9/24/2024

speaker
Operator
Conference Call Operator

Good morning and welcome to the Altamira Therapeutics first half 2024 and business update conference call. On today's call are Thomas Meyer, Altamira's founder, chairman, and chief executive officer, and Kovidanga Panata, Altamira's chief operating officer. Earlier today, Altamira issued a news release with the first half 2024 financial results, as well as comprehensive business updates. 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 courage, 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 unity 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 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 and 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'll hand the call over to Altamira Therapeutics CEO, Thomas Meyer. Please begin.

speaker
Thomas Meyer
Founder, Chairman and Chief Executive Officer

Thank you, operator. Hello, everyone, and thank you for joining our first half 2024 financial results and business update call. I will kick off the call by providing an overview of recent corporate developments. Our Chief Operating Officer, Kawadonga Panita, will then discuss the progress in our new core business of RNA delivery. Finally, I will discuss our financials and outlook for 2024 before opening the call for any questions. In 2021, we entered the field of RNA delivery through the acquisition of Tracer Therapeutics and initiated our strategic repositioning around Tracer's exciting peptide-based nanoparticle technology for extrahepatic RNA delivery. Looking back, this was definitely the right decision to take Also, it has taken us longer than expected to harness the potential of the tracer technology, which we now call our oligophore and semaphore platforms. I'm pleased to say that we have made great progress and continue to gain momentum with our RNA delivery programs. This shows in various forms. Fresh in vivo data, recently published in Nature Immunology, a top-ranking scientific journal, show dramatic reductions in cancer growth following treatment with CBTB46 mRNA delivered with our Semo4 nanoparticle technology. Development of both the Oligo4 and the Semo4 platforms, as well as of our AM401 and AM411 flagship programs in KRAS-driven cancers, and in rheumatoid arthritis is progressing, benefiting from our new access to a lab space at the Switzerland Innovation Park in the Basel area. At the same time, we are evaluating our platforms for use in cardiac regeneration and for mRNA vaccines in joint projects with two partners. Through our business development activities, We're exploring and discussing additional exciting collaboration opportunities with other pharma and biotech companies. While we progress with our RNA delivery activities, we keep working towards completion of our strategic repositioning by divesting or licensing out our legacy assets. We already divested part of our venture nasal spray business, By retaining a 49% stake and additional economics from share of licensing revenues and in case of a sale, we will still participate significantly in the upside of this business. The main focus of our current partnering activities is on AM125, our bed ASD nasal spray for the treatment of vertigo. In connection with the repositioning, we have also been optimizing our cost structure, significantly reducing the cash burn rate and contributing to this further simplifying the group structure. Ultimately, the goal will be to have a much different business model. Compared to the development of drug products, we expect to operate a much less capital-intense business based on revenues from contract development, and revenue streams from licensing rights to our RNA delivery technology. Last week, we raised in a public offering of common shares gross proceeds of $4 million to strengthen our financial position and support the ongoing transition to the new business model. The shares were issued together with warrants, which could provide us with up to $8 million in additional cash upon reaching certain development and business milestones. Following the summary, I'm handing the call over to Covadonga Panera, our COO, who will provide you with a more detailed update on our RNA delivery business. Cova?

speaker
Kovidanga Panata
Chief Operating Officer

Thanks, Thomas, and good morning, everyone. These are exciting times to work in the RNA space. Research and development activities in Altamira's core business RNA delivery built on our peptide-based oligophore and semaphore nanoparticle platforms continue to progress. The key focus during the first half of the year has been on nanoparticle formulation and process development around the platforms, as well as on the evaluation and development of nanoparticles for delivery of specific siRNA and mRNA payloads for partners and for our two flagship programs, AM401 and AM411, the treatment of KVAS-driven cancers and rheumatoid arthritis, respectively. Evidence for the effectiveness and versatility of Altamira's RNA delivery platforms keeps growing, as shown by two recent scientific publications. A research group from Washington University presented in a preprint publication the results of a study showing that administration of SOD2 mRNA delivered systemically with semaphore nanoparticles to mice with abdominal aortic aneurysm, or AAA, resulted in a significant reduction in aorta dilation, delayed rupture, and promoted a significant improvement in survival rate. AAA is an inflammatory disease involving oxidative stress. caused by excessive levels of reactive oxygen species, which result in abnormal enlargement of the abdominal aorta and rupture may be life-threatening. In the second study published in Nature Immunology, semaphore was evaluated as a delivery vehicle for mRNA in the context of cancer. Here, another research group from Washington University showed that systemic administration of CBTB46 mRNA with semaphore nanoparticles to mouse models of sarcoma and metastatic breast cancer resulted in sustained CBTB46 expression, restored immune-stimulatory tumor microenvironment, and highly significant reduction in tumor growth. When CBTB46 mRNA nanoparticles were combined with an immune checkpoint inhibitor treatment, such as anti-PD-1, outcomes were even more pronounced, showing that an anti-PD-1 response involves the anti-PD responsive sarcoma model and in the anti-PD-1 refractory breast cancer model, generating long-term complete remission of tumor in many of the treated animals. Extended monotherapy with CBCT46 nanocorticals produced complete remission, even in the mice refractory to anti-PD-1 treatment. Mice with sarcoma eliminated through treatment did not develop additional tumors following repeated challenges, indicating the development of a protective immunological memory. Meanwhile, Alchamira's own development work has resulted in significant enhancement of nanoparticle stability, which has been one of the key challenges in handling and transport of RNA through formulation. Thanks to its new flow process production method, the company obtained formulations of oligophore nanoparticles that are stable in liquid form when stored at four degrees for a period of at least one month. These formulations were in addition able to withstand shaking stress without significant physical chemical changes. The ability of the nanoformulations to maintain their attributes during shaking stress is essential for transportation and one of the key limitations of lipid nanoparticles, the most common type of RNA delivery vehicle. Focusing on our proprietary development programs, AM401 and AM411, Altamira filed, during the first half of 2024, several patent applications with the U.S. Patent and Trademark Office. This aimed to complete the existing intellectual property and extend reaction of protection. For AM401, coverage of different KRAS mutations in cancer treatment with nanoparticles comprising the oligophore platform and a single siRNA sequence, poly-KRAS mute, is stopped. in vitro data confirmed the ability of polyKRAS-mute siRNA to knock down KRAS carrying the following mutations, G12C, G12V, G12D, G12R, G12A, and A146T, which account for the majority of the KRAS mutations in pancreatic, colorectal, and non-small cell lung cancer. For AM411, coverage of nanoparticles comprising sRNA sequences targeting the P65 protein, a component of the NS-kappa beta transcription factor, and oligophoresis. Activation of P65 has been observed in multiple types of cancer, as well as in many inflammatory diseases. For instance, P65 is a well-known key checkpoint in rheumatoid arthritis inflammation, and sought to regulate key biological processes that become dysregulated in rheumatoid arthritis. The company aims to advance both AM401 and AM411 towards an investigational new drug application filing with the FDA in 2026, and to out-license them either following the IND or after Phase I clinical trial at the latest. Altamira is pursuing a picks and shovels strategy with the RNA delivery business. This strategy is based on the licensing of its platform technology to partners in the biotech and pharma industry for the use with their own RNA payload. The first of such collaborations have been set up. With Hecate Therapeutics, a spin-off from King's College London, Altamira is working on nanocorticals based on the oligophore platform and comprising certain non-coding RNAs for the regeneration of damaged heart tissue following myocardial infarction in animal models. With Belgium-based universal group, Altamira is evaluating the use of the Semaphore platform for delivery of mRNA vaccine. Thanks to lower mRNA loss during cell entrance, the nanoparticles may allow for using lower doses and thus result in potentially more effective and efficient vaccine. Upon positive outcomes of these evaluations, Altamira and its partners intend to discuss and negotiate licensing agreements. Through its business development activities, the company is pursuing additional collaboration opportunities with other pharma and biotech companies. In August 2024, part of the company's expanding research and development team moved to Switzerland Innovation Park in Auschwitz near Basel. At the new location, the company has access to modern and well-equipped lab facilities to support its growing activity. I will now turn the call back to Tom.

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