Predictive Oncology Inc. (NASDAQ:POAI) Q4 2023 Earnings Call Transcript

Leaning heavily on this evidence in fact, we recently submitted a proposal to the RK Mellon Foundation to further enrich the data sets necessary for modeling, including sequencing activities, aggregation and curation of clinical information especially outcome data, and the digitization and futurization of more than 200,000 pathology slides currently in our possession, delivering significant value and unique insights to highly regarded collaborators such as Magee and through them gaining access to drug developers and CROs who can benefit from our models is a key factor in our business and corporate development efforts moving forward. Our work with both CRH and Magee confirm without question, our ability to aggregate, analyze, and model multi-omic data to successfully predict patient responses to certain drug targets across heterogeneous patient populations.

Again, it is the patient heterogeneity that is incorporated into our models that truly sets us apart from others in the industry, both new and established AI players, as patient heterogeneity is a major reason why oncology drugs fail in later stages of clinical development. Turning now to other collaborations that we have discussed in the past. Let me give you a brief update on Cvergenx, FluGen and Fuji [ph], as well as the most recent submission to the Center for the Advancement of Science and Space. You may recall that last February, we announced a collaboration with Cvergenx develop the first ever genomic spaced approach to precision radiation therapy and drug discovery using artificial intelligence. The objective of this collaboration was to leverage and maximize the combined power of Predictive Oncology’s expertise in artificial intelligence and Cvergenx proficiency in biomarker development to identify novel radio protector and radiosensitizer drugs.

Over the past year, we have made significant progress having now evaluated, trained, or developed models to predict changes in radio sensitivity for more than 3000 different drug exposures using well established gene expression databases. These findings form the basis of an NIH SBIR Phase 1 grant, screen vast libraries of compounds to accelerate the potential development of drugs, drug combinations, or repurposed drugs to sensitize or protect human subjects from the effects of radiation. The significance of identifying these radio sensitizers and radio protectors extend well beyond drug repurposing however. Using these models, for example, we can proactively screen workers in the nuclear energy industry and in the military and in a clinical setting, optimize the planning and treatment of patients receiving radiotherapy.

So our work with Cvergenx has potentially broad utility across a number of important applications. And in the process, we have been able to expand those datasets, which may be leveraged in several important ways with respect to commercialization. First, to screen individuals for radiation sensitivity or resistance to optimize the clinical efficiency of radiotherapy. Second, screening for interactions between sensitive or resistant patient tumor samples and therapeutic compounds. And third, to identify, combine, or develop novel or repurpose radio protective or radio sensitizing drugs. These are not isolated elements, but synergistic activities that created new and more interesting opportunities. For example, as you might remember, our Biologics Group is led by Dr. Larry DeLucas, former astronaut and Senior Scientist for the space station.

Because of that experience, and given his relationship with NASA, we recently submitted a proposal to the Center for the Advancement of Science and Space to use our technology on the space station. Larry and his team have now developed a novel membrane protein expression system to produce significant quantities of biologically active G protein coupled receptors, also known as GPCRs, and other membrane protein classes. The reason for this is that the microgravity environment in space can improve cell differentiation and increase the rate of cell growth and size which enhances the yield of expressed GPCRs. The more practical and immediate opportunity, however, is that this concept has also led to collaborations with Merck & Company, OCMS, and Red Wire Space.

As a result of these developments, we have just filed intellectual property or novel method and system for expression and purification of G protein coupled receptors. When issued, we will be in a position to broadly out license this technology to biopharma for numerous drug development applications. You may remember from our last call that Predictive Oncology and FluGen entered into a collaboration to develop a novel first of its kind flu vaccine to market as part of a multi-million dollar project funded by the Department of Defense for which a Phase 2B grant has been submitted to the NIH. I’m pleased to say that this grant has now been awarded, the details of which will be disclosed in the coming weeks pending approval by the Department of Defense.

Predictive Oncology will play a critical role in making FluGen’s vaccine more stable and sustainable in a refrigerated state, which is a crucial requirement in the drug development process. And lastly, Predictive Oncology and Fuji [ph] will in the next few weeks announce their intention to co-market our endotoxin detection and treatment technologies as a novel solution for injectable pharmaceuticals and biological products. According to a recent report by Future Market Insights, the $6 billion injectable drug market is expected to grow by 5.8%, reaching the projected value of $10 billion by 2034. Before turning the call over to Josh to review the financials, I would like to recap recent conference activity. During the initial months of 2024 we had a meaningful presence at several investor conferences geared toward raising awareness of our company among high quality institutional healthcare investors, as well as potential collaborators.

These include Biotech Showcase in San Francisco, The Bio CEO and Investor Conference in New York, the 2024 New Cancer Oncology Conference in New Orleans, during which I sat on a panel discussing the topic of precision medicine. And finally, the H.C. Wainwright First Annual Artificial Intelligence Based Drug Discovery and Development Conference. We have more such conference appearances planned for the balance of 2024 and we view these events as a critical element of our effort to create long-term value for both our partners and our shareholders. At this point, I will turn the call over to Josh Blacher. Josh.