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STRING OF PEARLS

TregTherapeutics’ technology platform is transformative in the truest sense of the word.

There is a well-known analogy, called a “String of Pearls,” that has gained recognition within the biotech/pharma industry. It was initially introduced by a respected leader in the industry to signify a strategic management concept of focusing upon an enterprise’s clearly defined areas of therapeutic strength and then strategically deciding upon which acquisition opportunities to pursue within those confines. We use the term to describe our technology platform – a coherent “string” upon which a series of curative vaccines, or “pearls,” are connected. Each pearl is strikingly similar, but at the same time, uniquely applicable to its own therapeutic indication within the scope of autoimmune disease.

The TregTherapeutics technology platform is truly transformative in its simplicity, its elegance, and its universal application. The platform is based on an underlying mechanism of action that is a common denominator among all autoimmune diseases. The premise is that, built upon this platform, unique tolerogenic vaccines for specific autoimmune diseases can be designed to eliminate the pathological immune response associated with them and to restore homeostasis. …Healing and restoration. Furthermore, this can be accomplished without global immunological compromise. TregTherapeutics is, thus, a purveyor of pearls, each a cure for a particular autoimmune disease, strung upon the commonality of the science – a thing of beauty and a foundation for the dream that will free so many people from the scourge of autoimmune disease. Yes, this is transformative, holding forth the promise of changing the world of those suffering with a myriad of autoimmune diseases and render impotent the plague of autoimmune disease forever.

We are starting with multiple sclerosis, and although there is work ahead, the implications for treating multiple sclerosis, as well as other autoimmune conditions in humans are profound.

This technology platform contains the secret for accomplishing so much for mankind. Elegant design and function linked together in a string of pearls that will change the world. A simple concept – a simple vaccine – a worthwhile enterprise – orchestrating human response to disease.

EXECUTIVE SUMMARY

The intention of management is to transition through the preclinical path and into a Phase 1 Clinical Trial within the next 30 months. The primary work to be done consists of translating the animal formula, as developed at ECU, into a humanized formulation that can be used in preclinical studies and clinical trials. Orphan Drug Designation should substantially abbreviate the requirements for larger market commercialization and provide an efficient route to clinical usage. Once the formulation is optimized, it will be manufactured for a primate proof of concept study, involving a spontaneous MS model in non-human primates, and for other IND-enabling preclinical studies to determine first in human dose requirements. We expect to submit an IND to CBER/FDA and initiate a Phase 1 Clinical Trial in 2020 with Phase 2 trials to follow. During the Phase 2 Clinical Trial, it is the intention to partner with a pharmaceutical company that possesses the resources to move the therapy through latter stages of Phase 2, in addition to, Phase 3 trials. There are several exit points that may prove to accelerate the development and expedite market entry. All options will be considered in due course at the appropriate time.

The initial funding must be sufficient for the company to attain reasonable milestones. A pre-IND FDA meeting constitutes an achievable value-inflection target that can be met within our self-imposed 30 month timeline window. The Company is seeking to raise equity funds to finance operations and execute development objectives. Further information and term sheet are available to qualified investors.

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