5/16/2023

speaker
Operator
Conference Call Operator

Good morning and welcome to the Altamira Therapeutics 2022 Results Conference Call. On today's call are Thomas Meyer, Altamira's Founder, Chairman, and Chief Executive Officer, and Kovidanga Pineda, Altamira's Chief Operating Officer. Earlier today, Altamira issued a news release with the full year 2022 financial results as well as a comprehensive business update. The release is available on the company's website at www.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 its 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 on our annual report on Form 20F and future filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent the company's views only as of today. It should not be relied upon as representing its views as of any subsequent date. While it 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 hand the call over to Thomas Meyer.

speaker
Thomas Meyer
Founder, Chairman, and Chief Executive Officer

Thank you, operator. Hello, everyone, and thank you for joining our 2022 Earnings and Business Update 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. Our Chief Operating Officer, Covadonga Panera, will discuss our RNA delivery technology, market position, and strategy. Finally, I will discuss our financials and outlook for the rest of 2023. We will then open the call for any questions. All in all, 2022 reflects continued progress on our strategic repositioning to become a leading pure play in RNA delivery technology for targets beyond the liver and with the effective and rapid release of RNA payloads within target cells. It is an incredibly exciting and dynamic emerging field of medicine. Many of you are already familiar with the nascent therapeutic RNA sector, which we and much of Wall Street believe has massively disruptive potential to transform the medical landscape. This is validated in part by the increasing cell site coverage, strong investment capital flows, and M&A in the sector over the past couple of years from Big Pharma. As to our legacy assets, we are fast approaching important clinical and regulatory milestones with our programs in OTC consumer health and in our ER therapeutics, which are key components in our strategy to divest or partner these legacy programs as the second and final step in our transformation to a pure play RNA delivery technology company. In addition, through this process, we expect to unlock the intrinsic value of our legacy businesses. While the transformation has taken longer than initially expected, as these are valuable assets, we look forward to its conclusion this year. Unpacking our strategic repositioning further, We have now essentially completed the clinical development program for BENCHO, our FDA-cleared drug-free nasal spray for protection against harmful airborne particles such as allergens. We await top-line data from our NASAR clinical trial later this month. We have also completed all planned development steps for our main inner ear therapeutic acid, AM-125, our beta histine nasal spray for the treatment of vertigo. Based on the positive outcomes from the phase two Travers clinical study in Europe, I'm delighted to announce today that we have just submitted an investigational new drug or IND application to the FDA for AM-125. We are actively engaged in divesting or out-licensing both BenQ and AM125. I will circle back with more detail on both our legacy assets, BenQ and AM125, in a few minutes. At this time, I'm pleased to introduce Covadonga Panera to discuss our flagship RNA programs. Cova.

speaker
Covadonga Panera
Chief Operating Officer

Thanks, Thomas, and good morning, everyone. Our RNA delivery technologies center on our oligophore and semaphore platforms. The technology is based on a patented peptide for delivery of RNA in nanoparticles to extrahepatic tissues with efficient endosomal release inside target cells. Both the delivery of RNA to tissues and organs beyond the liver and the speed and quantity of RNA payloads getting released into the cell's cytoplasm have remained major challenges for the application of RNA therapeutics to date. Those features, coupled with good stability, a great tolerability profile, as well as a strong versatility, render our technology extraordinary powerful, cutting edge, and we believe quite valuable. The versatility is shown by the large and still growing number of disease models in which delivery technology has already been successfully tested. To date, oligophore and semaphore have been tested in 17 different studies in vivo, with both short-interfering RNA and messenger RNA. The two most recent additions evaluated semaphore with mRNA in two interesting models. At the 2023 Osteoarthritis Research Society International World Congress, held in March in Denver, a Washington University research group presented data from a mouse model of meniscal injury, referring to the meniscus, which is the cartilage tissue pad that cushions the knee joint. Systemic delivery of DNA methyl transferase 3 beta mRNA with semaphore nanoparticles significantly reduced bone sclerosis, cartilage degeneration, and synovitis compared to controls. In addition, functional studies showed significantly decreased pain sensitivity and improved weight-bearing. In a March 2023 article preprint, another Washington University research group presented data from a mouse model of sarcoma and metastatic breast cancer. Systemic delivery of SYNC finger and BTB domain containing 46 mRNA transcription factor with semaphore nanoparticles promoted anti-tumor components in the tumor microenvironment and resulted in restriction of tumor growth. When the nanoparticle treatment was combined with an anti-PD1 checkpoint inhibitor, significantly synergistic effects in the controls of tumor growth were observed. generating long-term complete remission of tumor mass in many of the treated animals. Our business model is to make our delivery technology available for use by biopharmaceutical companies with their own RNA sequences under license. That is, we are providing the modern version of picks and shovels rather than digging for gold ourselves. This business model is capital efficient, and therefore offers great potential. Since 2022, we have stepped up our efforts to present and promote our oligophore and semaphore platforms by presenting at international conferences, submitting our research studies to medical journals, and increasing our business development activities targeted at potential partners in the biopharmaceutical industry. As I often attend or speak at these conferences, I can report we have increasingly succeeded with injecting oligophore and semaphore into the biotech industry lexicon. We continue to step up our business development efforts. As a result of these outreach efforts, we are confident to enter into the first collaboration agreements with biopharmaceutical companies this year. Concurrent with our development of oligophore and semaphore platforms, We have continued the development work in our two showcase program with Oligo4 platform for SRNA delivery. AM401 for the treatment of KRAS-driven tumors and IM411 for the treatment of rheumatoid arthritis. As a reminder, AM401 is a program for the treatment of KRAS-driven cancers. KRAS is the most frequently mutated oncogene in human cancer. Currently, only one specific mutation named G12C is addressable through pharmacological treatment, but there are many more oncogenic mutations that occur within this gene and that drive disease. Our approach seeks to tackle several mutations with one single product, which we call PolyK-RASmute. That is all one word spelled lowercase P-O-L-Y, uppercase K-R-A-S with a superscript M-U-T tagged on. We are testing AM401 in different in vitro and in vivo models with the aim of moving into IND enabling toxicology studies by Q4 2023. In February of this year, we expanded our intellectual property estate by filing a provisional patent application relating to PolyK RasMUTE. If granted, the patent would extend IP coverage for the AM401 program out to year 2043. AM411 targets a component of the NF-kappa-B inflammatory pathway and is under development for the treatment of rheumatoid arthritis. NF-kappa-B is a main inflammation checkpoint in this disease and has for a long time been considered undruggable. The reasons behind this are twofold. On the one side, it is an intracellular protein and as such, difficult to target using traditional small molecules. On the other hand, NF-kappa-B has important physiological function in non-disease cells. With a combination of an RNA-based therapy and our Oligo4 platform, we can address an intracellular target specifically in sites of inflammation, which in the case of rheumatoid arthritis are typically the joints. For AM411, we're aiming to start ING-enabling toxicology studies in the first half of 2024. The use of RNA therapeutics is thought to offer significant advantages for the treatment of diseases where resistant to drug develops over time, as is the case for KVAS-driven cancer and rheumatoid arthritis. RNA silencing down-regulates the target protein rather than inhibiting it, consequently reducing the likelihood of resistance because the target protein is simply not present in the tissue where it would induce resistance. Looking further forward, we aim to advance both AM401 and AM411 to an IND filing with FDA next year, and to then out-license them either following the IND or after a phase one clinical trial at the latest. Thomas, that's my report. Back to you.

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