Parkinson's business plan team three

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PhiNeTiCS
Bringing Movement Back
Shubhda Roy
Business Plan

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Table of Contents
I. Executive Summary................................................................................................................................................3
a. Mission......................................................................................................................................................................3
b. Unmet Clinical Need.........................................................................................................................................5
II. Products........................................................................................................................................................................6
a. Parkinson’s Overview......................................................................................................................................6
b. Patents......................................................................................................................................................................8
c. PKS1 antibody......................................................................................................................................................9
d. LDT and IVD for quantitative determination of PKS1.............................................................10
e. PKS1 Compound..............................................................................................................................................13
III. Market.......................................................................................................................................................................15
a. Market Opportunity.......................................................................................................................................15
b. Business Model.................................................................................................................................................16
c. Competitive Landscape................................................................................................................................19
d. Evaluation of the Industry.........................................................................................................................20
e. Marketing and Sales Plan...........................................................................................................................20
f. Competitive Advantage ................................................................................................................................21
g. Marketing Communication Plan ............................................................................................................21
IV. Production..............................................................................................................................................................24
a. Diagnostic Production Process Overview for PARK ELISA...............................................24
b. Employees and Subcontractors.........................................................................................................28
d. GMP/QSR Compliance .............................................................................................................................30
e. Regulatory and Clinical Strategy.......................................................................................................30
V Risk Factors..............................................................................................................................................................30
a. Risks Related to the Intellectual Property ..................................................................................31
b. Technical Risks.............................................................................................................................................32
c. Commercial Risks .......................................................................................................................................32
d. Compliance/Regulatory Affair Risks..............................................................................................33
e. Pharmaceutical Development Risks.....................................................................................................33
VI The Financial Plan...............................................................................................................................................33
a. Reimbursement...........................................................................................................................................33
b. ASR Labeled PKSA Antibody................................................................................................................34
c. LDT an and IVD-cleared PARK ELISA Kit.....................................................................................35
d. Desired Financing.......................................................................................................................................37
e. Use of Funds...................................................................................................................................................37
f. Exit Strategy...................................................................................................................................................37

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I. Executive Summary
a. Mission
PhINeTiCs is a start-up company focused on the development and commercialization of an
in vitro diagnostic used to diagnose and treat unmet clinical need associated with
Parkinson’s disease (PD). PD is the second most progressive neurodegenerative disorder in
the United States and worldwide.
Our mission is to assist physicians in diagnosing and treating PD as well as providing
diagnosed patients with additional, more effective treatment options. It would also be in our
best interest to create a partnership with a large research hospital(s) to create an LDT as a
joint venture. We would still hold the patent, and the other partner would continue with
research and development with the PKS1 biomarker. Currently, the only treatments
available are ones that decrease the severity of symptoms; there is no real cure due to the
late detection of the disease.
By developing novel diagnostic using PKS1 protein as a biomarker, we hope to expand our
market in the field of PD and reach patients who previously had few or no diagnostic
options available. In addition, we also hope that these innovative technological advances
will enable an earlier diagnosis of PD. We would also use the aforementioned joint venture
route as an exit strategy if the commercialization and marketing of our IVD was not as
successful as we would have liked.
This would also be a good strategy to use if it was realized later on that the correlation of
PKS1 biomarker and Parkinson’s is not as strong or as prevalent as originally thought. We
are a new, emerging biotechnology company that is looking to develop and commercialize
in vitro diagnostics that will assist in improving the quality of life of people suffering from
Parkinson’s Disease through early detection and treatment.

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Following are general guiding principles for the evolution of PhINeTiCs PKS1 Biomarker
Antibody from a Patent to a full-fledged Diagnostic Kit.
Commercialization of the Parkinson's assay will begin in the North East region of the United
States at the Mayo Clinic and Cleveland Clinic. These clinics are located where Parkinson's
disease has a higher prevalence, which we believe will lead to better patient recruitment.
Additionally, working with such prestigious clinics will help build credibility among key opinion
leaders. The agreement at these sites will occur over approximately 1-2 years.
Once the initial validation step is completed, we will then extend our reach across the entire
United States by partnering with LabCorp (or equivalent lab). After the validity of our test has
been confirmed, the test will then be submitted via de novo 510(k) submission to be cleared
for approval. We believe this will be classified as a Class II device based upon confirmation that
the PKS1 gene is linked to Parkinson's and through our validation testing. The intended use of
our device will not include treatment decision making (to treat or not to treat with a specific
drug). The package inserts for the diagnostic kit will be open label used as a screening tool for
for patients above 50 who are symptomatic. But the Marketing will be further targeted
towards the agricultural and Manufacturing industry where workers are exposed to toxins
found to increase the chances of developing Parkinson's.
MAYO & Cleveland Clinic develop LDT to dignose Parkinson’s using
PhiNeTiCS PKS1 Antibody Patent
PhiNeTiCS gets FDA Approval 510(k)– denovo for IVD Diagnostic Kitfor
detecting Parkinson disease
Maine BiotechnologyServices Manufacture IVD Diagnostic Kit for
PhiNeTiCS
Labcorp Commericialise Diagnostic Kit for PhiNeTiCS
Park Elisa Diagnostic Kitis available nationallyin USA by PhiNeTiCS

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The graph is a prediction of the future revenue generated over 10 years for PhINeTiCs for
selling the PARK ELISA Diagnostic Kit.
b. Unmet Clinical Need
The current diagnosis and treatment of Parkinson’s is slow and very tedious. Parkinson’s is
extremely hard to diagnose, and when it finally can be diagnosed, it is usually too late for
effective treatment. To diagnose PD, a neurologist will examine a patient’s medical history
and symptoms and if they find the appropriate indicators, will perform a neurological
examination. If the neurologist feels that the patient may have PD, the drug carbidopa-
levodopa may be administered. If after administering this drug product, there is significant
symptom improvement, this usually indicates that the patient is suffering from PD.
Some of the current treatment options include dopamine antagonists and monoamine
oxidase-B (MAO-B) inhibitors. Almost all available treatments are focused on alteration of
the dopaminergic pathways. While modification therapy, using neuroprotective molecules,
would be ideal as a treatment, there is no current proven efficacy. A neuroprotective agent’s
main function is to either slow, block or reverse disease progression; the monoclonal
antibody specific to the PKS1 protein has been considered a potential new class of neuro
protective agents that could satisfy the large unmet need for the treatment of PD.

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Early detection is key to helping fight this devastating disease. While there are treatments to
help mitigate symptoms, managing these symptoms is currently the only option. Therefore,
since detection is often too late to be useful for treatment, early detection via the PKS1
biomarker, both as a quantitative measure and predictive tool for early diagnosis, is a way to
address the unmet clinical need of PD.
PhINeTiCs ultimate goal is to fulfill the aforementioned unmet clinical need, specifically
the need to diagnose Parkinson’s Disease early enough that effective treatment may be
possible. By providing an effective IVD, earlier diagnosis of PD can be performed by
quantitatively measuring levels of the PKS1 protein in blood plasma. Our products and
novel methods will fulfill this unmet need to optimize early diagnosis and treatment options.
The use of MALDI-MS, matrix assisted laser desorption ionization mass spectrometry, or
ELISA assay with antibodies specific to PKS1 would provide results to determine whether a
patient can be diagnosed with PD. Along with an IVD, the identification of the PKS1
biomarker opens the doors for many potential targeted therapies.
II. Products
a. Parkinson’s Overview
Parkinson’s disease is a progressive neurodegenerative disorder that affects movement of
the body. The first signs of Parkinson’s usually start around the age of 50 and can be found
by a general practitioner, internist or neurologist. These specialists perform a neurological
and physical examination of the patient, since there are currently no diagnostic tests
specifically for Parkinson’s. The disease develops gradually, starting with a slight tremor or
balance issue and progressing to uncontrollable spasms or movements. Although there is no
cure, there are some treatments that can help to decrease the severity of the aforementioned
symptoms. The overall cause of PD is unknown, but it has been determined that elevated
levels of PKS1 protein in the blood have shown a correlation with the development and its
onset.
Diagnosis heavily relies on the presence of symptoms categorized into primary motor
symptoms, secondary motor symptoms and nonmotor symptoms. Every patient’s symptoms

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will vary based on the progression and severity of the disease. The four most common types
of primary motor symptoms are resting tremor, bradykinesia, rigidity and postural
instability. Resting tremors refer to slight tremors in the hands, feet, jaw, face or overall one
side of the body when the muscles are relaxed. About 70% of people experience these
shaking movements in the early stages of the disease. Bradykinesia is a decrease in
spontaneous movements of the body. To others, this symptom can look like abnormal
stillness or decreased facial activity. Bradykinesia can also affect a person’s ability to speak
properly, their walking abilities and everyday activities, such as cutting food or brushing
their teeth. Rigidity has been known to cause stiffness and inflexibility of the neck, arms
and legs. This can greatly reduce the person’s range of motion and cause pain and
discomfort. Postural instability is one of, if not the most, important indicators of Parkinson’s
disease. It can cause improper and poor posture, swaying and falling backwards from
moving too quickly.
Secondary motor symptoms include freezing of gait, shrinkage in handwriting, face
appearing less expressive and unwanted accelerations in movement. Nonmotor symptoms
include loss of smell, sleep disorders, mood disorders, low blood pressure when standing up,
excessive saliva, fatigue, depression, skin problems and bladder problems as well as many
others. These symptoms and the ones mentioned in the above paragraph can be seen in
other diseases/conditions such as strokes or hydrocephalus, but these can be eliminated as
possibilities through additional testings.
There are nearly one million Americans that have been diagnosed and are living with
Parkinson’s; approximately 60,000 Americans are diagnosed every year. On a larger scale,
there are anywhere from seven to ten million people living with Parkinson’s worldwide.
The number of people diagnosed with Parkinson’s disease tends to increase in those over
the age 50. Only approximately four percent of people are diagnosed prior to age 50. Men
are also 1.5 times more likely to acquire Parkinson’s than women.
Due to the complex and unknown nature of the disease, diagnosing Parkinson’s is incredibly
difficult. All treatments currently focus on the alteration of the deteriorating dopaminergic
pathway. Symptoms are said to develop when there is not enough dopamine in the brain.
Levodopa is an injectable synthesized molecule that is considered to be the precursor to
naturally occurring dopamine. Once this drug has crossed the blood/brain barrier, it can be

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converted into and replace the lost dopamine. Carbidopa is another molecule found in the
brain that can be synthesized and injected into the body to prevent the breakdown of
Levodopa. The combination of injecting these two synthesized molecules as a treatment
option is currently the best way to alleviate short-term motor symptoms. Unfortunately, in
the long run, the use of this combination treatment can be associated with the development
of dyskinesia, or involuntary muscle movements. Another treatment option currently
available to reduce symptoms are MAO-B inhibitors, such as Selegiline and Rasagiline.
MAO-B is an enzyme located in the brain that naturally breaks down dopamine. Inhibitors
of these enzymes prevent dopamine breakdown, allowing it to accumulate and decrease the
severity of several motor symptoms. Eventually the positive effects from the previous drug
treatments will begin to fade. At this point a final treatment, deep brain stimulation, can be
considered to alleviate the symptoms, but the positive effects of this will also fade after
time.
The protein biomarker, PKS1, has the potential to aid in earlier diagnosis and potential
treatment, in turn, increasing life expectancy of those diagnosed with PD. Many studies
have been performed to confirm that PKS1 is involved with dopamine regulation, the key
aspect of developing PD. Using a blood sampling technique, a sample is collected for
biomarker testing and analysis. If levels are elevated, this signifies a high possibility that
the patient is at risk or has already developed PD. Being able to detect this increased
concentration of PKS1 in the blood would enable an earlier diagnosis since it is a fairly
simple, non-invasive technique. The identification of this biomarker also opens the doors
for many potential targeted therapies.
b. Patents
The intellectual property described in United States Patent Application 8,675,309 and
products derived are essential in developing and commercializing innovative products.
Patents are actively facilitating and contributing to upstream and downstream
biotechnology activities in both developed and developing countries.

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Both mature and also also major emerging economies are making growing use of the patent
system to facilitate biotechnology research and commercialization. Intellectual property
rights have encouraged collaboration and partnerships between biotechnological entities
and enabled further research and development of new biotechnologies. [i]
PhINeTiCs intellectual property includes the novel use of PKS1 protein in the diagnosing,
screening, and treatment of Parkinson’s disease. The invention also provides an antibody
composition this is immunospecific for PKS1 and interacts with or modulates the expression
of PKS1.
[i] https://www.bio.org/articles/taking-stock-how-global-biotechnology-benefits-intellectual-property-rights
c. PKS1 antibody
The invention provides an antibody composition that is immunospecific for PKS1 and
interacts with or modulates the expression of PKS1. The monoclonal antibody specific to
PKS1 protein (PKS1AB) was created by first isolating pure PKS1 protein from bacteria and
subsequently isolating the polyclonal antibody from rabbit plasma. The PKS1 gene was
incorporated into the Thermo Scientific T7 vector and a transformation was performed using
bacteria model for the uptake of the gene and to produce the PKS1 protein. The isolated and
purified PKS1 protein is then introduced into a rabbit as an antigen. The rabbit is given a
booster of PKS1 3 months post-infection and the PKS1-specific antibodies are then isolated
and purified 7 months post-infection.
Another way to isolate and purify the antibody is through the use of hybridomas. By fusing
an PKS1-producing B-cell from the infected rabbit with a cancer myeloma, one can create
an immortal hybridoma that produces PKS1-specific antibodies. After they have been
isolated and purified, these PKS1-specific antibodies can be used in an ELISA to detect
PKS1 levels in a human sample. hINeTiCs’ tested the PKS1AB to PKS1 in two mouse

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models for Parkinson's disease (JAX® Mice Strains; 006582 and 009090). In each case the
antibody reduced the PD symptoms. PKS1AB has the potential to be used as a therapeutic
agent for Parkinson’s in humans.
d. LDT and IVD for quantitative determination of PKS1
The PKS1 protein has been identified as a key protein biomarker for Parkinson’s disease,
and elevated levels of the PKS1 protein in blood plasma has been correlated with the
development and onset of Parkinson’s disease. PKS1 levels can be quantitatively measured
as an LDT using MALDI-MS, matrix assisted laser desorption ionization mass
spectrometry, or as an IVD using an ELISA assay with antibodies specific to PKS1.
Using elevated levels of PKS1 to diagnose Parkinson’s disease is of particular importance as
it can be used to routinely test patients who may be at risk of developing Parkinson’s disease
- after exposure to chemicals linked to Parkinson’s onset, those with family history of
Parkinson’s disease, or as a standard routine evaluation. Furthermore, measuring the levels
of PKS1 can be used to observe a patient’s response to treatment.
Matrix-assisted laser desorption/ionization (MALDI) is a soft ionization technique used in
mass spectrometry, allowing the analysis of bio-molecules, which tend to be fragile and
fragment when ionized by more conventional ionization methods. The MALDI is a two step
process. Matrix material heavily absorbs UV laser light, leading to the ablation of upper
layer (~micron) of the matrix material. A hot plume produced during the ablation contains
many species: neutral and ionized matrix molecules, protonated and deprotonated matrix
molecules, matrix clusters and nanodroplets. The second step is ionization (more accurately
protonation or deprotonation). Protonation/deprotonation of analyte molecules takes place in
the hot plume. Some of the ablated species participate in protonation/deprotonation of
analyte molecules.
The recent advancement in technology for mass spectrometry-based targeted protein
quantification has opened new avenues for a broad range of proteomic applications in
clinical research. The major breakthroughs are highlighted by the capability of using a
“universal” approach to perform quantitative assays for a wide spectrum of proteins with

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minimum restrictions and the ease of assembling multiplex detections in a single
measurement. The quantitative approach relies on the use of synthetic stable isotope labeled
peptides or proteins, which precisely mimic their endogenous counterparts and act as
internal standards to quantify the corresponding candidate proteins. Mass spectrometry
provides approach, can precisely detect a wide variety a peptides/proteins via high mass
accuracy and/or peptide sequencing. This approach provides high selectivity and specificity,
and technically avoids most of the problems associated with optimization of multiple assays
in a single measurement. In addition, the mass spectrometry based technique has a unique
capability to perform candidate-based proteome browsing and measure absolute levels of
post-translational modifications (PTMs). MALDI-MS is a platform technology for
emerging applications of clinical proteomics and biomarker development.
MALDI-MS was used in targeted protein quantification. Blood plasma from patients with
confirmed Parkinson’s disease was analyzed by MALDI-MS and compared to blood plasma
from “normal” patients. The level of PKS1 in Parkinson’s disease patients was on average
50 times the normal concentration.

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Enzyme-linked immunosorbent assay (ELISA) is a molecular biology technique commonly
used to determine the presence of or to quantify the amount of a protein or antibody. As an
alternative method to MALDI-MS, PhINeTiCs’ constructed a “Sandwich” ELISA to
measure blood plasma levels of PKS1 protein. Using an enzyme-conjugated secondary
antibody can increase the sensitivity of an ELISA. Substrates are added to an ELISA to
produce a color change that is proportional to the amount of enzyme in the well (and by
association, the amount of PKS1, primary antibody, and secondary antibody. [ii]

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Specifically in this case, an ELISA was used to clinically quantify PKS1 protein levels from
human blood plasma samples against MALDI-MS results. Using ELISA, PhINeTiCs
achieved a clinical sensitivity of 95% in detecting blood plasma PKS1 levels that were more
than 2x normal concentration and 99% sensitivity at 3x normal concentration.
PhINeTiCs is going to be focusing on ELISA as part of this business plan.
MALDI-MS is going to be used for future growth.
[ii] http://en.wikipedia.org/wiki/ELISA#
e. PKS1 Compound
There are currently no biomarkers which can be used to diagnose Parkinson’s disease.
However, the PKS1 protein has been identified as a key protein biomarker for Parkinson’s
disease, and elevated levels of the PKS1 protein in blood plasma has been correlated with
the development and onset of Parkinson’s disease.
While the primary role of PKS1’s involvement in Parkinson’s disease development is not
fully understood at this time, research in mice indicated that PKS1 is linked in dopamine re-

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uptake. PKS1 production may also increase as a response to toxin exposure in the brain. In
the mouse model, low levels PKS1 was shown to down-regulate dopamine transport (DAT)
function, while high levels of PKS1 have shown to up-regulate DAT function. DAT is
responsible for removing dopamine from the neural synapse.
When DAT’s functionality is blocked the synapse becomes flooded with dopamine, and
vice versa. PKS1 production may increase with the response to specific toxins as a result of
a genetic mutation, or it may accumulate through the loss of ability of the neurons to
reabsorb and breakdown the protein through some currently unknown mechanism.
Normal levels of PKS1 protein in human blood plasma was determined experimentally to be
10 +/- 5 units. Increased levels of PKS1 protein may be a result of the protein
overproduction by the brain in a response to either selective toxin exposure, an increase of
dopamine, inability to reabsorb and breakdown PKS1, or some other mechanism yet to be
determined.
PKS1 levels in the blood plasma of Parkinson’s patients average 523 +/- 135 units, and it
will remain at this level throughout a Parkinson’s patient’s life. The PKS1 biomarker can be

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measured and differentiate patients with onset of the disease up to 2 years prior to physical
manifestation of symptoms, as levels of PKS1 in the blood plasma increase over this period.
The PKS1 protein is a product of a single gene in humans designated as DNA Homo
sapiens. The PKS1 gene for encoding PKS1 protein is located on chromosome 5q near
marker D5S816. PKS1 protein constitutes a single form with 270 amino acids, protein
sequence Home sapiens.
The PKS1 gene has one haplogroup, H1, and there is only one form noted in all ethnicities.
Gene mapping was performed using polymerase chain reaction (PCR). From liquid
chromatography – mass spectroscopy (LC-MS), BIOJH was able to determine PKS1’s
molecular weight of 89.43 KD.
III. Market
a. MarketOpportunity
Parkinson’s disease is a neurodegenerative movement disorder that progresses over time.
The malfunction and death of crucial neurons in the brain causes this disease. Specifically,
it affects an area of the brain known as substantia nigra. The dying neurons send chemical
signals in the form of dopamine to a section of the brain controlling coordination and
movement. With the condition worsening, less dopamine is produced, therefore, affecting a
person’s movement and coordination making it uncontrollable.
Even though much research has been done with Parkinson’s to determine the cause, it still
remains unknown. As many as one million Americans live with Parkinson's disease, with
approximately 60,000 diagnosed each year. From what researchers know, they believe it is a
combination of genetic and environmental factors. Age has been identified as one the
biggest risk factors as there is a 2-4% risk of people over 60 developing Parkinson’s
compared to 1-2% of the general population. Approximately 15-25% of people who
develop Parkinson’s have a relative with the disease. Several gene mutations have been
determined to directly cause Parkinson’s. However, these only affect a small population of
families. Most of these genes, PINK1, LRRK2 and DJ-1, are involved in dopamine
regulation pathways.

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Additionally, environmental factors such as toxins or injury may play a role in the
development of this disease. Research performed indicates that rural living, well water,
manganese and pesticide/insecticide/herbicide exposure. A synthetic neurotoxin, MPTP is
also known to cause immediate Parkinson symptoms. Other potential environmental risk
factors include area of residence, occupation, pesticide exposure, exposure to metals and
solvents/polychlorinated biphenyls (PCBs).
There are areas in the Midwest and in Northeast known as the Parkinson’s belt where this
disease is much more prevalent. Occupations in the manufacturing industry specifically for
miners, agricultural workers and welders there is a higher risk due to their jobs and the
exposure that comes along with it. It has also been shown that toxins, in general, can inhibit
the mechanism of tyrosine hydroxylation, which is extremely important for the formation of
dopamine. Exposure to any of these toxins appears to have a great affect on the onset and
development of Parkinson’s disease.
The target potential for a novel diagnostic test for Parkinson’s would encompass most, if not
all, of the those with the aforementioned risk factors. This would include anyone over the
age of 50, those located in the Parkinson’s belt, people with a family history of genetic
mutations causing Parkinson’s and careers that lead to exposure of hazardous metals,
pesticides, insecticides and other toxins. With this in mind, the target market will be anyone
over the age of fifty with a family history of Parkinson’s, anyone over the age of fifty who
has worked in an industry where they have been exposed to harmful toxins for greater than
two years, anyone under the age of fifty who has worked in an industry where they have
been exposed to harmful toxins for greater than two years and display symptoms of
Parkinson’s disease. Men and women that work in the agricultural, mining, metallurgy, or
manufacturing or any industries are at a higher risk of being exposed to toxins such as lead,
mercury, copper, cyanide, manganese, herbicides, pesticides, insecticides and specific
chemicals like Paraquat, Rotenone, Maneb, Toluene MPTP, N-hexane, Carbon Disulfide,
Carbon Monoxide and Trichloroethylene.
b. Business Model
Currently there is no well-established bio-marker present to reliably diagnose Parkinson’s.
The prognosis of PD is challenging, complex and lengthy. The neurologist uses a

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combination of diagnostic methods spread over months, including multiple doctor’s visits to
make a prognosis. This includes patient’s medical history, four specific motor movements,
PET and DAT scans, United Parkinson’s Disease Rating Scale and detailed neurological
examination. Clinical diagnosis is finally confirmed based on significant improvement in
symptoms in response to medication. Even after such elaborate testing, the diagnosis is
error-prone. It is estimated that 30 percent or more of patients are misdiagnosed. This costs
time, money and stress.
PD is mostly identified via abnormal motor symptoms, showing in a person. By this time 60
percent of all dopamine neurons within specific regions of the basal ganglia may have been
lost. Though there is no cure for Parkinson, early detection helps in quicker treatment, slows
the progression of the disease, improves patient’s quality of life and cuts costs used for
diagnosis and treatment. PhINeTiCs PARK- Eliza test can accomplish quick results, helping
patients receive treatments, sooner and improving the quality of their lives.
PhINeTiCs will partner with Mayo and Cleveland clinic to develop a Laboratory Diagnostic
Kit. In the mean-while, PhINeTiCs will apply for a 510(k) de-novo approval for an IVD as a
level (II) device with the FDA. On receiving FDA clearance for PARK Elisa as a diagnostic
kit, PhINeTiCs will work with “Maine Biotechnology Services” to manufacture the kit.[3]
[3] http://www.mainebiotechnology.com/
Mayo and Cleveland clinic will enter into a contractual agreement to only use the LDT on
patients till the IVD is commercially available. Once the Diagnostic kit is available,
PhINeTiCs in collaboration with LabsCorp will sell and commercialize the drug
nationwide.
Special focus will be on the north east and mid-west region which is considered the
Parkinson’s belt.[3] The occurrence of PD is higher in this geographical region due to
environmental factors like exposure to toxins in the manufacturing, agricultural and mining
industry. PhINeTiCs will partner up with industries with higher chances of toxin exposure,
to include PD diagnostic test as part of their annual health care screening.

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LabsCorp has 1700 locations [4] nationwide to provide convenient access to high-quality
laboratory testing services. LabsCorp has a network of 29 primary clinical laboratories and
seven specialty laboratories, accredited by the College of American Pathologists (CAP) and
licensed through the Clinical Laboratory Improvement Amendment (CLIA). There will
1,600 LabsCorp facilities, along with mini clinics in Walgreens, CVS Pharmacy, Rite Aid,
Physician office, Urgent Clinics for convenient specimen collection.
PD is linked with a major economic burden to both patients and society. With
disease progression, other causes of disability, such as cognitive decline, dysphagia, and
incontinence lead to further caregiver and financial burden.
Over [5] an 8-year span from 1992 to 2000, Medicare beneficiaries with PD used more
healthcare services in all categories and had more out-of-pocket expenses than those without
Parkinson’s.
Parkinson’s disease -related loss of productivity accounts for 30% to 40% of major direct
costs.[6] There was a comparison done for direct and indirect expenditures for patients with
[3]. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2865395/
[4]. https://www.Labcorp.com/wps/portal/patient
[5]. http://www.ajmc.com/publications/supplement/2012/408_12sep_parkinsons/a408_12sep_boland_s168to75
[6] .http://www.ajmc.com/publications/supplement/2012/408_12sep_parkinsons/a408_12sep_boland_s168to75
PD compared to matched controls without PD. Total annual direct costs were slightly more
than double for PD patients compared with controls ($23,101 vs $11,247; P <.001). While
additional costs were seen in outpatient services, hospitalizations, and prescription drugs,
nearly half of this excess cost was due to long-term care expenses.
The total cost in the United States may be as high as $23 billion annually when combining
all indirect and direct costs. In improving both economic and health-related patient
outcomes in PD, it is worthwhile to examine the impact of early diagnosis and treatment.

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PhINeTiCs is proud to be able to help the aging population for an early detection of
Parkinson’s and relieve them of financial hardships and an improved quality of life using the
Park-Eliza detection kit, specifically in the Parkinson’s belt in the United States.
Once the company has established strong foot hold in the USA, it will expand to other parts
of the world to help diagnose this disease.
c. Competitive Landscape
There are many pharmaceutical companies that have the potential to create competition,
fortunately for us, there are no other IVDs currently approved and being marketed for the
diagnosis and treatment of Parkinson’s disease via the detection of PKS1 protein. This
protein biomarker has been shown to play a major role in dopamine regulation in the brain,
which is what ultimately causes the onset of Parkinson’s disease. The only way to currently
diagnose Parkinson’s is through a physical and neurological exam based on symptoms such
as tremors and balance issues. PhINeTiCs’ ability to create and commercialize this
diagnostic successfully and deliver significant results will assist in conquering the unmet
clinical need of this neurodegenerative disorder.
PhINeTiCs is striving to reach a large number of people affected by this disease via our
exclusive patent for the PKS1 biomarker. We also hope to partner with both the Mayo and
Cleveland Clinics for validation and Labcorp for commercialization. Partnering with the
Mayo and Cleveland Clinics will enable clinical data to be collected as well as to obtain the
validation for the LDT. Using Labcorpwill help to expand the diagnostic globally and target
a more narrow population of people in certain industries that have a higher risk due to toxin
exposure.

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d. Evaluation of the Industry
For about 1 million patients in the US with Parkinson, with many going undetected
there is no cure. But for the 60,000 patients detected with PD every year, having a
early detection diagnostic test will be helpful in slowing down the progression of the
disease.
The current detection process of diagnosing PD is complex, lengthy, involves multiple
kinds of testing, and is still error prone. Having a simple, accurate, diagnostic test with
accurate results is very critical to treat patients with Parkinson.
e. Marketing and Sales Plan
Park Elisa is a diagnostic test that can be used to screen for Parkinson’s disease. PhINeTiCs
plans to partner with the Cleveland and Mayo Clinics, located in the prime areas for
Parkinson’s in order to help validate the diagnostic. These clinics will exclusives rights to
the diagnostic test. These locations would be used as clinical testing sites to try and reach as
many patients as possible. With more than one location, this would enable the validation
and clinical trials to move much quicker than with one location. This process is estimated to
take up to two years. Additionally, partnering with these well-known entities will put
PhINeTiCs in a much better position as we are now associated with prestigious, well
established companies. Once the test has been validated, we would partner with Labcorp, a
global company commercialize the diagnostic test.
With extremely limited sales and marketing resources, we would need to create our own
sales and marketing teams once the diagnostic test becomes validated. In the meantime, we
will begin distributing pamphlets using Labcorp marketing and sales teams as they travel
and interact with other companies in the industry. Once our own sales and marketing forces
are created, this will enable us to directly market our IVD to the proper target populations.

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f. Competitive Advantage
PhINeTiCs is focused on creating the first IVD diagnostic kit for earlier detection of
Parkinson’s disease via the PKS1 biomarker, which is known to be crucial in the
development of the disease. In addition, having possession of the patent to this biomarker
enables us complete freedom to begin developing potential therapeutic treatments in
conjunction to the recently developed IVD. With earlier detection of the disease, this
increases the likelihood of successful treatment of symptoms that affect over ten million
people worldwide.
Additionally, being the only diagnostic currently under development for Parkinson’s
disease, we have great competitive advantage over other companies producing drugs that
simply mitigate symptoms. Current treatments approved to reduce the symptoms of
Parkinson’s include carbidopa/levodopa therapy, dopamine antagonists, anticholinergics,
MAO-B inhibitors, COMT inhibitors and even surgery known as deep brain stimulation. As
mentioned previously, these aforementioned treatments only moderate the symptoms. There
are no current treatments out there that are able to reverse or cure symptoms.
If our IVD diagnostic kit becomes validated and has successful clinical trials, potential
therapeutics could then be developed to reverse or even eliminate the symptoms of
Parkinson’s disease. Using the PKS1 biomarker as a target molecule, drug products could
be created to help regulate the dopamine pathway and effectively control the process.
g. Marketing Communication Plan
As previously mentioned, we will first utilize Labcorp to help distribute pamphlets. Once
our own sales and marketing teams are assembled, we will distribute pamphlets and
brochures regarding the IVD to physician offices, walk-in clinics, senior housing and drug
stores and pharmacies, such as CVS, since they have the Minute Clinics. Specifically, these
locations within the Parkinson’s belt would be targeted. Florida, West Virginia, Maine and

22
Pennsylvania would also be focused on since these have the highest percentages of seniors
over the age of 65: 17.2%, 15.8%, 15.6% and 15.4% respectively. [7]
Additionally, we would strive to form a relationship with industrial companies, specifically
those that expose their employees to toxins known to have an influence in the development
of Parkinson’s disease, such as mining, construction, metallurgy, painting and agriculture.
Providing these specific industries with information about our newly developed IVD and
the risks of toxins related to the development and onset of Parkinson’s disease, will provide
them with the knowledge to take the necessary actions with their employees and have them
tested early on if they are symptomatic or have a family history of the disease. This
partnership and knowledge will be beneficial to the companies by saving them time and
money, since Parkinson’s requires multiple tests and doctor visits to diagnose.
We would also send mass emails to all people over the age of 65. [8] While many may think
that is not a good marketing tactic to use since the older population is not accustomed to
technology, it has been showed that approximately 60% of 50-64 year olds are online. In
addition, 95% of seniors use email and 66% have searched the internet for medical or health
related information. Therefore, we believe that using mass email to seniors would be a great
marketing tactic for PhINeTiCs.
Lastly, attending Parkinson’s disease conferences and conventions throughout the year and
around the country would enable us to market and promote our IVD even further. Attendees
of these conferences and conventions would be one of the best populations to target as they
most likely have some type of connection with the disease and could utilize the IVD for
their company or in the treatment of their patients. Listed are all the conferences and
conventions that PhINeTiCs team is going to be attending in 2015 and 2016. This is the
same time, our diagnostic Kit is going to be validated in top notch research hospitals getting
the credibility required to sell the product commercially.
Attending Listed 2014‐2016 Conferences:

23
Conference
Date Location
Translating Research into Exercise 4
Brain Change Approaches for
Individuals with Parkinson's
Disease
June 14, 2015 - June 18, 2015 San Diego, CA,
USA
Parkinson's 2015 July 02, 2015 London, United
Kingdom
World Parkinson Congress
4th World Parkinson Congress
September 20-23, 2016 Portland, OR
29th Annual Symposium on the
Etiology, Pathogenesis, and
Treatment of Parkinson Disease and
Other Movement Disorders
September 12, 2015
Ft. Myers, FL,
USA
World Federation of Neurology
XXII World Congress of Neurology
October 31-November 5, 2015 Santiago, Chile
Movement Disorders: Current
Concepts and Practice
November 13, 2015 -
Boston, MA, USA

24
[7] http://www.pdf.org/en/parkinson_statistics
[8] http://www.kbmg.com/wp-content/uploads/2011/08/KBMG_WP_23Rules_WebSavvySeniors.pdf
http://www.movementdisorders.org/MDS/2014-2015-2016-Conference-Calendar.htm
IV. Production
a. Diagnostic ProductionProcess Overview forPARK ELISA
PKS1 monoclonal antibodies are being produced using the transgenic rabbit technology.
This will allow growth of "fully" human antibodies. This prevents side-affects caused by
chimeras or humanized antibodies.
November 14, 2015
20th International Congress of
Parkinson's Disease and Movement
Disorders
June 19, 2016 - June 23, 2016 Berlin, Germany

25
Using Hybridoma technology myeloma cells are fused with cells of a rabbit immunized with
the desired antigen. This produces a hybridoma which is harvested for PKS1 monoclonal
antibodies. [9]
The PKS1 monoclonal antibodies are being scaled up using single-use bioreactors in a
Chinese Hamster Ovary (CHO) suspension cell culture. The single use bioreactors [10]
prevents the need for cleaning or sterilization, preventing cross contamination and
improving biological and process safety.

26
[9] http://en.wikipedia.org/wiki/Monoclonal_antibody
[10] http://en.wikipedia.org/wiki/Singlese_bioreactor#Advantages_and_disadvantages
The number of parts in this bioreactor is less, making validation for large scale production
easier and cuts costs by 60%.

27
PhINeTiCs has compliance with all ICH Q5 series guidance’s to ensure it has quality,
safety and efficacy. [11] PARK ELISA (Enzyme-linked Immunoassay) test kit production
will utilize the PKS1 antibody attached to a solid phase microtiter plate (96 wells).
During the pre-production process the scale up methodology for PhINeTiCs IVD-“PARK
ELISA” is determined. This includes the design, target, safety issues,
upstream/downstream processing, operating/control parameters technical, and performance
characteristics such as precision, specificity, and sensitivity, etc. Once the methodology is
defined, it is documented in manufacturing specifications, flow diagram and detailed
protocols which determine the appropriate production and process controls.
[11] http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html

28
b. Employees and Subcontractors
There is going to be an executive steering committee, which will manager all Compliance,
quality issues, regulations and relationships with the contractors. The below [12] outlined
governance structure for escalation and communication path that is going to be followed
during the manufacturing and Commercialization process, while working with the
contractors.
[12] http://www.ehcca.com/presentations/pharmacongress9/kelly_t2_pm.pdf

29
A written contract between PhINeTiCs and all contractors is going to be signed to ensure
good communication, establish expectations for acceptable service, monitoring, FDA
Audits, reporting non-conformance, performance matrix, compliance with good
manufacturing practices, good distribution practices and good clinical practices
(GMP/GDP/GCP).
Contract Research Organization
Mayo Medical Laboratories
3050 Superior Drive NW
Rochester, MN 55901
Cleveland Clinic Laboratories
9500 Euclid Ave,
Cleveland, OH 44106
Services: Clinical trial design, Clinical (Phases 1, 2, and 3) study management including
protocol development, patient enrollment and site activation, site monitoring, IWR
services, and clinical supplies management
Contract Manufacturing Organization
Maine Biotechnology Services
1037R Forest Ave.
Portland Maine 04103
Services: IVD Kit Manufacturing and Distribution
Clinical Packaging and Distribution
Diamond Kitting Solutions Kit Packaging Products
155 Commerce Drive
Rochester, New York 14623
Services: Clinical packaging, storage, and distribution

30
d. GMP/QSR Compliance
When developing the Parkinson's Test Kit, it is of utmost importance to follow GMP and
QSR regulations outlined in 21 CFR 820, to ensure a quality product is developed and
maintained. When working with the Mayo and Cleveland clinics, and commercialization
with Labcorp, strict document authoring, review, approval, and retention guidelines will be
put in place. All documents will be stored in a secure electronic data management system
which includes version control and strict security settings. All non-electronic records will be
kept on site for a minimum of two years, and then shipped to an off site storage location for
the remained of the life of the product. In addition to document controls, design controls,
purchasing controls, identification and traceability, production and process controls,
acceptance activities, labeling, handling, storage, etc. will be followed as described in the
CFR.
In addition to following these regulations ourselves, our company commits to ensure that
any partner labs abide by these same regulations. Audits will be performed prior to contract
finalization, so that it can be assured our product is manufactured at the highest quality
standards. Periodically, audits will be performed throughout the life of the contract. If any
deficiencies are found, our company will work with our partner to bring them back into
compliance as quickly as possible.
e. Regulatory and Clinical Strategy
PhINeTiCs plans to develop the PARK ELISA Test Kit initially as a Laboratory
Developed Test (LDT). The development and clinical validation of the LDT will be
performed at the Cleveland and Mayo Clinics. It is expected that the clinical validation
will take approximately one to two years due to the increased Parkinson’s population in
these areas. Once the test has been validated, a partnership with Labcorp would be
pursued to commercialize the kit. Prior to this partnership, PhINeTiCs will submit the
validated LDT to FDA via the de novo 510(k) pathway. Even though there are no other
test kits for Parkinson’s, which would normally require a PMA submission, our
company believes that our test will receive a de novo classification due to the risk-

31
benefit ratio, and be classified as a Class II device. The review time for a 510(k)
submission is 90 calendar days.
As a life cycle management activity, the PARK ELISA Kit will be paired with a
therapeutic treatment. The confirmatory Phase III study will be conducted under an
Investigational Device Exemption (IDE), and a Pre-Market Authorization (PMA)
submitted to FDA for approval. The review time for a PMA is 180 calendar days.
V Risk Factors
a. Risks Relatedto the Intellectual Property
PhiNeTiCs is a smaller biotechnology firm and is regarded as a larger risk than currently
established device and pharmaceutical companies.
Our largest risk is in regards to the intellectual property and advancing sciences. Our current
patent covers the isolation and analysis of PKS1, the agents and technologies utilized for
testing, or any monoclonal derivatives of that product.
The publishing and validating of our device will present a significant research opportunity
for our competitors. It is probable that an interaction between our testing agent and other
similar biomarkers may lead to discovery of other indicators that can aid in diagnosis. If that
does happen, dependent upon the time frame, it has the potential to severely limit our
market exclusivity.
Another potential risk is the possibility of decreased diagnostic efficacy during the
development and validation phase. This represents a negligible risk because of the extensive
testing that has already taken place but must nonetheless be accounted for.

32
Being a start-up, our biotechnology company does not have the financial resources, to get
involved in patent infringement battles. This could be very detrimental to our risk on
investment (ROI).
In the USA patenting Genes is not permitted, which prevents us from patenting the
discovery of the PKS1 Gene. The only patent we have is the intellectual property for,
isolation and analysis of PKS1. Therefore, losing the IP on our patent is our highest risk
factor.
b. TechnicalRisks
With only one patent and product in our company portfolio we are at a greater risk of loss
due to routine delays and setbacks. These include but are not limited to regulatory
processing delays, design errors and delays in manufacturing and mass production. Our
ability to overcome these problems is very limited and will require reliance on those outside
the company. Manufacturing equipment, staff, and overall productivity will need to be
contracted out. These partnerships come with inherent risks, but are necessary to meet
production goals for the device.
c. CommercialRisks
With the completion of the Human Genome Project and improved technology, the discovery
of the diagnostic biomarkers is on the rise. If the PARK Elisa diagnostic kit is a commercial
success, it is a matter of time, before another company comes up with a generic brand of our
diagnostic kit. This is a very big commercial risk for us.
PhiNeTiCs plans to partner up with manufacturing companies where employees have higher
exposure to toxins especially in the Parkinson’s belt and push them to get our diagnostic kits
as part of their on-boarding process. If the companies do not like this idea and prevent us
from promoting this, it can be a major commercial setup back for us.

33
d. Compliance/RegulatoryAffair Risks
We do believe our product should be a class II device and have ample evidence to support
that. Should the FDA disagree it will be very time consuming to go back and forth to get the
designation we are requesting. The is always the possibility of new guidance documents
being released that will require a change in our regulatory strategy.
e. PharmaceuticalDevelopmentRisks
Further down the line, once an agreement has been struck with a pharmaceutical research
and development team it will be very prudent to closely monitor for other breakthroughs in
therapy. The monoclonal antibody that can be developed from our patent will still work
along the dopaminergic pathway, and therefore can be described as symptomatic treatment.
In the event of large strides in research in the next few years a new treatment can potentially
be developed that addresses the root causes of the disorder as opposed to disease
management. The research and development phase of novel monoclonal antibodies can last
longer than 15 years allowing more time for changes in approaches to therapy. This may
decrease the attractiveness of our molecule, but is a problem that may not need
consideration until a significant amount of other benchmarks have been reached.
VI The Financial Plan
a. Reimbursement
Health Insurance coverage in United States in the year 2013, by age, is displayed in the grid
below. PhINeTiCs will be selling diagnostic kits for population aged anove 50. Private
Health Insurance either directly or via an employer will be the main source of
reimbursement for us. But Medicare, Medicaid definitely plays a role.

34
https://www.census.gov/content/dam/Census/library/publications/2014/demo/p60-250.pdf
Due to the inception of the “Affordable Care Act (ACA) or "ObamaCare” in 2014, every
uninsured person can choose to get coverage. PhINeTiCs is a small start-up and any
changes in the insurance policies of private health insurance companies, trying to compete
with ObamaCare will have a major impact on us.
As the company grows, PhINeTiCs needs to put contingencies in place to make sure
insurance policy changes does not impact us. We will need to build relationship with the
companies, payers and work with them. To ensure the annual screening for the Parkinson’s
Diagnostic kit is available at an affordable price to all above the age of 50 as part of base
model in all levels of the insurance plan.
b. ASR Labeled PKSA Antibody
Cleveland and Mayo Clinic will use PKSA Antibody as an active ingredient or the
analyst specific reagent (ASR) to develop the LDT for the Parkinson’s diagnostic test.
The clinics will be using LDT on its patients for diagnosing Parkinson, until the IVD test
for PARK ELISA is commercially available, and limited-use license for using the ASR
expires. This will help PhINeTiCs validate PKS1 and gain credibility from success in the

35
prestigious research hospitals. The ASR antibody would be sold at $400 per 0.1mg,
which is sufficient for 150 tests.
We will provide the ASR to academic research laboratories for free. The ASR antibody
does not need FDA approval for research purposes and can be immediately used as a
diagnostic kit. This will ensure, that most academic research labs try the test, at least
once. Allowing a faster validation and market penetration, once the IVD diagnostic test
is commercially available.
c. LDT an and IVD-clearedPARK ELISA Kit
The PARK ELISA LDT and subsequent IVD kits are intended for the market of Parkinson’s
Disease patients who are diagnosed and require yearly prognosis of disease progression as
well as for screening and diagnosis high risk populations. Currently there is no IVD
available as a diagnosis or prognosis tool. Therefore we project to achieve 95% market
penetration rate in 3 years following marketing clearance of our IVD in 2020. The rapid
penetration is due to the fact that measuring PKS1 is critical to selecting a patient treatment
regimen, and we had seeded the market prior to the IVD clearance through the sale of LDTs
at Mayo and Cleveland Clinic.
The LDT test will be performed by Cleveland and Mayo clinic and reimbursed at 30$ with
1-10% of the total Parkinson’s Disease market reached over 5 years of and with 15% royalty
coming back to the company
LDT: Tiered CPT Code(s): 83520 (Sensory Neuropathy Complete Antibody Panel) at a cost
of $30/test, Numbers used to calculate PhINeTiC’s predicted yearly profit over the course of
4 years from PARK ELISA kit sales.
Year1
US Overall
cases of
PD2
Number
of
patients
screened
for PD3
Predicted
market
penetration
CPT
cost of
test
Royalty
(15% of
test
revenue)
Predicted
Yearly
Revenue
2015 1,000,000 1,000,000 2% $30.00 $4.50 $90,000.00

36
2016 100000 1400000 4% $30.00 $4.50 $252,000.00
2017 1210000 1540000 6% $30.00 $4.50 $415,800.00
2018 1331000 1694000 8% $30.00 $4.50 $609,840.00
1Based on 5 years to develop IVD
2Assume 10% rate of increase of PD prevalence per yeari since the number of baby boomers are increasing
3
Assume 3x(increase in prevalence) for screening +1x prevalence for prognosis
The IVD test will be sold to laboratories at 70% of the CPT reimbursement with a 30%
margin on those sales coming back to the company.
IVD: Tiered CPT Code(s): 83520 (Sensory Neuropathy Complete Antibody Panel) at a
cost of $30/test, Numbers used to calculate PhINeTiC’s predicted yearly profit over the
course of 4 years from PARK ELISA kit sales.
Year1
US Overall
cases of
PD2
Number of
patients
screened
for PD3
Predicted
market
penetration
CPT
cost of
test
70% of
CPT
code
MARGIN
(30% of test
revenue)
Predicted
Yearly
Revenue
2020 1,610,510 2049740 30% $30.00 $21.00 $6.30 $3,874,009
2021 1,771,561 2254714 60% $30.00 $21.00 $6.30 $8,522,819
2022 1,948,717 2480185 95% $30.00 $21.00 $6.30 $14,843,910
2023 2,143,589 2728204 95% $30.00 $21.00 $6.30 $16,328,301
1Based on 5 years to develop IVD
2Assume 10% rate of increase of PD prevalence per yearii
3Assume 3x(increase in prevalence) for screening +1x prevalence for prognosis
Predicted Yearly Revenues

37
To maximize profit potentials, it will be important to explore selling the ELISA kit
globally.
d. DesiredFinancing
e. Use of Funds
PhINeTiCs plans to utilize the funds received for the following activities:
 Development and clinical validation of the LDT at the Cleveland and Mayo Clinics
 MDUFMA Fees for de novo 510(k) submission
 Commercialization and partnership with LabCorp
 Phase II/III clinical trial with companion diagnostic drug candidate
 MDUFMA Fees for PMA submission
f. Exit Strategy
Large pharmaceutical entities are always looking to gain access to novel products held by
smaller pharmaceutical or biotechnology companies. Acquiring PhINeTiCs and its

38
innovative PKS1 biomarker patent would enable them to perform more research on the
biomarker and even develop other LDT, IVD or companion diagnostic tools. These
advancements would be able to help detect Parkinson’s disease at an earlier stage and may
even lead to the development of drugs that can greatly influence symptoms or cure the
disease
i http://www.healthcommunities.com/parkinsons-disease/incidence-prevalence.shtml
ii http://www.healthcommunities.com/parkinsons-disease/incidence-prevalence.shtml

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