Greetings. Welcome to Altamira Therapeutics Investor Conference Call. At this time, all participants are in a listen-only mode. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to Deborah Chen, who will open the call on behalf of management. Deborah, you may begin.
Good morning, and welcome to Altamira Therapeutics Investor Call. On today's call, Thomas Meyer, Altamira's Chairman and Chief Executive Officer, will discuss the company's strategy and answer questions submitted by investors via email. During today's call, we'll be making 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 strategy or expectations. Forward-looking statements are based on management's current expectations and beliefs and involve significant risk and uncertainties that can 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 of 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' view 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 will now hand the call over to Thomas Meyer.
Thank you, Deborah. Hello, everyone, and thank you for taking the time to join us for today's investor call. As our company is going through an important transformative period, we found that it might be appropriate to discuss the big picture of our strategy and to field questions from investors. I will start with a brief look back to June 2021, the time when we announced the acquisition of Trasir Therapeutics and our intention to become a pure-play RNA technology company. This pivot to RNA came as a big surprise to many investors, I guess. Actually, it had been in the making for quite some time and was the result of a thorough review of various strategic options.
We felt that we had a great development pipeline, but that it was underappreciated by the market, which focused on therapeutic areas like cancer, immunology or diabetes or new technologies such as gene editing or RNA rather than on inner ear disorders, our traditional area of expertise. Many people suffer from tinnitus, hearing loss or dizziness. Yet, for many investors, these are pretty exotic disorders. As a small company, we simply lack the critical mass to advance these exotic inner ear programs to the finish line and generate adequate returns for shareholders. This is why we decided to move into RNA, a field with immense potential that is attracting a lot of interest on Wall Street. To go where the music plays. The move into RNA was actually not that far-fetched as it might have seemed at first glance.
Trasir's key asset is a cell-penetrating peptide to deliver RNA into target cells. This is actually a transporter technology. Through our hearing loss program, we have been working with a cell-penetrating peptide for many years, hence there was a clear fit. We have been working with this technology, which we call OligoPhore and SemaPhore, for more than a year now, and I can say that we are even more excited about it than back in June 2021. This technology is great. It has a truly great potential as it allows to deliver RNA molecules to target tissues outside the liver, which has remained largely elusive so far. Plus, it allows to have essentially the whole RNA payload released inside cells compared to only 1% or 2% with current technology. We have been quite busy with moving OligoPhore and SemaPhore forward.
With AM-401, we're going after KRAS-driven cancers, which are among the deadliest tumors around. With AM-411, we are going after rheumatoid arthritis, a very common and debilitating problem. Now, this is very important, it is not our intention to become an oncology or rheumatology company. The goal here is to scale up the technology, open INDs with the FDA and move into early clinical trials. Further development of these two programs or of any new additional programs shall be done by partners. We are seeing ourselves as providers of a technology platform which we out-license to RNA developers for their own programs. For this, we have been working on business development and raising our visibility through presentations at conferences and publications.
This means that we'll move towards a new business model based on licensing fee streams rather than the current model with recurrent funding needs from capital markets. We believe this will be a big plus for investors. All this is not happening overnight, of course, but we have been making great progress so far. This is the way forward for Altamira. We see in our RNA business the potential to make a big difference for patients, for the company, and for its investors. As you know, we also announced in June 2021 that in order to become a pure-play RNA company, we would seek to divest or spin off our legacy business within 12-18 months, pending various milestones. Since then, we have executed on these milestones.
To just name a few of them, we completed successfully the proof of concept phase ll trial with AM-125, our nasal spray for treating vertigo or dizziness. With Bentrio, our other nasal spray, we completed successfully a house dust mite study. We obtained FDA clearance for marketing Bentrio in the U.S. in allergic rhinitis. We signed up several partners in Asia for marketing and distributing Bentrio. While overall positive, I have to admit that we would have hoped to reach some of these milestones earlier, and that we also had some setbacks. The 510(k) procedure for Bentrio took longer than expected, and we were unable to capitalize overall on the demand for supportive protection against COVID-19 in Europe. National laws restricted or prevented direct-to-consumer marketing and regulatory agencies put any product with any reference to COVID-19 under scrutiny and requested clinical trial data to support any claims.
Also, we had demonstrated clinically that Bentrio protects against airborne allergens and is the same mode of action with viral particles. This was considered insufficient. Now, we tried to generate precisely such clinical data in COVID-19 patients when submitting a request for a clinical trial in India. However, that submission unfortunately got delayed by about one year. As you know, we then switched to plan B, which was to start a trial in Bulgaria, North Macedonia. Just yesterday, we could announce the completion of enrollment into that trial. We therefore hope to have the required supportive data soon. Let me point out that Project Bentrio was born in 2020 out of our previous experience in developing nasal sprays as a drug-free medical device with a rapid path towards commercialization.
While we had never been active in the over-the-counter or OTC consumer health business before, we knew that this is a competitive business and it takes a lot of efforts, substantial financial resources and appropriate sales and marketing infrastructure to build a successful brand. Lacking this on our own, we turned early on to partnering, first in Asia and in Middle Eastern markets based on our European clearance for the product. We managed to find great partners there who launched their respective approval processes. Please bear in mind that Bentrio is a medical device, and unlike other fast-moving consumer goods like toothpaste, it cannot simply be put on the shelves but needs to be approved first. All the product submissions that were done earlier this year or last year already, they helped to build the pipeline for future sales.
In Europe, we gained valuable experience from marketing Bentrio, in particular in the main market, Germany. We were excited to receive positive feedback from a growing number of users reporting how Bentrio helped them to deal with allergic rhinitis or to help them protect against other airborne particles than allergens. People who tried out all kinds of treatments to provide relief from allergy, they told us, "Now finally I found something that helps." This is very promising. We are seeing Bentrio as a great drug-free and preservative-free alternative to medicated sprays and consider the market potential to be very substantial. In particular, the market for drug-free alternatives is very interesting. There are a lot of products based on saline water, seawater, but they are just there to rinse your nose, actually to help to clean.
Now, Bentrio is also drug-free, but it offers protection for several hours, and it helps to have contact here even when the first few minutes after application are over. When you're exposed, you are protected. This is a big advantage over seawater sprays, and we feel that this will be a major advantage. Now, this market potential will be best addressed by established strong players in the OTC consumer health space. Following the 510(k), we intensified our discussions with various companies in the space, in particular on the large U.S. and European markets. With a triple mode of action and broadband protection, Bentrio is uniquely positioned for success in the marketplace.
To conclude with the big picture, we are on track with the execution of our strategy of becoming a leading RNA technology company and divesting or spinning off our legacy business to become a highly focused company, unlock intrinsic value, and create additional shareholder value. Now I'd like to turn over to the Q&A section with questions submitted through emails. The first questions relate to our RNA program. Could you provide a long-term timeline for the OligoPhore and SemaPhore platforms? When does Altamira plan to start its first trial for its mRNA IP? We are currently aiming to have an IND open by the FDA in 2023 for our AM-401 program in KRAS-driven cancers, and in 2024 for our AM-411 program in rheumatoid arthritis. Therefore, the first clinical trial with a drug product based on our platform would start in 2024.
The next question is around our COVAMID trial with Bentrio. We received several similar questions, which is why I'm summarizing them. What are the implications of the COVAMID trial in acute COVID-19 for Bentrio's labeling from a regulatory and commercial perspective? Which countries would honor the results of the trial? A positive outcome of the trial will clearly strengthen our position in those countries where we currently do not have regulatory clearance for viral infection. This concerns mainly Europe, the U.S., and China, and in most cases will probably require a separate submission. It will also help to strengthen the marketing of Bentrio in those countries where we currently have clearance also for viral infection. This is the case, for example, for the U.K. and several Asian markets.
The trial in Bulgaria was conducted in accordance with internationally recognized standards and should therefore meet quality requirements of all major regulatory agencies. The next questions relate to the planned divestiture or spin-off of the legacy assets. Since we received, again, several similar questions, I'm summarizing them also here. Number one is, what types of deals is Altamira looking for? One-time sale, licensing rights, partnerships with royalties or all of this. We are open to various types of transactions or deals. Under one scenario, we will spin off a subsidiary comprising the legacy assets. We have reserved the ticker symbol NOSE or nose, which should symbolize here, the nasal spray programs, obviously. This is the scenario when we retain some sort of ownership in the assets. The other scenario is the divestiture of assets or a combination of sale and partnership.
Under the second scenario, there would be most likely a customary mix of upfront milestone and royalty payments. Number two, what is the value of the legacy assets, and what is the price you are looking for? Well, this is a delicate question, but a good one. Of course, we do have some concrete numbers in our heads, but for obvious reasons, we won't share them here. Assets of this kind tend to be valued on discounted future cash flows and/or some comparable assets in the market. We recently communicated our investment so far in AM-125, which were $18 million, and in Bentrio, which were $15 million. This gives already some idea. Even if the focus of many investors is squarely on Bentrio, they should not forget about AM-125.
Given that dizziness is affecting so many people worldwide, there is an existing market for the oral formulation of the active substance, betahistine, that is $450 million, and we have IP issued in key markets. Now overall, we are definitely seeking to maximize the value of our legacy assets for the benefit of the company and its shareholders. Number three, what is the value of a positive outcome of the COVID trial? Well, a positive outcome would clearly add to the value significantly. Just consider that the market for OTC cough and cold remedies is significantly larger than that for allergy relief. We expect COVID-19 to stay with us for some time, and let's not forget about human rhinovirus infections or influenza.
However, as of today, Bentrio is first and foremost a product cleared for allergic rhinitis in major markets, including U.S., Europe, and also several Asian markets, more to come, with the OTC markets being $ billions in size. While infection comes on top of this and gives it additional value potential, this is how we are positioning the product in our discussions. By the way, Bentrio should also work in case of molds, fungi, or air pollution. There is a lot of upside potential here. Moving on to the next question, which relates to patents. Could you update investors about patent status? Our RNA technology is covered by patents in major markets owned by Washington University and licensed exclusively to us. They run to 2034. We see several opportunities for creating additional IP in this area.
AM-125, as already mentioned, is patented in most relevant countries with protection to 2038. For Bentrio, we have filed a patent application which has already entered the patent prosecution phase in the U.S. If issued, this will provide protection until 2040. The last questions relate to funding. Regarding the cash position and burn rate, I'm referring to our publicly filed communications. The half-year financials, as previously announced, are scheduled for early October. Other question, can you please elaborate on the purpose of increasing the number of authorized shares disclosed to important milestones? I understand that the proposed increase in the number of authorized shares looks quite impressive at first sight. However, authorized does not mean issued. This is just part of good corporate housekeeping to provide the company with flexibility in case of corporate finance or other transactions.
Being a long-term shareholder myself, I'm definitely sensitive to dilution, as you can imagine. To summarize our catalysts that we expect in the next several weeks or months. On Bentrio, we just announced the completion of the enrollment, and we expect data readout here in the fourth quarter. Our previous assays in human nasal epithelial cells clearly showed that Bentrio protects against the SARS-CoV-2 . Therefore, we are quite confident of a positive readout here on the primary outcomes of the study. We will restart on Bentrio a large study in Australia that is in seasonal allergic rhinitis. This study was reported with interim results to the FDA for the 510(k) and was quite important here. Now we will complete enrollment here, so the allergy season is going to start fairly soon.
We expect here then in Q1 additional results. On AM-125, well, we expect to file the IND, so that will be a major milestone here. We have been quite busy compiling all the data and all the information here for a submission, which would then lead to the start of phase lll trials. Now, overall, of course, the key topic will be here the legacy business that we are seeking to spin off or divest. Please stay tuned. There are exciting times waiting for us. Thank you very much for sending in your questions. I hope today's call helped to answer them. We are approaching a very exciting time as we are getting closer to year-end. Thank you very much for your attention and support.
Thank you, ladies and gentlemen. This does conclude today's conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.