Item 1.01 Entry Into a Material Definitive Agreement
On July 14, 2017, the Company acquired 95% of the outstanding common stock
of Prana Therapeutics, Inc. for 5,761,500 shares of the Company's common stock.
Prana is a Delaware corporation, incorporated in 2012. Prana's flagship
product is Epidiferphane(TM), a proprietary formulation composed of three
botanical extracts that has demonstrated efficacy at preventing and treating
several conditions and disease indications, including:
o Managing the negative side effects of chemotherapy;
o Treating inflammatory diseases such as back pain and arthritis; and
o Reducing tumor progression.
Negative Side Effects Of Chemotherapy
An estimated 650,000 patients undergo chemotherapy each year, in the
US alone, at a cost of approximately $12 billion. Although, there are
several protocols to minimize the side effects associated with
chemotherapy, there is currently no protocol that prevents these
symptoms. Preclinical data have shown Epidiferphane to be effective in
preventing Anemia (low red blood cells), Neutropenia (low white blood
cells), attenuating Chemotherapy Induced Peripheral Neuropathy, and
protecting the endogenous neural stem cell population that is
associated with Chemofog (memory problems). At least one of these
conditions is experienced by 90% of patients going through
chemotherapy.
Inflammatory Disease
Approximately 150 million patients suffer from inflammation and pain
associated with arthritis and back-centric conditions, spending in
excess of $30 billion on treatments, many of which have significant
side effects. Epidiferphane(TM), in combination with nutritional
ketosis, reduces levels of cytokines that contribute to inflammatory
diseases and in a small number of patients has been reported to reduce
pain, morning stiffness and improve sleep.
Brain Tumors
There are approximately 80,000 new brain cancer diagnoses in the US
each year; Glioblastoma, the most common type, has a survival
diagnosis of approximately 12 months. In pre-clinical rodent testing,
Epidiferphane(TM), in conjunction with a nutritional ketosis, has been
shown to double the mean life expectancy, increase the effectiveness
of chemotherapy, and sensitize chemotherapy resistant tumors to
standard of care drugs.
Prana's products are not used with marijuana.
Prana's plan of operations for the next twelve months is as follows:
o File two Investigational New Drug applications with the FDA;
o Initiate a clinical trial in the United States to determine the
ability of Epidiferphane to treat the side effects of chemotherapy;
2
o Initiate a clinical trial in the United States to determine the
ability of Epidiferphane to treat back pain;
o Initiate a clinical trial in Italy for elderly patients with
inflammatory diseases such as back pain and arthritis; and
o Pursue the granting of its patents applications in the USA and
internationally.
Prana estimates that it will need approximately $500K in capital over the
next twelve months.
Prana had gross revenue of $5,593 and $2,754, respectively, for the twelve
months ended December 31, 2016 and the six months ended June 30, 2017