We believe that our biomanufacturing platform, SimplePath, offers a major alternative to the methods of chemical compound production.(Incorporated in Nevada)

Invizyne believes it has discovered and is developing a process that could significantly change biomanufacturing by means of leveraging cell-free multi-step enzyme-based systems that will be able to transform natural or renewable resources into sought after chemicals. We believe that our biomanufacturing platform, known as SimplePath™, will be an important alternative to the current methods of chemical compound production, which methods today are generally chemical synthesis, natural extraction, and synthetic biology. Our objective with SimplePath™ is to enable the efficient production of a diverse range of select chemicals that are used in pharmaceuticals, fuels, materials, food additives, for example. We believe that SimplePath™ not only can maximize the value of these chemicals but also will contribute to the development of novel chemical compounds that should open new markets and business opportunities.

Invizyne was established in 2019, and is a pre-revenue, development stage company. Our primary operational activities to date have been development of the SimplePath™ platform. Application of the platform and the range and type of potential products are largely still in the development stage. We have only produced certain potential products in a laboratory setting, producing only laboratory quantities. As such the platform has not been tested in terms of broader market acceptance or manufacturing both at introductory and commercial levels. Whether or not we can commercialize our platform and whether or not the potential products we currently have determined possible with the platform can be manufactured and sold at commercial levels, at this stage, is uncertain.

Our SimplePath™ platform consists of a series of enzyme based biomanufacturing systems that leverage natural processes to perform complex chemical conversions that convert a starting material into a desired end-product. Each SimplePath™ system is composed of one or more “modules” which consist of one or more enzymes that work together to perform a defined biocatalytic conversion. While a module can operate independently, multiple modules can be coupled and designed to work together in a defined sequence. This sequencing of enzymatic steps is referred to as a “cascade” or an “enzyme cascade”. Each SimplePath™ system is comprised of several key parts (i.e. substrate(s) (the substance on which an enzyme acts), enzymes, cofactors (a substance, other than the substrate, whose presence is essential for the activity of an enzyme), defined operating conditions, selected purification processes, and other system specific elements) that act together to produce one or more intended products.

The roots of the SimplePath™ platform trace back to a more than decade-long research endeavor at Professor James Bowie’s laboratory at UCLA, where the core innovations underlying the SimplePath™ platform were developed.

One of the most common methods of synthesizing new molecules is chemical synthesis. Chemical synthesis is the construction of complex chemical compounds from simpler ones. It is applied to all types of chemical compounds. This process is often expensive and environmentally damaging or polluting. Energy use, which is usually high in this process, is often a factor in determining the viability of making an end-product. Most chemical synthesis methods also produce significant waste and often use petroleum-derived chemicals to derive the end-product. Side products can be difficult to separate from the main product; although some by-products are welcomed if they have their own commercial viability. Chemical synthesis, also, may have long and complex production cycles.

Natural extraction, another common method of sourcing molecules, typically is inefficient, especially when the desired molecule is only found in small concentrations in a plant or other organism. Natural extraction processes can use large amounts of energy when compared to the end result achieved. Often, environmentally damaging solvents are used in the extraction process. Traditional methods of natural extraction typically generate substantial amounts of waste product, which presents issues of local pollution and waste management. There is often an issue of the purity of the end-product, and in many instances the purification process will damage or destroy the active agent being sought. Achieving industrial quantity is an issue in natural extraction. Using natural resources, such as plants, may actually result in over harvesting with consequences to biodiversity, damaging land resources, and local income and related societal issues.

Synthetic biology, another form of synthesizing new molecules, seeks to rewire a unicellular organism, such as yeast, using genetic engineering to produce the desired molecule end-product. This approach has some benefits over the other two methods mentioned above, but it has been more difficult than originally thought to realize the sought after end-product in a timely fashion and at a reasonable cost. The desired molecule using this method, is often toxic to the organism, especially as concentrations increase; as a result molecule yields tend to be low given competing processes within the organism. The intricate interactions and regulatory networks within cells (in essence, the complex and often interdependent series of control systems that orchestrate activities within a cell) make it difficult to predict and optimize the desired outcomes. There tend to be issues achieving long term yield and productivity using synthetic biology when production is scaled up and subjected to industrial conditions.

Companies working in the biobased industry are addressing the world’s environmentally and socioeconomically unsustainable dependence on petroleum, still the key feedstock, which is the raw material used to produce the final product, for a wide array of products. Developing chemical the raw material feedstocks from renewable sources and using catalytic chemistry to create high-value chemicals that replace petrochemical products, among others, is critical to help achieve global sustainability. Biofuels are a major focus of the biobased industry. The biobased industry, however, is expanding into additional sectors, such as agriculture, products using acrylic acid, food production and safety, cleaning products, lubricants, detergents, fertilizers and many other chemicals in common use today. Researchers and firms are increasingly focusing on the development, production and commercialization of bio-derived replacements for many basic chemicals that are commonly used in many industries. These replacements may even be “drop-in” direct substitutes for their petroleum-derived counterparts.

Invizyne believes it is developing a new technology process that we believe has the potential to change the way molecules are created in the future. In our laboratory, for the limited number of molecules that we have worked with to date, we believe our SimplePath™ platform performs the same conversions targeted by other cell engineering technologies. We believe that instead of using whole organisms to make biobased molecules, our platform uses only the specific enzymes that are involved in the multi-step biocatalytic process of making the molecule of interest. This discovery and understanding appears to simplify the biobased process of synthesizing a new molecule and eliminates many of the inherent limitations and bottlenecks of the legacy technologies. Although not yet tested by independent third parties, we believe for many products, that the SimplePath™ platform and processes can be effective, less environmentally damaging or polluting, and more cost-effective than traditional methods, depending on the product that is being made. Although not yet achieved, based on our laboratory results, we also believe SimplePath™ is more predictable and can be scalable. We believe our technology has the potential to create the next generation of innovative biomanufacturing systems that leverage the power of enzymes, which we call Biomanufacturing 2.0.

We estimate that the potential applications of the SimplePath™ platform are many in addition to those that we are studying at present. In the pharmaceutical space, the platform could be used to produce new drugs. In the biofuel space, it could be used to produce cleaner and fuels as effective as those in current use. In the food space, it could be used to create new flavors and fragrances. In the industrials space, it could be used to produce less environmentally damaging or polluting and more sustainable industrial chemicals. Invizyne currently has focused its development efforts on two platform areas: pharmaceutical drug discovery and biofuels. In the drug discovery space, the Company is currently working to produce CBGA, the “mother cannabinoid” from which other cannabinoids are derived, along with other select downstream cannabinoids which could have potential applications as therapeutics, subject to required FDA regulatory approval and compliance. In the biofuel space, Invizyne is working to produce isobutanol, a four-carbon alcohol with a branched structure that can be used as a biofuel or as a building block to higher value downstream molecules.

Through our research and development, we believe that we have successfully demonstrated, in the laboratory setting, the feasibility of manufacturing chemicals using our SimplePath™ processes. On the basis of these achievements, we believe our processes can be scaled up to achieve commercial production capabilities. Once there is indication of proven manufacturing processes at commercial scale, for a particular chemical or set of chemicals, we believe that we will be able to enter the market to offer processes that will be able to meet the growing demand for sustainable, high-quality, chemical products.

Commercialization Strategy

Our current, primary commercialization strategy is to collaborate with third parties to engage in aspects of product research, testing, marketing, manufacturing, and product distribution. Such collaborations will involve out-licensing our technologies. We believe that using such a commercialization strategy will allow us to reduce our capital requirements and accelerate development and market acceptance and development of the SimplePath™ platform and processes. However, such a strategy will require us to locate and enter into advantageous agreements and maintain a collaboration relationship where we will likely have to continue to provide research and development and actively maintain and protect our patents and other intellectual property or obtain the use of intellectual property rights held by third parties. There is no assurance that this marketing strategy will achieve the results that we seek or that they will be maintained.

Note: Invizyne Technologies has not produced any revenue so far, according to the prospectus. Through June 30, 2024, Invizyne Technologies has received $12.74 million ($12,739,318) in U.S. government grants from the U.S. Department of Energy for work related to isobutanol and from the National Institutes of Health (NIH) for work relating to cannabinoids.

In October 2024, the company received another cost share grant of about $1 million from the U.S. Department  of Defense BioMADE initiative to help fund next steps toward cell-free biomanufacturing of isobutanol.

Note: Net loss is for the 12 months that ended June 30, 2024.

*Potential conflict of interest for the underwriter of this IPO – From the prospectus: “Because the underwriter, MDB Capital, is a wholly owned subsidiary of MDB, and MDB prior to the offering beneficially owns 62.86% of our Common Stock, there may be a conflict of interest among the Company, underwriter and MDB in conducting the offering and its terms.”

(Note: Invizyne Technologies priced its IPO at $8.00 – the assumed IPO price in the prospectus- and priced 1.875 million shares to raise $15.0 million on Tuesday night, Nov. 12, 2024. Background: The company filed to go public in February 2024.)