Altamira Therapeutics Ltd.

Good morning and welcome to Altamira Therapeutics conference call. On today's call are Thomas Meyer, Altamira Therapeutics founder, chairman, and chief executive officer, and Marcel Gramad, Altamira Therapeutics chief financial officer, who will present the company's financial results for the second half and full year of 2021 and provide a business update. The accompanying slides can be found on the Altamira website in the investor section. Earlier today, Altamira Therapeutics issued a news release with the second half and full year 2021 financial results, as well as a business update. The release is available on the company's website at ir.altamiratherapeutics.com and has been filed with the SEC. During today's call, the company 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, financial, or business performance, or our 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 our clinical trials, the clinical utility of our product candidates, the timing or likelihood of regulatory filings and approvals, our intellectual property position and our financial position, as well as those described in the risk factor section in our annual report form 20F and future filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change. With that, I will hand the call over to Thomas Meyer.

Thank you, Holly. Hello, everyone, and thank you for taking the time join Altamira Therapeutics earnings and business update call. On today's call, I will provide an update on our various development projects, an overview of recent corporate developments, as well as an update on our strategy. Following my update, our CFO, Marcel Grimaud, will provide an overview of our second half and full year 2021 financials. Finally, I will discuss our outlook for the rest of the year and we will then open the call for any questions. So overall, 2021 was truly a transformative year for our company. During the year, we laid the groundwork to reposition our company through a key strategic acquisition to enter the exciting and dynamic market of RNA therapeutics. In addition to repositioning our business towards RNA therapeutics, we also continued to progress our non-RNA legacy programs towards achieving key value enhancing catalysts. In the weeks and months ahead, we expect to approach several clinical and regulatory milestones. At the same time, we have been preparing for the second major step of our transformation, the planned divestiture or spinoff of our legacy business. Last June, at the time of our expansion into RNA therapeutics, we expected to complete this step within 12 to 18 months. We feel that we are on track to meet this objective and anticipate executing on it in the second half of this year. With that step, we shall more fully unlock the intrinsic value of our legacy business and become a pure play RNA therapeutics company with great potential in a fast-growing and disruptive sector of human medicine. First, I will discuss our vision for RNA Therapeutics, how we are building this business and our goals. RNA Therapeutics have generated significant attention over the last few years. The ability to control the expression of disease-relevant genes through short interfering RNA or siRNA or messenger RNA or mRNA or other types of RNA holds great promise. By engaging targets that are otherwise undruggable by small molecules and proteins, whole new avenues are expected to open up with RNA therapeutics for treating a third to intractable diseases. In 2021, RNA therapeutics of the siRNA or antisense oligonucleotide type generated nearly $5 billion in sales. But this may be scratching the surface of its potential. Some analysts project that by 2030, this is a medical field that could expand nearly five times to over $25 billion. at a compounded annual growth rate of 17.6%. The global market for mRNA therapeutics is even bigger. Think of mRNA vaccines, among others, and should grow from $46.7 billion in 2021 to more than $100 billion by 2026, regardless of the type of RNA therapeutic. Delivery into target cells and tissues has proved to be a major challenge, as RNA is inherently unstable and tends to show poor cellular uptake. Various delivery technologies have been developed to address these challenges, including the use of nanocarriers or bioconjugates for targeted delivery. While there has been substantial progress with delivery of RNA payloads to the liver, other target issues in organs have remained difficult to reach. Another challenge has been the low amount of RNA payload that becomes available within the cell, which has been reported at 1 to 2 percent only. These challenges have clearly prevented more widespread adoption of RNA therapeutics so far. However, our proprietary peptide-based technology platforms which are called oligophore and semaphore, seek to address some of these main issues and challenges, enabling safe and effective delivery of RNA molecules into target cells outside the liver using systemic or local administration. With our nanoparticle technology, we can protect the RNA payload from degradation in the circulation as well as achieve rapid cellular uptake and efficient release inside the cell, the technology has been successfully tested in numerous animal disease models, including indications in various types of cancer and inflammatory diseases. All these results, to which I refer, have been published in peer-reviewed journals and can be found on our website. So with full understanding of the challenges and opportunities and following our deep dive into the science, we entered the RNA therapeutic space in June 2021 through our shares-based acquisition of Tracer Therapeutics. Tracer is a pioneer in the development of nanoparticles for extrahepatic nucleic acid delivery. It was founded in 2014 as a spinoff from Washington University in St. Louis. Our strategy in RNA therapeutics is based on two pillars. Number one, we are developing RNA therapeutics to demonstrate the clinical proof of concept for our technology platform. For this, we have selected KRAS-driven cancers, which may affect the pancreas, lungs, or colorectum as the first indication for drug development. We have initiated a preclinical development program for AM401 and are aiming for an FDA IND in 2023 to be followed by a clinical proof of concept study in humans. Number two, we are proactively seeking to leverage our technology platform through partnering. Considering the suitability of our platform for multiple therapeutic indications, especially in oncology and immune diseases, but also elsewhere and for various types of RNA molecules. We aim to leverage it through collaborations with other biopharmaceutical companies and the out licensing of technology for specific indications. In this way, we intend to become a delivery platform company. I'm pleased with the way that we have developed our RNA therapeutics business since June of last year. We published new in vivo data showing successful treatment of adult T-cell leukemia lymphoma or ATLL, a rare yet sometimes very aggressive cancer, and abdominal aortic aneurysm, a frequent inflammatory process associated with a high risk of mortality due to rupture if left untreated. These two studies further added to the growing body of evidence regarding the safety and efficacy of our technology in vivo. To implement our growth strategy in RNA, we have made some key hires, which included Samuel Wickline, MD as Chief Scientific Officer. Dr. Wickline is the founder of Tracy Therapeutics and lead inventor of the oligophore semaphore technology. He had a very productive and distinguished career at Washington University, and the University of South Florida. Recently, Kabadonga Panera, she has a PhD, joined us as chief development officer. Dr. Panera has over 15 years of experience in drug development and over seven years of experience as an R&D manager at a clinical stage RNA biopharma company called Silentis. Last but not least, I'm pleased to report that we have already made solid early progress with our business development activities, raising the profile of IL-4 semaphore within the community. Across this nascent sector, we are excited to see the strong need and interest in delivering RNA therapeutics to extra hepatic targets and to achieve significantly better efficiency in the release of the therapeutic inside cells. compared to currently available technology. This is evident through the rapidly growing amount of preclinical and clinical research in this area, as well as increasing numbers of academic and professional biotech journal articles published in addition to a lot of capital flowing into the space and a highly active mergers and acquisitions scene. Moving on to slide 12. Concurrent with building our RNA business, we also achieved substantial progress in our non-RNA legacy business. Here, we are laying the foundations for long-term growth with our two nasal spray programs, Ventrio and AM125. As for our innovative drug-free Ventrio nasal spray, we continue to expand the set of data supporting its efficacy and safety in the protection against airborne allergens, and viruses. Simultaneously, we are ramping up global over-the-counter distribution by partnering with international distributors. As for our AM125 nasal spray for vertigo treatment, we are approaching important milestones this year, featuring the readout from our Travis Phase 2 proof concept study and the submission of an IND application to the FDA. we are very excited about the prospects for this product, which has the potential to fill an important gap in the US market for vestibular treatments. I'll circle back on this in a minute. I will now discuss Bentrio. In 2021, we made significant progress with Bentrio. Bentrio is an OTC product, which means a doctor's prescription is not necessary to purchase it. Following positive results, from our first clinical trial in allergic rhinitis in the second quarter of 21, which showed a significant reduction in nasal symptoms over four hours of controlled exposure to grass pollen in a challenge chamber compared to no protection, we initiated two further studies in the allergy indication. In Canada, we initiated a house dust mite challenge study with allergic rhinitis patients, for which we are expected to see data readouts in the second quarter of 2022, so very soon. House dust mite allergens constitute the prime cause of respiratory allergies, that is, allergic rhinitis and allergic asthma, with prevalent estimates for allergen sensitization ranging between 65 and 130 million persons in the general population worldwide. or as many as 50% among asthmatic patients. In the U.S., they are the second most common source of sensitization right after plant-related allergens, such as in hay fever, and may be present all year long. Meanwhile, in Australia, we have a larger study called the NASAAR trial that is ongoing with patients who are naturally exposed to seasonal allergens. In this study, participants self-administered Bentio or a saline nasal spray control over two weeks. We expect another trial to report data in either the fourth quarter of this year or Q1 of 2023. In the viral infection indication for Bentio, we generated additional in vitro data using the highly relevant in vitro assay with human nasal epithelial cells. we are very pleased to see that BenQ significantly lowers infectious viral titer when applied prior to or after infection with SARS-CoV-2, not only for the wild type, but also with both the Delta and Omicron variants. In addition, similar positive effects in the same type of assay were also shown in H1N1 influenza virus infection, bird flu further confirming the broad protective scope of ventrile. Obviously, the next step in testing ventrile was to set up a clinical trial in COVID-19. However, this turned out to be rather challenging due to the unpredictable up and down of infection cases, while it usually takes several months to do this study setup. Our plans for clinical testing were delayed in 2021 in August as we waited for regulatory approval in India. However, we were able to start the randomized controlled COVA-MID trial in Bulgaria last month, that is in March 2022. Enrollment has been progressing swiftly so far, and Altamira may complete the study in the third quarter of 2022. That will be a major milestone. Back in the third quarter of 2021, we launched Dentrio commercially in Germany and Austria, first via online pharmacies, followed by brick and mortar pharmacies, starting late in the fourth quarter of last year. Sales in 2021 reached approximately 0.1 million Swiss francs, with the product launch and adoption slowed by various regulatory restrictions, on direct-to-consumer marketing for use against SARS-CoV-2 and the lack of specific clinical evidence since we didn't have our clinical data yet. In the first quarter of this year, ventriloquial revenues continue to grow, reaching approximately 2.5 times that of the full-year 2021 level. We have received the first orders from distributors and expect revenues from ventriloquial supplies to accelerate following further marketing clearances and respective product launches. In addition, under our agreement with NIOS covering China, in the first quarter we received an upfront payment of $1 million. Further, we may receive development and commercial milestones of up to $22.5 million and upon production transfer, a staggered royalty on net sales at a high single to low double digit percentage. The key focus of our marketing campaigns in the current pollen season in the northern hemisphere, we have been receiving an increasing number of positive feedback from people suffering from allergic rhinitis, like these two here. So a gentleman who happens to be a medical doctor told us for many years I've been suffering from allergic rhinitis and sinusitis and tried out many different treatments, but without success. Thanks to Bentrio, I could significantly reduce the irritation of my nasal mucosa. Another gentleman, using Bentrio, my sneezing is almost zero now, and I'm no longer blowing my nose every 10 minutes. So allergy is a very important market for Bentrio. viral infection is another important one. So geographically, the German speaking European countries have been serving as the primary test markets. To be clear, marketing even a highly efficacious OTC product direct to consumers is expensive. While the entire planet has a far higher awareness of airborne viruses and other harmful airborne particles than it did two years ago, We plan to market and distribute Ventrio through established distributors, leveraging their expertise and economies of scale in OTC consumer health markets worldwide. We have already established marketing and distribution agreements covering more than 20 international markets. Our initial current partners include Wellesta Holdings, covering India, Singapore, Malaysia, Indonesia, Philippines, Vietnam, Taiwan, Morocco, Avernus Pharma covering the United Arab Emirates, Saudi Arabia, Kuwait, Qatar, Bahrain, Oman, and Nuance Pharma, which is covering China mainland, Hong Kong, Macau, and South Korea. We are in ongoing discussions to expand into other countries and geographic regions, including North America, Europe, and other markets. As of today, Bentrio has been cleared for sale in the countries of the European Union, Switzerland, UK, Singapore, and Malaysia. Now, for the U.S. market, we filed with the FDA in October 2021 a 510K application for pre-market clearance of Bentrio in the allergy indication. The review of the submission is still ongoing at this point. One should note that it's not unusual for the FDA to request additional information during such processes and that a clock stop applies to the calculation of the total review time as such requests are out. I will conclude my report on Ventriol by highlighting the establishment of our OTC consumer health business unit to support our further growth with this promising product. The business unit will be headed by Jean Lachance, starting next month. Jean brings an outstanding track record of more than 20 years of global marketing and sales experience in OTC consumer health and pharmaceutical products, including with some of the world's largest brand name OTC manufacturers like Merck Consumer Care, which is now Bayer Consumer Care, Schoenplau and Abbott Laboratories. His experience spans multiple therapeutic areas and product categories, including cough and cold and allergy, to which Benfeo belongs. Now turning towards our advancements in the AM125 program to treat vertigo. In regard to the development of our AM125 program for the treatment of vertigo, we experienced intermittent slowdowns in recruitment for the Travers Phase II trial due to COVID-19 in 2020 and also in 2021. The neurosurgery that is triggering acute vertigo that we were seeking to treat with AM125 in this trial is considered an elective procedure and therefore got delayed at quite a few study sites. Finally, in March 2020, we were able to complete enrollment into the second part of the trial. The top line data from the trial are expected to be announced in the current second quarter of 2020. An interim analysis of the first part of the trial had already demonstrated a dose-dependent improvement in balance, as well as good safety and tolerability of ascending doses of AM125. At the highest dose of 20 mg, which is taken three times daily by a nasal spray, AM125-treated patients demonstrated a 2.6-fold improvement in the so-called tandem Romberg test performance from baseline to six weeks compared to those who received placebo. So that means they could maintain their balance much longer. This positive outcome was supported by similar improvements in additional efficacy measures, including additional objectives as well as clinician and patient reported outcomes. We are currently preparing the submission of an IND to the FDA for the next steps in the clinical development of AM125. Here is why we are so excited about the potential for AM125. So the product is an intranasal formulation of betahistine, which has been widely used for decades in tablet form as a vestibular stimulant and standard of care in vertigo treatment and management around the world, with the U.S. being a notable exception. Vestibular dysfunction affects more than one-third of the U.S. population 40 years of age and older. As you grow older, you get more balance problems. Because of its ability to circumvent first-pass metabolism, AM125 has been shown to have 5 to 29 times higher bioavailability than orally administered beta-histine. Even without a US market, worldwide sales of the current oral beta-histine product are approximately $450 million a year. If approved and marketed in the U.S. and globally, we believe that the market potential for AM125 could reach $1 billion or more. We intend to pursue distribution partnering opportunities with AM125 as a more scalable model than distributing and marketing ourselves. I would now like to hand the call over to our Chief Financial Officer, Marcel Grimmel, to run through highlights of our second half and full year 2021 financial results.

Excuse me. I'm showing that Marcel's line disconnected. I will reconnect his line right now. Just one moment, please.