What were the main highlights and achievements for Aphios in 2023?

As the year evolved, Aphios focused on a few strategic approaches that are mission-centric. One of those approaches focused on ESG factors and how our approach to biotechnology fosters and assists in environmental sustainability. Additionally, the company also placed a focus on nanotechnology drug delivery – how to better deliver drugs to target therapeutic indications, whether it is for CNS, cancer, or infectious diseases. Nanotechnology drug delivery reduces dosing levels and frequency and improves efficacy and clinical response to the drug. Due to the complexity of biology, often a combination of therapies is required which can be facilitated by AI, and this was the third area of focus for us. What makes Aphios’ technology platforms unique?

Aphios’ enabling technology platforms are based on environmentally friendly technologies where we use advanced scientific techniques to improve nanotechnology drug delivery, accelerate drug discovery and manufacturing processes, remove harmful pathogens from biologics and the human blood supply, and provide a viable biofuel solution for the future. We are exploiting the physiochemical properties of near-critical, critical, and supercritical fluids. When compressed, these fluids exhibit enhanced thermodynamic properties of penetration, selection, solvation, and expansion. We manipulate these SuperFluids on a cellular level to increase process selectivity and speed while reducing processing steps, toxic organic usage, and manufacturing costs.

We were awarded an NIH grant to develop a double-nanoencapsulation mRNA vaccine for COVID-19 using these SuperFluids to improve both its efficacy and stability. The mRNA molecule that encodes the coronavirus Spike protein will be first nano-encapsulated in lipid nanoparticles (LPN) or small uniform liposomes (nanosomes) and then into biodegradable polymer nanospheres (PNS). The mRNA LPN will remain in the body longer and will sustain the persistence of antibodies to the coronavirus. Additionally, double-encapsulation of the mRNA vaccine construct in PNS will protect the lipid mRNA nanoparticle from degradation and increase shelf stability at room and refrigerator temperatures. Can you elaborate on the work Aphios is doing in the Alzheimer’s Disease (AD) space?

Aphios wants to go beyond what is already available on the market and is developing APH-1104, a novel α-secretase modulator and potential AD therapeutic that will not only help delay or prevent symptoms from becoming worse but will also increase memory by the regeneration of synapses or synaptogenesis. Is the life sciences industry already adapting to climate shifts and mitigating that risk?

Climate change, population increase, urbanization, deforestation, etc. will have an impact on our quality of life as well as our biology as there are effects on ecosystems and the habitats for viruses to which our bodies have no natural immunity. The industry will have to adapt by either creating better and quicker vaccines, or we will have to be able to rid those new viruses quickly from biologics and biotechnology products which can be a carrier of viruses. Aphios, which means virus-free, has the core mission to not only contain viruses but also to treat underlying infectious diseases.

As the climate in the northern parts of the US gets hotter, we will have problems with malaria, which kills more people than any other infectious disease in the world. To address the need for effective pathogen inactivation and removal techniques for human blood plasma and plasma-derived products, Aphios is now commercializing a green CFI (Critical Fluid Inactivation) technology that can inactivate enveloped and non-enveloped viruses with no residual contamination and negligible denaturation of proteins and enzymes. CFI does not damage proteins and enzymes since it is purely physical and does not involve the use of chemicals, heat, or irradiation, and it is a scalable closed system, fluid-liquid/solid contacting technique. Can you elaborate on Aphios’ strategy to build partnerships, and what makes the company a compelling investment case?

We have advanced several therapeutic products and technology platforms that are both ESG-sensitive and mature for establishing partnerships. For example, developing a technology that can improve the delivery and stability of mRNA vaccines and therapeutics, provides a platform for collaborations in several therapeutic areas. As we are in an election year, many investors are cautious and are waiting to see what happens before they invest. There is thus a significant amount of capital sitting on the side, inflation will go down, and interest rates will decrease, meaning the IPO market should be taking off soon. Aphios has a subsidiary, Zindol LLC, which we plan to take public, depending on market conditions, to develop our lead drug candidate for chemotherapy-induced nausea and vomiting, as well as for other indications of nausea such as GLP-1 medication-related nausea, hyperemesis in pregnancy, and postoperative nausea and vomiting. Aphios’ key priority moving forward in 2024 will be to launch Zindol LLC as a company through private and/or public financing and work toward FDA approval of Zindol.