Group4_Week10_Final_Business_Plan_VERSION_8(1)

Nommas Life Sciences LLC
Business Plan
[Mission and Goals of the Business
We are committed to improving patient care by providing advanced,
innovative tests in the field of oncology. We are devoted to be the foremost
experts in the diagnosis technology. We continue to develop diagnostics test
that advance precision medicine.
.]
2015
Viet Nguyen, Sarah McCormack, Steve Scelsi
Thinzar Myint, Roxanne Aniceto, Suzie Oware
GROUP 4

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Table of Contents
I. Executive Summary................................................................................................... 2
Our Company.............................................................................................................................. 2
Mission & Goals ......................................................................................................................... 2
Vision Statement......................................................................................................................... 3
SWOT ......................................................................................................................................... 4
II. Scientific Background ............................................................................................... 8
Research & Development ........................................................................................................... 8
Timeline and Milestones........................................................................................................... 14
III. The Product: NCDK................................................................................................ 16
Overview & Scope.................................................................................................................... 16
The Technology ........................................................................................................................ 17
Manufacturing........................................................................................................................... 18
Intellectual Property.................................................................................................................. 20
IV. Financials.................................................................................................................. 23
Startup & Capitalization ........................................................................................................... 23
5-yr Forecast ............................................................................................................................. 25
Investor Equity.......................................................................................................................... 26
Exit Strategies........................................................................................................................... 27
V. Marketing Plan ........................................................................................................ 28
Marketing Plan.......................................................................................................................... 28
Marketing Strategy.................................................................................................................... 32
VI. Operational Plans .................................................................................................... 36
VII.Management & Organization................................................................................. 39
VIII. Appendices........................................................................................................ 43
I. Financial Statements.......................................................................................................... 43
II. Relevant Patents............................................................................................................. 47
IX. References: ............................................................................................................... 50

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I. Executive Summary
Our Company
Nommas Life Sciences LLC (Nommas) is a commercial-stage, technology-based hybrid
company. Nommas is advancing personalized patient care by providing physicians with accurate
patients’ diagnosis and response to a specific therapy based on patients’ cancer’s unique
molecular phenotype. We aim to improve the early detection and management of diseases by
providing distinguished diagnostic technologies and clinical accuracy. By achieving these goals,
we can offer patients and health professionals around the world the benefits of distinguished
predictive ability and earlier diagnosis. Our vision is to help patients by redefining the cancer
treatment paradigm.
Mission & Goals
We are committed to improving patient care by providing advanced, innovative tests in
the field of oncology. We are devoted to be the foremost experts in the diagnosis technology.
Current applications for lambodies are to diagnose cancer and monitor progress of treatment. Our
future applications will include the treatment of additional diseases such as HIV, asthma, cystic
fibrosis, and COPD. We continue to develop diagnostics tests that advance precision medicine.
Our mission is to improve patient diagnostics and increase laboratory productivity.
Outline of Goals
The company is currently developing a variety of point-of-care in-vitro diagnostics
ELISA like cancer detecting kits. As we expand our portfolio into the cancer detection area with
lambodies, we draw from our extensive expertise in ELISA type assaying to assist in developing
the newer and more cost effective and diverse selection of sensitive lambodies as a novel
diagnostic method of cancer detection.

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The company target sales are 3000 units at $500/ unit for the first year of sales. Sub
sequential target sales growth is 30% increase each year.
Vision Statement
Purpose of this Plan – Why we need you!
The business plan seeks $750,000 for 20% return rate at year 5 maturity period. $750,000
will be used for ongoing two-year development of the company’s technology platform and
expansion of commercial efforts to support the lambodies NCDKTM
.
Regulatory and Political Impact
U.S. Affordable Care Act 2010 expanded insurance coverage, implements delivery
system reforms and placed a renewed focus on cost and quality. ACA expands the U.S. patient
population eligible for Medicaid and provides new insurance coverage for individuals through
state and federally-operated health insurance exchanges. ACA’s mandates to have health
insurance for all United States residents increases patients’ access to health care and diagnostic
procedures. Anyone whose insurance covers diagnostic testing will have access to our
NCDKTM
.
Medical & Diagnostic Laboratories Industry Overview
Our competitors in the industry provide analysis and diagnostic services by examining
body fluids and producing images of the body for medical professionals and patients. Our major
competitors are Alliance HealthCare Services, LabCorp, Quest Diagnostics, and RadNet (US),
Biomnis (France), CML HealthCare (Canada), and Sonic Healthcare (Australia) (Hoovers,
2014). The demand for service is linked to the number people who are aware of their
predisposition genotype of cancer genes and those who can afford medical treatment.

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Strengths & Opportunities
Nommas uses a proprietary approach to discover molecular correlation with clinical
outcomes resulting in the rapid commercialization of multivariant tests. Nommas is changing the
paradigm of companion diagnostics development. We bring innovative diagnostics to market
that help inform treatment decisions and improve patient care in a cost effective manner.
Nommas is the first commercial company in the world to develop and manufacture
lambodies assays used in the detection of a number of cancers. The company’s expertise is in
advancing products through expanded global distribution network and a management team with
many years of relevant experience.
SWOT
 Fulfilling unmet need in diagnostic market
 Modern communication technologies
 Established startup funds with low overheads
 Rapid commercialization multivariant tests
 First to manufacture lambodies in cancer detection
 Strong Finance Management Team
 Can reach worldwide market in diagnostic products
 Can expand to monitor HIV detection
 Protecting patents worldwide
 International licensing opportunities
 Developing multi-patients & multi-cancer detection kits
 NOMMAS has clearly defined strategy, underpinning the Founders’
confidence in our long-term revenue targets and profitability.
 Big Pharmaceuticals are collaborating with diagnostic and biomarker
companies.
s
Strengths
Opportunities

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 Biotechnology inputs and technical workers are expensive.
 Competitors granted patents for tumor detection assay, screening for
biomarkers and polypeptide binding assay
 Manufacturing similar products by competitors using non-exclusive
license
 Breast cancer and prostate detection test is currently available competitors
 Qiagen and Roahe have partnered with AstraZeneca to support
development of diagnostics for investigational oncology medicines
(AZ_Annual_report_2014_EN.pdf)
 Lack of diversity in scientific specialties and collaboration
 Lack of robust distribution systems and purchasing mechansims.
 Lack of attracting international market due to the government policies and
procedures.
 Lack of presense in international market weakening patent inforcement
 Lack of strong relationship with patients and professionals
Unfair Advantage
Commercial unfair advantages of lambodies are as follows:
 A diverse selection of glycan-binding monoclonal lambodies can be generated in high
specificity and affinity.
 Antibodies are small enough to allow for greater perfusion into tissues.
 Compared to conventional antibodies, lambodies’ stability are highly resistant to
changes in pH, temperature, and exposure to denaturants.
 The kits are cost efficient because lambodies can be produced in yeast, whereas most
conventional antibodies are produced in mammalian cells.
Threats
Weaknesses

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Business Opportunity, Product and Market Attractiveness
Nommas manufactures point-of-care in vitro diagnostics for tumor diagnosis, prognosis,
and cancer therapy. Recombinant Variable Lymphocyte Receptors (lambodies) using tumor
specific glycans can detect and differentiate various types of human tumors as tested on human
cancer tissue microarrays.
Lambodies meet the demand for safe, reliable, and low-cost screening methods for the
multitude of cancers with high specificity to tumor specific glycans. Applications for this
invention include a noninvasive cancer diagnostics from body fluids, in vivo tumor imaging
reagents, and therapeutic tools, for selective targeting of cancer cells for destruction.
In 2014 14.1 million new cases of cancer were reported and it is expected that by 2020
cancer is estimated to rise to 17.1 million new cases. The market for novel cancer detection
should reach 1.8 billion and expected to grow to 10 billion by 2019. Our multi-variant diagnostic
products would be sold on a worldwide basis to hospitals, clinical laboratories, commercial
reference laboratories, and research institutions.
Plan to Out-maneuver the Competition
In the current market, there are diagnostic tests available for colorectal cancer. Corgenix
is currently developing point-of-care Ebola test kits and Lassa fever virus test kits. Nommas will
be the first multi-cancer detection kit in the medical diagnostic industry. Our marketing efforts
will focus on clinical diagnostic cancer detection phases as well as collaborating with federal and
private institutes. Our profitability will depend on efficient operations and good marketing. We
will expand our product offerings that can be distributed quickly and provide service support.

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We can compete effectively by providing specialized analyses and specialized training
performing tests (Hoovers, 2014).
Large integrated companies have streamlined economies of infrastructure, purchasing,
supply chain, and distribution. We can compete by focusing on NCDKTM
and specializing in the
United States to start until we establish a dominant market share.

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II. Scientific Background
Research & Development
Lambody Development
Sea lampreys are water-dwelling animals that produce antibody-like proteins which bind
to polysaccharides. Dubbed “lambodies” their binding affinity for sugars is much stronger and
more specific than traditional antibodies. This unique capability of these molecules makes them
ideally situated to detect the presence of polysaccharides associated with disease, such as those
on tumor cells (Varki, Kannagi, & Toole, 2009). Compared to normal cells, cells which are
cancerous display and secrete proteins and lipids with distinctive polysaccharide arrangements.
These polysaccharides, or glycans, can be used as biomarkers to detect the presence of different
types of cancers. Although more than 7,000 human glycan determinants have been discovered,
only a tiny fraction of those are bound by existing proteins (Lockwood, 2012).
Lambodies produced by Nommas would have an advantage over current methods of
detecting glycans. Conventional antibodies can be produced against glycans by immunizing
animals with glycoproteins. However, these antibodies have been found to bind the glycans very
weakly, which would severely limit their usefulness. Alternatively, lectins are proteins found in
human and other cell types which naturally bind to glycans, but they do not act with any real
specificity (Almogren et al., 2012). Lambodies, on the other hand, are highly specific for their
target, and bind with affinities that are up to 100 times greater than traditional antibodies. This
property is due to a highly variable sequence in their binding region, linked to a rigid structure.
The rigid portion of the lambody anchors the glycan, providing greater binding strength, while
the variable region allows for greater binding specificity (Lockwood, 2012). Additionally,
lambodies exhibit enhanced stability when compared to traditional antibodies. They are highly
resistant to changes in temperature, pH, and other denaturing factors. They are also cheaper to

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make as they can be produced by yeast, while other antibodies must be produced by mammalian
cells (U.S. Patent No. WO2013078425 A1, 2013). These characteristics make our lambodies
greatly superior to other methods of cancer detection.
Current State (Existing Technology)
Currently, we have a unique technology for high-throughput selection of lambodies of
interest, the Yeast Surface Display (YSD) platform. Here, sea lampreys are immunized with an
antigen of interest. For our purposes, this would be a glycan commonly associated with cancer.
Within four weeks, the lampreys produce antibodies against that glycan. These antibodies are
harvested and cloned into a Saccharomyce cerevisiae yeast library, which displays the antibodies
on the yeast surface (Tasumi, et al., 2009). This yeast library is then subjected to two rounds of
magnetic-activated cell sorting (MACS), using the glycan antigen as a probe. This step enriches
the antibodies which bind to the target glycan. Individual clones are then isolated by two rounds
of fluorescence-activated cell sorting (FACS) and screened for their specific binding capabilities
to the target glycan using surface plasmon resonance (SPR) by BIAcore, and by ELISA. The
antibody with the best specificity and affinity for a cancer glycan is selected. The antibody
coding region is then cloned into a yeast expression vector as a fusion protein, containing the
diversity region from the lamprey lymphocyte linked to a multimerization domain that allows
two lambody subunits to dimerize (Hong et al., 2012).
Future Directions
Using the technique described above, we have already discovered lambodies which can
accurately detect glycans associated with breast cancer, lung carcinoma, lung adenocarcinoma,
squamous cell carcinoma, colon adenocarcinoma, and prostate adenocarcinoma (U.S. Patent No.
WO2013078425 A1, 2013). Future rounds of the surface display platform would be directed at
discovering lambodies for additional cancer types, and for subtypes of these and other cancers.

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Here we should also note that although the technique described above calls for immunizing sea
lampreys with a cancer-associated glycan, this step is not always necessary as lampreys also
produce glycan-binding antibodies without having ever been exposed to a particular antigen.
While the described method would provide a more targeted approach, it would also be possible
to discover lambodies for cancers even in naïve lampreys. This method could be useful in cases
where no good antigens are known. Excellent binders of glycotope targets can generally be
obtained from modest-sized YSD libraries of 108
clones, which is easily obtainable from about
100 naïve lamprey larvae and adults (Tasumi, et al., 2009).
Clinical Applications
Diagnose cancer
We plan to use our unique glycan-binding lambodies to develop NCDKTM
which can be
used directly to detect cancer. The NCDKTM
will be composed of standard 96-well ELISA plates
pre-coated with a selection of lambodies. The different lambodies on each plate will all be
binders of the same cancer type, such as breast cancer. A single patient sample will be added to
the entire plate. Each sample can be applied at two concentrations in triplicate wells, allowing for
12 different lambodies to detect a specific cancer type to be placed on one plate (Figure 1).
Therefore, each plate will present a robust assay which is highly specific for distinct
cancer types. These tests were originally developed to be used with blood, but they can also be
used with any bodily fluid, such as serum, urine, or saliva (U.S. Patent No. WO2013078425 A1,
2013).

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Figure 1. Sample layout of an ELISA plate which can test one patient, at two concentrations, for
twelve lambodies (Source: Adapted from Qiagen. (n.d.). Retrieved from:
https://www.qiagen.com/us/resources/resourcedetail?id=f0f5c1a8-d4ec-46d2-ab4c-
73c6233ca9f9&lang=en.)
We currently have half the lambodies needed to make kits to detect six cancers. We will
first screen for lambodies to complete these kits, then add more kits to our line as additional
lambodies for different cancers are discovered. As lambodies are much more sensitive than
conventional antibodies, our diagnostic kits will be able to diagnose cancer even in very early
stages, before it would be detectable by other methods, using noninvasive techniques from body
fluids.
A variation of this kit will have ELISA plates coated with the same lambody in all 96
wells. This product could be used by high-throughput diagnostic labs with enough patient
samples to fill entire plates.

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Monitor progress of treatment
Once a cancer has been diagnosed and is in treatment, our same NCDKTM
can be used to
monitor the effectiveness of the therapy. These highly sensitive kits will be superior to
conventional methods for detecting small variations in the tumor cells.
Imaging cancer
Although many cancers are detectable from body fluids, when solid tumors are found
they are often biopsied for analysis. The same lambodies we use for our NCDKTM
can be easily
adapted into a product that can serve for cancer imaging. Here, each lambody type will be
conjugated to a detectable label. Initially, we plan to use peroxidase and a fluorescent marker.
Different lambodies will be sold separately in 1 ml tubes. These labeled lambodies can be
applied to cross-sections of tumor biopsies for in situ visualization of tumor cells under a
microscope. They can be used for both immunohistochemistry (IHC) and immunofluorescence
applications, and can serve for the initial diagnosis, to monitor the efficacy of therapeutics, and
to monitor recurrence. Existing lambodies are already proven to be effective at imaging cancer
cells (Hong et al., 2012).
Figure 2. Lambody VLRB.aGPA.23-mFc conjugated to horseradish peroxidase and used to stain
lung large cell carcinoma (Hong et al., 2012).

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Deliver treatment to specific cells
In addition to our continuing work to discover novel lambodies for our NCDKTM
and
cancer imaging platforms, a future project will be the development of lambodies which can be
used as therapeutic tools. Here, lambodies will be conjugated to a cancer therapeutic agent and
injected into a patient. The lambody will specifically bind to cancerous cells, and deliver its drug
to only those cells. This treatment method will provide a highly targeted approach which will
deliver therapeutics only to cancer cells, minimizing the toxic side effects that occur when drugs
are taken up by healthy cells. An additional benefit of this technology is the small size of
lambodies, which will allow for greater perfusion into the patients tissues and more successful
drug delivery (U.S. Patent No. WO2013078425 A1, 2013). Additionally, due to the extreme high
binding affinities of lambodies, it is possible that they may act as cancer-inhibiting agents on
their own by interfering with cancer cell functions, even without the presence of a therapeutic
agent (Hong et al., 2012).
Treat additional diseases
Although we initially intend to focus on cancer, lambodies can be developed to recognize
a variety of diseases. Initial studies have found lambodies against many biomedically important
glycotopes, including HIV (poly-Man9 and gp120), N-acetylneuraminic acid (which is linked to
chronic inflammation), and two types of mucins (the glycoproteins aOSM and aGPA) (Hong et
al., 2012), which are linked to asthma, cystic fibrosis, and COPD (Singh, Chaturvedi, & Batra,
2007). We intend to explore additional diseases which could benefit from detection by
lambodies.
Develop high-throughput method for screening new Lambodies
Current lambody screening methods analyze the binding of small batches of clones, using
only about 10-40 clones per target glycan out of thousands of positive clones which are sorted

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(Hong, et al., 2012). In order to fully exploit the power of this technology, we need to develop a
high-throughput technique to screen and validate large clone numbers.
Timeline and Milestones
Screen for Lambodies to complete first 6 cancer diagnostic kits
July 2015 – October 2015
FDA Approval process
November 2015 - April 2016
Manufacture and Marketing of first round Diagnostic Kits
May 2016 – October 2016
Launch Diagnostic Kits
November 2016
Discovery phase and FDA approval for second round of cancer Diagnostic Kits
Development of high-throughput screening techniques
May 2016 – December 2016
Launch second round Diagnostic Kits
January 2017
Begin Discovery for Therapeutic Lambodies for cancer
Begin Discovery for non-cancer Diagnostic Kits
February 2017
Developmental Resources
Nommas is currently looking to lease 3,500 square feet of laboratory and office space in
Bethesda, MD. Our state of the art facilities will include three laboratory areas. The main lab will
be used for cell culture, cell sorting, and other general lab activities. This lab will contain the
FACSJazz cell sorter and BIAcore T100, along with the ELISA plate washer and reader,
biological safety cabinets, and incubators. We will also have a small clean room which we will
use for PCR prep and sample running. Additionally, animal quarters will house the sea lampreys
in 10 gallon tanks.

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Table 1. Initial equipment needed to furnish the laboratory space.
Equipment Needed Quantity Price ($)
FACS: BD FACSJazz 1 130,000
MACS: Dynal DynaMag Magnet 2 1,112
SPR: BIAcore T100 1 100,000
Elisa Plate Washer: Titertek Zoom HT Microplate Washer with
vacuum disposal system
1 23,500
Elisa plate reader: BioTek ELx800 Absorbance Microplate
Reader with stacker
1 14,495
PCR: Eppendorf Mastercycler pro PCR System 3 31,398
Biological Safety Cabinet: Labconco Purifier Cell Logic Class II
A2 4 ft. wide cabinet
3 38,562
Refrigerator: Fisher Scientific Isotemp Lab Refrigerator, 49 cu. ft.
with alarm
2 14,522
-20 Freezer: Nor-Lake Scientific 24 cu. ft. with alarm, manual
defrost
2 10,352
-80 freezer: Fisher Scientific Isotemp Ultra-Low Temperature 28
cu. ft. with alarm
2 31,354
Incubator: Fisher Scientific Isotemp CO2 Water-Jacketed 4 25,132
Centrifuge: Sorvall Legend XTR (Refrigerated), TX-750 rotor,
and tube adapters
2 44,594
Microscope: Zeiss AxioLab A1 microscope 1 5,792
Balance: Mettler Toledo NewClassic 0.1g balance, 620g capacity 1 1,110
Water bath: Fisher Scientific Isotemp Digital-Control Water Bath,
2 L capacity
2 1,667
Autoclave: Fisher Scientific SterilElite Tabletop Autoclave 1 6,574
Aquarium: Marina 10 gallon tanks with filter system 20 1,220
Pipettes, single channel: Gilson Pipetman Starter Kit 5 4,240
Pipettes, multichannel: Gilson Pipetman Multichannel 2 2,422
Culture flasks: Corning Cell Culture Treated Flasks, 175 cm2
culture area, case
10 3,760
Elisa plates: Costar 96-well round-bottom plates,case 25 4,825
Media: Sigma-Aldrich YPD Broth, 1 Kg 5 895
TOTAL 497,526
Animal Use
Sea lampreys will be used for discovering novel lambodies. All animal use will be
conducted in accordance with the NIH Guide for the Care and Use of Laboratory Animals.
No other animals will be needed for our research. All personnel who are in contact with animals
will receive training on their proper handling and use.

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III. The Product: NCDK
Overview & Scope
Highly specific glycan-binding antibodies will be developed into NCDKTM
for the
detection of cancer; these glycans are expressed in almost all human tumor cells (Hong et. al,
2012). The initial product will be designed for specific cancers for each plate, one per customer.
This product will be used as a confirmatory, quantifiable diagnostic kit for a specified
cancer to be used by a point-of-care physician with ELISA-reading capabilities or contract
laboratory organizations (CLO). Nommas will initially market four distinct products: two (2)
types of single cancer plates for single-patients and multiple-patients focusing on the five most
common cancers (breast, prostate, lung carcinoma, lung adenocarcinoma, and colon),
fluorescent-labeled lambodies for use in cancer imaging, and the fourth “product” will be the
licensing agreements to third party manufacturers to create their own combination plates using
the lambody technology.
Nommas will purchase lampreys from Acme Lamprey Company located in Harrison,
Maine and Lamprey Services in Ludington, Michigan. We will also contract ImmunoChemistry
Technologies LLC in Bloomington, Minnesota to distribute our final products. Nommas Cancer
Detecting Kit are of three product types for detecting 5 common cancers, namely breast, prostate,
lung carcinoma, lung adenocarcinoma, and colon.
This innovation applies the lambody antibody affinity to detect the presence of cancerous
glycan antigens with high affinity. The NCDKTM
has created a sandwich ELISA kit to detect and
quantify potentially cancerous cells in a sample.
The Nommas Advantage
Lambodies can be engineered to a high affinity for early stage cancers, whether
noninvasive or via in vivo tumor biopsies. Since almost all tumor cells have glycoproteins,

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lambodies would be able to detect trace amounts of cancerous cells without first known specific
cancer biomarkers (e.g., CA-125). Glycan structures have been shown as a cancer biomarker
(Adamczyk, Tharmalingam, & Rudd, 2010).
ELISA tests in general are highly accurate with a high specificity without the need of
radioactive material or invasive procedures (Manning, 2014). As seen in HIV testing, it is suited
for testing many people at one time.
The Technology
Current State of the Cancer Detecting Technology
Current ELISA kits available for cancer focus on specific biomarkers associated with
certain types of cancer (Li, Wang, Xu, & Zhang, 2013) or have antibodies created against the
proteins from an identified cancer gene (Wayner et al., 2011). Both of these aforementioned
methods use voided urine. Other tests look for heritable cancer gene markers --such as BRCA1--
via sequencing and PCR amplification, but this does not necessarily confer the development or
diagnosis of that disease (Lim et al., 2010). It is known how to differentiate healthy and tumor
cells as well as between different cancers using ELISA tests (Luka, Arlen, & Bristol, 2011;
Herzon et. al, 2014)
The NCDK Technology
The Lambodies innovation builds upon the research of Zeev Pancer, Li Mao, Xia Hong,
and Zhi-Qing Ma to develop and market a patent-pending ELISA kit for the rapid detection of
cancer for early diagnosis (Hong et al., 2012). Their current patent application is through the
Patent Cooperation Treaty and is assigned to the University of Maryland in Baltimore; Nommas
has already filed for the technology transfer license.

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Figure 3. Lambody staining of normal and cancer tissues. (A, E, G) Normal lung, colon, and
prostate tissue. (B, C, D, F, H) Lung, colon, and prostate carcinomas (Hong et al., 2012).
Manufacturing
Materials Needed
1 As quoted by ImmunoChemistry Technologies LLC in the development of Antibody
Sandwich Assays:
 Analyte
 Antibodies + label (e.g., HRP)
 Analyte negative samples
 Analyste positive samples
2 The kits themselves will contain the standard materials supplied in sandwich ELISA
kits:
 1x User Manual
 2x Plate sealing tape
 1x 96-well microtitre lambody cancer plate
 1x .5ml 18umol/L Standard

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 1x 1.5ml Standard diluent
 1x 6ml HRP-lambody conjugate reagent
 1x 6ml sample diluent (cancer)
 1x 6ml Chromogen Solution A
 1x 6ml Chromogen Solution B
 1x 6ml Stop solution
 1x 20ml 30X Wash Solution
3 The interpretation of ELISA kits require additional materials not included:
 37 degree incubator
 Standard Enzyme reader
 Pipettes & tips
 Distilled water
 Test tube & beakers for dilutions
 Absorbent paper
 Spectrophotometer
Sourcing
Most of these items are easily sourced from manufacturers of other ELISA kits. The
HRP-linked lambodies, the calibrator liquids, and possibly the conjugate would be proprietary to
Nommas.
A potential source for additional research and design help and compliance is Valnet in
Puerto Rico. Our company will obtain lamprey animals from Acme Lamprey Company located
in Harrison, Maine and lamprey larvae from Lamprey Services in Ludington, Michigan.
Nommas will contract the final assembly and distribution through ImmunoChemistry

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Technologies LLC in Bloomington, Minnesota who specialize in mass producing ELISA
kits. The final product will be branded and marketed by Nommas.
Quality Assurance
Manufacturing will be performed by Contract Manufacturing Organizations (CMO)
where all activities, duties, and responsibilities are outlined in documentation with companies
who comply with Good Manufacturing Practices (GMP) regulations and are properly equipped
to do so (Tobin, 11.3.7). There are several bids between different companies at the
moment. Facilities, equipment, process, and methods validations will take place at all research
institutions and manufacturing plants.
During the beginning part of the FDAApproval Process, Nommas will perform studies
with the National Committee for Clinical Laboratory Standards (NCCLS) protocol EP5-A to test
its validity. Clinical performance will be executed in conjunction with a panel of volunteer blood
donations from partner cancer sites and healthy donors.
All positive results will be characterized by individual patient’s medical history and
confirmed using Western Blot. Lambodies results should be used in addition to other data to
confirm a cancer diagnosis in a patient, including symptoms, medical records, imaging results,
and other tests.
Intellectual Property
Licensing
To protect our invention and claims therein, our patent officer applied for [U.S. Patent
Application(s) Serial Number(s), Filing Date(s), and Patent Number(s) (if issued): US
20110230374] patents have been filed in the United States and Puerto Rico. “Title of Patent
Application(s): High affinity recombinant sea lamprey antibodies selected by yeast surface

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display platform”. We have made available non-exclusive licenses for companies interested in
similar technology. There is a $100,000 nonexclusive patent and 2% royalty on licensing of the
technology or product as agreed by founders. Nommas has signed co-confidentiality agreements
with key employees requiring that they forbear from disclosing confidential information of the
company and assign to the company all rights in any inventions made while in the company’s
employ relating to the company’s activities.
Technology & IP Strategy
Roxanne Aniceto is patent officer for Nommas. All patents are enforceable and defensible
and registered in countries where our product will be produced. In its initial stages, patents have
been authored and filed in countries where R&D will be performed: the United States and Puerto
Rico. Concurrently, our US patent application will be filed with the Patent Cooperation Treaty
(PCT) and reviewed for 30 months after.
The principal areas (general description) of the patents applied for are as follows:
1 The lambody-biomarker-HRP conjugate covering 6 cancers product
2 The use of lamprey antibodies in the diagnosis of pathological conditions
3 The statistical analysis method to examine the combination of biomarkers to
provide the most accurate diagnostic results
4 The creation and development of specific lambodies for diagnostic antigens.
While care is taken to prevent other claims of lamprey antibody-based inventions, non-
exclusive licenses will be available for competitor manufacturers to produce the same product in
different styles.
Trademark application has been filed on the name Nommas. Fictional trade name for
Nommas and Nommas LLC has also been recorded in Maryland and Virginia, our local working
area. Trademark applications are in the process for the single patient plates, the multiple patient

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plates, and the labeled lambodies. No conflicts or other use of these names have been found in
an initial search.
Product Pricing & Cost
The cost per unit is estimated to be $500 per kit for plates, which will most often be
covered by insurance companies. A more cost effective solution would be to run multiple tests
per plates via CLO. Companies wishing to lease a license from Nommas to produce their own
plates will be a significant source of income, but prices have yet to be decided.
Cost of production for each unit is negligible once the assay has been researched and
developed, but the CFO estimates the cost of manufacturing to be approximately $125 per kit
(including solutions, materials, and packaging). Further information is available from the Chief
Financial Officer.

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IV. Financials
Nommas bases projections on a modest estimate of 3000 units of the NCDKTM
sold into
the market for the use of laboratory cancer diagnostic testing for the five listed cancer types, this
amounts to less than approximately one half of one percent penetration into the market in the
first full year of sales. Once the significance of the NCDKTM
has been demonstrated and the
impact of a fast and accurate diagnostic kit, then sales is expected to increase rapidly. A rise by
33% with targets of 4000 units in the second full year of sales and an additional 25% increase in
the third year of sales can projected with good confidence. Sales and marketing believe the
NCDKTM
with unit target of 5000 per year from the 3rd
year on is realistically attainable. A
portion of the sales increase in years 3 will be driven by additional test kits being available for
the other 47% of cancer types. As the new kits come into production then Nommas will expand
the portfolio of its NCDKTM
to include all major and rare forms of cancer. Nommas look to
provide the fastest and most accurate way of determining a diagnosis with high precision and
accuracy. This would provide healthcare providers with the pertinent information they require
such that appropriate treatment measures can be performed more quickly.
Startup & Capitalization
The six member founding team of Nommas has raised a total of two million in total
funds. Each founder has committed $200,000 towards the startup costs. Nommas have also been
granted financing through a small business back loan of an additional $800,000 at a rate of
2.99%. Additionally, Nommas founders have secured $100,000 from the Small Business
Innovation Research (SBIR) program that is run by the federal government. The SBIR aids
startups with financial grants in two phases, Phase I to “establish technical merit” and Phase II
for commercialization. The grant issued to Nommas is used to further the R&D efforts toward

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commercializing the Nommas Cancer Detecting Kit (NCDKTM
). The NCDKTM
for R&D
diagnostics has shown promise as a faster and more accurate test, not only towards the accurate
positive or negative detection of cancer, but also by identifying the specific type of cancer. The
NCDKTM
does this by taking advantage of the highly specific glycan profiling relative to
different cancer types.
Nommas has sought the licensing of the Lambody technology from the University of
Maryland. The terms of the patent licensing are $100,000 upfront for the nonexclusive patent and
additional 2% royalty on all products and services related to the licensed technology.
In addition to the phase I SBIR grant, a SBIR Phase II grant is expected to be acquired in
the amount of $500,000. Currently Nommas is also seeking an ANGEL investor to partner with
and support Nommas in the effort to create the cancer detection kit in the amount of $750,000
over the course of two years of development. This support will be spread out over a period of
two years with initial investment of $500,000 in the first year with subsequent $250,000 in the
second year to support manufacturing and marketing efforts. The R&D of the various lambodies
to be developed for the initial top five cancer targets is expected to take six to nine months. An
additional four months’ time is estimated to finalize plating configurations and final product
specifications, testing, assembly and manufacture the initial NCDKTM
to bring to market. The
kits themselves will use a standard 96 well plate that is used in a variety of applications such as
ELISA test and rapid HIV testing kits.
Regulatory approval is estimated conservatively at 6 months from application to
approval. Allowing two months for initial project startup such as minor building improvements,
equipment installations and general project delays and corrective actions brings the total

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estimated production time to market at 21 months. Once FDA approval is granted then an
aggressive marketing strategy is in place to start to educate and drive sales of the NCDKTM
.
5-yr Forecast
Nommas’s facility is a 3,500ft2
in Bethesda, MD near the National institutes of Health.
There are minimal improvements required to the leased space as it previously was a laboratory
for research purposes. Investments of $600,000 in general lab equipment, material and office
space design and infrastructure are required. There is an estimated $50,000 in computer,
communications and related networking cost estimated, as well as $15,000 in other
administrative costs, which include but are not limited to accounting and attorney fees, utilities,
and general office supplies.
Additionally, the $750,000 sought by an ANGEL investing partner, will be directed
towards the R&D development of the glycan biomarkers specific to the target cancer types. This
includes but is not limited to purchase of cancer cell lines, associated materials, personnel and
equipment related to glycan identification. As for the manufacturing and related logistics,
Nommas looks to partner with third party sellers to limit the investment needed in manufacturing
and distribution. The first three years of business look to have negative cash flow due to the
initial investments in infrastructure and laboratory equipment investments.
Any partnership would see returns in the third year of business which would coincide
with the first full year of sales. The break even analysis shows a required 1750 units to be sold at
the 500$/unit to reach the breakeven point on an annual basis. Nommas targets are for sales of
3000 units in the first year of sales with assistance from our manufacturing and distribution
partners. Our estimates of 30% sales growth initial sales growth figures from year to year of
33%, 25%, and 20% for the first three years are modest considering the market size for cancer

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detection diagnostics in the US. These conservative numbers do not include potential markets for
the NCDKTM
s worldwide.
Nommas looks to reach its target sales figures by focusing marketing efforts on clinical
diagnostic cancer detection laboratories (i.e. hospitals) as well as academia and other research
institutes (i.e. NIH) as the target market for our product. Given the novel technology being used
with standard conventional 96 well plates reduces the manufacturing costs significantly allowing
for production costs of $100 per unit.
The advantage of being able to manufacture the NCDKTM
using a standard 96 well plate
increases the NCDKTM
marketability as it would work with any current mechanized 96 well plate
equipment for reading and analysis of results. The ease of use should allow for sales to reach the
break even milestone in the fourth year of business and put Nommas on track to reach
profitability by the fifth year on. The break even analysis takes into account the fixed costs of
roughly one million in fixed operational, costs of goods sold as well as other expenses as
outlined in the income statement not including the first year of startup which more financial
resources were necessary. Also the 5 year forecast assumes that staffing levels remain relatively
the same as the manufacturing and distribution of the NCDKTM
are outsources to a third party
vendor that is paid not on the manufacturing as well as a 10% royalty of sales as compensation
for distribution.
Investor Equity
The investment partner will see a 20% rate of return from their investment at the end of 5
years. The first three years of development Nommas looks to have negative cash flow. By the
third full year of business and the first full year of sales, then payments of the investment over
the course of the following 3 years will see the $750,000 investment returned in the amount of

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$900,000. This analysis is contingent that Nommas meets the conservative estimates of sales
goals in the first full year of sales of 3000 units. This is reflected in the positive income
statement in year three. The subsequent negative cash flow in year 3 is a reflection of the first of
three annual payments to return to the investor their stake with a rate of 20% on their investment.
Exit Strategies
Exit mechanisms include either liquidation of cash and assets to repay the investors as a
last resort. More likely, the rights to licensing of production and subsequent sale of the NCDKTM
to interested third parties that would absorb and buyout the company with investors’ interest
taking priority. If the NCDKTM
kit is as successful as Nommas expects it to be and over time
proves itself to be an invaluable tool in the detection and fight against cancer, Nommas founders
would highly consider taking the company through the complex and arduous path of an IPO. In
the case of an IPO the investor’s shares would be allocated an appropriate amount of stock and a
seat of representation on the board of directors. The founders all have passionate dedication to
see the technology and its use to help end the plight of cancer come to fruition and become a
successful tool in the fight against cancer.

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V. Marketing Plan
Marketing Plan
Market Size
The World Health Organization (WHO) reported an estimated 12.7 million new cases of
cancer diagnosed per year, and is estimated that in 2012 the total number of cases per year will
be at least 14.1 million per year (Globocan, 2015). As far as the need for a cancer diagnostics kit
in the world, Transparency Market Research showed in 2013, the global diagnostics market for
cancer had a value $101 billion (US dollars) in research for diagnostics products. With the
amount of new cases of cancer being reported at staggering amounts to the tune of .002 percent
of the population but ranks as the number two killer on causes of death (Globocan, 2015). The
market for America cancer diagnosis has estimations that about 1.5 million Americans to be
diagnosed with cancer in 2012 making up about .004 percent of the population. Nommas will
look to capitalize on a market that has no end in sight. We will begin in America, and then
expand that market globally once we have successfully established our product as the top
oncological diagnostics tool.
Diagnostic Trends
The WHO reported that within the next 20 years over 20 million new cases of cancer per
year will be reported. Our hope is to be able to at least occupy 1% of the global market (# of
cases of cancer) and at least 33% on the United States market (Globocan, 2015). These rates
would give us a rough estimation of between 500,000 to 700,000 people using our diagnosis tool.
Pending our patent approval by the FDA we could guarantee a strong grip on diagnosis tools for
cancer in the U.S. Current diagnosis tools are not only looking to detect cancer, but ways to
detect specific types of cancer. If the diagnosis of a cancer cannot be specifically determined,
then treatments may not useful in removing any potentially harmful cells.

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Market Trends
Secular Market (5-25 years)
Stocks in biotechnology have had an average annual return of 27.4% in the past 5 years.
This number is promising because it is a pretty substantial growth and great rebound from the
economic downfall of 2008. This number represents sales of stock since 2009 in biotechnology
based companies. (Biotech, 2014) If this growth continues, along with the growth of cancer
diagnostics rates, which is expected to reach 20 million cases per year within the next 20 years,
then it will seem as though funds for research in this department will not see and end.
Primary Market (1-2 years)
As of May 2014, the market has taken a slight downturn due to selling of stocks in the
first quarter caused by the concern of value by some biotechnology sectors. We do not look at
this as a negative at Nommas, but as an opportunity to set our company apart from other
companies that cannot compete with us. We look to have an extremely successful product that no
matter how the market fluctuates, there will be no wavering support for our cancer diagnosis kit.
Secondary Market (weeks to months)

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Looking at our current competitions
market, trends over the last several
months have shown growth in the cancer
diagnostics market. As shown in Figure 2.
The figure shows some ups and down but
a rate of growth none the less.
Figure 4. Current price of stocks over the last three months.
(Google, 2015)
Market Portion
The WHO recognizes cancer to be the number one contributors of death across the globe
with a reported 8.2 million deaths in 2012 (Cancer, 2015). There are more than one type of
cancers with top five; lung, liver, stomach, colorectal, and breast cancer accounting for 4.2
million of those deaths. Being able to diagnose a cancer in early stages would help drastically cut
the rates of cancer deaths. If Nommas can even save one life, this product that would be worth
investing in.
Demographics
Cancer shows no discrimination for which it attacks. Whether you are Caucasian, African
American, Asian, male or female, cancer will find a way to rear its ugly head. Our market is so
large, we decided to market towards people with specific cancers, mainly the top 4 leading
deaths from cancer, until we can prove that our kits work to diagnose other types of cancers. The
cancers we will be looking to diagnose initially are:
 Lung- The people that are more apt to fall into this category are the elderly and black
men. Elderly people over the age of 65, turn out to be about 66% of the population
when being diagnosed with lung cancer. In 2015 the American Cancer Society’s

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estimate for the U.S. of new cases of lung cancer is believed to be about 221,200 new
cases, and sex has little bearing on who is more likely to be diagnosed with lung
cancer (115k men, 106k women) (Cancer.org, 2015). Finally, it has been shown that
black men have a 20% higher propensity of being diagnosed with cancer.
 Colorectal- it is the third most common cancer in the world and third leading cause
of cancer death (Siegel, Desantis & Jema, 2014). Over a third of the cancer diagnosed
population is over the age of 80 (Siegel, Desantis & Jema, 2014). The African
American community is at a higher risk than any other ethnicity. (Siegel, Desantis &
Jema, 2014)
 Breast- Is one of the largest categories of cancer that affect woman. About 1 in every
8 women will develop invasive breast cancer in their lifetime. Estimate for 2015 give
a number of about 231,000 new cases of invasive breast cancer being diagnosed in
women, and about 40,000 women will die because of breast cancer (Cancer.org,
2015). Currently there are 2.8 million breast cancer survivors, including those who
are still being treated.
 Prostate- Estimates in 2015 project that there will be about 220,800 new cases of
prostate cancer, resulting in about 27,540 deaths. About 1 in 7 men with diagnosed
with prostate cancer, and about 60% of those cases will happen in men aged 65 and
older (Cancer.org, 2015).
Market Growth Potential
The market does not have a foreseeable end in sight. As long as people are ingesting
carcinogens by foods or environments, the prevalence of cancer does not seem to be
disappearing. Estimated growth based on the WHO, puts cancer diagnosis up to 20+million new

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cases by the year 2020 based on a continual annual growth rate of 7.6% yearly. Diagnosing
cancer is the first step to treatment. Demand for diagnosis tests will continue to grow as
prognosis of cancer continues to elevate.
Marketing Strategy
Target Market
An estimated 14.1 million people were diagnosed with some type of cancer. Nommas is
looking to capture at least 1% of the market in the U.S. before we decide to take our product to a
global level and help other countries where different cancers have a higher prevalence. Nommas
wants to be a major leader in cancer diagnosis tools as the market is showing no signs of slowing
down.
By year 2, Nommas looks to have patents in place for our specific lambodies that can
already detect 5 different markers in cancers through the use of our ELISA kits. Once we have
fully entrenched ourselves in the U.S. market, we can begin to expand different types of
diagnosis kits. The possibility for expansion of kits may allow for our company look for ways to
diagnose different diseases. Stepping up to foreign markets, means more money will be invested
into marketing as Nommas will send well educated employees to travel to foreign countries, and
apply for foreign patents. At this point we will already have a product that we know and the
market recognizes. Consequently we will be able to save money by reduction in our research and
development.
Consumer Market
Nommas will look to address a single market, maximizing and strengthening our
relationships in the U.S. within the first couple years. Nommas knows that our main consumers
of this product are people with a cancer suspicion, or diagnosed with cancer, unsure what type.

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In order for those people to be diagnosed they need to either go to oncology clinics, hospitals, or
private physicians. The way in which we wish to represent our company is by approaching an
Oncologist via professional to professional. Additional networking will be distributed through
pamphlets about our product.
Primary Market
Oncologists are well respected health professionals, who normally build an extremely
important rapport with their patients as it is a very intimate process. What Nommas looks to do is
build a rapport with oncologists, cancer clinics, and/or hospitals, to let them know what our
product has to offer. Seeing as our product is not projected to be ready until the fourth quarter of
our second year, we will limit our marketing to the tune of about $5,000 in the first year. We
plan on sending out pamphlets to all 1,400+ facilities that are accredited by the Commission on
Cancer (COC) of the American College of Surgeon. We will also be focusing a lot of time on
partnering with the National Cancer Institute and there 65 centers that focus on research in
reducing cancer rates. After we send out our pamphlets, we will have several people in the first
year contacting all institutes to give more information and follow up with our pamphlets.
In years 2 and 3 we will ramp up marketing by sending members of our team into the
field and focusing on face to face interactions, selling our product on a more intimate level. We
will focus on the National Cancer Institute. If we can build a relationship with an established
organization, such as the National Cancer Institute, then it will be that much easier to convince
leading oncologist to use our product for a diagnosis specific to cancer. If we can ascertain at
least 15% of the Oncologists that we interact with, our product should be able to infect the
market and convince other Oncologists to then use NCDKTM
.
Secondary Market

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Nommas’ secondary market will be the focus of our 4th
and 5th
year of our marketing
plan. This market will be comprised of the patients themselves. Once we have established
ourselves as a reputable company and product, we will be able to place reading materials about
our product into cancer clinics. This should allow us to stay within our $50,000 budget for years
4 and 5. We will place pamphlets in all clinics, and will also see how we can gather emails to
patients that have a cancer suspicion, and try to target them to ask their doctor about our kits.
Nommas will primarily be focusing on the primary market, as we should be able to gather
enough business from oncologist using our product for cancer diagnosis.
Competitive Strategy
There are other cancer diagnosing products and companies on the market, but there is yet
to be a company that has grabbed the market by the horns. What Nommas looks to provide that
other companies have yet to do is a test that checks for multiple markers that have a relation with
different types of cancer. We also look to pride ourselves on customer service, and the ability to
answer any questions that might come from the labs that will be running the test on the patient’s
blood using our Nommas CDK.
Direct Competition
Genomic Health – can be considered Nommas most direct competition. What Genomic
Health has working for them is, that they are the only commercialized gene detection system for
the diagnosis of the gene that has a high correlation to breast cancer diagnosis and treatments.
Genomic Health also at this moment has a lot of momentum with their OncoDX kit that helps to
detect prostate cancer genes that can help with treatment options.
Indirect Competition

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Hologics Inc.- offers a wide variety of cancer diagnostics tools along with a huge variety
of testing assays that look for HPV, HIV, and Cystic Fibrosis to name a couple of diagnostics
assays. Hologics offers a wide variety of tools that we, at Nommas, would not be focused on, as
the tools that are used are not using our lambodies technology. Hologics offers mammogram
machines, MRI machines and CTA scanners. Hologics has implanted itself as a competitor in
large equipment distribution and diagnosing products. But they do not focus all of their efforts on
cancer diagnosis; therefore it does not look as though this company would be any competition
when our smaller more reliable product will be introduced into the market.

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VI. Operational Plans
Legal Entity
Nommas was founded in 2008 and incorporated in Maryland State. As a biomedical
company, we are focused on the creation of the most advanced approaches to diagnosing cancer.
Based in Bethesda, Maryland, Nommas’ effort to fulfill the unmet medical needs in cancer
treatment by utilizing tumor specific glycans that can detect different kinds of human tumor
tested on human cancer tissue microarrays.
Regulations & Compliance
Our invention and operations will be in compliance of Federal, State, Local, and
International laws, policies, and regulations to ensure the safety and efficacy of our products.
Agencies directly involved are FDA, IRB, OSHA, and IHC. As a class II medical device
Nommas will consult with the FDA’s Center for Devices and Radiological Health (CDRH).
According to FDA “All clinical evaluations of investigational devices, unless exempt, must have
an approved IDE before the study is initiated” The primary regulations that govern the conduct
of clinical studies are included in the Code of Federal Regulations, Title 21 (21 CFR):
 21 CFR 812, Investigational Device Exemptions, covers the procedures for the conduct
of clinical studies with medical devices including application, responsibilities of sponsors
and investigators, labeling, records, and reports.
 21 CFR 50, Protection of Human Subjects, provides the requirements and general
elements of informed consent;
 21 CFR 56, Institutional Review Boards, covers the procedures and responsibilities for
institutional review boards (IRBs) that approve clinical investigations protocols;

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 21 CFR 54, Financial Disclosure by Clinical Investigators, covers the disclosure of
financial compensation to clinical investigators which is part of FDA’s assessment of the
reliability of the clinical data
 21 CFR 820 Subpart C, Design Controls of the Quality System Regulation, provides the
requirement for procedures to control the design of the device in order to ensure that the
specified design requirements are met (www.fda.gov). FDA Meetings will be conducted
in accordance to the guidance document “Early Collaboration Meetings Under the FDA
Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff”.
Despite that Nommas will outsource our manufacturing aspect of operations to Contract
Manufacturing Organizations (CRO) it is to our credit to have a good understanding of Good
Manufacturing Practices (GMP). Trials will be conducted at the National Committee for Clinical
Laboratory Standards (NCCLS) where they will adhere to Good Laboratory Practices (GLP).
Our facility as well as employees who work at Nommas will be subject to Occupational Safety
and Health Administration (OSHA) Policies.
Security Systems
Nommas has stringent confidentiality policy and as such all officials and employees have
signed confidentiality agreements. Entry to the facility will be by passcode and alarm system
installed in all external entries. An off-site computer back up will be available while nightly
duplication and back-up has been instituted. All inventories are documented and also sensitive
documents are locked in fireproof cabinets.
Location & Facilities
Nommas is planning to lease a facility of 3,500 square feet in Bethesda, MD. This
location will have office spaces and laboratory spaces, including a PCR clean room and animal
quarters. While our research and development, administrative, and quality assurance activities

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will be conducted in the same area of the building, the company’s manufacturing operations and
clinical trials have been contracted to Acme Lamprey Company and ImmunoChemistry
Technologies. To have the facility functional an estimate of $600,000 will be spend on
infrastructure, office design and lab equipment. Nommas has future plans to acquire
approximately 15,000 square feet state of the art facility where several in-house functions will
take place.
Figure 3. Laboratory design.
Retrieved from
http://be.ucsd.edu/facilities?q=instructcore

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VII. Management & Organization
Nommas has a dynamic management team as well as advisory board have expertise in
scientific and regulatory submissions which will help in developing new technologies and
expedite commercialization. Our other management team has experience in the establishment of
early-stage companies and business management. Below is the profile of our founders and their
roles, including the names of our advisory board.
Senior Leadership Team
Continued on next page…
Thinzar Myint (CEO)
Founder - She was the Chairman of College Park Capital, a firm he formed to manage private
equity investment activities in technology startup ventures, primarily related to the Internet, since
2008. From 2005 until 2008,she served as the Chairman, President and Chief Executive Officer
of SLK Development Corporation, a software manufacturer that was acquired by IBM
Corporation in 1995.
Roxanne Aniceto (CTO)
Founder – Ms. Aniceto served as Chairman and Chief Executive Officer of TE Connectivity Ltd.
(formerly Tyco Electronics Ltd.), a global provider of engineered electronic components,
network solutions, undersea telecommunication systems and specialty products. She joined Tyco
International in 2000 as President of Tyco Engineered Products and Services and was appointed
Chief Executive Officer in January 2006, when Tyco Electronics was formed and later became
an independent, separately traded entity.
Viet Nguyen (CFO)
Founder – Mr. Nguyen was the President of OTC Group Inc., a bank holding company that
provides lending, advisory and leasing services to small and middle market businesses. He was
Chief Financial Officer of Merrill Lynch & Co., a financial services firm, from December 2005
to December 2008. Prior to that Mr. Nguyen was Executive Vice President and Chief Financial
Officer of Student First, a stock exchange group from June 2000 to March 2005.
Sarah McCormack (CSO)
Founder -Dr.McCormack was the David H. Koch Professor of Biology at the Massachusetts
Institute of Technology (MIT) and Board Memeber of the Jamie Lee Curtis Institute for
Integrative Cancer Research. She joined the MIT faculty in 1992 and was director of its Center
for Cancer Research from 2001 to 2008.

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Organization Chart
Scientific Advisory Board
The Scientific Advisory Board at Nommas will be comprised of leading scientists in the
cancer research field. They are knowledgeable about cutting-edge cancer diagnostics and will be
able to guide scientific activities. While they will not vote on corporate issues, they will bring
valuable experience to the table and will serve to provide non-biased advice about any scientific
questions that arise. They will meet quarterly to discuss how our research is advancing,
Steven Scelsi (CMO)
Founder - Mr. Scelsi was most recently the chief marketing officer at Accuray Incorporated, a
premier radiation oncology company. Previously, Scelsi played a key leadership role in building
commercial capabilities at Transkaryotic Therapies, an early stage biotechnology company
acquired by MedTech Pharmaceuticals. He remained at MedTech from 1998 to 2007 to lead the
worldwide commercial functions for its newly created Human Genetic Therapies division as
chief commercial officer. During his tenure at MedTech, Scelsi successfully launched and led
the commercial efforts for four orphan products for rare genetic diseases, Teramatic®
for Hunter
syndrome, Regall®
for Fabry disease, Tysonia®
for hereditary angioedema, and Velcro®
for
Gaucher disease.
Susanna Oware (COO)
Founder- With over 15 years of combined experience in business development, Ms. Oware has
served as the Chief Operations Officer for Pambroke Medical Devices in Raleigh, North Carolina
for 8 years and a manager for clinical research for 7 years at New Hope Medical Center. With
her valid skills in regulatory submissions Ms. Oware will ensure proper submissions to FDA for
approvals.

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regulatory steps we need to take, and to provide strategic direction. They will report their
findings to the Board of Directors.
We previously mentioned we currently have four members who have agreed to serve on
our advisory board. Jeffrey Gildersleeve, PhD, is a co-inventor of the Lambody technology. He
is the head of the Chemical Glycobiology Section of the National Cancer Institute at the NIH.
His work involves the interface of chemistry, glycobiology, and immunology. Kevin Cullen,
M.D., is the Director of the University of Maryland Greenebaum Cancer Center. He is a
professor of medicine at the University Of Maryland School Of Medicine and the head of the
Program of Oncology, and is on the National Cancer Advisory Board. Derek Maetzold comes to
us with 23 years of experience as a senior biopharmaceutical leader. He has been the CEO of
several successful biotech startups, and will provide expertise in commercial leadership, business
development and sales, and marketing leadership. Roberta Cook, PhD, has 18 years of
experience in the pharmaceutical industry. She specializes in working with regulatory agencies
to bring new diagnostic products from the bench to the market. As Nommas becomes more
established, we will add additional members to the advisory board who complement the valuable
Collaborators
We plan to collaborate with the University of Maryland Medical Center in order to obtain
cancer patient blood samples to test with our diagnostic kits. This exchange will be facilitated by
Dr. Kevin Cullen, who is the Director of the University of Maryland Greenebaum Cancer Center
and also serves on our Scientific Advisory Board.
Research Personnel
Four of the founders of Nommas have extensive scientific experience leading research
projects, and will be in charge of managing our research and development activities. In addition,
we plan to hire four employees who will be based in the lab conducting research. One postdoc

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position will conduct binding analysis using a Biacore. A second postdoc position will similarly
be filled by a candidate experienced in cell sorting and/or flow cytometry. An animal technician
will be tasked with care and handling of the sea lampreys, in addition to helping with general lab
activities. An additional technician will be in charge of cell culture and ELISA assays.
Employees Recruitment and Rewards
We currently have 6 permanent employees comprising our senior management team, with
plans to immediately hire 4 additional employees as R&D Personnel. A 20% return on
investment after the third year of sales which is projected as our full year of sales of 3000 units.
Founders have plans for a possible IPO, however they are not finalized as any such plan will be
contingent on sales and scale up opportunities.

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VIII. Appendices
I. Financial Statements
Income Statement
Sales (a) Year One Year Two
Year
Three
Year Four Year Five
Nommas CDK - 50,000 1,500,000 2,000,000 2,500,000
Education (i) - 5,000 10,000 15,000 20,000
Maintenance & Licensing - - - - -
Total Sales 0 55,000 1,510,000 2,015,000 2,520,000
Cost of Goods Sold (b) 10,000 300,000 400,000 500,000
Gross Profit 0 45,000 1,210,000 1,615,000 2,020,000
Operating Expenses
Wages (c) -850,000 -850,000 -850,000 -850,000 -850,000
Research & Development -600,000 -150,000 -150,000 -150,000 -150,000
Business Partner Fees (h) 0 -5,500 -151,000 -201,500 -252,000
Marketing Support (d) -5,000 -75,000 -75,000 -50,000 -50,000
Patent Licensing & Royalties -100,000 -1,100 -30,200 -40,300 -50,400
Rent (e) -50,000 -51,500 -53,045 -54,636 -56,275
Payroll Tax Expense -8,500 -8,500 -8,500 -8,500 -8,500
Total Operating Expenses -1,613,500 -1,141,600 -1,317,745 -1,354,936 -1,417,175
Other Expenses
Interest Expense & Taxes 0 -3,300 -90,600 -120,900 -151,200
Depreciation Expense (g) -40,000 -40,000 -40,000 -40,000 -40,000
Computer and Networking -50,000 -5,000 -5,000 -5,000 -5,000
Administrative (e) -15,000 -15,000 -15,000 -15,000 -15,000
Total Other Expenses -105,000 -63,300 -150,600 -180,900 -211,200
Net Income -1,718,500 -1,159,900 -258,345 79,164 391,625
Referring Schedules
a) Sales Forecast and Schedule of Revenues
b) Sales Forecast and COGS
c) Personnel
d) Marketing
e) Utilities, insurance, licensing
f) Debt
g) Depreciation
h) Revenue share to sales partners.

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i) Education and usage seminars
Cash Flow
Cash Flows From Operations Year One Year Two
Year
Three
Year
Four
Year Five
Net income -1,718,500 -1,159,900 -258,345 79,164 391,625
Depreciation -40,000 -40,000 -40,000 -40,000 -40,000
Accounts payable (e) 6,000 6,600 7,260 7,986 8,785
Accounts receivable -1,000 -30,000 -40,000 -50,000
Inventory 50,000 50,000 50,000 50,000
Total Cash Flows From Operations -1,752,500 -1,144,300 -271,085 57,150 360,409
Cash Flows From Investing Activities
Purchase of equipment (a) -150,000 -10,000 -10,000 -10,000 -10,000
Total Cash Flows From Investing
Activities
-150,000 -10,000 -10,000 -10,000 -10,000
Cash Flows From Financing
Activities
Borrowing of short-term debt (b) 500,000 250,000
Repayment of short-term debt (c) -300,000 -300,000 -300,000
SBIR Grants 100,000 500,000
Sales of stock (d) 1,200,000
Total Cash Flows From Financing
Activities
1,800,000 750,000 -300,000 -300,000 -300,000
Net Cash Flows 1,650,000 740,000 -310,000 -310,000 -310,000
Cash, End of Period -102,500 -404,300 -581,085 -252,850 50,409
Notes
a) Lamprey & Lab Equipment and
relates supplies
b) Angel Investor partnership
c) Payment of ANGEL Investor @ 20%
return =$900K
d) Owner investment

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Balance Sheet
Year One Year Two Year
Three
Year
Four
Year Five
Assets:
Current Assets
Cash -102,500 -404,300 -581,085 -252,850 50,409
Accounts Receivable (a) 1,000 30,000 40,000 50,000
Inventory (b) 50,000 50,000 50,000 50,000
Total current assets: -102,500 -353,300 -501,085 -162,850 150,409
Long Term Assets
Property, Plant and Equipment (c) 550,000 550,000 550,000 550,000 550,000
Less: Accumulated depreciation -40,000 -80,000 -120,000 -160,000 -200,000
Net property, plant and equipment 510,000 470,000 430,000 390,000 350,000
Total assets: 407,500 116,700 -71,085 227,150 500,409
Liabilities and Stockholders'
Equity
Current liabilities
Notes payable
Accounts payable (e) 6,000 6,600 7,260 7,986 8,785
Total current liabilities 6,000 6,600 7,260 7,986 8,785
Long-term liabilities (d) 320,000 270,000 180,000 140,000 100,000
Total liabilities: 326,000 276,600 187,260 147,986 108,785
Stockholders' equity
Partners’ Capital (f) 1,800,000 1,000,000
Partners' Retained Capital -1,718,500 -1,159,900 -258,345 79,164 391,625
Total liabilities and stockholders'
equity
407,500 116,700 -71,085 227,150 500,409
Notes and Referring Schedules
a) Assumes 30 day collections
b) COGS
c) Property and Equipment
d) Bank Loan
e) Assumes 30/60/90 day payments
f) Capital

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Figure 1: Break Even Point at 1,750 Units Sold
-1500000
-1000000
-500000
0
500000
1000000
1500000
0 500 1000 1500 2000 2500 3000 3500
Break Even Analysis
Unit Sales P&L

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II. Relevant Patents
Patent 1
Title: “Cancer diagnostic kit and cancer diagnostic method”
Patent Agency: USPTO Filed: July 18, 2008
Number of Claims: 5 Granted: April 17, 2012
Claims are: [X] Broad or [ ] Narrow Expires: July 18, 2028
Synopsis:
 A kit using a polynucleotide of partial sequences or the antibody binding to an amino acid
sequence. Makes for finding a CT antigen. In the past, antibodies have had low frequencies
Assignees
 Inventors: Ono, Toshiro, Nakayama, Eiichi
 Assignee-Pre-Issue: National University Corporation Okayama University
 Assignee-At-Issue: National University Corporation Okayama University
Is the company a rival?
No, we will probably use some of this technology to develop diagnostic cancer tumor antigens
via lambodies.
Threat & Analysis
 This patent is not a major threat to our business; it depends on whether our scientists decide
to use amino acid sequences as an antigen to be detected.
 It would be beneficial to also partner with the assignees and cross-license the use of amino
acid sequences in cancer detection.
Patent 2
Title: “Use of plasma HSP90 related to malignancy”
Patent Agency: USPTO Filed: November 26, 2007
Number of Claims: 8 Granted: November 12, 2013
Claims are: [X] Broad or [ ] Narrow Expires: November 26, 2027
Synopsis
 “Invention” includes levels of HSP90a, method of isolating non-cellular fluid, method of
comparing HSP90a levels before/after administration of anti-HSP90a drugs; increase in
levels over set level indicative of cancer.
 Determination of type of cancer by changes in levels
Assignees
 Inventors: Burger, Angelika M. & Sausville, Edward A.
 Assignee-Pre-Issue: NIH, University of Maryland, Baltimore
 Assignee-At-Issue: University of Maryland, Baltimore
 US Government has certain rights in the invention
 This is not a perceived rival; work for non-profit companies and academics. The product is
not very much like our own.
Threat & Analysis
 This patent is not a direct threat to our business; it may be useful to incorporate this
technology into our ELISA kit in exchange for a cross-license to use and produce our kits.
This technology can be helpful in quantifying cancers in single-person plates

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Patent 3
Title: “Systems and methods of screening biomarkers in bodily fluids”
Patent Agency: USPTO Filed: October 18, 2010
Number of Claims: 12 Granted: August 6, 2013
Claims are: [X] Broad or [ ] Narrow Expired: October 18, 2013
Synopsis:
 “...platform comprosiming a plurality of detection sites each capable of receving a diagnostic
marker, a stabilzing agent, and a detection agent.”
Assignees
 Inventors: Selinfreund, Richard H; Vig, Rakesh; Gill, Richard P
 Assignee-Pre-Issue: Companion Diagnostics Inc
 Assignee-at-Issue: Companion Diagnostics Inc
Yes, the patent assignee is a corporate entity and the technology is one that would be
necessary in the stable detection of cancer and other assays.
Threat & Analysis
 This patent does pose a threat to our business; other companies may obtain licenses for it and
directly compete with us, but its basis will is an underlying aspect to our own technology. As
a general patent we need to properly license the technology from them or develop stable
biomarker on our own.
Patent 4
Title: “Recognition molecules for the treatment and detection of tumors”
Patent Agency: USPTO Filed: January 23, 2004
Number of Claims: 37 Granted: July 15, 2014
Claims are: [ ] Broad or [X] Narrow Expires: January 23, 2024
Synopsis:
 Focuses on using glycosylated MUC1 as a tumor marker and their recognition molecules in
the invention via amino acid sequences
Assignees
 Inventors: Goletz, Setffen; Danielczyk, Antje; Stahn, Renate; Karsten, Uwe
 Assignee-Pre-Issue: Nemod Biotherapies, Glycotope
 Assignee-at-Issue: Glycotope
 Yes, they have developed a method of cancer detection and antibody creation. They are
“leaders in glycobiology” focusing on biotherapies (our future products) and cancer detection
 They have 9 therapeutics in their development pipelines.
Threat & Analysis
 This patent does pose a threat to our business; we will need to carefully read their patent to
determine if our method of glycan detection is already patented (although the use of
lambodies is not). Nommas Life Sciences LLC may need to focus on a different glycolated
protein other than MUC1.
 We can attempt to cross-license or partner with this international company, although we
would most likely dominate the US domestic market. They also perform contract research
and may prove to be a valuable asset to our company.

of 54
Patent 5
Title: “Diagnostic panel of cancer antibodies and methods for use”
Patent Agency: USPTO Filed: February 27, 2009
Number of Claims: 8 Granted: July 10, 2012
Claims are: [X] Broad or [ ] Narrow Expired: February 27, 2029
Synopsis:
 Antibodies can be used to detect increased levels of antigens in breast, ovarian, colorectal
cancers. Malignancy can be detected for colorectal, breast, ovarian, or pancreatic. Using four
antigens, can diagnose with 91% accuracy. Provides a method of distinguishing between
Stage I and Stage II cancers with at least two antigens; thus identify aggressive treatment or
moderate treatment needs.
Assignees
 Inventors: Disis, Mary L; Goodell, Vivian; Lu, Hailing
 Assignee-Pre-Issue: NIH, DHHS, DEITR, University of Washington
 Assignee-at-Issue: University of Washington
Not really, the assignees are government groups, whose work are for the betterment of the
public rather than for personal profit. Licenses or cross-licenses can be made using this
technology
Threat & Analysis
 This patent does not pose a significant threat to our business; other companies may obtain
licenses for it and directly compete with us, but its basis will is an underlying aspect to our
own technology. Nommas Life Sciences LLC would be focusing on breast and colorectal
cancers initially and focus on the other (ovarian, pancreatic, etc.) at a future time.
 We can attempt to cross-license or partner with this international company, although we
would most likely dominate the US domestic market. They also perform contract research
and may prove to be a valuable asset to our company.

of 54
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