of course the product to the U. S. Also for viral infection as quickly as possible. Now based on the current classification of drugs and devices, it is a little bit, let's say, in between and this is why we have submitted here a request for designation to the FDA.
The process is not concluded yet. We also see that there has recently been some movement at the FDA in terms of definitions and classifications. So for us, it is important here obviously to make it available also for this label. However, here the key focus is definitely on getting it to the market already for the allergy indication.
Great. Thank you. Do you have any idea of when you'll have any guidance on potential timing from the FDA on determining the path forward for the viral indication?
Well, we would hope that this is going to happen within the next few months. Clearly, as I said here, the key priority is to get it on the market to make it available to customers already for allergy. And I think this could be a very good timing actually. So if you take the average duration here, we are talking about 6 months. So that could take us to the end of Q1.
And we know that, well, allergy season is then starting depending on the state, but the timing for that would actually fit quite nicely.
And the last question, thank you for taking my questions. Who would be the ideal partner in the U. S. For this opportunity? You mentioned partnering in the U.
S. Rather than self launching. Thank you again for taking the questions.
Yes. Okay. Yes. So, well, we are looking for a partner that has a good and strong footprint here in OTC Consumer Health. I mean, preferably in allergy or cough and cold or someone who would like to expand into that line of business here that has already some presence.
I mean this is clearly this is a game about distribution and footprint in the market. And this is why we also believe that it's best here to do this in collaboration with a strong partner rather than go with on our own.
Thank you.
Thank you.
Thank you. And we did have another question coming from Howard Kaibowski. Howard, your line is live.
Hey, Thomas. Thank you very much for the presentation and congratulations on Bentrio. I got 2 or 3 questions here depending how you break them up. First one, when do you think you'll be able to disclose the specific Asian distributors, the countries they represent? And part 2 of that, are these partnerships going to be contingent on the successful INDIA trial?
Okay. Good morning, Howard. So we will probably make an announcement as soon as we will have the registration in those countries. To your second point, no, this is not contingent.
Okay. And then actually my second my next question is sort of related to your first answer. So just curious since BENTRIO is considered a device, not a drug, I'm curious why we why that registration is still waiting for the drugs controller general's approvals. Is BENTRIO considered a drug in India or is that approval required for any trial?
Yes. So, yes, the name is a bit misleading. So when it says a drugs controller, that agency is actually also in charge of medical devices. So they are in charge of all trials.
Understood. So that was a little confusing there. And do you have any guidance on when you think the trial might start? Because originally, you guys reported Q3, so that's only 2 more days left. Yes.
Well, yes, we have been ready for some time now. So while we are waiting here the green light, I mean, this is obviously out of our hands. So I mean, as I said, we would be basically ready to move. So hopefully, we will get this green light in the near term.
And one more question regarding the INDIA trial. And so is Bensio being tried as an Ayurvedic device in India or is it going to be considered a non Ayurvedic device? So in other words, the trial registration can label drugs as either Ayurvedic or non Ayurvedic. And are you able to tell us which one or?
Well, we do not label our products as Ayurvedic. So you know what we have on our label. So this is what we communicate officially. So from our side, we are not making any claims to Ayurvedic or not.
Okay. All right. Thank you very much, Thomas. Congratulations.
You're welcome. Thank you.
Thank you. And there were no other questions in the queue at this time.
Okay. Thank you very much, operator, and thanks to everyone for joining the call today and your interest in BENTRIO and AltaMiro Therapeutics. Have a great and successful day. Take care. Bye bye.
Thank you, ladies and gentlemen. This does conclude today's conference. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.