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 Gremaud, 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 Investors 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 Factors section in our annual report Form 20-F 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 to 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 Gremaud, 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 spin off 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 hitherto 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 deliver, other target issues and 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% 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 therapeutics space in June 2021 through our shares-based acquisition of Trasir Therapeutics.

Trasir 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 pancreas, lungs, or colorectum as the first indication for drug development. We have initiated a preclinical development program for AM-401 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 outlicensing 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, M.D., as Chief Scientific Officer. Dr.

Wickline is the founder of Trasir 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, Covadonga Pañeda, she has a PhD, joined us as Chief Development Officer, Dr.

Pañeda has over 15 years of experience in drug development and over 7 years of experience as an R&D manager at a clinical stage RNA biopharma company called Sylentis.

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 OligoPhore/SemaPhore within the community.

Across this nascent sector, we are excited to see the strong need and interest in delivering RNA therapeutics to extrahepatic targets and to achieve significantly better efficiency in the release of the therapeutic inside cells compared to currently available technology.

This is evidenced 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 acquisition sea. 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, Bentrio and AM-125.

As for our innovative drug free Bentrio 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're ramping up global over the counter distribution by partnering with international distributors.

As for our AM-125 nasal spray for vertigo treatment, we are approaching important milestones this year, featuring the readout from our TRAVERS Phase 2 proof of 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 [indiscernible] 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 2021, 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 prevalence estimates for allergen sensitization ranging between 65 million and 130 million persons in the general population worldwide, or as many as 50% among asthmatic patients.

In the US, 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 NASAR trial that is ongoing with patients who are naturally exposed to seasonal allergens.

In this study, participants self-administered Bentrio 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 Bentrio, 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 Bentrio significantly lowers infectious viral titer when applied prior to or after infection with SARS-coronavirus-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 Bentrio. Obviously, the next step in testing Bentrio was to set up a clinical trial in COVID-19.

However, this turns 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 COVAMID trial in Bulgaria last month. That is in March 2022. Enrollment has been progressing swiftly so far, and also [indiscernible 0:17:00] complete the study in the third quarter of 2022. That will be a major milestone.

Back in the third quarter of 2021, we launched Bentrio 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 CHF 0.1 million, with the product launch and adoption slowed by various regulatory restrictions on direct to consumer marketing for use against SARS-coronavirus-2 and the lack of specific clinical evidence since we didn't have our clinical data yet.

In the first quarter of this year, Bentrio revenues continued 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 Bentrio supplies to accelerate following further marketing clearances and the respective product launches.

In addition, under our agreement with Nuance 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 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 Bentrio 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 US market, we filed with the FDA in October 2021 a 510(k) application for premarket 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 Bentrio 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, Schering-Plough and Abbott Laboratories.

His experience spans multiple therapeutic areas and product categories including cough and cold and allergy to which Bentrio belongs. Now turning towards our advancements in the AM-125 program to treat vertigo.

In regards to the development of our 125 program for the treatment of vertigo, we experienced intermittent slowdowns in recruitment for the TRAVERS Phase 2 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 AM-125 in this trial is considered an elective procedure that 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 has already demonstrated a dose dependent improvement in balance, as well as good safety and tolerability of ascending doses of AM-125.

At the highest dose of 20 milligram, which is taken three times daily by a nasal spray, AM-125 treated patients demonstrated a 2.6 fold improvement in the so-called tandem Romberg test performance from baseline to six weeks compared to those 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 objective 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 AM-125.

Here is why we are so excited about the potential for AM-125. 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 US being a notable exception.

Vestibular dysfunction affects more than one-third of the US 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, AM-125 has been shown to have 5 to 29 times higher bioavailability than orally administered betahistine.

Even without US market, worldwide sales of the current oral betahistine product are approximately $450 million a year. If approved to market it in the US and globally, we believe that the market potential for AM-125 could reach $1 billion or more.

We intend to pursue distribution partnering opportunities with AM-125 at a more scalable model than distributing and marketing ourselves. I would now like to hand the call over to our Chief Financial Officer, Marcel Gremaud, 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 this line right now. Just one moment please..

So while waiting for Marcel to reconnect, Joanna, could you please jump ahead to my next slides, slide 30. Okay, so let's hope that Marcel will reconnect. He's currently traveling..

Yes. Thank you, Thomas. I'm sorry the line interrupted here. But I'm back now and can present you the financial statements. But before reviewing our financial results for the second half and full year of 2021, I would like to note that the financial statements are presented in Swiss francs.

To help you with interpreting the financials, please consider that 1 Swiss franc is the equivalent of about $1.07. Starting with the second half of 2021. During the second half of 2021, we reported our first revenues of about CHF 0.1 million from the initial launch of Bentrio last summer with two online pharmacies in Germany and in Austria.

For the second half of 2021 ended 31st of December 2021, we saw an increase in net loss of CHF 10.6 million or CHF 0.76 per share from CHF 5.5 million or CHF 0.75 per share for the second half of 2020. The main factor contributing to the net loss in the second half of 2021 was an increase in total operating expenses.

Total OpEx for the second half of 2021 was CHF 8.9 million compared to CHF 3 million for the second half of 2020.

The total second half of 2021 operating expenses consisted of research and development that increased to CHF 5.5 million compared to CHF 2 million for the second half of 2020, while general and administrative expenses were CHF 1.9 million compared to CHF 1.1 million for the second half of 2020. Now moving on to our full-year 2021 financial results.

For the full year of 2021, net loss increased to CHF 17.4 million or CHF 1.31 per share compared to CHF 8.2 million or CHF 1.36 per share for the full year of 2020. Again, the main factor contributing to the net loss for the full year of 2021 was an increase in total operating expenses.

Total operating expenses for the full year of 2021 was CHF 15.4 million compared to CHF 5.5 million for the full year of 2020.

The total 2021 operating expenses consisted of research and development expenses of CHF 8.5 million compared to CHF 2.9 million for the full year of 2020, while general and administrative expenses were CHF 4.9 million compared to CHF 2.6 million for the full year 2020.

In the context of our strategic repositioning, we have deprioritized our development programs in tinnitus, hearing loss and antipsychotic induced weight gain, and have written off all related intangible assets in 2021. Cash and cash equivalents at December 31, 2021 totaled CHF 1 million compared to CHF 11.3 million at December 31, 2020.

During the first quarter of 2022, we raised CHF 5 million from FiveT Investment Management Ltd. to a convertible loan agreement. The loan is convertible into common shares of our stock at $1.95 per share. It carries the interest of 10% per annum and will mature on February 8, 2023 if not converted by FiveT or prepaid by Altamira.

In addition, as already mentioned by Thomas, we received CHF 1 million as an upfront payment from Nuance Pharna.

For financial year 2022, we expect our total cash requirements to be in the range of CHF 11 million to CHF 13 million, for which we can draw upon our cash position, as well as our equity line with Lincoln Park Capital and our at-the-market program with ATP.

Additionally, other sources of funding may arise from our planned spin-off or divestiture of all or parts of our legacy business, which is our plan. Also, there is no assurance. With that, I will like to turn the call back to Thomas..

Thank you, Marcel. So before taking questions, I would like to take the time to wrap things up and discuss our future roadmap. So, we accomplished several key milestones in 2021 and we expect this trend to accelerate through 2022.

While executing on our repositioning strategy towards RNA therapeutics, we continue to invest in our non-RNA legacy business. I will highlight now some of the key events that are expected to be catalysts for the business over the next few quarters.

We expect to see readouts on the house dust mite challenge study with allergic rhinitis patients in the current second quarter of this year. Top line data from our AM-125 TRAVERS Phase 2 in vertigo is anticipated also in the current second quarter of 2022.

We are preparing the submission of an IND to the FDA for the next steps in the clinical development in the 125 program. Our seasonal allergic rhinitis NASAR, our clinical trial, is expected to report top line data either in the fourth quarter of 2022 or first quarter of next year.

Our COVAMID trial with Bentrio in acute COVID-19 may be completed in the third quarter of 2022, obviously driven here by the rate of infections. In our RNA based business, we plan to submit an IND to the FDA in 2023 for KRAS-driven cancer treatment using RNA therapeutics.

Apart from this rich pipeline of events and outcomes, we look forward to FDA feedback on our eventual 510(k) submission and will continue to progress all plans for the divestiture or spin off of our legacy programs. I'm very proud of our team's hard work and dedication as we focus our efforts around RNA therapies while advancing our legacy programs.

I'm very excited about being part of the ongoing RNA revolution in medicine and also about the potential for our nasal sprays to help potentially millions of people protect themselves against airborne allergens and viruses or to regain their sense of balance.

At the same time, I genuinely believe that our strategic pivot will offer a great opportunity to unlock significant value for all of our shareholders, both near and long term. As always, I look forward to sharing periodic updates as we continue to advance our mission.

And I would now like to turn the call back to the operator who will open the line for questions.

Holly?.

[Operator Instructions]. Your first question for today is coming from Andrew Scott..

Really a lot of progress last year. You have a tremendous amount of science. I don't think people really appreciate the full value of what you have. I've got plenty of questions, but just in case other people have questions, I don't want to hog up the phone. But I'd like to focus on your RNA program going forward.

Can you give investors an idea on what separates your RNA program versus a lot of the other technologies out there.

I know you also – and if you can sort of talk a little bit more about the potential therapeutic target you might be going after, I know you mentioned pancreas, lungs, colorectal, and you just had really good in vitro data for ATLL lymphoma.

But if you could just talk a little bit more about what's distinguishing in your RNA program versus others, I'd appreciate it. .

There will be a lot to talk about, for sure. So I think, here, it really boils down to two aspects. So far, RNA products, our therapeutics molecules, they have been delivered, in most cases, to the liver, which is fine if your target is in the liver, you want to achieve something in the liver, either with mRNA or siRNA.

There are lots of important diseases, disorders that originate there. There is great technology for this. And actually, there has been a lot of M&A activity around this. There was just a couple of months ago the takeout of company called Dicerna for almost 3 billion by Novo in Europe, and there have been other things.

So, this is great, fascinating technology. However, when you want to reach other targets, then, okay, it becomes a kind of challenge here.

So, either you try to treat the problem locally which is not very feasible in most cases or you go by IV administration, so you inject that, and then you have to make sure that your RNA actually survives the journey traveling through your body and does not get degraded before it reaches the target cell.

So, our technology is already taking care of that, and it is delivering here these RNA molecules to non-hepatic targets, and primarily the sweet spot is really oncology. So we have tested this in several oncology models. In all of them, it worked very nicely. We have tested it in inflammation, inflammatory diseases, it has also worked very nicely.

So, you get this IV and it travels to the target tissue. This is a little bit the Holy Grail what the industry has been looking for. So, to have something that goes where you want it to go, and not, let's say, expose the whole rest of the body and dilute it and everything, so very precise, targeted delivery.

And then, once it enters the cell, that's the second advantage. So, here, this technology, OligoPhore/SemaPhore, allows to actually harvest, so to speak, actually almost entirely the complete RNA the molecule that is brought inside the cell, so called endosomal release, whereas classic technology lipid nanoparticles, they deliver 1% or 2%.

So imagine, you bring something to your targets, this is very specific, and inside the target then you have here a very efficient release. So, this is truly outstanding what we have here. So we have picked among the various disease models where we tested the technology – or Trasir tested it, we picked KRAS-driven cancer for a variety of reasons.

So number one, strong data; number two, very strong unmet medical need. If you take pancreatic cancer, colorectal cancer, lung cancer, they all have very high mortality rates. And so KRAS, it has been called the beating heart of cancer. So basically, which decides on whether a cancer is to grow and you want to switch that off.

And so, this is a fantastic, very interesting target. Now, there are other companies out there that are working with small molecules and they have struggled a lot. So here, we see a great opportunity to actually achieve a great therapeutic outcome here with this, let's call it, laser beam type of treatment, so that you can deliver it very effectively.

Now what indication we will then test, at this point, without going too much into detail, the goal here is to get an IND open. And then we'll do a Phase 1 in cancer patients.

And then one scenario here that is quite likely is that we will actually enroll patients with KRAS-driven cancer, whether it's pancreatic or colorectal, or non-small cell lung cancer. So that's still to be determined, but we focused on this first. And besides that, okay, we are seeking to leverage the data that we generate.

And so, it's a great, it's an amazing potential here, and this is why we are excited. And so, we are so excited that we decided, okay, our other programs, our legacy programs, which are also great, well, let's focus here on RNA and let's see that we become a pure play.

This is the area of the biggest potential and the others we will find here a way to actually unlock here the potential for this. So, a very long answer to your question. I hope this is what you were looking for. .

[Operator Instructions]. There are no further questions in queue. I would like to turn the floor back over to the management team..

Okay, thank you, Holly. Well, it's already late. I believe we've covered all the highlights thoroughly today. So, I will simply thank everyone for attending this morning's call. And thank you, Andrew, for your good question. And I will wish you a terrific day ahead. Thank you very much. Goodbye..

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..