Good morning, and welcome to Altamira Therapeutics conference call. On today's call, Thomas Meyer, Altamira's Chairman and Chief Executive Officer, will provide an update on the company's Bentrio 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 factor 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 Altamira 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 Bentrio. For the benefit of those who are new to Altamira's story, I will begin with a brief discussion on Bentrio's mechanism of action and how it works with other interventions to help prevent and treat infections and allergies. I will briefly review Bentrio'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 Bentrio 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. Second, it traps airborne particles via electrostatic effects. Third, Bentrio humidifies the nasal mucosa, thus aiding its functionality as the body's natural defense against airborne particles. Importantly, Bentrio's proprietary gel formulation allows for an extended residence time within the nose to provide protection for at least three hours. We envision individuals using Bentrio 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. Much like stacking layers of hole-ridden Swiss cheese, layering multiple interventions could increase protection significantly. In the case of SARS-CoV-2, these layers could include vaccination, masks, social distancing, proper indoor ventilation, and of course, Bentrio. Because of its ability to protect against different kinds of airborne viruses, Bentrio 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-2. According to the Centers for Disease Control and Prevention, influenza has caused between 9 and 45 million illnesses, 140 to 810,000 hospitalizations, and 12 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-19. 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 a comeback in the coming winter season. Regarding COVID-19, 219 million people have been infected worldwide so far, and the infection has caused over 4.5 million deaths. Bentrio 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 11.1 million visits to physician offices resulted in a primary diagnosis of allergic rhinitis. Last year, $4 billion worth of OTC allergy medications were sold in the U.S. The OTC market for cough and cold remedies is estimated to reach $12 billion in the U.S. this year. Simply put, Bentrio's market potential is substantial. We previously filed four 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 mucoadhesive polymer and clay particles. In addition, an international patent application has been filed, potentially covering dozens of international markets. Bentrio has been tested for its efficacy, safety, and tolerability in numerous preclinical and clinical studies. It has been shown to significantly decrease viral titers of SARS-CoV-2 and influenza A in functional human nasal epithelia. Daily application of Bentrio for four days, starting 10 minutes prior to inoculation with SARS-CoV-2, 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 Bentrio for four days resulted in an 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 Bentrio 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. Bentrio has demonstrated also efficacy in allergic rhinitis patients. In a clinical pollen chamber study, four hours before controlled hour exposure, patients allergic to grass pollen received either a single dose of Bentrio or a methylcellulose powder spray, a marketed comparator. The study met its primary endpoint. Participants given Bentrio reported a statistically significant decrease in mean total nasal symptom score of 111 points, compared with participants exposed to pollen without Bentrio nasal spray protection. In addition, this study demonstrated a rapid onset of 20 to 40 minutes and a long protective effect of four hours. In addition to showing that Bentrio was well-tolerated, this study established Bentrio's substantial equivalence to the marketed comparator with superior efficacy ratings from both patient clinicians. We are currently planning to conduct two additional clinical studies in allergy, one 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 Bentrio, primarily in the prevention, but also in the treatment of acute COVID-19. 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-19. The other household members will receive Bentrio for prophylaxis or a placebo. The household member triggering the quarantine will receive Bentrio or placebo to evaluate the therapeutic effect. The study will take place in India. We are awaiting approval by the Drugs Controller General of India any time now. The primary focus of our current marketing campaign is on the need for extra protection against SARS-CoV-2. 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. Bentrio may be used by children six 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 bentrio.com website already receiving about 2,500 visitors per day in Germany, our first market, and this number keeps going up. Bentrio'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 Bentrio directly. Our strategy in select other European countries and internationally is to market Bentrio 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 Bentrio's tested shelf life will continue to increase. With this, we are now moving into the second stage of Bentrio'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, Bentrio was CE marked as a Class 1 medical device under the EU's Medical Device Directive. While the CE mark allows us to market Bentrio 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 Bentrio in the first European countries, marking our transition from a development stage to commercial stage company. We initially launched Bentrio 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 Apotheke, which translates to shop pharmacy and has 7 million customers, and Medikamente per Klick, which translates to drugs by click and has 3.5 million 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 Bentrio'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(k) 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(k) pre-market notification for Bentrio to the FDA. The average review time for this kind of submission is about six months, but of course, the exact timing is out of our hands. Once cleared, we anticipate partnering Bentrio 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(k) pathway for Bentrio's prevention and treatment of viral infections. Accordingly, we have sought advice from the FDA to determine the applicable regulatory pathway for Bentrio and 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 larger countries and/or countries with larger unmet needs, such as those with low SARS-CoV-2 vaccination rates. I'm very pleased to say that we have already signed letters of understanding with distributors in two key Southeast Asian countries, with Bentrio's national registrations being initiated. We consider our pipeline of leads with international distributors exciting. In summary, Bentrio addresses multibillion-dollar markets. We have in place a robust intellectual property strategy to protect this opportunity. Bentrio 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-19 and allergies in more detail. In Europe, we have launched Bentrio in the first market 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(k) premarket application for Bentrio'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. If you have any questions or comments, please press star one on your phone at this time. We ask that while posing your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality. Please hold while we poll for questions. Once again, ladies and gentlemen, if there are any questions from the lines, please press star one on your phone at this time. Your first question is coming from Jim Molloy from Alliance Global Partners. Jim, your line is live. Hi. Good morning, Thomas. Good afternoon. Thank you for taking my question. 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(k), 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. Since the beginning, we have been focusing here first and foremost on the 510(k) pathway as it allows to reach the market relatively quickly. Here it was clear that we are talking about the allergy indication. I think the allergy indication on its own is already a very significant one. 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. We believe that they will continue to play a major role here, especially in case of highly acute allergic reactions. However, with Bentrio here we have something that is completely drug-free, and it's also preservative-free. 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. One of them is a predicate device. We definitely see a lot of upside potential here. People who are looking for some natural options that actually take care of the nose without irritation and burning and these things. The other potential use here is the product in combination with one of the classic ones. Consider that if there is an allergy season that is on, you use Bentrio here before you go out and expose yourself to pollen. 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. That will be then reserved for, let's say, more severe periods during the allergy season. There are, as a standalone or in combination, there is a great potential out there. Getting to the viral infection. Obviously here 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. 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. For us, it is important here obviously to make it available also for this label. 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. I think this could be a very good timing, actually. If you take the average duration here, we are talking about six months. That could take us to the end of Q1, and we know that, well, allergy season is then starting, depending on the state. The timing for that would actually fit quite nicely. Great. 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. Yeah. Well, we are looking for a partner that has a good, strong footprint here in OTC consumer health, 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, 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 it on our own. Thank you. Thank you. Thank you. Once again, ladies and gentlemen, if you wish to enter the queue to ask a question, please press star one on your phone at this time. We did have another question coming from Howard Kabowski. Howard, your line is live. Hey, Thomas. Thank you very much for the presentation, and congratulations on Bentrio. I got two or three questions here, depending on 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? Part two of that, are these partnerships going to be contingent on the successful India trial? Okay. Good morning, Howard. 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. Actually my next question is sort of related to your first answer. Just curious, since Bentrio is considered a device, not a drug, I'm curious 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? Yeah. The name is a bit misleading. 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. That, yeah, that was a little confusing there. Do you have any guidance on when you think the trial might start? Originally, you guys reported Q3, so that's only two more days left. Yes. Well, yeah. We have been ready for some time now. Well, we are waiting here the green light. This is obviously out of our hands. As I said, we would be basically ready to move, so hopefully we will get this green light in the near term. One more question regarding the India trial. Is Bentrio being tried as an Ayurvedic device in India, or is it going to be considered a non-Ayurvedic device? So- So in other words, t he Indian trial registration can label drugs as either Ayurvedic or non-Ayurvedic. Are you able to tell us which one? Well, we do not label our product as Ayurvedic. You know what we have on our label. This is what we communicate officially. From our side, we are not making any claims to Ayurvedic or not. Got it. Okay. All right. Thank you very much, Thomas. Congratulations. You're welcome. Thank you. Thank you. There were no other questions in the queue at this time. Okay. Thank you very much, operator. Thanks to everyone for joining the call today and your interest in Bentrio and Altamira 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.