Intiva Biopharma Inc. Corporate Summary
INTIVA BioPharma Inc. ("BioPharma" or “the Company”) is pursuing the formulation of cannabinoid-based drugs for
medical conditions and disorders. The Company is a wholly-owned subsidiary of U.S. publicly-held Kinder Holding Corp.
(KDRH).
BioPharma’s drug development strategy consists of:
(a) the determination of medical conditions and disorders that could potentially benefit from cannabinoid-based formulations;
(b) conducting “freedom to operate” investigations on these conditions;
(c) the preparation of patent applications and the prosecution of such application and/or the licensing of existing patents;
(d) identifying the regulatory pathway with the U.S. Food and Drug Administration (FDA); and
(e) proceeding with clinical trials under FDA protocols for submission to obtain approval for the particular product(s).
BioPharma’s strategy is to develop drugs containing cannabinoids and/or terpenes for various medical conditions and
disorders. Because of the illegality of cannabis at the federal level in the United States, the Company seeks to initially
focus its development on cannabinoids that are synthetically produced. Some of these synthetics, have been approved
by the U.S. Food and Drug Administration for various medical conditions. While plant-based cannabinoids are Schedule 1
substances under the Controlled Substances Act, synthetic Tetrahydrocannabinol (THC) is a Schedule 3 substance.
Although synthetics are still Controlled Substances, the Schedule 3 status facilitates research including trials in the
United States, and generally simplifies working with the substance. However, if the Company decides to proceed with
trials using plant-derived cannabinoids, because of the difficulty in proceeding with those trials in the United States
(given that plant-derived cannabinoids are classified as Schedule 1 substances), the Company will proceed with those
trials in a jurisdiction where that research is legal, such as Israel.
Based on Management's assessment of the nature of the Company’s anticipated business model, and the current
condition and trends of the public trading markets, Management believes that it may be in the Company’s best interests
for BioPharma stock to be publicly traded. In this regard, the Company has entered into a share exchange agreement
with a publicly-traded “shell”company, Kinder Holdings (KDRH), however, there can be no assurance that transaction will
be completed. It is anticipated that the name of Kinder Holdings will be changed to INTIVA BioPHarma Inc.
BioPharma through wholly-owned subsidiaries, is pursuing cannabinoid formulations for different applications, specific
medical conditions and/or disorders. The Company's primary reason for forming these subsidiaries is to provide
additional flexibility regarding financing. Given the significant cost of drug development, the Company anticipates that it
will need substantial additional financing, and the additional flexibility for financing its development activities on a
project-by-project basis by establishing these separate subsidiaries could be extremely helpful. As a result, the Company
would have the potential alternatives of financing its drug development activities at the BioPharma level, or by
potentially involving financial and/or strategic partners interested in a specific drug development direction at the
specific subsidiary level. In any of these situations, the Company's ability to proceed with its drug development activities
would be dependent upon its being able to obtain the requisite financing on terms that are acceptable to the Company –
and there is no assurance that this will occur.
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INTIVA? ?Kotzker? ?Pharmaceuticals? ?Inc.? ?("Kotzker")
In March 2017, Kotzker licensed certain intellectual property developed by Dr. Joseph Morgan of Kotzker Consulting. The
intellectual property includes patent applications relating to the use of cannabinoid receptor modulators and terpenes in
the acute treatment during exposure to organophosphorus nerve agents and/or organophosphorus insecticides.
BioPharma has completed and submitted a Pre-Investigational New Drug meeting request with the FDA, with the
objective of scheduling a meeting with the FDA in Washington in the near future to discuss its proposed formulations
and project development program.
Because of the implications of a nerve agent drug candidate for homeland defense, first responders and military
applications, BioPharma also may seek government grants for funding the pre-clinical or clinical trials for this drug
candidate. The Company has not investigated the existence or availability of any such grants, and there is no indication
or assurance that the Company will be able to obtain a grant of this nature.
INTIVA? ?Sharir? ?Inc.? ?("Sharir")
In February 2017, a provisional U.S. patent application was filed on behalf of BioPharma (and subsequently for the
benefit of Sharir) relating to the use of cannabinoids and/or terpenes to treat myotonic and muscular diseases such as
dystrophia diseases. The patent application relates to methods and compositions for treating such diseases with the use
of cannabinoids. The patent application covers the administration of the product(s) by such delivery systems as topical,
oral, nasal, inhalation or a combination thereof.
We believe that a cannabinoid-based formulation could be beneficial to treat the symptoms of the muscular disorders,
and are hopeful that the regulatory pathway to treat the muscular disorders will be as expeditious as possible.
Muscular dystrophy is a general term that describes a group of genetic muscular diseases wherein muscles weaken and
break down over time without the involvement of the nervous system. Some of the more common types of muscular
dystrophy include:
(i) Duchenne Muscular Dystrophy, which is the most common form of muscular dystrophy that begins in early
childhood and is characterized by increasing weakness in the pelvic and shoulder girdles that eventually leads to
respiratory and heart failure;
(ii) Becker Muscular Dystrophy, which is a less severe form of, and has a later patient onset and progression,
than Duchenne Muscular Dystrophy;
(iii) Emery-Dreifus Muscular Dystrophy, which begins early in a patient’s life and is characterized by a slowly
progressing weakening of the upper arm and pelvic girdle, but the muscles are not hypertrophied;
(iv) Facioscapulohumeral Muscular Dystrophy, which is a relatively benign form of muscular dystrophy, whereby
muscle atrophy of the face, shoulder girdle and arm occurs;
(v) Limb-Girdle Muscular Dystrophy, which is a slowly progressing form of muscular dystrophy that may affect
either males or females, and is characterized by a weakening or wasting of the pelvic or shoulder girdles;
(vi) Myotonic Muscular Dystrophy, which is a rare, slowly progressing form of muscular dystrophy that is
characterized by myotonia and followed by muscle atrophy of the face and neck, cataracts, hypogonadism,
frontal balding and cardiac abnormalities; and
(vii) Oculopharyngeal Muscular Dystrophy, which is characterized by adult onset and weakening of the external
ocular and pharyngeal muscles which causes ptosis, ophthalmoplegia and dysphagia.
There are currently no known cures for muscular dystrophy, however, various drugs have been developed and
administered to help manage various symptoms. The U.S. Food and Drug Administration (FDA) pathway for the
September 2017 - Page 2
development of drugs for many of these genetic muscular diseases fall under the Orphan Drug Act of 1983, which was
passed to facilitate the development of orphan drugs.
Other? ?Provisional? ?Patent? ?Applications
In June/July 2017, BioPharma filed the following provisional U.S. patent applications with the United States Patent
Office:
? A provisional U.S. patent application for methods and compositions for treating lipidosis with cannabinoids
and/or terpenes. ?The patent application methods involve the administration of a drug comprising one or more
cannabinoids and/or terpenes.
Examples of lipidosis conditions include:
(i) Gaucher’s Disease;
(ii) Neimann-Pick Disease;
(iii) Fabry’s Disease;
(iv) Wolman’s Disease;
(v) van Bogaert’s Disease;
(vi) Generalized (GM1) Ganliosidosis;
(vii) Tay-Sachs Disease;
(viii) Sultatide Lipidosis; and
(ix) Krabbe’s Disease.
Lipidoses are genetic disorders, passed from parents to their children, characterized by defects of the digestive
system that impair the way the body uses dietary fat. When the body is unable to properly digest fats, lipids
accumulate in body tissues in abnormal amounts.
There is great variance in the symptoms, available treatments, and long-term consequences of these conditions.
Some of the conditions become apparent shortly after the infant is born. In other lipid disorders, symptoms may
not develop until adulthood. For most of the lipidoses, diagnosis is suspected based on symptoms and family
history. There are many different symptoms that accompany these disorders, some of which include chronic
pain, in the palms, soles and abdomen, edema of the legs, osteoporosis, rigidity that lead to tonic seizures and
convulsions. Tests of blood, urine, and tissue can be used to confirm the diagnosis. Genetic testing can be used,
in some cases, to identify the defective gene. Some of these disorders can be controlled with changes in the
diet, medications, or enzyme supplements. However, for many of these diseases, no treatment is available.
Some may cause death in childhood or contribute to a shortened life expectancy.
Lipidoses are very rare. The number of people affected depends on the specific disease, but for many diseases
incidence is as little as one in 40,000 people. Some of these diseases have a higher prevalence in specific
populations. Many are pediatric diseases or have a pediatric form. The U.S. Food and Drug Administration (FDA)
pathway for the development of drugs for many of these lipidoses fall under the Orphan Drug Act of 1983, which
was passed to facilitate the development of orphan drugs.
? A provisional U.S. patent application for methods and compositions for treating lipofuscinosis, in particular
neural ceroid lipofuscinosis and macular degeneration associated with lipofuscinosis, with cannabinoids
and/or terpenes. The methods consist of the administration of a drug comprising of one or more cannabinoids
and/or one or more terpenes. The patent application methods consist of the administration of a drug comprising
one or more cannabinoids and/or one or more terpenes.
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Lipofuscinosis is any disorder associated with the abnormal storage of lipofuscins. Lipofuscins is a yellow to
brownish pigment granule found in the muscle, heart, liver, kidney, adrenal, retina and nerve cells undergoing
slow regressive changes and accumulating in lysomes with age. Lipofuscin is the product of oxidation and
polymerization of the membrane lipids of autophagocytosed organelles.
Lipofuscin accumulation is believed to be a major risk factor in macular degeneration and Stargardt disease,
which is an inherited juvenile form of macular degeneration. Abnormal accumulation of lipofuscin in the nerve
cells can result in neurodegenerative disorders, referred to as neuronal ceroid lipofuscinoses (NCLs).
NCLs collectively are often referred to as Batten disease.
There are five main types of NCLs:
? Congenital NCL is a rare and severe form of NCL that appears in newborns. Infants with congenital NCL
have abnormally small heads, experience seizures and typically die shortly after birth;
? Infantile NCL, also known as Santavuori-Haltia disease appears between 6 months and 2 years of age
and infants with the disease have abnormally small heads and experience myoclonic jerks or sharp
muscle spasms. Most children with infantile NCL die before the age of 5.
? Late Infantile NCL, also known as Jansky-Bielschowsky disease appears between 2 to 4 years of age and
infants with the disease lose muscle coordination and experience seizures. Most children with late
infantile NCL die by age 12.
? Juvenile NCL, also known as Spielmeyer-Vogt-Sjogren-Batten disease or Batten disease appears in
children between 5 to 10 years of age and children with the disease develop vision problems and/or
seizures. As the disease progresses the children lose sight, the seizures increase and cognitive and motor
skills become impaired. Children with juvenile NCL die in their late teens or early twenties.
? Adult NCL, also known as Kufs disease or Parry’s disease appears in adults typically before the age of 40
years old and exhibit similar symptoms to the other forms of NCL but the symptoms are usually milder
and progress at a much slower rate.
The U.S. Food and Drug Administration (FDA) pathway for the development of drugs for many of these forms of
Lipofuscinosis fall under the Orphan Drug Act of 1983, which was passed to facilitate the development of orphan
drugs.
? A provisional U.S. patent application for methods and compositions for treating restless legs syndrome with
cannabinoids and/or terpenes. ?The patent application methods involve the administration of a drug comprising
a cannabinoid and/or a terpene.
Restless leg syndrome (RLS) otherwise known as Willis-Ekbom Disease and Wittmaack-Ekbom Syndrome is a
term used to describe a neurological sensory disorder that also interferes with sleep and is thus also considered
a sleep disorder.
The symptoms of RLS include the compelling, irresistible, or uncontrollable urge to move, restlessness, and
abnormal, unpleasant, or uncomfortable sensations in the limbs or the skin of the feet, legs, arms, or elsewhere
which include pain, aching, throbbing, pulling, itching, crawling, creeping, burning, jerking, fidgety, antsy,
electrical, pins and needles, buzzing, and twitching. The movements may be persistent, repetitive, periodic, or
intermittent with symptoms
? A provisional U.S. patent application for method and compositions for sexual health with cannabinoids and/or
terpenes.? ? ?Sexual health is a major topic of discussion and research because it affects both males and females.
Sexual health issues, sometimes termed sexual dysfunction, may be the result of organic issues, psychological
issues or a combination of both. Examples of organic issues include vascular diseases, such as those associated
with hypertension or diabetes mellitus, prescription medication, and/or by psychiatric disease such as
depression. Examples of psychological factors include fear, performance anxiety and interpersonal conflict.
September 2017 - Page 4
Sexual health issues and sexual dysfunction issues in particular may impair sexual performance, diminish
self-esteem and disrupt personal relationships thereby inducing personal distress.
Male sexual health issues or dysfunction issues include male erectile dysfunction, ejaculatory disorders, such as
premature ejaculation, anorgasmia (inability to achieve orgasm) and desire disorders such as hypoactive sexual
desire disorder (lack of interest in sex)Female sexual health issues or dysfunction issues can be defined as the
difficulty or inability of a woman to find satisfaction in sexual expression. The Diagnostic and StatisticaManual of
Mental Disorders identifies three categories of female sexual health issues or dysfunction issues: (1) genitopelvic
pain/penetration disorder; (2) sexual interest/arousal disorder; and (3) female orgasmic disorder.
Officers,? ?Directors,? ?and? ?Members? ?of? ?the? ?Advisory? ?Board
Bios of officers, directors and members of the Company’s advisory board can be viewed at:
www.intivabiopharma.com/management
Company? ?Contacts
Jeffrey Friedland, Chief Executive Officer
Tel. 646 450 8909
Email jeffrey@intiva.us
Alain Bankier, Chief Strategy Officer
Tel. 646-251-2511
Email abankier@gmail.com
Disclosure? ?and? ?Forward-Looking? ?Statements
This summary is not an offer to sell any securities. Offers can be only be made to accredited investors in jurisdictions where the offer
or sale can legally be made.
This summary contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995.
For this purpose, any statements contained herein or which are otherwise made by or on behalf of the Company that are not
statements of historical facts may be deemed forward-looking statements. Without limiting the generality of the foregoing, words
such as “may,” “will,” “to,” “plan,” “expect,” “believe,” “anticipate,” “intend,” “could,” “should,” “would,” “estimate,” or “continue,”
or the negative or other variations thereof or comparable terminology are intended to identify forward-looking statements.
Shareholders are cautioned that all forward-looking statements involve risk and uncertainties which may cause results to differ
materially from those set forth in the statements. Such risks and uncertainties include, but are not limited to the following: the
success of research and development activities and the speed with which regulatory authorizations and product launches may be
achieved; government regulation generally; competitive developments; the ability to successfully market products domestically and
internationally; difficulties or delays in manufacturing or issues relating to manufacturing capacity; commercial obstacles to the
successful introduction of brand products generally; legal defense costs, insurance expenses, settlement costs, and the risk of an
adverse decision or settlement relating to product liability, patent protection, governmental investigations, and other legal
proceedings; the Company’s ability to acquire and protect patents and other intellectual property both domestically and
internationally; the absence of certainty regarding the receipt of required regulatory approval or the timing, costs, or terms of such
approvals; any changes in business, political and economic conditions; business interruption due to hurricanes or other events
outside of the Company’s control; and the Company's access to and receipt of sufficient capital to be able to pursue its business and
business objectives.
Readers are cautioned not to place reliance on these forward-looking statements, which are valid only as of the date they were
made. The Company undertakes no obligation to update or revise any forward-looking statements to reflect new information or the
occurrence of unanticipated events or otherwise, except as expressly required by law.
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